Spring Intro 2023

30/03/2023

Data protection - Example

+1 ME for new indica tion

Data Exclusivity + Market Exclusivity 8+2

Supplementary Protection Certificate

PIP

Patent

Patent start 10.1996

Patent expiry 10.2016

10.2021

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Intellectual Property and Data Exclusivity

Understand that medicinal products are eligible for • 8 years Data Exclusivity • 2 years Marketing Exclusivity • 1 year Marketing Exclusivity extension (in all indications!) • Top tip: Remember your 8+2+1

• Completion of your paediatric plan leads to additional protection • Understand the differences between orphan and non-orphan ‘exclusivity’ • Your IP department will be responsible for applying for SPC • Top tip: Make sure you inform the IP Department of all approvals to ensure submission deadline for SPC is not missed

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