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FTC Steps Into FDA’s ‘Ministerial’ Gap, Seeks Delisting Of REMS Patent

 
• By Brenda Sandburg

Jazz’s REMS patent appears to cover only a method of distributing Xyrem not a method of using the drug and if so should be delisted from FDA’s Orange Book, FTC argues in Jazz infringement suit against Avadel, which had itself sued FDA seeking release from patent certification requirement.

Orange patent
FTC files brief in suit over listing of patents in FDA's Orange Book • Source: Shutterstock

The US Federal Trade Commission suggests that Jazz Pharmaceuticals improperly listed its patent on a system for distributing Xyrem (sodium oxybate) in the US Food and Drug Administration’s “Orange Book” because the patent does not claim the drug itself or a method of using it.

The FTC filed an amicus brief in Jazz’s infringement suit against Avadel Pharmaceuticals in the US District Court for...

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More from Legal & IP

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By Dave Wallace

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By Dean Rudge

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

 
• By Dave Wallace

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

More from Generics Bulletin

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By Dave Wallace

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By Dean Rudge

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 
• By Urtė Fultinavičiūtė

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.