The PIPRA model: Collaborative management of public sector IP INNOVA workshop Stockholm, Sweden

1. The PIPRA model:Collaborative management of public sector IPINNOVA workshopStockholm, Sweden Gregory D. Graff, PhD PIPRA INNOVA workshop

2. Overview • IP in agricultural R&D • The problem: technology access for non-market applications • The solution: PIPRA • Four areas of activity • Structure of the organization • Translating the model into R&D for neglected diseases? • Key issues and conclusions INNOVA workshop

3. The problem:Access to IP for small and non-market crops • Little application of new biotechnologies to improve genetics in ‘neglected’ crops • small market specialty crops • non-market ‘humanitarian’ applications in subsistence crops • Constraints on access to IP for development of “average” small market/non-market products • patent proliferation • fragmentation, a typical project requires IP controlled by multiple owners • lack of awareness, capacity • uncertainty • transaction costs • high licensing costs • refusals to deal • Constraints on out-licensing IP for academic/public sector • Excessive use of “exclusivity” tied up key enabling technologies • Very small field of potential commercial licensees with FTO • Fragmentation: no single institution can provide a development partner with full set of IP to ensure FTO • Large proportion of patents unlicensed INNOVA workshop

4. A solution: Coordinating public sector “technology providers” • Public research universities and institutes • Generate 25 percent of the IP in the agbio technology space • Share common goals to advance agriculture and benefit the public • PIPRA, the Public Intellectual Property Resource for Agriculture • Self initiated, growing ‘organically’, internally supported by administrations, researchers, and tech transfer • A commitment to manage IP to facilitate broadest possible application • Coordinated by a small professional staff engaged in ‘scaleable’ activities Source: Graff et al, Nature Biotechnology, 2003 INNOVA workshop

5. PIPRA activities: 4 platforms Each platform builds upon the previous ones: • IP data and analysis • Education, outreach, and advising on IP management and strategy • Development and dissemination of “unencumbered” research tools • Collaborative marketing and pooling of member institutions’ IP INNOVA workshop

6. IP data and analysis:Looking before we leap • PIPRA database • Integrated view of all member institutions’ agricultural IP, country by country • Includes licensing status, fields of use (i.e. availability) • Contact information of responsible manager at member OTT • What technologies can be accessed from public sector/PIPRA institutions? • FTO analyses • Background research by PIPRA staff • When needed, opinions obtained pro bono from leading IP attorneys of the PIPRA affiliates network • What is essential for FTO with a particular technology component? • Field of technology landscapes (horizontal view, across published technologies) • Integrating research literature and patent literature • Who has published/claimed what across a broad area? • R&D pipeline analyses (vertical view, down the development pipeline) • Integrating research and patent literature with product development data (fieldtrials, regulatory) • Who is moving what types of technologies toward market? INNOVA workshop

7. Education, outreach, & advisingBeing a guide through the patent thicket • Audiences: • PIPRA member OTT staff and researchers • Research sponsors • Potential licensees/users of IP • IP policy makers and institutional capacity builders in developing countries • Education: • Consultations • Workshops • Presentations • Website and newsletters • MIHR/PIPRA licensing handbook • PIPRA white papers • Peer reviewed publications • IP course curriculum development INNOVA workshop

8. Development of research tools:Responding to common IP needs with tangible solutions • Plant transformation vectors project (2006-2009) • Designs based on accessibility of IP • Pre-negotiated to assure • research use • humanitarian use • reasonable terms for conversion to commercial license • Maximize use of technology components owned by PIPRA members • Remainder of components from industry on defined terms • Sufficiently broad technical characterization to enable wide range of crop R&D • To be demonstrated in pilot projects • To be broadly disseminated under unified, standardized MTA • Potential for other kinds of research tools INNOVA workshop

9. Collaborative licensing:Creating an IP clearinghouse to facilitate licensing • Marketing • Leveraging the PIPRA database, IP analyses, and technology/industry expertise of PIPRA staff • Outreach materials highlight accessible technologies • Fielding inquiries from industry and “matchmaking” • Inclusion of technology components in developing PIPRA research tools • Potential for much more proactive marketing • Patent Pooling • Where complementarity requires coordination • Initially, coordinating IP around PIPRA research tools • Potential for extension into other areas INNOVA workshop

10. How PIPRA helps small market technology development in agriculture Public sector agbio IP ‘portfolio’ Product Development Partnerships INNOVA workshop

11. PIPRA structure • Consortium of member institutions • Currently 32 • Join by signing the PIPRA Memorandum of Understanding • Currently no fees • Governance • Executive Committee, drawn from member institutions • Campus Advisory Board • Funding • Rockefeller Foundation • Funded projects • Facilities • Provided as ‘in-kind’ support by UC Davis • Staff • Executive Director • Principals (PhD/JD level) • Analysts, Interns, Support Staff • Affiliates network • IT/patent data firms • Law firms and law schools • Others INNOVA workshop

12. PIPRA members (as of Jan 2006) • Arizona State University, as represented by Arizona Technology Enterprises LLC • Boyce Thompson Institute • Cornell University • Donald Danforth Plant Science Center • Fundación Chile, Chile • Iowa State University • International Maize and Wheat Improvement Center (CIMMYT), Mexico • International Potato Center (CIP), Peru • International Rice Research Institute (IRRI), Philippines • Kansas State University • Michigan State University • North Carolina State University • Ohio State University • Parco Technologico Padano, Italy • Purdue University • Salk Institute  • St. Augustine University of Tanzania • Samuel Roberts Noble Foundation • State University of New Jersey, Rutgers • University of Arizona • University of Arkansas, Division of Agriculture • University of California-Berkeley • University of California-Davis • University of Florida • University of Georgia Research Foundation • University of Idaho • University of Kentucky • University of Missouri-Columbia • University of Saskatchewan, Canada • University of Wisconsin, Wisconsin Alumni Research Foundation • Virginia Tech, College of Agriculture and Life Sciences • Washington State University  INNOVA workshop

13. PIPRA member institutions INNOVA workshop

14. PIPRA’s Network of Affiliates • Townsend and Townsend and Crew • Morrison and Foerster • DLA Piper Rudnick Gray Cary • Harness, Dickey, and Pierce • Foley Hoag • Edwards and Angell • Baker and McKenzie • Public Interest IP Advisors (PIIPA) • Washington University School of Law • Franklin Pierce Law School • CIP, Chalmers and Gothenberg Universities • M-CAM.com • Reel2.com • LightYears IP • Center for Application of Molecular Biology in International Agriculture (CAMBIA), Australia • African Agricultural Technology Foundation (AATF) • Instituto de Direito do Comercio International e Desenvolvimento (IDCID), Brazil INNOVA workshop

15. Possibilities for applying this model to R&D for neglected diseases? • Wider scope of technologies for human health: • Vaccines • Drugs/biologics • Diagnostics • Devices • Control over “background” and “foreground” IP plays an important role in PDPs for neglected diseases (Moran et al, 2005) • Variable capacity for IP management among PDPs • Some quite sophistocated • Others not so • Academic research already an important source of IP for PDPs (Moran et al, 2005) • 1/3 of neglected drug PDP spending goes to academics • 1/3 of PDP projects involve translating academic leads into neglected disease drugs ‘PDP’ still a new model, not yet applied to many potential technology developments. INNOVA workshop

16. Possibilities for applying this model to a regional system of universities? • Scalable services to assist local/on campus offices • data management • professional services • market analysis • IP marketing • Active or preferential ‘matchmaking’ with regional entrepreneurs and regional public-private technology development consortia • Collaborative representation of regional technology out-licensors on the global technology market • Define and set best practices in out licensing • Representation at international events • Establish satellite offices: London, Beijing, San Francisco INNOVA workshop

17. Supporting Materials INNOVA workshop

18. PIPRA’s 2005-2006 Executive Committee • Gerard BarryGolden Rice Network CoordinatorInternational Rice Research Institute (IRRI)E-mail: g.barry@cgiar.org • John ByattAssociate Director, Life Sciences University of FloridaE-mail: jbyatt@rgp.ufl.edu • Carlos FernandezFundación ChileE-mail: cfernandez@fundacionchile.cl • Lisa Lorenzen Director of Industry Relations & Biotechnology Liaison Iowa State University Email: llorenze@iastate.edu • Henry Lowendorf Associate Director Office of Cooperative Research Yale University Email: henry.lowendorf@yale.edu • Irvin MettlerSenior Licensing OfficerOffice of Technology LicensingUniversity of California-BerkeleyE-mail: imettler@berkeley.edu • Karel SchubertVice President, Technology Management & Science AdministrationDonald Danforth Plant Science CenterE-mail: kschubert@danforthcenter.org INNOVA workshop

19. PIPRA Staff and Contact Information PIPRA Plant Reproductive Biology Building Extension Center Drive University of CaliforniaPlant Sciences, Mail Stop 5 Davis, CA 95616-8780 Tel: +1 (530) 754-6717 Fax: +1 (530) 752-2278 www.pipra.org Alan Bennett, Executive DirectorEmail: abbennett@ucdavis.edu Phone: +1 (530) 754-1411 Sara Boettiger, Program ManagerEmail: sara.hearn@ucop.edu Phone: +1 (530) 754-6725 Cecilia Chi-Ham, Research ScientistEmail: clchiham@ucdavis.eduPhone: +1 (530) 754-6717 Josef Geoola, IP analyst Email: jngeoola@ucdavis.edu Phone: +1 (530) 754-6717 Gregory Graff, Research Economist Email: gdgraff@ucdavis.edu Phone: +1 (530) 752-2705 INNOVA workshop

20. References • Gregory D. Graff, Susan E. Cullen, Kent J Bradford, David Zilberman, and Alan B. Bennett, “The Public-Private Structure of Intellectual Property Ownership in Agricultural Biotechnology,” Nature Biotechnology, 21(9), September 2003, 989-995 • Amy Kapczynski, Samantha Chaifetz, Zachary Katz, and Jochai Benkler, “Addressing Global Health Inequities: An Open Licensing Approach for University Innovations,” Berkeley Technology Law Journal, 20(2), Spring 2005, 1032-1114 • Mary Moran, Anne-Laure Ropars, Javier Guzman, Jose Diaz, and Christopher Garrison, The New Landscape of Neglected Disease Drug Development, Pharmaceutical R&D Policy Project, London School of Economics, The Wellcome Trust: London, September 2005 • Lori Pressman, Richard Burgess, Robert M Cook-Deegan, Stephen J McCormack, Io Nami-Wolk, Melissa Soucy, and LeRoy Walters, “The Licensing of DNA Patents by US Academic Institutions: an Empirical Study,” Nature Biotechnology, 24(1), January 2006, 31-39 INNOVA workshop