Update on the Medicines Patent Pool

Sandeep Juneja

November 06, 2012

• The Pool seeks public health oriented

licences that take into account

legitimate interests of all parties

• Improvement over status-quo

• Using its IP & legal expertise, the Pool

aims to continually improve existing

agreements and sign new and better

agreements. It strives to:

o Include as many low and middle

income countries as possible

o Promote terms that maximise

public health benefits and

ensure lowest sustainable cost

for quality medicines in as many

countries as possible

• Funded by UNITAID

• Operational since end-2010

Pool

Royalties

Licensors

Patents

Sub-

Licensees

Out-

Licenses

License

Management

by the Pool

Product

introductions

Market Impact

Feedback

How the Pool works*

* Generalized schematic; may be different for specific licenses

The Pool is an innovative licensing mechanism

for HIV medicines

2

Ensuring access in the

changing ARV patent landscape

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

Support to the Pool from key stakeholders

in global health

4

National Health

Organizations and

Communities

Global Health

Organizations

Generics

Companies

Donor

Agencies

Originator

Companies

“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

“The Medicines Patent Pool has potential to support

access to more appropriate and affordable ARVs in

developing countries by setting incentives for product

adaptation and generic production. We will encourage

the pharmaceutical sector to engage actively with the

Medicines Patent Pool to support the availability of

more appropriate and affordable ARVs.”

- Towards zero infections: The UK’s

position paper on HIV in the

developing world, May 2011

“We welcome the Patent Pool Initiative launched by

UNITAID in order to facilitate production of affordable

generic medicines well-adapted for use in resource-poor

settings, and we invite the voluntary participation of

patent owners, private and public, in the project.”

– Group of 8 Declaration, G8

Summit of Deauville, France,

May 2011

Support to the Pool from key stakeholders

in global health(2)

5

“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, Global Fund

Partnership Forum, June 2011

“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, June 2011

“We think that the Medicines Patent Pool is an

important initiative towards achieving universal access

to the newer HIV medicines… At WHO we will be

pleased to give priority to any of the newly developed

FDCs for assessment by our WHO / UN Prequalification

Programme in order to facilitate its rapid uptake by the

funding agencies and national governments.”

- Hans V. Hogerzeil, former

director, WHO Essential Medicines

and Pharmaceutical Policies,

October 2010

“UNAIDS strongly encourages other antiretroviral patent

holders to establish agreements with the Pool, and for

generic manufacturers to utilize the licenses that the

Pool can facilitate to expand access to antiretroviral

treatment.”

- Paul De Lay, Deputy

- Executive Director,

- UNAIDS, October 2011

“The Medicines Patent Pool offers a way forward that could work for both people living with HIV and for companies…

where patents exist, the Pool is a way to manage them so that public health goals are still achieved, and people living

with HIV are not barred from getting the medicines they need.”

NEPHAK, Press Release, December 2011

Licensing-in

•US NIH

•Gilead Sciences Concluded

•Boehringer Ingelheim

•Bristol Myers-Squibb

•F. Hoffman-La Roche

•Viiv Healthcare

In negotiations

•Abbott Laboratories

•Merck & Co

•Tibotec / Johnson & Johnson

Not in Negotiations

Licensing-out: Gilead products

Aurobindo

Cobicistat

Elvitegravir

Emtricitabine

Quad

Emcure

Cobicistat

Elvitegravir

Emtricitabine

Quad

Hetero

Cobicistat

Elvitegravir

Emtricitabine

Quad

Laurus

Cobicistat

Elvitegravir

Emtricitabine

Quad

Tenofovir

Medchem

Cobicistat

Elvitegravir

Emtricitabine

Quad

Tenofovir

Licensing processes

to ensure market impact

8

Sign in-

licences

Review

Expression of

Interest forms

from generics

Negotiate out-

licences

Sign out-

licences

Conduct

technology

transfer

Reporting step

Licensing step

Only as required

Monitor WHO PQ,

USFDA, SRA

approval status

Monitor in-

country

registration

status

Progress reviews

Kick-Off generic

collaboration

Dispute

resolution Assess impact

Collect & report

market feedback

Monitor royalties

1

2

3

Phase 1: Out-licensing

Phase 2: Development

Phase 3: Commercialization

Status of Gilead licences

9

Sign in-

licences

Review

Expression of

Interest forms

from generics

Negotiate out-

licences

Sign out-

licences

Conduct

technology

transfer

Reporting step

Licensing step

Only as required

Monitor WHO PQ,

USFDA, SRA

approval status

Monitor in-

country

registration

status

Progress reviews

Kick-Off generic

collaboration

Dispute

resolution Assess impact

Collect & report

market feedback

Monitor royalties

1

2

3

Phase 1: Out-licensing

Phase 2: Development

Phase 3: Commercialization

✔ ✔ ✔

✔

✔

✔

Further developments on the Gilead licence

10

Added amendments to improve current agreement

1. Included South Sudan

2. Incorporated language based on CS feedback:

a) clarified covenant “not to sue” on FTC post TDF termination

b) clarified Gilead’s position on Compulsory Licences

3. Waived the Pool’s administrative fee

Started technology transfer

• Cobicistat/Elvitegravir: API technology transfer to Pool licensees accomplished

• Quad: formulation technology transfer to follow

• FTC process improvement: shortly

Earned LES “Deals of Distinction” Award 2012

• Gilead & NIH licences with MPP awarded “deals of distinction” by the Licensing Executives

Society – USA & Canada

Expression of Interest process

11

Potential Licensees

• An Expression of Interest (EOI) process to enable potential licensees to seek licences online has

been designed and is being implemented

• The EOI process includes details such as

• Capabilities in R&D and manufacturing

• Product development plan and strategy

• Regulatory timelines

• Fitment of the product in the overall ARV/business strategy

• The Pool aims to fairly offer sub-licences to all qualified generics manufacturers while exercising

due care and diligence to not undermine stability of the generic ARV market

Working paper, updated

annually; Preview of the 2012-

update outcome alongside; full

paper out shortly - comments

will be welcome. Watch out at:

http://www.medicinespatentpo

ol.org/licensing/target-

medicines/

Compounds with (*) are pipeline compounds

Priority products for the Pool

• Most complete single

source of ARV patent

status data

• Covers 24 compounds

in 78 countries

• Searchable by

compound and by

country (or region)

• To be regularly

updated

• Starting point for

more thorough

searches

Patent status database

Thank You

www.medicinespatentpool.org