Letters Follow Federal Trade Commission Crackdown on Manufacturers’ Abuse of Patent Listings to Delay Competition

Text of Letters (PDF)

Washington, D.C. – U.S. Senator Elizabeth Warren (D-Mass.) and U.S. Representative Pramila Jayapal (D-Wash.) sent letters to eight pharmaceutical companies urging them to voluntarily de-list over 100 patents that the Federal Trade Commission (FTC) has determined may be improperly or inaccurately listed in the Food and Drug Administration’s (FDA’s) Orange Book. De-listing these patents would allow for life-saving inhalers and diabetes drugs to enter the market as generics, lowering drug prices for Americans.

The FDA’s Orange Book contains a list of drugs approved by the FDA, as well as related patent and exclusivity information. If a generic manufacturer infringes on one of these patents, the brand-name drug company can sue them, forcing the FDA to stop approving generic competitors for 30 months. Some pharmaceutical companies take advantage of this system by listing ‘sham’ patents in the Orange Book to hold off generic competition — increasing health care costs for patients and driving up insurance premiums. 

“Drug manufacturers’ patent gaming tactics can drive up drug prices, contribute to higher premiums and out-of-pocket costs for patients, and increase costs for Medicare and Medicaid,” wrote the lawmakers. “We have long been concerned by these and other pharmaceutical industry abuses of the patent system to stifle competition, prolong drug monopolies, and price-gouge patients.” 

Under President Biden, the FTC has begun to crack down on pharmaceutical companies’ sham patent listings in the Orange Book. In November 2023, the FTC sent notices to ten companies regarding their improperly or inaccurately listed patents that appeared to violate Section 5 of the Federal Trade Commission Act. Following this action, Senator Warren and Representative Jayapal wrote to the CEOs of those companies, and in response, some de-listed their improperly listed patents. But other companies have refused to de-list these patents, leading to further scrutiny. 

On April 30, 2024, the FTC sent a second set of notice letters to eight pharmaceutical companies and some of their subsidiaries identifying 130 additional patent listings that appear to violate Orange Book policies and Section 5 of the Federal Trade Commission Act. Senator Warren and Representative Jayapal are again writing to the CEOs of these companies in an effort to ensure they de-list the patents and to obtain additional information on further actions needed by FTC and FDA to prevent this patent abuse.

“(W)e urge you to voluntarily de-list the patents named in the FTC’s letter, and any other patents you have listed that unfairly block competition,” wrote the lawmakers. “We applaud the FTC’s leadership in challenging ‘junk’ patent listings that, together with other anticompetitive conduct, cost consumers and the U.S. health care system billions of dollars each year.” 

The lawmakers wrote to Amphastar Pharmaceuticals, Covis Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, and Teva Branded Pharmaceutical Products R&D, Inc. 

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 May 2024, Senator Warren and Representative Lloyd Doggett (D-Texas) sent a letter to Secretary of the Department of Commerce, Gina Raimondo, and Under Secretary Laurie Locascio, highlighting the lawmakers’ new review of public comments on the agency’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights and urged them to strengthen and finalize the guidance. 
• In May 2024, Senators Warren,  Bernie Sanders (I-Vt.), and Jeff Merkley (D-Ore.) wrote to the Chamber of Commerce expressing concern and demanding an explanation for the organization’s opposition to the Biden administration’s proposal to boost competition and lower drug prices for American families and businesses by allowing agencies to consider price when deciding to exercise their “march-in rights” under the Bayh-Dole Act. 
• In March 2024, Senator Warren sent the letter in response to GlaxoSmithKline (GSK) discontinuing the brand-name version of Flovent HFA, the go-to inhaler for children, blasting the company  for its price-gouging strategy that may cause millions of children to lose access to one of the few drugs that is appropriate to treat their asthma and allergies. 
• In February 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 February 2024, Senator Warren and Representative Jayapal announced that three drug manufacturers pulled their sham patents after warnings, and urged the FDA to continue fighting against Big Pharma’s patent abuse. 
• 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 Rep. 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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