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