Friday, February 15, 2013

Myriad's BRCA Claims Held Patent Eligible in Australia


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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