Halozyme因默克公司侵犯专利起诉后者，涉及Keytruda的皮下注射制剂-动脉网

Halozyme Sues Merck for Patent Infringement over Subcutaneous Keytruda Formulation

CISION 等信源发布 2025-04-24 20:30



可切换为仅中文







Complaint filed in

投诉已提交

New Jersey

新泽西州

alleges

声称

Merck uses Halozyme's patented MDASE technology to develop SC Keytruda

默克使用Halozyme的专利MDASE技术开发SC Keytruda

Halozyme is seeking damages and injunctive relief to stop the infringement

Halozyme正在寻求损害赔偿和禁令救济以阻止侵权行为。

SAN DIEGO

圣地亚哥

，

April 24, 2025

2025年4月24日

/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:

/PRNewswire/ -- Halozyme Therapeutics, Inc.（纳斯达克：

HALO

光环

) (Halozyme), a biotechnology company that pioneered the use of human hyaluronidase for subcutaneous drug delivery, today filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (Merck) in U.S. District Court in

) (Halozyme)，一家开创了人体透明质酸酶用于皮下药物输送的生物技术公司，今天在美国地方法院对默克公司（Merck Sharp & Dohme Corp.）提起了专利侵权诉讼。

New Jersey

新泽西州

。

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.

Halozyme认为，默克公司癌症药物Keytruda的皮下制剂侵犯了其自2011年起申请的多项专利，这些专利旨在保护其突破性的MDASE皮下递送技术。皮下注射（SC）Keytruda已完成三期临床试验，默克公司已公开表示计划在2025年推出该SC产品。

Merck has used Halozyme's technology to develop SC Keytruda without Halozyme's permission..

默克公司在未获得Halozyme许可的情况下，使用Halozyme的技术开发了皮下注射型Keytruda。

'We are filing this lawsuit to protect the innovative technology that we pioneered through years of painstaking research and development,' said Dr.

“我们提起这项诉讼是为了保护我们通过多年精心研究和开发所开创的创新技术，”博士说道。

Helen Torley

海伦·托尔利

, 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.'

哈尔ozyme公司总裁兼首席执行官。“我们的技术可以减轻治疗负担，并通过实现快速、大容量的皮下药物输送来改善严重疾病患者的治疗效果。”

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..

Halozyme与制药公司合作，为患者的利益提供重要药物的皮下注射版本。Halozyme的MDASE透明质酸酶技术受到强大的专利组合保护。Halozyme预计默克将为其使用的知识产权获得商业许可，但默克未能这样做，反而计划在明知侵犯Halozyme的MDASE专利的情况下推出SC Keytruda。

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.

这些专利源于Halozyme对近7000种人类透明质酸酶修饰的广泛研究。其中，这些由Halozyme开创的透明质酸酶为治疗药物的快速皮下注射提供了一种机制。Halozyme的研发工作制定了一条选择可能影响人类透明质酸酶活性和稳定性的潜在修饰的路线图。

Halozyme's comprehensive studies and innovations were a significant advancement to the field of human-derived hyaluronidases. .

Halozyme的全面研究和创新对人类来源的透明质酸酶领域是一项重大进展。

'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,

“默克公司早就知道Halozyme的专利，但仍然继续采用Halozyme的技术来开发SC Keytruda，” Halozyme的首席法律顾问表示。

Mark Snyder

马克·斯奈德

. '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.'

“根据他们的公开评论，他们似乎打算在今年晚些时候推出SC Keytruda，尽管这明显侵犯了我们的专利。在我们的诉讼中，我们正在寻求损害赔偿和禁令救济以阻止侵权行为。”

None of the MDASE patent rights which Halozyme is seeking to enforce in this suit relate to the Company's ENHANZE

Halozyme在本案中试图执行的任何MDASE专利权均与公司的ENHANZE技术无关。

licensing program. The MDASE patents are not licensed to any of Halozyme's licensees. Therefore, the outcome of this dispute will not impact ENHANZE

许可计划。MDASE专利并未授权给Halozyme的任何被许可方。因此，此争议的结果不会影响ENHANZE。

, the ability of any licensee to use ENHANZE

，任何被许可人使用ENHANZE的能力

, or revenues Halozyme receives from ENHANZE

，或 Halozyme 从 ENHANZE 获得的收入

licensees.

被许可人。

About Halozyme

关于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

Halozyme是一家生物制药公司，致力于推进颠覆性解决方案，以改善新兴和现有疗法的患者体验和治疗效果。作为ENHANZE技术的创新者，

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.

Halozyme专有的经商业验证的解决方案，利用药物递送技术与专利酶rHuPH20，旨在促进注射药物和液体的皮下递送，目标是通过快速的皮下递送改善患者体验并减轻治疗负担。在至少一个主要地区和超过100个全球市场中，Halozyme的ENHANZE技术已在十种商业化产品中投入上市后使用，惠及超过一百万患者的生命。

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.

向领先的制药和生物技术公司提供技术，包括罗氏、武田、辉瑞、杨森、艾伯维、礼来、百时美施贵宝、argenx、ViiV Healthcare、中外制药和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.

Halozyme还利用其先进的自动注射器技术，自行或与合作伙伴共同开发、生产和商业化药物-设备组合产品，这些技术旨在提供商业或功能上的优势，例如提高便利性、可靠性、耐受性，增强患者的舒适度和依从性。

The Company has two commercial proprietary products, Hylenex.

公司有两种商业专有产品，Hylenex。

and XYOSTED

和 XYOSTED

, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris, Inc.

，与梯瓦制药和迈兰公司的附属公司麦克德莫特实验室有限公司合作的商业产品及持续的产品开发计划。

Halozyme is headquartered in

Halozyme总部位于

San Diego, CA

加利福尼亚州圣地亚哥

and has offices in

并且在以下地点设有办公室

Ewing, NJ

尤因，新泽西州

and

和

Minnetonka, MN.

明尼通卡，明尼苏达州。

Minnetonka

明尼通卡

is also the site of its operations facility.

也是其运营设施的所在地。

For more information visit

欲了解更多信息，请访问

www.halozyme.com

and connect with us on LinkedIn and Twitter.

并在LinkedIn和Twitter上与我们联系。

Safe Harbor Statement

安全港声明

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

除了历史信息外，上述声明还包括前瞻性陈述，包括但不限于有关 Halozyme 的 ENHANZE 可能的活动、益处和属性的陈述。

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.

以及MDASE™药物递送技术，这些技术可能的作用方式，它们在帮助其他注射治疗药物的分散和吸收方面的潜在应用，还包括有关这些技术某些其他潜在益处的陈述，例如通过皮下递送更快速地输送大剂量注射药物，并有可能减轻患者的治疗负担并改善患者预后。这些前瞻性声明还包括Halozyme对默克公司（Merck Sharp & Dohme, Corp.）提起的专利侵权诉讼相关声明，以维护Halozyme的专利权，包括Halozyme认为默克的皮下注射Keytruda侵犯了其多项专利、默克关于皮下注射Keytruda商业上市时间的公开声明，以及Halozyme认为该诉讼不会影响其ENHANZE技术的信念。

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.

许可计划。这些前瞻性陈述涉及 Halozyme 无法控制的风险和不确定性，可能导致实际结果与前瞻性陈述中的结果有重大差异。前瞻性陈述通常（但并非总是）通过使用诸如“预期”、“相信”、“实现”、“可能”、“将”、“能够”、“意图”、“估计”、“预见”、“计划”、“预测”、“很可能”、“潜在”、“可能”、“应该”、“继续”等类似含义的词语来识别。

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.

实际结果可能与前瞻性陈述中包含的预期存在重大差异，这是由于多种因素造成的，Halozyme无法对这些前瞻性陈述提供任何保证，并提醒读者不要过度依赖这些前瞻性陈述。特别是，对于本新闻稿中提到的诉讼相关进展、诉讼结果或与诉讼相关的任何可能补救措施，均无法提供任何保证。实际结果也可能因其他风险和不确定性而与本新闻稿中包含的预期存在重大差异，包括与我们专利的可执行性和有效性、诉讼成本、意外的不良事件或患者接受ENHANZE®联合治疗时的体验或结果以及竞争状况相关的风险和不确定性。

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 r.

这些因素以及可能导致与本新闻稿中包含的前瞻性声明存在重大差异的其他因素，已在 Halozyme 最近向证券交易委员会提交的年度和季度报告中进行了更详细的讨论。除非法律要求，Halozyme 没有义务更新前瞻性声明以反映。

Contacts:

联系人：

Tram Bui

电车布伊

VP, Investor Relations and Corporate Communications

副总裁，投资者关系与企业传播

609-359-3016

tbui@halozyme.com

Paul Gallagher

保罗·加拉格尔

Teneo