A tool to monitor public health sensibility of IP laws. Presented by Gaelle Krikorian, IRIS, ITPC-MENA, France.

1. A tool to monitor
public health sensibility
of IP laws
Gaëlle Krikorian
IRIS, ITPC Mena

2. Objectives
• Qualitative analysis of legal and regulatory provisions on IPR
and other exclusive rights that might have an impact on A2M
• Study in 3 countries: Egypt, Morocco, Tunisia
• Compare the situations and options
 Develop a tool to assess the IP landscape

3. Methodology
• Assess
• Flexibilities (possible under TRIPS)
• Protections > WTO
• Scores -3, -2, -1, 0, +1, +2, +3
• Impact +, Impact –
• Limit/increase protection, facilitate/complicate the implementation of a
flexibility, mitigate a provision etc.

4. Flexibilities

5. Patentability
• What can be patented (quality and quantity)
• Patentability criteria (new, inventive)
• New uses, minor modifications (Morocco)
• Combinations of products (Morocco)
• Method of treatments or diagnostic, etc.
Egypt Tunisia Morocco
+1 +2 -1

6. Patent opposition
• Pregrant
• Postgrant
• Ban of pregrant opposition (Morocco)
• Possibility of pregrant opposition (Tunisia)
• Observations only (Morocco)
• Action at the level of patent office (Egypt)
• Through legal action (Morocco, Tunisia)
At stake: quality and quantity of the patents
Egypt Tunisia Morocco
+1,5 +0,5 -1

7. Compulsory licensing
• Grounds: large (Egypt), narrow (Morocco), excessive prices (Tunisia, Egypt)
• Procedure: who, how (court, administrative act)
• Types of license: compulsory, government use, etc.
• Effects on implementation: No generic on the market during patent (Morocco)
Egypt Tunisia Morocco
+3 -1 -2

8. Parallel import
• Exhaustion of rights: once the product is on the market, the right
holder has exhausted its rights to control the product on this market
• National (Morocco), regional, international (Tunisia, Egypt)
Egypt Tunisia Morocco
+1 +1 -1

9. Research exception / Bolar provision
• The rights do not apply to experimental acts using the invention
(Morocco, Tunisia, Egypt)
• The patent do not apply to study, trials, operations in order to obtain
marketing approval (Tunisia, Morocco)
Egypt Tunisia Morocco
+0,5 +1 +1

10. Protections

11. Extension of patent duration
Beyond 20 years (WTO/TRIPS)
• « Delays » between MA/patent filing and MA/patent granting (US) (Morroco,
delay of more than 4 years, addition of max 2.5 years)
• « Delays » between marketing approval and patent filing (EU) (ALECA Tunisia)
Egypt Tunisia Morocco
0 0 -1

12. Data exclusivity
• Different from data protection (WTO/TRIPS art. 39.3)
• Data exclusivity: 5 years (Morocco), New uses (Morocco), No MA in
case of CL (Morocco), ALECA (Tunisia)
Egypt Tunisia Morocco
0 0 -1

13. Linkage
• Health authorities refuse to grant MA in case of patent : introduced
by US FTA (Morocco)
Egypt Tunisia Morocco
0 0 -1

14. Scores
Egypt Tunisia Morocco
Patentability +1 +2 -1
Opposition +1,5 +0,5 -1
Compulsory license +3 -1 -2
Parallel import +1 +1 -1
Research exception /
Bolar
+0,5 +1 +1
Patent duration
extension
0 0 -1
Data exclusivity 0 0 -1
Linkage 0 0 -1

15. Conclusions
• A tool for analysis:
• Assessment of the situation in a country
• Exploration of what exists elsewhere
• A tool to help question/shape laws and policies:
• For civil society and policy makers
• Interactive: discuss analysis, exchange about results, improve
• Develop the mapping
• A data base ?