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UPC CFI 552/2025

Jun 18, 2025·EP3854403: USE OF SUBSTITUTED AMINOPROPIONATE COMPOUNDS IN TREATMENT OF SARS-COV-2 INFECTION

Case details
Status
Interim Phase
Action
Revocation
Category
Main Revocation Action
Parties
Claimants
Reps: Christine Kanz (Hoyng Rokh Monegier); Amandine Métier (Hoyng-Rokh-Monegier Paris); Peter van Schijndel (Hoyng-Rokh-Monegier Amsterdam)
Respondents
Reps: Camille Pecnard (LAVOIX); Pierre-Emanuel Meynard (LAVOIX); Charlotte Cuny (LAVOIX); Béatrice Holz (LAVOIX); Aude Veynante Gardey (LAVOIX); Michael Schlauch (LAVOIX)
Division
Milan CD
Judges
Technology
Pharmaceuticals · Small Molecule · Organic Chemistry
Language
English
First decided
May 4, 2026
Claims
At issue1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Revoked1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Notes: All claims revoked for lack of inventive step. Independent claims 1 and 6 (and all dependent claims 2-5 and 7-11) were found obvious in view of prior art establishing Remdesivir's broad-spectrum anti-coronavirus activity. The Main Request amendment (removing 'a geometric isomer') was admissible but did not cure the inventive step deficiency. All eight auxiliary requests were likewise dismissed without detailed analysis.
Decisions
  • 2026-05-04
    RevokedRevocation meritsRevocation Action

    The Central Division (Milan seat) revoked European Patent EP 3854403 in its entirety, finding that the patent lacks inventive step. The attack based on insufficient disclosure was dismissed, but all amendment requests (main request and eight auxiliary requests) were also dismissed as none overcame the inventive step objection. The defendant (patent proprietor) bears the legal costs fixed by party agreement at €800,000.

    Legal issues:Inventive step (Art. 56 EPC) — whether use of Remdesivir against SARS-CoV-2 was obvious at priority date given prior art on broad-spectrum coronavirus activitySufficiency of disclosure (Art. 83 EPC / Art. 138(1)(b) EPC) — whether undefined stereochemistry at phosphorus in Formula I rendered claims insufficiently disclosedApplication to amend patent (Main Request and Auxiliary Requests 1-8) — admissibility and allowability under Art. 123 and 84 EPCDefinition of person skilled in the art and common general knowledge at priority date (21 January 2020)Reasonable expectation of success vs. mere hope of success in the context of emerging viral diseaseValue of proceedings and recoverable costs under Art. 69 UPCA
Documents
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action.phaseChange.caseClose2026-05-05Not public
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action.summons.oralHearing2025-11-07Not public
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Acknowledgement-of-lodging2025-09-08Not public
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Correction following formal checks2025-09-08Not public
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Formal-checks_Request-for-correction2025-09-08Not public
Acknowledgement-of-lodging2025-09-08Not public
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Application to amend the patent2025-09-05Not public
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Request re value of the dispute and ceiling of recoverable costs2025-09-05Not public
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Acknowledgement-of-lodging2025-09-05Not public
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Exhibit 582025-09-05Not public
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Exhibit 84b2025-09-05Not public
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Exhibit 512025-09-05Not public
Exhibit 672025-09-05Not public
Statement in defense2025-09-05Not public
Exhibit 82a2025-09-05Not public
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Headnote-and-Keywords2025-09-04Not public
Outcome of the Order2025-09-04Not public
ORDER 4 SEPTEMBER2025-09-04Public
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ORDER 4 SEPTEMBER2025-09-04Public
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250901_R.9 Application_Reply to request for decision by default2025-09-01Not public
Exhibit 13a2025-09-01Not public
Receipt2025-09-01Not public
Generic application R.9.1 RoP re service2025-08-29Not public
Exhibit 6. CoA, 29 July 2024, Nec Corporation2025-08-29Not public
Exhibit 5. Email exchanges between LAVOIX and the Registry of 26 and 27 August 20252025-08-29Not public
Exhibit 11. 15th draft of the UPC RoP of 31 May 2013 (extract)2025-08-29Not public
Exhibit 10. LD Hamburg_25 August 2025_Med-El v Nurotron2025-08-29Not public
Exhibit 7. CoA_5 August 2024_Daedalus2025-08-29Not public
Exhibit 8. CoA_6 August 2024_Nera Corporation2025-08-29Not public
Exhibit 12. 18th draft of the UPC RoP 19 October 2015 markup version (extract)2025-08-29Not public
Exhibit 2. Letter to CD Milan Registry2025-08-29Not public
CMS screenshot2025-08-29Not public
Exhibit 9. CoA_5 August 2024_Panasonic2025-08-29Not public
Exhibit 3. Email exchanges between LAVOIX and the Milan Central Division Clerk of 11, 18 and 21 July 20252025-08-29Not public
Exhibit 1. Email exchanges between LAVOIX and the Milan Central Division Clerk of 7 and 8 July 20252025-08-29Not public
Receipt2025-08-28Not public
250827_Request_for_Decision_by_Default_R3552025-08-27Not public
Exhibit HRM 26_UPC_CD Paris_CFI_412-20232025-08-27Not public
Acknowledgement of access to case2025-08-27Not public
Receipt2025-08-06Not public
Exhibit HRM 24b_LD Mannheim_UPC_CFI_445_2025_Refusal_of_service_ENG2025-08-05Not public
Exhibit HRM 25a_LK Duesseldorf_UPC_CFI_318_2025_VU2025-08-05Not public
Exhibit HRM 25b_LD Duesseldorf_UPC_CFI_318_2025_Decision by Default2025-08-05Not public
Exhibit HRM 22_Letter dated 11 July 2025 to CD Milan Registry2025-08-05Not public
Exhibit HRM 24a_LK Mannheim_UPC_CFI_445_2025_AASI verweigerte Zustellung_DE2025-08-05Not public
250805_UPC_CFI_552_2025_ACT_29152_2025_R9 Request re Service2025-08-05Not public
Exhibit HRM 23_Request for Unitary Effect2025-08-05Not public
Exhibit HRM 21_UPC_CFI_552_2025_ACT_29152_2025_Screenshot2025-08-05Not public
Notification Of Service2025-07-09Not public
Proof of service2025-07-09Not public
communicationCheck2025-06-27Not public
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Letter-for-Service2025-06-20Not public
Panel-Appointment2025-06-20Not public
EPO-Request-for-case-pending2025-06-20Not public
Acknowledgement-of-lodging2025-06-20Not public
Formal-checks_Notification-of-positive-outcome2025-06-20Not public
Exhibit HRM 03_Stadler-20032025-06-20Not public
Exhibit HRM 06a_Twitter post Dr Kevin Olival2025-06-20Not public
Exhibit HRM 01_A1 application EP4032025-06-20Not public
Exhibit HRM 15_Lescure2025-06-20Not public
250618_Revocation action2025-06-20Not public
Exhibit HRM 12_Brown-20192025-06-20Not public
Exhibit HRM 13_Sheahan-20202025-06-20Not public
Exhibit HRM 07_Wuhan seafood market pneumonia virus isolate Wuhan Hu 1 complete geno Nucleotide NCBI2025-06-20Not public
Exhibit HRM 20_CIDRAP website article2025-06-20Not public
Exhibit HRM 09_Gillings website article2025-06-20Not public
Exhibit HRM 14_Holshue2025-06-20Not public
Exhibit HRM 04_Peck-20152025-06-20Not public
Exhibit HRM 05_Virological - Novel 2019 coronavirus genome - SARS-CoV-2 coronavirus2025-06-20Not public
Exhibit HRM 18_Beigel 20192025-06-20Not public
Exhibit HRM 11_Sheahan-20172025-06-20Not public
Exhibit HRM 17_BBC article2025-06-20Not public
Exhibit HRM 06b_Enlarged version of phylogenetic tree2025-06-20Not public
Exhibit HRM 02a_Proof of payment_DE2025-06-20Not public
Exhibit HRM 10_Nature Microbiology2025-06-20Not public
Exhibit HRM 19_Lo 20172025-06-20Not public
Exhibit HRM 08_Baric declaration_literature2025-06-20Not public
Exhibit HRM 02a_Proof of payment_DE2025-06-20Not public
Exhibit HRM 16_Agostini-20182025-06-20Not public
Formal-checks_Request-for-correction2025-06-19Not public
Exhibit HRM 07_Wuhan seafood market pneumonia virus isolate Wuhan Hu 1 complete geno Nucleotide NCBI2025-06-18Not public
Exhibit HRM 06b_Enlarged version of phylogenetic tree2025-06-18Not public
Exhibit HRM 02a_Proof of payment_DE2025-06-18Not public
Exhibit HRM 14_Holshue2025-06-18Not public
Exhibit HRM 05_Virological - Novel 2019 coronavirus genome - SARS-CoV-2 coronavirus2025-06-18Not public
Exhibit HRM 19_Lo 20172025-06-18Not public
Exhibit HRM 02a_Proof of payment_DE2025-06-18Not public
Exhibit HRM 01_A1 application EP4032025-06-18Not public
Exhibit HRM 11_Sheahan-20172025-06-18Not public
Exhibit HRM 10_Nature Microbiology2025-06-18Not public
250618_Revocation action2025-06-18Not public
Exhibit HRM 06a_Twitter post Dr Kevin Olival2025-06-18Not public
Exhibit HRM 12_Brown-20192025-06-18Not public
Exhibit HRM 15_Lescure2025-06-18Not public
Exhibit HRM 20_CIDRAP website article2025-06-18Not public
Exhibit HRM 09_Gillings website article2025-06-18Not public
Exhibit HRM 08_Baric declaration_literature2025-06-18Not public
Exhibit HRM 13_Sheahan-20202025-06-18Not public
Exhibit HRM 04_Peck-20152025-06-18Not public
Exhibit HRM 16_Agostini-20182025-06-18Not public
Exhibit HRM 17_BBC article2025-06-18Not public
Exhibit HRM 03_Stadler-20032025-06-18Not public
Accepted arguments
What the court agreed with — by party.

  • The skilled person (virologist researching antiviral drugs for coronaviruses) would have had a high expectation of success that Remdesivir would be effective against SARS-CoV-2, based on prior art documents (HRM 09, HRM 10, HRM 11, HRM 12, HRM 16) showing broad-spectrum anti-coronavirus activity via highly conserved RdRP

    ClaimantLegal basis: Art. 56 EPC; EPO Guidelines G-VII-13; UPC_CoA 464/24 (25 November 2025)

  • The objective technical problem was finding a drug with antiviral activity against SARS-CoV-2, not merely testing Remdesivir against the new virus; but given that the prior art clearly suggested Remdesivir as the solution, the claimed invention lacked inventive step

    ClaimantLegal basis: Art. 56 EPC; UPC_CoA_528/2024 (Amgen v Sanofi, 25 November 2025) §11-12

  • Formula I in the granted claims already encompassed both isomers due to the chiral phosphorus in the drawing, making the Main Request amendment (removing 'geometric isomer') admissible under Art. 123 and 84 EPC, though still not inventive

    ClaimantLegal basis: Art. 123(3) EPC; Art. 84 EPC; R. 50.2 RoP
Rejected arguments
What the court did not agree with — and why.

  • The patent is insufficiently disclosed because Formula I's stereochemistry at phosphorus is undefined, constituting an undue burden for the skilled person to identify/separate the two isomers

    ClaimantLegal basis: Art. 83 EPC / Art. 138(1)(b) EPC

  • The skilled person would not have had a reasonable expectation of success because differences in the NiRAN subdomain and exonuclease proofreading activity (nsp14) of SARS-CoV-2 introduced substantial uncertainty about Remdesivir's efficacy; the skilled person would only have had a 'hope of success'

    RespondentLegal basis: Art. 56 EPC

  • The skilled person should be defined as an independent virologist with no links to any pharmaceutical company, and the prior art documents relied upon by the claimant were commercially motivated and lacked scientific credibility

    RespondentLegal basis: Art. 56 EPC

  • The patent should be maintained in amended form per the Main Request or one of the eight Auxiliary Requests

    RespondentLegal basis: R. 50.2 RoP; Art. 123 EPC; Art. 84 EPC

  • The value of proceedings should be set at €6,800 (cost of the patent application) rather than €20 million

    RespondentLegal basis: R. 152.3 RoP; R. 370.6 RoP