Randy Woodson Associate Dean and Director Publicly Funded Agricultural Biotechnology Research

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 crops Low value traits – human nutritional amplification Low value traits – human nutritional amplification Public sector (university) breeders Public sector (university) breeders Developing country agriculture Developing country agriculture

IMPLEMENTATIONTECHNOLOGIES(genes) ENABLINGTECHNOLOGIES GERMPLASM All major ag-biotechnology companies have assembled technology platforms through mergers and strategic cross-licensing Integrated Technology Platform is Required

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

Second Tier ( 51 organizations with more than 40 patents each) 30 % Top Tier (5 organizations) 29% Third Tier (1470 organizations with fewer than 40 patents each) 41% Dupont Monsanto Syngenta Aventis Dow Source: Aurigin Systems Concentration of ownership of agbio patents Number of IP documents worldwide: US, EU, JP, WO Source: Graff et al., 2003

Largest public sector agbiotech IP holders: Second tier (>40 documents each) University of CaliforniaUniversity of California Cornell UniversityCornell University USDA-ARSUSDA-ARS Rutgers UniversityRutgers University Massachusetts General HospitalMassachusetts General Hospital University of FloridaUniversity of Florida Salk InstituteSalk Institute North Carolina State UniversityNorth Carolina State University University of WisconsinUniversity of Wisconsin Purdue UniversityPurdue University Washington State UniversityWashington State University Michigan State UniversityMichigan State University Iowa State UniversityIowa State University Max Plank GesellschaftMax Plank Gesellschaft (Germany) Ministry of Agriculture, Forestry, & FisheriesMinistry of Agriculture, Forestry, & Fisheries (Japan) CSIROCSIRO (Australia) Institut National de la Recherche AgronomiqueInstitut National de la Recherche Agronomique (France) Institut fur Genbiologische Forschung BerlinInstitut fur Genbiologische Forschung Berlin (Germany) Plant Bioscience LtdPlant Bioscience Ltd (UK) Ministry of Agriculture and Agri- foodMinistry of Agriculture and Agri- food (Canada)

Trait analysis: environmental stress resistance

What characterizes public sector agbiotech IP? Broad variety of technologiesBroad variety of technologies –Enabling technologies (“engineering tools”) –Trait technologies (the “software”) –Germplasm (the “hardware”) –Agronomic complements (“accessories”) Highly scatteredHighly 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 Uplifting the MassesCreators of Knowledge Economic Development State funding of public universities often tied to economic development agendas and promote partnerships with the private sector.