Initiative for Medicines, Access & Knowledge introduces Hepatitus C Patent Strategies. The presentation starts with an introduction to I-MAK a non-profit organization of lawyers and scientists. The presentation includes an account of pricing issues for a course of medicine to cure Hepatitis C, and questions the legitimacy of companies claiming patents which keep prices high.

1. Introduction to Hepatitis C Patent
Strategies
Initiative for Medicines, Access, & Knowledge
1 June 2015

2. Who we are
I-MAK is a non-profit organization of lawyers and scientists representing the
rights of low-income patients worldwide. We believe all people have the right
to access affordable, life-saving medicines for HIV/AIDS and other diseases.
We expand access to lower-cost generic medicines by addressing legal and
policy barriers:
• Challenging unmerited drug patents
• Partnering with stakeholders to achieve law and policy reforms
• Conducting advocacy
• Generating evidence-based research on intellectual property (IP)
We believe the patent system is broken and disproportionately represents
private interests over patient rights. Our mission is to change this.
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3. Where we work
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I-MAK founded; began working on HIV/AIDS in India
Working in > 48 countries and additional disease areas
(HCV, malaria, TB, avian flu, vaccines, non-communicable diseases – focus
on scaling HCV work to multiple middle- and high-income countries)
Argentina
Brazil
Russia
China
Ukraine
India
Philippines
Indonesia
Vietnam
Thailand
Egypt
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2006
2014
European Patent
Organization

4. Pricing Issues:
– Launched at $1000 per pill in HICs, totaling
$84,000 for 12 week course
– $7500 for 12 week course in some MICs (Note:
73% of people with HCV reside in MICs)
– Limited $900 price in Egypt and selected country
programs, along with donations in Georgia,
provide misleading picture to the public about
Gilead’s pricing structures for the majority of
people with HCV
Sofosbuvir (Hepatitis C Medicine)

5. Patent Issues:
• Not a new drug
• Not inventive (obvious)
• Based on an old compound + routine science
Bilateral Licenses: Gilead + Indian drug manufacturers
• Exclusion of 50 middle-income countries (50 million
people)
• Supplier Lock-Up: Generics prohibited from supplying
these countries even in absence of patents
Sofosbuvir (Hepatitis C Medicine)

6. Intervention
Types of Intervention:
- Patent Challenges Filed in Argentina, Brazil, China,
Europe, India, Russia, Ukraine
- Dialogue with Patent Offices Conducted in Egypt,
Morocco, Thailand (Note: Egypt has rejected patent)
- Compulsory Licensing
- Drug Pricing Advocacy
Rationale:
- Open the door for generic market entry,
- Incentivize generics
- Serve as leverage in price negotiations
Sofosbuvir: Interventions (2013-2015)

7. How we work: patent challenges
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8. Potential benefits:
• If every person with hepatitis C in these five
countries would be treated - that is 40 million -
the cost savings would be $270 billion.
• If these governments treat just 8 million people
with hepatitis C in these five countries, based on
current percent HIV treatment coverage rates,
the cost savings are $50 billion.
Impact Analysis

9. Assumptions:
– Gilead price for 3,000 patients, 12 week course
$900 USD
– Remaining 1,861,840 patients purchase from
Gilead at middle-income country price of $7,500
(price given to Brazil used as proxy)
– Generic price available at $515 (see Methodology
slide)
Difference between purchasing directly from
Gilead, and purchasing generics is $13 billion
Scenario 1: Sofosbuvir Cost Savings for Ukraine

10. Assumptions:
- Gilead offers $900 price to all 1,864,840
people with HCV in Ukraine.
- Generic price is available at $515.
Difference between purchasing directly from Gilead,
and purchasing generics is $718 million
Scenario 2: Sofosbuvir Cost Savings for Ukraine

11. Impact Analysis: I-MAK Methodology
I-MAK’s analysis of potential savings from access to generic sofosbuvir in five MICs -
Argentina, Brazil, China, Russia and Ukraine - is based on disease prevalence numbers
from the paper "Evolving Epidemiology of Hepatitis C" (Lavanchy, 2010). To calculate
full potential cost savings, we multiplied the number of HCV infections by the current
percent treatment coverage for HIV, as a proxy for what HCV treatment levels could
reach in each country, then multiplied that number by the estimated difference in
price between generic and branded SOF.
For branded prices, we assumed $900 for a 12 week course of treatment in Ukraine,
and $7,500 in all other countries, based on actual quoted prices from Gilead to
Ukraine and Brazil. Prices for the other three countries were unavailable at the time of
publication, but reports thus far suggest that only Ukraine will be offered Gilead's
lowest access price of $900. The price in Russia may be even higher given that it is a
high income country. For generic pricing, our estimate of $515 took into account
experts’ projections of the generic launch price in India ($770) and the long-term
potential price (~$136)*, as well as a 7% royalty rate and 6% generic price premium
(based on generic HIV drug pricing data in LICs vs. MICs).
Impact Analysis: I-MAK Methodology

12. International Press Coverage

13. International Press Coverage

14. International Press Coverage

15. International Press Coverage

16. Future Action:
- Targeted interventions by civil society and generic
suppliers, e.g. patent challenges
- Government intervention to curb excessive pricing,
e.g. issuance of government use or compulsory
licenses, using local production or price caps as leverage.
- Global campaign on pricing of hepatitis C drugs
The Way Forward