A German court ordered a halt to sales in Germany of Merck (MSD)'s cancer drug "Keytruda SC," which uses Alteogen's formulation-switching technology.
The court granted a preliminary injunction filed by a rival of Alteogen, and the decision 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 alleged patent infringement.
The panel found that Keytruda SC would infringe one of Halozyme's MDASE patents in Europe and ordered the suspension of launch activities for Keytruda SC in Germany.
Halozyme is considered a rival to Alteogen. The two companies each developed their own technology to convert intravenous (IV) therapies into subcutaneous (SC) formulations. The principle is to enzymatically break down hyaluronic acid in subcutaneous tissue to speed drug absorption.
Mark Snyder, Halozyme's chief legal officer (CLO), said in a statement, "We are very pleased that a German court has issued a preliminary injunction for MSD's patent infringement," and added, "Halozyme is doing everything possible 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 issued an official position on whether it will appeal. Halozyme said it expects the injunction to remain in place even if an appeal is filed. A patent invalidation suit that MSD filed in Aug. is pending before the German Federal Patent Court.
The ruling put the brakes on sales of Keytruda SC in Germany. The fallout could push back launch schedules in other European countries as well. It does not affect sales and distribution of the existing Keytruda IV formulation.
In Korea's industry, the granting of the injunction was analyzed as not posing a direct patent dispute risk to Alteogen. Alteogen's "ALT-B4" is based on a human-derived hyaluronidase variant, and its technological structure differs from Halozyme's.