OSI PHARMACEUTICALS, LLC v. APOTEX INC.

  • Oct 4 2019
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  • Category: CAFC Updates

OSI Pharmaceuticals appeals the decision of the Patent Trial and Appeal Board holding certain claims of U.S. Patent No. 6,900,221 (relating to method for the treatment of non small cell lung cancer using N-(3-ethynylphenyl)-6,7-bis(2-methoxyeth-oxy)-4-quinazolinamine, i.e., Tarceva®) unpatentable as obvious. The CAFC finds that, properly read, the combinations of the prior art applied do not provide substantial evidence supporting the Board’s findings of reasonable expectation of success, noting that this holding does not mean that efficacy data is always required for a reasonable expectation of success or that “absolute predictability of success” is required. Accordingly, the CAFC reverses the Board’s obviousness determination.

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