Public consultation on supplementary protection certificates (SPCs) and patent research exemptions

The Single Market Strategy, adopted in October 2015, announced that the Commission will ‘consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations’.

In particular, the Strategy aimed to explore a recalibration of certain aspects of patent and supplementary protection certificate (SPC) protection, and announced that this recalibration could comprise the following 3 elements:

• the creation of a European SPC title
• an update of the scope of EU patent research exemptions
• the introduction of an SPC manufacturing waiver 

SPCs are a unique intellectual property right that constitute an extension (of up to 5 years) to the term of a patent right (of 20 years). SPCs apply to innovative pharmaceutical and plant protection products that have been authorised by regulatory authorities. They aim to offset the loss of effective patent protection that occurs due to the compulsory and lengthy testing and clinical trials that products require prior to obtaining regulatory marketing approval. The relevant EU legislation is Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96 on SPCs covering pharmaceutical and plant protection products respectively.

The ‘Bolar’ patent exemption aims at speeding up the entry of generic medicines into the market by allowing early preparatory development on generics to obtain pre-market regulatory approval, even when the SPC of the reference medicine is still in force. The Bolar exemption is regulated at EU level for the pharmaceutical industry only. This is done through Article 13(6) of Directive 2001/82/EC and Article 10(6) of Directive 2001/83/EC. The scope of the EU Bolar exemption has been updated in some EU countries, to meet new pharmaceutical-related requirements among other things. With this consultation the Commission seeks the views of stakeholders on the SPC and patent research exemption of SPCs. Citizens and stakeholders are invited to provide feedback on their experience and knowledge, which the Commission will carefully analyse before deciding whether and to what extent it should take further action. Input from stakeholders will be used for evaluation of the above legislation and impact assessment of any potential modification of the SPC and patent exemption framework in the EU.