UPC Central Division Revokes Chinese Military Medical Institute's Remdesivir Patent in Landmark Inventive Step Ruling
核心洞察
The UPC Central Division in Milan has fully revoked the Chinese Academy of Military Medical Sciences' European patent covering remdesivir for treating SARS-CoV-2 (搜索) infection, with a decision issued on 4 May 2026.
Gilead Sciences brought the revocation action on the same day the patent was granted, arguing lack of inventive step and insufficiency, and secured a first-instance victory well before the parallel EPO opposition has progressed.
The ruling provides critical guidance on the UPC's "holistic approach" to inventive step, emphasizing that the technical problem must be defined broadly from the patent as a whole rather than from a pre-selected closest prior art document.
The Unified Patent Court (UPC) Central Division in Milan has fully revoked European Patent 3,854,403, held by the Chinese Academy of Military Medical Sciences (AMMS), which claimed the use of remdesivir for treating SARS-CoV-2 (搜索) infection. The decision, issued on 4 May 2026 (case ID: UPC_CFI_552/2025), marks a significant victory for Gilead Sciences, which brought the revocation action on the very day the patent was granted — 18 June 2025.
The value of the patent dispute was set at €20 million. However, under a mutual cost agreement reached between the parties during the oral hearing on 16 April 2026, AMMS is required to pay only €800,000 to Gilead. The panel, consisting of Andrea Postiglione, Marije Knijff, and Xavier Dorland-Galliot, delivered its ruling significantly faster than the European Patent Office (EPO), where an opposition proceeding remains pending with a deadline for comments set at 30 June 2026.
The UPC's Holistic Approach to Inventive Step
The ruling provides substantial guidance on how the UPC assesses inventive step, particularly in the pharmaceutical sector. The court applied the "holistic approach" previously established by the UPC Court of Appeal in Amgen v Sanofi and Regeneron and Edwards v Meril. This approach differs structurally from the EPO's long-standing problem-solution method.
Under the holistic approach, the first step is to establish the objective of the invention — the technical problem — from the perspective of the skilled person, based on the entire patent. This is followed by asking whether, starting from a realistic starting point in the relevant field and wishing to solve that objective problem, the skilled person would (not could) have arrived at the claimed solution.
The court explicitly criticized the EPO's problem-solution approach for introducing an element of hindsight. The decision explains that basing the objective technical problem on distinguishing features of the claim over the closest prior art carries a risk that knowledge of the solution itself may be introduced into the framing of the problem. By contrast, the UPC's approach evaluates the solution based on the description in conjunction with the drawings and claims, reducing the risk of hindsight.
Formulating the Technical Problem
Gilead argued for a narrow formulation: merely testing remdesivir against the new coronavirus strain. The court rejected this, holding that the technical problem must be defined broadly in light of the invention's contribution to the art. Since the patent refers to therapeutic efficacy, the court framed the problem as the identification of an effective antiviral substance against a novel virus — not simply testing remdesivir on a new virus.
The Skilled Person and the State of the Art
The court emphasized that the skilled person is fictitious and represents an average level of knowledge in a specific technical field. The skilled person should not be identified as any real person working in the relevant field, or for any real pharmaceutical company. Differentiating characteristics such as connections to a specific company are not admissible.
Notably, the court indicated that the skilled person prioritizes the most recent and detailed sources from the state of the art, because "scientific progress requires ongoing reassessment of previous knowledge; thus, experts select up-to-date and comprehensive documents." This suggests that attacks based on older documents may be weaker than those based on publications shortly before the priority date.
AMMS attempted to undermine Gilead's prior art by arguing that certain publications were "promotional" and "commercial in nature." The court decisively dismissed this position, stating that scientific opinion becomes part of the state of the art when published, unless later refuted. The court noted that dismissing a publication as lacking credibility simply because the research had been funded by a pharmaceutical company "went against the very logic of the system."
Reasonable Expectation of Success
AMMS argued that the choice of remdesivir represented a significant step forward and that the skilled person would not have had a "reasonable expectation of success," citing that mutations in viruses may lead to functional differences and altered drug sensitivity. The court disagreed, holding that simply suggesting unexpected outcomes was not adequate. The decision states that the skilled person only questions information when documented prejudice exists in the literature, and that risk and doubt are part of scientific progress. The court found that there is a reasonable expectation of success when data or experiences indicate that the tested solution can yield a positive result, even when uncertainty exists.
Strategic Implications
With the UPC's decision, Gilead has swiftly pre-empted a potential infringement dispute that could have jeopardized its drug marketed under the brand name Veklury. Remdesivir is a broad-spectrum antiviral medication used for Ebola virus disease (搜索) and Marburg virus infections (搜索), but since the coronavirus pandemic it has been used primarily as a post-infection treatment for COVID-19 (搜索).
Gilead was represented by a German-French-Dutch team from Hoyng ROKH Monegier, led by partners Christine Kanz, Amandine Métier, and Peter van Schijndel. In parallel EPO opposition proceedings, Gilead is working with Chris Hoggett of Carpmaels & Ransford, alongside partners Jennifer Antcliff and Paul Kaufman.
The decision underscores the UPC's procedural advantage in speed: a first-instance decision has been reached before the patent proprietor has even responded to the opposition filed at the EPO. This highlights the UPC's growing importance as a strategic forum for validity attacks in the pharmaceutical sector. It remains to be seen whether AMMS will appeal the ruling.