Yvonne D'Arcy v Myriad Genetics Inc & Anor
(5 September 2014)
A five-judge bench of the Full Court of the Federal Court of
Australia (Full Court) has today unanimously decided that Myriad
Genetics Inc's (Myriad) patent covering the isolated BRCA1 gene
(Patent) is patentable subject matter in Australia.
The Full Court elected not to follow the reasoning of the U.S.
Supreme Court, when it found in 2013 that certain claims of a
closely related U.S. Patent of Myriad were invalid, as the claim to
isolated nucleic acid was a claim to a "product of
nature" and not patentable subject matter.
The key issue for determination by the Full Court under
Australian law was whether the invention in the Patent - which
claimed isolated nucleic acids, including isolated DNA and RNA -
constitutes a 'manner of manufacture' for the purposes of
section 18(1)(a) of the Patents Act 1990 (Cth) (Act). The
nucleic acids claimed in the Patent (Invention) are naturally
occurring materials that have been 'isolated', which
essentially means that they have been extracted from cells obtained
from the human body and purged of other biological materials with
which they were associated.
At first instance, Justice Nicholas found that the Invention
constituted a 'manner of manufacture' and, therefore, the
Patent was valid. The Federal Court of Australia (Court),
therefore, dismissed the application to revoke the Patent. The Full
Court agreed with the trial judge's finding that the Patent was
valid and dismissed the appeal.
The Full Court confirmed that the test for whether an invention
was a manner of manufacture turned on whether it resulted in an
artificial state of affairs providing a new and useful effect that
is of economic significance, which is the test set out in the
National Research Development Corporation Case (NRDC
The claims of the Patent relate to isolated nucleic acid coding
for mutant or polymorphic BRCA1 gene. These mutations in the BRCA1
gene can serve as indicators of a woman's risk of developing
breast cancer, among other things.
In the first instance decision, the Court said that there were
three considerations that supported its finding that the Invention
was a 'manner of manufacture':
The Australian High Court has indicated in the NRDC Case that
the concept of what constitutes a 'manner of manufacture'
has a 'broad sweep', to encompass developments in
technology that are, by their nature, often unpredictable.
Because the DNA and RNA in the Invention does not naturally
exist outside of human cells – but requires human
intervention in order to exist – it is an artificially
created state of affairs.
It would be a very odd result if a person whose skill and
effort culminated in the isolation of a DNA sequence could not be
independently rewarded by grant of a patent because the isolated
sequence was held to be inherently non-patentable.
At first instance the Court did affirm that naturally occurring
DNA and RNA as they exist inside the cells of a human body are not
patentable. However, it also pointed out that the Court was not
required to ask whether a composition of matter is a "product
of nature" for the purpose of deciding whether or not it
constitutes patentable subject matter.
The Full Court has reiterated that view in delivering its
reasons in Court, finding that:
"...the isolated nucleic acid,
including cDNA, has resulted in an artificially created state of
affairs for economic benefit. The claimed product is properly the
subject of letters patent."
Next Steps – Further Appeal
Either party may seek special leave to appeal the Full Court's
decision to the High Court of Australia.
Impact on Gene Patenting
Unless this decision is successfully appealed, it will stand to
affirm that isolated genetic material of the type in the Patent can
be a manner of manufacture capable of patent protection. More
broadly, this decision appears to support the proposition that,
where human intervention is required to isolate an otherwise
naturally occurring substance or organism from its usual
surroundings and chemical associations, the isolated material could
constitute patentable subject matter.
We have also previously written about the first instance
decision and its potential impact of this dispute on gene patenting
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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