GSIPA2M, Plenary 2, The role of civil society - Gaelle Krikorian

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

Government & Nonprofit

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

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

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.

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

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

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

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

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

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

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

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

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

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 ?

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This document summarizes a presentation on combating counterfeit electronic parts through increased legal tools and enforcement efforts. It outlines current US criminal laws against trafficking counterfeit goods and labels. Proposed legislation aims to strengthen customs authorities to seize more counterfeits and increase information sharing. Regulators may require contractors to prove they are not buying or selling counterfeit IT products. International agreements obligate trading partners to enforce intellectual property rights at customs. Additional enforcement tools include registering trademarks abroad, using government advocates, and understanding foreign enforcement systems. Companies can help by having anti-counterfeiting training and education programs and raising awareness overseas.

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Unitaid has funded several projects related to intellectual property for HIV, HCV, and TB medicines since 2010. The first project provided over $56 million to the Medicines Patent Pool to negotiate voluntary licenses for HIV medicines and expand to HCV and TB. Other projects supported using TRIPS flexibilities like opposition of patent applications in India, Argentina, Brazil, Thailand and Ukraine. Unitaid is funding these IP projects because patents can limit access and affordability of medicines or block appropriate formulations, and TRIPS flexibilities provide solutions. The funding aligns with Unitaid's mandate to support countries using compulsory licensing or other TRIPS flexibilities when IP barriers limit competition and price reductions.

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This document discusses how social movements often start with a single person taking a stand at a pivotal moment, such as Mohamed Bouazizi in Tunisia, Nelson Mandela in South Africa, and Mahatma Gandhi in India. It notes that movements need funding to continue but is unclear whether getting funding should be the goal or if funding will come as a result of actions. The document raises getting funding as both something necessary and something that results from movements.

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This document discusses a donor's perspective on funding to eliminate intellectual property barriers that restrict access to HIV treatment. It notes that the donor organization, Aidsfonds, provides 1-2 million euros annually for international projects. Past funding has increased capacity for intellectual property issues in several countries. The rationale for supporting this work is that medicine prices are key to treatment access and many people living with HIV are in middle-income countries. There is also a clear need as few donors support this type of work, which could have a high impact by changing national policies and reducing prices. The document outlines some dilemmas in obtaining funding and measuring the effects of intellectual property projects.

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This document discusses the importance of intellectual property (IP) work to ensure access to HIV and HCV treatment. It provides the following key points: 1. IPPCru has been monitoring government drug procurement in Russia since 2010 and their analytical reports are now considered the best available on treatment access in the region. 2. While HIV treatment coverage in Russia has increased from 15-20% in 2013 to 35-40% in 2017, 600,000 people still need treatment. Price reductions of 60-85% have occurred for generic drugs but patents until 2030 prevent generics and price reductions for other drugs. 3. IP work is important to challenge patents like the SOF patent in Russia to help lower prices and

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