Legal Basis
Supplementary protection certificates in the European Union were based primarily upon two regulations:
- Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products which entered into force on January 2, 1993. This has been cancelled by the below specified recodified regulation no. 469/2009 with effect from May 2009
- 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 which entered into force on February 8, 1997
The above Regulations have now been codified under the following regulation:
- 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 (Codified version)
Supplementary protection certificates may come into life at the expiry of a national or European patent. However, the European Patent Convention (EPC) needed to be modified to allow such "extension" of the term of European patent. Article 63 of the EPC was modified on December 17, 1991 to specify to, although European patents have a term of 20 years as from the date of filing of the application (Art. 63(1)),
- " nothing (...) shall limit the right of a Contracting State to extend the term of a European patent, or to grant corresponding protection which follows immediately on expiry of the term of the patent, under the same conditions as those applying to national patents: (...)
- (b) if the subject-matter of the European patent is a product or a process of manufacturing a product or a use of a product which has to undergo an administrative authorisation procedure required by law before it can be put on the market in that State. "
This constituted the first revision of the European Patent Convention since its signature in 1973.
The paediatric extension is based primarily upon:
- Regulation 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
- Regulation 1902/2006 of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use
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