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

Notion of species Notion of species telostelos

Some ReadingSome Reading The Frankenstein Syndrome. Ethical and Social Issues in the The Frankenstein Syndrome. Ethical and Social Issues in the

Genetic Engineering of AnimalsGenetic Engineering of Animals (Cambridge, Mass.: (Cambridge, Mass.: Cambridge University Press, 1995), Cambridge University Press, 1995),

P. W. Taylor, P. W. Taylor, Respect for Nature. A Theory of Environmental Respect for Nature. A Theory of Environmental EthicsEthics (Princeton: Princeton University Press, 1986), p. 45. (Princeton: Princeton University Press, 1986), p. 45. Cf. especially pp. 119–29. Cf. especially pp. 119–29.

M. W. Fox, ‘Transgenic Animals: Ethical and Animal Welfare M. W. Fox, ‘Transgenic Animals: Ethical and Animal Welfare Concerns’, in P. Wheale and R. McNally (eds), Concerns’, in P. Wheale and R. McNally (eds), The Bio-The Bio-Revolution. Cornucopia or Pandora’s Box?Revolution. Cornucopia or Pandora’s Box? (London and (London and Winchester, Mass.: Pluto Press, 1990)Winchester, Mass.: Pluto Press, 1990)

M. Banner, Report of the Committee to Consider the Ethical Implications of Emerging Technologies in the Breeding of Farm Animals (UK Ministry of Agriculture, Fisheries and Food, 1995).

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 fail under the rubric of noveltyappear to fail 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 Kamloops v. Nielson Kamloops v. Nielson [1984] 2 S.C.R. 2 [1984] 2 S.C.R. 2

Available at http://csc.lexum.umontreal.ca/en/1984/1984rcs2-2/1984rcs2-2.html

Authority may establish law as a matter of public policyAuthority may establish law as a matter of public policy

Does ethical orientation / approach alter Does ethical orientation / approach alter how patenting issue is construed under how patenting issue is 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