BIG PHARMA WATCH: MERCK EXPEDITES ANTI-COMPETITIVE STRATEGY ON BLOCKBUSTER CANCER DRUG

Big Pharma Giant’s Patent Abuse Scheme for Keytruda Will Extend Monopoly Pricing, Undermine Competition from More Affordable Alternatives

In case you missed it, pharmaceutical giant Merck recently indicated it will expedite an anti-competitive product hopping strategy designed to extend exclusivity and monopoly pricing on its blockbuster cancer drug, Keytruda.

At the J.P. Morgan Healthcare Conference earlier this month, Merck CEO Rob Davis said the brand name drug company “was planning to offset Keytruda’s loss of exclusivity by moving up plans to file for approval and launch a subcutaneous version of Keytruda by the end of 2025.”

Keytruda, which generated nearly $29 billion in revenue for the Big Pharma giant in 2024, is already patent-protected in the U.S. until 2028. To further extend monopoly pricing and undermine competition from more affordable alternatives beyond 2028, Merck first announced it would seek the new formulation and accompanying added patents in 2022.

According to STAT News coverage of Merck’s progress in pursuing the Keytruda reformulation in November, “the new under-the-skin, or subcutaneous, formulation of Keytruda could represent a major way of holding on to a larger share of Keytruda’s $25 billion in annual sales than would otherwise occur when the medicine’s U.S. patent expires in 2028.”

Merck’s strategy is a case study of Big Pharma’s patent abuse. Big Pharma companies file new patents for changes such as intake method or dosage on existing products that don’t represent truly new innovations or improve clinical benefits for patients. This enables Big Pharma to add to patent thickets designed to block competition from more affordable alternatives, keep drug prices high and boost profits.

“I don’t think it’s going to improve the safety or the effectiveness of the drug,” said Dr. Shailender Bhatia, an oncologist at the Fred Hutchinson Cancer Center in Seattle, when Merck first announced the reformulation on Keytruda to change delivery method.

“It’s the way the pharmaceutical companies now use that system — it’s all about taking up as much space as possible, making it difficult for anybody to enter,” Tahir Amin, co-founder of Initiative for Medicines, Access & Knowledge (I-MAK), said in Reuters coverage of Merck’s scheme. “Keytruda is going to be the next Humira by all accounts.”

According to research from I-MAK, Merck has already filed 129 patent applications on Keytruda – more than half of which were filed after the drug’s initial approval by the U.S. Food and Drug Administration (FDA). The Big Pharma company has been granted 53 patents on this one drug. I-MAK estimates that Americans will spend at least $137 billion on Keytruda while the drug faces no competition due to its extended exclusivity that already totals more than eight years — without reflecting the added impact of the Big Pharma giant’s latest reformulation patent strategy.

Merck’s maneuver on Keytruda is just the latest example of how Big Pharma games the patent system to extend monopolies, keep prices high and boost profits — at tremendous cost to American patients and the U.S. health care system.

The new administration and lawmakers can crack down on Big Pharma’s patent abuse and foster greater competition in the market to lower drug prices for consumers by building on bipartisan momentum for market-based solutions in the last Congress, including the unanimous U.S. Senate passage of Cornyn-Blumenthal (S.150) in July 2024. The bill would hold Big Pharma accountable for patent thickets that block competition from more affordable alternatives and impose billions of dollars in higher drug costs on patients and the U.S. health care system each year. The nonpartisan Congressional Budget Office (CBO) estimated the bill, in the version passed by the Senate, would save $1.8 billion.

Read more on Merck’s expedited plan to extend patent protections on Keytruda HERE. 

Read more on Merck’s progress toward filing new patents on Keytruda HERE.

Read about how Big Pharma’s patent abuse blocks competition from more affordable alternatives HERE.

Learn more about bipartisan, market-based solutions to hold Big Pharma accountable HERE.

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