Eli Lilly & Co. v. Perrigo Co.

• Decision Date: 22 August 2016
• Docket Number: 1:13-cv-00851-SEB-DKL
• Citation: 202 F.Supp.3d 918
• Parties: ELI LILLY AND COMPANY, Eli Lilly Export S.A., Acrux DDS PTY Ltd., Plaintiffs, v. PERRIGO COMPANY, Perrigo Israel Pharmaceuticals Ltd., Actavis Laboratories UT, Inc. formerly known as Watson Laboratories Inc., Amneal Pharmaceuticals LLC, Lupin Pharmaceuticals, Inc., and Lupin Ltd., Defendants.
• Court: U.S. District Court — Southern District of Indiana

202 F.Supp.3d 918

ELI LILLY AND COMPANY, Eli Lilly Export S.A., Acrux DDS PTY Ltd., Plaintiffs,

v.PERRIGO COMPANY, Perrigo Israel Pharmaceuticals Ltd., Actavis Laboratories UT, Inc. formerly known as Watson Laboratories Inc., Amneal Pharmaceuticals LLC, Lupin Pharmaceuticals, Inc., and Lupin Ltd., Defendants.

1:13-cv-00851-SEB-DKL

United States District Court, S.D. Indiana, Indianapolis Division.

Signed August 22, 2016

Alissa Keely Lipton, Finnegan Henderson Farabow Garrett & Dunner LLP, Boston, MA, Amanda K. Murphy, Finnegan, Henderson, Farabow Garrett & Dunner, LLP, Washington, DC, Charles Edmund Lipsey, Jessica L.A. Marks, L. Scott Burwell, Finnegan Henderson Farabow Garrett & Dunner LLP, Reston, VA, Danielle A. Duszczyszyn, Finnegan Henderson Farabow Garrett Dunner LLP, Pro Hac, Vice, Jan M. Carroll, Terri L. Bruksch, Manisha Arvind Desai, Eli Lilly & Company, Oni N. Harton, Barnes & Thornburg LLP, Indianapolis, IN, Jennifer M. Vein, Laura P. Masurovsky, Mareesa A. Frederick, Finnegan Henderson Farabow Garrett & Dunner LLP, Washington, DC, for Plaintiffs.

Alice L. Riechers, Anuj K. Wadhwa, Conly Wythers, Erin M. Forbes, Gregory Andrew Duff, Lauren M. Lesko, Robert M. Teigen, William A. Rakoczy, Christine J. Siwik, Rakoczy Molino Mazzochi Siwik LLP, Kathryn Wendel Bayer, Ryan Dunigan, Winston & Strawn LLP, Emily N. Winfield, Duane Morris LLP, Chicago, IL, Sally F. Zweig, Katz & Korin P.C., James M. Hinshaw, Briana Lynn Clark, Bingham Greenebaum Doll LLP, Indianapolis, IN, Robert J. Schuckit, Schuckit & Associates, Zionsivlle, IN, Christopher S. Kroon, Duane Morris, LLP, Boston, MA, for Defendants.

FINDINGS OF FACT AND CONCLUSIONS OF LAW AND FINAL JUDGMENT BASED THEREON

SARAH EVANS BARKER, JUDGE

This matter is before the Court for decision on the issues of validity, enforceability, and infringement of three patents owned by Plaintiff Acrux DDS PTY Ltd. ("Acrux"). Plaintiff Eli Lilly Export S.A. is the exclusive worldwide licensee of the patents at issue in this litigation and has licensed its rights in the United States to Plaintiff Eli Lilly and Company ("Lilly"). Plaintiffs hold an approved New Drug Application ("NDA") No. 022504 for the manufacture and sale of testosterone

metered transdermal solution, 30 mg/1.5mL used to treat males for conditions associated with a deficiency or absence of endogenous testosterone. Lilly markets the product disclosed in NDA No. 022504 under the tradename Axiron®. Axiron® was approved by the Food and Drug Administration ("FDA") on November 23, 2010. In connection with the NDA, Lilly listed nine patents in the Orange Book, including: U.S. Patent Nos. 6,299,900 ("the '900 patent") ; 6,818,226 ("the '226 patent") ; 6,923,983 ("the '983 patent"); 8,071,075 ("the '075 patent") ; 8,419,307 ("the '307 patent") ; 8,435,944 ("the '944 patent") ; 8,177,449 ("the '449 patent") ; 8,807,861 ("the '861 patent") ; and 8,993,520 ("the '520 patent").

This action arises out of the Abbreviated New Drug Applications ("ANDA") for the commercial manufacture, use, and sale of generic versions of Axiron® filed by Defendants Perrigo Company and Perrigo Israel Pharmaceuticals Ltd. (collectively, "Perrigo"); Actavis Laboratories UT, Inc. ("Actavis"); Amneal Pharmaceuticals LLC ("Amneal"); and Lupin Pharmaceuticals, Inc. and Lupin Ltd. (collectively, "Lupin"), respectively. As will be described in more detail below, each Defendant sought FDA approval to market its generic transdermal testosterone product before expiration of the patents Lilly listed in the Orange Book, and, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), each ANDA includes a "paragraph IV certification" to Plaintiffs' patents, in which each Defendant has certified that certain patents are invalid and/or would not be infringed by Defendants' manufacture, use, or sale, of their generic testosterone products.

Plaintiffs proceeded to trial on the following representative patent claims: claim 13 of the '075"formula" patent against Actavis; claim 20 of the '944"axilla" patent against all defendants; and claims 9 and 10 of the '861"applicator" patent against all defendants. Defendants contend that their proposed ANDA products would not infringe the asserted claims of the '861 patent and that each of the asserted claims of the '861 patent and the '944 patent are invalid. Actavis also contends that the asserted claim of the '075 patent is invalid.

A bench trial on these issues was conducted over nine (9) days, the first eight of which ran from June 16, 2016 to/through June 28, 2016, and a final day of trial occurred on July 21, 2016. Having now considered the evidence adduced at trial and the parties' post-trial submissions, we hold, for the reasons set forth in detail below, as follows: (1) claim 13 of the '075 patent is invalid for lack of written description and enablement; (2) claim 20 of the '944 patent is invalid for obviousness; (3) the asserted claims of the '861 patent are not infringed by Actavis's, Perrigo's or Lupin's accused products; (4) claims 9 and 10 of the '861 patent are neither anticipated nor obvious and are therefore valid and enforceable; and (5) Amneal's applicator product and/or its use will directly and indirectly infringe the asserted claims of the '861 patent.

Findings of Fact

I. The Parties

A. Plaintiffs

Lilly is an Indiana corporation that has its corporate offices and principal place of business in Indianapolis, Indiana. Lilly is engaged in the business of research, development, manufacture, and sale of pharmaceutical products throughout the world. Eli Lilly Export S.A. is a Swiss corporation and wholly-owned subsidiary of Lilly. Its corporate offices and principal place of business are located at 16 Chemin des Coquelicots, The Air Centre, 1214 Vernier/Geneva, Switzerland. Acrux is an Australian corporation and its corporate offices and principal place of business are located at 103-113 Stanley Street, West Melbourne VIC 3003, Australia. Acrux is engaged in the development and commercialization of pharmaceutical products.

B. Defendants

Perrigo Company is a Michigan corporation with its principal place of business in Allegan, Michigan. Perrigo Israel Pharamceuticals is an Israeli corporation with a principal place of business at 29 Lehi Street, Bnei Brak 51200, Israel. The Perrigo Defendants are engaged in the business of making and selling generic drugs, which they distribute in Indiana and throughout the United States. On April 3, 2012, Perrigo Israel submitted ANDA No. 204255, pursuant to 21 U.S.C. § 355(j), seeking approval from the FDA to sell "Testosterone Metered Transdermal Solution, 30 mg/1.5 mL." By letter dated October 16, 2015, the FDA informed the Perrigo Defendants of its tentative approval of ANDA No. 204255.

Actavis (formerly known as Watson Laboratories, Inc.) is a Delaware corporation with its principal place of business in Salt Lake City, Utah. Actavis is engaged in the business of making and selling generic drugs, which it distributes in Indiana and throughout the United States. On January 29, 2013, Actavis filed ANDA No. 205328, pursuant to 21 U.S.C. § 355(j), seeking approval from the FDA to sell "Testosterone Topical Solution, for Topical Use, 30 mg of Testosterone

per Pump Actuation." By letter dated July 29, 2015, the FDA informed Actavis of its tentative approval of ANDA No. 205328.

Amneal is a Delaware corporation with its principal place of business in Bridgewater, New Jersey. Amneal is engaged in the business of making and selling generic drugs, which it distributes in Indiana and throughout the United States. On March 14, 2014, pursuant to 21 U.S.C. § 355(j), Amneal filed ANDA No. 206998, seeking approval from the FDA to sell "Testosterone Topical Solution, 30 mg/1.5 mL."

Lupin Pharmaceuticals is a Delaware corporation with its principal place of business in Baltimore, Maryland. Lupin Ltd. is an Indian corporation with its principal place of business located at B/4 Laxmi Towers, Bandra-Kurla Complex, Bandra (E), Mumbai 400 051, India. Lupin Pharmaceuticals is a wholly-owned subsidiary of Lupin Ltd. The Lupin Defendants are engaged in the business of making and selling generic drugs, which they distribute in Indiana and throughout the United States. On April 13, 2015, Lupin submitted ANDA No. 208061, pursuant to 21 U.S.C. § 355(j), seeking approval from the FDA to sell "Testosterone Topical Solution, 30 mg/1.5 mL."

Each of Defendants' ANDA filings references Plaintiffs' NDA No. 022504 for Axiron® (testosterone) Metered Transdermal Solution 30 mg/1.5 mL as the referenced listed drug.

II. The Patents-In-Suit

A. The '075 Patent

U.S. Patent No. 8,071,075, entitled "Dermal penetration enhancers and drug delivery systems involving the same," issued on December 6, 2011, to named inventors Barry Leonard Reed, Timothy Mathias Morgan, and Barrie Charles Finnin. PTX-1 at 2. The '075 patent was assigned to Acrux DDS Pty Ltd. upon issuance. Id.

The '075 patent issued from U.S. Patent Application No. 11/905,926 filed on October 5, 2007. PTX-1 at 2. The '926 application is a continuation of U.S. Patent Application No. 10/759,303 filed on January 20, 2004, which issued as U.S. Patent No. 7,438,203. Id. The '303 application is a continuation-in-part of U.S. Patent Application No. 09/910,780 filed on July 24, 2001, which issued as U.S. Patent No. 6,818,226. Id. The '780 application is a divisional of U.S. Patent Application No. 09/125,436, which was filed as International Patent Application No. PCT/AU97/00091, filed on February 19, 1997, which issued as U.S. Patent No. 6,299,900. Id. The '075 penetration enhancer patent claims priority to Australian Provisional Patent Application No. 8144 filed on February 19, 1996.¹ Id.

Plaintiffs are asserting claim 13 of the '075 patent against Actavis.² Claim 13 depends from claims 1, 5, 9, 10, and 11. Claim 13 and the claims from which it depends recite as follows:

1. A transdermal drug delivery system comprising:

(a) a therapeutically effective amount of testosterone;

(b) at least one

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