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NL – Janssen Biotech v. Samsung Bioepis / Manufacturing Waiver

02 Feb 2024

Janssen Biotech Inc. v. Samsung Bioepis NL B.V., PI Proceedings, District Court The Hague, The Netherlands, 23 January 2024, Case no. ECLI:NL:RBDHA:2024:701

PI proceedings, SPC. Explanation of Manufacturing Waiver Regulation (EU) No. 2019/933. Manufacturing of biosimilar for export to third countries. Samsung Bioepis successfully invokes the manufacturing waiver. Reference number of marketing authorisation in export country may be provided later (once it is publicly available). The Regulation does not require that no relevant patent rights are in force in the intended export countries and/or that the manufacturer demonstrates this in advance. Temporary storage is permitted under the exemption.

A copy of the judgment (in Dutch) can be read here.