#Germany #Halozyme #Munich #KEYTRUDA #Merck

Halozyme Secures Legal Win

Halozyme Therapeutics, Inc. has achieved a significant legal victory with a German court granting a preliminary injunction against Merck's distribution of Keytruda SC within Germany. This ruling, issued by the Munich Regional Court's 7th Civil Division, underscores the court's alignment with Halozyme's claims regarding imminent patent infringement. The specific patent at dispute is Halozyme's MDASE™ patent, European Patent No. 2 797 622 (EP 622), which is critical in the biopharmaceutical landscape.

Merck's recent efforts aimed at launching Keytruda SC in Germany have now come to a halt as a result of this injunction. Despite the potential for Merck to appeal the decision, Halozyme is optimistic about the court's ruling standing firm. Notably, the injunction does not impact the intravenous (IV) version of Keytruda, which remains accessible to patients since it does not infringe on Halozyme's patent.

Mark Snyder, Chief Legal Officer of Halozyme, expressed satisfaction with the court's ruling, highlighting the strength of their arguments concerning patent validity and infringement. The MDASE technology, which allows for rapid, high-volume delivery of subcutaneous drugs, is a product of extensive research and development over several years.

This development is pivotal, marking a critical point in Halozyme's ongoing battle to protect its intellectual property against what it sees as infringement by Merck. Furthermore, this legal action is part of a broader strategy by Halozyme to enforce its MDASE™ patents in multiple jurisdictions, including an ongoing case in the U.S. federal district court in New Jersey. In this latter case, Halozyme alleges that Keytruda's subcutaneous formulation, marketed in the United States under the name QLEX, violates 15 of its patents linked to MDASE™ technology.

Halozyme’s development of MDASE™ has been extensive, closing in on 7,000 modifications to human hyaluronidases, which form the foundation of their innovative subcutaneous drug delivery mechanism. This technology has considerably advanced the field, particularly for the administration of therapeutic drugs.

It is also worth noting that Halozyme's MDASE™ patents are separate from its ENHANZE® licensing program and do not interfere with existing partnerships or revenue streams related to ENHANZE®. Halozyme has collaborated with numerous leading pharmaceutical companies, including Roche and Takeda, leveraging its proprietary drug delivery technology.

Additionally, Halozyme is advancing its commitment to enhancing patient treatment experiences. The company is developing Hypercon™, a new microparticle technology that promises to set new standards in drug and biologics concentration, aiming to extend the range and efficiency of subcutaneous delivery. The anticipated outcomes of Hypercon™ hold the potential to broaden therapeutic opportunities available for patients, aligning with Halozyme's aim of transforming patient care through innovative solutions.

Halozyme’s diverse array of product offerings, bolstered by advanced auto-injector technologies, underscores its dedication to enhancing patient comfort and adherence. With products such as Hylenex® and XYOSTED®, alongside partnerships and ongoing development programs with companies like Teva Pharmaceuticals, Halozyme is poised for future growth in the biopharmaceutical sector.

As Halozyme continues its legal and developmental initiatives, the company’s strategic focus remains clear: protect its intellectual property while bolstering its role as a leader in biopharmaceutical innovation. The next phases in this patent dispute, alongside advancements in drug delivery technologies, will be crucial as the company navigates the complexities of the healthcare landscape.

For more details on Halozyme’s ongoing developments and innovations, you can visit their official website or connect with them through their social media channels.