Isolated nucleic acids patentable in Australia

An appeal court has confirmed that isolated nucleic acids are patentable in Australia.  In a unanimous decision handed down on 5 September 2014 (D’Arcy v Myriad Genetics Inc [2014] FCAFC 115), the Full Bench of the Federal Court upheld an earlier decision that a claim directed to an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide was patentable subject matter in Australia.

This was a controversial and highly publicised case involving the BRCA1 gene, mutations in which have been shown to predispose women to certain forms of breast and ovarian cancer.  The appellant, Queensland cancer patient Yvonne D’Arcy, argued that isolated nucleic acids are not materially different from cellular nucleic acids and that naturally occurring DNA and RNA molecules, even in an isolated form, are products of nature and cannot form the basis of a valid patent.  The patentee, Myriad Genetics Inc. (Myriad) contended that isolated nucleic acids differ from nucleic acids found in human cells chemically, structurally and functionally, and therefore they constituted patentable subject matter.  It was not in dispute that the identification of the BRCA1 gene, its nucleic acid sequence and the characteristics and sites of the mutations identified, involved an inventive step.

The five judges of the full Federal Court agreed with the primary judge that the question as to whether the isolated gene was patentable subject matter must be decided in accordance with the NRDC case, which it described as ‘the long accepted articulation of the principles to be applied to patentability and to the question of what is the proper subject matter for a patent’.   The full court confirmed that this decision ‘covers both processes and products’ and ‘is not to be applied in a narrow sense’.  In this case, the court found that the claimed product was not the same as the naturally occurring product, there being structural differences, but more importantly, functional differences because of isolation.  Thus, the court found that the isolated nucleic acid resulted in an artificially created state of affairs for economic benefit and was therefore proper subject matter for a patent.

The primary judge had considered recent legislative history on this issue and found nothing to suggest that it was the intention of the Australian Parliament to exclude isolated human genes from patentable subject matter.  The Australian Law Reform Commission’s (ALRC’s) 2004 report on gene patenting did not favour any change to the settled practice of granting patents to isolated genetic material.  In 2011, the majority of a Senate Committee found that a controversial Private Members’ Bill to ban the patenting of biological materials should not be passed.  Also in 2011, the Australian Government’s response to the ALRC report specifically accepted the ALRC’s recommendation that Australian patent law should not be amended to exclude genetic materials from patentability.  The Full Court commented that ‘While these legislative matters do not affect what constitutes patentable subject matter …., Parliament has considered, and has specifically declined, to exclude purified and isolated gene sequences from the scope of patentable subject matter.’

The Full Court also considered the decision of the US Supreme Court in relation to Myriad’s corresponding US patents.  In that decision, the US Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. However, cDNA was held to be patent eligible because it is not naturally occurring.

While acknowledging that the claims under consideration were not identical, the Full Federal Court analysed the US decision, concluding that;

‘It is difficult to reconcile that Court’s endorsement of the reasoning in Chakrabarty, with its rejection of isolated nucleic acid as eligible for patentability.  With respect, the Supreme Court’s emphasis on the similarity of “the location and order of the nucleotides” existing within the nucleic acid in nature before Myriad found them is misplaced.  It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful.’

The Full Federal Court also discussed in some detail the decision in the USA at first instance and commented that it found the reasoning of two of the judges at first instance, ‘based on an analysis of the products as products and not on the information that they contain, to be consistent with patent law, and persuasive.’  Thus, Australia has a more liberal approach to the patenting of isolated nucleic acids than the USA, with our Full Federal Court confirming that they are proper subject matter for a patent.  This is consistent with the long-standing practice of the Australian Patent Office, which has been to allow claims to purified or isolated genetic material, including human genes.

It is not yet known whether there will be an appeal against the current decision.  However, an appeal to Australia’s highest court, the High Court, would require Special Leave of that court to proceed.

If you have any specific enquiries about this decision, or gene patents generally, please contact Debra Tulloch.

This article was written by Debra Tulloch.