ToolGen, a South Korean leader in gene editing technology, has escalated its intellectual property dispute by filing a patent infringement lawsuit against Lonza Netherlands B.V. in the Hague District Court. The lawsuit alleges that Lonza is infringing ToolGen's European patent (EP 4 357 457) covering CRISPR-Cas9 RNP technology in its production of CASGEVY, the world's first approved CRISPR-based gene therapy.
Patent Infringement Claims
The legal action centers on ToolGen's assertion that Lonza is using its proprietary CRISPR Cas9 RNP source technology without authorization at Lonza's state-of-the-art Dutch facility. ToolGen's patent describes a platform technology that directly delivers a CRISPR Cas9 RNP complex formed by combining Cas9 protein and guide RNA in an optimal molar ratio into cells, which plays a crucial role in enhancing the efficiency and accuracy of gene editing.
CASGEVY, developed by Vertex Pharmaceuticals and CRISPR Therapeutics using CRISPR technology, represents a breakthrough as the world's first gene-editing treatment. The therapy offers a new therapeutic option for patients with sickle cell disease and beta-thalassemia and has been approved and commercialized in the UK, US, and Europe. Lonza manufactures CASGEVY at its Netherlands facility under a long-term supply agreement with Vertex.
Strategic Legal Expansion
This Dutch lawsuit represents an extension of ToolGen's broader intellectual property enforcement strategy. The company previously filed a patent infringement lawsuit in the UK in April against companies involved in the sale and production of CASGEVY. By directly targeting key European production sites, ToolGen aims to reaffirm the importance of its core technology and strengthen intellectual property protection across the region.
Company Position and Industry Impact
Jong Sang Ryu, CEO of ToolGen, emphasized the company's position on the litigation: "Behind the successful commercialization of CASGEVY lies the pivotal role of ToolGen's proprietary CRISPR-Cas9 RNP platform. Toolgen filed this lawsuit because it cannot accept the unauthorized use of its proprietary technology."
The CEO clarified that the lawsuit is not intended to restrict patient access to life-changing therapies, but rather to secure fair recognition and just compensation for the value of ToolGen's innovations. The company remains open to exploring an amicable resolution of the dispute, ultimately fostering a sustainable and mutually beneficial ecosystem.
ToolGen's Technology Foundation
ToolGen was founded in 1999 by renowned gene editing scientist Dr. Jin-Soo Kim and has established itself as a unique player in the gene editing space. The company is distinguished as the only organization that has successfully developed all three major gene editing platforms: ZFN, TALEN, and CRISPR-Cas9, positioning it as a comprehensive leader in genome editing technology development.
