The first judicial consideration in Australia of whether a method of diagnosis is patentable subject matter has found that the claimed methods of diagnosis were correct subject matter for a patent. The decision1 will be welcome news to patentees and patent applicants in the diagnostic technology space and confirms Australia as a fertile ground for patenting diagnostic inventions.
The dispute is the equivalent to litigation in both the US2 and UK3 which considered the validity and infringement of patents directed to methods of non-invasive pre-natal diagnosis using cell-free fetal DNA (cffDNA) obtained from maternal serum or plasma.
Manner of manufacture in Australia
In Australia, for a claim to define a patentable invention, it must be directed to a “manner of manufacture”.
The most recent Australian authority setting out the requirements for determining manner of manufacture comes from the Australian “Myriad” High Court decision4. The High Court identified two criteria, which it considered necessary, but not always sufficient for patentability of an invention, as follows:
Ostensibly, Myriad concluded that in determining whether a claim is directed to patentable subject matter, the question to be asked is whether something has been made by human action. The second criterion identified in the Myriad decision builds on prior authority from Australian courts in relation to manner of manufacture, which asked the question of whether the claimed invention results in an “artificially created state of affairs of economic significance".5
The claims considered by the Court
The claims before the Court in the present judgement relate to detection methods performed on maternal serum or plasma.
Claim 1 in question provides:
A detection method performed on a maternal serum or plasma sample from a pregnant female, which method comprises detecting the presence of a nucleic acid of foetal origin in the sample.
Dependent claims define that the nucleic acid may be amplified, including specific nucleic acids and used for determining the sex of the foetus. Further independent claims are directed to methods of performing pre-natal diagnosis on a maternal blood sample (claims 22, 25 and 26).
The Court’s response to Ariosa’s submissions
In arguing that the invention as claimed does not involve a “manner of manufacture”, Ariosa submitted:
a) that what is claimed in each claim is a “mere discovery” of a naturally occurring phenomenon, and not a method involving a practical application that in substance goes beyond the discovery itself, and as a result there is no “artificially created state of affairs”; and
b) properly understood, the “end result” of each claim does not involve an artificially created state of affairs, as it results in information only.
In considering the first issue raised by Ariosa, Beach J referred to the Australian Myriad decision which establishes that the starting point for determination of patentable subject matter requires the identification of the substance of the relevant claim.
In construing the claims in light of the specification as a whole and relevant prior art, his Honour acknowledged that while the exact methods of detection were not explicitly recited in the claims,
“the invention is “undoubtedly” an artificial non-invasive detection method involving artificial DNA amplification methods and synthetic probes deriving from the presence of cfDNA in the maternal circulation from both the mother and developing fetus”6 (Judge's emphasis).
Beach J agreed with Sequenom that the substance of the claimed method “applies and follows on from, but is different to,” the identification of a natural phenomenon, i.e. the presence of cffDNA in maternal blood. The specification taught that the discovery of cffDNA offered a new approach for non-invasive prenatal diagnosis.
Slamming the door shut on Ariosa, the judge said “…the invention builds on, practically applies and reduces to practice a discovered substance found in nature, namely cffDNA in maternal blood, to provide a new, inventive, useful, artificial method of detection of cffDNA, and where the method is of economic significance".7
The second issue raised by Ariosa was whether there is an artificially created state of affairs or the whether the result is simply information.
Beach J commented that:
“[a] claimed process that results in a new and useful effect, so that the new result is an artificially created state of affairs providing economic utility, may be considered a manner of manufacture in the vast majority of cases… In the present case the relevant claims involve human interaction and the creation of an artificially created state of affairs discernible by an observer. The artificially created state of affairs is the detection of cffDNA in the tested sample.8
The judge found that there was artificial human intervention and an artificially created state of affairs in at least:
a) the taking of a maternal blood from a pregnant female;
b) the separation of the maternal blood into its component parts;
c) the extraction of nucleic acids from the plasma component of a material blood sample; and
d) a step to discriminate between maternal and cffDNA in the sample.
In disposing of Ariosa’s allegation that the end result of each claim is information only, Beach J stated that the claims are to methods of identifying or detecting a nucleic acid having a particular characteristic, not the nucleic acids or the information encoded by such nucleic acids per se.
The Australian High Court in Myriad stated that considering the criteria at 1. and 2. above, will typically be sufficient to determine whether a claim is directed to a manner of manufacture when the substance of the invention falls within the existing concepts of manner of manufacture. However, where a new class of claim involves a significant new application or extension of the concept of manner of manufacture, “other factors”, including factors connected directly or indirectly to the purpose of the Patents Act, may be relevant.
In the present decision, Beach J commented that it was not necessary to deal with those “factors” given that he had found methods of diagnosis to fall squarely within the established concept of manner of manufacture. However, for completeness, Beach J briefly considered the Sequenom claims in light of several of the “other factors” identified in Myriad, including the breadth of the claims, the influence on coherency of Australian law, and consistency with foreign law.
The High Court in Myriad was critical of the broad scope of claims at issue, which were said to arguably cover situations where a pathologist had no interest in looking at the specific polymorphisms or mutations. However, in the present case, Beach J took the view that a person seeking to detect cffDNA from material serum or plasma, would necessarily be aware of that fact and would be deliberately employing the method actually invented and claimed as all prior methods focussed on the detection of cellular DNA. Accordingly, even if he had deemed it necessary to take into consideration the “other factor” of claim breadth, Beach J did not consider the Sequenom claims to be unduly broad.
Regarding coherency of Australian law, Beach J referred to an Australian High Court decision that found methods of medical treatment patentable9 and noted clear similarities:
“A new and inventive method of detecting a naturally occurring phenomenon or undertaking a form of diagnosis based thereon ought not to be distinguished from a method of preventing or treating a naturally occurring phenomenon".10
Finally, Beach J noted that the Illumina proceedings in the UK had found equivalent claims to be patentable. However, in contrasting the finding that equivalent claims were not patentable in the US, Beach J considered that the US Court’s dissection of the claims into their constituent parts was contrary to at least 2 Australian High Court decisions. The observations of Linn J in the US where he felt “he was bound by Mayo and lamented the outcome” were noted.
This long awaited decision provides clarity on the patentability of diagnostic methods in Australia. The judge in this instance used very strong language to assert that methods of diagnosis fall squarely within the concept of “manner of manufacture” under Australian law, and therefore are directed to patentable subject matter.
The decision aligns with long-standing Australian Patent Office practice to allow claims to diagnostic methods and emphasises that any diagnostic method that involves human intervention should be patentable subject matter under Australian law.
Ariosa has yet to appeal the decision, and therefore while the decision is good news for patentees in the diagnostic space, this may not be the final word.
1 Sequenom, Inc. v Ariosa Diagnostics, Inc.  FCA 1011
2 Ariosa Diagnostics Inc. Sequenom, Inc. 788 F3d 1371 (3d Cir 2015) (Ariosa (US))
3 Illumina, Inc & Anor v TDL Genetics Ltd & Ors  EWHC 1497 (Pat) (17 June 2019) (Illumina)
4 D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334 (Myriad),
5 National Research Development Corporation v Commissioner of Patents  HCA 67; (1959) 102 CLR 252 (NRDC)
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9 Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd  HCA 50; (2013) 253 CLR 284 (Apotex)
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