06 September 2015

The ‘Skilled Person’ is a ‘Pale Shadow’ and a ‘Tool’ – Australian High Court Rules on Obviousness

ShadowmanLast week I predicted that the High Court would affirm the finding of five judges of the Federal Court of Australia that AstraZenenca’s patents covering low-dosage forms of the cholesterol-lowering drug marketed as CRESTOR (having the active ingredient rosuvastatin) are invalid on grounds of obviousness.

In the much-anticipated decision in AstraZeneca AB v Apotex Pty Ltd (et al) [2015] HCA 30, five judges of the High Court, in four distinct concurring opinions, have unanimously fulfilled that prediction.  In doing so, they have successfully disappointed anybody who was hoping for some interesting developments in the law of obviousness in Australia, and gladdened the hearts of those who value certainty and stability in the law, notwithstanding that there may be opportunities for improvement.

There were two issues before the High Court.  Firstly there was what I have previously called the ‘selection’ question.  The law applicable to the rosuvastatin patents permits the use of a single prior art document as the basis for assessing obviousness, and has nothing to say about the process by which that document is identified, other than that it must be information that would be ‘ascertained, understood and regarded as relevant’.  The High Court has confirmed that the fact that a selected document might be just one of many that would meet this requirement, and that all of the others would result in the skilled person heading off down a different path, does not expressly enter into the inquiry.  As a result, the Federal Court panel was correct in finding the rosuvastatin low-dose patents invalid for obviousness.

Secondly, there was the ‘starting point’ question, which addresses whether the perspective from which the contribution of the invention should be viewed is that of the inventor, as stated in the patent specification, or some other perspective determined on the basis of evidence and/or the prior art.  This was potentially the more interesting and controversial issue, because there have (arguably) been inconsistent findings on this question at the Federal Court level.  The High Court dodged the issue, by finding it unnecessary to address the ‘starting point’ question in view of its finding on the first question.  As a result, the decision of the Federal Court panel, that the starting point is determined objectively, and not from the subjective position of the inventor, remains undisturbed.

In an effort, perhaps, to keep things interesting, Chief Justice French provided some additional characterisation of the ‘person skilled in the relevant art’.  While it is not news that this is not a real person, but rather a hypothetical construct created for the purposes of patent law, we can now add to the list of dehumanising qualities that he or she is but a ‘pale shadow of a real person’ and a ‘tool of analysis’!

Answering the ‘Selection’ Question

The ‘selection’ question comes down to the distinct roles of subsections 7(2) and 7(3) of the Patents Act 1990.  While section 7 has been amended since AstraZeneca’s patents were filed, the general role of its various subsections remains the same.  Subsection 7(2) says that an invention involves an inventive step unless it would be obvious to a skilled person based on common general knowledge, and any additional information as mentioned in subsection 7(3).

The role of subsection 7(3) is thus to identify the sources of information which can be ‘added’ to common general knowledge for the purposes of the obviousness analysis of s 7(2).  On the face of it, information is either ‘in’ under s 7(3), or it is not.  AstraZeneca argued, in effect, that the process by which candidate sources of information would be evaluated and selected (or not) should be taken into account.  In particular, it argued that an impermissible ‘combination’ of documents was involved in comparing various items of information in order to identify just one as being the best basis for making progress towards the claimed invention.

All of the High Court judges disagreed with this proposition.

Chief Justice French said (at [22]):

The relevance requirement is a threshold criterion for consideration, by the court, of a prior art publication in conjunction with common general knowledge for the purpose of determining obviousness. The process leading to its identification plays no role in that determination.

Justice Kiefel stated (at [85]):

AstraZeneca's submissions elide the stipulations of ss 7(2) and 7(3), when the purposes of those sub-sections are quite distinct. The purpose of s 7(3) is to identify documents which may be used for the s 7(2) question of obviousness. The sub-section does so by reference to attributes of a document and the information contained in it, as seen through the eyes of the skilled person. So long as the information in the document has those attributes stipulated by s 7(3) it may be used for the purposes of the enquiry under s 7(2).

Justices Gageler and Keane explained (at [115]):

Section 7(2) does not contemplate that a choice between apparently effective solutions must be attributed to the notional skilled addressee, much less that the notional skilled addressee might be so befuddled by an embarrassment of choices as to cease pursuit of the solution.

Finally, Justice Nettle wrote a short opinion, substantially concurring with French CJ and Kiefel J, in which he stated (at [120]):

As French CJ and Kiefel J conclude, there is nothing in ss 7(2) or 7(3) which precludes the person skilled in the art from looking at more than one document (whether sequentially or comparatively or otherwise) for the purposes of determining the relevance of any single document.

I conclude from this that there is no ‘filter’ in s 7(3), and that any item of prior art information that meets its plain requirements (as amended from time-to-time) is ‘in the mix’ for the purpose of assessing obviousness.  The process by which information might be identified and selected in any particular case is irrelevant.  All of the ‘work’ as to whether information falling within the terms of s 7(3) establishes obviousness is done by s 7(2).

Why Did the High Court Even Take On This Appeal?

The High Court’s affirmation of the Full Federal Court is so routine and categorical, I was caused to wonder why it had even granted special leave for AstraZenenca to appeal.  Fortunately, Justices Gageler and Keane took the time to explain (at [98]):

In this case, special leave to appeal was granted principally to allow this Court to address difficulties said to attend the interpretation of s 7(2) and (3) of the Patents Act 1990 (Cth). The arguments advanced by AstraZeneca on these issues in this Court were without substance; they were also distinctly elusive in their presentation. The shifts which occurred in AstraZeneca's position during the course of argument should not be allowed to obscure the reality that these provisions give rise to no difficulties of interpretation material to the outcome of this case.

In other words, AstraZeneca stands accused (by these two judges, at least) of having virtually ‘tricked’ the Court into believing that there was some important question of statutory construction requiring resolution when, in fact, it was all just smoke and mirrors. 

I think that this is a little harsh.  As I wrote in my previous article, I consider that there would be some merit to a ‘purposive’ view of the law on obviousness that allows more scope to consider evidence of the actual processes of innovation in the relevant field of endeavour.  After all, the primary purpose of requiring an ‘inventive step’ is to ensure that patents are granted for meritorious advances in the art, while being denied for developments that are merely routine, requiring no special skill or effort.

A ‘Pale Shadow’ and a ‘Tool’

The approach to assessing obviousness – and in particular to establishing the relevant prior art against which the assessment is made – is rigidly circumscribed by the terms of section 7 of the Australian Patents Act 1990.  I have written on a number of previous occasions about the problems with this statutory provision, most recently in Can the High Court Fix Australia’s Obviousness Problem?  (The short answer, it seems, is ‘no’.)  In other jurisdictions, the obviousness inquiry is generally more fluid, and allows decision-makers substantially free rein to assess whether an invention is obvious or inventive based upon whatever evidence may be available in relation to the state of the art, and common knowledge and practice of skilled workers in the field.

The High Court has confirmed that this is not the case in Australia.  The law (as considered in the AstraZeneca case, and as it now stands following the Raising the Bar reforms in 2013) provides for obviousness to be assessed in relation to a single piece of prior art information.  (It now also provides for combination of sources of information, but the ‘single piece’ also remains as a stand-alone provision.) 

What the High Court has said, in rejecting AstraZeneca’s arguments on the ‘selection’ question, is that the existence of a relevantly-available document that shows an invention to be obvious is sufficient to invalidate a claim.  This is so even if there are numerous other sources of information that might lead the skilled worker in different directions in search of a solution or a way forward.  Any skill or judgment that might be involved in selecting a particular source of information as a basis for proceeding towards the invention is irrelevant: the document exists; it is available; that is enough.

Of course, this is not how things work in the real world.  However, as Chief Justice French has explained (at [23]), the skilled person who provides the standard for assessing inventive step in the patent law does not live in the real world:

There was a tendency in AstraZeneca's arguments to confer upon the "person skilled in the relevant art" more human characteristics of volitional and purposive action than are necessary for its function. The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person — a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.

So there you have it: a pale shadow and a tool of analysis.  It is just as well this is not a real person – their feelings would no doubt be terribly hurt!

Conclusion – Continuing Relevance, Despite Amendments

As I have mentioned already, section 7 has been amended (more than once, as it happens) since AstraZeneca’s rosuvastatin low-dose patents were filed.  In particular, the law as it applies to this case does not permit combining information from multiple prior art documents, and expressly requires that a s 7(3) document be ‘ascertained, understood and regarded as relevant’ by the skilled person.  These restrictions have since been removed.

However, the division of ‘labour’ between the obviousness enquiry in s 7(2), and the identification of relevant prior art information sources in s 7(3), remains.  Thus the High Court’s unanimous ruling that the two subsections have distinct roles that should not be conflated will have continuing relevance, despite the amendments to the Patents Act.

In my opinion, however, this division between identification and use of prior art information, and the explicit role of common general knowledge in s 7(2), is unduly artificial, and continues to distinguish the Australian law of obviousness from the corresponding laws of other major jurisdictions.  I have said it before, and I will no doubt say it again in the future, but I continue to live in hope that the Australian law will one day contain a simple and flexible requirement – that a patentable invention must not be obvious to a skilled person, having regard to the state of the art.


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