The Full Federal Court of Australia has confirmed in a unanimous decision of 5 judges that isolated genetic material is patentable subject matter in Australia.

The decision of the Full Federal Court of Australia in D’Arcy v Myriad Genetics [2014] FCAFC 115 issued on 5 September 2014. This decision is on appeal from the decision of Justice Nicholas’ in Cancer Voices Australia v Myriad Inc [2013] FCA 65 on which we have previously reported.

The patentat issue related to the BRCA1 gene. Myriad Genetics had discovered that mutations in the BRCA1 gene are associated with a predisposition to breast cancer and ovarian cancer. The same or similar patents have been the subject of extensive litigation in the United States, culminating in the decision of the Supreme Court in Association for Molecular Pathology v Myriad Genetics which we reported here.

Like the Association of Molecular Pathology in the United States, Mrs D’Arcy was attempting to argue that isolated genetic material was not patentable subject matter. In order to be patentable subject matter in Australia,the subject matter must be a “manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies".

The seminal decision interpreting this section is the decision of the High Court ofAustralia. National Research Development Corporation v Commissioner of Patents[1959] HCA 67; (1959) 102 CLR 252 (NRDC) which requires that the invention relate to an artificially created state of affairs, the significance of which is economic. This decision had been reaffirmed by the High Court of Australia in Apotex Pty Ltdv Sanofi-Aventis Australia Pty Ltd [2013] HCA 50.

The Full Federal Court held that an isolated nucleic acid sequence was an artificially created state of affairs. In doing so they set out that the following principles regarding patentable subject matter under Australian law:

  •  The boundaries of what ispatentable under section 6 shift in accordance with development of science and technology.
  • Human intervention which creates an artificial state of affairs having a discernable effect is essential.
  • Notions of utility, ingenuity and invention whilst also having there place after patentable subject matter is considered are also relevant in considering the context in which patentability is to be assessed.
  • There is no requirement for a consideration of whether the composition of matter is a “product of nature”, or whether a microorganism is “markedly different” from something that already exists in nature, nor are such considerations helpful.
  • There is a real distinction between a discovery of a scientific principle or fact and the implementation of the discovery to a useful end.
  • The principles of NRDC are not restricted to methods. They apply equally to products.
  • The test for whether a product is a patentable invention is whether it “consists of an artificially created state of affairs, not whether the product produces or fails to produce an artificial effect”.

The Court also considered overseas jurisdictions and legislative history.

With regard to the decision of the Supreme Court of the United States in Association for Molecular Pathology v Myriad Genetics the court noted that this decision was based largely around an exception under US law that laws of nature and natural products are not patentable, and focussed on the information contained in the nucleic acid sequence. The Full Federal Court preferred the reasoning of Lourie J and Moore J in the Court of Appeals for the Federal Circuit decision of Association for Molecular Pathology v United States Patent and Trademark Office and Myriad Genetics, Inc, 689 F.3d 1903(2012) which focussed on the product rather than the information contained within the product.

The Full Federal Court also noted that, unlike the American Congress, the Australian legislature has considered whether to exclude claims to isolated genetic materials and declined to introduce such an exclusion.

In applying the principles set out above to an isolated nucleic acid molecule the Full Federal Court considered:

  • The claims were not to genetic code. There is a distinction between a claim to a written sequence of nucleotides and to an isolated nucleic acid sequence.
  • An isolated nucleic acidmolecule is a chemical molecule which is “chemically, structurally andfunctionally different to what occurs in nature”. Particular emphasis was placed on the functionality aspect of this test, i.e. the isolated nucleic acid molecule could be used in ways the in situ molecule could not.

The Full Federal Court concluded that an isolated nucleic acid was directed to patentable subject matter. The claims did not relate to a “mere discovery” because the isolated nucleic acid is different from that which exists in nature. They did not claim a product of nature, and even they did there is no such exclusion under Australian law. An isolated nucleic acid was clearly an artificially created state of affairs which had economic benefit.

The result in this case is unsurprising (at least to us!). It seems clear that so long asNRDC is applied, isolated nucleic acid molecules will remain patentable. In the media, opponents of patents to isolated genetic material often provide a myriad (pun intended) of policy reasons why genetic material should not be patentable. Whether or not these reasons are valid, as noted by the Full Federal Court:

“This case is not about the wisdom of the patent system. It is about the application of Australian patent law, as set out in the Act and as developed by the courts since theStatute of Monopolies.

It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability. That has been considered by the ALRC and by Parliament and has not occurred. It is not a matter for the court, but for Parliament to decide. Parliament has considered the question of the patentability of gene sequences and has chosen not to exclude them but to make amendments to the Act to address, in part, the balance between the benefits of the patent system and the incentive thereby created, and the restriction on, for example, subsequent research.”

Mrs D’Arcy has applied for special leave to appeal to the High Court of Australia. It is unclear whether such leave will be granted. On the one hand the High Court of Australia has recently affirmed the applicability of NRDC in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd and so they may decide the issue does not require further consideration. On the other hand the Court may consider this case to be of such fundamental importance that it requires consideration.