Merck Faces German Ruling Limitingโ Keytruda Formulation patent
Dรผsseldorf, Germany – Merck & โCo.suffered a setback in aโฃ German patent court today, asโ aโ ruling invalidated a key โformulation patent for its blockbuster cancer drug, Keytruda. The decision opens the door for biosimilarโค competition in Germany, potentially impacting sales of โthe drug inโฃ one of Europe’s largest pharmaceutical markets.
The Regional Court of Dรผsseldorf foundโ that Merck’s patent covering a specific formulation of Keytrudaโค – a formulation designed to allow subcutaneous administration – was invalid, according to a statement from biosimilar โขmanufacturer Amgen.โ This rulingโ stems from a challenge brought by Amgen, mirroring ongoing patent disputes โขbetween the two companies in the United States concerning Halozyme Therapeutics’ ENHANZEยฎ drug delivery technology, which enables subcutaneous injectionsโข of large-molecule drugs likeโข 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 specificallyโ concerns the patentโ protecting the subcutaneous formulation, introduced to offer patients a more convenient administration method than intravenous infusion. The loss โขof this patent protection in Germany coudl accelerate the entry of โขbiosimilars, eroding Merck’s market share and pricing power.
The dispute centers around โฃthe use ofโ Halozyme’s ENHANZEยฎ technology. Merck licenses โขENHANZEยฎ to create the subcutaneous formulation of Keytruda. Amgen argues that Merck’s patent claims improperly extend protection โฃbeyond the licensed technology,effectively blocking legitimate competition. โฃSimilar arguments are beingโข made in U.S. courts, where Amgen is also challenging the validity of Merck’s Keytrudaโข patents.
“We โare pleased with the German court’s decision, which โreinforces our position that this patent is invalid,” an Amgen spokesperson said. “We remain โขcommitted to bringing โคhigh-quality, affordable biosimilars to patients.”
Merck has stated its intention to appeal the German court’s decision. The company maintains that its patents โare valid and protect its notable investment in Keytruda’s progress andโฃ formulation. The outcome of the appeal, and the parallel cases inโค the United States, will be crucial in determining theโ future competitive landscape for Keytruda and the broader market for subcutaneous biologics.
