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Lilly v. Eagle Pharmaceuticals, Inc.

United States District Court, D. Delaware

March 21, 2019

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

          MEMORANDUM

          M. GOLDBERG, J.

         Currently pending is the claim construction for U.S. Patent No. 7, 772, 209 (“the '209”) as submitted by Plaintiff Eli Lilly and Company (“Lilly”) and Defendant Eagle Pharmaceuticals, Inc. (“Eagle”). (D.I. 53; D.I. 60; D.I. 63; D.I. 81; D.I. 85). The '209 patent covers a method of administering pemetrexed disodium after pretreating patients with folic acid and vitamin B12. I held a Markman Hearing on January 23, 2019. (D.I. 91).

         I. APPLICABLE PRECEDENT

         “It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude.” Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004). The proper construction of a patent claim is a question of law. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015). As a general rule, claim terms are given their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005). There are only two exceptions to the general rule: (i) when the patentee acts as its own lexicographer and sets out a definition; or (ii) the patentee has disavowed the full scope of the claim term either in the specification or during prosecution. Unwired Planet, LLC v. Apple Inc., 829 F.3d 1353, 1358 (Fed. Cir. 2016).

         To determine the ordinary and customary meaning, courts look first and foremost to the intrinsic evidence, which is the claim language, the specification, and the prosecution history. Leseman, LLC v. Stratasys, Inc., 730 Fed.Appx. 912, 914 (Fed. Cir. 2018). Where necessary, courts may also look to the extrinsic evidence, which includes “expert and inventor testimony, dictionaries, and learned treatises.” Phillips, 415 F.3d at 1317 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995)). Extrinsic evidence may not be used “for the purpose of varying or contradicting the terms of the claims.” Markman, 52 F.3d at 981. “The construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction.” Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).

         II. CONSTRUCTION OF DISPUTED TERMS

         The parties initially submitted two terms for construction that are no longer disputed. In its responsive brief, Eagle agreed to not dispute Lilly's proposed construction of the claim term “Vitamin B12.” (D.I. 81 at 19). Therefore, in the attached order, I adopt the parties' agreed-upon construction for “Vitamin B12.” At the Markman hearing, the parties also agreed that I did not need to construe the claim term “methylmalonic acid lowering agent.” (D.I. 91 at 80:1-6).

         The following is my ruling on the terms that remain in dispute.

         A. “administration of pemetrexed disodium” / “administering pemetrexed disodium” / “administering” / “is administered” / “administration” / “pemetrexed disodium” / “the pemetrexed disodium”

Claim Term

Lilly

Eagle

Court's Construction

“administration of pemetrexed disodium”

“administering pemetrexed disodium”

“a liquid administration of pemetrexed disodium (i.e. a solution containing at least two sodium ions for each pemetrexed ion)”

Construe separate terms below[1]

Construe separate phrases below

“administering”

“is administered”

“administration”

Construe combined phrase above[2]

“giving remedially, giving treatment, dispensing, meting out”

“is given remedially, is given treatment, is dispensed, is meted out”

“the act of giving remedially, giving treatment, dispensing, meting out”

“giving remedially, giving treatment, dispensing, meting out”

“is given remedially, is given treatment, is dispensed, is meted out”

“the act of giving remedially, giving treatment, dispensing, meting out”

“pemetrexed disodium” “the pemetrexed disodium”

Construe combined phrase above[3]

“the chemical compound pemetrexed disodium”

“the chemical compound pemetrexed disodium”

         As an initial matter, I must decide whether to construe the combined phrase “administration of pemetrexed disodium” (and its variants) or the separate terms “administration” and “pemetrexed disodium” (and their variants). For several reasons, I will construe the separate terms instead of the combined phrase.

         First, the specification demonstrates that “pemetrexed disodium” is capable of being defined and understood as a standalone term as the specification expressly defines “antifolate” as a standalone term, and pemetrexed disodium is the preferred example of an “antifolate.” (See D.I. 53-1, Ex. 2 at 4:28-43).

         Second, Lilly is correct that every time the term “pemetrexed disodium” appears in the '209 patent it is used in conjunction with the terms “administering” or “administration of.” (D.I. 91 at 23:12-15). But the '209 patent also uses “administering” and “administration of” in conjunction with many other compounds and drugs that are not “pemetrexed disodium” including “antifolates, ” “methylmalonic acid lowering agent, ” “folic acid, ” “FBP binding agent, ” and “Vitamin B12.” (D.I. 53-1, Ex. 2 at 1:55-61; 2:32-67; 3:1-18; 3:53-58; 4:25-43; 5:5-50; 6:13-52). “It is well-established … that claim terms are to be construed consistently throughout a patent.” Phil-Insul Corp. v. Airlite Plastics Co., 854 F.3d 1344, 1359 (Fed. Cir. 2017). Lilly's approach to claim construction could create an inconsistency. Specifically, Lilly proposes that “administration of pemetrexed disodium” mean “liquid administration of pemetrexed disodium, ” which suggests that other compounds and drugs mentioned in connection with “administration” must also be administered via a liquid.[4] But the specification makes clear this is not the case. (See Section II. A.2. below). Any inconsistency could be easily avoided by construing the separate terms.

         Finally, there is no reason to construe the full phrase “administration of pemetrexed disodium” when I will be required to construe the standalone term “pemetrexed disodium” in any event. The term “pemetrexed disodium” also appears in the disputed phrase “effective amount of pemetrexed disodium.” The patent specification provides a standalone definition for “effective amount.” If I adopt the patent's standalone definition of “effective amount, ” then I will still need to construe “pemetrexed disodium” as a standalone term so that the parties have a complete definition for the disputed phase “effective amount of pemetrexed disodium.” Given all of the above, I do not see ...


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