In the Pemetrexed II decision, the German Federal Supreme Court (BGH) ruled in the interesting legal area of Intervention of a third party and injunction and, incidentally, overturned the previous decision of the BPatG, which had declared the patent invalid.
The case Pemetrexed II concerned the European patent (EP 1 313 508) on the use of pemetrexed disodium in combination with vitamin B12 to inhibit the growth of tumours. Patent claim 1 is directed to purpose-bound substance protection for the combination of the two active substances mentioned.
The Federal Patent Court (Bundespatentgericht, BPatG) had initially declared this patent invalid in patent revocation proceedings; the defendant successfully appealed against this. The Federal Supreme Court (BGH) overturned the BPatG’s decision and, in its Pemetrexed II decision, secured the legal validity of the patent for injunction (X ZR 150/18).
Intervention of a third party and injunction patent
Since an application for a preliminary injunction for infringement of the patent in suit was also filed against the intervening party at the Munich District Court, the Federal Court of Justice’s Pemetrexed II judgment resulted in a decision in the interesting legal area of intervening party and injunction patent. A patent in respect of which an injunction is to be issued is called an injunction patent for short.
The Federal Supreme Court ruled that in patent nullity proceedings, intervening on the side of the plaintiff in the appeal instance is not inadmissible because the intervening party is attacking the patent with another revocation action on which the patent court has not yet ruled. This is an important decision of the Federal Court of Justice, because it contradicts another view, which is even represented in the literature (Hall/Nobbe in Benkard, PatG, 11th ed., § 81).
The Federal Court of Justice deliberately contradicted this view and emphasised that a legal interest could not be denied because the intervening party – as in this case – had filed its own nullity action against the patent in suit. This applies at least, the BGH explained, if – as here – the patent court has not yet ruled on the action of the intervening party and the proceedings to which the intervening party declares its intervention are already pending in the appeal instance.
In such a constellation, the intervening party’s own invalidity action does not represent a more efficient legal protection option compared to intervening in the appeal proceedings, the BGH explained.
A brief digression: Intervention
If two parties are involved in Germany in a civil case, third parties still have the possibility to participate in the case. In this case, the third party – the so-called intervening party – joins the case, either on the side of the plaintiff or on the side of the defendant.
Such an intervention has advantages and disadvantages for a third party. The advantage is that the intervening party can participate in the proceedings between the main parties and also comprehensively assert means of attack and defence. However, an intervention can be disadvantageous if the outcome of the proceedings is not satisfactory. This is because, as an intervener, he can no longer object that the legal dispute was inadequately conducted by the respective main party.
The BGH emphasised that in the course of the appeal proceedings an earlier decision on the validity of the patent could be expected. An Intervention of a third party can lead to a faster decision also on the basis of a comprehensive investigation of the facts, the court added.
Reasonable expectation of success
Whether there is a reasonable expectation of success in pursuing a solution is to be determined in each individual case:
- taking into account the field of expertise at issue,
- the size of the incentive for the expert,
- the effort required to pursue a particular approach and the alternatives, if any, to be considered
- and the alternatives, if any, to be considered, as well as their respective advantages and disadvantages.
Incidentally, this is also in line with the BGH case law according to X ZR 59/17- Fulvestrant. In this case, the Federal Supreme Court had ruled on the suggestion of a solution for an expert. According to this decision, the suggestion depended on the associated expectation of success. The requirements for a reasonable expectation of success cannot be formulated in a generally applicable manner, but must be determined in each individual case – precisely under the aspects also mentioned here regarding a reasonable expectation of success.
Formulation for an active pharmaceutical ingredient for human use
In the development of a formulation for an active pharmaceutical ingredient for human use, however, the BGH had added in the Fulvestrant case that it was not generally decisive whether the person skilled in the art could expect to find a result suitable for a clinical trial.
An appropriate expectation of success in this case could already result from the possibility of verifying the efficacy and tolerability of a formulation in an animal experiment with sufficient predictive value for therapeutic use in humans.
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