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

Protective briefs A protective brief is a common instrument to ensure that one is heard before the court considers an ex parte injunction. A protective brief is an anticipatory defence brief filed when one is concerned about an ex parte injunction, eg, before launching a product or attending a trade fair or conference in Germany. The brief is filed with an online repository accessible only to the German courts. Should a provisional injunction request be filed, the court would search the repository for a protective brief and decide how to proceed. A provisional injunction is still possible, namely when the protective brief fails to convince. If the court decides not to issue the pro ‑ visional injunction, it may contact the petitioner and recommend that they withdraw their request. If this is not done or the petitioner refuses, the court will proceed to inter partes proceedings. The protective briefs are valid for six months but can be renewed. Objection by the respondent against an injunction order If a respondent is faced with an ex parte injunction, they can – at any time – file an objection with the court, which will cause the court to schedule a hearing, as set out below. Oral hearing in provisional injunction proceedings If the provisional injunction is not requested ex parte or if the court does not grant it, the court will serve the provisional injunction request on the respondent and schedule an oral hearing, typically held about two to three months later. The same applies if the respondent objects to a pro ‑ visional injunction order. Parties may submit arguments until the oral hear ‑ ing concludes, with no preclusion rules applied. The opposing party must respond immediately to any new submissions. The court will only exclude an assertion if it determines that a party deliberately withheld it to ambush the opposing party. Given this procedural flexibility, parties must prepare comprehensively for

all possible scenarios and ensure that potential wit ‑ nesses and party experts attend the hearing. Upon the hearing, the court issues a judgment. This judgment can be appealed. It is also merely provi ‑ sional – the defendant can, at any time, request that the provisional injunction be lifted due to changed circumstances. Relation to main proceedings Provisional injunction proceedings are independent of the main action in Germany. Respondents can request the court to set a deadline for commencing a main action, which is rarely used. 1.4 Structure of Main Proceedings on Infringement/Validity Patent infringement proceedings in Germany are bifur ‑ cated. The infringement courts are not permitted to hold that a patent is invalid. Parallel invalidity proceedings must therefore be pending to argue a patent’s invalidity in an infringe ‑ ment action. Either the defendant or a third party may initiate such proceedings, which can be an opposition before the EPO or GPTO, or a nullity action before the Federal Patent Court ( Bundespatentgericht ). Opposi ‑ tion must be filed within nine months of the grant. Once this nine-month opposition period expires and no opposition is pending, a nullity action becomes admissible. In the infringement proceedings, upon the main oral hearing, if: • the requirement of parallel invalidity proceedings is met; and • the infringement court should conclude that the patent is infringed, then the court may, in its discretion, order a stay of the infringement proceedings pending a decision in the parallel invalidity proceedings. In exercising this dis ‑ cretion, the court must balance the interest in non- contradictory decisions with the plaintiff’s interest in a timely decision on infringement. Defendants should, therefore, not wait too long before commencing a nul ‑ lity action.

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