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Overview · Filed: Jun 2, 2023

UPC_CFI_1/2023

ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)

RevocationMain Revocation ActionMunich CDRevocationCase Closed
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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.