Democrats petition US patent office to probe Merck's new Keytruda requests
Democrats in both the House of Representatives and the Senate are asking the US Patent and Trademark Office (PTO) to take a closer look at Merck’s pending patents for its megablockbuster cancer drug Keytruda.
Sen. Elizabeth Warren (D-MA)’s office announced Thursday that the senator, alongside Senate Health committee chair Bernie Sanders (I-VT) and Reps. Katie Porter (D-CA) and Pramila Jayapal (D-WA), wrote a letter to PTO director Kathi Vidal on Wednesday — asking Vidal to scrutinize any new patent requests from Merck for Keytruda, which hauled in $20.9 billion last year.
The lawmakers accused the pharma giant of using the US patent system to protect its monopoly on the drug, saying that Merck’s attempts to patent a subcutaneous formulation of Keytruda is akin to “extending its monopoly power over the drug” and seems to be an example of anti-competitive business practices.
“What actions will USPTO take to ensure that Merck’s attempt to seek dozens of patents ‘does not unnecessarily delay getting generic, biosimilar and more affordable versions of those drugs into the hands of Americans who need them?’” the politicians added, saying that the patent office should reject any of Merck’s patent requests “that do not clearly meet the agency’s standards of novelty, utility, and non-obviousness.”
A Merck spokesperson told Endpoints News in response to the letter that “Merck is continuously innovating to enhance the benefits of Keytruda in order to reach greater numbers of patients and to increase efficacy and convenience of the treatment.”
The spokesperson added, “When appropriate, Merck protects this additional innovation through the filing of patent applications, particularly when we view the innovation as novel, useful and nonobvious.”
Warren and Sanders have spoken out against the pharmaceutical industry before.
More recently, Warren asked the Federal Trade Commission to investigate certain pharma buyout deals last month — notably Amgen’s $28 billion plan to take over Horizon Therapeutics and Indivior’s proposed acquisition of Opiant for $145 million upfront. The senator, in a letter to FTC chair Lina Khan and two of the commissioners, called the deals “rampant consolidation in the pharmaceutical industry.”
Sanders, a long-time critic of the pharmaceutical industry and newly-tapped chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP), has been proactive in his critiques of industry. The senator recently condemned reported plans from Covid vaccine giant Moderna to price its vaccine between $110 and $130 per dose in the US, a 300% increase, and has plans to grill Moderna CEO Stephane Bancel next month.
“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients,” Sanders wrote at the time.
Moderna later said people won’t need to pay out-of-pocket for its Covid vaccine, regardless of insurance status.