medicines patent pool

The Medicines Patent Pool:

Promoting innovation and access through public health-oriented licences

Ethan GuillenFebruary 2013

WHY DO WE NEED A PATENT POOL FOR HIV MEDICINES?

• Significant HIV treatment needs in developing countries

• International commitment to treat 15 million people by 2015

• Generic competition central to treatment scale-up of past decade

• Newer HIV medicines widely patented in developing countries

• Important formulations needed in developing countries often not developed or barriers to access

The Context

Despite recent progress in access to HIV medicines, there is still significant need for

additional treatment

Source: The Global AIDS Epidemic Fact Sheet, UNAIDS, July 2012

• More than 8 million people in developing countries on ART by end of 2011

• But further 6.8 million people are in urgent need of treatment as per WHO guidelines

• Approximately 19.4 million more people are also HIV positive in developing countries and will need treatment

• 1.4 million new people on treatment in 2011

• New evidence shows huge benefits of early start for treatment

Dec. 20110

5

10

15

20

25

30

35

40

Will Need Treatment

Needing Treatment

Receiving Treatment

PLH

IV (

M)






The Context

UN Political Declaration (2011)

“Commit to accelerate efforts to achieve the goal of universal access to antiretroviral treatment for those eligible based on World Health Organization HIV treatment guidelines… with the target of working towards having 15 million people living with HIV on antiretroviral treatment by 2015”

UN Political Declaration on HIV/AIDS, 2011






The Context

Generic Competition & Treatment Scale-Up

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010$0

$100

$200

$300

$400

$500

$600

$700

$800

0

1000000

2000000

3000000

4000000

5000000

6000000

7000000

People in LMICs on treatmentLowest generic price first line ARV reg-imenOriginator price of first-line ARVs

$10,400

$2700






The Context

New HIV medicines are more widely patented in developing countries…

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

ARVs as proportion of total treatment costs*

*Based on 2009 weighted average costs across LMICs. Data from Schwartländer et al. May 2011.

1st line 2nd line $-

$500

$1,000

$1,500

$2,000

$2,500

ARVNon-drug cost of ART






The Context

Fixed Dose Combinations (or “three-in-one pills”)

• Analysis of patent-related challenges to the uptake of Fixed Dose Combinations (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 to generic competition for 7 in at least one developing country (greater barriers for 3 FDCs)

• 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

THE MEDICINES PATENT POOL

Medicines Patent Pool Goal and Mission

16

The Medicines Patent Pool: An Innovative Licensing Mechanism for HIV

1. Enable generics versions of existing compounds

2. Promote Fixed-DoseCombinations

3. Facilitate development of adapted formulations (e.g.

paediatrics)

Established in July 2010 with the support of

The Pool is governed by the Board and the Expert Advisory Group

Medicines Patent Pool Governance Board

Charles Clift, ChairBernard Pécoul

Malebona Precious MatsosoSigrun MøgedalPaulo Teixeira

Expert Advisory GroupMaximilliano Santa Cruz, Chair

Labeeb AbboudJonathan BergerAlexandra Calmy

Shing ChangCarlos Correa

Nelson Juma OtwomaEun-Joo MinLita Nelsen

Achal PrabhalaGracia Violeta Ross

Wim Vandevelde18

The Global Market for ARVs

• Developing countries represent a small proportion (6%) of the total global ARV market (~$14 billion in 2009)

• But the majority of people on treatment globally (92% of ~7 million) and in need of treatment

• High-volume, low-price, low-margin business model

94%

6% 8%

92%

2009 Global ARV Sales 2010 Global ARV Volumes (person*years)

How We Work

Prioritise HIV medicines

Invite relevant patent holders

Negotiate Public Health-

Oriented Licenses

Sign Agreements

Sub-licence to generics

Based on analysis of medical needs, potential patent barriers

To negotiate licences allowing others to make and sell generic versions of patented medicines in developing countries, or develop adapted formulations

The Pool seeks licences that push the status quo forward, with the aim of ensuring access to medicines for all people living with HIV in developing countries

Licences go to the Pool

And others, such as product development partnerships (PDPs), who are then free to develop, produce and sell medicines in agreed countries under strict quality assurance. Pool staff work with sub-licensees on product development and regulatory approval.

Identification of Patent Status of HIV Medicines

• Patent status data collected for 24 HIV compounds in 76 low and middle income countries with support of WIPO and national patent offices

• 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.

PROGRESS TO DATE

Patent Holder StatusPatent 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




Boehringer-Ingelheim




In negotiations. In negotiations. In negotiations. In negotiations.

Bristol-Myers Squibb




In negotiations. In negotiations. In negotiations. In negotiations.

F. Hoffman-La Roche


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.



Merck & Co. Sent letter on 1 December







Tibotec/J&J Sent letter on 1 December

Not currently in negotiations. Reply received 31 January



Not currently in negotiations. J&J’s decision received in December.

Not currently in negotiations. Pool responds to J&J’s decision in January.


US NIH Licence agreement signed Sept 2010.

In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.

ViiV Healthcare(GSK/Pfizer)


In negotiations. In negotiations. In negotiations. In negotiations. In negotiations. In negotiations.

23

Geographical Scope of Voluntary Licences

Pfize

r/Viiv

(MVC)

Abbott (

LPV/r)

Mer

ck (E

FV)

J&J (

ETR)

Bristo

l-Mye

rs S

quibb (d

4T, d

dI,...

Mer

ck (R

AL)

Roche

(SQV, N

FV)

J&J (

DRV)

GSK/Viiv

(AZT,

3TC

, ABC)

Boehrin

ger In

gelhei

m (N

VP)

Gilead

/Poo

l (EV

G)

Gilead

/Poo

l (COBI)

J&J (

RIL)

Gilead

/Poo

l (TD

F, F

TC)

NIH/P

ool L

icense

Object

ive

0

20

40

60

80

100

120

140

160

Uncertain TDF statusNo TDF patentHigh-income (HIC)Upper-middle income (UMIC)

Core Principles for Pool Licences

Patent Holder

s

Generics

Generics

Consultative Process

BoardEAG

Medicines Patent Pool

Patent

Holders

• Licenses are negotiated from a public health, pro-access perspective

• Licences are transparent - text of licences available on Pool website

• Significant improvement on the pre-existing situation for as many people living with HIV as possible

• Aim to include all low and middle income countries, including through the use of differentiated royalties according to income and disease burden

• Ensure that terms and conditions are consistent with the use of TRIPs flexibilities/Doha Declaration TRIPS and Public Health

• Raise the bar for licensing in the HIV field

• Manage licences with a public health focus

• Work with partners to promote the development of needed formulations

Achievements so far…

• Unprecedented transparency on what HIV medicines are patented in which countries

• Higher standard on number of countries covered by licences (but still long way to go)

• Recognition of importance of licensing compounds as early as possible (e.g. late-stage pipeline)

• Opening up of the market for generic tenofovir (key first-line ARV) in a large number of middle-income countries

• Right to supply countries issuing a compulsory licence included in licence (probably for first time)

• Unprecedented transparency in disclosing full text of licence

• Recognition of a new business model for ARV licensing, through an entity with a public health mandate 26

…but a long way to go

• Successfully negotiating public-health oriented licences with key flexibilities from more patent holders; pushing geographic scope with aim of all developing countries

• Contributing to opening up the markets for second-line and third-line ARVs

• Enabling the development of new fixed dose combinations that meet treatment needs

• Providing for greater diversification in manufacturing of ARVs (e.g. local production)

• Continue to change industry norms towards greater public health focus in licensing practices 27

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

medicines patent pool

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