1. Pink Sheet
  2. >>Market Access

USPTO-FDA Collaboration: Stakeholders Advocate Action From PTAB Proceedings To Examiner Resources

 
• By Brenda Sandburg

AUTM advocates reform or elimination of inter partes review, DOJ warns of antitrust liability from misrepresentation, and AAM recommends modifying system for measuring productivity of patent examiners.

USPTO FDA patent
USPTO and FDA get public input on their collaboration to bolster the reliability of patents • Source: Nielsen Hobbs; Pink Sheet|Shutterstock image

The US Patent and Trademark Office was inundated with more than 200 comments in response to its call for public input on proposed initiatives to bolster the robustness and reliability of patents. Stakeholders agreed that patent examiners need to have more resources and training. But they offered opposing views on nearly every other topic.

The USPTO published a list of questions for the public to address in an October Federal Register notice. They asked...

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
Start Free Trial

Already a subscriber?

More from Market Access

More from Pink Sheet

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.