Learning from Case Law, Case C-794/25): Is it possible for an approved pro-drug of a previously approved API to be eligible for a Supplementary Protection Certificate(SPC) in the EU?

This post is an attempt to provide salient information on Case C-794/25 Referring court Østre Landsret, Denmark (High Court of Eastern Denmark) Parties to the main proceedings1 Applicant/Appellant: Stada Arzneimittel AG Defendant/Respondent: Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceutical Company Ltd. Product concerned1…

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European Court cases involving Supplementary Protection Certificates

Last updated: 17 July 2026 To view updates, click on the ‘+’ sign below. The table below is an attempt to present some court cases involving Supplementary Protection Certificates. You can read more about Supplementary Protection Certificates (SPCs) and Supplementary…

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FAST-EU, a pilot initiative that enables an accelerated assessment of multinational clinical trials in the European Union

Last updated: 2 July 2026 For updates, click on the ‘+’ sign below. This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic…

Read MoreFAST-EU, a pilot initiative that enables an accelerated assessment of multinational clinical trials in the European Union