On Friday, the Federal Court handed down its long-awaited
decision in Cancer Voices Australia v Myriad Genetics Inc
 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
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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discussion of the subjects dealt with. It is not intended to be,
and should not used as, a substitute for taking legal advice in any
specific situation. DLA Piper Australia will accept no
responsibility for any actions taken or not taken on the basis of
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further information, please refer to www.dlapiper.com
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