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8/14/2019 Libertad de operación FTO
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PROGRAMA FIA - PIPRA
LA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓNAGROALIMENTARIA
Aplicando el estado del arte yAplicando el estado del arte ylibertad para operar en lalibertad para operar en la
investigación y desarrolloinvestigación y desarrollo
Cecilia ChiCecilia Chi--HamHam
Directora Ciencia y TecnologíaDirectora Ciencia y Tecnología
clchiham@ucdavis.educlchiham@ucdavis.eduPIPRA, UC DavisPIPRA, UC Davis
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www.iphandbook.com
En las áreas agrícola, es cada día mas
importante entender el rol de los patentes y
la propiedad intelectual en investigación,desarrollo, y comercialización.
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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 esp@cenet.com
– Google Patent http://www.google.com/ptshp?tab=wt
– 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 – Others: Westlaw, Lexis, STN, etc.
Explore other Databases and ResourcesExplore other Databases and Resources
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www.PIPRA.orgwww.search.pipra.org
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PATENTES INIA LA CRUZ, Robison Vargas, Director
Nombre SolicitudAsociado
Vinculación empresa
Matriz para la atracción y consumo de avispas
Vespula sp. Que comprende un alimento a
base de carne animal; cebo que comprende la
matriz antes mencionada. 03208-2007
En proceso de licenciamiento con
empresa nacional y conversaciones con
empresas extranjeras
Uso de extractos Etanólicos de Cuesco de
Palta Persea americana Mill , variedad Hass,
como Acaricidas e Insecticidas 03612-2007 PUCV
Formación de Consorcio empresarial,
entre empresarios e INIA
Uso de compuestos químicos orgánicos
individuales del tipo alcoholes, aldehidos ycetonas, como atrayentes de la avispa V.
germanica 03850-2007
En proceso de licenciamiento con
empresa nacional y conversaciones conempresas extranjeras
Estación Cebo para avispas chaqueta amarilla 0226-2008
En proceso de licenciamiento con
empresa nacional y conversaciones con
empresas extranjeras
Equipo y método de limpieza de productos
agrícolas y de huevos de gallina mediante
aspersión con agua a presión 3272-2008
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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
productos.
Identifica elementos de PI que pueden afectar I&D.
Panorama del momento del Estado del Arte de pantes
en un área de tecnología.
PIPRA provee análisis de estado del arte de patentes
para apoyar desarrollo y adopción de proyectos y
productos.
Identifica elementos de PI que pueden afectar I&D.
Panorama del momento del Estado del Arte de pantes
en un área de tecnología.
Red PIPRA:
Estudios y Servicios Legales (alugnos, pro bono)
Townsend and Towsend and Crew
DLA Piper Rudnick Gray Cary
Morrison and Foerster
Harness, Dickey and Pierce
Foley Hoag
Edwards & Angell
Baker & McKenzie
Public Interest IP Attorneys (PIIPA)
Fulbright & Jaworski
Pierce Law, Franklin Pierce Law Center
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Freedom to Operate FTO
Libertad para Operar
…is an ongoing legal assessment of the…is an ongoing legal assessment of the
intellectual property rights covering aintellectual property rights covering aparticular technology space.particular technology space.
…performed to ensure that a new…performed to ensure that a new
innovation does not infringe other’sinnovation does not infringe other’s
intellectual property.intellectual property.
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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?)
Replace with substitute technologies with greater FTO
Purchase the Patent(s) or In-License rights
Cross-License
Invent around the blocking patent Develop a patent pool or a clearinghouse
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Proceso de Análisis Estado de Arte
I. Define Subject MatterII. Formulate TeamIII. Define Questions and IP Search
Strategy
IV. InvestigationV. Product of the Search
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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, etc.• Material transfer agreements and property trail
– Distinguish ‘core’ and ‘substitutable’ technologies
Geographies – Countries in which the product will be developed, manufactured,
approved by regulatory agencies, and marketed/sold
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.
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Stanton Gelvin, Purdue University
Kan Wang, Iowa State University
Pal Maliga, Rutgers University
David Ow, USDA-ARS, UC Berkeley
Brian Miki, Agriculture and Agri-Food Canada
Vibha Srivastava, University of Arkansas
Chris Taylor, Donald Danforth Plant Science Center
David Tricoli, University of California Davis
Francois Torney, Iowa State University
Robert Houtz, University of Kentucky
Michael Lang, Harness, Dickey & Pierce, P.L.C.
Michael Ward, Morrison & Foerster LLPClinton Neagley, University of California, Davis
Charles McManis, Washington University Law School
James Surber, Patent Attorney, Bryan Cave Chuck LLP
Chuck McManis, Washington University School of Law
Robert Horsch, MonsantoQi Wang, Monsanto
Keith Redenbaugh, Seminis Vegetable Seeds
Kathy Swords, Biotech Business Development, J.R. Simplot Company
Alan Bennett, PIPRA, University of California Davis
Karel Schubert, Donald Danforth Plant Science Center
Sara Boettiger, PIPRA, University of California Berkeley
Cecilia Chi-Ham, PIPRA, University of California Davis
SCIENTISTSSCIENTISTSSCIENTISTSSCIENTISTS
AttorneysAttorneysAttorneysAttorneys
AgAg--Biotech CompaniesBiotech CompaniesAgAg--Biotech CompaniesBiotech Companies
Regulatory ExpertsRegulatory ExpertsRegulatory ExpertsRegulatory Experts
PIPRAPIPRAPIPRAPIPRA
II. Formular Equipo
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III. Define Questions
Interview and laboratory history
– Interview scientific, technical, and technology transfer/IP
staff – Technical description of the technology
Review 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 congruentwith the projects immediate and future goals.
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IV. Nivel I Estado de Arte/Libertad para Operar
Review Patent Search ResultsReview Patent Search Results Identify Patents (present risks)
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)
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
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Nivel II Estado de Arte/Libertad para Operar
Construct IP Priority Timeline and “Landscape”
– Group Patent Risks by Subject Matter – Determine relative Patent Dominance
• priority date
• broader vs. narrower patents-- Broader patents may have leverage to seekhigher fees/control entry into the market
– Timeline of public information ‘prior art’ with patent history
– Construct Vertical / International Families
– Claim analysis by legal counsel
– Obtain & Evaluate Patent File Histories
Check Patent Litigation Records – Held Invalid? Unenforceable?
– Interferences?
Patent Landscape | Based on Public informationPatent Landscape | Based on Public information
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Check Business and News Records
Patentee’s Website / Annual Report SEC Filings by Patentee – “Risks”
Press Releases by Patentee
Industry-Specific and General News Reports
Is the Patentee likely to Enforce IP rights?
cont…cont… NivelNivel II.II.
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Nivel III. Estado de Arte/FTO
Unpublished Patent Applications
– U.S. Provisional Applications
– U.S. Utility Applications < 18 months – File Histories of Pending Applications
Unpublished research data, manuscripts
Business Goals / Project Status
Threatened Litigation
Patent Landscape | Requires Confidential Information andPatent Landscape | Requires Confidential Information and
Cooperation from Patentee, Contracts and Grants and TechCooperation from Patentee, Contracts and Grants and Tech
Transfer OfficesTransfer Offices
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Contracts affecting Ownership – Assignments, Licenses
– Funding/research agreements
– Availability/Licensing information• Usually not public information
• PIPRA’s ag-IP portfolio includes licensing information
cont…cont… NivelNivel IIIIII
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V. Producto de Análisis de Estado de Arte
Attorney-Client Privilege – According to US law product of FTO search is considered attorney-
client privilege information
– Information remains confidential if the client chooses to do so – Not all legal counsel are attorneys…thus Degree of protection may varySuch terms should be discussed in advance
Oral Advice of Counsel Written Report
– Scope of Search, Search Strategies – Listing of Identified Risks – Analysis of Identified Risks
Formal Written Opinion – Noninfringement or Invalidity
Patent Landscape Changes over Time – FTO product is a “Living Document” and requires constant updates
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Caso 1
VISTA PANORAMICA DEL
ESTADO DEL ARTE
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Research Sponsored by:
US Department of Energy,Chevron, & BP
Estado de arte de Biocombustibles
Clark, Jensen, et al. Estudio PIPRA
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Mas de 1400 patentes y aplicaciones relacionadasMas de 1400 patentes y aplicaciones relacionadas
con producción decon producción de EtOHEtOH lignoligno--cellulosicocellulosico..
N o .
p a t e n t s a n d a p
p l i c a t i o n s
Clark, Jensen, et al. Estudio PIPRA
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No. patents and applications
= 0 1-5 6-10 11-20 21-40 >100
Chemical Physical CA/PH Enzymes Process Enzymes EEO ProcessPRETREATMENT SACCHARIF’N FERMENTATION C ’
P R O C E S S E S
Private
Public
Genencor USA
Novozymes USA
DSM Netherlands
Dupont USA
Novo Nordisk USA
Hebrew University of Jerusalem Israel
Verenium USA
BASF Germany
Andritz Austria
AB Enzymes Germany
Lund University Sweden
Dartmouth USA
University of Florida USA
Midwest Research Institute USA
Iogen Energy Corp Canada
Arkenol USA
Clark, Jensen, et al. Estudio PIPRA
Distribución de Patentes por Tecnología y SectorDistribución de Patentes por Tecnología y Sector
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Caso 2
LIBERTAD DE OPERAR
SUBSITUYENDO TECNOLOGIAS
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Technical audits of Expression ConstructTechnical audits of Expression Constructfor path to commercializationfor path to commercialization
Monsanto CompanyRockefeller University
Monsanto
RB
nptII
nos3’UTR
rpfF of X. campesti
rfpF of X. fastidiosa
Nos 3’UTR
LB
35S
35S
rpfB of X. campestris
Eili/LillyNovartis
No IPRS identified
Hyg
Monsanto
Monsanto CompanyRockefeller University
No IPRS identified
Monsanto ????
DSF in Transgenic Grape RootstocksDSF in Transgenic Grape Rootstocks PIPRA Recombinase GenePIPRA Recombinase Gene--Excision VectorExcision Vector
PVPs
Agro-bacteriaMediatedTransformation RB
DEF2
MAS3’UTR
rpfF of X. campesti
rfpF of X. fastidiosa
Nos 3’UTR
LB
MAS
34S
rpfB of X. campestris
RRS
Cyt Deam
NOS 3’UTR
34S
Univ. Kentucky
No IPRS identified
Univ. California
No IPRS identified
Monsanto ????
RRS
Univ. California
Recomb
35S 3’UTR
IP/34SRockefeller UnivUCalifornia
USDA
Purdue Univ.
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Caso 3
CONSIDERANDO TECNOLOGIA
DOMINIO PUBLICO O PATENTADA
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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
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http://nobelprize.org/nobel_prizes/medicine/laureates/2006/press.html
RNAi tecnología para suprimir
la expresión de genes de una
forma directa y eficiente.
Potencial para:
Terapéutica humano
Biotecnología en Agricultural
Otras
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Gene Suppression in Genetically ImprovedSpecialty Crops
11982,982, CalgeneCalgene
CommercializedCommercialized firstfirsttransgenic croptransgenic crop
CalgeneCalgene FLAVRSAVRFLAVRSAVRTMTM
PolygalacturonasePolygalacturonase
antisenseantisense
Delayed fruit ripeningDelayed fruit ripening
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Un ublished Data, 2009 Chi-Ham, Clark, Bennett
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Caso 4
ARMANDO PAQUETES
TECNOLOGICOS
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IP Strategy IP Strategy – – pPIPRA pPIPRA Vector LicensingVector LicensingModel Model
Royalty free
Fee
basedRevenue flow
Plant TransformationTechnology ProvidersPre-negotiated licensing terms
research use
PIPRADesign, test, and disseminate planttransformation vector Materials underResearch/Commercial
MTA/Licenses
humanitarian
use
commercial use
Colaboraciones publico privado para
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Arcadia Biosciences, provides trait technologies
PIPRA, transformation technologies underhumanitarian, royalty-free terms
AATF (African Agricultural Technology
Foundation), facilitates collaboration USAID-Funding
Colaboraciones publico-privado paradesarrollar tecnologías.
Arroz con uso Eficiente de Nitrógeno y Tolerancia a Suelos Salinos para pequeños
agricultores en África.
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PROGRAMA FIA - PIPRA
LA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓNAGROALIMENTARIA
Aplicando el estado del arte de laAplicando el estado del arte de la
información en la investigacióninformación en la investigación
Cecilia ChiCecilia Chi--HamHam
Directora Ciencia y TecnologíaDirectora Ciencia y Tecnologíaclchiham@ucdavis.educlchiham@ucdavis.edu
PIPRA, UC DavisPIPRA, UC Davis
II Formular Equipo
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II. Formular Equipo
Develop a team capable of analyzing allaspects of the product development
Build multidisciplinary team
– Technical: scientific, biotech, pharma
– IP/technology transfer, patent agents, internal orexternal legal counsel• Legal counsel/ patent attorneys may be sought only if the warranted (later
stages, significant legal questions)
• Consider pro-bono legal counsel (i.e. Public Interest Intellectual PropertyAdvisors); IP service groups (MIHR, PIPRA, university)
– Regulatory & business development experts
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