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Supplementary Protection Certificate (SPC)

Patent protection for an invention is valid for 20 years from the filing date of the patent application. For medicinal products for the treatment of humans and animals, as well as many agricultural chemicals used as plant protection products, a marketing authorization must be obtained. This procedure is independent from the procedure for the grant of patent. However, patent holders for pharmaceuticals or plant protection products, although they have a patent for their product, cannot use it commercially before the marketing authorization has been obtained. This procedure may last for years.

In the case of patents for pharmaceuticals or plant protection products, the duration of protection can be extended for up to five years. This extension of patent protection is called supplementary protection certificate (SPC). The purpose of the SPC is to allow proportional compensation to the patent holder for the time that elapses between the date of filing the patent application and the date when the first marketing authorization in the Republic of Serbia is granted, which is the first day when the patent holder can actually offer his product on the Serbian market.

SPCs refer to the active substance or combination of active substances protected by a patent valid in the Republic of Serbia, which has obtained the marketing license issued by the Medicines and Medical Devices Agency of Serbia (ALIMS), or the Plant Protection Directorate of the Ministry of Agriculture, Forestry and Waterworks of the Republic of Serbia.

SPCs do not prolong the basic patent as such, but it refers to the protection according to the patent exclusively for the certain product included in the marketing license for a certain pharmaceutical or plant protection product.

Who can file the application for an SPC?

The application for an SPC is filed by the holder of a basic patent, whose subject matter protected is a chemical substance, a procedure for the obtaining that substance or the use of that substance as a pharmaceutical or as a plant protection product.

SPCs are granted to the holder of basic patent protecting active ingredient or his legal successor in title, but not to the holder of license or manufacturer.

Duration of SPC

Protection according to the granted SPC lasts for the period equal to the period that lapsed from the filing date of the application for a basic patent to the date of the first marketing authorization to place the product on the market in the Republic of Serbia, reduced by a period of five years. Duration of protection by SPC starts when the validity of the basic patent lapses and it cannot be longer than five years. For the maintenance of SPC, the holder of the SPC has an obligation to pay annual administrative fees in compliance with the special regulation.

Supplementary Protection Certificate waiver (SPC waiver)

The Patent Law (“Official Gazette RS” no. 99/2011, 113/2017/ state law, 95/2018, 66/2019 and 123/2021) introduces the exception to the protection by the SPC for products, or medicinal products containing those products, produced with the purpose of export and/or storage. According to the provisions of Articles 114a-114v of the Patent Law, the producers of the generic or biosimilar products are able to obtain exception to the protection by the SPC (SPC waiver) for the production of the product, or medicinal products containing such product, for the purpose of export to the third countries, in which IP protection, (patent or SPC), for those products has expired or has never existed, as well as for the storage of product supplies for the first day of entry into the market of the Republic of Serbia, immediately after the expiry of the certificate for that product. According to this exception, it is allowed to produce for export generic or biosimilar products in the course of the entire period of the duration of SPC, while the production and storage shall be allowed only during the last six months before the expiry of the SPC for the first day of entry on the market of the Republic of Serbia.

The producers of the generic or biosimilar products that intend to use the SPC waiver, according to the article 114a of the Patent Law, have the obligation with regard to that intention, to inform the holder of the SPC and the Intellectual Property Office of the Republic of Serbia. Notification with the information, in compliance with the article 114b of the Law, must be provided on the prescribed form, at least three months before the date of the beginning of production, or at least three months before the beginning of the first related act which would otherwise be forbidden on the basis of the protection by SPC. In addition to that, the producer has the obligation to inform the Intellectual Property Office and the holder of the SPC about all changes of data stated in the prescribed form before those changes begin to be implemented.

The SPC waiver is implemented on the SPC for which the application has been filed on July 1, 2019 or after that date. Also, on July 2, 2022, the SPC waiver is implemented also on certificates for which the SPC application has been filed before July 1, 2019, but only for those which became valid and implemented on that date or after it.  The SPC waiver is not implemented on certificates which became valid and implemented before July 1, 2019

These provisions enabled the harmonization with the 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, which entered into force in the EU on July 1, 2019.

List of received notifications: under preparation.


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