Eli Lilly and Co. v. Hospira, Inc., No. 18-2126 (Fed. Cir. 2019)Annotate this Case
Lilly markets the compound pemetrexed in the form of a disodium salt as Alimta®, which is indicated, both alone and in combination with other active agents, for treating certain types of non-small cell lung cancer and mesothelioma. Patent disputes about Alimta® reach back more than a decade. DRL, Hospira, and Actavis submitted New Drug Applications (NDA) under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(b)(2), relying on Lilly’s clinical data for pemetrexed disodium but each seeks to market different pemetrexed salts. The district court concluded that the NDA submission infringed the 209 patent under 35 U.S.C. 271(e)(2) and prohibited FDA approval of the products at issue until the expiration of that patent. The Federal Circuit reversed in part. The finding of literal infringement in the Hospira Decision was clearly erroneous in light of the court’s claim construction of “administration of pemetrexed disodium.” The court otherwise affirmed the infringement holding; the district court did not err in its application of the doctrine of equivalents in either decision.