The Medicines Patent Pool aims to promote innovation and access to HIV medicines through public health-oriented licensing agreements. It has had some successes in negotiating voluntary licenses from patent holders that allow for generic production of HIV drugs in more developing countries. However, more work remains to be done to further expand access, including obtaining licenses for newer second and third line treatments, enabling the development of new fixed-dose combinations, and supporting more local manufacturing in developing regions. The Pool's goal is to establish a new norm of public health-focused licensing that benefits those in need of treatment globally.

1. The Medicines Patent Pool:
Promoting innovation and access through public
health-oriented licences
Ethan Guillen
February 2013

2. WHY DO WE NEED A PATENT POOL FOR
HIV MEDICINES?

3. The Context
• Significant HIV treatment needs in developing countries
• International commitment to treat 15 million people by 2015
• Generic competition central to treatment scale-up of past decade
• Newer HIV medicines widely patented in developing countries
• Important formulations needed in developing countries often not
developed or barriers to access

4. Despite recent progress in access to HIV medicines, there
is still significant need for additional treatment
• More than 8 million people in
40 developing countries on ART by end of
2011
35
30 • But further 6.8 million people are in
Will Need Treatment urgent need of treatment as per WHO
25 guidelines
PLHIV (M)
Needing Treatment
20 Receiving Treatment • Approximately 19.4 million more
people are also HIV positive in
15
developing countries and will need
10 treatment
5 • 1.4 million new people on treatment
in 2011
0
Dec. 2011 • New evidence shows huge benefits of
early start for treatment
Source: The Global AIDS Epidemic Fact Sheet, UNAIDS, July 2012

5. The Context
• Significant HIV treatment needs in developing countries
• International commitment to treat 15 million people by 2015
• Generic competition central to treatment scale-up of past decade
• Newer HIV medicines widely patented in developing countries
• Important formulations needed in developing countries often not
developed or barriers to access

6. UN Political Declaration (2011)
“Commit to accelerate efforts to achieve the goal of universal
access to antiretroviral treatment for those eligible based on
World Health Organization HIV treatment guidelines… with the
target of working towards having 15 million people living with
HIV on antiretroviral treatment by 2015”
UN Political Declaration on HIV/AIDS, 2011

7. The Context
• Significant HIV treatment needs in developing countries
• International commitment to treat 15 million people by 2015
• Generic competition central to treatment scale-up of past decade
• Newer HIV medicines widely patented in developing countries
• Important formulations needed in developing countries often not
developed or barriers to access

8. Generic Competition & Treatment Scale-Up
$2700 $10,400
$800 7
Millions
$700
6
$600
5
$500
4
$400
3
$300
2
$200
1
$100
$0 0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
People in LMICs on treatment
Lowest generic price first line ARV regimen
Originator price of first-line ARVs

9. The Context
• Significant HIV treatment needs in developing countries
• International commitment to treat 15 million people by 2015
• Generic competition central to treatment scale-up of past decade
• Newer HIV medicines widely patented in developing countries
• Important formulations needed in developing countries often not
developed or barriers to access

10. New HIV medicines are more widely patented in
m
tna
V ie tan
ekis
Uzb y
gu a
1995 and later ARVs
U ru
a in e
U kr
Total number of product patents pending or granted, by jurisdiction, for older
d
ilan
Tha
an
k is t
Taji fric
a
th A
S ou
ka
Lan
S ri
developing countries…
si a
Rus
ne s
ippi
Phil
u
Per
n
is t a
Pre-1995 ARVs
Pak
compounds (pre-1995) and newer compounds (post-1995)*
)
am
a ries
Pan u nt
6 co
I (1
OA P
g ua
ara
N ic
o
oc c
M or a
g ol i
M on
i co
M ex
ia
ays
Mal
stan
gyz
Kyr
Source: Patent Status Database on Selected HIV Medicines (MPP)
an
Jord
si a
on e
In d
ia
In d as
dur
Hon a la
tem
Gua )
pt ries
Egy unt
9 co
O(
E AP
b ia
om
C ol
na
C hi
le
C hi
z il
Bra
ina
ent
A rg
eria
A lg e s)
enia n t ri
A rm c ou
( 18
PO e
A RI si b l
pos
AL
TOT
8
0
12
4

11. …and have many years left before expiry
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
1985 1990 1995 2000 2005 2010 2015 2020 2025 2030
Darunavir
Ritonavir
` Lopinavir
Atazanavir
Tenofovir DF
Fosamprenavir
Maraviroc
Etravirine
Rilpivirine
Raltegravir
Elvitegravir
Dolutegravir
Cobicistat
SPI-452
1985 1990 1995 2000 2005 2010 2015 2020 2025 2030

12. ARVs as proportion of total treatment costs*
$2,500
$2,000
$1,500
ARV
Non-drug cost of ART
$1,000
$500
$-
1st line 2nd line
*Based on 2009 weighted average costs across LMICs. Data from Schwartländer et al. May 2011.

13. The Context
• Significant HIV treatment needs in developing countries
• International commitment to treat 15 million people by 2015
• Generic competition central to treatment scale-up of past decade
• Newer HIV medicines widely patented in developing countries
• Important formulations needed in developing countries often not
developed or barriers to access

14. Fixed Dose Combinations
(or “three-in-one pills”)
• Analysis of patent-related challenges to the uptake of
Fixed Dose Combinations (FDCs) undertaken for the
Global Fund Market Dynamics and Commodities ad hoc
Committee
• Out of 10 recommended FDCs with at least one
supplier, potential IP barriers to generic competition
for 7 in at least one developing country (greater
barriers for 3 FDCs)
• All 6 FDCs known to be either in development, or
having very recently obtained regulatory
approval, appear to face patent barriers to generic
competition in some developing country jurisdictions

15. THE MEDICINES PATENT POOL

16. Medicines Patent Pool Goal and Mission
16

17. The Medicines Patent Pool: An Innovative Licensing
Mechanism for HIV
1. Enable generics versions of
existing compounds
2. Promote Fixed-Dose
Combinations
3. Facilitate development of
adapted formulations (e.g.
paediatrics)
Established in July 2010 with the support of

18. The Pool is governed by the Board and the
Expert Advisory Group
Medicines Patent Pool Governance Board
Charles Clift, Chair
Bernard Pécoul
Malebona Precious Matsoso
Sigrun Møgedal
Paulo Teixeira
Expert Advisory Group
Maximilliano Santa Cruz, Chair
Labeeb Abboud
Jonathan Berger
Alexandra Calmy
Shing Chang
Carlos Correa
Nelson Juma Otwoma
Eun-Joo Min
Lita Nelsen
Achal Prabhala
Gracia Violeta Ross
Wim Vandevelde
18

19. The Global Market for ARVs
2009 Global ARV Sales 2010 Global ARV Volumes
(person*years)
6% 8%
94% 92%
• Developing countries represent a small proportion (6%) of the total
global ARV market (~$14 billion in 2009)
• But the majority of people on treatment globally (92% of ~7
million) and in need of treatment
• High-volume, low-price, low-margin business model

20. How We Work
Negotiate
Prioritise HIV Invite relevant Public Health- Sign Sub-licence to
medicines patent holders Oriented Agreements generics
Licenses
Based on analysis To negotiate The Pool seeks Licences go to And others, such as
of medical licences allowing licences that push the Pool product development
needs, potential others to make and the status quo partnerships
patent barriers sell generic forward, with the (PDPs), who are then
versions of aim of ensuring free to
patented medicines access to develop, produce and
in developing medicines for all sell medicines in
countries, or people living with agreed countries under
develop adapted HIV in developing strict quality
formulations countries assurance. Pool staff
work with sub-
licensees on product
development and
regulatory approval.

21. Identification of Patent Status of
HIV Medicines
• Patent status data collected for
24 HIV compounds in 76 low and
middle income countries with
support of WIPO and national
patent offices
• Provided for the first time a
clear understanding of what is
patented where
• Included in a searchable
database on our website
• Today: most complete single
source of patent status data on
HIV medicines. Widely used by
public health actors.

22. PROGRESS TO DATE

23. Patent Holder Status
Patent Holder Q4 2010 Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012
Abbott Sent letter on Not currently in Not currently in Not currently in Not currently in Not currently in Not currently in
Laboratories 1 December negotiations. negotiations. negotiations negotiations negotiations negotiations
Reply received 26
January.
Boehringer- Sent letter on Not currently in Not currently in In negotiations. In negotiations. In negotiations. In negotiations.
Ingelheim 1 December negotiations. negotiations.
Reply received 19
January.
Bristol-Myers Sent letter on Not currently in Not currently in In negotiations. In negotiations. In negotiations. In negotiations.
Squibb 1 December negotiations. negotiations.
Reply received 26
January.
F. Hoffman-La Sent letter on Preparing for In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.
Roche 1 December negotiations.
Gilead Sciences Sent letter on In negotiations. In negotiations. Licence agreement Licence agreement Licence agreement Licence agreement
1 December Reply received 14 signed July 2011. signed July 2011. signed July 2011. signed July 2011.
February Amended in Amended in Amended in
November 2011. November 2011. November 2011.
Merck & Co. Sent letter on Not currently in Not currently in Not currently in Not currently in Not currently in Not currently in
1 December negotiations. negotiations. negotiations. negotiations. negotiations. negotiations.
Reply received 28
January.
Tibotec/J&J Sent letter on Not currently in Not currently in Not currently in Not currently in Not currently in Not currently in
1 December negotiations. negotiations. negotiations. negotiations. J&J’s negotiations. Pool negotiations.
Reply received 31 decision received in responds to J&J’s
January December. decision in January.
US NIH Licence agreement In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.
signed Sept 2010.
ViiV Healthcare Sent letter on In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.
23
(GSK/Pfizer) 1 December

24. Geographical Scope of Voluntary Licences
160
140
120
100
High-income (HIC)
Upper-middle income (UMIC)
80
Lower-middle income (LMIC)
60 Low-income (LIC)
40
20
0

25. Core Principles for Pool Licences
• Licenses are negotiated from a public
health, pro-access perspective
Patent • Licences are transparent - text of licences
Holders Generics
available on Pool website
• Significant improvement on the pre-
existing situation for as many people living
with HIV as possible
• Aim to include all low and middle income
EAG Board countries, including through the use of
differentiated royalties according to
income and disease burden
• Ensure that terms and conditions are
Patent Medicines
Holders Generics consistent with the use of TRIPs
Patent Pool
flexibilities/Doha Declaration TRIPS and
Public Health
Consultative Process • Raise the bar for licensing in the HIV field
• Manage licences with a public health focus
• Work with partners to promote the
development of needed formulations

26. Achievements so far…
• Unprecedented transparency on what HIV medicines
are patented in which countries
• Higher standard on number of countries covered by
licences (but still long way to go)
• Recognition of importance of licensing compounds as
early as possible (e.g. late-stage pipeline)
• Opening up of the market for generic tenofovir (key
first-line ARV) in a large number of middle-income
countries
• Right to supply countries issuing a compulsory licence
included in licence (probably for first time)
• Unprecedented transparency in disclosing full text of
licence
• Recognition of a new business model for ARV
licensing, through an entity with a public health
mandate 26

27. …but a long way to go
• Successfully negotiating public-health oriented
licences with key flexibilities from more patent
holders; pushing geographic scope with aim of all
developing countries
• Contributing to opening up the markets for
second-line and third-line ARVs
• Enabling the development of new fixed dose
combinations that meet treatment needs
• Providing for greater diversification in
manufacturing of ARVs (e.g. local production)
• Continue to change industry norms towards
greater public health focus in licensing practices
27

28. Supporting Statements
“"A successful patent pool will help in accelerating the scaling up of
access to care and treatment and will reduce the risk of stock out of
medicines in the developing world.“
– Michel Sidibe, Executive Director, UNAIDS, July 2010
“Encouraging the voluntary use, where appropriate, of new mechanisms such as
partnerships, tiered pricing, open-source sharing of patents and patent pools
benefiting all developing countries, including through entities such as the
Medicines Patent Pool, to help reduce treatment costs and encourage
development of new HIV treatment formulations, including HIV medicines and
point-of-care diagnostics, in particular for children.”
-UN General Assembly Political Declaration on HIV/AIDS
“We welcome the Patent Pool Initiative launched by UNITAID…and we invite the
voluntary participation of patent owners, private and public, in the project.” –
G8 Summit, Deauville, France, May 2011
“Encourage the use of new mechanisms such as the UNITAID Medicines Patent
Pool to help reduce treatment costs and promote the development of new
treatment formulations, including paediatric formulations and fixed-dose
Partnership Forum combinations.” – Sao Paulo Parliamentary Declaration on Access to
Medicines and Other Pharmaceutical Products, Global Fund Partnership
Forum, June 2011
I commend UNITAID for taking the initiative to establish the Medicines Patent
Pool and commend the companies that are in negotiations with the Patent Pool
-Margaret Chan, Director General of WHO, July 2011

29. Thank You!
www.medicinespatentpool.org