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Halozyme Fights Back: Patent Infringement Claim Against Merck

Halozyme Therapeutics, Inc., a leading biotechnology company known for its innovation in drug delivery systems, has filed a lawsuit against Merck Sharp & Dohme Corp. in a bid to protect its patented technology. The suit, lodged in New Jersey, underscores a heated dispute over the development of a subcutaneous (SC) formulation of Merck's cancer immunotherapy, Keytruda. Halozyme claims that the formulation infringes on its patented MDASE technology, which facilitates the delivery of medications through subcutaneous administration.

The Backbone of the Lawsuit

Halozyme's complaint is centered around multiple patents issued since 2011 that cover the MDASE subcutaneous delivery technology. This technology allows for the rapid and efficient delivery of drugs, making treatment more accessible and manageable for patients. The recent completion of phase 3 clinical tests for SC Keytruda positions Merck on the cusp of a 2025 product launch, further intensifying the stakes in this legal encounter. Halozyme asserts that Merck has gone ahead with the SC formulation using its proprietary technology without obtaining necessary licenses or permissions.

According to Dr. Helen Torley, president and CEO of Halozyme, the lawsuit aims to safeguard technology developed after years of rigorous research and development. This commitment to advancing patient care is reflected in Halozyme's comprehensive patent portfolio, which protects its innovations in human hyaluronidase use for drug delivery.

Merck's Knowledge of Infringement

Halozyme's Chief Legal Officer, Mark Snyder, indicated that Merck has long been aware of Halozyme's patent protections but has forged ahead with developing SC Keytruda nonetheless. By doing so, Snyder claims, Merck has deliberately infringed on Halozyme's patent rights. Halozyme is seeking both damages and a court injunction to prevent the commercial release of SC Keytruda, which they argue would further compound the infringement.

The MDASE patented technology has evolved through extensive research into nearly 7,000 variations of human hyaluronidases, enabling the effective subcutaneous administration of therapeutic agents. The innovative roadmap that Halozyme developed has positioned it as a frontrunner in the pharmaceutical biotechnology field.

Implications of the Lawsuit

The ongoing dispute bears significant implications not only for Halozyme and Merck but for the pharmaceutical industry at large. If Halozyme prevails, it could reinforce the importance of patent protections and intellectual property rights within biotechnology sectors where innovation is pivotal for advancing patient care. However, this battle raises questions about the access to pivotal treatments and the development landscape for upcoming therapies.

Importantly, Halozyme clarifies that this lawsuit does not impact its ENHANZE® licensing program, asserting that the MDASE patents in question are distinct from those licensed to other pharmaceutical partners. Summary judgment in this case may set precedents that affect future collaborations and licensing agreements in the industry.

About Halozyme

Founded with the objective to enhance patient experiences and outcomes through innovative solutions, Halozyme has dramatically changed the landscape of drug administration. Its pioneering work with the ENHANZE® technology — a proprietary enzyme driving subcutaneous delivery — has transformed how injected therapeutics are delivered, considerably improving treatment adherence and comfort for over a million patients worldwide. The company's strategic partnerships with several leading pharmaceutical firms signify its role as a key player in advancing healthcare outcomes.

As this lawsuit unfolds, all eyes will be on the courtroom, where the future of subcutaneous drug delivery technology hangs in the balance. The outcome not only affects Halozyme and Merck but could also dictate the trajectory of technological innovation in medical treatment for years to come.

For more information on Halozyme, visit www.halozyme.com and follow them on LinkedIn and Twitter to stay updated on further developments regarding this case.