Malaria Vaccine Initiative
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1 Malaria Vaccine Initiative Intellectual Property Rights and Vaccines in Developing Countries WHO Meeting April 19-20, 2004 Patricia Atkinson Roberts Sr. Officer, Commercialization & Corporate Partnerships
2 Malaria Vaccine Initiative Accelerating the development of promising malaria vaccines and ensuring their availability and accessibility in the developing world.
3 Why is intervention critical? Barrier 1: Existing market forces are insufficient to drive malaria vaccine development Barrier 2: Malaria vaccines are not perceived to be technically feasible
4 Low Scientific Complexity Mening A/C Probable Orphans Low Risk-Low Return Orphan Zone High Risk-Low Return Rotavirus Pneumo Market Product Low Risk-High Return Possible Product High Risk-High Return High Hookworm, Schisto * Malaria TB, AIDS Cancer Therapeutic Low Market Attractiveness (Based on Developed Country Markets) High
5 Challenges impacting the malaria vaccine IP environment Industry willingness to develop and supply Bringing new players to the field Survival for small companies with malaria as a lead product Challenging environment for malaria-specific IP Need for non-malaria technologies
6 MVI s IP Principles MVI s practice is not to own IP IP rights are generally held by partners MVI acts as a safety net for public sector investment No/low-cost technology transfer (PATH, third party) if IP holder chooses not to develop or manufacture
7 MVI s IP Principles Malaria-specific IP should be easily accessible by the field Public domain or patent pool? Goal: Prevent lock up by the private sector MVI believes IP is necessary For innovation Fiscally important to biotech and pharmaceutical industry
8 Vaccine Candidate Portfolio ICGEB WRAIR FMP-1 MVDB QIMR PvRII MSP1:3D7 MSP1:FVO AMA1:3D7 AMA1:FVO LaTrobe MSP2:3D7 MSP2:FVO Monash SMMU RAP-2 MSP4 MSP5 CP2.9 Oxford Apovia GSK GSK MVA:CSO FP9:CSO ICC-1132:S ICC-1132:A ICC-1132:M RTS,S LSA1 Genvec CDC AMA1:MSP1 CSP:SSP2:LSA1 FALVAC1A LSA3,S CSP AMA1 CSP:LSA1 AMA1:MSP1
9 IP issues vary by partner Biotech companies Multinational vaccine manufacturer Government (e.g., NIH, DoD) Academia Contract manufacturer
10 Pharma Partner Biotech Partner Academic Partner Gov t Partner Endemic Trial site Nonendemic Trial site Apovia GSK MVDU ICGEB Oxford Monash QIMR WRAIR La Trobe GenVec Inc. Contractor
11 MVI Vaccine Development Projects Walter Reed Oxford GSK ICGEB Genvec Apovia MVDB Monash La Trobe QIMR Lead Partner Clinical trial site
12 What will it take? Proces s A1 A2 Proces s Adj. Delivery Platform A5 A4 A3
13 Combination vaccines Proces s A1 A2 Proces s Adj. Delivery Platform A5 A4 A3
14 Royalty stream 1% 2% 2% 30% 1% 10% 2% 8% 2% 2%
15 IP landscape for malaria vaccines Malaria-specific IP Unlikely to be of great commercial value Impedes development and testing of antigens High transaction costs (time and money) for access to IP Unrealistic sense of value Confusing IP landscape leads to avoidance IP holders unlikely to see return on investment? We could not give our malaria technologies away. -M. Freire
16 MSP-1: A case in point...
17 MSP-1 complexities Conflicting claims? overlapping claims, different inventors Little IP heritage limited backward or forward citations uncertain relationships Qualitative questions about validity and enforceability of MSP-1 patent families
18 MSP-1 Patent Map
19 IP landscape for malaria vaccines Non-Malaria Technologies Non-malaria-specific technologies are critical to the portfolio Likely to contribute to a more effective vaccine Increase industry participation in the field but this complicates the IP environment for a malaria vaccine IP ownership is critical for commercialization/investment IP can prevent access for neglected diseases But, developers may use malaria to advance their technology without a long-term commitment to MVI s market
20 IP landscape for malaria vaccines Non-Malaria Technologies Adjuvant supply commitments are especially important Guarantees of pre-clinical, clinical, and commercial access
21 MVI s IP initiatives Patent pool study (Q2/Q3 2004) Guiding principles: Ensure recognition for the inventors and their institutions Ensure that if others profit from a malaria vaccine that the inventor will in some way also profit Ensure that the organizational responsibilities for commercialization of government-funded research can be met
22 MVI s IP initiatives Guiding principles (cont d ): Decrease the transaction time and costs for licensing IP License IP on a non-exclusive basis to prevent monopolies Not pay patent costs for marginal patents (reward inventors for letting their marginal patents lapse) Adjuvant access commercial strategy (Q2 2004)
23 The Vision
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