GERMANY Trends and Developments Contributed by: Peter Klusmann, Gregor König, Dirk Schüßler-Langeheine and Lasse Christian Weinmann, HOFFMANN EITLE
opinions and due diligence work. His areas of scientific expertise include therapeutic proteins such as antibodies and blood factors, CAR T-cells, diagnostic methods, sequencing technologies, vaccines, and small RNA-based drugs.
HOFFMANN EITLE Arabellastr. 30 81925 München Germany
Tel: +49 89 91 40 90 Fax: +49 89 91 83 56
Email: pm@hoffmanneitle.com Web: www.hoffmanneitle.com
The German FCJ and the UPC CoA on Inventive Step – Good Times for Patentees The evolving case law of the FCJ Unlike the European Patent Office (EPO), the German Federal Court of Justice (FCJ) does not apply the “problem-solution” approach for the assessment of inventive step. While the EPO formulates an “objec ‑ tive technical problem” by relying on technical effects which are associated with the feature(s) that distin ‑ guish the claimed invention from a “closest prior art”, the FCJ does not endorse this approach but insists that the technical problem must be formulated in a general and neutral manner (eg, FCJ X ZR 41/13 – “ Quetiapin ”). The FCJ acknowledges that when assessing the obvi ‑ ousness of a path to a claimed invention, it may be relevant whether the steps taken by the skilled person would have been associated with a reasonable expec ‑ tation of success. However, unlike the EPO, which assesses a reasonable expectation of success for the (entire) solution of the “objective technical problem”, the FCJ assesses a reasonable expectation of suc ‑ cess for each (individual) step on the skilled person’s path to the invention, which may lead to different outcomes. According to the FCJ’s criteria, the courts shall determine, with due regard to the technical field
in question, the extent of incentives for the skilled per ‑ son, the effort required for adopting and pursuing a particular approach, and the alternatives in question, if applicable, as well as their respective advantages and disadvantages (eg, FCJ X ZR 59/17 – “ Fulvestrant ”, FCJ X ZR 24/19- ”Phytase“ , FCJ X ZR 150/18 – ” Pem- etrexed II ”, and FCJ X ZR 65/18 – “ Tadalafil ”). As previously reported, the FCJ has issued three recent decisions – X ZR 77/23 (“ Testosterone Ester ”), X ZR 83/21 (“ Sorafenib Tosylate ”), and X ZR 92/23 ( “Mirabegron” in which the court denied a reasonable expectation of success and acknowledged inventive step. In these cases, the effort required to conduct further studies, the lack of routine tests, and the com ‑ plexity of the relationships between the drug at issue and the therapeutic effect in question played a role in the court’s decision to acknowledge inventive step. These decisions constitute a patentee-friendly trend that reflects the FCJ’s increasing appreciation of the value of late-stage research, such as clinical research. Interplay with the UPC The first UPC decisions on inventive step have been handed down, including the long-awaited Court of Appeal (CoA) decision in Sanofi/Regeneron v Amgen on Amgen’s EP 3 666 797, relating to monoclonal anti ‑
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