Federal Court confirms that isolated genetic material is patent-eligible

Posted by Dennis Schubauer and John Fairbairn

Image courtesy of net_efekt

On 15 February 2013, the Federal Court of Australia handed down its much anticipated decision in Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 relating to whether human genetic material is patentable in Australia. In what is the first Australian judicial consideration of the issue, Nicholas J held that claims for isolated naturally occurring DNA and RNA are patentable subject matter. This decision (and any appeal) will be closely reviewed by the many interested bodies presently debating whether, as a matter of policy, patents covering genetic materials are appropriate.

Background

For present purposes it is sufficient to note that genes found in the human body are made of nucleic acids and that useful diagnostic and therapeutic tests can be developed by identifying particular genes (and variants of such genes) that are associated with certain diseases.

Myriad owns Australian patent no. 686004 (the Patent), which relates to a gene associated with human breast and ovarian cancer known as the 'BRCA1' gene. The Applicants, which included an organisation representing Australians affected by cancer, commenced proceedings to revoke the Patent. The primary basis of their case was that the claims in issue did not satisfy the requirements of s 18(1)(a) of the Patents Act 1990 (Patents Act) because each claim comprises 'isolated' nucleic acid (either DNA or RNA) that is not materially different to nucleic acid that occurs in nature. Importantly other typical grounds of invalidity, such as lack of novelty or inventive step, were not in issue.

Section 18(1)(a) of the provides that an invention is patentable if, amongst other things, it 'is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies'. Nicholas J stated that this issue must be determined in accordance with the principles enunciated by the High Court in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (the NRDC Case). The relevant test was summarised as being whether a substance consists of 'an artificial state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavour'. The Applicants accepted the claimed invention was of economic significance.

The decision

His Honour held that:

1. 'There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent.'
2. 'However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.'
3. The issue of whether this was an artificial state of affairs must be considered in context and 'does not turn upon what changes have been made to the chemical composition of such substances as a result of them having been isolated'.
4. In this case there was an artificial state of affairs because 'in 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. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell'.

Nicholas J observed that '[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'.

Comment

The decision affirms the existing patent office approach that isolated genetic material can qualify as a 'manner of manufacture'. The result of the decision is also consistent with the position in much of Europe and in the United States. In the United States, the Court of Appeals for the Federal Circuit upheld the validity of similar claims covering isolated BRCA1 genes, although that case is the subject of an appeal to the Supreme Court.

Nonetheless, patents claiming isolated gene sequences are by no means safe from attack.

First, as noted above, there were several grounds of invalidity that were not argued (eg. novelty and inventive step) and his Honour expressly noted that his 'reasons have nothing to say about the possible invalidity of the disputed claims on any other grounds'. In the case, the patent at issue was relatively 'old', with a priority date of 12 August 1994. Since 1994, there have been considerable advances in genetic technology, including in techniques for isolating and sequencing genes, and in 2003 the Human Genome Project sequenced and mapped the complete human genome.

Second, the recent Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Amendment Act) means that higher standards (including inventive step, utility, sufficiency and disclosure) will apply to Australian patents and applications examined after 15 April 2013. Interestingly, Nicholas J even noted that new section 7A of the Patents Act (which requires a patent to disclose a 'specific, substantial and credible use for the invention') will 'make it more difficult for patent applicants to obtain patent protection for expressed sequence tags'. These higher patentability standards will provide further grounds for challenging patents.

In addition, various proposals have been and continue to be put to Parliament to reform this area of patent law. While the decision provides guidance on some of the underlying patent eligibility criteria, it remains a contested and developing area of the law and public policy. Regardless of whether the Australian decision is appealed, it seems unlikely that this case will settle the controversy regarding gene patents.