1011 - INRUD

inrud.org

1011 - INRUD

Anthony D. So, MD, MPA, Quentin Ruiz‐Esparza, Eric Giannella,

Cecilia Oh, and Pascale Boulet

Program on Global Health and Technology Access

Sanford School of Public Policy, Duke University, United States

ICIUM, Antalya, Turkey

November 16, 2011

Supported in part under

NIH/NHGRI grant

R01‐HG0003763


Malaria Vaccine Initiative:

Example of Potential Patent Thicket

All priority

patents

Original

distribution of

patents

Distribution of

patents at time of

landscape analysis

167 patent

families

27 (69%) originally

held by public

organizations

8 (21% of total) still

available for license

from public holder

19 (48% of total)

39 priority patents made unavailable lbl

for licensing

12 (31%) originally

held by private

organizations

Shotwell SL. Patent Consolidation and Equitable Access: PATH’s Malaria Vaccines.2007


Pooling Across Value Chain of R&D

Patents and

Licensing

Proprietary

Exclusive license

Non‐proprietary

Non‐exclusive license

Material

transfer

Data

sharing

Negotiated access

to private

compound

libraries

Negotiated

access to

proprietary data

Public repository of

compounds

Open access database

“Copyleft” rules

Publication

Traditional

subscriber paidaccess

journal

Open access

repositories and

journals


Tiering Arrangements for Pools

Paying market

Resource‐limited

market


Tiering by Disease

Neglected diseases

based on FDA

Priority Voucher list

TB

Malaria

Cholera

Trachoma

Buruli Ulcer

Fascioliasis

Trypanosomiasis

Schistosomiasis

Dracunculiasis

Onchocerciasis

Soil-transmitted helminthiasis

Lymphatic Filariasis

Leishmaniasis

Leprosy

Dengue

Pool for Open Innovation

Yaws

Against Neglected Tropical Diseases

Neglected

diseases

defined by WHO

Rabies

Cysticercosis

Echinococcosis

Chagas

WIPO Consortium’s

Re:Search


Tiering by Country

Income Status

Global distribution for three neglected tropical diseases (NTD),

divided by least developed countries and all other countries

Trypanosomiasis Leishmaniasis Chagas disease

Deaths* DALYs* Deaths** DALYs* Deaths* DALYs*

Total 47,717 1,523,587 51,094 2,086,725 14,414 658,215

LDC†

34,673 1,090,075 7,774 342,266 0 12,678

Non-

LDC† 13,044 433,512 43,320 1,744,458 14,414 645,536

% in

LDC 73% 72% 15% 16% 0% 2%

*World Health Organization Department of Measurement and Health Information December 2004

World Health Organization. Department of Measurement and Health Information. December 2004.

†UN Conference on Trade and Development. The Least Developed Countries Report. 2009.


Status of GSK pool patents

in LDCs

82 patent families

(100%)

65 families with

8 families with

no current or

pending WO

prospective LDC applications

filings (79%) (10%)

9 patent families

with LDC filings

(11%)

Source: GlaxoSmithKline, 2009.


Tiering Access to AIDS Drugs

Gilead (TDF, prior to Gilead-MPP agreement)

Extent of coverage for different tiering criteria

For AIDS treatment

Levels of coverage under different tiering schemes

Bristol Myers-Squibb

Merck (TDF/FTC/EFV)

Abbott

Gilead-MPP Agreement: TDF

Gilead-MPP Agreement: COBI

Gilead-MPP Agreement: EVG and Quad

The 15.2 Million Person Gap

0 5 10 15 20 25 30

No. of people living with HIV

• Access under Bristol-Myers Squibb Category 1 tiering arrangement: 11.0 million

• Access under Gilead Category 1 tiering arrangement: 26.2 million

• Access under Merck Category 1 tiering arrangement: 23.1 million

• Access under Abbott Category 1 tiering arrangement: 22.4 million

• Access under the Gilead-MPP Agreement for TDF: 26.4 million

Data Source: UNAIDS


The “Shift” of Disease Burden from Low‐ to

Middle‐Income Countries

Global distribution of NTD burden* by

Global distribution of NTD burden* by

2002 country income classification** 2009 country income classification**

7,000

7,000

DAL LYs (,000)

6,000

5,000

4,000

3,000

2,000

Non‐LIC

LIC

DALY LYs (,000s)

6,000

5,000

4,000

3,000

2,000

Non‐LIC

LIC

1,000

1,000

0 0

*World Health Organization. Department of Measurement and Health Information. December 2004.

**World Bank. World Bank national accounts data, and OECD National Accounts data files. 2010.


Evolving Patent Pooling for

Neglected Diseases

Research

Commons

GSK‐proposed

Patent Pool

Traditional

Patent

Pool

Trusted, Third

Party

Intermediary


A Pool for Neglected Diseases

PUSH

POOL

PULL

OPEN SOURCE

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