|Council of the European Union, European Parliament
|Official Journal of the European Union
Regulation of the European Parliament and of the Council of 20 May 2019 refining certain aspects of patent and Supplementary Protection Certificate (SPC) protection for medicinal products by introducing a manufacturing exemption for export purposes.
The European Union's Single Market Strategy announced a targeted recalibration of certain aspects of patent and SPC protection to boost the competitiveness of regulated industries such as the pharmaceutical industry. In May 2016 the European Parliament endorsed the need for action on the EU SPC regime and urged the European 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.
This initiative proposes an amendment to the European Union's legislation on Supplementary Protection Certificates for medicinal products (Regulation (EC) No 469/2009) and aims to introduce a so-called manufacturing exemption for export purposes (also known as a manufacturing waiver) during the term of an SPC.
The Commission presented the proposal on 28 May 2018. Ambassadors from Member States adopted a general approach on behalf of the Council of the European Union on 16 January 2019, and an informal agreement between the co-legislators on a compromise text was reached on 14 February.
|Business and Industry
|Intellectual Property, Medicines | Medical Devices, Pharmaceuticals
|Trademarks | Patents
|European Union [EU]