Life Sciences and Pharma IP Litigation 2025

GERMANY LAW AND PRACTICE Contributed by: Dr. Clemens Tobias Steins, Dr. Michael Pfeifer, Dr. Daniel Grohs and Dr. Bianca-Lucia Vos, Hoffmann Eitle

even technically complex cases if duly support - ed by the explanations in the petitioner’s written submissions. Validity The standard for determining patent validity has been a topic of significant debate in recent years. Generally, most courts require that valid - ity be confirmed beyond just the initial grant of the patent. This confirmation may come from the fact that the patent has withstood inter partes proceedings, such as an opposition, or has faced challenges from third-party observa - tions during the prosecution phase. However, there have always been exceptions to this rule, especially in the context of early generic market entry. A panel of the Regional Court (Landger - icht) Munich sought to challenge the prevailing practice by referring questions for a preliminary ruling to the Court of Justice of the European Union (CJEU). The CJEU ruled that the practice of rejecting provisional injunction requests when the patent’s validity has not been confirmed in inter partes proceedings is contrary to EU law (judgement of April 28, 2022, C-44/21), and argued, inter alia, that European patents enjoy a presumption of validity upon grant. This judge - ment did not do much to resolve the differences. The Munich Regional Court sees it as confirma - tion of its more liberal approach. Other judges criticise that their practice was misrepresented to the CJEU, resulting in a decision not address - ing actual practice. Urgency After becoming aware of the infringement and the infringer, the petitioner must promptly file their request for a provisional injunction without undue delay. A period of about four weeks is not considered an undue delay, but any significantly longer period requires a reasonable justification,

such as the need for experiments, which must also be conducted expeditiously. If, in the specific scenario, a confirmation of validity is required, a decision in inter partes pro - ceedings, eg, by the Opposition Division, may start a new urgency clock. Procedure Requesting a provisional injunction to be granted ex parte The petitioner may request that the provisional injunction be granted ex parte, ie, without hear - ing the respondent, but must justify that there is exceptional time pressure. The court must consider this request in light of the respondent’s constitutional right to proce - dural equality of arms. In principle, the respond - ent must be heard, but there are exceptions. Exceptions are, for example, cases of excep - tional urgency or if the petitioner has sent a warning letter. An ex parte injunction is often issued within one to two working days. The court may also hear the respondent in writ - ing before issuing a cease-and-desist order, which may take about two weeks. Enforcing an ex parte injunction The petitioner must execute the provisional injunction by serving it on the respondent. The court may make the execution conditional on the respondent being provided security for their claim to be compensated for the harm incurred due to the enforcement of the provisional injunc - tion, should the provisional injunction be lifted later. Such security is usually provided in the form of a bank guarantee from a German bank.

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