Proposal for amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

The Single Market Strategy announced a targeted recalibration of certain aspects of patent and SPC (Supplementary Protection Certificate) protection to boost the competitiveness of regulated industries such as the pharmaceutical industry. The aim was to tackle the following problems:

i) loss of export markets (including new business opportunities), and lack of timely (namely ‘day-1’) entry onto Member State markets following expiry of the SPC, for EU-based manufacturers of generics and biosimilars, due to unintended effects stemming from the current EU SPC regime adopted almost three decades ago, and in view of changes in the pharmaceutical sector (e.g. the emergence of biosimilars); 

ii) fragmented implementation of the SPC regime in Member States, which may be solved in connection with the upcoming EU unitary patent, and the possible creation thereafter of a unitary SPC title; 

iii) fragmented implementation of the ‘Bolar’ patent exemption. 

The European Parliament’s Resolution on the Single Market Strategy endorsed the need for actions on the EU SPC regime and ‘urge[d] the Commission to introduce and implement before 2019 an SPC manufacturing waiver’, so as to boost the competitiveness of the generics and biosimilars sector, but ‘without undermining the market exclusivity granted under the SPC regime in protected markets’. 

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