Category EU case-law

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

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 Authority (the ANSM) and Eli Lilly. Specifically, it concerns the opinion of Attorney General…

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European Court cases involving Supplementary Protection Certificates

Last updated: 24 December 2025 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: 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…

Read MoreLearning 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

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…

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Using the outcome of Case T-611/18 (Pharmaceutical Works Polpharma S.A vs the EMA) to better understand aspects of EU medicines legislation

Last updated: 21 December 2023 See updates at the end of the post. The parties involved in the case The parties involved in this case were Pharmaceutical Works Polpharma S.A versus the European Medicines Agency (Case T-611/18) supported by the…

Read MoreUsing the outcome of Case T-611/18 (Pharmaceutical Works Polpharma S.A vs the EMA) to better understand aspects of EU medicines legislation

Learning from Case Law -Understanding the complexities associated with the affixing of proprietary trademarks to repackaged generic medicinal products, for parallel trade

Last updated: 25 July 2024 See updates at the end of the post. This post is an attempt to facilitate an understanding of some of the complexities associated with the affixing of proprietary trademarks to repackaged generic medicinal products, for…

Read MoreLearning from Case Law -Understanding the complexities associated with the affixing of proprietary trademarks to repackaged generic medicinal products, for parallel trade