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Patenting. Issues. What can be patented? Conceptual limits Novelty Manufacture Usefulness Paris Convention for the Protection of Industrial Property, available at http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html Ethical limits ordre public or “morality” - PowerPoint PPT Presentation
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Patenting Patenting
Issues Issues
What can be patented?What can be patented? Conceptual limitsConceptual limits
NoveltyNovelty ManufactureManufacture Usefulness Usefulness
Paris Convention for the Protection of Industrial Property, Paris Convention for the Protection of Industrial Property, available at available at http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.htmlhttp://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html
Ethical limitsEthical limits ordre publicordre public or “morality” or “morality” Exception for public policyException for public policy
Kamloops v. NielsonKamloops v. Nielson An authority “because it formulated one policy of An authority “because it formulated one policy of
operation rather than another. cannot be held to be operation rather than another. cannot be held to be negligent “negligent “
History History Res nullius, res propria and res Res nullius, res propria and res
communiscommunis Res nulliusRes nullius: something that belongs to no-: something that belongs to no-
oneone because it cannot be ownedbecause it cannot be owned
airair rainrain
because it in fact is not owned (“unoccupied”)because it in fact is not owned (“unoccupied”) Res propriaRes propria: something that is private : something that is private
propertyproperty Res communisRes communis: something that is owned in : something that is owned in
common (collectively)common (collectively)
Argument based on doctrine Argument based on doctrine of of res communisres communis
Res communisRes communis can become can become res propria res propria when society when society accepts rules for converting it to private useaccepts rules for converting it to private use
This involves the ability to establish control over it.This involves the ability to establish control over it. Law of the seaLaw of the sea
In 18In 18thth century century Blackstone Blackstone Commentaries on the Laws Commentaries on the Laws of Englandof England,,
Modern of 10-mile limit in maritime lawModern of 10-mile limit in maritime law United Nations Office for Outer Space Affairs, United Nations Office for Outer Space Affairs,
Agreement Governing the Activities of States on the Agreement Governing the Activities of States on the Moon and Other Celestial BodiesMoon and Other Celestial Bodies (available at (available at www.oosa.unvienna.org/SpaceLaw/outerspt.htmwww.oosa.unvienna.org/SpaceLaw/outerspt.htm
Implications of Implications of “manufacture”“manufacture”
Can species can be manufactured?Can species can be manufactured? Can genes be manufactured?Can genes be manufactured? Species can be owned?Species can be owned? Can genes be owned?Can genes be owned?
““Higher Life Forms”Higher Life Forms”
Definition Definition LegislativeLegislative Social Social Ethical Ethical
Defensibility Defensibility
Implications of Implications of ChakrabartyChakrabarty
Can patent unicellular organismCan patent unicellular organism Unicellular structure as limiting caseUnicellular structure as limiting case
Therefore may extend to whole Therefore may extend to whole functioning / cellular make-upfunctioning / cellular make-up
Side- issue: Notion of species Side- issue: Notion of species telostelos
Logical requirements for the notionLogical requirements for the notion Species as “natural kind”Species as “natural kind” ““natural kind” as logically/ontologically natural kind” as logically/ontologically
delimiteddelimited ““natural kind” as internally natural kind” as internally
controlled/directedcontrolled/directed Basis in Aristotelian ontology of Basis in Aristotelian ontology of
naturenature
Question to keep in mindQuestion to keep in mind
Does Does MonsantoMonsanto give an answer? give an answer? Does Does ChakrabartyChakrabarty give an answer? give an answer? Patenting human genes v. patenting Patenting human genes v. patenting
human genome?human genome?
Gene v. GenomeGene v. Genome
Gene is part of genomeGene is part of genome Genome =full set of genetic Genome =full set of genetic
information encoded by the information encoded by the chromosomes of an organismchromosomes of an organism Therefore:Therefore:
Individual genome is unique to an organismIndividual genome is unique to an organism Even clones don’t share all genesEven clones don’t share all genes
Species genome is statistically definedSpecies genome is statistically defined
‘‘Gene” can be understood in Gene” can be understood in two sensestwo senses
Logical senseLogical sense ““Form” or pattern of structure that functions Form” or pattern of structure that functions
like a code or like instructions for assemblylike a code or like instructions for assembly Material senseMaterial sense
Entity that expresses the form or principle of Entity that expresses the form or principle of structurestructure
Distinction is analogous to Aristotelian Distinction is analogous to Aristotelian form/(primary) substance distinctionform/(primary) substance distinction
Further Questions Further Questions
What if genome entirely constructedWhat if genome entirely constructed From preexisting genesFrom preexisting genes From new genesFrom new genes From modified genesFrom modified genes
See See The Ballad of Lost C’MellThe Ballad of Lost C’Mell
Human “manufacture”Human “manufacture”
What is produced in the scientific effort to What is produced in the scientific effort to isolate and purify a gene is not the gene isolate and purify a gene is not the gene quaqua form but the gene form but the gene quaqua substance. substance.
This holds true even if the gene sequence This holds true even if the gene sequence in question is a truncated segment of the in question is a truncated segment of the overall genomeoverall genome Structure is not produced but isolatedStructure is not produced but isolated If it were otherwise, later patent applications If it were otherwise, later patent applications
for the same gene sequence would not fail for the same gene sequence would not fail because different substance would be because different substance would be produced each timeproduced each time
Preliminary inferencePreliminary inference
If what is patented is the form and If what is patented is the form and not the substance, then patent not the substance, then patent entitlement is not met when a gene entitlement is not met when a gene is isolated because the form is not is isolated because the form is not the product of human manufacturethe product of human manufacture
Therefore it seems that a crucial Therefore it seems that a crucial condition of patent entitlement failscondition of patent entitlement fails
Novelty: isolated genesNovelty: isolated genesBCR 1 and BCR2BCR 1 and BCR2
The isolated gene sequence is not newly The isolated gene sequence is not newly produced produced quaqua form but is merely the isolation form but is merely the isolation of something that already existsof something that already exists The fact that it does not exist The fact that it does not exist quaqua isolated segment isolated segment
does not entail that did not exist before does not entail that did not exist before Analogy to isolation of reactive elements like hafnium, Analogy to isolation of reactive elements like hafnium,
rubidium, etc. which cannot be patented because they are rubidium, etc. which cannot be patented because they are “naturally occurring elements”“naturally occurring elements”
Therefore the subject of the patent application Therefore the subject of the patent application does not appear to be noveldoes not appear to be novel
Consequently the patent entitlement would Consequently the patent entitlement would appear to fails under the rubric of noveltyappear to fails under the rubric of novelty
Novelty - againNovelty - again
Claim Claim isolated genes function differently from isolated genes function differently from
genes in their natural occurrence genes in their natural occurrence Reply Reply
Commits logical Commits logical ignoratio elenchiignoratio elenchi Confuses function of genes with themselves Confuses function of genes with themselves
Function of entities always depends on Function of entities always depends on contextcontext
Example of elements again provides good Example of elements again provides good analogyanalogy
Novelty – once moreNovelty – once more
Implication if argument acceptedImplication if argument accepted Would entail that ownership in artificial Would entail that ownership in artificial
gene could be circumvented by using gene could be circumvented by using the artificial gene in a slightly different the artificial gene in a slightly different biological embeddingbiological embedding
Some distinctions that are Some distinctions that are central to the standard central to the standard
position on patenting genetic position on patenting genetic materialmaterial
Analysis Analysis Question of the legitimacy of ownership Question of the legitimacy of ownership
claim cannot be settled by saying that claim cannot be settled by saying that we can construct laws that confer legal we can construct laws that confer legal entitlemententitlement
Analogy of gene to land is faulty Analogy of gene to land is faulty because a gene is a because a gene is a formform or principle of or principle of structure, whereas land is a (primary) structure, whereas land is a (primary) substance and not a principle of substance and not a principle of structurestructure
Analysis - continuedAnalysis - continued
Accepting legal device centering in Accepting legal device centering in primacy of occupation involves primacy of occupation involves inconsistency in legal frameworkinconsistency in legal framework notion of primacy of occupancy presupposes notion of primacy of occupancy presupposes
that what is occupied pre-exists occupationthat what is occupied pre-exists occupation Analogy works only if genes are pre-existing Analogy works only if genes are pre-existing
intellectual entitiesintellectual entities clear law that one cannot patent naturally clear law that one cannot patent naturally
occurring intellectual entities (math, physics, occurring intellectual entities (math, physics, etc.)etc.)
Analysis - continuedAnalysis - continued
Primacy-of-occupation doctrine requires Primacy-of-occupation doctrine requires ability to establish controlability to establish control
This is not possible with naturally occurring This is not possible with naturally occurring genetic sequencesgenetic sequences
Logically, therefore, “primacy-of-occupation Logically, therefore, “primacy-of-occupation doctrine” would entail that naturally doctrine” would entail that naturally occurring genes cannot be patentedoccurring genes cannot be patented Doctrine requires that control must precede Doctrine requires that control must precede
recognition of claimrecognition of claim This application reverses the orderThis application reverses the order
Artificial genes are not Artificial genes are not subject to these difficultiessubject to these difficulties
Individual genesIndividual genes Whole life-formsWhole life-forms
Three considerationsThree considerations
subsequent independent subsequent independent constructionconstruction
not known at time of patenting but not known at time of patenting but subsequent discovery of pre-subsequent discovery of pre-existenceexistence
subsequent evolutionary subsequent evolutionary developmentdevelopment
Subsequent independent Subsequent independent constructionconstruction
Current legal rule is that first inventor has Current legal rule is that first inventor has exclusive proprietary rightexclusive proprietary right
May be theoretically unjust but has sound May be theoretically unjust but has sound pragmatic basispragmatic basis Impossibility of adjudicating independence claimsImpossibility of adjudicating independence claims Therefore would undermine notion of exclusionary Therefore would undermine notion of exclusionary
right inherent in concept of patentabilityright inherent in concept of patentability Ethical rules that are impossible to implement may Ethical rules that are impossible to implement may
be fine theoretically but are mere be fine theoretically but are mere flatus vocisflatus vocis
Not known at time of patenting but Not known at time of patenting but subsequent discovery of pre-subsequent discovery of pre-
existenceexistence
Invalidates patentInvalidates patent Novelty rule is not epistemically Novelty rule is not epistemically
subjective but objectivesubjective but objective Not about what Not about what did subjectively know did subjectively know
but about what but about what existedexisted
Subsequent evolutionary Subsequent evolutionary developmentdevelopment
Does not invalidate patent becauseDoes not invalidate patent because Contradicts logicContradicts logic of novelty criterion of novelty criterion
itselfitself Accept Platonic metaphysicsAccept Platonic metaphysics Accept Aristotelian notion of speciesAccept Aristotelian notion of species
Contradicts logicContradicts logic of novelty of novelty criterion itselfcriterion itself
Basis is Lockean thesis that worker is Basis is Lockean thesis that worker is entitled to fruits of labourentitled to fruits of labour
Transposed to IP domain is thesis that Transposed to IP domain is thesis that inventor is entitled to claim ownership inventor is entitled to claim ownership of novel intellectual productof novel intellectual product
Before invention, artificial genes exist Before invention, artificial genes exist only as potentials inherent in nature only as potentials inherent in nature
In that sense, In that sense, allall inventions lack inventions lack noveltynovelty
Accept Platonic metaphysicsAccept Platonic metaphysics
Ontologically, claim that existed in Ontologically, claim that existed in nature prior to invention requires nature prior to invention requires Platonic metaphysicsPlatonic metaphysics
Would obviate distinction between Would obviate distinction between invention structure and expression of invention structure and expression of structure in material termsstructure in material terms
Question Question
Remember the Remember the KamloopsKamloops test test Authority may establish law as a matter Authority may establish law as a matter
of public policyof public policy Does ethical orientation / approach Does ethical orientation / approach
alter how patenting issue is alter how patenting issue is construed under construed under KamloopsKamloops??
DeontologicalDeontological Utilitarian/contractarianUtilitarian/contractarian
Some other questionsSome other questions
Does patenting of genome establish Does patenting of genome establish control over reproduction?control over reproduction?
Is there a public policy basis for Is there a public policy basis for permitting patenting?permitting patenting?
Genetically tailored medicineGenetically tailored medicine Cost of productionCost of production Orphan drugsOrphan drugs
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