Dr. Reddy's failed to provide persuasive, objective evidence that it has a "reasonable apprehension" of being sued by Pfizer for infringing a Zoloft (sertraline) patent, a Newark, N.J. federal judge rules July 7. The court dismissed Reddy's action seeking a declaratory judgment that its ANDA will not infringe Pfizer's '699 patent, which expires on Sept. 28, 2010. Reddy's filed an ANDA with a Paragraph IV certification against the '699 patent, but Pfizer did not sue within the 45 days following notification. The court rejected Reddy's arguments that Pfizer's infringement lawsuit against first ANDA filer Ivax on the '699 patent provides a reasonable basis for believing that Reddy's ultimately would be sued. Pfizer and Ivax settled their litigation in 2002, and the settlement "allows Ivax to begin marketing its generic sertraline product at the end of the expiration of" the compound patent in June 2006, the court said...
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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 EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
