The Medicines Patent Pool - Stimulating Innovation, Improving access
1. The Medicines Patent Pool
Stimulating Innovation, Improving
access
Ellen ‘t Hoen
Medicines Patent Pool
UNITAID Technical Briefing WHA, Geneva 18 May 2011
Despite recent progress in access to HIV medicines,
there is still significant need for additional treatment
• > 6 million people in
developing countries on
35 ART by end of 2009
30
People (Millions)
• But further 10 million
25 people are in urgent need
20 Will Need of treatment as per WHO
Treatment guidelines
15 In Need of
10 Treatment • An additional 18 million
Treated people are HIV positive and
5 will need treatment
0
• 1.2 million new people on
2009 treatment in 2009, but 2.6
million new infections
Source: World Health Organization. Towards universal access: Scaling up priority HIV/AIDS interventions in the health 2
sector. http://www.who.int/hiv/pub/2010progressreport/summary_en.pdf
2. Numbers of PLHIV on ART will Rise
Current
Number on ART Tx 2.0
Community
25,000,000 Optimised regimen
20,000,000
15,000,000
10,000,000
5,000,000
0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Source: UNAIDS Investment Framework - preliminary data. 2011
The Context: HIV/AIDS Market
• Low and middle income countries represent a small
proportion of current global sales for HIV/AIDS (a fraction
of 6%) and highly concentrated in a handful of countries.
• For 2nd and 3rd line drugs: less than 3%
• But over 90% of the disease burden
3. The Context
• Generic competition central to treatment scale-up of past decade
Price of 1st line regimen down to under 1% of original price
• Widespread patenting of newer drugs in developing countries
Limited generic availability and limited price reductions
Differential pricing: not same impact on pricing as robust generic
competition
• Promising FDCs / formulations often not developed
WHO Committee on Essential Medicines has identified opportunities
• Financial crisis
budgets for purchase of HIV medicines not growing
• Treatment Needs
WHO Treatment Guidelines (earlier start; drugs with less side effects)
People in developing countries developing resistance to 1st line
Special (unmet) needs of children with HIV
New evidence: HIV treatment prevents transmission of HIV
Context: Patents on some new ARVs
Product +/- Expiry date
Atazanavir (Novartis/BMS) 2017
Cobicistat (Gilead) 2027
Darunavir (J&J/Tibotec) 2023
Etravirine (J&J/Tibotec) 2019
Fosamprenavir (ViiV) 2018
GSK 572 –Dolutegravir (ViiV) 2026
Raltegravir (MSD) 2025
Rilpivirine (J&J/Tibotec) 2022
Ritonavir hs (Abbott) 2024
Tenofovir DF (Gilead) 2018
Maraviroc (Pfizer) 2019
4. The Medicines Patent Pool
Public Health Vision
To improve access to appropriate affordable HIV
treatments in developing countries
Medicines Patent Pool Mission
The patent pool will bring down the prices of HIV drugs,
facilitate the development and production of improved
formulations (e.g., fixed dose combinations and paediatric
and heat-stable formulations) by providing access to
intellectual property relating to these products
7
History of the Medicines Patent Pool
2006 2008 2009 2010
May 2008
CIPIH 2006 Broad stakeholder
WHO Global Strategy
recommendation: consultation
and Plan of Action
"Patent pools of included Voluntary Establishment of the
upstream technologies Patent Pools Developed the Medicines Patent
may be useful in some (upstream and implementation plan Pool
circumstances to downstream) for the medicines
promote innovation patent pool
relevant Formal licensing
July 2008 negotiations begin
to developing Ongoing dialogue with
countries.” UNITAID Executive
Board patent holders and with
NIH grants first
other ARV drug
MSF and KEI proposed Supports the principle licence to the Pool
manufacturers
to UNITAID to set up a of establishing a
medicines patent pool. patent pool and
requests the Decision by UNITAID
secretariat to Board to fund
undertake all
necessary actions for
this establishment.
UNITAID funds the operations of the Pool under a 5-year8MOU
5. Three Main Objectives
•Enable the development of fixed
dose combinations (FDCs) of
which the patents are held by
different entities
•Enable the development of
adapted formulations for children
or for specific developing country
needs (e.g., heat stable)
•Accelerate the availability of
generic versions of new ARVs in
developing countries
•
9
How the Pool Works
Royalties
Sub-
Licensee
Licensor Pate
nts
Sub-
Licensee
Licensor Patents Sub-
Licensee
Pool Sub-
Patents
Licensor Licensee
Sub-
Licensee
Patents
Licensor
Sub-
Licensee
Patents
Licensor Sub-
Licensee
Royalties
6. Where we stand today
• The Medicines Patent Pool is open for business, and a
dialogue has been opened with all known patent holders
• Medicines Patent Pool is fully staffed and equipped to deal
with its responsibilities
• The NIH became the first to licence patents to the Pool
• Negotiations on terms and conditions are on-going with 5
potential licensors
• Consultations have also been held with generic
manufacturers
• External legal / licensing experts in collaboration with WIPO
• Prioritisation based on latest scientific evidence in
collaboration with the WHO and UNITAID
• Information about and produced by the Pool made available
on the website
• Exploring potential opportunities and financing mechanisms
for developing formulations and FDCs with UNITAID, WHO and
Chatham House
– 11 July London meeting on innovation in HIV treatment
11
Support for the Medicines Patent Pool
"One promising “We urge all public “We think that the Medicines "A successful
initiative that can institutions and Patent Pool is an important patent pool will
help decrease the pharmaceutical companies initiative towards achieving help in accelerating
cost of patents for to follow the measures universal access to the newer the scaling up of
the Index taken by the NIH, and to HIV medicines….At WHO we access to care and
Countries is the share without delay their will be pleased to give priority treatment and will
patent pool patents on this and other to any of the newly developed reduce the risk of
initiative of antiretrovirals with the FDCs for assessment by our stock out of
UNITAID" Medicines Patent Pool, in WHO/ UN Prequalification medicines in the
order to facilitate access Programme in order to developing world"
ATM Index 2010 to these treatments at the facilitate its rapid uptake by
(Engagement with Michel Sidibe,
lowest possible price for the funding agencies and
PP included as UNAIDS Executive
countries in need national governments.”
one of the issues Director (July
measured in the Prof. Kazatchkine, Dr. Hans Hogerzeil, Director 2010)
Index) Executive Director Global Essential Medicines and
Fund Pharmaceutical policies
(October 2010)
“This licence underlines the U.S. Government’s commitment to the Medicines Patent Pool
and its goal to increase the availability of HIV medicines in developing countries. We are
now discussing licensing to the Medicines Patent Pool other patents that could have a positive
impact on the treatment of HIV/AIDS.”
NIH Director Francis S. Collins, M.D., Ph.D. 12
7. Patent Holder Engagement
Patent Holder Q4 2010 Q1 2011
Sent letter on Not currently in negotiations.
Abbott Laboratories
1 December Reply received 26 January
Sent letter on Not currently in negotiations.
Boehringer-Ingelheim*
1 December Reply received 19 January
Sent letter on Not currently in negotiations.
Bristol-Myers Squibb*
1 December Reply received 26 January
Sent letter on
F. Hoffman-La Roche In negotiations
1 December
Sent letter on
Gilead Sciences In negotiations
1 December
Sent letter on Not currently in negotiations.
Merck & Co.*
1 December Reply received 28 January
Sequoia Pharmaceuticals In negotiations
Sent letter on Not currently in negotiations.
Tibotec/Johnson & Johnson*
1 December Reply received 31 January
Licence granted
US National Institutes of Health In negotiations
September
Sent letter on
ViiV Healthcare In negotiations
1 December
Patent Status Database