Spring Intro 2023

16/02/2023

Orphan Market Exclusivity • Orphans benefit from additional, indication specific protection lasting 10 years (unless revoked) which runs in parallel with conventional benefits • During this time HAs cannot accept submission for the same product (or a similar product…) • Further extended by an extra 2 years if they complete a PIP

Conventional benefits Orphan ME (Indication 1)

2 yrs

8 yrs

2 yrs*

10 years

Orphan ME (Indication 2)

2 yrs*

10 years

*On completion of a PIP

The Organisation for Professionals in Regulatory Affairs

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Navigating Patents • No restriction on submission timelines – prevents commercialisation • Patents valid for 20 years from the date of filing the patent application • Supplementary protection certificates: • Extend the period of IP protection to compensate companies for the period between filing of the patent and regulatory approval by up to 5 years • Total protection period should not exceed a period of 15 years • i.e. no SPC if period between patent filing date and regulatory approval is less than 5 years (patent would already provide 15+ years of protection). • Potential scope for a 6 month SPC extension on completing a PIP.

The Organisation for Professionals in Regulatory Affairs

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