1. Patenting

2. Issues What can be patented? What can be patented? Conceptual limits Conceptual limits Novelty Novelty Manufacture Manufacture Usefulness Usefulness Paris Convention for the Protection of Industrial Property, available at http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html Paris Convention for the Protection of Industrial Property, available at http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html Ethical limits Ethical limits ordre public or “morality” ordre public or “morality” Exception for public policy Exception for public policy Kamloops v. Nielson Kamloops v. Nielson An authority “because it formulated one policy of operation rather than another. cannot be held to be negligent “ An authority “because it formulated one policy of operation rather than another. cannot be held to be negligent “

3. History Res nullius, res propria and res communis Res nullius: something that belongs to no-one Res nullius: something that belongs to no-one because it cannot be owned because it cannot be owned air air rain rain because it in fact is not owned (“unoccupied”) because it in fact is not owned (“unoccupied”) Res propria: something that is private property Res propria: something that is private property Res communis: something that is owned in common (collectively) Res communis: something that is owned in common (collectively)

4. Argument based on doctrine of res communis Res communis can become res propria when society accepts rules for converting it to private use Res communis can become res propria when society accepts 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 sea Law of the sea In 18 th century Blackstone Commentaries on the Laws of England, In 18 th century Blackstone Commentaries on the Laws of England, Modern of 10-mile limit in maritime law Modern of 10-mile limit in maritime law United Nations Office for Outer Space Affairs, Agreement Governing the Activities of States on the Moon and Other Celestial Bodies (available at www.oosa.unvienna.org/SpaceLaw/outerspt.htm United Nations Office for Outer Space Affairs, Agreement Governing the Activities of States on the Moon and Other Celestial Bodies (available at www.oosa.unvienna.org/SpaceLaw/outerspt.htm

5. Implications of “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?

6. “Higher Life Forms” Definition Definition Legislative Legislative Social Social Ethical Ethical Defensibility Defensibility

7. Implications of Chakrabarty Can patent unicellular organism Can patent unicellular organism Unicellular structure as limiting case Unicellular structure as limiting case Therefore may extend to whole functioning / cellular make-up Therefore may extend to whole functioning / cellular make-up

8. Side- issue: Notion of species telos Logical requirements for the notion Logical requirements for the notion Species as “natural kind” Species as “natural kind” “natural kind” as logically/ontologically delimited “natural kind” as logically/ontologically delimited “natural kind” as internally controlled/directed “natural kind” as internally controlled/directed Basis in Aristotelian ontology of nature Basis in Aristotelian ontology of nature

9. Notion of species telos Some Reading Some Reading The Frankenstein Syndrome. Ethical and Social Issues in the Genetic Engineering of Animals (Cambridge, Mass.: Cambridge University Press, 1995), The Frankenstein Syndrome. Ethical and Social Issues in the Genetic Engineering of Animals (Cambridge, Mass.: Cambridge University Press, 1995), P. W. Taylor, Respect for Nature. A Theory of Environmental Ethics (Princeton: Princeton University Press, 1986), p. 45. Cf. especially pp. 119–29. P. W. Taylor, Respect for Nature. A Theory of Environmental Ethics (Princeton: Princeton University Press, 1986), p. 45. Cf. especially pp. 119–29. M. W. Fox, ‘Transgenic Animals: Ethical and Animal Welfare Concerns’, in P. Wheale and R. McNally (eds), The Bio- Revolution. Cornucopia or Pandora’s Box? (London and Winchester, Mass.: Pluto Press, 1990) M. W. Fox, ‘Transgenic Animals: Ethical and Animal Welfare Concerns’, in P. Wheale and R. McNally (eds), The Bio- Revolution. Cornucopia or Pandora’s Box? (London and 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).

10. Question to keep in mind Does Monsanto give an answer? Does Monsanto give an answer? Does Chakrabarty give an answer? Does Chakrabarty give an answer? Patenting human genes v. patenting human genome? Patenting human genes v. patenting human genome?

11. Gene v. Genome Gene is part of genome Gene is part of genome Genome = full set of genetic information encoded by the chromosomes of an organism Genome = full set of genetic information encoded by the chromosomes of an organism Therefore: Therefore: Individual genome is unique to an organism Individual genome is unique to an organism Even clones don’t share all genes Even clones don’t share all genes Species genome is statistically defined Species genome is statistically defined

12. ‘Gene’ can be understood in two senses Logical sense Logical sense “Form” or pattern of structure that functions like a code or like instructions for assembly “Form” or pattern of structure that functions like a code or like instructions for assembly Material sense Material sense Entity that expresses the form or principle of structure Entity that expresses the form or principle of structure Distinction is analogous to Aristotelian form/(primary) substance distinction Distinction is analogous to Aristotelian form/(primary) substance distinction

13. Further Questions What if genome entirely constructed What if genome entirely constructed From preexisting genes From preexisting genes From new genes From new genes From modified genes From modified genes See The Ballad of Lost C’Mell See The Ballad of Lost C’Mell

14. Human “manufacture” What is produced in the scientific effort to isolate and purify a gene is not the gene qua form but the gene qua substance. What is produced in the scientific effort to isolate and purify a gene is not the gene qua form but the gene qua substance. This holds true even if the gene sequence in question is a truncated segment of the overall genome This holds true even if the gene sequence in question is a truncated segment of the overall genome Structure is not produced but isolated Structure is not produced but isolated If it were otherwise, later patent applications for the same gene sequence would not fail because different substance would be produced each time If it were otherwise, later patent applications for the same gene sequence would not fail because different substance would be produced each time

15. Preliminary inference If what is patented is the form and not the substance, then patent entitlement is not met when a gene is isolated because the form is not the product of human manufacture If what is patented is the form and not the substance, then patent entitlement is not met when a gene is isolated because the form is not the product of human manufacture Therefore it seems that a crucial condition of patent entitlement fails Therefore it seems that a crucial condition of patent entitlement fails

16. Novelty: isolated genes BCR 1 and BCR2 The isolated gene sequence is not newly produced qua form but is merely the isolation of something that already exists The isolated gene sequence is not newly produced qua form but is merely the isolation of something that already exists The fact that it does not exist qua isolated segment does not entail that did not exist before The fact that it does not exist qua isolated segment does not entail that did not exist before Analogy to isolation of reactive elements like hafnium, rubidium, etc. which cannot be patented because they are “naturally occurring elements” Analogy to isolation of reactive elements like hafnium, rubidium, etc. which cannot be patented because they are “naturally occurring elements” Therefore the subject of the patent application does not appear to be novel Therefore the subject of the patent application does not appear to be novel Consequently the patent entitlement would appear to fail under the rubric of novelty Consequently the patent entitlement would appear to fail under the rubric of novelty

17. Novelty - again Claim Claim isolated genes function differently from genes in their natural occurrence isolated genes function differently from genes in their natural occurrence Reply Reply Commits logical ignoratio elenchi Commits logical ignoratio elenchi Confuses function of genes with themselves Confuses function of genes with themselves Function of entities always depends on context Function of entities always depends on context Example of elements again provides good analogy Example of elements again provides good analogy

18. Novelty – once more Implication if argument accepted Implication if argument accepted Would entail that ownership in artificial gene could be circumvented by using the artificial gene in a slightly different biological embedding Would entail that ownership in artificial gene could be circumvented by using the artificial gene in a slightly different biological embedding

19. Some distinctions that are central to the standard position on patenting genetic material

20. Analysis Question of the legitimacy of ownership claim cannot be settled by saying that we can construct laws that confer legal entitlement Question of the legitimacy of ownership claim cannot be settled by saying that we can construct laws that confer legal entitlement Analogy of gene to land is faulty because a gene is a form or principle of structure, whereas land is a (primary) substance and not a principle of structure Analogy of gene to land is faulty because a gene is a form or principle of structure, whereas land is a (primary) substance and not a principle of structure

21. Analysis - continued Accepting legal device centering in primacy of occupation involves inconsistency in legal framework Accepting legal device centering in primacy of occupation involves inconsistency in legal framework notion of primacy of occupancy presupposes that what is occupied pre-exists occupation notion of primacy of occupancy presupposes that what is occupied pre-exists occupation Analogy works only if genes are pre-existing intellectual entities Analogy works only if genes are pre-existing intellectual entities clear law that one cannot patent naturally occurring intellectual entities (math, physics, etc.) clear law that one cannot patent naturally occurring intellectual entities (math, physics, etc.)

22. Analysis - continued Primacy-of-occupation doctrine requires ability to establish control Primacy-of-occupation doctrine requires ability to establish control This is not possible with naturally occurring genetic sequences This is not possible with naturally occurring genetic sequences Logically, therefore, “primacy-of-occupation doctrine” would entail that naturally occurring genes cannot be patented Logically, therefore, “primacy-of-occupation doctrine” would entail that naturally occurring genes cannot be patented Doctrine requires that control must precede recognition of claim Doctrine requires that control must precede recognition of claim This application reverses the order This application reverses the order

23. Artificial genes are not subject to these difficulties Individual genes Individual genes Whole life-forms Whole life-forms

24. Three considerations subsequent independent construction subsequent independent construction not known at time of patenting but subsequent discovery of pre-existence not known at time of patenting but subsequent discovery of pre-existence subsequent evolutionary development subsequent evolutionary development

25. Subsequent independent construction Current legal rule is that first inventor has exclusive proprietary right Current legal rule is that first inventor has exclusive proprietary right May be theoretically unjust but has sound pragmatic basis May be theoretically unjust but has sound pragmatic basis Impossibility of adjudicating independence claims Impossibility of adjudicating independence claims Therefore would undermine notion of exclusionary right inherent in concept of patentability Therefore would undermine notion of exclusionary right inherent in concept of patentability Ethical rules that are impossible to implement may be fine theoretically but are mere flatus vocis Ethical rules that are impossible to implement may be fine theoretically but are mere flatus vocis

26. Not known at time of patenting but subsequent discovery of pre-existence Invalidates patent Invalidates patent Novelty rule is not epistemically subjective but objective Novelty rule is not epistemically subjective but objective Not about what did subjectively know but about what existed Not about what did subjectively know but about what existed

27. Subsequent evolutionary development Does not invalidate patent because Does not invalidate patent because Contradicts logic of novelty criterion itself Contradicts logic of novelty criterion itself Accept Platonic metaphysics Accept Platonic metaphysics Accept Aristotelian notion of species Accept Aristotelian notion of species

28. Contradicts logic of novelty criterion itself Basis is Lockean thesis that worker is entitled to fruits of labour Basis is Lockean thesis that worker is entitled to fruits of labour Transposed to IP domain is thesis that inventor is entitled to claim ownership of novel intellectual product Transposed to IP domain is thesis that inventor is entitled to claim ownership of novel intellectual product Before invention, artificial genes exist only as potentials inherent in nature Before invention, artificial genes exist only as potentials inherent in nature In that sense, all inventions lack novelty In that sense, all inventions lack novelty

29. Accept Platonic metaphysics Ontologically, claim that existed in nature prior to invention requires Platonic metaphysics Ontologically, claim that existed in nature prior to invention requires Platonic metaphysics Would obviate distinction between invention structure and expression of structure in material terms Would obviate distinction between invention structure and expression of structure in material terms

30. Question Remember the Kamloops test Remember the Kamloops test Kamloops v. Nielson [1984] 2 S.C.R. 2 Kamloops v. Nielson [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 policy Authority may establish law as a matter of public policy Does ethical orientation / approach alter how patenting issue is construed under Kamloops? Does ethical orientation / approach alter how patenting issue is construed under Kamloops? Deontological Deontological Utilitarian/contractarian Utilitarian/contractarian

31. Some other questions Does patenting of genome establish control over reproduction? Does patenting of genome establish control over reproduction? Is there a public policy basis for permitting patenting? Is there a public policy basis for permitting patenting? Genetically tailored medicine Genetically tailored medicine Cost of production Cost of production Orphan drugs Orphan drugs