FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.
You may also be interested in...
FTC Steps Into FDA’s ‘Ministerial’ Gap, Seeks Delisting Of REMS Patent
Jazz’s REMS patent appears to cover only a method of distributing Xyrem not a method of using the drug and if so should be delisted from FDA’s Orange Book, FTC argues in Jazz infringement suit against Avadel, which had itself sued FDA seeking release from patent certification requirement.
What Will USPTO-FDA Collaboration Look Like? Stakeholders To Weigh In On Proposed Initiatives
Agencies are holding public ‘listening session’ to get input on method of use patents and ‘skinny labeling,’ REMS patenting, PTAB proceedings and other topics.
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.