Supplementary protection certificates
A supplementary protection certificate may be granted if the subject matter of the patent is a product as such, a process for its manufacture, or the use of a product, in respect of a product that is subject to an official authorisation procedure before it can be placed on the market and commercially exploited.
Because of the time that elapses between the filing of a patent application and the authorisation to place the product on the market as a medicinal product or plant protection product, the period of effective patent protection for such inventions is shorter than for others.
These products are active ingredients or a combination of active ingredients of medicinal products or plant protection products.
The protection conferred by such a supplementary protection certificate is therefore extended, within the scope of the protection conferred by the basic patent, only to the product authorised to be placed on the market as a medicinal product or plant protection product.
A supplementary protection certificate confers the same rights as the patent and is subject to the same limitations and obligations.
Procedure for obtaining patent protection in Slovenia
Unless otherwise provided for in the regulations below, the provisions on patents of the law governing the acquisition and protection of industrial property rights apply, mutatis mutandis, to the supplementary protection certificate for medicinal products or plant protection products.
The application for a supplementary protection certificate should be filed with the Office within six months of the date of authorisation to place the product on the market as a medicinal product or plant protection product, as the case may be, in the Republic of Slovenia.
If the authorisation is given before the basic patent is granted, the application for a supplementary protection certificate may be filed within six months from the date the patent is granted.
In accordance with Article 13(3) of Regulation (EC) No 469/2009 and Article 36 of Regulation (EC) No 1901/2006, the application for an extension of the duration of a supplementary protection certificate may be filed when lodging the application for a supplementary protection certificate or when the application for the certificate is pending. The application for an extension of the duration of a supplementary protection certificate already granted should be lodged not later than two years before the expiry of the certificate. During the first five years of application of Regulation (EC) No 1901/2006, the application for an extension of the duration of a supplementary protection certificate may be lodged not later than six months before the expiry of the certificate.
Duration of a supplementary protection certificate
A supplementary protection certificate takes effect immediately after the expiry of the term of the basic patent (which protects the product) for a period equal to the period that elapsed between the date of the application for the basic patent and the date of the first authorisation to place the product on the market in the European Community (the Member States of the European Community, Norway, Iceland and Liechtenstein), reduced by five years, but for a maximum of five years, and is valid only in Slovenia.
The period of duration may be extended once for six months where Article 36 of Regulation (EC) No 1901/2006 on medicinal products for paediatric use applies.
Note: An authorisation granted in Switzerland to place a product on the market is valid in Liechtenstein (possibly with a time delay) and is deemed to be an authorisation granted in the European Community.
To maintain , you must pay annual fees, which are due each year on the "anniversary" of the date of application.
To maintain the validity of your supplementary protection certificate, you must pay annual fees, which are due each year on the "anniversary" of the certificate's effective date (the first day after the basic patent expires).
Notifying the Office of changes to the certificate
The Office keeps registers of industrial property rights. If you wish to transfer your supplementary protection certificate to a new holder, or if you have changed your name, registered name, address or registered office, you must register the change in the relevant supplementary protection certificate register.
You can also contact the Office if you need a certificate of the supplementary protection certificate from the register.
Publication of notices from the maker
An exception to the protection conferred by the supplementary protection certificate for the making of a product, or a medicinal product containing that product, for the purpose of export outside EU Member States or for the purpose of storing for a limited period of time before the expiry of the certificate is provided for in Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.
A supplementary protection certificate does not confer protection against certain acts which would otherwise require the consent of the holder of the certificate. These acts comprise:
- the making of a product, or a medicinal product containing that product, for the purpose of export to third countries (outside the EU);
- any related act that is strictly necessary for the making in the EU or for the actual export;
- the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate;
- any related act that is strictly necessary for the making, in the EU, for the purpose of storing or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.
The maker must notify the authority in the Member State in which making is to take place and the holder of the certificate of the information referred to in this regulation.