Spring Intro 2023

30/03/2023

Data protection - Example

PIP reward would extend SPC ~3 month beyond Data Exclusivity + Market Exclusivity

Effective potential paediatric reward period 01.2022 – 04.2022

MAA submission 12.2010

Data Exclusivity + Market Exclusivity 8+2

Supplementary Protection Certificate

PIP

Patent

MAA Approval 01.2012

Patent start 10.1996

10.2021

Patent expiry 10.2016

01.2022

The Organisation for Professionals in Regulatory Affairs

95

Data protection - Example

Adding new indication ~ 3 month beyond SPC/PIP for ALL indications

+1 yr Market Exclusivity for addition of significant indication 01.2022 -01.2023

Effective potential paediatric reward period 01.2022 – 04.2022

MAA submission 12.2010

+1 ME for new indica tion

Data Exclusivity + Market Exclusivity 8+2

PIP

Supplementary Protection Certificate

Patent

MAA Approval 01.2012

Patent start 10.1996

10.2021

Patent expiry 10.2016

01.2022

The Organisation for Professionals in Regulatory Affairs

96