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.
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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