FDA, USPTO Collaboration Could Expand Review Of Pharma Patents, Explore ‘Skinny Label’ Policy

The two agencies are pursuing initiatives to address instances of patents being used improperly to delay competition. FDA may play greater role in PTAB proceedings and training patent examiners.

Patent collaboration
US FDA and USPTO team up to assure patents do not delay generic and biosimilar competition • Source: Shutterstock

The US Food and Drug Administration and US Patent and Trademark Office are moving forward with initiatives to prevent patents from being used to improperly delay competition. These actions will give the FDA a role in proceedings evaluating pharmaceutical patents and in training patent examiners.

FDA Commissioner Robert Califf and USPTO Director Kathi Vidal announced their collaboration in a 6 July joint blog post....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

More from Pink Sheet

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

 
• By 

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.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.