UPC: Genentech and Roche gather evidence from Organon in allegation of infringement of breast cancer drug patent

On 6 May 2025, Genentech and Roche petitioned the Brussels Local Division for ex-parte orders for inspection and the preservation of evidence against two pharmaceutical manufacturing facilities in the Netherlands and Belgium, owned by Organon. 

The patent at issue (EP 2238172) protects the anti-HER2 antibody pertuzumab (brand name Perjeta) which is owned by Genentech and is marketed in the EU for breast cancer treatment. Perjeta’s global market value is CHF3.6 billion (approx. $4.4 billion) as of 2024. Organon licenced the rights to manufacture and distribute a biosimilar of pertuzumab from Chinese company Henlius. Organon contacted Genentech and Roche in April 2025 and communicated their intention to launch the biosimilar product in Europe after receiving EMA marketing authorisation. 

Genentech and Roche’s request specifically focused on gathering evidence of disulfide reduced acidic variants of the antibody in the biosimilar composition to establish if Organon’s product infringed claim 1 of the patent. The Brussels LD authorised the collection of evidence at both Organon facilities, requiring the provision of a security by Genentech and Roche. The Court laid on heavy financial penalties in the order of €200k should either Organon entity delay the inspection or attempt to contact the other entity. The order authorized the collection of evidence relating to claim 1 as a whole and was not limited solely to establishing the presence of disulfide variants. The Court was confident to rely on the appointed experts to filter out evidence that did not fall within the scope of the order.

It can be speculated if the Brussels LD’s was happy to grant this order based on a conviction that the patent, having survived opposition in March 2025, is likely to be valid. Either way, it would seem that big-pharma has now adopted the evidence gathering tools provided by the UPC. These have hitherto only been used for inventions in other fields, for example for inspection of heavy machinery.  This attempt relates to a high value patent, and was rewarded by the UPC with a broad order and large penalties for non-compliance.