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Eli Lilly and Co. v. Apotex, Inc.

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

December 23, 2019

ELI LILLY AND COMPANY, Plaintiff/Counter Defendant,
APOTEX, INC., Defendant/Counter Claimant.



         This patent infringement case is before the Court for construction of patent terms relevant to methods of administering the compound pemetrexed disodium, which is a pharmaceutical product manufactured and sold by Plaintiff Eli Lilly and Company (“Lilly”) as ALIMTA®. Lilly brought this patent infringement action against Defendant Apotex, Inc. (“Apotex”). In lieu of conducting a Markman hearing, the parties submitted comprehensive briefs, exhibits, and proposed findings of fact and conclusions of law concerning the proper construction of disputed terms and phrases of the patent at issue, U.S. Patent No. 7, 772, 209 (the “‘209 patent”).


         Lilly is a corporation organized and existing under the laws of the State of Indiana with its principal place of business in Indianapolis, Indiana. Lilly is a company involved in the formulation, manufacture, and selling of pharmaceuticals. Apotex is a corporation organized and existing under the laws of Canada, having a place of business in Toronto, Ontario, Canada. Apotex is in the business of manufacturing, marketing, and selling generic drug products.

         The patent at issue in this infringement suit, the ‘209 patent, is titled “Antifolate Combination Therapies” and relates to Lilly's anti-cancer agent ALIMTA®. The '209 patent was issued on August 10, 2010, and Lilly is the assignee of the '209 patent. ALIMTA® is used to treat patients with malignant pleural mesothelioma or for the initial treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer. ALIMTA® is also indicated as a single-agent for the treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy. Further, ALIMTA® is indicated for maintenance treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Lilly sells ALIMTA® in the United States pursuant to a New Drug Application that has been approved by the Food and Drug Administration (“FDA”).

         Lilly contends that the New Drug Application filed by Apotex with the FDA for the manufacture and sale of its Pemetrexed for Injection (100 mg/vial and 500 mg/vial) products before the ‘209 patent expires infringes upon the ‘209 patent. Lilly further contends that Apotex's Pemetrexed for Injection products will be marketed as a competing product to ALIMTA®. As a result, Lilly filed this infringement action against Apotex on August 21, 2017.

         ALIMTA® (pemetrexed disodium) is an antifolate drug that is known to disrupt the folic acid pathway which can contribute to the reduction of cancer cells. The ‘209 patent relates to a method of administering pemetrexed disodium along with folic acid and vitamin B12, a methylmalonic acid lowering agent, in order to reduce the toxicities associated with the administration of pemetrexed disodium. This discovery made by Lilly results in a reduction of certain toxic effects caused by the administration of antifolates through the presence of a methylmalonic acid lowering agent without adversely affecting the therapeutic efficacy of the antifolate (Filing No. 88-1 at 3-4).

         The parties agreed on the construction of the claim terms or phrases “patient, ” “vitamin B12, ” “methylmalonic acid lowering agent, ” and the preamble of claim 1 (Filing No. 85 at 1). The parties initially disagreed about claim 12's “an improved method for administering pemetrexed disodium” and “improvement.” Id. at 6. Lilly asserted that the phrase and term are part of a Jepson claim and thus do not require additional construction[1]. Apotex initially asserted that the phrase is a preamble, and the term “improvement” should be construed as “the improvement is the addition of the administration of vitamin B12 in a method that.” Id. However, in its Responsive Markman Brief, Apotex acknowledged that “there may no longer be a relevant dispute” concerning “improvement.” (Filing No. 113-1 at 41.) In its proposed findings of fact and conclusions of law, Apotex suggested the following language, which is consistent with Lilly's position that the phrase and term do not require the Court's construction:

418. The parties disputed the meaning of the term “improvement” as it is used in claim 12 of the ‘209 patent. ECF 85 at 6.
419. Based on the parties' subsequent briefing, however, the Court finds that the parties now agree that there is no need to construe this term. ECF 88 at 27 (“The Court should not separately construe this legal term of art.”); ECF 113-1 at 35 (“Based on Lilly's opening brief, there may no longer be a relevant dispute.”).
420. The Court, therefore, declines to construe the “improvement” term because there is no longer a material dispute.

(Filing No. 163-1 at 128.) In light of this development, the Court declines to construe claim 12's phrase and term “an improved method for administering pemetrexed disodium” and “improvement.”


         “Victory in an infringement suit requires a finding that the patent claim covers the alleged infringer's product or process, which in turn necessitates a determination of what the words in the claim mean.” Markman v. Westview Instruments, Inc., 517 U.S. 370, 374 (1996) (citation and quotation marks omitted). The construction of patent claims, which requires determining the meaning and scope of the claims, is a matter of law for the court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 988 (Fed. Cir. 1995), aff'd 517 U.S. 370. The Federal Circuit has explained, “[i]t 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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citations and quotation marks omitted); see also Vitronics Corp. v. Conceptronic, 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“First, we look to the words of the claims themselves . . . to define the scope of the patented invention.”).

         The words in patent claims 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, 415 F.3d at 1312-13 (citations omitted); see also Home Diagnostics, Inc. v. LifeScan, Inc., 381 F.3d 1352, 1358 (Fed. Cir. 2004) (“customary meaning” refers to the “customary meaning in [the] art field”). “In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words.” Phillips, 415 F.3d at 1314.

         There are two exceptions to the general rule of applying the ordinary meaning to claim terms: “1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.” Thorner v. Sony Comput. Entm't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). To become one's own lexicographer, “a patentee must clearly set forth a definition of the disputed claim term other than its plain and ordinary meaning.” Id. (citation and quotation marks omitted). “It is not enough for a patentee to simply disclose a single embodiment or use a word in the same manner in all embodiments[;] the patentee must ‘clearly express an intent' to redefine the term.” Id. (citation omitted). Additionally, “[t]he patentee may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002).

         When interpreting claim terms, the court first looks to the intrinsic evidence, which includes the claims themselves, the specification, and the prosecution history. See Interactive Gift Express, Inc. v. CompuServe Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (“[I]n interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history. Such intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language.”). And within that intrinsic evidence, courts first “look to the claim language.” Id. When reviewing the claims, the specification, or the prosecution history, if these intrinsic sources define a claim term, that definition shall apply even if it differs from the term's ordinary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366-67 (Fed. Cir. 2002). Although claims must be read in light of the specification, the court should not limit a claim by restricting its scope based on a preferred embodiment within the specification. Phillips, 415 F.3d at 1323. “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Id. at 1313.

         In addition to relying on intrinsic evidence in ascertaining the scope of an invention's claim, the court also may look to extrinsic evidence, which includes evidence outside of the patent and prosecution history such as expert testimony, dictionaries, and learned treatises. Id. at 1317; see also Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999). Courts may “rely on dictionary definitions when construing claim terms, so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents.” Phillips, 415 F.3d at 1322-23 (internal citation omitted).


         Similar to the Court's previous approach in the Eli Lilly v. Teva Parenteral Medicines case (No. 1:10-cv-1376-TWP-DKL), the Court will briefly discuss the background of the ‘209 patent, resolve the dispute concerning a person of ordinary skill in the art, and then construe the disputed claim terms and phrases at issue in this action.

         A. The ‘209 Patent

         The ‘209 patent, titled “Antifolate Combination Therapies, ” concerns the administration of pemetrexed disodium in combination with folic acid and a methylmalonic acid lowering agent to reduce the toxicity levels associated with the administration of pemetrexed disodium. Specifically, the antifolate, pemetrexed disodium, prevents other compounds, known as reduced folates, from binding to particular enzymes that are essential in the growth of potentially cancerous tumors. However, certain toxicities are associated with the administration of pemetrexed disodium. The ‘209 patent discloses a method of administering pemetrexed disodium in conjunction with certain amounts of folic acid and a methylmalonic acid lowering agent, such as vitamin B12, to reduce toxicity levels without affecting the efficacy of the antifolate.

         B. Person of Ordinary Skill in the Art

         Claim terms and phrases are construed from the perspective of a person of ordinary skill in the art (“POSA”) to whom the patent is addressed. “The inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation.” Phillips, 415 F.3d at 1313. “The descriptions in patents are not addressed to the public generally, to lawyers or to judges, but, as section 112 [of Title 35] says, to those skilled in the art to which the invention pertains or with which it is most nearly connected.” Id. (citation omitted).

         Lilly asserts that, “[i]n this case, the art of the '209 patent deals with the medical problem of toxicity associated with chemotherapeutic treatment, and the POSA is therefore a medical oncologist.” (Filing No. 88 at 13.) Lilly points out, “[a]ll of the experts in this case agree that the POSA for the '209 patent at least includes a medical oncologist, and this definition of the POSA is consistent with the definition previously adopted by the Court for the '209 patent.” Id.

         Apotex acknowledges the Court's previous determination of the person of ordinary skill in the art for the ‘209 patent as a medical oncologist, and then Apotex suggests that, “[i]n this Lilly v. Apotex case, however, Lilly's current theory of literal infringement implicates questions of pharmaceutical chemistry, dosage forms and formulations.” (Filing No. 86 at 26.)

Therefore, based on (1) the Court's description of the POSA in the Teva Case, and (2) Lilly's current literal infringement theory and description of the POSA, Apotex proposes that, for purposes of the claim construction disputes in this Apotex Case, the POSA would include a medical oncologist, as described by the Court above, as well as an individual with experience in drug formulation sufficient to address the pharmaceutical chemistry, dosage form, and formulation aspects of the ‘209 Patent.


         After the parties submitted their claim construction briefs, the United States Court of Appeals for the Federal Circuit issued its decision in Eli Lilly & Co. v. Hospira, Inc., 933 F.3d 1320 (Fed. Cir. 2019). Following that decision, “Lilly withdr[ew] its assertion of literal infringement against Apotex in this case.” (Filing No. 248 at 1.) Because Apotex's proposal to include a person experienced in drug formulation is based upon Lilly's literal infringement theory, which is now withdrawn, the Court declines to include a drug formulator in the description of the person of ordinary skill in the art in this case. The parties agree that the person of ordinary skill in the art is a medical oncologist, and the Court sees no reason to depart from its previous determination that the person of ...

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