For the better part of a year, Merck & Co. and Halozyme have been locked in an intellectual property disagreement over the the pharma giant's new, under-the-skin version of cancer megablockbuster Keytruda.
Now, in an early win for subcutaneous drug developer Halozyme, a German court has told Merck to stop launch activities for Keytruda SC in the country, where the New Jersey pharma is known as Merck Sharp & Dohme.
A German court granted Halozyme's request for a preliminary injunction, finding that there is "imminent infringement" of one of Halozyme's patents in Europe, Halozyme said in a Dec. 4 press release.
The patent at issue is the European Patent No. 2 797 622, Halozyme said, which falls in its Mdase family of intellectual property. The Halozyme tech "was developed through years of rigorous research to enable rapid, high-volume subcutaneous drug delivery," the company's chief legal officer Mark Snyder said in a statement.
Merck sees things differently. In a statement, a spokesperson said the company "strongly" disagrees with the result.
"We consider Halozyme’s patent to be invalid globally and their allegation of infringement to be without merit," the Merck spokesperson added. "We are confident in our legal position and believe that, ultimately, we will prevail in the courts."
Merck's Keytruda SC won approval from the European Commission less than a month ago, with the pharma giant saying at the time that launch timing would depend on reimbursement procedures in individual countries. After EU approval of new pharmaceutical products, drug companies engage in country-by-country procedures and negotiations to move toward launches.
In Halozyme's press release, the subcutaneous specialist said Merck's "launch activities for Keytruda SC in Germany that are within the scope of the order must be halted." The order is appealable, but Halozyme said it's confident the decision would stand up to such an attempt.
Merck's well-established intravenous version of Keytruda remains available in the country, Halozyme said.
Merck has initiated proceedings in an attempt to nullify the patent at issue in the German Federal Patent Court, and the case remains pending.
The issue stretches far beyond Germany, as Halozyme has pledged "global enforcement" of its Mdase patents. The effort includes a U.S. case filed in federal court in New Jersey.
When Halozyme filed that lawsuit in April, a Merck spokesperson said the company believed the case was "meritless."
The subcutaneous version of Keytruda picked up FDA approval in September and is marketed as Keytruda Qlex in the U.S. Despite the pending litigation, Merck didn't hesitate and moved to quickly launch the drug in the country.
Back in March, Halozyme CEO Helen Torley said at an investor conference that she hoped the companies could strike a licensing pact with a "reasonable" royalty rate. Failing that, Snyder said the company remained ready to take Merck to court.