4.4 Consideration
108 Fundamental to the appeal is the contention that what is claimed is a mere discovery of a naturally occurring phenomenon, and not a method involving a practical application that goes beyond the discovery itself. Here, the appellants identify the discovery as the fact that cffDNA from maternal plasma or serum was a source of foetal DNA. They submit that there is no artificially created state of affairs arising from the invention as claimed. Furthermore, they submit that the "end result" of each claim results in information only, being the detection of cffDNA. The appellants rely substantially on the decision in Myriad in support of their appeal.
109 For an invention to be patentable, it must meet the relevant requirements of the Act including s 18(1)(a) which requires that the invention, as claimed, be a manner of manufacture within the meaning of s 6 of the Statute of Monopolies. Schedule 1 to the Act defines "invention" as "any manner of new manufacture the subject of letters patent and grant of privilege within s 6 of the Statute of Monopolies, and includes an alleged invention". This element of patentability was considered in NRDC, Apotex and more recently in Myriad.
110 According to NRDC, as explained in Myriad, the relevant question to be posed is: "Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?" (Myriad at [18] (plurality), citing NRDC at 269).
111 The common law has developed standards by which patentable subject matter may be assessed by reference to the determination of what is a manner of manufacture. In NRDC Dixon CJ, Kitto and Windeyer JJ emphasised the long-established requirement that a patentable invention must involve more than mere discovery of a scientific fact or law of nature. However, at 263-264 they counselled caution in too quickly using such distinctions, quoting Frankfurter J in the United States Supreme Court decision Funk Bros. Seed Co v Kalo Inoculant Co (1948) 333 US 127 at 134, 135 (92 Law Ed 588, at 591), where his Honour said:
It only confuses the issue ... to introduce such terms as 'the work of nature' and the 'laws of nature'. For these are vague and malleable terms infected with too much ambiguity and equivocation. Everything that happens may be deemed 'the work of nature', and any patentable composite exemplifies in its properties 'the laws of nature'. Arguments drawn from such terms for ascertaining patentability could fairly be employed to challenge almost any patent.
112 Their Honours continued in NRDC at 264:
The truth is that the distinction between discovery and invention is not precise enough to be other than misleading in this area of discussion. There may indeed be a discovery without invention - either because the discovery is of some piece of abstract information without any suggestion of a practical application of it to a useful end, or because its application lies outside the realm of "manufacture". But where a person finds out that a useful result may be produced by doing something which has not been done by that procedure before, his claim for a patent is not validly answered by telling him that although there was ingenuity in his discovery that the materials used in the process would produce the useful result no ingenuity was involved in showing how the discovery, once it had been made, might be applied. The fallacy lies in dividing up the process that he puts forward as his invention. It is the whole process that must be considered: and he need not show more than one inventive step in the advance which he has made beyond the prior limits of the relevant art.
113 The Court went on to explain this point by reference to the distinction between a mere idea and its application by reference to Watt's invention of the use to which steam may be put (at 264):
This is perhaps nowhere more clearly put than it was by Fletcher Moulton LJ in Hickton's Patent Syndicate v Patents and Machine Improvements Co Ltd when he said of Watt's invention for the condensation of steam, out of which the steam engine grew: "Now can it be suggested that it required any invention whatever to carry out that idea when once you had got it? It could be done in a thousand ways and by any competent engineer, but the invention was in the idea, and when he had once got that idea, the carrying out of it was perfectly easy. To say that the conception may be meritorious and may involve invention and may be new and original, and simply because when you have once got the idea it is easy to carry it out, that that deprives it of the title of being a new invention according to our patent law, is, I think, an extremely dangerous principle and justified neither by reason nor authority".
(citations omitted)
114 Three points of emphasis may be noted from these passages. First, the distinction between mere discovery and an invention lies in its practical application to a useful end. Secondly, it is important that the invention be considered as a unitary concept, not segregated artificially into parts. The invention may arise from an idea and then be applied in a perfectly well known way, and yet the combined effect of the idea and its application may result in patentable subject matter, as arose from the example described in Hickton's Patent Syndicate v Patents and Machine Improvements Co Ltd (1909) 26 RPC 339. The approach of the appellants in the present appeal, which seeks to disaggregate the discovery of cffDNA in maternal plasma or serum from the method used to harness that discovery, tends to overlook these matters. Thirdly, an invention may reside in an abstract idea, such as the condensation of steam that is then put to a useful end, even though the way of putting it to that end can be carried out in many useful ways, all of which are otherwise known.
115 In Apotex the High Court considered whether methods of treatment of the human body using a known substance would amount to a manner of manufacture. At [230] Crennan and Kiefel JJ referred to an earlier passage at 264 in the NRDC case:
In determining that a novel use of known substances (for the eradication of weeds from crops) was a patentable invention, this Court (Dixon CJ, Kitto and Windeyer JJ) decided that it was not essential that a process produce or improve a vendible article. Their Honours explained, by reference to the doctrine of analogous uses set out in BA's Application:
"If ... the new use that is proposed consists in taking advantage of a hitherto unknown or unsuspected property of the [known] material ... there may be invention in the suggestion that the substance may be used to serve the new purpose; and then, provided that a practical method of so using it is disclosed and that the process comes within the concept of patent law ultimately traceable to the use in the Statute of Monopolies of the words 'manner of manufacture,' all the elements of a patentable invention are present ... It is not necessary that in addition the proposed method should itself be novel or involve any inventive step".
(emphasis added, citations omitted)
116 Later, their Honours considered and approved the reasoning of Lockhart J in Anaesthetic Supplies Pty Limited v Rescare Limited [1994] FCA 304; 50 FCR 1 at 19. At [240] their Honours said:
In the majority, Lockhart J found that once the notion of the necessity for a vendible product (as in Re C & W's Application) is eliminated (as it was in the NRDC Case), there is no distinction in principle between a product for treating humans and a method for treating humans. ... His Honour said:
"I see no reason in principle why a method of treatment of the human body is any less a manner of manufacture than a method for ridding crops of weeds as in NRDC. Australian courts must now take a realistic view of the matter in the light of current scientific development and legal process; the law must move with changing needs and times ...
If a process which does not produce a new substance but nevertheless results in 'a new and useful effect' so that the new result is 'an artificially created state of affairs' providing economic utility, it may be considered a 'manner of new manufacture' within s 6 of the Statute of Monopolies".
(emphasis added in Apotex, citations omitted)
117 Claim 1 in issue before the Court in Apotex was for a method of preventing or treating psoriasis, and claimed a previously unknown therapeutic use of a pharmaceutical substance which was known for other therapeutic uses disclosed in an earlier patent (at [276]). The Court rejected a submission that the subject matter of the claim was "essentially non-economic" (French CJ at [50], Crennan and Kiefel JJ at [277], Gageler J at [314]). Crennan and Kiefel JJ provided seven reasons for this conclusion at [278]-[285] (with which Gageler J agreed at [314]). Two aspects are presently material. In the first, their Honours noted at [278] that the requirement that an invention have "economic utility" raises the same considerations as those applicable in the UK and Europe that an invention be susceptible or capable of industrial application. This was, they said, apparent from the definition of "exploit" in the Act.
118 The reference to that definition serves to emphasise the distinction between product and method claims and, in respect of method claims, to demonstrate that a "product" in the sense of a tangible thing is not required for patentability. In this respect, the plurality in Myriad noted at [16] that the definition of "exploit" distinguishes "between an invention which is a product and an invention which is a method or process which may or may not yield a product" (emphasis added). They noted that in Northern Territory v Collins [2008] HCA 49; 235 CLR 619 at [18] Gummow ACJ and Kirby J "linked that distinction to the way in which, over time, the expression 'manner of manufacture"' had been construed to include the practice and means of 'making', as well as its product, which would include an economically useful outcome effected by an inventive method" (emphasis added).
119 In the fourth aspect discussed by Crennan and Kiefel JJ, their Honours said at [282]:
... the subject matter of a claim for a new product suitable for therapeutic use, claimed alone (a product claim) or coupled with method claims (combined product/method claims), and the subject matter of a claim for a hitherto unknown method of treatment using a (known) product having prior therapeutic uses (a method claim), cannot be distinguished in terms of economics or ethics. In each case the subject matter in respect of which a monopoly is sought effects an artificially created improvement in human health, having economic utility. It could not be said that a product claim which includes a therapeutic use has an economic utility which a method or process claim for a therapeutic use does not have. It could not be contended that a patient free of psoriasis is of less value as a subject matter of inventive endeavour than a crop free of weeds. Patent monopolies are as much an appropriate reward for research into hitherto unknown therapeutic uses of (known) compounds, which uses benefit mankind, as they are for research directed to novel substances or compounds for therapeutic use in humans. It is not possible to erect a distinction between such research based on public policy considerations.
(emphasis added)
120 In their concluding remarks in relation to patentability, Crennan and Kiefel JJ noted at [287] that the expression "essentially non-economic" came from the requirement that the subject matter of a patent must have useful application in the sense that it must be capable of being practically applied in commerce or industry in the sense of being "susceptible or capable of industrial application". These observations serve to reinforce the proposition that it is not necessary for a method or process claim to have as its outcome or result a tangible product or output in order to be a method that produces an economically useful outcome. What is necessary is that there be "a new and useful effect".
121 The decision of the High Court in Myriad concerned the inherent patentability of a claim to an isolated DNA sequence that mirrored naturally occurring genetic information. Although three claims were in issue, it is sufficient to refer for present purposes to claim 1, which was in the following terms:
An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No:1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.
122 The reference to "coding for a mutant or polymorphic BRCA1 polypeptide" was to an isolated nucleic acid molecule which, when compared to the standard reference sequence set forth in SEQ.ID No:1, exhibits one or more of the 54 mutations or polymorphisms delineated in Tables 12, 12A, 14 and 18 (Gageler and Nettle JJ at [115]) and which were said to be present in women with familial breast cancer (at [117]).
123 Before the Full Court of the Federal Court in D'Arcy v Myriad Genetics Inc [2014] FCAFC 115; 224 FCR 479 (Allsop CJ, Dowsett, Kenny, Bennett and Middleton J) (Myriad (Full Court)), Ms D'Arcy submitted that isolated nucleic acid was not materially different to cellular nucleic acid and that naturally occurring DNA and RNA, even in isolated form, are products of nature that could not form the basis of a valid patent: Myriad at [82] (plurality); Myriad (Full Court) at [162]. Myriad, on the other hand, contended that its claims were for a product consisting of an artificial state of affairs providing a new and useful effect of economic significance, and that isolated nucleic acid differed from the nucleic acid found in a human cell chemically, structurally and functionally: Myriad at [82] (plurality), Myriad (Full Court) at [163]. Myriad failed.
124 In the High Court the plurality accepted that claim 1 was formally expressed as a product claim (at [6], [86]) but found that at the outset the invention as claimed must be construed having regard to the breadth and substance of the claims in issue (at [87]). It found that the code claimed refers to the sequence of nucleotides which, in a cellular environment, can ultimately be translated into the BRCA1 polypeptide, and that that sequence can properly be described as "information" which is stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide. That is the same information as that contained in the DNA of the person from which the nucleic acid was isolated. The plurality concluded at [89] that:
It is the existence of that information which is an essential element of the invention as claimed. The product is the medium in which that information resides. That characteristic also attaches to cDNA, covered by the claims, which is synthesised but replicates a naturally occurring sequence of exons.
125 The plurality found that whilst there were chemical, structural and functional differences between the isolated nucleic acids and nucleic acids found in the cellular environment, none of those played any part in the definition of the invention as claimed in the claims. The focus of the claims was on genetic information: at [90], [91]. So characterised, the plurality considered that the fact of the existence of the requisite mutations or polymorphisms was a matter of chance, it was not "made" or "artificially created" (an apparent reference to factor 1 set out at [28] of the plurality's reasons): at [91]. Nor was the isolated BRCA1 gene to be considered of economic significance necessary to satisfy factor 2, the plurality saying at [85]:
The economic significance necessary to the patentability of an "artificially created state of affairs" in the sense used in NRDC is not demonstrated by stating that the artificially created state of affairs is a step along the way to a process or method itself claimed as an artificially created state of affairs of economic significance.
126 In this context the plurality rejected the finding of the Full Court that the isolation of the nucleic acid also led to an economically useful result, because the claim was not to the method of treatment of breast and ovarian cancers, but was a claim to the isolated gene used to identify an individual's susceptibility to such cancers.
127 Having so characterised the invention, the plurality found that this subject matter lay at the boundaries of the concept of manner of manufacture (at [93]). It was not an artificially created state of affairs of economic utility. They considered that the very large number of the isolated nucleic acids that could fall within the claim raised the risk of a chilling effect upon legitimate innovative activity outside the boundaries of the monopoly and risked creating a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors (factor 3) (at [93]). Furthermore, they considered that to extend the concept of manner of manufacture to include the invention claimed would not contribute to the coherence of the law, having regard to Apotex (factor 4) (at [94]). Nor did Australia's international obligations suggest otherwise (factor 5) ([94]).
128 The decision of the plurality may be understood to endorse the long-established approach to patentable subject matter as it was considered in NRDC, noting the importance of factors 1 and 2 which will ordinarily be sufficient to determine the question (at [28]). Where a new class of claim involves a significant new application of the concept of manner of manufacture, it will be necessary to have regard to other factors, including those identified as factors 3 to 6 at [28] of Myriad.
129 It is apparent from the foregoing that the facts upon which the decision in Myriad was based are materially different to the present case, most particularly because the claim in issue there was for a product, being the isolated BRCA1 gene sequence. Other claims in the patent did concern methods of use, and the specification referred to these, but, as the plurality noted at [71] those claims were not in issue.
130 However, some indications as to the approach to be taken in assessing whether a method claim is a manner of manufacture may be seen from the reasons of the other members of the High Court.
131 Gageler and Nettle JJ considered that for a claimed invention to qualify as a manner of manufacture it must be something more than a mere discovery, and that the essence of invention inheres in its artificiality or distance from nature (at [126]). They said at [128]:
Relevantly, the artificiality of a product may be perceived in a number of factors, including the labour required to create it and the physical differences between it and the raw natural material from which it is derived. Regardless, however, of the amount of labour involved or the differences between the product and the raw natural material from which it is derived, it is necessary that the inventive concept be seen to make a contribution to the essential difference between the product and nature.
(citation omitted)
132 The reference here to "inventive concept" is not to be understood as a disaggregation of the integers of the invention as claimed, or a departure from the approach in NRDC at 264, but rather to the inventive concept apparent from the invention claimed as a whole.
133 Their Honours' reasoning at times alluded to method claims, and their likely patentability, by way of contrast with the product claim. Their Honours noted at [137] that the application of naturally occurring phenomena to a particular use may be a manner of manufacture if it amounts to a new process or method of bringing about an artificially created state of affairs of economic significance. They said "[e]ven so, the inventor cannot claim to have invented the naturally occurring product as opposed to the process of application". Their Honours distinguished between on the one hand what they perceived may be patentable subject matter in the form of a method of using the discovery of a connection between the BRCA1 gene in a person and a medical condition, and on the other, a claim to the BRCA1 gene sequence itself (at [147]):
It was not disputed that the first respondent might justly lay claim to the discovery that, if an isolated fragment comprising the BRCA1 gene is found upon examination to exhibit the specified mutations and polymorphisms, their presence is or may be indicative of particular kinds of malignancy in the cell. Nor was it disputed that a process or method of using known technology to isolate a sequence of nucleic acid comprising the BRCA1 gene and examining it for the presence of the specified mutations and polymorphisms for the purpose of detecting or predicting malignancy might be patentable. But, as has been observed, the discovery of a natural correlation is not patentable as such and its discovery does not entitle the first respondent to patent the BRCA1 gene as a product, whether or not afflicted by the specified mutations and polymorphisms.
(emphasis added, citations omitted)
134 Gageler and Nettle JJ concluded that although claim 1 was restricted to isolated nucleic acid comprising the mutated BRCA1 gene, it was "in truth a claim for a monopoly over the right to apply long-established methods for the isolation and amplification of specific nucleotide fragments to the isolation and amplification of a patient's naturally occurring BRCA1 gene, where and if it is found upon subsequent examination that the patient's BRCA1 gene happened to be afflicted by any of the specified mutations and polymorphisms" (at [160]). This was not a manner of manufacture.
135 Relevant to the current inquiry, their Honours said:
[168] It is not disputed that a process or method of detecting the increased likelihood of certain kinds of malignancy by isolating the BRCA1 gene and examining it for the presence of any of the specified mutations and polymorphisms may be patentable subject matter as a process [NRDC at 262; Apotex; Hickton's Patent Syndicate] (subject to considerations of novelty and inventive step when compared to the prior art base). But, to repeat, claim 1 is not a claim for any such process. It is a claim for a monopoly over such isolated fragments of naturally occurring DNA as comprise the BRCA1 gene as are found upon examination to contain the (naturally occurring) specified mutations and polymorphisms.
[169] In the result, the claim extends too far. The difficulty for the first respondent is that, having discovered a presumably good and perhaps ground-breaking process for detecting the probability of certain kinds of malignancy by reference to the presence of particular mutations and polymorphisms in the BRCA1 gene, the first respondent has attempted to patent those sequences of the gene themselves notwithstanding that, even when isolated, they are naturally occurring and therefore not new.
(emphasis added, citation omitted from [169])
136 Gordon J at [252] also cited Fletcher Moulton LJ's reasoning in Hickton's Patent Syndicate where he said at 348:
In my opinion, invention may lie in the idea, and it may lie in the way in which it is carried out, and it may lie in the combination of the two; but if there is invention in the idea plus the way of carrying it out, then it is good subject-matter for Letters Patent."
(emphasis added by Gordon J)
137 Her Honour characterised Myriad's idea, concept or principle as being that specific mutations or polymorphisms in the BRCA1 gene sequence suggest a predisposition to breast cancer and ovarian cancer (at [254]). But that was not the idea carried out in claim 1 which was the product claim. It is instructive to note her Honour's reasoning also contrasted the result as it applied to the product claim with her view of the correct conclusion in relation to the method claims:
[256] What then did Myriad do? It took the idea, concept or principle that specific mutations or polymorphisms in that sequence suggest a predisposition to breast cancer and ovarian cancer and moved to carry out that idea, concept or principle, or embody it in a manner of new manufacture, in claims 4-30. The validity of those claims is not in issue.
[257] Claim 4 may be taken as an example. In simple terms, it comprises a nucleic acid probe in which the nucleotide sequence is a portion of an isolated nucleic acid with the characteristic identified in claim 1. In general terms, a probe is a fragment of isolated nucleic acid of variable length which is used to detect the presence of complementary nucleotide sequences and to investigate tissue samples to see whether particular genes are being expressed. A probe for BRCA1 alleles may be derived from sequences of the BRCA1 region or its cDNA. Probes are usually constructed artificially and have a radioactive label attached.
[258] The invention in claim 4 carried into effect the idea that specifically identified mutations or polymorphisms in a sequence of the BRCA1 gene suggest a predisposition to breast cancer and ovarian cancer by testing for the presence of one or more of the specifically identified mutations or polymorphisms. That is an invention.
138 By contrast, claim 1 was not to a means of carrying out the invention but to the isolated sequence.
139 As Myriad makes clear, it is of importance first to consider what in substance is the invention as claimed. This depends on the construction of the claim, when read in in the context of the specification as a whole and in the light of the common general knowledge as it stood at the priority date.
140 In our view, the authorities demonstrate that the relevant claims of the patent in suit here represent a manner of manufacture, and that the primary judge did not err in so concluding.
141 One commences with consideration of the substance of the invention having regard to the disclosure of the specification. The specification informs the skilled reader that the invention "provides a detection method performed on a maternal serum or plasma sample from a pregnant female", which comprises detecting the presence of nucleic acid of foetal origin in the sample, thereby "provides a method of prenatal diagnosis" (page 2 lines 20 to 24, emphasis added). This explanation is given after the revelation of the discovery that the answer to the search for non-invasive prenatal diagnosis techniques using foetal cells in maternal blood lies in the maternal plasma, the very material that those investigating a non-invasive technique had been throwing away in their investigations (page 2 lines 5 to 9).
142 In this context, the invention described may be seen to be a new means by which foetal DNA may be detected which does not involve dangerous invasive sampling or encounter the difficulty involved in using maternal blood which has very low concentrations of foetal DNA. Instead, it supplies a method of taking maternal blood, separating from it the plasma or serum and then using tools to detect the presence of a nucleic acid of foetal origin. The specification supplies examples of how to perform these steps and how to detect the foetal nucleic acid. The person skilled in the art could be in no doubt about the use to be made of the invention so described. Such a person would understand it to be a method whereby the secrets of cffDNA, valuable for the diagnosis of foetal abnormalities, could be unlocked without the problems of using invasive techniques and without the complications associated with detecting and then amplifying DNA found in the scarce foetal cells in maternal blood. The specification provides a number of examples of contexts in which the method may be used, such as in sex determination or determining the RhD status of a foetus.
143 Against this background one now turns to consider the substance of the invention claimed in the relevant claims.
144 Claim 1 commences by identifying that it is for a "detection method performed on a maternal serum or plasma sample from a pregnant female" (emphasis added). The primary judge found at [1272] that "detect" in this context is not a term of art but has its ordinary English meaning of "[t]o uncover, lay bare, expose, display (something covered up or hidden)" and "[t]o discover, find out, ascertain the presence, existence, or fact of (something apt to elude observation)". He also found (at [484]) that the experts agreed that "detect" here means demonstrating the presence of non-maternal nucleic acid that is inferred to be of foetal origin.
145 The invention claimed in claim 1 involves the elements of two broad and simply described integers, being a detection method:
(1) performed on a maternal serum or plasma sample from a pregnant female,
(2) which method comprises detecting the presence of a nucleic acid of foetal origin in the sample.
146 Integer (1) involves the detection method being performed on maternal plasma or serum from a pregnant female. The means is not specified or limited. The common general knowledge at the priority date required that this involve obtaining the analysis material by extracting blood and then separating out the plasma and, if desired, obtaining the serum by removing clotting factors from the plasma.
147 Integer (2) involves the use of an unspecified technique to detect and distinguish nucleic acid of maternal origin from nucleic acid of foetal origin. One such technique is PCR. As his Honour said at [1274]:
Without such a step, one cannot detect or identify cell-free fetal DNA, as opposed to simply extracellular DNA from an unknown source, in the sample.
148 A simple example is the detection of a Y chromosome, which would assist in identifying whether the gender of the foetus is male. In the state of the art at the priority date the preferred means of doing so involved PCR, although other techniques could be used. Regardless of the technique, human intervention was undoubtedly required.
149 Professor Fisk, one of the experts called by the respondent, explained in his first affidavit (at [88]):
At the priority date, I would have understood that "detecting the presence of" would require discriminating between nucleic acids of fetal origin on the one hand and nucleic acids of maternal origin on the other (see, for example, Patent, page 4, line 30 to page 5 line 2 and the various references in the Patent to the "detection rate"). Without such a step, one would not be able to detect the presence of fetal DNA or know whether a given sample contains fetal nucleic acid and, at the priority date, the method, without such a step, would be of little or no apparent utility for prenatal diagnosis (being the subject matter of the Patent). At the priority date, one way of ascertaining the presence of fetal DNA in a given sample would be to take steps to try to probe or identify fetal sequences that are not possessed by the mother. The simplest case would be, as variously described in the Patent, specifically identifying sequences from the Y chromosome (for male fetuses), which would necessarily not be possessed by the pregnant female.
150 The person skilled in the art knew how to ascertain gender from nucleic acid. As the primary judge explained in a passage in the judgment setting out the agreed common general knowledge (at [109]):
As at the priority date, the sex of a male fetus would be apparent if a particular molecular test involved the PCR amplification of sequences known to be from the Y chromosome. In other words, if you could detect by PCR a Y-specific fragment, it was most likely that the fetus was male. This required sequence information for the Y chromosome to be known to allow for the design of primers to result in the Y specific PCR products. Further, the loci would need to be known to be unique to the Y chromosome. As at the priority date, there were Y-specific sequences published in the literature which could be used as PCR primers.
151 The steps involved in (a) to (d) of [494] of the primary judge's reasons, set out in section 4.1 above, are not specified by claim 1, and accordingly the method so claimed is not limited to those steps. However, the primary judge found that in order to achieve the result of detection within integer (2) those steps were "at least" required. We do not consider that his Honour in so concluding was impermissibly adding integers to the claim. Rather, his Honour was demonstrating that although the method is broadly expressed, there was no means known within the common general knowledge whereby the method of the claim could be achieved without significant human intervention. The person skilled in the art would understand that to perform the detection method within what we have described as integer (1), plasma or serum needs to be separated from blood. To "detect" the nucleic acid of foetal origin within integer (2), analysis involving the use of a molecular technique such as PCR is required.
152 The appellants submit that the difficulty with this analysis is that despite the human mediation, "detection" is no different from the discovery that cffDNA is detectable. They involve the same thing. They submit that in substance there is no application of the discovery by simply claiming the detection of what has been discovered to exist.
153 However, such an approach tends to obscure the correct identification of the invention. It lies not in the mere observation that cffDNA is to be found in maternal plasma (or serum), but in the explanation as to how that knowledge may be unlocked for others to use it (that is, the explanation of how to extract the cffDNA from the plasma or serum). It is the idea coupled with a practical means of application that makes the invention.
154 The primary judge found at [494] that:
The artificially created state of affairs is the detection of cffDNA in the tested sample. This "product" is, by definition the result of human action and is not naturally occurring. The inventive method does not simply produce an abstract, intangible situation. It is not just the "information" encoded by the naturally occurring cffDNA itself.
155 We agree with that conclusion. Unlike the position in Myriad, claim 1 is not, as a matter of substance, directed to genetic information, but to a method involving the practical application of a means for identifying and discriminating between maternal and foetal nucleic acid. Although foetal nucleic acid occurs in nature, the substance of the invention is not cffDNA itself, but the identification of that particular nucleic acid as a part of a method. It is impermissible to disaggregate the integers of the method to point only to the cffDNA as the "invention". Identification of the substance of the invention does not involve disregarding material aspects of the claim language. The invention as claimed is not merely output, but the detection process which yields an output. This is the very type of subject matter considered to fall on the correct side of the line between discovery of a scientific fact or law of nature and invention: NRDC at 264; Hickton's Patent Syndicate; Apotex at [240]; Myriad at [137] (Gageler and Nettle JJ) and [252] (Gordon J).
156 The uses to which the method of claim 1 can be put are various. The primary judge's summary of the common general knowledge at [108] (see section 2.3 above) provides some examples. In this context it is apparent that the detection of nucleic acid of foetal origin provides valuable insight for those in the art and is of economic utility.
157 As we have noted earlier, authorities from NRDC onwards demonstrates that a "vendible product" in the sense of a tangible thing is not required before a claimed invention can amount to a manner of manufacture (NRDC at 269), "manufacture" being a conception which as early as 1795 was considered to extend "to any new results of principles carried into practice ... new processes in any art producing results useful to the public": NRDC at 270, citing Boulton v Bull (1795) 1 H Bl 493 at 492; 126 ER 651 at 666 (emphasis added). An artificially created improvement in human health brought about by applying a known pharmaceutical product for a new condition resulting in treatment of psoriasis satisfied the requirement in Apotex. The observation made by Crennan and Kiefel JJ at [282] of that case warrants repetition:
... Patent monopolies are as much an appropriate reward for research into hitherto unknown therapeutic uses of (known) compounds, which uses benefit mankind, as they are for research directed to novel substances or compounds for therapeutic use in humans.
158 In NRDC the Court contrasted abstract information (not patentable) with the use of such information in a practical application (patentable) (at 264). Notably, the definition of "exploit" in the Act notes that a patentee is given the exclusive right to "use the method", and as the plurality observed in Myriad at [16], a method may or may not yield a "product".
159 These matters compel the rejection of the appellants' submission to the effect that the "output" of the method is mere information and accordingly cannot amount to a manner of manufacture. Whereas the invention lies in the idea that cffDNA may be detected in maternal serum or plasma, which may then be carried out using known means of detection, the method is not relevantly different to the process postulated by Gageler and Nettle JJ at [168] (see also [137], [147], [169]), or the use of the probe in claim 4 of the Myriad patent to convey the information that the presence of particular genes within complementary nucleotide sequences indicates a malignancy as postulated by Gordon J at [257]. Here, the invention as claimed carries into effect an idea that the presence of information within the naturally occurring code of a person will be useful. By a process of detection that information is yielded up. The claim construed as a whole necessarily involves an artificially created state of affairs yielding an outcome that is of economic utility. We reject the submission that because, disaggregated from the method, the result of the detection of foetal nucleic acid is information about a naturally occurring state of affairs, the requirements of Myriad factors 1 and 2 are not satisfied. The invention as claimed cannot be separated into discrete parts.
160 Nor do we accept that a conclusion of patentability as a manner of manufacture would be inconsistent with Research Affiliates, RPL Central or Rokt. The appellants seek to draw on these cases in support of their submission that although human action may have been involved in the performance of the method claims, the end result or outcome of the method is simply information, being the presence of cffDNA, which was discovered by Professor Lo. For the reasons given above, the characterisation of the outcome of the method as "information" does not disqualify the present invention. That is not to say that every method yielding information will be patentable. The consideration of patentable subject matter does not involve a one size fits all approach. In each of those cases the question for consideration was whether or not a mere scheme or plan was nonetheless a manner of manufacture because invention lay not only in the scheme but also the means by which it was realised using computerisation: Aristocrat v Commissioner of Patents [2020] FCA 778; 382 ALR 400 at [89] (Burley J). See RPL Central at [96]. The present case does not involve a scheme or plan implemented on the medium of a computer, which would involve different considerations.
161 It is appropriate to note that there is no real prospect of falling out of step with the international community of patent decisions in reaching this conclusion, because there are disparate approaches taken abroad to the question of patentable subject matter, involving different legal tests, none of which is in the same form as that which has developed in Australia.
162 One example arises by reference to the Illumina decision in the United Kingdom. In the United Kingdom ss 130(7) and 1(2) of the Patents Act 1977 (UK) are framed so as to have as nearly as practicable the same effect as the corresponding provisions of arts 52(2) and (3) of the Convention on the Grant of European Patents (opened for signature 5 October 1973, 1065 UNTS 199 (entered into force 7 October 1977)): Illumina at [184]. Those articles state that discoveries "as such" are not inventions.
163 In Illumina Carr J considered whether or not claim 1 of a patent (similar to claim 1 presently in suit, but which included the added words at its end "wherein said nucleic acid is a paternally inherited sequence which is not possessed by said pregnant female" (at [81])) fell within the prohibition that discoveries "as such" are not patentable inventions: at [184]. At [184] to [189] he identified the relevant legal test, drawn from Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46; [2005] RPC 9 at [77] (Hoffman LJ) and Tate & Lyle Technology td v Roquette Freres [2010] FSR 1 at [75] (Lewison J) as being whether, as a matter of substance and not mere form, the invention claimed "is a practical product or process, not information about the natural world". This involved applying a four-part structured approach to objections to excluded subject matter set out by the Court of Appeal in Aerotel Ltd v Telco Holdings; Mcrossan's Application [2007] RPC 7 and Symbian Ltd v Comptroller General of Patents [2009] RPC 1, involving: first, properly construing the claim; secondly, identifying the "actual contribution"; thirdly, asking whether the identified contribution falls solely within the excluded subject matter; and, finally, checking whether the actual or alleged contribution is "technical in nature" (at [186]). His Honour concluded that claim 1 was not to a discovery as such and accordingly was patentable subject matter (at [189]).
164 In the United States the Court of Appeals for the Federal Circuit considered a similar patent to the one in suit in Australia, where claim 1 was expressed as "a method for detecting a paternally inherited nucleic acid of foetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of foetal origin in the sample": Ariosa (US) at 1373-1374. At 1375 the Court noted the established position that laws of nature, natural phenomena and abstract ideas are not patentable subject matter, and that in Mayo Collaborative Servicees v Prometheus Laboratories Inc 566 US 66, 132 S.Ct 1289 (2012) the Supreme Court set out a framework for distinguishing ineligible patents on the basis that they claimed such a law of nature, natural phenomena or abstract idea by first, determining whether the claims are directed to a "patent ineligible concept" and, secondly, if so, considering the elements of each claim both individually and as an ordered combination to determine whether additional elements "transform the nature of the claim" into a patent-eligible application. The second step is considered to be a search for an "inventive concept" that is sufficient to ensure that the patent in practice amounts to "significantly more than a patent upon the [ineligible concept] itself" (at 1375, quoting Mayo at 1294). The Court determined that by applying that specific test, Sequenom's claim was not for patentable subject matter: at 1378.
165 Quite apart from the diverging approaches, and different results in respect of similar claims, it is apparent that the legal analysis developed over recent years in the United Kingdom (and Europe) and the United States diverges from that identified in the line of authorities identified in NRDC, Apotex and Myriad.
166 In our view the invention of claim 1 falls firmly within the concept of a manner of manufacture as that term is to be understood having regard to the authorities, being an artificially created state of affairs of economic utility (NRDC, Myriad at [28] (plurality)). We do not consider that it represents a new class of claim involving a significant new application or extension of the concept, such that factors 3 to 6 identified by the plurality in Myriad require consideration: see Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177; 238 FCR 27 at [118] - [119] (Kenny, Bennett and Nicholas JJ).
167 Having reached this conclusion in relation to claim 1, it follows that the same result applies in respect of each of dependent claims 2, 3, 5, 6, 9, 13 and 14 which explicitly add detail to the method of claim 1. Claims 22, 23 and 25 are methods for the provision of a "prenatal diagnosis" following the performance of the method in the first class (being claims 2, 3, 5, 6 and 9) and therefore are also a manner of manufacture for the reasons given. Grounds 1 to 5 of the appeal are accordingly dismissed.