German Court Blocks Merck's Subcutaneous Keytruda Launch in Patent Dispute with Halozyme
核心洞察
A Munich Regional Court issued a preliminary injunction preventing Merck (搜索) from distributing its new subcutaneous formulation of Keytruda in Germany due to patent infringement claims by Halozyme Therapeutics.
The dispute centers on the berahyaluronidase alfa (搜索) component developed by Alteogen, which Halozyme claims infringes its European patent on MDASE platform technology for drug delivery.
German patients retain access to the original intravenous Keytruda formulation, while the subcutaneous version offers reduced treatment time from 30 minutes to just a couple of minutes.
A Munich Regional Court has issued a preliminary injunction blocking Merck (搜索) from distributing its new subcutaneous formulation of Keytruda in Germany, marking a significant setback for the pharmaceutical giant in a widening patent dispute with Halozyme Therapeutics over the bestselling cancer (搜索) treatment.
The court ruled that Merck (搜索)'s subcutaneous formulation would infringe on a patent held by Halozyme in Europe, requiring the company to halt its launch of Keytruda SC in Germany. The decision affects the subcutaneous version that was approved in the European Union last month, though patients requiring Keytruda will still have access to the existing intravenous version, which remains unaffected by the patent dispute.
Patent Dispute Over Drug Delivery Technology
The litigation focuses on the berahyaluronidase alfa (搜索) component developed by Alteogen, which enables the delivery of larger volumes of drug material and improves dispersion and absorption through the skin. Halozyme claims this component falls under the scope of European patent No. 2 797 622, which covers its MDASE platform that uses modified human hyaluronidases (搜索) for drug delivery.
Merck (搜索) is simultaneously challenging Halozyme's patents, arguing they are too broad in scope. The dispute has expanded beyond Germany, with both companies engaged in litigation over subcutaneous Keytruda in the United States, where the product recently received approval as Keytruda Qlex.
Clinical and Commercial Implications
The subcutaneous formulation represents a significant advancement in patient convenience, requiring only a couple of minutes to deliver compared to the 30-minute intravenous infusion of the original formulation. According to Merck (搜索), this reduces "chair and treatment" time for patients by approximately half, though the new version still requires administration by a healthcare professional.
Keytruda SC has been approved for use in most of the solid tumor (搜索) indications already granted for intravenous Keytruda, which generated $23 billion in sales during the first nine months of the year, making it Merck (搜索)'s biggest-selling drug. The subcutaneous version could prove strategically important as the original formulation faces patent expiration starting in 2028, potentially helping extend patent-protected life for the franchise before biosimilar versions of the intravenous form enter the market.
Industry Response and Legal Outlook
"We are very pleased that a German court has issued a preliminary injunction for MSD's patent infringement," said Mark Snyder, Halozyme's chief legal officer. "Halozyme is doing everything possible to vigorously defend and enforce the MDASE patents, and we are confident we will prevail at trial."
Halozyme expressed confidence that the preliminary injunction decision will withstand appeal if challenged, while noting that proceedings against its patent initiated by Merck (搜索) in August remain pending before the German Federal Patent Court. The company's MDASE technology has also been utilized in rival cancer (搜索) immunotherapies, including Bristol-Myers Squibb (搜索)'s Opdivo and Roche's Tecentriq, both of which have received approval for subcutaneous versions.
Merck (搜索) has not yet issued a statement regarding its intentions following the injunction but is expected to appeal the decision. The outcome of this patent dispute could have broader implications for the development and commercialization of subcutaneous cancer (搜索) treatments across the pharmaceutical industry.