GERMANY TRENDS AND DEVELOPMENTS Contributed by: Dr. Peter Klusmann, Gregor König, Dr. Dirk Schüßler-Langeheine and Dr. Lasse Christian Weinmann, Hoffmann Eitle
In Germany, there is no pre-warning of an infring - ing product launch, such as certain post-grant regulatory or other pre-launch steps which would have to be undertaken by a generic com - petitor prior to launch. As a clearing instance for pharmaceutical databases, IFA, therefore, plays a key role in the effective pre-emptive preven - tion of market disturbance by the offering and launching of an infringing generic product. For patentees, it has thus been of particular interest to what specific remedies they are enti - tled against IFA in relation to (infringing) products which have not been published yet in the Lauer- Taxe, but for which IFA has obtained a request for inclusion in their databases. On the one hand, a (pre-emptive) provisional injunction against IFA can effectively prevent offer (and launch) of the infringing product from the outset. On the other hand, an obligation of IFA to inform the patentee about a request for having an infringing product listed in their databases would yield information useful for seeking a provisional injunction direct - ly against the pharmaceutical company offering the infringing product. Against this background, a provisional injunc - tion of the Regional Court (RC) Munich I issued in March 2024 for Bayer against IFA in relation to the (prevention of the) listing of generic rivar - oxaban products attracted a lot of interest. The RC held IFA responsible for checking whether infringement was obvious, stating that patent infringement should have been obvious for IFA even in relation to the case at hand where the infringement allegation was based on infringe - ment by equivalent means. Most remarkably, the RC also ordered IFA to inform Bayer about any request for the listing of an infringing generic product.
However, as the Higher Regional Court (HRC) Munich was about to reverse the RC’s decision on IFA’s appeal, Bayer withdrew the request for a provisional injunction so that the RC’s decision lost its effect. In the introduction of the oral hear - ing in the appeal proceedings on 5 December 2024, the HRC took the preliminary view that patent infringement was not obvious and that the HRC would not concur with the RC’s position on the extent of IFA’s responsibility to examine and assess the patent situation. As Bayer withdrew the request for a provisional injunction after hearing the HRC’s preliminary view, there is no written decision based on the court’s reasoning. It remains to be seen what position other German courts will take on the extent of IFA’s responsibilities, given that there is no recourse to the FCJ in provisional injunc - tion proceedings and there may be deviating approaches taken by different Higher Regional Courts. Liability under German Patent Law for Damages Incurred after Patent Expiry or Abroad In two recent decisions, the FCJ developed the concept that a patentee is generally entitled to claim any damages resulting from patent infringement, even if the relevant damage occurs only after patent expiry or outside the territory of patent protection. While the underlying cases do not concern life science patents, the rationale behind the FCJ decisions can be highly relevant for calculating damages in cross-border life sci - ence patent disputes. The general idea underlying the FCJ’s decisions is this: An act of infringement deprives the pat - entee of business opportunities associated with the patent. As a result, the patentee should be entitled to claim all profits resulting from the
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