1. Mechanisms to address IP related Barriers in Middle-Income Countries
Othoman Mellouk
ITPC-MENA

2. 1st vague of generic competition is unlikely to happen…
Significant increase in access to treatment: 14M
Generic competition played an important role: most ARVs used for 1st line Tx are off patent
However:
Increasing need of 2nd, 3rd line ARVs, untreated co-infections HepC, TB
In the post TRIPS-Era, the generic competion seen for 1st line ARVs is unlikely to happen unless we address patents and other IP barriers
Most recently developed drugs are patented in developing countries or countries with high production capacity (India+++)
11/15/2018

3. TRIPS is Flexible…
TRIPS sets a minimum standard for IP prtection including granting patents on pharmaceutical products
However:
TRIPS include public health safeguards to protect access to medicines: Flexibilities
Transition periods, patentability criteria, parallel imports, compulsory licences, government use licenses,exception to patent rights,patent oppositions
Implementation of TRIPS in several developing countries has been biaised by « pro IP oriented » technical assistance
Several Developing countries are engaged in FTAs: TRIPS+
Only few countries used the TRIPS flexibilities  Price decrease  More Access
11/15/2018

4. Emergency to address IP barriers to maintain the scaling up
Least developped countries have been provided an extension to 2021 to grant patents on medicines  Law reform
Middle Income Countries should start fully taking advantage of the TRIPS Flexibilities
11/15/2018

5. Global HIV/AIDS epidemic: MICs vs. LICs
Middle-income countries (MICs) comprise a growing share of the global HIV/AIDS burden, but have lower rates of antiretroviral (ARV) treatment coverage vs. low-income countries (LICs)
% of eligible patients receiving ARV treatment
Proportion of people living with HIV by country income level
HICs
N/A
LICs
37%
MICs
33%
Source: Schwartländer, Bernhard. “What will it take to turn the tide?” UNAIDS/IMF, AIDSinfo Online Database and I-MAK analysis.

6. Why focus on middle-income countries?
They are home to almost half of the world's population, 1/3 of people living on less than $2 per day, and a large and growing share of HIV infections (currently 62%)
They pay exorbitantly high ARV prices1, which makes closing the treatment gap unaffordable. This is due to:
Patent monopolies: ARV companies file more patents in MICs than LICs, effectively blocking generic competition which would dramatically lower prices. However, many of these patents are unmerited.2
Exclusion from drug access initiatives: ARV companies offer tiered pricing or generic licenses to LICs, but most MICs1 are excluded from these programs.
They represent a large unmet need – no other global HIV interventions focus on MICs
“Ensuring universal HIV treatment access in middle- income countries remains a major challenge”
– 2013 UNAIDS Global Report on the AIDS Epidemic
Source: World Bank, AIDSinfo online database and I-MAK analysis.
Notes: 1 Statements are most applicable to MICs outside of sub-Saharan Africa (SSA), as MICs in SSA are typically included in originator drug access programs. 2 Many patents do not meet the lawful criteria for inventiveness. Under TRIPS, countries may deny patents if a drug is not truly inventive, e.g. when companies make minor modifications and apply for follow-on patents – a practice known as evergreening.

7. ITPC Consortium MIC intervention overview
Remove patent barriers to generic competition in four focus MICs by reforming their patent laws, challenging undeserved patents, and advocating for the selective use of compulsory licenses1. Increase access to more affordable generic ARVs, generating $150M annual savings across the four countries, which can be used to treat 130,000 additional patients. Influence other countries to follow these precedents and achieve similar results.
Objectives
Intended outcomes
1 A compulsory license is an authorization granted by the government to use another's intellectual property without the consent of the patent holder, while paying a reasonable royalty to the patent holder. Subject to certain conditions, the TRIPS agreement allows developing countries to issue compulsory licenses for medicines  if the country cannot otherwise access the medicine at an affordable price.

8. Focus countries of intervention
Ukraine
Brazil
Thailand
Argentina
Focus countries selected based on:
Disease burden: Countries comprise 1.3M people needing ARV treatment
Impact potential: Large potential impact given significant overspend on ARVs
Readiness for action: Poised for patent law reform given existing momentum and partner support; local capacity for generic ARV production
Capacity: Strong in-country leaders to challenge patents and reform laws

9. Country example: ARV prices in Argentina
Key ARVs in Argentina are priced % higher than generic versions
Prices for target ARVs per patient per year (pppy)
Argentina does not use TDF in first-line therapy as recommended by the WHO, citing cost-effectiveness as the primary reason
Key second- and third-line ARVs
In other focus countries, price premiums for targeted ARVs are %.
Source: MSF “Untangling the Web”, 16th Ed. Where prices were not listed, lowest prices in WHO GPRM used

10. Plan of action 1 2
File patent oppositions1 on key ARVs that do not represent true innovations
Reform patent laws to improve patentability criteria/anti-evergreening2 measures; expand patent opposition mechanisms; and strengthen compulsory licensing grounds and procedures 3 4
Advocate for selective use of compulsory licenses by dialoguing with government and pursuing necessary law reforms
Create technical working groups and strategy guides to support the success of IP interventions build capacity with government & civil society partners
1 Patent s can be opposed either before or after they are granted (known as pre-grant and post-grant oppositions) by providing patent offices with evidence that the product does not demonstrate inventiveness and/or enhanced therapeutic efficacy.
2 Evergreening occurs when companies make minor product modifications and apply for follow-on patents.

11. Coalition members: Country leadership
Fundación Grupo Efecto Positivo (Argentina)
Promotes HIV treatment access through political/social engagement and policy dialogue on ARV patents, working with broad network of gov. & civil society partners
Associação Brasileira Interdisciplinar de AIDS (Brazil)
25 year old organization, globally recognized as a leading HIV and human rights NGO, with deep experience in patent oppositions and law reform
AIDS Access Foundation (Thailand)
Over 20 years experience working closely with government and community, including on policy, free trade agreements, compulsory license issuance, and patent litigation
All-Ukrainian Network of PLWH (Ukraine)
Largest PLHIV organization in Ukraine with strong government relationships that intervenes on key ARV patent litigations

12. Coalition members: Global leadership
International Treatment Preparedness Coalition (ITPC)
Global grassroots network of people living with HIV and their supporters united in promoting access to treatment
Pioneer in treatment access advocacy, community education and capacity building around ARV access
Initiative for Medicines, Access & Knowledge (I-MAK)
Expert team of lawyers and scientists that challenge invalid drug patents to facilitate generic competition, catalyze price reductions and improve access
Provides technical support to country partners to challenge patents and reform patent systems
Leading global patent oppositions unit in the public interest

13. Projected impact of intervention
Financial impact
Patient impact
Cost savings per ARV = ( current price -generic price1) x # of patients taking the drug
Additional patients treatable = total ARV cost savings / average per-patient cost of treatment
$150M annual savings across 10 target ARVs
130,000 additional patients2 treatable with savings
Impact will be magnified as patent law reforms affect other medicines and as additional countries follow these precedents
1 Generic prices assume a premium above the lowest international generic prices. For Brazil and Argentina, a 230% premium is assumed based on the average price difference between lowest international generic prices and locally-produced generic ARVs. For Thailand and Ukraine, price premiums of 36% and 26% were calculated based on historical price premiums paid on ARVs in publicly available procurement data.
2 Assumes that all financial savings are reinvested in scaling-up treatment to additional patients.

14. Return on investment
A $6M investment will drive significant impact for these four MICs, representing an ROI of 107x
$650M
$641M
Annual savings of $150M across four countries
Savings can treat an additional 130,000 patients with HIV/AIDS
This represents an investment of ~$45 for each additional life saved
500
350
107x
200 10
$6M
Total intervention costs
5-year net present value (NPV) of annual savings in 4 focus countries

15. Thank You
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