IP Update

IP legislation updates bring benefits to the Serbian Pharma Industry

The National Assembly of the Republic of Serbia recently adopted amendments to the Law on Patents, which is another important change in Serbian IP legislation this year, in addition to the New Law on Protection of Trade Secret, that  entered into force back in June, following the recent changes in the fields of copyright and trademarks.

The amendments to the Law on Patents introduced changes to the regulation of supplementary protection certificates (“SPC”) and protection of inventions by petty patents (i.e. utility models). These changes should further align Serbian IP law with the EU acquis (especially, the Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019).

The main amendments relate to SPCs, which are an intellectual property right that serves as an extension to a patent right. This extension, which can last for a maximum of 5 years, can be obtained if the subject of patent protection relates to medicines and plant protection products. The amendments prescribed the exemption from the SPCs protection, to increase competitiveness and encourage the growth of the Serbian generic pharmaceutical industry.

Before the amendments were made, the local medicine producers could not perform the preparatory work for the production of a medicine or storage of a medicine that is protected by an SPC on the territory Serbia, which put them in an unequal position concerning producers from the countries in which SPC right does not exist. As soon as SPC protection in Serbia would expire, producers from these countries could immediately place their products on the Serbian market, unlike the local producers, which could only then start with the preparatory work to produce the medicines. This made local producers far less competitive on the market.

The amendments eliminate this disparity by stipulating that domestic pharma producers can start with the production of a medicine covered by the SPC, but not earlier than six months before the expiration of the SPC, for the purpose of the storage on the territory of Serbia and subsequent placing on the market.  In addition, production of medicines still covered by an SPC will be possible for export, provided that the packaging of the medicines is marked with special prescribed markings.

These provisions will start to apply as of 2 July 2022 and will not apply to SPCs that came into force before the amendments were adopted.

Provisions of the Law on Patents that regulate the procedure of protection and substantial examination of a petty patent are also amended. Petty patents are granted without examination, meaning that, novelty, inventive step, and industrial applicability are not examined. The amendments expand the subject of a petty patent protection, so that it can protect a product and not just a solution related to the construction of a product, or the arrangement of its components as prescribed before. In addition, the procedure conducted by the competent authority when examining applications for the grant of a petty patent is described in detail as well. The objective of these amendments is an increase in the number of filed applications for small patents, which would contribute to the competitiveness of local entities in the domestic and foreign markets. The increased number of petty patents will also enable the wider use of IP box tax incentives available in Serbia.

New provisions regulating small patents will start to apply as of 23 December 2021.

The information in this document does not constitute legal advice on any particular matter and is provided for general informational purposes only.