You must Bolar alone: Polish Supreme Court confirms exclusion of third-party manufacturers from the Bolar exemption
In a decision handed down on October 23, 2013, the Polish Supreme Court confirmed that the Bolar exemption does not cover activities by third-party manufacturers, i.e. supplying active ingredients for studies and trials to be conducted by third-party generic manufacturers (court docket: IV CSK 92/13). Parallel proceedings in Germany are pending. We have reported before…