case_text: Counsel for Sanofi-Aventis submitted that enabling disclosure, not mere disclosure, is required for anticipation, citing, most recently, Lindgren J in Alphapharm Pty Ltd [2008] FCA 559 at [160] [161] and the decision of the House of Lords in SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323. By way of introduction, it is worth remarking that the phrase "enabling disclosure" was brought to prominence by the speech of Lord Hoffmann in Biogen Inc v Medeva plc [1996] UKHL 18 ; [1997] RPC 1 , (1996) 36 IPR 438. That decision concerned the requirements for a valid patent under the 1997 United Kingdom Act (based upon the European Patent Convention) but did not concern the question of anticipation. The most important question was whether a later patent could claim an earlier priority date because it was "supported" by the earlier specification. That is a concept similar to, but narrower than, whether a later patent is fairly based upon an earlier specification in our law (cf F Hoffman-La Roche & Co AG v Commissioner of Patents [1971] HCA 3 ; (1971) 123 CLR 529 ; CCOM Pty Ltd v Jiejing Pty Ltd [1994] FCA 1168 ; (1994) 51 FCR 260 ; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 ; (2004) 217 CLR 274). It may be accepted that, in the case of a claim for a chemical compound by formula, in order to be valid, the specification would have to disclose how it might be manufactured (s 40). The phrase was also used in the speech of Lord Oliver in Asahi Kasei Kogyo KK's Application [1991] RPC 485 , to which I shall return. The phrase is reasonable shorthand in relation to the disclosure required for there to be anticipation of a process or method claim but, in my opinion, has little, if any, relevance to anticipation of a product claim or a claim for a chemical compound by formula. Indeed, it is apt to mislead in relation to the latter. For a product claim, the novelty must lie in the product not the means of producing it ( May & Baker Ltd v Boots Pure Drug Co Ltd (1948) 65 RPC 255 at 281 282). By the same token, a new process to obtain an old product will have novelty. 64 Something was sought to be made of the fact that PCR 4099 or derivative 1 was not unmistakably pointed to as the best of the compounds. There was competing evidence from the experts related to that question. In my view, that was a red herring as far as novelty is concerned. On any view, it was expressly disclosed as one of the most promising of the compounds. The invention was not limited to the most effective or most promising example. The invention was a broad class. As Lord Hoffmann lucidly explained in Biogen Inc [1996] UKHL 18 ; [1997] RPC 1 at 48 49, 36 IPR 438 at 455: "If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms. The patentee need not show that he has proved its application in every individual instance. On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them. Thus if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect: see May & Baker Ltd v Boots Pure Drug Co Ltd [1950] RPC 23 at 50. On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them."


case_outcome: cited

case_text: It was submitted on behalf of Sanofi-Aventis that neither PCR 4099 nor either of the enantiomers of that compound were "taught" in the sense of recommended by the French patent, citing Bristol-Myers Squibb Co v FH Faulding & Co Ltd [2000] FCA 316 ; (2000) 97 FCR 524 at [67] per Black CJ and Lehane J. That case concerned a method of administration of a naturally occurring drug to a patient. The full passage is as follows: "What all those authorities contemplate, in our view, is that a prior publication, if it is to destroy novelty, must give a direction or make a recommendation or suggestion which will result, if the skilled reader follows it, in the claimed invention. A direction, recommendation or suggestion may often, of course, be implicit in what is described and commonly the only question may be whether the publication describes with sufficient clarity the claimed invention or, in the case of a combination, each integer of it." 63 That language is quite conventional in relation to a dose regime. The actual decision in the case was that there was anticipation of the dosage regime claimed in the patent in suit by the earlier publication which included the following ( Bristol-Myers Squibb Co [2000] FCA 316 ; 97 FCR 524 at [71] ): "Further studies to evaluate the feasibility of shorter infusion time, 3 hours versus 24 hours and a lower 135mg/m2 versus a maximum tolerated dose of 175mg/m2 are now in progress in relapsing ovarian cancer patients both in Canada and in Europe. Already more than 200 patients have been entered into this four-arm randomized, NCIC guided international study. Indeed, the 3 hours infusion time administration schedule proved to be feasible, if given concomitantly to profylactic [sic] measures as high dose dexamethasone, cimetidine and difenhydramine. This makes even outpatient treatment with this first available representative of this new class of antitumor agents possible." (cf Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91 ; (2006) 154 FCR 31 at 60). In any event, the problem does not arise in the present case. The invention disclosed and claimed by the French patent necessarily carried the implication of a direction, recommendation or suggestion. That is the consideration for which the monopoly was granted.


case_outcome: followed

case_text: Counsel for Sanofi-Aventis submitted that enabling disclosure, not mere disclosure, is required for anticipation, citing, most recently, Lindgren J in Alphapharm Pty Ltd [2008] FCA 559 at [160] [161] and the decision of the House of Lords in SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323. By way of introduction, it is worth remarking that the phrase "enabling disclosure" was brought to prominence by the speech of Lord Hoffmann in Biogen Inc v Medeva plc [1996] UKHL 18 ; [1997] RPC 1 , (1996) 36 IPR 438. That decision concerned the requirements for a valid patent under the 1997 United Kingdom Act (based upon the European Patent Convention) but did not concern the question of anticipation. The most important question was whether a later patent could claim an earlier priority date because it was "supported" by the earlier specification. That is a concept similar to, but narrower than, whether a later patent is fairly based upon an earlier specification in our law (cf F Hoffman-La Roche & Co AG v Commissioner of Patents [1971] HCA 3 ; (1971) 123 CLR 529 ; CCOM Pty Ltd v Jiejing Pty Ltd [1994] FCA 1168 ; (1994) 51 FCR 260 ; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 ; (2004) 217 CLR 274). It may be accepted that, in the case of a claim for a chemical compound by formula, in order to be valid, the specification would have to disclose how it might be manufactured (s 40). The phrase was also used in the speech of Lord Oliver in Asahi Kasei Kogyo KK's Application [1991] RPC 485 , to which I shall return. The phrase is reasonable shorthand in relation to the disclosure required for there to be anticipation of a process or method claim but, in my opinion, has little, if any, relevance to anticipation of a product claim or a claim for a chemical compound by formula. Indeed, it is apt to mislead in relation to the latter. For a product claim, the novelty must lie in the product not the means of producing it ( May & Baker Ltd v Boots Pure Drug Co Ltd (1948) 65 RPC 255 at 281 282). By the same token, a new process to obtain an old product will have novelty. 120 The latter decision has subsequently been discussed by the High Court in Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd [1998] HCA 19 ; (1998) 194 CLR 171 , particularly at [36] [40] per Brennan CJ, Gaudron, McHugh and Gummow JJ and in Lockwood Security Products [2007] HCA 21 ; 235 ALR 202 ; (2007) 81 ALJR 1070 at [106] [107]. It is made clear that external evidence cannot be relied upon. The same ground of invalidity was examined in some detail by the Full Court in Merck & Co Inc [2006] FCAFC 91 ; 154 FCR 31 at [20] [75] (cf at first instance Arrow Pharmaceuticals Ltd v Merck & Co Inc (2004) 213 ALR 182 , (2004) 63 IPR 85 at [80] [97]). The true scope of this ground of invalidity is difficult to discern in a case such as the present where the claims are for conventional products (albeit defined by chemical formula) and processes for the manufacture of products compared, say, with Merck & Co Inc [2006] FCAFC 91 ; 154 FCR 31 which dealt with a variation of a dosage regime. It is clear that the grounds of novelty and obviousness must be considered as such rather than through this prism ( CCOM Pty Ltd [1994] FCA 1168 ; 51 FCR 260 at 295 295).


case_text: The qualification is expressed in various places including by Lord Reid in C Van der Lely NV v Bamfords Ltd [1963] RPC 61 at 71: "But Lord Westbury must have meant experiments with a view to discovering something not disclosed. He cannot have meant to refer to the ordinary methods of trial and error which involve no inventive step and are generally necessary in applying any discovery to produce a practical result." In that case, the question was whether a skilled reader would infer from photographs of a machine in magazine articles that the rake wheels of the alleged anticipating machine were ground driven rather than gear driven. It is interesting that Lord Reid went on to say ([1963] RPC 61 at 72): "The appellants' first argument is that it is not enough that the photograph should disclose a probability that the wheels were ground driven. There cannot be anticipation, they say, unless this is shown clearly and unmistakably. I cannot accept that argument. I would agree that the anticipating material must be as good for practical purposes as the material in the appellants' specification. But I can see no practical difference between a definite statement of fact and material from which the skilled man would clearly infer its existence. So the question is whether the typical skilled man would infer ground drive from the photograph. It would not be enough that a quick-witted man would guess that. But in this case I think that it is proved that the ordinary skilled man would have had good grounds for reaching the conclusion that these wheels were ground driven. He could not have been certain, but practical men act on something less than absolute certainty."


case_outcome: considered

case_text: The position established in Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was of relatively short duration. Until then, the wider view of Williams J in HPM Industries Pty Ltd v Gerard Industries Ltd [1957] HCA 47 ; (1957) 98 CLR 424 had applied (see Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd [1978] HCA 61 ; (1978) 141 CLR 305 per Aickin J at 329 330). The 1990 Act widens the prior art base, but does not change the nature of the issue. Leaving aside Aktiebolaget [2002] HCA 59 ; 212 CLR 411 , the principal survey of the topic by the High Court since Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 ; (2007) 235 ALR 202 , (2007) 81 ALJR 1070 , particularly at [31] [66]. That case did not involve the problem that arises here. It is noteworthy that the Court said of the 1990 provisions (at [127]): "As stated above, by enlarging the prior art base through including relevant prior disclosures beyond those disclosures proven to be part of the common general knowledge, these provisions raise the threshold for inventiveness. However, the idea remains that the prior disclosures to be taken into account, even as enlarged by s 7(3), are being considered for a particular purpose. That purpose is the purpose of looking forward from the prior art base to see what a person skilled in the relevant art is likely to have done when faced with a similar problem which the patentee claims to have solved with the invention." (Emphasis added.) (cf Firebelt Pty Ltd v Brambles Australia Ltd [2002] HCA 21 ; (2002) 188 ALR 280 , (2002) 76 ALJR 816 at [33] as to combination patents.) The applicants do not seek to utilise the contents of the prior specification as an admission as to common general knowledge (cf Lockwood Security Products [2007] HCA 21 ; 235 ALR 202 , 81 ALJR 1070 at [105] [109]). Rather, it is a statement of the nature of the inventive step that is claimed (cf in another context, Commissioner of Patents v Microcell Ltd [1959] HCA 71 ; (1959) 102 CLR 232). 119 That decision was delivered several months after the decision of another Full Court of the High Court in Commissioner of Patents v Microcell Ltd [1959] HCA 71 ; 102 CLR 232. In that case it was held that the specification did not disclose a patentable invention the headnote succinctly summarises the gist of the decision as follows: "It is not an inventive idea for which a monopoly can be claimed to take a substance which is known and used for the making of various articles and make out of it an article for which its known properties make it suitable, although it has not in fact been used to make that article before." In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 ; (1995) 183 CLR 655 at 664 the High Court quoted with approval the following passage from the NRDC Case [1959] HCA 67 ; 102 CLR 252 at 261 262 per Dixon CJ, Kitto and Windeyer JJ: "the Commissioner may properly reject a claim for a process which is not within the concept of a "manufacture". But the case cited [ie Microcell] 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".


case_outcome: distinguished

case_text: The most recent reference to the topic in Australia is that by the Full Court in Ranbaxy [2008] FCAFC 82 at [105] : "A patent application will overcome a prior publication, as a selection patent, if the following criteria are met: • there must be some substantial advantage to be secured by the use of the selected members; • the whole of the selected members must possess the advantage in question; • the selection must be in respect of a quality of a special character, which can fairly be said to be peculiar to the group; and • the advantage possessed by the selected members must be clearly disclosed in the specification. (see Re IG Farbenindustrie AG's Patents (1930) 47 RPC 289 at 322-3)." However, that was said in considering the ground of false suggestion rather than lack of novelty. It is a fair brief summary of the position as it was understood at the time of the 1952 Act based upon the authority to which reference was made Re IG Farbenindustrie AG's Patents (1930) 47 RPC 289. This remained the basis of the law in the United Kingdom, at least until the decision of the House of Lords in EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303. 79 It seems to me that it is too late in the day to find that the principles explained by Maugham J in IG Farbenindustrie AG's Patents (1930) 47 RPC 289 are not relevant to the question of anticipation under the 1952 Act (and the 1990 Act, for that matter). That is not to recognise a special class of patents the reference to a selection patent is a convenient shorthand to pick up the relevant principles concerning anticipation. I approach the United Kingdom cases from and including EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303 with caution. I must also endeavour to keep separate questions of anticipation, on the one hand, and obviousness, on the other. The distinction is not always easy to discern in the authorities on this topic, including the seminal judgment of Maugham J. 80 There is a question as to whether the selection patent principles apply to a compound specifically identified in the early specification as a member of the larger class (eg as an example or derivative) or whether it is restricted to the express identification (for the first time) of a particular member of the larger class with the special characteristic. The latter was conceded by the patentee in EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303. In the Court of Appeal, Buckley LJ had favoured the view that the concession was necessary (395) but, in the House of Lords, Lord Simon preferred to leave the point open ([1982] FSR 303 at 315). I favour the view of Buckley LJ as more in accordance with the rationale as explained by Maugham J and with his description of the class as follows ( IG Farbenindustrie AG's Patents (1930) 47 RPC at 321): "The second class comprises patents (the so-called selection patents) based on a selection of related compounds such as the homologues and substitution derivatives of the original compounds which presumably have been described in general terms and claimed in the originating patent." 81 If that view is correct, then the patent in suit is not a selection patent in the ordinary sense as PCR 4099 and each of the enantiomers were expressly disclosed and claimed in the earlier patents and are expressly referred to in the patent in suit. In one sense, the dextro-rotatory enantiomer is selected from that sub-class. There is authority to suggest that selection can be from a small class (per Buckley LJ in Beecham Group Ltd's (Amoxycillin) Application, Re [1980] RPC 261 at 292; EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303 per Lord Wilberforce at 310; but, cf Institut Francais du Petrole des Carburants et Lubricants' Application, Re [1972] FSR 147 at 154, [1972] RPC 364). I will therefore assume, contrary to my own opinion, that the principle can apply to the present case on that basis if the requirements are met. 86 The phrase in In the matter of Esso Research and Engineering Co's Application (Shell) [1960] RPC 35 at 53 was "advantages peculiar to themselves" or, as Lord Wilberforce put it in EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303 at 309 "unrecognised advantages". Buckley LJ said in Beecham Group Ltd's (Amoxycillin) Application, Re [1980] RPC 261 at 292: "... the substance must be truly new and the advantage to be gained from its selection must be the inventor's own discovery as opposed to mere verification by him of previous predictions or of what was previously predictable; in other words, it must be unexpected." The specification in question here was, no doubt, drawn with this concept in mind. However, the advantages here are not different in kind from those described and predicted in the earlier patent specifications. Even if such an advantage could be satisfied by a quantum leap in relation to an earlier claimed advantage, the results here are by no means out of the range of results predictable from the tests done on the examples in the earlier specification.


case_text: Counsel for Sanofi-Aventis submitted that enabling disclosure, not mere disclosure, is required for anticipation, citing, most recently, Lindgren J in Alphapharm Pty Ltd [2008] FCA 559 at [160] [161] and the decision of the House of Lords in SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323. By way of introduction, it is worth remarking that the phrase "enabling disclosure" was brought to prominence by the speech of Lord Hoffmann in Biogen Inc v Medeva plc [1996] UKHL 18 ; [1997] RPC 1 , (1996) 36 IPR 438. That decision concerned the requirements for a valid patent under the 1997 United Kingdom Act (based upon the European Patent Convention) but did not concern the question of anticipation. The most important question was whether a later patent could claim an earlier priority date because it was "supported" by the earlier specification. That is a concept similar to, but narrower than, whether a later patent is fairly based upon an earlier specification in our law (cf F Hoffman-La Roche & Co AG v Commissioner of Patents [1971] HCA 3 ; (1971) 123 CLR 529 ; CCOM Pty Ltd v Jiejing Pty Ltd [1994] FCA 1168 ; (1994) 51 FCR 260 ; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 ; (2004) 217 CLR 274). It may be accepted that, in the case of a claim for a chemical compound by formula, in order to be valid, the specification would have to disclose how it might be manufactured (s 40). The phrase was also used in the speech of Lord Oliver in Asahi Kasei Kogyo KK's Application [1991] RPC 485 , to which I shall return. The phrase is reasonable shorthand in relation to the disclosure required for there to be anticipation of a process or method claim but, in my opinion, has little, if any, relevance to anticipation of a product claim or a claim for a chemical compound by formula. Indeed, it is apt to mislead in relation to the latter. For a product claim, the novelty must lie in the product not the means of producing it ( May & Baker Ltd v Boots Pure Drug Co Ltd (1948) 65 RPC 255 at 281 282). By the same token, a new process to obtain an old product will have novelty.


case_text: The position established in Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was of relatively short duration. Until then, the wider view of Williams J in HPM Industries Pty Ltd v Gerard Industries Ltd [1957] HCA 47 ; (1957) 98 CLR 424 had applied (see Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd [1978] HCA 61 ; (1978) 141 CLR 305 per Aickin J at 329 330). The 1990 Act widens the prior art base, but does not change the nature of the issue. Leaving aside Aktiebolaget [2002] HCA 59 ; 212 CLR 411 , the principal survey of the topic by the High Court since Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 ; (2007) 235 ALR 202 , (2007) 81 ALJR 1070 , particularly at [31] [66]. That case did not involve the problem that arises here. It is noteworthy that the Court said of the 1990 provisions (at [127]): "As stated above, by enlarging the prior art base through including relevant prior disclosures beyond those disclosures proven to be part of the common general knowledge, these provisions raise the threshold for inventiveness. However, the idea remains that the prior disclosures to be taken into account, even as enlarged by s 7(3), are being considered for a particular purpose. That purpose is the purpose of looking forward from the prior art base to see what a person skilled in the relevant art is likely to have done when faced with a similar problem which the patentee claims to have solved with the invention." (Emphasis added.) (cf Firebelt Pty Ltd v Brambles Australia Ltd [2002] HCA 21 ; (2002) 188 ALR 280 , (2002) 76 ALJR 816 at [33] as to combination patents.) The applicants do not seek to utilise the contents of the prior specification as an admission as to common general knowledge (cf Lockwood Security Products [2007] HCA 21 ; 235 ALR 202 , 81 ALJR 1070 at [105] [109]). Rather, it is a statement of the nature of the inventive step that is claimed (cf in another context, Commissioner of Patents v Microcell Ltd [1959] HCA 71 ; (1959) 102 CLR 232).


case_outcome: discussed

case_text: The source, Flour Oxidizing Co Ltd v Carr & Co Ltd (1908) 25 RPC 428 , concerned an invention for "[i]mprovements in conditioning or improving the quality of recently ground flour, semolina, or the like", one of the claims of the relevant patent being for a "process of conditioning flour and the like, passing the same with full exposure through an atmosphere containing a gaseous oxide of nitrogen or chlorine or bromine oxidising agent in the gaseous or vapourised state". The alleged anticipation being discussed by Parker J in the relevant passage ( Flour Oxidizing Co Ltd 25 RPC 428 at 457) was entitled "[i]mprovements in and relating to the treatment of alimentary substances and beverages" essentially by subjecting the substances to the action of electricity.


case_text: The reference by Lord Reid to "clearly and unmistakably" no doubt refers to the same source as lay behind the well-known passage from the later Court of Appeal judgment in General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 457 at 485 486: "If the prior inventor's publication contains a clear description of, or clear instructions to do or make , something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated. If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented : Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. ((1908) 25 R.P.C. 428 at 457, line 34, approved in B.T.H. Co Ltd v Metropolitan Vickers Electrical Co. Ltd. (1928) 45 R.P.C. 1 at 24, line 1). A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee. [Emphasis added.] 54 The patent in suit in General Tire & Rubber Co [1972] RPC 457 was for a process for making a compound suitable for tyre treads by mixing synthetic rubber with oil and carbon black and for the compound thus made (at 470). The issue in General Tire & Rubber Co [1972] RPC 457 , as appears from the general treatment of anticipation from 486 497, focussed upon the method or process. The references to a signpost and a flag, which have excited later imaginations, deal with a situation in which the language and the directions given as to process or method were equivocal. The main principle is that, if the prior inventor's publication contains a clear description of something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty. Alternatively, if the prior inventor's publication contains clear instructions to do or make something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty. 68 After referring to the well-known passage from General Tire & Rubber Co [1972] RPC 457 at 485 486 and citing various other cases, his Honour said ( Alphapharm [2008] FCA 559 at [161] ): "What does "enabling disclosure" mean in the context of a product claim? It means that the earlier disclosure must point unmistakeably to the (+)-enantiomer of citalopram, as distinct from the racemate, as a drug desirable to obtain." I take "as distinct from" to mean "separately from" not "instead of" or "as opposed to". This does not include any separate requirement of enablement in accordance with SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323 and is consistent with my opinion.


case_title: Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd [1978] HCA 61 ; (1978) 141 CLR 305


case_outcome: applied

case_text: The usual starting point in discussion of anticipation is the judgment of Lord Westbury LC in Hill v Evans (1862) 1A IPR 1 , (1862) 4 De GF & J 288, (1862) 31 LJ Ch 457 , (1862) 6 LT 90, (1862) 45 ER 1195 , particularly the following (1A IPR 1 at 6 7): "the antecedent statement must be such that a person of ordinary knowledge of the subject would at once perceive, understand, and be able practically to apply the discovery without the necessity of making further experiments and gaining further information before the invention can be made useful. If something remains to be ascertained which is necessary for the useful application of the discovery, that affords sufficient room for another valid patent. ... There is not, I think, any other general answer that can be given to this question than this: that the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent. The invention must be shewn to have been before made known. Whatever, therefore, is essential to the invention must be read out of the prior publication. If specific details are necessary for the practical working and real utility of the alleged invention, they must be found substantially in the prior publication." None of the reports set out the particulars of the plaintiff's patent. For those details it is necessary to go to the related case of Hills v London Gaslight Co 5 H and N 312, referred to by Lord Westbury LC in Hill v Evans (1862) 1A IPR 1 at 3. The description of the invention was "an improved mode of compressing peat and of manufacturing gas and of obtaining certain substances applicable to purifying the same". It consisted of passing gas through a mixture with the object of purifying the gas and then renovating the purifying material. Each of the specifications cited against Hill's patent was also process or method patent. Heard's was a patent for the application of lime in the purification of gas, croll's patent was directed to an improved method of purifying coal gas from ammonia and Laming's patent also dealt with the process of purification of gas. The general statements by Lord Westbury LC need to be understood in the context of the facts of that case. With a qualification to be mentioned, the principle was established that all integers of an invention must be in the prior specification if novelty is to be defeated. In the case of a process or method, that means each integer of the process or method.


case_title: HPM Industries Pty Ltd v Gerard Industries Ltd [1957] HCA 47 ; (1957) 98 CLR 424


case_text: Section 233 of the 1990 Act has been applied on the basis that a 1952 Act patent can now only be revoked on a ground provided for by the 1990 Act but as if it corresponds with the similar ground available under the 1952 Act (eg NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1993] FCA 404 ; (1993) 44 FCR 239 per Lockhart J at 250 254 (agreed in by Northrop J at 241 and Burchett J at 268); ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc [2000] FCA 1349 ; (2000) 106 FCR 214 at [22] [23]; and Abbott Laboratories v Corbridge Group Pty Ltd [2002] FCAFC 314 , (2002) 57 IPR 432 at [81] ). This is a somewhat strange result as the grounds do not correspond, particularly in relation to lack of novelty and obviousness. Uninstructed by authority, I should have thought that the intention was to maintain the status quo in relation to revocation for 1952 Act patents with time to run under the 1990 Act in other words, the grounds for revocation would be those set out in s 100(1) of the 1952 Act. That would maintain the status quo and neither advantage nor disadvantage the 1952 Act patentee. However, that approach is not reflected in the authorities and has not been contended for by either party. 125 As I have found that claim 1 and dependent claims lack novelty, this ground adds nothing to that result. The 1990 Act contemplates revocation claim by claim (s 138(3)); the 1952 Act ground is "that the patent was obtained on a false suggestion or representation" (s 100(1)(k)). Nonetheless, the Full Court in ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc [2000] FCA 1349 ; (2000) 106 FCR 214 at [93] held that the opening words of s 100(1) of the 1952 Act contemplated claim by claim revocation. 126 It was submitted for the patentee that the descriptions "unexpected" and "interesting" are expressions of opinion and can only be falsified or made misleading by establishing that they were not genuinely held. That distinction is well-known in the fields of misrepresentation, misleading conduct contrary to s 52 of the Trade Practices Act 1974 (Cth) and defamation. There is a good deal to commend the approach in this context. There is material in the internal documents of Sanofi-Aventis that would provide some support for such a case. However, it was pointed out on behalf of Sanofi-Aventis that such a case had not been pleaded or presented by the applicants. Further, that does not appear to be the way in which the issue was approached by the Full Court in Ranbaxy [2008] FCAFC 82 at [131] [141] where it was considered objectively. The decision of the Full Court in ICI Chemicals [2000] FCA 1349 ; 106 FCR 214 may support an objective approach as it was held that a false suggestion or representation may be made in good faith although the false statement in that case could possibly be regarded as a statement of fact not a statement of opinion (see ICI Chemicals [2000] FCA 1349 ; (2000) 106 FCR 214 at [88] [91]). 128 Even if the statements were false, it must be asked whether the suggestion or representation was "a material inducing factor which led to the grant" ( ICI Chemicals [2000] FCA 1349 ; (2000) 106 FCR 214 at [88] citing Prestige Group (Aust) Pty Ltd v Dart Industries Inc (1990) 26 FCR 197 at 201 per Lockhart J and 218 per Gummow J, with whom Northrop J agreed). 130 However, in the present case the Patent Office file shows no indication that the examiner was conscious of any potential problem or raised one with the patentee. That being so, the approach of the Full Court in Ranbaxy [2008] FCAFC 82 would require a negative answer to the question as to whether the false statements did materially induce the decision (see also ICI Chemicals [2000] FCA 1349 ; 106 FCR 214 at [92] ). In any event, I would be inclined to think that by the time this application was being considered, patent officers would have regarded the description of a finding as "unexpected" or "interesting" in the field of selection patents as likely to be a patent attorney's "puff" rather than a serious statement of fact.


case_text: Crennan J made a passing reference to patents of addition (to which I shall return) and selection patents in Imperial Chemicals Industries Pty Ltd v Commissioner of Patents [2004] FCA 1658 ; (2004) 213 ALR 399 , (2004) 63 IPR 476 , (2005) AIPC 92-055 at [66] . Her Honour also referred to a decision of Delegate Barker in University of Georgia Research Foundation Inc v Biochem Pharma Inc (2000) 51 IPR 222 , (2001) AIPC 91-676. It is quite clear from that decision that the Commissioner of Patents has applied the IG Farbenindustrie AG's Patents (1930) 47 RPC 289 principles for many years (see also Pfizer Inc v Commissioner of Patents [2005] FCA 137 ; (2005) 141 FCR 413 at [10] and [11]). Gummow J made a delphic reference to the topic in Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 529, (1990) 16 IPR 545 , (1990) AIPC 90-670 where, after reference to the decision of Falconer J in Re Genentech Inc's (Human Growth Hormone) Patent [1989] RPC 613 at 629 633, he said: "[s]election patents may require special attention, but that is a matter for another day." As I said earlier, the decision of Falconer J appeared to be and, in my opinion, was, a departure from the manner in which the law of anticipation had been understood in the United Kingdom and in Australia up to that time.


case_outcome: referred to

case_text: The first case in the United Kingdom Court of Appeal to consider selection patents was In the matter of Esso Research and Engineering Co's Application (Shell) [1960] RPC 35 where the principle was explained as follows ([1960] RPC 35 at 53): "So it is that you may have first the scientist who discovers and discloses the whole range and who may obtain patent protection for the subject-matter of his discovery or the means of manufacturing them what Maugham, J. called the "originating patent". But within such a range there is room also for the second scientist whose researches may discover and disclose that certain of the items or a section of them have advantages peculiar to themselves, hitherto unknown; and, if so, then there would appear to be no ground on reason or principle why patent protection should not be, in proper cases, available to the second scientist." (See also Institut Francais du Petrole des Carburants et Lubricants' Application, Re [1972] FSR 147, [1972] RPC 364; May & Baker Ltd (1948) 65 RPC 255.) 86 The phrase in In the matter of Esso Research and Engineering Co's Application (Shell) [1960] RPC 35 at 53 was "advantages peculiar to themselves" or, as Lord Wilberforce put it in EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303 at 309 "unrecognised advantages". Buckley LJ said in Beecham Group Ltd's (Amoxycillin) Application, Re [1980] RPC 261 at 292: "... the substance must be truly new and the advantage to be gained from its selection must be the inventor's own discovery as opposed to mere verification by him of previous predictions or of what was previously predictable; in other words, it must be unexpected." The specification in question here was, no doubt, drawn with this concept in mind. However, the advantages here are not different in kind from those described and predicted in the earlier patent specifications. Even if such an advantage could be satisfied by a quantum leap in relation to an earlier claimed advantage, the results here are by no means out of the range of results predictable from the tests done on the examples in the earlier specification.


case_text: In my view, the inventive step is not to be judged on the basis that either PCR 4099 or the dextro-rotatory enantiomer of it is the starting point. It may seem anomalous that the major compound might be obvious because of the statements in the specification in suit but that salts of it are not. However, the salts are novel without any special consideration as selection patents. To take the specification in suit into account in this way to judge the obviousness of these claims would have to be based upon a general principle, not restricted to selection patents. There is much to be said for the view that a patentee should be held to the advance in the art identified in the specification for the purposes of judging whether there is an inventive step. Put another way, the contents of the specification in suit would be taken into account in identifying the inventive step for the purposes of judging obviousness. However, no authority was cited that directly establishes such a principle. Even application of it to selection patents is doubtful. A similar issue arose in the recent Full Court decision in Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd [2008] FCAFC 139 in connection with a mechanical invention under the 1990 Act. To the extent that the decision has any application to these cases, it tends against the applicants' contention as to the use that can be made of statements in the specification in suit as to the inventive step, although the reasoning is not altogether clear (see Insta Image Pty Ltd [2008] FCAFC 139 at [38] [61] and [80] [115]). The applicants' contention is a step too far for a single judge. It follows that claims 2 5 do represent an inventive step compared with common general knowledge in Australia at the time. 113 If the inventive step were identified as having the single enantiomer of clopidogrel as the starting point, I would have held that each salt claimed was obvious. It was known that a pharmaceutically acceptable salt was useful for administration of an active compound. It was known how to prepare such salts using known mineral or organic acids. The acids chosen here hydrochloric acid sulfuric acid, hydrobromic acid and taurocholic acid were conventional. They were (with the exception of taurocholic acid) the acids utilised in relation to the salts of PCR 4099 in the French patent. Standard methods of preparation of the salts were known. 114 Claim 6 is the principal process claim. It describes in a general way the process of liberating the dextro-rotatory enantiomer from the racemic compound PCR 4099 by means of diastereomeric salt formation. The desire to obtain the dextro-rotatory enantiomer of the racemic compound is taken for granted. The claim does not relate to that choice; it relates only to the means of doing so. Novelty lies in the fact that no prior art discloses the use of that process in relation to that particular compound to obtain that particular enantiomer. That method was well-known in the field in Australia at the priority date as a classic means of obtaining the enantiomers of a racemic compound. What the specification in suit discloses is that the classic method worked in this case. The patentee sought to establish, principally through Mr Badorc, firstly, that the method did not always work in relation to particular compounds and, secondly, that the application of the method in this case required choices to be made in the light of difficulties encountered in the course of carrying it out that were not standard, and were not obvious. A number of other methods of obtaining the enantiomers of a racemic compound were known at the priority date and it was also contended that the choice of one over the other was not obvious. 115 None of those contentions detract from the fact that claim 6 represents a classic process being applied to a known compound to produce the desired result. The relevance of Mr Badorc's evidence to the issue is doubtful at least. Even if admissible, in my opinion, the particular application of the method by Mr Badorc did not involve any inventive step. Mr Badorc's evidence of the steps he took by way of diastereomeric salt formation, leading to the successful experiment on 21 March 1986, was challenged in various respects, principally because of apparent discrepancies between that evidence and the contemporaneous records. His explanations were far from convincing. Even if his evidence is accepted, the steps he took were typical of the trial and error that was necessarily involved with the use of such a technique. Even if there were an inventive step in the particular application by Mr Badorc, claim 6 is not so limited. Each of the additional integers in claims 7, 8 and 9 was well-known in the field in Australia at the priority date and were available as part of the ordinary process of trial and error. They do not reflect any particular inventive step identified by Mr Badorc. 116 The fact that a process may not always work in particular circumstances and that there were other available alternatives does not establish that it was inventive to choose to use it. The choice of one known process over other known processes may be inventive in some circumstances perhaps where the received wisdom would point in the other direction or the result was unexpected. There were no such circumstances here. For the sake of completeness, I should say that there was no inventive step involved (or claimed) in ascertaining the pharmacological characteristics of the respective enantiomers.


case_text: The first case in the United Kingdom Court of Appeal to consider selection patents was In the matter of Esso Research and Engineering Co's Application (Shell) [1960] RPC 35 where the principle was explained as follows ([1960] RPC 35 at 53): "So it is that you may have first the scientist who discovers and discloses the whole range and who may obtain patent protection for the subject-matter of his discovery or the means of manufacturing them what Maugham, J. called the "originating patent". But within such a range there is room also for the second scientist whose researches may discover and disclose that certain of the items or a section of them have advantages peculiar to themselves, hitherto unknown; and, if so, then there would appear to be no ground on reason or principle why patent protection should not be, in proper cases, available to the second scientist." (See also Institut Francais du Petrole des Carburants et Lubricants' Application, Re [1972] FSR 147, [1972] RPC 364; May & Baker Ltd (1948) 65 RPC 255.) 81 If that view is correct, then the patent in suit is not a selection patent in the ordinary sense as PCR 4099 and each of the enantiomers were expressly disclosed and claimed in the earlier patents and are expressly referred to in the patent in suit. In one sense, the dextro-rotatory enantiomer is selected from that sub-class. There is authority to suggest that selection can be from a small class (per Buckley LJ in Beecham Group Ltd's (Amoxycillin) Application, Re [1980] RPC 261 at 292; EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303 per Lord Wilberforce at 310; but, cf Institut Francais du Petrole des Carburants et Lubricants' Application, Re [1972] FSR 147 at 154, [1972] RPC 364). I will therefore assume, contrary to my own opinion, that the principle can apply to the present case on that basis if the requirements are met. 101 It is difficult to see how this patent could have been valid without disclosing the starting point or the master patent in the specification. To do so would have amounted to obtaining the patent on a false suggestion or representation within the meaning of s 100(1)(k) of the 1952 Act or be in breach of s 40(1)(a) of that Act by not describing the invention (see Sami S Svendsen Inc v Independent Products Canada Ltd [1968] HCA 65 ; (1968) 119 CLR 156 at 159 and 164 165). The same applies under the 1990 Act. Hence the necessity to spell out that step and the advantage in the complete specification ( Re IG Farbenindustrie AG's Patents (1930) 47 RPC 289 at 323; Institut Francais du Petrole des Carburants et Lubricants' Application, Re [1972] FSR 147 at 154, [1972] RPC 364). The specification of the patent in suit is drafted consistently with that obligation. The cases on selection patents discuss both novelty and obviousness by reference to the nature of the selection from the earlier patent specification to the later claim.


case_text: Counsel for Sanofi-Aventis submitted that enabling disclosure, not mere disclosure, is required for anticipation, citing, most recently, Lindgren J in Alphapharm Pty Ltd [2008] FCA 559 at [160] [161] and the decision of the House of Lords in SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323. By way of introduction, it is worth remarking that the phrase "enabling disclosure" was brought to prominence by the speech of Lord Hoffmann in Biogen Inc v Medeva plc [1996] UKHL 18 ; [1997] RPC 1 , (1996) 36 IPR 438. That decision concerned the requirements for a valid patent under the 1997 United Kingdom Act (based upon the European Patent Convention) but did not concern the question of anticipation. The most important question was whether a later patent could claim an earlier priority date because it was "supported" by the earlier specification. That is a concept similar to, but narrower than, whether a later patent is fairly based upon an earlier specification in our law (cf F Hoffman-La Roche & Co AG v Commissioner of Patents [1971] HCA 3 ; (1971) 123 CLR 529 ; CCOM Pty Ltd v Jiejing Pty Ltd [1994] FCA 1168 ; (1994) 51 FCR 260 ; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 ; (2004) 217 CLR 274). It may be accepted that, in the case of a claim for a chemical compound by formula, in order to be valid, the specification would have to disclose how it might be manufactured (s 40). The phrase was also used in the speech of Lord Oliver in Asahi Kasei Kogyo KK's Application [1991] RPC 485 , to which I shall return. The phrase is reasonable shorthand in relation to the disclosure required for there to be anticipation of a process or method claim but, in my opinion, has little, if any, relevance to anticipation of a product claim or a claim for a chemical compound by formula. Indeed, it is apt to mislead in relation to the latter. For a product claim, the novelty must lie in the product not the means of producing it ( May & Baker Ltd v Boots Pure Drug Co Ltd (1948) 65 RPC 255 at 281 282). By the same token, a new process to obtain an old product will have novelty. 103 The position established in Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was of relatively short duration. Until then, the wider view of Williams J in HPM Industries Pty Ltd v Gerard Industries Ltd [1957] HCA 47 ; (1957) 98 CLR 424 had applied (see Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd [1978] HCA 61 ; (1978) 141 CLR 305 per Aickin J at 329 330). The 1990 Act widens the prior art base, but does not change the nature of the issue. Leaving aside Aktiebolaget [2002] HCA 59 ; 212 CLR 411 , the principal survey of the topic by the High Court since Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 ; (2007) 235 ALR 202 , (2007) 81 ALJR 1070 , particularly at [31] [66]. That case did not involve the problem that arises here. It is noteworthy that the Court said of the 1990 provisions (at [127]): "As stated above, by enlarging the prior art base through including relevant prior disclosures beyond those disclosures proven to be part of the common general knowledge, these provisions raise the threshold for inventiveness. However, the idea remains that the prior disclosures to be taken into account, even as enlarged by s 7(3), are being considered for a particular purpose. That purpose is the purpose of looking forward from the prior art base to see what a person skilled in the relevant art is likely to have done when faced with a similar problem which the patentee claims to have solved with the invention." (Emphasis added.) (cf Firebelt Pty Ltd v Brambles Australia Ltd [2002] HCA 21 ; (2002) 188 ALR 280 , (2002) 76 ALJR 816 at [33] as to combination patents.) The applicants do not seek to utilise the contents of the prior specification as an admission as to common general knowledge (cf Lockwood Security Products [2007] HCA 21 ; 235 ALR 202 , 81 ALJR 1070 at [105] [109]). Rather, it is a statement of the nature of the inventive step that is claimed (cf in another context, Commissioner of Patents v Microcell Ltd [1959] HCA 71 ; (1959) 102 CLR 232). 120 The latter decision has subsequently been discussed by the High Court in Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd [1998] HCA 19 ; (1998) 194 CLR 171 , particularly at [36] [40] per Brennan CJ, Gaudron, McHugh and Gummow JJ and in Lockwood Security Products [2007] HCA 21 ; 235 ALR 202 ; (2007) 81 ALJR 1070 at [106] [107]. It is made clear that external evidence cannot be relied upon. The same ground of invalidity was examined in some detail by the Full Court in Merck & Co Inc [2006] FCAFC 91 ; 154 FCR 31 at [20] [75] (cf at first instance Arrow Pharmaceuticals Ltd v Merck & Co Inc (2004) 213 ALR 182 , (2004) 63 IPR 85 at [80] [97]). The true scope of this ground of invalidity is difficult to discern in a case such as the present where the claims are for conventional products (albeit defined by chemical formula) and processes for the manufacture of products compared, say, with Merck & Co Inc [2006] FCAFC 91 ; 154 FCR 31 which dealt with a variation of a dosage regime. It is clear that the grounds of novelty and obviousness must be considered as such rather than through this prism ( CCOM Pty Ltd [1994] FCA 1168 ; 51 FCR 260 at 295 295).


case_text: Counsel for Sanofi-Aventis submitted that enabling disclosure, not mere disclosure, is required for anticipation, citing, most recently, Lindgren J in Alphapharm Pty Ltd [2008] FCA 559 at [160] [161] and the decision of the House of Lords in SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323. By way of introduction, it is worth remarking that the phrase "enabling disclosure" was brought to prominence by the speech of Lord Hoffmann in Biogen Inc v Medeva plc [1996] UKHL 18 ; [1997] RPC 1 , (1996) 36 IPR 438. That decision concerned the requirements for a valid patent under the 1997 United Kingdom Act (based upon the European Patent Convention) but did not concern the question of anticipation. The most important question was whether a later patent could claim an earlier priority date because it was "supported" by the earlier specification. That is a concept similar to, but narrower than, whether a later patent is fairly based upon an earlier specification in our law (cf F Hoffman-La Roche & Co AG v Commissioner of Patents [1971] HCA 3 ; (1971) 123 CLR 529 ; CCOM Pty Ltd v Jiejing Pty Ltd [1994] FCA 1168 ; (1994) 51 FCR 260 ; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 ; (2004) 217 CLR 274). It may be accepted that, in the case of a claim for a chemical compound by formula, in order to be valid, the specification would have to disclose how it might be manufactured (s 40). The phrase was also used in the speech of Lord Oliver in Asahi Kasei Kogyo KK's Application [1991] RPC 485 , to which I shall return. The phrase is reasonable shorthand in relation to the disclosure required for there to be anticipation of a process or method claim but, in my opinion, has little, if any, relevance to anticipation of a product claim or a claim for a chemical compound by formula. Indeed, it is apt to mislead in relation to the latter. For a product claim, the novelty must lie in the product not the means of producing it ( May & Baker Ltd v Boots Pure Drug Co Ltd (1948) 65 RPC 255 at 281 282). By the same token, a new process to obtain an old product will have novelty. 64 Something was sought to be made of the fact that PCR 4099 or derivative 1 was not unmistakably pointed to as the best of the compounds. There was competing evidence from the experts related to that question. In my view, that was a red herring as far as novelty is concerned. On any view, it was expressly disclosed as one of the most promising of the compounds. The invention was not limited to the most effective or most promising example. The invention was a broad class. As Lord Hoffmann lucidly explained in Biogen Inc [1996] UKHL 18 ; [1997] RPC 1 at 48 49, 36 IPR 438 at 455: "If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms. The patentee need not show that he has proved its application in every individual instance. On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them. Thus if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect: see May & Baker Ltd v Boots Pure Drug Co Ltd [1950] RPC 23 at 50. On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them." 77 The first case in the United Kingdom Court of Appeal to consider selection patents was In the matter of Esso Research and Engineering Co's Application (Shell) [1960] RPC 35 where the principle was explained as follows ([1960] RPC 35 at 53): "So it is that you may have first the scientist who discovers and discloses the whole range and who may obtain patent protection for the subject-matter of his discovery or the means of manufacturing them what Maugham, J. called the "originating patent". But within such a range there is room also for the second scientist whose researches may discover and disclose that certain of the items or a section of them have advantages peculiar to themselves, hitherto unknown; and, if so, then there would appear to be no ground on reason or principle why patent protection should not be, in proper cases, available to the second scientist." (See also Institut Francais du Petrole des Carburants et Lubricants' Application, Re [1972] FSR 147, [1972] RPC 364; May & Baker Ltd (1948) 65 RPC 255.)


case_text: That language is quite conventional in relation to a dose regime. The actual decision in the case was that there was anticipation of the dosage regime claimed in the patent in suit by the earlier publication which included the following ( Bristol-Myers Squibb Co [2000] FCA 316 ; 97 FCR 524 at [71] ): "Further studies to evaluate the feasibility of shorter infusion time, 3 hours versus 24 hours and a lower 135mg/m2 versus a maximum tolerated dose of 175mg/m2 are now in progress in relapsing ovarian cancer patients both in Canada and in Europe. Already more than 200 patients have been entered into this four-arm randomized, NCIC guided international study. Indeed, the 3 hours infusion time administration schedule proved to be feasible, if given concomitantly to profylactic [sic] measures as high dose dexamethasone, cimetidine and difenhydramine. This makes even outpatient treatment with this first available representative of this new class of antitumor agents possible." (cf Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91 ; (2006) 154 FCR 31 at 60). In any event, the problem does not arise in the present case. The invention disclosed and claimed by the French patent necessarily carried the implication of a direction, recommendation or suggestion. That is the consideration for which the monopoly was granted. 120 The latter decision has subsequently been discussed by the High Court in Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd [1998] HCA 19 ; (1998) 194 CLR 171 , particularly at [36] [40] per Brennan CJ, Gaudron, McHugh and Gummow JJ and in Lockwood Security Products [2007] HCA 21 ; 235 ALR 202 ; (2007) 81 ALJR 1070 at [106] [107]. It is made clear that external evidence cannot be relied upon. The same ground of invalidity was examined in some detail by the Full Court in Merck & Co Inc [2006] FCAFC 91 ; 154 FCR 31 at [20] [75] (cf at first instance Arrow Pharmaceuticals Ltd v Merck & Co Inc (2004) 213 ALR 182 , (2004) 63 IPR 85 at [80] [97]). The true scope of this ground of invalidity is difficult to discern in a case such as the present where the claims are for conventional products (albeit defined by chemical formula) and processes for the manufacture of products compared, say, with Merck & Co Inc [2006] FCAFC 91 ; 154 FCR 31 which dealt with a variation of a dosage regime. It is clear that the grounds of novelty and obviousness must be considered as such rather than through this prism ( CCOM Pty Ltd [1994] FCA 1168 ; 51 FCR 260 at 295 295). 121 In my opinion, it cannot be said that the patent in suit claims an invention that is not new on the face of the specification without regard to what may be described as external evidence. Indeed, the specification has been drawn in a fashion which is designed to ensure that the claims are new if the contents of the specification are accepted. I do not agree that the French specification is incorporated by reference as a whole and for all purposes into the specification in suit. It is incorporated sufficiently to understand the reference to the racemic compound in the specification in suit. Even if that be wrong, and it is incorporated as a whole (as appeared to be the case with some prior documents in the Full Court decision in Merck & Co Inc [2006] FCAFC 91 ; 154 FCR 31) , it would take the matter no further than the decision to which I have come on novelty. 122 The next ground to be considered is that the patent was obtained on a false suggestion or representation (1952 Act, s 100(1)(k); 1990 Act, s 138(3)(d)). The first false and misleading representation alleged was the statement: "in an unexpected manner only the dextro-rotatory enantiomer Id exhibits a platelet aggregation inhibiting activity, the levo-rotatory enantiomer Il being inactive". (Emphasis added.) It is accepted that the statement as to the relative activity is accurate but it is alleged that it was not "unexpected". This was linked with the following representation: "The pharmacological study just presented has demonstrated the interesting inhibitory properties towards platelet aggregation of the compound Id and the absence of any activity of its isomer Il." (Emphasis added.) 123 Those statements were obviously designed to support the claim to novelty for the dextro-rotatory enantiomer to counter any suggestion that this was merely another use for a known substance and, in particular, to support a claim for novelty based upon selection.


case_text: The phrase in s 100(1)(g) of the 1952 Act, "was not novel in Australia", is similar in substance to the phrase in s 7(1) of the 1990 Act "not novel in the light of" various kinds of information. To say that the claim of a patent is not novel in that sense is to say that it adds nothing new to that with which it is compared. In the case of a paper anticipation, it assumes that the product described is made or the process outlined is followed. Each integer of the claimed invention must be disclosed in the prior publication. The reverse infringement test is a practical way of detecting whether that is so in most cases ( Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 ; (1977) 137 CLR 228 at 235). 44 The patent in suit claims a chemical compound with a specific property namely, the capacity to rotate plane-polarised light to the right. That property distinguishes it both from the racemate and from the levo-rotatory enantiomer. The dextro-rotatory enantiomer is not expressly identified as such in the French patent. Counsel for Sanofi-Aventis submits that it is not possible from the face of the earlier specifications to say which enantiomer is the levo-rotatory and which is the dextro-rotatory the most that can be said is that both are in the racemate. Furthermore, it is said that that difference is significant so far as pharmacological efficacy and toxicity were concerned as disclosed in the complete specification of the patent in suit. Thus, the patentee's contention is that this is something new and different novel in form and in substance. 45 On the other hand, the formula identified as derivative 1 or example 1 in the French patent and corresponding patents (PCR 4099) has the identical formula to the enantiomer in suit. I am satisfied that the skilled but not inventive reader of the French and corresponding patents would understand that the derivative in question (in common with all of the derivatives) was the racemate and that all of the technical explanations as to the means of obtaining that (and other) derivatives and as to the testing of them related only to the racemate and not to any individual enantiomer. There is no express suggestion that either enantiomer had in fact been separately obtained or tested for efficacy or toxicity. That said, it was commonly known, and was spelled out in the French patent, that the compound in question was a racemate with one chiral centre and two enantiomers one dextro and the other levo. There were express references to the enantiomers in both the body of the specification and in the claims of the French and corresponding patents, with the detail most clearly spelled out in the Canadian patent. The express references to the enantiomers in the French and corresponding patents (particularly the Canadian patent) plainly carry the claim that the enantiomers are within the compounds disclosed.


case_text: A threshold question of law arises. It is submitted for the patentee that, once it is accepted that clopidogrel was not part of common general knowledge in Australia, let alone the broader teachings of the French patent, the ground of lack of inventive step is misconceived and has no possibility of success. It is pointed out that the statutory phrase is "what was known or used in Australia", before the priority date. It is well-established that that phrase refers to common general knowledge in the relevant field in Australia, that is to say, "the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old" ( Minnesota Mining & Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 ; (1980) 144 CLR 253 at 292). 102 This submission was described as heretical. I, therefore, carefully reread the analysis of s 100(1)(e) of the 1952 Act by Aickin J in Minnesota Mining [1980] HCA 9 ; 144 CLR 253 , particularly at 287 295. That analysis is not directed to the question that arises here. There is no indication in that case that any of the patent specifications relied upon were cited in the patent in suit, that they had any connection with the patentee or that the patentee was aware of them. It was not a selection patent in any sense. 103 The position established in Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was of relatively short duration. Until then, the wider view of Williams J in HPM Industries Pty Ltd v Gerard Industries Ltd [1957] HCA 47 ; (1957) 98 CLR 424 had applied (see Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd [1978] HCA 61 ; (1978) 141 CLR 305 per Aickin J at 329 330). The 1990 Act widens the prior art base, but does not change the nature of the issue. Leaving aside Aktiebolaget [2002] HCA 59 ; 212 CLR 411 , the principal survey of the topic by the High Court since Minnesota Mining [1980] HCA 9 ; 144 CLR 253 was in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 ; (2007) 235 ALR 202 , (2007) 81 ALJR 1070 , particularly at [31] [66]. That case did not involve the problem that arises here. It is noteworthy that the Court said of the 1990 provisions (at [127]): "As stated above, by enlarging the prior art base through including relevant prior disclosures beyond those disclosures proven to be part of the common general knowledge, these provisions raise the threshold for inventiveness. However, the idea remains that the prior disclosures to be taken into account, even as enlarged by s 7(3), are being considered for a particular purpose. That purpose is the purpose of looking forward from the prior art base to see what a person skilled in the relevant art is likely to have done when faced with a similar problem which the patentee claims to have solved with the invention." (Emphasis added.) (cf Firebelt Pty Ltd v Brambles Australia Ltd [2002] HCA 21 ; (2002) 188 ALR 280 , (2002) 76 ALJR 816 at [33] as to combination patents.) The applicants do not seek to utilise the contents of the prior specification as an admission as to common general knowledge (cf Lockwood Security Products [2007] HCA 21 ; 235 ALR 202 , 81 ALJR 1070 at [105] [109]). Rather, it is a statement of the nature of the inventive step that is claimed (cf in another context, Commissioner of Patents v Microcell Ltd [1959] HCA 71 ; (1959) 102 CLR 232).


case_text: It is contended by the applicants that the claims in suit do not represent an invention because they are not a manner of new manufacture s 100(1)(d) of the 1952 Act combined with the definition of "invention" in s 6; s 18(1) of the 1990 Act together with the definition of "invention" in the dictionary in Sch 1. The most illuminating discussion of that which is encompassed by "a manner of manufacture" is that by the High Court in National Research Development Corp v Commissioner of Patents (NRDC Case) [1959] HCA 67 ; (1959) 102 CLR 252 where the extended meaning of the phrase in accordance with principles which were developed for the application of s 6 of the Statute of Monopolies was explained by reference to the authorities up to that point. In my opinion, it could not be suggested that the subject matter of the present claims is outside that extended notion. The claims are for compounds and processes in a field of useful pharmacological application. 119 That decision was delivered several months after the decision of another Full Court of the High Court in Commissioner of Patents v Microcell Ltd [1959] HCA 71 ; 102 CLR 232. In that case it was held that the specification did not disclose a patentable invention the headnote succinctly summarises the gist of the decision as follows: "It is not an inventive idea for which a monopoly can be claimed to take a substance which is known and used for the making of various articles and make out of it an article for which its known properties make it suitable, although it has not in fact been used to make that article before." In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 ; (1995) 183 CLR 655 at 664 the High Court quoted with approval the following passage from the NRDC Case [1959] HCA 67 ; 102 CLR 252 at 261 262 per Dixon CJ, Kitto and Windeyer JJ: "the Commissioner may properly reject a claim for a process which is not within the concept of a "manufacture". But the case cited [ie Microcell] 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".


case_text: Crennan J made a passing reference to patents of addition (to which I shall return) and selection patents in Imperial Chemicals Industries Pty Ltd v Commissioner of Patents [2004] FCA 1658 ; (2004) 213 ALR 399 , (2004) 63 IPR 476 , (2005) AIPC 92-055 at [66] . Her Honour also referred to a decision of Delegate Barker in University of Georgia Research Foundation Inc v Biochem Pharma Inc (2000) 51 IPR 222 , (2001) AIPC 91-676. It is quite clear from that decision that the Commissioner of Patents has applied the IG Farbenindustrie AG's Patents (1930) 47 RPC 289 principles for many years (see also Pfizer Inc v Commissioner of Patents [2005] FCA 137 ; (2005) 141 FCR 413 at [10] and [11]). Gummow J made a delphic reference to the topic in Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 529, (1990) 16 IPR 545 , (1990) AIPC 90-670 where, after reference to the decision of Falconer J in Re Genentech Inc's (Human Growth Hormone) Patent [1989] RPC 613 at 629 633, he said: "[s]election patents may require special attention, but that is a matter for another day." As I said earlier, the decision of Falconer J appeared to be and, in my opinion, was, a departure from the manner in which the law of anticipation had been understood in the United Kingdom and in Australia up to that time. 108 The specification in suit does not explain in express terms the reason or motivation for separating and testing the enantiomers and comparing the results with those for the racemic mix. It is assumed that the enantiomers might be separated. The reason for that course is not disclosed. There is no statement, for example, of the problems concerning tolerance and toxicity which are now known to have affected the racemic mix and to have led to the search for a better alternative. The inventive step claimed, in relation to the product claim for the dextro-rotatory enantiomer, was the unexpected nature of the result. It is as if, in the course of an investigation, an unexpected result occurred. That can be sufficient to provide subject matter (as it used to be called) for an invention in appropriate circumstances. The references to the French patent in the complete specification of the patent in suit are sufficient to permit reference to the French specification but only to understand the context of the disclosure of the particular racemate. The discussion by Gummow J (agreed with by Jenkinson J) in Nicaro Holdings Pty Ltd 91 ALR 513 at 532 539 is apposite, although directed to novelty in that case.


case_text: That decision was delivered several months after the decision of another Full Court of the High Court in Commissioner of Patents v Microcell Ltd [1959] HCA 71 ; 102 CLR 232. In that case it was held that the specification did not disclose a patentable invention the headnote succinctly summarises the gist of the decision as follows: "It is not an inventive idea for which a monopoly can be claimed to take a substance which is known and used for the making of various articles and make out of it an article for which its known properties make it suitable, although it has not in fact been used to make that article before." In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 ; (1995) 183 CLR 655 at 664 the High Court quoted with approval the following passage from the NRDC Case [1959] HCA 67 ; 102 CLR 252 at 261 262 per Dixon CJ, Kitto and Windeyer JJ: "the Commissioner may properly reject a claim for a process which is not within the concept of a "manufacture". But the case cited [ie Microcell] 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".


case_text: Section 233 of the 1990 Act has been applied on the basis that a 1952 Act patent can now only be revoked on a ground provided for by the 1990 Act but as if it corresponds with the similar ground available under the 1952 Act (eg NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1993] FCA 404 ; (1993) 44 FCR 239 per Lockhart J at 250 254 (agreed in by Northrop J at 241 and Burchett J at 268); ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc [2000] FCA 1349 ; (2000) 106 FCR 214 at [22] [23]; and Abbott Laboratories v Corbridge Group Pty Ltd [2002] FCAFC 314 , (2002) 57 IPR 432 at [81] ). This is a somewhat strange result as the grounds do not correspond, particularly in relation to lack of novelty and obviousness. Uninstructed by authority, I should have thought that the intention was to maintain the status quo in relation to revocation for 1952 Act patents with time to run under the 1990 Act in other words, the grounds for revocation would be those set out in s 100(1) of the 1952 Act. That would maintain the status quo and neither advantage nor disadvantage the 1952 Act patentee. However, that approach is not reflected in the authorities and has not been contended for by either party.


case_title: Pfizer Inc v Commissioner of Patents [2005] FCA 137 ; (2005) 141 FCR 413


case_text: Even if the statements were false, it must be asked whether the suggestion or representation was "a material inducing factor which led to the grant" ( ICI Chemicals [2000] FCA 1349 ; (2000) 106 FCR 214 at [88] citing Prestige Group (Aust) Pty Ltd v Dart Industries Inc (1990) 26 FCR 197 at 201 per Lockhart J and 218 per Gummow J, with whom Northrop J agreed).


case_text: A little earlier than the decision in Alphapharm [2008] FCA 559 , Young J had considered a similar issue in Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (No 2) [2006] FCA 1787 , (2006) 71 IPR 46. One question was whether the formula in claim 1 of the relevant patent claimed only the racemate and not the enantiomers separate from the racemate. The patentee, Warner-Lambert, called, amongst other witnesses, Professor Christopher Easton and Professor Peter Scammells, who gave evidence for Sanofi-Aventis in these cases. The applicant for revocation, Ranbaxy, called, inter alia, Dr Keith Watson, who was called by Apotex, one of the applicants, in these cases. His Honour's findings about common general knowledge (so far as is relevant) were as follows ( Ranbaxy [2006] FCA 1787 , 71 IPR 46 at [113] ): "(7) The biological activity of a racemate in a biological system can be quite different from that of a single enantiomer. The physical and biological properties of a racemate differ from that of an individual enantiomer in various respects: for example, there may be differences in solubility between the racemate and its enantiomers and differences in pharmacological properties. (8) The normal expectation is that there would be one enantiomer that is approximately twice as active as the racemate in terms of its operation in the target biological system. (9) Before 30 May 1986, the skilled team would expect that the R enantiomer was very likely to be the active, or more active, enantiomer, but this could not be known with certainty without isolating and testing the enantiomer. (10) Conversely, it was very likely to be the case that the S enantiomer was inactive, or substantially less active, than the R enantiomer, but this could not be known with certainty until the enantiomers had been isolated and tested. (11) Well before 30 May 1986, it was common general knowledge amongst medicinal chemists that racemic mixtures could be separated into the individual enantiomers by well-known methods of resolution. Indeed, undergraduate chemical students were taught procedures to resolve enantiomers. It was also generally known before May 1986 that enantiomers could be obtained by chiral synthesis. (12) As at 30 May 1986, it was feasible to use resolution or chiral synthesis to obtain a single enantiomer drug. Pharmaceutical companies had produced single enantiomer synthetic drugs either by way of resolution from the corresponding racemic mixture or by way of chiral synthesis prior to May 1986. (13) As at May 1986, it was known that enantiomers could have different biological properties and that it may be desirable to separate and remove the less active enantiomer." 71 His Honour found that the formula did include claims for the enantiomers as such, notwithstanding that there was no reference to them. An important part of his reasoning was as follows ( Ranbaxy [2006] FCA 1787 , 71 IPR 46 at [121] [122] and [128] [129]): "Perhaps the most important background consideration against which the claims of the 981 Patent must be construed is that the skilled addressee would know that HMG-CoA reductase inhibitors, such as the class of compounds referred to in claim 1, are enantiomeric and that one enantiomer is very likely to be more active than the other. The skilled addressee would also know that the biological activity of a racemate will be different from that of the single enantiomers, and that the active or more active enantiomer will be approximately twice as active as the racemate. In these circumstances, confronted by a structural formula in claim 1 that shows relative stereochemistry, the skilled reader would consider that the structural formula was intended to claim both enantiomers, as well as racemic mixtures. I do not think that the skilled addressee would read the structural formula as one that was intended to exclude the more active enantiomer. Reading the specification as a whole, the skilled addressee would discern that the patentee had not isolated the individual enantiomers and that the absolute stereochemistry of the more active enantiomer, and that of the less active enantiomer, had not been defined. The skilled addressee would also know that, while it had not yet been done by the patentee, it was a routine step to obtain the individual enantiomers by resolving the racemic mixture, and that it was also possible to make the individual enantiomers by chiral synthesis. In those circumstances, the skilled addressee would expect, in the absence of a clear indication to the contrary, that claim 1 of the patent was intended to include the more active enantiomer. ... In these circumstances, in the absence of any clear indication or language to the contrary, the skilled addressee as at May 1986 would read claim 1 as encompassing both individual enantiomers, as well as mixtures of them. As Warner-Lambert submitted, it would make no sense to exclude patent protection for the more active enantiomer. The point was well made by Professor Easton in the course of his affidavit evidence when he said that to confine the subject of the 981 Patent to racemic mixtures would exclude the thing (the active or more active enantiomer) that he, and any person working in the field as at May 1986, would know to be the key to the useful activity of the compounds disclosed by the patent. It is not in dispute that structural formula I would be construed by the skilled addressee as including a trans racemate of the compounds of the formula. But there is no reason why the skilled reader would construe the formula as meaning only the trans racemate, thereby excluding both the R-trans and the S-trans enantiomers. In the absence of a clear indication to the contrary, it offends common sense to construe structural formula I in that way." Young J referred to decisions on the same patent in England and the United States which adopted a similar construction. 73 Although the decisions in Alphapharm [2008] FCA 559 and Ranbaxy [2006] FCA 1787 , 71 IPR 46 turned in large measure upon the evidence in each case, a difference in approach can be detected on the question involving the disclosure of enantiomers, with Ranbaxy [2006] FCA 1787 , 71 IPR 46 favourable to the applicants on this issue, and Alphapharm [2008] FCA 559 being neutral. In neither case was there the express reference to enantiomers such as there is in the French and corresponding patents here. The priority dates of the relevant patents are also interesting when compared with the priority dates in issue here. In Ranbaxy [2006] FCA 1787 , 71 IPR 46 , the priority date of the broader patent was 30 May 1986 and that of the enantiomer patent 21 July 1989. In the case of Alphapharm [2008] FCA 559 the Australian Citalopram Patent had a priority date of 14 January 1976 and the enantiomer patent 14 June 1988. The common general knowledge found by Lindgren J to relate to the enantiomer patent and by Young J to relate to the broader patent was very much in the same time band as that relevant to construction of the patent in suit here. Naturally, the field of each invention is somewhat different but the principles of stereochemistry as they were understood at the time should not have varied much. There is no suggestion of any crucial and widely known developments during the years in question. 133 Here, there is no suggestion that any of the process claims do not work in that sense and there is no suggestion that the compounds claimed do not usefully inhibit platelet aggregation. Indeed, it has not been contended that the compounds claimed are not better in that respect than the racemate. I do not see that the claims that the properties were "unexpected" or "surprising" have anything to do with that concept. The decision of Young J in Ranbaxy [2006] FCA 1787 , 71 IPR 46 must have been based upon the view that the specification there was construed as promising a particular level of result. The correctness of the decision on this point was left open in the Full Court ( Ranbaxy [2008] FCAFC 82 at [142] [144]).


case_text: The present cases are applications for revocation of a patent pursuant to s 138(3) of the Patents Act 1990 (Cth) (the 1990 Act). The patent claims an enantiomer of a racemate where that racemate was disclosed and claimed by an earlier patent. This has been an issue in relation to other compounds, most recently in two judgments published after the close of evidence and, in one case, after the close of addresses the decision of Lindgren J in Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 and the decision of the Full Court in Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC [2008] FCAFC 82 respectively. 72 The Full Court upheld the decision of Young J on the basis that the conclusion was open to the judge on the evidence, although the Full Court did appear to adopt some of the judge's reasoning ( Ranbaxy [2008] FCAFC 82 at [60] [77]). 76 The most recent reference to the topic in Australia is that by the Full Court in Ranbaxy [2008] FCAFC 82 at [105] : "A patent application will overcome a prior publication, as a selection patent, if the following criteria are met: • there must be some substantial advantage to be secured by the use of the selected members; • the whole of the selected members must possess the advantage in question; • the selection must be in respect of a quality of a special character, which can fairly be said to be peculiar to the group; and • the advantage possessed by the selected members must be clearly disclosed in the specification. (see Re IG Farbenindustrie AG's Patents (1930) 47 RPC 289 at 322-3)." However, that was said in considering the ground of false suggestion rather than lack of novelty. It is a fair brief summary of the position as it was understood at the time of the 1952 Act based upon the authority to which reference was made Re IG Farbenindustrie AG's Patents (1930) 47 RPC 289. This remained the basis of the law in the United Kingdom, at least until the decision of the House of Lords in EI Du Pont De Nemours & Co (Witsiepe's) Application [1982] FSR 303. 82 It is convenient to state once again the summary of those requirements from the Full Court decision in Ranbaxy [2008] FCAFC 82 at [105] : "• there must be some substantial advantage to be secured by the use of the selected members; • the whole of the selected members must possess the advantage in question; • the selection must be in respect of a quality of a special character, which can fairly be said to be peculiar to the group; and • the advantage possessed by the selected members must be clearly disclosed in the specification." 83 There is a substantial advantage to be secured by the use of the dextro-rotatory enantiomer of PCR 4099 as compared with use of either the racemic mixture or the levo-rotatory enantiomer. It is better tolerated or less toxic than either and as effective as the racemate with a lesser concentration. That proved to be the difference between success as a pharmaceutical drug and otherwise. In that sense, the first of the criteria is satisfied. The second and fourth criteria are also, obviously, satisfied. 84 However, is the selection in respect of a quality of a special character? It will be recalled that the complete specification of the French patent, and corresponding patents, described the advantages of the invention as follows: "The toxicological and pharmacological investigations reported above demonstrate the low toxicity of the compounds of the invention, as well as their excellent tolerance and their inhibiting properties on blood-platelet aggregation, and their anti-thrombotic activity, which make them very useful in medical therapeutic applications." The claims were not limited to any particular result. In my opinion, that is a good description of the performance of the dextro-rotatory enantiomer of PCR 4099. It was obvious from the specification of the French and corresponding patents that it was not claimed that each compound within the class would have equal qualities indeed, the report of the tests demonstrated that that was not so the advantages were described very generally. 126 It was submitted for the patentee that the descriptions "unexpected" and "interesting" are expressions of opinion and can only be falsified or made misleading by establishing that they were not genuinely held. That distinction is well-known in the fields of misrepresentation, misleading conduct contrary to s 52 of the Trade Practices Act 1974 (Cth) and defamation. There is a good deal to commend the approach in this context. There is material in the internal documents of Sanofi-Aventis that would provide some support for such a case. However, it was pointed out on behalf of Sanofi-Aventis that such a case had not been pleaded or presented by the applicants. Further, that does not appear to be the way in which the issue was approached by the Full Court in Ranbaxy [2008] FCAFC 82 at [131] [141] where it was considered objectively. The decision of the Full Court in ICI Chemicals [2000] FCA 1349 ; 106 FCR 214 may support an objective approach as it was held that a false suggestion or representation may be made in good faith although the false statement in that case could possibly be regarded as a statement of fact not a statement of opinion (see ICI Chemicals [2000] FCA 1349 ; (2000) 106 FCR 214 at [88] [91]). 129 In Ranbaxy [2008] FCAFC 82 it was said (at [135] [138]): "The ground of false suggestion or misrepresentation must involve some misleading or deception of the Commissioner or the Commissioner's delegate, being the person who makes the grant. To establish the ground, there must be a finding that the Commissioner or the Commissioner's delegate was in some way misled or deceived by the suggestion or representation in question and that being so misled or deceived contributed to or caused the decision to grant the patent. The Commissioner was a party to the proceeding but took no substantive part in the proceeding. The Commissioner may have taken the view that Ranbaxy was prosecuting the alleged grounds of invalidity with sufficient vigour for the Commissioner not to be involved. Ranbaxy adduced no evidence as to the way in which the alleged false suggestions or misrepresentations operated on the decision making process of the Commissioner. Where it is alleged that a patent was obtained on or by false suggestion or misrepresentation, it is relevant, although not decisive, that the Commissioner has made no complaint about being misled or deceived. In the absence of an allegation of fraud, which involves an examination of the state of mind of the patent applicant, it is not sufficient to make out the ground of false suggestion or misrepresentation to prove simply that a false or misleading statement was made and nothing else. That is to say, even if a suggestion or representation is shown to be false or misleading, that, of itself, is not sufficient reason to draw an inference that the suggestion or representation contributed to the decision to grant the patent. In the present case, there was no explicit evidence to the effect that, if there had been no assertion that the effectiveness of the relevant compounds was surprising and unexpected, the Enantiomer Patent would not have been granted. While inferences can be drawn, in the absence of any evidence concerning the Commissioner's decision making process, the inferences must be reasonably cogent." (Original emphasis.) In that case the examiner had questioned the patentability of the claim to the enantiomer where the racemate had previously been published. The statements which were found to be false were made on behalf of the patentee in order to overcome the examiner's objection. In those circumstances, the Full Court agreed with the conclusion of the primary judge that the necessary element of causation was present. 130 However, in the present case the Patent Office file shows no indication that the examiner was conscious of any potential problem or raised one with the patentee. That being so, the approach of the Full Court in Ranbaxy [2008] FCAFC 82 would require a negative answer to the question as to whether the false statements did materially induce the decision (see also ICI Chemicals [2000] FCA 1349 ; 106 FCR 214 at [92] ). In any event, I would be inclined to think that by the time this application was being considered, patent officers would have regarded the description of a finding as "unexpected" or "interesting" in the field of selection patents as likely to be a patent attorney's "puff" rather than a serious statement of fact. 133 Here, there is no suggestion that any of the process claims do not work in that sense and there is no suggestion that the compounds claimed do not usefully inhibit platelet aggregation. Indeed, it has not been contended that the compounds claimed are not better in that respect than the racemate. I do not see that the claims that the properties were "unexpected" or "surprising" have anything to do with that concept. The decision of Young J in Ranbaxy [2006] FCA 1787 , 71 IPR 46 must have been based upon the view that the specification there was construed as promising a particular level of result. The correctness of the decision on this point was left open in the Full Court ( Ranbaxy [2008] FCAFC 82 at [142] [144]).