The Unified Patent Court (UPC) is an international court set up by participating European Union Member States to deal with the infringement and validity of both Unitary Patents1 and European patents. The Agreement on a Unified Patent Court (UPCA) entered into force on 1st June 2023 with the intention of obviating costly parallel patent litigation in the participating European Union Member States and thereby enhancing legal certainty for rights holders.
The aforementioned Agreement established a transitional period of seven years - which may be prolonged by up to a further seven years – in which the following options are available for litigation involving "classic" European patents, as granted by the European Patent Office:
- Actions for infringement or for revocation of the European patent may still be brought before national courts of the Member States (Article 83(1) of the UPC Agreement).
- According to Article 83(3) UPCA, applicants for and proprietors of a "classic" European patent, as well as holders of a supplementary protection certificate (SPC) issued for a product protected by a "classic" European patent, can "opt out" their application, patent or SPC from the exclusive competence of the UPC.
As a result of a validly submitted opt-out2, the UPC will have no jurisdiction concerning any litigation related to this application, patent or SPC. (It is important to note that the possibility of opting out or bringing an action before a national court during the transitional period is not available for Unitary Patents.) In effect, in this transitional period, for European patents that have not been opted out of the UPC, undertakings have had and retain a choice as to whether to bring either national or UPC proceedings.
The engagement of undertakings with the UPC in the first 18 months of its existence does suggest that the UPC is becoming established as an important forum for patent disputes in Europe. As of the 30th November 2024, 585 cases were pending before the First Instance of the UPC (Case load of the Court_end November_2122024.pdf) across an array of technological sectors. However, the engagement of life sciences corporations with the UPC has been mixed.
The number of pharmaceutical disputes before the UPC remains extremely low, with many pharmaceutical innovators having opted all of their European patents out of jurisdiction of the UPC3. In contrast, the engagement of medical technology undertakings with the UPC has been more significant, which may be a corollary to medical devices being underpinned by fewer patents than may be involved in traditional pharmaceutical disputes, thus making cases simpler to litigate within the procedural timelines of the UPC.
It is postulated that the reluctance of pharmaceutical companies to litigate disputes before the UPC may be due to one of more of: the risk of UPC-wide relief being granted against an undertaking; the uncertainty as to whether the targeted time line in which the UPC aims to hand down first instance decisions (12-14 months) will be met in practice given the practicalities of case management and the complexity of pharmaceutical cases; the challenges faced by defendants in filing comprehensive defences and counterclaims given the "front-loaded" UPC procedures; and, the expense of UPC proceedings given the complexity of pharmaceutical patent disputes and the challenges of coordinating UPC procedures with national proceedings beyond the European Union.
Pharmaceutical innovators may also be adopting a cautionary approach as case law is developed over time and it becomes clearer the degree to which inter alia assessments of validity and infringement are influenced by UPC judges' (previous) national approach.
Despite many experienced national judges moving to the UPC, there have certainly been inconsistencies in first instance decisions between different UPC divisions as regards the assessment of inventive step, the use of prosecution history in claim interpretation and in the assessment of patent infringement by equivalence. Given that the approach of national courts to these issues is often clearer, pharmaceutical businesses may favor the lower risk, higher predictability of outcome and slower timelines before national forums than before the UPC. When conflicting first instance decisions are eventually handled by the Court of Appeal of the UPC and the approach to legal issues becomes harmonized, pharmaceutical business may better be able to assess the risks and outcomes of engaging with the UPC.
For the time being, multiple national actions may still be preferable to the risk of central revocation for high value pharmaceutical patents. Given that UPC judges have also limited the number of arguments which may be laid before them – in view of the procedural timelines sought by the UPC - the opposition procedure before the European Patent Office will also remain key to pharmaceutical undertakings challenging the validity of European patents.
The recent Abbott Diabetes Care Inc.4case represents an example of the Court of Appeal departing from the position of the first instance and providing greater clarity on matters of added subject matter in patents and the scope of injunctions which may be awarded as a remedy to patent infringement. It is considered that further clarifying decisions of the Court of Appeal may be required to overcome the so-far muted engagement by pharmaceutical businesses with the UPC.
Footnotes
1. A European patent with unitary effect – or Unitary Patent – is a European patent, granted by the European Patent Office under the rules and procedures of the European Patent Convention (EPC), to which, at the patent proprietor's request, unitary effect is given for the territory of the EU Member States participating in the Unitary Patent system that have ratified the Agreement on a Unified Patent Court (UPCA). A Unitary Patent will therefore cover the territory of the following Member States: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia and Sweden.
2. The application to opt out can only be made via the Case Management System (CMS) of the UPC which implements all procedural requirements for an opt-out or a withdrawal of an unauthorized opt-out pursuant to Rule 5 and 5A of the Rules of Procedure of the UPC. The opt-out will take effect upon its entry in the EPO Register (Article 83(3) UPCA). It will be possible to withdraw any such an opt-out at any time, unless an action has already been brought before a national court (Article 83(4) of the UPC Agreement). The opt-out can only be made in respect of all states for which the European patent has been granted or which have been designated in the European patent application. Such an opt-out is only possible as long as no action has been brought before the UPC in respect of the application, patent or SPC.
3. Pharmaceutical disputes before the UPC include the following. Innovator versus Innovator Disputes: Sanofi v. Amgen (Evolocumab/PCSK9 antibody patent; revoked at Munich Local Division); Sanofi and Regeneron v. Amgen (Second medical, European Patent No. EP3536712B); GSK v Pfizer RSV (Dusseldorf Local Division). Biosimilar Disputes: Novartis v Celltrion; Alexion v Amgen and Samsung Bioepis. Originator versus Generic medicine disputes: Sanofi v Accord and others.
4. Abbott Diabetes Care Inc. v. Sibio Technology Limited and Umedwings Netherlands B.V.,Unified Patent Court of Appeal, 14th February 2025, Case no. UPC_CoA_382/2024: The Court of Appeal held that an injunction can be awarded on general terms, without the need for restriction to specific infringing products; according to the Court, the need for a limitation of an injunction to specific infringing products cannot be inferred from Article 62(1) UPCA. The judgment of the Court of Appeal also reversed the decision of the first instance holding that a term included - by amendment during prosecution - into the claims of the patent-in-suit represented an impermissible intermediate generalization.
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