Experiences in managing intellectual property in publicprivate partnerships for development of negle

1
Experiences in managing intellectual property
in public-private partnerships for development
of neglected health products

• Roy Widdus, Ph.D
• CropLife International Annual Conference
• Brussels, 2 June 2005

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Public-private partnerships in health

• Types of public-private partnerships for health
• Product development partnership (PDPs)
• Why and how PDPs manage intellectual property
  issues
• Access conditions
• Application of the PPP/PDP approach to other areas

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Components of the public and private sectors

• PUBLIC
• SECTOR
• Inter-Government Agencies
• - Government Agencies

CIVIL SOCIETY - Academia - Philanthropies -
NGOs, PVOs, etc - Other not-for-profits

• FOR-PROFIT
• ORGANIZATIONS
• - Pharmaceutical companies
• - Biotech companies
• Other health companies
• Non-health companies

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Collaborative relationships between public and
private sectors
Public sector
Public Sector Programs Private Sector
Participants
Govtl and Multi-lateral agencies
PPPs - Legally independent - Hosted by a CS NGO
A
Health sector companies including pharma
D
E
F
B
C
G
PPPs orchestrated by companies,
For-profit institutions
Civil Society (CS) NGOs
Private Sector
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Many people still lack access to essential drugs
Percentage of population with regular access to
essential drugs (1997)
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Impediments to new health product development
and delivery for neglected diseases
Ideal situation
Health system
Research
Product and manufacturing development
Regulation
Introduction strategies
Wide Appropriate use
Current reality
No planning for use in LMICs and initial cost
Unattractive return on investment for
commercial RD
Weak health services infrastructures
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Types of public-private partnerships for health

• Product development partnerships
• Partnerships for improving access to medicines
• Global coordinating and financing mechanisms
• Partnerships for strengthening health systems

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Trends in partnering
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PPPs addressing health product development and
delivery Current activities
Health system
Research
Product and manufacturing development
Regulation
Introduction strategies
Wide, appropriate use
Product development PPPs
Product delivery PPPs
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Existing global PPPs for health products

• Vaccines
• IAVI
• (SAAVI)
• MVI
• IDRI
• HHVI
• MVP
• Aeras/TB
• PDVI
• JEVI
• Diagnostics
• (TBDI)
• FIND

• Drugs
• MMV
• GATBDD/TB Alliance
• MSF-DNDi
• IOWH, etc
• Contraceptives
• CONRAD/CIICR
• Microbicides
• IPM, GMI, MDP
• Bed nets

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Product development partnerships

• Individual candidate projects
• Meningitis A Vaccine Project at PATH
• Multi-candidate/portfolio based
• IAVI, IPM, MMV, MVI, TB Alliance, Aeras, DNDi,
  etc
• These vary on many criteria
• - Legal status, etc

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Much PDP variation depends on choice of
product/disease focus

• Scientific challenge
• Repeat, significantly improve, first product in
  field, new class
• State of the field, scientifically vitality
• Availability of partners, extent of need to do
  it all
• Potential public health benefit (not just disease
  burden)
• Delivery context (exists /-, functions, public
  vs private)
• Hence, most of the operations/role variation is
  understandable
• (and probability of critical mass/success)

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MMV Portfolio 2004 Largest-ever Portfolio of
Antimalarial Drug RD
Accelerated Development Projects
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The win/win proposition

• MMV Gets
• Rights in DEC
• IPR in Field
• Drug Supply
• Return on non DEC Sales

• MMV Invests
• Background IPR
• Link to RBM
• Expertise

Public
Joint RD

• Pharma Invests
• Chemistry
• IPR
• Toxicology
• Know How
• Assets in Kind
• Technology
• Liability coverage

• Pharma Gets
• Rights in non DEC
• IPR outside Field
• PR Benefit
• HR Benefit

Private

• The deal is sustained by balancing
  incentives/costs for each partner

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Virtual RD is essentially project and portfolio
management through relationships and contracts
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PDP Funders

• Foundations
• Gates, Rockefeller, Wellcome Trust
• Bilateral aid agencies
• Other
• Industry in-kind

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Why PDPs need to manage IP?

• Acquiring right to develop candidate products
• In-licensing
• IP is generated from PDP investments
• Product patents, rare
• Proprietary data for regulatory application
• Process and use patents
• Technical know-how
• PDPs need to leverage their (funders) investments
  for their public health goal i.e., access for
  poor populations

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How PDPs handle intellectual property- sometimes
termed access conditions

• At product development stage
• In-licensing of IP owned by commercial
  collaborators
• Options to continue development
• Disposition of IP generated by PDP funding
• Leverage of PDP funding for distribution/supply
  stage
• At distribution/supply stage
• Provisions for supply
• Pricing approaches e.g., at cost, cost plus,
  and volumes
• Markets/countries to receive preferential prices
• Disposition of IP generated, and sometimes
  agreements for technology transfer
• Paper by Anthony Taubman for IPPPH has an
  extensive review
• Report from IPPPH/MIHR consultation in late 2004
  updates that report

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PDPs, IP management and access to medicines

• Intellectual property protection in itself is not
  an incentive to innovation
• Investment in product development or
  manufacturing requires a potential purchaser
• Creating a market is important
• Where IP plays a role it is typically not the
  basic patent that is of highest concern but the
  IP from investment of resources/skills that are
  needed for actual proof of product utility
• Unproven patents are of little value
• Many things beyond IP are important in
  determining access to medicines
• There has been an imbalance in knowledge of IP
  management but PDPs are playing by the rules
  and becoming competent in handling IP
  negotiations professionally

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UN Millennium Development Goals 2000

• Eradicate extreme poverty and hunger
• Achieve universal primary education
• Promote gender equality and empower women
• Reduce child mortality
• Improve maternal health
• Combat HIV/AIDS, malaria, and other diseases
• Ensure environmental sustainability
• Develop a global partnership for development

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New Types of PDPs for the poor

• Global Alliance for Livestock Vaccines
• Pesticide development
• Expression of natural products for medical uses
  (Malaria)
• Drought tolerant crop initiative
• For subsistence farmers
• maize, rice, other crops