THe Latest Thinking on Best Strategies for Use of Supplementary Certificates

Abstract

Supplementary Protection Certificates (SPCs) are distinct from patents and market authorisations (MAs). An SPC provides proprietary protection in relation to medicinal products authorised to be placed on the market in the EEA containing an active ingredient protected by a patent. It takes effect at the end of the term of the patent for the active ingredient in a medicinal product. It is granted in recognition of the fact that, unlike other patentable subject matter, pharmaceuticals and agrochemicals are susceptible to losing a portion of their patent life to the demands of obtaining marketing authorisation for them. This paper looks at the basis for SPCs, when and why SPCs can be granted and some of the issues that need to be considered and addressed to receive maximum benefit from them.