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.

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....