1. Pink Sheet

Patents Face 'Real Threat' From Inter Partes Review; PTAB Open To Change

 
• By Brenda Sandburg

Pfizer attorney says brand-name drug companies no longer can rely on the outcome of ANDA litigation to predict date of generic competition; PTAB chief judge observes that there is 'opportunity to get some more certainty for patent owners.'

For biopharma patent owners, the impact of inter partes review (IPR) proceedings can be summed up in one word: uncertainty. They say this patent challenge process prevents them from knowing when they can rely on their intellectual property rights.

It used to be that disputes over small molecule patents "would go through ANDA litigation and come to a successful...

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

More from Pink Sheet

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By Cathy Kelly

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.