addressing innovation and access through voluntary licensing: the medicines patent pool chan park...
TRANSCRIPT
Addressing Innovation and Access Through Voluntary
Licensing: The Medicines Patent Pool
Chan ParkWashington, D.C.
25 July 2012
Patenting of ARVs in developing countries has increased over
recent years
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Pre-1995 ARVs 1995 and later ARVs
Num
ber
of
AR
Vs
for
whic
h
basi
c pate
nts
were
sought
Source: Medicines Patent Pool Database
• Patenting of ARVs in developing countries is more common for medicines developed after 1995 than for those developed before 1995 (date of entry into force of the TRIPS agreement)
As a result, newer drugs are more widely patented today
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Basic patent granted
Basic patent filed, under appeal, designated under international agreement, opposed
Num
ber
of
terr
itori
es
Patent pending in India
Patent granted in India
Pre-1995 ARVs
Post-1995 ARVs
Many secondary patents on ARVs complicate the issue further
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Basic patent granted Basic patent filed, under appeal, designated under international agreement, opposed
Secondary patent granted Secondary patent filed, under appeal, designated under international agreement, opposed
Num
ber
of
terr
itori
es
Pre-1995 Post-1995
Only includes some select secondary patents: but there are many more
Patent expiry is still a long way away...
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
Challenges for Fixed Dose Combinations may be particularly
problematic
• Out of 11 recommended FDCs with at least one supplier, potential IP barriers to generic competition for at least 9
• All 7 FDCs under development or recently approved appear to face patent barriers to generic competition in some developing countries
Source: Medicines Patent Pool, Challenges for the Uptake of Fixed-Dose Combinations: An Analysis of Intellectual Property Issues
• Some needed FDCs also not being developed, including for paediatric HIV
Source: Joint submission by Medicines Patent Pool, WHO and UNITAID to the WHO Committee on the Selection and Use of Essential Medicines
Mechanisms to overcome patent barriers
• UNAIDS-UNDP-WHO policy brief analyses a number of mechanisms:
– Use of TRIPS flexibilities E.g.:• Extension of the exception for LDCs• Limit what is patentable (e.g. India)• Use of competition law to increase number of producers (e.g. South
Africa)• Opposition procedures• Compulsory licences or government use (e.g. Brazil, Malaysia,
Mozambique, Rwanda, Thailand, Zambia, Zimbabwe)• Others• http://www.unaids.org/en/media/unaids/contentassets/documents/
unaidspublication/2011/JC2049_PolicyBrief_TRIPS_en.pdf
– Voluntary Licences: can result in improved access. But need to include key public heath safeguards.
Concerns With Existing Bilateral Voluntary Licences
• Licences are secret. Only basic features are disclosed.
• Wide range of restrictions may impact negatively on access
• Licences given to few hand-picked manufacturers
• No voluntary licences for a number of products (e.g. dolutegravir, lopinavir, maraviroc, ritonavir)
• Very restrictive ones for others (e.g. darunavir, etravirine, raltegravir)
Patent Holder
s
Generics
Bilateral Licences
Core Principles for Pool Licences
Generics
Consultative Process
BoardEAG
Medicines Patent Pool
Patent
Holders
Pool Licences • Licenses negotiated from a public health, pro-access perspective
• Improvement for as many people living with HIV in LMICs as possible
• Ensure terms and conditions are consistent with the use of TRIPs flexibilities
• Improving industry norms for voluntary licensing
• Manage licences with a public health focus
• Work with partners to promote the development of needed formulations
The Medicines Patent Pool: an Innovative Public-Health Oriented Voluntary Licensing Mechanism
for HIV
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• Accelerate the availability of generic versions of new antiretrovirals in developing countries
• 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)
•
Three Main Objectives
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Prioritise HIV
medicines
Invite patent
holders to negotiate
Negotiate public health-
oriented licences
Sign agreements
Sub-licence to generics
Enhance access
How does it work?
Prioritise HIV Medicines by Clinical and Market/IP Priority
Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
Clinical / Medical Priority
Market / IP Priority
ARV Prioritisation
Working Paper+ =
Medicines Patent Pool ARV Priorities
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Compound Clinical Priority
Market / IP Priority
Level 1 Priorities
Atazanavir (ATV) High High
Dolutegravir (DLG)*
High High
Cobicistat (COB)* High High
Elvitegravir (EVG)* High High
Lopinavir (LPV) High High
Rilpivirine (RIL) High Medium
Ritonavir (RTV) High Medium
Efavirenz (EFV) High Medium
Tenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium High
Abacavir (ABC) Medium Medium
Darunavir+ Medium Medium
Compound Clinical Priority
Market / IP Priority
Level 2 Priorities
Lamivudine (3TC) High Low
Nevirapine (NVP) High Low
Zidovudine (AZT) High Low
Emtricitabine (FTC) Medium Low
Level 3 Priorities
Fosamprenavir (FPV)
Low High
Maraviroc (MVC) Low High
Didanosine (ddI) Low Medium
Saquinavir (SQV) Low Medium
* Indicates pipeline product
Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
By-product of Prioritization: the Patent Status Database
What Is It?• Patent status data collected for 24 HIV compounds in 76 low and middle income countries
• 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.
Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
"Knowing the patent status of different ARVs is important when looking at whether or not there are barriers for treatment providers to import these drugs into a particular country. The patent status database is an incredibly useful resource as it provides the most comprehensive pool of the available information on patent statuses, and combines this into one easy to use search engine.”
MSF
“UNICEF's aim is to have as complete, a factual picture as we can on patents for HIV medicines in developing countries, which can affect whether the medicine can be sent to a
particular country. The Medicines Patent Pool’s Patent Status Database for Selected HIV Medicines takes an invaluable step towards furthering access to treatment of HIV/AIDS amassing information from numerous patent registries and jurisdictions
into an easily navigable resource available to the public.” - UNICEF
“In the midst of a current patent regime that is at times not so transparent, this database is a great and valuable tool for
players in the field, and one we regularly check as part of our procedures for determining a patent status. [It] ultimately
allow[s] us to focus more of our energy into the actual delivery of HIV medicines to the ones who need it.”
IDA Foundation
"The Medicines Patent Pool database is an essential impartial reference source for Global
Fund Principal Recipients to understand the patent status of ARVs in their country – and it should be
further expanded to include more countries.” The Global Fund
Patent Holder Q4 2010 Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012
Abbott Laboratories
Sent letter on 1 December
Not currently in negotiations. Reply received 26 January.
Not currently in negotiations.
Not currently in negotiations
Not currently in negotiations
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. In negotiations. 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. In negotiations. In negotiations. In negotiations.
F. Hoffman-La Roche
Sent letter on 1 December
Preparing for negotiations.
In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.
Gilead Sciences Sent letter on 1 December
In negotiations.Reply received 14 February
In negotiations. Licence agreement signed July 2011.
Licence agreement signed July 2011. Amended in November 2011.
Licence agreement signed July 2011. Amended in November 2011.
Licence agreement signed July 2011. Amended in November 2011.
Merck & Co. Sent letter on 1 December
Not currently in negotiations. Reply received 28 January.
Not currently in negotiations.
Not currently in negotiations.
Not currently in negotiations.
Not currently in negotiations.
Not currently in negotiations.
Tibotec/J&J Sent letter on 1 December
Not currently in negotiations. Reply received 31 January
Not currently in negotiations.
Not currently in negotiations.
Not currently in negotiations. J&J’s decision received in December.
Not currently in negotiations. Pool responds to J&J’s decision in January.
Not currently in negotiations.
US NIH Licence agreement signed Sept 2010.
In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.
ViiV Healthcare(GSK/Pfizer)
Sent letter on 1 December
In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.
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Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
Geographical Scope of Voluntary Licences
Pfize
r/Viiv
(MVC)
Abbot
t (LP
V/r)
Merck
(EFV
)
J&J (
ETR)
Bristo
l-Mye
rs S
quib
b (d
4T, d
dI, A
TV)
Merck
(RAL)
Roche
(SQV, N
FV)
J&J (
DRV)
GSK/V
iiv (A
ZT, 3
TC, A
BC)
Boehr
inge
r Ing
elhe
im (N
VP)
Gilead
/Poo
l (EV
G)
Gilead
/Poo
l (COBI)
J&J (
RIL)
Gilead
/Poo
l (TD
F, FT
C)
NIH/P
ool L
icens
e
Objec
tive
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Low-income (LIC) Lower-middle income (LMIC)Upper-middle income (UMIC) High-income (HIC)
Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
Pool Licences
# o
f co
untr
ies
Sub-Licence to Generics
• Four sub-licences signed
• Three have made use of key flexibility negotiated by the Pool opening up the market for TDF
• Advanced discussions with several other potential licensees
Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
MPP’s Post-Licensing M&E Process
Decision PointLicensing StepReporting StepOnly If Required
Sign In-Licences
Send Expression of Intent (EOI)
Screen EOI Replies
Negotiate Out-Licences
Sign Out-
Licences
Conduct First Quarterly Review
Kick-Off Generic
Collaboration
Conduct Tech Transfer per
licence terms
1st originator approval for pipeline
product
Liaise with WHO PQ, as appropriate
Monitor Registration
Status
Conduct Progress Reporting
Monitor Royalties
Annual Review of
Licensors + Sub-
Licensees
Collect Market
Feedback on Sub-
Licensees
Assess Impact
Initiate Dispute
Resolution
Achievements so far…
• Unprecedented publication of full text of licence
• Patent transparency on what HIV medicines are patented in which countries
• Two patent holders in the Pool, and several others in negotiation
• Higher standard on number of countries covered by licence (but still long way to go)
• Recognition of importance of licensing medicines as early as possible (e.g. pipeline compounds) to reduce delay in developing countries
• Provisions in licences consistent with the use of TRIPS flexibilities
• Recognition of a new business model for ARV licensing, through an entity with a public health mandate
Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
…but a lot to be done
• Successfully negotiating public-health oriented licences with key flexibilities from more patent holders
• Further expanding number of countries benefitting from licences
• Contributing to opening up the markets for second-line, third-line and pipeline ARVs in more countries
• Enabling the development of new fixed dose combinations and adapted formulations that meet treatment needs
• Providing for greater diversification in manufacturing of ARVs
• Continue to change industry norms towards greater public health focus in licensing practices
Prioritise HIV medicines
Invite relevant patent holders to
negotiate
Negotiate public health-oriented
licencesSign agreements
Sub-licence to generics
Enhance access
Supporting Statements
“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
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
“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 and Other Pharmaceutical Products, Global Fund Partnership Forum, June 2011
Partnership Forum
“"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
THANK YOU
www.medicinespatentpool.org