Shire Dev., LLC v. Mylan Pharm., Inc.

• Decision Date: 27 January 2017
• Docket Number: Case No: 8:12–cv–1190–T–36AEP
• Citation: 235 F.Supp.3d 1298
• Parties: SHIRE DEVELOPMENT, LLC, Shire Pharmaceutical Development, Inc., Cosmo Technologies Limited and Nogra Pharma Limited, Plaintiffs, v. MYLAN PHARMACEUTICALS, INC. and Mylan, Inc., Defendants.
• Court: U.S. District Court — Middle District of Florida

235 F.Supp.3d 1298

SHIRE DEVELOPMENT, LLC, Shire Pharmaceutical Development, Inc., Cosmo Technologies Limited and Nogra Pharma Limited, Plaintiffs,

v.MYLAN PHARMACEUTICALS, INC. and Mylan, Inc., Defendants.

Case No: 8:12–cv–1190–T–36AEP

United States District Court, M.D. Florida.

Signed January 27, 2017

Andrew Wasson, David A. Zwally, Edgar H. Haug, Elizabeth Murphy, Erika Selli, Jason Kanter, Jason A. Lief, Jessica H. Zafonte, Joseph Saphia, Angus Chen, Erin A. Lawrence, Janice Ye, Michelle Irwin, Camille Turner, Frommer Lawrence & Haug LLP, New York, NY, Jacqueline T. Carricato, Mahlon Herbert Barlow, III, Paul David Watson, Robert L. Chapman, Sivyer Barlow & Watson PA, Tampa, FL, for Plaintiffs.

Benjamin H. Hill, III, Carolina Yvonne Blanco, Scott A. McLaren, Hill Ward Henderson, PA, Alejandro J. Fernandez, Brinks Gilson & Lione, Tampa, FL, Brianna Lynn Kadjo, Alston & Bird, LLP, East Palo Alto, CA, James C. Grant, Alston & Bird, LLP, Anil H. Patel, George J. Barry, III, Meghan M. Rachford, Micheal L. Binns, Robert J. Waddell, Timothy Harold Kratz, McGuire Woods, LLP, Atlanta, GA, Jitendra Malik, Alston & Bird, LLP, Durham, NC, Joseph M. Janusz, Alston & Bird, LLP, Charlotte, NC, Joseph R. Sozzani, Brinks Gilson & Lione, Largo, FL, Lance Soderstrom, Deepro R. Mukerjee, Alston & Bird, LLP, New York, NY, Kimberly Tolland Mydock, Robert Eric Bilik, Rory John Diamond, McGuireWoods, LLP, Jacksonville, FL, for Defendants.

OPINION AND ORDER

Charlene Edwards Honeywell, United States District Judge

I. INTRODUCTION

This cause came before the Court at a four-day bench trial held from September 26 to September 29, 2016. Following the trial, the parties submitted proposed Findings of Fact and Conclusions of Law (Docs. 499, 500). Upon due consideration of the testimony, exhibits received into evidence, argument of counsel, and the applicable law, and being fully advised in the premises, the following, issued pursuant to Federal Rule of Civil Procedure 52(a), constitutes the Court's findings of fact and conclusions of law on the issue of patent infringement.¹

Shire filed this patent infringement case pursuant to the Hatch–Waxman Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355. Plaintiffs² (collectively "Plaintiff" or "Shire") sued Defendants³ (collectively "Defendant" or "Mylan")⁴ over Mylan's Abbreviated New Drug Application ("ANDA") seeking the Food and Drug Administration's ("FDA") approval to manufacture, use, and sell a generic equivalent of a Shire pharmaceutical product named Lialda ® ("Lialda"). Shire seeks a declaratory judgment of infringement of U.S. Patent No. 6,773,720 (the "'720 Patent"), entitled "Mesalazine controlled release oral pharmaceutical compositions." Mylan denies that its ANDA Product infringes the '720 Patent.

II. FINDINGS OF FACT

A. The Parties

1. Shire Development LLC is a limited liability company organized and existing under the laws of the State of Delaware, having its principal place of business at 725 Chesterbrook Boulevard, Wayne, Pennsylvania 19087. See Statement of Admitted Facts, Doc. S–502, ¶ 1. Shire Pharmaceutical Development Inc. is a corporation organized and existing under the laws of the State of Maryland, having its principal place of business at 1801 Research Boulevard, Rockville, Maryland 20850. Id. at ¶ 2. Cosmo Technologies Limited ("Cosmo") is a company organized and existing under the laws of Ireland, having its principal place of business at 2, Duncairn Terrace, Bray Co., Wicklow, Ireland. Id. at ¶ 3. Giuliani International Limited (now known as Nogra Pharma Limited) is a company organized and existing under the laws of Ireland, having its principal place of business at 33 Sir John Rogerson's Quay, Dublin 2, Ireland. Id. at ¶ 4.

2. Cosmo Technologies Limited is the owner of the '720 patent on assignment from Cosmo S.P.A. Nogra Pharma Limited is an exclusive licensee of the '720 patent and has granted Shire Pharmaceutical Development Inc. an exclusive sublicense. Id. at ¶ 16.

3. Mylan Pharmaceuticals Inc. is a corporation organized and existing under the laws of the state of West Virginia having a place of business at 491 Chestnut Ridge Road, Morgantown, West Virginia 26505. Id. at ¶ 5. Mylan Inc. is a corporation organized and existing under the laws of the state of Pennsylvania having a place of business at 1500 Corporate Drive, Canonsburg, Pennsylvania 15317. Id. at ¶ 6. Mylan Pharmaceuticals is a wholly-owned subsidiary of Mylan Inc. Id. at ¶ 7.

B. Background

4. Shire is the holder of New Drug Application ("NDA") No. 22–000, which relates to delayed release mesalamine tablets, 1.2 g. Id. at ¶ 8. On January 16, 2007, the United States Food and Drug Administration ("FDA") approved the marketing of the delayed release mesalamine tablets, 1.2 g, described in NDA No. 22–000. Id. at ¶ 9. The delayed release mesalamine tablets, 1.2 g, described in NDA No. 22–000 are sold in the United States by Shire using the trademark Lialda ®. Id. at ¶ 10. Lialda is a delayed-release mesalamine tablet used to treat ulcerative colitis.

5. U.S. Patent No. 6,773,720 ("the '720 patent"), entitled "Mesalazine controlled release oral pharmaceutical compositions," was issued by the United States Patent and Trademark Office ("USPTO") on August 10, 2004. Id. at ¶ 11. U.S. Patent Application No. 10/009,491 ("the '491 application"), from which the '720 patent issued, was filed in the USPTO on June 8, 2000. Id. at ¶ 12. In the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" ("Orange Book"), the '720 patent is listed in the entry for Lialda ®>. The '720 patent expires on June 8, 2020. Id. at ¶ 13.

6. Mylan Pharmaceuticals submitted Abbreviated New Drug Application ("ANDA") No. 20–3574 to the FDA under § 505(j) of the Federal Food, Drug, and Cosmetic Act ("FDCA") (codified at 21 U.S.C. § 355(j) ), seeking approval to engage in the commercial manufacture, use, or sale of mesalamine delayed-release tablets, 1.2 g ("Mylan's ANDA Product" or "Mylan's Product") prior to expiration of the '720 patent. Id. at ¶ 17. The ANDA contains data for the purpose of establishing bioequivalence to Lialda ®. It identifies Lialda ® as the Reference Listed Drug and provides data for an exhibit batch of Mylan's ANDA Product, labeled 1042070 (the "exhibit batch"). Id. at ¶ 20. The exhibit batch of Mylan's ANDA Product is representative of the product that Mylan will sell, if approved by the FDA. See Tr. Day 2 am (Testimony of Dr. Deshmukh) and Tr. Day 1 pm (Testimony of Mr. Pananchukunnath).

7. The November 24, 2015 Resubmission and Amendment to ANDA No. 20–3574 provided data for three validation batches of Mylan's ANDA Product, labeled 3040706, 3040780, and 3040826 (collectively, "validation batch"). See Doc. S–502 at ¶ 21. Mylan did not change the formulation composition, drug product manufacturing process, or controls between its exhibit batch and validation batch. See Tr. Day 2 am (Testimony of Dr. Deshmukh). Mylan's November 24, 2015 Resubmission and Amendment to ANDA No. 20–3574 reports to FDA that "[t]here are no changes to the formulation composition, Drug Product manufacturing process or controls." See Doc. S–502 at ¶ 22. Thus, data and representations in Mylan's original ANDA submission, such as its Product Development Report and dissolution data, also apply to Mylan's validation batch. See Tr. Day 2 am (Testimony of Dr. Deshmukh).

8. Mylan Pharmaceuticals submitted a certification pursuant to 21 U.S.C. § 355(b)(2)(A)(iv) in ANDA No. 20–3574 that the '720 patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use, sale, offer for sale, or importation of Mylan's ANDA Product. See Doc. S–502 at ¶ 24. By letters dated April 12, 2012, Mylan Pharmaceuticals provided notification of paragraph IV certifications regarding the '720 patent pursuant to 21 U.S.C. § 355(j)(2)(B)(i)-(iv) of the FDCA and 21 C.F.R. § 314.95 in connection with ANDA No. 20–3574. Id. at ¶ 25.

9. On May 25, 2012, Shire filed this suit for declaratory relief against Mylan Pharmaceuticals and Mylan Inc. alleging infringement of the '720 patent. Id. at ¶ 26. Shire asserts that Mylan's commercial manufacture, use, sale or offer for sale in the United States and importation into the United States of Mylan's ANDA Product would infringe claims 1 and 3 of the '720 patent. Id. at ¶ 29.

10. On August 27, 2012, Mylan filed counterclaims, including inter alia , for a declaratory judgment that the '720 patent is not infringed. Id. at ¶ 27. It denies that its ANDA Product, if manufactured, used, sold, or offered for sale in the United States or imported into the United States would infringe claims 1 and 3 of the '720 patent. Id. at ¶ 30. Mylan dismissed its invalidity claims and defenses prior to trial. Id. at ¶ 31.

C. The '720 Patent

11. The '720 Patent at issue in this case contains 4 claims. Shire alleges infringement of Claims 1 and 3 of the '720 Patent. Claim 1 is the '720 Patent's only independent claim. It provides:

Controlled-release oral pharmaceutical compositions containing as an active ingredient 5-amino-salicylic acid, comprising:

a. an inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, dior triglycerids, waxes, ceramides, and cholesterol derivatives with melting points below 90° C[ ], and wherein the active ingredient is dispersed both in said lipophilic matrix and in the hydrophilic matrix;

b. an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer hydrophilic matrix consists of compounds selected from the group consisting of polymers or copolymers of acrylic or methacrylic acid, alkylvinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives, alginic acid, and natural or synthetic gums;

c. optionally other excipients; wherein the active ingredient is present in an amount

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