CC_586764/2023

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

Parent infringement case:UPC_CFI_14/2023

RevocationCounter Claim for RevocationMunich CDCounter claim for revocationCase Closed

Overview Decisions Reasoning Citations Documents Timeline

Plain-English summary

Regeneron Pharmaceuticals brought a revocation counterclaim against Amgen's EP 3 666 797 B1 (anti-PCSK9 antibody patent) before the Central Division (Munich Section). The Central Division revoked the patent in its entirety over 17 contracting member states, finding that Amgen's Main Request and all 17 Auxiliary Requests lacked inventive step; Amgen was ordered to bear Regeneron's legal costs agreed at EUR 1.375 million, against a case value of EUR 100 million.

Accepted arguments

What the court agreed with — by party.

EP 3 666 797 B1 (anti-PCSK9 antibody) lacks inventive step over the prior art
ClaimantLegal basis: Art. 56 EPC; Art. 138(1)(a) EPC; Art. 65(2) UPCA
Note: Regeneron's inventive step attack succeeded against Amgen's Main Request and all 17 Auxiliary Requests; multiple realistic starting points were identified in the prior art.

Rejected arguments

What the court did not agree with — and why.

EP 3 666 797 B1 Main Request and all 17 Auxiliary Requests are valid and inventive
RespondentLegal basis: Art. 56 EPC; Art. 76 UPCA
Reason: All 17 auxiliary requests lacked inventive step for the same reasons as the Main Request; the Central Division applied Art. 76 UPCA (decisions on merits only on submitted grounds) and found no valid form of the patent.

Key legal principles

Doctrines and rules cited in the reasoning.

claim interpretation uses technical meaning for skilled person, not philological meaning; patent description may act as its own lexicon priority right under Art. 87 EPC: subject-matter of claim must be derivable directly and unambiguously from the priority application by skilled person using common general knowledge inventive step assessment starts from a realistic starting point in prior art; multiple realistic starting points are permissible and there is no requirement to identify the 'most promising' starting point inventive step denied where skilled person would be motivated to arrive at the claimed solution and would implement it as a next step; absence of reasonable expectation of success does not follow merely from existence of alternative solutions in prior art for denying inventive step it is sufficient that skilled person without inventive contribution would arrive at a result covered by the claim arbitrary selection from several equivalent possibilities does not contribute to inventive step

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Prior art relied on

References cited and the role they played.

prior art starting points in the anti-PCSK9 antibody field (multiple realistic starting points identified by Central Division)Obviousness combination

Claim construction notes

EP 3 666 797 B1 claims antigen-binding proteins directed to PCSK9. The Central Division interpreted claim terms using their technical meaning for the skilled person in the antibody/cholesterol-lowering field, with the patent description serving as a lexicon for specialised terms. Priority validity was also assessed: the claimed subject-matter had to be derivable directly and unambiguously from the priority application using common general knowledge.