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EU supplementary protection certificates and paediatric extensions: eligibility, duration, applications, manufacturing waiver, CJEU case law, and reforms including unitary SPCs, biotech SPC extension and crisis compulsory licensing

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Practice notes
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This Practice Note introduces supplementary protection certificates (SPCs) and paediatric extensions (PEs) in the EU. It sets out why they were created, when and how to seek them, and their duration. It also reviews leading Court of Justice rulings interpreting Regulation (EC) 469/2009 and Regulation (EC) 1610/96, the regimes governing SPCs for medicinal products and plant protection products (PPPs) in the EU...

Supplementary protection certificates (SPCs)

What is an SPC?

An SPC continues the protection afforded by a patent for a specific medicinal or plant protection product for up to five years, subject to meeting defined criteria (see: Conditions for obtaining an SPC in an EU Member State below). It does not prolong the patent term for subject-matter beyond the SPC’s scope and is therefore not a ‘patent term extension’ in itself. The rights conferred by an SPC in relation to the product mirror those granted by the underlying patent. For further detail on patents, see Practice Note: Introduction to patents. An SPC is a national right and, in the EU, operates at that level...

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Nicole Jadeja
Nicole Jadeja

I am an IP litigator specialising in patent litigation in the life sciences sector. Having graduated with a science degree, I spent several years working in clinical trials in the pharmaceutical industry, before qualifying as a lawyer. Whilst I have litigated all types of IP, my experience in recent years has been litigating for pharmaceutical companies. As well as being an experienced litigator in the UK Courts and the European Patent Office, I have experience of litigating in the Court of Justice of the European Union having worked on two seminal cases which were referred to this Court, one concerning SPCs and one concerning counterfeit goods in transit. I frequently advise on multi-jurisdiction patent disputes, co-coordinating litigation in various European and other jurisdictions. I am Vice Chair of the IP Committee of the BioIndustry Association and a member of the Life Sciences Committee of the...

Christopher Leung
Christopher Leung

Christopher is an Associate in the IP Protection and Enforcement Group at Fieldfisher. His experience spans a broad range of IP rights including patents and SPCs, trade marks, copyright, database rights and domain names. Christopher has a particular interest in litigation in the life sciences field and has experience of patent and SPC proceedings before the UK Intellectual Property Office, Patents Court, Court of Appeal and Court of Justice of the European Union, including acting as lead assistant in Sandoz Ltd & Anor v G.D. Searle LLC & Anor and Master Data Center, Inc. v The Comptroller General of Patents. Christopher also advises clients on the management of their global trade mark portfolios and the enforcement of their soft IP rights, and has acted in various high profile soft IP disputes including Karen Millen v Karen Millen Fashions Ltd & Anor (trade marks) and 77m Ltd v...

Web page updated on 21/05/2026

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