Completion of Phase I Safety Trials for FDA Approval May Not Be Sufficient to Show Reasonable Expectation of Success

OSI PHARMACEUTICALS, LLC v. APOTEX INC

Before Stoll, Newman, and Taranto. Appeal from the Patent Trial and Appeal Board.

Summary: A pharmaceutical company’s statement touting the completion of Phase I safety trials for FDA approval is not sufficient to show that a skilled artisan would have had a reasonable expectation of success in combining the prior art.

Apotex requested an Inter Partes Review of OSI’s patent directed to a method for the treatment of non-small cell lung cancer (“NSCLC”) using erlontinib. Erlontinib is an epidermal growth factor receptor (“EGFR”) inhibitor that can be beneficial to cancer treatment. Apotex argued—and the Board agreed—that OSI’s claims were obvious over Schnur, a reference teaching treatment of cancers, but not specifically NSCLC, with erlontinib, in view of either OSI’s 10-K filing with the SEC or a review article analyzing anti-cancer studies. The Board found that OSI’s 10-K which stated that OSI had completed Phase I safety trials of erlontinib for treatment of NSCLC provided a skilled artisan with a reasonable expectation of success of achieving the claimed invention in light of Schnur’s teachings. The Board also found that the review article, in its analysis of EGFR inhibitor studies (including studies of erlontinib), concludes that EGFR inhibitors would have acceptable therapeutic properties for NSCLC and thus could be combined with Schnur to teach the claimed invention.

The Federal Circuit reversed the Board’s decision, holding that the Board’s finding of a reasonable expectation of success is not supported by substantial evidence. The Federal Circuit noted that Phase I trials are conducted primarily to evaluate safe dosage range and side effects. The Federal Circuit further acknowledged that 99.5% of drugs entering Phase II trials for the treatment of NSCLC failed. Thus, the mere statement to the SEC that erlontinib completed Phase I trial, with no evidence of efficacy of the treatment, could not support a finding of reasonable expectation of success. Furthermore, the Court held that the Board misinterpreted the review article’s conclusion regarding EGFR inhibitors to teach more than substantial evidence supports. It found that neither of the references relied on by the review article disclosed specifically treating NSCLC with erlontinib. Accordingly, the Court reversed the Board’s determination of obviousness.

Editor: Paul Stewart