The National Assembly of the Republic of Serbia adopted the Amendments to the Patent Act (“Amendments“) on December 8, 2021. The Act seeks to harmonize local protection of inventions regulations with those of the European Union. It also looks to eliminate certain shortcomings that have been identified in the application of the existing Patent Act.
Therefore, the most important changes relate to the supplementary protection certificate and the protection of inventions through a utility model system. The changes will have a significant impact on the Serbian pharmaceutical industry and potentially incentivize investments by domestic entities. These changes seek to eliminate the disparity that exists between domestic and foreign pharmaceutical manufacturers. Namely, the Amendments expand the range of products that can be protected by a utility model.
Therefore, to eliminate inequalities between domestic and foreign business entities, the Amendments stipulate that domestic business entities may perform preparatory activities for the manufacturing and storage of pharmaceuticals, regardless of whether a certificate of additional protection exists in the Republic of Serbia. However, such an exemption did not exist under the provisions of the previously applicable Patent Act. More importantly, the previous version forbade businesses to perform preparatory processes for pharmaceutical manufacturing or for the storage of pharmaceuticals that were protected by a certificate in Serbia.
As a result, domestic manufacturers weren’t allowed to build manufacturing capacities, storage capacities, or perform any other preparatory processes necessary for the manufacturing and authorization of the pharmaceuticals as long as the certificate was valid. All because the holder of the certificate in Serbia could have prevented third parties from performing preparatory processes in Serbia.
On the other hand, in countries where the certificate was not valid, pharmaceutical manufacturers could take all the preparatory actions to produce the medicine. Thus, they had a competitive advantage over Serbian manufacturers as they could become a market participant in Serbia after the expiration of the certificate in the country. Therefore, business entities from countries where there was no protection certificate were in a far more favorable position compared to Serbian business entities.
As a result of the Amendments, Serbian manufacturers can start manufacturing pharmaceuticals six months before the expiration of the certificate. Therefore, the novelty’s value lies in increasing the competitiveness of pharmaceutical companies in Serbia, EU countries and other countries.
However, the new provisions will only begin to apply to certificates that come into force and apply from July 2, 2022.
The Amendments expand the range of products that can be protected by utility models. Namely, the previously valid Patent Act limited the use of utility models to products related to the product construction or component arrangements whereas now all products can be protected by utility models.
However, the Amendments also prescribe exceptions to utility models implementation, so that utility models cannot protect inventions in the field of biotechnology, substances, medicines, substances or compositions contained technology used in surgical or diagnostic or treatment procedures, plant varieties or animal breeds, as well as patentable procedures.
Intellectual property is a dynamic field and it impacts the entire economy and especially the IT industry. In late 2021, amid growing violations of intellectual property rights via piracy and counterfeiting, Serbia adopted Amendments to the Act on Special Authorities for the Sake of Efficient Protection of Intellectual Property Rights. The Act transferred the competence for determining violations of intellectual property rights (including the software and database rights violations from the Ministry of Trade, Tourism and Telecommunications to the Ministry of Finance – Tax Administration.
Jasmina Glavšić
