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What is a supplementary protection certificate
What is protected by a supplementary protection certificate?
Medicinal products and plant protection products, for which an authorisation to place the product on the market has been granted by a relevant authority, may be protected by supplementary protection certificates.
What are conditions for granting a supplementary protection certificate?
A supplementary protection certificate may be granted for any medicinal product or plant protection product which was, prior to being placed on the market, subject to an administrative authorisation procedure provided that following conditions are met in the Slovak Republic on the filing date:
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the medicinal product or plant protection product is protected by a valid basic patent (Slovak or European with a designation for the Slovak Republic),
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valid authorization to place the medicinal product or plant protection product on the market as a medicine or preparation for plant protection has been granted,
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the product has not already been the subject of a certificate,
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the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product or plant protection product.
A supplementary protection certificate can only be granted to an owner of a basic patent or to his legal successor in title.
What is a basic patent?
Basic patent is a patent, which protects a medicinal product or a plant protection product as such, a preparation for plant protection, a process to obtain a medicinal product or a plant protection product or application of a medicinal product or plant protection product and which is designated by its holder for the purpose of the procedure for grant of a certificate.
Requirements of an application for granting a supplementary protection certificate
An application for granting a supplementary protection certificate shall include duly completed application form and a copy of authorization to place a medicinal product or a plant protection product on the market in the Slovak Republic. If such authorization to place a medicinal product or plant protection product on the market in the Slovak Republic is not the first authorization granted in the Community, an application shall contain also any document proving that an earlier authorization in the Community was granted, including date the authorization was granted and identity of a medicinal product or a plant protection product.
An application form for granting a supplementary protection certificate is available in the filing room of the Industrial Property Office of the Slovak Republic (hereinafter referred to as "the Office") in Banská Bystrica and in the Branch Office in Bratislava. It can also be printed out from this web page.
An applicant is obliged to pay a relevant filing fee. Administrative fee is payable within 15 days form delivery of notification on assignment of an application number.
When and where to file a supplementary protection certificate application?
An application has to be filed within 6 moths from the date on which the first authorization to place a medicinal product or a plant protection product on the market in the Slovak Republic was granted. If authorization was granted before a basic patent was granted, an application has to be filed within 6 moths from the date of granting a basic patent.
A supplementary protection certificate application can be filed in person with the filing room of the Office in Banská Bystrica or with the Branch Office in Bratislava. An application can also be sent by post.
Rights conferred by a supplementary protection certificate
An owner of a supplementary protection certificate shall have the same rights and obligations and shall be subject to same limitations as an owner of a basic patent.
Term of protection by a supplementary protection certificate
The certificate shall 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 authorization to place the product on the market in the Community, reduced by a period of five years.
In order to calculate the duration of the certificate is the date of the first authorization within the meaning of Article 13(1) of the Regulation of the European Parliament and Council Regulation (EC) No. 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products, the date on which the decision to place the product on the market in the Community was communicated to the holder. The certificate shall take effect at the end of the lawful term of the basic patent. The duration of the certificate may not exceed five years from the date on which it takes effect.
This period may be exceeded for another six months in case of medicinal products on which studies pursuant to experimental paediatric plan authorised by European Medicines Agency (EMEA) have been performed.
The owner shall be obliged to pay an annual maintenance fee pursuant to the Act on Administrative Fees.