A favorable June 5 ruling for private-labeler Perrigo to launch its own version of the acid reducer Pepcid Complete reflects the influence of the recent U.S. Supreme Court decision that expanded the situations under which an invention can be considered obvious (1"The Pink Sheet" May 7, 2007, p. 7). Johnson & Johnson/Merck sued Perrigo for patent infringement after the private-labeler submitted an ANDA with a Paragraph IV certification to FDA to manufacture and market an equivalent of the famotidine/antacid combination, but the formulation patent concerning the use of the H2 blocker famotidine was invalidated on the grounds that it was obvious. In the precedent-shifting KSR v. Teleflex case, the Supreme Court said courts should now look at factors such as market demands and predictable solutions to a problem in assessing obviousness...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
