CAFC Reverses PTAB’s Obviousness Ruling in OSI v. Apotex
December 3, 2019
Authored and Edited by Kathryn R. Judson; Justin J. Hasford
In OSI Pharmaceuticals, LLC v. Apotex Inc., No. 2018-1925 (Fed. Cir. Oct. 4, 2019), the CAFC reversed the PTAB’s conclusion that a reasonable factfinder could conclude a person of ordinary skill in the art would have had a reasonable expectation of success in using erlotinib to treat non-small cell lung cancer in a mammal. The CAFC held “the Board misinterpreted the asserted references to teach more than substantial evidence supports,” and the references provided no more than hope, which is “not enough to create a reasonable expectation of success in a highly unpredictable art.” This case involved a patent covering the use of erlotinib to treat non-small cell lung cancer. Further discussion of the decision can be found on Finnegan’s Federal Circuit IP Blog.
drugs, United States Court of Appeals for the Federal Circuit (CAFC), Obviousness (35 USC § 103), Patent Trial and Appeal Board (PTAB), Investigational New Drug Application (INDA), Orange Book
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