One of the critical tests for whether or not a patent’s claims are valid is the test of whether the claims each include an ‘inventive step’. An inventive step requires a material new idea, feature, or process that would not have been an obvious next step from what had gone before. An important recent case in the Australian Federal Court addressed a critical question in how to decide what constitutes an inventive step.
It is generally the mark of a significant case when an expanded panel of five judges hears a matter in the Full Court of the Australian Federal Court rather than the usual three judge panel. The recent ‘Crestor decision’ (AstraZeneca AB v Apotex Pty Ltd  FCAFC 99) is no exception, addressing the important issues of novelty, inventive step, fair basis, entitlement and others. The most interesting question that the case examined was how to assess the existing level of knowledge in the field covered by the patent, and therefore how significant a new development in that field would need to be in order to be called ‘an inventive step’. This has important implications for those seeking to assess whether an invention is likely to be patentable, and what features to include in a patent’s claims.
Crestor is the market name for the drug Rosuvastatin which is a member of the statin group of drugs used widely in the treatment of hypercholesterolemia. It provides significant revenue for AstraZeneca as the only manufacturer of the drug in Australia. Although AstraZeneca holds no patent on Rosuvastatin itself it has, to date, been protected from generic competition in Australia by an interlocutory injunction pending a decision around two related patents they do hold. The first (referred to in the decision as the ‘low dose patent’) covers the use of Rosuvastatin to treat hypercholesterolemia with a certain dosage regime. The second (referred to in the decision as the ‘cation patent’) relates to a pharmaceutical composition comprising Rosuvastatin with certain inorganic salts purported to improve stability and lower the rate of degradation.
The Full Court decision was an appeal from the decision of a single judge. On the question of how to decide what the existing level of knowledge in a field is – the ‘starting point’ – the single judge had relied on an earlier Full Federal Court decision (Apotex Pty Ltd v Sanofi-Aventis  FCAFC 134 ‘the Sanofi decision’) as being influential.
The ‘Starting Point’
The starting point issue revolved around what information the Court could, and should, pay heed to when deciding whether or not a claim of a patent is obvious. In particular, the Court addressed whether the information provided in the patent specification itself, describing the existing situation and the problem the invention sought to solve, should be taken into account in assessing the right starting point.
The single judge answered this in the positive. He therefore used information in the patent specification – that Rosuvastatin was an existing drug that was known by the inventors to treat hypercholesterolemia – to find that simply developing different dosages of the drug was obvious and not an inventive step, even though Rosuvastatin was not thought to form part of common general knowledge among skilled people in this field.
In considering this in the Crestor decision the Full Court noted that “It is the claim which must be the primary point of reference for any exercise by way of identification (or characterisation) of the invention” and that, in Australia, “whether a claim of a patent is invalid for lack of inventive step is determined by comparing the invention…as claimed…against the common general knowledge” and any prior art information. The Court came to the conclusion that “the relevant provisions of the Act do not expressly or impliedly contemplate that the body of knowledge and information…may be enlarged by reference to the inventor’s…description in the complete specification”.
The Court noted that an approach which effectively relied on the skill of the patent’s draftsman in their choice of how to describe the existing knowledge base, could not be relied upon as an objective basis for determination of inventive step. A further point was that information discussed in the specification as forming part of the problem addressed by the invention may not (as in this case) be part of the prior art base or the common general knowledge of a person of skill in the art. It would therefore seem strange to rely on this knowledge, at least in part, as a component of an obviousness argument.
The Court noted that the approach taken in the Sanofi case “gives rise to the possibility that a claim for an invention by one inventor might be invalid as lacking an inventive step while a claim by a different inventor might still be valid” this would be even if the claims were written in the same words and had the same priority date etc. The Court expressed the clear view that this could not be a proper approach under the Patents Act applying to the low dose and cation patents.
While the Court recommended a different approach on inventive step from that taken by the single judge, the overall outcome of the case was no better for AstraZeneca, and for other reasons both the low dose and cation patent were invalidated by the Full Court. The only option left now to AstraZeneca to keep generic competition at bay is to appeal the case to the High Court.
This decision would appear to encourage a sensible approach to assessing inventive step which is objective and consistent with the language of the legislation. The comments of the five judge panel effectively prevent the Federal Court having to take the starting point approach of the Sanofi decision into account in future.
This decision reminds us that when assessing the obviousness of an invention it is the invention as defined by each relevant claim, with all of the elements of each claim taken into account, that delineates the enquiry. Further, the thought processes of the inventors themselves and the level of knowledge possessed by the inventors cannot be part of that assessment, unless that information has itself been shown to form part of the prior art or common general knowledge. In general, the fact that an invention may have been obvious to the person who invented it does not mean that it is obvious to others with the common general knowledge of people skilled in that field.
As such it reconfirms that in deciding whether it might be possible to protect an idea, potential patent applicants should consider not whether their new invention was obvious to them, but whether it would have been obvious to other people who are skilled in their field. If you have trade secrets and confidential information, not available to others, that leads your organisation to a useful new innovation, even if it seems like an obvious development, it may be possible to protect the innovation with a patent.