Abstract

Due to quick development of proprietary methodologies, systems or technologies pharmaceuticals and biotechnology industry requires a variety of IPRs protection mechanisms. Going forward, the complex R&D projects and their long-term character impose a necessity of transparency concerning IPRs protection. Stakeholders should not be provided with a misleading impression about the protection breadth, the likelihood of patent grant or the ability of the company to enforce its patent rights. The paper explores and analyses the critical IPRs protection issues disclosed by European biopharmaceutical companies in the narrative parts of their annual reports. These critical issues refer to IPRs protection strategy, risk and mitigation policies, R&D and IPRs regulatory framework, patent portfolio, infringements or litigations, and exclusive rights. The examination of disclosure practices proved that the IPRs protection-related risks and exclusive rights were the most frequently reported areas.

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