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Supplementary protection certificate meaning

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What does Supplementary protection certificate mean?
A supplementary protection certificate (SPC) is a national intellectual property right that extends the effective exclusivity of a patented medicinal or plant protection product to offset regulatory delay in obtaining a marketing authorisation. It is used to manage patent term extension strategy and the timing of generic and biosimilar entry. SPCs are governed by legislation: for medicines, Regulation (EC) No 469/2009; for plant protection products, Regulation (EC) No 1610/96. In the UK, these rules form retained EU law (as amended post‑Brexit); in Ireland, the EU Regulations apply directly. Interpretation has been shaped by CJEU case law; in the UK, pre‑Brexit CJEU authority remains influential, though divergence is possible. Key features: - Granted by the UKIPO or the Intellectual Property Office of Ireland where: (i) the product is protected by a basic patent in force; (ii) a first valid marketing authorisation in the UK/EEA exists; (iii) no prior SPC protects the product; and (iv) the application is filed within six months of the first authorisation or patent grant (whichever is later). - Duration begins on expiry of the basic patent and is the period between the first UK/EEA authorisation and the patent filing date, reduced by five years, capped at five years. A...
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NEWS
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NEWS
IP weekly: SPC refusal for drospirenone, Dyson UPC injunction (UK excluded), SEP/FRAND royalty depositories, CJEU pastiche sampling, plus UK/EPO updates, webinars and trackers

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NEWS
Weekly life sciences legal highlights: unitary patents, EMA 2023 and paediatric IRIS, Human Medicines changes, CMA clearance of Cochlear/Oticon Medical merger, Horizon Europe report—6 June 2024

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PRACTICE NOTES
Life sciences regulatory and IP glossary (Q–V): medicines, medical devices, pharmacovigilance, ATMPs, clinical trials, Specials, NHS pricing and access

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PRACTICE NOTES
EU life sciences case law tracker 2020–2022 (archived): CJEU and General Court judgments on SPCs, medicinal products/devices, parallel imports, advertising, access to EMA documents, and trade marks

ARCHIVED This Practice Note is archived and no longer maintained. It monitored EU cases pertinent to the life sciences sector during 2020–2022. To follow EU case progress from 2023 onwards, including live matters, see Practice Note: Life sciences cases tracker—EU. For current EU legislative proposals, consultations and developments relevant to life sciences, see Practice Note: Life sciences tracker—EU. For current UK legislative proposals, consultations and developments, as well as notable UK cases relevant to life sciences, see Practice Notes: Life sciences tracker—UK and Life sciences cases tracker—UK... Judgments—Supplementary protection certificates For archived supplementary protection certificate (SPC) rulings, see Practice Note: Life sciences tracker [Archived]—Judgments—Supplementary protection certificates... Court of Justice of the European Union Santen SAS v Directeur général de l’Institut national de la propriété industrielle (Case C-673/18, ECLI:EU:C:2020:531) — judgment delivered on 9 July 2020...

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PRACTICE NOTES
EU life sciences litigation and regulatory case tracker: key CJEU, General Court, EPO and UPC rulings on SPCs, medicines, devices, borderline products, trade marks and access to documents

This Practice Note is designed to monitor the progress of EU cases relevant to the life sciences industry. For earlier life sciences materials, see Practice Note: Life sciences tracker [Archived]... Judgments-Supplementary protection certificates For archived supplementary protection certificate (SPC) judgments, see Practice Note: Life sciences tracker [Archived]-Judgments-Supplementary protection certificates... Court of Justice of the European Union What's happening? When? Find out more Teva BV and Teva Finland Oy v Merck Sharp & Dohme LLC; Merck Sharp & Dohme LLC v Clonmel Healthcare Limited - Joined Cases C-119/22 and C-149/22 19 December 2024: preliminary ruling of the Court of Justice (Third Chamber) issued. 6 June 2024: Opinion of the Advocate General (AG). 21 February 2022: reference made to the Court of Justice by the Supreme Court of Ireland. 17 February 2022: reference made to the Court of Justice by the Supreme Court of Finland. Requirements for obtaining an...

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