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ACT 597355/2023

—·EP3536712: METHODS FOR REDUCING LIPOPROTEIN(A) LEVELS BY ADMINISTERING AN INHIBITOR OF PROPROTEIN CONVERTASE SUBTILISIN KEXIN-9 (PCSK9)

Case details
Status
—
Action
Infringement
Category
Main Infringement Action
Parties
Claimants
Reps: Niels Hölder (Hoffmann Eitle); Mike Gruber (Hoffmann Eitle); Michael Pfeifer (Hoffmann Eitle); Daniel Wise (Carpmaels & Ransford); Agathe Michel-De Cazotte (Carpmaels & Ransford)
Division
Dusseldorf LD
Judges
Technology
Pharmaceuticals · Antibody/Biologics · Organic Chemistry
Language
—
First decided
May 13, 2025
Claims
At issueall
Not infringedall
Notes: Düsseldorf LD dismissed infringement action on second medical use claim of EP3536712 B1 and dismissed counterclaim for revocation; no specific claim numbers enumerated in operative order.
Decisions
  • 2025-05-13
    Not infringedInfringement meritsInfringement Action

    The Düsseldorf Local Division dismissed Sanofi and Regeneron's infringement action and Amgen's counterclaim for revocation concerning EP3536712 (a second medical use patent for evolocumab in paediatric patients), finding no infringement of the second medical use claim and that the counterclaim for revocation was also unfounded, with each side bearing the costs of the proceedings they lost.

    Legal issues:Second medical use claims (Art. 54(5) EPC)Infringement of second medical use claimsNovelty of second medical use claimsInventive step / obviousnessPleading ignorance (inadmissibility)Counterclaim for revocation
Documents
  • 41D863BDF8522246D15222766D55D6B0_en.pdf2025-05-13EN
Coverage: Partial.Reasoning extracted with partial coverage — some sections may be incomplete.
Plain-English summary

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.

Accepted arguments
What the court agreed with — by party.

  • 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

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

    Note: 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

    RespondentLegal basis: Inventive step / obviousness under EPC

    Note: 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

    ClaimantLegal basis: UPC Rules of Procedure

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

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

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

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

    Reason: 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

    Respondent

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

Key legal principles
Doctrines and rules cited in the reasoning.
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

Browse other cases on this principle.

Claim construction notes

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.