April 27, 2023

Warren, Jayapal Call on Patent Office to Take Critical Steps to Lower Drug Prices and Fight Big Pharma’s Patent Abuse

Text of Letter (PDF)

Washington, D.C. – U.S. Senator Elizabeth Warren (D-Mass.) and U.S. Representative Pramila Jayapal (D-Wash.) sent a letter to Kathi Vidal, Director of the United States Patent and Trademark Office (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 outline six specific actions that the USPTO should take. 

“For decades, powerful pharmaceutical companies and other large corporate actors have repeatedly abused the patent system to stifle competition and prolong their market power, showing no regard for the harm done to patients through sustained high prices,” wrote the lawmakers. “The pharmaceutical industry’s continued abuse of the patent system, which has resulted in enormous corporate profits and inexcusable harms to patients, has demonstrated that more aggressive steps are needed.”

The lawmakers recommend that the USPTO use its existing authority to take the following actions: 

  • Revise the USPTO’s practice of granting obvious patents by rejecting additional obvious patents filed by pharmaceutical companies for a single drug product, regardless of terminal disclaimers.
  • Stipulate that patents tied together by terminal disclaimers should all stand or fall together when challenged to help combat the patent thickets pharmaceutical companies have created that intimidate potential competitors from entering the market.
  • Raise filing fees and limit the number and time period for continuation applications to discourage pharmaceutical companies from using excessive indistinct patents to create problematic patent thickets.
  • Require applicants to disclose at the time of filing whether the drug compound covered by the patent application is in clinical trials and assign more examiners to scrutinize those applications. 
  • Reverse policies that have led to an increase in discretionary denials of petitions filed through the inter partes review (IPR) process, which offers a quick and less expensive alternative to litigation for challenging patents. 
  • Establish an office dedicated to building public transparency, serving the public interest, and improving interagency communication to ensure the public can better access basic information about patents, such as expiration dates, owners, licensing, and application statuses and to strengthen accountability of the U.S. patent system.

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 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 Angus King (I-Maine) and Representative Lloyd Doggett (D-Texas) led their colleagues in sending a follow-up letter to Health and Human Services (HHS) Secretary Xavier Becerra that urged the Secretary to exercise his authority to lower the price of cancer treatment drug 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 Angus King (I-Maine) and Representatives Lloyd Doggett (D-Texas), Joaquin Castro (D-Texas), Sara Jacobs (D-Calif.), and Katie Porter (D-Calif.), led a group of 100 members from across the ideological spectrum to urge Health and Human Services (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 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.
  • Senator Warren has also introduced legislation that would radically reduce drug prices through public manufacturing of prescription drugs, including the Affordable Drug Manufacturing Act with Representative Jan Schakowsky (D-Ill.). With Senator Jeanne Shaheen (D-N.H.), she introduced the End Taxpayer Subsidies for Drug Ads Act, legislation that would close a big pharma advertising loophole.