ToolGen Initiates Legal Action Against Lonza for Patent Violations in the Netherlands

ToolGen Takes Legal Action Against Lonza for Patent Infringement

In a significant legal development, ToolGen, Inc. (KOSDAQ: 199800), a forefront company in genome editing technology, has filed a patent infringement lawsuit against Lonza Netherlands B.V. This legal action, aimed at protecting its intellectual property rights, was initiated in the District Court of The Hague on September 8, 2025. The lawsuit asserts that Lonza, a contract development and manufacturing organization (CDMO) responsible for producing CASGEVY—the first CRISPR-based gene therapy authorized for human use—infringes on ToolGen's European patent (EP 4 357 457) that covers essential CRISPR-Cas9 RNP technology.

Background of CASGEVY

CASGEVY is a groundbreaking treatment developed through a collaboration between Vertex Pharmaceuticals and CRISPR Therapeutics. This innovative therapy is intended for patients suffering from sickle cell disease and beta-thalassemia, and it has received regulatory approval in the United Kingdom, the United States, and the European Union. Lonza, under a long-term supply agreement with Vertex, plays a critical role in the production of CASGEVY at its facilities in the Netherlands.

This lawsuit marks ToolGen's second legal action in Europe, succeeding a similar one filed in the United Kingdom in April against various parties involved in the sale and production of CASGEVY. By targeting a critical production hub in Europe, ToolGen emphasizes its commitment to safeguarding its intellectual property rights associated with its pioneering CRISPR-Cas9 RNP technology.

The Importance of Intellectual Property

Jong Sang Ryu, CEO of ToolGen, has expressed the significance of this lawsuit, stating, "Behind the successful commercialization of CASGEVY lies the pivotal role of ToolGen's proprietary CRISPR-Cas9 RNP platform." He further elaborated that the aim of the lawsuit is not to obstruct patient access to innovative therapies but rather to ensure fair acknowledgment and compensation for the substantial value derived from ToolGen's technological advancements.

The move underscores the ongoing challenge within the biotechnology landscape where proprietary technologies are frequently at the center of legal disputes. ToolGen seeks not only to protect its innovations but also to foster a healthy ecosystem that respects intellectual property and encourages further advancements in genetic therapies.

Looking Ahead

As the case unfolds, ToolGen remains open to discussions that could lead to an amicable resolution of the dispute. The company acknowledges the necessity of collaboration and dialogue in the biotechnology sector, emphasizing the collective goal of making transformative therapies available to patients in need. Maintaining a balance between innovation, intellectual property rights, and patient access will be crucial as the industry progresses.

The outcome of this lawsuit against Lonza could significantly impact the future landscape of genome editing technologies and patent rights, further highlighting the importance of protecting pioneering scientific advancements in the face of competition and legal challenges. ToolGen's decisive action reflects its dedication to preserving the integrity of its inventions and ensuring they are utilized ethically and equitably within the medical community.