After facing a setback in Germany late last year, Merck & Co.’s European marketing plans for its below-the-skin Keytruda SC are growing more complicated.
A specialized Dutch patent court in The Hague has found that Merck—known as Merck Sharp & Dohme outside the U.S. and Canada—infringed on one of drug delivery specialist Halozyme’s Mdase patents related to subcutaneous biopharmaceutical formulations.
In turn, the court has ordered Merck to stop making and marketing the cancer drug in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. The injunction also forbids Merck “to facilitate infringement by its affiliates, including by allowing the use of its European Marketing Authorization,” Halozyme said in an Oct. 7 release.
With the decision, patients using intravenous Keytruda will have continued access to their medicine in the select European countries, said Halozyme, adding that it was “very pleased the Dutch court recognized the validity and infringement” of the Mdase patent. The technology, addressed in this particular instance by Halozyme’s so-called EP622 patent, took “years of rigorous research” to achieve, the company added.
Merck, for its part, said it disagreed “strongly” with the court’s decision in an emailed statement.
“We consider Halozyme’s patent to be invalid globally and its allegation of infringement to be without merit,” a company spokesperson said.
The injunction shouldn’t be unfamiliar territory for Merck, which faced similar pushback in Germany late last year. Germany often serves as a proving ground for drug launches in the EU, which require individual access agreements with member states after formal European Medicines Agency sign-off on a product.
In that case, a German court also told Merck to halt its launch activities for Keytruda SC in the country, finding cause for “imminent infringement” of one of Halozyme’s patents in Europe.
At the time, Merck made similar statements about its take on the validity of Halozyme’s charges.
Halozyme is a well-known partner of Big Pharmas in the drug delivery space, having helped bring forward subcutaneous formulations of Johnson & Johnson’s Darzalex, Roche’s Ocrevus and argenx’s Vyvgart, to name just a few examples. In those instances, the formulations utilize Halozyme’s Enhanze licensing program and are distinct from the Mdase patents, meaning the Merck litigation won’t affect those agreements, Halozyme clarified Wednesday.
Merck started racking up green lights for its below-the-skin Keytruda offering last year in an approval push that could extend the aging mega-blockbuster’s revenue runway. The subcutaneous drug received an FDA approval in September and is marketed as Keytruda Qlex in the United States, where Merck is also facing ongoing patent litigation brought by Halozyme.
Keytruda Qlex/SC specifically leverages Alteogen’s berahyaluronidase alfa to establish its subcutaneous bona fides, with Halozyme alleging that Alteogen tech infringes its broad portfolio of modified hyaluronidase patents known as Mdase.
In that case, Halozyme is alleging infringement of 15 patents by Keytruda Qlex, with the intellectual property in question dating back to 2011.
Subcutaneous Keytruda was subsequently approved in Europe last November.
With the new cross-border restriction coming down this week, Merck will be “evaluating next steps,” the company’s spokesperson said Wednesday, stressing that the group remains “confident in our overall legal position” and believes that “ultimately, we will prevail in the courts.”