Eligibility Cannot be Raised in IPR Appeal

Neptune Generics v. Eli Lilly (Fed. Cir. 2019)Mylan Labs v. Eli Lilly (Fed. Cir. 2019) This appeal combines twelve different inter partes review (IPR) proceedings. In each case, the PTAB Board sided with the patentee — holding that the claims of Lilly’s U.S. Patent 7,772,209 were not proven invalid.  On appeal, the Federal Circuit has affirmed. Premetrexed disodium is a drug treatment for malignant mesothelioma that works as a folate antagonist — blocking cell usage of folic acid necessary for rapid DNA replication.  The drug has major side effects addressed by the Lilly patent.  In particular, the claimed invention calls for a pre-treatment of a patient with folic acid and vitamin B12 in order to reduce the risk skin rashes, fatigue, etc. The patent itself calls the idea here “surprising[] and unexpected[]” — since the pre-treatment with folic acid does not appear to reduce the therapeutic efficacy of the premetrexed…

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