Randy Woodson

Associate Dean and Director

Publicly Funded Publicly Funded Agricultural Agricultural Biotechnology Biotechnology ResearchResearch

Challenges in bringing Ag Biotech to marketChallenges 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 RegulationsCost 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 BiotechMarket 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 BiotechnologyMissed Opportunities in Ag Biotechnology

• Low-value crops Low-value crops • Low value traits – human nutritional amplificationLow value traits – human nutritional amplification• Public sector (university) breedersPublic sector (university) breeders• Developing country agricultureDeveloping country agriculture

IMPLEMENTATIONIMPLEMENTATIONTECHNOLOGIESTECHNOLOGIES

(genes)(genes)

ENABLINGENABLINGTECHNOLOGIESTECHNOLOGIES

GERMPLASMGERMPLASM

All major ag-biotechnology companies have assembledAll major ag-biotechnology companies have assembledtechnology platforms through mergers and strategic cross-licensingtechnology platforms through mergers and strategic cross-licensing

Integrated Technology Platform is RequiredIntegrated Technology Platform is Required

Can Public Research Organizations Can Public Research Organizations Take a Similar Approach?Take a Similar Approach?

• IP management strategies (PIPRA) – IP pooling– Sharing licensing information– Educating research scientists– Non-exclusive licensing

QuestionsQuestions

• 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 PatentsGrowth in Ag Biotech Patents

0

100

200

300

400

500

600

700

800

85 87 89 91 93 95 97 99

PrivateAcademic/Government

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%

DupontMonsantoSyngentaAventisDow

Source: Aurigin Systems

Concentration of ownership of agbio patentsConcentration of ownership of agbio patents

Number of IP documents Number of IP documents worldwide: US, EU, JP, WOworldwide: US, EU, JP, WO

Source: Graff et al., 2003

Largest public sector agbiotech IP holders: Largest public sector agbiotech IP holders: Second tier (>40 documents each) Second tier (>40 documents each)

• University of CaliforniaUniversity of California• Cornell UniversityCornell University• USDA-ARSUSDA-ARS• Rutgers UniversityRutgers University• Massachusetts General Hospital Massachusetts 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 Gesellschaft Max Plank Gesellschaft (Germany)

• Ministry of Agriculture, Forestry, & Ministry of Agriculture, Forestry, &

Fisheries Fisheries (Japan)

• CSIRO CSIRO (Australia)

• Institut National de la Recherche Institut National de la Recherche

Agronomique Agronomique (France)

• Institut fur Genbiologische Forschung Institut fur Genbiologische Forschung

Berlin Berlin (Germany)

• Plant Bioscience Ltd Plant Bioscience Ltd (UK)

• Ministry of Agriculture and Agri-Ministry of Agriculture and Agri-

food food (Canada)

Trait analysis:Trait analysis:environmental stress resistanceenvironmental stress resistance

TTeecchhnnoollooggyy PPuubblliicc PPrriivvaattee

Common enabling technologies for stress 1 7

General stress resistance(methods, genes, proteins, plants)

9 10

Stress induced promoters 5 5

Temperature and dehydration resistance 16 10

Metal, salt, pH resistance 12 9

What characterizes public sector What characterizes public sector agbiotech IP?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 ResearchPublic 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 IPAccess 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 The Transition of the Public Research UniversityUniversity

Uplifting the Masses Creators of Knowledge Economic Development

State funding of public universities often tied to economic development agendas and promote partnerships with the private sector.