UPC CFI 505/2023
Jan 10, 2024·EP3536712 · METHODS FOR REDUCING LIPOPROTEIN(A) LEVELS BY ADMINISTERING AN INHIBITOR OF PROPROTEIN CONVERTASE SUBTILISIN KEXIN-9 (PCSK9)
Action number: ACT 597355/2023
- Case details
- StatusCase Closed (No infringement)ActionInfringementCategoryMain infringement action
- Parties
- Claimants
- Sanofi Biotechnology SASOperating co.
- Regeneron Pharmaceuticals Inc.Operating co.
Representatives- Niels Hoelder-Hoffmann Eitle
- Mike Gruber-Hoffmann Eitle
- Michael Pfeifer-Hoffmann Eitle
- Daniel Wise-Carpmaels & Ransford
- Agathe Michel-De Cazotte-Carpmaels & Ransford
Respondents- Amgen Inc.Operating co.
- Amgen Europe B.V.Operating co.
- Amgen NVOperating co.
- Amgen GmbHOperating co.
- Amgen B.V.Operating co.
- Amgen S.A.S.Operating co.
- Amgen S.R.L.Operating co.
Representatives- Johannes Heselberger-Bardehle Pagenberg
- Nadine Westermeyer-Bardehle Pagenberg
- Division
- Dusseldorf LD
- Technology
- ChemistryBiotechnology · Pharmaceuticals
- Language
- English
- First decided
- May 13, 2025
- EPO Opposition
- Amgen Inc.Withdrawn2024-02-29
| Infringement found | Median days to first decision | |
|---|---|---|
| All UPC | 53% (62/117) | 124 |
| Dusseldorf LD | Locked | Locked |
| Judge Ronny Thomas | Locked | Locked |
| Judge Berenice Thom | Locked | Locked |
| Judge András Kupecz | Locked | Locked |
| Judge Xavier Dorland-Galliot | Locked | Locked |
At the UPC: Sanofi Group (33 cases)·Amgen Group (19 cases)
This dispute contains 5 other proceedings
UPC CoA 641/2025·UPC CoA 646/2025·UPC CFI 534/2025·UPC CFI 195/2025·CC 24999/2024
Start a free trial to see how each one ended.
More cases: Dusseldorf LD·2023
- 2025-05-13Infringement ActionPublic
Summary: 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.
Show the legal issues (6)
- Second medical use claims (Art. 54(5) EPC)
- Infringement of second medical use claims
- Novelty of second medical use claims
- Inventive step / obviousness
- Pleading ignorance (inadmissibility)
- Counterclaim for revocation
| Document title | Date | Public |
|---|---|---|
| Cover sheet | 2025-11-03 | Not public |
| Application document Defendant | 2025-11-03 | Not public |
| Receipt | 2025-11-03 | Not public |
| Receipt | 2025-06-27 | Not public |
| 250623 Request re. Audio Recording | 2025-06-23 | Not public |
| Outcome of the Order | 2025-06-16 | Not public |
| Workflow closed | 2025-06-16 | Public |
| Receipt | 2025-06-13 | Not public |
| 20250613_Application_cost_decision_Amgen | 2025-06-13 | Not public |
| Headnote-and-Keywords | 2025-05-13 | Not public |
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.
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) EPCNote: 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 EPCNote: 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 ProcedureNote: Court held that RoP do not acknowledge pleading ignorance, supporting claimant's position that such objections are disregarded.
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) EPCReason: 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
RespondentReason: Dismissed; patent held not invalid (specific grounds not detailed in the available excerpt).
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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.