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UPC CFI 123/2024

Mar 19, 2024·EP3167888: TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA PATIENTS BY AN INHIBITOR OF COMPLEMENT

Case details
Status
Case Closed
Action
Provisional measures
Category
Provisional Measures
Parties
Claimants
Reps: Elena Hennecke
Respondents
Reps: Andrea Ritter
Division
Hamburg LD
Judges
Technology
Organic Chemistry
Language
English
First decided
Jun 26, 2024
Decisions
  • 2024-06-26
    PI deniedPreliminary injunctionApplication for provisional measures

    The Hamburg Local Division dismissed Alexion Pharmaceuticals' application for a preliminary injunction against Samsung Bioepis based on EP 3 167 888, finding that while direct infringement could be established, the court could not be sufficiently certain of the patent's validity given the EPO Technical Board of Appeal's history of rejecting correction requests for SEQ ID NO:4, and thus denied the measure.

    Legal issues:preliminary injunction standard Art. 62(2) UPCAvalidity certainty requirement Art. 62(4) UPCApatent claim interpretation from perspective of skilled personEPO opposition division revocation likelihood
Documents
Document titleDatePublic
Acknowledgement-of-change-of-a-representative2025-05-12Not public
Application-RoP293-Receipt2025-05-12Not public
Formal-checks_Notification-of-positive-outcome2025-05-12Not public
Acknowledgement-of-change-of-a-representative2025-05-12Not public
Application-RoP293-Receipt2025-05-12Not public
Formal-checks_Notification-of-positive-outcome2025-05-12Not public
Acknowledgement-of-change-of-a-representative2025-05-12Not public
Application-RoP293-Receipt2025-05-12Not public
Formal-checks_Notification-of-positive-outcome2025-05-12Not public
Application-RoP2932025-05-07Not public
Application2025-05-07Not public
Application-RoP2932025-05-07Not public
Application2025-05-07Not public
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Application2025-05-07Not public
redacted version2025-04-17Not public
redacted version2025-04-17Not public
redacted version2025-04-17Not public
Outcome of the Order2024-09-30Not public
Confirmation of appointment – oral hearing recording2024-09-30Public
Receipt2024-09-26Not public
Request to the Registrar for the recording of the oral hearing to be made available (RoP115)2024-09-25Not public
Closing workflow (ORD_38057_2024)2024-08-15Not public
Order with grounds (ORD_38130_2024)2024-07-17Not public
Outcome of the Order2024-06-28Not public
clooing workflow2024-06-28Public
Anordnung 262A2024-06-28Public
Order 262A objection2024-06-28Public
Measures_DecisionOutcome_Notification.pdf2024-06-26Not public
Order without grounds2024-06-26Public
Recording2024-06-26Not public
Recording2024-06-26Not public
closing workflow2024-06-26Public
Acknowledgement-of-lodging2024-06-26Not public
Blank document uploaded only for closing the workflow2024-06-26Not public
summons2024-06-25Not public
closing written proceedings2024-06-25Public
20240621 UPC Alexion_v_SB EP888_-_response_re_262A_request_for_confidentiality_for_rejoinder2024-06-21Not public
20240621 UPC Alexion_v_SB EP888 - response_re_262A_request_for_confidentiality_for_objection2024-06-21Not public
Comments2024-06-21Not public
Anhoerung R262A2024-06-18Not public
Anhoerung R262A2024-06-18Not public
Closing workflow2024-06-18Public
Comments regarding confidentiality of information, R262A RoP2024-06-17Not public
Exhibit FBD 38a2024-06-14Not public
Comments2024-06-14Not public
Application for confidentiality pursuant to R.262A RoP2024-06-14Not public
Exhibit SS39 - Letter Alexion to German HCP of 8 May 20242024-06-14Not public
Counter-reply to Applicant's reply to Objection against Application for provisional measures2024-06-14Not public
Exhibit SS37.1 - Exhibit 1 to Second declaration by Prof Kontermann2024-06-14Not public
Exhibit SS39 - Letter Alexion to German HCP of 8 May 20242024-06-14Not public
Exhibit SS35 - SB Opposition EPO 2 May 20242024-06-14Not public
Exhibit SS34 - Tacken et al (2005)2024-06-14Not public
Exhibit SS29 Kaplan, Current Opinion Investigation Drugs 2002, “Eculizumab”2024-06-14Not public
Exhibit SS33 - Alexion submission EPO 15 Nov 20122024-06-14Not public
Exhibit SS37 - Second declaration Prof Kontermann2024-06-14Not public
Exhibit SS36 - Submission SB re EP 888 of 13 June 20242024-06-14Not public
Exhibit SS38 - Redacted Witness Statement of Christopher Stothers2024-06-14Not public
Exhibit SS30 Drugs in R&D, January 2007, Eculizumab2024-06-14Not public
Counter-reply to Applicant's reply to Objection against Application for provisional measures2024-06-14Not public
Exhibit SS40 - Judgment SB v Alexion HP-2024-0000202024-06-14Not public
Exhibit SS31 Alexion Press Release 29 January 20022024-06-14Not public
Exhibit SS32 - Alexion press release 15 March 20022024-06-14Not public
Exhibit SS28 - Alexion’s Defence in UK proceedings HP-2024-0000202024-06-14Not public
Anordnung Vorlage2024-06-14Not public
Alexion Frist R262A2024-06-12Not public
20240604 UPC LD HH - Alexion v SB - R262A - Response SB to court order2024-06-04Not public
Outcome of the Order2024-05-31Not public
Deadline R262.22024-05-31Public
Outcome of the Order2024-05-31Not public
Deadline Duplik2024-05-31Public
Comment on SB 262A Application2024-05-29Not public
Receipt2024-05-29Not public
Request for extension of time for response to Applicant's submission2024-05-28Not public
Receipt2024-05-24Not public
Duplik deadline2024-05-24Not public
R 262.2 Application2024-05-24Not public
Exhibit FBD 612024-05-24Not public
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Part I of the Reply2024-05-24Not public
Exhibit FBD 662024-05-24Not public
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Exhibit FBD 362024-05-24Not public
Exhibit FBD 382024-05-24Not public
Applicant R262A2024-05-22Not public
Receipt2024-05-21Not public
Outcome of the Order2024-05-16Not public
Frist Samsung2024-05-16Public
Receipt2024-05-16Not public
Rule 9.3 Request for deadline extension2024-05-16Not public
Exhibit FBD FV 12024-05-16Not public
Exhibit FBD FV 22024-05-16Not public
Procedural order oral heraring2024-05-07Public
Request for Confidentiality pursuant to Rule 262A RoP - RoP 9 application2024-04-30Not public
Request for Confidentiality pursuant to Rule 262A RoP2024-04-30Not public
Exhibit SS12024-04-30Not public
Comments pursuant to RoP2642024-04-30Not public
Exhibit SS242024-04-30Not public
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Exhibit SS102024-04-30Not public
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Redacted version of Comments pursuant to RoP2642024-04-30Not public
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Confidential Exhibit SS262024-04-30Not public
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Exhibit SS202024-04-30Not public
Exhibit SS14.72024-04-30Not public
Exhibit SS222024-04-30Not public
Exhibit SS132024-04-30Not public
Invitation to Lodge2024-04-23Not public
Panel-Appointment2024-04-17Not public
Acknowledgement of access to case2024-04-04Not public
Notification Of Service2024-03-26Not public
Service2024-03-26Not public
Panel-Appointment2024-03-26Not public
Invitation to Lodge2024-03-20Public
Letter for Service2024-03-20Not public
Receipt2024-03-20Not public
Application to request confidentiality from the public2024-03-19Not public
Panel-Appointment2024-03-19Not public
Application-For-Measures-Receipt2024-03-19Not public
Formal-checks_Notification-of-positive-outcome2024-03-19Not public
Application-For-Measures-Acknowledgement2024-03-19Not public
Exhibit FBD 162024-03-19Not public
Exhibit FBD 112024-03-19Not public
Exhibit FBD 62024-03-19Not public
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Application for Provisional Measures2024-03-19Not public
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Confidential Exhibit 22024-03-19Not public
Exhibit FBD 72024-03-19Not public
Exhibit FBD 122024-03-19Not public
Set of Exhibits 5a2024-03-19Not public
Exhibit FBD 142024-03-19Not public
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Exhibit FBD 102024-03-19Not public
Exhibit FBD 12024-03-19Not public
Set of Exhibits 5b2024-03-19Not public
Confidential Exhibit 22024-03-19Not public
Application for Provisional Measures2024-03-19Not public
Plain-English summary

Alexion Pharmaceuticals applied for a preliminary injunction at the Hamburg Local Division against Samsung Bioepis regarding EP 3 167 888 B1 (eculizumab biosimilar, paroxysmal nocturnal haemoglobinuria). The court found direct infringement could be established but denied the injunction because the EPO Technical Board of Appeal had repeatedly rejected all of Alexion's attempts to correct SEQ ID NO:4 and had refused claim sets covering eculizumab across the entire patent family, creating sufficient doubt about validity that the court could not grant the measure.

Accepted arguments
What the court agreed with — by party.

  • Sufficient certainty of patent validity is required before granting provisional measures; the court must also consider the likelihood that the EPO opposition/TBA will revoke the patent

    RespondentLegal basis: Art. 62(4) UPCA; R. 211.2 RoP

    Note: The Hamburg court denied provisional measures because the TBA's repeated rejection of all attempts to correct SEQ ID NO:4 (amino acids 1-22 signal peptide) demonstrated serious doubt about the patent's validity that the court could not overcome.

  • Direct infringement of EP 3 167 888 B1 by Samsung Bioepis could be established

    ClaimantLegal basis: Art. 25 UPCA

    Note: The court accepted that infringement could be established, but denied the measure on the validity ground alone.

Rejected arguments
What the court did not agree with — and why.

  • Preliminary injunction against Samsung Bioepis based on EP 3 167 888 B1

    ClaimantLegal basis: Art. 62(4) UPCA; R. 211.2 RoP

    Reason: Although infringement was established, the court lacked sufficient certainty of patent validity: the EPO TBA had rejected all of Alexion's attempts to correct SEQ ID NO:4 and multiple claim sets covering eculizumab across the EP 888 family, creating a real likelihood the opposition division would revoke the patent.

Key legal principles
Doctrines and rules cited in the reasoning.
Provisional measures require sufficient certainty of patent validity, not merely the court's own viewCourt must consider the likelihood of EPO opposition/TBA outcome when assessing validity for PI purposesPatent claims interpreted from the perspective of the person skilled in the art, taking purpose into accountValidity doubt created by repeated TBA rejection of correction attempts is a decisive factor against PI

Browse other cases on this principle.

Claim construction notes

The court had to interpret EP 3 167 888 claims in relation to SEQ ID NO:4 (the antibody light chain sequence). The TBA had repeatedly held that SEQ ID NO:4 as filed included the signal peptide (amino acids 1-22), that the skilled person could not discount this, and that Alexion's attempted corrections were not permissible. The court's own view on claim construction favoured Alexion, but the TBA's contrary approach to the same sequence created the validity uncertainty that defeated the PI.