Unitary Patents – MedTech leads the way!

The Unitary Patent (UP) System in Europe, launched in June 2023, has just celebrated its second anniversary.

A UP is a single patent that covers 18 European Union (EU) Member States. Whilst the European Patent Office (EPO) has always granted European patents that were regularly mistaken for such unitary rights, it was not possible to enforce these earlier patents in single court actions across Europe. Instead, each granted European patent had to be “validated” in European states of commercial interest to the patent proprietor. Wide validation could get costly. It is consequently uncommon for earlier European Patents to have been validated widely throughout the EU, leading to a patchwork of validation in only a few (often fewer than four) EU countries. With the UP now being (alongside the earlier option of traditional validations) available, considerable cost savings for companies who want wide geographic coverage has become available.

“Classical” European patent system, in which a granted European patent can be validated in any of 39 EPC Member States, effectively turning the European patent into a bundle of individual national patents

UP System, in which a UP based on a granted European patent provides unitary effect in these 18 EU Member States: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia, Sweden. (Up to seven additional EU Member States have indicated that they want to join in the future). 

Alongside the UP, a new court structure, the Unified Patent Court (UPC), has been created. The UPC has sole jurisdiction over Ups, so that patent proprietors who chose UPs are forced to fight any court cases based  on the UP at this new court. 

Fear of the unknown had initially tempered the enthusiasm of prospective users of both UP and UPC. However, over the last two years, over 57,000 unitary patents have been registered at the EPO, over 880 court cases have been initiated before by the UPC, and over 1200 decisions and orders have been issued by the UPC. Considering that the UP System has only been operational for two years, it is clear that the UPC has gained trust and that both UP and UPC are a great success!

An interesting observation about the UP System is that unitary protection has been particular popular for patents in the field of medical technology (MedTech). According to the statistics made available by the EPO, among all technical fields, MedTech leads the UP filings with over 7200 UP requests so far. This might not be too surprising given that MedTech is one of the top technical fields of European patent applications (according to the annual EPO Patent Index reports). However, compared with other top technical fields (computer technology, digital communication, electrical machinery, transport, and pharmaceuticals), MedTech has one of the highest UP uptake rates of 29.1% over the last two years. 

As illustrated in the graph below (based on EPO data), since the launch of the UP System, the average uptake rate of all technical fields and the individual uptake rates of the top technical fields are all generally increasing. Further, among the top technical fields, MedTech constantly has a higher uptake rate than the average and it is only outperformed by pharmaceuticals (which also relate to innovation in the medical space!).

Note: The uptake rate is defined as percentage of UP requests received with respect to European patents granted in the same year. The data for 2025 is up to 10 June 2025.

Meanwhile, in the UPC, various MedTech patents have been or are being litigated. Some of the high-profile cases include Dexcom v. Abbott concerning continuous glucose monitoring device (EP3831282B, UPC_CFI_395/2023), Meril Life Sciences v. Edwards Lifesciences concerning prosthetic heart valve (EP3646825B, UPC_CFI_15/2023), Insulet v. Eoflow and Menarini concerning insulin patch pump (EP4201327B, UPC_CFI_400/2024, UPC_CoA_768/2024), etc. Despite having just open its door for two years, the UPC has become a significant venue for strategic MedTech litigation in Europe.

So why is MedTech leading the way in the UP? 

While there is no simple answer to this, as different companies may have different patent protection and enforcement strategies and priorities, and different patented products or services may warrant different treatments, we believe at least two factors are in play.

The first factor is that MedTech inventions tend to warrant broader territorial scope of protection and the UP can offer this in a simple and cost effective manner. 

As health challenges are universal, MedTech inventions, such as medical devices, diagnostics, digital health solutions, tend to find use in every country. Further, the end-user markets of the MedTech products and services, the associated supply chain, the R&D hub, the manufacturing and assembly hub, the entry points of infringing MedTech goods, the major MedTech trade show venues, the markets where competitors are active, etc., tend to be distributed in different territories across Europe. Also, medical devices that are available in the market in the EU would have already passed the rigorous and complicated regulatory approval process. In other words, the medical devices would be “ready” for multiple markets from a regulatory standpoint. All these may motivate or justify the need to seek broader territorial coverage for MedTech inventions.

The UP is an excellent tool for this as it can provide territorial coverage in 18 EU Member States easily and cost-effectively (see our earlier post on cost comparison between UP and “classic” European patent).

The second factor is that MedTech companies are generally developing more trust in the UP and the UPC. 

Before the introduction of the UP System, patent proprietors had to enforce their European patent rights in different territories in individual national courts. With the UP, however, patent proprietors can now enforce their patent rights in all of the 18 EU Member States centrally at the UPC. This means that a single lawsuit at the UPC could determine whether the UP is infringed, a win in all 18 States, or whether the UP is invalid, a loss of rights in all 18 states. Despite the risk of such a one blow kill, MedTech companies have enthusiastically embraced the UP, as indicated by the high and rising uptake rate. This would suggest that MedTech companies are increasingly confident that the UP and UPC will enable them to defend their market position.

While the future can be hard to predict, we believe that as the UP System continues to develop and mature, MedTech patent owners will become more familiar and comfortable with it, and will increasingly consider the UP and the UPC as an important strategic patent protection and enforcement tool.

For more information about the UP and the UPC, please get in touch or go to our dedicated UPC hub. 

References:

1. https://www.epo.org/en/about-us/statistics/statistics-centre#/unitary-patent
2. https://www.unified-patent-court.org/en
3. https://www.epo.org/en/applying/european/unitary/unitary-patent
4. https://www.unified-patent-court.org/en/news/case-load-court-start-operation-june-2023-update-31-may-2025
5. MedTech Europe, Facts & Figures 2024: https://www.medtecheurope.org/wp-content/uploads/2024/07/medtech-europes-facts-figures-2024.pdf
6. https://www.epo.org/sites/default/files/styles/ratio_16_9/public/2024-08/Current%20UP%20states%2018_0.jpg?h=0de24f6b&itok=aRtOiaE9
7. https://www.epo.org/sites/default/files/styles/original_dimensions/public/2025-03/EPO%20member%20states%20map%20EN_12.2024%20%281%29.jpg?itok=T51eFqT1
8. https://www.epo.org/sites/default/files/styles/ratio_16_9/public/2025-03/Patent%20index%202024%20landing%20page_graphs_cards_980x551px7.png