chan park presentation, 25 july 2012

Addressing Innovation and Access Through Voluntary Licensing: The

Medicines Patent Pool

Chan Park Washington, D.C.

25 July 2012

Patenting of ARVs in developing countries has increased over recent years

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0

4

8

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Albania Arm

enia Bosnia and H

erzegovina EAPO

(9 countries) G

uatemala

Honduras

Jordan Lithuania M

oldova M

ongolia Panam

a Vietnam

Colom

bia India Indonesia Kyrgyzstan M

orocco N

icaragua Peru Tajikistan Egypt G

eorgia Sri Lanka U

zbekistan Algeria Brazil Chile M

alaysia U

kraine U

ruguay O

API (16 countries) Thailand ARIPO

(18 countries) China M

exico Pakistan Russia Argentina Philippines South Africa TO

TAL possible N

umbe

r of

ARV

s fo

r w

hich

ba

sic

pate

nts

wer

e so

ught

Pre-1995 ARVs 1995 and later ARVs

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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55

60

65

70

75

Num

ber

of t

erri

tori

es

Basic patent filed, under appeal, designated under international agreement, opposed

Basic patent granted

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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Secondary patent filed, under appeal, designated under international agreement, opposed Secondary patent granted Basic patent filed, under appeal, designated under international agreement, opposed Basic patent granted

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 Transi3on for Developing Countries

TRIPS Transi3on 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 Exis/ng 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 Holders Generics

Bilateral Licences

Core Principles for Pool Licences

Generics

Consultative Process

Board EAG

Medicines Patent Pool

Patent Holders

Pool Licences •  Licenses nego3ated from a public health, pro-‐access perspec3ve

•  Improvement for as many people living with HIV in LMICs as possible

•  Ensure terms and condi3ons are consistent with the use of TRIPs flexibili/es

•  Improving industry norms for voluntary licensing

•  Manage licences with a public health focus

•  Work with partners to promote the development of needed formula3ons

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


Invite relevant patent holders to

negotiate

Negotiate public health-oriented

licences Sign 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


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


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



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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.



negotiate




"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 par/cular country. The patent status database is an incredibly useful resource as it provides the most comprehensive pool of the available informa3on 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

par3cular 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 informa/on from numerous patent registries and jurisdic/ons into an easily navigable resource available to the public.” -‐

UNICEF “In the midst of a current patent regime that is at 3mes 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] ul/mately allow[s] us to focus more of our energy into the actual delivery of HIV medicines to the ones who need it.”

IDA Founda1on

"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

AbboX Laboratories

Sent le_er on 1 December

Not currently in nego3a3ons. Reply received 26 January.

Not currently in nego3a3ons.

Not currently in nego3a3ons




Boehringer-‐Ingelheim




In nego3a3ons. In nego3a3ons. In nego3a3ons.

In nego3a3ons.

Bristol-‐Myers Squibb




In nego3a3ons. In nego3a3ons. In nego3a3ons.

In nego3a3ons.

F. Hoffman-‐La Roche


Preparing for nego3a3ons.

In nego3a3ons. In nego3a3ons. In nego3a3ons. In nego3a3ons.

In nego3a3ons.

Gilead Sciences Sent le_er on 1 December

In nego3a3ons. Reply received 14 February

In nego3a3ons. Licence agreement signed July 2011.

Licence agreement signed July 2011. Amended in November 2011.



Merck & Co. Sent le_er on 1 December







Tibotec/J&J Sent le_er on 1 December

Not currently in nego3a3ons. Reply received 31 January



Not currently in nego3a3ons. J&J’s decision received in December.

Not currently in nego3a3ons. Pool responds to J&J’s decision in January.


US NIH Licence agreement signed Sept 2010.

In nego3a3ons. In nego3a3ons. In nego3a3ons. In nego3a3ons. In nego3a3ons.

In nego3a3ons.

ViiV Healthcare (GSK/Pfizer)


In nego3a3ons. In nego3a3ons. In nego3a3ons. In nego3a3ons. In nego3a3ons.

In nego3a3ons.

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Geographical Scope of Voluntary Licences

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Low-income (LIC) Lower-middle income (LMIC) Upper-middle income (UMIC) High-income (HIC)



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Pool Licences

# of

cou

ntri

es

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



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MPP’s Post-Licensing M&E Process

Decision Point

Licensing Step

Reporting Step

Only 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



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…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



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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

chan park presentation, 25 july 2012

Documents

india patent

patent expiry

developing countries

arvs post

patent barriers unaidsundp

countries trips transi3on

later arvs source

trips agreement