Case: Merck &amp; Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91 ; (2006) 154 FCR 31
Outcome: cited
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 &amp; 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 &amp; Co Inc [2006] FCAFC 91 ; 154 FCR 31 at [20] [75] (cf at first instance Arrow Pharmaceuticals Ltd v Merck &amp; 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 &amp; 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 &amp; 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.