1. Aplicando el estado del arte y
p y
libertad para operar en la
investigación y desarrollo
investigación y desarrollo
Cecilia Chi
Cecilia Chi‐Ham
Chi‐
Directora Ciencia y Tecnología
clchiham@ucdavis.edu
PROGRAMA FIA ‐ PIPRA
PIPRA, UC Davis
PIPRA UC D i
LA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓN
AGROALIMENTARIA

2. www.iphandbook.com
En las áreas agrícola, es cada día mas
importante entender el rol de los patentes y
la propiedad intelectual en investigación,
la propiedad intelectual en investigación
desarrollo, y comercialización.

3. 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
g 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
www.delphion.com
– Others: Westlaw, Lexis, STN, etc.
Explore other Databases and Resources

4. www.PIPRA.org
www.search.pipra.org

5. PATENTES INIA LA CRUZ, Robison Vargas, Director
Asociad Vinculación empresa
Vinculación empresa
Nombre Solicitud o
Matriz para la atracción y consumo de avispas En proceso de licenciamiento con
Vespula sp. Que comprende un alimento a empresa nacional y conversaciones con
base de carne animal; cebo que comprende la empresas extranjeras
matriz antes mencionada. 03208‐2007
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 INIA
Uso de compuestos químicos orgánicos En proceso de licenciamiento con
individuales del tipo alcoholes, aldehidos y empresa nacional y conversaciones con
cetonas, como atrayentes de la avispa V.
cetonas como atrayentes de la avispa V empresas extranjeras
empresas extranjeras
germanica 03850‐2007
En proceso de licenciamiento con
empresa nacional y conversaciones con
empresas extranjeras
t j
Estación Cebo para avispas chaqueta amarilla 0226‐2008
Equipo y método de limpieza de productos
agrícolas y de huevos de gallina mediante
aspersión con agua a presión 3272‐2008

7. Estado de Arte para Implementación de Proyectos
PIPRA provee análisis de estado del arte de patentes
para apoyar desarrollo y adopción de proyectos y
productos.
d Red PIPRA
PIPRA:
Estudios y Servicios Legales (alugnos, pro bono)
Identifica elementos de PI que pueden afectar I&D.
Identifica elementos de PI and Towsend and Crew
Townsend
que pueden afectar I&D
DLA Piper Rudnick Gray Cary
Panorama del momento del Estado del Arte de pantes
Morrison and Foerster p
en un área de tecnología. Dickey and Pierce
Harness,
Foley Hoag
Edwards & Angell
g
Baker & McKenzie
Public Interest IP Attorneys (PIIPA)
Fulbright & Jaworski
Pierce Law, Franklin Pierce Law Center

8. Freedom to Operate FTO
Libertad para Operar
b d
…is an ongoing legal assessment of the
is an ongoing legal assessment of the
intellectual property rights covering a
particular technology space.
ti l t h l
…performed to ensure that a new
innovation does not infringe other’s
g
intellectual property.

9. 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

10. Proceso de Análisis Estado de Arte
I. Define Subject Matter
II.
II Formulate Team
Formulate Team
III. Define Questions and IP Search
Strategy
IV. Investigation
V. Product of the Search
P d t f th S h

11. 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.
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
Ti f
– 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.

12. II. Formular Equipo
Stanton Gelvin, Purdue University
Kan Wang, Iowa State University
SCIENTISTS Pal Maliga, Rutgers University
David Ow, USDA‐ARS, UC Berkeley
Brian Miki, Agriculture and Agri‐Food Canada
Vibha Srivastava, University of Arkansas
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
R b H U i i fK k
Michael Lang, Harness, Dickey & Pierce, P.L.C.
Michael Ward, Morrison & Foerster LLP
Attorneys Clinton Neagley, University of California, Davis
g y, y ,
Charles McManis, Washington University Law School
James Surber, Patent Attorney, Bryan Cave Chuck LLP
Chuck McManis, Washington University School of Law
Ag‐Biotech Companies
Ag‐Biotech Companies Robert Horsch, Monsanto
Robert Horsch Monsanto
Qi Wang, Monsanto
Keith Redenbaugh, Seminis Vegetable Seeds
Regulatory Experts
Kathy Swords, Biotech Business Development, J.R. Simplot Company
Alan Bennett, PIPRA, University of California Davis
Karel Schubert, Donald Danforth Plant Science Center
PIPRA Sara Boettiger, PIPRA, University of California Berkeley
Cecilia Chi‐Ham, PIPRA, University of California Davis

13. 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 congruent
y p q g
with the projects immediate and future goals.

14. IV. Nivel I Estado de Arte/Libertad para Operar
Are there blocking patents that could preclude pursuing a new goal?
Based on Public information
 Review Patent Search Results
 Identify Patents (present risks)
y
 Identify Patent Applications (potential future risks)
 Determine IP Ownership and Status
 Maintenance Status‐‐ anticipated expiration date, abandoned, etc.
 Check Assignment Records
 Availability/Licensing information
o Usually not public information (PIPRA‐Network)

15. Nivel II Estado de Arte/Libertad para Operar
Patent Landscape | Based on Public information
 Construct IP Priority Timeline and Landscape
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 history
Timeline of public information ‘prior art’ with patent history
– Construct Vertical / International Families
– Claim analysis by legal counsel
– Obtain & Evaluate Patent File Histories
Obtain & Evaluate Patent File Histories
 Check Patent Litigation Records
– Held Invalid? Unenforceable?
– I t f
Interferences?
?

16. cont… Nivel
cont… Nivel II.
 Check Business and News Records
Check 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?

17. Nivel III. Estado de Arte/FTO
Patent Landscape | Requires Confidential Information and
Cooperation from Patentee, Contracts and Grants and Tech
Transfer Offices
Transfer Offices
 Unpublished Patent Applications
– U.S. Provisional Applications
– U.S. Utility Applications < 18 months
– File Histories of Pending Applications
 Unpublished research data, manuscripts
p , p
 Business Goals / Project Status
 Threatened Litigation
Threatened Litigation

18. cont… Nivel
cont… Nivel III
 Contracts affecting Ownership
– Assignments, Licenses
Assignments Licenses
– Funding/research agreements
– Availability/Licensing information
/
• Usually not public information
• PIPRA’s ag‐IP portfolio includes licensing information
’ f l l d l f

19. 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
client 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 vary
Such 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 Risks
Analysis 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

20. Caso 1
VISTA PANORAMICA DEL
ESTADO DEL ARTE
ESTADO DEL ARTE

21. Estado de arte de Biocombustibles
Clark, Jensen, et al. Estudio PIPRA
Research Sponsored by:
US Department of Energy,
Chevron, & BP

22. Mas de 1400 patentes y aplicaciones relacionadas
con producción de EtOH ligno‐cellulosico.
con producción de EtOH ligno‐cellulosico.
p g
d applications
No. patents and
Clark, Jensen, et al. Estudio PIPRA

23. Distribución de Patentes por Tecnología y Sector
PROCESSES
C’ P
PRETREATMENT SACCHARIF’N FERMENTATION
Chemical Physical CA/PH Enzymes Process Enzymes EEO Process
Genencor USA
Novozymes USA
Dupont USA
Novo Nordisk USA
Verenium USA
BASF Germany
Andritz Austria
Private
DSM Netherlands
AB Enzymes Germany
Midwest Research Institute USA
University of Florida USA
University of Florida USA
Dartmouth USA
Lund University Sweden
Hebrew University of Jerusalem Israel
Public
Iogen Energy Corp Canada
Arkenol USA
Clark, Jensen, et al. Estudio PIPRA No. patents and applications
= 0 1‐5 6‐10 11‐20 21‐40 >100

24. Caso 2
LIBERTAD DE OPERAR
SUBSITUYENDO TECNOLOGIAS
SUBSITUYENDO TECNOLOGIAS

25. Technical audits of Expression Construct
for path to commercialization
DSF in Transgenic Grape Rootstocks LB
PIPRA Recombinase Gene‐
PIPRA Recombinase Gene‐Excision Vector
RRS
MAS Purdue Univ.
LB
Monsanto Company
Rockefeller University
Rockefeller University DEF2
Univ. Kentucky
35S MAS3’UTR
Monsanto
IP/34S Rockefeller Univ
nptII UCalifornia
Eili/Lilly Recomb
Novartis Hyg
USDA
nos3’UTR 35S 3’UTR
Monsanto
34S Univ. California
Cyt Deam
Monsanto Company 35S NOS 3’UTR
Rockefeller University
RRS
Univ. California
No IPRS identified rpfF of X. campesti 34S
No IPRS identified rfpF of X. fastidiosa
rpfF of X. campesti
No IPRS identified
Monsanto ???? rpfB of X. campestris
rfpF of X. fastidiosa
Nos 3’UTR
N 3’UTR No IPRS identified
No IPRS identified
rpfB of X. campestris
PVPs Monsanto ????
Nos 3’UTR
Agro‐bacteria
Mediated RB
Transformation RB

26. Caso 3
CONSIDERANDO TECNOLOGIA
DOMINIO PUBLICO O PATENTADA

27. 3/2009 Revista Science: RNAI Descubrimiento del Año
Fire and Mello 2006 Premio Nobel Fisiología y Medicina

28. RNAi tecnología para suprimir
la expresión de genes de una
forma directa y eficiente.
Potencial para:
Terapéutica humano
Terapéutica humano
Biotecnología en Agricultural
Otras
http://nobelprize.org/nobel_prizes/medicine/l
http://nobelprize org/nobel prizes/medicine/l
aureates/2006/press.html

29. Gene Suppression in Genetically Improved
p y p
Specialty Crops
1994 Calgene
994, Calgene
994,
Commercialized first
Commercialized first
transgenic crop
g p
Calgene FLAVRSAVRTM
Polygalacturonase
antisense
Delayed fruit ripening
Delayed fruit ripening

30. Unpublished Data, 2009 Chi‐Ham, Clark, Bennett

31. Caso 4
ARMANDO PAQUETES
TECNOLOGICOS

32. PIPRA’s Plant Transformation
Marker Free Technology Platforms
gy
3. Excision marker
Univ California
1. Selectable markers
1 S l t bl k
MAS Promoter, BRCD/Purdue 4. Transposase
NPTII Univ California
2. Constitutive Promoters
Univ California,
Cornell Univ.,
Cornell Univ
AgriFood Canada,
•Comprised of multiple patented components (PIPRA Members)
•Incorporates technical, legal, and regulatory design features
p
•Compatible with:
– Agrobacteria and Non‐Agrobacteria strains (Transbacter, Cambia)
– T‐DNA transfer borders from Agrobacteria or Plant Derived

33. IP Strategy
IP Strategy – pPIPRA Vector Licensing
Vector Licensing
Model
Plant Transformation
Technology Providers
Pre‐negotiated licensing terms
Pre negotiated licensing terms
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

34. 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
Foundation), facilitates collaboration
d i ) f ili ll b i
 USAID-Funding

35. Aplicando el estado del arte de la
p
información en la investigación
Cecilia Chi‐
Cecilia Chi‐Ham
Directora Ciencia y Tecnología
clchiham@ucdavis.edu
PIPRA, UC Davis
PROGRAMA FIA ‐ PIPRA
LA GESTIÓN DE PROPIEDAD INTELECTUAL EN LA INNOVACIÓN
AGROALIMENTARIA

36. 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
IP/technology transfer, patent agents, internal or
t f t t t i t l
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
Regulatory & business development experts
l t &b i d l t t