CD Milan - No fear of failure: The UPC on the skilled person and reasonable expectation of success (UPC_CFI_552/2025)
UPC Case Law | 22.10.2026
Court docket: CD Milan, Decision of 04.05.2026
UPC_CFI_552/2025 [EP 3 854 403]
Parties: Gilead Sciences, Inc. v. Academy of Military Medical Sciences
Contributor: Marianna Galliani
Headnote
1. The person skilled in the art, outlined in Art. 56 EPC, is a notional figure who represents an average level of knowledge in a specific technical field and whose knowledge reflects the common general knowledge (CGK) at the priority date. This fictitious individual cannot be identified with any real person working in the technical domain of the invention. The skilled person is not required to possess (or disregard) a distinct affiliation, nor is it necessary; therefore, differentiating characteristics such as connections to a specific company are not admissible.
2. The person skilled in the art is an objective, rational figure who does not display fear of failure. The defendant incorrectly projects subjective attitudes onto this notional individual by likening them to Prof. XXXX. The skilled person questions information only when documented prejudice exists in relevant literature, and it is the party's responsibility to highlight proven flaws. Simply suggesting unexpected outcomes is inadequate. Recognising that risk and doubt are part of scientific progress, the skilled person would not reject a solution due to subjective concerns about possible failure.
3. The difference between an expectation of success and a mere hope of success does not depend on the researcher’s subjective state of mind. There is a reasonable expectation of success when the scientific data or experiments indicate that the tested solution can yield a positive result, despite the general uncertainty arising from the necessary experimentation and the application of the scientific method. A reasonable expectation of success is therefore based on reason and knowledge of scientific data, even though the expert knows that the outcome is never certain until it is the subject of clinical trials. Therefore, it can be said that the greater the realism or reasonableness of the starting point, the greater the expectation of success. Hope for success, on the other hand, arises when the result is based on sheer assumptions or there is a contradiction in the sources, so that the outcome is considered possible but not reasonable.
Relevance of the decision
The revocation decision UPC_CFI 552/25 (Gilead Sciences, Inc v Academy of Military Medical Sciences) concerns EP 3 854 403, whose main independent claim relates to remdesivir for use in treating a disease or an infection caused by SARS-CoV-2.
The skilled person was defined consistently with EPO case law as a notional figure, namely an "experienced practitioner who has average knowledge and abilities and who is aware of what the common general knowledge was in the relevant art concerned at a particular time" (T 1787/20). The Court rejected any company-specific characterization, stating that the skilled person "cannot be identified with any real person" and need not have or lack "connections to a specific company" (cf. points 46-49).
For the interpretation of second medical use claims, the Court aligned with EPO case law, treating claims directed to "the use of a drug, to its preparation, or to limited substance protection" alike, with the claimed therapeutic effect being a "functional technical feature of the claim", citing T 609/02 (cf. points 62-63).
Although sufficiency of disclosure was acknowledged, inventive step was denied (cf. points 78-128). In assessing the prior art, the Court provided some further insight into the skilled person's mindset, stating that the skilled person "prioritizes the most recent and detailed sources, as scientific progress requires ongoing reassessment of previous knowledge; thus, experts select up-to-date and comprehensive documents" (cf. point 88).
The key divergence from EPO practice appears in the Court's criticism of the problem-solution approach: it may involve a "risk" that feature selection is "unconsciously influenced by knowledge of the solution itself", which may lead to "selecting, among the many available technical features, precisely those that turned out to be relevant to the comparison between the two solutions, with a possible distortion of the analysis" (cf. point 99). By contrast, the UPC's "holistic approach" reconstructs the inventive concept from the claim as a whole, description and drawings, aiming at identifying the contribution over the prior art, followed by the determination of realistic starting points and the assessment of whether, for a skilled person, the described solution could be considered obvious in light of the available background knowledge (cf. point 100).
On obviousness, the Court further held that the skilled person is “an objective, rational figure who does not display fear of failure” and would not reject a solution because of “subjective concerns about possible failure” (point 118). It then aligned with EPO case law on expectation of success, holding that obviousness may exist where there is a “reasonable expectation of success”, not certainty (point 119), whereas “hope to succeed” is “merely the expression of a wish” (point 122).
Applying the above standards, the Court concluded that the available prior art already provided clear suggestions that remdesivir could be used as an antiviral agent for the COVID-19 coronavirus infection. Based on these suggestions, which included explanations as to why remdesivir could work against this virus, the skilled person would have performed the necessary in vitro tests to confirm the hypothesis (cf. point 128).