Supplementary Protection Certificate (SPC)
For medicinal products and plant protection products the term of protection can be extended up to five years.
Patent protection for an invention is valid for 20 years from the patent application's filing date. In the case of patents for medicinal products and plant protection products, the term of protection can be extended by up to five years. This extension of the term of protection is called a Supplementary Protection Certificate (SPC).
The SPC covers the active compound or compounds which are protected by the patent and which are authorized for sale on the market by the Medical Products Agency or the European Commission, and the Swedish Chemicals Agency. The SPC's term of protection begins when the patent's validity has expired and can never be longer than five years.
The purpose of an SPC is to compensate the patent owner for the time that passes between the patent's filing date and the date the product is authorized for sale in an EEA country, meaning the first day that the patent owner can actually make money by selling their product to consumers.
The rules regarding SPCs for patents are based on two EC regulations:
- Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products.
- Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products.
An SPC for a medicinal product can, in turn, be extended by six months if the patent owner has tested the medicinal product's suitability for children. One condition for PRV to extend the term of protection by six months is that the medicinal product is protected by an SPC. The product must also be authorized for sale in all EU member states. The rules regarding extensions to SPCs are based on:
- Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products.
- Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.
Exception for manufacturing
Provided that the manufacturing is done for the purpose of exporting the products outside the EU, manufacturers of generic drugs and biosimilars will be able to commence manufacturing and/or storing during the protection period of the supplementary protection certificate.
The manufacturing exception will mainly apply to supplementary protection certificates that are applied for on or after the date of entry into force of the Regulation.
The exception applies under certain conditions, among them, the maker is obliged to inform the holder of the certificate and the relevant national authority, for Sweden it is PRV, where manufacturing and storing take place.
Supplementary protection certificates for unitary patents
There are no fixed plans to introduce unitary supplementary protection certificates (SPCs). Hence, an application for supplementary protection based on a patent with unitary effect should be filed directly with the national patent authorities. Consequently, the unitary patent will be divided into a number of national supplementary protection rights after the expiry of the basic patent.