The Unified Patent Court Central Division in Milan revoked European Patent 3854403, which claimed Remdesivir for use in treating SARS-CoV-2 (Covid-19) infection, following an invalidity action brought by Gilead Sciences against the Academy of Military Medical Sciences.
The ruling (UPC_CFI_552/2025), handed down on 4 May 2026, centers on whether the antiviral drug’s application against the coronavirus involved an inventive step. Gilead Sciences filed the revocation action on the date the unitary patent was granted, asserting that the patent was invalid due to a lack of inventive step and insufficiency. The patent proprietor, the Academy of Military Medical Sciences, defended the patent, but the Central Division ultimately sided with the challenger.
The UPC Holistic Approach Versus the EPO Problem-Solution Framework
The decision offers a clear look at how the Unified Patent Court assesses inventive step compared to the European Patent Office.
The Milan Central Division criticised the EPO’s problem-solution approach for introducing an element of hindsight. By evaluating the patent’s description, drawings, and claims first, the UPC framework aims to reduce that risk.
In Plain English: The Clinical Takeaway
1. What the court decided: Judges in Milan revoked a European patent held by the Academy of Military Medical Sciences that claimed Remdesivir for use in treating SARS-CoV-2 (Covid-19) infection.
2. Why the legal test matters: The court used a “holistic approach” to the assessment of inventive step, which evaluates the technical problem on the basis of the patent, reducing the risk of hindsight knowledge of the claimed invention unallowably influencing how the technical problem is framed.
3. Speed of the court: This UPC invalidity ruling arrived well ahead of parallel opposition proceedings at the European Patent Office, which had set a deadline of 30 June 2026 to respond to the opposition.
Evaluating State of the Art, Credibility, and Expectations of Success
The ruling clarifies several procedural and evidentiary standards for future pharmaceutical litigation.
The court highlighted that citations relied on by the Academy of Military Medical Sciences did not contradict those Gilead relied on, and simply reflected a more cautious approach. It noted that publications that may have been sponsored by industry remain credible and relevant for the assessment of inventive step, whereas subsequent publications disproving earlier research may result in the earlier publication no longer being considered accurate or a realistic starting point.
| Legal and Institutional Forum | Approach to Inventive Step | Key Procedural Milestones |
|---|---|---|
| Unified Patent Court (UPC) Central Division | Holistic approach | Revoked Patent 3854403 on 4 May 2026 (UPC_CFI_552/2025) |
| European Patent Office (EPO) | Problem-solution approach | Opposition division set a response deadline of 30 June 2026 |
Future Litigation and the Speed of the Unified Patent Court
The decision highlights the UPC’s procedural advantage in terms of speed. While Gilead also opposed the patent at the EPO, the UPC reached a first-instance revocation decision well before the parallel EPO opposition has progressed. It remains to be seen whether the Academy of Military Medical Sciences will appeal the decision.
References
- Unified Patent Court Central Division. UPC_CFI_552/2025, Decision of 4 May 2026 – Gilead v Academy of Military Medical Sciences.
