IP Management Strategies in Public Research Institutions


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IP Management Strategies in Public Research Institutions

  1. 1. Gines-Mera Fellowship Workshop CIAT, Colombia May 12-13, 2010 y , The 3D’s in PGR for Latin America Discovery::Development::Delivery IP Management Strategies in Public Research Institutions Celebrating the life and spirit of Maria Jesus (Chusa) Gines & Veronica Mera Enabling access to intellectual property Cecilia Chi-Ham for the development of Director Science & Technology, PIPRA improved crops p p clchiham@ucdavis.edu Photo: Scott Bauer, USDA
  2. 2. Origins Created by Rockefeller and McKnight Foundations in 2004 Mandate of addressing intellectual property issues in support of public sector agricultural innovation i d t f bli t i lt li ti in developing l i countries and for developing countries.
  3. 3. Public Sector + Responds to the IP challenge Small Business Innovation Research Program (SBIR)
  4. 4. The public sector has a long and  venerable history of providing the  world with important agricultural  ld  i h i   i l l  Origins innovations… Photo credit: Norman Borlaug Institute for International Agriculture
  5. 5. Agricultural research – increasingly a private asset… Encouraged in the US by legislation, the Bayh-Dole Act, passed by Congress in 1980, public sector research bli t h institutions have also used IPRs to manage agricultural innovations. IPR systems world-wide.
  6. 6. … which creates IP challenges for public research and missed opportunities for crop development. Numerous proprietary  technologies h l i IP &TP  uncertainty High transaction costs “Golden” rice
  7. 7. Agricultural innovation in developing countries Outside the US and Europe there is little private sector innovation p activity in agriculture. Public Sector Investment in Agricultural R&D accounts for: ~90% in Developing Countries ~95% in Latin America ~50% in Industrialized Countries An implicit role for the public sector to complete the R&D pipeline especially in developing countries Pardey, P., Beintema, N., Dehmer, S., and Wood, S. Agricultural Research A Growing Global Divide (Aug 2006)
  8. 8. Over time PIPRA has evolved to meet public sector needs • PIPRA began as a “patent clearinghouse” model focused in agricultural biotechnology • BUT we learned that public sector institutional needs were focused on: • Understanding and implementing IPR strategies • Understanding and implementing commercialization strategies • Accessing technology • Developing institutional capacity to manage IPR and commercialization. • Interacting with the private sector • Drafting and negotiating agreements • AND the demand stretched beyond agriculture to include health and energy technologies. • We are a service organization – offering education and project- ff based strategic advice in IP and commercialization.
  9. 9. + What do we do? Technology Scouting Commercialization Strategy Intellectual Property Rights Regulatory Issues Licensing & Agreements g g PIPRA Labs Education and outreach
  10. 10. 53 Universities and Agricultural Research Centers 15 Countries www.pipra.org Headquarters: University of California, Davis www.fia.pipra.org Satellite Office: FIA Fundacion para la Innovacion Agraria Santiago, Chile
  11. 11. Technology scouting PIPRA works with researchers and project managers to identify technologies that suit demand. Using search engines to look across public domain and patented technologies. tech olo ie Interfacing with technology owners to better understand accessibility and technical issues of the technology. Advising on due diligence to assess potential partners. Exploring options and provide evidence to support informed decision-making. Technology scouting can be a critical step in finding the right institutional partners for DEVELOPMENT and ensuring DELIVERY.
  12. 12. Intellectual Property Rights Freedom to Operate …is an ongoing legal assessment is of the intellectual property rights covering a particular t h l i ti l technology space. …performed to ensure that a new p innovation does not infringe other’s intellectual property. other s
  13. 13. FTO For Project Implementation PIPRA provides FTO information to enable project development and deployment. Patent landscapes consider project’s technical needs, contractual agreements, and relevant geographical areas. IP plan identifies possible p p p patents and p patent applications that may affect the development and commercialization of the technology of interest and identifies technology substitutions substitutions. Work with in house IP Scientist and Analysts & Network of Attorneys, including pro-bono services.
  14. 14. Agricultural products may contain different patented parts and processes Golden Rice vs Golden Rice v2
  15. 15. IPR Management in Industry vs Academia FTO Search is a dynamic on-going analysis on- Should be conducted as EARLY as possible in the research planning stages Ag-biotech g Industry Intellectual Idea Property p y Research a d esea c and Launch Development Regulatory + 0-15 years ?? years Academia/Humanitarian Project Intellectual Idea Research and Property P t Re- Launch Development Regulatory Design
  16. 16. INTELLECTUAL PROPERTY AND AGRICULTURAL BIOTECHNOLOGY Disease/Stress resistance Traits Nutritional enhancement Stress (salt/drought) tolerance Vectors Promoters + Enabling Technologies Selectable markers Transformation Methods Cultivars Germplasm
  17. 17. Intellectual property clearances are complex and may need to address multi-national frameworks Australia World Germany Japan US Brazil B il Japan Europe US Application pp Pending US US
  18. 18. Grape transformation system 1. Grape flower buds 2. Excised anthers 3. Callus from anthers 4. Resistant callus colonies after Agrobacterium inoculation 5. Transgenic grape embryos w/GFP 6. Germinating embryos 7. Elongating shoots 8. Rooted plant Courtesy David Tricoli
  19. 19. +
  20. 20. US 6,174,724 Promoter (CaMV35S) NPTII Kan Res A chimeric plant-expressible gene, said gene plant expressible comprising in the 5' to 3' direction: (a) a promoter region derived from a gene that is naturally expressed in a plant cell and that is capable of effecting mRNA transcription in the selected plant cell to b RNA t i ti i th l t d l t ll t be transfonned, transfonned, operably linked to (b) a structural DNA sequence encoding a polypeptide that p permits the selection of transformed plant cells containing p g said chimeric gene by rendering said transformed plant cells resistant to an amount of an antibiotic that would be toxic to non-transformed plant cells, operably linked to non- (c) a non-translated region of a gene naturally expressed in non- plant cells, said region encoding a signal sequence for polyadenylation of mRNA. Promoter Antibiotic Res
  21. 21. + IPR Review Sample: Crop Improvement for Developing Countries R&D Jurisdictions: US Mexico, India, and Pakistan Type of IPR by Jurisdiction Technology US MX IN1 PK1 Trait Promoter IPRS IPRS None None Trait Gene IPRs None None None 3’UTR None None None None Selection Gene IPRs None None None Selection None None None None Promoter Gene Silencing IPRs None None None Plasmid Research only license obligations Transformation None None None None Method Public-Private P t P bli P i t Partnerships, MTA Restrictions are sometimes more critical th IPR hi R t i ti ti iti l than IPRs. To Ensure Deployment: NGOs and Funding Agency are requesting IP and TP Reviews.
  22. 22. FTO Case Study: Public Domain Technologies: Tissue Specific Promoter Tech ogy sc hnolo ng coutin Fenton, G., Chi-Ham, C.L., and Boettiger, S. and Freedom to operate: The law firm's approach and role.
  23. 23. Agronomic Characteristics (nutrition/processing) Sugar/solid content Fruit Ri F it Ripening i US5914446 and US6124528 US5512466 1-aminocyclo propane-1- sucrose phosphate synthase Nutrition carboxylic acid deaminase US5234834 and US5739409 US6031154 Frk1 polypeptide Monellin or thaumatin US6608246 Chalcone Isomerase US5723746 and US5859330 US6011199 (modify flavonoids) S-adenosylmethionine hydrolase alcohol dehydrogenase II (improved flavor) US6156956 ACC Synthase US5328999 and US5585545 Excluding specific Antisense endo-1, 4-b-glucanase Control Gene Expression promoter constructs US6392121 Gemini virus vectors for gene expression in plants E8 Promoter US6118049 Synthetic E8/E4 Hybrid and gene – Public Domain – Promoter combination, Bio-pharmaceutical the promoter itself US6551820 plant expressed anti-hepatitis vaccines is in the public domain Fenton, G., Chi-Ham, C.L., and Boettiger, S. and Freedom to operate: The law firm's approach and role. The Handbook of Best Practices for Management of Intellectual Property in Health and Agriculture. www.iphandbook.org (2007)
  24. 24. PIPRA LABS--developing research tools for agricultural biotechnology Enabling Technologies for Plant Transformation extensively patented in the US Disease/Stress resistance Traits Nutritional enhancement Stress (salt/drought) tolerance Vectors Promoters Enabling Technologies g g Selectable markers Transformation Methods Cultivars Germplasm
  25. 25. PIPRA’s Plant Transformation Marker Free Technology Platforms gy 3. Excision marker Univ California 1. Selectable markers MAS Promoter, BRCD/Purdue 4. Transposase NPTII Univ California 2. Constitutive Promoters U v Ca o a, Univ California, Cornell Univ., AgriFood Canada, • Comprised of multiple patented components (PIPRA Members) • Incorporates technical, legal, and regulatory design features • Compatible with: p – Agrobacteria and Non-Agrobacteria strains (Transbacter, Cambia) – T-DNA transfer borders from Agrobacteria or Plant Derived
  26. 26. IP Strategy –Licensing Model for Enabling Technologies g g IP and TP Manag ent geme Plant Transformation Technology Providers Pre-negotiated Pre negotiated licensing terms T M humanitarian use PIPRA Design, test, and disseminate plant research use transformation vector Materials under Research/Commercial MTA/Licenses commercial use Royalty free y y Fee based Revenue flow
  27. 27. Public-Private Partnership: Ag Technology for SE Africa Public-Private-Partnerships for the Development & P bli P i t P t hi f th D l t Delivery of Nitrogen-Use Efficient and Salt tolerant rice to small holder farmers in Africa Arcadia Biosciences provides trait Biosciences, technologies PIPRA, transformation technologies under , g humanitarian, royalty-free terms AATF (African Agricultural Technology Foundation), facilitates collaboration USAID-Funding
  28. 28. Biofuel Patent Landscape Research Sponsored by: US Department of Energy, Chevron, & BP
  29. 29. Over 1400 relevant patents and patent applications related t production of li l t d to d ti f lignocellulosic EtOH ll l i and the number of filings is increasing ions No. patents and applicati d
  30. 30. Overview of Patenting activity C’ PROCESSES PRETREATMENT SACCHARIF’N FERMENTATION P Chemical Physical CA/PH Enzymes Process Enzymes EEO Process Genencor USA Novozymes USA Dupont USA Novo Nordisk USA Verenium BASF USA Germany Private Andritz Austria DSM Netherlands AB Enzymes Germany Midwest Research Institute USA University of Florida USA Public Dartmouth USA Lund University Sweden Hebrew University of Jerusalem Israel Iogen Energy Corp Canada Arkenol USA No. patents and applications =0 1-5 6-10 11-20 21-40 >100
  31. 31. Gene Suppression in Genetically Improved Crops Fire and Mello 2006 Nobel Prize in Physiology and y y Medicine RNAI Science Breakthrough Technology of the Y T h l f th Year 1980’s Calgene Commercialized first transgenic crop Calgene FLAVRSAVRTM Polygalacturonase antisense Delayed fruit ripening
  32. 32. The intellectual property landscape for gene suppression technologies in plants Nature Biotechnology , Jan. 2010 Chi-Ham, Clark, Bennett
  33. 33. Beyond IP to Regulatory Issues N + Regulatory Assistance • Introduction of projects to US regulatory Agencies • Field Trial Selection & Coordination • Mobility of Plant Material; MTA, Interstate Permits • Regulatory Science
  34. 34. Improving d li I i delivery of f technologies… …can require: IPR strategies Commercialization strategies Drafting & negotiating agreements Implementing institutional policies to support better IPR & commercialization strategies
  35. 35. + East Coast Fever Newcastle Disease Rift Valley Fever Porcine Cysticercosis GALVmed: commercialization strategies for livestock vaccines for the very poor. www.galvmed.org
  36. 36. + Building New Markets to support women and small farmer farmers in Honduras Building an Ornamental Industry in Honduras Addressing: ornamental production; post-harvest and cold-storage chain; logistical support. USAID Funds Supporting small scale producers and women farmers Strategic Partners for a Market Driven approach
  37. 37. Publishes Information about IP strategy and management 2,000 pages 150+ chapters Practical guide to IP for developing countries www.IPHANDBOOK.org
  38. 38. Engages practitioners i workshops t i E titi in k h to improve IPR and commercialization management skills – in Asia, Latin America, and Africa. , , UC Davis International Law School-PIPRA: Licensing Academy in Summer 2010
  39. 39. + Trends in US Filing and Patent Patenting Traits 20 18 18 US Patent Filings (110) 16 16 14 nds 13 US Patent Issued (39) 12 arching Emergi Tren 12 10 10 ing 8 8 8 7 6 5 5 5 4 4 4 4 33 33 3 2 2 2 2 2 2 1 11 1 1 0 0 0 0 0 Resea 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Preliminary Information: Patenting Trends may overlap with Plant Breeders Rights
  40. 40. US 7,235,719 CULTIVATED TOMATO PLANT HAVING INCREASED BRIX VALUE AND METHOD OF PRODUCING SAME Claim 1 - A cultivated tomato plant of the species Lycopersicon esculentum having a genome comprising an introgression derived from Lycopersicon pennellii said introgression pennellii, increasing the Brix value of fruits of said cultivated tomato plant by at least 6% as compared to a plant of the same genotype without the introgression, where said introgression introgression consists essentially of the introgression of tomato plant Lycopersicon pennellii IL 9-2-6.
  41. 41. US 7,348,467 METHOD FOR PRODUCING PLANTS WHICH ARE RESISTANT TO CLOSTEROVIRUSES Claim 1 - 1. A method for producing cucumber plants which are resistant to closteroviruses occurring in cucumber, the method comprising the steps of: a. providing a plant of Cucumis sativus accession PI 250147, b. crossing the Cucumis sativus plant provided in step a with Cucumis sativus culture breeding material, c. collecting the seeds resulting from the cross in step b, d. regenerating the seeds into plants, e. provide one or more backcross generations by crossing the plants of step d or selfed offspring thereof with Cucumis sativus culture breeding material to provide backcross plants, f. selfing plants of step e and growing the selfed seed into plants, g. evaluating the plants of step f for resistance to cucumber closteroviruses, and h. identifying and selecting plants which are resistant to the cucumber closteroviruses.
  42. 42. Thank you www.pipra.org www.fia.pipra.org Celebrating the life and spirit of Maria Jesus (Chusa) Gines & Veronica Mera