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Latin American Consortium on Biotechnology IP

Latin American Consortium on Biotechnology IP. E. Richard Gold Director, Centre for Intellectual Property Policy. Outline. Origin Problematic Areas of activity Future. Origin. Formed in 2005 at Montreal IPMG workshop with policy-makers from the Americas

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Latin American Consortium on Biotechnology IP

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  1. Latin American Consortium on Biotechnology IP E. Richard Gold Director, Centre for Intellectual Property Policy

  2. Outline • Origin • Problematic • Areas of activity • Future

  3. Origin • Formed in 2005 at Montreal IPMG workshop with policy-makers from the Americas • Initial participation from Argentina, Brazil, Cuba and Peru with Venezuela joining later • Will hold 2nd meeting after this workshop

  4. Problematic • Latin America and the Caribbean enjoy several advantages • Biodiversity • Possess strong research centres • Peaceful and friendly relations between countries • Share common approaches to biosafety, biodiversity and IP

  5. Problematic • The region lacks, however, important inputs • Lack skills and capacity in managing IP • Financial resources necessary to develop innovation and seek and maintain IP protection internationally

  6. Problematic • IP both over and under-protected • Under protected in that opportunities to develop local industry and solve local problems are missed • Over-protected in that cooperate less than even countries with longer history of strong IP protection

  7. Areas of activity • Initial members of consortium felt that priority for regional cooperation should be on biotechnological innovation rather than issues of traditional knowledge • Focus on non-legislative, informal cooperation

  8. Areas of activity • Two central missions to consortium • Capacity-building in IP and IP management in the region • Creation of model agreements to facilitate inter-institutional and regional research cooperation • Prepared Agreement between the various institutional partners and seeking more

  9. Future • Identify governmental science and technology policy institutions to join • Identify regional academic researchers and partners • Complete audit of existing capacity building initiatives in the region and identify opportunities for regional courses

  10. Future • Complete audit of national IP laws • Prepare model agreements that take into account the differences within the region to facilitate research • Obtain funding to undertake work • Identify manager to move project forward

  11. Need for PDV vaccine • 1992: WHO sets goal to integrate Hep B vaccination in all vaccine programs by 1997 • By 2001, 126 countries (~66%) have Hep B vaccine programs • The main reason is cost ($1.50-$2.70) • Demand ~500 M doses / yr WHO 2002. WHO Vaccine Preventable Diseases Monitoring System: 2002 Global Summary. Document No. WHO/V&B02.20

  12. Vaccine Funding Gap http://www.vaccinealliance.org/site_repository/resources/fundinggap_0204.pdf

  13. Chronic Hepatitis B INDIA • ~1 B people • 20 – 70,000,000 chronically infected • Biotechnology capacity • Appropriate regulations http://www.cdc.gov/ncidod/diseases/hepatitis/slideset/hep_b/slide_9.htm

  14. Arizona BioDesign & ProVacs • 1990 Strep mutans sAG produced in tobacco • 1992 Hep B subunit sAG in tobacco via A.t. • 1995-2000 oral immunogenicity demonstrated for PDVs • 1999 Phase 1 clinical trials • 2004 Phase 2 clinical trials http://www.azbio.org/centers/vaccines.html Charles Arntzen

  15. Question What strategy for deploying this technology ought be adopted to ensure that PDVs can be used in India in a manner which is sustainable from a business standpoint, mindful of intellectual property issues, compliant with existing regulations, while ensuring the highest level of access to Indian citizens?

  16. Production

  17. Regulation

  18. Regulatory Categories INDIA Cost Delay Uncertainty Production Considerations Intellectual Property Seeds and Genetic Materials Cultivation Manufacturing Product Approval US Cost Delay Uncertainty

  19. APS 2 APS 1 Case studies Sales Production Sales Production Rate_Production Rate_Sales Rate_Production Rate_Sales Rate_Investment Rate_Investment GDP GDP RD_Invesmtent RD_Invesmtent Rate_GDP Rate_GDP Rate_Expenditures Rate_Expenditures Data collection Influence diagram RD_Invesmtent Domain map Rate_Investment Rate_Expenditures Sales Production Rate_Production Rate_Sales Rate_Project Rate_Scientific_To_Technical Scientific_Knowledge Technical_Knowledge GDP Rate_GDP APS 3 Rate_Products_Or_Processes Sales Delay_Expiration Production Rate_Production Rate_Sales Rate_Investment Delay_Innovation GDP RD_Invesmtent Rate_GDP Innovations Rate_Expenditures Licenses Patents Delay_Patents_Pool Rate_Patents Rate_Licenses Rate_Expiration Delay_Protection Patents_Pool Data Simulation model Rate_Patents_Pool collection IPMG Platform

  20. h S t T l a Economic e Revenues v w n Business capabilities, licensing efficiency i e , f n r , o u r e i t t c h u u b t o r i n t r s v t Knowledge o s a n Innovation, technology transfer org, early $, basic $ i i d r t i a management f n f h v , i o h t l a l n a t l Licensing, formal diff of knowledge, education/training/degree a c n e w e i I t w i l o e Media activiy , s p , e e s e r f u o g u n e y Revenues, public opinion awarness n e d t e v i / l e g v Patent value, exclusionary value, value IP i b e n r e a e r i , r n Sales, revenue, public op awareness s Innovation t S u d , e Exclusionary value, award of patent s i a a t e c management l a r r u Innovation, technology transfer org t l a S t / r n o S t s o t a h i r t e Value of IP, exclusioanry value Quality of risk analysis, media activity a r t f l n a c i r u r e Stability of political infra i a W d l Exclusionary value a b E c n IP box f Patent eligible invention Scope reg diversity i o f t i i r i l o a t a p t v n o f o o Risk n N n y management t I Scientific infra, innovation i l i b a t S s t n Integrity of e m living things e e r Stability of political infrastructure g a P I Distributive e d justice a r t l a r e Sovereignty t a l i t l u M International human rights IMPG Influence Diagram

  21. Hypothetical Scenarios HYP 1 US India US PPPproduction US Firm distribution HYP 2 US India US PPP production Indian Firm distribution HYP 3 US India US PPP Tech Trans Indian Firm Prod/Dist

  22. Valuation Table

  23. Data Model

  24. Level-Rate Diagrams

  25. PDV Influence Diagram

  26. PDV Production (ha)

  27. Infant Infection (yr)

  28. HepB Mortality in Infants

  29. Non-Infant Infection (yr)

  30. HepB Mortality Non-Infant

  31. Vaccination Costs (yr)

  32. Total Vaccination Costs

  33. PDV Cost Comparison

  34. Conclusions • Preliminary results indicate that the model is a valuable analytical tool which can be used dynamically to make predictions about the effects of regulatory burden on PDV diffusion • Demonstrates the tractability of the IMPG approach • Validates the modelling process • Offers concrete input into potential alternative policy strategies adapted to PDV and comparable technologies

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