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AstraZeneca AB v. Aurobindo Pharma Ltd.

United States District Court, D. Delaware

February 2, 2017

ASTRAZENECA AB, Plaintiff,
v.
AUROBINDO PHARMA LTD., et al. Defendants.

          MEMORANDUM

         I. INTRODUCTION

         In this consolidated patent infringement action, plaintiff AstraZeneca alleges that pharmaceutical products proposed by defendants Aurobindo Pharma Ltd., Aurobindo Pharma U.S.A., Wockhardt Bio AG, Wochardt USA LLC, Amneal Pharmaceuticals LLC, Sun Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Sun Pharma Global FZE, Mylan Pharmaceuticals Inc., Watson Laboratories, Inc., and Actavis Laboratories FL, Inc. (collectively "Aurobindo") infringe the asserted claims of U.S. Reissue Patent No. RE44, 186 ("RE'186 patent" or "the patent-in-suit").[1] The court held a three-day bench trial on September 19, 2016 through September 21, 2016. (D.I. 369-371.) Presently before the court are the parties' proposed finding of fact and conclusions of law concerning the validity of the RE'186 patent, specifically whether the asserted claims are invalid as obvious under 35 U.S.C. § 103. (D.I. 373, 374, 375.)

         Pursuant to Federal Rule of Civil Procedure 52(a), having considered the entire record in this case and the applicable law, the court concludes that the asserted claims of the RE'186 patent are not invalid due to obviousness. These findings of fact and conclusions of law are set forth in further detail below.

         II. Findings of Fact[2]

         A. The Parties

         1. Plaintiff AstraZeneca is a company operating and existing under the laws of Sweden, with its principal place of business at S-151 85 Södertälje, Sweden.

         2. Plaintiffs subsidiary, AstraZeneca Pharmaceuticals LP, is a limited partnership operating and existing under the laws of Delaware, with its principal place of business at 1800 Concord Pike, Wilmington, Delaware 19803.

         3. Wockhardt Bio AG. is a corporation organized and existing under the laws of Switzerland, having a principal place of business at Grafenauweg 6, 6300 Zug, Switzerland.

         4. Wockhardt USA LLC is a limited liability company, existing under the laws of the State of Delaware and having a principal place of business at 20 Waterview Boulevard, Parsippany, New Jersey 07054.

         5. Wockhardt USA LLC is an indirect subsidiary of Wockhardt Bio AG.

         6. Aurobindo Pharma Ltd. is a corporation organized and existing under the laws of India, having a principal place of business of Plot #2, Maitri Vihar, Ameerpet, Hyderabad - 500038, Andhra Pradesh, India.

         7. Aurobindo Pharma U.S.A., Inc. is a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 6 Wheeling Road, Dayton, New Jersey 08810.

         8. Aurobindo Pharma U.S.A., Inc. is a wholly owned subsidiary of Aurobindo Pharma Ltd.

         9. Amneal Pharmaceuticals LLC is a limited liability company, existing under the laws of the State of Delaware and having a principal place of business at 400 Crossing Boulevard, Third Floor, Bridgewater, New Jersey 08807.

         10. Sun Pharmaceutical industries Ltd. is a company organized and existing under the laws of India, having a principal place of business at Acme Plaza, Andheri-Kurla Rd., Andheri (E), Mumbai - 400 059, India.

         11. Sun Pharma Global FZE is a company organized and existing under the laws of the United Arab Emirates, having a principal place of business at Executive Suite #43, Block Y, SAEF Zone, P.O. Box 122304, Sharjah, United Arab Emirates.

         12. Sun Pharma Global FZE is a wholly-owned subsidiary of Sun Pharma Global Inc., a corporation organized and existing under the laws of the British Virgin Islands, which in turn is a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd.

         13. Mylan Pharmaceuticals Inc. is a corporation organized and existing under the laws of West Virginia, having a principal place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505.

         14. Watson Laboratories, Inc. is a corporation organized and existing under the laws of Nevada, having a principal place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054.

         15. Actavis Laboratories FL, Inc. (f/k/a Watson Laboratories, Inc. - Florida) is a corporation organized and existing under the laws of Florida, having a principal place of business at 4955 Orange Drive, Davie, Florida 33314.

         16. The court has subject matter jurisdiction and personal jurisdiction over all parties.

         B. Background

         1. These consolidated actions arise out of Defendants' submission of several Abbreviated New Drug Applications ("AND As") under § 505(j) of the Federal Food, Drug and Cosmetic Act to the United States Food and Drug Administration ("FDA"), seeking approval to market and sell generic saxagliptin pharmaceutical drug products prior to the expiration of AstraZeneca's RE' 186 patent.

         2. Saxagliptin is chemical compound that is an FDA-approved DPP4 inhibitor that has been used to treat type 2 diabetes. Saxagliptin has the following chemical structure:

         (IMAGE OMTTED)

         3. Saxagliptin's structure includes a cw-4, 5-cyclopropyl group fused to a cyanopyrrolidine ring. The resulting czs-4, 5-cyclopropyl-cyanopyrrolidine moiety represents the PI group. Saxagliptin also contains a 3-hydroxyadamantyl group that is C-linked through a quarternary carbon (a carbon with four non-hydrogen groups attached to it) to the peptide backbone, resulting in primary amine. The C-linked 3-hydroxyadamantyl glycine moiety represents the P2 group.

         4. AstraZeneca is the holder of New Drug Application ("NDA") No. 022350, by which the FDA granted approval for the marketing and sale of 2.5 mg and 5 mg strength saxagliptin hydrochloride tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.

         5. AstraZeneca markets 2.5 mg and 5 mg strength saxagliptin hydrochloride tablets in the United States, through its Delaware subsidiary AstraZeneca Pharmaceuticals ...


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