Genentech and Roche Secure UPC Evidence Orders Against Organon's Pertuzumab Biosimilar
核心洞察
Genentech and Roche obtained ex-parte orders from the Brussels Local Division to inspect Organon's manufacturing facilities in the Netherlands and Belgium for evidence of patent infringement related to their breast cancer (搜索) drug Perjeta.
The dispute centers on patent EP 2238172 protecting pertuzumab, a $4.4 billion anti-HER2 (搜索) antibody, with Organon planning to launch a biosimilar after receiving EMA marketing authorization.
The court authorized broad evidence collection with €200,000 penalties for non-compliance, marking a significant adoption of UPC evidence gathering tools by pharmaceutical companies.
Genentech and Roche have successfully petitioned the Brussels Local Division of the Unified Patent Court (UPC) for ex-parte orders to inspect pharmaceutical manufacturing facilities owned by Organon, marking a significant milestone in pharmaceutical patent enforcement under the new European patent system.
On May 6, 2025, the pharmaceutical giants secured court orders for inspection and preservation of evidence at two Organon facilities in the Netherlands and Belgium. The action targets potential infringement of patent EP 2238172, which protects the anti-HER2 (搜索) antibody pertuzumab, marketed under the brand name Perjeta for breast cancer (搜索) treatment.
High-Stakes Patent Dispute
The patent dispute involves substantial commercial interests, with Perjeta generating a global market value of CHF 3.6 billion (approximately $4.4 billion) as of 2024. Organon had licensed rights to manufacture and distribute a pertuzumab biosimilar from Chinese company Henlius and contacted Genentech and Roche in April 2025 to communicate their intention to launch the biosimilar product in Europe following EMA marketing authorization.
The evidence-gathering request specifically focused on identifying disulfide reduced acidic variants of the antibody in the biosimilar composition to establish whether Organon's product infringed claim 1 of the patent. However, the Brussels Local Division authorized broader evidence collection relating to claim 1 as a whole, not limited solely to establishing the presence of disulfide variants.
Court Imposes Strict Compliance Measures
The Brussels Local Division granted the orders with stringent enforcement mechanisms, requiring Genentech and Roche to provide security and imposing heavy financial penalties of €200,000 should either Organon entity delay the inspection or attempt to contact the other entity. The court expressed confidence in relying on appointed experts to filter out evidence that did not fall within the scope of the order.
The court's willingness to grant such a broad order may reflect confidence in the patent's validity, particularly given that it survived opposition proceedings in March 2025.
Landmark UPC Pharmaceutical Enforcement
This case represents a significant development in pharmaceutical patent enforcement, as it marks the first major adoption of UPC evidence gathering tools by big pharma companies. These inspection procedures had previously been utilized only for inventions in other fields, such as heavy machinery inspections.
The successful petition demonstrates the pharmaceutical industry's growing confidence in the UPC system for high-value patent disputes. The court's response, granting a broad order with substantial penalties for non-compliance, suggests the UPC is prepared to provide robust enforcement mechanisms for pharmaceutical patents worth billions in market value.