ToolGen Files Patent Infringement Lawsuit Against Lonza in the Netherlands

On September 8, 2025, ToolGen, Inc. (KOSDAQ: 199800), a leading company in genome editing technology, announced that it has filed a patent infringement lawsuit against Lonza Netherlands B.V. This case, brought before the District Court of The Hague, focuses on the unauthorized use of ToolGen's CRISPR-Cas9 RNP technology by Lonza in the manufacture of CASGEVY, the world's first approved CRISPR-based gene therapy for treating sickle cell anemia and beta-thalassemia.

The lawsuit alleges that Lonza, a Contract Development and Manufacturing Organization (CDMO), infringed on ToolGen's European patent (EP 4 357 457) during the production of CASGEVY in its Dutch facility. CASGEVY, developed by Vertex Pharmaceuticals and CRISPR Therapeutics, represents a groundbreaking advance in gene therapy, having received regulatory approval in the United Kingdom, the United States, and the European Union.

This legal action is ToolGen's second European measure in this matter, following a similar lawsuit filed in the UK earlier in April targeting parties involved in the sales and manufacturing of CASGEVY. With this move, ToolGen aims to strengthen the protection of its intellectual property rights, particularly focusing on a central manufacturing hub in Europe that underscores the significance of their foundational CRISPR-Cas9 technology.

Jong Sang Ryu, CEO of ToolGen, emphasized the crucial role of their proprietary CRISPR-Cas9 RNP platform in the successful commercial use of CASGEVY. He stated, “ToolGen has filed this lawsuit because it cannot accept the unauthorized use of its technology. The aim of this lawsuit is not to limit patient access to life-changing therapies but to secure fair recognition and appropriate compensation for the value of our innovations. We remain open to amicable solutions to foster a sustainable and mutually beneficial ecosystem.”

The CRISPR technology has revolutionized genetic editing, providing new treatment paradigms for previously untreatable conditions. However, with this power comes the responsibility of protecting intellectual property to ensure continued research and development in this rapidly evolving field. By fortifying its legal stance, ToolGen is actively working to maintain the integrity of its innovations and the investments made in developing groundbreaking therapies.

Lonza, which has a significant role in the biotechnology landscape as a CDMO, is poised to respond to the lawsuit, and the proceedings will likely shed light on broader discussions regarding patent rights in the biotech sector. The outcome of this litigation could have far-reaching implications not only for ToolGen and Lonza but also for other companies operating in the gene therapy space.

As this legal battle unfolds, industry watchers will be keenly observing developments in patent law as it applies to cutting-edge medical treatments like gene therapies, which are shaping the future of medicine. ToolGen's robust legal actions are indicative of its commitment to protecting its innovations and ensuring that the advancements in gene editing technology are utilized ethically and legally.

The case exemplifies the high stakes involved in biotechnology, where intellectual property rights can significantly impact the accessibility of life-saving therapies. Stakeholders in the health and biotechnology sectors are undoubtedly keeping a close eye on the proceedings to see how they may influence future collaborations and developments in gene therapy technologies.