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Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.

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

August 25, 2015

ELI LILLY AND COMPANY, Plaintiff,
v.
TEVA PARENTERAL MEDICINES, INC., APP PHARMACEUTICALS, LLC, PLIVA HRVATSKA D.O.O., TEVA PHARMACEUTICALS USA INC., BARR LABORATORIES, INC., Defendants. ELI LILLY AND COMPANY, Plaintiff,
v.
APP PHARMACEUTICALS, LLC, Defendant
v.
FRESENIUS KABI USA, LLC, Defendant

          For ELI LILLY AND COMPANY, Plaintiff: Adam L. Perlman, Bruce Roger Genderson, PRO HAC VICE, WILLIAMS & CONNOLLY LLP, Washington, DC; Andrew V. Trask, PRO HAC VICE, WILLIAMS & CONNOLLY, Washington, DC; Anne N. DePrez, Jan M. Carroll, BARNES & THORNBURG LLP, Indianapolis, IN; David M. Krinsky, Dov P. Grossman, Ellen E. Oberwetter, Megan A. Hughes, PRO HAC VICEs, WILLIAMS & CONNOLLY, LLP, Washington, DC.

         For TEVA PARENTERAL MEDICINES, INC., APP PHARMACEUTICALS, LLC, PLIVA HRVATSKA D.O.O., TEVA PHARMACEUTICALS USA INC., BARR LABORATORIES, INC., Defendants: Brian J. Prew, Daryl L. Wiesen, Elaine Herrmann Blais, Emily L. Rapalino, Michael B. Cottler, PRO HAC VICEs, GOODWIN PROCTER, LLP, New York, NY; Briana Lynn Clark, David O. Tittle, E. Ashley Paynter, Kandi Kilkelly Hidde, BINGHAM GREENEBAUM DOLL LLP, Indianapolis, IN; Natasha E. Daughtrey, GOODWIN PROCTER LLP, New York, NY.

         For ELI LILLY AND COMPANY, 1:11-cv-00942-TWP-TAB, Consol Plaintiff: Andrew V. Trask, PRO HAC VICE, WILLIAMS & CONNOLLY, Washington, DC; Anne N. DePrez, Jan M. Carroll, BARNES & THORNBURG LLP, Indianapolis, IN; Megan A. Hughes, WILLIAMS & CONNOLLY, LLP, Washington, DC.

         For APP PHARMACEUTICALS, LLC, 1:11-cv-00942-TWP-TAB, Consol Defendant: Brian J. Prew, Elaine Herrmann Blais, PRO HAC VICEs, GOODWIN PROCTER, LLP, New York, NY; Kandi Kilkelly Hidde, BINGHAM GREENEBAUM DOLL LLP, Indianapolis, IN; Natasha E. Daughtrey, GOODWIN PROCTER LLP, New York, NY.

          OPINION

         FINDINGS OF FACT AND CONCLUSIONS OF LAW FOLLOWING SECOND BENCH TRIAL HELD MAY 28, 2015

         TANYA WALTON PRATT, JUDGE, United States District Court, Southern District Of Indiana.

         This is a Hatch-Waxman patent infringement action brought by Eli Lilly and Company (" Lilly" ), the owner of U.S. Patent No. 7,772,209 (the " '209 patent" ), against Defendants Teva Parenteral Medicines, Inc. (" Teva Parenteral" ), Teva Pharmaceuticals USA, Inc. (" Teva Pharmaceuticals" ) (collectively with Teva Parenteral, " Teva" ), APP Pharmaceuticals, LLC (" APP" ), Barr Laboratories, Inc. (" Barr" ), and Pliva Hrvatska D.O.O. (" Pliva" ) (collectively, " Defendants" ) arising out of Defendants' filing of Abbreviated New Drug Applications (" ANDAs" ) with the FDA seeking approval to market the pemetrexed disodium products identified in Teva's ANDAs Nos. 90-352 and 90-674, APP's ANDA No. 90-384, and Barr's and Pliva's ANDA No. 91-111 (collectively, the " ANDA Products" ) and covered under the '209 patent. The '209 patent describes a method of administering a chemotherapy drug, pemetrexed disodium (" pemetrexed" ), with vitamins, which is marketed by Lilly under the trade name ALITMA® .

         This matter was before the Court for a second bench trial on May 28, 2015, on the issue of infringement of claims 9, 10, 12, 14, 15, 18, 19 and 21 (the " Asserted Claims" ) of the '209 patent" . During the first trial, the parties jointly stipulated to induced infringement and proceeded to trial only on the issue of validity. As part of their stipulation, however, defendants reserved the right to litigate infringement if the Supreme Court granted the then-pending petition for writ of certiorari in Lime-light Networks, Inc. v. Akamai Technologies, Inc., 134 S.Ct. 2111, 189 L.Ed.2d 52 (2014) and reversed or vacated the Federal Circuits decision. Following the United States Supreme Court's decision in Akamai, the parties jointly moved to remand their pending appeal so that they could litigate the issue of infringement.

         FINDINGS OF FACT

         The Court has set forth the facts of this case in its ruling from the first bench trial on the issue of validity, including the history of the development of antifolate chemotherapy and specifically ALITMA® , and thus the facts are not repeated in detail here. ( See Filing No. 336.) The following constitutes the basic facts giving rise to this infringement action, and the relevant factual findings as it relates to the second bench trial on the issue of indirect infringement.

         The patent-in-suit is U.S. Patent No. 7,772,209, which was issued to Lilly on August 10, 2010, and Lilly is the current owner of the '209 patent. The '209 patent covers the method of administration of ALIMTA® , requiring that physicians co-administer the drug with folic acid and vitamin B12 to reduce the incidence of patient toxicity caused by pemetrexed. Lilly sells pemetrexed in the United States under the trademark ALIMTA® for treatment of specific types of lung cancer and mesothelioma. The Defendants in this case seek FDA approval to market generic forms of pemetrexed, and further seek to sell their pemetrexed products with prescribing information (TX 3018) and patient information (TX 3017) that provides instructions to both doctors and patients that is identical to the methods described in the '209 patent.

         Lilly is asserting claims 9, 10, 12, 15, 18, 19, and 21 of the '209 patent with respect to the ANDA Products. TX 1 at cols. 11-12. Each claim requires pretreatment with a specified amount of folic acid, up to 1000 ¼ g, and with vitamin B12 in the amount of 55-1,500 ¼ g in claims 12, 14 and 21, and 1000 ¼ g in claims 15, 18, and 19, prior to administering pemetrexed. Claims 19, 21, and 22 further require a specific schedule for those pretreatments, and claims 15, 18 and 19 require administration of vitamin B12 by intramuscular injection. The Defendants' product labeling for their proposed generic versions of ALITMA® instructs doctors to follow exactly the claimed regimen, as the ANDA Products will be required to be distributed with materially identical labeling as that for ALITMA® . See 21 U.S.C. § 355(j)(2)(A)(v).

         The primary focus of the infringement trial is on whether the steps of the claimed methods may be attributed to a single actor, thus supporting a finding that Defendants would induce infringement of the Asserted Claims. Specifically, the parties dispute whether physicians will directly infringe the patent by directing or controlling the administration of folic acid to patients. Claim 12 of the '209 patent describes an improved method for administering pemetrexed disodium, comprising " a) administration of between 3500 ¼ g and about 1000 ¼ g of folic acid prior to the first administration of pemetrexed disodium; b) administration of about 500 ¼ g to about 1500 ¼ g of vitamin B12, prior to the first administration of pemetrexed disodium; and c) administration of pemetrexed disodium." TX. 1 at col. 11-12. The prescribing information for ALITMA® states that physicians administering the treatment should " instruct patients to initiate folic acid 400 mcg to 1000 mcg orally once daily beginning 7 days before the first dose of ALITMA® ." TX 3018 at 2. The instructions also state that physicians should " [a]dminister vitamin B12 1 mg intramuscularly 1 week prior to the first dose of ALITMA and every 3 cycles thereafter" and that physicians should " [a]dminister dexamethasone 4 mg by mouth twice daily the day before, the day of, and the day after ALITMA administration." Id. Both Lilly's and the Defendants' experts, Dr. Bruce A. Chabner, M.D. and Dr. Thomas K. Schulz, M.D., agreed that, following these labels, the doctor or other medical professional will administer the vitamin B12 by injection, and pemetrexed by infusion. Tr. 138, 139, 141, 189. However, it is the patient, at the instruction of the physician, who must obtain and take the folic acid.

         I. ...


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