Case: Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 ; (2002) 212 CLR 411
Outcome: cited
At the outset, it is necessary to describe the attributes of the skilled addressee and the relevant patent area. The skilled addressee is a legal construct and is assumed to be a person, or team, who is "not 'particularly imaginative or inventive'": Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [288] per French and Lindgren JJ. This does not mean that the addressee is a technician or person with only practical and non-academic qualifications. In fields such as chemistry, the addressee can be a person or group with high level qualifications and a capacity for original research: Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 ; (2002) 212 CLR 411 at [30] . The test formulated by the majority in Alphapharm at [53]-[54] is whether the addressee would directly be led, as a matter of course, to pursue one avenue in the expectation that it may well produce the claimed result. Their Honours referred to the approach taken by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboraties Ltd [1970] RPC 157 at 187-188. His Honour framed the question in terms of whether a notional research group, at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and of the facts of the nature and success of a chemical, would be led directly as a matter of course to try a particular substitution in the expectation that it might well produce a useful alternative to, or better drug than, the existing drug or a body useful for any other purpose. 152 In approaching the question of obviousness, it is necessary to assess the inventiveness of the invention and not simply to examine each integer in isolation. In Alphapharm , the majority said at [58]: "The tracing of a course of action which was complex and detailed, as well as laborious, with a good deal of trial and error, with dead ends and the retracing of steps is not the taking of routine steps to which the hypothetical formulator was taken as a matter of course." This observation is pertinent to the present case. Mere verification or discovery is not an invention. An invention may be made by a brilliant sudden insight or act or by a slow and laborious approach: see In re Farbenindustrie AG's Patents (1930) 47 RPC 289 at 322 per Maugham J. Obviousness is not determined by asking whether a particular avenue of research is worth a try. 179 In addition, Professor Reynolds gave evidence of the lengthy research and experimental process and the detailed steps taken by him over 18 years to arrive at the invention, taking account of different stages and streams of research in relation to the formation of complexes at various pH values to increase the yield, the extensive trial and error involved and the consideration of documents teaching away from the invention. These elements are important considerations in relation to the question of obviousness: see Alphapharm at [53]. 180 Dr Mackinlay was asked by NSI to describe, by way of a hypothetical research project ("the HRP"), how he would have gone about developing a chemical entity that would take advantage of the interaction between casein and calcium phosphate and have the maximum amount of calcium phosphate bound. This was based on the assumption that it was part of the common general knowledge that calcium phosphate binds to casein. 181 The University levelled several criticisms at the HRP. First, the University submitted that Dr Mackinlay's opinion was affected by hindsight. Secondly, it contended that the HRP assumed part of the inventive process. Thirdly, it was submitted that Dr Mackinlay proceeded on the wrong test of obviousness by having regard to whether "straightforward" or "routine" steps could be taken to make the invention. 184 In relation to the second issue it can be seen from the parameters of the HRP that it assumes part of the inventive process, namely, the recognition of a desirable outcome. The desirable outcome was an advanced treatment for dental caries using calcium phosphate and casein. The University submits that, because of this assumption, the HRP lacked a "context", in the sense that the end goal was a given. The University also refers to the approach outlined by the High Court in Alphapharm at [53]. In this case, the High Court stated that the question is whether the person or group would be led directly as a matter of course to try the claimed invention in the expectation that it might well produce a useful result. This indicates the importance of context in providing a useful result. The research is then evaluated in the light of a given purpose, result or direction. Dr McKinnon said that he would want to know about the purpose or context of a HRP before embarking on it. He said that, without this information, he would not have embarked on the HRP engaged in by Dr Mackinlay because it lacked direction and definition. 185 In relation to the third issue, the University submits that Dr Mackinlay proceeded on the basis that the making of adjustments in relation to pH, temperature, ionisation and concentration were "routine" and that this disclosed an erroneous approach to the question of obviousness. The correct and different test that was accepted in Alphapharm at [53] is whether a person would be led directly, as a matter of course, to try the claimed invention in the expectation that it may well produce a useful or better alternative to the product that existed previously. 186 Finally, it is submitted by the University that the outcome of the HRP does not correspond with the terms of the invention because it does not refer to the form of the amorphous calcium phosphate and omits an important integer of Claim 7. 187 In my view, there is cogency in these submissions by the University and I accept them. I do not give any significant weight to the HRP on the question of obviousness.