Merck & Co Inc v Arrow Pharmaceuticals Ltd

[2006] HCATrans 616

[2006] HCATrans 616

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
  Sydney  No S244 of 2006

B e t w e e n -

MERCK & CO INC

Applicant

and

ARROW PHARMACEUTICALS LIMITED

Respondent

Application for special leave to appeal

GLEESON CJ
GUMMOW J

TRANSCRIPT OF PROCEEDINGS

AT SYDNEY ON FRIDAY, 10 NOVEMBER 2006, AT 9.34 AM

Copyright in the High Court of Australia

MR J.M. EMMERSON, QC:   If the Court pleases, I appear with my learned friend, MS K.J. HOWARD, SC, for the applicant.  (instructed by Cropper Parkhill)

MR D.K. CATTERNS, QC:   May it please the Court, I appear with my learned friend, MR H.P.T. BEVAN, for the respondent.  (instructed by Baker & McKenzie)

GLEESON CJ:   Yes, Mr Emmerson.

MR EMMERSON:   If the Court pleases, in this case we seek leave to raise the question of whether there is a so‑called threshold test for inventiveness that must be applied by the courts in considering validity of patents, which test is additional to and independent of the test that is laid down by section 7 of the Act.  We say that the result of this so‑called threshold test is that there are two separate and independent tests for invention, one as provided by statute and set out fully in section 7 and the other sections which are referred to there, and that is one in which there is a defined prior art base against which inventive step could be tested and one is told exactly what can be taken into account.

The so‑called threshold test involves, it would appear, a different comparison, though it is not clear precisely how that comparison is to be made.  It includes, at least in the form applied in the Full Court in the present case the possibility that a document which is recited in a specification to be incorporated by reference can be taken as forming part of the basis for comparison against which inventive step is tested.

Now, in our submission, this involves applying a test which is quite inconsistent with the scheme set out under the Act.  It does not require, it would appear, for the base to be part of common general knowledge.  It does not require the base to be something else which may be taken into account pursuant to section 7.  It appears that it can be applied simply on the basis of an incorporation by reference into the specification, regardless of whether that incorporation by reference is properly construed as a statement that this is the common general knowledge in Australia.

This problem arises strikingly in the present case because the two principal pieces of prior art relied upon by the Full Court were not considered by the primary judge at all.  They were not shown to be part of common general knowledge.  They were not shown to be admissible prior art within section 7.  They were simply incorporated by reference in a different context.

The approach of the Full Court is based in part on the decision of the majority of this Court in Philips v Mirabella, though it goes importantly past what was held by that Court.  We seek leave to challenge at both stages, namely, we wish to say that there is no threshold test for inventiveness.  The test for inventiveness is that laid down in the Act specified by section 7 when read with the prior art base.

GUMMOW J:   This Court said in Philips (1995) 183 CLR 665 at 664 was:

apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject . . . is absent –

and that seems to have been interpreted rather differently here where there is the expression “the threshold issue is whether it appears”.

MR EMMERSON:   Yes, your Honour.  Our position is that if quality of inventiveness meant no more than that one must compare what is claimed with what is shown to be part of common general knowledge, then we have no difficulty with it, but the reference to quality of inventiveness appears to have been taken, by the Full Court at least, as incorporating a subjective element, that is to say, one looks to see what the inventor actually did and asked whether, as viewed from the inventor’s perspective, this involved an inventive act or quality of inventiveness.

The notion of what appears on the face of the specification, in our submission, ought not to be treated as being determinative of the issue in any event.  That is a phrase which arose from the decision of this Court in Microcell when a quite different problem was before the Court, namely, that the Commissioner had refused to accept an application for a patent.  The Commissioner refused it on the grounds that if accepted that patent would be invalid and the main argument before the Court was whether that was a correct approach or whether the Commissioner was bound to accept an application even if, having accepted it, it could then have been immediately revoked.

In that context, this Court said clearly this is wrong if you can see on the face of the specification that no valid patent could be granted, but, in our submission, this Court was never laying down a proposition that there was a separate ground of invalidity, namely, whether an invention appeared on the face of the specification.  The question of whether it appeared on the face of the specification then no valid patent could be granted, involved looking at the specification but seeing, in our submission, whether, according to the statutory test, no valid patent could be granted, rather than, as the Full Court approached the matter in this case, asking the question at large whether there is some quality of inventiveness.

So the Full Court relied almost exclusively on two pieces of prior art which were neither of them shown to be part of common general knowledge, they were neither of them shown to be admissible in other ways and they were not even quoted in extenso relevantly in the patent specification.  The patent specification used a form of drafting in which it talked about incorporation by reference, but we would say that the mere fact that a prior document is incorporated by reference into a specification does not mean that it thereby automatically becomes part of the prior art base against which inventive step is tested.

GLEESON CJ:   Does any of this arise unless you succeed on the issue of novelty?

MR EMMERSON:   We have to succeed on both issues, your Honour.

GUMMOW J:   That is what I was going to ask you as well.

MR EMMERSON:   Yes, that is true but, in our submission, not only did the Full Court fall into error on the issue of novelty, but did so on a point of law which, in our submission, it is appropriate for this Court to consider, and that involves really going to the heart of what is the test for want of novelty and whether as approached by this Court it can be dealt with by essentially asking whether all the specific integers in a claim appear expressly in the prior art, or whether, as we would contend, that in order to be novelty defeating, the prior art document must be an enabling disclosure.

Now, that arises clearly in the present case because the particular prior art that is relied upon contains a mere suggestion that further clinical trials should be conducted to test a particular proposition.  That is something which could only be checked by performing various other trials, whether they be animal or human trials.  In the actual case, Merck carried out both animal trials and human trials over three years and at the end of that period of course the product could be put on the market.  But there had to be evidence of both efficacy and safety so that a dose which would be effective for the purposes of treating osteoporosis could also be administered safely.

GUMMOW J:   This product was on the market for some years before.

MR EMMERSON:   It was, yes.

GUMMOW J:   How did it get therapeutic approval if there was a dosage problem with side effects if it was taken on a daily basis?

MR EMMERSON:   Your Honour, simply because it was a very effective drug and although the dosing was extremely inconvenient, as the Court would have said ‑ ‑ ‑

GLEESON CJ:   People were prepared to put up with the gastroenterological problems.

MR EMMERSON:   Precisely, but nevertheless as a treatment for osteoporosis or a method of preventing osteoporosis it was highly effective and so it was used.  But the invention in the present case we say ‑ ‑ ‑

GUMMOW J:   Your invention is said to be an evergreening activity, which is a pejorative expression, I suppose.

MR EMMERSON:   With respect, your Honour, it is just a pejorative expression and it takes the matter no further.  It was a further problem which was solved by my clients.  The anterior problem of course was the use of this particular drug for osteoporosis, but it had these terrible problems.  The problems were overcome by the dosage regimen which is the subject of the claims in the present case.

Now, whatever “evergreening” means –and it appears to be an expression used in the United States and as your Honour Justice Gummow rightly says, with respect, a pejorative use – it simply does not form part of a basis under our law for holding a patent to be invalid.  Indeed, to be fair to the learned primary judge, while he perhaps allowed the concept of evergreening to colour his views on the whole case, he did not go so far as saying this is a separate head of invalidity which has to be added to the other ones.

Now, the other related chain of reasoning coming out of the Microcell Case was that here was a substance that was already known for a use which is involving treating the same disease.  In our submission, that approach has an element of the pea and thimble trick because of course alendronate was known for preventing and treating osteoporosis under the old regime, with all its problems.  What had not been solved were the problems.

Now, when you do solve the problems you are of course still administering the same drug, which is highly efficacious, for the same disease, and we in no sense seek to go away from that.  That was the nature of the problem.  It was a difficult problem.  It was eventually solved by my clients and a patent was granted for it.

But we say again that there is no special reason on the basis of Microcell for saying that any new use for an old substance is unpatentable.  Far from it.  This Court in Microcell itself recognised that there was no rule that any use of an old substance for an analogous purpose was patentable, and said so.  This Court in NRDC in a decision which was handed down very shortly after Microcell made this point expressly.  So we say that, so far as the court relied on the fact that the substance in question was already known for treating the disease in question, that simply leaves out all the relevant content of the invention.

Could I just quickly say that, so far as novelty is concerned, in our submission, the question of enablement is ripe for consideration by the Court.  It has been considered recently by the House of Lords in the Paroxetine Case.  It has been expressly held that there are two tests, a test of disclosure and a test for enablement, both of which must be satisfied by a prior document if it is to be held bad for want of novelty.  We say that this Court ought to look at it because what we have are some cases which perhaps tend to support an enablement test.  Some, especially a number of those grouped together under reverse infringement ‑ ‑ ‑

GUMMOW J:   Do you refer to that decision of Lord Hoffmann’s in your written submissions?

MR EMMERSON:   Yes, we deal with that in paragraph 44 of our written submissions.  I think I referred to it before your Honours just as the Paroxetine Case.

GUMMOW J:   Yes.

MR EMMERSON:   The other issue that we wish to ventilate on the subject of novelty is the question of these documents.  Ordinarily when one talks about something have been prior published, you are talking about a document which is available to members of the public.  In formulating the test under the 1990 Act, the form of words used is “information made publicly available in a document” and “information made publicly available by the doing of an act”, and that is found in the definition section of the Act.

Now, in our submission, before it can be said that something is information made publicly available or information in a document that is publicly available or information made publicly available by the doing of an act, then public availability, we would argue, means what it says.

GUMMOW J:   Now, could you just tell us, am I right in thinking that in the United States your client lost its patent for obviousness in the Court of Appeals of the Federal Circuit.

MR EMMERSON:   Yes, your Honour.  Obviousness of course was ultimately not decided either at first instance here or on appeal.

GUMMOW J:   Yes, I appreciate that.  What is the situation in the United Kingdom?

MR EMMERSON:   The situation in the United Kingdom again is that my clients have failed on obviousness, but they have not failed on novelty, so neither of the two matters that we would seek to bring before this Court are determined.

GUMMOW J:   Is there any point about treatment of the human body in the United Kingdom?

MR EMMERSON:   There is learning about treatment of the human body, but what has happened is that that has been codified ‑ ‑ ‑

GUMMOW J:   Yes, but was that used against you?

MR EMMERSON:   No, I do not think it was.  The claims in the United Kingdom case were drafted in such a way that they did not in terms claim a method of treatment.

GUMMOW J:   Yes, thank you.

MR EMMERSON:   Might I in just one further sentence say we also sought to lay before this Court evidence of the importance of this matter.

GLEESON CJ:   Yes, we have read that, thank you.

MR EMMERSON:   If the Court pleases.

GLEESON CJ:   Yes, Mr Catterns.

MR CATTERNS:   May it please the Court.  As our learned friends recognised, of course, we succeeded on two grounds, each of which would be fatal to the validity of the patent and, as our friends also rightly say, his Honour Justice Gyles put his toe in the water on obviousness but ultimately made no decision on it.  Your Honours, our initial submission is that this is a very clear case of lack of novelty and so the question of the invention or manufacture or the threshold point, as our friends put it, will not arise, but ‑ ‑ ‑

GUMMOW J:   Is there any point that we should look at in this country arising from SmithKline in the United Kingdom, that judgment of Lord Hoffman’s?

MR CATTERNS:   Your Honour, the law of novelty is always interesting, but we submit it has not changed the position since Hill v Evans and the present case - and I was going to embark on that – is a case where the disclosure matches the claims, as was said in Hill v Evans, for the purposes of practical utility, which is just another way of saying enabling disclosure, I submit.  That is where enabling disclosure comes from I think via the United States, but we submit it is still the same test and the question is, are all the integers disclosed in combination of course - and there is no submission made to the contrary of that – with sufficient clarity – and there is no submission made about that.

Then our friends shift to the question of whether or not enabling disclosure means you have to prove it in some way by clinical trials.  Of course, your Honours, the clinical trials on humans that our learned friends refer to, which they needed to get therapeutic approval for the once a week dosage, occurred after the patent.  There is no discussion of clinical trials in the specification.  There is discussion of experiments on dogs, but no clinical trials.  So we submit the question of enabling disclosure just simply does not arise and those disclosures match the claims.

Your Honours, if I may deal with that question first, the claims are in several places, but page 63 of the book.  The claims came from something like 365 down to 10.  The appeal concerned only claims 1, 2 and 3.  A couple of other claims survive which deal with a different drug.  Your Honours can see in claim 4 it is a different drug called risedronate.  The other claims from 5 onwards were composition claims and they are not the subject of the appeal.  Your Honours, there is a difference amongst 1, 2, and 3, and we focused on 3, which is the broadest and also therefore the most commercially significant.  Perhaps if I do them in order.  Your Honours see claim 1 is:

A method of preventing osteoporosis in a human, comprising orally administering to said human a pharmaceutically effective amount comprising about 35mg -

Then the drug is narrowed to alendronate monosodium trihydrate which was our learned friends’ commercial product, sometimes called Fosamax once weekly on a continuous schedule.  The difference between 1 and 2 is that 2 is a method of treating.  The amount is 70 milligrams once weekly.  But 3 rolls in treating or preventing.  Instead of specifying the amount as 35 or 70, it has just said “pharmaceutically effective”, although those words appear in 1 and 2.  Then the salt is broader, “a pharmaceutically acceptable salt of alendronate”, out of a group, sodium, salts, et cetera, once weekly. 

Your Honours, there was some dispute – I will take your Honours quickly to the articles said to anticipate about – because they mention 40 milligrams and 80 milligrams, but it does not any longer seem to be in dispute that as a matter of substance we can treat 40 as equivalent to 35 for the purposes of novelty and 80 as equivalent to 70.  That is derived both from the evidence before his Honour, the trial judge, and also the specification itself.

So our submission is that those three claims are clearly disclosed in the articles.  They are at various places, but most fully in his Honour Justice Gyles’ reasons.  They were called the Lunar News articles, your Honours.  The first is at page 16.  Lunar News was a commercial publication but with scholarly ambitions or pretensions that the author of the articles sold osteoporosis diagnosing equipment, but he wrote scholarly footnoted articles, and your Honours see at page 16 ‑ ‑ ‑

GUMMOW J:   These were relied on in the American case too, I think, for obviousness.

MR CATTERNS:   Yes, your Honour.  Of course that is the difference.  We cannot prove they are common general knowledge here – Astra and MMM - or were not able to.  So your Honours see in that passage a reference to the difficulties with alendronate – “low oral bioavailability”.  The question of gastrointestinal distress is by his Honour the Chief Justice.  Then, your Honours, in bold – sorry, perhaps one line more:

This regime may be difficult for the elderly to maintain chronically.  An intermittent treatment program, (for example, once per week, or one week every three months), with higher oral dosing, needs to be tested.

In a sense, your Honours, our friends’ argument boils down to the fact that that says with appropriate level of caution, “needs to be tested” somehow takes it out of an enabling disclosure.  We submit that is wrong, with respect.  All the integers are there of claim 3 in combination.  It is later that we get the dosage amounts.  So, your Honours, the next one is the July 1996 issue at the bottom of page 17, referring again to alendronate, and at the top of 18 it says it is the “first satisfactory” therapy.  Then at line 20:

The difficulties with oral bisphosphonates –

having referred, I repeat, to alendronate –

may favour their episodic (once/week) –

I skip “cyclical” –

administration.  Even oral alendronate potentially could be given in a 40 or 80 mg dose once/week to avoid dosing problems -

Finally, your Honours, the last article is at 22, paragraph 41, and there is a further discussion, and at about line 45:

In the human, there is little difference between 5 and 10 mg/day of alendronate, so the 10 mg dose theoretically could be given only 3X a week or the 40 mg dose once per week.

There was in fact already a pill in a 40 milligram size used for a different disease called Paget’s Disease, but also relating to bone density.

So, your Honours, we respectfully submit that those disclosures disclose all of the integers in combination, and I do not think our friends disagree with that any more.  So no question of enabling disclosure gets engrafted onto our law whereby these are not sufficiently enthusiastic, nor whereby they convey a sufficient certainty or degree of proof via clinical trials, just as with the patent, for the purposes of practical utility, going back to the 1840s, it suggests taking these things in the relevant doses once a week.  So we respectfully submit that is a clear anticipation.

Your Honours, the other question on novelty is whether or not the articles made publicly available - your Honours, there is a clear finding not challenged that literally 11,000 copies of these articles were sent out around the world and, as your Honours know, around the world is sufficient, but in addition numerous copies were sent in Australia.  In fact the articles were sent to our learned friends’ inventors and the question is, is that made publicly available?

We respectfully submit of course it is in terms of section 7(1) of the Act which now codifies almost literally 400 years of learning since 1623 that something must be new and a single disclosure has always been held to be sufficient if made to somebody free in law and equity to disclose it to the next person, and whether or not it is physically to be found in a library catalogue or a computer search is neither here nor there.  So we respectfully submit that that is a clear anticipation or respectively three clear anticipations, and the patent is plainly bad.

Your Honours, as to the so‑called threshold question –and perhaps on the way, “evergreening” is not our phrase - it was a fashionable phrase at the time because of the amendments related to the Free Trade Agreement Act ‑ ‑ ‑

GUMMOW J:   It was used in the Australian Parliament though.

MR CATTERNS:   Exactly, your Honour, and indeed some tightening of the provisions of the Act came in, particularly in relation to – in the Therapeutic Goods Act.  But of course it is a ground - by section 138 it is a ground of invalidity on which you can revoke a patent in that it is not a patentable invention, and section 18(1) says in the preliminary words – uses the words “an invention is a patentable invention” and that then led the High Court in Philips v Mirabella to the dictionary, the schedule, which takes one back to the Statute of Monopolies ‑ ‑ ‑

GUMMOW J:   This point seems to have started life in Microcell, does it not, as to what the Commissioner could do administratively in a very clear case?

MR CATTERNS:   Exactly, your Honour, and ‑ ‑ ‑

GUMMOW J:   Why achieve a futility by granting something if it is immediately liable to revocation?

MR CATTERNS:   Precisely, your Honour, and I accept that the patents were not examined in those days for obviousness.

GUMMOW J:   Exactly.

MR CATTERNS:    So the ground got invented, as the High Court explains in Microcell, but, your Honour, the next case in the CLRs is the NRDC Case which expressly deals with what one might call two elements of the ground of manufacture.  The first ground which was the decision in that case is whether, to put it crudely, this is the kind of thing which is patentable according to the principles developed in over 350 years; in other words, the herbicide, a method of improving the crops.

Secondly though, their Honours expressly referred to Microcell and the, to use a shorthand, mere new use ground referred to there.  But since then, your Honours, the Act was enacted in 1990, the definition continues to be hearkened back to the Statute of Monopolies and, as your Honours remember, in Ramset – I am skipping Philips – the Court expressly distinguished Philips, some obiter in Philips, on the ground that Philips v Mirabella dealt with the new Act, the 1990 Act, and indeed – and our friends do not dispute this of course – the Philips did consider section 18(1), the preliminary words, and 18(1)(a), “manner of manufacture” and the definition, and applied Microcell on this question of whether the necessary quality of inventiveness ‑ ‑ ‑

GUMMOW J:   What do you say about the affidavit that has been put on as to what appear to be practical difficulties that flow for draftspersons?

MR CATTERNS:   We respectfully criticise the idea that patent attorneys might disclose less than what they ought to have disclosed in a specification, if that is what emerges, but secondly, your Honour, the idea that Australia is in a unique position in patent law has not stopped us from having a unique position with respect to obviousness.  We do have.  The same patent attorney who is advising their client applying for or revoking a patent in Australia must tell them that our law of obviousness is different as to the prior art base because in America and the UK our friends lose easily on obviousness because one of those articles can be taken for granted as a stepping stone.

So you get your one article which section 3 embraces to some extent here but with preconditions, your Honour remember ascertained regarded as understood and regarded as relevant.  So even the extension in our Act of section 7(3) does not broaden the Alphapharm v Astra Case and the MMM Case to the extent that we have the law of the UK and the US has in obviousness, so, your Honour, yes, our law is different.  Those countries each all have a threshold requirement.  They may not have, because they do not need, this particular one of no invention on the face of the specification.  So we respectfully submit nothing turns on that.  The law is slightly different here and patent attorneys have to do their job.

So, your Honours, given that and given the fact that in the Ramset Case recently this Court distinguished Philips but on a particular ground which was where the integer did not appear on the face of the ‑ ‑ ‑

GUMMOW J:   …..it though.

MR CATTERNS:   Yes, your Honour.  So no trouble about that, with respect, but no criticism, we submit, of Philips v Mirabella.  Indeed the passage was cited, the idea of the necessary quality of invention available on the face of the specification.  So, your Honours, then we have a case which we submit is on all fours with Philips except for one thing, which is Justice Gyles did not need to, but the Full Court did, find that the necessary quality of inventiveness was apparently not there on the face of the specification.  The Full Court brought in the documents expressly incorporated by reference, and we would respectfully submit ‑ ‑ ‑

GUMMOW J:   You use this expression “threshold issue”, which is worrying.

MR CATTERNS:   Yes, your Honour, I would prefer to stick to the statutory phrase, whether or not there is a – there is no question that it is a ground of revocation, that it is not a matter of manufacture or an invention as defined in the Act.  Your Honours, we then say that in giving some

content to that, Philips v Mirabella, cited again in Ramset, uses the phrase “the necessary quality of inventiveness not apparent on the face of the specification”.  So it is a case where, when you look on the face of the specification, it is clearly in effect not asserted when it is properly understood to be inventive.

Your Honours, that then takes us down to looking at the facts of the instant case where both courts went through it and said that the patentee in effect does not assert that it is inventive to try this once a week, or it is not clear enough that it is inventive – sorry, it is clear enough that it is not inventive to try this once a week.  The only difference, we submit, in principle between the Full Court and Justice Gyles is the Full Court brought in the documents expressly incorporated by reference, and we submit that cannot be a wrong extension of the principle in Philips v Mirabella.  So, your Honours, we respectfully submit that the patent is clearly bad on the two grounds.  May it please the Court.

GLEESON CJ:   Yes, Mr Emmerson.

MR EMMERSON:   If the Court pleases, in our submission, the objection of want of an inventive step put under the rubric of manner of manufacture is in fact unique to Australia.  It is not something which arises in other jurisdictions or has been considered in other jurisdictions in this case.  It does impose serious difficulties in drafting.

If a patent is drafted in a jurisdiction in which it is required to refer generally to related art and that carries no particular penalties for the draftsman, then we say that it is anomalous if, when a patent so drafted comes here, any reference to another article leads to that article not only being treated as being there for reference but being treated as if it formed the starting point for a test for inventive step.

That has absolutely no parallel in any other country and, in our respectful submission, we say that this is something which should be looked at by this Court and in particular in the form in which it emerged in the decision of the court below in the present case.  That is particularly startling because the Full Court reached its decision without considering any admissible prior art at all.

So far as the question of an enabling disclosure is concerned, precisely the point that we want to deal with is illustrated by my learned friend’s submissions.  My learned friend submitted all the integers were present in the prior art documents, the Lunar News articles; that is sufficient.  We say it is not because that formulation of the test completely obscures the nature of the present invention which is concerned with a dosage regimen.

Now, our analysis of the reason why our learned friend’s submissions are wrong on this point and why the Full Court went wrong on this point is that in each case there was a tendency to tick off integers, are the various integers disclosed in the earlier document, without asking the question whether the document puts the reader in a position where the reader can carry out the invention.  That is what enablement is looking at.  If one looks at the Lunar News articles, they are quoted at the appeal book page 106.  They are all in the form of things needing to be tested and things potentially could be given.

Now, if you get to the point of saying that something needs to be tested, no doubt you are disclosing all the integers in that something, but you are not disclosing the critical point in the present case that then tests are carried out and those tests showed that this combination of integers works.  Anyone can write down a grab bag of list of things that could be tested, and in fact the Lunar News articles mention a whole variety of things that could be tested.  But we say that that does not put the reader in the possession of the invention, so it does not, properly considered, enable the performing of the invention in the sense discussed in the House of Lords in the recent Paroxetine Case.  Our submission is that this is a matter which should also be looked at by this Court.

We also wish to argue that there is a critical difference between the notion of information which has merely been published which appeared under the old Act, and information made publicly available by the doing of an act which is the form of words in our Act.  If the Court pleases.

GLEESON CJ:   Whether a proposal or suggestion for testing amounts to an anticipation is a matter of fact that will turn on particular terms used in different publications.  There are insufficient prospects of success on this proposed ground of appeal to support the grant of special leave.  Without success on this issue, the applicant could not succeed on an appeal.  That conclusion makes it unnecessary to express any view on the use made in the Federal Court of the reasoning in Commissioner of Patents v Microcell Limited (1959) 102 CLR 232 and subsequent statements in NV Philips v Mirabella International Pty Limited (1995) 183 CLR 655.

This application does not provide an appropriate occasion to consider the argument sought to be advanced on this issue.  There is nothing in any of the other proposed grounds of appeal that would attract a grant of special leave.  The application is refused with costs.

AT 10.21 AM THE MATTER WAS CONCLUDED