Gilead Sciences v Academy of Military Medical Sciences (CFI, 4 May 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 4 May 2026 (UPC_CFI_552/2025), the Milan Central Division grants Gilead Sciences’ revocation action and revokes in its entirety the Academy of Military Medical Sciences’ unitary patent EP 3 854 403, which claimed the use of remdesivir to treat SARS-CoV-2 infection. For lack of inventive step over two January 2020 publications suggesting that remdesivir would be effective against the new coronavirus, all applications to amend are dismissed. The decision usefully clarifies the reasonable expectation of success in medical use claims.

Facts and procedure

The patent, claiming priority from a Chinese application of 21 January 2020, concerns the use of substituted aminopropionate compounds, including remdesivir (GS-5734), to treat SARS-CoV-2, unitary effect was registered on 23 July 2025. Gilead filed the action on 18 June 2025. The proprietor filed a main request and eight auxiliary requests. Amendments proposed later in the rejoinder were excluded by order of 16 March 2026. After the hearing in Milan on 16 April 2026, the parties agreed costs at EUR 800,000 (paragraphs 1 to 4).

The applicable law

Inventive step (Art. 56 EPC, Art. 65 UPCA) is assessed under the Court of Appeal’s framework in Amgen v Sanofi: an objective problem defined without hindsight, a realistic starting point, and whether the skilled person would (not merely could) have arrived at the claimed solution, which requires a pointer and a reasonable expectation of success. Amendments must comply with Art. 84 and 123(3) EPC.

Question

Was the use of remdesivir against SARS-CoV-2 obvious at the priority date, in light of publications predicting its efficacy against the emerging Wuhan virus?

Decision

The therapeutic effect is a functional feature of claims 1 and 6, and SARS-CoV-2 and 2019-nCoV designate the same virus (paragraphs 62 to 70). Deleting ‘a geometric isomer’ is allowed (paragraphs 79 and 80), and the insufficiency attack, unsupported by serious doubts, fails (paragraphs 71 to 78). The technical problem, framed broadly, is to find an effective antiviral against the new virus (paragraphs 35 to 40).

The commentary HRM 09 and the editorial HRM 10 of January 2020, which report remdesivir’s efficacy against SARS-CoV-1 and consider it likely to work against emerging coronaviruses, are a realistic starting point (paragraphs 102 to 111). The skilled person, an objective figure with no fear of failure, had a reasonable expectation of success, verifiable by routine in vitro testing. The proprietor’s doubts are described as purely speculative, and sequence differences would not have deterred the skilled person (paragraphs 114 to 130). Criticism based on the authors’ industry funding is rejected (paragraphs 131 to 135). As no auxiliary request meets the objection, the patent is revoked for all Contracting Member States (paragraphs 136 to 140). The proprietor bears the agreed costs of EUR 800,000, the value of the case is set at EUR 20 million (paragraphs 141 to 151).

Key points for practice

• A reasonable expectation of success rests on scientific data or experiments. Mere hope rests on assumptions or contradictory sources.
• The skilled person is a notional figure: links to a particular company are disregarded, as is the funding of prior-art authors.
• Short publications, such as commentaries or editorials, can be a realistic starting point where they point to a specific compound.
• Practical point: for a medical use claim filed at the very start of an outbreak, the prior art of the preceding days needs close scrutiny, commentaries and editorials included.

Provisions applied

Agreement on a Unified Patent Court

Art. 65(2), 69(1) and 73(1)

Rules of Procedure

Rules 30.1, 50.2, 118.5, 119, 150.2, 152.3 and 370.6

European Patent Convention

Art. 54(2) and (5), Art. 56, Art. 84, Art. 123(3), Art. 138(1)(b)

Case law cited

Amgen v Sanofi, Court of Appeal, 25 November 2025, NanoString v 10x Genomics, Court of Appeal, 11 March 2024 (UPC_CoA_335/2023), Insulet v EOFlow, Court of Appeal (UPC_CoA_768/2024), bioMérieux v Labrador, 23 October 2025, NanoString v Harvard, Munich Central Division, 17 October 2024, Fujifilm v Kodak, Düsseldorf Local Division, 28 January 2025

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.