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Fighting unjust drug pricing to save lives
Removing global patent barriers
Initiative for Medicines, Access & Knowledge
July 2016
Our Goal: Restoring integrity to the patent system
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.
We expand access to lower-cost generic medicines by:
• Challenging unmerited drug
patents
• Initiating law and policy reform
• Conducting advocacy on drug
pricing and unjust patents
•
•
Creating evidence-based research
on intellectual property (IP)
Driving social change through our
practice-based solutions
We believe the patent system is broken and disproportionately represents private
interests over patient rights. Our mission is to change this.
www.i-mak.org
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Global HIV/AIDS epidemic: MICs vs. LICs
Middle-income countries (MICs) comprise the majority of the global HIV/AIDS
burden, but have lower rates of antiretroviral (ARV) treatment coverage compared
to low-income countries (LICs)
Proportion of people living with HIV by country income level
100%
80%
31%
% of PLHIV receiving
ARV treatment (2015)
65%
60%
70%
40%
68%
20%
33%
28%
2010
2015
HICs
N/A
MICs
44%
LICs
52%
0%
2000
Low-income
Middle-income
High-income
I-MAK analysis July 2016 using AIDSinfo Online Database (2015 data) and World Bank country classifications.
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MICs have high disease burden yet struggle to treat
patients because of high prices
Middle-income countries (MICs) in particular are being left behind as the global
community focuses on solutions (e.g. generic licensing) for low-income countries (LICs).
LICs
MICs
World population1
9%
75%
HIV infections2
28%
70%
HCV infections3
13%
70%
Example HIV drug pricing4:
• ATV
• LPV/r
• RAL
$183
$250
$675
< $2K
< $2K
< $5.5K
48%
66%
% of global HIV+ people needing
treatment2
1) World Bank population data (2015). 2) I-MAK analysis July 2016 using AIDSinfo online database (2015 data). 3) "Evolving Epidemiology of Hepatitis C." Lavanchy, 2010
and Cui et al 2013 (China). 4) LIC prices obtained from MSF’s “Untangling the Web” pricing guide, 17th edition, and indicate either generic or originator access pricing.
MIC prices cited are based on a subset of MICs outside of Sub-Saharan Africa (SSA), as those within SSA often receive similar pricing as LICs.
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Hepatitis C (HCV) is a leading cause of death but
lifesaving medicines are unaffordable
• There are 80 to 150M global HCV infections and 700K annual
deaths.
• Sofosbuvir (SOF), a lifesaving HCV treatment from Gilead
Sciences, is priced exorbitantly high1 and needs to be combined
with a second drug to be effective, adding to the cost
─ MICs: $900-15,000
─ HICs: Up to $84,000
• In June 2016 the USFDA and European Medicines Agency
approved velpatasvir (VEL) in a co-formulation with SOF
─ The first single-tablet regimen effective in all HCV genotypes
─ Likely to become the leading hepatitis C treatment
─ Launch price of $74,760 in the U.S.
1. Prices cited are for countries not covered by Gilead’s generic voluntary license, which allows LICs and certain MICs to
purchase the drug generically for <$1050. Prices were obtained from various MICs outside of sub-Saharan Africa.
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How we determine if patents are unmerited
Our patent challenges target life-saving drugs that meet
two criteria:
1. are not reaching patients
2. have unmerited patents
• Under patent law, a drug must be new, inventive & useful to
merit a patent.
• Inventiveness is determined based on existing science in the
public domain. Old science = no patent.
www.i-mak.org
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We only challenge unjustified patents
I-MAK systematically
analyzes drug patent
applications for key diseases
to ensure we only challenge
illegitimate patents
We have a 90% success rate
challenging unmerited patents
www.i-mak.org
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Sofosbuvir is not inventive under patent law
I-MAK is challenging both patent applications for SOF based on lack of
“inventive step”:
1. The base compound structure would have
been obvious in light of earlier HCV nucleosides
dating back to 1996 and anticancer nucleosides
dating back to the 1980s.
2. The prodrug approach (“ProTide technology1”)
has been used since the 1990s and is a common
method.
• Documented in the literature: The prodrug was based on an
inactive HCV nucleotide (Perrone, 2007)
• An earlier patent discloses the same nucleoside analog and the
same prodrug for anticancer use.2
1) ProTide technology is a prodrug approach used for SOF as well as other HIV antiviral medicines, including stavudine, abavacir, and zidovudine.
Perrone, Plinio et al. “Application of the Phosphoramidate ProTide Approach to 4’-Azidouridine Confers Sub-micromolar Potency versus Hepatitis C
Virus on and Inactive Nucleoside,” J. Med. Chem., 2007: 50.
2) International Patent No. WO 2005/012327
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Our global partners: challenging patents
together worldwide
MENA & EECA
www.i-mak.org
Supported by the Open Society Foundation (OSF) and
Médecins Sans Frontières (MSF)/Doctors without Borders
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Geographic focus: MICs and select HICs
• MICs = 13 of the top 20 high-burden countries
• ~38% of HCV infections are in MICs & HICs
excluded from Gilead’s voluntary license (VL)
with generic suppliers
• I-MAK + partner intervention countries3 = 53%
of infections
Global HCV infections (159M)1
18%
HICs
20%
MICs
49%
MICs
13%
LICs
Excluded
from VL
Included
in VL
SOF prices2
up to ~$84K
(branded)
~$900-$15K
(branded)
<$1000
(generic)
Top 20 high-burden HCV countries
#
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Country
India
China
Egypt
Indonesia
Pakistan
Russia
USA
Dem Rep of Congo
Nigeria
Japan
Cameroon
Brazil
Uganda
Philippines
Italy
Ukraine
Uzbekistan
Turkey
Ethiopia
Thailand
# of HCV
infections (M)
18.2
13.6
11.8
9.4
9.4
5.8
5.4
4.0
3.3
3.1
2.8
2.6
2.2
1.9
1.9
1.9
1.8
1.5
1.5
1.5
1) "Evolving Epidemiology of Hepatitis C." Lavanchy, 2010. and World Bank data. 2) Branded prices from country data & new articles. Generic prices from
https://testandtreathepatitisc.files.wordpress.com/2015/03/finindian-generic-sofosbuvir-summary_15sep-10-version.pdf. 3) Includes countries for which I-MAK is
providing TA, which includes patent challenges, landscaping, validity and strategy. Coalition countries also include Argentina, Vietnam and the EU.
Patent challenges 2006
www.i-mak.org
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A global movement to lower prices and save lives
www.i-mak.org
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Coordinated case filings in 5 countries spurs
international press coverage
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Progress and early wins on sofosbuvir
SOF efforts in progress
Impact to date
• Our coalition has initiated work in
9 countries + 38 countries in the
EU:
• Gilead negotiating with countries
it had not negotiated with before
• Gilead added more MICs to the
licenses (never included before in
licenses)
• Gilead dropped prices for certain
MICs
• Generics and branded companies
filed their own challenges
• New generics entered market
(outside licenses)
• First challenge by medical NGO
publicly: moved the HIC
conversation on drug pricing
– Argentina, Brazil, China, Egypt,
EU, India, Morocco, Russia,
Thailand, Ukraine.
Initial victories
• Three countries have already
rejected SOF patent applications
following intervention or
oppositions:
– China: Jun 2015
– Egypt: Feb 2014*
– Ukraine: Jun 2015
* Daclatasvir also rejected
www.i-mak.org
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SOF Patent Status (Jul 2016)
Country
Base
Prodrug
Other
Argentina
Pending
Pending, opposed
Brazil
Pending, opposed
Pending
China
Granted
Rejected, under re-exam
Egypt
No patent
Patent rejected
EU
Pending
Granted, opposed
India
Pending
Granted, seeking reversal
Indonesia
Granted
No patent
Co: Rejected
Morocco
Russia
Granted
Granted, invalidation action
Thailand
Pending
Pending
Ukraine
No patent
No patent
Vietnam
No patent
No patent
Philippines
Granted
www.i-mak.org
I: Granted; I: Granted
I = Intermediary
Co = Combination
Cr: Refused, appealed
Cr = Crystalline
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