By Rufina Cheung of Wolters Kluwer, CCH
Five judges of the Full Federal Court have unanimously held that isolated nucleic acid (DNA or RNA), including cDNA, is patentable, because it resulted in an artificially created state of affairs for economic benefit: D’Arcy v Myriad Genetics Inc (2014) AIPC ¶92-478;  FCAFC 115 at . “Isolated” nucleic acid is DNA or RNA that has been isolated from the cell nucleus, ie separated from other cellular components and removed from its naturally occurring environment.
This was an appeal from Cancer Voices Australia v Myriad Genetics Inc (2013) (2013) AIPC ¶92-455;  FCA 65, which was reported in CCH’s Australian Industrial & Intellectual Property service. The Full Federal Court unanimously dismissed the appeal.
Australia vs USA
This decision means that Australian law is inconsistent with the law in the United States. Isolated natural DNA is not patentable in the United States. The US Supreme Court rejected a claim over isolated nucleic acids for broadly the same reasons advanced by the appellant, Yvonne D’Arcy, in this case. The US Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. On the other hand, cDNA (synthetically created DNA) was held to be patent eligible because it is not naturally occurring: , Association for Molecular Pathology v Myriad Genetics, Inc, 596 US 12-398 (2013).
Intellectual property policy vs law
The court emphasised that this was not a case about intellectual property policy. “This case is not about the wisdom of the patent system … It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability. That has been considered by the ALRC and by Parliament and has not occurred”: –, cf . The court noted that in the United States, Congress has not considered the patentability of gene sequences: .
This case concerned a patent which related to methods and materials for locating and detecting a human gene (BRCA1), some mutant alleles of which caused susceptibility to breast and ovarian cancer. Earlier studies had localised the gene within a very large region which was not well mapped, making it extremely difficult to design and implement strategies for isolating the BRCA1 gene. The invention involves the use of the gene in diagnosing predisposition to breast and ovarian cancer. As a result of the work involved in the invention, two markers were discovered which represented the physical boundaries of the BRCA1 locus. This enabled the BRCA1 gene to be isolated. Claim 1 was to an isolated nucleic acid coding for a mutant or polymorphic protein.
The appellant, Yvonne D’Arcy, contended that isolated nucleic acid is not materially different to cellular nucleic acid, and that naturally occurring DNA and RNA even when isolated, are products of nature that cannot be patentable: . The High Court in NRDC held that it is sufficient for a product to result in “an artificially created state of affairs”, leading to “an economically useful result”: . Ms D’Arcy submitted that this artificially created state of affairs was not the product itself but rather the effect or end result that it produced: . She argued that the isolated nucleic acid had not been used to produce any artificial effect: .
She submitted that even though isolation required human intervention, it was not artificial, because the coding was the same as in nature and the nucleic acid sequence was unchanged: . Alternatively, she argued that isolation by itself was insufficient for artificiality: . Her arguments focused on the information contained in the nucleic acid sequence and dismissed the chemical, structural or functional differences as irrelevant: .
The respondents, Myriad Genetics Inc (the patent owner) and Genetic Technologies Limited, argued that the claims were to a product that consisted of an artificial state of affairs providing a new and useful effect that was of economic significance, and was therefore a manner of manufacture. Myriad Genetics contended that isolated nucleic acid was different from nucleic acid found in a human cell chemically, structurally and functionally.
Full Federal Court’s decision
Importantly, the Full Federal Court made the following points in its joint judgment:
• Product must CONSIST of an artificially created state of affairs, it need not PRODUCE an artificial effect:
– “… the isolated nucleic acid is itself an artificial state of affairs. It is removed from the genome and from the cell. In order to determine whether an invention claimed is a relevant product, the question is whether it consists of an artificially created state of affairs, not whether it produces or fails to produce an artificial effect. NRDC does not, contrary to what Ms D’Arcy submits, require the claimed isolated nucleic acid to produce an artificial effect or an artificially created state of affairs. This submission represents an unduly narrow understanding of the reasoning in NRDC, which is not a statute nor is it to be narrowly construed. The ‘artificial effect’ or ‘artificial state of affairs’ to be considered in this case is the isolated nucleic acid itself, removed from its natural environment and from the cellular components that enable it to function in vivo”: –.
• Focus on nucleic acid as a product, not on the information it contains:
– The subject matter of the claims “is to a compound; a nucleic acid. It is not a claim to information”: .
– “Claim 1 is not to the genetic code. What is claimed is an isolated nucleic acid, a chemical molecule … To identify the invention as lying in the concept of information said to be embodied in a sequence of nucleotides ignores the language of the claim”: .
– “With respect, we find the reasoning of Lourie J and Moore J, based on an analysis of the products as products and not on the information that they contain, to be consistent with patent law, and persuasive”: .
– The US Supreme Court’s reasoning focused on the information contained in the nucleic acid, and not on the product itself: .
• An isolated nucleic acid is chemically, structurally and functionally different from the nucleic acid existing in the human body:
– “What is claimed is an isolated nucleic acid, a chemical molecule characterised in a certain way, which is chemically, structurally and functionally different to what occurs in nature”: .
– “What is being claimed is not the nucleic acid as it exists in the human body, but the nucleic acid as isolated from the cell. The claimed product is not the same as the naturally occurring product. There are structural differences but, more importantly, there are functional differences because of isolation”: .
– “To this extent we differ, with respect, to the primary judge. In our view the products the subject of claim 1 are different to the gene comprising the nucleic acid sequence as it exists in nature”: .
– “… the exonic sequence does not exist as such in nature. Naturally occurring genomic DNA consists of both introns and exons”: .
– “… the claims are for tangible materials. Genomic DNA sequence does not exist outside the cell and in that sense it can be said that an isolated chemical is not the same as the chemical in situ. One difference is that the isolated chemical can be manipulated and utilised in ways that the other cannot. That is, they may have different uses or functions, including those set out in the specification. Treating the claim as one to chemical entities, they are not the same as the nucleic acid sequence encoding the BRCA1 polypeptide in situ. They have different beginnings and different ends”: .
– “The gene that contains the mutation or polymorphism exists in nature. However, until it was isolated, it could not be used to identify the mutation or polymorphism. Once it was isolated, the presence of the mutation or polymorphism that indicates a likelihood of cancer could not be determined without comparison with the tables of the Patent. This reflects a difference between the gene in its natural state and after isolation”: .
– “Ms D’Arcy says that the cDNA ‘consists of the very sequence of exons that exists in the cell’ but that is misleading. The mRNA contains the exons but that is not the same as the cellular or genomic DNA. The cDNA is made artificially, by reverse transcription of the mRNA, to which it is complementary but not identical. So, the polynucleotide sequence of cDNA is different to that of genomic DNA”: .
– “The isolation of the nucleic acid also leads to an economically useful result — in this case, the treatment of breast and ovarian cancers”: . The economic benefit of the claimed invention was not in dispute: .
• An appeal to “nature” is not useful:
– “… expressions such as ‘the work of nature’ or ‘the laws of nature’ are not found in the statute; nor are they useful tools of analysis”: .
– “The isolated DNA can be characterised as material derived from naturally occurring material. This is not excluded from patentability within the reasoning of NRDC. The use of a living organism to produce a substance such as an antibiotic is patentable. It is not a question whether there is any overlap between what occurs in nature and that which is claimed. If so, all biological material would be inherently unpatentable”: .
– “In Australia, there is no statutory or jurisprudential limitation of patentability to exclude ‘products of nature’. To the contrary, the High Court has specifically rejected such an approach”: .
– “The US Supreme Court accepted that cDNA is patentable. It rejected the isolated nucleic acid of claim 1 because it accepted wrongly, with respect, that the isolated nucleic acid is a ‘product of nature’. In any event, that exclusion is not in accordance with the principles of patent law in Australia and has been specifically rejected as a reason for exclusion in NRDC”: .
• Focus on differences, not similarities:
– “… consistent with NRDC and Australian law, the analysis should focus on differences in structure and function effected by the intervention of man and not on the similarities”: .
– “With respect, the Supreme Court’s emphasis on the similarity of ‘the location and order of the nucleotides’ existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful. The fact that, hypothetically, if the isolated DNA sequence were replaced into the cell it would express the same proteins is irrelevant. Following Chakrabarty and NRDC, the isolated nucleic acid has ‘markedly different characteristics from any found in nature’; Myriad did not merely ‘separate that gene from its surrounding genetic material’”: –.
• Metaphors should be used with care: Metaphors should be used with care when analysing patentability, because they can be inappropriate and unhelpful: –, , . It was inappropriate to liken an isolated nucleic acid to a branch being snapped off a tree, because a branch does not change when it is simply divorced from a tree, whereas the chemical and physical makeup of an isolated nucleic acid renders it different from its natural counterpart: . The metaphor of an imaginary microscope focusing in on the claimed nucleic acid, as it existed in the human body, was unhelpful because the claim did not relate to the nucleic acid as it existed in the human body; instead it related to the nucleic acid as isolated from the cell: .
This case will be reported in CCH’s Australian Industrial & Intellectual Property service, and may be cited as D’Arcy v Myriad Genetics Inc (2014) AIPC ¶92-478;  FCAFC 115.
Stay tuned for further analysis.