GERMANY Trends and Developments Contributed by: Peter Klusmann, Gregor König, Dirk Schüßler-Langeheine and Lasse Christian Weinmann, HOFFMANN EITLE
Preliminary injunction on IFA to disclose generic applications and pause listings In recent years, it has become common practice in Germany for patent holders to enforce their pat ‑ ents not only against the pharmaceutical companies responsible for manufacturing, offering, and launching an infringing generic product on the German market, but also against IFA GmbH. IFA GmbH is the issuing agency for the German national pharmaceutical identification number ( Pharmazentralnummer , PZN), the Pharmacy Product Number (PPN) and the Unique Device Identification (UDI), acting as a clearinghouse for the German phar ‑ maceutical market. Further, entries in the IFA database serve as the basis for pharmaceutical databanks such as the Lauer-Taxe, which mark the start of offering a pharmaceutical product in Germany, also for pat ‑ ent law purposes. Competition law prevents IFA from sharing information on upcoming listings, which will typically become public only shortly before the start of the offering. While this exposes IFA itself to claims for potential infringement of patent rights, originators are left with only a short window to prevent a generic launch at risk.
In the multifaceted dispute on rivaroxaban marketed by Bayer as Xarelto®, the Regional Court Munich (21 O 2080/24) proposed a solution to IFA’s dilemma. The Court issued a preliminary injunction against IFA that required it: • to disclose applications for generic listings of generic rivaroxaban capsules, which it considered to obviously infringe Bayer’s dosage patent EP 1 845 961 for rapid release tablets under the doctrine of equivalence; and • not to list such generic products for at least thirty days following such information. The Regional Court identified a risk of first perperation based on IFA’s refusal to confirm it would not list hard capsule generic products before EP’961 expired. As it ordered IFA to disseminate otherwise confidential information, this provided Bayer with sufficient time to obtain a preliminary injunction against the generics themselves. Bayer later withdrew its request for an injunction against IFA and prevented a decision by the Higher Regional Court (6 U 1431/24). It thus remains to be seen whether the Regional Court’s creative handling of a complex legal situation will be repeated in sub ‑ sequent cases.
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