This note discusses regulatory data protection (or data exclusivity) and market protection (marketing exclusivity). It identifies their legal bases, defines relevant legal terms and case law, and explains why these forms of protection are essential for the innovative medicines industry. This note also discusses the periods of time for which these forms of protection exist and how they interrelate with protection afforded by patents and supplementary protection certificates. Additionally, this note summarises enforcement issues, including possible challenges to the grant (or refusal to grant) of generic marketing authorisations.

Originally published in Practical Law.