Managing SPCs under the unitary patent system

The application of supplementary protection certificates to the unitary patent system poses numerous complexities, both legal and practical, as Christopher Stothers and Paul Abbott of Arnold & Porter describe.

In this article, we identify the key issues and provide tips to help potential users best prepare for the new system.

It can often take many years to obtain a marketing authorisation (MA) to place a new medicinal product on the market, due to the necessity of ensuring the safety and efficacy of such products. This can mean that the 20-year period of monopoly protection enabled by a patent is insufficiently long for the originator to recover the investment put into research and development.

To improve the protection of innovation in the pharmaceutical sector, EU Regulation 469/2009(SPC regulation) provides for an additional period of protection if an MA is not granted until more than 4.5 years after the ‘basic patent’ covering the product in question is filed. This period—conferred by an SPC—commences on the expiry of the ‘basic patent’.