Module 6

03/10/2024

Why do we need data protection when products have patent protection?

Pre Clinical research & development

Marketing

Clinical trials

Expected cost $467,000,000

$335,000,000

4 years 4 months

5 years 8 months

Data from JA DiMasil/Journal of Health Economics 22 (2003) 151-185 (2000 figures)

The Organisation for Professionals in Regulatory Affairs

Data Exclusivity

49

Comparison of patents and regulatory data protection

Regulatory data protection

Patents/SPC

Protects data relating to safety and efficacy of authorised product

•

Protects compound, manufacturing process, formulation, therapeutic use

•

Action by innovator against regulatory authority

•

Action by patent owner against generic competitor

•

Public law remedy: revocation of marketing authorisation

•

Private law remedy: injunction and damages

•

8+2(+1) years protection

•

20 years from filing + up to five years SPC

•

Common factor: both designed to protect and reward innovator’s investment in original/improved product

The Organisation for Professionals in Regulatory Affairs

Data Exclusivity

50

25