Life Sciences and Pharma IP 2026

GERMANY Law and Practice Contributed by: Clemens Tobias Steins, Michael Pfeifer, Daniel Grohs and Bianca-Lucia Vos, HOFFMANN EITLE

patent’s validity, urgency, and the parties’ respective interests. Infringement In practice, there are no particular differences between a provisional injunction and the main pro ‑ ceedings with respect to infringement. The court must be convinced that the patent has been infringed or that the infringement is imminent. The experienced patent panels, especially in Düsseldorf and Munich, are accustomed to handling even technically complex cases if adequately supported 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. Gener ‑ ally, most courts require that the validity be con ‑ firmed beyond just the initial grant of the patent. This confirmation may stem from the fact that the patent has withstood inter partes proceedings, such as an opposition, or has faced challenges from third-party observations during prosecution. However, there have always been exceptions to this rule, especially in the context of early generic market entry. A panel of the Regional Court ( Landgericht ) Munich sought to chal ‑ lenge the prevailing practice by referring questions for a preliminary ruling to the Court of Justice of the European Union (CJEU). The CJEU ruled that a prac ‑ tice of rejecting provisional injunction requests when the patent’s validity has not been confirmed in inter partes proceedings is contrary to EU law (judgment of April 28, 2022, C-44/21). The CJEU has held, inter alia, that European patents enjoy a presumption of validity upon grant. This judgment did little to resolve the differences. The Munich Regional Court sees it as confirmation of its more liberal approach. Other judg ‑ es criticise that their practice was misrepresented to the CJEU, resulting in a decision that did not address the 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 experi ‑ ments, which must also be conducted expeditiously. A favourable decision in inter partes validity proceed ‑ ings, eg, by the Opposition Division, can start a new urgency clock. Procedure Requesting a provisional injunction to be granted ex parte The petitioner may request that the provisional injunc ‑ tion be granted ex parte, ie, without hearing the respondent, but must justify exceptional time pres ‑ sure. The court must consider this request in light of the respondent’s constitutional right to procedural equali ‑ ty of arms. In principle, the respondent must be heard, but there are exceptions. Exceptions include cases of exceptional 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 writing 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 applicant providing security to respondent for their claim in the event that the provisional injunction is later lifted, compensating respondent for any harm incurred as a result of the enforcement of the provi ‑ sional injunction. Such security is usually provided in the form of a bank guarantee from a German bank. If the provisional injunction is not executed in the man ‑ ner described above within one month of its issuance, the respondent may request that it be lifted on this ground alone. It will typically not be possible to apply for a new provisional injunction because of the lack of urgency.

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