Political agreement by European Parliament and Council on Commission proposal to introduce an export and stock-piling waiver to SPC legislation
On February 14, 2019 the European Commission has issued a Press Release informing that the European Parliament and Council have reached a political agreement on a targeted adjustment that the Commission proposed in May 2018 to Supplementary Protection Certificates (SPCs), i.e. an intellectual property (IP) arrangement related to pharmaceutical products.
The new Regulation introduces a carefully framed exception (‘export manufacturing waiver’) to the patent protection of an original medicine for export and stock-piling purposes.
Supplementary Protection Certificates (SPC) extend patent protection for medicinal products, which must undergo lengthy testing and clinical trials before obtaining regulatory marketing approval. Thanks to the waiver, EU-based companies will be entitled to produce and export a generic or biosimilar version of an SPC-protected medicine during the term of the certificate. The waiver will support Europe’s pharmaceutical manufacturing base and Europe’s pioneering role in research and development of biosimilars.
