Apotex Pty Limited v Warner-Lambert Company LLC & Ors [2018] HCATrans 149 (17 August 2018)

Last Updated: 21 August 2018

[2018] HCATrans 149

IN THE HIGH COURT OF AUSTRALIA

Office of the Registry
Sydney No S66 of 2018

B e t w e e n -

APOTEX PTY LIMITED (ACN 096 916 148)

Applicant

and

WARNER-LAMBERT COMPANY LLC

First Respondent

PF PRISM CV

Second Respondent

PFIZER IRELAND PHARMACEUTICALS

Third Respondent

PFIZER ASIA PACIFIC PTE LTD

Fourth Respondent

PFIZER AUSTRALIA PTY LTD (ACN 008 422 348)

Fifth Respondent

Application for special leave to appeal

KIEFEL CJ
KEANE J

TRANSCRIPT OF PROCEEDINGS

AT SYDNEY ON FRIDAY, 17 AUGUST 2018, AT 9.57 AM

Copyright in the High Court of Australia

____________________

MR D.K. CATTERNS, QC: May it please the Court, I appear with my learned friends, MR N.R. MURRAY and MR M.B. FLEMING, for the applicant. (instructed by Ashurst Australia)

MR A.J.L. BANNON, SC: I appear for the respondents with my learned friend, MR C. DIMITRIADIS, SC. (instructed by Allens Lawyers)

KIEFEL CJ: Yes, Mr Catterns.

MR CATTERNS: May it please the Court. Your Honours, as the Court well knows, it is a basic requirement of patent law that a patent specification must describe the invention fully. That has been the bargain, literally, for centuries. His Honour the primary judge acknowledged that this is a question of consideration of the statutory monopoly. It means that the skilled addressee, the person who reads the specification, must be able to perform the invention. The content of the obligation varies with different types of patent, we submit. This patent is for a second medical use, a phrase your Honour Justice Crennan used in the Leflunomide Apotex v Sanofi Case.

KIEFEL CJ: I think you are referring to my former colleague.

MR CATTERNS: Yes, your Honour. This patent claims a new use of a drug in a class whose potential use had been published for other indications but was not common general knowledge. For a primary patent for a new compound the inventor must fully describe how to make the compound, but for a subsequent patent to a method of treatment, we submit, with its more confined novelty, as was also pointed out in the joint judgment in the Apotex Case, the patentee must fully describe how to perform the method. Of course, your Honours, methods of treatment are a fundamental area of patent discourse.

In the present case, and I will go to the claims, your Honours, they are at page 161, conveniently, if I can go to them very quickly. In paragraph 14 on page 161, at the top of the page, claim 1 is:

A method for treating pain comprising administering a therapeutically effective amount –

that is crucial:

of a compound of Formula I.

I think there are hundreds of compounds within that formula. Claim 3 we see down in paragraph 17, about line 35, is “A method according to Claim 1” which is “administering a therapeutically effective amount”:

wherein the compound administered is named (S)-3-(aminomethyl) –

et cetera. That is pregabalin, the drug of interest. We submit that what is required is to administer that drug in the expectation that the treatment will be effective. His Honour the primary judge construed the claim that way at page 42, paragraph 130, picking up the Leflunomide Apotex v Sanofi Case, which says that methods of treatment relate to the purpose of the administering doctor. Your Honours can see:

they prescribed a drug for the purpose of providing treatment and in the expectation that the treatment would be effective.

There is no doubt that includes administering it safely. The Full Court said so at paragraph 129. I do not need to go to it. Of course, your Honours, we submit that in light of that finding – that is, the doctor’s purpose or expectation – any argument that you could just simply administer the pill or stick a needle into a patient cannot be right. I will come to the errors in a second. It was common ground that the doctor could not have that expectation, referred to by his Honour, on the basis of the description alone. I will show that shortly. There was a finding about that.

Your Honours, the only case on sufficiency in the High Court, since the Court had exclusive jurisdiction in patents, including appeals from the Commissioner, is the Kimberly-Clark Case which, as your Honours know - - -

KIEFEL CJ: That largely governs this case, does it not?

MR CATTERNS: Yes, your Honour.

KIEFEL CJ: It is no part of your case, either here or below, to challenge anything said in Kimberly-Clark.

MR CATTERNS: That is right, your Honour. May I go to that, where his Honour quotes it, at page 70. It is a dictum picked up from the textbook by Blanco White. It begins at the bottom of page 70, the very last line:

The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions –

if I could put a metaphorical break there:

or prolonged study of matters presenting initial difficulty?

Our short submission, which I will make good, I hope, in a few paragraphs is that the courts below focused on the first half of that, the question of inventions, which their Honours treated as the antithesis of routine, and did not provide a sufficient analysis of the question of prolonged study of matters presenting initial difficulty.

` Your Honours, I accepted a moment ago that we regard this as the governing issue your Honour the Chief Justice put to me. We do not have to treat the words “prolonged study of matters presenting initial difficulty” as a statute. It is a question of the concept; it was derived from the colour television case, Valensi, where the initial difficulty was that there were errors in the specification.

The real question is, your Honours: how much work is too much? We submit that there is the second half, “prolonged study of matters presenting initial difficulty”.

KEANE J: But their Honours addressed that.

MR CATTERNS: We submit they did not, your Honour.

KEANE J: Paragraphs 126 and 127 on page 186.

MR CATTERNS: Your Honour, the problems with those paragraphs – I will go straight on to a couple more paragraphs there where we go to.....the question is whether they provided enough information. But then their Honours in 126 accept our friend’s submission that:

The need for time, cost and detailed work will not –

that does not mean insufficient:

where, as here, the work involved is of a routine and conventional kind.

With respect, it is beside the point that we - as their Honours say - did not venture to say what would be sufficient. That is not the question in this case. The question is: is this sufficient? As a matter of fact, we did venture to say. We said that it might involve work of a level up to phase 2 studies. In some cases, such as the – two cases that were before the High Court, the super statin case that was before the High Court, it was phase 2 studies in the patent. In the Viagra case, Eli Lilly v Pfizer, there were phase 1 studies that showed efficacy.

Skipping, if I may, to answer your Honour’s question, in paragraph 129 is where the error is clear. Their Honours accept our friends – our friends were the appellants below - on a different point. They raise a valid point of distinction relevant to our criticism that the specification does not contain specific dosages or a safety and toxicity profile and that a clinician would not use the compounds without that information.

Their Honours note his Honour’s finding that from the Commissioner’s perspective this information would be necessary, you would have to do further work. No breach of the requirement because, in the circumstances of the present case – I am sorry to be continuing, your Honour, at 22 – the work required to put the invention into practice was routine. So the answer to too much work - - -

KEANE J: That is not inventive.

MR CATTERNS: Yes, your Honour. That is the first half only of the Kimberly-Clark question. “Routine”, we all agree, is the antithesis of inventive in our little narrow area of discourse – Sir Keith Aickin in the Wellcome Foundation Case. Just thinking of it logically, the bargain is that you enable the skilled addressee to perform the invention. Logically, there are two ways in which you are going to fail that. The first is that the skilled addressee has to be inventive. The second is if he or she has to do too much work.

KIEFEL CJ: But does not the latter “too much work”, which I think was referred to as undue burden, the skilled address having to do too much, really address both aspects of the Kimberly-Clark test? That is essentially the case you ran below, was it not?

MR CATTERNS: Yes, your Honour. We said that the amount of work which his Honour found, which we do not quibble with, which his Honour said was extensive and time-consuming et cetera - and we know the nature of it and the experts explained in detail what it was - that is too much work. It is not just an answer to too much work to say it is routine. Indeed, your Honours, it is very clear that their Honours draw that distinction in paragraph 132, where their Honours say at the bottom of 187, “too much work”:

The primary judge disagreed. As we have noted, his Honour reasoned that, if the steps . . . are readily apparent . . . and they are standard or routine –

just standard or routine; not too much, your Honour:

then the test for sufficiency will be satisfied.

No error, and no error in the finding that it was routine. Once this is accepted – namely, that it is routine – it is beside the point. That is the error, your Honours. We cannot do better than that. That is our best point on the error. Their Honours say:

it is beside the point that, in undertaking the task, the person skilled in the art might need to apply considerable skill, effort and resources, or that the work might be complex, time-consuming and expensive. Work of this kind would not be of the character captured by the second limb –

Your Honours, we submit that that is plainly incorrect. Their Honours have not asked the question whether applying considerable skill, effort and resources found to be complex, time-consuming and expensive is too much work. Their Honours’ answer to it, as was his Honour’s, is just merely that it is routine. If I may briefly make good what I submitted, that that is his Honour’s error too - - -

KEANE J: Mr Catterns, in paragraph 133 their Honours say:

Work of this kind would not be of the character captured by the second limb of the test in Kimberly-Clark (i.e., work requiring prolonged study of matters presenting initial difficulty).

They have referred to it in terms, and now the answer to that question is one of fact and degree. Insofar as it is a matter of fact and degree, your difficulty is that you have concurrent findings against you.

MR CATTERNS: But, your Honours, their Honours do not say, “As a matter of fact and degree, this is not too much”. Their Honours go on yet again, three or four lines later, to say the further steps are “routine in character”. So their answer to the question of fact and degree is not, “This is too much or too little,” but, “It is routine”.

KEANE J: But they say:

the need for such steps does not mean that the description has not enabled the person skilled in the art to work the invention.

MR CATTERNS: Yes, your Honour. That is the error. There must be a point at which the amount of work left to the skilled addressee, not inventive work, is too much work, and that is a crucial question we wish to ventilate. And we submit that, on his Honour’s findings, what is left – and it could be millions of dollars and many years – is too much work. If the patentee merely describes some experiments in rats, gives a range of dosages for a range of compounds which none of the experts said was of any utility to them, then they are not performing the statutory bargain.

KIEFEL CJ: Mr Catterns, what do you say to what the Full Court said at paragraph 120 with respect to his Honour’s dealing with what his Honour meant by his reference to “routine”? I think it has to be read with paragraph 119.

MR CATTERNS: Your Honour, we submit his Honour focused only on routine and his Honour continually treated that as a dichotomy with inventive. Your Honours see that in paragraph 129, the passages I took your Honours to.

If I could just show your Honours a couple of passages in his Honour the primary judge’s reasons, in paragraph 264 at page 78, under the heading of “Drug development and approval”, his Honour described the considerable amount of work you need to do – 264, 265 and 266 on page 79.

Then there was a conference, with all of the experts I think in it, five or six of them and highly distinguished. In their joint report, they said, at the top of page 80, that they answered two questions they had given themselves:

Given the information in the Patent, what steps need to be taken to treat pain in humans in clinical trials?

Secondly, regulatory, and there is no doubt that his Honour’s finding I am about to go to, as the Full Court acknowledges, relates both to treating pain and not just regulatory. The short point is at paragraph 269, his Honour says:

The fact that steps 1 to 5 or 6 –

but 1 to 5 is enough for our point of view:

would involve complex, time consuming and expensive work is not controversial. But that does not mean that the steps involved are not routine for the notional skilled team or that the work required to be performed . . . cannot be performed without the need for invention.

Your Honours, we submit that that fails to address the second part of the Kimberly-Clark limb. A final example is his Honour’s dealing with the Viagra case, Eli Lilley. But just a conclusion, looking at the Full Court at page 78, paragraph 263, again your Honours see there is that dichotomy between routine and further invention without looking at the question of whether what is left is too much work. May it please the Court.

KIEFEL CJ: We need not trouble you, Mr Bannon.

In our view this matter raises no new question of principle. There is no reason to doubt the correctness of the application of the courts below of settled principles to the steps necessary to enable the skilled addressee to perform the claimed invention. Special leave is refused with costs.

AT 10.15 AM THE MATTER WAS CONCLUDED