Eli Lilly and Co. v. Teva Pharmaceuticals Usa

• Citation: 657 F.Supp.2d 967
• Decision Date: 23 September 2009
• Docket Number: No. 1:06-cv-1017-SEB-JMS.,1:06-cv-1017-SEB-JMS.
• Parties: ELI LILLY AND COMPANY, Plaintiff, v. TEVA PHARMACEUTICALS USA, INC., Defendant.
• Court: United States District Courts. 7th Circuit. United States District Court (Southern District of Indiana)

657 F.Supp.2d 967

ELI LILLY AND COMPANY, Plaintiff, v. TEVA PHARMACEUTICALS USA, INC., Defendant.

No. 1:06-cv-1017-SEB-JMS.

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

September 23, 2009.

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Alissa Keely Lipton, Amy E. Purcell, David S. Forman, Jennifer H. Roscetti, Laura P. Masurovsky, Mark Jeremy Feldstein, 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, Terri L. Bruksch, Barnes & Thornburg LLP, Indianapolis, IN, Robert Francis McCauley, Finnegan Henderson Farabow Garrett & Dunner LLP, Palo Alto, CA, for Plaintiff.

Adam G. Kelly, Daniel W. Celander, Edward H. Rice, Jordan A. Sigale, Julie P. Samuels, Marina N. Saito, Steven M. Lubezny, Loeb & Loeb, LLP, Chicago, IL, James Dimos, Joel E. Tragesser, Frost Brown Todd LLC, Indianapolis, IN, Michael J. Freno, Steven J. Lee, Walter E. Hanley, Jr., Kenyon & Kenyon LLP, New York, NY, for Defendant.

FINDINGS OF FACT AND CONCLUSIONS OF LAW FOLLOWING BENCH TRIAL

SARAH EVANS BARKER, District Judge.

This matter is before the Court for decision on the issues of validity, enforceability, and infringement of various patents held by Plaintiff, Eli Lilly and Company ("Lilly"). Lilly holds an approved New Drug Application ("NDA") No. 20-815 directed toward the use of raloxifene hydrochloride 60 mg tablets for the prevention or treatment of osteoporosis in post-menopausal women. Lilly markets the product disclosed in NDA No. 20-815 under the tradename EVISTA®. In connection with this NDA, Lilly listed twelve patents in the Orange Book, including: U.S. Patent Nos. 5,393,763 ("the '763 patent"); RE39,049 ("the '049 patent"); 5,457,117 ("the '117 patent"); RE38,968 ("the '968 patent"); 5,478,847 ("the '847 patent"); RE39,050 ("the '050 patent"); 6,458,811 ("the '811 patent"); 6,797,719 ("the '719 patent"); 6,894,064 ("the '064 patent"); 6,906,086 ("the '086 patent"); 5,811,120 ("the '120 patent"); and 5,972,383 ("the '383 patent") (collectively, "Lilly's raloxifene patents").

Defendant, Teva Pharmaceuticals USA, Inc. ("Teva"), subsequently filed an Abbreviated New Drug Application ("ANDA") No. 78-193 with the FDA for raloxifene hydrochloride 60 mg tablets for the prevention of osteoporosis in postmenopausal women. Teva sought FDA approval to market its generic raloxifene hydrochloride product before expiration of the patents Lilly listed in the Orange Book. Pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), Teva's ANDA included a "paragraph IV certification" to Lilly's raloxifene patents, in which Teva certified that each of Lilly's raloxifene patents is invalid, unenforceable, or would not be infringed by Teva's manufacture, use, or sale of its generic raloxifene product.

After receiving notice of the ANDA filing and paragraph IV certification, Lilly brought this suit against Teva for infringement of the '086 patent, the '968 patent, and the '049 patent (collectively, "the bone loss patents"); the '050 patent ("the low dose patent"); and the '811 patent, the '719 patent, and the '064 patent (collectively, "the particle size patents"). The bone loss and low dose patents cover the oral administration of raloxifene hydrochloride for prevention or treatment of postmenopausal osteoporosis. The particle size patents cover pharmaceutical compositions containing raloxifene particles having a certain size distribution. Teva concedes infringement of the bone loss patents and the low dose patent if they are found valid and enforceable, but challenges their validity and enforceability on the following grounds: obviousness, lack of enablement, and inequitable conduct. With regard to the particle size patents, Teva contends that its generic raloxifene product does not infringe, and that even if its product did infringe, the particle size patents are invalid on the basis of obviousness and lack of enablement.

The hearing on Lilly's motions for a temporary restraining order and preliminary injunction was consolidated with the trial, which was conducted to the Court over eleven (11) days, between March 9, 2009, and March 24, 2009. On the opening day of trial, Teva notified the Court that it had received notice of final approval from the FDA of its generic raloxifene product. On that same day, the Court entered a TRO prohibiting Teva from launching its generic raloxifene product in the United States for ten days, subject to extension based on the duration of Lilly's proofs in support of its motion for preliminary injunctive relief. On the second day of trial, Teva informed the Court that it would voluntarily withhold launch of its generic raloxifene product until April 23, 2009, in order to allow the Court to have a sufficient opportunity to rule on the preliminary injunction issues. On April 22, 2009, 609 F.Supp.2d 782, the Court granted Lilly's renewed motion for injunctive relief, preliminarily enjoining Teva from launching its generic raloxifene product in the United States, effective beginning on April 23, 2009, until the issuance of the Court's final ruling on the merits.

On the last day of trial, a post-trial briefing schedule was set for submission of the parties' final findings and conclusions, post-trial briefs, and responses. The final submission was due on or before June 22, 2009 [Docket No. 595]. Having now considered the evidence adduced at trial and the parties' post-trial submissions, we hold, for the reasons set forth in detail below, that: (1) the bone loss patents are valid and enforceable and Teva's proposed commercial raloxifene product infringes claims 1-3 of the '086 patent; claims 1, 3, and 4 of the '968 patent; claims 1, 2, 5-9, 11, 12, 19, 20, 28, 31, 33, and 34 of the '049 patent; (2) the low dose patent is valid and enforceable and Teva's proposed commercial raloxifene product infringes claims 1, 2, 5, 7, and 12-15 of the '050 patent; and (3) claims 1, 3, 6, 7, and 10 of the '811 patent and claims 1-3 of the '064 patent are invalid for lack of written description.

Findings of Fact

I. The Parties

Plaintiff, Lilly, is an Indiana corporation that has its principal place of business in Indianapolis, Indiana. It is engaged in the business of research, development, manufacture, and sale of pharmaceutical products throughout the world. Defendant, Teva, is a Delaware corporation engaged in the business of making and selling both innovative and generic drugs which it distributes in Indiana and throughout the United States.

II. The Patents in Suit

The '086 patent (PTX 11)¹ and the '968 patent (PTX 16), a reissue of U.S. Patent No. 5,457,117 (PTX 13), were issued to Larry Black. They were thereafter assigned to and are now owned by Lilly. PTX 348A; PTX 6A. The '049 patent (PTX 15), a reissue of U.S. Patent No. 5,393,763 (PTX 12), was issued to Larry Black and George Cullinan and was assigned to, and is now owned by, Lilly. PTX 5A. Collectively referred to as "the bone loss patents," these patents share a common specification and have an effective U.S. application filing date of July 28, 1992. Lilly asserted claims 1-3 of the '086 patent, claims 1, 3, and 4 of the '968 patent, and claims 1-2, 5-9, 11-12, 19-20, 28, 31, and 33-34 of the '049 patent. The parties agreed by stipulation to present evidence at trial regarding the bone loss patents on representative claims 1, 2, and 3 of the '086 patent.² Claim 1 of the '086 patent is representative and provides:

1. A method of inhibiting post-menopausal bone loss in a post-menopausal woman in need of treatment to prevent or treat post-menopausal osteoporosis comprising administering a single daily oral dose to said woman of an effective amount of ... [raloxifene] hydrochloride.

PTX 11 at col. 20:2-8.

The '050 "low dose" patent (PTX 17), a reissue of U.S. Patent No. 5,478,847 (PTX 14), was issued to Michael Draper and Larry Black. It was assigned to, and is now owned by, Lilly. PTX 347A; PTX 352A at ¶ 9; PTX 2214. It has an effective U.S. filing date of March 2, 1994. Lilly asserted claims 1-2, 5, 7, and 12-15 of the low dose patent. The parties agreed by stipulation to present evidence at trial on representative claims 14 and 15 of the '050 patent. Claim 14 of the low dose patent is representative and reads:

14. A method of preventing post-menopausal osteoporosis in a postmenopausal woman in need of treatment to prevent post-menopausal osteoporosis comprising administering to said woman a hydrochloride salt of ... [raloxifene] in an amount of 60 mg/day.

PTX 17, col. 14:65-15:17.

The '811 (PTX 18), '719 (PTX 19), and '064 (PTX 20) patents (collectively "the particle size patents")³ were issued to Gordon Arbuthnot, Brian Dalder, Kerry Hartauer, Wayne Luke, and Robert Stratford and were assigned to, and are now owned by, Lilly. Hartauer 1237:1-1238:24; PTX 350A. These patents share a common specification and have an effective U.S. application filing date of March 26, 1996. Lilly asserted claims 1-3, 6-7, and 10-12 of the '811 patent. By stipulation, the parties presented evidence at trial on representative claims 1, 3, 6-7, and 10 of the '811 patent. Claims 1 and 6 of the '811 patent are illustrative and read:

1. A compound of formula I [raloxifene] and pharmaceutically acceptable salts and solvates thereof, characterized in that the compound is in particulate form, said particles having a mean particle size of less than about 25 microns, at least about 90% of said particles have a size of less than about 50 microns.

6. A pharmaceutical composition comprising or formulated using a compound according to claim 1, or a pharmaceutically acceptable salt or solvate thereof, in combination with one or more pharmaceutically acceptable carriers, diluents or excipients.

PTX 18, col....