Los Angeles Biomedical Research Institute v. Eli Lilly & Co., No. 16-1518 (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, finding that the specification of the provisional application did not disclose the dosage limitation, then construed: “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis”; “arresting or regressing the at least one of the penile tunical fibrosis and corporal tissue fibrosis”; and “continuous long-term regimen.” The Board 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.