arvs patent
TRANSCRIPT
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 110
Update on the Medicines Patent Pool
Sandeep Juneja
1 November 2011
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 210
Pool
Sub-License
eSub-
License
e
Sub-
License
e
Sub-
License
e
Sub-
License
e
Sub-
Licensee
Sub-
License
e
Royalties
Royalties
P a t e n t s
Patents
P a t e n t s
Patents
Patents
Licensor
Licensor
Licensor
Licensor
Licensor
Generics
version of
new amp
existing
compounds
FDCs
Adapted
formulations(eg
paediatrics)
The Medicines Patent Pool
Established in 2010 with the support of
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 310
Changing ARV Patent Landscape
1983097983096983093 19830979830970 1983097983097983093 983090000 98309000983093 983090010 98309001983093 98309009830900 9830900983090983093 98309009830910
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983122983137983148983156983141983143983154983137983158983145983154
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983123983120983113983085983092983093983090
1983097983096983093 19830979830970 1983097983097983093 983090000 98309000983093 983090010 98309001983093 98309009830900 9830900983090983093 98309009830910
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 410
Context Patents on some new ARVs
Product +- Expiry date
Atazanavir (BMS) 2017
Cobicistat (Gilead) 2027Darunavir(JampJTibotec)
2013
Etravirine (JampJTibotec) 2019
Fosamprenavir (ViiV) 2018
GSK 572 ndashDolutegravir
(ViiV)
2026
Raltegravir (Merck) 2022
Rilpivirine(JampJTibotec)
2022
Ritonavir (Abbott) 2013
Tenofovir DF (Gilead) 2018Maraviroc (ViiV) 2019
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 510
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1 983108983141983139983141983149983138983141983154
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1 983108983141983139983141983149983138983141983154
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In formal negotiations Licence agreement signed
Licensing-in
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 610
bull All licensees ndash Existing TDF licence amended amp restated includes 3 pipeline drugs COBI EVG and
Quad retains covenant not to sue on FTC
ndash Standard territory TDF - 112 countries COBI - 103 EVG-Quad - 100
ndash Field expanded to Hepatitis-B for TDF ndash Licensees can make any combination (prior approval required for EVG)
ndash Data Exclusivity waiver by Gilead where applicable licensee not to pursue DE
ndash Paediatrics no royalty distribution outside the territory thru GS distributors
bull Pool licensees
ndash Patent Pool a licensee tripartite agreement between GS-Pool-sub-licensee
ndash Licensee right to terminate without cause each compound individually terminable
ndash Provides for publication of licence agreement
ndash Ability of sub-licensees to supply outside the territory against compulsory license
ndash Royalties not payable if patents declared invalid in India
bull Unchanged ndash Licensees to be based in India ndash Sourcing of API from other licensees ndash One time tech transfer
To the best of our understanding
Gilead licence key features
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 710
bull Aurobindo Pharma ndash Large established vertically integrated ARV player
ndash Terminated TDF part of the licence on signing
Licensing-out
bull Medchem International
ndash New player in ARVs
Gilead licence so far out-licensed to
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 210
Pool
Sub-License
eSub-
License
e
Sub-
License
e
Sub-
License
e
Sub-
License
e
Sub-
Licensee
Sub-
License
e
Royalties
Royalties
P a t e n t s
Patents
P a t e n t s
Patents
Patents
Licensor
Licensor
Licensor
Licensor
Licensor
Generics
version of
new amp
existing
compounds
FDCs
Adapted
formulations(eg
paediatrics)
The Medicines Patent Pool
Established in 2010 with the support of
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 310
Changing ARV Patent Landscape
1983097983096983093 19830979830970 1983097983097983093 983090000 98309000983093 983090010 98309001983093 98309009830900 9830900983090983093 98309009830910
983124983122983113983120983123 983124983154983137983150983155983145983156983145983151983150 983142983151983154
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983123983156983137983158983157983140983145983150983141
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983122983137983148983156983141983143983154983137983158983145983154
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983123983120983113983085983092983093983090
1983097983096983093 19830979830970 1983097983097983093 983090000 98309000983093 983090010 98309001983093 98309009830900 9830900983090983093 98309009830910
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 410
Context Patents on some new ARVs
Product +- Expiry date
Atazanavir (BMS) 2017
Cobicistat (Gilead) 2027Darunavir(JampJTibotec)
2013
Etravirine (JampJTibotec) 2019
Fosamprenavir (ViiV) 2018
GSK 572 ndashDolutegravir
(ViiV)
2026
Raltegravir (Merck) 2022
Rilpivirine(JampJTibotec)
2022
Ritonavir (Abbott) 2013
Tenofovir DF (Gilead) 2018Maraviroc (ViiV) 2019
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 510
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1 983108983141983139983141983149983138983141983154
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983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
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983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
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983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983116983145983139983141983150983139983141 983137983143983154983141983141983149983141983150983156983155983145983143983150983141983140 983114983157983148983161 983090011
983117983141983154983139983147 amp 983107983151 983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
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983123983141983153983157983151983145983137
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983124983145983138983151983156983141983139983114983151983144983150983155983151983150
amp 983114983151983144983150983155983151983150
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
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983155983145983143983150983141983140 983123983141983152983156 983090010
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983126983145983145983126 983112983141983137983148983156983144983139983137983154983141983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
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In formal negotiations Licence agreement signed
Licensing-in
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 610
bull All licensees ndash Existing TDF licence amended amp restated includes 3 pipeline drugs COBI EVG and
Quad retains covenant not to sue on FTC
ndash Standard territory TDF - 112 countries COBI - 103 EVG-Quad - 100
ndash Field expanded to Hepatitis-B for TDF ndash Licensees can make any combination (prior approval required for EVG)
ndash Data Exclusivity waiver by Gilead where applicable licensee not to pursue DE
ndash Paediatrics no royalty distribution outside the territory thru GS distributors
bull Pool licensees
ndash Patent Pool a licensee tripartite agreement between GS-Pool-sub-licensee
ndash Licensee right to terminate without cause each compound individually terminable
ndash Provides for publication of licence agreement
ndash Ability of sub-licensees to supply outside the territory against compulsory license
ndash Royalties not payable if patents declared invalid in India
bull Unchanged ndash Licensees to be based in India ndash Sourcing of API from other licensees ndash One time tech transfer
To the best of our understanding
Gilead licence key features
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 710
bull Aurobindo Pharma ndash Large established vertically integrated ARV player
ndash Terminated TDF part of the licence on signing
Licensing-out
bull Medchem International
ndash New player in ARVs
Gilead licence so far out-licensed to
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 310
Changing ARV Patent Landscape
1983097983096983093 19830979830970 1983097983097983093 983090000 98309000983093 983090010 98309001983093 98309009830900 9830900983090983093 98309009830910
983124983122983113983120983123 983124983154983137983150983155983145983156983145983151983150 983142983151983154
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983113983150983140983145983150983137983158983145983154
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983117983137983154983137983158983145983154983151983139
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983122983137983148983156983141983143983154983137983158983145983154
983109983148983158983145983156983141983143983154983137983158983145983154
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983107983151983138983145983139983145983155983156983137983156
983123983120983113983085983092983093983090
1983097983096983093 19830979830970 1983097983097983093 983090000 98309000983093 983090010 98309001983093 98309009830900 9830900983090983093 98309009830910
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 410
Context Patents on some new ARVs
Product +- Expiry date
Atazanavir (BMS) 2017
Cobicistat (Gilead) 2027Darunavir(JampJTibotec)
2013
Etravirine (JampJTibotec) 2019
Fosamprenavir (ViiV) 2018
GSK 572 ndashDolutegravir
(ViiV)
2026
Raltegravir (Merck) 2022
Rilpivirine(JampJTibotec)
2022
Ritonavir (Abbott) 2013
Tenofovir DF (Gilead) 2018Maraviroc (ViiV) 2019
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 510
983120983137983156983141983150983156 983112983151983148983140983141983154 983121983092 98309009830890 983121983089 9830900983089983089 983121983090 9830900983089983089 983121983091 9830900983089983089
983105983138983138983151983156983156
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1 983108983141983139983141983149983138983141983154
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983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
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983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
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983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
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983110 983112983151983142983142983149983137983150983085983116983137
983122983151983139983144983141
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
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983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983116983145983139983141983150983139983141 983137983143983154983141983141983149983141983150983156983155983145983143983150983141983140 983114983157983148983161 983090011
983117983141983154983139983147 amp 983107983151 983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
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983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
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983123983141983153983157983151983145983137
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983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983124983145983138983151983156983141983139983114983151983144983150983155983151983150
amp 983114983151983144983150983155983151983150
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 9830911 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
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983150983141983143983151983156983145983137983156983145983151983150983155
983125983123 983118983113983112 983116983145983139983141983150983139983141 983137983143983154983141983141983149983141983150983156
983155983145983143983150983141983140 983123983141983152983156 983090010
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983126983145983145983126 983112983141983137983148983156983144983139983137983154983141983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
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In formal negotiations Licence agreement signed
Licensing-in
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 610
bull All licensees ndash Existing TDF licence amended amp restated includes 3 pipeline drugs COBI EVG and
Quad retains covenant not to sue on FTC
ndash Standard territory TDF - 112 countries COBI - 103 EVG-Quad - 100
ndash Field expanded to Hepatitis-B for TDF ndash Licensees can make any combination (prior approval required for EVG)
ndash Data Exclusivity waiver by Gilead where applicable licensee not to pursue DE
ndash Paediatrics no royalty distribution outside the territory thru GS distributors
bull Pool licensees
ndash Patent Pool a licensee tripartite agreement between GS-Pool-sub-licensee
ndash Licensee right to terminate without cause each compound individually terminable
ndash Provides for publication of licence agreement
ndash Ability of sub-licensees to supply outside the territory against compulsory license
ndash Royalties not payable if patents declared invalid in India
bull Unchanged ndash Licensees to be based in India ndash Sourcing of API from other licensees ndash One time tech transfer
To the best of our understanding
Gilead licence key features
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 710
bull Aurobindo Pharma ndash Large established vertically integrated ARV player
ndash Terminated TDF part of the licence on signing
Licensing-out
bull Medchem International
ndash New player in ARVs
Gilead licence so far out-licensed to
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 410
Context Patents on some new ARVs
Product +- Expiry date
Atazanavir (BMS) 2017
Cobicistat (Gilead) 2027Darunavir(JampJTibotec)
2013
Etravirine (JampJTibotec) 2019
Fosamprenavir (ViiV) 2018
GSK 572 ndashDolutegravir
(ViiV)
2026
Raltegravir (Merck) 2022
Rilpivirine(JampJTibotec)
2022
Ritonavir (Abbott) 2013
Tenofovir DF (Gilead) 2018Maraviroc (ViiV) 2019
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 510
983120983137983156983141983150983156 983112983151983148983140983141983154 983121983092 98309009830890 983121983089 9830900983089983089 983121983090 9830900983089983089 983121983091 9830900983089983089
983105983138983138983151983156983156
983116983137983138983151983154983137983156983151983154983145983141983155
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 983090983094 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983106983151983141983144983154983145983150983143983141983154983085
983113983150983143983141983148983144983141983145983149
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 1983097 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983106983154983145983155983156983151983148983085983117983161983141983154983155
983123983153983157983145983138983138
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 983090983094 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983110 983112983151983142983142983149983137983150983085983116983137
983122983151983139983144983141
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983120983154983141983152983137983154983145983150983143 983142983151983154 983150983141983143983151983156983145983137983156983145983151983150 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983111983145983148983141983137983140 983123983139983145983141983150983139983141983155 983123983141983150983156 983148983141983156983156983141983154 9831519831501 983108983141983139983141983149983138983141983154
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155983122983141983152983148983161 983154983141983139983141983145983158983141983140 1983092 983110983141983138983154983157983137983154983161
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983116983145983139983141983150983139983141 983137983143983154983141983141983149983141983150983156983155983145983143983150983141983140 983114983157983148983161 983090011
983117983141983154983139983147 amp 983107983151 983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 983090983096 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983123983141983153983157983151983145983137
983120983144983137983154983149983137983139983141983157983156983145983139983137983148983155
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983124983145983138983151983156983141983139983114983151983144983150983155983151983150
amp 983114983151983144983150983155983151983150
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 9830911 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983125983123 983118983113983112 983116983145983139983141983150983139983141 983137983143983154983141983141983149983141983150983156
983155983145983143983150983141983140 983123983141983152983156 983090010
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983126983145983145983126 983112983141983137983148983156983144983139983137983154983141983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
In formal negotiations Licence agreement signed
Licensing-in
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 610
bull All licensees ndash Existing TDF licence amended amp restated includes 3 pipeline drugs COBI EVG and
Quad retains covenant not to sue on FTC
ndash Standard territory TDF - 112 countries COBI - 103 EVG-Quad - 100
ndash Field expanded to Hepatitis-B for TDF ndash Licensees can make any combination (prior approval required for EVG)
ndash Data Exclusivity waiver by Gilead where applicable licensee not to pursue DE
ndash Paediatrics no royalty distribution outside the territory thru GS distributors
bull Pool licensees
ndash Patent Pool a licensee tripartite agreement between GS-Pool-sub-licensee
ndash Licensee right to terminate without cause each compound individually terminable
ndash Provides for publication of licence agreement
ndash Ability of sub-licensees to supply outside the territory against compulsory license
ndash Royalties not payable if patents declared invalid in India
bull Unchanged ndash Licensees to be based in India ndash Sourcing of API from other licensees ndash One time tech transfer
To the best of our understanding
Gilead licence key features
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 710
bull Aurobindo Pharma ndash Large established vertically integrated ARV player
ndash Terminated TDF part of the licence on signing
Licensing-out
bull Medchem International
ndash New player in ARVs
Gilead licence so far out-licensed to
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 510
983120983137983156983141983150983156 983112983151983148983140983141983154 983121983092 98309009830890 983121983089 9830900983089983089 983121983090 9830900983089983089 983121983091 9830900983089983089
983105983138983138983151983156983156
983116983137983138983151983154983137983156983151983154983145983141983155
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 983090983094 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983106983151983141983144983154983145983150983143983141983154983085
983113983150983143983141983148983144983141983145983149
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 1983097 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983106983154983145983155983156983151983148983085983117983161983141983154983155
983123983153983157983145983138983138
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 983090983094 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983110 983112983151983142983142983149983137983150983085983116983137
983122983151983139983144983141
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983120983154983141983152983137983154983145983150983143 983142983151983154 983150983141983143983151983156983145983137983156983145983151983150 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983111983145983148983141983137983140 983123983139983145983141983150983139983141983155 983123983141983150983156 983148983141983156983156983141983154 9831519831501 983108983141983139983141983149983138983141983154
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155983122983141983152983148983161 983154983141983139983141983145983158983141983140 1983092 983110983141983138983154983157983137983154983161
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983116983145983139983141983150983139983141 983137983143983154983141983141983149983141983150983156983155983145983143983150983141983140 983114983157983148983161 983090011
983117983141983154983139983147 amp 983107983151 983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 983090983096 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983123983141983153983157983151983145983137
983120983144983137983154983149983137983139983141983157983156983145983139983137983148983155
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983124983145983138983151983156983141983139983114983151983144983150983155983151983150
amp 983114983151983144983150983155983151983150
983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150 983150983141983143983151983156983145983137983156983145983151983150983155
983122983141983152983148983161 983154983141983139983141983145983158983141983140 9830911 983114983137983150983157983137983154983161
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983118983151983156 983139983157983154983154983141983150983156983148983161 983145983150
983150983141983143983151983156983145983137983156983145983151983150983155
983125983123 983118983113983112 983116983145983139983141983150983139983141 983137983143983154983141983141983149983141983150983156
983155983145983143983150983141983140 983123983141983152983156 983090010
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
983126983145983145983126 983112983141983137983148983156983144983139983137983154983141983123983141983150983156 983148983141983156983156983141983154 983151983150
1 983108983141983139983141983149983138983141983154
983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155 983113983150 983150983141983143983151983156983145983137983156983145983151983150983155
In formal negotiations Licence agreement signed
Licensing-in
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 610
bull All licensees ndash Existing TDF licence amended amp restated includes 3 pipeline drugs COBI EVG and
Quad retains covenant not to sue on FTC
ndash Standard territory TDF - 112 countries COBI - 103 EVG-Quad - 100
ndash Field expanded to Hepatitis-B for TDF ndash Licensees can make any combination (prior approval required for EVG)
ndash Data Exclusivity waiver by Gilead where applicable licensee not to pursue DE
ndash Paediatrics no royalty distribution outside the territory thru GS distributors
bull Pool licensees
ndash Patent Pool a licensee tripartite agreement between GS-Pool-sub-licensee
ndash Licensee right to terminate without cause each compound individually terminable
ndash Provides for publication of licence agreement
ndash Ability of sub-licensees to supply outside the territory against compulsory license
ndash Royalties not payable if patents declared invalid in India
bull Unchanged ndash Licensees to be based in India ndash Sourcing of API from other licensees ndash One time tech transfer
To the best of our understanding
Gilead licence key features
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 710
bull Aurobindo Pharma ndash Large established vertically integrated ARV player
ndash Terminated TDF part of the licence on signing
Licensing-out
bull Medchem International
ndash New player in ARVs
Gilead licence so far out-licensed to
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 610
bull All licensees ndash Existing TDF licence amended amp restated includes 3 pipeline drugs COBI EVG and
Quad retains covenant not to sue on FTC
ndash Standard territory TDF - 112 countries COBI - 103 EVG-Quad - 100
ndash Field expanded to Hepatitis-B for TDF ndash Licensees can make any combination (prior approval required for EVG)
ndash Data Exclusivity waiver by Gilead where applicable licensee not to pursue DE
ndash Paediatrics no royalty distribution outside the territory thru GS distributors
bull Pool licensees
ndash Patent Pool a licensee tripartite agreement between GS-Pool-sub-licensee
ndash Licensee right to terminate without cause each compound individually terminable
ndash Provides for publication of licence agreement
ndash Ability of sub-licensees to supply outside the territory against compulsory license
ndash Royalties not payable if patents declared invalid in India
bull Unchanged ndash Licensees to be based in India ndash Sourcing of API from other licensees ndash One time tech transfer
To the best of our understanding
Gilead licence key features
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 710
bull Aurobindo Pharma ndash Large established vertically integrated ARV player
ndash Terminated TDF part of the licence on signing
Licensing-out
bull Medchem International
ndash New player in ARVs
Gilead licence so far out-licensed to
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 710
bull Aurobindo Pharma ndash Large established vertically integrated ARV player
ndash Terminated TDF part of the licence on signing
Licensing-out
bull Medchem International
ndash New player in ARVs
Gilead licence so far out-licensed to
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 810
bull Most complete single
source of ARV patent
status data
bull Covers 24 compounds
in over 60 countries
bull Searchable by
compound and by
country (or region)
bull To be regularly
updated
bull Starting point for
more thorough
searches
Patent status database
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 910
Working paper published
for comments Available
athttpwwwmedicinespat
entpoolorgWHAT-WE-
DOTarget-Medicines
Compounds with () arepipeline compounds
Summary of Priorities for the Medicines Patent Pool
CompoundClinicalPriority
MarketIPPriority
Level 1 Priorities (medium or high priority under bothcriteria)
Atazanavir (ATV) High High
Dolutegravir (DLG) High HighCobicistat (COB) High High
Elvitegravir (EVG) High High
Lopinavir (LPV) High HighRilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High MediumTenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium HighAbacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low formarketIP)
Lamivudine (3TC) High LowNevirapine (NVP) High Low
Zidovudine (AZT orZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low
Level 3 Priorities (medium or high for marketIP andlow for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium
Priority products for the Pool
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You
8112019 ARVs Patent
httpslidepdfcomreaderfullarvs-patent 1010
Thank You