Science With Africa

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Towards Global Access the Intellectual Property
Management Strategy of the Pharma-Planta
Consortium

• Science With Africa
• Addis Ababa
• 3-7 March 2008
• Harry Thangaraj
• St Georges University, London
• Pharma-Planta Consortium

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Molecular farming the production of recombinant
pharmaceutical or industrial proteins in
plants. An unprecedented opportunity to produce
valuable molecules economically and on a massive
scale.
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Proofs of concept for recombinant Plant Made
Pharmaceuticals
Monoclonal antibodies Streptococcus mutans
Non-Hodgkins lymphoma (x12) Tumour antigens
HIV Rabies Vaccine antigens Hepatitis B sAg
E. coli LT Norwalk virus capsid Tetanus
toxin C fragment Measles H Rabies G Respiratory
syncytial virus F Newcastle disease
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Pharma-PlantaAn EU Framework 6 Integrated
Project (IP)
2004 - 2009 12M Euros of public
funding Recombinant Pharmaceuticals from Plants
for Human Health
39 Principal Investigators 28 Academic
Institutes, 3 SMEs
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Project Objectives
www.pharma-planta.org
1. To build a plant based production platform for
pharmaceuticals relevant to both European and
global markets.
2. To produce important therapeutic molecules in
transgenic plants, that will be developed through
regulatory requirements, GMP, pre-clinical
toxicity testing and Phase I human clinical trials
3. A commitment to humanitarian use by the poor
in developing countries. Includes ensuring both
product and technology access with maximal
affordability in mind.
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Development of pharmaceuticals in GM plants
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Target Molecules (examples)

• Human Immunodeficiency Virus (HIV)
• p24, nef, tat antigens and the neutralising mAbs
  C2F5 and C2G12
• TuberculosisESAT-6 and Ag85B
• Rabiestwo neutralising human monoclonal
  antibodies
• Diabetes
• human glutamic acid decarboxylase GAD65

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Product Development and IP

• IP (mainly patents) is a key tool to facilitate
  translation of bench research
• Licensing of IP is often essential to facilitate
  product and process development through
  partnerships and/or negotiations with the
  industrial sector

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Altruism vs. control freakery

• IP is all about monopolies BUT
• Monopoly can be used for the public good
• Control is often necessary for delivering new
  medicines (patent your own inventions)
• The right licensing negotiations and terms can
  ensure access at affordable prices to poorer
  populations
• Differential pricing
• Geographically limited exclusivity
• Geographically limited patenting
• Field of use/Humanitarian use exemption
• Licensing to companies in IDCs (lowering cost of
  production affordable access in local markets.

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Principles

• Access Affordability Adoption
• Statement of humanitarian intent IP generated
  to be freely available to promote access for
  populations in need
• Cross partner access to IP to meet humanitarian
  objectives
• Negotiating patent thickets and in-licensing

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Principles

• Actively work with developing country partner
  (CSIR) to transfer technologies
• Active negotiation with industry
• Patenting to control downstream development
• Actively engage with individual institutional
  TTOs.

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Patent thickets

• Freedom to operate (FTO) analysis
• Full evaluation of IP of patent thickets
  applicable to each technology in order to aid
  market/commercialisation decisions
• Comprehensive searches of prior art and patent
  databases
• Geographical coverage legal status claims
  analysis

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Patent thickets

• However
• Global health product developers (example PDPs)
  are encountering some difficulties accessing
  available tools and achieving FTO
• IP assembly is becoming increasingly complex due
  to fragmentation of rights

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Fragmentation of IP rights

• Multiple players involved in all areas of key
  biotechnology
• IP rights spread across these multiple players.
• Fragmentation of rights makes it difficult for a
  single institution can provide its commercial
  partner with a complete set of IP rights to
  ensure FTO

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What enables FTO?

• FTO can be enabled through the diligent process
  of analysing and then assembling all the
  background IP rights that are associated with
  materials and processes - to deliver a
  specific product (or technology) for a specific
  use.
• In-licensing and negotiation with right holders
  are crucial elements of FTO
• Assembly of such rights translate into a package
  of permissions and licences enables market entry
  through a commercial partner.

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Necessity of using 3rd party patented technologies

• If I have seen further, it is by standing on the
  shoulders of giants Sir Isaac Newton
• Limited potential for inventing around to
  bypass IPRs in complex biotechnological
  innovation

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Step-wise FTO Evaluation

• FTO review - comprehensive documentation of all
  IP and licences that involves every single
  component of each technology
• Materials, methods, including methods of
  transforming cells, plus all DNA elements
  promoters, terminators, vectors, sequences for
  homologous recombination etc.
• Result of analysis (eg) 7 licences may be
  required for production of a single HIV-1
  neutralising MoAb in maize

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Later stages

• Negotiate in-licences when appropriate in order
  to complete a full FTO assembly
• Identify appropriate commercial partners after
  demonstrating due diligence in FTO assembly of IP
  rights