The research project attempts to shed more light to the legal issues that result from the SPC Regulation. More precisely, the author focuses on the question whether the existing rules of the European patent law and the enforcement of these rules by the European institutions may contribute efficiently to the goals declared at the SPC Regulation. In this context, it is examined whether and to what extent the regulatory regime of the SPC, the related case law as well as the interaction of the SPC Regulation with the Unified Patent System enable or prevent the abusive use of the examined legal instrument as a method of “evergreening”. In the end, the author provides a critical overview of the Study of the MPI on the SPCs as well as of the proposal of the European Commission for amending the related Regulation. More precisely, it is attempted to examine whether and to what extent the proposed by the EC legislative changes are in line with the goals of the SPC Regulation. In this context, the author turns to the results reached in the first chapter of the research project that has been dedicated to the legislative history of the related statute. These results are also used in order to provide an overview on whether the Study of the MPI takes in mind the reasons for which the SPC Regulation has been initially introduced to the European legal order. The very last part of the research project summarizes all issues that need to be addressed in the future by the European legislator. More specifically, the author attempts to categorize all open points related to the application of the SPC Regulation. After listing all these points, the author provides ideas on how the related legal framework would be more efficiently applied. In this context, certain legal provisions are proposed with the aim of adding more arguments to the dialogue regarding the necessity of amending the SPC Regulation.
In spite the fact that there is a satisfactory number of articles and commentaries in regard to the legislative development and goals of the SPC Regulation as well as of the corresponding legal instruments enacted to other jurisdictions, the continuous development of the European case law related to the SPC has not permitted the comparative analysis of the conflicting issues stemming from the decisions of the ECJ. More precisely, the existing literature lacks circumstantial argumentation on the basis of which it could be examined whether the regulatory tools and the approach adopted by the ECJ can contribute efficiently to the striking of a fair balance among the protection of the public health and the freedom of competition as well as to the restriction of the “evergreening” of pharmaceutical patents. In this context, the research project attempts to cover this gap in the literature and provide guidance to the European legislator. Moreover, there is at the time no comments in the related literature on the newly published Study of the MPI as well as on the proposal of the EC for the amendment of the SPC Regulation.