IP lawyer: Australian court rules isolated gene sequences are patentable

In D’Arcy v Myriad Genetics Inc a full bench of five justices has unanimously affirmed the decision of the initial trial judge (in Cancer Voices Australia v Myriad Inc), holding that claims of Australian patent 686004 directed to isolated nucleic acid molecules encoding mutant or polymorphic BRCA1 polypeptides are patentable.

The central issue in the appeal was whether a patent may be granted for a naturally occurring nucleic acid molecule which has been removed from its natural environment and isolated from all cellular components. The patent in question covers the isolated BRCA1 gene and its breast and ovarian cancer-promoting mutations, as well as methods of diagnosing breast and ovarian cancer, or predisposition thereto, based on the detection of mutations in BRCA1. However, in these proceedings the patent was challenged solely on the basis that claims directed to isolated BRCA1-encoding nucleic acids are not a manner of manufacture.

The appeal focused on Claim 1, which recites:

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.

The appellant (D’Arcy) submitted that isolated nucleic acid is no different from cellular nucleic acid, and that naturally occurring DNA and RNA – even in isolated form – are products of nature that cannot form the basis of a valid patent. The appellant argued that the sequence of the isolated nucleic acid is the same as that which occurs in nature and thus it is not an invention.

Section 18(1)(a) of the Patents Act 1990 requires that the claimed invention be a “manner of manufacture” within the meaning of Section 6 of the Statute of Monopolies in order to constitute patentable subject matter. At first instance the trial judge applied the broad construction given to the term ‘manner of manufacture’ by the High Court in National Research and Development Corporation v Commissioner of Patents, finding that each of the challenged claims was directed to an artificially created state of affairs with economic utility that therefore met the manner of manufacture requirement.

The full court, in considering the question of patentable subject matter, emphasised the need for there to be human intervention that creates an artificial state of affairs with discernable effect, and emphasised the distinction between “discovery of a scientific principle or fact and deployment of such to a useful end by a procedure”. It also noted that concepts such as ‘products of nature’ and ‘laws of nature’ have no place in an analysis of patentable subject matter under Australian law.

Critical to the conclusion reached by both the trial judge at first instance and the full court is the term ‘isolated’ as it appears in the patent claims and the effect of nucleic acid isolation. Concurring with the primary trial judge, the full court made it clear that DNA and RNA that occur naturally inside the cells of the human body cannot be the subject of a valid patent. However, the judges drew a clear distinction between DNA and RNA as they exist within cells and isolated molecules. The court concluded that there are structural and, more importantly, functional differences between naturally occurring and isolated nucleic acids as a result of the isolation, and that these changes are of critical importance. It held that isolated nucleic acid sequences are distinct chemical entities, not simply purified forms of a natural material. Moreover, arising from this the court emphasised that the patent claims are to chemical compounds per se, not to information content. Thus, the appropriate approach in determining the question of patentable subject matter is to consider the claimed matter as chemical compounds, rather than based on the genetic information they may contain.

Citing National Research and Development Corporation the full court held that the isolation of the BRCA1-encoding nucleic acids led to an economically useful result, being the diagnosis and treatment of breast and ovarian cancer. As such, it took the view that this is precisely what is intended by the manner of manufacture requirement under Australian law. The court rejected the view that the myriad claims represent a mere discovery, arguing that the information content of the nucleic acids is largely irrelevant and instead focusing on the artificial nature of the isolated nucleic acids as discrete chemical entities having economic use.

This decision contrasts sharply with that of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics Inc, in which it held that a naturally occurring DNA segment is a product of nature and is therefore not patentable, even if isolated. The Supreme Court distinguished between genomic DNA and cDNA, arguing that the latter is not a product of nature and is thus patent-eligible subject matter. The US decision focused primarily on the information contained in the genetic sequence, the approach expressly rejected by the Federal Court in Australia.

In reaching its decision the full court noted that whether gene sequences should be excluded from patentability on policy or ethical grounds is not a matter for the court, but for Parliament, and that Parliament has previously considered and specifically declined to exclude purified and isolated gene sequences from the scope of patentable subject matter.

However this issue remains alive with the recent filing by D’Arcy of an application to the High Court for special leave to appeal the Federal Court decision. It remains to be seen whether the High Court will hear the appeal.