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The Danish Maritime and Commercial High Court rules on complex matters of patent-law concerning the right to claim priority in accordance with G 1/22 and G 2/22 and the right to include post published data following G 2/21 in Danish preliminary injunction proceedings.
The case concerns the protection of Bristol-Myers Squibb's patent rights to the chemical compound apixaban. Apixaban is the active ingredient in the medicinal product Eliquis® which is one of the most widely used anticoagulants globally.
On 1 May 2025, Teva started exploitation of its own medicinal product also containing apixaban as its active ingredient. Consequently, Bristol-Myers Squibb filed for a preliminary injunction with the Danish Maritime and Commercial High Court.
During the proceedings, Teva argued that the patent was invalid on three grounds; (i) an invalid priority claim as the patent applicant was not the owner of the priority application when the application was filed; (ii) lack of inventive step; and (iii) insufficiency of disclosure.
In the issuance of its decision, the Court had to decide on complex patent-law issues such as the right to claim priority and when post-published data may be allowed. In doing so, the Court also interpreted the decisions issued by the European Board of Appeals in the cases G 1/22 and G 2/22, and G 2/21.
Novelty / priority
First turning to the issue of priority, the court concluded that the question had to be decided in accordance with the principles established by the European Board of Appeals in G 1/22 and G 2/22.
Accordingly, the court observed that there is a strong presumption of validity, and, as a rule, that transfers of priority may be valid albeit informal or tacit, unless specific circumstances give rise to serious doubts as to the right of priority.
After examining the evidence presented, the Court found that Teva had not demonstrated any special circumstances indicating unlawful transactions or the like within the BMS group.
Inventive step
Concerning the issue of inventive step, the Court found that, although some similarities existed between apixaban and select compounds in the prior art, that comparison also identified major differences requiring that the skilled person needed guidance as to how to arrive at apixaban.
Then turning to the inclusion of post-published data, the court applied the two-conditions test set forward in the G 2/21 ruling that it had been permissible to rely on post published data, i.e. concluding that apixaban was encompassed by the technical teaching of the patent application as filed and also embodied by the same originally disclosed invention, thereby not changing the nature of the claimed invention.
As to the first condition, the Court found that the patent application included the technical teaching that lactam-containing compounds of the invention including apixaban which were produced in the examples of the application and specified in claim 8 were potential factor Xa inhibitors, and that this teaching has not been amended by limiting the patent application to apixaban specifically.
Further, the patent application need not expressly identify apixaban as a preferred compound; the patent's general technical teaching sufficed, which teaching was later confirmed by the post-published data.
As Teva had not provided evidence demonstrating that the technical effect was or could not have been achieved, the second condition had also been satisfied. Therefore, the post-published data could be considered in the assessment of inventive step.
Insufficiency of disclosure
Lastly turning to the question of insufficient disclosure, the Court in short found that the skilled person would be able to carry out the invention based on the description as provided in the patent.
The Court's decision
On 24 September 2025, the Court issued its decision in which it on all claims ruled unanimously in favor of Bristol-Myers Squibb.
Notably, the Court's decision seems aligned with the case law evolved after the issuance of G 2/21, namely that post-published evidence is allowed when the claimed subject-matter and the technical effect "fit" the original technical teaching, i.e. when the original application already points the skilled person to the same problem/solution space and the subsequently filed data confirms it.
The Court granted the preliminary injunction without postage of security and Bristol-Myers Squibb was awarded legal costs in full.
Plesner represented Bristol-Myers Squibb before the Danish Maritime and Commercial High Court.
Read the Danish Maritime and Commercial High Court's decision (in Danish)
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