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What is a supplementary protection certificate (SPC)?
What are SPCS & how do they work?
What programs does SPC offer?
What are the different types of SPCs?
How do I apply for an SPC?
Are SPCS a national rights?
2 days ago · Whether you need to take action will depend on where your SPC or SPC application is in the process. It will also depend on which authorisations you have filed with, or notified to, the IPO on 1 ...
Our Services. It’s not just rehoming and home visits here at the Scottish SPCA. Did you know that we offer a range of services to help care for your animals? We’re more than a 'one trick pony'!
- The Current Status of Brexit
- What The 2018 Act Does and Why It Is Relevant to SPCS
- Why Does The Northern Ireland Protocol Matter?
- Other Important Changes
- The Paediatric Regulation
- A Second Shot?
- Find Out More
Has Brexit happened already? The Prime Minister's office insists it has (and some say 10 Downing Street has even banned the word!). This is because the UK actually left the EU at 11pm on 31 January 2020. On this date the European Union (Withdrawal) Act 2018 (2018 Act) repealed the European Communities Act 1972, by which EU law ultimately takes effe...
Whether or not the UK and EU strike a free-trade deal by the end of December 2020, section 3(1) 2018 Act currently states that direct EU legislation, so far as it is operative immediately before the end of the Implementation Period, will also form part of domestic law on and after that day. This includes Regulation 469/2009 which governs SPCs in EU...
As the law presently stands, the Northern Ireland Protocol will have an impact on SPCs. The Protocol will take effect after 31 December 2020 and place Northern Ireland (NI) in the UK customs territory and, for the most part, under UK law. However, it also commits NI to align with certain EU regulatory laws on goods, including medicinal products. Bu...
Although the grant of an SPC will be based on the first UK authorisation to place the product on the market as a medicinal product, the period of duration of the SPC will be based on the first authorisation for the product in either the EEA or the UK. The recently introduced manufacturing waiver will continue to apply in the UK. In particular – aft...
The Paediatric Regulation (1901/2006), which permits extension of an SPC by six months when a paediatric investigation plan (PIP) is approved, will be restated in the Human Medicines Regulations 2012 (2012/1916), also with necessary modifications. After 31 December, the MHRA will make decisions for the UK based on the administration of its own syst...
Over the years, the CJEU's rulings on the SPC Regulation have become somewhat notorious for a lack of clarity and consistency. After 31 December, existing EU case law on these issues will continue to have authority in the UK, but only at the level of first instance – the Court of Appeal and Supreme Court will be able to depart from these decisions ...
If you would like to discuss any of the issues raised in this article, please contact a member of our Patents & Innovation team.
- SPCs are national rights: there is no pan-European SPC. You must apply for an SPC in each country for which you want SPC protection (at the national patent office).
- Some non-EU European counties (such as Switzerland, Albania, Bosnia and Herzegovina, Macedonia, and Serbia) have their own, separate SPC systems, which are closely modelled on the EU system.
- To apply for an SPC, you must have a valid marketing authorisation for the product in the country where you are applying: the marketing authorisation can be from an EU or EAA national regulatory authority; or it may be an EU marketing authorisation granted by the European Medicines Agency (EMA).
- To apply for an SPC, you must also have a granted patent that covers the product, and that patent must be in force in the country where you are applying.
Supplementary Protection Certificates (or SPCs) are a complementary intellectual property right to patents that provide additional years of protection for products that are subject to regulatory approval.
Aug 30, 2023 · The requirements for grant of an SPC are set out in Article 3 of the SPC Regulation. Article 3(a) requires that the product be “protected” by a basic patent. Articles 3(b) and 3(d) require that the SPC be based on the first valid authorisation to place the product on the market as a medicinal product.
Aug 30, 2023 · What are SPCs? A Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation 1. The highest tribunal hearing disputes involving SPCs for EU member states is the Court of Justice of the European Union (CJEU).
