The issue of whether an invention claimed in a patent is obvious (occasioning the patent liable to be revoked) was at the core of the High Court decision in Aktiebolaget Hässle v Alphapharm handed down on 12 December 2002. The High Court by majority overturned a unanimous Full Federal Court decision that had upheld the primary judge’s finding that the patent in question was obvious.
The appellants, members of the Astra pharmaceutical group ("Astra"), were the patentee and exclusive licensee of a patent for an oral formulation containing omeprazole, a compound found to be effective in treating stomach ulcers. The patent was granted under the Patents Act 1952, and accordingly that Act applied. The respondent, Alphapharm, distributed generic drugs and wished to import and sell in Australia a generic form of Astra’s patented omeprazole formulation. Astra commenced infringement proceedings against Alphapharm, which by its cross-claim sought revocation of Astra’s patent.
In upholding Astra’s patent, the High Court by majority held that the primary judge and the Full Court had each erred in law in their reasoning leading to the conclusion that the patent was obvious, and had failed fully to appreciate the divergence between Australian and UK case law on the issue of obviousness. In particular:
- the Full Court had asked whether "it would be worthwhile to try each of the integers that was ultimately successfully used" and had concluded that where each of the integers was worthwhile trying, the combination of those integers must be "obvious". This focussed (incorrectly, in the High Court’s opinion) on whether the process of research, as opposed to the end result, was obvious.
- the Full Court had improperly considered whether each integer of the patent was "obvious", rather than looking at whether the combination of integers was "obvious". This focus on each integer went against earlier cases as well as the words of the 1952 Act, which ask whether the invention (as opposed to each separate integer) was obvious.
The above is succinctly put by the majority (Gleeson CJ, Gaudron, Gummow and Hayne JJ) in the following passage in the joint judgment:
"First, the statute does not ask whether a particular avenue of research was obvious to try so that the result claimed therefore is obvious…Paragraph (e) of s 100(1) of the 1952 Act, applied to the present case, asks whether the combination claimed in claim 1 was obvious. The paragraph does not fix upon the direction to be taken in making efforts or attempts to reach that particular solution to the problem identified in the Patent. Nor does it direct an inquiry respecting each integer of the claimed combination. The paragraph asks whether "the invention…as claimed", here the combination, was obvious, not each of its integers."
The correct test in determining whether a patent is obvious, stated the majority, is to ask the question posed by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1070] RPC 157 (conveniently put in general terms by Callinan J):
"Would the notional research group at the relevant date, in all the circumstances …directly be led as a matter of course to try [the invention claimed] in the expectation that it might well produce [a useful desired result]?"
Significant to at least one of the members of the High Court (Callinan J, who agreed with the majority) was the fact that one of Alphapharm’s expert witnesses, who had not been shown the patent, despite having written several reports, was unable to come to the precise formulation claimed in the patent (although it should be noted, as Justice Kirby pointed out, that the expert witness was conducting a hypothetical formulation of the substance, which presented its own difficulties).
Vigorous dissents were given by Justices McHugh and Kirby, both of whom considered that the issue of obviousness was one of fact and was therefore more appropriately to be determined by the trial judge and the Full Court.
The result of this decision is that the test for obviousness propounded by the High Court (at least in relation to the 1952 Act) is harder to satisfy than that stated by the trial judge and the Full Federal Court, and thus not as favourable to parties wishing to cross-claim for revocation on grounds of obviousness.
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