Federal Court finds that isolated DNA is patentable subject matter in Australia

Federal Court finds that isolated DNA is patentable subject matter in Australia

Federal Court finds that isolated DNA is patentable subject matter in Australia

Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65

In a much anticipated judgment, on 15 February 2013, the Federal Court of Australia has confirmed that isolated nucleic acid (including isolated DNA and RNA) is patentable in Australia. The Federal Court’s decision is welcomed and follows the Government’s recent rejection of calls for an outright ban on the patenting of genes and other biological materials.

Cancer Voices Australia’s Application

On 8 June 2010, Cancer Voices Australia (CVA) filed an application with the Federal Court seeking, amongst other things, declarations that claims of Myriad’s Australian patent directed to isolated nucleic acids coding for variations of a gene linked to various forms of cancer (the BRCA1 gene), were invalid.

CVA alleged that the invention claimed in the claims, namely isolated, naturally occurring DNA and RNA, was not patentable subject matter.1

Importantly, CVA did not seek to challenge the validity of the claims on the basis that Myriad’s invention was not new or inventive, nor did it seek to challenge the validity of other claims of Myriad’s patent directed to cancer diagnostic methods, notwithstanding the fact that it was the attempted commercial exploitation of the diagnostic methods that caused great public concern and triggered the establishment of a number of extra-Governmental inquiries into gene patenting in Australia.

Patentable subject matter in Australia

Justice Nicholas accepted that the question of whether Myriad’s invention was patentable subject matter had to be decided according to the principles set out by the High Court in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 (the NRDC case).

For an invention to be patentable in Australia, it must (in addition to being new, useful and not obvious) be a “manner of manufacture”. Justice Nicholas explained that following the NRDC case, an invention will satisfy this requirement if it consists of an “artificially created state of affairs” which is of “economic significance”.2

An “artificially created state of affairs”

Whilst conceding that Myriad’s invention had economic significance, CVA argued that the invention did not involve an artificially created state of affairs, asserting that there was no material difference between the claimed isolated nucleic acids and the corresponding nucleic acids in their natural state within the human body.

Justice Nicholas rejected CVA’s assertions. His Honour found that whether the invention was a “product of nature” or “markedly different” to something that already existed in nature was not relevant to the question of the creation of an artificial state of affairs, explaining that3

…even if the physical properties of the material have not changed, the removal of the material from its natural environment and its separation from other cellular components may still give rise to what might reasonably be described as an artificial state of affairs.4

His Honour went on to find that the isolated nucleic acids as claimed (which, he accepted may, in some circumstances, have the same chemical composition and structure as that found in the cells of human beings) in fact constituted an artificial state of affairs.

In reaching this conclusion, his Honour regarded the following considerations as relevant:

  • the broad approach to the concept of “manner of manufacture” adopted by the High Court in the NRDC case;
  • the fact that the claimed isolated nucleic acids were the product of human intervention and that in the absence of such intervention, “naturally occurring nucleic acid does not exist outside the cell, and “isolated” nucleic acid does not exist inside the cell”5; and
  • the development of the invention required immense research, expense and intellectual effort.

In relation to the latter consideration, his Honour explained that:

It would lead to very odd results if a person whose skill and effort culminated in the isolation of an [isolated DNA sequence] could not be independently rewarded by the grant of a patent because the isolated [DNA sequence], no matter how practically useful or economically significant, was held to be inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposes of the Act, not to give full effect in such situations to the broad language used by the High Court in NRDC.

Federal Court’s decision is consistent with parliamentary intentions, Patent Office practice and international experience

Justice Nicholas observed that his conclusions were consistent with:

  • parliamentary intentions (which his Honour gleaned from the Government’s express rejection of an outright and arbitrary ban of the patenting of genes following investigations and reports by the Australian Law Reform Commission, the Legal and Constitutional Affairs Legislation Committee, the Advisory Council on Intellectual Property and the Senate Community Affairs References Committee6);
  • Australian Patent Office practice and decisions; and
  • the legal position in the UK and many other parts of Europe.

New “experimental use” exception overcomes gene patenting concerns

His Honour also recognised that the “experimental use”7 exception to patent infringement in Australia (which came into effect in April 2012), overcame one of the key concerns said to be associated with isolated DNA and RNA patents, namely the impact that such patents may have on future genetic research and the development of new diagnostic and therapeutic technologies that rely upon such research.

The Federal Court’s decision will assist to maintain certainty and confidence, both domestically and internationally, in the operation of the biotechnology sector in Australia.

His Honour made an award of costs against CVA and CVA has been given until 15 March 2013 to decide whether to file an appeal against the decision.

Should you have any questions or wish to discuss any topics within this article, please contact Bill Pickering.

Endnotes

  1. Section 18 (1) (a) of the Patents Act 1990 (Cth).
  2. Cancer Voices Australia v Myriad Genetic Inc [2013] FCA 65 at [100]
  3. Cancer Voices Australia v Myriad Genetic Inc [2013] FCA 65 at [103]
  4. Cancer Voices Australia v Myriad Genetic Inc [2013] FCA 65 at [104]
  5. Cancer Voices Australia v Myriad Genetic Inc [2013] FCA 65 at [108]
  6. /pub/detail/502/gene-patent-ban-rejected-by-senate-committee
    /pub/detail/455/banning-the-patenting-of-biological-materials-in-australia-fact-v-fiction
  7. /pub/detail/614/intellectual-property-laws-amendment-raising-the-bar-act-2012