Patentable subject matter in Australia: the Myriad legacy

Subsection 18(1)(a) of the Patents Act 1990 codifies the requirement for an invention to be a manner
of manufacture within the meaning of s 6 of the Statute of Monopolies in order to qualify for patent
protection in Australia.

Since the landmark decision in National Research Development Corporation v Commissioner of

Patents [1959] 102 CLR 252 (NRDC), the High Court determined that in order to meet the
requirement of manner of manufacture, an invention must relate to an artificially created state of
affairs that is of economic significance.

In October 2015, the High Court issued the decision in DArcy v Myriad Genetics Inc. [2015] HCA 35
(Myriad), in which Yvonne DArcy sought revocation of the Myriad patent claims directed to isolated
nucleic acids encoding mutant or polymorphic forms of the BRCA1 polypeptide that are markers for
breast cancer. The basis of the revocation action was that the patent claims in dispute did not
constitute a manner of manufacture and therefore were not eligible for patent protection.

In its decision, the High Court found that, although the claimed isolated nucleic acids were chemically
distinct from nucleic acids that exist in nature, when properly construed, the claims related merely to
formation. The Court went on to reason that this information existed in nature, was not made by
humans, and therefore could not be considered a manner of manufacture.

The Court criticised the characterisation of isolated nucleic acids as a class of artificial chemical
compounds as elevating form over substance. The Court considered that the information stored in
the nucleic acids coding for mutant or polymorphic BRCA1 polypeptide was an essential element of
the claims in issue and concluded that information was the same as the information contained in the
DNA of a person from which the nucleic acids were isolated.

The US Supreme Court in a counterpart decision held that cDNA or other nucleic acids sufficiently
altered by human intervention would constitute patentable subject matter.

In Myriad, the High Court cautioned against a formulaic application of the NRDC principles. Although
the NRDC principles continue to be helpful, the terminology of an artificially created state of affairs of
economic significance was not intended to be an exhaustive concept of manner of manufacture or
to be applied as a verbal formula to usurp the statutory language of the Patents Act.

The lower courts had failed to recognise that the artificial state of affairs must be linked to inventive
concept, utility or economic significance in order to qualify for patent protection, as opposed to a mere
step along the way.

The High Court refined the criteria in NRDC to include broad policy factors to be considered when
assessing the eligibility of patentable subject matter in Australia.

The question of whether a new class of invention is patentable should instead be decided on a case-
by-case basis, having regard to whether the decision to uphold the patent to the invention as claimed:

give rise to a large new field of monopoly protection with potentially negative effects on
innovation;
have a chilling effect on activities beyond those formally the subject of the exclusive rights
granted to the patentee;
involve assessing important and conflicting public and private interests;
enhance or detract from the coherence of the law relating to inherent patentability;
be consistent or inconsistent with Australians obligations under international law and patent
laws of other countries;
best be left for the legislature.

If any of these considerations are affirmatively answered, then the claims in question do not constitute
a manner of manufacture.