Patent Infringement Lawsuit | Business | Technology
Introduction: Patent Wars Escalate
In a strategic escalation of Europe’s fiercest CRISPR–Cas patent war, ToolGen, Inc., the Seoul‑based pioneer of CRISPR RNP (ribonucleoprotein) delivery technology, has sparked a critical development: Vertex Pharmaceuticals—the developer of CASGEVY®, the world’s first CRISPR‑based genome‑editing therapy—and its manufacturing partner Lonza Netherlands now face separate legal challenges in the Netherlands.
A Circuitous Legal Clash
ToolGen first filed a patent infringement lawsuit in the United Kingdom in April 2025, accusing Vertex and its manufacturing partners—including Lonza and Roslin Cell Therapies—of infringing its European patent EP 4 357 457 (EP 457), relating to CRISPR RNP delivery technology (juve-patent.com, iptradenews.com). The company explicitly stated that the action was not intended to restrict patient access to CASGEVY®, but rather to secure fair compensation through licensing (juve-patent.com, kilburnstrode.com, themedicinemaker.com).
In what appears to be a preemptive countermove, Vertex has filed a nullity (revocation) action in the Netherlands against the very same EP 457 patent (juve-patent.com). Given that the therapy is produced at Lonza’s Geleen facility in the Netherlands—a site approved by the FDA, EMA, and MHRA—the Dutch litigation strikes at the heart of CASGEVY’s commercial manufacturing base (lonza.com).
Grounds for Litigation
ToolGen’s patent covers a method of delivering the Cas9 protein in its active form directly into cells—CRISPR RNP—avoiding the risks of DNA or mRNA vectors, such as unwanted genomic insertion and cellular toxicity (iptradenews.com, themedicinemaker.com, kilburnstrode.com). ToolGen argues that CASGEVY relies on this patented technology without proper licensing.
Vertex’s nullity suit targets EP 457, a divisional patent derived from EP 3 397 759, seeking to invalidate the patent to clear the path for continued manufacture and commercialization of CASGEVY(juve-patent.com).
The Dutch Angle: Why It Matters
The Netherlands is a hub of life sciences manufacturing in Europe—Lonza’s Geleen facility is a pivotal site for CASGEVY production under a long-term supply agreement with Vertex signed in September 2024 (lonza.com). A successful nullity suit in the Netherlands could thus critically undermine efforts to block or restrict manufacturing of CASGEVY, even as the UK litigation unfolds with requests for injunctions and licensing talks (juve-patent.com, iptradenews.com).
By engaging both jurisdictions, ToolGen is applying pressure on both the commercial and legal fronts—seeking a global licensing solution rather than just financial damages.
Strategic and Legal Significance
- Territorial interplay: Parallel litigation across the UK and the Netherlands indicates the complexity of cross-border patent enforcement in the EU, where court decisions in one jurisdiction can significantly impact operational realities in another.
- Manufacturing leverage: Targeting Lonza via Dutch courts—closest to CASGEVY’s production facility—could yield immediate and practical leverage, beyond theoretical IP claims.
- Industry implications: This case underscores the challenges of patent thickets in CRISPR therapeutics and the importance of careful freedom‑to‑operate analysis. It may set precedents for future disputes in high-stakes, gene‑editing therapies (juve-patent.com, kilburnstrode.com, wsgr.com).
Looking Ahead
Both lawsuits are in their early stages. In the UK, ToolGen’s action (registered as UK High Court case HP‑2025‑000013) is proceeding through the courts (juve-patent.com). In the Netherlands, Vertex’s nullity suit is ongoing—but details remain sparse at this point (juve-patent.com).
Observers across the biotech and IP landscapes will be watching closely. A ruling in either venue could drive strategic licensing negotiations—or, if unfavorable to ToolGen, limit its ability to enforce its patents even in core production jurisdictions.
Key Timeline at a Glance
| Date | Event |
|---|---|
| November 2023 | CASGEVY receives UK authorization (MHRA) |
| February 2024 | CASGEVY obtains approval from the European Commission |
| Sept 2024 | Vertex & Lonza enter commercial manufacturing agreement for CASGEVY (Geleen facility) |
| April 2025 | ToolGen files infringement suit in UK against Vertex, Lonza, RoslinCT |
| Early 2025 | Vertex counters with nullity suit against EP 457 in the Netherlands |
Conclusion: Biopharma Disputes on the Rise Globally
The dual tracks of litigation—ToolGen’s infringement suit in the UK and Vertex’s nullity action in the Netherlands—exemplify the increasingly strategic use of overlapping jurisdictions in biopharma IP disputes. As CASGEVY represents the first marketed CRISPR-based therapy, this legal battle could shape the blueprint for patent licensing and commercial partnerships in the gene-editing age.
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