Halozyme Sues Merck for Patent Infringement over Subcutaneous Keytruda Formulation
Rhea-AI Summary
Halozyme Therapeutics (NASDAQ: HALO) has filed a patent infringement lawsuit against Merck in U.S. District Court in New Jersey over the subcutaneous formulation of Keytruda. The complaint alleges that Merck's subcutaneous (SC) Keytruda infringes multiple patents related to Halozyme's MDASE technology, which were filed beginning in 2011.
The lawsuit comes as Merck plans to launch SC Keytruda in 2025 following completed phase 3 clinical testing. Halozyme claims Merck developed the SC formulation without permission, despite being aware of Halozyme's patents. The company is seeking damages and injunctive relief to stop the infringement.
Importantly, the disputed MDASE patent rights are separate from Halozyme's ENHANZE® licensing program and will not impact existing licensees or related revenues. The patents stem from Halozyme's research involving nearly 7,000 modifications to human hyaluronidases, which enable rapid subcutaneous administration of therapeutic drugs.
Positive
- Patent portfolio protection could lead to potential damages or licensing revenue from Merck
- Lawsuit demonstrates strength and value of Halozyme's MDASE technology IP
- Legal action doesn't affect existing ENHANZE licensing program revenue stream
Negative
- Legal costs associated with patent litigation
- Uncertainty of lawsuit outcome could impact investor confidence
- Risk of extended legal proceedings affecting resources and management focus
Insights
Halozyme sues Merck for unauthorized use of patented subcutaneous delivery technology in upcoming Keytruda formulation, seeking damages and injunction.
Halozyme's lawsuit against Merck represents a significant intellectual property confrontation in the pharmaceutical space. At the heart of this dispute is Halozyme's MDASE technology, which enables rapid, high-volume subcutaneous drug delivery – a valuable innovation that improves patient experience by reducing treatment burden.
The legal claims appear substantive, based on patents Halozyme has held since 2011 resulting from research into nearly 7,000 modifications to human hyaluronidases. This extensive R&D created what Halozyme describes as a "roadmap" for selecting modifications that impact enzyme activity and stability – representing a major advancement in the field.
What makes this case particularly noteworthy is Halozyme's assertion that Merck proceeded with development despite being "long aware" of Halozyme's patents. This allegation, if proven, could potentially support claims of willful infringement, which typically carries enhanced damages.
Halozyme is pursuing both monetary damages and injunctive relief that could potentially block Merck's planned 2025 launch of subcutaneous Keytruda. Patent litigation in pharmaceutical cases often involves complex scientific evidence and can extend for years through various appeals.
Importantly, Halozyme has explicitly clarified that this litigation doesn't affect its ENHANZE® licensing program or associated revenues, as the MDASE patents at issue are separate from those licensed through ENHANZE®. This strategic distinction helps isolate the dispute to specifically target Merck's alleged unauthorized use without disrupting Halozyme's broader business relationships.
Halozyme's patent lawsuit against Merck demonstrates strong IP protection stance, with potential upside from damages while safeguarding existing revenue streams.
This litigation highlights Halozyme's commitment to aggressively protecting its intellectual property, a crucial asset for biotechnology companies. By challenging a pharmaceutical giant like Merck, Halozyme signals to the market that it won't allow unauthorized use of its proprietary technologies, regardless of the opponent's size.
The case centers specifically on Merck's subcutaneous formulation of Keytruda, which has completed Phase 3 testing and appears headed for market launch later this year. As one of Merck's flagship products, Keytruda generates substantial revenue, and a subcutaneous version would represent a significant advancement in administration convenience.
From a financial perspective, this lawsuit creates potential upside through either damages or forced licensing if Halozyme prevails, while the company has simultaneously protected its existing business by clarifying that the dispute does not impact its ENHANZE® program or associated revenue streams. This strategic positioning limits downside risk while pursuing potential gains.
Halozyme's technology clearly delivers substantial value by enabling rapid subcutaneous administration of therapeutics that would otherwise require lengthy intravenous infusions. This patient-centric innovation emerged from extensive research into thousands of enzyme modifications – representing significant R&D investment that warrants protection.
While patent litigation inherently carries uncertainty and legal expenses, Halozyme appears to be taking a calculated approach by pursuing this action only after Merck allegedly proceeded with development despite awareness of the patents. The timing – filing just before Merck's anticipated launch – suggests a carefully considered legal strategy.
Complaint filed in
Halozyme is seeking damages and injunctive relief to stop the infringement
Halozyme believes the subcutaneous formulation of Merck's cancer medicine, Keytruda, infringes multiple patents that Halozyme filed beginning in 2011 to protect its groundbreaking MDASE subcutaneous delivery technology. Subcutaneous (SC) Keytruda has completed phase 3 clinical testing and Merck has publicly commented on its intention to launch the SC product in 2025. Merck has used Halozyme's technology to develop SC Keytruda without Halozyme's permission.
"We are filing this lawsuit to protect the innovative technology that we pioneered through years of painstaking research and development," said Dr. Helen Torley, president and chief executive officer of Halozyme. "Our technology can ease the burden of treatment and improve patient outcomes by making possible rapid, high-volume subcutaneous drug delivery for patients with serious medical conditions."
Halozyme partners with pharmaceutical companies to make subcutaneous versions of important medicines available for the benefit of patients. Halozyme's MDASE hyaluronidase technology is protected by a robust patent portfolio. Halozyme expected Merck to obtain a commercial license for the intellectual property it is using, but Merck has failed to do so and instead plans to launch SC Keytruda while knowingly infringing on Halozyme's MDASE patents.
The patents at issue arise from Halozyme's extensive research into nearly 7,000 modifications to human hyaluronidases. Among their uses, these hyaluronidases pioneered by Halozyme provide a mechanism for the rapid subcutaneous administration of therapeutic drugs. Halozyme's research and development resulted in a roadmap for selecting potential modifications to human hyaluronidases that can impact their activity and stability. Halozyme's comprehensive studies and innovations were a significant advancement to the field of human-derived hyaluronidases.
"Merck has long been aware of Halozyme's patents and still proceeded to appropriate Halozyme's technology in order to develop SC Keytruda," said Halozyme's Chief Legal Officer, Mark Snyder. "Based on their public comments, it appears they intend to launch SC Keytruda later this year despite the clear infringement of our patents. In our lawsuit, we are seeking damages and injunctive relief to stop the infringement."
None of the MDASE patent rights which Halozyme is seeking to enforce in this suit relate to the Company's ENHANZE® licensing program. The MDASE patents are not licensed to any of Halozyme's licensees. Therefore, the outcome of this dispute will not impact ENHANZE®, the ability of any licensee to use ENHANZE®, or revenues Halozyme receives from ENHANZE® licensees.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris, Inc.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of Halozyme's ENHANZE® and MDASE™ drug delivery technologies, the possible method of action of these technologies, their potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of these technologies including facilitating more rapid delivery of high-volume injectable medications through subcutaneous delivery and potentially easing the treatment burden for patients and improving patient outcomes. These forward-looking statements also include statements with respect to Halozyme's patent infringement suit against Merck Sharp & Dohme, Corp., to enforce Halozyme's patent rights, including Halozyme's belief that Merck's SC Keytruda infringes multiple Halozyme patents, Merck's public statements with respect to the timing of the commercial launch of SC Keytruda and Halozyme's belief that the suit will not impact its ENHANZE® licensing program. These forward-looking statements involve risks and uncertainties beyond Halozyme's control that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors and Halozyme can offer no assurance with respect to such forward-looking statements and cautions the reader not to place undue reliance on these forward-looking statements. In particular, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. Actual results could also differ materially from expectations contained in this press release as a result of other risks and uncertainties including those related to the enforceability and validity of our patents, the cost of litigation, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatments and competitive conditions. These and other factors that may result in material differences from the forward-looking statements contained in this press release are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Paul Gallagher
Teneo
917-573-5051
paul.gallagher@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
FAQ
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