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UPC CFI 1/2023
Jun 2, 2023·EP3666797 +1 more: ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)
- Case details
- StatusCase ClosedActionRevocationCategoryMain Revocation Action
- Parties
- Division
- Munich CD
- Technology
- Biotech · Antibody · Biotechnology
- Language
- English
- First decided
- Jun 29, 2023
- Last decision
- Feb 24, 2024
Claims
At issueall
Revokedall
Notes: EP 3 666 797 B1 revoked entirely (UPC's first revocation case); Main Request and all 17 Auxiliary Requests lacked inventive step.
Decisions
- 2024-10-22Application RoP262.1 (b)
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.
Legal issues:Third-party access to court file under R.262.1(b) RoPBalance of interests in concluded proceedingsTransparency of UPC proceedings - 2024-07-16RevokedRevocation meritsRevocation Action
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.
Legal issues:Claim interpretation in revocation proceedingsPriority validity under Art. 87 EPCAssessment of inventive step and realistic starting point in prior artObviousness and reasonable expectation of successTechnical effect as indication of inventive step - 2024-02-24Revocation Action
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.
Legal issues:consolidation of related actionsvalue of proceedings for costs purposesadmission of documents - 2024-01-24Revocation Action
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.
Legal issues:Admission of late expert declarations under Rule 9.1 RoPClose of written procedure and finality of pleadings - 2023-09-20DismissedRevocation meritsRevocation Action
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.
Legal issues:Public access to case file R. 262.1(b) RoPLegitimate reason for third-party accessPrinciple of open proceedings Art. 45 UPCA - 2023-08-24JurisdictionalPreliminary objection
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.
Legal issues:Preliminary objection Rule 19 RoPJurisdictionUPC Registry as one courtRevocation action - 2023-06-29Revocation Action
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.
Legal issues:Admission of exhibitsService dateRevocation action
Documents
| Document title | Date | Public |
|---|---|---|
| Procedural Order App_47163/2024 | 2024-10-23 | Not public |
| Procedural Order App_47172/2024 | 2024-10-23 | Not public |
| Final Order anonymised | 2024-07-16 | Not public |
| DecisionOutcome | 2024-07-16 | Not public |
| decision revocation action 1/2023 | 2024-07-16 | Public |
| decision revocation action 1/2023 | 2024-07-16 | Not public |
| Announcement | 2024-07-04 | Public |
| ORAL_HEARING_REFERENCING_459505-2023 | 2024-06-05 | Not public |
| ORAL_HEARING_REFERENCING_459505-2023 | 2024-06-05 | Not public |
| interimProcedureClosure | 2024-05-22 | Not public |
| Receipt | 2024-05-13 | Not public |
| Receipt | 2024-05-13 | Not public |
| 2024.05.10 Sanofi and Regeneron Slides - signed | 2024-05-10 | Not public |
| 2024.05.10 Cover letter accompanying slides - signed | 2024-05-10 | Not public |
| 2024.05.10 Sanofi and Regeneron Slide Reference Table - signed | 2024-05-10 | Not public |
| Amgen slides | 2024-05-10 | Not public |
| Amgen R 9 Appl - filing slides | 2024-05-10 | Not public |
| Outcome of the Order | 2024-05-07 | Not public |
| extension order slides | 2024-05-07 | Public |
| Outcome of the Order | 2024-05-07 | Not public |
| order re admission of documents | 2024-05-07 | Public |
| Receipt | 2024-05-07 | Not public |
| Extension request | 2024-05-06 | Not public |
| Amgen Reply to Prel Order 30 April 2024 | 2024-05-03 | Not public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Not public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Public |
| Outcome of the Order | 2024-04-30 | Not public |
| order closing workflow | 2024-04-30 | Public |
| PO | 2024-04-30 | Not public |
| Receipt | 2024-04-26 | Not public |
| Receipt | 2024-04-26 | Not public |
| Receipt | 2024-04-26 | Not public |
| 2024.04.26 RoP 9.1 Application re C37a (signed) | 2024-04-26 | Not public |
| C37a - US 60_818234 (priority document to BMS patent application) (signed) | 2024-04-26 | Not public |
| Annex 1 - Updated Consolidated List of Exhibits and Evidence (signed) | 2024-04-26 | Not public |
| C54a - Amgen infringement claim (EN translation) | 2024-04-26 | Not public |
| Annex 1 - Updated Consolidated List of Exhibits and Evidence (signed) | 2024-04-26 | Not public |
| C37a - US 60_818234 (priority document to BMS patent application) (signed) | 2024-04-26 | Not public |
| C54a - Amgen infringement claim (EN translation) | 2024-04-26 | Not public |
| 2024.04.26 RoP 9.1 Application re C37a (signed) | 2024-04-26 | Not public |
| C54a - Amgen infringement claim (EN translation) | 2024-04-26 | Not public |
| C37a - US 60_818234 (priority document to BMS patent application) (signed) | 2024-04-26 | Not public |
| 2024.04.26 RoP 9.1 Application re C37a (signed) | 2024-04-26 | Not public |
| Annex 1 - Updated Consolidated List of Exhibits and Evidence (signed) | 2024-04-26 | Not public |
| summons | 2024-04-19 | Not public |
| summons oral hearing | 2024-04-19 | Public |
| Hearing-Dates | 2024-04-19 | Not public |
| writtenProcedureClosure | 2024-04-19 | Not public |
| Receipt | 2024-04-05 | Not public |
| Receipt | 2024-04-05 | Not public |
| Receipt | 2024-04-05 | Not public |
| 2024.04.05 - Claimants Case Summary - signed | 2024-04-05 | Not public |
| 2024.03.07 Reply to Amgen Defence to the Counterclaim for Invalidity (signed) | 2024-04-05 | Not public |
| Annex 2 - Notice of experts (signed) | 2024-04-05 | Not public |
| Annex 1 - Cross-reference table (signed) | 2024-04-05 | Not public |
| Annex 1 - Cross-reference table (signed) | 2024-04-05 | Not public |
| Annex 2 - Notice of experts (signed) | 2024-04-05 | Not public |
| 2024.03.07 Reply to Amgen Defence to the Counterclaim for Invalidity (signed) | 2024-04-05 | Not public |
| 2024.04.05 - Claimants Case Summary - signed | 2024-04-05 | Not public |
| Annex 2 - Notice of experts (signed) | 2024-04-05 | Not public |
| 2024.03.07 Reply to Amgen Defence to the Counterclaim for Invalidity (signed) | 2024-04-05 | Not public |
| Annex 1 - Cross-reference table (signed) | 2024-04-05 | Not public |
| 2024.04.05 - Claimants Case Summary - signed | 2024-04-05 | Not public |
| 20240405 Amgen Cover Letter Case Summary | 2024-04-05 | Not public |
| 20240321 Amgen Response CD to Sanofi submission re Pan declaration | 2024-04-05 | Not public |
| 20240405 Case Summary | 2024-04-05 | Not public |
| 2024.03.07 Reply to Amgen Defence to the Counterclaim for Invalidity (signed) | 2024-03-07 | Not public |
| 2024.03.07 Reply to Amgen Defence to the Counterclaim for Invalidity (signed) | 2024-03-07 | Not public |
| 2024.03.07 Reply to Amgen Defence to the Counterclaim for Invalidity (signed) | 2024-03-07 | Not public |
| Order to combine cases ACT_459505/2023 and CC_586764/2023 | 2024-03-04 | Not public |
| order to combine cases | 2024-02-27 | Not public |
| order to combine cases | 2024-02-27 | Public |
| Receipt | 2024-02-06 | Not public |
| Receipt | 2024-02-06 | Not public |
| Exhibit | 2024-02-05 | Not public |
| Application | 2024-02-05 | Not public |
| Exhibit | 2024-02-05 | Not public |
| Application for a procedural order pursuant to Rule 9(1) RoP | 2024-02-05 | Not public |
| Order Local Division 2 February 2024 | 2024-02-05 | Not public |
| C10a priority document | 2024-02-05 | Not public |
| D99 Edrees et al 2005 | 2024-02-05 | Not public |
| Outcome of the Order | 2024-01-24 | Not public |
| RoP 9.1 order final | 2024-01-24 | Not public |
| 20240119 Amgen Response CD Order Rule 9 application | 2024-01-19 | Not public |
| Representation | 2024-01-17 | Not public |
| preliminary order 16 January 2024 RoP 9.1 | 2024-01-16 | Not public |
| Template-Order | 2024-01-16 | Not public |
| Acknowledgement-of-change-of-a-representative | 2024-01-16 | Not public |
| Receipt | 2024-01-16 | Not public |
| rejoinAmendPatentDefence | 2024-01-15 | Not public |
| Rejoinder to Reply to Defence to Application to amend | 2024-01-15 | Not public |
| Exhibit E14 | 2024-01-15 | Not public |
| Exhibit E13 | 2024-01-15 | Not public |
| Exhibit C113 | 2024-01-15 | Not public |
| Exhibit E15 | 2024-01-15 | Not public |
| Exhibit C112 | 2024-01-15 | Not public |
| Application | 2024-01-15 | Not public |
| Exhibit C114 | 2024-01-15 | Not public |
| App-R293-Receipt | 2024-01-09 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-01-09 | Not public |
| Acknowledgement-of-lodging | 2023-12-22 | Not public |
| Explanations re Application for change of Representative (R. 293 RoP) | 2023-12-22 | Not public |
| Acknowledgement-of-lodging | 2023-12-13 | Not public |
| D75 - Blundell 2004 | 2023-12-13 | Not public |
| D88 - Arkin and Wells 2004 | 2023-12-13 | Not public |
| D74 - Blundell 2002 | 2023-12-13 | Not public |
| D76 - Hansen 2002 | 2023-12-13 | Not public |
| D86 - Benjannet 2012 | 2023-12-13 | Not public |
| D93 - O. Pan declaration | 2023-12-13 | Not public |
| D78 - Dunbar 2013 | 2023-12-13 | Not public |
| D91 - Lin 2003 | 2023-12-13 | Not public |
| D79 - Dubuc 2010 | 2023-12-13 | Not public |
| D82 - Chan 2009.pdf | 2023-12-13 | Not public |
| D89 - Wells and Clendon 2007 | 2023-12-13 | Not public |
| D87 - Wetterau 1998 | 2023-12-13 | Not public |
| D71 - Ladner 2007 | 2023-12-13 | Not public |
| Annex 1 - Updated List of cited Documents Defendant Amgen | 2023-12-13 | Not public |
| D72 - McPherson 2008 | 2023-12-13 | Not public |
| D97 - Transcript of Feb 22, 2019 Trial Hearing (S. Jackson) | 2023-12-13 | Not public |
| D80 - Paul 2013 | 2023-12-13 | Not public |
| D96 - MGI-Mouse Facts | 2023-12-13 | Not public |
| D81 - Prof. Boyd's Chart from US Proceedings | 2023-12-13 | Not public |
| 2nd Declaration of Dr. R. Parker | 2023-12-13 | Not public |
| D92 - US8710192B2 (Novartis) | 2023-12-13 | Not public |
| D73 - Manjasetty 2008 | 2023-12-13 | Not public |
| D98 - Internal Amgen research document (2012) | 2023-12-13 | Not public |
| 2nd Declaration of Prof. A. Rees | 2023-12-13 | Not public |
| D84 - Fraser 1995 | 2023-12-13 | Not public |
| D95 - Horton Parker Joint Expert Report | 2023-12-13 | Not public |
| D83 - Wight and Merrilees 2004 | 2023-12-13 | Not public |
| D94 - Weider 2016 | 2023-12-13 | Not public |
| D77 - Brunzelle 2004 | 2023-12-13 | Not public |
| D90 - Oltersdorf 2005 | 2023-12-13 | Not public |
| D85 - Abstract book - PCSK9 conference Nantes (2010) | 2023-12-13 | Not public |
| Defendants Rejoinder to Reply to defence (13.12.2023) | 2023-12-13 | Not public |
| D70 - Sandin 2004 | 2023-12-13 | Not public |
| replyAmendPatentDefence | 2023-12-13 | Not public |
| Defendants Reply to Claimants Defence to Application to amend | 2023-12-13 | Not public |
| amendPatentDefence | 2023-12-05 | Not public |
| 2023.11.13 Sanofi CD Reply to Defence - signed | 2023-12-05 | Not public |
| Acknowledgement-of-lodging | 2023-12-04 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2023-12-04 | Not public |
| Auxiliary Requests AR1 - AR17 (clean version) | 2023-12-04 | Not public |
| Auxiliary Requests AR1 - AR17 (marked-up versions) | 2023-12-04 | Not public |
| Defendant Amgens Application to Amend (AR1-AR17) | 2023-12-04 | Not public |
| Receipt | 2023-12-04 | Not public |
| Defendants Defence to Revocation (includes Application to Amend) | 2023-12-01 | Not public |
| Auxiliary Requests AR1-17 (clean version) | 2023-12-01 | Not public |
| Auxiliary Requests AR1-17 (marked-up version) | 2023-12-01 | Not public |
| Outcome of the Order | 2023-11-27 | Not public |
| closing workflow | 2023-11-27 | Not public |
| Outcome of the Order | 2023-11-22 | Not public |
| 22112023 RoP 9.3(a) order | 2023-11-22 | Not public |
| Receipt | 2023-11-22 | Not public |
| Defandants additional comments re Rule 9.3 RoP (time extension request) | 2023-11-21 | Not public |
| Response to Amgen request 587598 for an extension to Rejoinder | 2023-11-20 | Not public |
| Response to Amgen request 587598 for an extension to Rejoinder | 2023-11-20 | Not public |
| Response to Amgen request 587598 for an extension to Rejoinder | 2023-11-20 | Not public |
| Preliminary order RoP 9.3(a) | 2023-11-20 | Not public |
| Preliminary order RoP 9.3(a) | 2023-11-20 | Not public |
| Response to Amgen request 587598 for an extension to Rejoinder | 2023-11-17 | Not public |
| Receipt | 2023-11-17 | Not public |
| Reasoned Request (Time Extension) pursuant to Rule 9 RoP | 2023-11-16 | Not public |
| Acknowledgement-of-lodging | 2023-11-13 | Not public |
| E7 - signed | 2023-11-13 | Not public |
| C86 - signed | 2023-11-13 | Not public |
| C54 - signed | 2023-11-13 | Not public |
| C83 - signed | 2023-11-13 | Not public |
| C63 - signed | 2023-11-13 | Not public |
| C56 - signed | 2023-11-13 | Not public |
| C58 - signed | 2023-11-13 | Not public |
| C71 - signed | 2023-11-13 | Not public |
| C95 - signed | 2023-11-13 | Not public |
| C84 - signed | 2023-11-13 | Not public |
| C102 - signed | 2023-11-13 | Not public |
| C60 - signed | 2023-11-13 | Not public |
| C59 - signed | 2023-11-13 | Not public |
| C64 - signed | 2023-11-13 | Not public |
| C92 - signed | 2023-11-13 | Not public |
| C89 - signed | 2023-11-13 | Not public |
| C38a - signed | 2023-11-13 | Not public |
| C80 - signed | 2023-11-13 | Not public |
| C62 - signed | 2023-11-13 | Not public |
| C108 - signed | 2023-11-13 | Not public |
| C87 - signed | 2023-11-13 | Not public |
| C90 - signed | 2023-11-13 | Not public |
| C67 - signed | 2023-11-13 | Not public |
| C101 - signed | 2023-11-13 | Not public |
| C93 - signed | 2023-11-13 | Not public |
| C110 - signed | 2023-11-13 | Not public |
| C65 - signed | 2023-11-13 | Not public |
| C69 - signed | 2023-11-13 | Not public |
| E9 - signed | 2023-11-13 | Not public |
| C55 - signed | 2023-11-13 | Not public |
| C96 - signed | 2023-11-13 | Not public |
| C81 - signed | 2023-11-13 | Not public |
| 2023.11.13 Sanofi CD Reply to Defence - signed | 2023-11-13 | Not public |
| C99 - signed | 2023-11-13 | Not public |
| C106 - signed | 2023-11-13 | Not public |
| C75 - signed | 2023-11-13 | Not public |
| C111 - signed | 2023-11-13 | Not public |
| C104 - signed | 2023-11-13 | Not public |
| C91 - signed | 2023-11-13 | Not public |
| C82 - signed | 2023-11-13 | Not public |
| E10 - signed | 2023-11-13 | Not public |
| C70 - signed | 2023-11-13 | Not public |
| C100 - signed | 2023-11-13 | Not public |
| C98 - signed | 2023-11-13 | Not public |
| C57 - signed | 2023-11-13 | Not public |
| C107 - signed | 2023-11-13 | Not public |
| C78 - signed | 2023-11-13 | Not public |
| C94 - signed | 2023-11-13 | Not public |
| C74 - signed | 2023-11-13 | Not public |
| C103 - signed | 2023-11-13 | Not public |
| E8 - signed | 2023-11-13 | Not public |
| C105 - signed | 2023-11-13 | Not public |
| C77 - signed | 2023-11-13 | Not public |
| C85 - signed | 2023-11-13 | Not public |
| C66 - signed | 2023-11-13 | Not public |
| C68 - signed | 2023-11-13 | Not public |
| C73 - signed | 2023-11-13 | Not public |
| C72 - signed | 2023-11-13 | Not public |
| C76 - signed | 2023-11-13 | Not public |
| C88 - signed | 2023-11-13 | Not public |
| C79 - signed | 2023-11-13 | Not public |
| C61 - signed | 2023-11-13 | Not public |
| C97 - signed | 2023-11-13 | Not public |
| C109 - signed | 2023-11-13 | Not public |
| Official Date | 2023-10-16 | Not public |
| Order RoP 28 dated 16 October 2023 | 2023-10-16 | Not public |
| Reply to preliminary order setting provisional dates (signed) | 2023-10-11 | Not public |
| Reply to preliminary order setting provisional dates (signed) | 2023-10-11 | Not public |
| Reply to preliminary order setting provisional dates (signed) | 2023-10-11 | Not public |
| Defendants Reply to PO No. 577997 (no objections) | 2023-10-09 | Not public |
| preliminary order Rule 28 RoP | 2023-10-04 | Not public |
| Provisional Date | 2023-10-04 | Not public |
| Acknowledgement-of-lodging | 2023-09-14 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2023-09-14 | Not public |
| Divisional Application as filed (OA) - EP3666797A1_Part I | 2023-09-12 | Not public |
| Annex 1 - List of Cited Documents Defendant Amgen | 2023-09-12 | Not public |
| D28 - Press Release BMS Isis | 2023-09-12 | Not public |
| D24 - US 2009/0275053 | 2023-09-12 | Not public |
| D62 - Novotny 1983 | 2023-09-12 | Not public |
| D13 - McCuskey 2008 | 2023-09-12 | Not public |
| D58 - Paull 2019 | 2023-09-12 | Not public |
| D33 - Esteve 2004 | 2023-09-12 | Not public |
| D20 - Nassoury 2007 | 2023-09-12 | Not public |
| D29 - WO 2008/1057797 | 2023-09-12 | Not public |
| D47 - Glaser 1992 | 2023-09-12 | Not public |
| D9 - Crooke 2005 | 2023-09-12 | Not public |
| D48 - Baerga-Ortiz 2002 | 2023-09-12 | Not public |
| D10 - Bell 2013 | 2023-09-12 | Not public |
| D23 - Grefhorst 2008 | 2023-09-12 | Not public |
| D26 - Poirier 2009 | 2023-09-12 | Not public |
| D56 - Parameswaran And Liu 2013 | 2023-09-12 | Not public |
| D3 - Frank-Kamenetsky et al. 2008 | 2023-09-12 | Not public |
| AR1-AR17 (marked-up) | 2023-09-12 | Not public |
| D40a - Appendix A Wang Lab Notebook | 2023-09-12 | Not public |
| D17 - Maxwell 2005 | 2023-09-12 | Not public |
| E6 - Declaration of Prof. T. Rees (with CV) | 2023-09-12 | Not public |
| D61 - Jia 2004 | 2023-09-12 | Not public |
| D68 - Examiner interview notes re TPOs (March 15, 2023) | 2023-09-12 | Not public |
| D34 - Eliassen 2006 | 2023-09-12 | Not public |
| D15 - Lagace Supplemental_Data to C3 | 2023-09-12 | Not public |
| D16 - Horton 2003 | 2023-09-12 | Not public |
| D54 - DeGenst 2005 | 2023-09-12 | Not public |
| D55 - Rudenko_full_validation_report 2001 | 2023-09-12 | Not public |
| D30 - Horton 2009 | 2023-09-12 | Not public |
| D41 - EP 2 358 756 B1 | 2023-09-12 | Not public |
| D38 - Kondrashov 2008 | 2023-09-12 | Not public |
| D40 - Declaration of Wei Wang | 2023-09-12 | Not public |
| Annex 2 - ASO Technology | 2023-09-12 | Not public |
| D7 - Kruth 2001 | 2023-09-12 | Not public |
| D44 - Chowdhury 1999 | 2023-09-12 | Not public |
| D43 - Roberts 1987 | 2023-09-12 | Not public |
| E5 - Declaration of Dr R. Parker (with CV) | 2023-09-12 | Not public |
| D60 - Soto 2019 | 2023-09-12 | Not public |
| D36 - Baran 2017 | 2023-09-12 | Not public |
| D11 - Brown and Goldstein 1986 | 2023-09-12 | Not public |
| D5 - WO 2008/043753 A2 | 2023-09-12 | Not public |
| Defendant Amgen's Defence to Revocation | 2023-09-12 | Not public |
| D39 - Declaration of Kelly Berry | 2023-09-12 | Not public |
| D27 - Poirier 2008 | 2023-09-12 | Not public |
| D18 - Seidah 2006 | 2023-09-12 | Not public |
| D12 - Brown and Goldstein 1979 | 2023-09-12 | Not public |
| D53 - Pedrioli and Oxenius 2021 | 2023-09-12 | Not public |
| D52 - Perelson Weisbuch 1995 | 2023-09-12 | Not public |
| D22 - Ioannidis 2005 | 2023-09-12 | Not public |
| D64 - Choi 2012 | 2023-09-12 | Not public |
| D8 - Ni et al. 2010 | 2023-09-12 | Not public |
| Divisional Application as filed (OA) - EP3666797A1_Part III | 2023-09-12 | Not public |
| D69 - Examiner Notes about irrelevance of TPOs (March 27, 2023) | 2023-09-12 | Not public |
| D6 - WO 2008/057457 A2 | 2023-09-12 | Not public |
| D21 - Homer 2008 | 2023-09-12 | Not public |
| D59 - Hu 2017 | 2023-09-12 | Not public |
| D49 - Rudenko 2002 | 2023-09-12 | Not public |
| D46 - MacCallum 1996 | 2023-09-12 | Not public |
| AR1 - AR17 (clean version) | 2023-09-12 | Not public |
| D57 - Nature Editorial 2011 | 2023-09-12 | Not public |
| Divisional Application as filed (OA) - EP3666797A1_Part IV | 2023-09-12 | Not public |
| D42 - US 8,357,371 B2 | 2023-09-12 | Not public |
| D40b - Appendix B Wang Lab Notebook | 2023-09-12 | Not public |
| D19 - Graham 2007 | 2023-09-12 | Not public |
| D50 - Edwards 2003 | 2023-09-12 | Not public |
| D25 - McNutt 2009 | 2023-09-12 | Not public |
| D66 - Bell 2006 | 2023-09-12 | Not public |
| D35 - Lo Surdo 2011 | 2023-09-12 | Not public |
| D31 - US 8,420,098 B2 | 2023-09-12 | Not public |
| D63 - Spencer 2002 | 2023-09-12 | Not public |
| D14 - Havel and Hamilton 2004 | 2023-09-12 | Not public |
| D37 - Rees 2020 | 2023-09-12 | Not public |
| D2 - US 7,737,266 B2 (Alnylam) | 2023-09-12 | Not public |
| D65 - Subramaniam 2005 | 2023-09-12 | Not public |
| Divisional Application as filed (OA) - EP3666797A1_Part II | 2023-09-12 | Not public |
| D32 - Mitchell 2014 | 2023-09-12 | Not public |
| D45 - Ye 2022 | 2023-09-12 | Not public |
| D67 - Examiner Interview Notes (March 1, 2023) | 2023-09-12 | Not public |
| D51 - Raybould 2021 | 2023-09-12 | Not public |
| D4 - Kastelein 2006 | 2023-09-12 | Not public |
| D1 - Seeking alpha Alnylam 2017 | 2023-09-12 | Not public |
| Preliminary_Objection_DecisionOutcome | 2023-08-24 | Not public |
| Order rejecting Preliminary Objection dated 24 August 2023 | 2023-08-24 | Not public |
| 554674/2023/OH/2MU/UPC202308173pm | 2023-08-23 | Not public |
| 554674/2023/OH/2MU/UPC202308173pm | 2023-08-23 | Not public |
| Outcome of the Order | 2023-08-21 | Not public |
| order re 9.3(a) request - granting 2 weeks extension | 2023-08-21 | Not public |
| Comments pursuant to RoP264 | 2023-08-21 | Not public |
| Comments pursuant to RoP264 | 2023-08-21 | Not public |
| Comments pursuant to RoP264 | 2023-08-21 | Not public |
| Outcome of the Order | 2023-08-18 | Not public |
| order closing application | 2023-08-18 | Not public |
| Outcome of the Order | 2023-08-18 | Not public |
| order closing application | 2023-08-18 | Not public |
| Outcome of the Order | 2023-08-18 | Not public |
| order closing application | 2023-08-18 | Not public |
| Outcome of the Order | 2023-08-17 | Not public |
| Re Rule 9.3(a) request - closing this application | 2023-08-17 | Not public |
| Preliminary Order 17 August 2023 Rule 9 Application | 2023-08-17 | Not public |
| Receipt | 2023-08-17 | Not public |
| Letter adding co-representatives 17-Aug-2023 (signed) | 2023-08-17 | Not public |
| Receipt | 2023-08-17 | Not public |
| Receipt | 2023-08-17 | Not public |
| Receipt | 2023-08-17 | Not public |
| Receipt | 2023-08-17 | Not public |
| order re public attendance PO hearing 17082023 (ORD_562392_2023) | 2023-08-16 | Not public |
| order re public attendance PO hearing 17082023 | 2023-08-16 | Not public |
| public attendance order hearing 17082023 | 2023-08-16 | Not public |
| Supplementary Submission to Extension Request | 2023-08-16 | Not public |
| Application | 2023-08-16 | Not public |
| Submission in Reply to Claimants Response to Preliminary Objection (Rule 49.1 RoP) | 2023-08-15 | Not public |
| Reasoned Request pursuant to Rule 9 RoP | 2023-08-15 | Not public |
| Hearing-Dates | 2023-08-09 | Not public |
| Hearing invitation 17 August 1500 | 2023-08-09 | Not public |
| commentPreliminaryObjection | 2023-08-08 | Not public |
| Exhibit CR-PO 1 - signed | 2023-08-08 | Not public |
| Comment on Preliminary objection | 2023-08-08 | Not public |
| Annex to Exhibit CR-PO 2 - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 6a - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 5b - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 6b - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 4a - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 2 - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 5a - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 4b - signed | 2023-08-08 | Not public |
| Exhibit CR-PO 3 - signed | 2023-08-08 | Not public |
| Template-Order | 2023-08-04 | Not public |
| Receipt | 2023-07-31 | Not public |
| 2023.07.28 - Withdrawal of document request - Action no 459505-2023 - Signed AGC | 2023-07-28 | Not public |
| preliminaryObjection | 2023-07-25 | Not public |
| Preliminary Objection of defendant (R. 48 and R. 19.1 RoP) | 2023-07-25 | Not public |
| Exhibit ED 2 | 2023-07-25 | Not public |
| Exhibit ED 1 | 2023-07-25 | Not public |
| Formal-checks_Request-for-correction | 2023-07-25 | Not public |
| Preliminary Objection according to R. 48 and R 19.1 RoP | 2023-07-21 | Not public |
| Exhibit ED1 | 2023-07-21 | Not public |
| Exhibit ED2 | 2023-07-21 | Not public |
| Formal-checks_Request-for-correction | 2023-07-17 | Not public |
| Acknowledgement-of-lodging | 2023-07-12 | Not public |
| Reply of Defendant (Amgen) to intended appointment of TQJ | 2023-07-12 | Not public |
| Acknowledgement-of-adding-a-missing-party-or-Applicant | 2023-07-05 | Not public |
| Acknowledgement-of-adding-a-missing-party-or-Applicant | 2023-07-05 | Not public |
| UPC_CFI_1-2023 - Formal Response to the Procedural Order of the Court 536514_2023 dated 29-06-2023 - signed | 2023-06-29 | Not public |
| Outcome of the Order | 2023-06-29 | Not public |
| Order Generic Application | 2023-06-29 | Not public |
| Acknowledgement of access to case | 2023-06-29 | Not public |
| Receipt | 2023-06-27 | Not public |
| B1E - EP3666797 - signed | 2023-06-23 | Not public |
| C1b - US 61_066577 - signed | 2023-06-23 | Not public |
| B1P - EP3666797 - signed | 2023-06-23 | Not public |
| C34B - Turk 2006 - signed | 2023-06-23 | Not public |
| C35 - Goldstein Brown 1975 - signed | 2023-06-23 | Not public |
| C1a - US 61_063949 - signed | 2023-06-23 | Not public |
| C18 - Sarkar et al 2019 - signed | 2023-06-23 | Not public |
| E3 - Boyd declaration_CV - signed | 2023-06-23 | Not public |
| C10 - WO 2008 125623 - signed | 2023-06-23 | Not public |
| C2a - US 61_063980 - signed | 2023-06-23 | Not public |
| P1 - 60_957668 - signed | 2023-06-23 | Not public |
| C46 - Hoogenboom and Chames 2000 - signed | 2023-06-23 | Not public |
| Payment Receipt - signed | 2023-06-23 | Not public |
| C3 - Lagace 2006 - signed | 2023-06-23 | Not public |
| P3F - 61 010630 - signed | 2023-06-23 | Not public |
| B1Q - EP3666797 - signed | 2023-06-23 | Not public |
| P2A - 61_008965 - signed | 2023-06-23 | Not public |
| A1F - WO 2009 026558 - PCT application as filed - signed | 2023-06-23 | Not public |
| C49 - WO 2010 077854 - signed | 2023-06-23 | Not public |
| C23 - Antibody Engineering Methods and Protocols - signed | 2023-06-23 | Not public |
| C6 - Qian 2007 - signed | 2023-06-23 | Not public |
| C4 - Zhang 2007 - signed | 2023-06-23 | Not public |
| B1M - EP3666797 - signed | 2023-06-23 | Not public |
| P3E - 61 010630 - signed | 2023-06-23 | Not public |
| C53 - European Patent Register for 19207796.4 - signed | 2023-06-23 | Not public |
| C20 - Bottomley 2009 - signed | 2023-06-23 | Not public |
| C15 - Seidah 2003 - signed | 2023-06-23 | Not public |
| B1O - EP3666797 - signed | 2023-06-23 | Not public |
| C33 - Benjannet 2004 - signed | 2023-06-23 | Not public |
| C16 - Cohen 2005 - signed | 2023-06-23 | Not public |
| C22 - Phage display a laboratory manual - signed | 2023-06-23 | Not public |
| C2c - Gao 2013 - signed | 2023-06-23 | Not public |
| C32 - Park 2004 - signed | 2023-06-23 | Not public |
| C39 - Brown Goldstein 2006 - signed | 2023-06-23 | Not public |
| P2B - 61_008965 - signed | 2023-06-23 | Not public |
| E2 - Horton Declaration_CV - signed | 2023-06-23 | Not public |
| C5 - Kwon 2008 - signed | 2023-06-23 | Not public |
| C1d - Preliminary opinion of the Enlarged Board in G1 22 and G2 22 - signed | 2023-06-23 | Not public |
| C19 - Ramasamy 2014 - signed | 2023-06-23 | Not public |
| B1K - EP3666797 - signed | 2023-06-23 | Not public |
| C12 - Piper 2007 - signed | 2023-06-23 | Not public |
| P4A - 61_086133 - signed | 2023-06-23 | Not public |
| C51 - Maggon 2007 - signed | 2023-06-23 | Not public |
| C21 - Cameron 2006 - signed | 2023-06-23 | Not public |
| C25 - Rashid 2005 - signed | 2023-06-23 | Not public |
| C29 - Abifadel 2003 - signed | 2023-06-23 | Not public |
| C31B - Sun 2005 - signed | 2023-06-23 | Not public |
| B1B - EP3666797 - signed | 2023-06-23 | Not public |
| C34A - Turk 2006 - signed | 2023-06-23 | Not public |
| C11 - Horton 2006 - signed | 2023-06-23 | Not public |
| C37B - WO2008105797 - signed | 2023-06-23 | Not public |
| B1G - EP3666797 - signed | 2023-06-23 | Not public |
| A1B - WO 2009 026558 - PCT application as filed - signed | 2023-06-23 | Not public |
| C36 - Seidah 2007 - signed | 2023-06-23 | Not public |
| E4 - Zwicker declaration - signed | 2023-06-23 | Not public |
| C34D - Turk 2006 - signed | 2023-06-23 | Not public |
| C1c - PCT request for C1 - signed | 2023-06-23 | Not public |
| C43 - Claims and accompanying letter Feb 2020 - signed | 2023-06-23 | Not public |
| B1F - EP3666797 - signed | 2023-06-23 | Not public |
| B1R - EP3666797 - signed | 2023-06-23 | Not public |
| B1J - EP3666797 - signed | 2023-06-23 | Not public |
| C1 - WO 2009 100297 - signed | 2023-06-23 | Not public |
| B1L - EP3666797 - signed | 2023-06-23 | Not public |
| A1D - WO 2009 026558 - PCT application as filed - signed | 2023-06-23 | Not public |
| P3C - 61 010630 - signed | 2023-06-23 | Not public |
| B1S - EP3666797 - signed | 2023-06-23 | Not public |
| B1N - EP3666797 - signed | 2023-06-23 | Not public |
| P4B - 61_086133 - signed | 2023-06-23 | Not public |
| C47 - Glennie and Johnson 2000 - signed | 2023-06-23 | Not public |
| C17 - Seidah and Prat 2022 - signed | 2023-06-23 | Not public |
| C37A - WO2008105797 - signed | 2023-06-23 | Not public |
| C7 - Fisher 2007 - signed | 2023-06-23 | Not public |
| C27 - Maxwell 2004 - signed | 2023-06-23 | Not public |
| P3D - 61 010630 - signed | 2023-06-23 | Not public |
| C48 - Duff 2009 - signed | 2023-06-23 | Not public |
| C1f - Ni 2011 - signed | 2023-06-23 | Not public |
| C8 - Cunningham 2007 - signed | 2023-06-23 | Not public |
| B1C - EP3666797 - signed | 2023-06-23 | Not public |
| B1D - EP3666797 - signed | 2023-06-23 | Not public |
| B1I - EP3666797 - signed | 2023-06-23 | Not public |
| C1e - Wikipedia simvastatin - signed | 2023-06-23 | Not public |
| A1A - WO 2009 026558 - PCT application as filed - signed | 2023-06-23 | Not public |
| C24B - Hoogenboom 2005 - signed | 2023-06-23 | Not public |
| C40 - Summary of European national case law on sufficiency of disclosure - signed | 2023-06-23 | Not public |
| C38 - WO2009055783 - signed | 2023-06-23 | Not public |
| C26 - Holla 2007 - signed | 2023-06-23 | Not public |
| E1 - Schwartz Declaration_Citations - signed | 2023-06-23 | Not public |
| P3B - 61 010630 - signed | 2023-06-23 | Not public |
| C28 - Cohen 2006 - signed | 2023-06-23 | Not public |
| P3A - 61 010630 - signed | 2023-06-23 | Not public |
| C9 - McNutt 2007 - signed | 2023-06-23 | Not public |
| C45 - Claims filed in November 2022 and sections of response - signed | 2023-06-23 | Not public |
| C41 - Kuroda 2012 - signed | 2023-06-23 | Not public |
| C24A - Hoogenboom 2005 - signed | 2023-06-23 | Not public |
| C31A - Sun 2005 - signed | 2023-06-23 | Not public |
| C44 - Claims filed with response to EESR and sections of response - signed | 2023-06-23 | Not public |
| C2b - PCT request for C2 - signed | 2023-06-23 | Not public |
| C42 - Zhao 2006 - signed | 2023-06-23 | Not public |
| C50 Weiner 2006 - signed | 2023-06-23 | Not public |
| C30 - Berge 2006 - signed | 2023-06-23 | Not public |
| C14 - Lopez 2008 - signed | 2023-06-23 | Not public |
| C34C - Turk 2006 - signed | 2023-06-23 | Not public |
| C52 - National register extracts - signed | 2023-06-23 | Not public |
| C49a - US 61_168753 - signed | 2023-06-23 | Not public |
| A1E - WO 2009 026558 - PCT application as filed - signed | 2023-06-23 | Not public |
| B1A - EP3666797 - signed | 2023-06-23 | Not public |
| A1C - WO 2009 026558 - PCT application as filed - signed | 2023-06-23 | Not public |
| B1U - EP3666797 - signed | 2023-06-23 | Not public |
| C2 - WO 2009 100318 - signed | 2023-06-23 | Not public |
| B1H - EP3666797 - signed | 2023-06-23 | Not public |
| B1T - EP3666797 - signed | 2023-06-23 | Not public |
| P3G - 61 010630 - signed | 2023-06-23 | Not public |
| B1V - EP3666797 - signed | 2023-06-23 | Not public |
| C13 - Hampton 2007 - signed | 2023-06-23 | Not public |
| Notification Of Service | 2023-06-23 | Not public |
| Letter for Service | 2023-06-23 | Not public |
| Rule 9 Order final | 2023-06-23 | Not public |
| Panel-Appointment | 2023-06-20 | Not public |
| statementOfRevocation | 2023-06-02 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2023-06-02 | Not public |
| Letter to Registry - Sanofi v Amgen - Uploading Issues on CMS - signed | 2023-06-01 | Not public |
| 2023.06.01 - Letter to the UPC - Lodging of Revocation Action | 2023-06-01 | Not public |
| Sanofi v Amgen - Revocation Action - EP 3 666 797 – signed v2 | 2023-06-01 | Not 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) UPCANote: 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 EPCNote: 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 EPCReason: 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 UPCAReason: 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.