Key Points:

There is now greater certainty about patentable subject matter in the field of genetics, but that's only one element in the broader questions of validity to be considered when assessing any patent.

On 5 September 2014, five judges of the Full Federal Court upheld a lower court's decision that isolated human DNA was patentable subject matter, providing further clarity in this controversial area of law (D’Arcy v Myriad Genetics Inc [2014] FCAFC 115).

There has been ongoing worldwide debate as to whether genetic material should be patentable subject matter. Last year, the US Supreme Court held that isolated genes were not patentable subject matter merely by virtue of being isolated (Association for Molecular Pathology v Myriad Genetics Inc 596 US 12-398 (2013)).

Australian courts have come to a different conclusion.

Cancer Voices Australia's challenge to the patent for the isolated BRCA1 gene

In 2010, Cancer Voices Australia (a network of cancer advocacy groups) and breast cancer survivor Yvonne D'Arcy brought proceedings in the Federal Court of Australia seeking to invalidate claims 1 to 3 of a patent granted to Myriad Genetics.

Myriad Genetics' patent related to the isolated BRCA1 gene which, when mutated, is thought to be responsible for at least 80% of cases of familial breast and ovarian cancer. Myriad Genetics had succeeded in isolating the nucleic acid of the BRCA1 gene from the environment in which it naturally occurs in human cells.

Cancer Voices Australia argued that claims 1 to 3 of the Myriad patent did not satisfy the "manner of manufacture" test for patentable subject matter. In response, Myriad argued that, by virtue of the process of isolation, the isolated genetic material in its artificial environment was different in substance from the naturally occurring genetic material.

Under section 18(1)(a) of the Patents Act, an invention must be a "manner of manufacture" in order to be patentable. The key authority on the "manner of manufacture" concept is the pivotal NRDC decision.[1] In that case, the High Court held that the key elements in determining whether an alleged invention is a "manner of manufacture" are whether the invention resulted in an "artificially created state of affairs", and whether it produced an economically useful result.

Justice Nicholas of the Federal Court held the isolated genetic material covered by the Myriad patent constituted an "artificially created state of affairs", qualifying it as patentable subject matter under the Patents Act 1990, as interpreted by case law. He emphasised the importance of isolating the genetic material.

Yvonne D'Arcy appealed Justice Nicholas' decision to the Full Federal Court. Before a specially convened panel of five judges, D'Arcy argued that something that occurs in nature cannot be artificial (and hence cannot amount to an artificially created state of affairs) and that the mere isolation of the genetic material was insufficient to justify the grant of a patent.

The basic principles of patentable subject matter applied by the Full Federal Court

In upholding the decision of Justice Nicholas that the claims were patentable subject matter, the Full Court confirmed the following principles relating to patentable subject matter or "manner of manufacture":

  • The boundaries of patentability must be flexible enough to encompass developments in science and technology, and should not be interpreted too narrowly.
  • An essential component of patentability is an artificial state of affairs with a useful effect, created by human intervention.
  • The concepts of utility, ingenuity and invention may help inform manner of manufacture by illuminating new results of established principles that are brought about by human intervention and which create an artificial state of affairs and some useful result.
  • Expressions such as "the work of nature" or the "laws of nature" are not helpful. If construed too narrowly, almost everything could be said to have some origin in nature. Further, the High Court has rejected the approach that there is a limitation on patentable subject matter on this basis.
  • There is a real distinction between discovery of a scientific principle or fact and actually putting it towards a useful end.

Why was the isolated nucleic acid of the BRCA1 gene patentable?

In relation to the Myriad patent, the Full Court held that:

  • the claims are to the isolated nucleic acid, which should be regarded as a compound, and not merely "information";
  • the nucleic acid has valuable economic use; and
  • the claim is wider than for a "mere discovery"; as the nucleic acid, as isolated from the cell, has structural and functional differences from the nucleic acid as it exists in the human body. The fact that, hypothetically, the sequence could have expressed the same proteins if it were in the human body was irrelevant, because the isolated DNA had characteristics that were fundamentally different from those found in nature.

The Full Court agreed with Justice Nicholas that naturally occurring DNA and RNA as they exist in human cells cannot be patentable subject matter. However, in this case the claims were for the genetic material that had been extracted from human cells, and from which all other biological materials had been removed. Therefore, the Myriad patent could never be infringed by naturally occurring DNA and RNA. This demonstrates the fallacy of concerns expressed following the decision at trial that Myriad now "owned" anyone's genes.

The Full Court held that the isolated material itself is an artificially created state of affairs and, although isolated DNA can be considered to be material derived from naturally occurring material, that does not exclude it from patentability. As such, claims 1 to 3 of the Myriad patent were valid.

In closing, the Full Court also mentioned the 2004 report on gene patents by the Australian Law Reform Commission, and noted that "Parliament has considered, and has specifically declined, to exclude purified and isolated gene sequences from the scope of patentable subject matter." Therefore, the Court was reluctant to decide on an issue which it believed was one for Parliament.

Does this mean any isolated genetic material can be patented?

This case has gained particular attention in the media, not only because of the conceptual questions regarding patentability but also the context in which these questions have arisen. Much commentary has focused on the emotive issue of equitable access to cancer testing (even though Myriad's licensee does not charge any licence fees for genetic testing). That issue is a far broader one than the question of patentability of isolated human DNA; the decision in this case is only a single component in the broader scheme of patent protection, which seeks, through legislation and judicial decisions, to balance the interests of protection of innovation and accessibility of technology.

As with the decision at first instance, there are some limitations on the wider effects of the appeal decision. The case only dealt with the threshold question of whether isolated genetic material is patentable. It did not address any of the other requirements for patentability. It should not be assumed that isolated naturally occurring genetic material would always satisfy the novelty and inventiveness requirements for patentability. In particular, in some cases the isolation of naturally occurring genetic material may well not involve an inventive step – a question that was conceded by both parties in the present case.

Furthermore, only the claims relating to the genetic material itself were challenged. The patent also included claims for methods of diagnosis, and the Full Court noted the recent High Court decision in Apotex v Sanofi in which the patentability of methods of treatment of the human body was confirmed.

Thus, while the decision provides a greater degree of certainty in relation to patentable subject matter in the field of genetics, that question is only one element in the broader questions of validity to be considered when assessing any patent.

Kate Grutzner