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UPC CFI 552/2025

Jun 18, 2025·EP3854403 Unitary patent · USE OF SUBSTITUTED AMINOPROPIONATE COMPOUNDS IN TREATMENT OF SARS-COV-2 INFECTION

Case details
Status
Case Closed (Patent revoked)
Action
Revocation
Category
Main revocation action
Parties
Claimants
Representatives
Respondents
Representatives
Division
Milan CD
Technology
  • Chemistry
    Pharmaceuticals
Language
English
First decided
May 4, 2026
EPO Opposition
How this compares
The court's record for this kind of case, counted in first-instance rulings. A figure in brackets is the number of rulings a rate rests on.
Patent revokedMedian days to first decision
All UPC37% (34/91)124
Milan CDLockedLocked
Judge Andrea PostiglioneLockedLocked
Judge Marije KnijffLockedLocked
Judge Xavier Dorland-GalliotLockedLocked

At the UPC: Gilead Sciences, Inc. (5 cases)·Academy of Military Medical Sciences (5 cases)

Decisions
  • 2026-05-04
    Revocation ActionPublic

    Summary: The Central Division (Milan seat) revoked European Patent EP 3854403 in its entirety, finding that the patent lacks inventive step. The attack based on insufficient disclosure was dismissed, but all amendment requests (main request and eight auxiliary requests) were also dismissed as none overcame the inventive step objection. The defendant (patent proprietor) bears the legal costs fixed by party agreement at €800,000.

    Show the legal issues (6)
    • Inventive step (Art. 56 EPC) — whether use of Remdesivir against SARS-CoV-2 was obvious at priority date given prior art on broad-spectrum coronavirus activity
    • Sufficiency of disclosure (Art. 83 EPC / Art. 138(1)(b) EPC) — whether undefined stereochemistry at phosphorus in Formula I rendered claims insufficiently disclosed
    • Application to amend patent (Main Request and Auxiliary Requests 1-8) — admissibility and allowability under Art. 123 and 84 EPC
    • Definition of person skilled in the art and common general knowledge at priority date (21 January 2020)
    • Reasonable expectation of success vs. mere hope of success in the context of emerging viral disease
    • Value of proceedings and recoverable costs under Art. 69 UPCA
Document titleDatePublic
Receipt2026-06-03Not public
Cover sheet2026-06-03Not public
Application document Applicant2026-06-03Not public
Case closed2026-05-05Not public
Decision2026-05-04Not public
Decision2026-05-04Public
Communication2026-05-03Not public
Communication2026-04-16Not public
Other Documents2026-04-16Not public
Receipt2026-04-15Not public
Accepted arguments
What the court agreed with — by party.
  • The skilled person (virologist researching antiviral drugs for coronaviruses) would have had a high expectation of success that Remdesivir would be effective against SARS-CoV-2, based on prior art documents (HRM 09, HRM 10, HRM 11, HRM 12, HRM 16) showing broad-spectrum anti-coronavirus activity via highly conserved RdRP

    ClaimantLegal basis: Art. 56 EPC; EPO Guidelines G-VII-13; UPC_CoA 464/24 (25 November 2025)
  • The objective technical problem was finding a drug with antiviral activity against SARS-CoV-2, not merely testing Remdesivir against the new virus; but given that the prior art clearly suggested Remdesivir as the solution, the claimed invention lacked inventive step

    ClaimantLegal basis: Art. 56 EPC; UPC_CoA_528/2024 (Amgen v Sanofi, 25 November 2025) §11-12
  • Formula I in the granted claims already encompassed both isomers due to the chiral phosphorus in the drawing, making the Main Request amendment (removing 'geometric isomer') admissible under Art. 123 and 84 EPC, though still not inventive

    ClaimantLegal basis: Art. 123(3) EPC; Art. 84 EPC; R. 50.2 RoP
Rejected arguments
What the court did not agree with — and why.
  • The patent is insufficiently disclosed because Formula I's stereochemistry at phosphorus is undefined, constituting an undue burden for the skilled person to identify/separate the two isomers

    ClaimantLegal basis: Art. 83 EPC / Art. 138(1)(b) EPC
  • The skilled person would not have had a reasonable expectation of success because differences in the NiRAN subdomain and exonuclease proofreading activity (nsp14) of SARS-CoV-2 introduced substantial uncertainty about Remdesivir's efficacy; the skilled person would only have had a 'hope of success'

    RespondentLegal basis: Art. 56 EPC
  • The skilled person should be defined as an independent virologist with no links to any pharmaceutical company, and the prior art documents relied upon by the claimant were commercially motivated and lacked scientific credibility

    RespondentLegal basis: Art. 56 EPC
  • The patent should be maintained in amended form per the Main Request or one of the eight Auxiliary Requests

    RespondentLegal basis: R. 50.2 RoP; Art. 123 EPC; Art. 84 EPC
  • The value of proceedings should be set at €6,800 (cost of the patent application) rather than €20 million

    RespondentLegal basis: R. 152.3 RoP; R. 370.6 RoP