Nicole_Jadeja_220_portraitNicole Jadeja is a Senior Associate at Rouse Legal and a member of the BIA’s Intellectual Property Advisory Committee. Here Nicole writes about the Supplementary Protection Certificate Frequently Asked Questions document prepared for BIA members.

Supplementary Protection Certificates (SPCs) are an important part of the suite of intellectual property (IP) rights on offer to incentivise medical research and development. They are intended to compensate an innovative company for regulatory delays that can erode the exclusivity period provided by a patent.  Given the long development timelines for biopharmaceutical companies and the narrow window of exclusivity provided once marketing authorisation has been granted in some cases, SPCs can extend exclusivity for a further period of up to five years.

It is important for companies, small as well as large, to understand the SPC regime even if you do not yet have a marketed product. Given that for an SPC to be valid a number of criteria need to be met it is important for companies to consider the issue early and plan their IP strategy and management appropriately.

While the criteria for the grant of an SPC may appear simple on paper, there are a number of ongoing issues in the life sciences field, largely playing out through cases brought before the Court of Justice of the European Union (CJEU), affecting whether or not an SPC can or will be granted in certain scenarios.

The BIA’s Intellectual Property Advisory Committee (IPAC) monitors these substantive policy issues currently under debate and also, where appropriate, makes direct representations to the UK Intellectual Property Office (IPO) regarding specific questions before the CJEU when relevant. Given the complexities of application of the SPC regulation, especially in the life sciences field, opportunities for such comment are coming along more often than you might think.

Given the key policy issues under debate and the important practical considerations for bioscience companies to consider, the BIA’s SPC Frequently Asked Questions document provides a succinct introduction and overview to this important part of IP law. The document covers practical filing and qualification criteria, how SPC terms are calculated, and touches upon some of the issues currently before the Courts. If anyone would like to find out further information about SPCs or the Committee, please feel free to get in touch with Antonis Papasolomontos. Nicole attended the last hearing at the CJEU for the joined cases of Actavis (C-443/12), Georgetown University (C-484/12) and Eli Lilly (C-493/12) and would be happy to answer any questions people might have about this.