Eli Lilly & Co. v. Teva Parenteral Med., Inc., No. 11-1561 (Fed. Cir. 2012)
Annotate this CaseGeneric pharmaceutical manufacturers filed abbreviated new drug applications, seeking FDA approval to market generic formulations of the chemotherapy agent pemetrexed, currently marketed as Alimta. Permetrexed won FDA approval in 2004 for use in treating mesothelioma and then in 2008 for treatment of non-small cell lung cancer. A 1989 patent application claimed pemetrexed and a broader group of related antifolates containing pemetrexed’s characteristic core structure. The application, eventually abandoned, founded a family of related applications that yielded the three patents at issue; two have expired, but the 932 patent remains in effect until 2016, due to a patent term extension of over four years to compensate for delays, 35 U.S.C. 156. The ANDAs asserted that the 932 patent was invalid, unenforceable, or would not be infringed by the proposed generic products, 21 U.S.C. 355(j)(2)(A)(vii)(IV). Lily, which markets Alimta, sued alleging infringement, 35 U.S.C. 271(e)(2)(A). The district court rejected arguments that the 932 patent claims were invalid for obviousness-type double patenting over two earlier-issued claims. The Federal Circuit affirmed.
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