Will Australia follow the US and prohibit the patenting of genes and biological material? Grant Shoebridge of Shelston IP takes a look

A decision is expected later this year from the Australian High Court in D’Arcy v. Myriad Genetics. This case is essentially equivalent to the US Myriad Supreme Court case and so will provide a definitive judgement in relation to the patentability of isolated genes in Australia, which the lower courts have unanimously found to be patentable. The decision will most likely be the final chapter in the gene patent debate in Australia that has included two Senate inquiries, private members’ bills and two Federal Court decisions.

The gene patent debate in Australia was initiated in 2008 when Genetic Technologies, an Australian company, decided to enforce its rights in relation to a Myriad patent that described mutations in genes called BRCA1 and BRCA2, useful in determining susceptibility to breast and ovarian cancer.

The perceived potential increase in breast cancer screening costs resulted in a great deal of emotive press, and allegations were made that “gene patents” were placing many women’s lives at risk.

Ultimately, Genetic Technologies backed down, and Myriad offered to surrender the patent but not before revocation proceedings against the validity of the patent were initiated in the Federal Court. Significantly, the only claims challenged by the revocation action were those defining gene sequences per se. The claims directed to methods of using gene sequences were not challenged.

In its judgement, the Federal Court held that isolated genes do constitute an “artificially created state of affairs” consistent with patentable subject matter under Australian law because in the absence of human intervention, naturally occurring genes do not exist outside the cell, and “isolated” DNA does not exist inside a cell.

The decision of the Federal Court was appealed to the Full Court of the Federal Court and heard by an enlarged bench of five judges. In a unanimous decision, the Full Court affirmed the decision of the trial judge that isolated genetic/biological material does represent patentable subject matter under Australian law.

The perceived ‘gene patent scare’ also motivated senator Bill Heffernan to secure an inquiry by the Senate’s community affairs committee into the patentability of genes and other biological material. Ultimately, the report of the Senate committee did not include a recommendation to amend the Australian Patents Act to prohibit the patenting of isolated genes and other biological materials. The report of the inquiry, did, however, include a dissenting view from a number of senators that resulted in a private member’s bill, which was introduced into the Senate (the Patent Amendment [Human Genes and Biological Material] Bill 2010), and sought to amend the Patents Act 1990 by excluding from patentability genes and other biological materials. This private member’s bill was subject to a further Senate inquiry.

In the second Senate inquiry, it was considered that although the bill was “well intentioned”, it did not represent an effective solution to any potential or perceived problems that may be caused by the patenting of genes and biological material. In fact, it was believed that if the bill was enacted it would result in a large number of adverse consequences across the patent system that would affect a range of industries and healthcare sectors. As such, the committee of the second Senate inquiry made one recommendation—that the Senate should not pass the bill.

The High Court

Despite the unanimity of six Federal Court judges in deeming isolated genes patentable, the High Court granted special leave to appeal the decision of the Full Court.

The High Court’s decision has the potential to affect the biotechnology sector, as well as impact on patentability standards more broadly. For example, as seen in the US, an adverse decision for Myriad may impact the patentability of all isolated biological material. Given the high stakes, the Institute of Patent and Trademark Attorneys of Australia filed a submission to appear as an amicus curiae in this case.

Intervention by IPTA

IPTA’s submissions addressed a broad proposition in relation to the patentability of any isolated biological material and made reference to Australian constitutional law and innovation policy. IPTA’s submissions included affidavits detailing the importance of patent protection for isolated biological materials in bringing innovation to market, by a number of senior Australian patent attorneys, including Shelston partner Grant Shoebridge, and scientists.

IPTA’s submissions also focused on a constitutional law question not raised by the parties, and hoped that raising this important issue would increase the likelihood that IPTA’s intervention would be allowed. Ultimately, IPTA’s intervention submission was refused. There is little doubt, however, that the High Court will have reviewed IPTA’s submissions and affidavits and may well be guided by them.

The High Court hearing

Under Australian law, patent eligibility is guided by the principles of the High Court’s decision in National Research Development Corporation v Commissioner of Patents (1959, HCA 67). In that landmark decision, it was held that subject matter was considered patent eligible if it was “an artificially created state of affairs” having “economic significance”.

Given the relevant principles of patentability, the issues considered by the High Court during the two-day hearing included the construction of the relevant claims and whether the test for patentability requires an association between an invention’s artificialness and its economic use.

In regard to claim construction, the relevant claim in the Myriad patent defines: “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.”

Appearing for D’arcy, David Catterns QC, argued that since the relevant claims refer to a nucleic molecule “coding for” a polypeptide, the claims define sequence information and, that sequence information is identical whether or not the defined nucleic acid molecule is inside a cell or isolated. Catterns also submitted that isolated nucleic acids without any limitation to a useful application are claims to products of nature and should be excluded from patentability. The full bench of seven High Court judges appeared to be receptive to the arguments presented by Catterns.

In contrast, the High Court judges were far more interrogative of Myriad’s barrister, David Shavin QC, who argued that the claims in question refer to an isolated chemical molecule and, on that basis, define an artificially created state of affairs. Shavin also submitted that there was nothing in the statute which requires a claim directed to a composition to define the composition’s usefulness (economic utility), which is typically described in the patent specification. Shavin also made submissions in relation to the desired current consistency of Australia’s patent laws with its major trading partners and the Australian Parliament’s repeated decisions not to exclude isolated genes and other biological material from patent eligibility.

The High Court judges repeatedly queried Shavin in relation to how the isolated nucleic acid defined in the claims was associated with its “economic significance”. The judges appeared to take the position that the utility of the claimed isolated nucleic acid resided in the sequence information rather than its state of being isolated.

If the High Court holds this line in its decision and D’Arcy’s appeal is allowed, there is a possibility that patent eligibility would require a nexus between an invention’s economic utility and its artificialness.

At this stage, there is uncertainty how such a decision may impact on the patentability of other isolated biological material such as isolated biological compounds used, for example, as a pharmaceutical agent.

If, on the other hand, the High Court dismisses D’Arcy’s appeal, those opposed to gene patents will almost certainly attempt to have new legislation introduced into the Patents Act, specifically excluding isolated genes and other biological material from patentability.

However, given that a Senate inquiry recommended that isolated genes not be excluded from patentability as well as the failure of parliamentary private members bills in favour of gene patent reform, the prospect of a change in the law to exclude the patenting of isolated genes appears to be remote.

D’Arcy v Myriad Genetics, when it is handed down, will most likely represent a landmark Australian High Court decision, and Shelston IP will be well placed to provide advice in relation to how the decision may impact the patentability of biological inventions in Australia.

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