21 August 2012

Patent Office Allows Declaratory Evidence in Re-examination

Alza Corporation [2012] APO 70 (21 June 2012)

Re-examination – lack of novelty – inherency – role of expert evidence

Nicotine PatchBack in February we wrote about the available avenues to challenge a granted Australian patent – requesting re-examination by the Patent Office, and/or commencing revocation proceedings in the Federal Court of Australia (see Attacking Australian Patents – Re-examination & Revocation).

Re-examination is by far the cheaper, faster and less complex option, and in principle it allows the party requesting re-examination to remain anonymous.  However, it has a number of drawbacks, one of which is that re-examination can be based only upon documentary prior art, and not upon prior art information made available only through the doing of an act, i.e. prior use.  Most practitioners would conclude that this limitation prevents the decision maker from considering material other than documents published before the priority date of the patent claims, and in particular that the written or verbal testimony of witnesses would be excluded.

It is therefore interesting that a recent decision of the Australian Patent Office appears to have opened the door to allowing declaratory or affidavit evidence, e.g. of a suitably-qualified expert, to be considered in re-examination proceedings, at least so long as it is ‘primary’ evidence which is pertinent to the matters under consideration.

While the evidence in question concerned the proper interpretation of a prior art document for the purpose of establishing whether or not certain patent claims were novel, there does not appear to be any reason why the same principles would not apply to expert evidence in relation to whether or not a claimed invention involves an inventive step.  Loath as we are to utter the words ‘floodgates’ or ‘slippery slope’, we wonder whether this might lead to re-examination becoming a form of ex parte ‘mini-opposition’?


Alza Corporation is the patentee in respect of Australian patent no. 774594, which relates to semi-transparent nicotine transdermal patches, such as are used to assist smokers in quitting the habit.  In particular, claim 1 of the patent recites a transdermal nicotine patch having ‘an opacity index of less than 48.6% so as to permit the natural skin colour of the subject to whom the device is applied to be visible through said device, while substantially preventing degradation of nicotine on exposure of the device to light.’

The patent has an earliest priority date of 18 December 1998.

A request for re-examination was filed by LTS Lohman Therapie-Systeme AG (‘Lohman’).  The request identified two documents alleged to be relevant to novelty and inventive step.

Three adverse re-examination reports were issued, the last of which indicated that since various objections had not been overcome, the best way to progress the re-examination was by way of a hearing.  The matter was heard in Canberra on 29 March 2012, with the patentee appearing by telephone.

In addition to the two prior art documents, Lohman submitted a declaration from an expert witness, Dr Mohammad Sameti, who had conducted an experiment to reproduce a transdermal patch according to the directions provided in one of the two prior art documents.  The objective of the experiment was to determine whether the resulting device would have ‘an opacity index of less than 48.6%’ as claimed in the patent, since the opacity/transparency of the patch was not apparent from reading the prior art document.

The experiments established that the patch produced by Dr Sameti indeed had ‘an opacity index of less than 48.6%’ .


Section 98 of the Patents Act 1990 provides that:

(1) On re-examining a complete specification, the Commissioner must ascertain and report whether, to the best of his or her knowledge, the invention, so far as claimed in any claim and when compared with the prior art base as it existed before the priority date of that claim:
(a) is not novel; and
(b) does not involve an inventive step.

(2) For the purposes of subsection (1), the prior art base is to be taken not to include information made publicly available only through the doing of an act (whether in or out of the patent area).

Subsection (1) limits the grounds of re-examination to those based on prior art (i.e. lack of novelty and/or inventive step), while subsection (2) essentially restricts the prior art which can be relied upon to public documents, even though prior public use or sale are equally grounds of invalidity in a revocation action before the Federal Court.

The law regarding the assessment of novelty is conveniently summarised by Justice Annabelle ‘Apple/Samsung’ Bennett in Danisco A/S v Novozymers A/S (No 2) [2011] FCA 282, at [248] (citations omitted, emphasis added):

A claimed invention is deprived of novelty if it has been given to the public prior to the priority date. One way of this occurring is if a product or a process has been prior used. Another is if information that equates to the claimed invention has been published. To constitute an anticipation, a prior publication must, before the priority date of the claims of the patent, disclose all of the integers of the claimed invention. There are, however, circumstances in which a prior publication does not expressly make that complete disclosure but still deprives the subsequently claimed invention of novelty…. One example is where the skilled reader understands the disclosures of the prior publication to include a missing integer. Another is where the prior publication contains a direction to use a process that inevitably or inexorably results in something within a claim

It is therefore possible that even if a prior publication does not expressly disclose some feature or characteristic of a product, it may nonetheless effectively ‘disclose’ the product if, by following the published directions, a skilled person would inevitably produce something having that feature or characteristic.

This is the closest that the Australian law comes to a ‘doctrine of inherency’.


Alza (the patentee) argued that Lohman was ‘not entitled to provide any material other than documents that it asserts show a lack of novelty or inventive step’ (and by extension, the Hearing Officer was not entitled to consider the Sameti declaration).  It relied on Capral Aluminium Ltd v G&J Koutsoukos Holdings Pty Ltd [2004] FCA 1199, in which the court directed the Patent Office to re-examine a patent, but refused to order that the Commissioner consider material from the file wrapper of a US application, on the basis that (paragraph [9]):

…the Commissioner should consider issues of validity by reference to primary material and not additional material which might indicate the views others took in broadly analogous circumstances.

The Hearing Officer readily dismissed this objection.  At paragraph [4] he cited Commissioner of Patents v Emperor Sports Pty Ltd [2006] FCAFC 26 (at [493]):

The Commissioner is an administrative decision-maker equipped with technical expertise. Subject to the rules of natural justice both common law and statutory …, he or she is entitled to make use of that expertise, and draw inferences that may be rationally drawn from technical knowledge, including how skilled persons of various descriptions may act in their respective occupations…

With regard to the Capral decision, he concluded (at [6]):

The file wrapper shows what another Patent Office did in similar circumstances, and represents an opinion and not primary evidence. The declaration in the present case is clearly evidence. It is consistent with the decision in Capral for me to have regard to the declaration, and give it consideration according to its relevance.

Ultimately, the Hearing Officer concluded (at [41])that:

It is clear that the results obtained by Dr Sameti are highly relevant. The results provide a sound basis to conclude that the device [produced by following a specific example in the prior art] has an opacity index of 0%.

As a result, all of Alza’s claims limited only by a maximum opacity index were found to lack novelty.


Based on this decision, so long as the fundamental grounds for re-examination are a lack of novelty and/or inventive step, a decision maker (the Commissioner, or a delegate such as an examiner or hearing officer) is entitled to consider any additional evidence that may be available, to the extent that it is relevant to determining questions of fact.

In this case, expert evidence was supplied to address the question of what would ‘inevitably or inexorably’ result from following specific directions in a prior art publication.  This evidence was considered to be ‘highly relevant’, and no doubt strongly influenced the decision.

On the basis of this approach, there would seem to be no barrier to presenting expert evidence in a re-examination request that is relevant to other legitimate issues.  This could include evidence of common general knowledge, and/or routine procedures in a particular field of endeavour, which may be pertinent to the question of whether a claimed invention involves an inventive step.

The absence of such evidence is often fatal to re-examination requests which are based on anything other than a clear lack of novelty on the face of the prior art.  It will be interesting to see whether the Alza decision results in an increase in re-examination requests accompanied by pertinent evidence to support the asserted grounds of invalidity.  If so, then re-examination – in terms of cost and complexity – would move a step closer to being a form of ‘poor man’s opposition’!
The author, Dr Mark Summerfield, is employed by the patent attorney firm within Watermark Intellectual Asset Management.  Lohman was represented in relation to the re-examination request by Watermark, which took no part in the hearing due to the ex parte nature of re-examination proceedings.  The author has had no direct involvement in the matter, and this article is based wholly upon the content of the published decision of the Australian Patent Office.  The views expressed in this article are independent and solely those of the author. (Also see our 'About' page.)


Mark said...

To the best of my knowledge, evidence of the kind you identify in par. 3 of the conclusion is pretty much mandatory for the reasons you state in par. 4 where the ground of inventive step is in play. This has been happening during re-examination (i.e. such evidence accepted by the APO) for at least 10 years, including declaratory evidence by and/or in support of inventors to rebut mere speculative assertions made in relation to the "common general knowledge".

Patentology (Mark Summerfield) said...

Thank you for your comment, Mark -- that is very interesting.

Most practitioners I know are highly sceptical of the value of re-examination, because of the poor chance of success in the absence of clearly anticipating prior art.

Are you aware of any cases where re-examination has been successful on grounds of lack of inventive step, due to evidence? I would be very interested to look at the details.


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