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FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

 
• By Brenda Sandburg

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Patent skyline
The USPTO and FDA were advised on patent policy changes to prevent unjustified delays in competition. • Source: Shutterstock

The US Food and Drug Administration should work with the US Patent and Trademark Office to verify information submitted for inclusion in the Orange Book is correct, a professor said at their joint public “listening session.”

S. Sean Tu, a professor at West Virginia University College of Law, focused on how the FDA and USPTO could deter creation of pharmaceutical patent thickets. He said continuation patents...

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