Preliminary injunction and order upheld

Case nos. BS-30976/2025-HJR, BS-31092/2025-HJR and BS-31684/2025-HJR

Order made on 8 January 2026

Bayer A/S and
Bayer Intellectual Property GmbH 
vs.
Teva Denmark A/S, 
Sandoz A/S and
Glenmark Pharmaceuticals Nordic AB
 

The pharmaceutical company Bayer is the holder of patent DK/EP 1 845 961 concerning a dose regime for the treatment of thromboembolic disorders with the active ingredient rivaroxaban and markets the pharmaceutical product Xarelto, the trade name for the active ingredient rivaroxaban, in Denmark. Bayer’s Danish patent has been validated by the Danish Patent and Trademark Office and registered in the Danish patent register.

Patent DK/EP 1 845 961 is the Danish version of European patent EP 1 845 961. The European patent was granted in April 2015 by the European Patent Office (EPO) following a decision by the EPO’s Examining Division. The European patent was later brought before the EPO’s Opposition Division and then before the EPO’s Technical Board of Appeal, which decided to uphold the patent in October 2021.

On 1 April 2024, Bayer’s ingredient patent on the active ingredient rivaroxaban expired, and other pharmaceutical companies began marketing products containing rivaroxaban.

In February to April 2024, Bayer filed motions to the Danish Maritime and Commercial Court for preliminary injunctions and orders against, among others, Teva Denmark A/S, Sandoz A/S and Glenmark Pharmaceuticals Nordic AB (“the generic companies”) with regard to the marketing etc. of a number of generic products containing rivaroxaban.

In its decision of 9 October 2024, the Danish Maritime and Commercial Court dismissed Bayer’s motions for preliminary injunctions and orders. The decisions were brought before the High Court which in March 2025, against security, issued preliminary injunctions and orders against the generic companies with regard to the marketing etc. of their generic products containing rivaroxaban.

The question before the Supreme Court was whether the High Court had been right to issue preliminary injunctions and orders.

The Supreme Court stated, among other things, that the standard of proof required of a plaintiff under Section 413(1) of the Danish Administration of Justice Act in order to establish that they have the right sought to be protected is less stringent than that required for a decision on the merits of the case in invalidity proceedings. In cases concerning a patent granted by the Danish patent authority or the EPO, there is a general presumption that the patent is valid. In a case concerning a preliminary injunction or order under Chapter 40 of the Administration of Justice Act, there is a clear general rule that the patent holder must substantiate its right solely by reference to the granted patent. A patent injunction case must therefore be decided on the basis of the decision of the patent authority, unless the opposing party is able to demonstrate particularly serious and manifest defects in the patent authority’s case handling or application of the law, or that the patent authority’s decision appears to be manifestly incorrect, e.g. as a result of significant new information.

The Supreme Court found that Bayer had not demonstrated particularly serious and manifest defects in the TBA’s case handling or application of the law, nor had Bayer demonstrated that the TBA’s decision appeared manifestly incorrect, not even with regard to the new information (prior art) that was first produced in the injunction proceedings. The information had thus not weakened the presumption of the patent’s validity to such an extent that Bayer had not substantiated the right for which protection was sought.

Regarding the specific infringement assessment, the Supreme Court stated that patent claims are the central element in a patent for determining the scope of protection of the patent. According to the EPO’s case law, the interpretation of patent claims must be based on a holistic approach to ensure that the claims are interpreted in a technically meaningful way and in light of the patent description and the technical background of the patent. The correct interpretation of claim features must therefore always be based on their technical literal meaning in the overall technical context of all features from the perspective of a person skilled in the art and not on a purely linguistic analysis of the wording of individual terms.

Based on an overall assessment of the circumstances of the case, the Supreme Court found that Bayer had substantiated that the generic companies’ marketing etc. of their generic products infringed Bayer’s exclusive rights under the patent.

The High Court had reached the same conclusion.