Patent Pooling and the Experience of the MPP – A model for sharing the value of innovation to ensure access
MPP's ED Greg Perry's presentation at IFPMA event on January 29, 2014.
1. Patent Pooling and the
Experience of the MPP–
A model
for sharing the value of innovation to ensure access
2. The MPP Background
Created to increase access to quality,
appropriate medicines for people living with
HIV in developing countries
Works by addressing a key challenge in HIV
medicines access: the need to share patents
Founded at the request of the international
community in 2010 through the innovative
financing mechanism UNITAID
Endorsed by WHO, the UN High Level Meeting on
AIDS, and the Group of 8 as a promising approach
to improving access to HIV medicines
3. The Treatment Gap
35.3
million people
live with HIV
worldwide and will
eventually need
treatment
26
million need
treatment now*
9.7
have it
*According to the WHO
Source: UNAIDS, WHO
4. MPP: Driving Innovation and
Access for Developing Countries
MILLIONS WAIT
FOR LIFE-SAVING
HIV TREATMENT.
How can we deliver?
Share Patents
• “Pool” patents &
technology through a
collaborative
voluntary licensing
system
• Create win-win
solutions for all
stakeholders
Advancing innovation,
access, and public health
Reward
Innovation
Spur New
Innovation
• Ensure continued
incentives for
innovation
• Facilitate
innovations
targeted at
developing
countries
• Enable development
of new fixed dose
combinations that
address treatment
needs
• Promote development
of adapted
formulations for
children
Ensure Access
• Accelerate
availability of more
affordable versions
of new ARVs in
developing countries
• Ensure access to
innovative products
in developing
countries
5. Needed HIV Medicines
Newer medicines
recommended by
the World Health
Organization
Fixed-dose
combinations
simplify treatment,
increase adherence
Special
formulations
needed for children
living with HIV
At this moment in time, the world faces both a great challenge
and a great opportunity in the fight against the HIV epidemic.
6. Increased Patenting of ARVs in
Developing Countries
Median number of developing countries in which basic
patents on ARV were filed (out of 75)
40
35
30
25
20
15
10
5
0
Pre-1995 ARVs
Post-1995 ARVs
Source: Medicines Patent Pool Patent Status
Database on Selected ARVs
6
7. How the MPP works
PATENT
HOLDERS
GENERIC
MANUFACTURERS
SubLicences
Licences
PEOPLE LIVING
WITH HIV
Medicines
ROYALTIES
Prioritise HIV
Medicines
Invite patent
holders to
negotiate
Negotiate
public-health
licences
Sign
agreements
Sub-licence
to generics
Manage
licensees
Increase
access
8. Promoting FDCs
through Patent Sharing
Generic access
Generic access
Patented
Generic access
Generic access
Patented, but
licensed to MPP
• Fixed-dose combinations
improve treatment adherence
for adults and children alike
U
• But face particular patent
challenges:
• Patents on just one
component can have
impact on access to
entire regimen
• There are also patents
on the combinations
themselves
9. The Public Health Perspective
• MPP seeks public health orientated
licenses covering:
– Widest number of developing countries
– Highest proportion of PLWHIV
– Non-restrictive terms to ensure competition
– Tech transfer provisions
– Flexibility to use in combinations
– Full transparency of terms
(These go beyond traditional B2B licensing
agreement between generic and originator )
11. Results to-date
• Licenses signed on 7 priority ARVs, including
WHO preferred 1st line treatment for both
adults and children
• 6 ARV manufacturers have licensed from the
MPP and are working on the development
and registration to cover up to 100 to 118
developing countries.
• 1 hybrid agreement includes price reduction
(90%) of brand product covering 138
countries
11
12. Work In Progress
• Started negotiation for a key WHO preferred
pediatric treatment.
• In advanced negotiation for the two most
important awaited new ARVs.
• Finalizing agreements with 2 HIV
manufactures to develop and manufacture
paediatric medicines.