December 12, 2025
1. Introduction
On November 25, 2025, the Court of Appeal (CoA) of the Unified Patent Court (UPC) issued two landmark decisions that provide the clearest articulation to date of how the UPC intends to establish inventive step. The decisions in Meril v Edwards (concerning EP 3 646 825) and Amgen v Sanofi/Regeneron (concerning EP 3 666 797) were handed down on the same day and deliberately apply an identical framework for assessing inventive step.
Both panels of the CoA expressly acknowledge the European Patent Office’s (EPO) problem-solution approach (PSA) but depart from it in important aspects, adopting instead a more “holistic” analysis. The UPC’s approach shares more similarities with the methodologies used in Germany and the UK than with the strict PSA structure employed at the EPO and in jurisdictions such as France, Italy, The Netherlands, and Sweden.
This development is significant for patent practitioners before the UPC. The CoA emphasized that while different EPC countries have varying approaches to inventive step assessment, these are “merely guidelines to assist in the establishment of inventive step as required by Art. 56 EPC, that, when properly applied, should and generally do lead to the same conclusion.” However, as these decisions demonstrate, the choice of methodology can significantly influence the outcome, particularly in complex cases involving pharmaceutical and medical device patents.
This article examines how the CoA assessed inventive step in both cases, derives the emerging UPC framework, and contrasts it with the EPO’s problem-solution approach.
2. Meril v Edwards
a) The Patent at Issue
EP 3 646 825 relates to a system comprising a prosthetic heart valve and a delivery catheter. The patent is a divisional application belonging to a family with a priority date from July 2011. Edwards Lifesciences, the patent proprietor, manufactures the SAPIEN 3 heart valve and sought to enforce the patent against Meril’s competing transcatheter heart valve products, including the “Myval Octacor” with its “Navigator” delivery systems.
The key claim features concern a collapsible and expandable annular frame made up entirely of hexagonal cells, with each hexagonal cell defined by six struts, including two opposing side struts extending parallel to a flow axis of the valve. This hexagonal cell structure allegedly provides advantages including reduced crimping profile and improved stability during crimping and expansion.
b) The CoA’s Inventive Step Assessment
The CoA affirmed the Court of First Instance’s finding that the patent (as amended by Auxiliary Request II) involves an inventive step. Critically, the CoA outlined a structured approach that differs substantially from the EPO’s methodology in the order of analysis.
The CoA established that the inventive step assessment follows this sequence:
Step 1: Establish the Objective Problem First
The CoA starts by establishing “what the object of the invention is, i.e. the objective problem.” This must be assessed from the perspective of the skilled person, with their common general knowledge, as at the priority date. Crucially, the CoA stated that this must be done “by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim, but by comparing the claim as a whole in the context of the specification and the drawings, thus also considering the inventive concept underlying the invention (the technical teaching).”
In Edwards, the objective problem was identified as improving the design of a balloon-expandable transcatheter prosthetic heart valve, specifically by reducing the crimping profile and providing stability during crimping and subsequent expansion.
Step 2: Identify Realistic Starting Points
Only after establishing the objective problem does the CoA consider the prior art. A starting point is “realistic” if the teaching thereof would have been of interest to a person skilled in the art who, at the effective date, wishes to solve the objective problem. The CoA emphasized there can be more than one realistic starting point, and the claimed invention must be inventive starting from each of them.
In Edwards, the prior art document “Levi” was accepted as a realistic starting point because it also related to prosthetic heart valves and aimed to reduce the crimped profile.
Step 3: Assess Whether the Skilled Person “Would” Arrive at the Claimed Solution
The final step requires determining whether the skilled person, starting from a realistic starting point and wishing to solve the objective problem, “would (and not only could)” have arrived at the claimed solution. The CoA emphasized that the skilled person “has no inventive skills and no imagination and requires a pointer or motivation that, starting from a realistic starting point, directs them to implement a next step in the direction of the claimed invention.”
In Edwards, the CoA found that Levi consistently taught using frames with a combination of rhomboid cells and hexagonal cells for different functions in different parts of the frame. The technical teaching of Levi was that different parts of the frame should employ different structures. Modifying the frame to be made up entirely of hexagonal cells as in the patent at issue would therefore be a “qualitative modification that goes against the general teaching of Levi.”
Furthermore, when considering combinations of prior art (Levi with stent disclosures such as shown in further prior art document “Fontaine”), the CoA held that the skilled person would need “a strong motivation to replace a feature of the heart valve frame taught by Levi with a feature disclosed for stents in Fontaine.” Such motivation was absent given the different technical requirements of heart valves versus stents.
An important headnote emerged from Edwards: “For an inventive step to be present, it is not necessary to show improvement of the technical teaching as defined by the patent claims over the prior art. Inventive step may also be found if the patent claims disclose a non-obvious alternative to solutions known in the prior art.” This statement may lower the threshold for defending patents and reinforces the UPC’s developing reputation as a pro-patentee forum.
3. Amgen v Sanofi/Regeneron
a) The Patent at Issue
EP 3 666 797 concerns antibodies that bind to PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9) for use in treating conditions related to elevated serum cholesterol levels, including hypercholesterolemia and atherosclerotic disease. The patent claims monoclonal antibodies that bind to the catalytic domain of PCSK9 and block the PCSK9-LDLR (Low-Density Lipoprotein Receptor) interaction.
The patent had been revoked by the Court of First Instance, which found the invention lacked inventive step. Amgen appealed, arguing that the Court of First Instance had applied the wrong legal framework, particularly regarding whether the skilled person had a reasonable expectation of success.
b) The CoA’s Inventive Step Assessment
The CoA set aside the first instance decision and upheld the patent, finding that the claims involve an inventive step. This decision aligned with the EPO Opposition Division’s finding (issued on 21 May 2025), though the reasoning differed in parts.
The CoA applied the same structured approach as in Edwards, but with additional elaboration on the concept of “reasonable expectation of success” – a concept particularly relevant in life sciences cases.
Step 1: Establish the Objective Problem
Following the same methodology, the CoA first established what the invention adds to the state of the art. The patent’s contribution was the use of antibodies targeting the extracellular PCSK9-LDLR interaction as a therapeutic treatment for cholesterol-related conditions.
Step 2: Identify Realistic Starting Points
The prior art document “Lagace” was accepted as a realistic starting point. The Court noted that Lagace disclosed research showing that secreted PCSK9 associates with LDLR and reduces hepatic LDLR protein levels, and specifically mentioned that “inhibitors of the protease [PCSK9] would be of therapeutic benefit for the treatment of hypercholesterolemia.”
Step 3: The “Would” vs. “Could” Analysis and Reasonable Expectation of Success
The CoA introduced a crucial refinement for life sciences cases: a claimed solution is obvious if the skilled person would have taken the next step “in expectation of finding an envisaged solution of his technical problem. This is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success.”
The CoA provided detailed guidance on what constitutes a “reasonable expectation of success”:
- A reasonable expectation of success “implies the ability of the skilled person to predict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful conclusion of that project within acceptable time limits.”
- The more unexplored a technical field of research, the more difficult it is to make predictions and the lower the expectation of success.
- Envisaged practical or technical difficulties, as well as costs involved in testing, may withhold the skilled person from taking a next step.
- Conversely, the stronger a pointer towards the claimed solution, the lower the threshold for a reasonable expectation of success.
Critically, the burden of proof remains with the party asserting invalidity. The CoA stated: “When the patentee brings forward and sufficiently substantiates uncertainties and/or practical or technical difficulties, the burden of proof that these would not prevent a skilled person from having a reasonable expectation of success, falls on the party alleging obviousness.”
In the Amgen case, the key issue was whether the skilled person at the priority date (January 2008) had reasonable expectation that an antibody blocking the PCSK9-LDLR interaction would be therapeutically effective in vivo. The CoA found they did not. At the priority date, there was insufficient scientific evidence that the extracellular pathway by which PCSK9 degrades LDLR was sufficiently relevant under physiological conditions for an antibody approach to succeed therapeutically.
The CoA rejected Sanofi/Regeneron’s argument that multiple pharmaceutical companies were already developing PCSK9 antibodies before the priority date as evidence of expectation of success. The CoA stated: “The fact that other persons or teams were working contemporaneously on the same project does not necessarily imply that there was a reasonable expectation of success. It may also indicate that it was an interesting area to explore with a mere hope to succeed.”
This distinction between “hope to succeed” and “reasonable expectation of success” may prove decisive in future life sciences patent disputes before the UPC.
4. The UPC’s Inventive Step Framework
Based on these two decisions, the UPC’s approach to inventive step can be summarized as follows:
Step 1: Establish the Objective Problem First
- Determine what the invention adds to the state of the art
- Consider the claim as a whole in the context of the specification and drawings
- Identify the technical teaching and technical effect(s) achieved
- Avoid pointers to the claimed solution in formulating the problem (anti-hindsight)
Step 2: Identify Realistic Starting Points
- A starting point is realistic if it would interest a skilled person seeking to solve the objective problem
- Consider prior art disclosing similar features or addressing similar problems
- Multiple starting points may exist. Inventiveness must be established from each
Step 3: Assess Whether the Skilled Person “Would” Arrive at the Solution
- The skilled person has no inventive skills and requires a pointer or motivation
- Ask whether the skilled person would (not merely could) take the next step
- In life sciences: assess whether there was a reasonable expectation of success
- The invention is non-obvious if it represents a non-obvious alternative, even without improvement
5. Key Differences from the EPO PSA
The UPC’s approach diverges from the EPO’s PSA in several respects:
a) Order of Analysis: Problem Before Prior Art
The most fundamental structural departure is the sequence. Under the PSA, the first step is selecting the “closest prior art,” and only then is the objective technical problem derived from the differences between the claim and that closest prior art. The UPC inverts this: the objective problem is established first from the patent itself, and only then are realistic starting points in the prior art identified.
This difference has practical significance. Under the PSA, the problem is inherently tied to a specific prior art document, potentially constraining the analysis. Under the UPC approach, the problem is defined more broadly based on the patent’s contribution to the art, allowing for consideration of multiple starting points without re-formulating the problem each time.
b) No “Closest Prior Art” Requirement
The EPO’s PSA requires identifying a single piece of “closest prior art” as the starting point. The UPC instead uses the concept of “realistic starting points” – plural. Any prior art that would have interested the skilled person trying to solve the objective problem can serve as a starting point, and the invention must be non-obvious from each of them. This arguably makes it easier to challenge patents, as multiple attacks can be mounted from different starting points.
However, the UPC’s requirement that there be a strong “pointer or motivation” to modify a starting point toward the invention may counterbalance this, making it harder to combine teachings from different prior art documents.
c) Holistic Assessment vs. Feature-by-Feature Analysis
The EPO’s approach tends toward a feature-by-feature comparison between the closest prior art and the claim to identify distinguishing features. The UPC explicitly rejects this, stating the assessment should be done “not by looking at the individual features of the claim, but by comparing the claim as a whole in the context of the specification and the drawings.”
This holistic approach may benefit patentees defending complex inventions where individual features appear trivial but their combination produces unexpected technical effects.
d) Non-Obvious Alternatives
The UPC explicitly recognizes that inventive step can exist for non-obvious alternatives, even without demonstrated improvement over the prior art. While the EPO also recognizes this in principle, the UPC’s explicit statement in Edwards suggests a more patentee-friendly approach where structural differences, if non-obvious, can support validity even without proven technical advantages.
e) Reasonable Expectation of Success in Life Sciences
The Amgen decision provides detailed guidance on “reasonable expectation of success” – a concept central to life sciences cases but often applied differently across jurisdictions. The UPC’s approach emphasizes scientific predictability based on facts known before research commenced, recognition that unexplored fields inherently have lower expectations of success, distinction between “hope to succeed” (insufficient) and “reasonable expectation” (required for obviousness), and burden shifting once the patentee substantiates difficulties.
This framework may prove more favorable to pharmaceutical and biotech patents than some national approaches, particularly for inventions made in rapidly developing scientific fields where complete understanding was lacking at the priority date.
6. Practical Implications for Practitioners
These decisions provide clarity for practitioners. Key takeaways include:
For patentees: Frame validity defenses around the holistic technical teaching of the patent and emphasize the absence of motivation in the prior art to make the specific combination of features claimed. In life sciences, document and substantiate scientific uncertainties that existed at the priority date.
For challengers: Given the multiple starting point approach, prepare attacks from several pieces of prior art. However, be prepared to demonstrate clear pointers or motivation – not just possibility – to modify each starting point toward the claimed invention. In life sciences, provide evidence that success was predictable, not merely hoped for.
For prosecution: The UPC’s approach may influence how claims are drafted and how specifications describe the technical problem and effects. Clear articulation of the technical teaching and the advantages of the claimed combination may strengthen patents in future UPC proceedings.
7. Conclusion
The CoA’s coordinated decisions in Meril v Edwards and Amgen v Sanofi/Regeneron establish a coherent framework for inventive step assessment at the UPC. This framework, while acknowledging the EPO’s problem-solution approach, represents a deliberate departure toward a more holistic analysis.
These decisions reinforce the UPC’s emergence as an important forum for European patent litigation, potentially with outcomes that may differ from both EPO proceedings and national court decisions. Given the finality of UPC decisions on validity (which prevail over divergent EPO outcomes), practitioners must adapt their strategies to this new framework.
The CoA’s approach appears balanced: the multiple starting point analysis and could/would distinction maintain rigorous scrutiny of patent validity, while the emphasis on holistic assessment, motivation requirements, and burden allocation provide meaningful protection for genuine innovations. As the UPC continues to develop its jurisprudence, these twin decisions will serve as the foundational precedent for inventive step analysis across all UPC divisions.
Authors
Bernd Holzgartner
Mingyan Xi