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.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
