Completion of Phase I Safety Trials for FDA Approval May Not Be Sufficient to Show Reasonable Expectation of Success
OSI PHARMACEUTICALS, LLC v. APOTEX INC Before Stoll , Newman, and Taranto. Appeal from the Patent Trial and Appeal Board. Summary : A pharmaceutical company’s statement touting the completion of Phase I safety trials for FDA approval is not…
October 7, 2019Federal Circuit2 min read