Access to Medicines

Global Health Policy Forum

EU Commission – DG RTD April 2016

Thomas Bombelles

Head, Global Health

Buruli Ulcer Lymphatic filariasis

Chagas disease (American

trypanosomiasis)

Onchocerciasis

Cysticercosis Rabies

Dengue/dengue hemorrhagic fever Schistosomiasis

Dracunculiasis (guinea-worm disease) Soil transmitted helminthiasis

Echinococcosis Trachoma

Endemic treponematoses (Yaws) Podoconiosis

Foodborne trematode infections Snakebite

Human African trypanosomiasis Malaria

Leishmaniasis Tuberculosis

Leprosy

21 NTDs and conditions, malaria & TB

What is WIPO Re:Search?

• Platform for sharing IP assets and resources in order to catalyze

research and development on NTDs, malaria, and tuberculosis

• “Beyond Patents”: shared IP assets and resources include pharmaceutical

compounds, technologies, know-how, data, research facilities, hosting

arrangements, etc.

• Emphasis on voluntary collaborations – Providers only advertise and

make available assests that they are willing to share.

How does it work?

• Members upload assets and resources onto the searchable, public WIPO

Re:Search database

• Partnership Hub administrator actively facilitates specific

collaborations between WIPO Re:Search Members

• Supporting services include sabbaticals / hosting arrangements, access to

WIPO resources, training and distance learning, access to journals and

publications, technical advice from WHO, targeted recruitment of new Users

and Providers, etc.

WIPO BVGH WHO Companies Research Institutes

Academics

Who is involved?

Who are WIPO Re:Search Members?

• Providers: contribute IP

and resources

• Users: utilize contributed

IP and resources in their

neglected disease

research

• Supporters: support

Consortium’s mission,

activities, and objectives

Members represent 100+ for-profit, government,

academic, and nonprofit research organizations

Funding members

Alnylam Pharmaceuticals

California Inst of Tech

Center for World Health & Medicine

Eisai Pharmaceuticals;

Takeda

Fundacao Oswaldo Cruz (FioCruz)

GlaxoSmithKline (GSK)

Infectious Disease Research Institute (IDRI)

iThemba Pharmaceuticals

Kenyan Agricultural Research Institute (KARI)

Kumasi Centre for Collaborative Research (KCCR)

Liverpool School of Tropical Medicine

Mass. Inst of Technology (MIT)

McGill University

Merck (MSD)

National Center for Genetic Engineering and Biotechnology (BIOTEC)

Northeastern Univ.

Novartis

PATH

Pfizer

Sanofi

South African Medical

Research Council

Stanford University

Swiss Tropical and Public Health Institute

Univ. of Buea, Cameroon

Univ of Cal--Berkeley

Univ. of Dundee

Univ of Washington

National Institutes of Health (NIH)

Walter Reed Army Inst. of Research

(WRAIR)

Anacor Pharmaceuticals

Univ. of Kansas

International Vaccine Institute (IVI)

GALVmed

Sabin Vaccine Institute

Univ of Calgary

Univ of Cal—San Francisco

Africa Fighting Malaria

Assoc. of Univ Tech Managers

(AUTM)

BIO

Indian Council for Medical Research

International Federation of Pharma Manufacturers & Assoc.

(IFPMA)

Kenya Medical Research Institute (KEMRI)

Mahidol University

Tech Transfer Summit Ltd

US Patent & Trademark

Office (USPTO)

Theodor Bilharz Research Institute; Bibliotecha Alexandrina

Emory Univ.

Massachusetts General Hospital Drugs for Neglected Diseases

initiative (DNDi)

Medicines for Malaria Venture (MMV)

Seattle BioMed

Public Interest Intellectual Property Advisors (PIIPA)

National Inst. of Industrial

Property (INPI) Africa Inst. of Biomedical Science &

Technology (AiBST)

World Health Organization

Centre for Malaria Diagnostics (ANDI)

Foundation for Innovative New Diagnostics (FIND)

Eskitis Institute at Griffith University

University of Edinburgh 104 (April 2016)

WIPO Re:Search Members

60 Degrees Pharmaceuticals

Aberystwyth University

Africa Fighting Malaria

Guiding Principles: Ensuring access

WIPO Re: Search Guiding Principles, page 3

“Providers agree to grant Users royalty-free licenses to this Intellectual Property for research and development, anywhere in the

world, of products, technologies or services, for the sole purpose of addressing public health needs for any or all NTDs in LDCs. …

to make or have made such products, technologies or services, and to import and export….”

“Consider in good faith the issue of access to these products for all developing countries, … taking into account the economic

development of the countries and the need to facilitate access to disadvantaged populations.”

“Users shall be allowed to retain ownership of and apply for registration of intellectual property rights generated as they deem fit,

but shall be encouraged to license to third parties through WIPO Re:Search new intellectual property rights generated under an

agreement made pursuant to membership in the Consortium under terms consistent with these Guiding Principles.”

“For the avoidance of doubt, Providers will not make any claims to rights in new intellectual property, materials or derivatives of

materials generated by a User under a license agreement made pursuant to membership in this Consortium, but may require such

User not to assert such new intellectual property rights against the Provider.”

Руководящие принципы

Principes directeurs

基本指針

Principios Rectores

Princípios Orientadores

指导原则

Richtlinien

مبادئ توجيهية

Licensing Terms

• Royalty-free for research, development and manufacture anywhere in

the world.

• Royalty-free sales of resulting products in all LDCs.

• Consider in good faith the granting of a license for sales in all developing

countries, taking into consideration the economic development of the

countries and the need to facilitate access to disadvantaged populations.

• Licensees allowed to retain ownership of new IP and are encouraged to

license to third parties through WIPO Re:Search.

• No reach-through claims to new IP, materials or derivatives of materials

generated by licensee, but licensor may ask for a non-assertion to such new

IP.

Examples of WIPO Re:Search Agreements 100 (April 2016)

Partnering across the globe

Basic

Research

Discover

y

Target ID

Target

validation

Screenin

g

Hits ID

Dose

Respons

e

Optimizat

ion

Pre-

clinical

Clinical

Malaria

Tuberculosis

Schistosomias

is

Human

African

Trypanosomia

sis

Leishmaniasis

Diarrheal

Disease

Soil-

transmitted

helminthiasis

Chagas

disease

Dengue fever

Onchocersiasi

s

Buruli ulcer

Lymphatic

filariasis

Fungal

disease

WIPO Re:Search Pipeline

Dr Cho-Ngwa, River Blindness Researcher from

Cameroon

“I see this as an opportunity not

only to gain invaluable experience

and knowledge from a world-class

company like Novartis, but to

develop relationships that I can

leverage to advance my research

upon my return” – Fidelis Cho-

Ngwa, University of Buea,

Cameroon

http://www.ow.ly/wJNzF

Partnership Stories: Sabbaticals

Patents and WHO MLEM – Clarifying

the Debate on IP and Access

2016 WIPO Study confirms, 95% of the drugs on the

MLEM are off-patent.

The remaining 5% of medicines (20 drugs) under patent

protection are largely for antivirals (especially HIV), but

also for non-communicable diseases (HCV, oncology)

and others.

The percentage of developing countries covered by each

of the 20 patent portfolios varies widely from less than

1% to 44% with a median of 15%.

Patents and WHO MLEM – Clarifying

the Debate on IP and Access

Patents for essential drugs appear more commonly in

higher income countries with larger populations where

there are relatively more market and manufacturing

opportunities.

Patent transparency is critical to addressing access

concerns for essential medicines.

Patent Landscape Report on

Neglected Diseases

Human African Trypanosomiasis, Chagas Disease,

Leishmaniasis, Onchocherciasis and Lymphatic

Filariasis

Prepared for:

World Intellectual Property Organization at the Request

of DNDi

Prepared by: Landon IP February, 2016

Thank you.

Additional information:

thomas.bombelles@wipo.int

www.wipo.int