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Jayapal, Warren Announce Three Drug Manufacturers Pulled Sham Patents after Warnings, Urge FDA to Continue Fight Against Big Pharma Companies’ Patent Abuse

Warren, Jayapal Announce Three Drug Manufacturers Pulled Sham Patents after Warnings, Urge FDA to Continue Fight Against Big Pharma Companies’ Patent Abuse

Lawmakers Probed Big Pharma’s Sham Patent Claims after FTC Warnings in December 2023; Are Now Sharing Responses with FDA to Assist in Development of New Orange Book Guidance 

Text of Letter (PDF)
Pharma Companies’ Responses to Lawmakers’ December 2023 Letters (PDF)

Washington, D.C. – U.S. Representative Pramila Jayapal (D-Wash.) and U.S. Senator Elizabeth Warren (D-Mass.) released responses from eight pharmaceutical companies to letters they sent the companies in December 2023, revealing that, after receiving warnings from Federal Trade Commission (FTC), three of the companies immediately delisted inappropriate patents from the Orange Book, including a number of patents for epinephrine injectors and inhalers.

Representative Jayapal and Senator Warren shared these responses in a letter to Dr. Robert Califf, Commissioner of the Food and Drug Administration (FDA), and commended the agency for announcing its intent to issue new guidance this year on “Submission of Patent Information for Listing in the Orange Book” (Orange Book). The lawmakers urged FDA to fight back against pharmaceutical companies’ efforts to misuse the Orange Book.  

“In December 2023, the FTC took an important step on behalf of consumers, writing to 10 drug manufacturers and ‘challeng(ing) more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed’ in the Orange Book… Soon after FTC’s announcement, we wrote to these same manufacturers, asking them a series of questions and urging them to withdraw any improperly listed patents as rapidly as possible. We have received answers to our questions, and are attaching them here in order to assist FDA as the agency develops its new Orange Book guidance,” wrote the lawmakers.

Drugmakers’ response to FTC’s challenge of improper patent listings was rapid and significant. Two of the manufacturers, Kaléo and Amneal, indicated they would be delisting every patent challenged by FTC, plus five additional patents. GlaxoSmithKline (GSK) indicated that the company would be delisting 12 of 14 patents identified by FTC, plus an additional five “in light of evolving policies and developments in the law regarding the listing of drug-device combinations.” 

“This was a remarkable success for FTC, with drug manufacturers announcing the withdrawal of 27 challenged patents within weeks of being asked to do so. At the same time, this rapid response reveals the extent to which drug manufacturers have been blatantly misusing the patent system and gaming FDA’s Orange Book policies, demonstrating that more work remains,” continued the lawmakers. 

The lawmakers noted that the FTC and FDA should continue to fight pharmaceutical companies’ misuse of the Orange Book, which discourages competition, and that FDA’s new guidance provides an opportunity to clarify the rules. 

“Our August 2023 letter to FDA asked that you update the guidance and rules for listing patents in the Orange Book and develop a review and validation system to remove improperly-listed patents. The new information on drug manufacturers’ patent withdrawals described in this letter provides an important update that we hope will inform FDA as you develop these new rules. We thank you for your efforts to end drug manufacturers’ patent abuse and lower drug costs for all Americans,” concluded the lawmakers. 

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