UPC Court of Appeal - Two landmark decisions: What 5 things do you need to know?

4-minute read | Impact: High | Action required: Review litigation strategy

Towards the end of 2025, the Court of Appeal of the Unified Patent Court (UPC) delivered two decisions^[1],[2] that will fundamentally shape patent litigation strategy across Europe. 

The rulings, one from each panel of the Court of Appeal, establish binding precedent on critical issues ranging from patent validity standards to the limits of injunctive relief. For general counsel managing IP portfolios and considering freedom to operate, understanding these developments is essential.

The New Framework for Inventive Step: Raising the Bar for Validity Challenges

In both decisions, the Court of Appeal set out a detailed framework for assessing inventive step that will govern validity challenges across all technology sectors. 

The Court of Appeal explicitly acknowledged that there are various ways to assess inventive step (e.g. one of those approaches being the so-called ’problem-solution-approach’ used by the European Patent Office and some national jurisdictions but not necessarily being the only possible approach).  The Court of Appeal stated that these different approaches to inventive step should generally lead to the same conclusion when properly applied. 

The Court clarified that the analysis must be conducted strictly from the perspective of the skilled person at the priority date, focusing on whether they would - not merely could - have arrived at the claimed solution with a reasonable expectation of success.

Crucially, in the comprehensive Amgen v. Sanofi biotechnology case, the Court placed the burden of proof for demonstrating reasonable expectation of success squarely on the party asserting invalidity. This represents a significant shift that in-house teams should factor into their litigation risk assessments. When evaluating whether to pursue or defend against revocation actions, counsel must now consider whether challengers can meet this heightened evidentiary burden.

The Court emphasized that uncertainty in the prior art—such as conflicting theories about biological mechanisms or conditional suggestions requiring further research—can negate reasonable expectation of success. This principle extends well beyond pharmaceuticals. In any field where the state of the art contains competing approaches or unresolved technical questions, patent holders now look to have stronger grounds to defend validity.

Claim Interpretation: Therapeutic Effectiveness and Sufficiency of Disclosure

In Amgen v. Sanofi, the Court of Appeal also addressed how to interpret medical use claims, holding that such claims inherently require therapeutic effectiveness—meaning the treatment must cause a "noticeable improvement" in the patient's medical condition and be "meaningful." While this arose in a pharmaceutical context, the underlying principle may have broader implications: for instance, will functional claim language be interpreted to require meaningful technical effect, not merely any detectable result? 

On sufficiency of disclosure, the Court confirmed that where claims contain functional features, disclosure of specific instructions for every conceivable embodiment is not required, as long as the skilled person can obtain suitable embodiments within the scope of the claim with reasonable trial and error. This approach should inform both patent drafting strategies and validity assessments.

Injunctions and Proportionality: The Patient Access Exception

In Meril v Edwards, the Court of Appeal extended a patient-access exception to injunctive relief for life-saving medical devices. While reaffirming that injunctions shall generally be granted where infringement is found, the Court held that proportionality under Article 3 of the Enforcement Directive may require exceptions where third-party interests - particularly patient health - are at stake.

The Court modified an injunction to exempt certain devices where a physician confirms that the device is the only available treatment option for a particular patient, providing a balance between patent rights and public health considerations.

This, however, does not imply a general departure of the UPC from granting comprehensive injunctions upon finding infringement in fields where patient health is not at issue. However, where patient health is at stake, patent holders should anticipate proportionality arguments and be prepared to address whether alternative treatments exist, especially for technology that may be considered lifesaving. Conversely, alleged infringers in the medical device and pharmaceutical sectors now have a recognized - though narrow - pathway to limit injunctive relief based on patient access concerns.

Added Matter: The "Clearly and Unambiguously Derivable" Standard

Both decisions addressed added matter challenges, with the Court confirming that literal support in the original application is not required—it is sufficient if the skilled person would derive it “directly and unambiguously using their common general knowledge and seen objectively and relative to the date of filing”. However, the Court will scrutinize whether combinations of features represent arbitrary selections from lists or have proper basis in the original disclosure. 

For in-house counsel reviewing patent prosecution files, this standard requires careful attention to how amendments during prosecution relate back to the original filing. The question is whether the skilled person would “clearly and unambiguously derive” the amended subject matter from the original disclosure.

Procedural Developments: Competence, Party Identity and Amendments

In Meril v Edwards, the Court of Appeal resolved a critical jurisdictional question regarding when parties are "the same" under Article 33(4) UPCA, which governs competence for direct revocation actions. The Court held that "same parties" requires legal entities to be identical or to have such a degree of identity that a judgment against one would have res judicata effect against the other.

This has immediate practical implications for corporate groups. Different legal entities within the same corporate family are unlikely to be "the same parties" for jurisdictional purposes, even if they are closely related commercially. This may create strategic opportunities—or vulnerabilities—depending on how your corporate structure is organized and which entities hold patent rights or face infringement allegations.

On patent amendments, the Court confirmed that it has discretion to allow subsequent amendment requests if they could not reasonably have been introduced earlier and do not unreasonably hinder the opposing party. This flexibility is important for respondents facing validity challenges, but the timing and strategic justification for amendments will be scrutinized by the Court.

Strategic Implications for In-House Counsel

These decisions reveal several key themes that should inform IP strategy:

First, validity challenges at the UPC face a higher bar than for example before the EPO. The Court's emphasis on reasonable expectation of success, assessed from the skilled person's perspective with the burden on the challenger, means that patents with credible technical merit are more likely to survive revocation attempts. This may influence forum selection decisions and settlement calculations.

Second, the UPC is developing a sophisticated, technology-neutral approach to patent law. The Court explicitly acknowledged that different national approaches to inventive step should generally lead to the same conclusion when properly applied, and it is working to harmonize these approaches within a coherent UPC framework to build a unified European patent jurisprudence.

Third, injunctions in the life-sciences field may not be granted if patient health is at stake. The patient-access exception to injunctions demonstrates that the UPC will not apply rigid rules but will exercise discretion to achieve proportionate outcomes where needed, while keeping the general approach of issuing injunctions in case of infringement in all other instances. This flexibility creates opportunities for creative advocacy while keeping uncertainty at a minimum.

Fourth, procedural issues matter enormously. Questions of competence, party identity, and the admissibility of amendments can determine whether and where cases proceed. In-house counsel should work closely with litigation teams to map out procedural strategy early, considering corporate structure, entity selection, and timing of amendments.

Looking Ahead

Both decisions were issued by the Court of Appeal with explicit precedential intent, including comprehensive numbered headnotes designed to provide guidance across the UPC system. These are foundational decisions that will shape UPC practice for years to come. Indeed, the Court of Appeal referred to these decisions in its final substantive decision of the year^[3].

For general counsel, the message is clear: the UPC Court of Appeal is rapidly establishing itself as a sophisticated, authoritative voice in European patent law. Its decisions demand careful attention, not just for their immediate holdings but for the broader principles they establish. As the UPC system matures, staying ahead of these developments will be essential for effective IP portfolio management and litigation strategy across Europe and globally.

Need Strategic Guidance?

For guidance on navigating the UPC and its implications for your patent litigation strategy, contact your usual contact in Bird & Bird's Intellectual Property litigation team or email upc@twobirds.com.

This analysis has been prepared by legal professionals with extensive experience in patent litigation and UPC proceedings, advising multinational corporations, start-ups, research institutions, and innovative businesses on all aspects of patent protection and enforcement.

1. UPC CoA 528/2024 & UPC CoA 529/2024, 25 November 2025 - Amgen v Sanofi
2. UPC CoA 464/2024 and others, 25 November 2025 - Meril v Edwards (Edwards was represented by Bird & Bird LLP)
3. UPC_CoA_71/2025, 29 December 2025 - VMR v NJOY