Landmark decision from the Supreme Court in preliminary injunction proceedings on patents

On 8 January 2026, the Danish Supreme Court rendered a landmark decision when upholding the Eastern High Court's decisions to grant preliminary injunctions against Teva Denmark A/S, Sandoz A/S and Glenmark Pharmaceuticals Nordic AB in a patent dispute brought by Bayer A/S and Bayer Intellectual Property GmbH. The proceedings are part of a pan-European complex regarding generic medicinal products containing the active substance rivaroxaban, used for the treatment of thromboembolic disorders by once daily administration of the drug.

In assessing validity, the Supreme Court first noted that Bayer's patent was granted by the European Patent Office (EPO) and maintained by the Technical Board of Appeal (TBA). Against that background, the Supreme Court affirmed that under section 413 of the Danish Administration of Justice Act, there is a strong presumption that a patent is valid. Accordingly, Bayer had - by mere reference to the granted patent - as a clear starting point made probable that the patent was valid. 

To substantiate their invalidity defence, the generics had submitted multiple alleged prior art documents, which were not part of the TBA's evidentiary basis. The Supreme Court observed that the new evidence did not show the existence of any serious or manifest deficiencies with the TBA's legal or factual assessments. Additionally, the new allegedly prior art documents did not establish that the TBA's decision was clearly incorrect. Accordingly, the presumption of validity was not weakened to such an extent that Bayer had failed to sufficiently establish that the patent was valid.

Hereby, the Supreme Court established a standard for testing validity of granted patents in Danish preliminary injunction proceedings for the first time. 

The generic companies' argument that the test adopted by the UPC Court of Appeal in NanoString Technologies v. 10x Genomics (CoA_335/2023), i.e. that it is "more likely than not" that the patent is valid, should also apply in Danish proceedings, was therefore rejected.

In the assessment of infringement, the Supreme Court noted inter alia that a holistic approach must be taken when interpreting the patent claims, ensuring that the claims are interpreted in a technically meaningful way and in the light of the patent description and the technical background of the patent. On this background, the Supreme Court agreed with the interpretation adopted by the TBA that the patent feature relating to half-life was "redundant" and did not constitute an independent technical limitation of the claim. 

The generic companies had argued that it would be contrary to the Danish doctrine of patent claims, in which it is the wording of the patent claim that is essential when interpreting the claim, and that it would therefore not be possible for features in a patent claim to be redundant when assessing infringement. This was firmly rejected by the Supreme Court.

On this basis, the Supreme Court found that Bayer had rendered it probable that the generics' products infringed Bayer's patent.   

The Supreme Court's decision can be found here (in Danish).

Plesner represented Bayer in the proceedings.

Main action proceedings before the Maritime and Commercial High Court are still ongoing against Teva, Sandoz, Glenmark, Stada and Viatris (represented by Kromann Reumert, BuggeValentin, HortenDahl, Loeven and Gorrissen Federspiel).