Newsletter: Supplementary protection certificate (SPC) for medicinal products

Supplementary protection certificate (SPC) for medicinal products – Proposal for the implementation of the SPC manufacturing waiver for export and stockpiling into the Norwegian Patents Act

The Norwegian Ministry of Justice and Emergency Administration has submitted a proposal for the incorporation of Regulation (EU) 2019/933 into the Norwegian Patents Act Section 62 a.

In May 2019, the European Parliament and the European Council adopted a proposal to introduce a manufacturing exemption to Regulation (EC) 469/2009 on the supplementary protection certificates (SPCs) for medicinal products. The new Regulation, (EU) 2019/933, allows manufacturers of generics and biosimilars to manufacture a product protected by an SPC, in the EU / EEA area during the term of protection of an SPC, for the exclusive purpose of exporting the products to markets outside EU where the product is not protected by patent and/or SPC. This can facilitate the ability of manufacturers of generic and biosimilars to compete in third country markets, and increase the ability to enter the EU / EEA market rapidly after the certificate expires. In addition, the Regulation includes an exemption for manufacturing of products during the last six months of the term of the SPC for the purpose of storage (“stockpiling”)  in order to place the product on the market after the expiry of the certificate.

The Regulation requires the maker to notify both the SPC holder and the industrial property office of the Member State in which the manufacturing is to take place within a certain deadline.

The Regulation can be found here and information (in Norwegian) from the Ministry here.

The amendment is currently on public consultation. The deadline for providing comments has been set to 6 March 2020. Kvale expects the proposal to be incorporated into Norwegian law within 2020.

Kvales IP/TMT team is highly ranked amongst Norwegian law firms. Please contact our partners Anne Marie Sejersted (H) or Ingvild Hanssen-Bauer if you have SPC or other IP related questions.