German court prohibits marketing of biosimilar that violates market exclusivity of an orphan drug through promotional material

German court prohibits marketing of biosimilar that violates market exclusivity of an orphan drug through promotional material

September 2023, Practical Law Life Sciences

The Munich Regional Court has held that the market exclusivity right conferred by Regulation (EC) 141/2000 on orphan medicinal products also grants orphan drug marketing authorisation holders the subjective right to enforce market exclusivity against competitor companies before civil courts.