Indianapolis, Indiana – Attorneys for Plaintiff, Eli Lilly and Company (“Eli Lilly”) of Indianapolis, Indiana filed suit in the Southern District of Indiana alleging that Defendants, Dr. Reddy’s Laboratories, Ltd. of Hyderabad, Telagana, India, and Dr. Reddy’s Laboratories, Inc., a New Jersey corporation, (collectively “Dr. Reddy’s”) infringed its rights in United States Patent No. 7,772,209 (“the ‘209 Patent”). Eli Lilly is seeking judgment that Dr. Reddy’s has infringed the ‘209 patent; that the effective date of any FDA approval for Dr. Reddy’s NDA product be not earlier than the expiration of the ‘209 patent; and for costs, expenses, and attorneys’ fees, along with any other relief the court may deem just and proper.
The Complaint asserts that Eli Lilly sells ALIMTA ®, an FDA approved product used in combination with Cisplatin to treat patients with specific types of cancer. Eli Lilly claims that it is the assignee of the ‘209 patent, a method patent which was upheld as valid by the Federal Circuit in, Eli Lilly and Company v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017). Dr. Reddy’s and Eli Lilly were engaged in a previous lawsuit concerning Dr. Reddy’s NDA No. 208297 and the ‘209 patent. According to the Complaint in this matter, the court found in the previous lawsuit that the filing of NDA No. 208297 indirectly infringed specific claims of the ‘209 patent and entered final judgment in favor of Eli Lilly. Eli Lilly claims that because Dr. Reddy’s did not challenge the validity of the ‘209 patent as a counterclaim or affirmative defense in the previous litigation over the ‘209 patent and NDA No. 208297, Dr. Reddy’s is barred by collateral estoppel or res judicata from doing so in this case.
Dr. Reddy’s has filed an amendment to NDA No. 208297, and the Complaint alleges that the purpose of this amendment was to obtain approval of the product before the expiration of the ‘209 patent. Eli Lilly is claiming infringement of the ‘209 patent based on its belief that Dr. Reddy’s NDA product delivers the same active Pemetrexed moiety as the ‘209 patent. Further, Eli Lilly alleges that Dr. Reddy’s NDA product when used as directed will infringe claims 1-22 of the ‘209 patent under the doctrine of equivalents. As such, Eli Lilly is seeking judgment of infringement, costs, expenses, and attorneys’ fees.