Warren, Jayapal Announce Three Drug Manufacturers Pulled Sham Patents after Warnings, Urge FDA to Continue Fight Against Big Pharma Companies’ Patent Abuse | U.S. Senator Elizabeth Warren of Massachusetts

February 16, 2024

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. Senator Elizabeth Warren (D-Mass.) and U.S. Representative Pramila Jayapal (D-Wash.) 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.

Senator Warren and Representative Jayapal 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. 

Senator Warren has led efforts to use every tool available to the government to lower drug prices and fight Big Pharma’s anti-competitive business practices:

• In January 2024, Senators Warren and Angus King (I-Maine) and U.S. Representative Lloyd Doggett (D-Texas) led 75 lawmakers in sending a letter to the Biden administration in support of strengthening and finalizing its draft guidance to protect taxpayers and reduce prescription drug prices. The lawmakers submitted a public comment supporting the “Interagency Guidance Framework for Considering the Exercise of March-In Rights” and calling for changes to ensure increased transparency, oversight, and accessibility of medical products invented through taxpayer-funded research and development.
• In December 2023, Senator Warren published an op-ed in Newsweek commending the Biden administration’s announcement that price can be considered in the government’s decision to march-in on a drug, effectively lowering drug costs, and calling on Americans to fight back against an industry that has been taking advantage of them for decades. 
• In December 2023, Senator Warren issued a statement after the Biden administration announced it would issue guidance to federal agencies that would allow the government to seize patents of certain expensive drugs developed with taxpayer support to create more competition and lower prices.
• In December 2023, Senator Warren and Representative Jayapal sent letters to the CEOs of 8 pharmaceutical companies urging them to voluntarily remove sham patent claims improperly included in the FDA’s Orange Book and end their unlawful practices that delay competition and drive up costs for patients and taxpayers.
• In December 2023, Senator Warren and Representative Jan Schakowsky (D-Ill.) reintroduced the  Affordable Drug Manufacturing Act, legislation that would radically reduce drug prices through public manufacturing of prescription drugs. 
• In September 2023, Senator Warren and Representative Jayapal sent a letter to FTC Chair Lina Khan urging the FTC to issue a policy statement about the improper listing of drug-related patents in the FDA’s Orange Book. 
• In August 2023, Senator Warren and Representative Jayapal sent a letter to FDA Commissioner Dr. Robert M. Califf, urging him to close loopholes that pharmaceutical companies have exploited to block generics from entering the market, keeping drug prices high and maximizing profits. 
• In June 2023, Senators Warren and Angus King (I-Maine) and Representative Lloyd Doggett (D-Texas) sent a letter to Department of Commerce (DOC) Secretary Gina Raimondo and Department of Health and Human Services (HHS) Secretary Xavier Becerra asking for information on the membership, process, timeline, and scope of work of the recently announced Interagency Working Group for Bayh-Dole.
• In April 2023, Senator Warren and Representative Jayapal sent a letter to Kathi Vidal, Director of the USPTO, calling on USPTO to take immediate action and use its existing administrative authorities to help lower drug prices and hold pharmaceutical companies accountable for anti-competitive business practices. The lawmakers outlined six specific actions that the USPTO should take. 
• In February 2023, Senators Warren and Bernie Sanders (I-Vt.) and Representatives Jayapal and Katie Porter (D-Calif.) sent a letter to the USPTO, calling on the agency to give close scrutiny to any of Merck’s requests for new patents for Keytruda, a biological treatment used to treat cancer, citing new reports about Merck’s ongoing abuse of the patent system to protect its monopoly on the drug. 
• In January 2023, Senators Warren and King and Representative Doggett led their colleagues in sending a follow-up letter to HHS Secretary Xavier Becerra that urged the Secretary to exercise his authority to lower the price of cancer treatment Xtandi. 
• In December 2022, Senator Warren and Representative Jayapal sent a letter to Director Kathi Vidal following up on their June 2021 letter about USPTO’s efforts to hold pharmaceutical companies accountable for anti-competitive business practices and tackle high drug prices.
• In June 2022, Senators Warren and King and Representatives Doggett, Joaquin Castro (D-Texas), Sara Jacobs (D-Calif.), and Porter led a group of 100 members from across the ideological spectrum to urge HHS Secretary Xavier Becerra to swiftly act and use his existing authorities to lower prices on critical prescription drugs.
• In April 2022, Senator Warren sent a letter to HHS Secretary Becerra, sharing the findings from a letter that over 25 legal and public health experts sent to her outlining three powerful legal tools the Biden administration could use to lower drug prices. 
• In March 2022, Senator Warren and her colleagues called out drug manufacturers for squeezing American families with rapid and widespread price hikes on prescription drugs.
• In February 2022, Senators Warren and King and Representative Doggett urged HHS to exercise its march-in rights for the life-saving cancer drug Xtandi to dramatically lower its price for millions of Americans.
• In June 2021, Senator Warren led a letter questioning PhRMA’s lobbying efforts to block policies that would lower drug costs for millions of Americans.

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