FAQ - Frequently Asked Questions - Supplementary protection certificates
What is a supplementary protection certificate?
A supplementary protection certificate provides additional protection to the protection of basic patents and takes effect upon the expiry of the basic patent. The supplementary protection certificate cannot protect any invention, but only products which may be marketed exclusively on the basis of an authorisation issued by the competent authority. Such products are pharmaceuticals and plant protection products.
What is a basic patent?
A basic patent is a patent which protects the product to be protected by the certificate, or the method of obtaining or using that product, and which has been designated by its proprietor for the purposes of the proceedings for the grant of a supplementary protection certificate.
What is a product?
Výrobkom sa rozumie
- aktívna zložka alebo kombinácia aktívnych zložiek liečiva a
- aktívna látka alebo kombinácia aktívnych látok výrobku na ochranu rastlín.
What rights does the holder of a supplementary protection certificate have?
The holder of a supplementary protection certificate has the same rights as the holder of a patent, but the protection conferred by the certificate applies only to the product covered by the marketing authorisation. Thus, a basic patent may protect several products, whereas a single supplementary product ceertificate provides protection only for one specific product.
Why pharmaceuticals and plant protection products can also be protected by a supplementary protection certificate
As long as the competent authority does not approve the placing on the market of the medicinal product or plant protection product, the patent holder cannot make economic use of his protected invention (the medicinal product or plant protection product cannot be placed on the market). This may cause the period of time during which the patent proprietor can actually benefit from his exclusive rights to exploit the invention to be significantly shortened. The protection of the supplementary product certificate largely compensates for this shortening.
Who can be granted a supplementary protection certificate?
A supplementary protection certificate may be granted only to the holder of the basic patent or his successor in title.
What is the term of protection of the supplementary protection certificate?
The term of protection of a supplementary protection certificate is not fixed - it is calculated individually for each certificate and can last from one day to five years. In the case of medicinal products tested for paediatric use, the duration of protection can be extended to up to five and a half years. The term of protection of the supplementary protection certificate depends on the length of time elapsed between the date of filing of the basic patent application and the date of authorisation to place the medicinal product or plant protection product on the market.
When can I apply for a supplementary protection certificate?
The application for a supplementary protection certificate must be submitted within six months of the date of authorisation to place the medicinal product or plant protection product on the market. If the authorisation to place the medicinal product/plant protection product on the market is granted before the basic patent is granted, the application for the supplementary protection certificate must be filed within six months of the date of grant of the basic patent.
Is there a fee for protection by a supplementary protection certificate?
The filing of the application for a supplementary protection certificate and the maintenance of the certificate shall be subject to the payment of the relevant administrative or maintenance fees.
When can a supplementary protection certificate be granted?
The Industrial Property Office of the Slovak Republic (hereinafter referred to as the Office) shall grant a supplementary protection certificate for a medicinal product or a plant protection product, if the application for its granting has been filed within the prescribed time limit, and if on the date of filing the application in the Slovak Republic
- the product is protected by a basic patent,
- the product has obtained a valid marketing authorisation,
- the product has not yet been granted a certificate; and
- the marketing authorisation is the first such authorisation.
What legislation governs the procedure for an application for a supplementary protection certificate?
Sú to nariadenie Európskeho parlamentu a Rady (ES) č. 469/2009 zo 6. mája 2009 o dodatkovom ochrannom osvedčení pre liečivá a nariadenie Európskeho parlamentu a Rady ES č. 1610/96 z 23. júla 1996 o zavedení dodatkových ochranných osvedčení na výrobky na ochranu rastlín (These are 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 and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of supplementary protection certificates for plant protection products).
What is the procedure for an application for a supplementary protection certificate?
The Office shall check the formalities of the application and publish the application in the Gazette of the Office after the application for the grant of the certificate has been submitted. After publication of the application, the Office shall examine whether the conditions for the grant of the certificate are fulfilled. The Office shall inform the applicant of any formal or substantive deficiencies in the application. The proceedings on the application for a certificate may, depending on the circumstances of the particular case, be terminated by the granting of a certificate, the refusal of the application for a certificate or the discontinuance of the proceedings on the application.