Hope Does Not Create a Reasonable Expectation of Success: Federal Circuit Reverses Obviousness Determination

In OSI Pharmaceuticals, LLC v. Apotex Inc., No. 2018-1925 (Fed. Cir. Oct. 4, 2019), the Federal Circuit reversed the PTAB’s determination that certain claims of U.S. Patent No. 6,900,221 were unpatentable as obvious.

Before the Board, Apotex sought an IPR to cancel several claims of OSI’s ’221 patent, covering the use of erlotinib to treat non-small cell lung cancer (NSCLC). Apotex argued obviousness in light of prior art and OSI’s 10-K disclosure with the Securities and Exchange Commission. The Board agreed with Apotex and held that the prior art references would have provided “a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal.”

On appeal, the Federal Circuit reversed the Board’s obviousness determination, holding that the Board misinterpreted the prior art to “teach more than substantial evidence supports.” The Court reasoned that the references offer “no more than hope,” and that no information about erlotinib’s success in treating NSCLC was disclosed. The Court made clear a reasonable factfinder could not find a reasonable expectation of success in this case.