SEOUL, South Korea — ToolGen, a prominent player in genome editing, has initiated legal proceedings against Dutch manufacturer Lonza Netherlands B.V. The lawsuit, filed in The Hague, alleges that Lonza infringes on ToolGen’s patent rights while producing CASGEVY, the first authorized CRISPR-based gene therapy for treating sickle cell disease and beta-thalassemia.
According to the claims, Lonza’s production processes at its Dutch facility violate ToolGen’s European patent (EP 4 357 457), which is centered on the CRISPR-Cas9 RNP technology. CASGEVY, developed collaboratively by Vertex Pharmaceuticals and CRISPR Therapeutics, has gained regulatory approval in multiple regions, including the United Kingdom, United States, and European Union.
This lawsuit marks a continuation of ToolGen’s legal strategy following a similar action taken in the United Kingdom in April, targeting multiple parties associated with CASGEVY’s development and distribution. ToolGen seeks to underscore the significance of its foundational technology within the CRISPR space and to bolster the protection of its intellectual property rights.
Jong Sang Ryu, CEO of ToolGen, stated the company cannot accept the unauthorized usage of its patented technology and emphasized that this legal action is not intended to hinder patient access to necessary treatments. Instead, he argued that it aims to ensure appropriate recognition and compensation for ToolGen’s innovations, highlighting an openness to resolving the matter amicably.
The move to file the lawsuit in The Hague is particularly crucial for ToolGen, as it seeks to protect its interests in a key European market. By taking aim at Lonza, which plays a significant role in the manufacturing supply chain, ToolGen hopes to assert its patent rights and safeguard the future viability of its CRISPR technology.
CASGEVY is notable for its groundbreaking application in gene therapy, representing a significant advancement in medical treatments for genetic disorders. As the biotech landscape continues to evolve, legal battles concerning intellectual property rights are becoming increasingly common, reflecting the competitive nature of the industry.
ToolGen’s commitment to protecting its innovations reinforces the ongoing discourse on patent ownership within biotechnology, where the implications reach far beyond corporate interests and impact patients seeking transformative therapies.
This legal development underscores the complexities surrounding CRISPR technology’s commercialization and the competitive legal environment in which such breakthroughs are realized.
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