Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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

Executive Summary

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.

You may also be interested in...

FDA-USPTO Collaboration: Stakeholders Want More Clarity On Orange Book Patent Listings

Officials from the two agencies note the real-world benefit of cross-training in helping patent examiners find prior art based on product labeling. A USPTO administrative patent judge also nixes a suggestion that the agency hold proceedings to determine if patents were properly listed in the Orange Book.  

USPTO-FDA Collaboration: Stakeholders Advocate Action From PTAB Proceedings To Examiner Resources

AUTM advocates reform or elimination of inter partes review, DOJ warns of antitrust liability from misrepresentation, and AAM recommends modifying system for measuring productivity of patent examiners.

USPTO Has Not Seen ‘Deluge’ Of Inconsistent Statements From Applicants

Agency did not intend to ‘strong-arm or threaten’ anyone in its duty to disclose notice, patent office legal advisors say. Applicants should assess whether information required by FDA on new method of manufacturing or different formulation impacts patentability.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts