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. 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. Public Sector
+
Responds to the IP
challenge
Small Business Innovation Research Program
(SBIR)

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. 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. … 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. 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. 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. +
What do we do?
Technology Scouting Commercialization Strategy
Intellectual Property Rights Regulatory Issues
Licensing & Agreements
g g PIPRA Labs
Education and outreach

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. 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. 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. 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. Agricultural products may contain
different patented parts and processes
Golden Rice vs Golden Rice v2

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. 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. 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. 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. +

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. + 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. 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. 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. 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. 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. 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. 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

29. Biofuel Patent Landscape
Research Sponsored by:
US Department of Energy,
Chevron, & BP

30. 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

31. 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

32. 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

33. The intellectual property landscape for gene suppression
technologies in plants
Nature Biotechnology , Jan. 2010 Chi-Ham, Clark, Bennett

34. 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

35. 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

36. +
East Coast Fever
Newcastle Disease
Rift Valley Fever
Porcine Cysticercosis
GALVmed: commercialization
strategies for livestock
vaccines for the very poor.
www.galvmed.org

37. + 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

38. Publishes Information about
IP strategy and management
2,000 pages
150+ chapters
Practical guide to IP for developing countries
www.IPHANDBOOK.org

39. 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

40. + 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

41. 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.

42. 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.

43. Thank you
www.pipra.org
www.fia.pipra.org
Celebrating the life and spirit of
Maria Jesus (Chusa) Gines
&
Veronica Mera