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Übersicht · Eingereicht: 19. März 2024

UPC_CFI_123/2024

TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA PATIENTS BY AN INHIBITOR OF COMPLEMENT

Einstweilige MaßnahmenEinstweilige MaßnahmenHamburg LDProvisional measuresCase Closed
ÜbersichtEntscheidungenBegründungZitateDokumenteZeitverlauf
Zusammenfassung in einfacher Sprache

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.

Angenommene Argumente
Was das Gericht akzeptiert hat — nach Partei.

  • 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

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

    Hinweis: 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

    KlägerRechtsgrundlage: Art. 25 UPCA

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

Zurückgewiesene Argumente
Was das Gericht nicht akzeptiert hat — und warum.

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

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

    Begründung: 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.

Zentrale Rechtsgrundsätze
In der Begründung herangezogene Doktrinen und Regeln.
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

Weitere Fälle zu diesem Grundsatz ansehen.

Hinweise zur Anspruchsauslegung

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.