The subject of the planned research is the instrument of data exclusivity as regulated in Directive 2001/83/EC and implemented into Polish law on the basis of the Act of 6 September 2001 – the Pharmaceutical Law.
The general aim of the research is to analyse and present the EU’s legal regime of data exclusivity as an instrument of legal protection for innovative medicinal products.
The specific research activities necessary to achieve the general aim are the following:
a. to analyse data exclusivity as an instrument of protection of undisclosed information, against the background of the requirements laid down in Art. 39(3) of the TRIPS Agreement;
b. to analyse the concept of data exclusivity as an instrument of protection of intellectual property through comparison of particular rules concerning data exclusivity with corresponding rules related to patents and SPCs. These are in particular: premises of protectability, extent of protection as well as temporary and territorial scope of protection, purpose of legal protection, its limitations, enforcement and effectiveness of protection, and revocation and expiry of the protective titles.
c. to analyse the role of data exclusivity in the overall legal protection for innovative medicinal products by means of: (i) analysis of legal regulations existing at the interface of the protective regimes (e.g. Bolar exemption, non-effectiveness of compulsory licence); (ii) analysis of relations, and also dependencies, between data exclusivity, patents and SPCs; and (iii) analysis of patent strategies, other protective strategies and market practices related to usage of the instrument of data exclusivity
d. to analyse data the exclusivity regime in US law and compare it with the system of data exclusivity in the EU; the analysis will concern legal solutions referring to particular groups of products covered by data exclusivity as well as the location of data exclusivity in the system of legal protection of medicinal products.