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Publicly Funded Agricultural Biotechnology Research. Randy Woodson Associate Dean and Director. Challenges in bringing Ag Biotech to market. Cost of regulatory approval Market valuation (minor crops; niche markets) Public funding of agricultural research Access to IP Sharing of information
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Publicly Funded Agricultural Biotechnology Research Randy Woodson Associate Dean and Director
Challenges in bringing Ag Biotech to market • Cost of regulatory approval • Market valuation (minor crops; niche markets) • Public funding of agricultural research • Access to IP • Sharing of information • Changing research university agenda
Cost of Regulations • Challenge • $10 to $100MM (or greater) to bring single product to market • Limits this to the private sector and to high value, high impact Ag products • Approach • University-industry (private and not-for-profit) partnerships • Public funding of Ag biotech research • IR-4 organization to develop data for biotech applications in the “public good”
Market Value and Ag Biotech • Challenges • Commercial focus is on commodities and market share • Niche market, minor crops and developing country opportunities can be ignored in this environment • Fragmented industry tends to limit influence (strawberry growers vs. soybean growers) • IP ownership (enabling technologies) can limit use of biotech traits • Limited industry and public support
Missed Opportunities in Ag Biotechnology • Low-value crops • Low value traits – human nutritional amplification • Public sector (university) breeders • Developing country agriculture
Integrated Technology Platform is Required IMPLEMENTATION TECHNOLOGIES (genes) GERMPLASM ENABLING TECHNOLOGIES All major ag-biotechnology companies have assembled technology platforms through mergers and strategic cross-licensing
Can Public Research Organizations Take a Similar Approach? • IP management strategies (PIPRA) • IP pooling • Sharing licensing information • Educating research scientists • Non-exclusive licensing
Questions • What is the total existing stock of IP covering agricultural biotechnologies? • Who holds that agbiotech IP? • What proportion is held by public sector institutions? • What characterizes public sector agbiotech IP? • Supply side: how to move the public inventory? • Demand side: can public sector meet user needs?
Growth in Ag Biotech Patents Source: Graff et al., 2003
Dupont Monsanto Syngenta Aventis Dow Top Tier (5 organizations) Third Tier (1470 organizations 29% with fewer than 40 patents each) 41% Second Tier (51 organizations with more than 40 patents each) 30% Concentration of ownership of agbio patents Number of IP documents worldwide: US, EU, JP, WO Source: Aurigin Systems Source: Graff et al., 2003
University of California Cornell University USDA-ARS Rutgers University Massachusetts General Hospital University of Florida Salk Institute North Carolina State University University of Wisconsin Purdue University Washington State University Michigan State University Iowa State University Max Plank Gesellschaft (Germany) Ministry of Agriculture, Forestry, & Fisheries (Japan) CSIRO (Australia) Institut National de la Recherche Agronomique (France) Institut fur Genbiologische Forschung Berlin (Germany) Plant Bioscience Ltd (UK) Ministry of Agriculture and Agri-food (Canada) Largest public sector agbiotech IP holders: Second tier (>40 documents each)
What characterizes public sector agbiotech IP? • Broad variety of technologies • Enabling technologies (“engineering tools”) • Trait technologies (the “software”) • Germplasm (the “hardware”) • Agronomic complements (“accessories”) • Highly scattered • Across technology systems • Across institutions
Public Funding of Ag Research • Public Ag research funding is down • Increased support for Genomics • Focus is on major crops, animals and pests • Support for Biotechnology Risk Assessment • Helps to establish production quidelines such as refugia for pest-resistance management • Need for IR-4 type system for regulatory data • Provides public funding to support the registration package for minor-use pesticides
Access to IP • Exchange of information and material is more tightly controlled through MTA, even between academic scientists • Academic Scientists often seek industry support and/or collaborations to gain access to IP, technology and to bring products to market • This can “tie up” discoveries by first rights of refusal agreements and publication limitations
The Transition of the Public Research University Economic Development Uplifting the Masses Creators of Knowledge State funding of public universities often tied to economic development agendas and promote partnerships with the private sector.