Newsalert - Regulation (EU) concerning the supplementary protection certificate for medicinal products


The Council of the EU definitively approved a regulation proposal amending regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (“SPC”).

The SPC is an intellectual property right which extends the duration of patent protection for medicinal products so as to offset the lapse of time brought about by the performance of the clinical/administrative activities required for the marketing of the product.  

The new Regulation sets forth a waiver to the scope of protection conferred by the SPC by allowing makers of generics and biosimilars established in the EU to perform certain activities which would otherwise require the consent of the SPC holder. In particular, pursuant to this waiver the following activities shall be considered lawful:

  • the making of a product for the purpose of export to third countries in which protection does not exist or has expired; and
  • the making and storing of a product for the purpose of its marketing within the EU, however no earlier than six months before the expiry of the relevant SPC.

The waiver also applies to the performance, by the maker or by third parties who are in a contractual relationship with the maker, of any related acts that are “strictly necessary” to the above (by way of indication, synthesis of an active ingredient or advertising for the exclusive purpose of export to third-country destination).

The exemptions are however subject to certain requirements and conditions, including, amongst others, prior notification and information duties towards the competent authorities and the certificate holder, the affixing of a logo, in the forms set out in the Regulation, on exportation products, as well as the imposition of individual contractual obligations to the third persons involved by the maker in the relevant activities.

The new Regulation will affect only SPCs that are applied for starting from the date the Regulation enters into force. SPCs applied for before such date will be subject to a transitional regime.

The Regulation will enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. According to the press release of the Council of the EU, the Regulation is expected to enter into force by 1 July 2019.