Libertad De Operación Cecilia Chi -Ham, UC Davis
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Transcript of Libertad De Operación Cecilia Chi -Ham, UC Davis
Aplicando el estado del arte y Aplicando el estado del arte y p yp ylibertad para operar en la libertad para operar en la investigación y desarrolloinvestigación y desarrolloinvestigación y desarrolloinvestigación y desarrollo
Cecilia ChiCecilia Chi‐‐HamHam
PROGRAMA FIA ‐ PIPRA
Cecilia ChiCecilia Chi HamHamDirectora Ciencia y TecnologíaDirectora Ciencia y Tecnología
[email protected]@ucdavis.eduPIPRA UC D iPIPRA UC D iLA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓN
AGROALIMENTARIA
PIPRA, UC DavisPIPRA, UC Davis
www.iphandbook.com
En las áreas agrícola, es cada día mas importante entender el rol de los patentes y
la propiedad intelectual en investigaciónla propiedad intelectual en investigación, desarrollo, y comercialización.
Patent Databases Free
– USPTO (Free and $ portals)• Patent Application Information Retrieval (PAIR): http://portal.uspto.gov/external/portal/pair• Patents/applications http://www.uspto.gov/patft/index.html• Patent assignment http://assignments.uspto.gov/assignments/?db=pat
– European Patent Office [email protected]– Google Patent http://www.google.com/ptshp?tab=wtg p // g g /p p– PIPRA Ag‐IP www.search.pipra.org– CAMBIA Patent Lens http://www.patentlens.net/daisy/patentlens/patentlens.html
– NCBI:PubMed www.pubmed.gov
Subscription/fee based– GenomeQuest www.genomequest.com
Delphion www delphion com– Delphion www.delphion.com– Others: Westlaw, Lexis, STN, etc.
Explore other Databases and ResourcesExplore other Databases and Resources
www.PIPRA.orgwww.search.pipra.org
PATENTES INIA LA CRUZ, Robison Vargas, Director
Asociad Vinculación empresaNombre Solicitud
Asociado
Vinculación empresa
Matriz para la atracción y consumo de avispas Vespula sp. Que comprende un alimento a
En proceso de licenciamiento con empresa nacional y conversaciones con
base de carne animal; cebo que comprende la matriz antes mencionada. 03208‐2007
empresas extranjeras
Uso de extractos Etanólicos de Cuesco de Palta Persea americana Mill, variedad Hass, Formación de Consorcio empresarial, como Acaricidas e Insecticidas 03612‐2007 PUCV entre empresarios e INIAUso de compuestos químicos orgánicos individuales del tipo alcoholes, aldehidos y cetonas como atrayentes de la avispa V
En proceso de licenciamiento con empresa nacional y conversaciones con empresas extranjerascetonas, como atrayentes de la avispa V.
germanica 03850‐2007empresas extranjeras
En proceso de licenciamiento con empresa nacional y conversaciones con
t jEstación Cebo para avispas chaqueta amarilla 0226‐2008
empresas extranjeras
Equipo y método de limpieza de productos agrícolas y de huevos de gallina mediante aspersión con agua a presión 3272‐2008
Estado de Arte para Implementación de ProyectosEstado de Arte para Implementación de Proyectos
PIPRA provee análisis de estado del arte de patentes para apoyar desarrollo y adopción de proyectos y
d
PIPRA provee análisis de estado del arte de patentes para apoyar desarrollo y adopción de proyectos y
d Red PIPRAproductos.
Identifica elementos de PI que pueden afectar I&D
productos.
Identifica elementos de PI que pueden afectar I&D
Red PIPRA:Estudios y Servicios Legales (alugnos, pro bono)
Identifica elementos de PI que pueden afectar I&D.
Panorama del momento del Estado del Arte de pantes
Identifica elementos de PI que pueden afectar I&D.
Panorama del momento del Estado del Arte de pantes
Townsend and Towsend and Crew DLA Piper Rudnick Gray CaryMorrison and Foerster p
en un área de tecnología.p
en un área de tecnología.Harness, Dickey and PierceFoley HoagEdwards & AngellgBaker & McKenzie Public Interest IP Attorneys (PIIPA)Fulbright & JaworskiFulbright & JaworskiPierce Law, Franklin Pierce Law Center
Freedom to Operate FTOb dLibertad para Operar
is an ongoing legal assessment of theis an ongoing legal assessment of the…is an ongoing legal assessment of the …is an ongoing legal assessment of the intellectual property rights covering a intellectual property rights covering a
ti l t h lti l t h lparticular technology space. particular technology space.
…performed to ensure that a new …performed to ensure that a new innovation does not infringe other’s innovation does not infringe other’s ggintellectual property.intellectual property.
Estrategias de Manejo de PI en base a Análisis de Estado de Arte
Abandon or modify business/research goals (field of use, geographies)
Assume current path despite FTO risk evaluation (can one tolerate risk of infringement litigation?)one tolerate risk of infringement litigation?)
Replace with substitute technologies with greater FTO
Purchase the Patent(s) or In‐License rights Purchase the Patent(s) or In License rights
Cross‐License
Invent around the blocking patent Invent around the blocking patent
Develop a patent pool or a clearinghouse
Proceso de Análisis Estado de Arte
I. Define Subject MatterII Formulate TeamII. Formulate Team III. Define Questions and IP Search
StrategyStrategyIV. Investigation
P d t f th S hV. Product of the Search
I. Definir Tecnología para Estado de Arte Define subject mater
– Describe technology– Anticipated field of use
Dissect the technology– Identify technologies used to make the product including:
• Trait genes, germplasm, selectable markers, transformation technologies, methodologies etcmethodologies, etc.
• Material transfer agreements and property trail– Distinguish ‘core’ and ‘substitutable’ technologies
Geographies Geographies– Countries in which the product will be developed, manufactured,
approved by regulatory agencies, and marketed/sold
Ti f Time‐frames– Awareness of 18 month period of periods of silence of US patent
applications– Patent Maintenance or Life‐time (US 17 or 20 years)– ONGOING analysis to be performed as early in the development phase as
possible.
Stanton Gelvin, Purdue University
II. Formular Equipo Kan Wang, Iowa State UniversityPal Maliga, Rutgers University
David Ow, USDA‐ARS, UC BerkeleyBrian Miki, Agriculture and Agri‐Food Canada
Vibha Srivastava, University of Arkansas
SCIENTISTSSCIENTISTSSCIENTISTSSCIENTISTS
Vibha Srivastava, University of ArkansasChris Taylor, Donald Danforth Plant Science Center
David Tricoli, University of California DavisFrancois Torney, Iowa State UniversityR b H U i i f K kRobert Houtz, University of Kentucky
Michael Lang, Harness, Dickey & Pierce, P.L.C.Michael Ward, Morrison & Foerster LLP
Clinton Neagley, University of California, Davis AttorneysAttorneysAttorneysAttorneys g y, y ,Charles McManis, Washington University Law SchoolJames Surber, Patent Attorney, Bryan Cave Chuck LLPChuck McManis, Washington University School of Law
Robert Horsch Monsanto
AttorneysAttorneysAttorneysAttorneys
AgAg‐‐Biotech CompaniesBiotech CompaniesAgAg‐‐Biotech CompaniesBiotech Companies Robert Horsch, MonsantoQi Wang, Monsanto
Keith Redenbaugh, Seminis Vegetable Seeds Kathy Swords, Biotech Business Development, J.R. Simplot Company
AgAg Biotech CompaniesBiotech CompaniesAgAg Biotech CompaniesBiotech Companies
Regulatory ExpertsRegulatory ExpertsRegulatory ExpertsRegulatory Experts
Alan Bennett, PIPRA, University of California DavisKarel Schubert, Donald Danforth Plant Science CenterSara Boettiger, PIPRA, University of California Berkeley Cecilia Chi‐Ham, PIPRA, University of California Davis
PIPRAPIPRAPIPRAPIPRA
III. Define Questions
Interview and laboratory history
/– Interview scientific, technical, and technology transfer/IP staff
– Technical description of the technologyReview published literature, presentations, research proposals, etc.
– Deconstruction of the technology components, methods, protocols, germplasm etc.
– Acquisition trail: MTA—who got what from whom?
– Source of research funds, confidentiality agreements, employment agreements IP restrictions imposed by funding sources, collaborators, universities, etc.
Meticulously develop series of questions congruent y p q gwith the projects immediate and future goals.
IV. Nivel I Estado de Arte/Libertad para Operar
Are there blocking patents that could preclude pursuing a new goal?Are there blocking patents that could preclude pursuing a new goal?
Based on Public informationBased on Public information
Review Patent Search ResultsReview Patent Search Results Identify Patents (present risks)y
Identify Patent Applications (potential future risks)
Determine IP Ownership and StatusDetermine IP Ownership and Status Maintenance Status‐‐ anticipated expiration date, abandoned, etc.
Check Assignment Records
Availability/Licensing informationo Usually not public information (PIPRA‐Network)
Nivel II Estado de Arte/Libertad para Operar
Construct IP Priority Timeline and “Landscape”
Patent Landscape | Based on Public informationPatent Landscape | Based on Public information
Construct IP Priority Timeline and Landscape– Group Patent Risks by Subject Matter– Determine relative Patent Dominance
• priority date• priority date• broader vs. narrower patents‐‐ Broader patents may have leverage to seek higher fees/control entry into the market
– Timeline of public information ‘prior art’ with patent historyTimeline of public information prior art with patent history– Construct Vertical / International Families– Claim analysis by legal counsel– Obtain & Evaluate Patent File HistoriesObtain & Evaluate Patent File Histories
Check Patent Litigation Records – Held Invalid? Unenforceable?
I t f ?– Interferences?
cont… cont… NivelNivel II.II.
Check Business and News RecordsCheck Business and News Records Patentee’s Website / Annual Report
SEC Filings by Patentee – “Risks”g y
Press Releases by Patentee
Industry‐Specific and General News Reports
Is the Patentee likely to Enforce IP rights?
Nivel III. Estado de Arte/FTOPatent Landscape | Requires Confidential Information and Patent Landscape | Requires Confidential Information and Cooperation from Patentee, Contracts and Grants and Tech Cooperation from Patentee, Contracts and Grants and Tech Transfer OfficesTransfer Offices
Unpublished Patent Applications
Transfer OfficesTransfer Offices
– U.S. Provisional Applications
– U.S. Utility Applications < 18 months
– File Histories of Pending Applications
Unpublished research data, manuscriptsp , p
Business Goals / Project Status
Threatened LitigationThreatened Litigation
cont… cont… NivelNivel IIIIII
Contracts affecting Ownership– Assignments Licenses– Assignments, Licenses
– Funding/research agreements
/– Availability/Licensing information• Usually not public information
’ f l l d l f• PIPRA’s ag‐IP portfolio includes licensing information
V. Producto de Análisis de Estado de Arte
Attorney‐Client Privilege– According to US law product of FTO search is considered attorney‐
client privilege informationclient privilege information– Information remains confidential if the client chooses to do so– Not all legal counsel are attorneys
…thus Degree of protection may vary…thus Degree of protection may varySuch terms should be discussed in advance
Oral Advice of Counsel Written Report Written Report
– Scope of Search, Search Strategies– Listing of Identified Risks– Analysis of Identified RisksAnalysis of Identified Risks
Formal Written Opinion– Noninfringement or Invalidity
Patent Landscape Changes over Time Patent Landscape Changes over Time– FTO product is a “Living Document” and requires constant updates
Caso 1Caso 1
VISTA PANORAMICA DEL
ESTADO DEL ARTEESTADO DEL ARTE
Estado de arte de Biocombustibles
Clark, Jensen, et al. Estudio PIPRA
Research Sponsored by: US Department of Energy,
Chevron, & BP
Mas de 1400 patentes y aplicaciones relacionadas Mas de 1400 patentes y aplicaciones relacionadas con producción de con producción de EtOHEtOH lignoligno‐‐cellulosicocellulosico. . pp gg
ons
d ap
plicati
tents an
dNo. pa
Clark, Jensen, et al. Estudio PIPRA
PRETREATMENT SACCHARIF’N FERMENTATION PROCE
SSES
Distribución de Patentes por Tecnología y Sector Distribución de Patentes por Tecnología y Sector
Chemical Physical CA/PH Enzymes Process Enzymes EEO Process
PRETREATMENT SACCHARIF’N FERMENTATION
C’ P
Genencor USA
Novozymes USA
Dupont USA
PrivateNovo Nordisk USA
Verenium USA
BASF Germany
Andritz Austria
DSM Netherlands
AB Enzymes Germany
University of Florida USA
Midwest Research Institute USA
PublicHebrew University of Jerusalem Israel
Lund University Sweden
Dartmouth USA
University of Florida USA
Iogen Energy Corp Canada
Arkenol USA
No. patents and applications
= 0 1‐5 6‐10 11‐20 21‐40 >100
Clark, Jensen, et al. Estudio PIPRA
Caso 2Caso 2
LIBERTAD DE OPERAR
SUBSITUYENDO TECNOLOGIASSUBSITUYENDO TECNOLOGIAS
Technical audits of Expression Construct Technical audits of Expression Construct for path to commercializationfor path to commercialization
Monsanto CompanyRockefeller University
LB
DSF in Transgenic Grape RootstocksDSF in Transgenic Grape Rootstocks PIPRA Recombinase GenePIPRA Recombinase Gene‐‐Excision VectorExcision Vector
DEF2
LB
MAS
RRS
Purdue Univ.
Rockefeller University
Monsanto
nptII
35S
Eili/Lilly
DEF2
MAS3’UTR
Univ. Kentucky
IP/34S Rockefeller Univ UCalifornia
nos3’UTR
Eili/LillyNovartis Hyg
Monsanto
34S Univ. California
Recomb
35S 3’UTRUSDA
35SMonsanto CompanyRockefeller University
Cyt Deam
NOS 3’UTR
Univ. CaliforniaRRS
rpfF of X. campesti
rfpF of X. fastidiosa
N 3’UTR
rpfB of X. campestris
No IPRS identified
No IPRS identified
Monsanto ????
rpfF of X. campesti
rfpF of X. fastidiosa
34S
No IPRS identified
No IPRS identified
RB
Nos 3’UTR
PVPs
Agro‐bacteria Mediated Transformation RB
Nos 3’UTR
rpfB of X. campestrisNo IPRS identified
Monsanto ????
Caso 3Caso 3
CONSIDERANDO TECNOLOGIA DOMINIO PUBLICO O PATENTADA
3/2009 Revista Science: RNAI Descubrimiento del Año
Fire and Mello 2006 Premio Nobel Fisiología y MedicinaFire and Mello 2006 Premio Nobel Fisiología y Medicina
RNAi tecnología para suprimir la expresión de genes de una forma directa y eficiente.
Potencial para:Terapéutica humanoTerapéutica humano
Biotecnología en AgriculturalOtras
http://nobelprize org/nobel prizes/medicine/lhttp://nobelprize.org/nobel_prizes/medicine/laureates/2006/press.html
Gene Suppression in Genetically Improved Specialty Cropsp y p
11994994 CalgeneCalgene11994, 994, CalgeneCalgeneCommercialized Commercialized first first
transgenic croptransgenic cropg pg p
CalgeneCalgene FLAVRSAVRFLAVRSAVRTMTM
PolygalacturonasePolygalacturonaseantisenseantisense
Delayed fruit ripeningDelayed fruit ripeningDelayed fruit ripeningDelayed fruit ripening
Unpublished Data, 2009 Chi‐Ham, Clark, Bennett
Caso 4Caso 4
ARMANDO PAQUETES TECNOLOGICOS
PIPRA’s Plant Transformation Marker Free Technology Platformsgy
1 S l t bl k
3. Excision markerUniv California
1. Selectable markersMAS Promoter, BRCD/PurdueNPTII
2. Constitutive PromotersUniv California,Cornell Univ
4. TransposaseUniv 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
IP StrategyIP Strategy –– pPIPRApPIPRA Vector LicensingVector LicensingIP Strategy IP Strategy pPIPRApPIPRA Vector Licensing Vector Licensing Model Model
Plant TransformationTechnology ProvidersPre negotiated licensing termsPre‐negotiated licensing terms
humanitarian use
research usePIPRA Design, test, and disseminate plant transformation vector Materials under Research/Commercial
Royalty free
MTA/Licenses commercial use
y y
Fee basedRevenue flow
Colaboraciones publico-privado para desarrollar tecnologías.
Arroz con uso Eficiente de Nitrógeno y Tolerancia a Suelos Salinos para pequeños
agricultores en África.
Arcadia Biosciences, provides trait technologies PIPRA, transformation technologies under
humanitarian, royalty-free terms AATF (African Agricultural Technology
d i ) f ili ll b i Foundation), facilitates collaboration USAID-Funding
Aplicando el estado del arte de la Aplicando el estado del arte de la ppinformación en la investigacióninformación en la investigación
Cecilia ChiCecilia Chi‐‐HamHamDirectora Ciencia y TecnologíaDirectora Ciencia y Tecnología
PROGRAMA FIA ‐ PIPRA
[email protected]@ucdavis.eduPIPRA, UC DavisPIPRA, UC Davis
LA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓN AGROALIMENTARIA
II. Formular Equipo Develop a team capable of analyzing all
aspects of the product development
Build multidisciplinary team
– Technical: scientific, biotech, pharma
IP/t h l t f t t t i t l– IP/technology transfer, patent agents, internal or external legal counsel• Legal counsel/ patent attorneys may be sought only if the warranted (later
stages, significant legal questions)g , g g q )• Consider pro‐bono legal counsel (i.e. Public Interest Intellectual Property
Advisors); IP service groups (MIHR, PIPRA, university)
R l t & b i d l t t– Regulatory & business development experts