Issues and Concerns on IP and Patent Information in the Field of Health Pascale Boulet, IP

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Issues and Concerns on IP and Patent Information
in the Field of HealthPascale Boulet, IP
Policy advisor Drugs for Neglected Diseases
Initiative (DNDi)
WIPO Open - Ended Forum on Proposed Development
Agenda Projects , Oct 14th, 2009
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Neglected Diseases - primarily affect
developing countries - lie outside the world
market
Global Diseases
Most Neglected Diseases
Neglected Diseases
World pharmaceutical market 712 bn in 2007
Source IMS Health, 26.2.2008
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Only 21 New Drugs Developed for Neglected
Diseases (1975-2004)
Tropical diseases 18
1.3
TB 3
Total 1,556
Tropical diseases and tuberculosis account for
12 of the global disease burden but only 1.3 of
new drugs developed.
Source Chirac P, Torreele E. Lancet. 2006 May
12 1560-1561.
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Product Development Partnerships (PDPs) Filling
the Gaps in Translational Research and Product
Development
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DNDi Created in 2003
7 Founding Partners
4 Regional Support Offices
1 Affiliate
Indian Council of Medical Research (ICMR)
Coordination team Geneva consultants
Kenya Medical Research Institute (KEMRI)
Malaysian MOH
USA
Oswaldo Cruz Foundation Brazil
India
Médecins Sans Frontières (MSF)
Kenya
Brazil
Malaysia
Institut Pasteur France
2 Project Support Offices
WHO/TDR (permanent observer)
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DNDi Objectives
Primary Deliver 6 - 8 new treatments by 2014
for leishmaniasis, sleeping sickness, Chagas
disease, malaria Establish a robust portfolio
for new generation of treatments Secondary Use
and strengthen existing capacity in Disease
Endemic countries Raise awareness and advocate
for increased public responsibility
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DNDi Portfolio-Building Model

• New lead compounds
• Existing compounds

• New formulations (fixed-dose combinations)
• New indications of existing drugs

• Completing registration dossier
• Geographical extension

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Projects Portfolio August 2009

• 2 HAT LO Consortium
• Scynexis
• Pace Univ

• Compound mining
• E.g. nitroimidazoles, macrolides
• Chemical classes
• E.g. GSK, Merck,
• Target-based
• E.g. Dundees Drug Discovery Unit (DDU),
• Screening
• E.g. natural products (Kitasato, Eskitis), new
  technology (Institut Pasteur Korea), DDU at
  Dundee,

Alternative formulations Amphotericin B (VL)
Fexinidazole (HAT)
NECT Nifurtimox - Eflornithine
Co-Administration Stage 2 HAT
Combination therapy (VL in Asia)
Nitroimidazole backup (HAT)

• Combination therapy (VL in Africa)
• Paromomycin
• AmBisome
• Miltefosine

• VL LO Consortium
• Advinus
• CDRI

Oxaborole (HAT)
ASMQ (Malaria) Fixed-Dose Artesunate/Mefloquine
Drug combination (Chagas)
Exploratory
Combination therapy (VL in Latin America) in
preparation

• Chagas LO Consortium
• CDCO
• Epichem
• Murdoch Univ

ASAQ (Malaria) Fixed-Dose Artesunate/ Amodiaquine
Paediatric benznidazole (Chagas)
Azoles (Chagas)
Exploratory

• 8-aminoquinolines in preparation (VL)
• Sitamaquine
• Tafenoquine

6 to 8 new treatments
Exploratory
Reference screening centres LSHTM, Swiss
Tropical Institute, University of Antwerp
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Vision

• A collaborative, patients needs-driven, virtual,
  non-profit drug RD organisation to develop new
  treatments against the most neglected
  communicable diseases

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Management of RD projects

• Identification of research opportunities that
  have the highest potential to be translated into
  improved treatment options
• Sourcing of the research project into DNDi
  portfolio
• Building of the full development plan
• Identification and contracts with appropriate
  partners for each step in the development process
• Management of the efficient advancement of the
  project throughout the RD pipeline

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Well-Balanced Partnerships (public/private)
October 2008
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DNDis needs for IP access

• DNDi developing drugs on the basis of
• public compounds and data - no access issue
• proprietary (patented) compounds access needed
• confidential data and know-how access needed
• Access negotiated through
• Material transfer agreements to enable testing of
  compounds
• Research and license agreements to manage access
  to pre-existing IP and ownership of new IP
  generated through research partnership

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Needs for access to patent information

• Usually addressed through research license
  agreements
• Unsure patent landscaping studies would provide
  insight into new research opportunities, besides
  scientific publications
• Need of freedom to operate analysis to ensure
  that there are no pertinent patents that would
  impact DNDi development of a candidate compound,
  that is, that DNDi is "free to operate" without
  risk of patent infringement

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Thank you!