Intellectual Property and Development of Transgenic Horticultural Crops - Transgenic Horticultural Crops: Challenges and Opportunities - page 225

Of particular.concern.are.tangible.property.rights,.such.as.cell.lines,.transgenic.plants,.
germplasm,. and. plasmids.. Because,. as. described. above,. the. transfer. of. tangible.
property.often.occurs.under.the.terms.of.an.MTA.that.has.no.geographic.or.temporal.
limitation..These.terms.can.be.particularly.problematic.and.directly.impact.FTO.
Enabling.technologies.for.plant.transformation.or.transformation.vectors.combine.
several.components.such.as.promoters,.selectable.markers,.marker.removal.systems,.
and.more..Because.of.the.fundamental.role.that.these.technologies.play,.they.have.
been.extensively.patented..In.addition,.the.FTO.surrounding.enabling.technologies.
related.to.plant.transformation.is.further.complicated.because.these.technologies.are.
not.used.individually.but.are.combined.with.a.suite.of.related.enabling.technologies,.
speciic.trait.technologies,.and.deployed.in.many.different.plant.species..We.can.look.
at.a.relatively.simple.example.of.a.single.component.of.a.transformation.vector.to.
illustrate.the.elements.of.an.FTO.analysis.
The. target. technology. for. this. case. study. was. a. fruit-speciic. promoter. from. the.
tomato.E8.gene..The.E8.promoter.has.been.used.to.improve.fruit.quality,.extend.fruit.
shelf.life,.and.to.express.edible.human.vaccines.speciically.in.ripening.tomato.fruit. 7,8 .
The.irst.step.in.an.FTO.investigation.is.to.clearly.deine.the.target.technology..In.this.
hypothetical.case,.the.fruit-speciic.promoter.will.be.used.exactly.as.described.in.the.
initial.publications. 9,10 .The.promoters.in.these.publications.are.virtually.identical.and.
consist.of.about.2100.nucleotides.upstream.of.the.E8.structural.gene..Further.promoter.
characterization.identifying.the.location.and.sequence.of.functional.elements.within.
the.promoter.and.upstream.nucleotide.sequence.was.reported.in.Deikman.et.al. 9 .These.
publications.draw.the.technical.boundaries.surrounding.the.target.promoter.technol-
ogy.and.provide.important.prior.art.to.subsequently.iled.patents.
To. establish. the. relationship. of. publications. and. patents. that. describe. or. claim.
the.E8.promoter,.a.patent.landscape.must.irst.be.established..The.patent.landscape.
should. include. patents. and. patent. applications. closely. related. to. the. technology..
Keywords. and. authors. of. key. publications. are. used. to. search. for. patents. or. pat-
ent. applications.. A. separate. search. should. then. be. conducted. to. identify. patents.
or. patent. applications,. which. referenced. the. scientiic. publications. describing. the.
technology..Additionally,.in.the.E8.case,.patented.DNA.and.protein.sequence.data-
banks. were. searched. using. the. promoter's. DNA. sequence. as. a. query.. The. patent.
landscape.will.reveal.“family”.relationships.among.different.patents.and.published.
patent. applications.. Patent.families. include. later.patent. applications. that. claim. the.
beneit.of.an.earlier,.related,.application,.or.later.patent.applications.that.arise.from.
foreign.ilings.of.the.parent.application..Figure.10.1.illustrates.a.patent.family.aris-
ing.from.a.1989.patent.application.related.to.the.E8.promoter.iled.by.Agritope,.an.
agricultural.biotechnology.company.
An.informative.way.of.analyzing.the.FTO.search.results.is.to.construct.a.timeline.
of.scientiic.literature,.patent.applications,.and.issued.patents.on.the.speciic.tech-
nology.and.on.potentially.overlapping.subject.matter..Ordering.the.patents.and.
published.applications.according.to.their.priority.dates.(also.known.as.effective.
iling. dates). reveals. important. relationships.. For. example,. it. reveals. what. publica-
tions. or. patents. are. prior. art. against. newer. patents.. Since. patents. may. only. be.
granted.if.the.claims.are.both.novel.and.nonobvious.over.the.prior.art,.this.analysis.
reveals.the.relative.dominance.of.earlier,.broader.patents.over.later,.narrower.patents..