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Eli Lilly and Co. v. Apotex, Inc.

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

December 30, 2019

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

          ENTRY ON CROSS-MOTIONS FOR SUMMARY JUDGMENT

          TANYA WALTON PRATT, JUDGE

         This matter is before the Court on Cross-Motions for Summary Judgment filed pursuant to Federal Rule of Civil Procedure 56 by Plaintiff Eli Lilly and Company (“Lilly”) (Filing No. 231) and Defendant Apotex, Inc. (“Apotex”) (Filing No. 254). Lilly is the assignee of U.S. Patent No. 7, 772, 209 (the “‘209 patent”), titled “Antifolate Combination Therapies, ” which was issued on August 10, 2010. Lilly initiated this patent infringement action against Apotex, alleging that Apotex's New Drug Application filed with the U.S. Food and Drug Administration (“FDA”) for the manufacture and sale of its Pemetrexed for Injection products, infringes upon the ‘209 patent. The parties filed Cross-Motions for Summary Judgment on the infringement claim. For the following reasons, the Court grants Lilly's Motion for Summary Judgment and denies Apotex's Motion.

         I. BACKGROUND

         Lilly is a corporation organized and existing under the laws of the State of Indiana with its principal place of business in Indiana. Lilly is in the business of formulating, manufacturing, and selling pharmaceutical products. Apotex is a corporation organized and existing under the laws of Canada, having a place of business in Toronto, Ontario, Canada. Apotex is also in the business of developing, manufacturing, and selling pharmaceutical products.

         The patent at issue in this infringement action, 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. ALIMTA® is also 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 FDA (Filing No. 232-1 at 1-9, 294).

         ALIMTA® 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 concerns 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. Id. at 3-4.

         In its Complaint, Lilly contends that the New Drug Application filed by Apotex with the FDA for the manufacture and sale of its Pemetrexed for Injection 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® (Filing No. 1; Filing No. 232-1 at 365-68).

         The prosecution history of the ‘209 patent, began in June 2000 when Lilly filed its earliest patent application leading to the ‘209 patent. The application claimed methods of administering an antifolate in combination with a methylmalonic acid lowering agent and folic acid. The application specifically claimed the antifolate ALIMTA® (Filing No. 258-3 at 65-80). In April 2001, Lilly filed another patent application in the chain leading to the ‘209 patent. Like the June 2000 application, the April 2001 application claimed methods of administering an antifolate in combination with a methylmalonic acid lowering agent and folic acid, and the application specifically claimed the antifolate ALIMTA® (Filing No. 258-4 at 57-76).

         In June 2001, Lilly filed an international application under the Patent Cooperation Treaty leading to the ‘209 patent. The Patent Cooperation Treaty application also claimed methods of administering an antifolate in combination with a methylmalonic acid lowering agent and folic acid, and the application specifically claimed the antifolate ALIMTA®. Id. at 88-108.

         In September 2004, the USPTO rejected Lilly's claims using “wherein the antifolate is ALIMTA.” (Filing No. 258-7 at 111-21.) The office action explained, The following is a quotation of the second paragraph of 35 U.S.C. 112:

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 29, 30, and 33 (as depending from claim 9) are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The instant claims refer to the trade name “ALIMTA.” It is improper claim language to use a trademark or trade name in a claim to identify or describe a material or product. This not only renders a claim indefinite, but also constitutes an improper use of the trademark or trade name (MPEP § 2173.05 (u)).

(Filing No. 258-7 at 116.)

         In January 2005, Lilly submitted its response to the September 2004 rejections. Lilly amended the claims to read “pemetrexed disodium” rather than “antifolate” and canceled its claims that used “ALIMTA.” Lilly explained to the USPTO that the deletion of the “ALIMTA” claims rendered the patent examiner's September 2004 rejections moot. Id. at 145-55. In September 2005, the USPTO issued ...


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