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SPCs: Background

Certain products, such as human and veterinary medicinal products or so-called “plant protection products” (PPPs, such as agrochemicals), cannot be commercialised until an official review of safety and efficacy has been conducted and a formal marketing authorisation granted.

The time taken to complete such official reviews (including the time taken to gather the necessary safety and efficacy data) can consume a significant portion of the available patent term for regulated products, which can result in much shorter post-marketing exclusivity periods for those products as compared to non-regulated products.

SPCs are designed to combat this loss of post-marketing exclusivity, thereby encouraging innovation through ensuring that those investing in the research and development of new medicinal products or PPPs have a sufficient period of exclusivity to recoup their investments.

In this respect, SPCs are Europe’s answer to Patent Term Extensions (PTEs) in other countries, such as the US and Japan. However, in contrast to PTEs, SPCs do not actually extend patent term and are separate rights with their own unique (and unusual) characteristics.

The case law relating to SPCs is highly complex and rapidly evolving. It is therefore difficult to present a complete and accurate picture as to how SPCs work. However, for some basic information on SPCs, please see our list of Frequently Asked Questions, as well as the Wikipedia entry on SPCs (though please note that we cannot guarantee the accuracy of information provided on that Wikipedia entry).

If you have any questions relating to SPCs, please contact us. Park Grove IP is particularly well placed to advise on SPC-related matters, as its owner and founder, Mike Snodin, is an expert and has authored (and co-authored) a number of influential articles on SPCs.

Indeed, Mike has even devised new legal concepts that have subsequently been accepted by the Court of Justice of the European Union, namely zero / negative term SPCs (as accepted in C-125/10) and setting SPC term by reference to the Notification Date (as opposed to the Decision Date) associated with “centralised” Marketing Authorisations issued by the European Commission (as accepted in C-471/14).

Selected examples of Mike’s publications relating to SPCs can be found in our News & Publications section.

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