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 “Ministerial” Approach To Patent Listings Upheld By Appeals Court

This article was originally published in The Tan Sheet

Executive Summary

An appeals court's dismissal of Apotex' lawsuit against FDA relating to patent listings affirms a key provision in the final rule reforming Hatch/Waxman

You may also be interested in...



Califf Suggests Congress ‘Tighten Up Laws’ To Address Orange Book Abuses

US FDA Commissioner repeats longstanding FDA policy that the agency doesn’t have much power to address frivolous patent listings in the Orange Book, but seems to support Congress providing more authority.

Orange Book Policing May Increase, US FDA's Gottlieb Says

Commissioner says agency will modernize drug patent reference manual this year and consider potential changes to Orange Book administration policy. However, any transformative moves could trigger a court challenge.

Senate Generic Reform Bill Likely To Result In Earlier ANDA Filings

A bipartisan Senate bill would encourage earlier ANDA filings by generics firms to head off new innovator patent listings and secure sole rights to 180-day exclusivity

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS096110

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