Agriculture Reference
In-Depth Information
At.irst.sight.transgenic.technology.represents.a.rapid.and.simple.way.of.modifying.
plant.traits.for.the.development.of.novel.patentable.varieties..At.its.simplest.level,.it.
allows.the.modiication.of.traits.by.transfer.of.speciic.trait.genes.to.a.targeted.vari-
ety..If.the.gene.brings.about.a.change.in.a.protected.variety,.for.example.petal.color,.
a.plant.patent.in.the.United.States.could.potentially.protect.that.variety..However,.in.
UPOV.countries,.the.new.variety.would.be.viewed.as.essentially.the.same.as.the.par-
ent.variety,.or.“essentially.derived.”.The.developer.of.the.transgenic.variety.would.
require.a.license.from.the.owner.of.the.original.variety.before.commercialization.
In. practice,. however,. transgenic. technology. has. proven. to. be. both. technically.
demanding. and. expensive,. especially. when. the. full. range. of. intellectual. property.
issues.are.considered..Unlike.other.breeding.technologies,.the.transgenic.approach.
requires. use. of. multiple. novel. technologies,. genes,. and. vectors. each. of. which. can.
be.covered.by.a.utility.patent.restricting.the.use.of.that.technology.in.one.or.more.
territories.. These. patent-related. issues. have. been. discussed. in. detail. in. a. previous.
review.
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.In.short,.the.breadth.and.strength.of.a.patent.can.vary.greatly..For.exam-
ple,. engineering. novel. petal. color. might. involve. the. use. of. a. coding. sequence. for.
an.enzyme.involved.in.the.formation.of.a.novel.pigment..In.a.hypothetical.case,.a.
broad.patent.covering.all.uses.of.the.coding.sequence.to.modify.pigment.formation.
may.cover.this.coding.sequence..In.other.cases.the.breadth.of.the.patent.might.be.
restricted.to.a.narrower.subset.of.uses..For.example,.claims.may.only.be.granted.for.
use.of.the.coding.sequence.for.its.use.in.color.modiication.of.petals.of.a.speciic.
species..The.developer.and.his/her.patent.counsel.need.to.carefully.read.the.patent,.
its.claims,.and.the.prosecution.history.to.fully.understand.the.breadth.of.a.patent..
If. the. developer's. use. of. the. coding. sequence. falls. outside. the. granted. claims. of.
the. patent,. the. developer's. legal. counsel.may. determine.that. no.license.is. needed..
Conversely,.the.patent.may.be.suficiently.broad.to.make.commercialization.without.
a. license. from. the. patent. holder. impossible.. In. such. cases,. the. developer. needs. to.
negotiate.with.the.patent.holder.for.a.license..Licenses.may.also.be.required.for.the.
use.of.promoter.and.other.regulatory.sequences,.as.well.as.for.selectable.marker.cas-
settes.and.vectors.used.in.the.plant.transformation.process.
In. addition. to. those. covering. trait. gene. technology,. patents. exist. for. all. of. the.
commonly. used. plant. transformation. methods.. Although. many. of. the. major. pat-
ents.have.recently.expired,.or.are.close.to.expiring,.the.existence.of.even.a.few.patents.
for.which.licenses.are.required.can.add.signiicantly.to.the.cost.of.developing.and.
commercializing.a.transgenic.ornamental..Even.if.the.dominant.patent.for.a.given.
transformation. method. has. expired,. there. may. be. genus. speciic. transformation.
patents.covering.the.use.of.a.speciic.transformation.method.in.a.particular.genus..
The.situation.is.further.complicated.by.complexities.of.patent.law.and.the.complex.
way. in. which. a. patent.is. issued. and.deined.or.claimed..In.some. cases. a. patent. is.
so.narrowly.claimed.that.it.is.possible.to.easily.circumvent.the.patent..However,.to.
do.this.often.requires.engaging.services.of.a.skilled.patent.lawyer.familiar.with.the.
technology.ield.in.hand..A.full.legal.opinion.can.add.tens.of.thousands.of.dollars.to.
the.cost.of.product.development..Future.prospects.are,.however,.not.quite.so.gloomy..
Thus,.within.the.next.decade.or.so,.most.of.the.key.enabling.patents.should.expire.
and.fall.into.the.public.domain.and.the.prospect.for.developing.transgenic.orna-
mentals. should. improve.. In. addition,. university. and. non-proit. efforts. such. as. the.
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