Danish court upholds Bristol-Myers Squibb's apixaban patent in validity proceedings

The case concerned the validity of Bristol-Myers Squibb's patent no. EP 1 427 415 (the Patent) and supplementary protection certificate no. CR 2011 00028 covering the chemical compound apixaban. Apixaban is the active ingredient in the medicinal product Eliquis® which is one of the most widely used anticoagulants globally. 

The judgment from the Danish first instance patent court (the Maritime and Commercial High Court) provides a detailed analysis and assessment on the merits of the Patent's validity in view of the mentioned EPO Enlarged Board of Appeal decisions and subsequent practice following technical evidence from the parties and the court-appointed experts' appraisals. Specifically, Teva had alleged that the Patent lacked inventive step, sufficiency of disclosure and novelty (due to invalid priority).

Inventive step

First turning to the issue of inventive step, the court started out by noting that the assessment of inventive step should be made according to the EPO "Problem and Solution Approach".

The court found that the objective technical problem was to find an alternative factor Xa inhibitor. The court found that the application as filed described this effect by stating that “… a number of compounds of the present invention were found to exhibit Ki's of ≤ 10 μM, thereby confirming the utility of the compounds of the present invention as effective Xa inhibitors.” Since the court considered apixaban to be a selection invention, as apixaban was found to be comprised by a Markush formula in the prior art, it was further necessary that apixaban had a particular technical effect compared to the prior art.

The next question was whether the skilled person could deduce the (particular) technical effect, i.e. an improved factor Xa inhibition, as covered by the technical teachings of the patent, see G2/21. The data showing that apixaban had improved factor Xa inhibition were not in the application as filed but were subsequently filed. The court referred to T 116/18 and noted that "the purported technical effect together with the claimed subject-matter need only be conceptually comprised by the broadest technical teaching of the application as filed. This in turn means that said effect need not be literally disclosed", but it is sufficient that the skilled person "recognises that said effect is necessarily relevant to the claimed subject-matter". 

In relation to whether an improved effect was also part of the technical teaching of the application, the court noted with reference to T 1989/19 that: "once the above-mentioned criterion of derivability of a technical effect is met, the same applies to the improvement of that effect", and that "if a particular technical effect, … is deducible to the skilled person … their improvement is also to be regarded as implicitly derivable”. The court therefore found that a particular technical effect in the form of an improved effect as factor Xa inhibitor was encompassed by the technical teaching of the application as filed. BMS was therefore entitled to rely on the subsequently filed data showing the improvement, see G 2/21.

The court also found that this technical effect was embodied in the same invention, since the skilled person had no reason to doubt that the effect could be achieved by the solution specified in the patent claims. The court noted that there had been no change in the nature of the invention by the narrowing of a claim concerning 74 specific compounds to apixaban only. In particular, the court noted that it was not a requirement that apixaban had to be specifically mentioned as a preferred compound in the application. It is sufficient that the invention is comprised by the general teaching, and the invention can be specified further by the subsequently filed data. Therefore, both requirements of G 2/21 were met. Teva had therefore not proved that the Patent lacked inventive step.

Sufficiency of disclosure 

Turning to the question of sufficient disclosure, the court referred to paragraph 77 of the G 2/21-decision. 

Referring to its analysis under the assessment of inventive step, the court found that Teva had likewise not proved that it would not be credible to the skilled person that the therapeutic effect was achieved.

Whilst the application lacked specific experimental data for apixaban, in essence, the court found that the disclosure was sufficient and emphasised two points: Firstly, it is not a requirement that the application specifies that the invention is apixaban. Secondly, there must be concrete reasons why the skilled person would not find it credible that the claimed effect could be achieved, and the absence of preclinical studies is not such a reason in itself. 

Therefore, the court also found the invention to be sufficiently disclosed. 

Priority 

Lastly turning to the question of priority, the court stated that whilst EPO practice is not binding on national courts, Danish courts generally follow EPO practice for harmonization reasons. 

Accordingly, the court applied the principles established in the G 1/22 and G 2/22-decision, which confirms, among other things, that patent rights can be transferred without any written agreement or other formalities and still confer priority for the assignee. The court found no reason to suggest that a valid transfer of the priority right had not taken place, and hence the Patent had valid priority. The court also rejected Teva's argument that it was contrary to the Danish constitution to follow EPO practice in the present case.

The judgment 

The Court concluded that none of Teva's invalidity objections had rebutted the presumption of validity for the Patent, which was collectively supported by decisions from courts in other European countries. 

Consequently, the court found in favour of Bristol-Myers Squibb in full, and the injunction claims were granted.

Plesner represented Bristol-Myers Squibb in the proceedings. 

Read the Danish Maritime and Commercial High Court's decision (in Danish)