On 7 October 2015, the High Court of Australia released a decision in relation to the gene commonly known as the “breast cancer gene”.
In D’Arcy v Myriad Genetics Inc.  FCAFC 115, the High Court held that the patent held by Myriad Genetics Inc for isolated nucleic acids coding for a mutant form of BRCA1 (the “breast cancer gene”) is not patentable.
What are isolated nucleic acids?
Nucleotides are subunits of DNA (deoxyribonucleic acid).
In DNA, there are four nucleotide bases that exist naturally:
- (i) Adenine;
- (ii) Guanine;
- (iii) Thymine; and
- (iv) Cytosine.
A particular sequence of these nucleotides forms a gene.
An alternation of this sequence of nucleotides is known as a mutation.
The mutant form of BRCA1 gene, which was the subject of the High Court decision, was known to make people vulnerable to breast cancer and ovarian cancer.
Isolated nucleic acids are those sequences of nucleotides from DNA (or RNA – ribonucleic acid), which are separated from the human cell.
What is a patentable invention?
The Full Federal Court decision found that the isolated nucleic acids were patentable.
The Full Federal Court identified the nucleic acids, once separated from the human body, was different to the naturally existing nucleic acids.
They reasoned that the nucleic acids when they naturally exist in cells carried out cellular functions, but once they are isolated, they served a different function.
It was also critical for the Full Federal Court decision that:
- the isolated nucleic acids created an “artificial state of affairs” that was different to its naturally existing role; and
- this “artificial state of affairs” created an economic benefit.
The High Court approached the decision differently.
The High Court noted that that a particular sequence of nucleotides contained “information”. This information is not “made” by human action.
The High Court said that the “manner of manufacture” as defined in the Statute of Monopolies required that an invention involve some form of “making” or something brought about by human action.
The High Court referred to the Full Federal Court’s characterisation as an “artificially created state of affairs” and said that this was the incorrect test to use. Even if the “artificially created state of affairs” test was applied:
- a mutation is a naturally occurring phenomenon; and
- it is not something “made”.
Where to from here?
The High Court decision is similar to the US Supreme Court decision in Association for Molecular Pathology v Myriad Genetics Inc., which similarly reasoned that the sequences of nucleotides exist in nature and is not modified by being isolated.
A potential negative consequence of the High Court decision could be a lack incentive to invest in research which can have a drastic impact on the biotechnology and biochemistry industry. However, thus far, the High Court decision has been fairly narrowly interpreted.
IP Australia’s Examination Practice released after this decision identifies that:
- Isolated naturally occurring nucleic acid molecules including DNA, RNA whether human or non-human, coding or non-coding are clearly not patentable.
- Other forms of nucleic acids (e.g. cDNA and synthetic nucleic acids) are excluded to the extent that they simply replicate the naturally existing genetic material. However, it is noted that “subject matter of this type may be patentable where the utility of the invention lies in genetic information that has been ‘made’.”
It appears that the High Court decision is currently being interpreted to exclude nucleic acids that are simply containing naturally existing information. Consequently, the impact of the decision on wider biotechnology and biochemistry research could be limited.
If you wish to seek advice from our intellectual property law specialists, contact us on:
P: 02 6215 9100 or E:[email protected]