日時: 23 January 2019
By Lucy Holt
A Supplementary Protection Certificate (SPC) effectively extends the patent term for active ingredients present in pharmaceutical or plant protection products. SPCs are a national right, available in the member states of the EU.
The aim of an SPC is to compensate the patentee for the delay in obtaining this necessary regulatory approval required to use and sell such products.
Upon expiry of the patent, the SPC enters into force and usually lasts for up to five years. An extension of six months may be available for a medicinal active ingredient, if it has undergone paediatric testing.
SPCs are available in the UK under the following European legislation:
The corresponding UK legislation is Section 128B and Schedule 4A of the UK Patents Act 1977.
There are four conditions set out in Article 3, Regulation (EC) No 469/2009 for obtaining an SPC:
A number of cases are proceeding through the courts of Europe challenging these criteria, and the European Commission has appointed the Max Planck Institute and Copenhagen Economics to conduct studies on the legal and economic effects of SPCs respectively, and also launched a public consultation between October 2017 and January 2018.
Upon expiry of the patent, the SPC enters into force and can last for up to five years. An extension of six months may be available for a medicinal active ingredient, if it has undergone paediatric testing.
The duration of an SPC is equal to the period which has elapsed between the filing date of the patent application and the date of grant of the first marketing authorisation to market the product, less five years (Article 13, Regulation (EC) No 469/2009).
You can find this article and others in our Patent Issues Newsletter Spring 2019.