Addressing Innovation and Access Through Voluntary Licensing: The Medicines Patent Pool

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 A

RVs

for

whi

ch

basi

c pa

tent

s w

ere

soug

ht

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

Num

ber

of t

errit

orie

s

Patent pending in IndiaPatent 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, opposedSecondary patent granted Secondary patent filed, under appeal, designated under international agreement, opposed

Num

ber

of t

errit

orie

s

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

sGeneric

s

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

11

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


Level 1 PrioritiesAtazanavir (ATV) High HighDolutegravir (DLG)*

High High

Cobicistat (COB)* High HighElvitegravir (EVG)* High HighLopinavir (LPV) High HighRilpivirine (RIL) High MediumRitonavir (RTV) High MediumEfavirenz (EFV) High MediumTenofovir (TDF) High MediumEtravirine (ETV) Medium HighRaltegravir (RAL) Medium HighAbacavir (ABC) Medium MediumDarunavir+ Medium Medium

Compound Clinical Priority


Level 2 PrioritiesLamivudine (3TC) High LowNevirapine (NVP) High LowZidovudine (AZT) High LowEmtricitabine (FTC) Medium LowLevel 3 PrioritiesFosamprenavir (FPV)

Low High

Maraviroc (MVC) Low HighDidanosine (ddI) Low MediumSaquinavir (SQV) Low Medium

* Indicates pipeline product



negotiate




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 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




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.

15



negotiate




Geographical Scope of Voluntary Licences

Pfizer/

Viiv (

MVC)

Abbo

tt (LPV

/r)

Merck (

EFV)

J&J (ETR

)

Bristo

l-Myer

s Squi

bb (d4

T, ddI

, ATV

)

Merck (

RAL)

Roche

(SQV, N

FV)

J&J (DRV)

GSK/Vi

iv (AZT

, 3TC

, ABC)

Boeh

ringe

r Ingel

heim (N

VP)

Gilead

/Pool (

EVG)

Gilead/

Pool (C

OBI)

J&J (RIL)

Gilead

/Pool (

TDF, F

TC)

NIH/Pool

Licen

se

Objecti

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



negotiate




Pool Licences

# o

f cou

ntrie

s

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



negotiate




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



negotiate




…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



negotiate




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

Addressing Innovation and Access Through Voluntary Licensing: The Medicines Patent Pool

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