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UPC CFI 552/2025

18. Juni 2025·EP3854403 Einheitspatent · USE OF SUBSTITUTED AMINOPROPIONATE COMPOUNDS IN TREATMENT OF SARS-COV-2 INFECTION

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Verfahrensdetails
Status
Case Closed (Patent nichtig)
Verfahrensart
Nichtigkeit
Kategorie
Hauptnichtigkeitsklage
Parteien
Kläger
Vertreter
Beklagte
Vertreter
Division
Milan CD
Richter
Technologie
  • Chemistry
    Pharmaceuticals
Sprache
English
Erste Entscheidung
4. Mai 2026
EPA-Einspruch
Im Vergleich
Die Bilanz des Gerichts für diese Art von Verfahren, gezählt in erstinstanzlichen Entscheidungen. Eine Zahl in Klammern gibt an, auf wie vielen Entscheidungen eine Quote beruht.
Patent nichtigMedian Tage bis zur ersten Entscheidung
Gesamt-UPC37% (34/91)124
Milan CDGesperrtGesperrt
Richter Andrea PostiglioneGesperrtGesperrt
Richter Marije KnijffGesperrtGesperrt
Richter Xavier Dorland-GalliotGesperrtGesperrt

Vor dem UPC: Gilead Sciences, Inc. (5 Verfahren)·Academy of Military Medical Sciences (5 Verfahren)

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Dieser Streit umfasst 4 weitere Verfahren

UPC CoA 121/2026·UPC CoA 103/2026·UPC CFI 1968/2026·UPC APP 34350/2025

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Weitere Verfahren: Milan CD·2025

Entscheidungen
  • 2026-05-04
    Revocation ActionÖffentlich

    Zusammenfassung: 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.

    Rechtsfragen anzeigen (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
Dokumente
Alle 417 Dokumente anzeigen
DokumenttitelDatumÖffentlich
Receipt2026-06-03Nicht öffentlich
Cover sheet2026-06-03Nicht öffentlich
Application document Applicant2026-06-03Nicht öffentlich
Verfahren abgeschlossen2026-05-05Nicht öffentlich
Entscheidung2026-05-04Nicht öffentlich
Decision2026-05-04Öffentlich
Mitteilung2026-05-03Nicht öffentlich
Mitteilung2026-04-16Nicht öffentlich
Other Documents2026-04-16Nicht öffentlich
Receipt2026-04-15Nicht öffentlich
Angenommene Argumente
Was das Gericht akzeptiert hat — nach Partei.

  • 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

    KlägerRechtsgrundlage: 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

    KlägerRechtsgrundlage: 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

    KlägerRechtsgrundlage: Art. 123(3) EPC; Art. 84 EPC; R. 50.2 RoP
Zurückgewiesene Argumente
Was das Gericht nicht akzeptiert hat — und warum.

  • 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

    KlägerRechtsgrundlage: 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'

    BeklagterRechtsgrundlage: 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

    BeklagterRechtsgrundlage: Art. 56 EPC

  • The patent should be maintained in amended form per the Main Request or one of the eight Auxiliary Requests

    BeklagterRechtsgrundlage: 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

    BeklagterRechtsgrundlage: R. 152.3 RoP; R. 370.6 RoP