Senators Warren, Sanders, Representatives Jayapal and Porter Urge USPTO to Scrutinize Merck's Abuse of Patent Applications for Cancer Drug Keytruda

Press Release

Date: Feb. 23, 2023
Location: Washington, DC

United States Senators Elizabeth Warren (D-Mass.) and Bernard Sanders (I-Vt.) and Representatives Pramila Jayapal (D-Wash.) and Katie Porter (D-Calif.) sent a letter to the United States Patent and Trademark Office (USPTO), urging 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. Senator Warren and Rep. Jayapal wrote to the USPTO in December regarding their concerns about the pharmaceutical industry's broad use of anti-competitive practices that raise costs for patients and families.

"Should the USPTO approve new patent applications for the drug, biosimilar competitors could be shut out of the market until 2036, giving Merck a total period of nearly 35 years of patent protection for Keytruda -- monopoly protection that extends well beyond the intent of the Drug Price Restoration and Patent Term Restoration Act (Hatch-Waxman) and the Biologics Price Competition and Innovation Act," wrote the lawmakers.

Keytruda was first approved in 2014 and quickly became Merck's biggest seller, bringing in $5.4 billion in sales in the third quarter of 2022. The pharmaceutical giant has aggressively used the patent system to protect its monopoly on this drug and is now attempting to patent a new formulation of Keytruda that can be injected under the skin, raising concerns that these anti-competitive business practices will ultimately result in significant financial strain for patients.

"If approved, Merck's patent application for its subcutaneous formulation of Keytruda could shield the drug from competition for many years," wrote the lawmakers. "This approach -- and Merck's use of dozens of patents to fend off Keytruda competitors -- appear to be an example of the anti-competitive business practices, including double-patenting, patent thicketing, product hopping, and evergreening, that I have long been concerned about."

The lawmakers are urging USPTO to give close scrutiny to any of Merck's future requests for additional patents for Keytruda and further reject any that fail to meet the agency's mission to ensure the "system as a whole does not unnecessarily delay getting generic, biosimilar and more affordable versions of those drugs into the hands of Americans who need them."

"Abusive patent practices reduce competition and result in significant financial strain for patients," concluded the lawmakers. "The non-discounted annual price of Keytruda is $165,308, and that price has increased 147% in the five years since Keytruda was launched -- in large part because of limited competition."

Senator Warren has long worked to lower the price of prescription drugs and challenge the power of the pharmaceutical industry.

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 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.
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.
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.