Libertad de operación FTO

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

[email protected]@ucdavis.eduPIPRA, 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 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=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



www.PIPRA.orgwww.search.pipra.org



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


empresa nacional y conversaciones conempresas extranjeras

Estación Cebo para avispas chaqueta amarilla 0226-2008


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



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



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.



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



Proceso de Análisis Estado de Arte

I. Define Subject MatterII. Formulate TeamIII. Define Questions and IP Search

Strategy

IV. InvestigationV. 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, 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.



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



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.



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



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



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.



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



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



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



Caso 1

VISTA PANORAMICA DEL

ESTADO DEL ARTE



Research Sponsored by:

US Department of Energy,Chevron, & BP

Estado de arte de Biocombustibles

Clark, Jensen, et al. Estudio PIPRA



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




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


Distribución de Patentes por Tecnología y SectorDistribución de Patentes por Tecnología y Sector



Caso 2

LIBERTAD DE OPERAR

SUBSITUYENDO TECNOLOGIAS



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.



Caso 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



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



Gene Suppression in Genetically ImprovedSpecialty Crops

11982,982, CalgeneCalgene

CommercializedCommercialized firstfirsttransgenic croptransgenic crop

CalgeneCalgene FLAVRSAVRFLAVRSAVRTMTM

PolygalacturonasePolygalacturonase

antisenseantisense

Delayed fruit ripeningDelayed fruit ripening



Un ublished Data, 2009 Chi-Ham, Clark, Bennett



Caso 4

ARMANDO PAQUETES

TECNOLOGICOS



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



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.



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 Tecnologí[email protected]@ucdavis.edu

PIPRA, UC DavisPIPRA, UC Davis

II Formular Equipo



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

Libertad de operación FTO

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