UPC: Patient interest defence in good health

In a recent UPC decision, the interest of patients was discussed as a possible defence to infringement in the sphere of medical imaging equipment.

The decision on the merits¹ was issued in an infringement action, initiated by Claimant Hologic, and a counterclaim for revocation, lodged by Defendants Siemens Healthineers.

The Claimant primarily focuses on women’s health, and their patent² protects technology for controlling x-ray focal spot characteristics for tomosynthesis and mammography imaging. The Defendants’ product portfolio also included a mammography machine.

Infringement was found to have taken place, and the patent was upheld. Claim 1 of the patent recited a controller arranged to move a focal spot of an x-ray tube in synchronisation with the x-ray tube so that it appears to be fixed in space relative to a detector during exposure. The so-called Flying Focal Spot was said to reduce motion blur and achieve improved image precision.

A patentee’s right to an effective remedy for infringement, whether the product in question has entered the “channels of commerce” or not, is recognised in the 1994 TRIPS Agreement³. Also enshrined in that Agreement is the “need for proportionality between the seriousness of the infringement and the remedies ordered” and the need to take into account “the interests of third parties” when deciding on an appropriate infringement remedy. TRIPS is acknowledged by the subsequent European Enforcement Directive⁴, and its principles were respected in the Charter of Fundamental Rights of the European Union⁵. Both the Directive and the Charter were referenced by the Düsseldorf Local Division in the immediate decision as framing the implementation of Art. 63 UPCA, which codifies the grant of permanent injunctions in today’s UPC system.

It was stated in the decision that the application of Art. 63 as an enforcement mechanism meant that a permanent injunction was to be considered grantable as a rule where infringement was found, while the refusal to grant such an injunction was to be the exception. A special reason for curtailing an injunction may be observed when balancing the needs of third parties with the rights of patent holders. Namely, when considering the concept of proportionality, the UPC may take into account the interests of patients. The interests of patients, it was confirmed, may genuinely justify an exception to the right to injunctive relief and other corrective measures if it is established that the infringing embodiment either:

is the sole available treatment method; or
represents an improvement upon the available treatment methods.

There must also result a notable enhancement of the level of care achievable for the patient interest defence to succeed.

In the immediate situation, the facts weren’t regarded as justifying an exception to infringement because the Claimant named various other comparable 3D tomosynthesis systems on the market, such that there was apparently no single outlier in terms of features and capabilities. Unlike in Meril v Edwards⁶, where the continued supply of an device found to infringe the patent in question was permitted on the basis that, if sale of the device was prohibited, no devices of the type in question would be available to patients, this defence did not apply in the present case, despite the court’s appreciation of the advantages of the Defendants’ infringing technology.

It was concluded, nevertheless, that the public should be comprehensively informed about the infringement decision. It appears that there remains scope for further clarification on what is meant by a notable improvement in care when it comes to safeguarding patient interests. Hopefully, the now-confirmed longevity of the patient interest defence will help to maintain a healthy balance between rights and remedies in the region of medical device patents.

¹UPC_CFI_758/2024, UPC_CFI_259/2025; 10 June 2026

² EP 2352431 B1

³ Articles 44 and 46

⁴ Directive 2004/48/EC, paragraphs (4) and (5)

⁵ The Charter, 2012/C 326/02

⁶ UPC_CoA_464/2024; 25 November 2025

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