| Abstract [eng] |
The pharmaceutical industry is subject to one of the most stringent requirements. Because of these requirements the duration of a product patent protection is much shorter. In order to compensate such reduced duration of protection different countries provide for a possibility to extend the period of a patent issued to medicinal products. The EU patent law is not consistent; however a unanimous decision has been adopted as to granting of extra protection to medicinal products. This solution is to issue a supplementary protection certificate with respect to medicinal products. There is no single competent authority in the Community, which is responsible for the issuance of such certificate. The relevant competent authority of each Member State issues a certificate. Often many questions arise in the course of issuance of such certificates in different countries. The paper discusses the problems concerning the issuance of supplementary protection certificates for medicinal products. The aim of the research is to identify and analyze problematic aspects of the issuance of supplementary protection certificates for medicinal products. The analysis of case law and special literature deals with various problematic aspects related to the issuance of SPC. The conclusions summarize the principle problematic aspects of the issuance of SPC for medicinal products, which are related with the following: a) Interpretation of the term "product" provided for in Regulation No. 469/2009; b) Requirements for the issuance of SPC for medicinal products laid down in the said Regulation; c) Possibilities for the issuance of SPC with “negative” validity and calculation of the period of validity of SPC; d) Development of the Community. Still, most of the disputes arise from the interpretation of the term "product" and requirements for the issuance of SPC for medicinal products. These disputes emerge from a different approach of the patent offices of different Member States towards certain issues and gaps in laws, which have not been filled in by EJC. The paper notes that maybe the harmonization of patent laws could uniform the approach of the patent offices of different Member States towards certain issues. However, the comparison of the regulation of the Community and of the USA reveals that such harmonization shall not solve many of the problems associated with the issuance of SPC for medicinal products. More extensive case law of EJC dealing with the issuance of SPC for medicinal products could solve certain uncertainties as to the issuance of SPC. However, it takes much time for case law to develop. So far, some of the problematic issues associated with the issuance of SPC remain the subject matter of discussions. |
