Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., No. 15-2067 (Fed. Cir. 2017)Annotate this Case
Eli Lilly’s 209 patent, issued in 2010, relates to methods of administering the chemotherapy drug pemetrexed disodium after pretreatment with common vitamins—folic acid and vitamin B12. Pemetrexed is an antifolate that kills cancer cells by inhibiting the function of folates, a class of nutrients necessary for cell reproduction. The vitamin pretreatments reduce the toxicity of pemetrexed. Eli Lilly markets pemetrexed under the brand name ALIMTA®, and the drug is used to treat certain types of lung cancer and mesothelioma. Around 2008–2009, Defendants notified Eli Lilly that they had submitted Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of ALIMTA®. After the 209 patent issued, Defendants filed Paragraph IV certifications under 21 U.S.C. 355(j)(2)(A)(vii)(IV), declaring that the 209 patent was invalid, unenforceable, or would not be infringed. Eli Lilly filed suit for infringement under 35 U.S.C. 271(e)(2). The district court found and the Federal Circuit affirmed that, while no single actor performs all steps of the asserted claims because the actions of both physicians and patients are required, under Akamai Technologies (Fed. Cir. 2015), there was direct infringement attributable to physicians. Defendants are liable for inducing that infringement. The court asserted claims were not invalid for indefiniteness, obviousness, or obviousness-type double patenting.