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

Lilly’s Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit

 
• By Cathy Kelly

Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.

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.

More from Pink Sheet

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

Zimbabwe Tackles Medicines Falsification With New Requirements For Pharma

 
• By Neena Brizmohun

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.