December 06, 2022

Warren, Jayapal Call on US Patent Office to Prevent Big Pharma's Abuse of Patent System

Pharmaceutical Companies are Engaging in Anti-Competitive Business Practices and Abusing Patent Laws, Resulting in High Drug Prices for Americans 

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, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO), following up on their June 2021 letter about the office’s efforts to hold pharmaceutical companies accountable for anti-competitive business practices and tackle high drug prices. 

“On June 30, 2021, we wrote to the USPTO… describ(ing) how pharmaceutical companies use anti-competitive tactics such as patent evergreening, patent thickets, and product hopping to abuse our patent system and unfairly prolong government-granted monopoly rights for some drugs… The USPTO’s refrain from recognizing the predatory practices pharmaceutical companies use to maintain a chokehold on the prescription drug market, raises questions about whether the Office is fully cognizant of the ways in which evergreening, patent thickets, and product hopping undermine the legitimacy of our patent system or whether it views such practices as legitimate,” wrote the lawmakers

Since the last time the lawmakers wrote to the USPTO, the cost of prescription drugs has continued to climb – more than 3,000 drugs had a list price increase this year. The lawmakers note that while the Inflation Reduction Act will provide some relief from high drug prices, there are more actions USPTO and other administrative agencies can and should take. In September 2021, the Food and Drug Administration (FDA) wrote to USPTO, calling for a partnership to improve the patent examination process, a review of the misuse of the patent system, and data regarding patent review processes. 

“Although we are pleased with the USPTO’s efforts to collaborate with the FDA, we have ongoing concerns with the high cost of prescription drugs in America and the persistence of anti-competitive abuses of our patent system and remain concerned that USPTO is not moving quickly or aggressively enough to combat abuses of the patent system,” concluded the lawmakers. 

Given these concerns, Senator Warren and Representative Jayapal are asking USPTO to provide additional information about its initiatives to address the shortcomings of the patent system by December 19, 2022. 

Senator Warren has called on the government to use every tool to lower drug prices and crack down on corporate profiteering to bring down consumer costs:

  • 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.
  • On February 18, 2022, Senators Warren and King and Representative Doggett urged HHS to exercise march-in rights for life-saving cancer drug Xtandi to dramatically lower its price for millions of Americans.
  • On February 2, 2022, during a hearing of the Senate Finance Subcommittee on Fiscal Responsibility and Economic Growth, Senator Warren called out big pharma and insurance companies’ tricks to squeeze taxpayers and Medicare beneficiaries. She also called for passage of the Build Back Better Act, which includes provisions that could generate billions in savings and give the Department of Health and Human Services the authority to negotiate prices on some high-price drugs.
  • 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.
  • At a Senate Finance Committee hearing in May 2021, Senator Warren called for trade negotiations that put patients over big pharma profits.
  • 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.