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OSI Pharmaceuticals, LLC v. Apotex Inc.

In Some Contexts, Efficacy Data Necessary to Find Reasonable Expectation of Success

OSI Pharmaceuticals, LLC v. Apotex Inc., __ F.3d __, 2019 WL 4892078 (Fed. Cir. Oct. 4, 2019) (Newman, Taranto, STOLL) (PTAB) (3 of 5 stars)

Fed Cir reverses IPR cancelation of OSI’s claims as obviousness. OSI’s patent relates to treating non-small cell lung cancer (NSCLC) with erlotinib (marketed by OSI as Tarceva). The record did not support the Board’s determination that a person of ordinary skill would have had a reasonable expectation of success in combining references, one of which was an OSI 10-K filing disclosing that OSI was exploring using erlotinib to treat NSCLC, and that erlotinib had entered Phase II clinical trials. The opinion describes how the evidence did not contain sufficient evidence to support the Board’s determination that erlotinib’s anti-cancer activity against NSCLC was known in the prior art. It also describes how the evidence did not support a reasonable expectation of success, particularly due to the lack of efficacy data, noting that NSCLC generally has “over [a] 99.% % failure rate of drugs entering Phase II.” Op. at 16. Though OSI’s reference in its 10-K to a start of Phase II trials for erlotinib suggested that “some preclinical data exists, there is no basis for assuming that the data pertains to NSCLC as opposed to other cancers.” Id. at 17.

The opinion also rejects, per Celgene, 931 F.3d 1342 (Fed. Cir. 2019), OSI’s constitutionality challenge to the IPR based on retroactivity.

KEYWORDS: INTER PARTES REVIEW; OBVIOUSNESS (NO); REASONABLE EXPECTATION OF SUCCESS