Spring Intro 2023

30/03/2023

Protecting the Brand

Patent • Product; Formulation; Method of Use; Process • Valid for 20 years

Supplementary Protection Certificate (SPC) • Extra protection to take account of time it takes to obtain MA • Comes into force when patent expires • Maximum duration 5 years from patent expiry • Maximum of 15 years protection (patent + SPC) from date of 1 st MA • Paediatric extension (+ 6 months) • Must apply for SPC within 6 months of obtaining the MA • IP lawyer role but Regulatory role is to inform IP lawyer of approval

The Organisation for Professionals in Regulatory Affairs

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Data Protection 8+2+1 (Reg 726/2004; Dir 2001/83)

Pharmacological and Toxicological data in a reference product dossier may not be relied upon for a generic version • For a certain period of time 8 years Data Exclusivity • Regulator will not accept or review dossier cross-referencing data from a reference dossier approved within last 8 years 2 years Marketing Exclusivity • Regulator will accept and review dossier cross-referencing data from a reference dossier approved 8 years ago • But Marketing Authorisation will not be issued until 10 years after reference product approval 1 year Marketing Exclusivity extension (in all indications!) • New indication • To be obtained within 8 years of MA • Provides ‘significant clinical benefit’ compared to existing therapies

The Organisation for Professionals in Regulatory Affairs

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