Case: Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC [2008] FCAFC 82
Outcome: followed
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: &#8226; there must be some substantial advantage to be secured by the use of the selected members; &#8226; the whole of the selected members must possess the advantage in question; &#8226; 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 &#8226; 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 &amp; 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] : "&#8226; there must be some substantial advantage to be secured by the use of the selected members; &#8226; the whole of the selected members must possess the advantage in question; &#8226; 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 &#8226; 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]).