Category EU case-law

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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Learning from case law: Case C-118/24 AG opinion on whether a drug product licensed via the Article 10(i) of Directive 2001/83 abridged licensing procedure can ever be recognised as a generic of a biologic medicinal product

Last updated: 16 June 2026 To view updates, click on the ‘+’ sign below. This post is an attempt to provide salient information on Case C-118/24 concerning EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS vs the French Regulatory…

Read MoreLearning from case law: Case C-118/24 AG opinion on whether a drug product licensed via the Article 10(i) of Directive 2001/83 abridged licensing procedure can ever be recognised as a generic of a biologic medicinal product

Learning from Case Law: Case C‑456/24, AG opinion on whether or not a Supplementary Protection certificate (SPC) can be granted for an excipient

This post is an attempt to provide salient information on Case C-456/24 which concerns Halozyme Inc. vs the Supreme Administrative Court, Czech Republic. Specifically, it concerns the events leading up to the CJEU getting involved in the case as well…

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Learning from case law: Outcome of appeal request concerning SPC applications in the case of Halozyme Inc. vs the UK Intellectual Property Office

This is an attempt to present the facts leading to the outcome of the appeal request concerning Supplementary Protection Certificates (SPCs) in the case of Halozyme Inc. vs the UK Intellectual Property Office (IPO). The parties concerned Halozyme Inc. vs…

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Learning from Case Law: Mylan IRE Healthcare v European Commission (Case C-237/22) concerning orphan medicinal products

Last updated: 10 January 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to to provide information on Case C-237/22 concerning Mylan IRE Healthcare v European Commission, including clarification of the concepts of “Significant…

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Learning from Case Law: Opinion and judgement on Cases C-119/22 (MSD vs Teva) and C-149/22 (MSD vs Clonmel) on conditions under which SPCs may be granted for combination products in the EU

Last updated: 3 January 2025 To view updates, click on the ‘+’ below: This post is an attempt to to provide information on recent progress concerning two cases, one from the Finnish Market Court C-119/22 (Teva v MSD) and the…

Read MoreLearning from Case Law: Opinion and judgement on Cases C-119/22 (MSD vs Teva) and C-149/22 (MSD vs Clonmel) on conditions under which SPCs may be granted for combination products in the EU

Learning from Case Law: Preliminary ruling on Case C‑181/24 by the CJEU on the interpretation of Articles 3(b) and (d) of SPC Regulation (EC) No 469/2009

This post is an attempt to present the details of a preliminary ruling by the CJEU on Case C-181/24 (Genmab A/S vs Budapest High Court) on the interpretation of Articles 3(b) and (d) of Supplementary Protection Certificate (SPC) Regulation (EC) No 469/2009, in…

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Learning from Case Law: Non-profit organisations vs the Commission on refusal to grant access to four harmonised standards approved by CEN (Case T‑185/19 and appeal Case C-588/21 P)

Public.Resource.Org, Inc. and Right to Know CLG are both non-profit organisations whose main focus is to make the law freely accessible to all citizens.1 In 2018, they made a request to the European Commission Directorate-General for Internal Market, Industry, Entrepreneurship…

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Learning from Case Law: Mylan vs Gilead (case C-473/22) on potential Supplementary Protection Certificate (SPC) infringement

This post is an attempt to present some of the salient information from Case C-473/22 concerning Mylan vs Gilead on potential Supplementary Protection Certificate (SPC) infringement. The information provided below is by no means exhaustive. In order to develop a…

Read MoreLearning from Case Law: Mylan vs Gilead (case C-473/22) on potential Supplementary Protection Certificate (SPC) infringement