the medicines patent pool - who · •the pool seeks public health oriented licences that take into...
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Update on the Medicines Patent Pool
Sandeep Juneja
November 06, 2012
• The Pool seeks public health oriented
licences that take into account
legitimate interests of all parties
• Improvement over status-quo
• Using its IP & legal expertise, the Pool
aims to continually improve existing
agreements and sign new and better
agreements. It strives to:
o Include as many low and middle
income countries as possible
o Promote terms that maximise
public health benefits and
ensure lowest sustainable cost
for quality medicines in as many
countries as possible
• Funded by UNITAID
• Operational since end-2010
Pool
Royalties
Licensors
Patents
Sub-
Licensees
Out-
Licenses
License
Management
by the Pool
Product
introductions
Market Impact
Feedback
How the Pool works*
* Generalized schematic; may be different for specific licenses
The Pool is an innovative licensing mechanism
for HIV medicines
2
Ensuring access in the
changing ARV patent landscape
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
Support to the Pool from key stakeholders
in global health
4
National Health
Organizations and
Communities
Global Health
Organizations
Generics
Companies
Donor
Agencies
Originator
Companies
“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
“The Medicines Patent Pool has potential to support
access to more appropriate and affordable ARVs in
developing countries by setting incentives for product
adaptation and generic production. We will encourage
the pharmaceutical sector to engage actively with the
Medicines Patent Pool to support the availability of
more appropriate and affordable ARVs.”
- Towards zero infections: The UK’s
position paper on HIV in the
developing world, May 2011
“We welcome the Patent Pool Initiative launched by
UNITAID in order to facilitate production of affordable
generic medicines well-adapted for use in resource-poor
settings, and we invite the voluntary participation of
patent owners, private and public, in the project.”
– Group of 8 Declaration, G8
Summit of Deauville, France,
May 2011
Support to the Pool from key stakeholders
in global health(2)
5
“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 combinations.”
- Sao Paulo Parliamentary
Declaration on Access to
Medicines, Global Fund
Partnership Forum, June 2011
“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, June 2011
“We think that the Medicines Patent Pool is an
important initiative towards achieving universal access
to the newer HIV medicines… At WHO we will be
pleased to give priority to any of the newly developed
FDCs for assessment by our WHO / UN Prequalification
Programme in order to facilitate its rapid uptake by the
funding agencies and national governments.”
- Hans V. Hogerzeil, former
director, WHO Essential Medicines
and Pharmaceutical Policies,
October 2010
“UNAIDS strongly encourages other antiretroviral patent
holders to establish agreements with the Pool, and for
generic manufacturers to utilize the licenses that the
Pool can facilitate to expand access to antiretroviral
treatment.”
- Paul De Lay, Deputy
- Executive Director,
- UNAIDS, October 2011
“The Medicines Patent Pool offers a way forward that could work for both people living with HIV and for companies…
where patents exist, the Pool is a way to manage them so that public health goals are still achieved, and people living
with HIV are not barred from getting the medicines they need.”
NEPHAK, Press Release, December 2011
Licensing-in
•US NIH
•Gilead Sciences Concluded
•Boehringer Ingelheim
•Bristol Myers-Squibb
•F. Hoffman-La Roche
•Viiv Healthcare
In negotiations
•Abbott Laboratories
•Merck & Co
•Tibotec / Johnson & Johnson
Not in Negotiations
Licensing-out: Gilead products
Aurobindo
Cobicistat
Elvitegravir
Emtricitabine
Quad
Emcure
Cobicistat
Elvitegravir
Emtricitabine
Quad
Hetero
Cobicistat
Elvitegravir
Emtricitabine
Quad
Laurus
Cobicistat
Elvitegravir
Emtricitabine
Quad
Tenofovir
Medchem
Cobicistat
Elvitegravir
Emtricitabine
Quad
Tenofovir
Licensing processes
to ensure market impact
8
Sign in-
licences
Review
Expression of
Interest forms
from generics
Negotiate out-
licences
Sign out-
licences
Conduct
technology
transfer
Reporting step
Licensing step
Only as required
Monitor WHO PQ,
USFDA, SRA
approval status
Monitor in-
country
registration
status
Progress reviews
Kick-Off generic
collaboration
Dispute
resolution Assess impact
Collect & report
market feedback
Monitor royalties
1
2
3
Phase 1: Out-licensing
Phase 2: Development
Phase 3: Commercialization
Status of Gilead licences
9
Sign in-
licences
Review
Expression of
Interest forms
from generics
Negotiate out-
licences
Sign out-
licences
Conduct
technology
transfer
Reporting step
Licensing step
Only as required
Monitor WHO PQ,
USFDA, SRA
approval status
Monitor in-
country
registration
status
Progress reviews
Kick-Off generic
collaboration
Dispute
resolution Assess impact
Collect & report
market feedback
Monitor royalties
1
2
3
Phase 1: Out-licensing
Phase 2: Development
Phase 3: Commercialization
✔ ✔ ✔
✔
✔
✔
Further developments on the Gilead licence
10
Added amendments to improve current agreement
1. Included South Sudan
2. Incorporated language based on CS feedback:
a) clarified covenant “not to sue” on FTC post TDF termination
b) clarified Gilead’s position on Compulsory Licences
3. Waived the Pool’s administrative fee
Started technology transfer
• Cobicistat/Elvitegravir: API technology transfer to Pool licensees accomplished
• Quad: formulation technology transfer to follow
• FTC process improvement: shortly
Earned LES “Deals of Distinction” Award 2012
• Gilead & NIH licences with MPP awarded “deals of distinction” by the Licensing Executives
Society – USA & Canada
Expression of Interest process
11
Potential Licensees
• An Expression of Interest (EOI) process to enable potential licensees to seek licences online has
been designed and is being implemented
• The EOI process includes details such as
• Capabilities in R&D and manufacturing
• Product development plan and strategy
• Regulatory timelines
• Fitment of the product in the overall ARV/business strategy
• The Pool aims to fairly offer sub-licences to all qualified generics manufacturers while exercising
due care and diligence to not undermine stability of the generic ARV market
Working paper, updated
annually; Preview of the 2012-
update outcome alongside; full
paper out shortly - comments
will be welcome. Watch out at:
http://www.medicinespatentpo
ol.org/licensing/target-
medicines/
Compounds with (*) are pipeline compounds
Priority products for the Pool
• Most complete single
source of ARV patent
status data
• Covers 24 compounds
in 78 countries
• Searchable by
compound and by
country (or region)
• To be regularly
updated
• Starting point for
more thorough
searches
Patent status database
Thank You
www.medicinespatentpool.org