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UPC CFI 1/2023

2. Juni 2023·EP3666797 · ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)

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Verfahrensdetails
Status
Case Closed (Patent nichtig)In der Berufung aufgehoben, 25. Nov. 2025
Verfahrensart
Nichtigkeit
Kategorie
Hauptnichtigkeitsklage
Parteien
Kläger
Vertreter
Beklagte
Vertreter
Division
Munich CD
Richter
Technologie
  • Chemistry
    Biotechnology · Pharmaceuticals
Sprache
English
Erste Entscheidung
29. Juni 2023
Letzte Entscheidung
24. Feb. 2024
EPA-Einspruch
Berufung
Im Vergleich
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Patent nichtigMedian Tage bis zur ersten Entscheidung
Gesamt-UPC37% (34/91)124
Munich CDGesperrtGesperrt
Richter Ulrike VoßGesperrtGesperrt
Richter András KupeczGesperrtGesperrt
Richter Casper StruveGesperrtGesperrt

Vor dem UPC: Sanofi Group (33 Verfahren)·Amgen Group (19 Verfahren)

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Verwandte Verfahren
Alle Verfahren zu diesem Patent

Dieser Streit umfasst 3 weitere Verfahren

UPC CFI 2220/2025·UPC CoA 528/2024·UPC CFI 14/2023

3 weitere Beklagte zum selben oder einem verwandten Patent

UPC CFI 2221/2025·UPC CoA 529/2024·CC 586764/2023

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Weitere Verfahren: Munich CD·2023

Entscheidungen
  • 2024-10-22
    Application RoP262.1 (b)Öffentlich

    Zusammenfassung: Munich Central Division granted Dehns' (a UPC representative firm) request for access to written pleadings and evidence in the concluded Sanofi v. Amgen revocation proceedings under R.262.1(b) RoP. The Court found that since proceedings had concluded, the balance of interests normally favours granting access to third parties with a legitimate general interest.

    Rechtsfragen anzeigen (3)
    • Third-party access to court file under R.262.1(b) RoP
    • Balance of interests in concluded proceedings
    • Transparency of UPC proceedings
  • 2024-07-16
    Revocation ActionÖffentlich

    Zusammenfassung: The Munich Central Division (UPC's first-ever revocation case) revoked European patent EP 3 666 797 B1 (relating to an anti-PCSK9 antibody composition for treating hypercholesterolaemia, owned by Amgen) in its entirety for the territories of 17 UPC Contracting Member States. The patent was found to lack inventive step. All 17 auxiliary requests were also found to lack inventive step. Amgen (defendant/patent proprietor) was ordered to bear Sanofi's legal costs of EUR 1,375,000.

    Rechtsfragen anzeigen (5)
    • Claim interpretation in revocation proceedings
    • Priority validity under Art. 87 EPC
    • Assessment of inventive step and realistic starting point in prior art
    • Obviousness and reasonable expectation of success
    • Technical effect as indication of inventive step
  • 2024-02-24
    Revocation ActionÖffentlich

    Zusammenfassung: The Munich Central Division issued a procedural order combining two related revocation actions (Sanofi v Amgen and Regeneron v Amgen) into a single proceeding, admitted additional documents into evidence, rejected a request for an interim conference, and set the value of each action at EUR 100 million.

    Rechtsfragen anzeigen (3)
    • consolidation of related actions
    • value of proceedings for costs purposes
    • admission of documents
  • 2024-01-24
    Revocation ActionÖffentlich

    Zusammenfassung: The Munich Central Division judge-rapporteur issued a procedural order in the Sanofi v. Amgen revocation action, declining Sanofi's request to admit supplementary expert declarations filed in response to new points raised in Amgen's rejoinder, noting that the proper course was to raise the matter at the upcoming interim conference.

    Rechtsfragen anzeigen (2)
    • Admission of late expert declarations under Rule 9.1 RoP
    • Close of written procedure and finality of pleadings
  • 2023-09-20
    Revocation ActionÖffentlich

    Zusammenfassung: The Munich Central Division rejected an anonymous individual's R. 262.1(b) RoP application for access to pleadings and evidence filed in Sanofi's revocation action against Amgen (EP patent, case UPC_CFI_1/2023), holding that a personal and professional interest in forming an opinion on patent validity is not a legitimate reason for granting third-party access to the case file.

    Rechtsfragen anzeigen (3)
    • Public access to case file R. 262.1(b) RoP
    • Legitimate reason for third-party access
    • Principle of open proceedings Art. 45 UPCA
  • 2023-08-24
    Preliminary objectionÖffentlich

    Zusammenfassung: The Central Division (Munich) rejected Amgen's preliminary objection challenging jurisdiction over Sanofi's revocation action, holding that the UPC Registry functions as a single receiving mailbox for the whole court and that the action was validly filed.

    Rechtsfragen anzeigen (4)
    • Preliminary objection Rule 19 RoP
    • Jurisdiction
    • UPC Registry as one court
    • Revocation action
  • 2023-06-29
    Revocation ActionÖffentlich

    Zusammenfassung: The Central Division (Munich) issued a procedural order admitting Sanofi's supplementary exhibits to the Statement of Claim (filed via generic application) and confirming the date of service of the Statement for Revocation on Amgen.

    Rechtsfragen anzeigen (3)
    • Admission of exhibits
    • Service date
    • Revocation action
Dokumente
Alle 521 Dokumente anzeigen
DokumenttitelDatumÖffentlich
Procedural Order App_47163/20242024-10-23Nicht öffentlich
Procedural Order App_47172/20242024-10-23Nicht öffentlich
Final Order anonymised2024-07-16Nicht öffentlich
DecisionOutcome2024-07-16Nicht öffentlich
decision revocation action 1/20232024-07-16Öffentlich
decision revocation action 1/20232024-07-16Nicht öffentlich
Announcement2024-07-04Öffentlich
ORAL_HEARING_REFERENCING_459505-20232024-06-05Nicht öffentlich
ORAL_HEARING_REFERENCING_459505-20232024-06-05Nicht öffentlich
interimProcedureClosure2024-05-22Nicht öffentlich
Zusammenfassung in einfacher Sprache

Sanofi-Aventis brought the UPC's first-ever revocation action before the Munich Central Division challenging EP 3666797 B1 owned by Amgen — an anti-PCSK9 antibody formulation patent for treating hypercholesterolaemia (related to the evolocumab drug). The Central Division revoked the patent in its entirety across 17 Contracting Member States, finding the main claim and all 17 auxiliary requests lacked inventive step over the prior art. The decision established foundational UPC principles on claim interpretation, priority assessment, and the inventive step assessment framework. Amgen was ordered to pay Sanofi's costs of EUR 1,375,000.

Angenommene Argumente
Was das Gericht akzeptiert hat — nach Partei.

  • EP 3666797 lacks inventive step over the prior art

    KlägerRechtsgrundlage: Art. 138(1)(a) EPC; Art. 56 EPC; Art. 65(2) UPCA

    Hinweis: Munich Central Division found the main request and all 17 auxiliary requests lack inventive step; patent revoked in its entirety across 17 UPC Contracting Member States.

  • Priority date of EP 3666797 is not validly claimed, narrowing the relevant prior art window

    KlägerRechtsgrundlage: Art. 87 EPC

    Hinweis: Court considered priority validity as part of the analysis; the valid priority test requires that the skilled person can derive the claim subject-matter directly and unambiguously from the priority application using common general knowledge.

Zurückgewiesene Argumente
Was das Gericht nicht akzeptiert hat — und warum.

  • EP 3666797 is inventive; claimed anti-PCSK9 antibody formulation with specific pH and concentration features represents a non-obvious solution

    BeklagterRechtsgrundlage: Art. 56 EPC

    Begründung: Court found the claimed solution was obvious because the skilled person would be motivated to arrive at it as a next step in developing the prior art without inventive contribution; absence of alternative paths in prior art does not establish non-obviousness.

  • Auxiliary requests 1–17 each independently confer inventive step

    BeklagterRechtsgrundlage: Art. 56 EPC; Art. 76 UPCA

    Begründung: All 17 auxiliary requests lack inventive step for the same reasons as the main request; no specific arguments were advanced distinguishing each auxiliary request.

Zentrale Rechtsgrundsätze
In der Begründung herangezogene Doktrinen und Regeln.
Claim interpretation: skilled person applies technical meaning of terms using description and drawings, not philological reading; description may serve as patent's own lexiconPriority: claimed invention is 'same invention' under Art. 87 EPC if skilled person can derive claim subject-matter directly and unambiguously from priority application using common general knowledgeInventive step: starting point is a realistic prior art starting point (not necessarily the 'most promising'); there may be several realistic starting pointsNon-obviousness does not follow merely from the fact that alternative solutions existed in the prior art; decisive question is whether the claimed solution is non-obviousA feature selected arbitrarily from several possibilities cannot generally contribute to inventive stepTechnical effect or advantage over prior art may indicate inventive step

Weitere Fälle zu diesem Grundsatz ansehen.

Hinweise zur Anspruchsauslegung

The Munich Central Division addressed claim interpretation of EP 3666797 (anti-PCSK9 antibody composition for treating hypercholesterolaemia, particularly claim 1 specifying an antibody, pH range, and excipient concentration). The court applied a technical rather than philological approach, accepting that the description may define terms as the patent's own lexicon. On priority, the court applied the 'direct and unambiguous derivability' standard to assess whether the claimed subject-matter was supported by the priority application.