Lack of novelty
40 Section 100(1)(f) and (g) of the 1952 Act were as follows:
"(1) A standard patent may be revoked, either wholly or in so far as it relates to any claim of the complete specification, and a petty patent may be revoked, on one or more of the following grounds, but on no other ground:
…
(f) that the invention, so far as claimed in any claim of the complete specification or in the claim of the petty patent specification, as the case may be, is the subject of a valid claim of earlier priority date contained in the complete specification of a standard patent or in the petty patent specification of a petty patent;
(g) that the invention, so far as claimed in any claim of the complete specification or in the claim of the petty patent specification, as the case may be, was not novel in Australia on the priority date of that claim;"
Prior claiming is not a ground available in this case because of the received wisdom as to the application of s 233 of the 1990 Act.
41 The applicants rely upon the following publications prior to the priority date of the claims in suit:
"(a) Australian Patent No. 554358 laid open to public inspection at the Australian Patent Office on 19 January 1984 (the '358 Patent), being a translation of French Patent Application No. 82/12599 which was granted without amendment as French Patent No. 2 530 247 (the French Patent);
(b) French Patent Application No. 82/12599 laid open to public inspection at the Australian Patent Office on 15 March 1984 as European Patent Application No. 99802A;
(c) Canadian Patent No. 1,194,875 laid open to public inspection at the Australian Patent Office on 7 November 1985 (the Canadian Patent); and
(d) United States Patent No. 4,529,596 laid open to public inspection at the Australian Patent Office on 3 September 1985 (the US Patent)."
(Original emphasis.)
42 Each is a version of the French patent in slightly different language. Relevant portions of the French patent have been set out above. Particular reference has been made by the applicants to the following claims of the Canadian patent which are more detailed than in the French patent:
"1. A process for the preparation of derivatives of general formula (I):
in which Y may represent either a hydroxyl radical or an -OR group radical, in which R is a straight or branched lower alkyl radical, or Y represents a radical of the formula:
in which either R1 and R2, identical or different, represent a hydrogen atom or a straight or branched lower alkyl group; or R1 and R2 form together and with the nitrogen atom to which they are attached a heterocycle which may or may not include a second heteroatom chosen from the group containing oxygen and nitrogen, wherein the latter may be substituted by a lower alkyl or benzyl radical which may or may not be substituted; and X represents a hydrogen or halogen atom, or a lower alkyl radical; and their the addition salts with pharmaceutically acceptable mineral or organic acids if Y represents a radical of the -OR formula or of the -NR1R2 formula; R, R1 and R2 having the above-defined meanings, or with mineral bases if Y represents a hydroxyl radical; as well as the 2 enantiomers or their mixture of these compounds of formula (I); wherein:
- either, in order to prepare the esters of formula (I), in which Y represents a radical of the -OR formula, in which R has the above-defined meaning, and X has the above-defined meaning, the 4,5,6,7-tetrahydro-thieno[3,2-c]pyridine of formula (II) is condensed:
on a α-chlorophenylacetate of formula (III):
in which R and X have the above-defined meanings, then the derivative sought is obtained, which is isolated and, if desired, its enantiomers are separated and/or it is salified by mineral or organic acid action;
- or, in order to prepare the acid of formula (I) in which Y represents a hydroxyl radical and X has the above-defined meaning, the ester of formula (I), in which Y represents a radical of the -OR formula in which R and X have the above-defined meanings, is saponified, then the derivative sought is obtained, which is isolated and, if desired, its enantiomers are separated and/or it is salified by mineral or organic acid action;
- or, in order to prepare the compounds of formula (I), in which X has the above-defined meaning and Y represents a radical of the -OR formula, in which R has the above-defined meaning, or a radical of the -NR1R2 formula, in which R1 and R2 have the above-defined meanings, the acid of formula (I), in which X has the above-defined meaning and Y represents a hydroxyl radical, may or may not be activated, is reacted with either an alcohol of the H-OR formula, in which R has the above-defined meaning, or with an amine of the H-NR1R2 formula, in which R1 and R2 have the above-defined meanings, then the corresponding derivative sought is obtained, which is isolated and, if desired, its enantiomers are separated and/or it is salified by mineral or organic acid action.
…
8. Process according to claim 1, for the preparation of methyl α-[4,5,6,7-tetrahydro-thieno[3,2-c]-5-pyridyl]-o.chlorophenylacetate, wherein the 4,5,6,7-tetrahydro thieno[3,2-c]pyridine is condensed over the methyl 2-chloro-o.chlorophenylacetate, and the derivative sought, which is isolated, is obtained.
…
14. Derivatives of general formula (I):
in which Y may represent either a hydroxyl radical or an -OR group radical, in which R is a straight or branched lower alkyl radical, or Y represents a radical of the formula:
in which R1 and R2, identical or different, represent a hydrogen atom or a straight or branched lower alkyl group; or R1 and R2 form together and with the nitrogen atom to which they are attached a heterocycle which may or may not include a second heteroatom chosen from the group containing oxygen and nitrogen, wherein the latter may be substituted by a lower alkyl or benzyl radical which may or may not be substituted; and X represents a hydrogen or halogen atom, or a lower alkyl radical; and their addition salts with pharmaceutically acceptable mineral or organic acids if Y represents a radical of the -OR formula or of the -NR1R2 forrnula; R, R1 and R2 having the above-defined meanings, or with mineral bases if Y represents a hydroxyl radical; as well as the 2 enantiomers or their mixture of these compounds of formula (I); each time they are obtained by the process of claim 1 or its manifest chemical equivalents.
15. Methyl α-[4,5,6,7-tetrahydro-thieno[3,2-c]-5-pyridyl]-o.chlorophenyl-acetate, each time it is obtained by the process of claim 8 or its manifest chemical equivalents."
(Emphasis added.)
43 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) 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.
46 The relevant phrases in the French and Canadian patents - in the specification: "The invention relates both to each enantiomer and their mixture" (French patent) and "The invention also concerns each of the enantiomers and their mixture" (Canadian patent); in claim 1: "as well as the 2 [two] enantiomers or their mixture …" (French and Canadian patents); "and, if desired, its enantiomers are separated and/or it is salified" (Canadian patent); and in claim 14: "as well as one of the two enantiomers or their mixture" (French patent) and "as well as the 2 enantiomers or their mixture" (Canadian patent) - are consistent only with a disclosure of, and a claim to, each enantiomer (dextro and levo) separate from the racemate and from each other. I should say that the attempts by the witnesses for the patentee to deny that the claims of these patents encompassed each of the separated single enantiomers were, to say the least, not impressive.
47 The basis of the French and corresponding patents is that all compounds of the class claimed (whether exemplified or not) displayed useful inhibiting action on platelet aggregation and anti-thrombotic activity. The precise effect differed as between the various examples discussed. Although the compounds tested were racemates, no distinction as to pharmacological properties was drawn between the racemate and each of the single enantiomers. It follows that the patentee was asserting that the relevant qualities of each enantiomer were not to be relevantly distinguished from any particular racemate or the other enantiomer.
48 The claims for the separate enantiomers could be described as bare claims for efficacy without any foundation being shown for them in any part of the complete specification. There is no basis for knowing what, if any, efficacy or toxicity would apply to either enantiomer of any particular racemate. It is now known, of course, that one of the enantiomers of PCR 4099 was not only almost completely ineffective but was significantly more toxic than the other. That may have been exorbitant or covetous claiming (cf Mullard Radio Valve Co Ltd v Philco Radio & Television Corporation of Great Britain Ltd [1936] 2 All ER 920, (1936) 53 RPC 323 at 349). No doubt, if only the racemate were claimed, there would be a large risk that this would not protect against competition from a drug with one of the enantiomers as the active ingredient, which might be as efficacious as, and perhaps more efficacious than, the racemate as an active ingredient. The covetous nature of the claim does not advance Sanofi-Aventis' position. The dextro-rotatory enantiomer of PCR 4099 was identified as a compound with useful qualities concerning platelet aggregation. The truth or falsity of the claimed advantage is not relevant for this purpose.
49 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 [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) 123 CLR 529; CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (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.
50 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.
51 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."
52 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 Ltdv 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.]
53 The source, Flour Oxidizing Co Ltdv 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.
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.
55 The first case to which I have referred that suggested that disclosure of a chemical compound by formula was not disclosure for the purposes of anticipation was the decision of Falconer J in Re Genentech Inc's (Human Growth Hormone) Patent [1989] RPC 613, in which it was held that, for a disclosure of a chemical compound in a prior document to anticipate a later claim to that compound, the cited document must contain sufficient directions to enable the compound to be made ([1989] RPC at 629-635).
56 Asahi Kasei Kogyo KK's Application[1991] RPC 485 concerned the 1977 United Kingdom Act. Counsel for the Comptroller of Patents neatly, and, in my opinion correctly, summed up the law as it previously stood in the following way ([1991] RPC at 520):
"Novelty is a fundamental of patent law. Prior to the Act of 1977 it was settled law in the U.K. that "if the prior inventor's publication contains a clear description of, or clear instruction to do or make, something that would infringe that patentee's claim if carried out after the grant of the patentee's patent, that patentee's claim will have been shown to lack the necessary novelty", see: General Tire v. Firestone [1972] R.P.C. 457 at p 485. Accordingly under the Act of 1949 a claim to a chemical compound has been held to be anticipated by a statement that it has been prepared (Gyogyszeripari [1958] R.P.C. 51) or with a method for preparation which does not work (SKF [1968] R.P.C. 415). The latter cases were consistent with General Tire being instances where the prior documentation contained a description of the invention."
The House of Lords upheld the contrary view of Falconer J in Re Genentech Inc's (Human Growth Hormone) Patent [1989] RPC 613. The 1977 Act, in s 2(2), included the words "made available to the public". Counsel in Asahi [1991] RPC 485 suggested this may have made a difference to the test. Falconer J's reasoning did not appear to depend upon that distinction, although he did refer to a decision of the Technical Board of Appeal of the European Patent Office supporting his position. Falconer J expressly declined to follow decisions of the Patents Appeal Tribunal in Gyogyszeripara Kurato Interzet's Application [1958] RPC 51 and Smith Kline & French Laboratories' Application [1968] RPC 415 and the established practice of the Comptroller. Counsel for the petitioner for revocation in that case submitted that this was a departure from the long standing law in the United Kingdom as to anticipation and I agree with that submission.
57 Lord Hoffman's speech in SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323 spells out the current United Kingdom position with clarity. Under the 1977 United Kingdom Act "disclosure" and "enablement" are separate concepts and are cumulative requirements for anticipation, although there may be circumstances where disclosure will also satisfy enablement. In my opinion, at least in relation to product claims and claims for chemical compounds by formula, this is a departure from the law of Australia and from English law as it was applied up to 1977. I would respectfully suggest that it creates an anomalous relationship between anticipation and infringement.
58 In the present case, the earlier patent gave Sanofi-Aventis a monopoly in relation to the making and using of PCR 4099 and its enantiomers, together or separate, even though there was no description of a method of resolving the enantiomers.
59 I venture the view that the claimed symmetry between the disclosure requirements for validity of the earlier patent and disclosure for anticipation purposes does not exist or is anomalous in the case of a chemical compound described (adequately) by formula.
60 Nonetheless, Lord Hoffman's speech is useful in other respects. So far as the immediate point is concerned, in dealing with disclosure, he said (SmithKline Beecham (Paroxetine Methanesulfonate) Patent [2006] RPC 323 at 337, [34]-[35]):
"Did the Synthon application disclose an invention which, if performed, would infringe the SB patent? Because it covered a class of chemicals defined by reference to a formula, it disclosed a myriad of compounds, each of which may be regarded as an invention. But that does not matter if one of those inventions was the crystalline PMS claimed in the patent.
There seems to me no doubt that the application disclosed the existence of PMS crystals of 98 per cent purity and claimed that they could be made. Whether in fact they could be made is the question of enablement which I shall come to in a moment. But their existence and their advantages for pharmaceutical use were clearly disclosed in the application. And on the basis of the judge's finding of monomorphism, a PMS crystal of 98 per cent purity must necessarily have all the characteristics of the crystals claimed in the patent, including the IR and XRD spectra."
At 334 ([22]) he said:
"It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so."
Then, at 336 ([32]):
"In the case of disclosure, when the matter relied upon as prior art consists (as in this case) of a written description, the skilled person is taken to be trying to understand what the author of the description meant. His common general knowledge forms the background to an exercise in construction of the kind recently discussed by this House in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] R.P.C. 9. And of course the patent itself must be construed on similar principles. But once the meanings of the prior disclosure and the patent have been determined, the disclosure is either of an invention which, if performed, would infringe the patent, or it is not. The person skilled in the art has no further part to play."
61 The applicants contend that, in any event, the methods of resolving the enantiomers were part of the common knowledge of skilled persons in Australia at the priority date and would be applied as a matter of routine.
62 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) 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 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) 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.
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 [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."
65 In other words, examples are used to show the utility of the invention as a whole by providing a basis for generalising from them to the balance of the class claimed. The invention of the French and corresponding patents is not described by reference to a particular result as to efficacy or toxicity and the claims are not so limited. In my opinion, it is clear that the formula of PCR 4099 was expressly disclosed as having the claimed advantage and that the same claim was made in relation to each enantiomer. The same can be said of each of the specific examples.
66 The patent in suit identifies the dextro-rotatory enantiomer of example 1 as having all of the activity and the levo-rotatory enantiomer none, with efficacy at least as good as the racemate but less toxicity than the racemate. However, the dextro-rotatory enantiomer of PCR 4099 was clearly enough within the compounds claimed by the French and corresponding patents as having the beneficial effect illustrated by the result of testing of PCR 4099 and the other examples. That disclosure anticipates claim 1 of the patent in suit unless it can be viewed as a selection patent - a somewhat controversial topic. Before considering it, I should digress to some other authorities concerning racemates, including the two recent cases to which I referred earlier.
67 Lindgren J dealt with a somewhat similar situation in Alphapharm [2008] FCA 559 although, in that case, there was no express reference to, or claim to, the enantiomers of the racemate in the alleged anticipation. His Honour had construed the relevant claims of the patent in suit as relating only to the (+)- or dextro-rotatory enantiomer of citalopram, having a separate existence, not being an indistinguishable part of the unresolved racemate. His reasoning included the following (Alphapharm [2008] FCA 559 at [118]-[119]):
"The only context that I take into account in arriving at this conclusion is that it was part of common general knowledge: