United States District Court for the District of Delaware

Case 1:19-cv-01979-LPS Document 38 Filed 01/07/20 Page 1 of 132 PageID #: 461

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

NOVARTIS PHARMACEUTICALS ) CORPORATION, ) ) PLAINTIFF, ) ) v. ) ) 1:19-cv-01979-LPS ALKEM LABORATORIES LTD., AUROBINDO ) PHARMA USA INC., AUROBINDO PHARMA LTD., ) BIOCON PHARMA LIMITED, BIOCON LIMITED, ) BIOCON PHARMA, INC., CRYSTAL ) PHARMACEUTICAL (SUZHOU) CO., LTD., LAURUS ) LABS LIMITED, LAURUS GENERICS INC., LUPIN ) ATLANTIS HOLDINGS, S.A., LUPIN ) LIMITED, LUPIN INC., LUPIN PHARMACEUTICALS, ) INC., NANJING NORATECH PHARMACEUTICAL ) CO., LIMITED, TEVA PHARMACEUTICALS USA, ) INC., TORRENT PHARMA INC., TORRENT ) PHARMACEUTICALS LTD., ) ) DEFENDANTS. )

DEFENDANT ALKEM LABORATORIES, LTD.’S ANSWER AND COUNTERCLAIMS TO PLAINTIFF’S COMPLAINT

Defendant Alkem Laboratories, Ltd. (“Alkem”) by its undersigned counsel, answer the

Complaint filed by Novartis Pharmaceuticals Corporation (“Novartis”) as follows:

GENERAL DENIAL

Pursuant to Fed. R. Civ. P. 8(b)(3), Alkem denies all allegations in Novartis’ Complaint except those specifically admitted below:

NATURE OF THE ACTION

1. This is a patent infringement action arising under Title 35 of the United States Code and concerning Abbreviated New Drug Applications (“ANDAs”) submitted to the United States Food and Drug Administration (“FDA”) by the above-named defendants seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of sacubitril/valsartan tablets, generic versions of Novartis’s ENTRESTO® tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, prior to the expiration of U.S. Patents Nos. 8,101,659 (the “’659

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patent”), 8,796,331 (the “’331 patent”), 8,877,938 (the “’938 patent”), and/or 9,388,134 (the “’134 patent”).

ANSWER: Paragraph 1 of the Complaint contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, Alkem admits that Novartis’s

Complaint purports to assert an action for patent infringement based in part on Alkem filing of

Abbreviated New Drug Application (“ANDA”) seeking approval from the U.S. Food and Drug

Administration (“FDA”) to manufacture, use, sale, offer for sale, and/or importation of sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, prior to the alleged expiration dates of the ’659, ’331, ’938 and ’134 patents. Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the remaining allegations of Paragraph 1 of the Complaint and therefore denies them.

PARTIES

A. Novartis

2. Novartis Pharmaceuticals Corporation is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business in East Hanover, New Jersey.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 2 of the Complaint and therefore denies them.

B. Defendants

a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)

3. On information and belief, Alkem Laboratories Ltd. (“Alkem”) is a corporation organized and existing under the laws of India, having a principal place of business at Devashish Building, Alkem House, Senapati Bapat Road, Lower Parel, Mumbai, India 400 013.

ANSWER: Admitted.

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4. On information and belief, S&B Pharma, Inc. (“S&B”) is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801, and having a principal place of business at 405 South Motor Avenue, Azusa, California 91702. On information and belief, S&B is a wholly owned subsidiary of Alkem.

ANSWER: Pursuant to the stipulation (D.I. 7) approved by the court on December

3, 2019, S&B Pharma has been dismissed from the case. To the extent a response is required,

Alkem denies the allegations.

5. On information and belief, Alkem develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem admits that Alkem Laboratories, Ltd. is in the business of, among other things, developing, manufacturing, and selling generic pharmaceutical products including in the U.S. markets. Alkem avers that, solely for the purpose of this lawsuit, Alkem is not challenging venue or personal jurisdiction. Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of this paragraph and therefore denies them.

6. On information and belief, S&B develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Pursuant to the stipulation (D.I. 7) approved by the court on December

3, 2019, S&B Pharma has been dismissed from the case. To the extent a response is required,

Alkem denies the allegations.

7. By a letter dated September 9, 2019 (“Alkem Notice Letter”), Alkem notified Novartis that (i) Alkem had submitted to the FDA ANDA No. 213764 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Alkem ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, and that (ii) ANDA No. 213764 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659, ’331, ’938, and ’134 patents.

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ANSWER: Alkem admits that by a letter dated September 9, 2019, Alkem Laboratories,

Ltd. notified Plaintiff that Alkem Laboratories, Ltd. had submitted ANDA No. 213764 seeking

FDA approval, which may allow Alkem Laboratories, Ltd. to engage in the commercial manufacture, use, offer for sale, and/or sale of sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg referenced in ANDA No. 213764 (“Alkem’s ANDA Products”) in or into the United States, prior to the alleged expiration of the ’659, ’331, ’938, and ’134 patents. ANDA

No. 213764 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659,

’331, ’938, and ’134 patents. Alkem avers that, solely for the purpose of this lawsuit, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

8. Alkem has committed an act of infringement in this judicial district by filing ANDA No. 213764 with the intent to make, use, sell, offer for sale, and/or import the Alkem ANDA Products in or into this judicial district, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, denied.

9. On information and belief, S&B acted in concert with and under the direction of Alkem in the preparation and submission of ANDA No. 213764, and, if the ANDA is approved, will act in concert with and under the direction of Alkem to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

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10. Alkem, by itself or together with S&B, has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Alkem ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. Alkem had submitted ANDA No. 213764 seeking FDA approval for Alkem’s ANDA Products. Alkem avers that, solely for the purpose of this lawsuit, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

11. On information and belief, Alkem has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware either directly or indirectly through subsidiaries, agents, or affiliates, including S&B; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. Alkem avers that, solely for the purpose of this lawsuit, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

12. Alkem and S&B have availed themselves of the legal protections of the State of Delaware by, among other things, admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Biogen Int’l GMBH et al. v. Alkem Labs. Ltd. et al., C.A. No. 17-850 (D. Del.).

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. Alkem avers that, solely for the purpose

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of this lawsuit, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

13. Alkem, the entity identified in the Alkem Notice Letter as having submitted ANDA No. 213764, has agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213764 in the District of Delaware, and has agreed, only for the purposes of such action(s), not to challenge personal jurisdiction and venue in the District of Delaware.

ANSWER: Alkem admits that, solely for the purpose of this lawsuit, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)

14. On information and belief, Aurobindo Pharma USA Inc. is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at Corporation Service Company, 251 Little Falls Drive, Wilmington, Delaware 19808, and having a principal place of business at 279 Princeton-Hightstown Road, East Windsor, New Jersey 08520. On information and belief, Aurobindo Pharma USA Inc. is a wholly owned subsidiary of Aurobindo Pharma Ltd.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 14 of the Complaint and therefore denies them.

15. On information and belief, Aurobindo Pharma Ltd. is a corporation organized and existing under the laws of India, having a principal place of business at Plot No. 2, Maitri Vihar, Ameerpet, Hyderabad – 500 038, Andhra Pradesh, India.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 15 of the Complaint and therefore denies them.

16. On information and belief, Aurobindo Pharma USA Inc. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 16 of the Complaint and therefore denies them.

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17. On information and belief, Aurobindo Pharma Ltd. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 17 of the Complaint and therefore denies them.

18. By a letter dated September 6, 2019 (“Aurobindo Notice Letter”), Aurobindo Pharma USA Inc. notified Novartis that (i) Aurobindo Pharma USA Inc. had submitted to the FDA ANDA No. 213631 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Aurobindo ANDA Products”), seeking FDA approval to engage in the commercial 1 The Aurobindo Notice Letter identifies the sender and ANDA filer as “Aurobindo Pharma USA Inc.” and states that it is a Delaware corporation. The Delaware Department of State identifies this entity as “Aurobindo Pharma U.S.A., Inc.” manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products in or into the United States, including Delaware, prior to the expiration of the ”659, ’331, ’938, and ’134 patents, and that (ii) ANDA No. 213631 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 18 of the Complaint and therefore denies them.

19. Aurobindo Pharma USA Inc. has committed an act of infringement in this judicial district by filing ANDA No. 213631 with the intent to make, use, sell, offer for sale, and/or import the Aurobindo ANDA Products in or into this judicial district, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 19 of the Complaint and therefore denies them.

20. On information and belief, Aurobindo Pharma Ltd. acted in concert with and directed Aurobindo Pharma USA Inc. in the preparation and submission of ANDA No. 213631, and, if the ANDA is approved, will act in concert with and direct Aurobindo Pharma USA Inc. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 20 of the Complaint and therefore denies them.

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21. Aurobindo Pharma USA Inc., by itself or together with Aurobindo Pharma Ltd., has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Aurobindo ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 21 of the Complaint and therefore denies them.

22. On information and belief, Aurobindo Pharma Ltd. has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Aurobindo Pharma USA Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 22 of the Complaint and therefore denies them.

23. Aurobindo Pharma Ltd. has availed itself of the legal protections of the State of Delaware by, among other things, admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Allergan Sales, LLC et al. v. Aurobindo Pharma USA Inc. et al., C.A. No. 18-118 (D. Del.); Novartis Pharms. Corp. v. Accord Healthcare Inc., C.A. No. 18-1043 (D. Del.); Millennium Pharms., Inc. v. Aurobindo Pharma USA Inc. et al., C.A. No. 19-471 (D. Del.).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 23 of the Complaint and therefore denies them.

c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)

24. On information and belief, Biocon Pharma Limited is a corporation organized and existing under the laws of India, having a principal place of business at 20th KM, Hosur Road, Electronic City, Bangalore, 560100, India. On information and belief, Biocon Pharma Limited is a wholly owned subsidiary of Biocon Limited.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 24 of the Complaint and therefore denies them.

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25. On information and belief, Biocon Limited is a corporation organized and existing under the laws of India, having a principal place of business at 20th KM, Hosur Road, Electronic City, Bangalore, 560100, India.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 25 of the Complaint and therefore denies them.

26. On information and belief, Biocon Pharma, Inc. is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at Harvard Business Services, Inc., 16192 Costal Highway, Lewes, Delaware 19958, and having a principal place of business at 485 US Highway 1 S B305, Iselin, New Jersey 08830. On information and belief, Biocon Pharma, Inc. is a wholly owned subsidiary of Biocon Pharma Limited.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 26 of the Complaint and therefore denies them.

27. On information and belief, Biocon Pharma Limited develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 27 of the Complaint and therefore denies them.

28. On information and belief, Biocon Limited develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 28 of the Complaint and therefore denies them.

29. On information and belief, Biocon Pharma, Inc. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 29 of the Complaint and therefore denies them.

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30. By a letter dated September 3, 2019 (“Biocon Notice Letter”), Biocon Pharma Limited notified Novartis that (i) Biocon Pharma Limited had submitted to the FDA ANDA No. 213680 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Biocon ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, and that (ii) ANDA No. 213680 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 30 of the Complaint and therefore denies them.

31. Biocon Pharma Limited has committed an act of infringement in this judicial district by filing ANDA No. 213680 with the intent to make, use, sell, offer for sale, and/or import the Biocon ANDA Products in or into this judicial district, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 31 of the Complaint and therefore denies them.

32. On information and belief, Biocon Limited acted in concert with and directed Biocon Pharma Limited and/or Biocon Pharma, Inc. in the preparation and submission of ANDA No. 213680, and, if the ANDA is approved, will act in concert with and direct Biocon Pharma Limited and/or Biocon Pharma, Inc. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products in or into in the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 32 of the Complaint and therefore denies them.

33. On information and belief, Biocon Pharma, Inc. acted in concert with and under the direction of Biocon Pharma Limited and/or Biocon Limited in the preparation and submission of ANDA No. 213680, and, if the ANDA is approved, will act in concert with and under the direction of Biocon Pharma Limited and/or Biocon Limited to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 33 of the Complaint and therefore denies them.

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34. Biocon Pharma Limited, by itself or together with Biocon Limited and/or Biocon Pharma, Inc., has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Biocon ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 34 of the Complaint and therefore denies them.

35. On information and belief, Biocon Pharma Limited has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Biocon Pharma, Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 35 of the Complaint and therefore denies them.

36. On information and belief, Biocon Limited has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Biocon Pharma, Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 36 of the Complaint and therefore denies them.

37. Biocon Limited and Biocon Pharma, Inc. have availed themselves of the legal protections of the State of Delaware by, among other things, admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Sanofi-Aventis U.S. LLC et al. v. Biocon Ltd., C.A. No. 17-3 (D. Del.); Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc., C.A. No. 18-1043 (D. Del.).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 37 of the Complaint and therefore denies them.

38. Biocon Pharma Limited, the entity identified in the Biocon Notice Letter as having submitted ANDA No. 213680, has agreed with Novartis to litigate any patent action(s) concerning

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ANDA No. 213680 in the District of Delaware, and has agreed, only for the purposes of such action(s), not to challenge personal jurisdiction and venue in the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 38 of the Complaint and therefore denies them.

d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)

39. On information and belief, Crystal Pharmaceutical (Suzhou) Co., Ltd. (“Crystal”) is a corporation organized and existing under the laws of China, having a principal place of business at B4-101, Biological Nano Park, No. 218, Xinghu Street, Suzhou Industrial Park, China.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 39 of the Complaint and therefore denies them.

40. On information and belief, Crystal develops, manufactures, distributes, sells, and/or imports drugs for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 40 of the Complaint and therefore denies them.

41. By a letter dated September 4, 2019 (“Crystal Notice Letter”), Crystal notified Novartis that (i) Crystal had submitted to the FDA ANDA No. 213605 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Crystal ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, and that (ii) ANDA No. 213605 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 41 of the Complaint and therefore denies them.

42. Crystal has committed an act of infringement in this judicial district by filing ANDA No. 213605 with the intent to make, use, sell, offer for sale, and/or import the Crystal ANDA Products in or into this judicial district, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 42 of the Complaint and therefore denies them.

43. Crystal has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Crystal ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 43 of the Complaint and therefore denies them.

44. On information and belief, Crystal has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 44 of the Complaint and therefore denies them.

45. Crystal, the entity identified in the Crystal Notice Letter as having submitted ANDA No. 213605, has agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213605 in the District of Delaware, and has agreed, only for the purposes of such action(s), not to challenge personal jurisdiction and venue in the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 45 of the Complaint and therefore denies them.

e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)

46. On information and belief, Laurus Labs Limited is a corporation organized and existing under the laws of India, having a principal place of business at Serene Chambers, Road No. 7, Banjara Hills, Hyderabad-500 034, India.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 46 of the Complaint and therefore denies them.

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47. On information and belief, Laurus Generics Inc. is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at Intertrust Corporate Services Delaware Ltd., 200 Bellvue Parkway Suite 210, Wilmington, Delaware 19809, and having a principal place of business at 400 Connell Drive, Suite 5200, Berkeley Heights, New Jersey 07922. On information and belief, Laurus Generics Inc. is a wholly owned subsidiary of Laurus Labs Limited.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 47 of the Complaint and therefore denies them.

48. On information and belief, Laurus Labs Limited develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 48 of the Complaint and therefore denies them.

49. On information and belief, Laurus Generics Inc. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 49 of the Complaint and therefore denies them.

50. By a letter dated September 6, 2019 (“Laurus Notice Letter”), Laurus Labs Limited notified Novartis that (i) Laurus Labs Limited had submitted to the FDA ANDA No. 213676 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Laurus ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, and that (ii) ANDA No. 213676 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 50 of the Complaint and therefore denies them.

51. Laurus Labs Limited has committed an act of infringement in this judicial district by filing ANDA No. 213676 with the intent to make, use, sell, offer for sale, and/or import the Laurus ANDA Products in or into this judicial district, prior to the expiration of the ’659, ’331,

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’938, and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 51 of the Complaint and therefore denies them.

52. On information and belief, Laurus Generics Inc. acted in concert with and under the direction of Laurus Labs Limited in the preparation and submission of ANDA No. 213676, and, if the ANDA is approved, will act in concert with and under the direction of Laurus Labs Limited to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of Laurus ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 52 of the Complaint and therefore denies them.

53. Laurus Labs Limited, by itself or together with Laurus Generics Inc., has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Laurus ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 53 of the Complaint and therefore denies them.

54. On information and belief, Laurus Labs Limited has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Laurus Generics Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 54 of the Complaint and therefore denies them.

55. Laurus Labs Limited and Laurus Generics Inc. have availed themselves of the legal protections of the State of Delaware by, among other things, admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Genentech, Inc. v. Laurus Labs Ltd. et al., C.A. No. 19-104 (D. Del.); Boehringer Ingelheim Pharms. Inc. v. Laurus Labs Ltd. et al., C.A. No. 19-1596 (D. Del.).

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 55 of the Complaint and therefore denies them.

56. Laurus Labs Limited, the entity identified in the Laurus Notice Letter as having submitted ANDA No. 213676, has agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213676 in the District of Delaware, and has agreed, only for the purposes of such action(s), not to challenge personal jurisdiction and venue in the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 56 of the Complaint and therefore denies them.

f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)

57. On information and belief, Lupin Atlantis Holdings, S.A. is a corporation organized and existing under the laws of Switzerland, having a principal place of business at Landis & Gyr- Strasse 1, Zug, Switzerland 6300. On information and belief, Lupin Atlantis Holdings, S.A. is a wholly owned subsidiary of Lupin Limited.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 57 of the Complaint and therefore denies them.

58. On information and belief, Lupin Limited is a corporation organized and existing under the laws of the India, having a principal place of business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai 400 051, India.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 58 of the Complaint and therefore denies them.

59. On information and belief, Lupin Inc. is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801, and having a principal place of business at 111 South Calvert Street, 21st Floor, Baltimore, Maryland 21202. On information and belief, Lupin Inc. is a wholly owned subsidiary of Lupin Atlantis Holdings, S.A.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 59 of the Complaint and therefore denies them.

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60. On information and belief, Lupin Pharmaceuticals, Inc. is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at The Corporation Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801, and having a principal place of business at 111 South Calvert Street, 21st Floor, Baltimore, Maryland 21202. On information and belief, Lupin Pharmaceuticals, Inc. is a subsidiary owned jointly by Lupin Limited and Lupin Inc.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 60 of the Complaint and therefore denies them.

61. On information and belief, Lupin Atlantis Holdings, S.A. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 61 of the Complaint and therefore denies them.

62. On information and belief, Lupin Limited develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 62 of the Complaint and therefore denies them.

63. On information and belief, Lupin Inc. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 63 of the Complaint and therefore denies them.

64. On information and belief, Lupin Pharmaceuticals, Inc. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 64 of the Complaint and therefore denies them.

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65. By a letter dated September 3, 2019 (“Lupin Atlantis Notice Letter”), Lupin Atlantis Holdings, S.A. notified Novartis that (i) Lupin Atlantis Holdings, S.A. had submitted to the FDA ANDA No. 213808 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Lupin Atlantis ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents, and that (ii) ANDA No. 213808 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 65 of the Complaint and therefore denies them.

66. Lupin Atlantis Holdings, S.A. has committed an act of infringement in this judicial district by filing ANDA No. 213808 with the intent to make, use, sell, offer for sale, and/or import the Lupin Atlantis ANDA Products in or into this judicial district, prior to the expiration of the ’938 and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 66 of the Complaint and therefore denies them.

67. On information and belief, Lupin Limited acted in concert with and directed Lupin Atlantis Holdings, S.A. in the preparation and submission of ANDA No. 213808, and, if the ANDA is approved, will act in concert with and direct Lupin Atlantis Holdings, S.A. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 67 of the Complaint and therefore denies them.

68. On information and belief, Lupin Inc. acted in concert with and under the direction of Lupin Atlantis Holdings, S.A. and/or Lupin Limited in the preparation and submission of ANDA No. 213808, and, if the ANDA is approved, will act in concert with and under the direction of Lupin Atlantis Holdings, S.A. and/or Lupin Limited to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 68 of the Complaint and therefore denies them.

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69. On information and belief, Lupin Pharmaceuticals, Inc. acted in concert with and under the direction of Lupin Atlantis Holdings, S.A., Lupin Limited, and/or Lupin Inc. in the preparation and submission of ANDA No. 213808, and, if the ANDA is approved, will act in concert with and under the direction of Lupin Atlantis Holdings, S.A., Lupin Limited, and/or Lupin Inc. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 69 of the Complaint and therefore denies them.

70. Lupin Atlantis Holdings, S.A., by itself or together with Lupin Limited, Lupin Inc., and/or Lupin Pharmaceuticals, Inc., has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Lupin Atlantis ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 70 of the Complaint and therefore denies them.

71. On information and belief, Lupin Atlantis Holdings, S.A. has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Lupin Inc. and Lupin Pharmaceuticals, Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 71 of the Complaint and therefore denies them.

72. On information and belief, Lupin Limited has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 72 of the Complaint and therefore denies them.

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73. Lupin Atlantis Holdings, S.A., Lupin Limited, and Lupin Inc. have availed themselves of the legal protections of the State of Delaware by, among other things, admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Keryx Biopharmaceuticals, Inc. v. Lupin Ltd., C.A. No. 181968 (D. Del.); Ferring Pharms. Inc. et al. v. Lupin Inc. et al., C.A. No. 19-913 (D. Del.); Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd. et al., C.A. No. 19-1497 (D. Del.).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 73 of the Complaint and therefore denies them.

74. Lupin Atlantis Holdings, S.A., the entity identified in the Lupin Atlantis Notice Letter as having submitted ANDA No. 213808, has agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213808 in the District of Delaware, and has agreed, only for the purposes of such action(s), not to challenge personal jurisdiction and venue in the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 74 of the Complaint and therefore denies them.

g. Lupin Limited; Lupin Atlantis Holdings, S.A.; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213809)

75. Novartis incorporates paragraphs 57 – 64 as if fully set forth herein.

ANSWER: Alkem incorporates its answers to paragraphs 57-64 as if fully set forth herein.

76. By a letter dated September 3, 2019 (“Lupin Limited Notice Letter”), Lupin Limited notified Novartis that (i) Lupin Limited had submitted to the FDA ANDA No. 213809 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Lupin Limited ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents, and that (ii) ANDA No. 213809 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 76 of the Complaint and therefore denies them.

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77. Lupin Limited has committed an act of infringement in this judicial district by filing ANDA No. 213809 with the intent to make, use, sell, offer for sale, and/or import the Lupin Limited ANDA Products in or into this judicial district, prior to the expiration of the ’938 and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 77 of the Complaint and therefore denies them.

78. On information and belief, Lupin Atlantis Holdings, S.A. acted in concert with and under the direction of Lupin Limited in the preparation and submission of ANDA No. 213809, and, if the ANDA is approved, will act in concert with and under the direction of Lupin Limited to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 78 of the Complaint and therefore denies them.

79. On information and belief, Lupin Inc. acted in concert with and under the direction of Lupin Limited and/or Lupin Atlantis Holdings, S.A. in the preparation and submission of ANDA No. 213809, and, if the ANDA is approved, will act in concert with and under the direction of Lupin Limited and/or Lupin Atlantis Holdings, S.A. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 79 of the Complaint and therefore denies them.

80. On information and belief, Lupin Pharmaceuticals, Inc. acted in concert with and under the direction of Lupin Limited, Lupin Atlantis Holdings, S.A., and/or Lupin Inc. in the preparation and submission of ANDA No. 213809, and, if the ANDA is approved, will act in concert with and under the direction Lupin Limited, Lupin Atlantis Holdings, S.A., and/or Lupin Inc. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 80 of the Complaint and therefore denies them.

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81. Lupin Limited, by itself or together with Lupin Atlantis Holdings, S.A., Lupin Inc., and/or Lupin Pharmaceuticals, Inc., has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Lupin Limited ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 81 of the Complaint and therefore denies them.

82. On information and belief, Lupin Limited has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Lupin Inc., Lupin Pharmaceuticals, Inc., and Lupin Atlantis Holdings, S.A.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 82 of the Complaint and therefore denies them.

83. On information and belief, Lupin Atlantis Holdings, S.A. has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates, including Lupin Inc. and Lupin Pharmaceuticals, Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 83 of the Complaint and therefore denies them.

84. Lupin Limited, Lupin Atlantis Holdings, S.A. and Lupin Inc. have availed themselves of the legal protections of the State of Delaware by, among other things, admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Keryx Biopharmaceuticals, Inc. v. Lupin Ltd., C.A. No. 181968 (D. Del.); Ferring Pharms. Inc. et al. v. Lupin Inc. et al., C.A. No. 19-913 (D. Del.); Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd. et al., C.A. No. 19-1497 (D. Del.).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 84 of the Complaint and therefore denies them.

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85. Lupin Limited, the entity identified in the Lupin Limited Notice Letter as having submitted ANDA No. 213809, has agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213809 in the District of Delaware, and has agreed, only for the purposes of such action(s), not to challenge personal jurisdiction and venue in the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 85 of the Complaint and therefore denies them.

h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)

86. On information and belief, Nanjing Noratech Pharmaceutical Co., Limited (“Noratech”) is a corporation organized and existing under the laws of China, having a principal place of business at 6/F, Building F6, No. 9 Weidi Road, Jiangsu Life Science and Technology Innovation Park, Qixia District, Nanjing, China.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 86 of the Complaint and therefore denies them.

87. On information and belief, Noratech develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 87 of the Complaint and therefore denies them.

88. By a letter dated September 3, 2019 (“Noratech Notice Letter”), Noratech notified Novartis that (i) Noratech had submitted to the FDA ANDA No. 213671 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Noratech ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Noratech ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’938 and ’134 patents, and that (ii) ANDA No. 213671 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 88 of the Complaint and therefore denies them.

89. Noratech has committed an act of infringement in this judicial district by filing ANDA No. 213671 with the intent to make, use, sell, offer for sale, and/or import the Noratech ANDA Products in or into this judicial district, prior to the expiration of the ’938 and ’134 patents,

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an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 89 of the Complaint and therefore denies them.

90. Noratech has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Noratech ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 90 of the Complaint and therefore denies them.

91. On information and belief, Noratech has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 91 of the Complaint and therefore denies them.

92. Noratech, the entity identified in the Noratech Notice Letter as having submitted ANDA No. 213671, has agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213671 in the District of Delaware, and has agreed, only for the purposes of such action(s), not to challenge personal jurisdiction and venue in the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 92 of the Complaint and therefore denies them.

i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd. (ANDA No. 213577)

93. On information and belief, Teva Pharmaceuticals USA, Inc. is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at Corporate Creations Network Inc., 3411 Silverside Road, Tatnall Building Suite 104, Wilmington, Delaware 19810, and having a principal place of business at 1090 Horsham Road, North Wales, Pennsylvania 19454. On information and belief, Teva Pharmaceuticals USA, Inc. is a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 93 of the Complaint and therefore denies them.

94. On information and belief, Teva Pharmaceutical Industries Ltd. is a corporation organized and existing under the laws of Israel, having a principal place of business at 5 Basel Street, P.O. Box 3190, Petach Tikva, 49131, Isral.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 94 of the Complaint and therefore denies them.

95. On information and belief, Teva Pharmaceuticals USA, Inc. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 95 of the Complaint and therefore denies them.

96. On information and belief, Teva Pharmaceutical Industries Ltd., manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 96 of the Complaint and therefore denies them.

97. By a letter dated September 4, 2019 (“Teva Notice Letter”), Teva Pharmaceuticals USA, Inc. notified Novartis that (i) Teva Pharmaceuticals USA, Inc. had submitted to the FDA ANDA No. 213577 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Teva ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, and that (ii) ANDA No. 213577 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 97 of the Complaint and therefore denies them.

98. Teva Pharmaceuticals USA, Inc. has committed an act of infringement in this judicial district by filing ANDA No. 213577 with the intent to make, use, sell, offer for sale, and/or

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import the Teva ANDA Products in or into this judicial district, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 98 of the Complaint and therefore denies them.

99. On information and belief, Teva Pharmaceutical Industries Ltd. acted in concert with and directed Teva Pharmaceuticals USA, Inc. in the preparation and submission of ANDA No. 213577, and, if the ANDA is approved, will act in concert with and direct Teva Pharmaceuticals USA, Inc. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 99 of the Complaint and therefore denies them.

100. Teva Pharmaceuticals USA, Inc., by itself or together with Teva Pharmaceutical Industries Ltd., has taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Teva ANDA Products, that will be purposefully directed at Delaware and elsewhere.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 100 of the Complaint and therefore denies them.

101. On information and belief, Teva Pharmaceutical Industries Ltd. has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates including Teva Pharmaceuticals USA, Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 101 of the Complaint and therefore denies them.

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j. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)

102. On information and belief, Torrent Pharma Inc. is a corporation organized and existing under the laws of the State of Delaware, having a registered agent for the service of process at Corporation Service Company, 251 Little Falls Drive, Wilmington, Delaware 19808, and having a principal place of business at 150 Allen Road, Suite 102, Basking Ridge, New Jersey 07920. On information and belief, Torrent Pharma Inc. is a wholly-owned subsidiary of Torrent Pharmaceuticals Ltd.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 102 of the Complaint and therefore denies them.

103. On information and belief, Torrent Pharmaceuticals Ltd. is a corporation organized and existing under the laws of India, having a principal place of business at Off. Ashram Road, Ahmedabad – 380 009, Gujarat, India.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 103 of the Complaint and therefore denies them.

104. On information and belief, Torrent Pharma Inc. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 104 of the Complaint and therefore denies them.

105. On information and belief, Torrent Pharmaceuticals Ltd. develops, manufactures, distributes, sells, and/or imports drug products for the entire United States market and does business in every state including Delaware, either directly or indirectly.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 105 of the Complaint and therefore denies them.

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106. By a letter dated September 1, 2019 (“Torrent Notice Letter”), Torrent Pharma Inc. notified Novartis that (i) Torrent Pharma Inc., on behalf of Torrent Pharmaceuticals Ltd., had submitted to the FDA ANDA No. 213604 for sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (“Torrent ANDA Products”), seeking FDA approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, and that (ii) ANDA No. 213604 includes a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) against the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 106 of the Complaint and therefore denies them.

107. Torrent Pharma Inc. has committed an act of infringement in this judicial district by filing ANDA No. 213604 with the intent to make, use, sell, offer for sale, and/or import the Torrent ANDA Products in or into this judicial district, prior to the expiration of the ’659, ’331, ’938, and ’134 patents, an act of infringement that has led and will lead to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 107 of the Complaint and therefore denies them.

108. On information and belief, Torrent Pharmaceuticals Ltd. acted in concert with and directed Torrent Pharma Inc. in the preparation and submission of ANDA No. 213604, and, if the ANDA is approved, will direct and act in concert with Torrent Pharma Inc. to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products in or into the United States, including Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 108 of the Complaint and therefore denies them.

109. Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. have taken the costly, significant step of applying to the FDA for approval to engage in future activities, including the marketing of the Torrent ANDA Products, that will be purposefully directed at Delaware and elsewhere.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 109 of the Complaint and therefore denies them.

110. On information and belief, Torrent Pharmaceuticals Ltd. has systematic and continuous contacts with Delaware; has established distribution channels for drug products in Delaware; regularly and continuously conducts business in Delaware, including by selling drug products in Delaware, either directly or indirectly through its subsidiaries, agents, or affiliates including Torrent Pharma Inc.; has purposefully availed itself of the privilege of doing business in Delaware; and derives substantial revenue from the sale of drug products in Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 110 of the Complaint and therefore denies them.

111. Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. have availed themselves of the legal protections of the State of Delaware by, among other things, admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g., Bial-Portela & Ca., et al. v. Torrent Pharms. Ltd., et al., 18-279 (D. Del.); H. Lundbeck A/S, et al. v. Torrent Pharms. Ltd., et al., 18-672 (D. Del.).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 111 of the Complaint and therefore denies them.

112. Both Torrent Pharmaceuticals Ltd., the entity identified in the Torrent Notice Letter as having submitted ANDA No. 213604 through Torrent Pharma Inc., and Torrent Pharma Inc. have agreed with Novartis to litigate any patent action(s) concerning ANDA No. 213604 in the District of Delaware, and have agreed, only for the purposes of such action(s), not to challenge personal jurisdiction or venue in the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 112 of the Complaint and therefore denies them.

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JURISDICTION AND VENUE

113. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a).

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, Alkem admits that this Court has subject matter jurisdiction over Plaintiff’s claims for infringement under 35 U.S.C. §271(e)(2)(A) only.

Alkem denies that this Court has subject matter jurisdiction over any claims for infringement asserted by Plaintiff under 35 U.S.C. § 271(a), (b), or (c). Alkem denies the remaining allegations.

a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)

114. This Court has personal jurisdiction over Alkem and S&B because, on information and belief, each such Defendant has committed or has aided, abetted, contributed to, or participated in the commission of tortious acts of patent infringement in preparing and submitting ANDA No. 213764 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. Alkem’s ANDA contains a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV). Alkem avers that, solely for the purpose of this lawsuit and as relating to Alkem only, Alkem is not challenging venue or personal jurisdiction.

Alkem denies the remaining allegations.

115. This Court also has personal jurisdiction over Alkem and S&B because, on information and belief, each such Defendant, upon approval of ANDA No. 213764, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213764 that will be purposefully directed at Delaware, including the marketing of the Alkem ANDA Products in Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

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ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. Alkem avers that, solely for the purpose of this lawsuit and as relating to Alkem only, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

116. This Court also has personal jurisdiction over Alkem and S&B because, on information and belief, each such Defendant’s affiliations with the State of Delaware, including S&B’s incorporation in Delaware, and Alkem’s ownership of and actions in concert with S&B, are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

117. This Court also has personal jurisdiction over Alkem because Alkem has availed itself of the legal protections of the State of Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Alkem avers that, solely for the purpose of this lawsuit and as relating to

Alkem only, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

118. Alkem, the entity identified in the Alkem Notice Letter as having submitted ANDA No. 213764, has agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

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ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Alkem avers that, solely for the purpose of this lawsuit and as relating to

Alkem only, Alkem is not challenging venue or personal jurisdiction. Alkem denies the remaining allegations.

119. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Alkem and S&B.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

120. Venue is proper in this Court because S&B is incorporated in the State of Delaware and therefore resides in this judicial district, and because Alkem is a foreign entity who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)

121. This Court has personal jurisdiction over Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. because, on information and belief, each such Defendant has committed or has aided, abetted, contributed to, or participated in the commission of tortious acts of patent infringement in preparing and submitting ANDA No. 213631 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 121 of the Complaint and therefore denies them.

122. This Court also has personal jurisdiction over Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. because, on information and belief, each such Defendant, upon approval of ANDA No. 213631, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213631 that will be purposefully directed at Delaware, including the marketing of the Aurobindo ANDA Products in Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 122 of the Complaint and therefore denies them.

123. This Court also has personal jurisdiction over Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. because, on information and belief, each such Defendant’s affiliations with the State of Delaware, including Aurobindo Pharma USA Inc.’s incorporation in Delaware, and Aurobindo Pharma Ltd.’s ownership of and actions in concert with Aurobindo Pharma USA Inc., are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 123 of the Complaint and therefore denies them.

124. This Court also has personal jurisdiction over Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. because Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. have availed themselves of the legal protections of the State of Delaware, by admitting jurisdictionand asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 124 of the Complaint and therefore denies them.

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125. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 125 of the Complaint and therefore denies them.

126. Venue is proper in this Court because Aurobindo Pharma USA Inc. is incorporated in the State of Delaware and therefore resides in this judicial district, and Aurobindo Pharma Ltd. is a foreign entity who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 126 of the Complaint and therefore denies them.

c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)

127. This Court has personal jurisdiction over Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. because, on information and belief, each such Defendant has committed or has aided, abetted, contributed to, or participated in the commission of tortious acts of patent infringement in preparing and submitting ANDA No. 213680 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 127 of the Complaint and therefore denies them.

128. This Court also has personal jurisdiction over Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. because, on information on belief, each such Defendant, upon approval of ANDA No. 213680, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213680 that will be purposefully directed at Delaware, including the marketing of the Biocon ANDA Products in Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 128 of the Complaint and therefore denies them.

129. This Court also has personal jurisdiction over Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. because each such Defendant’s affiliations with the State of Delaware, including Biocon Pharma, Inc.’s incorporation in Delaware, and Bicon Pharma Limited’s and Biocon Limited’s ownership of and actions in concert with Biocon Pharma, Inc., are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 129 of the Complaint and therefore denies them.

130. This Court also has personal jurisdiction over Biocon Limited and Biocon Pharma, Inc. because Biocon Limited and Biocon Pharma, Inc. have availed themselves of the legal protections of the State of Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 130 of the Complaint and therefore denies them.

131. Biocon Pharma Limited, the entity identified in the Biocon Notice Letter as having submitted ANDA No. 213680, has agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 131 of the Complaint and therefore denies them.

132. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 132 of the Complaint and therefore denies them.

133. Venue is proper in this Court because Biocon Pharma, Inc. is incorporated in the State of Delaware and therefore resides in this judicial district, and Biocon Pharma Limited and Biocon Limited are foreign entities who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 133 of the Complaint and therefore denies them.

d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)

134. This Court has personal jurisdiction over Crystal because Crystal has committed tortious acts of patent infringement in preparing and submitting ANDA No. 213605 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 134 of the Complaint and therefore denies them.

135. This Court also has personal jurisdiction over Crystal because, on information and belief, Crystal, upon approval of ANDA No. 213605, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213605 that will be purposefully directed at Delaware, including the marketing of the Crystal ANDA Products in Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 135 of the Complaint and therefore denies them.

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136. This Court also has personal jurisdiction over Crystal because, on information and belief, Crystal’s affiliations with the State of Delaware are sufficiently continuous and systematic as to render Crystal essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 136 of the Complaint and therefore denies them.

137. Crystal, the entity identified in the Crystal Notice Letter as having submitted ANDA No. 213605, has agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 137 of the Complaint and therefore denies them.

138. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Crystal.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 138 of the Complaint and therefore denies them.

139. Venue is proper in this Court because Crystal is a foreign entity who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 139 of the Complaint and therefore denies them.

e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)

140. This Court has personal jurisdiction over Laurus Labs Limited and Laurus Generics Inc. because, on information and belief, each such Defendant has committed or has aided, abetted, contributed to, or participated in the commission of tortious acts of patent infringement in

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preparing and submitting ANDA No. 213676 with a certification pursuant to 21 .S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 140 of the Complaint and therefore denies them.

141. This Court also has personal jurisdiction over Laurus Labs Limited and Laurus Generics Inc. because, on information and belief, each such Defendant, upon approval of ANDA No. 213676, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213676 that will be purposefully directed at Delaware, including the marketing of the Laurus ANDA Products in Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 141 of the Complaint and therefore denies them.

142. This Court also has personal jurisdiction over Laurus Labs Limited and Laurus Generics Inc. because, on information and belief, each such Defendant’s affiliations with the State of Delaware, including Laurus Generics Inc.’s incorporation in Delaware, and Laurus Labs Limited’s ownership of and actions in concert with Laurus Generics Inc., are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 142 of the Complaint and therefore denies them.

143. This Court also has personal jurisdiction over Laurus Labs Limited and Laurus Generics Inc. because Laurus Labs Limited and Laurus Generics Inc. have availed themselves of the legal protections of the State of Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 143 of the Complaint and therefore denies them.

144. Laurus Labs Limited, the entity identified in the Laurus Notice Letter as having submitted ANDA No. 213676, has agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 144 of the Complaint and therefore denies them.

145. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Laurus Labs Limited and Laurus Generics Inc.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 145 of the Complaint and therefore denies them.

146. Venue is proper in this Court over Laurus Labs Limited and Laurus Generics Inc. because Laurus Generics Inc. is incorporated in the State of Delaware and therefore resides in this judicial district, and Laurus Labs Limited is a foreign entity who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 146 of the Complaint and therefore denies them.

f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)

147. This Court has personal jurisdiction over Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. because, on information and belief, each such Defendant has committed or has aided, abetted, contributed to, or participated in the

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commission of tortious acts of patent infringement in preparing and submitting ANDA No. 213808 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 147 of the Complaint and therefore denies them.

148. This Court also has personal jurisdiction over Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. because, on information and belief, each such Defendant, upon approval of ANDA No. 213808, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213808 that will be purposefully directed at Delaware, including the marketing of the Lupin Atlantis ANDA Products in Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 148 of the Complaint and therefore denies them.

149. This Court also has personal jurisdiction over Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. because, on information and belief, each such Defendant’s affiliations with the State of Delaware, including Lupin Inc.’s and Lupin Pharmaceuticals, Inc.’s incorporation in Delaware, Lupin Atlantis Holdings, S.A.’s ownership of and actions in concert with Lupin Inc. and Lupin Limited’s and Lupin Inc.’s ownership of and actions in concert with Lupin Pharmaceuticals, Inc., are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 149 of the Complaint and therefore denies them.

150. This Court also has personal jurisdiction over Lupin Atlantis Holdings, S.A., Lupin Limited, and Lupin Inc. because each has availed itself of the legal protections of the State of Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 150 of the Complaint and therefore denies them.

151. Lupin Atlantis Holdings, S.A., the entity identified in the Lupin Atlantis Notice Letter as having submitted ANDA No. 213808, has agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 151 of the Complaint and therefore denies them.

152. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 152 of the Complaint and therefore denies them.

153. Venue is proper in this Court because Lupin Inc. and Lupin Pharmaceuticals, Inc. are incorporated in the State of Delaware and therefore reside in this judicial district, and Lupin Atlantis Holdings, S.A. and Lupin Limited are foreign entities who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 153 of the Complaint and therefore denies them.

g. Lupin Limited; Lupin Atlantis Holdings, S.A.; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213809)

154. This Court has personal jurisdiction over Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. because, on information and belief, each such Defendant has committed or has aided, abetted, contributed to, or participated in the commission

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of tortious acts of patent infringement in preparing and submitting ANDA No. 213809 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 154 of the Complaint and therefore denies them.

155. This Court also has personal jurisdiction over Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. because, on information and belief, each such Defendant, upon approval of ANDA No. 213809, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213809 that will be purposefully directed at Delaware, including the marketing of the Lupin Limited ANDA Products in Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 155 of the Complaint and therefore denies them.

156. This Court also has personal jurisdiction over Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. because, on information and belief, each such Defendant’s affiliations with the State of Delaware, including Lupin Inc.’s and Lupin Pharmaceuticals, Inc.’s incorporation in Delaware, Lupin Atlantis Holdings, S.A.’s ownership of and actions in concert with Lupin Inc. and Lupin Limited’s and Lupin Inc.’s ownership of and actions in concert with Lupin Pharmaceuticals, Inc., are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 156 of the Complaint and therefore denies them.

157. This Court also has personal jurisdiction over Lupin Limited, Lupin Atlantis Holdings, S.A., and Lupin Inc. because each has availed itself of the legal protections of the State of Delaware, by admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 157 of the Complaint and therefore denies them.

158. Lupin Limited, the entity identified in the Lupin Limited Notice Letter as having submitted ANDA No. 213809, has agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 158 of the Complaint and therefore denies them.

159. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 159 of the Complaint and therefore denies them.

160. Venue is proper in this Court because Lupin Inc. and Lupin Pharmaceuticals, Inc. are incorporated in the State of Delaware and therefore reside in this judicial district, and Lupin Limited and Lupin Atlantis Holdings, S.A. are foreign entities who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 160 of the Complaint and therefore denies them.

h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)

161. This Court has personal jurisdiction over Noratech because Noratech has committed tortious acts of patent infringement in preparing and submitting ANDA No. 213671 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 161 of the Complaint and therefore denies them.

162. This Court also has personal jurisdiction over Noratech because, on information and belief, Noratech, upon approval of ANDA No. 213671, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213671 that will be purposefully directed at Delaware, including the marketing of the Noratech ANDA Products in Delaware, prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 162 of the Complaint and therefore denies them.

163. This Court also has personal jurisdiction over Noratech because, on information and belief, Noratech’s affiliations with the State of Delaware are sufficiently continuous and systematic as to render Noratech essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 163 of the Complaint and therefore denies them.

164. Noratech, the entity identified in the Noratech Notice Letter as having submitted ANDA No. 213671, has agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 164 of the Complaint and therefore denies them.

165. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Crystal.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 165 of the Complaint and therefore denies them.

166. Venue is proper in this Court because Noratech is a foreign entity who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 166 of the Complaint and therefore denies them.

i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd. (ANDA No. 213577)

167. This Court has personal jurisdiction over Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. because, on information and belief, each such Defendant has committed or has aided, abetted, contributed to, or participated in the commission of tortious acts of patent infringement in preparing and submitting ANDA No. 213577 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 167 of the Complaint and therefore denies them.

168. This Court also has personal jurisdiction over Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. because, on information and belief, each such Defendant, upon approval of ANDA No. 213577, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213577 that will be purposefully directed at Delaware, including the marketing of the Teva ANDA Products in Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 168 of the Complaint and therefore denies them.

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169. This Court also has personal jurisdiction over Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. because, on information and belief, each such Defendant’s affiliations with the State of Delaware, including Teva Pharmaceuticals USA, Inc.’s incorporation in Delaware, and Teva Pharmaceutical Industries Ltd. ownership of and actions in concert with Teva Pharmaceuticals USA, Inc., are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 169 of the Complaint and therefore denies them.

170. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 170 of the Complaint and therefore denies them.

171. Venue is proper in this Court over Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. because Teva Pharmaceuticals USA, Inc. is incorporated in the State of Delaware and therefore resides in this judicial district, and Teva Pharmaceutical Industries Ltd. is a foreign entity who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 171 of the Complaint and therefore denies them.

j. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)

172. This Court has personal jurisdiction over Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. because each such Defendant has committed or has aided, abetted, contributed to, or participated in the commission of tortious acts of patent infringement in preparing and submitting ANDA No. 213604 with a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), which acts have led to foreseeable harm and injury to Novartis, a Delaware corporation.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 172 of the Complaint and therefore denies them.

173. This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. because, on information and belief, each such Defendant, upon approval of ANDA No. 213604, will commit or will aid, abet, contribute to, or participate in future tortious acts of patent infringement permitted under ANDA No. 213604 that will be purposefully directed at Delaware, including the marketing of the Torrent ANDA Products in Delaware, prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 173 of the Complaint and therefore denies them.

174. This Court also has personal jurisdiction over Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. because, on information and belief, each such Defendant’s affiliations with the State of Delaware, including Torrent Pharma Inc.’s incorporation in Delaware, and Torrent Pharmaceuticals Ltd.’s ownership of and actions in concert with Torrent Pharma Inc., are sufficiently continuous and systematic as to render each such Defendant essentially at home in this forum.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 174 of the Complaint and therefore denies them.

175. Both Torrent Pharmaceuticals Ltd., the entity identified in the Torrent Notice Letter as having submitted ANDA No. 213604 in concert with Torrent Pharma Inc., and Torrent Pharma Inc. have agreed with Novartis to litigate this action in Delaware and not to contest personal jurisdiction or venue in Delaware in this action.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 175 of the Complaint and therefore denies them.

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176. For these reasons, and for other reasons that will be presented to the Court if jurisdiction is challenged, the Court has personal jurisdiction over Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 176 of the Complaint and therefore denies them.

177. Venue is proper in this Court over Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. because Torrent Pharma Inc. is incorporated in the State of Delaware and therefore resides in this judicial district, and Torrent Pharmaceuticals Ltd. is a foreign entity who may be sued in any judicial district, including Delaware. 28 U.S.C. § 1400(b); 28 U.S.C. § 1391(c)(3).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 177 of the Complaint and therefore denies them.

THE PATENTS-IN-SUIT AND ENTRESTO®

178. Novartis is the owner of the ’659 patent, titled “Methods of treatment and pharmaceutical composition.” The ’659 patent was duly and legally issued on January 24, 2012. A true and correct copy of the ’659 patent is attached hereto as Exhibit A.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, Alkem admits that Exhibit A purports to be a copy of the ’659 patent, which on its face indicates it is entitled “Methods of treatment and pharmaceutical composition.” Alkem is without sufficient information with which to form a belief as to the truth or accuracy as to whether Novartis is the owner of the ‘659 patent, and therefore denies the allegation. Alkem denies all remaining allegations.

179. The ’659 patent claims, inter alia, a pharmaceutical composition comprising (i) valsartan or a pharmaceutically acceptable salt thereof; (ii) sacubitril or sacubitrilat or a pharmaceutically acceptable salt thereof; and (iii) a pharmaceutically acceptable carrier; wherein (i) and (ii) are administered in combination in about a 1:1 ratio

ANSWER: Denied.

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180. Novartis is the owner of the ’331 patent, titled “Methods of treatment and pharmaceutical composition.” The ’331 patent was duly and legally issued on August 5, 2014. A true and correct copy of the ’331 patent is attached hereto as Exhibit B.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, Alkem admits that Exhibit B purports to be a copy of the ’331 patent, which on its face indicates it is entitled “Methods of treatment and pharmaceutical composition.” Alkem is without sufficient information with which to form a belief as to the truth or accuracy as to whether Novartis is the owner of the ‘331 patent, and therefore denies the allegation. Alkem denies all remaining allegations.

181. The ’331 patent claims, inter alia, a method for the treatment of heart failure or hypertension, comprising administering to a patient in need thereof a therapeutically effective amount of the combination of (i) valsartan or a pharmaceutically acceptable salt thereof; and (ii) sacubitril or sacubitrilat or a pharmaceutically acceptable salt thereof; wherein (i) and (ii) are administered in one unit dose form or in two separate unit dose forms.

ANSWER: Denied.

182. Novartis is the owner of the ’938 patent, titled “Compounds containing S-N- valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4- (3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations.” The ’938 patent was duly and legally issued on November 4, 2014. A true and correct copy of the ’938 patent is attached hereto as Exhibit C.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, Alkem admits that Exhibit C purports to be a copy of the ’938 patent, which on its face indicates it is entitled “Compounds containing S-N- valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-

(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations.” Alkem is without sufficient information with which to form a belief as to the truth or accuracy as to whether

Novartis is the owner of the ‘938 patent, and therefore denies the allegation. Alkem denies all remaining allegations.

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183. The ’938 patent claims, inter alia, trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3- ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3′-methyl-2′-(pentanoyl{2″-(tetrazol-5- ylate)biphenyl-4′-ylmethyl}amino)butyrate] hemipentahydrate (“sacubitril/valsartan trisodium hemipentahydrate complex”) in crystalline form.

ANSWER: Denied.

184. Novartis is the owner of the ’134 patent, titled “Compounds containing S-N- valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4- (3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations.” The 134 patent was duly and legally issued on July 12, 2016. A true and correct copy of the ’134 patent is attached hereto as Exhibit D.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, Alkem admits that Exhibit D purports to be a copy of the ’134 patent, which on its face indicates it is entitled “Compounds containing S-N- valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-

(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations.” Alkem is without sufficient information with which to form a belief as to the truth or accuracy as to whether

Novartis is the owner of the ‘134 patent, and therefore denies the allegation. Alkem denies all remaining allegations.

185. The ’134 patent claims, inter alia, a method for the treatment of heart failure or hypertension, in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex.

ANSWER: Denied.

186. Novartis is the holder of New Drug Application (“NDA”) No. 207620 by which the FDA granted approval for the commercial manufacturing, marketing, sale, and use of ENTRESTO® (sacubitril and valsartan) tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. ENTRESTO® currently is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction, and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of this paragraph and therefore denies them.

187. One or more claims of each of the ’659, ’331, ’938, and ’134 patents cover ENTRESTO® and/or the use thereof.

ANSWER: Denied.

188. The FDA’s official publication of approved drugs (the “Orange Book”) lists the ’659, ’331, ’938, and ’134 patents in connection with ENTRESTO®.

ANSWER: The Orange Book purportedly lists the ’659, ’331, ’938, and ’134 patents in connection with ENTRESTO®. Alkem denies the remaining allegations.

INFRINGEMENT BY EACH DEFENDANT OF THE PATENTS-IN-SUIT

189. Novartis incorporates paragraphs 1 – 112 and 178 – 188 as if fully set forth herein.

ANSWER: Alkem incorporates its answers to paragraphs 1 – 112 and 178 – 188 as if fully set forth herein.

a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)

190. On information and belief, Alkem, by itself or in concert with S&B, submitted to the FDA ANDA No. 213764 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. To the extent an answer is required, upon information and belief, Alkem admits Alkem submitted Alkem’s ANDA with the FDA. Pursuant to the stipulation (D.I. 7) approved by the court on December 3, 2019, S&B Pharma has been dismissed from the case.

Alkem denies the remaining allegations.

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191. This action was commenced within 45 days of Novartis’s receipt of the Alkem Notice Letter.

ANSWER: Admitted.

192. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products in or into the United States prior to the expiration of the ’659, ’331, ’938, and ’134 patents, Alkem, and, on information and belief, S&B, have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

193. On information and belief, when Alkem filed ANDA No. 213764, Alkem and S&B were aware of the ’659, ’331, ’938, and ’134 patents and that the filing of the ANDA with the request for its approval prior to the expiration of the ’659, ’331, ’938, and ’134 patents was an act of infringement of those patents.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required,

Alkem admits that it was aware of the ’659, ’331, ’938, and ’134 patents when ANDA No. 213764 was filed. All remaining allegations are denied.

194. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products in or into the United States will infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Denied.

195. The Alkem Notice Letter does not deny that the Alkem ANDA Products would infringe claims 1-4 of the ’659 patent, on any basis other than the alleged invalidity of those claims.

ANSWER: Denied.

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196. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products in or into the United States will directly infringe one or more claims of the ’659 patent.

ANSWER: Denied.

197. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products in or into the United States will directly infringe one more claims of the ’938 patent.

ANSWER: Denied.

198. On information and belief, the Alkem ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, which administration will constitute direct infringement of one or more claims of the ’331 patent. On information and belief, if the Alkem ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’331 patent. On information and belief, if the Alkem ANDA Products are approved, Alkem and/or S&B will actively encourage, recommend, or promote this infringement with knowledge of the ’331 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’331 patent.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

199. On information and belief, if the Alkem ANDA Products are approved, Alkem and/or S&B will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Alkem ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan, as recited in one or more claims of the ’331 patent. On information and belief, if the Alkem ANDA Products are approved, physicians and/or patients following the instructions in the Alkem ANDA Products will directly infringe one or more claims of the ’331 patent. On information and belief, if the Alkem ANDA Products are approved, Alkem and/or S&B will contributorily infringe one or more claims of the ’331 patent, and will do so with knowledge of the ’331 patent, and that the Alkem ANDA Products

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are especially made or especially adapted for use in infringing one or more claims of the ’331 patent and are not suitable for a substantial noninfringing use.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

200. On information and belief, the Alkem ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Alkem ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Alkem ANDA Products are approved, Alkem and/or S&B will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

201. On information and belief, if the Alkem ANDA Products are approved, Alkem and/or S&B will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Alkem ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Alkem ANDA Products are approved, physicians and/or patients following the instructions in the Alkem ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Alkem ANDA Products are approved, Alkem and/or S&B will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Alkem ANDA Products are

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especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

202. Novartis will be substantially and irreparably damaged by Alkem’s and/or S&B’s infringement of the ’659, ’331, ’938, and ’134 patents.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

203. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213764 be a date that is no earlier than July 14, 2023, the expiration of the ’659 and ’331 patents’ pediatric exclusivity, November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Alkem ANDA Products and any act committed by Alkem and/or S&B with respect to the subject matter claimed in the ’659, ’331, ’938, and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

204. On information and belief, Alkem and S&B have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products, including seeking approval of those products under ANDA No. 213764.

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ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

205. There is a substantial and immediate controversy between Novartis and Alkem and S&B concerning the ’659, ’331, ’938, and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Alkem and/or S&B will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: This paragraph contains legal conclusions and allegations to which no answer is required. Pursuant to the stipulation (D.I. 7) approved by the court on December 3,

2019, S&B Pharma has been dismissed from the case. To the extent an answer is required, denied.

b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)

206. On information and belief, Aurobindo Pharma USA Inc., by itself or in concert with Aurobindo Pharma Ltd., submitted to the FDA ANDA No. 213631 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 206 of the Complaint and therefore denies them.

207. This action was commenced within 45 days of Novartis’s receipt of the Aurobindo Notice Letter.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 207 of the Complaint and therefore denies them.

208. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products in or into the United States prior to the expiration of the ’659, ’331, ’938, and ’134 patents, Aurobindo Pharma USA Inc., and, on information and belief, Aurobindo Pharma Ltd., have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 208 of the Complaint and therefore denies them.

209. On information and belief, when Aurobindo Pharma USA Inc. filed ANDA No. 213631, Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. were aware of the ’659, ’331, ’938, and ’134 patents and that the filing of the ANDA with the request for its approval prior to the expiration of the ’659, ’331, ’938, and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 209 of the Complaint and therefore denies them.

210. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products in or into the United States will infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 210 of the Complaint and therefore denies them.

211. The Aurobindo Notice Letter does not deny that the Aurobindo ANDA Products would infringe claims 1-4 of the ’659 patent, and that the use of the Aurobindo ANDA Products would infringe claims 1, 2, and 4-8 of the ’331 patent, on any basis other than the alleged invalidity of those claims.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 211 of the Complaint and therefore denies them.

212. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products in or into the United States will directly infringe one or more claims of the ’659 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 212 of the Complaint and therefore denies them.

213. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products in or into the United States will directly infringe one more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 213 of the Complaint and therefore denies them.

214. On information and belief, the Aurobindo ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, which administration will constitute direct infringement of one or more claims of the ’331 patent. On information and belief, if the Aurobindo ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’331 patent. On information and belief, if the Aurobindo ANDA Products are approved, Aurobindo Pharma USA Inc. and/or Aurobindo Pharma Ltd. will actively encourage, recommend, or promote this infringement with knowledge of the ’331 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’331 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 214 of the Complaint and therefore denies them.

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215. On information and belief, if the Aurobindo ANDA Products are approved, Aurobindo Pharma USA Inc. and/or Aurobindo Pharma Ltd. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Aurobindo ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Aurobindo ANDA Products are approved, physicians and/or patients following the instructions in the Aurobindo ANDA Products will directly infringe one or more claims of the ’331 patent. On information and belief, if the Aurobindo ANDA Products are approved, Aurobindo Pharma USA Inc. and/or Aurobindo Pharma Ltd. will contributorily infringe one or more claims of the ’331 patent, and will do so with knowledge of the ’331 patent, and that the Aurobindo ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’331 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 215 of the Complaint and therefore denies them.

216. On information and belief, the Aurobindo ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Aurobindo ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Aurobindo ANDA Products are approved, Aurobindo Pharma USA Inc. and/or Aurobindo Pharma Ltd. will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 216 of the Complaint and therefore denies them.

217. On information and belief, if the Aurobindo ANDA Products are approved, Aurobindo Pharma USA Inc. and/or Aurobindo Pharma Ltd. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method

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for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Aurobindo ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Aurobindo ANDA Products are approved, physicians and/or patients following the instructions in the Aurobindo ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Aurobindo ANDA Products are approved, Aurobindo Pharma USA Inc. and/or Aurobindo Pharma Ltd. will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Aurobindo ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 217 of the Complaint and therefore denies them.

218. Novartis will be substantially and irreparably damaged by Aurobindo Pharma USA Inc.’s and/or Aurobindo Pharma Ltd.’s infringement of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 218 of the Complaint and therefore denies them.

219. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213631 be a date that is no earlier than July 14, 2023, the expiration of the ’659 and ’331 patents’ pediatric exclusivity, November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Aurobindo ANDA Products and any act committed by Aurobindo Pharma USA Inc. and/or Aurobindo Pharma Ltd. with respect to the subject matter claimed in the ’659, ’331, ’938, and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 219 of the Complaint and therefore denies them.

220. On information and belief, Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products, including seeking approval of those products under ANDA No. 213631.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 220 of the Complaint and therefore denies them.

221. There is a substantial and immediate controversy between Novartis and Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. concerning the ’659, ’331, ’938, and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 221 of the Complaint and therefore denies them.

c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)

222. On information and belief, Biocon Pharma Limited, by itself or in concert with Biocon Limited and Biocon Pharma, Inc., submitted to the FDA ANDA No. 213680 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 222 of the Complaint and therefore denies them.

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223. This action was commenced within 45 days of Novartis’s receipt of the Biocon Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 223 of the Complaint and therefore denies them.

224. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products in or into the United States prior to the expiration of the ’659, ’331, ’938, and ’134 patents, Biocon Pharma Limited, and, on information and belief, Biocon Limited and Biocon Pharma, Inc., have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 224 of the Complaint and therefore denies them.

225. On information and belief, when Biocon Pharma Limited filed ANDA No. 213680, Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. were aware of the ’659, ’331, ’938, and ’134 patents and that the filing of the ANDA with the request for its approval prior to the expiration of the ’659, ’331, ’938, and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 225 of the Complaint and therefore denies them.

226. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products in or into the United States will infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 226 of the Complaint and therefore denies them.

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227. The Biocon Notice Letter does not deny that use of the Biocon ANDA Products would infringe claims 1, 2, and 5-8 of the ’331 patent, on any basis other than the alleged invalidity of those claims.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 227 of the Complaint and therefore denies them.

228. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products in or into the United States will directly infringe one or more claims of the ’659 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 228 of the Complaint and therefore denies them.

229. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products in or into the United States will directly infringe one more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 229 of the Complaint and therefore denies them.

230. On information and belief, the Biocon ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, which administration will constitute direct infringement of one or more claims of the ’331 patent. On information and belief, if the Biocon ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’331 patent. On information and belief, if the Biocon ANDA Products are approved, Biocon Pharma Limited, Biocon Limited, and/or Biocon Pharma, Inc. will actively encourage, recommend, or promote this infringement with knowledge of the ’331 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’331 patent.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 230 of the Complaint and therefore denies them.

231. On information and belief, if the Biocon ANDA Products are approved, Biocon Pharma Limited, Biocon Limited, and/or Biocon Pharma, Inc. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Biocon ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Biocon ANDA Products are approved, physicians and/or patients following the instructions in the Biocon ANDA Products will directly infringe one or more claims of the ’331 patent. On information and belief, if the Biocon ANDA Products are approved, Biocon Pharma Limited, Biocon Limited, and/or Biocon Pharma, Inc. will contributorily infringe one or more claims of the ’331 patent, and will do so with knowledge of the ’331 patent, and that the Biocon ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’331 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 231 of the Complaint and therefore denies them.

232. On information and belief, the Biocon ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Biocon ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Biocon ANDA Products are approved, Biocon Pharma Limited, Biocon Limited, and/or Biocon Pharma, Inc. will actively encourage, recommend, or promote this infringement with knowledge of the ‘134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 232 of the Complaint and therefore denies them.

233. On information and belief, if the Biocon ANDA Products are approved, Biocon Pharma Limited, Biocon Limited, and/or Biocon Pharma, Inc. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Biocon ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Biocon ANDA Products are approved, physicians and/or patients following the instructions in the Biocon ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Biocon ANDA Products are approved, Biocon Pharma Limited, Biocon Limited, and/or Biocon Pharma, Inc. will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Biocon ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 233 of the Complaint and therefore denies them.

234. Novartis will be substantially and irreparably damaged by Biocon Pharma Limited’s, Biocon Limited’s, and/or Biocon Pharma, Inc.’s infringement of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 234 of the Complaint and therefore denies them.

235. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213680 be a date that is no earlier than July 14, 2023, the expiration of the ’659 and ’331 patents’ pediatric exclusivity, November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8,

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2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Biocon ANDA Products and any act committed by Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. with respect to the subject matter claimed in the ’659, ’331, ’938, and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 235 of the Complaint and therefore denies them.

236. On information and belief, Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products, including seeking approval of those products under ANDA No. 213680.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 236 of the Complaint and therefore denies them.

237. There is a substantial and immediate controversy between Novartis and Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. concerning the ’659, ’331, ’938, and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 237 of the Complaint and therefore denies them.

d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)

238. On information and belief, Crystal submitted to the FDA ANDA No. 213605 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 238 of the Complaint and therefore denies them.

239. This action was commenced within 45 days of Novartis’s receipt of the Crystal Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 239 of the Complaint and therefore denies them.

240. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products in or into the United States prior to the expiration of the ’659, ’331, ’938, and ’134 patents, Crystal has committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 240 of the Complaint and therefore denies them.

241. On information and belief, when Crystal filed its ANDA, it was aware of the ’659, ’331, ’938, and ’134 patents and that the filing of its ANDA with the request for its approval prior to the expiration of the ’659, ’331, ’938, and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 241 of the Complaint and therefore denies them.

242. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products in or into the United States will infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 242 of the Complaint and therefore denies them.

243. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products in or into the United States will directly infringe one or more claims of the ’659 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 243 of the Complaint and therefore denies them.

244. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products in or into the United States will directly infringe one more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 244 of the Complaint and therefore denies them.

245. On information and belief, the Crystal ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, which administration will constitute direct infringement of one or more claims of the ’331 patent. On information and belief, if the Crystal ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’331 patent. On information and belief, if the Crystal ANDA Products are approved, Crystal will actively encourage, recommend, or promote this infringement with knowledge of the ’331 patent, and with knowledge and intent that its acts will induce infringement of one or more claims of the ’331 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 245 of the Complaint and therefore denies them.

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246. On information and belief, if the Crystal ANDA Products are approved, Crystal will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Crystal ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Crystal ANDA Products are approved, physicians and/or patients following the instructions in the Crystal ANDA Products will directly infringe one or more claims of the ’331 patent. On information and belief, if the Crystal ANDA Products are approved, Crystal will contributorily infringe one or more claims of the ’331 patent, and will do so with knowledge of the ’331 patent, and that the Crystal ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’331 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 246 of the Complaint and therefore denies them.

247. On information and belief, the Crystal ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Crystal ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Crystal ANDA Products are approved, Crystal will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that its acts will induce infringement of one or more claims of the ’134 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 247 of the Complaint and therefore denies them.

248. On information and belief, if the Crystal ANDA Products are approved, Crystal will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Crystal ANDA Products are approved, those products will constitute

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a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Crystal ANDA Products are approved, physicians and/or patients following the instructions in the Crystal ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Crystal ANDA Products are approved, Crystal will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Crystal ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 248 of the Complaint and therefore denies them.

249. Novartis will be substantially and irreparably damaged by Crystal’s infringement of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 249 of the Complaint and therefore denies them.

250. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213605 be a date that is no earlier than July 14, 2023, the expiration of the ’659 and ’331 patents’ pediatric exclusivity, November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Crystal ANDA Products and any act committed by Crystal with respect to the subject matter claimed in the ’659, ’331, ’938 and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 250 of the Complaint and therefore denies them.

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251. On information and belief, Crystal has taken and continues to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products, including seeking approval of those products under ANDA No. 213605.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 251 of the Complaint and therefore denies them.

252. There is a substantial and immediate controversy between Novartis and Crystal concerning the ’659, ’331, ’938, and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Crystal will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 252 of the Complaint and therefore denies them.

e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)

253. On information and belief, Laurus Labs Limited, by itself or in concert with Laurus Generics Inc., submitted to the FDA ANDA No. 213680 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 253 of the Complaint and therefore denies them.

254. This action was commenced within 45 days of Novartis’s receipt of the Laurus Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 254 of the Complaint and therefore denies them.

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255. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products in or into the United States prior to the expiration of the ’659, ’331, ’938, and ’134 patents, Laurus Labs Limited, and, on information and belief, Laurus Generics Inc., have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 255 of the Complaint and therefore denies them.

256. On information and belief, when Laurus Labs Limited filed ANDA No. 213676, Laurus Labs Limited and Laurus Generics Inc. were aware of the ’659, ’331, ’938, and ’134 patents and that the filing of the ANDA with the request for its approval prior to the expiration of the ’659, ’331, ’938, and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 256 of the Complaint and therefore denies them.

257. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products in or into the United States will infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 257 of the Complaint and therefore denies them.

258. The Laurus Notice Letter does not deny that the Laurus ANDA Products would infringe claims 1 and 2 of the ’659 patent, and that the use of the Laurus ANDA Products would infringe claims 1, 2 and 5-8 of the ’331 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 258 of the Complaint and therefore denies them.

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259. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products in or into the United States will directly infringe one or more claims of the ’659 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 259 of the Complaint and therefore denies them.

260. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products in or into the United States will directly infringe one more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 260 of the Complaint and therefore denies them.

261. On information and belief, the Laurus ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, which administration will constitute direct infringement of one or more claims of the ’331 patent. On information and belief, if the Laurus ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’331 patent. On information and belief, if the Laurus ANDA Products are approved, Laurus Labs Limited and/or Laurus Generics Inc. will actively encourage, recommend, or promote this infringement with knowledge of the ’331 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’331 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 261 of the Complaint and therefore denies them.

262. On information and belief, if the Laurus ANDA Products are approved, Laurus Labs Limited and/or Laurus Generics Inc. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Laurus ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart

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failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Laurus ANDA Products are approved, physicians and/or patients following the instructions in the Laurus ANDA Products will directly infringe one or more claims of the ’331 patent. On information and belief, if the Laurus ANDA Products are approved, Laurus Labs Limited and/or Laurus Generics Inc. will contributorily infringe one or more claims of the ’331 patent, and will do so with knowledge of the ’331 patent, and that the Laurus ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’331 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 262 of the Complaint and therefore denies them.

263. On information and belief, the Laurus ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Laurus ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Laurus ANDA Products are approved, Laurus Labs Limited and/or Laurus Generics Inc. will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 263 of the Complaint and therefore denies them.

264. On information and belief, if the Laurus ANDA Products are approved, Laurus Labs Limited and/or Laurus Generics Inc. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Laurus ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Laurus ANDA Products are approved, physicians and/or patients following the instructions in the Laurus ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Laurus

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ANDA Products are approved, Laurus Labs Limited and/or Laurus Generics Inc. will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Laurus ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 264 of the Complaint and therefore denies them.

265. Novartis will be substantially and irreparably damaged by Laurus Labs Limited’s, and/or Laurus Generics Inc.’s infringement of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 265 of the Complaint and therefore denies them.

266. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213676 be a date that is no earlier than July 14, 2023, the expiration of the ’659 and ’331 patents’ pediatric exclusivity, November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Laurus ANDA Products and any act committed by Laurus Labs Limited and Laurus Generics Inc. with respect to the subject matter claimed in the ’659, ’331, ’938, and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 266 of the Complaint and therefore denies them.

267. On information and belief, Laurus Labs Limited and Laurus Generics Inc. have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products, including seeking approval of those products under ANDA No. 213676.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 267 of the Complaint and therefore denies them.

268. There is a substantial and immediate controversy between Novartis and Laurus Labs Limited and Laurus Generics Inc. concerning the ’659, ’331, ’938, and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Laurus Labs Limited and Laurus Generics Inc. will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 268 of the Complaint and therefore denies them.

f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)

269. On information and belief, Lupin Atlantis Holdings, S.A., by itself or in concert with Lupin Limited, Lupin Inc., and/or Lupin Pharmaceuticals, Inc., submitted to the FDA ANDA No. 213808 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 269 of the Complaint and therefore denies them.

270. This action was commenced within 45 days of Novartis’s receipt of the Lupin Atlantis Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 270 of the Complaint and therefore denies them.

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271. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products in or into the United States prior to the expiration of the ’938 and ’134 patents, Lupin Atlantis Holdings, S.A., and, on information and belief, Lupin Limited, Lupin Inc., and/or Lupin Pharmaceuticals, Inc., have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 271 of the Complaint and therefore denies them.

272. On information and belief, when Lupin Atlantis filed ANDA No. 213808, Lupin Atlantis, Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. were aware of the ’938 and ’134 patents and that the filing of the ANDA with the request for its approval prior to the expiration of the ’938 and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 272 of the Complaint and therefore denies them.

273. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products in or into the United States will infringe one or more claims of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 273 of the Complaint and therefore denies them.

274. The Lupin Atlantis Notice Letter does not deny that the Lupin Atlantis ANDA Products would infringe claims 1-11 of the ’938 patent and claims 1-15 of the ’134 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 274 of the Complaint and therefore denies them.

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275. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products in or into the United States will directly infringe one or more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 275 of the Complaint and therefore denies them.

276. On information and belief, the Lupin Atlantis ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Lupin Atlantis ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Lupin Atlantis ANDA Products are approved, Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and/or Lupin Pharmaceuticals, Inc. will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 276 of the Complaint and therefore denies them.

277. On information and belief, if the Lupin Atlantis ANDA Products are approved, Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and/or Lupin Pharmaceuticals, Inc. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Lupin Atlantis ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Lupin Atlantis ANDA Products are approved, physicians and/or patients following the instructions in the Lupin Atlantis ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Lupin Atlantis ANDA Products are approved, Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and/or Lupin Pharmaceuticals, Inc. will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Lupin Atlantis ANDA Products are especially

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made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 277 of the Complaint and therefore denies them.

278. Novartis will be substantially and irreparably damaged by Lupin Atlantis Holdings, S.A.’s, Lupin Limited’s, Lupin Inc.’s, and/or Lupin Pharmaceuticals’ infringement of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 278 of the Complaint and therefore denies them.

279. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213808 be a date that is no earlier than November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Lupin Atlantis ANDA Products and any act committed by Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and/or Lupin Pharmaceuticals, Inc. with respect to the subject matter claimed in the ’938 and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 279 of the Complaint and therefore denies them.

280. On information and belief, Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products, including seeking approval of those products under ANDA No. 213808.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 280 of the Complaint and therefore denies them.

281. There is a substantial and immediate controversy between Novartis and Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. concerning the ’938 and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 281 of the Complaint and therefore denies them.

g. Lupin Limited; Lupin Atlantis Holdings, S.A.; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213809)

282. On information and belief, Lupin Limited, by itself or in concert with Lupin Atlantis Holdings, S.A., Lupin Inc., and/or Lupin Pharmaceuticals, Inc., submitted to the FDA ANDA No. 213809 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 282 of the Complaint and therefore denies them.

283. This action was commenced within 45 days of Novartis’s receipt of the Lupin Limited Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 283 of the Complaint and therefore denies them.

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284. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products in or into the United States prior to the expiration of the ’938 and ’134 patents, Lupin Limited, and, on information and belief, Lupin Atlantis Holdings, S.A., Lupin Inc., and/or Lupin Pharmaceuticals, Inc., have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 284 of the Complaint and therefore denies them.

285. On information and belief, when Lupin Limited filed ANDA No. 213809, Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. were aware of the ’938 and ’134 patents and that the filing of the ANDA with the request for its approval prior to the expiration of the ’938 and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 285 of the Complaint and therefore denies them.

286. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products in or into the United States will infringe one or more claims of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 286 of the Complaint and therefore denies them.

287. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products in or into the United States will directly infringe one or more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 287 of the Complaint and therefore denies them.

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288. On information and belief, the Lupin Limited ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Lupin Limited ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Lupin Limited ANDA Products are approved, Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and/or Lupin Pharmaceuticals, Inc. will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 288 of the Complaint and therefore denies them.

289. On information and belief, if the Lupin Limited ANDA Products are approved, Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and/or Lupin Pharmaceuticals, Inc. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Lupin Limited ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Lupin Limited ANDA Products are approved, physicians and/or patients following the instructions in the Lupin Limited ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Lupin Limited ANDA Products are approved, Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and/or Lupin Pharmaceuticals, Inc. will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Lupin Limited ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 289 of the Complaint and therefore denies them.

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290. Novartis will be substantially and irreparably damaged by Lupin Limited’s, Lupin Atlantis Holdings, S.A.’s, Lupin Inc.’s, and/or Lupin Pharmaceuticals’ infringement of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 290 of the Complaint and therefore denies them.

291. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213809 be a date that is no earlier than November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Lupin Limited ANDA Products and any act committed by Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and/or Lupin Pharmaceuticals, Inc. with respect to the subject matter claimed in the ’938 and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 291 of the Complaint and therefore denies them.

292. On information and belief, Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products, including seeking approval of those products under ANDA No. 213809.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 292 of the Complaint and therefore denies them.

293. There is a substantial and immediate controversy between Novartis and Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. concerning the ’938 and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’938 and ’134 patents.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 293 of the Complaint and therefore denies them.

h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)

294. On information and belief, Noratech submitted to the FDA ANDA No. 213671 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Noratech ANDA Products prior to the expiration of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 294 of the Complaint and therefore denies them.

295. This action was commenced within 45 days of Novartis’s receipt of the Noratech Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 295 of the Complaint and therefore denies them.

296. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Noratech ANDA Products in or into the United States prior to the expiration of the ’938 and ’134 patents, Noratech has committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 296 of the Complaint and therefore denies them.

297. On information and belief, when Noratech filed its ANDA, it was aware of the ’938 and ’134 patents and that the filing of its ANDA with the request for its approval prior to the expiration of the ’938 and ’134 patents was an act of infringement of those patents.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 297 of the Complaint and therefore denies them.

298. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Noratech ANDA Products in or into the United States will infringe one or more claims of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 298 of the Complaint and therefore denies them.

299. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Noratech ANDA Products in or into the United States will directly infringe one or more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 299 of the Complaint and therefore denies them.

300. On information and belief, the Noratech ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Noratech ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Noratech ANDA Products are approved, Noratech will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that its acts will induce infringement of one or more claims of the ’134 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 300 of the Complaint and therefore denies them.

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301. On information and belief, if the Noratech ANDA Products are approved, Noratech will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Noratech ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Noratech ANDA Products are approved, physicians and/or patients following the instructions in the Noratech ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Noratech ANDA Products are approved, Noratech will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Noratech ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 301 of the Complaint and therefore denies them.

302. Novartis will be substantially and irreparably damaged by Noratech’s infringement of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 302 of the Complaint and therefore denies them.

303. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213671 be a date that is no earlier than November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Noratech ANDA Products and any act committed by Noratech with respect to the subject matter claimed in the ’938 and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 303 of the Complaint and therefore denies them.

304. On information and belief, Noratech has taken and continues to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Noratech ANDA Products, including seeking approval of those products under ANDA No. 213671.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 304 of the Complaint and therefore denies them.

305. There is a substantial and immediate controversy between Novartis and Noratech concerning the ’938 and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Noratech will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’938 and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 305 of the Complaint and therefore denies them.

i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd. (ANDA No. 213577)

306. On information and belief, Teva Pharmaceuticals USA, Inc., by itself or in concert with Teva Pharmaceutical Industries Ltd., submitted to the FDA ANDA No. 213577 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 306 of the Complaint and therefore denies them.

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307. This action was commenced within 45 days of Novartis’s receipt of the Teva Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 307 of the Complaint and therefore denies them.

308. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products in or into the United States prior to the expiration of the ’659, ’331, ’938, and ’134 patents, Teva Pharmaceuticals USA, Inc., and, on information and belief, Teva Pharmaceutical Industries Ltd., have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 308 of the Complaint and therefore denies them.

309. On information and belief, when Teva Pharmaceuticals USA, Inc. filed ANDA No. 213577, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd. were aware of the ’659, ’331, ’938, and ’134 patents and that the filing of the ANDA with the request for its approval prior to the expiration of the ’659, ’331, ’938, and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 309 of the Complaint and therefore denies them.

310. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products in or into the United States will infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 310 of the Complaint and therefore denies them.

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311. The Teva Notice Letter does not deny that the Teva ANDA Products would infringe claims 1-4 of the ’659 patent, and that the use of the Teva ANDA Products would infringe claims 1, 2 and 5-8 of the ’331 patent, on any basis other than the alleged invalidity of those claims.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 311 of the Complaint and therefore denies them.

312. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products in or into the United States will directly infringe one or more claims of the ’659 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 312 of the Complaint and therefore denies them.

313. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products in or into the United States will directly infringe one more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 313 of the Complaint and therefore denies them.

314. On information and belief, the Teva ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, which administration will constitute direct infringement of one or more claims of the ’331 patent. On information and belief, if the Teva ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’331 patent. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will actively encourage, recommend, or promote this infringement with knowledge of the ’331 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’331 patent.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 314 of the Complaint and therefore denies them.

315. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Teva ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Teva ANDA Products are approved, physicians and/or patients following the instructions in the Teva ANDA Products will directly infringe one or more claims of the ’331 patent. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will contributorily infringe one or more claims of the ’331 patent, and will do so with knowledge of the ’331 patent, and that the Teva ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’331 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 315 of the Complaint and therefore denies them.

316. On information and belief, the Teva ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Teva ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 316 of the Complaint and therefore denies them.

317. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Teva ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Teva ANDA Products are approved, physicians and/or patients following the instructions in the Teva ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Teva ANDA Products are approved, Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Teva ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 317 of the Complaint and therefore denies them.

318. Novartis will be substantially and irreparably damaged by Teva Pharmaceuticals USA, Inc.’s and/or Teva Pharmaceutical Industries Ltd.’s infringement of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 318 of the Complaint and therefore denies them.

319. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213577 be a date that is no earlier than July 14, 2023, the expiration of the ’659 and ’331 patents’ pediatric exclusivity, November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8,

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2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Teva ANDA Products and any act committed by Teva Pharmaceuticals USA, Inc. and/or Teva Pharmaceutical Industries Ltd. with respect to the subject matter claimed in the ’659, ’331, ’938, and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 319 of the Complaint and therefore denies them.

320. On information and belief, Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products, including seeking approval of those products under ANDA No. 213577.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 320 of the Complaint and therefore denies them.

321. There is a substantial and immediate controversy between Novartis and Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. concerning the ’659, ’331, ’938, and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 321 of the Complaint and therefore denies them.

i. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)

322. On information and belief, Torrent Pharma Inc., on behalf of Torrent Pharmaceuticals Ltd., submitted to the FDA ANDA No. 213604 under the provisions of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or

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importation of the Torrent ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 322 of the Complaint and therefore denies them.

323. This action was commenced within 45 days of Novartis’s receipt of the Torrent Notice Letter.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 323 of the Complaint and therefore denies them.

324. By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products in or into the United States prior to the expiration of the ’659, ’331, ’938, and ’134 patents, Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. have committed an act of infringement under 35 U.S.C. § 271(e)(2).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 324 of the Complaint and therefore denies them.

325. On information and belief, when Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. filed ANDA No. 213604, they were aware of the ’659, ’331, ’938, and ’134 patents and that the filing of their ANDA with the request for its approval prior to the expiration of the ’659, ’331, ’938, and ’134 patents was an act of infringement of those patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 325 of the Complaint and therefore denies them.

326. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products in or into the United States will infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 326 of the Complaint and therefore denies them.

327. The Torrent Notice Letter does not deny that the Torrent ANDA Products would infringe claims 1-4 of the ’659 patent, and that the use of the Torrent ANDA Products would infringe claims 1-10 of the ’331 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 327 of the Complaint and therefore denies them.

328. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products in or into the United States will directly infringe one or more claims of the ’659 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 328 of the Complaint and therefore denies them.

329. On information and belief, the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products in or into the United States will directly infringe one more claims of the ’938 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 329 of the Complaint and therefore denies them.

330. On information and belief, the Torrent ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, which administration will constitute direct infringement of one or more claims of the ’331 patent. On information and belief, if the Torrent ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’331 patent. On information and belief, if the Torrent ANDA Products are approved,

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Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. will actively encourage, recommend, or promote this infringement with knowledge of the ’331 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’331 patent.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 330 of the Complaint and therefore denies them.

331. On information and belief, if the Torrent ANDA Products are approved, Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Torrent ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure comprising administering to a patient in need thereof a therapeutically effective amount of sacubitril/valsartan or their pharmaceutically acceptable salts, as recited in one or more claims of the ’331 patent. On information and belief, if the Torrent ANDA Products are approved, physicians and/or patients following the instructions in the Torrent ANDA Products will directly infringe one or more claims of the ’331 patent. On information and belief, if the Torrent ANDA Products are approved, Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. will contributorily infringe one or more claims of the ’331 patent, and will do so with knowledge of the ’331 patent, and that the Torrent ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’331 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 331 of the Complaint and therefore denies them.

332. On information and belief, the Torrent ANDA Products, if approved, will contain instructions for practicing a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, which administration will constitute direct infringement of one or more claims of the ’134 patent. On information and belief, if the Torrent ANDA Products are approved, physicians and/or patients following said instructions will directly infringe one or more claims of the ’134 patent. On information and belief, if the Torrent ANDA Products are approved, Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. will actively encourage, recommend, or promote this infringement with knowledge of the ’134 patent, and with knowledge and intent that their acts will induce infringement of one or more claims of the ’134 patent.

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 332 of the Complaint and therefore denies them.

333. On information and belief, if the Torrent ANDA Products are approved, Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. will commercially manufacture, sell, offer for sale, and/or import those products, which will be specifically labeled for use in a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Torrent ANDA Products are approved, those products will constitute a material part of a method for the treatment of heart failure in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a sacubitril/valsartan trisodium hemipentahydrate complex, as recited in one or more claims of the ’134 patent. On information and belief, if the Torrent ANDA Products are approved, physicians and/or patients following the instructions in the Torrent ANDA Products will directly infringe one or more claims of the ’134 patent. On information and belief, if the Torrent ANDA Products are approved, Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. will contributorily infringe one or more claims of the ’134 patent, and will do so with knowledge of the ’134 patent, and that the Torrent ANDA Products are especially made or especially adapted for use in infringing one or more claims of the ’134 patent and are not suitable for a substantial noninfringing use.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 333 of the Complaint and therefore denies them.

334. Novartis will be substantially and irreparably damaged by Torrent Pharma Inc.’s and Torrent Pharmaceuticals Ltd.’s infringement of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 334 of the Complaint and therefore denies them.

335. Novartis is entitled to the relief provided by 35 U.S.C. § 271(e)(4), including an order of this Court that the effective date of any approval of ANDA No. 213604 be a date that is no earlier than July 14, 2023, the expiration of the ’659 and ’331 patents’ pediatric exclusivity, November 27, 2027, the expiration date of the ’938 patent’s pediatric exclusivity, and May 8, 2027, the expiration of the ’134 patent’s pediatric exclusivity, or a date no earlier than the expiry

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of any other patent extension or exclusivity to which Novartis is entitled, and an award of damages for any commercial sale or use of the Torrent ANDA Products and any act committed by Torrent Pharma Inc. and/or Torrent Pharmaceuticals Ltd. with respect to the subject matter claimed in the ’659, ’331, ’938, and ’134 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 335 of the Complaint and therefore denies them.

336. On information and belief, Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. have taken and continue to take active steps towards the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products, including seeking approval of those products under ANDA No. 213604.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 336 of the Complaint and therefore denies them.

337. There is a substantial and immediate controversy between Novartis and Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. concerning the ’659, ’331, ’938, and ’134 patents. Novartis is entitled to declaratory judgment under 28 U.S.C. §§ 2201 and 2202 that Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. will infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 337 of the Complaint and therefore denies them.

PRAYER FOR RELIEF

WHEREFORE, Novartis prays that this Court grant the following relief:

a. Alkem Laboratories Ltd.; S&B Pharma, Inc. (ANDA No. 213764)

338. Judgment that defendants Alkem and S&B have infringed one or more claims of the ’659, ’331, ’938, and ’134 patents by filing ANDA No. 213764;

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ANSWER: Pursuant to the stipulation (D.I. 7) approved by the court on December

3, 2019, S&B Pharma has been dismissed from the case. To the extent a response is required,

Alkem denies the allegations. Alkem further denies that Novartis is entitled to any relief from the

Court whatsoever.

339. A permanent injunction restraining and enjoining defendants Alkem and S&B, and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of the Alkem ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Pursuant to the stipulation (D.I. 7) approved by the court on December

3, 2019, S&B Pharma has been dismissed from the case. To the extent a response is required,

Alkem denies the allegations. Alkem further denies that Novartis is entitled to any relief from the

Court whatsoever.

340. An order that the effective date of any approval of ANDA No. 213764 be a date that is not earlier than the expiration dates of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem denies that Novartis is entitled to any relief from the Court whatsoever.

341. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Alkem ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem denies that Novartis is entitled to any relief from the Court whatsoever.

342. Damages or other monetary relief from defendants Alkem and S&B for the infringement, inducement of infringement and contributory infringement of the ’659, ’331, ’938, and ’134 patents;

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ANSWER: Pursuant to the stipulation (D.I. 7) approved by the court on December

3, 2019, S&B Pharma has been dismissed from the case. To the extent a response is required,

Alkem denies the allegations. Alkem further denies that Novartis is entitled to any relief from the

Court whatsoever.

343. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem denies that Novartis is entitled to any relief from the Court whatsoever.

344. Novartis’s costs and expenses in this action; and

ANSWER: Alkem denies that Novartis is entitled to any relief from the Court whatsoever.

345. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem denies the allegations and that Novartis is entitled to any relief from the Court whatsoever. Alkem respectfully requests that the Court: (a) dismiss the Complaint against

Alkem with prejudice; (b) enter judgment in favor of Alkem; (c) award Alkem its reasonable attorneys’ fees and costs of defending this action pursuant to 35 U.S.C. § 285; and (d) award Alkem such further relief as the Court deems just and appropriate.

b. Aurobindo Pharma USA Inc.; Aurobindo Pharma Ltd. (ANDA No. 213631)

346. Judgment that defendants Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. have infringed one or more claims of the ’659, ’331, ’938, and ’134 patents by filing ANDA No. 213631;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 346 of the Complaint and therefore denies them.

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347. A permanent injunction restraining and enjoining defendants Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd., and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of the Aurobindo ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 347 of the Complaint and therefore denies them.

348. An order that the effective date of any approval of ANDA No. 213631 be a date that is not earlier than the expiration dates of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 348 of the Complaint and therefore denies them.

349. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Aurobindo ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 349 of the Complaint and therefore denies them.

350. Damages or other monetary relief from defendants Aurobindo Pharma USA Inc. and Aurobindo Pharma Ltd. for the infringement, inducement of infringement and contributory infringement of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 350 of the Complaint and therefore denies them.

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351. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 351 of the Complaint and therefore denies them.

352. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 352 of the Complaint and therefore denies them.

353. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 353 of the Complaint and therefore denies them.

c. Biocon Pharma Limited; Biocon Limited; Biocon Pharma, Inc. (ANDA No. 213680)

354. Judgment that defendants Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. have infringed one or more claims of the ’659, ’331, ’938, and ’134 patents by filing ANDA No. 213680;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 354 of the Complaint and therefore denies them.

355. A permanent injunction restraining and enjoining defendants Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc., and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale or offer for sale in the United States, or importation into the United States, of the Biocon ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 355 of the Complaint and therefore denies them.

356. An order that the effective date of any approval of ANDA No. 213680 be a date that is not earlier than the expiration dates of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 356 of the Complaint and therefore denies them.

357. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Biocon ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 357 of the Complaint and therefore denies them.

358. Damages or other monetary relief from defendants Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc. for the infringement, inducement of infringement and contributory infringement of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 358 of the Complaint and therefore denies them.

359. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 359 of the Complaint and therefore denies them.

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360. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 360 of the Complaint and therefore denies them.

361. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 361 of the Complaint and therefore denies them.

d. Crystal Pharmaceutical (Suzhou) Co., Ltd. (ANDA No. 213605)

362. Judgment that defendant Crystal has infringed one or more claims of the ’659, ’331, ’938, and ’134 patents by filing ANDA No. 213605;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 362 of the Complaint and therefore denies them.

363. A permanent injunction restraining and enjoining defendant Crystal and its officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of the Crystal ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 363 of the Complaint and therefore denies them.

364. An order that the effective date of any approval of ANDA No. 213605 be a date that is not earlier than the expiration dates of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 364 of the Complaint and therefore denies them.

365. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Crystal ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 365 of the Complaint and therefore denies them.

366. Damages or other monetary relief from defendant Crystal for the infringement, inducement of infringement and contributory infringement of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 366 of the Complaint and therefore denies them.

367. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 367 of the Complaint and therefore denies them.

368. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 368 of the Complaint and therefore denies them.

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369. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 369 of the Complaint and therefore denies them.

e. Laurus Labs Limited; Laurus Generics Inc. (ANDA No. 213676)

370. Judgment that defendants Laurus Labs Limited and Laurus Generics Inc. have infringed one or more claims of the ’659, ’331, ’938, and ’134 patents by filing ANDA No. 213676;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 370 of the Complaint and therefore denies them.

371. A permanent injunction restraining and enjoining defendants Laurus Labs Limited and Laurus Generics Inc., and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of the Laurus ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 371 of the Complaint and therefore denies them.

372. An order that the effective date of any approval of ANDA No. 213676 be a date that is not earlier than the expiration dates of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 372 of the Complaint and therefore denies them.

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373. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Laurus ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 373 of the Complaint and therefore denies them.

374. Damages or other monetary relief from defendants Laurus Labs Limited and Laurus Generics Inc. for the infringement, inducement of infringement and contributory infringement of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 374 of the Complaint and therefore denies them.

375. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 375 of the Complaint and therefore denies them.

376. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 376 of the Complaint and therefore denies them.

377. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 377 of the Complaint and therefore denies them.

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f. Lupin Atlantis Holdings, S.A.; Lupin Limited; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213808)

378. Judgment that defendants Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. have infringed one or more claims of the ’938 and ’134 patents by filing ANDA No. 213808;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 378 of the Complaint and therefore denies them.

379. A permanent injunction restraining and enjoining defendants Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc., and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of the Lupin Atlantis ANDA Products prior to the expiration of the ’938 and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 379 of the Complaint and therefore denies them.

380. An order that the effective date of any approval of ANDA No. 213808 be a date that is not earlier than the expiration dates of the ’938 and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 380 of the Complaint and therefore denies them.

381. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Atlantis ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’938 and ’134 patents;

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 381 of the Complaint and therefore denies them.

382. Damages or other monetary relief from defendants Lupin Atlantis Holdings, S.A., Lupin Limited, Lupin Inc., and Lupin Pharmaceuticals, Inc. for the infringement, inducement of infringement and contributory infringement of the ’938 and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 382 of the Complaint and therefore denies them.

383. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 383 of the Complaint and therefore denies them.

384. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 384 of the Complaint and therefore denies them.

385. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 385 of the Complaint and therefore denies them.

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g. Lupin Limited; Lupin Atlantis Holdings, S.A.; Lupin Inc.; Lupin Pharmaceuticals, Inc. (ANDA No. 213809)

386. Judgment that defendants Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. have infringed one or more claims of the ’938 and ’134 patents by filing ANDA No. 213809;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 386 of the Complaint and therefore denies them.

387. A permanent injunction restraining and enjoining defendants Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc., and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of the Lupin Limited ANDA Products prior to the expiration of the ’938 and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 387 of the Complaint and therefore denies them.

388. An order that the effective date of any approval of ANDA No. 213809 be a date that is not earlier than the expiration dates of the ’938 and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 388 of the Complaint and therefore denies them.

389. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Lupin Limited ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’938 and ’134 patents;

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 389 of the Complaint and therefore denies them.

390. Damages or other monetary relief from defendants Lupin Limited, Lupin Atlantis Holdings, S.A., Lupin Inc., and Lupin Pharmaceuticals, Inc. for the infringement, inducement of infringement and contributory infringement of the ’938 and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 390 of the Complaint and therefore denies them.

391. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 391 of the Complaint and therefore denies them.

392. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 392 of the Complaint and therefore denies them.

393. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 393 of the Complaint and therefore denies them.

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h. Nanjing Noratech Pharmaceutical Co., Limited (ANDA No. 213671)

394. Judgment that defendant Noratech has infringed one or more claims of the ’938 and ’134 patents by filing ANDA No. 213671;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 394 of the Complaint and therefore denies them.

395. A permanent injunction restraining and enjoining defendant Noratech and its officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale or offer for sale in the United States, or importation into the United States, of the Noratech ANDA Products prior to the expiration of the ’938 and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 395 of the Complaint and therefore denies them.

396. An order that the effective date of any approval of ANDA No. 213671 be a date that is not earlier than the expiration dates of the ’938 and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 396 of the Complaint and therefore denies them.

397. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Noratech ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’938 and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 397 of the Complaint and therefore denies them.

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398. Damages or other monetary relief from defendant Noratech for the infringement, inducement of infringement and contributory infringement of the ’938 and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 398 of the Complaint and therefore denies them.

399. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 399 of the Complaint and therefore denies them.

400. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 400 of the Complaint and therefore denies them.

401. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 401 of the Complaint and therefore denies them.

i. Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd. (ANDA No. 213577)

402. Judgment that defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. have infringed one or more claims of the ’659, ’331, ’938, and ’134 patents by filing ANDA No. 213577;

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 402 of the Complaint and therefore denies them.

403. A permanent injunction restraining and enjoining defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale or offer for sale in the United States, or importation into the United States, of the Teva ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 403 of the Complaint and therefore denies them.

404. An order that the effective date of any approval of ANDA No. 213577 be a date that is not earlier than the expiration dates of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 404 of the Complaint and therefore denies them.

405. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Teva ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 405 of the Complaint and therefore denies them.

406. Damages or other monetary relief from defendants Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. for the infringement, inducement of infringement and contributory infringement of the ’659, ’331, ’938, and ’134 patents;

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ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 406 of the Complaint and therefore denies them.

407. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 407 of the Complaint and therefore denies them.

408. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 408 of the Complaint and therefore denies them.

409. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 409 of the Complaint and therefore denies them.

j. Torrent Pharma Inc.; Torrent Pharmaceuticals Ltd. (ANDA No. 213604)

410. Judgment that defendants Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. have infringed one or more claims of the ’659, ’331, ’938, and ’134 patents by filing ANDA No. 213604;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 410 of the Complaint and therefore denies them.

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411. A permanent injunction restraining and enjoining defendants Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd., and their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, sale, or offer for sale in the United States, or importation into the United States, of the Torrent ANDA Products prior to the expiration of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 411 of the Complaint and therefore denies them.

412. An order that the effective date of any approval of ANDA No. 213604 be a date that is not earlier than the expiration dates of the ’659, ’331, ’938, and ’134 patents, inclusive of any extensions and additional periods of exclusivity;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 412 of the Complaint and therefore denies them.

413. Declaratory judgment that the commercial manufacture, use, sale, offer for sale, and/or importation of the Torrent ANDA Products will directly infringe, induce infringement of, and/or contributorily infringe one or more claims of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 413 of the Complaint and therefore denies them.

414. Damages or other monetary relief from defendants Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. for the infringement, inducement of infringement and contributory infringement of the ’659, ’331, ’938, and ’134 patents;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 414 of the Complaint and therefore denies them.

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415. A declaration that this case is an exceptional case pursuant to 35 U.S.C. § 285 and an award of attorney’s fees;

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 415 of the Complaint and therefore denies them.

416. Novartis’s costs and expenses in this action; and

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 416 of the Complaint and therefore denies them.

417. Such other and further relief as the Court may deem just and proper.

ANSWER: Alkem is without sufficient information with which to form a belief as to the truth or accuracy of the allegations of Paragraph 417 of the Complaint and therefore denies them.

AFFIRMATIVE DEFENSES ALKEM’S ADDITIONAL DEFENSES

Alkem asserts the following defenses without prejudice to the denials in this Answer and

without admitting any allegations of Novartis’ Complaint not otherwise admitted.

FIRST ADDITIONAL DEFENSE (INVALIDITY OF ’659 PATENT)

The claims of the ’659 patent are invalid and/or unenforceable under 35 U.S.C. §§ 101, et

seq., including, inter alia, §§ 101, 102, 103, and/or 112, or under other judicially-created bases for

invalidation.

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SECOND ADDITIONAL DEFENSE (NON-INFRINGEMENT OF THE ’659 PATENT)

The manufacture, use, offer for sale, sale, or importation of the products described in

Alkem’s ANDA do not and will not infringe, directly or indirectly, either literally or under the

doctrine of equivalents, any valid and enforceable claim of the ’659 patent.

THIRD ADDITIONAL DEFENSE (INVALIDITY OF ’331 PATENT)

The claims of the ’331 patent are invalid and/or unenforceable under 35 U.S.C. §§ 101, et

seq., including, inter alia, §§ 101, 102, 103, and/or 112, or under other judicially-created bases for

invalidation.

FOURTH ADDITIONAL DEFENSE (NON-INFRINGEMENT OF THE ’331 PATENT)

The manufacture, use, offer for sale, sale, or importation of the products described in

Alkem’s ANDA do not and will not infringe, directly or indirectly, either literally or under the

doctrine of equivalents, any valid and enforceable claim of the ’331 patent.

FIFTH ADDITIONAL DEFENSE (INVALIDITY OF ’938 PATENT)

The claims of the ’938 patent are invalid and/or unenforceable under 35 U.S.C. §§ 101, et

seq., including, inter alia, §§ 101, 102, 103, and/or 112, or under other judicially-created bases for

invalidation.

SIXTH ADDITIONAL DEFENSE (NON-INFRINGEMENT OF THE ’938 PATENT)

The manufacture, use, offer for sale, sale, or importation of the products described in

Alkem’s ANDA do not and will not infringe, directly or indirectly, either literally or under the

doctrine of equivalents, any valid and enforceable claim of the ’938 patent.

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SEVENTH ADDITIONAL DEFENSE (INVALIDITY OF ’134 PATENT)

The claims of the ’134 patent are invalid and/or unenforceable under 35 U.S.C. §§ 101, et

seq., including, inter alia, §§ 101, 102, 103, and/or 112, or under other judicially-created bases for

invalidation.

EIGHTH ADDITIONAL DEFENSE (NON-INFRINGEMENT OF THE ’134 PATENT)

The manufacture, use, offer for sale, sale, or importation of the products described in

Alkem’s ANDA do not and will not infringe, directly or indirectly, either literally or under the

doctrine of equivalents, any valid and enforceable claim of the ’134 patent.

NINTH ADDITIONAL DEFENSE (FAILURE TO STATE A CLAIM)

Plaintiff’s Complaint, in whole and/or in part, fails to state a claim upon which relief can

be granted.

TENTH ADDITIONAL DEFENSE (LACK OF SUBJECT MATTER JURISDICTION)

Plaintiff’s complaint lacks subject matter jurisdiction over any and all claims asserted

under 35 U.S.C. § 271(a), (b), and/or (c), and for any and all claims asserted against Alkem.

ELEVENTH ADDITIONAL DEFENSE (FAILURE TO STATE A CLAIM FOR EXCEPTIONAL CASE OR WILLFUL INFRINGEMENT)

Plaintiff does not state a claim for an exceptional case and/or willful infringement, and thus

is not entitled to any such relief.

TWELFTH ADDITIONAL DEFENSE (NO COSTS)

Plaintiff is barred by 35 U.S.C. § 288 from recovering costs associated with this suit.

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THIRTEENTH ADDITIONAL DEFENSE (PROSECUTION HISTORY ESTOPPEL)

Plaintiff’s claims are barred in whole or in part by the doctrine of prosecution history

estoppel. Under this doctrine, Plaintiff cannot use the doctrine of equivalents to reclaim claim

scope surrendered during prosecution.

FOURTEENTH ADDITIONAL DEFENSE (UNCLEAN HANDS)

Plaintiff has unclean hands, which precludes any award of equitable or declaratory relief.

RESERVATION OF ADDITIONAL AFFIRMATIVE DEFENSES

Alkem reserves the right to plead any and defenses that may be revealed through the course

of discovery, including unenforceability.

COUNTERCLAIMS

For its counterclaims against Plaintiff/Counterclaim Defendant Novartis Pharmaceutical

Corporation (“Novartis”), Defendant/Counterclaim Plaintiff Alkem Laboratories Ltd. (“Alkem”)

states as follows:

THE PARTIES

1. Alkem Laboratories, Ltd. is a corporation organized under the laws of India, having

a place of business at Devashish Building, Alkem House, Senapati Bapat Road, Lower Parel,

Mumbai – 400 013, India.

2. Upon information and belief, Novartis Pharmaceuticals Corporation (“Novartis”)

is a corporation organized and existing under the laws of the State of Delaware, with its principal

place of business in East Hanover, New Jersey.

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JURISDICTION AND VENUE

3. These counterclaims arise ‘under the Patent Laws of the United States, 35 U.S.C. §

100 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.

4. The Court has jurisdiction over the subject matter of these counterclaims, pursuant

to 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202 based on an actual controversy between Alkem

and Novartis arising under the Patent Laws of the United States, 35 U.S.C. § 1 et seq.

5. The Court has personal jurisdiction over Novartis because Novartis has availed

itself of the rights and privileges of this forum by filing suit against Alkem in this judicial District

and, upon information and belief, because of Novartis systematic and continuous contacts with

Delaware by virtue of Novartis’s distribution of drugs for sale and use in Delaware.

6. Venue for these Counterclaims is proper in this judicial District, pursuant to 28

U.S.C. §§ 1391(b) and (c).

PATENTS-IN-SUIT

7. On or about January 24, 2012, the United States Patent and Trademark Office

(“USPTO”) issued U.S. Patent No. 8,101,659 (the “’659 patent”) entitled “Methods of treatment

and pharmaceutical composition.” Upon information and belief, Novartis owns the ’659 patent.

Upon information and belief, a true and correct copy of the ’659 patent is attached to the complaint

as Exhibit A.

8. On or about August 5, 2014, the USPTO issued U.S. Patent No. 8,796,331 (the

“’331 patent”) entitled “Methods of treatment and pharmaceutical composition.” Upon

information and belief, Novartis owns the ’331 patent. Upon information and belief, a true and

correct copy of the ’331 patent is attached to the complaint as Exhibit B.

9. On or about November 4, 2014, the USPTO issued U.S. Patent No. 8,877,938 (the

“’938 patent”) entitled “Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-

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4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-

pentanoic acid ethyl ester moieties and cations.” Upon information and belief, Novartis owns the

’938 patent. Upon information and belief, a true and correct copy of the ’938 patent is attached to

the complaint as Exhibit C.

10. On or about July 12, 2016, the USPTO issued U.S. Patent No. 9,388,134 (the “’134

patent”) entitled “Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-

methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic

acid ethyl ester moieties and cations.” Upon information and belief, Novartis owns the ’134 patent.

Upon information and belief, a true and correct copy of the ’134 patent is attached to the complaint

as Exhibit D.

11. Upon information and belief, Novartis is the holder of New Drug Application

(“NDA”) No. 207620 for Entresto® (sacubitril and valsartan) tablets, 24 mg/26 mg, 49 mg/51 mg,

and 97 mg/103 mg.

12. Upon information and belief, Novartis listed or caused to be listed the ’’659, ’331,

’938, and ’134 patents in FDA’s Approved Drug Products with Therapeutic Equivalence

Evaluations (“the Orange Book”) in association with Entresto® (sacubitril and valsartan) tablets,

24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.

13. Alkem filed ANDA No. 213764 seeking FDA approval to engage in the

commercial manufacture, use, or sale of the sacubitril/valsartan tablets, 24 mg/26 mg, 49 mg/51

mg, and 97 mg/103 mg (“Alkem’s ANDA Products”).

14. Alkem’s ANDA contained a “paragraph IV certification” under 21 U.S.C. §

355(j)(2)(A)(vii)(IV) to each of the ’659, ’331, ’938, and ’134 patents, certifying that the patents

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are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use, or sale

of the Alkem’s ANDA Product.

15. On October 17, 2019, Novartis filed this lawsuit alleging infringement of the ’659,

’331, ’938, and ’134 patents.

COUNT I: DECLARATORY JUDGMENT OF INVALIDITY OF THE ’659 PATENT

16. Alkem re-alleges and incorporate by reference the allegations in paragraphs 1-15

of these Counterclaims.

17. There is an actual, substantial, confirming, and justiciable controversy between the

parties regarding the invalidity of the ’659 patent, based on Novartis’ allegation in its Complaint

that Alkem has infringed or will infringe the ’659 patent.

18. Each and every claim of the ’659 patent is invalid for failure to satisfy one or more

provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 101,

102, 103, and 112.

19. The claims of the ’659 patent are obvious to a person of ordinary skill in the art

because each and every element of each and every claim of the ’659 patent was disclosed expressly

in one or more references and/or products which were publicly available before the earliest

possible priority date of the ’659 patent, including, but not limited to, those references and/or

products disclosed in Alkem’s Paragraph IV Certification Notice Letter, and the person of ordinary

skill in the art would have been motivated to combine those references and/or products as of the

earliest possible priority date of the ’659 patent, and would have had a reasonable expectation of

success in doing so.

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20. There is no objective evidence of non-obviousness of the claims of the ’659 patent,

nor would any such evidence, should it exist, have any nexus to the claimed purported inventions

of the ’659 patent.

21. The specification of the ’659 patent does not contain a written description of the

invention, and of the manner and process of making and using it, in such full, clear, concise, and

exact terms as to enable any person skilled in the art to which it pertains to make and use the same.

22. The ’659 patent does not describe the manner and process of making and using the

invention so as to enable a person of skill in the art to make and use the full scope of the invention

without undue experimentation.

23. Alkem is entitled to a judicial declaration that the claims of the ’659 patent are

invalid.

COUNT II: DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF THE ’659 PATENT

24. Alkem re-alleges and incorporate by reference the allegations in paragraphs 1-23

of these Counterclaims.

25. There is an actual, substantial, continuing, and justiciable controversy between the

parties regarding whether the filing of the Alkem’s ANDA and/or the manufacture, use, offer to

sell, sale, and/or importation into the United States of the Alkem’s ANDA Product infringes, has

infringed, or will infringe any valid and enforceable claim of the ’659 patent either directly or

indirectly, and either literally or under the doctrine of equivalents.

26. Alkem has not infringed, contributed to the infringement of, or induced the

infringement of any valid and enforceable claim of the ’659 patent either literally or under the

doctrine of equivalents and are not liable for such infringement. The claims of the ’659 patent or

its use are invalid, and “invalidity operates as a complete defense to infringement for any product,

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forever.” Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1335 (Fed. Cir. 1998) citing

Blonder–Tongue Laboratories, Inc. v. U. ILL. Foundation, 402 U.S. 313, 91 S.Ct. 1434, 28

L.Ed.2d 788 (1971).

27. Alkem is entitled to a judicial declaration that it has not infringed, contributed to

the infringement of, or induced the infringement of the ’659 patent either literally or under the

doctrine of equivalents; and that the manufacture, use, sale, offer for sale, or importation of the

Alkem’s ANDA Product has not infringed, does not infringe, and will not infringe any valid and

enforceable claims of the ’659 patent.

COUNT III: DECLARATORY JUDGMENT OF INVALIDITY OF THE ’331 PATENT

28. Alkem re-alleges and incorporate by reference the allegations in paragraphs 1-27

of these Counterclaims.

29. There is an actual, substantial, confirming, and justiciable controversy between the

parties regarding the invalidity of the ’331 patent, based on Novartis’ allegation in its Complaint

that Alkem has infringed or will infringe the ’331 patent.

30. Each and every claim of the ’331 patent is invalid for failure to satisfy one or more

provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 101,

102, 103, and 112.

31. The claims of the ’331 patent are obvious to a person of ordinary skill in the art

because each and every element of each and every claim of the ’331 patent was disclosed expressly

in one or more references and/or products which were publicly available before the earliest

possible priority date of the ’331 patent, including, but not limited to, those references and/or

products disclosed in Alkem’s Paragraph IV Certification Notice Letter, and the person of ordinary

skill in the art would have been motivated to combine those references and/or products as of the

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earliest possible priority date of the ’331 patent, and would have had a reasonable expectation of

success in doing so.

32. There is no objective evidence of non-obviousness of the claims of the ’331 patent,

nor would any such evidence, should it exist, have any nexus to the claimed purported inventions

of the ’331 patent.

33. The specification of the ’331 patent does not contain a written description of the

invention, and of the manner and process of making and using it, in such full, clear, concise, and

exact terms as to enable any person skilled in the art to which it pertains to make and use the same.

34. The ’331 patent does not describe the manner and process of making and using the

invention so as to enable a person of skill in the art to make and use the full scope of the invention

without undue experimentation.

35. Alkem is entitled to a judicial declaration that the claims of the ’331 patent are

invalid.

COUNT IV: DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF THE ’331 PATENT

36. Alkem re-alleges and incorporate by reference the allegations in paragraphs 1-35

of these Counterclaims.

37. There is an actual, substantial, continuing, and justiciable controversy between the

parties regarding whether the filing of the Alkem’s ANDA and/or the manufacture, use, offer to

sell, sale, and/or importation into the United States of the Alkem’s ANDA Product infringes, has

infringed, or will infringe any valid and enforceable claim of the ’331 patent either directly or

indirectly, and either literally or under the doctrine of equivalents.

38. Alkem has not infringed, contributed to the infringement of, or induced the

infringement of any valid and enforceable claim of the ’331 patent either literally or under the

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doctrine of equivalents and are not liable for such infringement. The claims of the ’331 patent or

its use are invalid, and “invalidity operates as a complete defense to infringement for any product,

forever.” Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1335 (Fed. Cir. 1998) citing

Blonder–Tongue Laboratories, Inc. v. U. ILL. Foundation, 402 U.S. 313, 91 S.Ct. 1434, 28

L.Ed.2d 788 (1971).

39. Alkem is entitled to a judicial declaration that it has not infringed, contributed to

the infringement of, or induced the infringement of the ’331 patent either literally or under the

doctrine of equivalents; and that the manufacture, use, sale, offer for sale, or importation of the

Alkem’s ANDA Product has not infringed, does not infringe, and will not infringe any valid and

enforceable claims of the ’331 patent.

COUNT V: DECLARATORY JUDGMENT OF INVALIDITY OF THE ’938 PATENT

40. Alkem re-alleges and incorporate by reference the allegations in paragraphs 1-39

of these Counterclaims.

41. There is an actual, substantial, confirming, and justiciable controversy between the

parties regarding the invalidity of the ’938 patent, based on Novartis’ allegation in its Complaint

that Alkem has infringed or will infringe the ’938 patent.

42. Each and every claim of the ’938 patent is invalid for failure to satisfy one or more

provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 101,

102, 103, and 112.

43. The claims of the ’938 patent are obvious to a person of ordinary skill in the art

because each and every element of each and every claim of the ’938 patent was disclosed expressly

in one or more references and/or products which were publicly available before the earliest

possible priority date of the ’938 patent, and the person of ordinary skill in the art would have been

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motivated to combine those references and/or products as of the earliest possible priority date of

the ’938 patent, and would have had a reasonable expectation of success in doing so.

44. There is no objective evidence of non-obviousness of the claims of the ’938 patent,

nor would any such evidence, should it exist, have any nexus to the claimed purported inventions

of the ’938 patent.

45. The specification of the ’938 patent does not contain a written description of the

invention, and of the manner and process of making and using it, in such full, clear, concise, and

exact terms as to enable any person skilled in the art to which it pertains to make and use the same.

46. The ’938 patent does not describe the manner and process of making and using the

invention so as to enable a person of skill in the art to make and use the full scope of the invention

without undue experimentation.

47. Alkem is entitled to a judicial declaration that the claims of the ’938 patent are

invalid.

COUNT VI: DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF THE ’938 PATENT

48. Alkem re-alleges and incorporates by reference the allegations in paragraphs 1-47

of these Counterclaims.

49. There is an actual, substantial, continuing, and justiciable controversy between the

parties regarding whether the filing of the Alkem’s ANDA and/or the manufacture, use, offer to

sell, sale, and/or importation into the United States of the Alkem’s ANDA Product infringes, has

infringed, or will infringe any valid and enforceable claim of the ’938 patent either directly or

indirectly, and either literally or under the doctrine of equivalents.

50. Alkem has not infringed, contributed to the infringement of, or induced the

infringement of any valid and enforceable claim of the ’938 patent either literally or under the

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doctrine of equivalents and are not liable for such infringement. The claims of the ’938 patent or

its use are invalid, and “invalidity operates as a complete defense to infringement for any product,

forever.” Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1335 (Fed. Cir. 1998) citing

Blonder–Tongue Laboratories, Inc. v. U. ILL. Foundation, 402 U.S. 313, 91 S.Ct. 1434, 28

L.Ed.2d 788 (1971).

51. The manufacture, use, offer for sale, sale, importation, and/or marketing of Alkem’s

ANDA Product described in Alkem’s ANDA has not infringed, does not infringe, and would not

—if made, used, sold, offered for sale, imported or marketed—infringe, either directly or

indirectly, the claims of the ’938 patent, either literally or under the doctrine of equivalents.

52. Alkem also does not infringe the ’938 patent because the patent claims do not cover

Alkem’s ANDA Product. The claims of the ’938 patent all require valsartan/sacubitril

hemipentahydrate in crystalline form, which is not found in Alkem’s ANDA Product, as detailed

in the September 9, 2019 Notice Letter to Novartis.

53. Alkem is entitled to a judicial declaration that it has not infringed, contributed to

the infringement of, or induced the infringement of the ’938 patent either literally or under the

doctrine of equivalents; and that the manufacture, use, sale, offer for sale, or importation of the

Alkem’s ANDA Product has not infringed, does not infringe, and will not infringe any valid and

enforceable claims of the ’938 patent.

COUNT VII: DECLARATORY JUDGMENT OF INVALIDITY OF THE ’134 PATENT

54. Alkem re-alleges and incorporate by reference the allegations in paragraphs 1-53

of these Counterclaims.

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55. There is an actual, substantial, confirming, and justiciable controversy between the

parties regarding the invalidity of the ’134 patent, based on Novartis’ allegation in its Complaint

that Alkem has infringed or will infringe the ’134 patent.

56. Each and every claim of the ’134 patent is invalid for failure to satisfy one or more

provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 101,

102, 103, and 112.

57. Alkem has not infringed, contributed to the infringement of, or induced the

infringement of any valid and enforceable claim of the ’134 patent either literally or under the

doctrine of equivalents and are not liable for such infringement. The claims of the ’134 patent or

its use are invalid, and “invalidity operates as a complete defense to infringement for any product,

forever.” Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1335 (Fed. Cir. 1998) citing

Blonder–Tongue Laboratories, Inc. v. U. ILL. Foundation, 402 U.S. 313, 91 S.Ct. 1434, 28

L.Ed.2d 788 (1971).

58. The claims of the ’134 patent are obvious to a person of ordinary skill in the art

because each and every element of each and every claim of the ’134 patent was disclosed expressly

in one or more references and/or products which were publicly available before the earliest

possible priority date of the ’134 patent, and the person of ordinary skill in the art would have been

motivated to combine those references and/or products as of the earliest possible priority date of

the ’134 patent, and would have had a reasonable expectation of success in doing so.

59. There is no objective evidence of non-obviousness of the claims of the ’134 patent,

nor would any such evidence, should it exist, have any nexus to the claimed purported inventions

of the ’134 patent.

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60. The specification of the ’134 patent does not contain a written description of the

invention, and of the manner and process of making and using it, in such full, clear, concise, and

exact terms as to enable any person skilled in the art to which it pertains to make and use the same.

61. The ’134 patent does not describe the manner and process of making and using the

invention so as to enable a person of skill in the art to make and use the full scope of the invention

without undue experimentation.

62. Alkem is entitled to a judicial declaration that the claims of the ’134 patent are

invalid.

COUNT VIII: DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF THE ’134 PATENT

63. Alkem re-alleges and incorporates by reference the allegations in paragraphs 1-62

of these Counterclaims.

64. There is an actual, substantial, continuing, and justiciable controversy between the

parties regarding whether the filing of the Alkem’s ANDA and/or the manufacture, use, offer to

sell, sale, and/or importation into the United States of the Alkem’s ANDA Product infringes, has

infringed, or will infringe any valid and enforceable claim of the ’134 patent either directly or

indirectly, and either literally or under the doctrine of equivalents.

65. The manufacture, use, offer for sale, sale, importation, and/or marketing of Alkem’s

ANDA Product described in Alkem’s ANDA has not infringed, does not infringe, and would not

—if made, used, sold, offered for sale, imported or marketed—infringe, either directly or

indirectly, the claims of the ’134 patent, either literally or under the doctrine of equivalents.

66. Alkem also does not infringe the ’134 patent because the patent claims do not cover

Alkem’s ANDA Product. The claims of the ’134 patent all require valsartan/sacubitril

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hemipentahydrate in crystalline form, which is not found in Alkem’s ANDA Product, as detailed

in the September 9, 2019 Notice Letter to Novartis.

67. Alkem is entitled to a judicial declaration that it has not infringed, contributed to

the infringement of, or induced the infringement of the ’134 patent either literally or under the

doctrine of equivalents; and that the manufacture, use, sale, offer for sale, or importation of the

Alkem’s ANDA Product has not infringed, does not infringe, and will not infringe any valid and

enforceable claims of the ’134 patent.

PRAYER FOR RELIEF

WHEREFORE, Alkem respectfully prays for judgment in their favor and against Novartis:

A. Declaring that the claims of the ’659, ’331, ’938, and ’134 patents are invalid;

B. Declaring that the manufacture, use, sale, offer for sale, importation, and/or

marketing of Alkem’s ANDA Product has not infringed, does not infringe, and would not—if

made, used, sold, offered for sale, imported, or marketed—infringe, either directly or indirectly,

any valid and/or enforceable claim of the ’659, ’331, ’938, and ’134 patents either literally or under

the doctrine of equivalents;

C. Ordering that Novartis’s Complaint be dismissed with prejudice and judgment

entered in favor of Alkem;

D. Declaring this case exceptional and awarding Alkem its reasonable attorneys’ fees

and costs under 35 U.S.C. § 285;

E. Ordering that Novartis and its officers, agents, servants, employees, attorneys,

successors and any person who acts in concert or participation with it, be preliminarily and

permanently enjoined from using the ’659, ’331, ’938, and ’134 patents to block, hamper, hinder

or obstruct FDA approval of Alkem’s ANDA; and

131 11459560/1 Case 1:19-cv-01979-LPS Document 38 Filed 01/07/20 Page 132 of 132 PageID #: 592

F. Awarding such other and further relief as the Court may deem just and proper.

Respectfully Submitted, Dated: January 7, 2020 /s/ Kenneth L. Dorsney Kenneth L. Dorsney, Esq. (#3726) MORRIS JAMES LLP 500 Delaware Avenue, Suite 1500 Wilmington, DE 19801 (302) 888-6800 [email protected]

Of Counsel: Stephen R. Auten, Esq. Richard T. Ruzich, Esq. Roshan P. Shrestha, Ph.D., Esq. Taft Stettinius & Hollister LLP 111 East Wacker Drive, Suite 2800 Chicago, IL 60601 312-527-4000 [email protected] [email protected] [email protected]

Attorneys for Defendant Alkem Laboratories, Ltd.

132 11459560/1