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2001.0 2002.0 2003.0 2004.0 2005.0 2006.0 2007.0 2008.0 2009.0 2010.00
1000000
2000000
3000000
4000000
5000000
6000000
7000000
$0
$100
$200
$300
$400
$500
$600
$700
$800
Lowest generic price first line ARV regimenOriginator price of first-line ARVsSeries3
$10,400$2700
Generic Competition & Treatment Scale-Up
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 Indinavir Efavirenz 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030 ` Lopinavir Atazanavir Tenofovir DF Fosamprenavir Maraviroc Etravirine Rilpivirine Elvitegravir Heat-stable ritonavir Raltegravir Dolutegravir Cobicistat SPI-452 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030
2011
Changing ARV Patent Landscape
Pool
Sub-License
eSub-
Licensee
Sub-License
e
Sub-License
e
Sub-License
eSub-
Licensee
Sub-License
e
Royalties
Royalties
Patents
Patents
Patents
Patents
Patents
Licensor
Licensor
Licensor
Licensor
Licensor
Generics version of existing compounds
FDCs
Adapted formulations (e.g. paediatrics)
The Medicines Patent Pool
Established in 2010 with the support of
Company Engagement
Patent Holder Q4 2010 Q1 2011 Q2 2011 Q3 2011
Abbott Laboratories
Sent letter on 1 December
Not currently in negotiations. Reply received 26 January
Not currently in negotiations.
Not currently in negotiations
Boehringer-Ingelheim
Sent letter on 1 December
Not currently in negotiations. Reply received 19 January
Not currently in negotiations.
In negotiations.
Bristol-Myers Squibb
Sent letter on 1 December
Not currently in negotiations. Reply received 26 January
Not currently in negotiations.
In negotiations.
F. Hoffman-La Roche
Sent letter on 1 December
Preparing for negotiation. In negotiations. In negotiations.
Gilead Sciences Sent letter on 1 December
In negotiations.Reply received 14 February
In negotiations. Licence agreement signed July 2011.
Merck & Co. Sent letter on 1 December
Not currently in negotiations. Reply received 28 January
Not currently in negotiations.
Not currently in negotiations.
Sequoia Pharmaceuticals
In negotiations. In negotiations. In negotiations.
Tibotec/Johnson & Johnson
Sent letter on 1 December
Not currently in negotiations. Reply received 31 January
Not currently in negotiations.
Not currently in negotiations.
US NIH Licence agreement signed Sept 2010.
In negotiations. In negotiations. In negotiations.
ViiV Healthcare Sent letter on 1 December
In negotiations. In negotiations. In negotiations.
In formal negotiations Licence agreement signed
Pool/Gilead Agreement
Key Features:
Includes: TDF, 3 pipeline drugs: cobicistat (COBI), elvitegravir (EVG) and Quad; retains covenant not to sue on emtricitabine (FTC)
Pipeline products inclusion will help accelerate bringing new products to market
Licensed Territory: for TDF, expanded to 112 countries; for COBI, changed to 103 countries; for EVG-Quad, 100 countries.
Licensees free to make any combination product (except EVG, where Gilead’s licensor JT required Gilead prior approval)
Royalties 3 % for TDF and 5% for the others, 0% pediatric formulations
Paediatric formulations: royalties waived for any paediatric formulations developed by licensee; allows for paediatric formulations to be made available outside Territory via licence to Gilead distributors, with appropriate compensation to licensee
Waiver of any data exclusivity rights, where applicable
Licensee can pick and choose licences (agreement is not bundled)
Provisions to ensure ability of Sub-licensees to supply countries outside the territory where a compulsory license for export has been issued
One time tech transfer (but with no extra obligation to pay royalty)
Provides for publication of licence agreement
Concerns:Limited to licensees based in India
Sourcing of API
Geographical scope
Geographical Scope
Largest Geographical scope of any VL to dateTDF: 112 countries (87.6%)
COB: 103 (82.7%)
EVG and Quad: 100 countries (82.7%)
A recognized shortcoming in the licence
Most difficult issue in negotiations with patent holders
Ask: all low and middle income countries. But Pool is a voluntary mechanism
Make as many people as possible better off, while ensuring no country worse off than status quo anteE.g. Important that licensees can supply countries under a CL
7
8
Current voluntary licensing geographic scope: numbers of
countries included
Criter
ia
Abbot
t (LP
V/r,RTV
)
Mer
ck (E
FV)
J&J/T
ibot
ec (E
TR)
BMS
(d4t
, ddI
, ATV
)
Mer
ck (R
AL)
Roche
(SQV,N
FV)
J&J/T
ibot
ec (
DRV)
J&J/T
ibot
ec (R
IL)
Viiv/G
SK (A
ZT,3T
C,ABC,D
LG)
Boehr
inge
r (N
VP)
OLD G
ilead
(TDF,
FTC)
Gilead
/Poo
l (EV
G)
Gilead
/Poo
l (COB)
Gilead
/Poo
l (TD
F,FT
C)
Objec
tive
0
20
40
60
80
100
120
140
160
Total # countries in geographic scope
Series1
9
Pool/Gilead license: PLHIV population breakdown by
income-group & drug
Low In
com
e Cou
ntrie
s
Lower
-Mid
dle
Inco
me
Count
ries
Upper
-Mid
dle
Inco
me
Count
ries
0
2000000
4000000
6000000
8000000
10000000
12000000
Number of PLHIV (by country income) in geo. scope
COBIEVGTotal countriesSeries4
Concluding comments
• License with Gilead not a template – agreements with other companies are likely to be different
• we will continue to work on improvements of existing licenses• We benefit from comments we receive and public debate on the
licenses
UNITAID
• UNITAID with others to encourage all HIV patent holders to enter into negotiations with the Pool
• IP goes beyond access -> role in innovation - I+A agenda -> • encourage uptake of licenses • encourage and steer/create the market for the development of
adapted formulations • To develop an i+a agenda beyond the pool• Put challenges for middle income countries on the agenda