September 2022
Supplementary protection certificates (SPCs) are:
- an idiosyncratic class of IP rights that extend the term of a patent’s protection by up to five years for specific innovative medicinal and plant protection products, with the potential for a further additional six months of protection available for medicines that have been tested for paediatric use.
- used to encourage particularly pharmaceutical innovation by compensating for the long time needed to obtain regulatory approval for drugs.
SPCs can be based on a national patent or a national validation of a European patent. Currently, there is no other legal way to obtain protection throughout the territory of the European Union.
As preparations for the Unified Patent Court and pan-European unitary patents move ahead – and it looks like these instruments are close from a practical perspective, the anticipated introduction of the new system expected to take place in first quarter of 2023 – the European Commission is still exploring how the new system can include unitary SPCs.
Ana-Maria Baciu and Cristiana Prodescu prepared an overview of the developments that may be expected and structured their article to cover aspects like:
- What are SPCs?
- Objectives behind change in EU pharma patent legislation
- Proposed unified SPC landscape
“While the emergence of the Unified Patent Court and unitary patent and unitary SPC instruments is still pending, it remains to be seen whether the European Commission, as publicly announced, will amend the existing SPC regulations for pharmaceutical and plant protection products before 2023.
Ultimately, it will be of great interest to see how this new system will be greeted by interested players – especially those in the pharmaceutical and medical technology industries”, highlighted Ana-Maria and Cristiana in their article.
The entire article, prepared for and published by ILO/Lexology is available here. Also, for ease of use and future reference, a PDF format can be downloaded here.
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SIMION & BACIU is a 2-time winner at the much-coveted Romania Law Firm of the Year award by Managing IP in 2021 and 2022. Also, the firm is the winner of the prestigious Trademark Firm of the Year for Romania at the 2022 Global IP Awards Gala presented by IAM and WTR.