Refocusing regulatory exclusivities: Regulatory data protection and marketing exclusivity as forms of pharmaceutical innovation policy

Protection of innovation in the pharmaceutical industry has traditionally been realised through protection of inventions via patents. However, in the European Union regulatory exclusivities restricting market entry of generic products confer tailored, industry specific protection for final, marketable products. This paper retraces the protection conferred by the different forms of exclusivity and assesses them in the light of recent transparency policies of the European Medicines Agency. The purpose of the paper is to argue for rethinking the role of regulatory data as a key tool of innovation policy and for refocusing the attention from patents to the existing regulatory framework. After detailed assessment of the exclusivity regime, the paper identifies key areas of improvement calling for reassessment so as to promote better functioning of the regime as an incentive for accelerated innovation. While economic and public health analysis necessarily provide final answers as to necessity of reform, this paper provides a legal perspective to the issue, appraising the current regulatory framework and identifying areas for further analysis.

Application of Open Innovation Paradigm in Small and Medium Enterprises in Russia

The objective of this study is to explore how the Open Innovation paradigm is applied in by small and medium-size enterprises in Russia. The focus of the study is to understand how the processes of research and development and commercialization proceed in these kind of companies and to which extent they apply open innovation principles. Russian leadership makes certain steps for transition from the export of raw materials to an innovative model of economic growth. The research aims to disclose actual impact of these attempts. The closed innovation model and the erosion factors which lead to the destruction of an old one and emergence of new model are described. Features of open innovation implementation and intellectual property rights protection in small and medium enterprises are presented. To achieve the objective, a qualitative case study approach was chosen. Research includes facts and figures, views and opinions of management of studied companies related to innovation process in the company and in Russia in general. The research depicts the features of Open Innovation implementation by SMEs in Russia. A large number of research centers with necessary equipment and qualified personnel allow case companies to use external R&D effectively. They cooperate actively with research institutes, universities and laboratories. Thus, they apply inbound Open Innovation. On the contrary, lack of venture capital, low demand for technologies within the domestic market and weak protection of intellectual property limit the external paths to new markets. Licensing-out and creation of spin-off are isolated cases. Therefore, outbound Open Innovation is not a regular practice.