FEDERAL CIRCUIT FINDS NO REASONABLE EXPECTATION OF SUCCESS IN VIEW OF HIGH FAILURE RATE FOR SIMILAR TREATMENTS AT TIME OF INVENTION

OSI PHARMACEUTICALS, LLC v. APOTEX INC., Appeal No. 2018-1925 (Fed. Cir. October 4, 2019).  Before Newman, Taranto, and Stoll.  Appealed from PTAB. (Obviousness; Reasonable Expectation Of Success)

Background:

OSI owns a patent directed to a method for treating non-small cell lung cancer (NSCLC) by administering N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine (erlotinib).  Apotex challenged the validity of the patent in an IPR proceeding, arguing that the patent claims were obvious over a prior patent (“Schnur”) in combination with either a scientific publication (“Gibbs”) or a Form 10-K, an annual financial form filed by OSI with the SEC (“OSI’s 10-K”).

Schnur disclosed erlotinib as a preferred compound among 105 different compounds for treating various human tumors, including lung tumors, but did not specifically identify NSCLC.  Gibbs, a review article, disclosed that erlotinib and another drug were in clinical trials and appeared to have good anti-cancer activity in preclinical models, particularly in patients with NSCLC.  OSI’s 10-K included a section titled “Product Development and Research Programs,” disclosing that erlotinib targets a variety of cancers, including NSCLC, and had completed Phase I safety trials and was beginning Phase II clinical trials.

The Board found that a person of ordinary skill in the art would have combined Schnur with the disclosures in Gibbs or OSI’s 10-K with a reasonable expectation of success of using erlotinib to treat NSCLC.

Issue/Holding:

Was the Board’s finding of a reasonable expectation of success supported by substantial evidence? (continue reading)

Summary by:  Megan Doughty

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