Agricultural Research Service Office of Technology Transfer

Technology Transfer

For Plant Breeders

What we will cover:

Material Transfer Agreements for plants

ARS’ process for releasing plant material

Plant Variety Protection Committee

Methods for protection of the intellectual property in plant varieties

Can unreleased germplasm be sharedfor breeding and/or evaluation?

yes, withappropriate documentation

Documentation:Cooperative research agreement Material Transfer Agreement

(MTA)Standard Material Transfer Agreement

(SMTA)

What are the purposes of an MTA?

Allow others to evaluate ARS germplasm

Allow others to breed with ARSgermplasm

Allow ARS to evaluate non-ARS germplasm

Allow ARS tobreed with non-ARS germplasm

What are the purposes of an MTA?(cont’d)

Confidential transfer of material & related informationProtects proprietary & patent rightsRestricts the use of material & related information

MTA does not authorize cooperative research and requires the signature

of the RL and TTC!

How do you develop an MTA?

Different MTA templates exist for evaluation and breeding

MTAs can be custom written for specific situations

Consult with your TTC for help in selecting or developing an MTA

Be sure to have your TTC reviewany MTA provided by another party

Legally-binding contract with pre-negotiated terms under the UN Food & Agriculture Organization (FAO)

Developed by International Treaty on Plant Genetic Resources for Food & Agriculture (PGRFA)

What is an SMTA?

SMTA must accompany each transfer of covered PGRFA materials

Establishes a multilateral system (MLS) for facilitated access to PGRFA and for sharing benefits arising from their use

What is covered by an SMTA?

64 food & feed cropslisted in Annex I

PGRFA in the InternationalAgricultural Research Center Collections

PGRFA ex situ collectionsof national governmentsor public domain

PGRFA donated or availableto MLS by public or private entities

What does the SMTA NOT cover?

Crops not listedin Annex I Chemical, pharmaceutical or

other non-food or non-feeduses of Annex I crops

Public collections not undernational government controlor private collections PGRFA found

in situ

What are the SMTA rules?

SMTA must be reported to the International Treaty

All non-confidential information resulting from

using PGRFA must be made available to the MLS

Research & breeding materials that incorporate PGRFA must be exchanged under the terms of the SMTA

The full text of the SMTA is available at ftp://ftp.fao.org/ag/agp/planttreaty/agreements/smta/SMTAe.pdf

Treaty Party

International Agricultural Research Center

NPGS, for accessions acquired under SMTA

Researcher who received PGRFA under an SMTA

What sources of germplasm mightbe subject to SMTA obligations?

NPS authorization is requiredto use SMTA material in an

ARS breeding program

Check with your RL, National Program Leader (NPL) & TTC

Seedlings bred from publically available germplasm (ARS germplasm) with SMTA protected germplasm becomes SMTA protected germplasm

If an ARS breeding program incorporates SMTA germplasm, then it is not publically available without restrictions

SY contacts TTC; TTC sends SMTA toOTT for processing

OTT gets officialNPS approval

SY / RL / NPL decide if SMTA materialshould be used

What is the procedure for usingSMTA material in breeding?

TTC send approvedSMTA to SY

If germplasm/variety isreleased using SMTA material, SY includes this fact in the Official Release Notice

ARS scientists have a long and successful history of developing both finished varieties and enhanced germplasm and transferring them through public release.

System for releasing plant materials: Policy

The ARS policy is to public release these materials without IP protection. However, exceptions to this policy for certain ARS developed or co-developed varieties may be made on a case-by-case basis.

Facilitate the release processfor plant materials developedor co-developed by ARS.

Plant material release system is designed to:

Allow timely decisions on IP protectionon a case-by-case basis.

ProcessUse of a new electronic systems, which is a subsystem, of ARIS for ALL plant releases whether or not IP protection is requested.

A new committee to make decisions on seeking IP for new plant varieties based on established criteria.

Training for ARS breeders and management on the new system.

Outreach to our customers and stakeholders.

Finished varietiesEnhanced germplasmGenetic lines / stocks

What plant materials canbe officially released?

SY writes draft Release Noticein consultation with NPL

Office support transfersdata into ARIS

SY & RL decide if ‘plant’is ready to be release

Answer 6 questions

Was this variety developed in cooperation with a university experiment station or other organization? What resources were contributed by the cooperator (e.g. technicians, breeders, land, facilities, services, test data, etc.)? List all cooperator employees who were directly involved in the breeding and selection of this material.

Question 1

Do not forget to state if SMTA material was used

Enter the complete draft textof proposed release notice.

Question 2

Do not forget to state if SMTA material was used

Who is expected to use the released plant material and how they will use it? What public or private organizations have requested this material for research, breeding or testing purposes? Have you consulted with any commodity groups?

Question 3

List any publications and/or public use of this plant material. Has the material been provided to anyone outside of USDA for field-testing purposes? Have seeds, cuttings, fruit or other materials been sold by cooperators? If so, give dates.

Question 4

Explain how protection will facilitate technology transfer that would otherwise not occur if the variety is publicly released. Does the variety have any special characteristics that would make protection desirable (e.g., niche market use, transgenic, incorporates proprietary technology, incorporates third party IP).

Question 5

Is there an international market for this variety? If so, in what countries? Have you sent the variety to anyone outside the U.S. for testing or breeding? If so, provide countries and dates.

Question 6

SY writes draft Release Noticein consultation with NPL

Office support transfersdata into ARIS

IP requested in ARIS ?

Yes No

Plant Variety IntellectualProperty Committee

(PVIP)

Hard copy of Release Notice sent to Administrator

for signature

SY & RL decide if ‘plant’is ready to be release

Plant Variety Intellectual Property Committee (PVIP)

*TTC*Breeder*RL*Area Director or designee*NPL*Patent Advisor (if a patentable crop)*Marketing & Information

Meets quarterly

Co-chaired by Gail Wisler NPS / June Blalock OTT

* Member varies based on variety in question

If co-owned, has the co-owner already expressed a favorable opinion about seeking protection?

Do we (or our co-owner) have experience with protecting and/or licensing this type of plant? If so, has this helped facilitate technology transfer?

Are there specific characteristics of this variety that make protection desirable? Have commercial seed

companies or nurseries expressed an interest in marketing and producing the variety for sale?

What are criteria for decidingif protection is sought?

Who are the U.S. end users (stakeholders) of this variety? Have they been consulted yet? If so, do they favor protection?

Would seeking protection enhance the competitiveness of U.S. growers in world markets and/or help level the playing field internationally?

Could seeking protection and licensing this variety impact negatively the ability of our breeders to access foreign germplasm?

In general, would seeking protection enhance technology transfer for this variety?

What are criteria for decidingif protection is sought? (cont’d)

Committee Recommendations

Defer for more informationRecommend public releaseRecommend filing a Plant Patent

or PVPC Application & LicensingRecommend for PVPC & publicrelease by university partnerRecommend for filing Plant Breeder’s

Rights & list countries of interest

What are the ways in whichplant material may be protected?

Asexually propagated plants: Plant Patent (PP)

http://www.uspto.gov/web/offices/pac/plant/

Sexually propagated plants:Plant Variety Protection

(PVP)http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateC&navID=PlantVarietyProtectionOffice&rightNav1=PlantVarietyProtectionOffice&topNav=&leftNav=ScienceandLaboratories&page=PlantVarietyProtectionOffice&resultType=&acct=plntvarprtctn

What information is neededfor PP or PVP application?

Breeding history related to prior art•Not obvious (PP)•Not essentially derived (PVP)

Complete botanical descriptionleaves simple, entire, symmetrical, lanceolate,apiculate tip; average 4.5 cm length, 2.4 cmwidth; adaxial surface black (RHS 202A); etc.

Distinctness/novelty of the claimed plantComparison with data to similar varieties

OTT submits application

Handbook for

Plant Breeders

Available on Web:http://www.ars.usda.gov/SP2UserFiles/Place/00000000/OTTGeneral/ARSPlantBreedersHandbook.pdf

Office of TechnologyTransfer is here to help

Your TTC & Patent Advisor are a source of information & help.

Call early & call often.