A number of key points arising from the recent AstraZeneca AB v Apotex Pty Ltd  FCAFC 99 decision have broad implications for the assessment of invention step under the Patents Act (1990).
The prior art base for inventive step cannot be enlarged by reference to the patent document in consideration.
The problem-solution approach to inventive step can only start from a problem that is known from the prior art.
An admission in a specification that something is common general knowledge or known from the prior art is not sufficient in itself to establish that this is the case, appropriate evidence is required.
Overall, it appears that this decision has lowered the bar when it comes to an assessment of inventive step. It seems that it is inappropriate to rely on problem outlined in specification unless it can be demonstrated that the problem is known from the prior art. We expect that this will make it difficult for examiners to maintain an inventive step objection, particularly it can be argued that the selection of a prior art problem is arrived at with an ex post facto analysis of the application in question and the solution provided.
Ultimately, this decision represents a divergence in the assessment of inventive step in Australia from the typical problem-solution approach commonly used by the European patent office.
So what is the approach to inventive step?
An appeal was brought before the Full Federal Court to consider, inter alia, the starting point for inventive step. The AstraZeneca AB v Apotex Pty Ltd  FCAFC 99 decision is the first time the Full Federal Court has considered the issue of the starting point for an assessment of inventive step under the Patents Act (1990)1.
A key issue considered in this appeal was whether a valid patent may be obtained under the Patents Act (1990) for an invention where the solution is obvious, but where the problem is neither common general knowledge (i.e. s7(2) of the Act) nor prior art information for the purpose of an inventive step assessment (i.e. s7(3) of the Act). A subsidiary issue was the impact of an admission that a feature was common general knowledge.
The prior art base for inventive step
In approaching this issue, the Court considered the scope of s7(2) and 7(3) and what information is included under these provisions, and stated that:
“…it is apparent that the relevant provisions of the Act do not expressly or impliedly contemplate that the body of knowledge and information against which the question whether or not an invention, so far as claimed, involves an inventive step is to be determined may be enlarged by reference to the inventor’s (or patent applicant’s) description in the complete specification of the invention including, in particular, any problem that the invention is explicitly or implicitly directed at solving.2”
The Court goes on to state that:
“If the problem addressed by a patent specification is itself common general knowledge, or if knowledge of the problem is s 7(3) information, then such knowledge or information will be attributed to the hypothetical person skilled in the art for the purpose of assessing obviousness. But if the problem cannot be attributed to the hypothetical person skilled in the art in either of these ways then it is not permissible to attribute a knowledge of the problem on the basis of the inventor’s “starting point” such as might be gleaned from a reading of the complete specification as a whole.3”
Thus in adopting a problem-solution approach to assess inventive step, it must first be demonstrated that the problem is either part of the common general knowledge, or a problem that has been identified in a prior art document. The Judgement is clear in that enlarging the prior art base by incorporating information disclosed in the patent application in question is not allowable under the Act.
Furthermore the Full Court comments that:
- the inventor’s starting point as ascertained from the complete specification may not be one that would suggest itself to the skilled addressee4,
- there is no specific requirement that the route travelled by the inventor to the invention is described5,
- there may be a number of potential ways of formulating a problem disclosed in a single patent application some of which give rise to valid claims and others invalid claims, but the validity of the claims should not turn on distinctions of this kind unless they are reflected in the claims6.
An admission in a specification and implications for inventive step
A subsidiary issue addressed in this decision is the relevance of an admission that a feature may be part of the common general knowledge, and whether such an admission could be relied upon as evidence that such a feature is part of the common general knowledge.
In many cases, the background section of a patent document references other prior art documents and discusses shortcomings with previous inventions, and may even identify a problem that the present inventor is attempting to overcome.
In this appeal, the Court considered whether it was permissible to take the problem identified in the specification and use that as a starting point for inventive step, the Court stated:
“It is true the contents of the complete specification may have an evidentiary significance, for example, as an admission (see Doric No 2 at  to ), which might lead to a finding that a piece of information referred to is common general knowledge or s 7(3) information. But that is quite different to supplementing the knowledge and information available for the purposes of s 7(2) with any knowledge or information that is, ex hypothesi, not common general knowledge and not s7(3) information.7”
Therefore, it seems that the use of the problem-solution approach first requires that appropriate evidence is provided that the problem identified in the specification is known to the skilled person.