UPC Analytics
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Übersicht · Eingereicht: —

ACT_597355/2023

METHODS FOR REDUCING LIPOPROTEIN(A) LEVELS BY ADMINISTERING AN INHIBITOR OF PROPROTEIN CONVERTASE SUBTILISIN KEXIN-9 (PCSK9)

VerletzungHauptverletzungsklageDusseldorf LDInfringement Action—
ÜbersichtEntscheidungenBegründungZitateDokumenteZeitverlauf
Abdeckung: Teilweise.Begründung teilweise extrahiert — einige Abschnitte können unvollständig sein.
Zusammenfassung in einfacher Sprache

Sanofi Biotechnologies and Regeneron Pharmaceuticals brought an infringement action against Amgen before the Düsseldorf Local Division concerning EP 3 536 712 B1, a second medical use patent claiming administration of the PCSK9 inhibitor evolocumab to reduce lipoprotein(a) levels in paediatric patients. The court dismissed the infringement action, finding that Amgen did not offer or place evolocumab on the market in a manner that led or could lead to the patented paediatric use; it also dismissed Amgen's revocation counterclaim, finding the patent not invalid. Costs were split, with claimants bearing infringement action costs and defendants bearing revocation counterclaim costs.

Angenommene Argumente
Was das Gericht akzeptiert hat — nach Partei.

  • Second medical use claim of EP 3 536 712 B1 requires that the alleged infringer offer or place the product on the market in a way that leads or may lead to the claimed therapeutic use, and this condition was not met for evolocumab in paediatric patients

    BeklagterRechtsgrundlage: Art. 54(4)(5) EPC; Art. 53(c) EPC

    Hinweis: Court accepted Amgen's position that the second medical use claim was not infringed because Amgen did not offer evolocumab for the patented paediatric indication in the manner required.

  • Inventive step of the second medical use claim may be negatived where the skilled person faces many uncertainties or expected difficulties, negating any motivation to implement the claimed use

    BeklagterRechtsgrundlage: Inventive step / obviousness under EPC

    Hinweis: Court articulated the principle that absence or negation of motivation prevents a finding of obviousness; applied in the counterclaim context.

  • Pleading ignorance (i.e., inability to admit or deny facts due to lack of knowledge) is inadmissible in UPC proceedings

    KlägerRechtsgrundlage: UPC Rules of Procedure

    Hinweis: Court held that RoP do not acknowledge pleading ignorance, supporting claimant's position that such objections are disregarded.

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

  • Infringement of the second medical use claim of EP 3 536 712 B1 by Amgen's evolocumab product in paediatric patients

    KlägerRechtsgrundlage: Art. 54(4)(5) EPC; Art. 53(c) EPC

    Begründung: Sanofi/Regeneron failed to establish that Amgen offered or placed evolocumab on the market in a way that leads or may lead to the patented therapeutic use in paediatric patients; all relevant facts and circumstances did not support infringement of the second medical use claim.

  • Counterclaim for revocation of EP 3 536 712 B1

    Beklagter

    Begründung: Dismissed; patent held not invalid (specific grounds not detailed in the available excerpt).

Zentrale Rechtsgrundsätze
In der Begründung herangezogene Doktrinen und Regeln.
Second medical use claims — infringement requires that the alleged infringer offers or places the product on the market in a way that leads or may lead to the claimed therapeutic useSecond medical use claims — notional novelty under Art. 54(5) EPC requires a specific use in a method under Art. 53(c) EPCInventive step — motivation to implement the claimed use may be absent or negated where many uncertainties existPleading ignorance is inadmissible in UPC proceedingsPurposive claim construction — scope of second medical use claim

Weitere Fälle zu diesem Grundsatz ansehen.

Hinweise zur Anspruchsauslegung

The court interpreted the second medical use claim of EP 3 536 712 B1 as requiring a specific therapeutic use — administration of a PCSK9 inhibitor (evolocumab) to reduce Lp(a) levels in paediatric patients — and held that the requirement of such behaviour cannot be defined abstractly but requires analysis of all relevant facts and circumstances of the specific patent claim.