Patents: Changes to supplementary protection certificates (SPC) for medicinal products from 1 July 2019

The regulation (EC No 469/2009) concerning the supplementary protection certificate (SPC) for medicinal products will be amended on 1 July 2019.

After the amendment, any third party can start manufacturing a product protected by an SPC for the purpose of export to third countries or storing before the SPC expires, if the conditions laid down in the regulation are met. The manufacturer must give a notification about starting the manufacturing to both the SPC holder and the patent authority that has granted the SPC, using a standard form for notification.

The amending regulation (EC No 2019/933), including the standard form for notification as Annex 1a, was published in the Official Journal of the European Union L 153 on 11 June 2019. Go to the EUR-Lex website to read the Official Journal of the European Union L 153.

Read more about supplementary protection certificates.

For more information, please contact:

Ms Saara Mustamäki
Senior Patent Examiner
Tel. +358 29 509 5905

Ms Pia Niinimäki
Senior Patent Examiner
Tel. +358 29 509 5490

Email: firstname.lastname@prh.fi

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Latest update 25.06.2019