Eli Lilly & Co, v. Los Angeles Biomedical Research Institute, No. 16-1547 (Fed. Cir. 2017)Annotate this Case
LAB’s 903 patent claims a method of “arresting or regressing” penile fibrosis, which can result in erectile dysfunction and penile deformation, by the long-term, daily administration of type 5 phosphodiesterase (PDE5) inhibitors. At Eli Lilly’s request, the Patent Trial and Appeal Board conducted inter partes review. The patent claimed priority from a 2002 Provisional Application. The Board first rejected LAB’s argument for the earlier priority date, construed three terms, and concluded that the claim limitation requiring the delivery of a dosage of up to 1.5 mg/kg/day for at least 45 days “would meet the claim requirement of a continuous, long-term regimen,” and that the combination of three prior references rendered the claims unpatentable as obvious. The Federal Circuit vacated, finding two claim constructions erroneous and that the Board did not make factual findings as to whether there was an apparent reason to combine the references to treat penile fibrosis and whether a person of skill in the art would have had a reasonable expectation of success from such a combination. In a separate opinion, the court specifically addressed one prior reference, Whitaker, stating that it may “suggest” long-term daily treatment by noting the beneficial effects of daily treatment (better erectile response and decreased side effects), but that is not enough. Whitaker does not disclose the claimed treatment regimen with sufficient clarity to satisfy the demanding standard for anticipation.