Regulatory Exclusivities

We regularly advise on the interplay between SPC protection and regulatory exclusivities

Regulatory Exclusivities

Our cross-disciplinary experience informs our due diligence and litigation work

Over recent years the interplay between SPC protection and the associated regulatory protections that come with a new marketing authorisation has grown considerably. We help clients navigate this area with advice on market exclusivity, data protection, orphan market exclusivity and additional terms of paediatric exclusivity.

Our experience in these cross-disciplinary issues allows us to step back and help our clients consider the wider implications of the choices and investments that they make. This expertise also informs our regular due diligence work and our litigation strategies.

For example, the advice of our specialist attorneys was sought in connection with products such as AFINITOR®, FIRAZYR®, RESOLOR®, REVESTIVE® and VOTUBIA®.