A German court ordered sales in Germany to be halted for Merck's cancer drug Keytruda SC, which uses Alteogen's formulation-switching technology.
A court granted an injunction filed by a competitor of Alteogen, and the move is expected to affect MSD's global launch plan for Keytruda SC.
Halozyme Therapeutics said on the 4th (local time) that the 7th Civil Chamber of the Munich Regional Court in Germany granted the company's request for a preliminary injunction over patent infringement.
The court found that Keytruda SC would infringe one of Halozyme's MDASE patents in Europe and ordered a halt to launch activities for Keytruda SC in Germany.
Halozyme is considered a rival to Alteogen. The two companies each independently developed technology to convert intravenous (IV) therapies into subcutaneous (SC) formulations. The principle is to enzymatically break down hyaluronic acid in subcutaneous tissue to help drugs absorb more quickly.
Mark Snyder, Halozyme's chief legal officer (CLO), said in a statement, "We are very pleased that the German court issued a preliminary injunction for MSD's patent infringement," and added, "Halozyme is doing everything it can to vigorously defend and enforce the MDASE patents, and we are confident we will prevail at trial."
MSD can appeal the injunction. The company has not yet released an official position on whether it will appeal. Halozyme said it expects the injunction to remain in place even if there is an appeal. A patent invalidation suit filed by MSD in Aug. is pending before the German Federal Patent Court.
The ruling has put the brakes on Keytruda SC sales in Germany. The impact could delay launch schedules not only in Germany but also in other European countries. It does not affect the sales and distribution of the existing Keytruda IV formulation.
In Korea's industry, analysts said the granting of the injunction does not pose a direct patent dispute risk to Alteogen. Alteogen's ALT-B4 is based on a human-derived hyaluronidase variant, and its technical architecture differs from Halozyme's.