Hologic v Siemens Healthineers (CFI, 10 June 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 10 June 2026 (UPC_CFI_758/2024 and UPC_CFI_259/2025), the Düsseldorf Local Division rules on the infringement action brought by Hologic, Inc. against four Siemens Healthineers companies under EP 2 352 431 (breast tomosynthesis system controlling the X-ray focal spot), directed at the MAMMOMAT B.brilliant mammography system in Germany, France and the Netherlands, and on the counterclaim for revocation.

The division dismisses the counterclaim for revocation, finds infringement of claim 1 and grants an injunction for Germany, France and the Netherlands, recall and destruction of the devices and publication of the decision. It clarifies the scope of recall where a reversible software deactivation is offered, and the proprietor’s interest in publication (paragraphs 318 to 328 and 340).

Facts and procedure

The patent, filed on 23 November 2009 claiming priority of 24 November 2008, survived an opposition rejected by the EPO, a rejection upheld by the Board of Appeal on 14 February 2024. The defendants deny infringement, rely on proportionality in view of patients’ access to breast imaging, a prior use right in Germany and a positive right of use, and counterclaim for revocation. The oral hearing took place on 14 April 2026.

The applicable law

Jurisdiction is deemed accepted absent a preliminary objection (Rule 19.7 RoP, paragraph 68), and turning two main requests into a main and an auxiliary request is allowed under Rule 263.2 RoP (paragraph 70). Construction follows Art. 69 EPC, inventive step is assessed under the Court of Appeal’s approach (Meril v Edwards, Amgen v Sanofi, paragraphs 215 to 225). The injunction rests on Art. 63(1) UPCA, which implements Art. 11 of Directive 2004/48, and may be refused only for special reasons (paragraphs 297 and 303 to 306).

Question

Should claim 1 receive the narrow construction argued by the defendants, is the patent valid, and can infringement by a mammography system be met with an injunction and recall despite patients’ interests and the possibility of a software modification?

Decision

Claim 1 is construed functionally: the detector surface may serve as the lower compression paddle, the controller may be software and outside the tube, and the effective focal spot need only « appear » fixed (paragraphs 82 to 127). The disclosure is sufficient, the amendments do not add matter, priority is valid and claims 1 and 7 are novel (paragraphs 133 to 214) and inventive starting from CC 4, CC 6 and CC 7, since no prior art teaches moving the static focal spot within the tube against the tube’s motion (paragraphs 226 to 250).

Infringement of claim 1 is established on the basis of the defendants’ own marketing material, which also amounts to offering under Art. 25(a) UPCA, imperfect compensation is irrelevant (paragraphs 252 to 273). Prior use is not shown, absent a firm decision to exploit before the priority date, and the positive right of use is rejected (paragraphs 275 to 294). There is no special reason to refuse an injunction: the proprietor need not work the patent itself, and other tomosynthesis systems are available, so patients’ interests do not justify an exception within the meaning of Meril v Edwards (paragraphs 297 to 309).

The order grants the injunction with penalty payments of up to EUR 10,000 per infringement, declares infringement, orders within two months information since 15 August 2018, recall and destruction of the products, with penalty payments of up to EUR 10,000 per day of delay, declares the four defendants jointly and severally liable for damages, and authorises publication on the claimant’s website for three months and in five industry journals. It refuses removal from the channels of commerce for lack of specific measures, destruction of tools and advertising material, and an interim award of damages (paragraphs 329 to 337). Costs of the infringement action are borne 80% by the defendants and 20% by the claimant, the defendants bearing the costs of the counterclaim. Interim cost awards of EUR 320,000 and EUR 80,000 are granted, the ceiling on recoverable costs is set at EUR 800,000 and no security is ordered (paragraphs 343 to 351).

Key points for practice

• Hospitals, doctors and universities using the devices form part of the channels of commerce covered by recall (paragraphs 318 and 319).
• A software deactivation avoids recall only if a return to the infringing state is objectively excluded, including through a manufacturer update (paragraph 327).
• Patients’ interests defeat an injunction only where the infringing product is the sole available treatment or notably improves care (paragraphs 306 to 309).
• Practical point: advertising that highlights the patented technology both proves infringement and grounds publication of the decision, limited here to five industry journals (paragraphs 266 to 270, 340 and 341).

Provisions applied

Agreement on a Unified Patent Court

Arts 24, 25, 28, 32, 33, 63, 64, 67, 68, 69, 80 and 82

Rules of Procedure

Rules 19.7, 118.8, 119, 150.2, 191, 263 and 354.4

European Patent Convention

Art. 69, Art. 56, Art. 83, Art. 123(2), Art. 138

Directive 2004/48/EC

Arts 3 and 11

Case law cited

NanoString v 10x Genomics, Court of Appeal, 11 March 2024, VusionGroup v Hanshow, Court of Appeal, 13 May 2024, Abbott v Sibio, Court of Appeal, 14 February 2025, Seoul Viosys v expert e-Commerce, Court of Appeal, 5 November 2025, Rematec v Europe Forestry, Court of Appeal, 17 February 2026, SodaStream v Aarke, Düsseldorf Local Division, 31 October 2024, Belkin v Philips, Court of Appeal, 3 October 2025, Meril v Edwards, Court of Appeal, 25 November 2025, Amgen v Sanofi, Court of Appeal, 25 November 2025, Ortovox v Mammut, Düsseldorf Local Division, 14 January 2025, M-A-S v Altech, Düsseldorf Local Division, 10 December 2025, Canon v Katun, Düsseldorf Local Division, 11 February 2026, Cup&Cino v Alpina, Düsseldorf Local Division, 18 March 2026

Related decisions

• Hologic v Siemens Healthineers, 9 March 2026, earlier decision in the same proceedings.

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.