Patenting

1. Patenting

2. 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” • Exception for public policy • Kamloops v. Nielson • 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 • because it cannot be owned • air • rain • because it in fact is not owned (“unoccupied”) • Res propria: something that is private property • 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 • This involves the ability to establish control over it. • Law of the sea • In 18th century Blackstone Commentaries on the Laws of England, • 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

5. Implications of “manufacture” • Can species can be manufactured? • Can genes be manufactured? • Species can be owned? • Can genes be owned?

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

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

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

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

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

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

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

13. 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. • This holds true even if the gene sequence in question is a truncated segment of the overall genome • 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

14. 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 • Therefore it seems that a crucial condition of patent entitlement fails

15. Novelty: isolated genesBCR 1 and BCR2 • 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 • 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 • Consequently the patent entitlement would appear to fails under the rubric of novelty

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

17. Novelty – once more • 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

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

19. Analysis • 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

20. Analysis - continued • 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 • Analogy works only if genes are pre-existing intellectual entities • clear law that one cannot patent naturally occurring intellectual entities (math, physics, etc.)

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

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

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

24. Subsequent independent construction • Current legal rule is that first inventor has exclusive proprietary right • May be theoretically unjust but has sound pragmatic basis • Impossibility of adjudicating independence claims • 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

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

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

27. Contradicts logic of novelty criterion itself • 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 • Before invention, artificial genes exist only as potentials inherent in nature • In that sense, all inventions lack novelty

28. Accept 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

29. Question • Remember the Kamloops test • Authority may establish law as a matter of public policy • Does ethical orientation / approach alter how patenting issue is construed under Kamloops? • Deontological • Utilitarian/contractarian

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