UPC CFI 123/2024
Mar 19, 2024·EP3167888 Unitary patent · TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA PATIENTS BY AN INHIBITOR OF COMPLEMENT
- Case details
- StatusCase ClosedActionProvisional measuresCategoryProvisional measures
- Parties
- Respondents
- Samsung Bioepis NL B.V.Operating co.
Representatives- Peter Meyer-Simmons & Simmons
- Andrea Ritter-Simmons & Simmons
- Division
- Hamburg LD
- Technology
- ChemistryBiotechnology · Pharmaceuticals
- Language
- English
- First decided
- Jun 26, 2024
- EPO Opposition
- Samsung Bioepis NL B.V.Withdrawn2024-05-02
- Amgen Technology (Ireland) Unlimited CompanyWithdrawn2024-10-28
- Salute HC Ilaç Pazarlama A.S.Admissible2025-01-31
| Preliminary injunction granted | Median days to first decision | |
|---|---|---|
| All UPC | 54% (38/70) | 124 |
| Hamburg LD | Locked | Locked |
| Judge Sabine Klepsch | Locked | Locked |
| Judge Alima Zana | Locked | Locked |
| Judge Stefan Schilling | Locked | Locked |
| Judge Rudi Goedeweeck | Locked | Locked |
At the UPC: AstraZeneca Group (13 cases)·Samsung Group (57 cases)
This dispute contains 6 other proceedings
UPC CoA 744/2025·UPC CFI 674/2025·UPC CFI 51/2025·UPC CFI 40/2025·UPC APP 43786/2024 and 1 more
3 other defendants litigating the same or a related patent
Start a free trial to see how each one ended.
More cases: Hamburg LD·2024
- 2024-06-26Application for provisional measuresPublic
Summary: 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.
Show the legal issues (4)
- preliminary injunction standard Art. 62(2) UPCA
- validity certainty requirement Art. 62(4) UPCA
- patent claim interpretation from perspective of skilled person
- EPO opposition division revocation likelihood
| Document title | Date | Public |
|---|---|---|
| Acknowledgement-of-change-of-a-representative | 2025-05-12 | Not public |
| Application-RoP293-Receipt | 2025-05-12 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-12 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-12 | Not public |
| Application-RoP293-Receipt | 2025-05-12 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-12 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-12 | Not public |
| Application-RoP293-Receipt | 2025-05-12 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-12 | Not public |
| Application-RoP293 | 2025-05-07 | Not public |
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.
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 RoPNote: 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 UPCANote: The court accepted that infringement could be established, but denied the measure on the validity ground alone.
Preliminary injunction against Samsung Bioepis based on EP 3 167 888 B1
ClaimantLegal basis: Art. 62(4) UPCA; R. 211.2 RoPReason: 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.
Browse other cases on this principle.
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.