Gilead v AMMS – the UPC Further Develops its Inventive-Step Framework
In its decision of 4 May 2026 (UPC_CFI_552/2025), the Milan Central Division revoked EP 3 854 403 B1, a patent directed to the use of remdesivir for the treatment of SARS-CoV-2 infection. The case arose from a revocation action filed by Gilead on the very day the patent was granted, illustrating once again the speed with which validity disputes can be resolved before the Unified Patent Court. Less than eleven months elapsed between the commencement of proceedings and the first-instance decision. By contrast, parallel opposition proceedings before the EPO remain pending and, at the time of writing, have not yet reached the substantive examination stage.
This decision provides important guidance on three central aspects of the UPC’s emerging inventive-step jurisprudence: the characterisation of the skilled person, the role of the reasonable expectation of success, and the continued development of the Court’s “holistic approach” to inventive step.
The Skilled Person Does Not Display “Fear of Failure”
The Court began by reiterating familiar principles. The person skilled in the art is a notional figure representing an average level of knowledge in the relevant technical field, whose knowledge reflects the common general knowledge at the priority date. The skilled person “cannot be identified with any real person working in the technical domain of the invention”. Nor can that person be characterised by reference to a particular employer, institution or commercial affiliation. According to the Court, “the skilled person is not required to possess (or disregard) a distinct affiliation”, and characteristics such as links to a particular company are therefore irrelevant.
The most striking part of the judgment is, however, the Court’s treatment of scientific uncertainty. Rejecting the defendant’s attempt to import the cautious attitude of its expert into the legal construct of the skilled person, the Court stated that “The person skilled in the art is an objective, rational figure who does not display fear of failure“. The skilled person questions information only where a documented prejudice exists in the literature. Merely pointing to uncertainty or the possibility of unexpected results is insufficient. Risk and doubt are inherent features of scientific progress and, in the Court’s view, the skilled person “would not reject a solution due to subjective concerns about possible failure”.
Although unusually phrased, the underlying message is clear. The UPC appears unwilling to allow inventive step to be supported by a reconstruction of scientific caution that is not grounded in objective evidence available at the priority date.
Reasonable Expectation of Success: Reason, Not Hope
The Court’s discussion of the reasonable expectation of success is equally noteworthy. Rather than treating the concept as a question of subjective confidence, the Court emphasised its objective foundation. According to the judgment, there is a reasonable expectation of success where “scientific data or experiments indicate that the tested solution can yield a positive result”, notwithstanding the uncertainty inevitably associated with further experimentation. By contrast, a mere hope of success exists where the expected result rests on assumptions or where the prior art provides contradictory signals.
Particularly interesting is the Court’s observation that “the greater the realism or reasonableness of the starting point, the greater the expectation of success“. This formulation closely links the expectation-of-success inquiry to the broader inventive-step analysis adopted by the UPC. The question is not whether success was guaranteed, but whether the available evidence provided a rational basis for expecting a positive outcome.
Applying this standard, the Court found that remdesivir represented an obvious avenue of investigation. Prior art disclosed its activity against other coronaviruses, explained its mechanism of action through inhibition of RNA-dependent RNA polymerase (RdRP), and showed the high degree of conservation of that target among coronaviruses. In those circumstances, confirming activity against SARS-CoV-2 through routine in vitro testing was considered an obvious next step accompanied by a reasonable expectation of success. The Court therefore rejected arguments based on general uncertainty surrounding the newly identified virus.
The Holistic Approach and the UPC’s Distance from the Problem-Solution Approach
The most significant aspect of the decision may ultimately be its continued elaboration of the UPC’s holistic approach to inventive step following the Court of Appeal’s decisions in Amgen v Sanofi and Edwards v Meril.
Relying expressly on Amgen, the Central Division reiterated that the objective problem must be established by determining what the invention adds to the state of the art and by considering the inventive concept underlying the invention. The Court emphasised that the technical problem should be formulated broadly and neutrally, without incorporating elements of the proposed solution.
This led the Court to reject the claimant’s attempt to formulate the problem merely as testing remdesivir against a newly identified coronavirus. Instead, the Court considered that the patent sought to solve the broader problem of finding a drug with antiviral activity against SARS-CoV-2 for the treatment of diseases caused by that virus.
More fundamentally, the decision appears to contain an implicit critique of the traditional EPO problem-solution approach. The UPC’s holistic methodology starts from the invention itself and asks whether, starting from a realistic starting point and wishing to solve the identified problem, the skilled person would have arrived at the claimed solution. The rationale, as several commentators have observed, is to minimise the risk that knowledge of the invention influences the formulation of the technical problem through the prior-art comparison exercise.
The Court did not suggest that the UPC and EPO approaches necessarily lead to different outcomes. Indeed, the result in this case would likely have been the same under a conventional EPO analysis. Nevertheless, the judgment confirms that the UPC is increasingly willing to articulate inventive step through its own conceptual framework and vocabulary.
Conclusion
In Gilead v AMMS, the Court sets out key concepts for assessing inventive step. The decision clarifies that the skilled person is a rational actor who “does not display fear of failure”, and that a reasonable expectation of success must be grounded in objective scientific evidence rather than subjective caution Further, inventive step is to be assessed through the UPC’s developing holistic approach, which involves formulating the technical problem from the application as a whole, rather than focusing on those features that distinguish the claim from a pre-selected closest prior art document.
Taken together, these elements suggest that the UPC is not abandoning established European patent principles. Rather, it is gradually constructing an autonomous methodology for inventive step—one that remains broadly compatible with EPO practice while increasingly defining itself through its own jurisprudence and terminology.
Philippe Ocvirk – Partner, European patent attorney
(Read the full decision: https://www.unifiedpatentcourt.org/en/node/183193)