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Focus: Federal Court win for gene patents, their creators and patients

27 February 2013

In brief: In a landmark decision that resolves the long-standing debate as to whether genes and their biological products warrant patent protection, the Australian Federal Court has found that isolated DNA and RNA are patentable subject matter. Partners Sarah Matheson (view CV) and Dr Trevor Davies (view CV) and Lawyer Yan-Lin Lee report.

How does it affect you?

  • The Federal Court decision, Cancer Voices Australia v Myriad Genetics Inc,1 handed down on 15 February 2013, provides some much-needed reassurance to the biotechnology industry and the Australian public.
  • The decision has helped to settle the political and ethical debate surrounding the issue of whether nucleic acid and other biological materials are patentable subject matter.
  • The Federal Court confirms that naturally occurring DNA or RNA as they exist inside cells of the human body are not patentable.

Introduction

In 2010, Cancer Voices Australia, a national advocacy organisation, together with breast cancer survivor Yvonne D'Arcy (collectively, CVA), initiated action in the Federal Court to revoke three claims of the BRCA1 patent owned by Myriad Genetics Inc and licensed exclusively to Melbourne-based company Genetic Technology Limited (collectively, Myriad).

Those claims are directed to isolated nucleic acid coding for germ-line mutations in the BRCA1 gene that can be used to detect predisposition to breast and ovarian cancers. Myriad's BRCA1 claims are not directed to genetic information of an individual per se, nor do they purport to cover naturally occurring DNA or RNA as it exists within the cell.

CVA contended that the relevant claims were invalid, on the ground that isolated nucleic acid is not a manner of manufacture that satisfies the threshold requirement for patentability. Interestingly, CVA did not raise any other grounds of invalidity, nor did they seek to challenge the other 27 claims directed to diagnostic testing methods using the isolated nucleic acid.

Under Australian law, a basic requirement of patentability is that the claimed invention be a manner of manufacture, meaning that the invention must consist of an artificial state of affairs of some practical utility in a field of economic endeavour. That state of affairs must be the result of human intervention.

The decision

The court found that isolated nucleic acid is patentable subject matter because it consists of an artificially created state of affairs that is of economic significance. Justice Nicholas explained that nucleic acid encoding for genes, when isolated from the natural cells in which it is found, constitutes a 'manner of manufacture' and therefore suitable subject matter for patent protection.

Justice Nicholas concluded that the removal of nucleic acid from its natural environment, and its separation from other cellular components, gives rise to an artificial state of affairs, notwithstanding that the chemical composition of the nucleic acid before and after isolation may be the same. His Honour relied on a number of matters in support of that conclusion, including that:

  • Australia's High Court has taken an expansive approach to the manner of manufacture inquiry in order to give effect to Parliamentary intention that patents should foster further innovation.
  • In the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell.
  • The process of isolation, extraction and purification of biological material often requires extensive skill and investment. As such, the research and intellectual effort expended in conducting that process should be rewarded accordingly, with the grant of exclusive rights for a limited period.

These findings were further reinforced by the fact that DNA and RNA, unlike human beings and their biological processes for generation, are not expressly non-patentable under the Patents Act 1990 (Cth).

To be patented, however, isolated nucleic acid or any other biological material must still meet the other patentability thresholds of novelty, inventive step and usefulness.

Importantly, the court confirmed that patent claims that are directed to isolated nucleic acid do not cover the genetic information of an individual and, as these claims are for isolated chemical compositions, they do not cover DNA or RNA in cells of a person.

The decision is consistent with the legal position of Australia's major trading partners and the longstanding practice of the Australian Patent Office.

While the popular press to date has focused on concerns that gene patenting will hinder future medical research, recent amendments to the Patents Act, particularly the new research exemption (which came into effect in April last year), seek to foster research and development of new diagnostic and therapeutic technologies. The amendments also aim to raise patent standards generally (including for biotechnology inventions), without eroding commercial incentives for the biotechnology industry. Those amendments come into effect on 15 April 2013.

Conclusion

This decision can be seen as a win for both innovators and users. Inventors can continue to protect and commercialise their innovations with the certainty that they will be rewarded for their extensive investment and efforts, and the public will benefit from better diagnostic testing and medical care.

An argument against gene patents is that they are the result of a discovery and not an invention. Our view is that the isolation of biological material from its cellular origin and developing a use for that isolated material is suitable subject matter for a patent. The Federal Court decision confirms that is the present state of the law in Australia.

However, we expect the global debate about the ethics of gene patenting will continue, even though gene patents per se are no longer being granted in a number of jurisdictions, including Australia. Whether any genetic material should be patentable is ultimately a matter for Parliament, not the courts, to decide.

A similar case is underway in the US, with a final appeal to be heard by the US Supreme Court in April 2013. The present position in the US remains that isolated genetic material is patent eligible. Australia will no doubt continue to observe the US developments keenly. However, relevant to any appeal by CVA in Australia, our Federal Court has signalled that the US position will not influence Australia's position on gene patents because of differences in the legal landscapes.

Footnotes
  1. [2013] FCA 65.

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