ToolGen Files Patent Infringement Lawsuit Against Lonza in the Netherlands

ToolGen Files Patent Infringement Lawsuit Against Lonza

On September 8, 2025, ToolGen, Inc. (KOSDAQ: 199800), a global leader in genomic editing technology, made headlines by announcing a patent infringement lawsuit against Lonza Netherlands B.V. Lonza is a well-known contract development and manufacturing organization (CDMO) responsible for producing CASGEVY, the world's first CRISPR-based gene therapy. This pivotal lawsuit was filed at the District Court of The Hague, emphasizing ToolGen's commitment to protecting its core technology.

The lawsuit centers around ToolGen's European patent (EP 4 357 457), which pertains to the CRISPR-Cas9 RNP technology used by Lonza in the production of CASGEVY for Vertex Pharmaceuticals. This groundbreaking therapy has already received approval in the United Kingdom, the United States, and the European Union for the treatment of sickle cell anemia and beta-thalassemia, conditions that have long plagued patients worldwide.

Under a long-term supply agreement with Vertex, Lonza has assumed the critical role of manufacturing CASGEVY in the Netherlands. By targeting Lonza as a significant European production hub, ToolGen aims to fortify its intellectual property rights concerning its revolutionary CRISPR-Cas9 RNP technology. This legal action follows a previous lawsuit filed by ToolGen in the United Kingdom earlier this year against parties involved in the sales and production of CASGEVY.

Jong Sang Ryu, CEO of ToolGen, commented on the situation: "The commercial success of CASGEVY fundamentally relies on ToolGen's proprietary CRISPR-Cas9 RNP platform. We felt compelled to file this lawsuit because we cannot allow the unauthorized use of our technology. Our intention is not to hinder patient access to life-changing therapies but to ensure fair recognition and appropriate compensation for the value of our innovations. We are open to exploring a friendly resolution to this conflict, promoting a sustainable and mutually beneficial ecosystem."

The legal dispute underscores the increasing importance of intellectual property rights within the biotechnology sector. As novel therapies emerge from the rapid advancements in genomic editing, companies like ToolGen and Lonza must navigate the delicate balance between innovation and legal compliance. With significant investments at stake, the outcome of this lawsuit could have far-reaching implications not only for the parties involved but also for the entire industry.

Casirivimab/imdevimab, the mixture underlying the CASGEVY therapy, stands at the forefront of modern medicine, enabling targeted genetic modification to treat previously debilitating diseases. As such, this case represents more than just a legal battle; it reflects the ongoing race within the biomedical field to establish and protect pioneering technologies.

As the case unfolds, it will undoubtedly attract attention from industry stakeholders, legal experts, and patients alike. All eyes will be on the court in The Hague as ToolGen seeks to defend its innovations, a move that may further pave the way for future breakthroughs in gene therapy. The legal landscape is set to become even more intricate as companies continue to forge ahead with novel therapies amidst the backdrop of patent laws and rights.

Ultimately, this lawsuit serves as a salient reminder of the critical role intellectual property plays in fostering innovation within the biotechnology space. The decisions made in this case could resonate well beyond the walls of the courtroom, influencing how gene therapies are developed, manufactured, and brought to market around the world.