decisions of romanian law courts in cases concerning the interpretation of article 3 (d) of regulation (ec) no 469/2009 of the european parliament and
decisions of romanian law courts in cases concerning the interpretation of article 3 (d) of regulation (ec) no 469/2009 of the european parliament and

Summary/Abstract: The supplementary protection certificate is considered at present as representing an accessory of a national or European patent granted for the purpose of extending the duration of the rights that the latter confers to its holder for an active substance or a combination of active substances. According to the above - mentioned patent and respectively, of the certificate, the holder has the exclusive right to manufacture and to sell the patented product, as well as the right to oppose to any counterfeiting of the protected product. The regulation related to the award of this protection title for medicinal products, within the European Union territory, represents the subject matter of the Regulation (EC) no. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version). The conditions for obtaining the respective certificate are set forth in art. 3. The study is intended for the presentation of the decisions rendered by the Romanian courts in the disputes related to the controversial interpretation of art. 3 letter d) of the Regulation, setting forth that the valid marketing authorization of the medicinal product, in compliance with the Directive 2001/83/EC or the Directive 2001/82/EC, as the case may be, should be the first marketing authorization of the product in its capacity as medicinal product. Likewise, the study describes the differences of the approach and of the settlement of the cases by the State Office for Inventions and Trademarks (OSIM) and by the national courts. The objective of this study is represented by the examination of these decisions as compared the European practice for the purpose of finding certain solutions of uniform interpretation of the Community legislation at the level of the Romanian courts.

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