Merck suffers a setback over Keytruda formulation in Germany

In a setback for Merck, a German court issued a preliminary injunction that prevents the company from distributing a new subcutaneous formulation of Keytruda in Germany. The ruling came as part of a widening patent infringement dispute with Halozyme Therapeutics over the bestselling cancer treatment.

The Munich Regional Court decided that Merck’s formulation would infringe on a patent held by Halozyme in Europe and so Merck is required to halt its launch for Keytruda SC in Germany. Patients requiring Keytruda will still have access to the existing intravenous version, which is not affected by the patent dispute or court order.

At issue are certain enzymes called Mdase that Halozyme developed to enable the administration of drugs by injection and that have formed the basis for a broader patent dispute between the companies on both sides of the Atlantic.