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HIV Treatment and Intellectual Property Rights: The
Experience of the Medicines Patent Pool
Esteban BurroneMelbourne – International AIDS Conference
July 2014 1
Innovation in HIV treatment
• 29 new ARV molecules developed for the treatment of HIV since virus discovered
• Several fixed dose combinations developed that contain 3 or 4 ARVs in one single pill
• Innovation on an unprecedented scale
• Need to ensure access
1985 1990 1995 2000 2005 2010 2015 2020 2025 2030
TRIPS Transition for Developing Countries
TRIPS Transition for Least Developed Countries Zidovudine Didanosine Stavudine Saquinavir Nevirapine Abacavir Emtricitabine Lamivudine Indinavir Efavirenz
Darunavir1985 1990 1995 2000 2005 2010 2015 2020 2025 2030 ` Lopinavir Atazanavir Tenofovir Disproxil Fumarate (TDF) Fosamprenavir Maraviroc Etravirine
Tenfovir Alfenamide Fumarate (TAF) Rilpivirine Raltegravir Elvitegravir
Ritonavir heat-stable Dolutegravir Cobicistat 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030
* Secondary patents on some of these products may extend patent protection beyond the date shown.
Patents on new ARVs
3
Increased Patenting of ARVs in Developing Countries
• Increased patenting of ARVs in developing countries for ARVs developed since 1995
• Analysis based on information for 75 developing countries accounting for 80% of people living with HIV
4
Pre-1995 ARVs Post-1995 ARVs
0
5
10
15
20
25
30
35
40
Median number of develop-ing countries in which basic patents on ARVs were filed
(out of 75)
Source: Medicines Patent Pool Patent Status Database on Selected ARVs (2012)
Pattern particularly visible in key countries of production of generic ARVs
5
Albania
Arm
eniaB
osnia and Herzego...
EAPO
(9 countries)G
uatemala
Honduras
JordanLithuaniaM
oldovaM
ongoliaPanam
aV
ietnamC
olombia
IndiaIndonesiaK
yrgyzstanM
oroccoN
icaraguaPeruTajikistanEgyptG
eorgiaSri LankaU
zbekistanA
lgeriaB
razilC
hileM
alaysiaU
kraineU
ruguayO
API (16 countries)
ThailandA
RIPO
(18 countries)C
hinaM
exicoPakistanR
ussiaA
rgentinaPhilippinesSouth A
fricaTO
TAL possible
0
4
8
12
Pre-1995 ARVs 1995 and later ARVs
Num
ber
of
AR
Vs f
or
whic
h
basic
pate
nts
were
sought
Source: Medicines Patent Pool Database
• Patenting of ARVs in developing countries is more common for medicines developed after 1995 than for those developed before 1995 (date of entry into force of the TRIPS agreement)
Challenges for Fixed Dose Combinations
Generic access
Patent held by A
• Fixed-dose combinations improve treatment adherence for adults and children alike
• But patents on single ARV can impact on the development of whole FDC
• There are also patents on the combinations themselves
Generic access
Long Lag from Originator Market Approval to Generic Availability
FDA/EMA Approval
0 1 2 3 4 5 6 7 8 9 10
Timeline From Originator Approval to Generic Availability:
Generic Approvals
Years
• Time from US FDA approval of new ARV molecules to availability as quality assured generics for developing countries has generally ranged from 5 to 10 years
THE MEDICINES PATENT POOL
8
PATENT HOLDERS
LicencesSub-Licences Medicines
MANUFACTURERS PEOPLE LIVING WITH HIV
ROYALTIES
Medicines Patent Pool
Established in 2010 with the support of
9
Key objectives
Promote robust competition to enable price
reductions for new ARVs
Facilitate the development of fixed-dose combinations
Promote development
of special formulations needed for
children living with HIV
Accelerate availability of new ARVs in developing countries
Prioritising HIV Medicines
Clinical Analysis:
“Which drugs are most
important for HIV
treatment?”
IP Analysis: “Which drugs are patented in developing countries?”
MPP priorities+ =
List of MPP Product PrioritiesCOMPOUNDS CLINICAL
PRIORITYMARKET/IP PRIORITY
Atazanavir High High
Dolutegravir High High
Lopinavir High High
Ritonavir High High
TAF High High
Cobicistat High High
Elvitegravir High High
Abacavir (paediatrics) High Medium
Emtricitabine High Medium (comb patents)
Efavirenz High Medium (comb patents)
TDF High Medium (comb patents)
Darunavir Medium/High Medium
Nevirapine Medium/High Medium
Etravirine Medium High
Raltegravir Medium High
Rilpivirine Medium High
Key Elements of MPP licences
• Negotiated from a public health perspective
• Non-exclusive licensing to qualified generic manufacturers
• Publication of full text of all licences
• More developing countries are able to benefit
• Enable development of fixed-dose combinations and paediatric formulations
• Possibility of technology transfer
• Enable supply to countries using TRIPS flexibilities
• Seek inclusion of provisions to open up markets for key medicines
Raising the bar for licensing in the HIV field
MPP Agreements
Medicines Patent Pool
Bristol-Myers Squibb
Gilead Sciences
National Institutes of Health
Roche Viiv Healthcare AbbVie Gilead
Sciences Merck/MSD
14
• Atazanavir • Tenofovir Disoproxil
• Fumarate (TDF)
• Emtricitabine• Cobicistat• Elvitegravir
• Darunavir (only secondary patent)
• Valganciclovir (discounted price)
• Abacavir (paediatric)
• Dolutegravir
Concluded Agreements Under negotiation
• Raltegravir (paediatric)
• Tenofovir Alafenamide Fumarate (TAF)
• Lopinavir (paediatric)
• Ritonavir (paediatric)
Medicines Patent Pool Out-Licensing
• MPP
Sublicensees
Aurobindo
Cipla
Desano
Emcure
Hetero
Laurus
Micro Labs
Mylan
Shasun
Shilpa
MPP has licensed 7 ARVs to 10 generic partners:• Tenofovir Disproxil
Fumarate• Emtricitabine• Elvitegravir• Cobicistat• Abacavir (paediatric)• Atazanavir• Dolutegravir
Currently managing 35 sub-licences
15
Key Challenge: inclusion of certain middle-income countries in licences
2000 2010 20200%
20%
40%
60%
80%
100%
70%
37%
13%
High
Upper middle
Lower middle
Low
Income category
Proportion of people living with HIV by country income category, 2000 - 2020
Source: UNAIDS, IMF 2012
One possible approach to address challenge in some MICs
• Market Segmentation (public/private)
– In many countries, national treatment programs cater for vast majority of people on treatment
– Generics able to supply national treatment programs
– Originators continue to cater for small private market
• Introduce royalties that are differentiated according to countries’ socio-economic circumstances
– Enables countries to benefit from robust generic competition which results in lower prices
– Royalty could take into account different variables: GDP per capita, inequality, disease burden, others