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

UsernamePublicRestriction

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...



Patent Office Opposes Ruling On Ovarian Cancer Drug, Wants Stronger Obviousness Standard

After Federal Circuit vacates district court ruling that patent on method of dosing ImmunoGen’s mirvetuximab soravtansine is indefinite and obvious, PTO warns of ‘well-documented problem’ of drug manufacturers receiving follow-on patents for ‘trivial modifications’ that delay generics.

FDA, USPTO In Middle Of Congressional Tug-Of-War Over Patents And Drug Pricing

Senators Hassan and Cassidy contend the lack of coordination between the two agencies may allow patent thickets to grow. Meanwhile, Sen. Tillis is pushing the agency to refute data alleging patents are to blame for high drug prices.

Generic Manufacturers Face Uphill Climb After Federal Circuit’s ‘Skinny Label’ Decision

Split appeals court denies en banc review of GSK v. Teva ruling, but suggests the district court could consider GSK’s patent declarations in determining whether Teva’s label is evidence of inducement to infringe. Teva plans to file petition for Supreme Court review.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146445

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

Cancel