8 September, 2014
D’Arcy v Myriad Genetics Inc [2014] FCAFC 115
WHAT YOU NEED TO KNOW
- In a unanimous and significant decision, a five-member bench of the Full Court of the Federal Court of Australia (Allsop CJ, Dowsett, Kenny, Bennett and Middleton JJ) has confirmed that a claim covering naturally occurring deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), which has been isolated, can be a “manner of manufacture” and therefore a patentable invention.
- The Full Court reached a contrary conclusion to the US Supreme Court, which, in relation to the corresponding US patent, held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.
- The decision continues a trend in which Australian courts have shown reluctance to exclude inventions in the medical sphere from patentability (on the basis of not being a “manner of manufacture”) where Parliament has declined to do so.
Background
In Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (Cancer Voices), Nicholas J dismissed an application by Cancer Voices Australia and Yvonne D’Arcy to revoke claims 1 to 3 of Australian Patent No. 686004 (the Patent) on the ground of lack of “manner of manufacture”. The Patent concerns the BRCA1 gene, mutations in which cause a predisposition to breast and ovarian cancer, as well as use of the BRCA1 gene in the diagnosis of predisposition to breast and ovarian cancer.
Ms D’Arcy appealed from Nicholas J’s decision, and the Full Court has now dismissed the appeal with no order as to costs.
The Invention Claimed
The appeal before the Full Court focussed on claim 1 of the Patent, which is to:
An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
A number of features of the claim may be observed:
- it is to a compound, an “isolated nucleic acid”, ie, tangible material and not genetic information;
- the isolated nucleic acid: is substantially separated from the other cellular components that naturally accompany native DNA or RNA; and codes for a mutant or polymorphic protein;
- “SEQ.ID No:1” is a sequence listing for the BRCA1 wild-type (or typical) gene and represents the coding sequence of a nucleic acid, being cDNA (or “complementary DNA” synthesised from a species of RNA known as messenger RNA), which encodes the BRCA1 polypeptide; and
- the “isolated nucleic acid” contains a sequence identified by comparison with tables which record the mutations or polymorphisms as variations in the encoding sequence shown in SEQ.ID No:1.
The single issue for determination was whether or not the claims to an “isolated nucleic acid” are for a “manner of manufacture”, as required by section 18(1)(a) of the Patents Act 1990 (Cth). In this regard the phrase “manner of manufacture” refers to
an artificially created state of affairs whose significance is economic. These principles were set out in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252, which was applied in this case.
Ms D’Arcy’s Submissions And The US Supreme Court Decision
Ms D’Arcy admitted that the claimed invention has economic significance, but said this was insufficient to make it a “manner of manufacture” and pressed three main points:
- “a human being’s DNA is not the thing we patent, unless isolation makes a difference”;
- isolation does not make a difference because the resulting product (the isolated nucleic acid) has the same coding as in nature. This is not an “artificial effect” or a sufficiently “artificial effect”; and
- the claims arise out of a discovery of “laws of nature”, which are not patentable.
corresponding US patent in Association for Molecular Pathology v Myriad Genetics, Inc, 596 US 12-398 (2013).
DNA and therefore patent-eligible.
- the challenged claims were not to the nucleic acid as it exists in the human body, but the nucleic acid as isolated from the cell;
- there are structural differences, but, more importantly, there are functional differences because of isolation. For example, without manipulation, isolated DNA cannot code for a protein or polypeptide, this being a function that occurs naturally within the cell; and
- while the gene that contains the mutation or polymorphism exists in nature, until it was isolated, it could not be used to identify the mutation or polymorphism. Once 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.
For further information, please contact:
Ben Miller, Partner, Ashurst
ben.miller@ashurst.com
Ashurst Intellectual Property Practice Profile in Australia
Homegrown Intellectual Property Law Firms in Australia