Rachel Oxley, partner and patent attorney at IP firm Mewburn Ellis provides thoughts on what the Unitary Patent and the opening of the Unified Patent Court could mean for medtech companies.
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The idea of a single patent covering multiple European countries has been around for many decades and on 1 June 2023, the Unitary Patent (UP) finally came into being along with a new European Court, the Unified Patent Court (UPC) that has exclusive jurisdiction over the new UP.
Traditionally, European patent applications have been prosecuted centrally at the European Patent Office and, at grant, the patent owner has decided in which European countries to “validate” the patent. The result was a bundle of national European patents, each one attracting its own annual maintenance fee and each one having to be litigated separately at the various national Courts if there was believed to be infringement in multiple jurisdictions.
With the introduction of the UP and the UPC, medtech companies can still prosecute their European patent applications centrally at the EPO in the same way as before but at grant you can chose to obtain a single Unitary Patent covering (at present) 17 EU countries (including Germany, France, Italy, Netherlands, for example). The resulting UP is a single, indivisible patent having unitary effect across the seventeen participating countries. The UP attracts a single annual maintenance fee which covers the maintenance costs for all seventeen countries.
More EU countries are expected to join the UP later. Notable absences from the scope of the UP are Spain and Poland, and all non-EU countries (including the UK, Switzerland and Norway, for example) but these exceptions can still be covered through the traditional validation route from the European patent application.
Using the UP route is currently optional and so medtech companies need to consider the pros and cons before deciding whether to select a UP at grant or whether to continue using the traditional validation route to a bundle of national European patents.
One consideration is cost. For Medtech companies that typically validate their European patent in four or more EU countries that are now participating in the UP, cost savings can be had by opting for a UP. These cost-savings are made up of potential translation cost savings at grant and on-going cost savings because of payment of only a single annual maintenance fee for the UP (rather than separate maintenance fees in each country). However, it should be noted that the possible cost savings will be eroded if you typically validate in multiple countries but selectively prune your protection to only a few countries (especially if those countries include non-EU countries). Indeed, in those circumstances, the cost of a UP may be greater than the cost of the traditional validation route.
Another, consideration is that if you opt for a UP, the resulting patent falls exclusively under the jurisdiction of the new Unified Patent Court. This has the advantage that the UP can be centrally litigated i.e. where you believe that infringement is occurring in multiple UP-participating countries, you can initiate a single infringement proceedings at the UPC rather than having to litigate separately in multiple national courts. The resulting decision will be enforceable across the jurisdictional scope of the UP. This could offer significant advantages to medtech companies by making infringement proceedings easier, quicker, and cheaper.
However, the flip side is that revocation proceedings can also be brought centrally at the UPC i.e. a third party can challenge the validity of your UP at the UPC and, if they are successful, you will lose your patent protection across all UP-participating jurisdictions in one go. So, opting for a UP is effectively putting all your eggs in one basket. This may not be wise for Medtech innovations that are of significant commercial value to you. In short, the benefits of pan-European enforcement must be weighed against the risk of pan-European revocation.
Another thing to bear in mind is that the UPC is, as yet, un-tested. Although it is made up of experienced patent judges drawn from across the UP member states who are expected to issue high quality decisions, there will inevitably be some uncertainty surrounding the predictability of UPC decisions until a body of UPC case law has been built up.
In summary, we recommend that medtech companies opt for a UP only where:
a) where they want to protect their innovation in more than four jurisdictions that are participating in the UP and where they are likely to want to maintain that jurisdictional scope of protection for the life of the patent (or at least for a prolonged period of time); and
b) they are not aware of anything that causes them concerns about the validity of their patent that could render it vulnerable to central revocation.
Given that, in our experience, validity is most usually challenged based on earlier disclosures that the patentee was unaware of at grant, it may be safest not to opt for a UP and instead use the traditional validation route where the technology protected in the patent is particularly commercially important to you.
One final point to consider is that where you have a bundle of national European patents granted before the UP/UPC came into force, the national European patents in the UP-participating states will, by default, also fall under the jurisdiction of the new UPC. However, it is possible to take action to opt out these patents from the jurisdiction of the UPC by filing a fairly simple form. If you have any granted European patents that are of significant commercial importance or for which you have any validity concerns, you may like to consider opting them out of the jurisdiction of the UPC in order to avoid the risk of central revocation. Where a granted patent has survived EPO opposition proceedings, you may also like to consider opting it out of the UPC to avoid giving the opponent a further opportunity to centrally attack your patent. Note that you can opt the patent back in later if you decide that you want to bring central infringement proceedings.
In summary, the UP and UPC offer a new option for medtech companies to obtain and enforce their patents in most EU countries. This option presents possibilities for cost savings and wider jurisdictional coverage along with a route for easier and cheaper multi-jurisdiction patent enforcement. However, this needs to be weighed up against the risk of central revocation.
