European Commission Starts Public Consultation on Supplementary Protection Certificates and "Bolar" Exemption
- 13/10/2017
- Articles
On 12 October 2017, the European Commission (the “Commission”) launched a public consultation on two crucial aspects of the patent regime that applies to medicines.
Supplementary Protection Certificates
Supplementary Protection Certificates (“SPCs”) extend for up to five years the patent rights in innovative active substances of pharmaceutical and plant protection products. They are designed to compensate for the loss of effective patent protection resulting from a series of steps that have to be taken prior to obtaining marketing authorisation.
“Bolar” exemption
The “Bolar” patent exemption seeks to accelerate the market entry of generic medicines by allowing preparatory development work that will enable pre-market regulatory approval even when the SPC pertaining to the reference medicine is still in place. At the EU level, the “Bolar” exemption applies only to pharmaceutical products for human and for veterinary use. The scope of this exemption has been modified in some EU member states by additional national rules.
Both the consultation document and the studies which the Commission commissioned on the subject can be found here.
The actual consultation document is also attached to facilitate review. The Commission created targeted questionnaires for the following categories of respondents: (i) the general public; (ii) innovators; (iii) generics and biosimilars; (iv) patients groups; farmers; doctors; health authorities; agricultural authorities; and insurers/tenderers; (v) national patent offices; judges; and intellectual property professionals; and (vi) public authorities related to science, industry, trade and competition.
The Commission’s patent law consultation is part of a larger effort to review the impact of regulatory incentives such as data and market exclusivities on the availability, affordability and accessibility of medicines and on the quality of medical innovation. For example, the Commission’s current review of the regulatory regime applicable to orphan medicines has to be understood in this light.
The Commission’s patent law consultation expires on 4 January 2018.
