Abstract

COMPARATIVE ANALYSIS BETWEEN BULGARIAN AND EUROPEAN PATENT LEGISLATION IN REGARD TO MEDICINAL PRODUCTS

Nadezhda I. Marchokova, Valentina B. Petkova*, Milen V. Dimitrov

ABSTRACT

Background: The aim of the study is to compare Bulgarian and European patent legislation in regard to medicinal products and to determine if Bulgarian legislation was harmonized with the EU. Methods: Documentary analysis was carried out. Use was made of the database of European Patent Office, Patent Office of the Republic of Bulgaria and eur-lex. The documents found were subjected to comparative analysis. Results: The Law on Patents and Utility Model Registration, as compared against the European Patent Convention in respect to the analyzed items, patentable inventions, exceptions to patentability, term of a patent and requirements of a patent application, has been harmonized. The Bulgarian Ordinance on the filing of applications and issuing of supplementary protection certificates for medicinal products and plant protection products has been harmonized to a certain degree with the European legislation with respect to definitions, conditions for obtaining a certificate, applying for a certificate, filing of an application for a certificate and term of the certificate. The specific cases in the Ordinance on extending the duration of a supplementary protection certificate were not analyzed. Conclusion: The Bulgarian Ordinance on the filing of applications and issuing of supplementary protection certificates for medicinal products and plant protection products has been harmonized with Council Regulation (EEC) â„– 1768/92, but was not updated in terms of Regulation (EC) â„– 469/2009 concerning the supplementary protection certificate for medicinal products.

Keywords: Patent, Supplementary protection certificate, Medicinal Product, Comparative analysis.