Big Pharma Giant Wants New Patents for Formulation Changes That Won’t Improve Clinical Benefit of Cancer Drug — Adding to Existing Patent Thicket of 129 Filed Applications

On Friday, Big Pharma giant Merck announced that it will seek new patents on its blockbuster cancer drug Keytruda, which last year brought in over $17 billion for the company. According to reporting from Reuters, Merck is seeking “to patent a new formulation of its $20 billion cancer immunotherapy Keytruda that can be injected under the skin, allowing it to protect its best-selling drug from competition expected as soon as 2028.”

This is just the latest example of a strategy Big Pharma companies have used repeatedly to extend their monopolies on blockbuster products – filing for patents for changes such as intake method or dosage 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.

Dr. Shailender Bhatia, an oncologist at the Fred Hutchinson Cancer Center in Seattle said, “I don’t think it’s going to improve the safety or the effectiveness of the drug.”

“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 the move. “Keytruda is going to be the next Humira by all accounts.”

According to research from I-MAK, Merck has filed for 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 new patent strategy.

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

The news is also yet another reason lawmakers must build on their recent major progress toward holding Big Pharma accountable, with additional market-based solutions to lower drug prices.

Read more on Merck’s plans to file new patents on Keytruda HERE.

Read about Merck’s Wall Street expectation besting third quarter earnings report HERE.

Read about how Big Pharma companies target cancer medications for higher prices and blockbuster profits HERE.

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

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