Transcript CENTRE FOR INTELLECTUAL PROPERTY POLICY

Latin American Consortium on
Biotechnology IP
E. Richard Gold
Director, Centre for Intellectual Property Policy
Outline
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Origin
Problematic
Areas of activity
Future
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
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
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
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
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
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
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
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
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
Vaccine Funding Gap
http://www.vaccinealliance.org/site_repository/resources/fundinggap_0204.pdf
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
Arizona BioDesign & ProVacs
http://www.azbio.org/centers/vaccines.html
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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
Charles Arntzen
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?
Production
Regulation
Regulatory Categories
Production Considerations
Intellectual Property
Seeds and Genetic Materials
Cultivation
Manufacturing
Product Approval
IPMG Platform
APS 1
Production
Rate_Production
Rate_Sales
Sales
Production
Rate_Production
Rate_Sales
Rate_Investment
RD_Invesmtent
Rate_Expenditures
Influence diagram
APS 2
Case studies
Sales
Rate_Investment
GDP
RD_Invesmtent
Rate_Expenditures
Rate_GDP
GDP
Rate_GDP
Data
collection
RD_Invesmtent
Rate_Investment Rate_Expenditures
Domain map
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
Production
Rate_Production
Rate_Sales
Delay_Expiration
Sales
Rate_Investment
Delay_Innovation
Innovations
RD_Invesmtent
Rate_Expenditures
Licenses
Rate_Licenses
Patents
Delay_Patents_Pool
Rate_Patents Rate_Expiration
Delay_Protection
Data
collection
Simulation model
Patents_Pool
Rate_Patents_Pool
GDP
Rate_GDP
Value of IP, exclusioanry value
Stability of political infra
Quality of risk analysis, media activity
Exclusionary value
Scope reg diversity
Risk
management
IP box
Patent eligible invention
Scientific infra, innovation
Integrity of
living things
Stability of political infrastructure
Distributive
justice
Sovereignty
International human rights
St abilit y of politi c al i nfr ast r uct ur e
Sal es, r ev enues, wealt h di st ri buti on, wealt h
Revenues, public opinion awarness
Patent value, exclusionary value, value IP
Sales, revenue, public op awareness
Innovation
Exclusionary value, award of patent
Innovation, technology transfer org management
Nont ariff barri er t ot r ade
Educ ati on/t r ai ni ng/ degr ee
Media activiy
Multil at er al tr adeI P agr ee ment s
St abili t y of politi cal i nfr astr uct ur e
Licensing, formal diff of knowledge, education/training/degree
Wealt h
Innovation, technology transfer org, early $, basic $
I nnov ati on
Knowledge
management
I nnov ati on
Economic
efficiency
Revenues
Business capabilities, licensing
Sal es, r ev enues, wealt h, f i nv ot her, f i nv T S
IMPG Influence Diagram
Hypothetical Scenarios
HYP 1
US
US PPP
production
India
US Firm
distribution
HYP 2
US
US PPP
production
India
Indian Firm
distribution
HYP 3
US
US PPP
Tech Trans
India
Indian Firm
Prod/Dist
Valuation Table
Data Model
Level-Rate Diagrams
PDV Influence Diagram
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B1
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Mortality rate
+
Infant mortality rate
Infant population
Birth rate
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-
Mortality rate due to
chronic infection
R1
B2
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+
+
Non-infant population
-
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-
+
R3
-
Desired production
adjustment
B5
B9
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+
Production
Mortality rate due to
acute infection
Infected population
B6
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Chronic cases
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B3
+
B4
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-
Acute cases
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B7
-
B10
B8
-
B11
Recovey rate after
acute infection
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Concentration wash
Market potential
Formulation
B14
B13
B16
Produced
PDV
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Adopters
Concentration loss
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B15
-
-
B17
mechanical loss
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+
+
+
B12
+
-
R2
B19
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Mechanical process
Virus carriers
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-
+
Formulation loss
+
Desired cost
adjustment
Sales of vaccines
PDV stock
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+
+
+
B20
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-
B18
PDV cost per dose
Total PDV cost
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Sales of imitative
vaccines
Sales of innovative
vaccine
+
+
+
Total cost of
vaccination
B21
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20
10
20
13
20
16
20
19
20
22
20
25
20
28
20
31
20
34
20
37
20
40
20
43
20
46
20
49
Production (ha)
PDV Production (ha)
4
3,5
3
2,5
2
1,5
1
0,5
0
Year
Hyp 1
Hyp 2
Hyp 3
3 500 000
3 000 000
2 500 000
2 000 000
1 500 000
1 000 000
500 000
0
20
10
20
13
20
16
20
19
20
22
20
25
20
28
20
31
20
34
20
37
20
40
20
43
20
46
20
49
Number of children
Infant Infection (yr)
Year
statu quo
hyp 1
hyp 2
hyp 3
250 000
200 000
150 000
100 000
50 000
0
20
10
20
13
20
16
20
19
20
22
20
25
20
28
20
31
20
34
20
37
20
40
20
43
20
46
20
49
Number of children
HepB Mortality in Infants
Year
statu quo
hyp 1
hyp 2
hyp 3
Non-Infant Infection (yr)
5 000 000
4 000 000
3 000 000
2 000 000
1 000 000
0
20
10
20
13
20
16
20
19
20
22
20
25
20
28
20
31
20
34
20
37
20
40
20
43
20
46
20
49
Number of people
6 000 000
Year
statu quo
hyp 1
hyp 2
hyp 3
HepB Mortality Non-Infant
40 000
30 000
20 000
10 000
0
20
10
20
13
20
16
20
19
20
22
20
25
20
28
20
31
20
34
20
37
20
40
20
43
20
46
20
49
Number of people
50 000
Year
statu quo
hyp 1
hyp 2
hyp 3
Vaccination Costs (yr)
20000000
10000000
5000000
0
20
10
20
13
20
16
20
19
20
22
20
25
20
28
20
31
20
34
20
37
20
40
20
43
20
46
20
49
$
15000000
Year
Hyp 1
Hyp 2
Hyp 3
Total Vaccination Costs
600 000 000
500 000 000
400 000 000
300 000 000
200 000 000
100 000 000
0
hyp 1
hyp 2
hyp 3
PDV Cost Comparison
Hypothesis 1
22 597 450
15 946 922
Hypothesis 2
21 664 161
15 257 325
Hypothesis 3
9 765 744
4 293 776
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