CABINET CHAILLOT

SUPPLEMENTARY PROTECTION CERTIFICATE

Presentation of the supplementary protection certificate

The supplementary protection certificate extends the duration of protection of a product used in the composition of a medicinal or phytopharmaceutical product, covered by a patent for a product, a process for obtaining a product or an application for a product.

Certificates concerning a medicinal product are governed by Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (OJEC No. L152/1 of 16 June 2009) codifying Council Regulation No. 1768/92 of 18 June 1992, which entered into force on 2 January 1993 and was amended by Regulation No. 1901/2006 of the European Parliament and of the Council of 12 December 2006, which entered into force on 26 January 2007.

The conditions for the issue and validity of certificates for plant protection products are laid down in Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 (OJEC No L198/31 of 8 August 1996). These provisions came into force on 8 February 1997.

Art. 3 Rt N° 469/2009: “A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product”.

Obtaining the SPC

-    Product condition
In the case of a medicinal product, the product is defined as "the active ingredient or the composition of active ingredients of a medicinal product".
For a phytopharmaceutical product, the product is "the active substance" or "the composition of active substances of a phytopharmaceutical product".

-    Basic patent requirement
The basic patent must be a patent in force on the date of filing of the application for a supplementary protection certificate, having effect in France. It can therefore be a French patent or a European patent having effect in France.
Whether it is a drug or a phytopharmaceutical product, the product must be mentioned in the wording of the claims of the basic patent.

-    Condition of marketing authorisation
The marketing authorisation must be the first authorisation granted in France for the product as a medicine or a phytopharmaceutical product.

A new therapeutic application of an active ingredient can be the subject of a SPC on the basis of the corresponding marketing authorisation, even if this product has already been the subject of a marketing authorisation for the first therapeutic application. The SPC will then be granted if the basic patent is a patent for a second therapeutic application of an active ingredient or a composition of active ingredients coinciding with the marketing authorisation invoked. The SPC will then only cover the new use of the active ingredient that is the subject of the basic patent.

The application for a supplementary protection certificate must be filed within six months of the date of the first marketing authorisation issued in France, or covering French territory, for the product.
If the marketing authorisation is prior to the grant of the basic patent, the application for a supplementary protection certificate must be filed within six months of the date of grant of the patent.

Duration of the SPC

Supplementary protection certificates take effect "at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community, reduced by a period of five years".

The term of the certificate may not exceed five years.

The term of protection may be extended for a single period of six months in the case of studies for paediatric use.