Australia’s High Court finds isolated genetic material not patent-eligible

The Australian High Court has unanimously allowed Ms D’Arcy’s appeal from the Full Federal Court decision in D’Arcy v Myriad Genetics Inc (2014) 224 FCR 479, holding that Myriad’s claims to isolated nucleic acids were not patentable subject matter.

The case relates to Australian Patent 686004, which includes claims to methods of diagnosing a predisposition for breast and ovarian cancer as well as claims to isolated nucleic acids related to those methods. The method claims were not in issue before the High Court whose decision relates to whether, under Australian law, the claims to the isolated nucleic acids were a “manner of manufacture” and therefore patentable subject matter.

Prior to today’s decision, a Full Federal Court had held that isolated nucleic acids were different to the gene comprising the nucleic acid sequence as it exists in nature, and that the isolation of the nucleic acid lead to an economically useful result – the treatment of breast and ovarian cancers. The Full Court concluded that the isolated nucleic acid, including cDNA, was an artificially created state of affairs of economic benefit, and was therefore patentable.

While the patent expired on 11 August 2015, the High Court today held that the invention claimed in the relevant claims (a nucleic acid coding for a BCRA1 protein with one or more specified variations indicative of susceptibility to breast cancer and ovarian cancer) did not fall within the concept of a manner of manufacture.

In making this finding the Court focussed on the significance of the genetic information in the nucleotides of the claims rather than the isolated nucleotides being a tangible product per se, stating:

Despite the formulation of the claimed invention as a class of product, its substance is information embodied in arrangements of nucleotides.  The information is not “made” by human action.  It is discerned.  That feature of the claims raises a question about how they fit within the concept of a “manner of manufacture”.  As appears from s 6 of the Statute of Monopolies, an invention is something which involves “making”.  It must reside in something.  It may be a product.  It may be a process.  It may be an outcome which can be characterised, in the language of NRDC, asan “artificially created state of affairs”.  Whatever it is, it must be something brought about by human action.

Consideration was also given to whether the isolated nucleic acids were an ‘artificially created state of affairs’, in relation to which the Court commented:

Ms D’Arcy also engaged with the finding by the Full Court that the isolated nucleic acids were patentable as “an artificially created state of affairs”.  Engaging with that criterion in this case places the question of patentability in too narrow a frame.  It invites debates about the application of categories such as “products of nature” versus “artificially created products” which may be distracting from the central issue, that is whether an essential integer of the claims, the genetic information, takes them outside the category of that which can be “made”.  But even if the criterion of an “artificially created state of affairs” were to define the area of discourse in this case, the fact of the existence of the requisite mutations or polymorphisms is a matter of chance.  It is not something “made”.  It is not “artificially created”.

The Court held that while the invention claimed might strictly classified as a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed:

Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture.  The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation.  To include it within the scope of a “manner of manufacture” involves an extension of that concept, which is not appropriate for judicial determination.

The finding that the features of the claims and their ‘substance as an invention’, related to ‘sequence information’ led to the conclusion that patentability would not serve the purposes of the concept of “manner of manufacture”.  The Court also attached the same informational characteristics to cDNA.

It is unclear whether the decision will only impact nucleic acids which are considered to essentially relate to genetic information, or will also apply to isolated nucleic acids that are functional in nature (e.g. inhibitory RNA, aptamers, ribozymes, riboswitches etc.).

The impact of the decision on 7 October, 2015 decision may not be known for some time.

BSc(Hons) MCommrclLaw PhD FIPTA GAICD

Mark’s work focuses on the preparation and prosecution of patent applications in Australia and internationally, due diligence, freedom to operate and invalidity advice for the pharmaceutical, biotechnology, health and medical device industries.