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

counsel accompanies the expert and is bound by a strict confidentiality order. The process concludes with the expert providing a written report, after which the court will decide whether to release an unredacted version, having considered the parties’ arguments. This final stage is generally completed within six months of the initial application. Per Section 493 Code of Civil Procedure, the expert report may be utilised in subsequent infringement or unrelated proceedings (Section 411a Code of Civil Procedure). 1.9 Declaratory Relief Under German law, declaratory actions require the plaintiff to demonstrate a specific legal interest in the declaration being sought for the action to be admis ‑ sible. Requests for declarations of non-infringement thus typically depend on a particular behaviour exhib ‑ ited by the defendant, such as claiming entitlement to certain rights in a warning letter. A negative declara ‑ tory action does not bar a main infringement action, nor does it determine the forum for such action. “Arrow declarations”, ie, requests for a declaration stating that a specific embodiment is either not novel or obvious in light of certain prior art (and thus cannot fall under the scope of protection of a patent granted later), have so far not been granted by a German court. In contrast, infringement actions typically contain merely a declaratory request that the defendant is obliged to reimburse the plaintiff for any damage suf ‑ fered from the infringement. As a result, German pat ‑ ent litigation typically consists of two phases: the first focuses on the infringement itself, while in the second phase, the amount of damages may be subject to a The claims of a patent – in light of the description and drawings – define the patent’s literal scope of protec ‑ tion, but due account shall be taken of any element equivalent to an element specified in the claim (Pro ‑ tocol on the Interpretation of Article 69 EPC). Based on the skilled person’s understanding of the claims, the court assesses whether modified means used in separate action (see 5.4 Damages ). 1.10 Doctrine of Equivalents

the contested embodiment are equally effective for solving the problem underlying the invention. This assessment is a three-staged test (FCJ, X ZR 168/00 – Schneidmesser I; X ZR 29/15 – Pemetrexed ), as out ‑ lined below. • Stage I: Does the contested embodiment solve the problem of the invention with features (the “Vari ‑ ant”) that are different from the claimed features, but which produce an identical effect in the context of the other features of the claim? • Stage II: If so, would the common general knowl ‑ edge of the priority date have enabled the skilled person to identify the Variant as having the same effect? • Stage III: If so, there will have been considerations that were necessary for the skilled person to iden ‑ tify the Variant as having the same effect: Are these considerations guided by the teaching of the pat ‑ ent claim, ie, would the skilled person have looked upon the contested embodiment with its Variant as being equivalent to the claimed embodiment in view of the teaching of the patent as covered by the patent claim? Despite the Variant, the skilled person must consider the contested embodiment to be based on the patent claim and, in a broader sense, still represents an embodiment of the pat ‑ ent. In striking a fair balance between the patentee’s inter ‑ est in covering equivalent solutions and legal certainty, the third question is particularly important. Case law assesses each feature in the context of the description as a whole. A limitation of the claims to a particular example from the description may result in pledging alternatively disclosed embodiments to the public (FCJ, X ZR 16/09 – Okklusionsvorrichtung ). Courts may turn to the patentee’s submissions in the grant proceeding to assess whether an amendment was indeed meant to limit the subject matter of the patent, ie, to distinguish the claimed invention from the prior art, or merely to overcome formal objections (FCJ, X ZR 29/15 – Pemetrexed ). A court must not find equivalent infringement if the claimed solution was not novel or inventive over the relevant prior art (so-called Formstein defence, FCJ, X ZR 28/85). The rationale for this defence is that the

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