Eli Lilly And Co. v. Sicor Pharm.S Inc, 1:06-cv-238-SEB-DML.

• Court: United States District Courts. 7th Circuit. United States District Court (Southern District of Indiana)
• Citation: 705 F.Supp.2d 971
• Docket Number: No. 1:06-cv-238-SEB-DML.,1:06-cv-238-SEB-DML.
• Parties: ELI LILLY AND COMPANY, Plaintiff,v.SICOR PHARMACEUTICALS, INC., Teva Pharmaceuticals USA, Inc., Teva Parenteral Medicines, Inc., Defendants.
• Decision Date: 31 March 2010

705 F.Supp.2d 971

ELI LILLY AND COMPANY, Plaintiff,
v.
SICOR PHARMACEUTICALS, INC., Teva Pharmaceuticals USA, Inc., Teva Parenteral Medicines, Inc., Defendants.

No. 1:06-cv-238-SEB-DML.

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

March 31, 2010.

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Alissa Keely Lipton, Jessica Ruth Underwood, Krista Entrop Bianco, Laura P. Masurovsky, Robert D. Bajefsky, Robert Frederic Shaffer, Ryan James Cudnik, William Barrett Raich, Finnegan, Henderson, Farabow, Garrett, & Dunner, LLP, Washington, DC, Charles Edmund Lipsey, L. Scott Burwell, Finnegan Henderson Farabow Garrett & Dunner LLP, Reston, VA, Jan M. Carroll, Barnes & Thornburg LLP, Indianapolis, IN, John D. Martin, Nelson Mullins Riley & Scarborough, LLP, Columbia, SC, Robert Francis McCauley, Finnegan Henderson Farabow Garrett & Dunner LLP, Palo Alto, CA, for Plaintiff.

David O. Tittle, Kandi Kilkelly Hidde, Steven G. Cracraft, Bingham McHale LLP, Indianapolis, IN, Elizabeth J. Holland, Karen Shen, Merri C. Moken, Michael J. Freno, Peter L. Giunta, Sheila Mortazavi, Steven J. Lee, Kenyon & Kenyon LLP, New York, NY, for Defendants.FINDINGS OF FACT AND CONCLUSIONS OF LAWSARAH EVANS BARKER, District Judge.

This matter is before the Court for decision following a trial on the issues of validity, enforceability, and infringement of two patents held by Plaintiff Eli Lilly and Company (“Lilly”): United States Patent Nos. 4,808,614 (“the '614 patent”) and 5,464,826 (“the '826 patent”). The ' 614 patent covers the compound gemcitabine, and the '826 patent covers the method of treating susceptible neoplasms in mammals with gemcitabine. Lilly markets gemcitabine for injection under the tradename GEMZAR®, which is approved for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer, and pancreatic cancer. (DTX 39.) ¹

Lilly is the holder of approved New Drug Application No. 20-509 for the use of Gemzar® as a treatment for these cancers. In January 2006, Defendant Sicor Pharmaceuticals, Inc. (“Sicor”) filed two Abbreviated New Drug Applications (“ANDAs”)

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under the Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585 (popularly known as the Hatch-Waxman Act), with the Food and Drug Administration (“FDA”) seeking approval to market generic versions of Lilly's gemcitabine product in two different dosage forms (200 mg and 1 g) prior to the expiration of the '614 and '826 patents. In August 2008, Defendant Teva Parenteral Medicines, Inc. (“Teva Parenteral”) ² filed a third ANDA seeking approval to market generic versions of gemcitabine in a third dosage form (2 g). Sicor's (and Teva Parenteral's) ANDAs included “paragraph IV certifications,” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), asserting that the claims of Lilly's '614 and ' 826 patents are invalid, unenforceable, or not infringed. As required by the Hatch-Waxman Act, Sicor and Teva Parenteral sent Lilly notice of these ANDA filings and paragraph IV certifications.

On February 15, 2006, after receiving notice of Sicor's ANDA filings and paragraph IV certification relating to the 200 mg and 1 g dosage forms, Lilly filed suit against Sicor and Teva USA alleging infringement of the '614 and ' 826 patents under 35 U.S.C. § 271(e)(2)(A) and 35 U.S.C. § 271(b). Within forty-five days of receiving Teva Parenteral's notice relating to the 2 g dosage form, on September 26, 2008, Lilly filed suit against Teva Parenteral and Teva USA alleging infringement of the '614 and '826 patents. On January 15, 2009, the Court issued an order consolidating the two previously separate actions.

With the present action, Lilly seeks an order: (1) requiring the FDA to change the effective date of ANDA Nos. 77-961 and 77-983 until after the expiration of the '614 and '826 patents; (2) prohibiting the FDA from approving Teva Parenteral's ANDA No. 090644 prior to the expiration of the patents, in accordance with 35 U.S.C. § 271(e)(4)(A); and (3) enjoining Defendants from the commercial manufacture, use, offer to sell, sale, or importation of their gemcitabine products prior to the expiration of Lilly's exclusivity, in accordance with 35 U.S.C. § 271(e)(4)(B).

Defendants have stipulated that if Claim 12 of the '614 patent and Claim 7 of the '826 patent are valid and enforceable, then Defendants' actions constitute infringement of those patents under 35 U.S.C. § 271(e)(2). (PTX 870, PTX 871).

Defendants challenge the validity of the '614 patent on the following grounds: anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103. Defendants challenge the validity of the '826 patent on the following grounds: obviousness-type double patenting, anticipation under 35 U.S.C. § 102, obviousness under 35 U.S.C. § 103, and lack of enablement under 35 U.S.C. § 112. Defendants further assert that Lilly is collaterally estopped from asserting the '826 patent against them as a result of a prior determination of invalidity in a related case brought by another pharmaceutical company against Lilly in another district court.³

On the final day of trial, a post-trial briefing schedule was set for submission of the parties' proposed findings of fact and conclusions of law, post-trial briefs, and responses. These submissions were due on or before November 30, 2009. [Docket No. 339]. Having now considered the evidence adduced at trial as well as the parties' post-trial submissions, we hold, as detailed below, that: (1) the '614 patent is valid and enforceable and Defendants' proposed

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commercial gemcitabine product infringes claim 12 of that patent; and (2) although the '826 patent is valid and enforceable in all other regards, Lilly is collaterally estopped from defending against Defendants' claim of obviousness-type double patenting relating to that patent, pending a final determination on appeal. Findings of Fact ⁴ The Parties

Plaintiff Eli Lilly and Company (“Lilly”) is an Indiana corporation with its 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.

Defendants Sicor Pharmaceuticals, Inc. (“Sicor”), now known as Teva Parenteral Medicines, Inc. (“Teva Parenteral”), and Teva Pharmaceuticals USA, Inc. (“Teva USA”) (collectively “Defendants”) are Delaware corporations. Defendants are engaged in the business of selling generic pharmaceutical products, which they distribute in Indiana and throughout the United States.⁵

The Patents-in-Suit

The '614 patent, issued on February 28, 1989 to Lilly, names Dr. Larry W. Hertel as the sole inventor. The '826 patent, issued on November 7, 1995 to Lilly, names Dr. Larry W. Hertel and Dr. Gerald B. Grindey as joint inventors. Both patents are owned by Lilly.

The '614 patent discloses and claims a series of 2'2'-difluoronucleoside analogs, including gemcitabine. (DTX 1; D.I. 261

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¶ 23.) Claim 12, the only claim being asserted from the '614 patent, specifically claims the nucleoside analog gemcitabine. (Radtke 432:13-20.) The chemical name of gemcitabine appears as the eighth compound in a list of thirty-six potential 2' 2'-difluoronucleosides. (DTX 1, col. 3, II. 55-56.) The '614 patent claims priority to U.S. Patent Application Ser. No. 473,883 (“the '883 Application”), filed on March 10, 1983.

The specification of the '614 patent details the antiviral utility of this class of nucleoside analogs. It also contains one paragraph describing the later-discovered anticancer activity of this class of nucleosides and providing specific dosages. (PTX 1 at col. 17, II. 53-68.) The '883 Application, which was the original application in this patent, does not disclose any anticancer activity in the difluoronucleoside analogs. (Radtke 475:17-19.) The anticancer disclosure of the '614 patent was added by Lilly in a continuation-in-part application (“CIP”), Ser. No. 677,146, filed on December 4, 1984 (“1984 CIP Application”). (PTX 7 at 42; D.I. 261 ¶ 30.)

Also on December 4, 1984, the same day of the filing of the 1984 CIP Application related to the '614 patent, Lilly filed a completely separate patent application, which eventually issued as the '826 patent. The '826 patent claims the benefit, under 35 U.S.C. § 120, of a series of applications, the earliest having been filed on December 4, 1984, U.S. Patent Application Ser. No. 677,783 (“the '783 Application”). (PTX 9 at 3-46.)

The '826 patent discloses and claims methods of treating susceptible neoplasms with gem-difluoronucleosides, including gemcitabine. Claim 7 of the '826 patent, the only claim of that patent being asserted here, claims a method of treating susceptible neoplasms in mammals, where the susceptible neoplasm is selected from the group consisting of leukemias, sarcomas, carcinomas, and myelomas, and comprising the administration of a therapeutically effective amount of gemcitabine as treatment for human patients. (PTX 2 at col. 23, 1.42-col. 24, 1.64; Green 220:25-221:6.)

Definition of Person of Ordinary Skill in the Art for the '614 Patent

At trial, Defendants' expert, Dr. Piet Herdewijn, and Lilly's expert, Katherine Radtke, testified that the person of ordinary skill in the art to which the '614 patent pertains would have a Ph.D. or equivalent degree in chemistry or the pharmaceutical sciences, with additional and considerable experience designing and synthesizing nucleoside analogs for biological purposes. (Radtke 432:25-433:15; Herdewijn 980:19-982:2.) Drs. Kathlyn Parker and Larry Overman held a similar view but did not include in their definition a particular expertise in nucleoside chemistry. (Overman 599:6-17; Parker 1137:21-1138:10.) The definition of a person of ordinary skill in the art does not appear to be a matter of major dispute between the parties. We...