ICYMI: NEW REPORT OUTLINES MERCK’S STRATEGY TO BLOCK COMPETITION, KEEP PRICES HIGH ON BLOCKBUSTER CANCER DRUG KEYTRUDA

Big Pharma Giant Engages in Product Hopping Strategy to Game the Patent System, Delay Competition and Extend Monopoly Pricing on Top Money-Making Oncology Drug

In case you missed it, a joint investigation by the International Consortium of Investigative Journalists (ICIJ) and USA TODAY analyzed the egregious pricing and anti-competitive practices employed by Big Pharma giant Merck to extend monopoly pricing on the company’s blockbuster cancer drug, Keytruda. The report found that Merck, through different entities, has filed more than 1,200 patent applications related to the drug in 53 different countries, regions and territories. According to the piece, these patents could help Merck extend exclusivity on Keytruda “for 14 years after its original patents expire in 2028.”

“Merck has employed several tactics to keep Keytruda’s price high – along with its profits,” the ICIJ and USA TODAY report stated, “Merck protects the drug from generic competition behind a growing wall of patents. The company lobbies to avoid negotiating the price of the drug with Medicare. And though studies have said lower doses based on weight are effective and would save money, the company has not moved to change dosing.”

Merck’s blockbuster cancer drug Keytruda provides a case study in the scale of Big Pharma’s patent abuse greed. In a 2021 study, I-MAK found Merck filed for 129 patent applications on Keytruda – more than half of which were filed after the drug’s initial approval by the Food and Drug Administration (FDA). The Big Pharma company has been granted 53 patents for this one drug. I-MAK estimated that Americans would spend at least $137 billion on Keytruda while the drug faced no competition due to its extended exclusivity that now totals more than a decade – without reflecting the added impact of the latest leg of the Big Pharma giant’s patent strategy.

Keytruda, which generated more than $31 billion in revenue for Merck in 2025, is already patent protected in the U.S. until 2028. Nevertheless, Merck is working to further extend monopoly pricing and undermine competition from more affordable alternatives beyond 2028 by seeking a new formulation and additional patents. Merck first announced in December 2022 that it would seek a new subcutaneous formulation of Keytruda, along with accompanying new patents to bolster its existing, significantly extended patent thicket. On top of Merck’s attempts to further extend patent exclusivity on the current version of Keytruda, the drug maker secured FDA approval of a new version of the drug, called Keytruda Qlex, in September 2025.

“If enough customers switch to the injectable version from the original infused Keytruda, it could delay competition until the 2030s, ICIJ reported, citing three industry experts.”

“Merck’s tactics with Keytruda are common – and legal – in the pharmaceutical industry. Once a drug company discovers an effective medicine that the public and the medical community demand, the company pulls legal levers to maintain that advantage for as long as it can,” the ICIJ and USA TODAY report found. “‘Squeezing as much life out of an original patent is par for the course’ in the drug industry, said Antonio Ciaccia, president of 3 Axis Advisors and an expert in drug pricing. ‘You get a breadwinner; you want to hold onto that breadwinner as long as you can.’”

Merck’s strategy is an example of product hopping, one of Big Pharma’s preferred patent abuse tactics for delaying competition from more affordable alternatives and keeping prices higher on their blockbuster drugs for longer. 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.

“Merck, either alone or jointly through partners, has employed the patent system to build a fortress around Keytruda of 50 active patents in the United States. Citing data from the initiative for Medicines, Access, and Knowledge, or I-MAK, ICIJ tracked more than 1,200 patent applications filed by Merck and other cancer research businesses. These applications related to the drug were in 53 countries, regions and territories. These patents could help Merck fend off competition and maintain high prices – and billions of dollars in revenue – for 14 years after its original patents expire in 2028, ICIJ found.”

“‘This scenario where a drug company obtains dozens of patents protecting different aspects of a blockbuster drug in order to ward off competition is quite common,’ said Dr. Benjamin Rome, a Harvard Medical School professor. ‘Just the existence of this patent thicket can scare away companies who would otherwise seek to make biosimilar versions of Keytruda, as the biosimilar makers need to spend exorbitant amounts of money to fight these patents in court.’”

Read the ICIJ and USA TODAY investigation HERE.

Read more on Merck’s product hopping playbook on Keytruda in The New York Times HERE.

Read more on Big Pharma’s patent abuse HERE.

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