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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