Intellectual Property and Development of Transgenic Horticultural Crops - Transgenic Horticultural Crops: Challenges and Opportunities - page 228

Similarly,.other.patents.may.limit.the.use.of.the.E8.promoter.in.chimeric.constructs.
that. contain. other. promoter. elements.. For. example,. another. of. Agritope's. patent,.
U.S..6,118,049,.claims.the.use.of.the.tomato.E8.promoter.fused.to.a.portion.of.the.
tomato. E4. promoter.. These. examples. illustrate. the. complexities. in. analyzing. the.
FTO.of.particular.DNA.elements..We.exemplify.that.FTO.may.differ.when.you.con-
sider.a.DNA.element.by.itself.(i.e.,.promoters).or.in.combination.with.other.elements.
(i.e.,.trait.genes).
This. example. provides. an. overview. of. the. data. and. information. that. should.be.
considered.in.an.FTO.analysis..It.is.not.dificult.to.imagine.how.the.complexity.of.
an. FTO. analysis. would. grow.dramatically. with.the. inclusion. of. multiple. enabling.
technologies,.one.or.more.trait.technologies.and.proprietary.germplasm..This.is.one.
of. the. challenges. of. understanding. IP. constraints. and. developing. FTO. strategies.
in.plant.biotechnology.where.multiple.complementary.technologies.are.necessarily.
integrated.to.develop.new.crop.varieties.
STRATEGIES FOR IP ACCESS
During. the. 1990s,. it. became. clear. that. universities. and. nonproit. agricultural.
research.institutions.were.constrained.in.their.historical.role.of.providing.many.new.
agricultural.innovations—particularly.biotechnology-derived.innovations—directly.
to.the.agricultural.industry.or.to.farmers..This.was.especially.apparent.for.specialty.
or.horticultural.crops.that.do.not.individually.occupy.the.large.acreage.of.agronomic.
crops.but.as.a.group.represent.a.high-value.agricultural.sector..While.there.are.many.
contributing. factors,. access. to. the. suite. of. proprietary. technologies. required. to.
produce. a. genetically. modiied. crop. has. been. frequently. cited. as. a. barrier. to. the.
commercialization.of.public.sector.agricultural.research. 12 .In.Europe,.a.similar.pic-
ture.emerged.in.2000,.when.a.Swiss.scientist.developed.“Golden.Rice,”.genetically.
modiied. rice. with. elevated. provitamin. A, 13 . which. triggered. an. intellectual. prop-
erty.audit..The. audit.revealed.that.70.proprietary.technologies.had.been.infringed.
in. the. development. of. Golden. Rice. and. illustrated. the. complex. patent. thicket. that.
surrounded.biotechnology.innovations.for.crop.improvement. 14
The. complex. IP. environment. surrounding. agricultural. biotechnology. research.
and.development,.exempliied.by.the.Golden.Rice.case.or.even.the.relatively.simple.
FTO.opinion.described.above,.has.spawned.some.new.strategies.and.new.organiza-
tions.committed.to.lower.the.IP.barriers.to.new.crop.developments.and.to.provide.
more.open.access.to.patented.technologies..These.issues.are.critical.for.small.private.
companies.attempting.to.enter.this.sector.but.can.also.be.important.for.public.or.not-
for-proit.research.institutions..Most.plant.biotechnology.laboratories.routinely.use.
patented.technologies.in.their.research.without.speciic.legal.permissions..Although.
patent.owners.have.rarely.been.concerned.about.academic.research.infringement.in.
agriculture,.there. are. many. examples.where. fundamental. biomedical. research. has.
been.challenged.because.of.IP.issues. 15 .In.addition,.projects.carried.out.in.public.or.
not-for-proit.institutions.that.are.targeted.toward.the.development.of.crops.for.devel-
oping.country.farmers.must.consider.the.IP.inputs.to.the.project..Increasingly,.the.
sponsors.of.such.research.are.requiring.the.full.analysis.and.disclosure.of.strategies.
to.ensure.global.access.to.all.IP.embodied.in.a.project.