GERMANY Trends and Developments Contributed by: Peter Klusmann, Gregor König, Dirk Schüßler-Langeheine and Lasse Christian Weinmann, HOFFMANN EITLE
effects are oftentimes sufficient to establish inventive step, the FCJ disregards surprising technical effects if the path to the invention was obvious (eg, BGH X ZR 41/13 – “ Quetiapin ”; BGH X ZR 128/09 – “ Repa- glinid ”). Accordingly, the fact that the feature in question was associated with a particular technical effect did not help the patentee in the case at issue. Despite this effect, the FCJ found the feature to be noticeable and decided that claim 1 lacked inventive step. In view of this background, it will be interesting to see how the CoA of the UPC will further develop its case law on the assessment of arbitrary features. In the above-cited PCSK9 first-instance case (UPC 1/2023), the Central Division of the UPC had stated that a fea ‑ ture that is selected in an arbitrary way out of several possibilities cannot generally contribute to inventive step and considered that the feature at issue, which defined the binding properties of a monoclonal anti ‑ body against PCSK9, was obvious. Similarly, the UPC Local Division in the first-instance DexCom v Abbott case (UPC_CFI_233/2023) rea ‑ soned that a feature that is merely a design choice among a number of available alternatives and has no particular or surprising effect cannot contribute to inventive step. In the recent second-instance decision of the CoA in the PCSK9 case (UPC_CoA_528/2024 and UPC_CoA_529/2024), the court did not explic ‑ itly comment on the assessment of arbitrary features made by the first-instance division but merely held that the medical use of the specified monoclonal anti ‑ body was non-obvious. However, despite the current lack of case law by the CoA on this point, it seems fair to assume that the CoA may generally agree with both the EPO and the German FCJ in that arbitrary features cannot be used to establish inventive step. Legal innovation on pharma patents in Munich In the shadow of the UPC, the Regional Court Munich I is establishing itself as a new go-to German forum for enforcing pharma patents, luring patentees with inno ‑ vative approaches to overcome long-held enforce ‑ ment shortcomings. The Regional Court Munich I
does not only stretch even beyond German national borders, as shown in the 20 countries’ injunction Eylea case discussed above, but also in the context of sec ‑ ond medical use patents and the responsibility of the pharmaceutical database provider IFA GmbH. Enforcement of second medical use patents Once generic alternatives are on the market, social insurance law mandates the substitution of originator medicines with cheaper (generic) products, regardless of ongoing patent coverage, for certain indications. In the 2019 decision on the use of the antiestrogenic agent fulvestrant in a certain treatment plan, the High ‑ er Regional Court of Düsseldorf (2 U 27/18) recog ‑ nized that infringement of second medical use claims is not limited to clear-cut cases of manifest presen ‑ tation ( sinnfällige Herrichtung ) in which one of the regulatory approved indications mirrors the patented use. Pharmaceutical companies may also infringe a second medical use if they take advantage of a par ‑ ticular prescription practice that is in accordance with the claim. The threshold for a “sufficient, not merely occasional use in accordance with the patent in suit,” however, so far, had proved difficult to overcome. With its preliminary injunction against generic sales of the leukaemia drug nilotinib (Tasigna), the Regional Court Munich (21 O 14559/24) indicated that a lower threshold may apply in cases of imminent generic launch. The patent in suit concerned the administra ‑ tion of nilotinib orally dispersed in apple sauce, which was recommended in the originator drug’s SmPC for patients unable to swallow hard capsules. Although, according to passages carved out of the generic SmPC, the court identified a first risk of perpetration in view of the substitution of originator products by generics, ordering generics, among others, to enter into indication-specific rebate agreements and to issue specific warnings to prescribers, pharmacies, and wholesalers. The injunction request was withdrawn after the High ‑ er Regional Court expressed doubts about the lower court’s applied standard. Nevertheless, the case dem ‑ onstrates significant judicial creativity that may prove instructive for future cases.
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