Patents, supplementary protection certificates and data exclusivity at the service of pharmaceuticals

The Object and Purpose of Intellectual Property / Susy Frankel (ed.) – Cheltenham: Edward Elgar Publishing, 2019, s. 218-239.

Legal protection for pharmaceutical innovations in the EU involves patents, supplementary protection certificates (SPC) and data exclusivity. The particular rights serve substantially the same purposes and overlap both in subject matter and in time, which raises doubts about their justification. This complex system has been built through various initiatives, including international agreements, legal acts at the Community level and national laws. The legal structure has been shaped extensively by case law, especially judgments of the Court of Justice of the European Union and decisions of the European Patent Office. This chapter presents how the particular legal instruments evolved and how they have influenced the scope of protection for pharmaceuticals. An overview of the legislative and case law milestones, as well as analysis of their rationales, allows for a better understanding of how the balance of interests among many stakeholders has been sought.

Innovation in the Polish health sector : A quality assessment

Geneve : World Intellectual Property Organization, 2019

Seria: Economic Research Working Paper 47

49 stron.

This working paper aims to present the specifics of innovation in the Polish health industry through the prism of the experiences and opinions of a representative group of 42 companies from both the pharmaceutical and medtech sectors. Through analysis of indepth interviews, it aims to illuminate the legal, economic and social mechanisms and phenomena that determine innovation in this sector. The survey examines which areas of the Polish health sector are most innovative, the understanding of innovation that prevails in the sector, and the characteristics of R&D activities carried out there. Subsequently, the study explores the general impact of intellectual property, and particularly of patent law on innovation, in the Polish health sector. Finally, it surveys the other economic and legal instruments currently stimulating innovation and how legal regulations and governmental policy could be modified to create an optimal pro-innovation environment. The conclusions include short legal and factual background of innovation in the Polish health sector, the summarized results of the conducted analysis and final comments concerning the level and culture of innovation within the examined industry.