The short answer
The Unified Patent Court (UPC) Düsseldorf Local Division found that Siemens Healthineers infringed a Hologic patent and refused to block the injunction on patient-interest grounds. A permanent injunction is the default once infringement is found. A medical device escapes it only if it is the sole available treatment, or a notable improvement on the options on the market.
What the UPC decided in Hologic v Siemens Healthineers
Hologic sued for infringement and Siemens Healthineers counterclaimed for revocation before the UPC Düsseldorf Local Division (UPC_CFI_758/2024 and UPC_CFI_259/2025). The decision on the merits is dated 10 June 2026. Marks & Clerk reported on it on 6 November 2026.
The patent is EP 2352431 B1. It covers control of the x-ray focal spot in tomosynthesis and mammography. Claim 1 describes a controller that moves the focal spot in step with the x-ray tube, so the spot appears fixed relative to the detector during exposure. This is called the "Flying Focal Spot". It is said to reduce motion blur and improve image precision.
Result
Infringement found
The court held that the defendants infringed the patent.
Result
Patent upheld
The revocation counterclaim did not succeed.
Result
Defence refused
The patient interest defence did not apply, and the public was ordered to be informed of the decision.
What is the patient interest defence?
The question was whether the interests of patients can justify an exception to an injunction and other corrective measures for infringement of a medical device patent.
The court framed Article 63 of the Unified Patent Court Agreement (UPCA) using TRIPS Articles 44 and 46, the Enforcement Directive 2004/48/EC and the EU Charter of Fundamental Rights. Proportionality lets the court weigh third-party interests, including patients, against the rights of the patent owner.
A permanent injunction is generally granted once infringement is found. Refusing one is the exception.
When can a medical device avoid an injunction?
The article explains that an exception may apply if the infringing product is either:
- the sole available treatment method, or
- an improvement on the available treatment methods.
Either way, there must be a notable enhancement in the level of care achievable for the patient. A product that is merely useful or better is not enough.
| Question | Hologic v Siemens |
|---|---|
| Is the product the only option? | No. Hologic pointed to other comparable 3D tomosynthesis systems on the market. |
| Is it a notable improvement? | The court recognised advantages of the technology, but found no situation like the one in Meril v Edwards. |
| Outcome | Injunction route stays open; patient interest defence refused. |
How this differs from Meril v Edwards
In Meril v Edwards (UPC_CoA_464/2024, 25 November 2025) the Court of Appeal allowed continued supply of an infringing device because, without it, no devices of that type would be available to patients. The Düsseldorf court found no equivalent situation here. Other comparable systems were available, so the defendants' product was not an outlier in features or capabilities.
What patent owners and device makers should do
Owners
Expect injunctions
Medical device patent owners can expect an injunction to be the normal remedy at the UPC.
Implementers
Document alternatives
Record which comparable products are on the market and any claimed clinical benefit before relying on this defence.
Both
Watch the test
What counts as a "notable improvement" in patient care still needs clarification from later decisions.
Bangladesh firms
Check UPC exposure
If you export medical devices to UPC states, assess patents there before launch.
This post summarises a published commentary by Marks & Clerk (Thomas Prock and Faye Campbell). Read the full decision for the exact reasoning.
Frequently asked questions
What is the UPC patient interest defence?
It is an argument that an injunction should be refused because patients need access to the infringing medical product. The UPC accepts it exists, but its conditions are narrow.
Did the defence succeed in Hologic v Siemens Healthineers?
No. The court found infringement, upheld the patent and refused the defence because comparable 3D tomosynthesis systems were on the market.
When might the defence succeed?
When the infringing product is the sole available treatment method or an improvement on available methods, with a notable enhancement in the level of care for the patient.
Which court decided the case?
The Unified Patent Court, Düsseldorf Local Division, on 10 June 2026.
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