This paper focuses on the potential impact of the new Technology Transfer Block Exemption (TTBE) on biotechnology firms, particularly with regards to small and medium-size enterprises, and assesses the challenges faced when implementing the new rules. It discusses EU competition law, in particular article 81(1) and 81(3) of the European Community Treaty, and outlines the pro-competitive criteria that undertakings are required to meet in their agreements. It outlines key concepts of the TTBE,

more »

... luding a brief comparison with the 1996 TTBE, and details of how biotechnology licences fit within the scope of the new TTBE. Reference is made to the Commission's Guidelines and the effects of competition on the biotechnology market. The paper also discusses the difficulties faced in gaining exemption and compares those faced by competitors and non-competitors, the importance of market share and provides a list of 'hardcore' and 'excluded' restrictions. Furthermore, the paper contains details of the guidance provided by the Commission on carrying out an individual assessment for parties whose agreements fall outside the block exemption.