Life Sciences Alert

On Friday, the Federal Court handed down its long-awaited decision in Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65.

The case, the first of its kind in Australia, concerned whether a valid patent may be granted for a claim that covers naturally occurring Deoxyribonucleic Acid (DNA) or Ribonucleic Acid (RNA) that has been 'isolated', that is, RNA and DNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.

The patent in issue claimed a human breast and ovarian cancer disposing gene (BRCA1).

Cancer Voices Australia challenged the validity of claims 1-3 of the patent on the sole basis that it did not satisfy the 'manner of manufacture' requirement in section 18(1)(a) of the Patents Act 1990 (Cth) (Patents Act), in that the isolated nucleic acid was not materially different to the nucleic acid that occurs in nature.

The term 'manner of manufacture' was previously considered by the High Court in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252. In that case, 'manner of manufacture' was held to incorporate a product that consists of 'an artificially created state of affairs which has economic significance'. In the present case, Cancer Voices Australia accepted that the subject matter of the patent was of 'economic significance'. Thus, the only issue the court was required to consider was whether the isolated DNA and RNA was 'an artificially created state of affairs'.

In finding that isolating nucleic acid constituted 'an artificially created state of affairs', and therefore was patentable subject matter, Justice Nicholas considered:

  • The 'broad sweep' interpretation given to 'manner of manufacture' in the National Research Development Corporation case
  • The distinction between 'isolated' and naturally occurring nucleic acid
  • The purposes of the Patents Act in rewarding the skill and effort of inventors.

Justice Nicholas expressly noted that Cancer Voices Australia abandoned an argument pursuant to section 18(2) of the Patents Act, which stipulates that human beings and the biological processes for their generation are not patentable inventions, leaving the law undecided in that respect. Further, we note that apart from disputing the claims were patentable subject matter, no other ground of invalidity was raised, including lack of novelty, lack of inventive step, lack of utility or lack of fair basis.

Cancer Voices Australia is presently considering the judgment and whether it will appeal the judgment.

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