December 14, 2023

Warren, Jayapal Blast Big Pharma's Sham Patent Claims, Urge Companies to End Abusive Patent Practices that Cost Patients Billions

FTC Warned Companies of Unlawful Listings that Delay Generic Competition Senators Ask Big Pharma to Remove Improper Listings from FDA “Orange Book”

Text of Letters (PDF)

Washington, D.C. —  In the wake of the Federal Trade Commission’s (FTC) warnings about drug manufacturers’ patent abuse, Senator Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) sent letters to the CEOs of 8 pharmaceutical companies urging them to voluntarily remove sham patent claims improperly included in the Food and Drug Administrations (FDA)’s “Orange Book” and end their unlawful practices that delay competition and drive up costs for patients and taxpayers. The letter follows the FTC’s warning to the 8 drug manufacturers that they have improperly listed drug patents in the FDA’s Orange Book, taking advantage of a loophole that delays generic competition. In the letters to the Big Pharma CEOs, the lawmakers urge the companies to voluntarily de-list these improperly listed patents — a move that would promote competition and lower costs for some of the most expensive or highly-used drugs on the market, including lifesaving products such as inhalers and EpiPens.

The letters were sent to the CEOs of: AbbVie, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Amneal Pharmaceuticals (Impax), Kaleo, Viatris (Mylan), and Teva/Norton. 

“The FTC pledged to scrutinize companies that engage in these practices for violating Section 5 of the Federal Trade Commission Act, and in November issued a warning letter to (your company) that appears to conclude that the company may be violating federal law with regard to its drug listings. Given these concerns, we urge you to voluntarily de-list the patents named in the FTC’s letter that you have listed in the Orange Book, and any other patents you have listed that unfairly block competition,” the lawmakers wrote. 

The FDA’s Orange Book contains a list of drugs approved by the FDA and related patent and exclusivity information, covering drug substances, drug products, and method of use. If a brand-name drug company sues a generic manufacturer for infringing on a patent listed in the Orange Book, the FDA is barred from approving a generic version of the drug for 30 months. Powerful Big Pharma players are therefore incentivized to strategically list “sham” patents in the Orange Book to hold off generic competition — increasing drug and health care costs for patients and driving up insurance premiums. 

“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. FDA has acknowledged these Orange Book-related issues and taken some steps to ‘ensure our system, as a whole, is not used to improperly delay getting more affordable drugs and biosimilars into the hands of Americans who need them,’” the lawmakers continued. 

The lawmakers have requested that the pharmaceutical companies de-list their improperly listed patents by December 16, and respond to their questions no later than January 15, 2024. 

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 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. 
  • Last week, 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 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.