The European Unified Patent Court and Unitary Patent provide a new approach to patent protection and enforcement in participating countries. The system went live on 1 June 2023, after years of delay and uncertainty caused by legal challenges and Brexit. We take a look at progress so far.
For some time, many have predicted a slow start with high percentages of opt outs from the Unitary Patent, and reluctance to use the UPC until it became clear how cases would be handled. A cautious approach was expected in the life sciences sector, where a single patent family can be vital for the protection of a new compound or technology. In contrast, technologies like mobile telephony tend to rely on a network of patents giving cumulative protection.
One of these predictions seems to have been borne out. Opt-outs from the Unitary Patent have been high.
On the take up of UPC cases, however, and despite the predictions, court filings have been active from the outset. And life sciences patents are well represented on the roster of those in dispute. One of the earliest cases was filed by Sanofi against Amgen as part of a wider patent battle over cholesterol-lowering drugs. Each side filed proceedings in relation to Amgen’s patent EP 3 666 797, with infringement and revocation both to be decided. These issues look set to be heard separately, with revocation to be dealt with by the Munich Central Division and infringement before the Munich Local Division. This kind of “bifurcation” of validity and infringement proceedings is a feature of German patent litigation, that is much criticised in jurisdictions that deal with the issues together. The cases are each valued at EUR 100m.
This case, as others, suffered from teething problems with the UPC’s Case Management System. The parties reportedly resorted to paper filings when the IT failed to work as it should.
Hearings are now beginning to take place, with an application for provisional measures between 10x Genomics, Inc. and others vs. NanoString Technologies Inc. before the Munich Local Division on 10 October, for example.
Early filings indicate that “protective letters” are being heavily used.
Alongside issues with the technical functionality of the case management system, concerns are being raised about access to documents for non-parties, and so the transparency of the system as a whole. Decisions are to be made publicly available, but access to other case documentation requires a “reasoned request”. The court’s rulings so far have not been favourable to public access, with legitimate reasons for access seeming to be narrowly interpreted, although appeals are expected. No doubt, as case law develops, issues like this will become clearer.
Life sciences organisations, even if not tempted to get involved immediately, will benefit from keeping a close eye on the early development of the UPC and its decision making. The progress of the early cases will provide valuable insights into how the court operates and the advantages and disadvantages of using the system.
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