Case: Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 ; (1981) 148 CLR 262
Outcome: discussed
An inventive step does not require any particular process of invention such as a flash of genius. However, there must be a step from one thing to another. In the case of a seminal invention, it may be from very little to something. The same might be said of any original invention. Where an inventor describes the step by reference to the starting point or base line and an end point or result, it is the inventiveness of that step that is to be judged, not, for example, the inventiveness of the base line or starting point. In making that judgment, the standard test is: "whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not." ( Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 ; (1981) 148 CLR 262 per Aickin J at 286). 109 The applicants submit that it would also be appropriate to inform the skilled addressee of the results of the testing of the formulations of PCR 4099 which had taken place up to November 1985 when the decision was made to attempt to obtain the enantiomers of PCR 4099. In particular, that between 1983 and 1985 there were reports of side effects and, in particular, convulsions and death in some animals. I cannot reconcile that submission with the narrow basis upon which inventive step is being considered. It is also questionable as to whether that would be consistent with the limited use to which evidence of what the inventor knows and does can be put (cf Wellcome Foundation Ltd [1981] HCA 12 ; 148 CLR 262 per Aickin J at 268 288). The patentee chose to omit those matters from the specification. 110 The result which might be described as unexpected in the light of the French specification was not so much the characteristics of the dextro-rotatory enantiomer (which were within the expected broad range) but rather the characteristics of the levo-rotatory enantiomer in particular, that it was inactive. It was common general knowledge among skilled workers in the field in Australia at the priority date that one of the two enantiomers might contain all of the activity. In my opinion, the discovery of that characteristic in this case was not so unexpected as to amount to an inventive step. Therefore, if, contrary to my opinion, claim 1 was novel and if it is to be considered in the light of the complete specification, then it was obvious and did not involve an inventive step. 111 It then becomes necessary to consider claims 2 5, which I do consider novel. The specification in suit refers to the finding of salts among the mineral and organic acid salts of the dextro-rotatory enantiomer, "which crystallize easily, are not hygroscopic and are sufficiently water-soluble as to make their use as active medicinal principals particularly advantageous". Three salts in particular are identified: hydrogen sulfate, the taurocholate and the hydrobromide. The hydrochloride had been identified as of use because it was in powder form. These compounds are the subject of claims 2, 3, 4 and 5. The conversion of the pure enantiomer to any of the salts was not suggested to have any particular difficulties that was described as being achieved "in standard manner" and "by means of standard methods". The specification in suit does not claim any inventive step in the method of obtaining the salts once clopidogrel was known the claims rest on the properties of the salts. Again, the critical issue is the correct starting point. If it is only common general knowledge in Australia at the priority date, then the ground of invalidity must fail, as clopidogrel was not part of that common general knowledge. On the other hand, if the starting point is that which is recounted in the specification of the patent in suit, including the racemic mix PCR 4099 disclosed in the French patent and the dextro-rotatory enantiomer, then there is at least substance in the contention that each of the claims was obvious.