Manner of Manufacture
87 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 1624 21 Jac 1 c 3. Schedule 1 to the Act defines "invention" as "any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention". This element of patentability was considered in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 ("NRDC") and, more recently, D'Arcy v Myriad Genetics Inc (2015) 258 CLR 334 ("Myriad"). According to NRDC, as explained in Myriad, for an invention to constitute a manner of manufacture in the relevant sense, it must first be "for a product made, or a process producing an outcome as a result of human action" and, secondly, it must have "economic utility": see Myriad at [28] per French CJ, Kiefel, Bell and Keane JJ. However, while these two characteristics are essential to the existence of a patentable invention, they will not always provide a sufficient criteria against which to determine whether an invention is a manner of manufacture. As their Honours also observed at [28]:
… When the invention falls within the existing concept of manner of manufacture, as it has been developed through cases, they will also ordinarily be sufficient. When 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 Act may assume importance …
Their Honours went on to identify at [28] a number of additional factors that may need to be considered when a new class of claim is in issue.
88 In their submissions the respondents did not suggest that the claims in suit in this case involve any new class of claim and did not make any submissions directed to the additional factors identified in Myriad at [28]. Rather, the focus of the respondents' submissions was on the principle considered by the High Court in Commissioner of Patents v Microcell Limited (1959) 102 CLR 232 ("Microcell") and the finding that what was claimed in that case was not patentable because (at 251):
We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter for a patent, and the position cannot be affected either by the fact that nobody thought of doing the thing before, or by the fact that, when somebody did think of doing it, it was found to be a good thing to do.
89 In that case the patent specification described an invention consisting of a self-propelled rocket projector comprising a tube of synthetic resinous material reinforced with mineral fibres. It was apparent on the face of the specification that the invention was said to reside in the use of such material in the construction of the self-repelled rocket projector. In the course of the High Court's judgment in Microcell, reference was made to the "old and well-established principle that the mere discovery of a new use of a particular known product is not what is meant by invention … [and] that where by the alleged invention no new product is obtained, no new method of manufacture suggested nor an old one improved, the discovery cannot be protected by a grant of Letters' Patent …". Their Honours said at 250:
Here the specification does not on its face disclose more than a new use of a particular known product. To use Lord Buckmaster's words, no new product is obtained, and there is no new method of manufacture suggested or an old one improved. Tubular self-propelled-rocket projectors were at the relevant time well-known articles of manufacture. Synthetic resinous plastics reinforced with mineral fibres, and in particular polyester plastics reinforced with glass or asbestos fibres, were well-known materials. These things are to be gathered from the specification itself, which contains no suggestion of novelty in relation to the article to be manufactured or the material to be used. It further appears from matter published in Australia as early as 1946 that the reinforced plastic materials referred to in the specification had been used in the manufacture of a wide variety of articles. The properties of those materials were known generally, and in particular it was well known that they possessed that combination of great strength and lightness wherein, according to the specification itself, lies their virtue for the purpose in hand. The matter published in 1946 refers to their "extraordinary strength in relation to weight" - they are "stronger for their weight than steel" - and to their high tensile strength - another quality which the specification regards as a virtue for the purpose in hand. It was well known too that they possessed high impact strength and high resistance to heat. In these circumstances we do not think it can be said, merely because it does not seem previously to have occurred to anyone to make a rocket projector out of reinforced plastic, that any inventive idea is disclosed by the specification.
90 Gageler and Nettle JJ referred to Microcell in Myriad. Their Honours said, in a passage that was relied on by the respondents in this case, at [129]-[131]:
[129] Admittedly, it has occasionally been doubted that there is any longer a threshold requirement of inventiveness as opposed to the specific requirements of inventive step and novelty for which s 18(1)(b) provides. It has also been suggested that it would be desirable to collapse the subject matter requirement into the specific inquiries of inventive step and novelty. The Advisory Council on Intellectual Property concluded that it would make sense for "questions of newness to be dealt with under the specific provisions for novelty and inventive step, rather than under the general umbrella of manner of new manufacture".
[130] But for present purposes, the law on the point appears to be tolerably clear. In Commissioner of Patents v Microcell Ltd, the Full Court held that the subject matter of a claim as disclosed in the specification must possess a quality of inventiveness or, in other words, the use of ingenuity that adds to the sum of human knowledge. In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd, the majority recognised that the quality of inventiveness must appear on the face of the specification. In Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171 (Ramset), the majority held that whether claimed subject matter is an invention for the purposes of s 100(1)(d) of the Patents Act 1952 (Cth) is distinct from inquiries as to inventive step, obviousness and novelty under s 100(1)(e) and (g), and that the court below had erred in considering "inventive merit" in light of prior art for the purposes of s 100(1)(d). The majority distinguished Philips on the basis that it was decided under the Patents Act 1990 (Cth). But, at a later point in the judgment, the majority also acknowledged that, where the subject matter of a claim as disclosed in the specification is plainly not an invention, the claim should be dismissed.
[131] Notwithstanding that Microcell did not establish a discrete "threshold" test, each of those decisions is consistent with the requirement, essential to the concept of a "manner of manufacture", that the subject matter of a claim have about it a quality of inventiveness which distinguishes it from a mere discovery or observation of a law of nature. That requirement is separate and distinct from the other requirements of inventive step and novelty. As Brennan, Deane and Toohey JJ stated in Philips, an alleged invention will:
"remain unsatisfied if it is apparent on the face of the relevant specification that the subject matter of the claim is, by reason of absence of the necessary quality of inventiveness, not a manner of new manufacture for the purposes of the Statute of Monopolies. That does not mean that the threshold requirement of 'an alleged invention' corresponds with or renders otiose the more specific requirements of novelty and inventive step (when compared with the prior art base) contained in s 18(1)(b). It simply means that, if it is apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further."
(some footnotes omitted)
91 The particulars given by the respondents in support of their manner of manufacture case were as follows:
(a) The alleged invention, as claimed in each of claims 1 to 4 of the Patent, is not the proper subject matter for the grant of a patent, in that it is not an "artificially created state of affairs":
(i) The essential oil claimed in each of claims 1 to 4 of the patent is naturally occurring.
(ii) The essential oil claimed in each of claims 1 to 4 of the patent is not "made".
(b) Further, the alleged invention, as claimed in each of claims 1 to 4 of the Patent, is not the proper subject matter for the grant of a patent, in that what is claimed is "the use of a known material in the manufacture of known articles for the purpose which its known properties make that material suitable": Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232. That is, at the priority date of the Patent the processes of distillation and steam distillation were known processes by which essential oils could be, or were, derived from native Australian shrubs.
(c) As to claims 5 to 9, the alleged invention as claimed in each claim is not the proper subject matter for the grant of a patent as the use of the essential oil in the method of treatment (in each claim) claims a known use for a known material. It was known at the earliest priority date of the Patent that essential oils obtained from native Australian shrubs referred to in paragraphs [29] to [36] of the affidavit of Dr Philip Allan Clarke sworn 20 June 2018 had, amongst other potential uses and applications, medicinal and therapeutic applications, including those mentioned in the said claims. No patentable subject matter resides in an alleged invention which seeks to claim a monopoly over attributes or capabilities inherent in and to, and/or attributes or capabilities known to be inherent in and to, essential oils.
(d) Further or in the alternative to (a) and (c), no manner of manufacture resides in a purported invention to a mere discovery (if there be one) that an essential oil derived from an Australian native shrub, such as the kunzea ambigua, may be a product and/or used in a method of treatment involving medicinal or therapeutic applications such as those mentioned in the claims. Such a discovery (if there be one) is not an invention capable of being the proper subject matter of a standard patent and is not a manner of manufacture.
92 As I have mentioned, the applicant accepts that claims 1-4 are invalid on the basis that they lack novelty. In those circumstances it is unnecessary to determine whether those claims are also invalid on the ground that they are not to a manner of manufacture. However, there are a number of observations that I will make in relation to that issue.
93 The respondents submitted that Mr Hood was not the first to discover an essential oil derived from Kunzea ambigua because the authors of the Morrison Paper published in 1922 and the Dragar Thesis published in 1984 had already extracted essential oil from Kunzea ambigua in connection with their investigations of the species many years before Mr Hood first produced essential oil from Kunzea ambigua growing on his property.
94 The difficulty with that submission is that the specification itself does indicate that the essential oil derived from Kunzea ambigua was a known substance that had been previously extracted from the plant. On the contrary, the specification states that it is the object of the invention described to provide a new essential oil. There is in my view nothing in the specification to suggest to the person skilled in the art that the essential oil of Kunzea ambigua had been extracted from the plant before the Priority Date. It is not apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject of letters patent is absent. The present case is therefore outside the ratio of the decision of the majority in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 ("Philips") at 663-664 per Brennan, Deane and Toohey JJ.
95 However, in Philips the majority (Brennan, Deane and Toohey JJ) went on to express the opinion that the same conclusion would follow even if the lack of inventiveness was not apparent on the face of the specification. Their Honours said at 666-667:
Strictly speaking, it is unnecessary to answer the question whether a process which could not be a proper subject matter for a patent according to traditional principle, for the reason that it is merely a new use of a known product, can nonetheless be a "manner of manufacture within the meaning of section 6 of the Statute of Monopolies" for the purposes of s 18(1)(a). However, in view of the fact that the argument in this Court and the judgments in the Full Court were primarily directed to that question, it is appropriate that we indicate that we consider that the above construction of s 18(1)'s threshold requirement of "an invention" goes a long way towards answering it since it would border upon the irrational if a process which was in fact but a new use of an old substance could be a "patentable invention" under s 18 if, but only if, that fact were not disclosed by the specification. In the context of that construction of s 18(1)'s threshold requirement of an "invention", the preferable conclusion is that the phrase "manner of manufacture within the meaning of section 6 of the Statute of Monopolies" in s 18(1)(a) should be understood as referring to a process which is a proper subject matter of letters patent according to traditional principle.
96 In Bristol-Myers Squibb Co v F H Faulding & Co Ltd (2000) 97 FCR 524 ("Faulding") the Full Court treated the majority decision in Philips as authority for the proposition that if, on the basis of what was known, as revealed on the face of the specification, the invention was obvious or did not involve an inventive step, the threshold requirement of inventiveness imposed by s 18(1) of the Act would not be met. Black CJ and Lehane J said at [30]:
The majority of the High Court in Philips explicitly say that their observations about a case where want of the threshold requirement of inventiveness is not apparent on the face of the specification are not necessary to their decision. And, in discussing the commencement point (what is "known") of the inquiry about inventiveness, their Honours refer only to the Microcell principle. In our view, in the light of the authorities to which we have referred, Philips stands for the proposition (as a matter of construction of the 1990 Act) that if, on the basis of what was known, as revealed on the face of the specification, the invention claimed was obvious or did not involve an inventive step - that is, would be obvious to the hypothetical non-inventive and unimaginative skilled worker in the field […] - then the threshold requirement of inventiveness is not met. Some elaboration, however, is required in relation to what the specification reveals as "known". If a patent application, lodged in Australia, refers to information derived from a number of prior publications referred to in the specification or, generally, to matters which are known, in our view the Court - or the Commissioner - would ordinarily proceed upon the basis that the knowledge thus described is, in the language of s 7(2) of the 1990 Act, part of "the common general knowledge as it existed in the patent area". In other words, what is disclosed in such terms may be taken as an admission to that effect. In substance, we think, that is what happened, both in Microcell and in Philips. If, however, the body of prior knowledge disclosed by the specification is insufficient to deprive what is claimed of the quality of inventiveness, then the only additional knowledge or information which will be taken into account is knowledge or information of a kind described in s 7(2) of the 1990 Act. That again, in our view, is consistent with the approach taken in Microcell. It is also, with respect, the only approach which does not, in practical terms, render s 18(1)(b)(ii) otiose. Of course, once that additional knowledge is taken into account, one is applying s 18(1)(b)(ii), not the opening words of s 18(1) - unless, perhaps, one might apply either, there being, in this respect, no difference between them.
The decision in Faulding is authority for the proposition that it is not enough to establish that an invention is not a manner of manufacture by showing that it lacks inventiveness unless the lack of inventiveness is apparent on the face of the specification. This is the approach followed in a number of subsequent Full Court decisions including Novozymes A/S v Danisco A/S (2013) 99 IPR 417 per Jessup J and AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324 ("AstraZeneca") at [379]-[387] per Besanko, Foster, Nicholas and Yates JJ.
97 In Myriad, Gageler and Nettle JJ said at [126]-[128]:
[126] For a claimed invention to qualify as a manner of manufacture it must be something more than a mere discovery. The essence of invention inheres in its artificiality or distance from nature; and thus, whether a product amounts to an invention depends on the extent to which the product "individualise[s]" nature. As Professors Sherman and Bently wrote:
"What then was required in order to move from the realm of discovery to that of invention? The simple answer was that it was necessary to show that abstract principles had been reduced to practice, that Nature had been individualised or activated … While philosophical or abstract principles could not on their own be patented, their embodiment in a material or practical form could. In these circumstances it was clear that in law it was the artificial or created nature of the final product, its distance from Nature, which ensured that an object became an invention rather than a mere discovery."
[127] The question then is whether the subject matter of the claim is sufficiently artificial, or in other words different from nature, to be regarded as patentable.
[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.
(footnotes omitted)
98 In the present case each of claims 1-4 is to an essential oil derived from plant matter of the kind identified in the claims. These claims are to the essential oil so derived in whatever form the extracted oil takes. This is significant because, according to the evidence, the chemical composition of the plant will vary depending on growing conditions and this will in turn affect the composition of the essential oil derived from the plant. While the chemical composition of the oil extracted from different plants will vary, this is due to the way in which the plant responds to the conditions in which it is grown and the stage at which it is harvested. The composition of the essential oil will mirror what is found in the plant. Moreover, the usual method by which the essential oil is extracted from the plant (ie. steam distillation) is one of great antiquity. It was common ground that essential oil has been extracted from plants using this process for many hundreds (perhaps thousands) of years. In those circumstances, a question arises as to whether the essential oil the subject of each of claims 1-4 is (adopting the language used by Gageler and Nettle JJ in Myriad at [127]) sufficiently artificial or different from nature to be regarded as patentable.
99 Of course, as the applicant now concedes, an essential oil of the kind referred to in each of claims 1-4 had been extracted and described in the documents that form part of the prior art base before the Priority Date with the consequence that each of those claims is invalid for lack of novelty. It is therefore unnecessary for me to express any final conclusion with respect to the issue of manner of manufacture as it relates to claims 1-4. However, it seems to me that if the question posed by Gageler and Nettle JJ in Myriad at [127] is the right question to ask, it is strongly arguable that the difference between the raw oil extracted from the Kunzea ambigua shrub is insufficiently artificial or different from nature to qualify as patentable subject matter.
100 I now turn to the challenge to the validity of claims 5-9 each of which is to a method of treatment. It is clear that each of claims 6-9 mistakenly refer to claim 4 when they should refer to claim 5. For the purposes of addressing the validity issues I will proceed as if the reference in claims 6-9 to claim 4 was a reference to claim 5.
101 The respondents accepted that a method of treatment may be patentable subject matter. The correctness of that proposition was confirmed by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 253 CLR 284 ("Apotex"). In that case the High Court rejected the submission that the subject matter of the claim in suit was "essentially non-economic" and therefore not to a manner of manufacture: see Apotex at [277] per Crennan and Kiefel JJ. Their Honours said at [283]:
[283] … a method claim in respect of a hitherto unknown therapeutic use of a (known) substance or compound satisfies the general principle laid down in the NRDC Case. Such a method belongs to a useful art, effects an artificially created improvement in something, and can have economic utility. The economic utility of novel products and novel methods and processes in the pharmaceutical industry is underscored by s 119A of the 1990 Act and by their strict regulation in the Therapeutic Goods Act 1989 (Cth) (the TGA).
102 It is apparent from the particulars of invalidity which I have previously set out that claims 5-9 of the patent are said by the respondents not to be to a manner of manufacture not because they lack economic utility but because they are for the "known use of a known material". The respondents rely on the principle discussed in Microcell to which I have previously made reference.
103 Dr Clark gave some evidence on a range of different plants in Australia from which essential oils may be derived. According to this evidence, there are roughly 20 to 50 different plant families in Australia from which essential oils may be derived. However, a large proportion of oils (approximately 70%) come from a small number of families (approximately 12 families). The main families of essential oil producing plants are the following:
(a) Myrtaceae;
(b) Rutaceae;
(c) Lamiaceae;
(d) Fabaceae;
(e) Poaceae;
(f) Santalaceae;
(g) Solanaceae.
104 Dr Clark also gave evidence that the genera of plants from Australia which were commonly and generally known by October 1996 for producing oils with therapeutic uses included:
(a) Eucalyptus/Corymbia - Myrtaceae family;
(b) Melaleuca ("tea tree") - Myrtaceae family;
(c) Leptospermum ("tea tree") - Myrtaceae family;
(d) Kunzea ("tea tree") - Myrtaceae family;
(e) Backhousia - Myrtaceae family;
(f) Santalum ("sandalwood") - Santalaceae family;
(g) Boronia - Rutaceae family;
(h) Prostranthera ("mint bush") - Lamiceae family;
(i) Cymbopogon ("Lemongrass") - Poaceae family;
(j) Callitris ("Australian pine") - Cupressaceae family.
105 One of the most well-known Australian essential oils in October 1996 was tea tree oil. There are also tea tree oils from New Zealand (and other places), which were commonly and generally known in Australia in October 1996.
106 Whilst I accept Dr Clark's evidence in relation to the different types of essential oils and their uses, I do not think it establishes that the essential oil derived from Kunzea ambigua had been used for therapeutic purposes before the Priority Date. It is true that Dr Clark's evidence shows that Australian Aboriginal people have used native plants for therapeutic purposes for thousands of years, including to treat infections, skin problems, colds and nasal conditions. However, Dr Clark did not suggest that any of those treatments involved extracting the essential oil of the plants nor did he suggest that Kunzea ambigua had been used by them for therapeutic purposes.
107 In submissions it was accepted by Mr Fox, correctly in my view, that the evidence did not establish that the essential oil derived from Kunzea ambigua had been used for therapeutic purposes before the Priority Date. Even if it is correct to say that such an essential oil was a known material, it has not been shown that it had known properties that made it suitable for use in the treatment of any of the ailments referred to in the claims. It is true that a person skilled in the art, if he or she was to ascertain the chemical composition of oil derived from Kunzea ambigua, may infer that there were some chemical components in the oil that may be useful as a treatment for one or more of the ailments referred to in the method of treatment claims. But the evidence given by Dr Carson and some of the other witnesses called by the respondents to that effect was more in the nature of a conjecture, it being recognised that the essential oil would need to be tested to determine whether it was suitable for such a purpose.
108 In my view the evidence does not support a finding that any of the method of treatment claims was for a known use of a known material. In any event, as I have previously observed, there is nothing on the face of the specification to suggest that the essential oil derived from Kunzea ambigua was not new or that the methods of treatment that used such an oil lacked the quality of inventiveness necessary to support the grant of a valid patent.
109 The respondents submitted that what Mr Hood claims to have discovered is that Kunzea ambigua is suitable for a number of uses including as a treatment for various ailments. They then submitted that the methods of treatment defined by the claims, and which Mr Hood is said to have invented, were based on anecdotal evidence obtained from family and friends to whom Mr Hood supplied his essential oil before the Priority Date. It was submitted that any discovery made about the use of Kunzea ambigua oil as a method of treatment was therefore made not by Mr Hood but by his family and friends.
110 These submissions involve an assertion that the methods of treatment defined by the relevant claims were either discovered by Mr Hood's family and friends to whom he supplied his essential oil or that those methods of treatment were first performed by Mr Hood's family and friends rather than Mr Hood himself. At their core these submissions involve an unparticularised contention that the use of the relevant methods of treatment was not novel because they were first used by Mr Hood's family and friends. I do not think that the involvement of Mr Hood's family and friends (as, in his words, "guinea pigs" who he asked to test his essential oil) can advance the respondents' manner of manufacture case. No case based on lack of novelty arising out of such use is pleaded. Nor is it pleaded that any one or more of Mr Hood's family or friends were inventors of the relevant methods of treatment and that the patent was obtained on the basis of a representation to some contrary effect.
111 The respondents also submitted that Mr Hood, the alleged inventor, was not a person skilled in the art and did not possess any scientific or technical qualification or experience which might provide a technical foundation for comprehending his assertion of having made any relevant discovery. It was submitted that nothing was discovered by Mr Hood in relation to the potential therapeutic uses of the essential oil which could "add to the sum of human knowledge". Reference was made in support of this submission to what was said by Gageler and Nettle JJ in Myriad at [165] where their Honours cited with approval the following well-known statement of Buckley J in Reynolds v Herbert Smith & Co Ltd (1902) 20 RPC 123 at 126:
Invention … adds to human knowledge, but not merely by disclosing something [not previously known]. Invention necessarily involves also the suggestion of an act to be done, and it must be an act which results in a new product, or a new result, or a new process, or a new combination for producing an old product or an old result.
112 As the patent specification makes clear, the method said to have been discovered by Mr Hood is one that takes advantage of the therapeutic properties of the essential oil referred to in the claims and the usefulness of those oils when topically applied as a treatment for various ailments. If this use of the essential oil provides an effective treatment for the different ailments referred to in the claims, then it is difficult to see why it is not correct, as a matter of principle, to describe Mr Hood as the inventor of a new method of treatment in circumstances where it is not alleged that any of the methods of treatment were used before the Priority Date except by Mr Hood and his family and friends.
113 The suggestion that Mr Hood was not a person skilled in the art and that he was not in any real position to know why the methods of treatment discovered by him were effective, wrongly assumes that it is only a person skilled in the art who is capable of conceiving of a patentable invention. As Aickin J reminded us in Wellcome at 286 "a valid patent may be obtained for something stumbled upon by accident [or] remembered from a dream […] if it otherwise satisfies the requirements of the legislation". There is nothing in the Act that requires that the inventor be a person skilled in the relevant art or that the inventor must have the same level of understanding of the invention as a person skilled in the art.