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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...

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Cigna Claims BMS Tied Revlimid Settlements to Pomalyst ‘Pay-for-Delay’ Scheme

 
• By Dean Rudge

Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
• By Dean Rudge

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

AAM Celebrates Court Backing Over Minnesota Pricing Law

 
• By Dave Wallace

The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.

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Zentiva Strikes Deal With Aboca To Expand CHC Offering

 
• By Tom Gallen

Czech Republic's Zentiva snaps up Aboca portfolio adding supplement brands marketed in European countries such France, Italy and Spain.

Will Amarin Finally Launch An Authorized Generic Version Of Vascepa?

 
• By Dean Rudge

As it offloads commercial rights to the brand in Europe, Amarin has for the umpteenth time teased the possibility of launching an authorized generic version of Vascepa in the US.

Bio-Thera And SteinCares Add Mega-Blockbuster Dupilumab To Latin America Alliance

 
• By Dean Rudge

Bio-Thera Solutions is back with its third agreement with Costa Rica-based SteinCares for the supply of a biosimilar in Latin America – this time for the Chinese firm’s proposed rival to Sanofi and Regeneron’s Dupixent (dupilumab)