Merck Faces German Ruling Limiting Keytruda Formulation patent
Düsseldorf, Germany – Merck & Co.suffered a setback in a German patent court today, as a ruling invalidated a key formulation patent for its blockbuster cancer drug, Keytruda. The decision opens the door for biosimilar competition in Germany, potentially impacting sales of the drug in one of Europe’s largest pharmaceutical markets.
The Regional Court of Düsseldorf found that Merck’s patent covering a specific formulation of Keytruda – a formulation designed to allow subcutaneous administration – was invalid, according to a statement from biosimilar manufacturer Amgen. This ruling stems from a challenge brought by Amgen, mirroring ongoing patent disputes between the two companies in the United States concerning Halozyme Therapeutics’ ENHANZE® drug delivery technology, which enables subcutaneous injections of large-molecule drugs like Keytruda.
Keytruda, an anti-PD-1 immunotherapy, is a cornerstone of cancer treatment, generating over $25 billion in global sales last year. The German ruling specifically concerns the patent protecting the subcutaneous formulation, introduced to offer patients a more convenient administration method than intravenous infusion. The loss of this patent protection in Germany coudl accelerate the entry of biosimilars, eroding Merck’s market share and pricing power.
The dispute centers around the use of Halozyme’s ENHANZE® technology. Merck licenses ENHANZE® to create the subcutaneous formulation of Keytruda. Amgen argues that Merck’s patent claims improperly extend protection beyond the licensed technology,effectively blocking legitimate competition. Similar arguments are being made in U.S. courts, where Amgen is also challenging the validity of Merck’s Keytruda patents.
“We are pleased with the German court’s decision, which reinforces our position that this patent is invalid,” an Amgen spokesperson said. “We remain committed to bringing high-quality, affordable biosimilars to patients.”
Merck has stated its intention to appeal the German court’s decision. The company maintains that its patents are valid and protect its notable investment in Keytruda’s progress and formulation. The outcome of the appeal, and the parallel cases in the United States, will be crucial in determining the future competitive landscape for Keytruda and the broader market for subcutaneous biologics.
