Case: Commissioner of Patents v Microcell Ltd [1958] HCA 58 ; (1959) 102 CLR 232
Outcome: applied
In advancing this argument, Ranbaxy did not go beyond matters which were apparent on the face of the complete specification for the Enantiomer Patent. The specification specifically refers to and incorporates the US Patent. It also refers to the 981 Patent as relevant prior art. In this sense, Ranbaxy based its argument squarely on the ground of invalidity that was recognised in Commissioner of Patents v Microcell Ltd [1958] HCA 58 ; (1959) 102 CLR 232 ( 'Microcell' ) and NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 ; (1995) 183 CLR 655 ( 'Philips' ). 175 For the reasons elaborated below, I do not accept that Ranbaxy's case on 'manner of manufacture' is foreclosed by the High Court's decision in Ramset . In my opinion, Ranbaxy's argument falls squarely within the framework of the High Court's decision in Philips . In Ramset , the High Court did not question the authority of Philips and, as the Full Court of this Court said in Bristol - Myers , nothing in Ramset detracts from the binding effect of Philips in this Court. As to merits of the argument, I have reached the conclusion that Ranbaxy has not established on the facts that the Enantiomer Patent claims 'nothing but ... a new use of an old substance'. Consequently, Ranbaxy has failed to establish that the Enantiomer Patent is invalid, and liable to revocation, on the ground that was recognised and applied in Microcell and Philips . My detailed reasons for this conclusion are also set forth below. 181 In the course of their reasons, Brennan, Deane and Toohey JJ discussed and approved the earlier High Court decisions in Microcell and National Research Development Corporation v Commissioner of Patents [1959] HCA 67 ; (1959) 102 CLR 252 ( 'NRDC' ). There is no doubt that their Honours considered that Microcell (a decision under the Patents Act 1903 (Cth)) and NRDC (a decision under the 1952 Act) applied with equal force to s 100(1)(d) of the 1952 Act and to the threshold requirement of 'invention' in s 18(1) of the 1990 Act. 187 Warner-Lambert relied on several passages in the majority judgment in Ramset for its contention that Ranbaxy's manner of manufacture argument was legally unavailable. Its contention that the doctrinal content of s 100(1)(d) of the 1952 Act did not extend to the manner of manufacture argument recognised and applied by the High Court in Microcell was based on the following passage at 190 [33] and [34]: 'In particular, s 100(2) assumes that issues of obviousness and lack of novelty are extracted by pars (e) and (g) of s 100(1) from what otherwise may have been their inclusion (by means of par (d)) in the general concept of invention within the ambit of s 6 of the Statute of Monopolies. Novelty and obviousness are dealt with specifically and exhaustively in pars (e) and (g). There remains no scope for the doctrine of secret use, as a qualification to obviousness and novelty, in par (d), and in s 100(2), no occasion to refer to par (d). What then was left to provide the doctrinal content of par (d)? Section 6 of the Statute of Monopolies excluded any manner of new manufacture which was "contrary to the Law" or "generally inconvenient". The classification of certain methods of treatment of the human body as an inappropriate subject for grants under the Act appears to rest on this footing. Further, it has long been established that "a clear distinction will be drawn between the discovery of one of nature's laws, and of its application to some new and useful purpose". Whilst discovery adds to the sum of human knowledge, s 6 of the Statute of Monopolies is concerned with a manner of new manufacture. Thus, in Neilson v Minister of Public Works (NSW) , Isaacs J, speaking of a discovery which might be applied in the improved treatment of sewage, said: "Assuming, therefore, the idea is original that the best conditions are fermentation short of putrefaction, still without some practical means of carrying out that idea so as to add to the sum of human art -- not merely human discovery -- the idea is not patentable." On the other hand, "manufacture" in s 6 is not restricted to vendible processes or their products and may include agricultural and horticultural processes involving the selective use of herbicides.' In my opinion, this passage does not go so far as to support Warner-Lambert's contention, and ultimately it is inconclusive. 188 The proposition that novelty and obviousness are dealt with specifically and exhaustively in s 100(1)(e) and (g), and not in s 100(1)(d), does not deny Ranbaxy's proposition that the ground of invalidity discussed in Microcell , NRDC and Philips falls squarely within s 100(1)(d) and s 18(1). The remainder of the passage poses, but does not definitively answer, the question of what is left to provide the doctrinal content of s 100(1)(d). Some examples are given, but they do not address the question whether the ground of invalidity recognised in Microcell , NRDC and Philips would fall within s 100(1)(d). So far as it goes, the distinction that is drawn between discovery and any manner of new manufacture tends to suggest that, if revocation were sought, cases like Microcell and NRDC would fall for consideration under s 100(1)(d). Earlier in their reasons at 183 [15], the majority in Ramset said that the right question when applying the definition of invention and the expression 'any manner of new manufacture' under the 1952 Act 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?"' The majority's endorsement of this test also tends to suggest that cases like Microcell and NRDC would have fallen within s 100(1)(d) of the 1952 Act, had revocation been sought on that ground. 192 In the present case, Ranbaxy based its argument on Microcell and Philips . The majority decision in Ramset does not cast any doubt on the soundness of Microcell . It also expressly approved the High Court's decision in NRDC , which in turn endorsed the principles discussed in Mircocell . 193 Microcell concerned an appeal from a decision of the Deputy Commissioner of Patents to refuse to accept a patent application in the exercise of powers conferred by s 46 of the Patents Act 1903 . The High Court considered that, if it appeared manifest that a valid patent could not be granted, the Commissioner had not merely the power but the duty to reject the application pursuant to s 46. The alleged invention concerned the use of synthetic resinous plastics reinforced with mineral fibres in the manufacture of self-propelled rocket projectors. The Court rejected an argument that the specification need do no more than claim an alleged invention. The Court concluded that 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 cannot be subject matter for a patent. It is not a claim for an invention as defined in the Act. The position cannot be affected by the fact that nobody had thought of doing the thing before or by the fact that it was found to be a good thing to do: at 246-247, 249, 250-251. 194 The question in NRDC was whether the claimed process fell within the category of inventions to which, by definition, the application of the 1952 Act was confined. In applying the definition of invention in s 6 of the 1952 Act, Dixon CJ, Kitto and Windeyer JJ said that the correct approach is not to ask whether the claim is for a manner or kind of manufacture, but to ask whether it is a proper subject of letters patent according to the principles which have been developed in the application of s 6 of the Statute of Monopolies. 195 In NRDC , Dixon CJ, Kitto and Windeyer JJ said at 261-262: 'The principles which govern the power to refuse a patent have been discussed recently in the case of Commissioner of Patents v. Microcell Ltd . It is shown in that case that in the portion of the definition of invention which includes in the meaning of the word an alleged invention, the word "alleged" goes only to the epithet "new" in the expression "a manner of new manufacture", and that accordingly the Commissioner may properly reject a claim for a process which is not within the concept of a "manufacture". But the case cited shows also that even if the process is within the concept the Commissioner is not bound to accept the allegation of the applicant that it is new, if it is apparent on the face of the specification, when properly construed, that the allegation is unfounded: see also Re Johnson's Patent . It is therefore open to the Commissioner in a proper case to direct the deletion of a claim for a process which may be seen from the specification, considered as a whole, to be "outside the whole scope of what is known as invention" because, in the words of Lord Buckmaster, when Solicitor-General, in Re B.A.'s Application it is "nothing but a claim for a new use of an old substance". But, as the Microcell Case emphasizes, it must always be remembered how much is wrapped up in the "nothing but". Lord Buckmaster did not use the words without explanation:-- " ... when once a substance is known," he said, "its methods of production ascertained, its characteristics and its constituents well defined, you cannot patent the use of that for a purpose which was hitherto unknown". And why? Because in the postulated state of knowledge the new purpose is no more than analogous to the purposes for which the utility of the substance is already known, and therefore your suggestion of the new purpose lacks the quality of inventiveness: see per Bowen L.J. in Elias v. Grovesend Tinplate Co . Unless invention is found in some new method of using the material or some new adaptation of it so as to serve the new purpose, no valid patent can be granted: see Moser v. Marsden; Pirrie v. York Street Flax Spinning Co., Ltd. If, however, the new use that is proposed consists in taking advantage of a hitherto unknown or unsuspected property of the material, the situation is not that to which Lord Buckmaster's language refers. In that case 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: see the Microcell Case. It is not necessary that in addition the proposed method should itself be novel or involve any inventive step: Hickton's Patent Syndicate v. Patents and Machine Improvements Co. Ltd. ' 196 The majority in Ramset agreed that NRDC sets out the correct way of approaching the definition of invention in the 1952 Act. As s 100(1)(d) provides for revocation where the claimed invention is not an invention within the meaning of the Act, there is no reason to suppose that the application of s 100(1)(d) should be approached in any different fashion from that explained in Microcell and NRDC . 197 The holding and the rationale of Philips were recently applied in Merck &amp; Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91 ; (2006) 68 IPR 511 ( 'Merck' ). At 529 [63], the Full Court (comprising Heerey, Kiefel and Dowsett JJ) said that Microcell , NRDC and Philips established the following propositions: '1. The opening words of s 18(1) ("a patentable invention is an invention that") impose a threshold requirement that the "patentable invention" be an "invention", that is to say an "alleged" "manner of new manufacture" within s 6 of the Statute of Monopolies ( Philips at CLR 663; ALR 121; IPR 453). 2. That requirement will not be met if, on the face of the specification, the subject matter: (a) lacks the necessary quality of inventiveness under the Statute of Monopolies ( Phillips at CLR 664; ALR 122; IPR 454) (b) is not new ( NRDC at CLR 262, ALR 115; IPR 65, Philips at CLR 664; ALR 122; IPR 454) 3. A new use of an old substance is not an invention if its known properties make it suitable for that use in such a case the new purpose is "no more than analogous to the purposes for which the utility of the substance is already known" ( NRDC at CLR 262; ALR 115; IPR 65) 4. But there will be an invention if the new use consists in taking advantage of a hitherto unknown or unsuspected property of the substance ( NRDC at CLR 262; ALR 115; IPR 65).' Subject to one matter, I consider these propositions are equally applicable to s 100(1)(d) of the 1952 Act. The qualification is that I am not sure what is meant by proposition 2(b) or that it adds anything to proposition 2(a). 198 In Wm Wrigley Jr Company v Cadbury Schweppes Pty Ltd (2005) 66 IPR 298 ( 'Wrigley' ) at 314-315 [87]-[93], Heerey J held that a manner of manufacture argument could be advanced under s 100(1)(d) of the 1952 Act so long as the ground in s 100(1)(d) was established on the face of the specification. His Honour expressly stated that this was the effect of the decision in Ramset . Furthermore, his Honour considered that the question whether or not the ground in s 100(1)(d) was established on the face of the specification was to be determined by considering and applying the principles discussed in Microcell . 201 As the US Patent is substantially identical to the 981 Patent I do not need to consider whether the citation of the 981 Patent as prior art would be sufficient for it to be characterised as information that appears on the face of the specification: see Bristol-Myers at 536 [30]; Microcell at 250; cf Ramset at 192-193 [40]. Nor do I need to consider the additional observations made by the majority in Philips (which were unnecessary for the decision) to the effect that s 18(1)(a) of the 1990 Act would permit the Court to look beyond the face of the specification in determining whether a claimed invention is nothing more than a new use of an old substance, and whether those observations can be reconciled with the reasoning in Ramset . My task is to apply the principles that were enunciated in Microcell , NRDC and Philips to the claims of the Enantiomer Patent. 203 It therefore cannot be said, at least not strictly, that the Enantiomer Patent claims 'nothing but a claim for a new use of an old substance'. In Microcell and NRDC , the High Court stressed that a lot is wrapped up in the expression 'nothing but': it contemplates a case where the substance is known, its methods of production ascertained, and its characteristics and constituents are well defined: NRDC at 261-262; Microcell at 249-251. Here, the question is whether the Enantiomer Patent claims a different class of compounds having characteristics and constituents that were identified by the US Patent and the 981 Patent; or whether it is nothing but a claim for a known compound with known properties. No question arises of the kind that was considered in NRDC : the compounds of the Enantiomer Patent are not being applied to a new use that takes advantage of hitherto unknown or unsuspected properties. Like the compounds of the 981 Patent, the compounds of the Enantiomer Patent are to be applied to the inhibition of the synthesis of cholesterol. 204 Ranbaxy attempts to meet these points by arguing that entirely routine steps, including the resolution of a racemate into its enantiomers and the selection of a preferred pharmaceutically acceptable salt, can be employed to narrow the class of compounds from those claimed in the 981 Patent to those claimed in the Enantiomer Patent. There are numerous difficulties with this argument, both at the level of principle and when one turns to the evidence. 205 In my view, Ranbaxy's argument requires an extension of the principles that the High Court applied in Microcell , NRDC , Philips and Ramset . Ranbaxy did not accept that this was so. It contended that racemic atorvastatin lactone was a known compound with known properties that were reported in Table 1 (compound 1) of the 981 Patent specification, and that the activity of this racemate is, and was, known to be due to the RR enantiomer. In closing submissions, however, senior counsel for Ranbaxy could not identify any case on 'manner of manufacture' that deals with a situation that is analogous to the present case where a selection process forms the basis of the compounds claimed by the later patent.