{"id":8673,"date":"2019-01-22T08:35:46","date_gmt":"2019-01-22T08:35:46","guid":{"rendered":"http:\/\/www.sib.it\/?p=8673"},"modified":"2019-01-22T08:45:38","modified_gmt":"2019-01-22T08:45:38","slug":"spc-waiver-draft-eu-regulation-takes-step-forward","status":"publish","type":"post","link":"https:\/\/www.sib.it\/en\/flash-news\/italiano-deroga-al-certificato-complementare-di-protezione-passo-avanti-sulla-proposta-di-regolamento\/","title":{"rendered":"SPC waiver: draft EU regulation takes a step forward"},"content":{"rendered":"

The representatives of EU member states have agreed on the so-called \u201cSPC waiver\u201d draft EU regulation that would allow EU-based companies to start manufacturing biosimilar and generic versions of a patented drug before the expiry of SPC protection. <\/em><\/p>\n

The Committee of Permanent Representatives in the European Union (COREPER) agreed<\/a> on 16 January 2019 on a draft EU regulation proposed by the European Commission<\/a> in May 2018\u00a0 that introduces a manufacturing waiver to the protection conferred to a patented pharmaceutical product by a supplementary protection certificate<\/strong> (SPC).\"certificato<\/p>\n

Introduced as an EU harmonised intellectual property right in 1992, the SPC provides an extension of patent protection for pharmaceutical products, for a maximum of five years, to compensate for the loss of profit due to the time required to obtain a marketing authorisation, during which the patented product cannot be marketed.<\/p>\n

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The aim of the SPC waiver<\/span><\/h2>\n

The proposed regulation is intended to allow EU-based generic and biosimilar manufacturers to produce generic or biosimilar versions of an SPC-protected pharmaceutical product during the term of the SPC<\/strong>, upon condition that it is done exclusively for the purpose of exporting to a non-EU market where the original pharmaceutical product\u2019s patent protection has expired or never existed.<\/p>\n

The waiver will apply only where :<\/p>\n