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The Medicines Patent Pool:
An Update
June 2012
Geneva, Switzerland
Pool
Sub-
Licensee
Sub-
Licensee
Sub-
Licensee
Sub-
Licensee
Sub-
Licensee
Sub-
Licensee
Sub-
Licensee
Royalties
Royalties
Patents
Patents
Patents
Licensor
Licensor
Licensor
Licensor
Licensor
Generics
versions of
existing
compounds
Fixed-Dose
Combinations
Adapted
formulations
(e.g.
paediatrics)
The Medicines Patent Pool
Established in 2010 with the support of
New HIV medicines are more widely patented in
developing countries…
7/2/2012 2
Total number of product patents pending or granted, by jurisdiction, for older
compounds (pre-1995) and newer compounds (post-1995)*
Source: Patent Status Database on Selected HIV Medicines (MPP)
…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
Fixed Dose Combinations
• Analysis of patent-related challenges to the uptake of 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 for 7 in at least one developing country (risk is higher for 3)
• 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
Priority Products for the Pool
Working paper published
for comments available
at:
http://www.medicinespat
entpool.org/WHAT-WE-
DO/Target-Medicines
Compounds with (*) are
pipeline compounds
In dark green: compounds
for which licences have
been obtained
In light green: compounds
for which negotiations are
ongoing
In light yellow: compounds
for which not currently in
negotiations
Summary of Priorities for the Medicines Patent Pool
Compound Clinical Priority
Market/IP Priority
Level 1 Priorities (medium or high priority under both criteria)
Atazanavir (ATV) High High
Dolutegravir (DLG)* High High Cobicistat (COB)* High High
Elvitegravir (EVG)* High High
Lopinavir (LPV) High High Rilpivirine (RIL) High High
Ritonavir (r) High High
Efavirenz (EFV) High Medium Tenofovir (TDF) High Medium
Etravirine (ETV) Medium High
Raltegravir (RAL) Medium High Abacavir (ABC) Medium Medium
Darunavir (DRV) Medium Medium
Level 2 Priorities (medium or high for clinical and low for market/IP)
Lamivudine (3TC) High Low Nevirapine (NVP) High Low
Zidovudine (AZT or ZDV)
High Low
Emtricitabine (FTC) High Low
Stavudine (d4T) Medium Low Level 3 Priorities (medium or high for market/IP and low for clinical)
Fosamprenavir (FPV) Low High
Maraviroc (MVC) Low High
Didanosine (ddI) Low Medium Saquinavir (SQV) Low Medium
Company Engagement: Patent Holders
Patent
Holder
Q4 2010 Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 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
negotiation
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
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
F. Hoffman-La
Roche
Sent letter on
1 December
Preparing for negotiation. 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.
Agreement signed
July 2011 +
amendments
Agreement signed
July 2011 +
amendments
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.
Sequoia
Pharma
In negotiations. In negotiations. In negotiations. In negotiations. 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.
Not currently in
negotiations.
US NIH Licence agreement
signed Sept 2010.
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 formal negotiations Licence agreement signed 6
The Pool’s licence with Gilead
(July 2011) • Key Features:
– Includes: tenofovir (TDF), cobicistat (COBI), elvitegravir (EVG), emtricitabine (FTC) and the combination product the Quad
– Geographical scope:
• TDF: 112 countries (87.6% of PLHIV in developing countries)
• COBI: 103 countries (82.7%)
• EVG-Quad: 100 countries (82.7%)
– Licensees can make combination products
– Royalties 3 – 5%. No royalties for paediatrics
– Waiver of any data exclusivity rights
– Generics can pick and choose products they license
– Generics can terminate licence at any moment
– Generics can supply countries that issue compulsory license
– One time technology transfer
– Provides for publication of licence agreement
– Licensees can oppose the patents
• Main Concerns:
– Limited to sub-licensees based in India – Geographical scope
• Aurobindo Pharma, Emcure Pharma – Large established ARV players
– Terminated TDF part of the licence on signing; now free to sell TDF where there are no patents, including, e.g. Argentina, Brazil, Chile, Colombia, Malaysia, Peru, Philippines, Ukraine, and Uruguay as long as manufacturers not using patented process
Out-licensing
• Medchem International – New player in ARVs
Gilead licence so far out-licensed to:
8
Patent Status Database
• Launched in April 2011
and regularly updated
• Patent status data
collected with support
of WIPO and national
patent offices for 24
compounds in 76 low
and middle income
countries
• Included in a
searchable database
on our website
• Most complete single
source of ARV patent
status data
• Searchable by
compound and by
country (or region)
• La
Patent Status Database
• The Pool’s patent status database is being utilised by different procurement actors to gain clarity on the IP landscape and ultimately minimise costs, where possible
• Recently added: Albania, Azerbaijan, Bosnia, Bulgaria, Dominican Republic, Lithuania, Moldova, Montenegro and Turkey
10
"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 patent status database is a very helpful tool that provides easy access to patent information that is otherwise
hardly available and difficult to obtain. Our procurement specialists use the tool as a starting point in determining the
best value supply option for clients." -I+ Solutions
“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
• Recently updated data on: Armenia, Brazil, China, India, Mexico, Peru, South Africa, Ukraine and Uruguay
THANK YOU
www.medicinespatentpool.org