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

With service, the court will set the defendant a one- month deadline to declare whether they intend to object to the request for invalidation, and a further month (extendable to two months if sufficient grounds are given) to substantiate the grounds for the objec ‑ tion. Within six months of service, the court shall issue a preliminary opinion. The parties can exchange further briefs, and the court can set further deadlines to guide this process. The main hearing is typically scheduled about 18 to 24 months after service, and a judgment is issued, usually about two months later. The nullity action is usually a reaction to being served an infringement action. Given the one-to-two-month preparation period required and the longer overall duration of nullity proceedings compared to infringe ‑ ment proceedings, infringement courts typically rule on both infringement and potential stays before nullity courts conduct their hearings. The above-mentioned (early) preliminary opinion has been introduced to assist the infringement court in deciding whether to stay. 1.6 Requirements to Bring Infringement Action While an infringement action can be filed before a patent grant, a cease-and-desist order (in main or provisional injunction proceedings) requires that the mention of the grant has been published. If a patent applicant wishes to stop infringements before the grant, an option may be to branch off a util ‑ ity model from the pending application. A cease-and- desist order can be based on such a utility model after a few days or weeks, as only registration is required. Utility models are available for product claims, includ ‑ ing medical use claims, and have a term of ten years (if branched off from a patent application, calculated from the filing date of the patent application they have branched off from). The plaintiff bears the burden of proof regarding the infringement, which can be challenging if the patent

regards a manufacturing process. The German Pat ‑ ent Act (GPA), however, reverses the burden of proof if the patented manufacturing process creates a new product. 1.7 Pre-Action Discovery/Disclosure Under German law, there is no pre-action discovery or disclosure. 1.8 Search and Seizure Orders Inspection orders are available under Section 140c GPA. While the requirements in the books have been mostly aligned with procedures known in other Euro ‑ pean jurisdictions following the implementation of the EU Enforcement Directive 2004/48, inspection pro ‑ ceedings in Germany still have their own procedural particularities. To obtain an inspection order, (i) the patentee or an authorised person is required to demonstrate that (ii) infringement is sufficiently likely, ie, that there are con ‑ crete indications for infringing acts by the defendant or another person, whereas (iii) the inspection into spe ‑ cific objects or documents assumed with the defend ‑ ant (iv) is necessary for the applicant for establishing its claims. The court will then assess the proportional ‑ ity of issuing such an order. In essence, an inspection order is most likely to be granted if the applicant has collected all pieces necessary to establish infringe ‑ ment, except for certain facts that are otherwise inac ‑ cessible to the applicant. Inspections can be sought in provisional proceedings (Section 140c(3) GPA) and granted ex parte, provided there is a sufficient reason (eg, concerns that the purpose of the inspection may be frustrated if the defendant had advance knowledge of the request) and, according to some courts, urgent action of the applicant. In order to ensure the confidentiality of the results while also fulfilling the proportionality requirement and permitting use of the obtained evidence in main proceedings, inspection requests are frequently com ‑ bined with an evidence preservation procedure, as detailed in Section 485 of the Code of Civil Proce ‑ dure. Under this process, known as the Düsseldorf procedure ( Düsseldorfer Verfahren ), a court-appointed expert conducts the inspection in accordance with tasks specified by the court. The applicant’s outside

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