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Eli Lilly and Co. v. Eagle Pharmaceuticals, Inc.

United States District Court, D. Delaware

October 25, 2018

ELI LILLY AND COMPANY, Plaintiff,
v.
EAGLE PHARMACEUTICALS, INC., Defendant.

          MEMORANDUM OPINION

          M. GOLDBERG, J.

         Plaintiff Eli Lilly & Company (“Lilly”) initiated this patent infringement action pursuant to the Hatch-Waxman Act in response to defendant Eagle Pharmaceuticals, Inc. (“Eagle”) filing a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a pemetrexed injection, 25mg/mL, 500 mg vial product (the “NDA Product”) before the expiration of U.S. Patent No. 7, 772, 209 (“the '209 patent”). Lilly is the assignee of the '209 patent. Lilly also makes and sells ALIMTA®, a drug containing pemetrexed disodium that is used for treatment of various types of cancer. Lilly believes that Eagle's NDA product will be marketed as a competing product to ALIMTA®.

         Currently pending is Eagle's motion for judgment on the pleadings pursuant to Fed.R.Civ.P. 12(c). (D.I. 28). I have subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331 and 1338(a). Venue is proper under 28 U.S.C. §§ 1391 and 1400(b).[1] For the reasons set forth below, I will deny Eagle's motion for judgment on the pleadings.

         I. BACKGROUND

         A. Procedural History

         On August 7, 2017, Eagle advised Lilly that it had submitted NDA No. 209472 to the FDA, seeking to market its own pemetrexed product based on Lilly's ALIMTA®, and that it had submitted a certification pursuant to 21 U.S.C. § 355(b)(2)(A)(iv) that Lilly's '209 patent will not be infringed by the manufacture, use, offer for sale, sale, or importation of Eagle's NDA product, or alternatively, that the '209 patent is invalid. (D.I. 7 at ¶ 1). Lilly then sued Eagle under 35 U.S.C. § 271(e)(2), alleging that the use of Eagle's proposed NDA Product will infringe the '209 patent either literally or under the doctrine of equivalents and that Eagle will induce and contribute to that infringement. (D.I. 1).

         Eagle answered Lilly's complaint on October 3, 2017, and asserted counterclaims for, inter alia, declaratory judgment of non-infringement. (D.I. 7). On October 24, 2017, Lilly answered Eagle's counterclaims, denying some of the factual allegations and denying that Eagle was entitled to any relief whatsoever. (D.I. 12). On May 31, 2018, Eagle filed this motion, which has been fully briefed. (D.I. 28; D.I. 35; D.I. 40).

         B. The '209 Patent

          The '209 Patent has two independent claims, claims 1 and 12, both directed to a method of administering pemetrexed disodium. Claim 1 reads:

A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

(D.I. 1-1 at 10:60-65). Claim 12 reads:

An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:
a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of ...

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