UPClytics
ENDE
Sign inStart trial
View all cases

UPC CFI 1/2023

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

Follow
Case details
Status
Case Closed (Patent revoked)Set aside on appeal, Nov 25, 2025
Action
Revocation
Category
Main revocation action
Parties
Claimants
Representatives
Respondents
Representatives
Division
Munich CD
Judges
Technology
  • Chemistry
    Biotechnology · Pharmaceuticals
Language
English
First decided
Jun 29, 2023
Last decision
Feb 24, 2024
EPO Opposition
Appealed
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
Munich CDLockedLocked
Judge Ulrike VoßLockedLocked
Judge András KupeczLockedLocked
Judge Casper StruveLockedLocked

At the UPC: Sanofi Group (33 cases)·Amgen Group (19 cases)

Start 14-day free trialAlready a user? Sign in
Related cases
All proceedings on this patent

This dispute contains 3 other proceedings

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

3 other defendants litigating the same or a related patent

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

Start a free trial to see how each one ended.

More cases: Munich CD·2023

Decisions
  • 2024-10-22
    Application RoP262.1 (b)Public

    Summary: 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.

    Show the legal issues (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 ActionPublic

    Summary: 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.

    Show the legal issues (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 ActionPublic

    Summary: 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.

    Show the legal issues (3)
    • consolidation of related actions
    • value of proceedings for costs purposes
    • admission of documents
  • 2024-01-24
    Revocation ActionPublic

    Summary: 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.

    Show the legal issues (2)
    • Admission of late expert declarations under Rule 9.1 RoP
    • Close of written procedure and finality of pleadings
  • 2023-09-20
    Revocation ActionPublic

    Summary: 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.

    Show the legal issues (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 objectionPublic

    Summary: 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.

    Show the legal issues (4)
    • Preliminary objection Rule 19 RoP
    • Jurisdiction
    • UPC Registry as one court
    • Revocation action
  • 2023-06-29
    Revocation ActionPublic

    Summary: 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.

    Show the legal issues (3)
    • Admission of exhibits
    • Service date
    • Revocation action
Documents
Show all 521 documents
Document titleDatePublic
Procedural Order App_47163/20242024-10-23Not public
Procedural Order App_47172/20242024-10-23Not public
Final Order anonymised2024-07-16Not public
DecisionOutcome2024-07-16Not public
decision revocation action 1/20232024-07-16Public
decision revocation action 1/20232024-07-16Not public
Announcement2024-07-04Public
ORAL_HEARING_REFERENCING_459505-20232024-06-05Not public
ORAL_HEARING_REFERENCING_459505-20232024-06-05Not public
interimProcedureClosure2024-05-22Not public
Plain-English summary

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.

Accepted arguments
What the court agreed with — by party.

  • EP 3666797 lacks inventive step over the prior art

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

    Note: 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

    ClaimantLegal basis: Art. 87 EPC

    Note: 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.

Rejected arguments
What the court did not agree with — and why.

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

    RespondentLegal basis: Art. 56 EPC

    Reason: 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

    RespondentLegal basis: Art. 56 EPC; Art. 76 UPCA

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

Key legal principles
Doctrines and rules cited in the reasoning.
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

Browse other cases on this principle.

Claim construction notes

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.