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Patenting
Issues
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What can be patented?
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Conceptual limits
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Novelty
Manufacture
Usefulness
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Paris Convention for the Protection of Industrial Property, available at
http://www.wipo.int/treaties/en/ip/paris/trtdocs_wo020.html
Ethical limits
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ordre public or “morality”
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Exception for public policy
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Kamloops v. Nielson
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An authority “because it formulated one policy of operation rather
than another. cannot be held to be negligent “
History
Res nullius, res propria and res
communis
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Res nullius: something that belongs to no-one
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because it cannot be owned
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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)
Argument based on doctrine of
res communis
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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
Implications of “manufacture”
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Can species can be manufactured?
Can genes be manufactured?
Species can be owned?
Can genes be owned?
“Higher Life Forms”
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Definition
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Legislative
Social
Ethical
Defensibility
Implications of Chakrabarty
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Can patent unicellular organism
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Unicellular structure as limiting case
Therefore may extend to whole
functioning / cellular make-up
Side- issue: Notion of species telos
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Logical requirements for the notion
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Species as “natural kind”
“natural kind” as logically/ontologically
delimited
“natural kind” as internally controlled/directed
Basis in Aristotelian ontology of nature
Question to keep in mind
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Does Monsanto give an answer?
Does Chakrabarty give an answer?
Patenting human genes v. patenting
human genome?
Gene v. Genome
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Gene is part of genome
Genome =full set of genetic information
encoded by the chromosomes of an
organism
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Therefore:
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Individual genome is unique to an organism
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Even clones don’t share all genes
Species genome is statistically defined
‘Gene” can be understood in two
senses
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Logical sense
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Material sense
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“Form” or pattern of structure that functions like a
code or like instructions for assembly
Entity that expresses the form or principle of structure
Distinction is analogous to Aristotelian
form/(primary) substance distinction
Further Questions
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What if genome entirely constructed
From preexisting genes
 From new genes
 From modified genes
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See The Ballad of Lost C’Mell
Human “manufacture”
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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
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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
Preliminary inference
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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
Novelty: isolated genes
BCR 1 and BCR2
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The isolated gene sequence is not newly
produced qua form but is merely the isolation of
something that already exists
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The fact that it does not exist qua isolated segment
does not entail that did not exist before
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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
Novelty - again
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Claim
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isolated genes function differently from genes
in their natural occurrence
Reply
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Commits logical ignoratio elenchi
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Confuses function of genes with themselves
Function of entities always depends on
context
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Example of elements again provides good analogy
Novelty – once more
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Implication if argument accepted
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Would entail that ownership in artificial gene
could be circumvented by using the artificial
gene in a slightly different biological
embedding
Some distinctions that are central
to the standard position on
patenting genetic material
Analysis
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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
Analysis - continued
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Accepting legal device centering in primacy of
occupation involves inconsistency in legal
framework
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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.)
Analysis - continued
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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
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Doctrine requires that control must precede
recognition of claim
This application reverses the order
Artificial genes are not subject to
these difficulties
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Individual genes
Whole life-forms
Three considerations
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subsequent independent construction
not known at time of patenting but
subsequent discovery of pre-existence
subsequent evolutionary development
Subsequent independent
construction
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Current legal rule is that first inventor has
exclusive proprietary right
May be theoretically unjust but has sound
pragmatic basis
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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
Not known at time of patenting but
subsequent discovery of pre-existence
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Invalidates patent
Novelty rule is not epistemically subjective
but objective
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Not about what did subjectively know but
about what existed
Subsequent evolutionary
development
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Does not invalidate patent because
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Contradicts logic of novelty criterion itself
Accept Platonic metaphysics
Accept Aristotelian notion of species
Contradicts logic of novelty
criterion itself
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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
Accept Platonic metaphysics
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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
Question
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Remember the Kamloops test
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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
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Some other questions
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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
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