Patents

The supplementary protection certificate protects medicinal products and plant protection products that can only be placed on the market under an authorisation issued by the competent authority.

A supplementary protection certificate may be granted for any medicinal product which is subject to an administrative authorisation procedure prior to its placing on the market, provided that the following requirements are met in the Slovak Republic at the date of application:

• the medicinal product is protected by a valid basic patent (Slovak or European with designation for the Slovak Republic),
• the medicinal product has obtained a valid marketing authorisation as a medicinal product,
• the medicinal product has not previously been granted a supplementary protection certificate, and
• the authorisation under point (b) is the first authorisation to place the medicinal product on the market as a medicinal product.

An SPC may also be granted for any plant protection product which is subject to an administrative authorisation procedure prior to placing on the market, provided that the following requirements are met in the Slovak Republic at the date of application:

• the plant protection product is protected by a valid basic patent (Slovak or European with designation for the Slovak Republic),
• the plant protection product has obtained a valid authorisation to be placed on the market as a plant protection product,
• the plant protection product has not been granted a supplementary protection certificate in the previous period,
• the authorisation under point (b) is the first authorisation to place the plant protection product on the market as a plant protection product.

A basic patent is a patent which protects a drug or plant protection product as such, a plant protection product, a method of manufacture of a drug or plant protection product or a use of a drug or plant protection product and which has been designated by its holder for the purposes of the certification procedure.

The application for a supplementary protection certificate must include a completed application form and a copy of the authorisation to place the medicinal product or plant protection product on the market in the Slovak Republic. Where the authorisation to place the medicinal product or plant protection product on the market in the Slovak Republic is not the first such authorisation issued in the Community, the application shall also include any document showing that the authorisation was issued in the Community, the date of its issue and the identity of the medicinal product or plant protection product.

The application form (Tlačivo (PDF, 869,1 kB)) for an SPC is available free of charge from the Industrial Property Office of the Slovak Republic (hereinafter referred to as the Office) in Banská Bystrica. It can also be printed from this page.

The applicant is obliged to pay the relevant administrative fee for filing the application. If the application fee has not been paid at the time of filing or in the amount specified, it shall be payable within 15 days from the date of receipt of a written request from the Office to pay it.

The application must be submitted within six months from the date of obtaining the first authorisation to place the medicinal product or plant protection product on the market in the Slovak Republic. If the authorisation was granted before the basic patent was granted, the application must be submitted within six months of the date of grant of the basic patent.

The application shall be submitted in paper form, either in person at the office of the Office in Banská Bystrica, or by post, or in electronic form using electronic systems (elektronických systémov) designated for that purpose.

The holder of a supplementary protection certificate has the same rights and obligations and is subject to the same restrictions as the holder of the basic patent.

The supplementary protection certificate shall be valid for a period of time equal to the period elapsed from the date of filing of the application for the basic patent to the date of the first authorisation to place the medicinal product or plant protection product on the market in the Community, reduced by five years, but not exceeding five years from the date of entry into force of the certificate.

For the purposes of calculating the term of validity of the certificate pursuant to Article 13(1) of 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, as amended, the date of the first authorisation to place the product on the market in the Community shall be the date on which the decision on such marketing authorisation is notified to the authorisation holder.

In the case of medicinal products for which studies have been carried out in accordance with a paediatric investigation plan approved by the European Medicines Agency, Európskou agentúrou pre lieky (EMA), this period may be extended for a further six months, subject to the conditions laid down.

A maintenance fee (udržiavacie poplatky) shall be payable for maintaining the validity of the certificate.