Patent Dispute Erupts Over Merck’s Injectable Keytruda
Merck is developing a new injectable version of its blockbuster cancer drug Keytruda, which could generate over $6 billion in annual sales2.
The new formulation uses an enzyme that allows Keytruda to be injected subcutaneously rather than administered intravenously, improving patient convenience12.
Halozyme Therapeutics claims the new Keytruda infringes on its patents for modified human hyaluronidases used in drug delivery5.
Merck disputes Halozyme's claim, stating it developed the enzyme independently, and has asked U.S. patent regulators to reconsider Halozyme's patents as overly broad34.
The dispute is critical for Merck as Keytruda generates nearly half of the company's sales, reaching $29 billion in 20242.
Keytruda's U.S. patent protection expires in 2028, adding urgency to Merck's efforts to extend the drug's market dominance23.
The patent clash comes as Merck also faces challenges from the Inflation Reduction Act, which could subject Keytruda to government price negotiations starting in 20261.
This patent dispute highlights the high stakes in the pharmaceutical industry as companies seek to protect and extend the lifecycles of their most valuable drugs through new formulations and delivery methods.
Sources:
1. https://www.fiercepharma.com/pharma/merck-expects-keytruda-fall-ira-price-cuts-2028
2. https://www.tipranks.com/news/merck-mrk-battling-to-protect-key-cancer-drug-as-patent-row-heats-up
3. https://markets.businessinsider.com/news/stocks/merck-s-keytruda-subject-of-brewing-patent-dispute-with-halozyme-wsj-says-1034442696
4. https://www.moomoo.com/news/post/50023118/market-chatter-merck-faces-patent-dispute-over-new-keytruda-version