1. Pink Sheet
  2. >>Legal & IP

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

 
• By Brenda Sandburg

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
Start Free Trial

Already a subscriber?

More from Legal & IP

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
• By Grace Moser

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

More from Pink Sheet

Malaysia Clarifies Drug Shortage Reporting Rules And Penalties For Non-Compliance

 
• By Neena Brizmohun

New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.

Dutch HTA Calls For “Socially Acceptable” Price For Gene Editing Therapy Casgevy

 
• By Francesca Bruce

Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.