Today the Federal Court of Australia issued a
decision in Cancer Voices Australia v. Myriad Genetics upholding the patent
eligibility of three of Myriad's patent claims that recite isolated BRCA-encoding
nucleic acids. Based on my understanding of the Australian court system
(gleaned from Wikipedia) the decision seems to be analogous to a federal
district court decision in the United States, i.e., the case was decided by a
single judge, it can be appealed to the Full Court (a panel of 3 to 5 judges),
and ultimately to the Australian High Court (the analog of the US Supreme
Court). As in the case of the US challenge to Myriad’s BRCA patents, only patent
eligibility is at issue, no other grounds of invalidity (including lack of
novelty, lack of inventive step, lack of utility or lack of fair basis) were
raised.
Looking to Australian precedent, the court held the
claimed nucleic acids to be patent eligible “manner[s] of manufacture” within
the meaning the Australian Statute of Monopolies, because the claimed nucleic
acids constitute “an artificially created state of affairs which has economic
significance.”
Although the Australian court came to the same
conclusion as the Federal Circuit with respect to the patent eligibility of the
claims, it declined to follow the reasoning of the Federal Circuit's Judge Lourie. In particular, the
court rejected Judge Lourie’s conclusion that the isolated DNA claims are
limited to DNA molecules that have been excised from the human chromosome in a
way that requires covalent bonds to be broken. The Australian judge found that
the claims are silent with respect to the length of the claimed nucleic acids, and
that "there is nothing to suggest either in the claims themselves or in
the body of the specification that the complete molecule of DNA as originally
found on chromosome 17 that has been isolated . . . would be outside the scope
of the disputed claims. . . . To interpret the disputed claims [so as to
require that every isolated DNA sequence within the scope of the claims must
have had at least some covalent bonds broken as a result the isolation process]
would require me to impose an impermissible gloss upon the words of the claim.”
I entirely agree with the Australian court,
and think that Judge Lourie was incorrect on this point.
In reaching its decision, the Australian court found
it to be significant that:
(1) The Australian High Court had previously interpreted
the scope of patent eligible subject matter expansively, and "made clear
that metaphorical analysis may not be helpful in determining whether or not
something constitutes patentable subject matter” [our US Supreme Court might
benefit from this approach];
(2) “[I]n the absence of human intervention,
naturally occurring nucleic acid does not exist outside the cell, and ‘isolated’
nucleic acid does not exist inside the cell;” and
(3) "It
would lead to very odd results if a person whose skill and effort culminated in
the isolation of a micro-organism (a fortiori, an isolated DNA sequence) could
not be independently rewarded by the grant of a patent because the isolated
micro-organism, no matter how practically useful or economically significant,
was held to be inherently non-patentable.”
The court
noted that it is “trite law that you cannot patent a discovery, but if on the basis
of that discovery you can tell people how it can be usefully employed, then a
patentable invention may result.”
The court made a number of other important observations:
(1) “The
disputed claims are not to genetic information per se. They claim tangible
materials. Much emphasis was placed by the [patent challengers] upon the informational
character of DNA as a storehouse of genetic information. But the disputed
claims are not to information as such. They could never be infringed by someone
who merely reproduced a DNA sequence in written or digitised form.
(2) “Because
each of the claims is to an isolated chemical composition, naturally occurring
DNA and RNA as they exist in cell are not within the scope of any of the
disputed claims and could never, at least not until they had been isolated,
result in the infringement of any such claim."
(3) “
[Australian precedent] does not require the Court to ask whether a composition
of matter is a “product of nature” for the purpose of deciding whether or not
it constitutes patentable subject matter. [Precedent] recognises that it may be
unhelpful to approach the problem in this way. I think this is especially so in
the field of biotechnology in which micro-organisms play a critical role in the
development, manufacture and use of diagnostic and therapeutic products and
techniques.”
(4) “[Australian
precedent] does not require the Court to ask whether a micro-organism is
“markedly different” to something that already exists in nature for the purpose
of deciding whether it constitutes patentable subject matter (cf. Chakrabarty
at 310).”
(5) “In
the context of biological material, an artificial state of affairs may manifest
itself in different ways. The physical properties of the naturally occurring
material may have changed as a result of it having been isolated. But even if
the physical properties of the material have not changed, the removal of the
material from its natural environment and its separation from other cellular
components may still give rise to what might reasonably be described as an
artificial state of affairs. “
(6) “In
my opinion the patentability of the isolated nucleic acids referred to in the
disputed claims does not turn upon what changes have been made to the chemical
composition of such substances as a result of them having been isolated. In
particular, the question of whether these substances constitute patentable
subject matter does not depend upon the type of chemical bond that may have
been broken in the process of isolating them.”
The court also found significant, although not determinative, the fact that the Australian Parliament had considered and rejected proposals to limit the patenting of isolated nucleic acids, as well as the long-standing practice of the Australian patent office to grant claims to isolated nucleic acids.
In short, the decision of the Australian court
broadly supports the patent eligibility of not only isolated DNA, but more
generally isolated naturally occurring molecules. It is entirely consistent with the
long-standing interpretation of the US patent office, and the general understanding in the US
prior to the Myriad case, that isolation of a naturally occurring molecule can
constitute sufficient human intervention to satisfy the requirement of patent
eligibility. It rejects many of the arguments being raised in the US by ACLU/PubPat
and their supporters.
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