Halozyme Therapeutics, Inc. has secured a major legal victory in Germany, where a court granted a preliminary injunction against Merck’s Keytruda SC (subcutaneous formulation). The ruling, dated June 24, 2024, temporarily blocks the sales and marketing of Keytruda SC within the German market.
The injunction is based on Halozyme’s patent rights concerning its proprietary ENHANZE technology. This technology utilizes recombinant human hyaluronidase enzyme to enhance drug delivery and forms a key component in Keytruda SC, allowing a more convenient administration compared to traditional intravenous methods.
Details of the Court Ruling
- The German court found Merck likely infringed Halozyme’s patent by using ENHANZE technology in Keytruda SC without authorization.
- The judge supported Halozyme’s claim that Merck is benefiting commercially from the technology without a proper license.
Company Reactions and Industry Impact
Halozyme’s CEO emphasized that protecting intellectual property is vital for fostering innovation and sustaining future drug development efforts. The company views the injunction as an important step in enforcing its patent portfolio across Europe, which is crucial for ongoing investment in medical research.
Merck has yet to provide an official response regarding the court decision. The injunction could pose challenges to Merck’s expansion strategy for Keytruda SC in Europe, where demand for more convenient cancer treatments is increasing.
Expert Views and Broader Implications
Pharmaceutical patent experts highlight this ruling as a significant reminder of the critical role of technology licensing in drug development. It also indicates courts are willing to act quickly to uphold patent holders’ rights and prevent unauthorized use.
Background on Keytruda SC and ENHANZE Technology
- Keytruda (pembrolizumab) is a leading immunotherapy used to treat multiple cancer types.
- The subcutaneous formulation enhances patient experience by reducing administration time and clinic visits.
- ENHANZE technology facilitates faster drug absorption under the skin, enabling this improved delivery method.
The legal dispute arose after Merck introduced Keytruda SC in European markets, triggering Halozyme’s challenge to protect its innovations. This ongoing case may progress to full court hearings if no settlement is achieved, drawing attention to how such conflicts can influence pharmaceutical partnerships and licensing arrangements across Europe.
Stay tuned to Questiqa Europe News for further updates on this evolving story.
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