ToolGen Initiates Patent Infringement Lawsuit Against Lonza in the Netherlands

On September 8, 2025, ToolGen, Inc., a global leader in genome editing technology, took a significant legal step by filing a patent infringement lawsuit against Lonza Netherlands B.V. The case was lodged in the District Court of The Hague, marking a crucial move in ToolGen's efforts to protect its innovative CRISPR-Cas9 technology in Europe.

Background of the Case

ToolGen asserts that Lonza has violated European patent EP 4 357 457, which safeguards the proprietary CRISPR-Cas9 RNP technology. This technology is pivotal for the intracellular delivery of Cas9 protein and guide RNA in optimized ratios. The patent infringement relates specifically to Lonza's production of CASGEVY, the world's first approved CRISPR-based gene therapy, developed by Vertex Pharmaceuticals and CRISPR Therapeutics to treat sickle cell disease and beta-thalassemia.

CASGEVY has already received approvals in significant markets, including the United Kingdom, the United States, and the European Union. Lonza operates its production facility in the Netherlands following a long-term supply agreement with Vertex.

Additional Legal Action

This lawsuit in the Netherlands represents ToolGen's second major legal action regarding CASGEVY, following a similar case initiated in April in the United Kingdom. Through this strategy, ToolGen aims to emphasize the importance of its CRISPR-Cas9 RNP technology while fiercely defending its intellectual property rights across Europe. The company's CEO, Jong Sang Ryu, expressed that the success of CASGEVY is largely attributable to ToolGen's unique technology. He stated, "We cannot accept the unauthorized use of our technology, and as such, we have initiated this lawsuit."

Keeping Patient Access in Focus

ToolGen is keen to clarify that this legal pursuit is not intended to hinder patient access to groundbreaking therapies. Instead, the company strives for fair recognition and appropriate compensation for the value of its innovations. Furthermore, ToolGen is open to reaching an amicable solution that promotes a sustainable and balanced ecosystem in the gene therapy sector.

The Importance of Intellectual Property Protection

With the evolution of gene editing technologies and the rapidly expanding biotech industry, the protection of intellectual property becomes increasingly critical. Patent rights are essential for fostering innovation, allowing companies like ToolGen to invest in research and development without the fear of their ideas being misappropriated. This lawsuit against Lonza serves as a testament to ToolGen's commitment to upholding the integrity of its patents, ensuring that innovators are duly compensated for their contributions to medical science.

In conclusion, as gene therapy becomes more prominent in modern medicine, the legal battles that unfold behind the scenes, such as the patent infringement lawsuit against Lonza, highlight the intricate balance between competition and collaboration in biotechnology. By asserting its patent rights, ToolGen aims not only to protect its interests but also to secure a place for fair practices within the industry, ultimately benefiting patients who rely on these life-saving therapies.