Amgen Inc. v. Sanofi-Aventis Deutschland GmbH

UPC-001724

This is a decision of the Court of Appeal of the Unified Patent Court issued on 25 November 2025 concerning appeals in a revocation action and a counterclaim for revocation. The judgment sets out headnotes addressing four key areas of patent law: claim interpretation, added matter, sufficiency, and inventive step. The decision establishes legal principles regarding the interpretation of dependent claims, the inherent therapeutic effectiveness requirement in medical use-format claims, the assessment of added matter as a question of law, the sufficiency test for functionally defined claims, and the framework for assessing inventive step.

Jurisdiction
European UPC
Court
Munich (DE) Local Division
Case Number
UPC-001724
Decision Date
25 November 2025

Detailed Summary

The judgment is issued by the Court of Appeal of the Unified Patent Court on 25 November 2025, concerning appeals in a revocation action and a counterclaim for revocation. The case references are UPC_CoA_528/2024 and UPC_CoA_529/2024. The specific parties and patent at issue are not identified in the provided text excerpt.

The judgment addresses four principal areas of patent law through its headnotes. First, regarding claim interpretation, the Court addresses whether conclusions can be drawn from dependent claims when interpreting the main claim, holding that this depends on the circumstances of the individual case. If a dependent claim merely adds an additional feature without providing a more specific description of the main claim features, this generally argues against drawing interpretive conclusions. Second, the Court addresses medical use-format claims, holding that it is an inherent claim feature that the claimed product must be objectively suitable for the claimed use and be therapeutically effective, requiring that the treatment causes a noticeable improvement of the patient's medical condition. Third, regarding added matter, the Court establishes that this assessment is a question of law to be decided on the basis of facts brought forward by the parties, with the relevant facts being the claims and the application as filed. Fourth, regarding sufficiency, the Court sets out the test for whether the skilled person can reproduce the claimed subject matter without inventive effort or undue burden.

& Analysis: On claim interpretation, the Court reasoned that the skilled person does not derive any minimum required effect from the claim or description, but the feature of therapeutic effect follows from the use of the medical use claim format itself. On added matter, the Court held that since the test is whether the relevant claims have basis in the application as a whole, the Court is allowed to look at the entire document. On sufficiency, the Court established that sufficiency must be examined on the basis of the patent as a whole (claims, description, and drawings) from the perspective of the skilled person with common general knowledge at the filing or priority date. The Court further reasoned that where a claim contains functional features, specific instructions for every conceivable embodiment are not required, and that a fair protection requires that variants of specifically disclosed embodiments equally suitable to achieve the same effect should also be protected. The Court also held that a reasonable amount of trial and error does not prevent enablement, and that the burden of presentation and proof lies with the party invoking invalidity. On inventive step, the Court began to outline the approach, establishing that the object of the invention (objective problem) must be assessed from the perspective of the skilled person with common general knowledge at the application or priority date, by establishing what the invention adds to the state of the art.

Final Order & Ruling: The provided text excerpt contains only the headnotes of the decision and is truncated mid-sentence in the inventive step section. The specific final order, ruling, and outcome of the appeals are not contained in the provided text.

Practitioner Note

This case demonstrates the evidentiary and procedural standards applied in patent matters before Munich (DE) Local Division. Understanding the court's reasoning in Amgen Inc. vs Sanofi-Aventis Deutschland GmbH is valuable context for structuring arguments or assessing risk in similar proceedings.

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Disclaimer: This page contains an automated summary based on publicly available judicial records. The content is generated for informational purposes only and does not constitute legal advice. Always verify details against the original source judgment before relying on this information for any legal purpose. If you believe any information is inaccurate, please contact us.

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