Propofol – USA

Propofol – USA

On Nov. 07, 2018, Federal Circuit affirmed (Rule 36 judgment) Patent Trial and Appeal Board’s decision that a patent covering Fresenius’ Diprivan® is invalid.
Previously, PTAB on Jun 07, 2017 in IPR2018-00186 issued final written decision & found certain claims of US 8,476,010 (expiring on 06/01/2025) unpatentable under obviousness. The ’010 patent relates to pharmaceutical formulations of propofol that are stored in containers having nonreactive, inert closures. PTAB in summary considering the trial record as a whole found that the use of silicone oil on the rubber stoppers was repeatedly identified as a solution to normal rubber stopper problem. PTAB credited the testimony of Dr. Feinberg that a person of ordinary skill in the art would have had a reasonable expectation of success in substituting a siliconized rubber stopper for an uncoated rubber stopper. It also would have been expected that this substitution would not have resulted in less stability for the emulsion nor in increased propofol degradation. In doing so, PTAB determined that Petitioner has shown by a preponderance of the evidence that claims 1, 13–15, 17, 18, 20, and 24–28 are unpatentable as obvious over prior arts.

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