Three years after opening its doors, the Unified Patent Court (UPC) has established itself as the main battleground for medtech patents in Europe. Faster than national courts and able to cover most of the European market with a single judgment, the UPC is a powerful tool, and one that needs to be used with care. For companies in the sector, especially small and medium-sized enterprises that rely on one or two key patents and for whom costs are a major factor in any decision, the choice of enforcement route, UPC or national courts, needs very careful thought.
To take stock, I compared my own experience litigating before the UPC with the perspective of Erik Krahbichler, founder of the Swedish firm Kipa and a former examiner at the European Patent Office (EPO), the body that assesses and grants European patents. KIPA with partner Pär Hjalmarsson and Erik Krahbichler, is currently involved in numerous UPC proceedings concerning medical technologies and is known for leading the European litigation over the Okklusionsvorrichtung, an occlusion device at the centre of a German judgment that has become a landmark ruling on patent protection under the doctrine of equivalents, a case I was honoured to contribute to, handling the Italian side of the dispute.
The UPC in numbers
Since 1 June 2023, the UPC has been operational in 18 member states, with effects reaching as far as the 40 countries party to the European Patent Convention. More than 1,100 proceedings have already been filed, mostly infringement actions, alongside revocation actions and applications for interim measures.
Timescales are markedly faster than national standards: applications for interim relief are decided in under four months on average, and decisions on the merits in fifteen to sixteen months. The outcomes point to a broadly balanced system: patent holders win roughly half of infringement actions, while in revocation proceedings the patent survives, in whole or in part, in around two-thirds of cases. These figures paint a picture of a system that is both accessible and competitive.
Medical devices are among the most heavily represented categories across UPC litigation as a whole. The Milan section of the Central Division, which has jurisdiction over life sciences matters, is seeing a steadily growing caseload.
From patent drafting to litigation
Kipa’s medtech client base is a mixed bag: multinationals with broad patent portfolios sit alongside SMEs for whom a single patent is vital. Krahbichler’s experience at the EPO points to one golden rule: patents must be drafted to a technically impeccable standard and structured to withstand judicial scrutiny even years down the line. When it comes to the path to follow once a dispute actually arises, though, we both agree there is no automatic answer. National systems offer well-established tools for establishing infringement, such as the “descrizione” in Italy or the “saisie-contrefaçon” in France, but the UPC now offers broadly equivalent powers of inspection and orders for the production of evidence, with the added advantage of acting on a European scale in a single set of proceedings.
The key differentiator lies mainly in the much faster timing of proceedings compared to national courts, in the cost structure, cheaper than UK litigation, broadly comparable to German proceedings, but covering multiple countries in a single action if designated, and in lawyers’ ability to gauge the individual tendencies of the judges involved.
Preparing before you step in
The UPC’s speed is both a strength and a risk. For claimants, short timescales mean fast results; for defendants who are not ready, the same clock becomes a trap. I fully share Krahbichler’s view here: given a front-loaded procedural model, where documents and arguments must be filed with the initial pleadings and there is little room to manoeuvre afterwards, businesses need a change of mindset.
Thorough research is essential before bringing or defending a claim, as it allows claimant to anticipate patent weaknesses and the defendant’s strategy. This creates a distinct advantage for patentees, who control when to initiate action, whereas defendants must react within the UPC’s tight, rigid deadlines.
On top of this comes the “all or nothing” effect of centralisation. A single action can secure an injunction covering most of the European market, but equally, a revocation judgment wipes out the patent across every UPC contracting state. This is a risk that affects small businesses in particular, for whom an upfront assessment of portfolio, strategy and costs is not an option but a necessity.
Towards a hybrid system
On the reform front, the UPC’s Advisory Committee is working on clearer rules on costs, which are currently variable and not always easily predictable, and on encouraging infringement and revocation actions to be heard together. For medtech, where certainty over timing matters almost as much as the outcome itself, these changes could make a real difference.
On procedure, Krahbichler is a strong advocate of the flexibility offered by the opt-out, the option to exclude a patent from the UPC’s jurisdiction and keep it under national courts: for as long as the costs and risks of the UPC remain high, this option remains a genuine safeguard, particularly for SMEs. Furthermore, the opt-out can be withdrawn at any time, provided the patent has not already been subject to an action before a national court. The likely scenario is a hybrid system, with the UPC dominating pan-European disputes while national patents and domestic litigation continue to coexist, not least because major medtech markets such as the UK, Switzerland, Spain, Poland and Turkey remain outside the system, for now. Three years in, the UPC has shown that continent-wide patent protection is now a well-established operational reality: those who know how to use it have, at their disposal, a more effective tool than any national system. The real challenge for medtech companies is arriving prepared, because in a fast, centralised system, the advantage held by those who are ready is every bit as sharp as the price paid by those who improvise.
