Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 1 of 11 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE GILEAD SCIENCES, INC., ) ) Plaintiff, ) ) v. ) C.A. No. ) MYLAN PHARMACEUTICALS INC., ) ) Defendant. ) COMPLAINT FOR PATENT INFRINGEMENT Plaintiff Gilead Sciences, Inc. (“Plaintiff”) brings this Complaint for patent infringement against Defendant Mylan Pharmaceuticals Inc. (“Mylan”) and alleges as follows: NATURE OF THE ACTION 1. This is a civil action for patent infringement by Mylan of U.S. Patent No. 8,148,374 (“the ’374 Patent”), arising under the patent laws of the United States, 35 U.S.C. § 100 et seq., and, more particularly 35 U.S.C. §§ 271(a), (b), (c), (e), and 281. This action relates to the Abbreviated New Drug Application (“ANDA”) No. 208982, filed by Mylan with the United States Food and Drug Administration (“FDA”) for approval to market generic versions of Gilead Sciences, Inc.’s Tybost® (cobicistat tablets) drug product prior to the expiration of the ’374 Patent. PARTIES 2. Plaintiff Gilead Sciences, Inc. is a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 333 Lakeside Drive, Foster City, California 94404. 3. On information and belief, Defendant Mylan Pharmaceuticals Inc. is a corporation organized and existing under the laws of the State of West Virginia, having a principal place of Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 2 of 11 PageID #: 2 business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505. On information and belief, Mylan is in the business of, among other things, manufacturing and selling generic copies of branded pharmaceutical products for the United States market. 4. On information and belief, and consistent with its practice with respect to other generic products, Mylan will act to distribute and sell its generic cobicistat tablet drug product that is the subject of ANDA No. 208982 (“Defendant’s ANDA Product”) throughout the United States, including within Delaware. On information and belief, Mylan knows and intends that Defendant’s ANDA Product will be distributed and sold in the United States, including within Delaware. JURISDICTION AND VENUE 5. This action arises under the patent laws of the United States of America. This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331 and 1338(a). 6. On information and belief, this Court has personal jurisdiction over Mylan because Mylan has purposefully availed itself of the benefits and protections of Delaware’s laws, such that Mylan should reasonably anticipate being haled into court in Delaware. On information and belief, Mylan has had persistent and continuous contacts within this judicial district, including developing, manufacturing, and/or selling pharmaceutical products that are sold in this judicial district. 7. On information and belief, Mylan is in the business of, among other things, formulating, developing, manufacturing, packaging, marketing, and selling generic copies of branded pharmaceutical products for the United States market, including in Delaware. On information and belief, Mylan, directly or through its affiliates and agents, formulates, 2 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 3 of 11 PageID #: 3 manufactures, packages, markets, and/or sells pharmaceutical products throughout the United States and in Delaware. 8. On information and belief, Mylan derives substantial revenue from selling generic pharmaceutical products throughout the United States, including in this judicial district. 9. On information and belief, Mylan is registered with the Delaware Board of Pharmacy as a “Pharmacy-Wholesale[r]” (License No. A4-0001719) and a “Distributor/Manufacturer CSR” (License No. DM-0007571). See Acorda Therapeutics, Inc. v. Mylan Pharm. Inc., 78 F. Supp. 3d 572, 593 (D. Del. 2015). 10. On information and belief, Mylan is registered to do business in Delaware under Delaware’s Business Registration Statute, 8 Del. C. §§ 371 and 376 (2010), and has thereby consented to suit in Delaware. Id. at 587-91. 11. On information and belief, Mylan has appointed Corporation Service Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware 19808, as its registered agent for receipt and service of process. 12. On information and belief, Mylan either sells its generic pharmaceuticals directly into Delaware or has a network of independent wholesalers and distributors with which it contracts to market generic pharmaceutical products in Delaware. See Acorda Therapeutics Inc. v. Mylan Pharm. Inc., Nos. 2015-1456, -1460, slip op. at 15 (Fed. Cir. Mar. 18, 2016). 13. This suit arises out of Mylan’s ANDA filing, “which is a prerequisite to obtaining FDA approval, which is necessary in order to sell Mylan’s Generic Product in the United States, including in Delaware.” Acorda, 78 F. Supp. 3d at 593. 14. This Court has repeatedly exercised jurisdiction over Mylan in prior cases under the Hatch-Waxman Act. See, e.g., Memorandum, Novartis Pharm. Corp. v. Mylan Inc., No. 14- 3 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 4 of 11 PageID #: 4 cv-820-RGA (D. Del. Mar. 16, 2015); Report & Recommendation, Forest Labs., Inc. v. Amneal Pharm. LLC, No. 14-cv-508-LPS (D. Del. Feb. 26, 2015); Opinion, Acorda Therapeutics, Inc. v. Mylan Pharm. Inc., No. 14-cv-935-LPS (D. Del. Jan. 14, 2015); Opinion, AstraZeneca AB v. Mylan Pharm., Inc., No. 14-cv-696-GMS (D. Del. Nov. 5, 2014). See also Acorda, slip op. at 12-13 (discussing why “litigation authorized by § 271(e)(2) and (5) meets Article III’s requirement of a case or controversy”). 15. On information and belief, Mylan has “litigated, as a defendant, over 50 other civil actions initiated in this jurisdiction in the last 19 years and affirmatively invoked this Court’s jurisdiction by asserting counterclaims in at least 46 of those cases.” See Acorda, 78 F. Supp. 3d at 577-78 (internal quotation marks omitted). 16. Mylan also engaged in Delaware-related activities in connection with its efforts to obtain FDA approval to market Defendant’s ANDA Product. On information and belief, Mylan sent a letter dated February 16, 2016 to Plaintiff Gilead Sciences, Inc., a corporation organized under the laws of the State of Delaware, stating that Mylan had submitted ANDA No. 208982 seeking approval to commercially manufacture, use, import, offer for sale, and sell Defendant’s ANDA Product prior to the expiration of the ’374 Patent. If Mylan succeeds in obtaining FDA approval, it would sell Defendant’s ANDA Product in Delaware and other states, causing injury to Plaintiff Gilead Sciences, Inc. in Delaware. See Acorda, slip op. at 8-9, 12-13. 17. On information and belief, Mylan has actual and constructive knowledge that Plaintiff Gilead Sciences, Inc. is a Delaware corporation. 18. On information and belief, Mylan has previously invoked this Court’s jurisdiction, or has stipulated and/or consented to personal jurisdiction in this district, including in prior patent cases. 4 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 5 of 11 PageID #: 5 19. On information and belief, Mylan litigates patent cases in federal courts as part of its business model as a manufacturer of generic drugs, including in this judicial district—where the highest percentage of all Hatch-Waxman cases were filed in the past five years. See Acorda, 78 F. Supp. 3d at 594 n.21; see also Acorda, slip op. at 16. 20. Venue is proper in this judicial district under 28 U.S.C. §§ 1391(b) and (c), and 1400(b). BACKGROUND 21. On April 3, 2012, the United States Patent and Trademark Office issued the ’374 Patent, entitled “Modulators of Pharmacokinetic Properties of Therapeutics.” A true and correct copy of the ’374 Patent is attached hereto as Exhibit A. 22. Plaintiff Gilead Sciences, Inc. is the assignee of the ’374 Patent, and holds title to the ’374 Patent. 23. The ’374 Patent claims compounds (along with their stereoisomers) and their associated salts and compositions, as well as methods for using the compounds. Cobicistat is one of the compounds claimed in the ’374 Patent. 24. Plaintiff Gilead Sciences, Inc. is the holder of approved New Drug Application (“NDA”) No. 203094 for 150 mg tablets of cobicistat, which is sold under the trade name Tybost®. Tybost® is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. 25. Tybost® is included in FDA’s list of “Approved Drug Products With Therapeutic Equivalence Evaluations,” also known as the “Orange Book.” Approved drugs in the Orange Book may be used as the basis of an applicant’s ANDA to obtain approval of the generic drug product under the provisions of 21 U.S.C. § 355(j). 5 Case 1:16-cv-00192-UNA Document 1 Filed 03/25/16 Page 6 of 11 PageID #: 6 26. The Orange Book lists patents that the NDA holder asserts cover the approved drug product. The ’374 Patent is listed in the Orange Book in association with Tybost®. The ’374 Patent claims cover Tybost®. 27. On information and belief, Mylan submitted ANDA No. 208982 to the FDA under § 505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j), seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Defendant’s ANDA Product—a generic version of Tybost®. 28. On information and belief, Mylan continues to seek approval of ANDA No. 208982 from the FDA and intends to engage in the marketing, commercial manufacture, use, offer for sale, sale, and/or importation of Defendant’s ANDA Product (including the commercial marketing and sale of Defendant’s ANDA Product in the State of Delaware) if the FDA approves ANDA No.