Alphapharm Pty Ltd & Ors v H Lundbeck A/S

[2016] HCATrans 52

[2016] HCATrans 052

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
  Sydney  No S218 of 2015

B e t w e e n -

ALPHAPHARM PTY LTD

First Applicant

APOTEX PTY LTD

Second Applicant

ASPEN PHARMA PTY LTD

Third Applicant

SANDOZ PTY LTD

Fourth Applicant

and

H LUNDBECK A/S

Respondent

Application for special leave to appeal

FRENCH CJ
GORDON J

TRANSCRIPT OF PROCEEDINGS

AT SYDNEY ON FRIDAY, 11 MARCH 2016, AT 10.31 AM

Copyright in the High Court of Australia

____________________

MR D.K. CATTERNS, QC:   May it please the Court, I appear with my learned friend, MR C. DIMITRIADIS, SC and MR N.R. MURRAY.  (instructed by King & Wood Mallesons)

MR A.J.L. BANNON, SC:   May it please the Court, I appear with my learned friend, MS K.J. HOWARD, SC, for the respondent.  (instructed by Corrs Chambers Westgarth)

FRENCH CJ:   Well, Mr Catterns, one of your tougher briefs, I think, not that I want to be discouraging. 

MR CATTERNS:   I have lost plenty, your Honour. 

FRENCH CJ:   As I understand it, the question central to the argument is whether the term “per se” used in section 70(2)(a) cannot accommodate a claim for a compound construed as a reference to the compound in a pure, isolated or separated state.

MR CATTERNS:   Yes, your Honour, absolutely.  Your Honour, we submit it is an important question with ramifications far beyond this case because we see many patents which we can call secondary patents which contain further criteria above and beyond the claim to the pharmaceutical substance itself.  Here, your Honour, that hendiadys, as the Full Court called it, “pure”, “isolated” or “separated” made a difference – it made a difference in making the claim novel over the patentee’s prior patent.

FRENCH CJ:   Well, you had the enantiomer taken out of a racemic mixture and it has different properties when it is there, as it were, by itself.

MR CATTERNS:   Yes, your Honour, but what “per se” means and we know this from, for example, the whole antitrust discourse, is when something is a breach in that discourse without the addition of a further criterion.

FRENCH CJ:   We know from the dictionary it means of itself.

MR CATTERNS:   Yes, your Honour, and the court’s reasoning here slides from the word “alone” meaning pure, isolated or separated and, in effect, equates that with “per se” and our submission ‑ ‑ ‑

FRENCH CJ:   You are saying it imports a process impermissibly.

MR CATTERNS:   I beg your Honour’s pardon?

FRENCH CJ:   You are saying it imports some sort of anterior process?

MR CATTERNS:   Not necessarily, your Honour.  At least it describes the state in which we find the pharmaceutical substance as opposed to the pharmaceutical substance per se.  We submit that is an important question.  It is a clear question of statutory construction, no dispute as to the facts.  We are not trying to re‑run the construction argument - we lost that, special leave refused.  We say that is a settled construction now – pure, isolated or separated.

FRENCH CJ:   As though it was written into the claim.

MR CATTERNS:   Exactly, your Honour.  We argued that that was a wrongful importation of an integer but their Honours held – upholding his Honour Justice Lindgren - that, in effect, it came from the plus – it to the skilled addressee meant pure, isolated or separated, albeit special leave refused.  So, your Honours, we submit that what has happened is that the Full Court has failed to face up to the ineluctable consequence of that which is that there is a further criterion and it is very important that patents not be allowed to be extended when there are further criteria.  It is clear that they are not allowed to be extended when it is for a method of treatment, for example, or a method of manufacture, although, your Honours, there is ‑ ‑ ‑

FRENCH CJ:   I appreciate your public policy argument about extension and freeing up for generic products and so forth.

MR CATTERNS:   Yes, your Honour, we were not going to weary the Court with that.  But it is - strikingly in the present case before the extension the patentee ended up with 32 years of protection because of overlapping patents which is what, of course, one does.  But, your Honour, we submit the words are intended to have a – of course they are - purpose as the Full Federal Court said in Boehringer. 

The way the Act worked, these extension provisions were brought in just before the 1990 Act and then there was a provision a little bit like the current provision.  Then, your Honours, that went away in 1994 when all patents were extended by four years.  Then after the usual processes of lobbying, et cetera, the Act was amended to put “per se” in.  The Court describes that history in the Boehringer Case.  I was not going to take time. 

Your Honours, by way of contrast, in paragraph – on page 87 which is where the section is set out, your Honours see (2)(a) and the crucial words that we say the Court erred in construing is:

one or more pharmaceutical substances per se must in substance . . . fall within the scope of the claim –

We submit that a claim that is qualified by this in the 80s is not a claim per se falling within the scope but a claim further narrowed to fit within the scope.  Your Honours, the contrast I wanted to draw is with ‑ ‑ ‑

FRENCH CJ:   Tell me, what is accommodated by the hendiadys that is not accommodated “per se”.  You say it is a narrowing.

MR CATTERNS:   Yes, your Honour, and a narrowing is a further ‑ we have not used the word “integer” but it is as if it were another integer.  It is a further criterion that narrows it just as a method of use of the substance would be or a method of making the substance would be or a – if your Honours remember – the 5 or 10 milligram dose of the substance would be a further narrowing.  That would take – so we submit that this decision which will be followed by the Commissioner, of course, will allow dosage patents to be extended.  Of course, it is fair enough to have dosage patents if they are novel and inventive, but this reading which we submit allows “per se” to cover anything where the only substance that is referred to is this one, though further qualified by its context, that broadens the section beyond the policy.

FRENCH CJ:   Unless you take the view that the particular qualifications, so‑called qualifications in this case – pure, isolated, separate - are not qualifications at all.  They are just other ways of saying that it is just this compound and nothing else which reduces to the proposition it is the compound per se.

MR CATTERNS:   Your Honour, I respectfully submit that is precisely where the Full Court went wrong by a verbal slippery slope from the word “alone”.  May I just show your Honours that but just first before I leave this page, (2)(b) is the exception where the method of production of the pharmaceutical substance DNA.

Your Honours, the paragraphs I was going to try and make good the submission I just made begin at paragraph 90 in the Full Court’s reasons at page 63 where their Honours refer to Justice Heerey.  Of course, it is a very different context, that case, where it was a ‑ ‑ ‑

GORDON J:   Boehringer.

MR CATTERNS:   Yes, your Honour.  It is a nasal spray.  It says at line 55:

‘a new and inventive product alone’ and that section 70(2)(a) makes extension rights available when the claim is for a pharmaceutical substance as such –

Your Honours, we respectfully adopt that but, your Honours, what happens then is, we submit, a slide from paragraph 90 to 96 where we get “alone” and words like it equals “per se” and that is impermissible statutory construction.  So, your Honours, we get “alone” from Justice Heerey.  That is then equated with “isolated” or “separated” or “pure”.  That is merely explaining a difference.  We agreed it did not add an integer but the integer was there but it is an integer that made a big difference on novelty between a new pharmaceutical substance on its own and a pharmaceutical substance.  Then, your Honours, in the next paragraph as this continues ‑ ‑ ‑

FRENCH CJ:   What are you comparing – what is pure, separated or isolated compared with?  Is that the comparison with the racemic mixture?

MR CATTERNS:   Yes, your Honour.  We see that, for example, in 96 where their Honours, say, refer to the hendiadys.  To explain that the:

enantiomer alone was claimed – without the (-)-enantiomer or the racemate.

It is “separately existing” is one of the phrases that was also used.

FRENCH CJ:   You have a mixture of two kinds of molecules and you separate out so it is just one kind of molecule.

MR CATTERNS:   Yes, your Honour.  But this condition, this hendiadys, draws a distinction between those narrowing the claim by making it in the context where the other enantiomer is not present, independently existing. 

FRENCH CJ:   That is because what has been separated out is a separate molecule with different properties from the racemic mixture.

MR CATTERNS:   Yes, your Honour.  It, in effect, had no activity at all.  Your Honours, in 91 the court again slips and adds at the end:

the word “itself” could just as easily have been used –

Then we have in 92:

Their reasoning was that the claim is to the (+)enantiomer and nothing else.

It simply means the pharmaceutical substance in itself whereas we agree it means by or in itself, but they are really meaning on its own, alone.  Your Honours, after some other errors in 93 and 94 we get to 96 where their Honours say it was used:

to explain that the (+)-enantiomer alone was claimed – without the (‑)‑enantiomer or the racemate.  That is, it was the enantiomer itself. 

Equal, per se, QED.  We respectfully submit that that has now given the statutory phrase no meaning whatsoever.  Your Honours in paragraph 87 on page 62 there is the quotation from what his Honour Justice Emmett said where his Honour said in dissent:

‘[The claim] by itself simply identifies the substance, in whatever surroundings it may exist’.

Your Honours, that is a claim to the substance, per se, in short, irrespective of its surroundings, whereas the way the court has read it, we accept not reading in an integer but construing the claim as it is, perceives in the claim this additional criterion and, your Honours, to add a criterion - or sorry, I beg your pardon – if a claim, a secondary patent like this has an additional criterion then it is not a claim to the substance per se.  Of course, the same therapeutic – when present in the racemate, the (+)-enantiomer is the one that gave the same therapeutic activity.

Your Honours, there are just two other little errors I wish to point to, if I may, which are not strictly errors of construction.  In paragraph 93, there is a reference to new chemical entity.  That is not in either the Therapeutic Goods Act or the Patents Act.  It is American jargon and the context in which his Honour Justice Lindgren put it aside related to the cross‑examination of a witness.  But, your Honours, at the very end of that at line 50:

the primary Judge was correct in concluding that it –

the isolated (+)-enantiomer:

satisfies s 70(2)(a) of the Act.

He did not because that was not in issue before his Honour.  We see that again, your Honours, at the end of 94 that our submission:

is wholly inconsistent with their Honour’s conclusion that the subject matter of the claim satisfied s 70(2)(a) of the Act –

Their Honours did not.  Their Honours make that clear in the next part of their reasons when our friends ran an estoppel because at the very bottom of page 65 their Honour’s say there are a couple of suggestions that it may have been:

a pharmaceutical substance per se . . . However, even if these suggestions rise to the level of a finding –

and we submit they do not, Alphapharm is not estopped but, your Honours:

The question whether the (+)-enantiomer of citalopram was a pharmaceutical substance per se was not an issue –

The question relevantly that was determined was whether or not it was section 70(3) was satisfied.  So, your Honours, we do submit that this is an important question of statutory construction.  It clearly arises and we submit that the Full Court was wrong.  May it please the Court.

FRENCH CJ:   Thank you, Mr Catterns.  We will not need to trouble you, Mr Bannon. 

In our view, the decision of the Full Court is unattended by sufficient doubt to warrant the grant of special leave.  Special leave will be refused with costs. 

AT 10.47 AM THE MATTER WAS CONCLUDED