GERMANY Trends and Developments Contributed by: Peter Klusmann, Gregor König, Dirk Schüßler-Langeheine and Lasse Christian Weinmann, HOFFMANN EITLE
was sufficiently relevant in vivo (ie, at physiological level) for an antibody approach to result in a thera ‑ peutically effective treatment. That being the case, the question of which percentage of decrease in LDL-C levels would be sufficient for a therapy to be consid ‑ ered effective need not be answered. It is interesting to note that the claim extends to the prevention of the disease. It remains to be seen whether this is intended as a new UPC approach with a higher threshold for obvi ‑ ousness. In this regard, it is interesting to note that, unlike the EPO, the UPC currently requires only a “realistic start ‑ ing point” in the prior art but does not adhere to the concept of selecting a “closest prior art” document for the assessment of inventive step, suggesting that the UPC does not apply the EPO’s problem-solution approach strictly (UPC 1/2023, headnote 3). This approach taken by the UPC resembles that of the Ger ‑ man FCJ. The similarity between these courts’ views on inventive step may help promote further interplay between the UPC and the FCJ on inventive step in the future. Further national development and 20 countries’ injunction based on the DoE at the Munich I Regional Court This development on inventive step/reasonable expectation is accompanied by two pharmaceutical use patents upheld by the Federal Patent Court this year (3 Ni 15/23 and 3 Ni 21/23). The first case is the parallel case of a PCSK9 antibody used in cardio ‑ vascular disease, patented by Regeneron for lowering of the lipoprotein Lpa. The Regeneron patent (EP 2 756 004) was attacked by Amgen during Regeneron’s enforcement and upheld by the Federal Patent Court. The other Federal Patent Court decision concerns EP 2 364 691, a patent for an intravitreal Aflibercept for ‑ mulation (Eylea) that formed the basis of the cross- border DoE-based injunctions discussed below and handed down by the Munich I regional court as a land ‑ slide injunction in 20 countries in October 2025. In this case, Munich Regional Court I found equivalent infringement and granted injunctive relief in Germany
and in 19 further European countries,. Strategically, the judgment signals that Munich is willing to: • accept broad cross–border jurisdiction and apply comparative equivalence analysis; • give strong weight to BPatG decisions for multi– state validity; and • enforce complex biologic patents robustly, includ ‑ ing against biosimilars planning pan–European launches. It, however, emphasized that, legally, it was a simple case of equivalent infringement, thereby justifying the cross-border assumptions it made. Specifically, the Munich Regional Court in this case decided the cross–border patent dispute in favor of Regeneron’s licensee, Bayer. EP 2 364 691 claims a stable intravitreal Aflibercept formulation. Biosimilar developers (Formycon, Klinge Biopharma, Teva, Rati ‑ opharm) had brought a declaratory non-infringement action in Germany and a number of other European countries. Regeneron and its licensee, Bayer, coun ‑ terclaimed for patent infringement and sought cross– border relief covering 19 additional states. The court dismissed the negative declaratory action and grant ‑ ed the injunction. Regarding international and local jurisdiction, it relied on the Brussels Ia Regulation to anchor jurisdiction at the seat of the German defend ‑ ants and on the Lugano Convention for the Swiss defendant. It found it legitimate that defendants with a German seat can be sued before any German patent court, notably the Munich court. A key foundation for proceeding on the merits was the first–instance validity judgment of the Federal Pat ‑ ent Court, which upheld the patent as requested. The Munich court afforded this BPatG decision a “ Leucht- turmcharakter ” a strong indication that the patent is likely valid not only in Germany but in parallel national parts in other EPC states. On that basis, it considered the legal status of the patent sufficiently stable across the 19 countries, even where the claims had not yet been formally amended at the national level, because the upheld, limited claims were seen as a “minus” within the granted claims.
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