In the United States District Court for the District of Delaware
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE NOVARTIS PHARMACEUTICALS CORPORATION Plaintiff, v. Civil Action No. _____ APOTEX INC., APOTEX CORP., BIONPHARMA INC., EMCURE PHARMACEUTICALS, HERITAGE PHARMACEUTICALS INC., EZRA VENTURES, LLC, GLENMARK PHARMACEUTICALS INC., USA, GLENMARK PHARMACEUTICALS LIMITED, HEC PHARM CO., LTD., HEC PHARM USA INC., HETERO USA INC., HETERO LABS LIMITED UNIT-V, HETERO LABS LIMITED, PRINSTON PHARMACEUTICAL INC., STRIDES GLOBAL PHARMA PRIVATE LIMITED, STRIDES PHARMA, INC., ZYDUS PHARMACEUTICALS (USA) INC., and CADILA HEALTHCARE LIMITED Defendants. COMPLAINT Novartis Pharmaceuticals Corporation (“Novartis”) by its attorneys hereby alleges as follows: NATURE OF THE ACTION 1. This is an action for patent infringement arising under the patent laws of the United States, Title 35, United States Code and for declaratory judgment pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201, et seq . This action relates to Abbreviated New Drug Applications (“ANDAs”) filed by the above-named defendants with the U.S. Food and Drug Administration (“FDA”) for approval to engage in the commercial manufacture, use, or sale of Fingolimod 0.5 mg capsules, generic versions of Novartis’s GILENYA ® Capsules, 0.5 mg, prior to expiration of U.S. Patent No. 10,543,179 (“the ’179 patent”). ME1 32500579v.1 PARTIES A. Novartis 2. Novartis Pharmaceuticals Corporation 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. B. The Generic Defendants a) Apotex Inc.; Apotex Corp. 3. Upon information and belief, Defendant Apotex Inc. is a corporation organized and existing under the laws of Canada, having a principal place of business at 150 Signet Drive, Toronto, Ontario, Canada M9L 1T9. 4. Upon information and belief, Apotex Inc. itself, and through its wholly- owned subsidiary and agent, Apotex Corp., develops, manufactures, and/or distributes generic drug products for marketing, sale, and/or use throughout the United States, including in this judicial district. 5. Upon information and belief, Defendant Apotex Corp. is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 2400 North Commerce Parkway, Suite 400, Weston, Florida 33326. 6. Upon information and belief, Apotex Inc. is in the business of, among other things, developing, manufacturing, and selling generic versions of branded pharmaceutical products for the U.S. market. Upon information and belief, Apotex Corp. is a wholly-owned subsidiary of Apotex Inc. and is controlled and/or dominated by Apotex Inc. Upon information and belief, Apotex Corp. develops, manufactures, and/or distributes generic drug products for marketing, sale, and/or use throughout the United States, including in this judicial district, at the - 2 - ME1 32500579v.1 direction, under the control, and for the benefit of Apotex Inc. Upon information and belief, Apotex Inc. established Apotex Corp. for the purposes of developing, manufacturing, and distributing its generic drug products throughout the United States, including in this judicial district. 7. Apotex Inc. and Apotex Corp. are collectively referred to hereafter as “Apotex” unless otherwise noted. 8. By a letter dated January 22, 2016, Apotex notified Plaintiff that Apotex had submitted to the FDA ANDA No. 207993 for Fingolimod 0.5 mg capsules, a drug product that is a generic version of GILENYA® (“Apotex’s ANDA Product”). The purpose of Apotex’s submission of the ANDA was to obtain approval under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to engage in the commercial manufacture, use, offer for sale, and/or sale of Apotex’s ANDA Product prior to the expiration of U.S. Patent No. 9,187,405 (“the ’405 patent”). 9. In its Notice Letter, Apotex notified Plaintiff that, as a part of its ANDA, Apotex had filed a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’405 patent asserting that the ’405 patent is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale of Apotex’s ANDA Product. 10. On the basis of this Notice Letter, Novartis filed suit against Apotex for infringement of the ’405 patent, which is still pending in this District. See Novartis Pharms. Corp. v. Apotex Inc. et al. , C.A. No. 18-cv-1038-LPS (D. Del.). Apotex answered, counterclaimed, and actively participated in this litigation prior to the case being stayed. See Novartis Pharms. Corp. v. Accord Healthcare Inc., et al , C.A. No. 18-1043-KAJ, D.I. 237 (D. - 3 - ME1 32500579v.1 Del.). Unlike other defendants, Apotex has not settled with Novartis, converted its Paragraph IV certification to Paragraph III, or otherwise withdrawn its ANDA, and thus appears to continue to pursue final approval from FDA to launch its product prior to expiration of the ’405 patent. 11. Upon information and belief, and consistent with their past practices, Apotex Inc. and Apotex Corp. acted collaboratively in the preparation and submission of ANDA No. 207993. 12. Upon information and belief, and consistent with their past practices, following any FDA approval of ANDA No. 207993, Apotex Inc. and Apotex Corp. will work in concert with one another to make, use, offer to sell, and/or sell the generic drug products that are the subject of ANDA No. 207993 throughout the United States, and/or import such generic drug products into the United States, including in this judicial district. 13. Apotex committed an act of infringement of the ’179 patent in this judicial district by filing ANDA No. 207993 with the intent to make, use, offer to sell, and/or sell the generic drug products that are the subject of ANDA No. 207993 in this judicial district, and/or will imminently commit an act of infringement by making, using, offering to sell, and/or selling the same, acts of infringement that will lead to foreseeable harm and injury to Novartis, a Delaware corporation. 14. Apotex Corp. is a Delaware corporation, has extensive contacts with the State of Delaware, and regularly does business in this District. On information and belief, Apotex Corp. is registered with the Delaware Board of Pharmacy, pursuant to Del. Code tit. 24, § 2540, as a licensed “Pharmacy—Wholesale[r]” (License No. A4-0001921) and “Distributor/Manufacturer CSR” (License No. DM-0008873). Moreover, on information and belief, Apotex Corp. has appointed a registered agent in Delaware (located at The Corporation - 4 - ME1 32500579v.1 Trust Company, Corporation Trust Center, 1209 Orange Street, Wilmington, DE 19801) for the receipt of service of process. 15. Apotex Inc. has extensive contacts with the State of Delaware, including through its subsidiary Apotex Corp., and regularly does business in this District, including through its subsidiary Apotex Corp. 16. Apotex has availed itself of the legal protections of the State of Delaware by, among other things, selecting the State of Delaware as the place of incorporation for Apotex Corp. and admitting jurisdiction and asserting counterclaims in lawsuits filed in the United States District Court for the District of Delaware. See, e.g. , Pfizer Inc. et al. v. Apotex Inc. et al. , C.A. No. 19-00747 (D. Del.); Vanda Pharm. Inc. v. Apotex Inc. et al. , C.A. No. 19-00685 (D. Del.); Bayer HealthCare LLC et al. v. Apotex Inc. et al. , C.A. No. 18-01465 (D. Del.); Astellas US LLC et al. v. Apotex Inc. , C.A. No. 18-01675 (D. Del.); Anacor Pharm., Inc. v. Ascent Pharm., Inc. et al. , C.A. No. 18-01673 (D. Del.); Genzyme Corp. et al. v. Apotex Corp. et al. , C.A. No. 18- 01795 (D. Del.); AstraZeneca AB et al. v. Apotex Inc. et al. , C.A. No. 18-02010 (D. Del.); Genentech, Inc. et al. v. Apotex Inc. et al. , C.A. No. 19-00123 (D. Del.); Genentech, Inc. et al. v. Apotex Inc. et al. , C.A. No. 19-00120 (D. Del.); Merck Sharp & Dohme Corp. v. Apotex Inc. et al. , C.A. No. 19-00313 (D. Del.); Pfizer Inc. et al v. Apotex Inc. et al. , C.A. No. 18-00795 (D. Del.); Otsuka Pharm. Co. v. Apotex Inc. et al. , C.A. No. 15-00109 (D. Del.); Aptalis Pharmatech, Inc. et al. v. Apotex Inc. et al. , C.A. No. 14-01038 (D. Del.); Apotex, Inc. et al. v. Senju Pharm. Co., Ltd. , C.A. No. 12-cv-00196 (D. Del.); Acorda Therapeutics, Inc. v. Apotex Corp. , C.A. No. 14-cv-00955 (D. Del.); Warner Chilcott Co., LLC v. Apotex, Inc. , C.A. No. 1:14-cv-00998 (D. Del.); Pfizer Inc. v. Apotex Inc. , C.A. No. 1:13-cv-02022 (D. Del.); Boehringer Ingelheim Pharm., Inc. v. Apotex Inc. et al. , C.A. No. 08-00065 (D. Del.). In - 5 - ME1 32500579v.1 particular, Apotex has admitted jurisdiction, filed counterclaims, and actively litigated two other patent cases related to GILENYA® in this District. See Novartis AG et al. v. Apotex Inc. et al. , C.A. No. 15-00975-LPS (D. Del.); Novartis Pharms. Corp. v. Apotex Inc. et al., C.A. No. 18- 1038-LPS (D. Del.). b) Bionpharma Inc. 17. Upon information and belief, Defendant Bionpharma Inc. is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 600 Alexander Road, Suite 2-4B, Princeton, NJ 08540. 18. Upon information and belief, Bionpharma Inc. is in the business of, among other things, developing, manufacturing, and selling generic versions of branded pharmaceutical products for the U.S. market, including in this District. 19. Bionpharma Inc. is referred to hereafter as “Bionpharma” unless otherwise noted.