UPC Court of Appeal — Amgen v. Sanofi & Regeneron (UPC_CoA_528/2024) — Sets Out the UPC’s Inventive-Step Framework: Realistic Starting Point, Objective Problem, “Would Not Could”

Background

Amgen, Sanofi, and Regeneron have litigated for years in multiple jurisdictions over Amgen’s PCSK9-inhibitor antibody patents, with the U.S. Supreme Court’s 2023 enablement ruling in Amgen v. Sanofi (598 U.S. 594) the most prominent prior chapter. This UPC Court of Appeal decision concerns a separate revocation action and counterclaim for revocation in the European patent landscape, decided on appeal from a Court of First Instance ruling. The appeal was decided alongside the Meril v. Edwards companion case and together the two decisions establish the UPC’s foundational inventive-step doctrine.

The Court’s Holding

The Court of Appeal articulated four sets of principles in its headnotes, providing the most extensive guidance to date on UPC patent-validity standards.

Claim interpretation. Whether conclusions can be drawn from a dependent claim’s subject matter when interpreting the main claim depends on the circumstances of each case. Where a dependent claim adds only an additional feature without describing the main-claim features more specifically, that generally argues against drawing inferences about the main claim from the dependent claim. For medical-use-format claims (“X for use in treating Y”), it is an inherent claim feature that the claimed product must be objectively suitable for the claimed use — that is, therapeutically effective — meaning the treatment must produce a noticeable improvement of the patient’s medical condition. The therapeutic-effect requirement follows from the use of the medical-use claim format itself, not from any specific phrase in the claim.

Added matter. Whether there is added matter is a question of law decided on the facts the parties present. The relevant facts are the claims and the application as filed. Because 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.

Sufficiency. Sufficiency is examined on the basis of the patent as a whole — claims, description, and drawings — from the perspective of the skilled person with their common general knowledge at the filing or priority date. The test is whether the skilled person can reproduce the claimed subject matter without inventive effort and without undue burden. The disclosure must show the skilled person at least one way to perform the claimed invention, or, for functional features, at least one technical concept that achieves the function. Where a claim has functional features, sufficiency does not require disclosure of how every conceivable embodiment within the functional definition can be obtained — fair protection requires that variants of disclosed embodiments equally suitable to achieve the same effect, which could not have been envisaged without the invention, also be protected. A reasonable amount of trial and error does not defeat sufficiency. The burden of presentation and proof of invalidity rests on the party invoking it.

Inventive step. The UPC’s inventive-step framework, as crystallized by this decision, runs as follows:

1. Object of the invention. Identify what the invention is — the objective problem — from the perspective of the person skilled in the art with their common general knowledge as of the priority date. Establish what the invention adds to the state of the art by comparing the claim as a whole in context of the description and drawings, considering the inventive concept underlying the invention.
2. Avoid hindsight. The objective problem should not contain pointers to the claimed solution.
3. The would-not-could test. A claimed solution is obvious when the skilled person, starting from a realistic starting point in the prior art and wishing to solve the objective problem, would (not merely could) have arrived at the claimed solution.
4. Realistic starting point. A starting point is realistic if it would have been of interest to the skilled person at the relevant date when wishing to solve the objective problem — for instance, if the prior-art reference already discloses similar features or addresses the same underlying problem. There can be more than one realistic starting point, and the claim must be inventive over each.
5. Pointers and motivation. The skilled person has no inventive skills and no imagination, and requires a pointer or motivation that, starting from the realistic starting point, directs them to implement a next step in the direction of the claimed invention. As a general rule, the claimed solution is not inventive when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention.
6. Reasonable expectation of success. A claimed solution is also obvious if the skilled person would take the next step in expectation of finding an envisaged solution to the technical problem — generally where results of the next step were clearly predictable, or where there was a reasonable expectation of success.

Key Takeaways

• The UPC has now articulated a unified inventive-step framework that stands alongside the EPO’s problem-solution approach but is independent of it. Practitioners should not assume EPO problem-solution analysis maps cleanly onto UPC inventive-step analysis — the two are similar but not identical.
• The “would not could” formulation is decisive. Mere availability of the next step in the prior art is not enough — the skilled person must actually take it as a routine matter or because of a clear pointer.
• Multiple realistic starting points are allowed. A patent must be inventive starting from each. Defendants in revocation can run multiple obviousness theories from different starting points; patentees must defend the inventive step from each.
• Medical-use claims have therapeutic effectiveness as an inherent claim feature even when not expressly recited. This is consequential for sufficiency and infringement analysis: a product that is not therapeutically effective for the claimed indication does not meet the claim.
• Added matter is decided on the application-as-a-whole basis, not section-by-section. Patentees can argue support from any part of the originally filed application.
• Burden of proof on invalidity rests on the challenger throughout. The patentee does not bear an affirmative burden to prove validity once the patent has been granted.

Why It Matters

This decision and the same-day Meril v. Edwards companion are the foundational UPC validity decisions. Until November 2025, UPC validity practice was operating largely on extrapolation from EPO Boards-of-Appeal jurisprudence and on local-division reasoning that varied across forums. The Court of Appeal’s clear inventive-step framework now provides a single doctrine that all local divisions must apply.

The decision is largely patentee-friendly in tone. The “would not could” requirement, the explicit anti-hindsight directive, the placement of the burden of proof on the invalidity challenger, and the recognition that functional-feature claims do not require disclosure of every conceivable embodiment all favor patent owners. But the framework also creates real obstacles for patentees: the multiple-realistic-starting-points rule means defendants can mount layered obviousness attacks, and the inherent-therapeutic-effect requirement for medical-use claims could be exploited by challengers who can show the claimed product does not achieve clinically meaningful improvement.

For pharmaceutical and antibody patents specifically, the medical-use claim discussion in this decision will reverberate. The 2023 U.S. Supreme Court enablement ruling in Amgen v. Sanofi sharply limited the scope of antibody-genus patents in the United States; the UPC’s medical-use ruling here similarly tightens the link between the claimed therapeutic effect and the patent’s substantive scope. Patentees should review their European antibody and small-molecule portfolios to confirm that medical-use claims have credible therapeutic-effect support; challengers will probe sufficiency where they suspect the claim sweeps in non-effective embodiments.