Intellectual Property and Development of Transgenic Horticultural Crops - Transgenic Horticultural Crops: Challenges and Opportunities - page 224

Tangible property rights . reside. with. the. property. owner.. MTAs. are. typically.
used.to.transfer.possession.of.materials.but.not.ownership..The.party.who.transfers.
the. materials. retains. full. ownership,. and. the. transfer. is. governed. by. a. contract,.
typically.specifying.the.term.of.the.transfer,.how.the.materials.may.and.may.not.
be.used,.and.other.related.issues,.such.as.conidentiality..MTAs.are.legal.contracts.
and. are. also. referred. to. as. bailments,. which. is. the. legal. term. for. a. contract. that.
transfers.physical.possession.but.not.ownership.of.personal.property..In.research,.
MTAs.are.often.used.for.transfer.of.materials.for.research.use.only,.allowing.sci-
entist.to.perform.academic.research..However,.there.is.typically.no.guarantee.or.
promise. that. the. owner. will. give. rights. for. commercial. applications.. Also,. the.
time.period.and.geographical.limitations.can.be.established.by.the.property.owner,.
and,. thus,. unlike. patents,. limitations. on. the. use. of. tangible. property. typically.
have. no temporal. or. geographic. limitations.. Research-use. only. MTAs. are. typi-
cally.easier.to.obtain,.especially.between.public.or.nonproit.research.institutions,.
but.could.represent.a.considerable.obstacle.downstream.if.the.materials.cannot.be.
used.for.commercial.applications.
FREEDOM TO OPERATE
Navigating.the.complex.IP.landscape.of.a.research.project.in.horticultural.biotech-
nology.requires.some.analytical.tools.and. specialized.analytical.capabilities. 6 .The.
analysis.requires.both.legal.and.scientiic.knowledge.as.well.as.access.to.both.patent.
and.literature.databases.and.typically.takes.the.form.of.what.is.known.as.a.freedom.
to.operate.(FTO).opinion..The.FTO.opinion.is.a.legal.assessment.about.whether.a.
research.project.or.the.development.of.a.new.product.can.proceed.with.a.low,.or.tol-
erable,.likelihood.that.it.will.not.infringe.existing.patents.or.other.types.of.IP.rights..
It. is. important. to. note. that. the. FTO. determination. is. not. absolute. but. relects. an.
evaluation.of.risk.since.there.is.typically.some.uncertainty.around.the.interpretation.
of.patent.claims.as. well. as.uncertainty.as.to. whether.new.IP. may. issue.or. be.dis-
covered.at.a.later.date..The.FTO.opinion.may.lead.to.a.range.of.options:.identifying.
in-licensing.targets,.considering.the.substitution.of.technologies.or.processes,.decid-
ing.to.ignore.the.potential.infringement,.investing.in.work-around.technologies,.or.
perhaps. deciding. to. abandon. the. project. all. together.. Although,. private. irms. are.
more.likely.to.engage.in.FTO.analysis.because.any.infringement.risk.may.directly.
affect.their.ability.to.develop.new.products,.and.their.ultimate.proitability,.public,.
and.not-for-proit.private.institutions. are.becoming.increasingly.aware.of.the.need.
for.better.FTO.information..This.is.particularly.true.for.research.projects.undertaken.
by.universities.or.not-for-proit.research.centers.for.the.speciic.purpose.of.producing.
new.crops.for.developing.countries..In.these.cases.where.deployment.is.anticipated,.
it.is.critical.that.IP.considerations.be.taken.into.account.early.in.the.research.process.
to.avoid.the.need.for.re-engineering.due.to.IP.constraints..Similarly,.horticulturists.
should.address.IP.needs.to.ensure.that.commercialization.is.not.halted.due.to.a.lack.
of.IP.clearance.
While.patents.are.the.most.common.type.of.IP.right.encountered,.a.thorough.FTO.
analysis.needs.to.assess.all.types.of.existing.property.rights.for.the.likelihood.that.the.
research. project. or. the. product. being. commercialized. infringes. terms. of. an. MTA..