GERMANY Law and Practice Contributed by: Clemens Tobias Steins, Michael Pfeifer, Daniel Grohs and Bianca-Lucia Vos, HOFFMANN EITLE
Acceptable Pre-Launch Preparations and 3.3 Acceptable Pre-Launch Preparations ). • Private prior use right (Section 12 GPA): While a prior use right in principle is limited to the actual use, courts have come to accept scaling up and amending the concerned embodiment unless the intrusion into the scope of protection is intensified (FCJ, X ZR 95/18). • Exhaustion: If the product in question has been put on the market within the EU or the EEA with the patentee’s consent, the patent protection in ques ‑ tion shall be deemed to have lapsed for the con ‑ cerned embodiment. As a transitional provision, EU law includes a specific mechanism for the parallel import of pharmaceuticals from later-acceding member states, taking into account the divergent levels of protection available at the time of applica ‑ tion. • Statute of limitations (ee 1.5 Timing for Main Pro- ceedings on Infringement/Validity ). • Section 139 (1)3 GPA, in theory, also allows the defendant to rely on third-party (patient) interests to argue that an injunction would have dispropor ‑ tionate effects, but plays little role in practice due to the very high bar. • If the DoE is applicable, the Formstein defence may be invoked (see 1.10 Doctrine of Equivalents ). • Due to Germany’s bifurcated system, a defend ‑ ant can only indirectly assert the invalidity of the patent concerned, namely by requesting a stay of the infringement proceedings in view of the suc ‑ cess chances of a pending validity attack before the EPO or the federal courts (see 1.16 Stays and Relevance of Parallel Proceedings ). 1.16 Stays and Relevance of Parallel Proceedings Stay Because of Parallel Invalidation Proceedings As explained under 1.4 Structure of Main Proceed- ings on Infringement/Validity , the infringement court can stay the action in view of parallel invalidation pro ‑ ceedings regarding the patent in suit. Stay Because of Parallel CJEU Proceedings Courts may also stay infringement proceedings when proceedings are pending at the CJEU (for example, when a preliminary ruling has been requested), should
the infringement court’s decision depend on the out ‑ come of those CJEU proceedings. Stay Because of Lis Pendens If proceedings involving the same cause of action between the same parties have been brought before another EU court, the German court must stay its proceedings under Article 29 Brussels I Regulation ((Regulation EC) No 44/2001 (recast)) until the court seized first has determined whether it has jurisdic ‑ tion. If the proceedings are merely related, the court that has been seized later has discretion to stay its proceedings (Article 30 Brussels Regulation I (recast)). No Discretionary Stay – Taking Foreign Judgements Into Consideration The court has no discretionary powers to stay the infringement proceedings, for example, to await a foreign decision in scenarios other than the one men ‑ tioned above. However, sometimes the court’s discre ‑ tionary scheduling powers can appear to be used to await a certain event. In principle, German courts must take into account a decision by a foreign court on another national part of the same European patent and, if the court reaches a different decision, explain why it diverges. Decisions from the USA or other overseas courts to the contrary are not considered persuasive, as their practices are seen as too different. 1.17 Patent Amendment A patent can only be amended in opposition or nullity proceedings, not through infringement proceedings. In infringement proceedings, however, a patent can be asserted in limited form by the plaintiff (eg, to reduce the risk of a stay). Plaintiffs may accomplish this ini ‑ tially through so-called “in particular” claims, in which they demonstrate that the contested embodiment also satisfies certain dependent claims or features from the description, while preserving their broadest cease- and-desist request without limitation. This allows the plaintiff to potentially limit the asserted claim later in the proceedings (ie, if the patent is upheld in such amended form).
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