- Steve Davey
Can I patent an isolated nucleic acid for genetic testing?
Updated: Sep 16, 2021
In the case of D'Arcy v Myriad Genetics Inc  HCA 35, the High Court of Australia unanimously determined that the isolated nucleic acids are not patentable in Australia. Neither are they patentable in the US. However, they are still patentable in Europe.
An isolated nucleic acid is a sequence of nucleotides derived from DNA or RNA which have has been 'isolated' or 'removed' from a cell nucleus. Nucleotides form the basic structural unit of nucleic acids such as Deoxyribo Nucleic Acid (DNA) or Ribo Nucleic Acid (RNA).
Myriad Genetics Inc from the USA isolated the nucleotides which code for mutations in the BRAC1 gene. These mutations are known to cause about 80% of breast and ovarian cancers. Myriad Genetics Inc developed a test for breast cancer and successfully patented the invention in Australia.
Yvonne D'Arcy is a breast cancer survivor. She started the court action to invalidate Myriad's patent. She did not want any one company to have a monopoly on breast cancer testing. She was worried that Myriad Genetics could artificially raise the testing prices beyond which many people could afford.
In order to be patentable, an invention must be "a manner of manufacture within the meaning of section 6 of the Statute of Monopolies" (section 18(1)(a) of the Patents Act). This obscure terminology was interpreted in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (the NRDC case). According to the NRDC case, the two key elements in determining whether an alleged invention is a "manner of manufacture" are whether the invention: (1) resulted in an "artificially created state of affairs"; and (2) produced an economically useful result.
In the Myriad case, the High Court held that these two requirements in the NRDC case are not a mechanistic test conferring a presumption of patentability. The High court said that you have to consider whether granting a patent:
"could give rise to a large new field of monopoly protection with potentially negative effects on innovation";
"could… have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee" for example, inhibiting researchers;
"would involve the court in assessing important and conflicting public and private interests and purposes";
"the coherence of the law relating to inherent patentability"; and
whether the extension of patentability to the particular subject matter "would involve law-making of a kind which should be done by the legislature".
There is already a statutory defence to patent infringement for experimental research under section 119C of the Patents Act.
The High Court seems to have aligned itself with the views of judges in America where the US Supreme Court held that Myriad's invention was unpatentable. However, in Europe, the judges found that isolated nucleic acids are patentable.