On 12 October 2017, the European Commission launched a public consultation on supplementary protection certificates (SPCs) and patent research exemptions in the pharmaceutical sector (and other sectors with regulatory market authorisations). This consultation is within the framework of the Single Market Strategy (adopted in 2015), one aim of which is to improve the patent system in Europe for such sectors. Proposals include the creation of a European SPC title (a ‘unitary SPC’), an update of the EU patent research exemptions (e.g. the EU ‘Bolar’ exemption, whose implementation in national law is not consistent), and the introduction of an SPC ‘manufacturing waiver’ (to allow manufacture during SPC term for export to countries with no SPC protection). This consultation, which closes on 4 January 2018, includes questions relating to the operation of both the SPC system and the ‘Bolar’ exemption within the future unitary patent and Unified Patent Court (UPC) system, covering issues such the following:
- The absence in the unitary patent legislation of a specific provision on the grant of SPCs - therefore, respondent’s understanding of whether national authorities could grant national SPCs on the basis of unitary patents, and whether there should be EU legislation or a Commission communication stating that the current SPC framework is compatible with the unitary patent.
- Whether there should be a unitary SPC, and if so
- what would be the benefits, which authority would grant, which languages would be preferred (for application and publication), and whether it should be available only for products authorised by a centralised marketing authorisation.
- for national patent offices – would their budget be significantly affected, and would they be able to participate in the implementation of a decentralised procedure to grant unitary SPCs.
- Whether there is a risk that the UPC could develop a practice in terms of the Bolar patent exemption that conflicts with the one consolidated in Irish, UK and German law/practice.
Regarding any changes to the EU SPC system in general, it should be noted that these must comply with CETA (the trade agreement between the EU and Canada, most of which came into force on 21 September 2017). For example, in CETA the EU has agreed to continue to provide 2-5 years SPC protection with the option to provide additional research incentives, e.g. Paediatric Extensions.