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CC 586764/2023

Nov 10, 2023·EP3666797 +1 more: ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)

Parent infringement case:UPC CFI 14/2023

Case details
Status
Case Closed
Action
Counterclaim for revocation
Category
Counter Claim for Revocation
Parties
Claimants
Reps: Niels Hölder (Hoffmann Eitle); Agathe Michel-De Cazotte (Carpmaels & Ransford); Daniel Wise (Carpmaels & Ransford)
Respondents
Reps: Johannes Heselberger
Division
Munich CD
Judges
Technology
Biotech · Antibody · Biotechnology
Language
English
First decided
Jul 16, 2024
Claims
At issueall
Revokedall
Notes: Patent EP 3 666 797 B1 revoked entirely; Main Request and all 17 Auxiliary Requests lacked inventive step.
Decisions
  • 2024-07-16
    RevokedRevocation meritsCounterclaim for revocation

    The patent EP 3 666 797 B1 was revoked in its entirety for all Contracting Member States in which revocation was requested. The Main Request and all 17 Auxiliary Requests were found to lack inventive step. The defendant (patent proprietor Amgen) was ordered to bear the claimant's legal costs, agreed at EUR 1.375 million.

    Legal issues:Claim interpretationPriority (Article 87 EPC)Inventive step (Article 56 EPC)Arbitrary selectionTechnical effect as indication of inventive step
Documents
Document titleDatePublic
Procedural Order App_47154/20242024-10-23Not public
Final Order anonymised2024-07-16Not public
DecisionOutcome2024-07-16Not public
decision revocation counterclaim 14/20232024-07-16Public
decision revocation counterclaim 14/20232024-07-16Not public
Announcement2024-07-04Public
Recording of Oral Hearing - Placeholder2024-06-06Not public
Recording of Oral Hearing - Placeholder2024-06-06Not public
interimProcedureClosure2024-05-22Not public
Receipt2024-05-13Not public
Receipt2024-05-13Not public
2024.05.10 Sanofi and Regeneron Slide Reference Table - signed2024-05-10Not public
2024.05.10 Sanofi and Regeneron Slides - signed2024-05-10Not public
2024.05.10 Cover letter accompanying slides - signed2024-05-10Not public
Amgen slides2024-05-10Not public
Amgen R 9 Appl - filing slides2024-05-10Not public
Outcome of the Order2024-05-07Not public
order extension slides2024-05-07Public
Receipt2024-05-07Not public
Extension request2024-05-06Not public
Outcome of the Order2024-04-30Not public
order closing workflow2024-04-30Public
Receipt2024-04-26Not public
Annex 1 - Updated Consolidated List of Exhibits and Evidence (signed)2024-04-26Not public
C54a - Amgen infringement claim (EN translation)2024-04-26Not public
2024.04.26 RoP 9.1 Application re C37a (signed)2024-04-26Not public
C37a - US 60_818234 (priority document to BMS patent application) (signed)2024-04-26Not public
summons2024-04-19Not public
summons oral hearing2024-04-19Public
Hearing-Dates2024-04-19Not public
Receipt2024-04-05Not public
Annex 2 - Notice of experts (signed)2024-04-05Not public
Annex 1 - Cross-reference table (signed)2024-04-05Not public
2024.04.05 - Claimants Case Summary - signed2024-04-05Not public
20240405 Case Summary2024-04-05Not public
20240405 Amgen Cover Letter2024-04-05Not public
writtenProcedureClosure2024-04-04Not public
Hearing-Dates2024-04-04Not public
order re CMS dates2024-04-04Public
Template-Order2024-04-04Not public
Hearing-Dates2024-04-04Not public
Acknowledgement-of-lodging2024-03-21Not public
20240321 Amgen Response CD to Sanofi submission re Pan declaration2024-03-21Not public
Acknowledgement-of-lodging2024-03-12Not public
Reply to Amgen Defence to the Counterclaim for Invalidity2024-03-12Not public
2024.03.07 Reply to Amgen Defence to the Counterclaim for Invalidity (signed)2024-03-07Not public
order to combine cases2024-02-27Public
Acknowledgement-of-lodging2024-01-25Not public
Formal-checks_Notification-of-positive-outcome2024-01-25Not public
Formal-checks_Notification-of-positive-outcome2024-01-24Not public
Acknowledgement-of-lodging2024-01-24Not public
D94 - Weider 20162024-01-24Not public
D40a - AppA Wang LNB2024-01-24Not public
AR1-17 (marked)_signed2024-01-24Not public
D14 - Havel and Hamilton 20042024-01-24Not public
D68 - Examiner interview notes re TPOs (15.3.2023)2024-01-24Not public
D20 - Nassoury 20072024-01-24Not public
D92 - US8710192B2 (Novartis)_PDFa2024-01-24Not public
D39 - Declaration of Kelly Berry2024-01-24Not public
D2 - US7737266B2 (Alnylam)2024-01-24Not public
D67 - Examiner Interview Notes (1.3. 2023)2024-01-24Not public
D66 - Bell 20062024-01-24Not public
D43 - Roberts 19872024-01-24Not public
D38 - Kondrashov 20082024-01-24Not public
D40b - AppB Wang LNB2024-01-24Not public
D35 - Lo Surdo 20112024-01-24Not public
D56 - Parameswaran And Liu 20132024-01-24Not public
D5 - WO 2008_043753 A22024-01-24Not public
D69 - Examiner Notes about irrelevance of TPOs (27.3.2023)2024-01-24Not public
D60 - Soto 20192024-01-24Not public
D15 - Lagace_Supplemental_Data to C32024-01-24Not public
D36 - Baran 20172024-01-24Not public
D11 - Brown and Goldstein 19862024-01-24Not public
D46 - MacCallum 19962024-01-24Not public
D54 - DeGenst 20052024-01-24Not public
D47 - Glaser 19922024-01-24Not public
D8 - Ni et al. 20102024-01-24Not public
D9 - Crooke 20052024-01-24Not public
Exhibit_BP_CC022024-01-24Not public
D52 - Perelson Weisbuch 19952024-01-24Not public
D55 - Rudenko_full_validation_report 20012024-01-24Not public
D25 - McNutt 20092024-01-24Not public
D48 - Baerga-Ortiz 20022024-01-24Not public
D27 - Poirier 20082024-01-24Not public
D51 - Raybould 20212024-01-24Not public
D16 - Horton 20032024-01-24Not public
D53 - Pedrioli and Oxenius 20212024-01-24Not public
D37 - Rees 20202024-01-24Not public
D59 - Hu 20172024-01-24Not public
D24 - US 2009_02750532024-01-24Not public
D44 - Chowdhury 19992024-01-24Not public
D65 - Subramaniam 20052024-01-24Not public
D40 - Declaration of Wei Wang2024-01-24Not public
D26 - Poirier 20092024-01-24Not public
D17 - Maxwell 20052024-01-24Not public
D29 - WO 2008_10577972024-01-24Not public
D12 - Brown and Goldstein 19792024-01-24Not public
D13 - McCuskey 20082024-01-24Not public
D1 - Seeking alpha_Alnylam 20172024-01-24Not public
D63 - Spencer 20022024-01-24Not public
D23 - Grefhorst 20082024-01-24Not public
Exhibit_Annex_22024-01-24Not public
D57 - Nature Editorial 20112024-01-24Not public
D18 - Seidah 20062024-01-24Not public
Exhibit_BP_CC012024-01-24Not public
D61 - Jia 20042024-01-24Not public
D22 - Ioannidis 20052024-01-24Not public
D33 - Esteve 20042024-01-24Not public
D4 - Kastelein 20062024-01-24Not public
D31 - US 8_420_098 B22024-01-24Not public
D30 - Horton 20092024-01-24Not public
D64 - Choi 20122024-01-24Not public
Exhibit_C302024-01-24Not public
D6 - WO 2008_057457 A22024-01-24Not public
D7 - Kruth 20012024-01-24Not public
D93 - Pan declaration_PDFa2024-01-24Not public
D10 - Bell 20132024-01-24Not public
Exhibit_BP_CC032024-01-24Not public
D41 - EP 2 358 756 B12024-01-24Not public
D3 - Frank-Kamenetsky et al. 20082024-01-24Not public
D62 - Novotny 19832024-01-24Not public
Defence to the counterclaim for revocation AND Application to amend the patent of Amgen2024-01-24Not public
D21 - Homer 20082024-01-24Not public
D45 - Ye 20222024-01-24Not public
D32 - Mitchell 20142024-01-24Not public
Exhibit_E52024-01-24Not public
D34 - Eliassen 20062024-01-24Not public
D49 - Rudenko 20022024-01-24Not public
D58 - Paull 20192024-01-24Not public
D19 - Graham 20072024-01-24Not public
AR1-17 (clean)_signed2024-01-24Not public
D50 - Edwards 20032024-01-24Not public
Exhibit_E62024-01-24Not public
D28 - Press Release BMS_Isis2024-01-24Not public
D42 - US8357371B22024-01-24Not public
D66 - Bell 20062024-01-24Not public
D12 - Brown and Goldstein 19792024-01-24Not public
D94 - Weider 20162024-01-24Not public
D49 - Rudenko 20022024-01-24Not public
D58 - Paull 20192024-01-24Not public
Exhibit_Annex_22024-01-24Not public
D65 - Subramaniam 20052024-01-24Not public
D8 - Ni et al. 20102024-01-24Not public
D36 - Baran 20172024-01-24Not public
D2 - US7737266B2 (Alnylam)2024-01-24Not public
D29 - WO 2008_10577972024-01-24Not public
D62 - Novotny 19832024-01-24Not public
D17 - Maxwell 20052024-01-24Not public
D51 - Raybould 20212024-01-24Not public
D16 - Horton 20032024-01-24Not public
D54 - DeGenst 20052024-01-24Not public
D18 - Seidah 20062024-01-24Not public
D37 - Rees 20202024-01-24Not public
D6 - WO 2008_057457 A22024-01-24Not public
D31 - US 8_420_098 B22024-01-24Not public
D69 - Examiner Notes about irrelevance of TPOs (27.3.2023)2024-01-24Not public
D24 - US 2009_02750532024-01-24Not public
D57 - Nature Editorial 20112024-01-24Not public
D40b - AppB Wang LNB2024-01-24Not public
AR1-17 (marked)_signed2024-01-24Not public
D42 - US8357371B22024-01-24Not public
D33 - Esteve 20042024-01-24Not public
D44 - Chowdhury 19992024-01-24Not public
D21 - Homer 20082024-01-24Not public
D34 - Eliassen 20062024-01-24Not public
D32 - Mitchell 20142024-01-24Not public
D63 - Spencer 20022024-01-24Not public
D38 - Kondrashov 20082024-01-24Not public
D20 - Nassoury 20072024-01-24Not public
D64 - Choi 20122024-01-24Not public
D26 - Poirier 20092024-01-24Not public
D39 - Declaration of Kelly Berry2024-01-24Not public
Defence to the counterclaim for revocation AND Application to amend the patent of Amgen2024-01-24Not public
D67 - Examiner Interview Notes (1.3. 2023)2024-01-24Not public
D9 - Crooke 20052024-01-24Not public
D59 - Hu 20172024-01-24Not public
D5 - WO 2008_043753 A22024-01-24Not public
Exhibit_E52024-01-24Not public
AR1-17 (clean)_signed2024-01-24Not public
D92 - US8710192B2 (Novartis)_PDFa2024-01-24Not public
D60 - Soto 20192024-01-24Not public
D35 - Lo Surdo 20112024-01-24Not public
Exhibit_BP_CC032024-01-24Not public
Exhibit_E62024-01-24Not public
D3 - Frank-Kamenetsky et al. 20082024-01-24Not public
D50 - Edwards 20032024-01-24Not public
D68 - Examiner interview notes re TPOs (15.3.2023)2024-01-24Not public
D45 - Ye 20222024-01-24Not public
D27 - Poirier 20082024-01-24Not public
D22 - Ioannidis 20052024-01-24Not public
Exhibit_BP_CC012024-01-24Not public
D47 - Glaser 19922024-01-24Not public
D1 - Seeking alpha_Alnylam 20172024-01-24Not public
D93 - Pan declaration_PDFa2024-01-24Not public
D11 - Brown and Goldstein 19862024-01-24Not public
D61 - Jia 20042024-01-24Not public
D14 - Havel and Hamilton 20042024-01-24Not public
D4 - Kastelein 20062024-01-24Not public
D53 - Pedrioli and Oxenius 20212024-01-24Not public
D52 - Perelson Weisbuch 19952024-01-24Not public
D55 - Rudenko_full_validation_report 20012024-01-24Not public
D19 - Graham 20072024-01-24Not public
D30 - Horton 20092024-01-24Not public
D41 - EP 2 358 756 B12024-01-24Not public
Exhibit_C302024-01-24Not public
D56 - Parameswaran And Liu 20132024-01-24Not public
D43 - Roberts 19872024-01-24Not public
D40a - AppA Wang LNB2024-01-24Not public
D46 - MacCallum 19962024-01-24Not public
D10 - Bell 20132024-01-24Not public
D28 - Press Release BMS_Isis2024-01-24Not public
D48 - Baerga-Ortiz 20022024-01-24Not public
D40 - Declaration of Wei Wang2024-01-24Not public
D23 - Grefhorst 20082024-01-24Not public
D25 - McNutt 20092024-01-24Not public
D13 - McCuskey 20082024-01-24Not public
D15 - Lagace_Supplemental_Data to C32024-01-24Not public
D7 - Kruth 20012024-01-24Not public
Exhibit_BP_CC022024-01-24Not public
Acknowledgement of access to case2024-01-09Not public
Notification Of Service2023-12-20Not public
Zustellnachweis2023-12-20Not public
epoUploadDocumentsWorkflow2023-12-05Not public
Document from EPO2023-12-05Not public
Letter for Service2023-12-01Not public
Panel-Appointment2023-11-30Not public
EPO-Request-for-case-pending2023-11-24Not public
Acknowledgement-of-lodging2023-11-24Not public
Formal-checks_Notification-of-positive-outcome2023-11-24Not public
W372023-11-24Not public
W642023-11-24Not public
W482023-11-24Not public
W292023-11-24Not public
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W532023-11-24Not public
W32023-11-24Not public
Revocation Counerclaim2023-11-24Not public
W262023-11-24Not public
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W432023-11-24Not public
W452023-11-24Not public
Correction of Formalities2023-11-24Not public
W152023-11-24Not public
W562023-11-24Not public
W212023-11-24Not public
W312023-11-24Not public
W572023-11-24Not public
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W622023-11-24Not public
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proof of payment2023-11-24Not public
W392023-11-24Not public
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W382023-11-24Not public
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Formal-checks_Request-for-correction2023-11-14Not public
W282023-11-10Not public
E32023-11-10Not public
W62023-11-10Not public
W582023-11-10Not public
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W232023-11-10Not public
W602023-11-10Not public
W362023-11-10Not public
W302023-11-10Not public
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W152023-11-10Not public
W332023-11-10Not public
W402023-11-10Not public
W272023-11-10Not public
W542023-11-10Not public
W72023-11-10Not public
W592023-11-10Not public
W132023-11-10Not public
W642023-11-10Not public
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W412023-11-10Not public
proof of payment2023-11-10Not public
W192023-11-10Not public
W532023-11-10Not public
W442023-11-10Not public
W492023-11-10Not public
W122023-11-10Not public
W562023-11-10Not public
W322023-11-10Not public
W202023-11-10Not public
W82023-11-10Not public
E12023-11-10Not public
W242023-11-10Not public
W142023-11-10Not public
W252023-11-10Not public
W552023-11-10Not public
W462023-11-10Not public
W262023-11-10Not public
W102023-11-10Not public
W12023-11-10Not public
W342023-11-10Not public
W22023-11-10Not public
Revocation Counerclaim2023-11-10Not public
W212023-11-10Not public
W422023-11-10Not public
W432023-11-10Not public
W572023-11-10Not public
W612023-11-10Not public
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W182023-11-10Not public
W622023-11-10Not public
W92023-11-10Not public
W382023-11-10Not public
W42023-11-10Not public
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W512023-11-10Not public
W392023-11-10Not public
W172023-11-10Not public
W632023-11-10Not public
E42023-11-10Not public
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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 lexiconpriority 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 knowledgeinventive 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 pointinventive 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 artfor denying inventive step it is sufficient that skilled person without inventive contribution would arrive at a result covered by the claimarbitrary selection from several equivalent possibilities does not contribute to inventive step

Browse other cases on this principle.

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.