![]() ![]() On appeal, the Federal Circuit found the communications prior art under pre-AIA § 102(f) (“A person shall be entitled to a patent unless (f) he did not himself invent the subject matter sought to be patented.”). ![]() Manufacturers reduce ABUK impurities in oxycodone and oxymorphone to below 0.001%” - the exact result claimed by Mallinckrodt. In the communications, the FDA “mandated that opioid The district court did make a major legal mistake - holding that confidential communications between the FDA and oxymorphone producers (including the patentee) were not prior art. However, following a bench trial the Delaware district court sided with the patentee - holding that the claims had not been proven invalid with clear and convincing evidence. Claim 1 is directed to a highly pure form of “oxymorphone” with “less than 0.001% of 14-hydroxymorphinone.”Īctavis argued that the claims were invalid as obvious. Patent 8,871,779 covering a form of the opioid oxymorphone. This is a case-in-point.Įndo is the exclusive licensee of Mallinckrodt’s U.S. Obviousness is a tough issue to appeal because its flexible fact-heavy analysis lends itself to giving deference to the fact-finder. ![]()
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