New Regulation on the Supplementary Protection Certificate (SPC) for medicinal products
The Regulation (EU) n°2019/933 which amends Regulation (EC) No 469/2009 on the SPC for medicinal products has been published in the Official Journal of the European Union (EU) on June 11, 2019 and will enter into force on July 1, 2019.
The Regulation (EC) No 469/2009 provides an extension of the patent term for a medicinal product subjected to a Marketing Authorization (MA) by five years and another extension of six months for patents covering pharmaceutical products for pediatric use.
Whereas the Regulation (EC) No 469/2009 does not provide any derogation to the protection conferred by a SPC, the Regulation (EU) No 2019/933 amends said Article 5 for providing such a derogation. It follows from this novel Article 5, paragraph (2), it could be possible to manufacture a product or a medicinal product containing an active principle which is covered by a SPC for the purpose of :
- its export to third-countries (non-EU countries) in which protection of the product or of the medicinal product is not or no longer protected ; or
- its storage to supply immediately after expiry of the protection
Related acts performed in the EU and strictly necessary for that making or for the actual export or the actual storing could be authorized : such related acts could include possessing; offering to supply; supplying; importing; using or synthesising an active ingredient for the purpose of making a medicinal product; or temporary storing or advertising for the exclusive purpose of export to third-country destinations. That exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker (see point 9 of the « whereas »).
However, on one hand, the producer will have to indicate in the standard form attached to the Regulation, the competent authority in the Member State in which the product will be made. On the other hand, he will have to provide the SPC holder with the information listed in said form within three months before the start of manufacturing, the latest.
Paragraph 2 of said Regulation shall apply to certificates that are applied for on or after 1 July 2019.
Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date, but it shall only apply to such certificates from 2 July 2022.
Paragraph 2 shall not apply to certificates that take effect before 1 July 2019.
Of course, at this stage no interpretation of these provisions has been made before the competent Courts ; thus its future application must be specified, and we recommend that you consult us before any exploitation if you intend to benefit from these new provisions, or on the contrary if you would like to determine whether a third party goes beyond these new provisions.