(a) The respondents' first fair basis case - claims 1, 2 and 3
607 The first case propounded by Apotex has asserted that the only disclosure in the Patent of formulations that met the advantageous attributes identified in the Patent were Formulations C and D. Formulation C comprised 667mg of paracetamol, had an SR:IR paracetamol ratio of 71:29 and released 39.4% of said paracetamol at 15 minutes, 64.4% at 60 minutes and 101.8% at 180 minutes. Formulation D comprised 665mg of paracetamol, had an SR:IR ratio of 69:31 and released 40.8% of said paracetamol at 15 minutes, 65.0% at 60 minutes and 101.8% at 180 minutes. Apotex asserts that claims 1, 2 and 3 travel beyond the aforementioned disclosure insofar as they claim a paracetamol content, IR:SR ratio and dissolution ranges that are not the same as or very close to those of Formulations C and D.
608 Apotex says that the sole relevant disclosure of a formulation in the Patent is Formulation C or D. Such a formulation has a dissolution profile broadly in the middle of the ranges of the claims. Its point is that the specification does not provide a "real and reasonably clear" disclosure of the wide range of formulations that are claimed in claims 1 to 3.
609 The specification refers on p 4 lines 12 to 14 to the "surprising" discovery that an "advantageous pharmacokinetic profile can be provided by a two-phase (immediate-release and sustained-release) formulation of paracetamol which satisfied a unique in vitro dissolution profile".
610 It may be accepted, and Professor Davies agreed, that the Patent does not represent that the surprising connection has been established by a validated level A IVIVC. Professor Davies agreed that the Patent does not describe any internal validation of the type described in the Grattan paper or the FDA guideline. Further, he agreed that the Patent does not describe any external validation of the type described in the Grattan paper or the FDA guideline. Professor Davies did, however, say in cross-examination:
but the patent provides the relationship clearly between the in vitro and the pharmacokinetic [properties].
611 I raised some questions with Professor Davies on this topic:
HIS HONOUR: If it doesn't maintain that there's some sort of relationship, what's the patent disclosing as to the basis of that relationship? Could you describe it as internal or how is the - remind me how is it ---? --- The patent is disclosing a relationship between the in vitro dissolution profile, as I read it, and the pharmacokinetic parameters that it has highlighted, in terms of the four key parameters that it has highlighted.
Yes. Yes? --- That's how it's describing that relationship.
But it's not actually describing how that relationship is established, or is it? --- That's correct. … Other than showing the individual examples and however it has come through, but it hasn't described how it has been achieved. I agree with that.
On no view could you say it has been described in an external sense, but you could say it has been described in an internal sense or is that ---? --- I think it's difficult to say that based on the definitions that's provided in the FDA document, that it's showing an internal - it's just showing through examples how it has come to those - the relationship between the in vitro dissolution profile and showing that that will give you, with the other elements of the claim, the pharmacokinetic parameters of the patent.
…
MS GODDARD: So it would be correct then, wouldn't it, Professor, that the specification of the patent is not representing a level A IVIVC correlation has been established? --- I think that's correct. It's not saying what form of the - from an FDA viewpoint the correlation is, but it's just showing you that there is a relationship between the dissolution profile and those key pharmacokinetic parameters.
612 Apotex contends that the Patent does not purport to set out or describe any detailed basis or validation process for any predictive relationship between the dissolution parameters and the advantageous pharmacokinetic profile. Clearly, Formulations A and B are not reference formulations. The Patent describes essentially one formulation that satisfies the pharmacokinetic criteria, being Formulation C (or D).
613 Apotex then generally asserts that for dissolution tests to be used as a surrogate for bioequivalence, a level A IVIVC is required, subject to some limited exceptions. Clearly the Patent does not refer to any validated IVIVC as having been undertaken. Rather, it just asserts that there is the required favourable in vitro/in vivo relationship without more.
614 After I had enquired about the difference between a correlation and a relationship, Professor Davies said:
There's a difference there. I'm using - I clearly think there is a relationship … between the in vitro and in vivo profile as the patent is teaching you. The patent comes to that view through some kind of correlation, but it doesn't describe what that correlation is.
615 But as I say, it is apparent that the Patent does not describe the use of any or any validated IVIVC.
616 As I have earlier indicated, with a given percentage dissolution, tablets with different amounts of drug will give different amounts of drug in vivo. In short, Apotex contends that it is impossible to tell without an IVIVC whether all formulations within the Patent's ranges will provide the advantageous pharmacokinetic profile. Apotex says that because there has been no disclosure of any or any validated IVIVC, the only disclosure in the Patent that can possibly provide a basis for the broad claims is:
(a) the results of Formulation C or D;
(b) the limited assertion of "a relationship" at p 4 lines 12 to 14; and
(c) the consistory clauses at p 4 line 26 to p 4a line 25.
617 As to the first aspect, Apotex submits that the results of Formulation C or D only provide a real and reasonably clear disclosure of those particular formulations. It contends that even taking into account the types of tolerances allowed by the FDA, the claimed formulations extend far beyond such tolerances.
618 Moreover, Apotex contends that any reference to the FDA's "10 per cent" level does not justify the breadth of the ranges.
619 Further, it is said that even if an allowance of ± 10% were somehow to provide a fall back for fair basing, even the narrowest claim, claim 3, does not have all of the limits within a ± 10% range of Formulation C when dose is considered. For claim 3, at the 180 minute time point Formulation C had 101.8% of its 666.6 mg dissolved, whereas applying the 95% lower claim limit to the 600 mg lower dose limit gives 570 mg, which is 85.5% of 666.6 mg (i.e. more than 10% below).
620 Further, it is said that the claim 2 and claim 1 limits are broader and have more time points outside this 10% range when the impact of dose is also factored in. For claim 2 at 60 minutes, 58% of 600mg (the lower claim limits) is 348 mg, which is 52.2% of Formulation C's 666.6mg, and 73% of 700mg (the upper claim limits) is 511 mg which is 76.7% of 666.6mg. Both are more than ± 10% of 64.4% from Table 2. Similarly at the 180 minute time point, the lower claim limits are 90% and 600mg, which gives 540mg which is 81% of 666.6 mg. Claim 1 is broader again.
621 Further, it is said that the skilled addressee knows that any assertion as to the provision of an equivalent in vivo effect for formulations falling outside a 10% range can only be supported by establishment of a validated IVIVC.
622 Apotex submits that the disclosure of the Patent amounts to no more than the particular disclosure of Formulation C or D. The Patent does not say that it arrives at the broad dissolution ranges by using the result for Formulation C or D +/- 10% for all compositions from 600-700 mg and 10%-45% IR: 55%-90% SR. It merely makes the assertion of "a relationship" or "a connection" at p 4 lines 12 to 14. It is said that this is insufficient to constitute a "real and reasonably clear disclosure".
623 It is said that there are no particular passages where the Patent is teaching you that the pharmacokinetic profile will always be achieved by formulations within the broad ranges.
624 As to the second aspect, Apotex asserts that it is clear that the skilled addressee would not read the dissolution ranges as having been set by any reliance on a connection or relationship referred to at p 4 lines 12 to 14.
625 Apotex has referred to Professor Davies' cross-examination:
MS GODDARD: [W]hat are the findings that you refer to specifically, if you wouldn't mind? --- The findings are the - I'm - in that paragraph I'm talking in terms of the invention of the patent. I'm talking about in the concept of what have the inventors found, what are their findings. They found that there is this advantageous pharmacokinetic parameters with a particular dissolution profile for a bilayer tablet with a particular ratios of paracetamol with a polymer - a matrix-forming polymer.
So is that - can I clarify - are you referring to the passage on page 4, lines 12 to 14 or are you referring to the data for formulation C and the in vivo data for formulation D? --- I believe I'm referring to the entirety of the patent, that the formulations C and D are exemplary examples of what the patent describes, I believe. It also shows formulations that lie outside the invention in terms of A and B.
Where does the patent tell you that the finding that such formulations - this is the top of the joint expert report on page 19 - would have the advantageous pharmacokinetic profile? --- When one reads the entirety of the patent, equally when one - we've talked about before, it's summarised in the fourth line - fourth paragraph, lines 12 to 14 of page 4 but then the patent goes on to discuss different aspects of the invention.
So more than that general reference, you can't point to anything in particular upon which you rely? --- I don't think that's what I've just said. I think I've said that the patent is clearly teaching you what the invention is about.
626 Moreover, Apotex contends that merely to move from the assertion of p 4 lines 12 to 14 to the consistory clauses on pp 4 to 4a or to the matching claims does not provide any fair basis.
627 It is said that the claims are broader than the disclosure in Example 2 (Formulation C) because the skilled addressee understands that there is no scientific rationale to support the in vitro ranges as claimed. It is said that there is no "real and reasonably clear" disclosure of an invention having that scope and accordingly the claims are not fairly based on the description.
628 This applies to each of the claims. It is said that there is no basis for even the narrower ranges of claims 2 and 3.
629 As to the third aspect, it is said that a consistory clause will not necessarily provide fair basis for a claim. What is required is more than a mere "coincidence of language", and other parts of the specification can, as they do here, show that what has been invented is of a narrower scope.
630 In my view, Apotex's assertions should be rejected.
631 The ranges specified in the claims are meaningful in the context of the Patent. As Professor Davies explained:
in the context of the patent - the patent teaches you you can have a range. It would be impossible to make the same formulation over and over again with exactly the same percentage. That's why you have these ranges. And that allows you to … understand that, you know, these formulations may release at different rates within the ranges of the patents but they will give you the pharmacokinetic attributes.
632 First, with respect to the paracetamol content issue, the following may be noted.
633 If one looks at an extract from the acetaminophen monograph from USP 24 NF 19, under the heading "Acetaminophen Tablets", the document states that "Acetaminophen Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labelled amount of C8H9NO2 (paracetamol)". In cross-examination, Professor Fassihi explained:
MS ROFE: So, within one batch of acetaminophen tablets it's allowable to have tablets containing 90 per cent and tablets containing 110 percent? --- Of the labelled … in a batch that is a acceptable range, yes, for the content uniformity.
634 Further, Dr Mooney agreed that it was impossible to produce tablets within or across batches with exactly the same content of active pharmaceutical ingredient. Moreover, he agreed that regulators such as the TGA and FDA permit a variance in the order of 10 to 20%.
635 Professor Davies also gave evidence that the content ranges specified in the claims were consistent with the content uniformity ranges allowed by regulatory authorities. Professor Davies explained that:
[T]he level of drug, six to 700, is well within the plus or minus 10 per cent allowed by regulatory authorities for the normal oral dose of formulations …
[B]ased on the teachings of the patent, a formulator would understand that the 600 milligrams is within 10 per cent of the label claim of the 650 that's shown for Formulation C. …
Now, the second concept of plus and minus 10 per cent relates to the nominal amount of drug in a - allowed in a formulation and the regulatory authorities allow plus and minus 10 per cent of the labelled claimed amount of drug. …
HIS HONOUR: --- you could take Formulation C ---? --- Yes.
--- or somebody reading the specification would look at Formulation C ---? --- Yes.
--- and take plus or minus 10 per cent in terms of the total milligrams? --- Yes. And it's within that range.
Yes. Yes? --- 600 to 700 is within the range of plus or minus 10 per cent of the labelled claim. … [T]his is the real world of pharma industry where they recognise that you cannot make a formulation of [650]; you would have to set a range and a specification.
MS GODDARD: And it depends how broad those ranges are allowed to be, of course? --- Yes, that's correct, but plus or minus 10 per cent is typical and the ranges set in the patent is narrower than that.
636 Formulation D, being the subject of the clinical trials reported in the Patent, had a total paracetamol content of 665mg: 90% of 665 is 598.5mg and 110% of 665 is 731.5mg. The paracetamol limits specified in claim 1 were within those limits.
637 There is no substance to the respondents' lack of fair basis complaint concerning the paracetamol content.
638 Second, the claims of the Patent are defined by the result to be achieved, namely, a bilayer tablet having a particular unique and advantageous in vitro dissolution profile. The Patent teaches that such a result may be achieved by varying the IR:SR ratio and the amount of matrix forming polymer in the formulation. The IR:SR ranges in the claims provide guidance to a skilled formulator as to the ratios (i.e. an unequal split of paracetamol across the IR and SR layers) that can produce the result claimed. The Patent teaches a skilled formulator that the IR:SR ratio parameter will not affect the in vivo performance of the formulation as long as the formulation satisfies the dissolution criteria of the claims.
639 In cross-examination, Professor Davies relevantly explained:
[T]his patent is teaching you that one can achieve that dissolution profile using the ranges of the paracetamol in the immediate release and sustained release phases of this bilayer tablet, and it's - and using a matrix forming polymer. The very fact the ranges as such are set, ultimately it has to achieve that release profile. And if it achieves the release profile, that release profile will give you your pharmacokinetic parameters. That's what the patent is teaching you. …
If it meets - I think if it meets the profile and it meets also the other elements of the claim, as formulator, based on the fact that certainly the dose is within the 10 per cent level, the percentage ranges are within the 10 per cent level as allowed by the FDA, this is teaching you that you can make the formulation, but it has got to achieve that particular release profile with the other elements of the claim. As a formulator, that's how I see it's teaching me.
640 There is no substance to the respondents' lack of fair basis complaint concerning the IR:SR ratio. Moreover, in my view it is superfluous in one sense to enquire how the IR:SR ratio was arrived at in terms of a fair basis challenge, particularly given the dissolution profile constraint.
641 Third, with respect to the dissolution ratio, Professor Fassihi noted that "[i]n a repeated dissolution study, using any one of USP Apparatuses 1, 2 or 3, variability in the measured dissolution profile for each sample of up to ±10% is considered normal …" and explained that:
The dissolution ranges in Claim 1 are precise and not expressed with any qualification such as the use of the word "about". I would normally expect the term "about" to be used, as dissolution involves an inherent level of ±10% variability. The patentee has been more strict in these claims, and I would expect that everything should fall within that range.
642 The USP monograph for acetaminophen extended release tablets identified a dissolution specification that was significantly broader than the specification set out in claims 1, 2 and 3 of the Patent, namely:
15 minutes: between 45% and 65%
60 minutes: between 60% and 85%
180 minutes: not less than 85%
643 Further, Dr Mooney understood that the width of the constraints included for the dissolution test claimed (e.g. 30 to 48% released after 15 minutes) were within the range of constraints typical for an in vitro quality control dissolution test, that the dissolution profile for claim 2 is narrower than for claim 1 and is narrower again in claim 3, and that the constraints included for the dissolution test in claims 2 and 3 (e.g. 38 to 44% released after 15 minutes) were more stringent than the range of constraints typical for an in vitro quality control dissolution test.
644 Professor Davies also explained:
I understand that the Patent, read in a common sense fashion, specifies in claims 1, 2 and 3, the dissolution profiles of the invention in a conventional way and as at April 2000, I would have no difficulty interpreting the dissolution specifications set out in the Patent.
The Patent, specifies the range of the amount of paracetamol that must be dissolved or released in vitro after or "at" an early, middle and late time point. This is consistent with, for example, the guidance document published by the FDA in 1997 entitled "Guidance for Industry - Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations" (the 1997 FDA Report), a copy of which is included in Tab 8 of Exhibit MCD-1. I was familiar with this document as at April 2000. At that time, the 1997 FDA Report would have been in my office either in hardcopy or saved electronically (or both).
Also consistent with the 1997 FDA Report:
(a) the last time point of each of the claims are the time points where at least 80% of drug has dissolved (see page 17 of the 1997 FDA Report); and
…
It is apparent from reading the Patent as a whole and having regard to the dissolution results reported for Formulations C and D, that the specified dissolution profile does not represent an arbitrary selection of dissolution values, but rather has been found to correlate with advantageous in vivo pharmacokinetic attributes, as described, for example, on page 3 lines 23-29 to page 4 lines 1 - 10 of the Patent.
…
I agree with Dr Mooney's comment at paragraph 242 of his affidavit that the width of the ranges specified in each of claims 1, 2 and 3 of the Patent are typical.
The middle point figures are practically identical to the dissolution figures reported in the Patent for Formulations C and D. Formulation C is reported to release 39.4% of paracetamol at 15 minutes and 64.4% at 60 minutes (page 13 of the Patent). Formulation D is reported to release 40.8% of paracetamol at 15 minutes and 65.0% at 60 minutes (page 15 of the Patent).
The 1997 FDA Report also indicates, at page 7, that differences in pharmacokinetic properties may be observed when there is a 10 percentage point difference in release rates. Especially given that the range specified in each of the claims is less than 10 percentage points apart from the respective middle points, I would expect all manufacturable formulations falling within the claims to possess the advantageous pharmacokinetic properties referred to above. The 1997 FDA Report states, on page 17, that ± 10% is recommended for in vitro dissolution profiles and that broader specifications may also be acceptable in certain circumstances.
In my view, the ranges specified in the Patent have been reasonably set with reference to the in vitro data for Formulations A and B (which the Patent teaches do not work), the in vitro data for Formulations C and D (which do work) and the guidance issued by regulators such as the FDA, referred to above. I accordingly disagree with Professor Tucker's comment at paragraph 232 of his affidavit that there is no scientific basis for the setting of the limits in the Patent.
645 The extract from the 1997 FDA Report referred to by Professor Davies provided that "The release rates, as measured by percent dissolved, for each formulation studied, should differ adequately (e.g., by 10%). This should result in in vivo profiles that show a comparable difference, for example, a 10% difference in the pharmacokinetic parameters of interest (Cmax or AUC) between each formulation". Further, the 1997 FDA Report under the heading "Setting Dissolution Specifications Without an IVIVC" recognised that a variation of ±10 percentage points is acceptable even where no IVIVC has been established.
646 Further, Professor Davies in cross-examination confirmed his view that the ranges specified in the claims were reasonably set with reference to the FDA guidelines, an understanding of the relationship between the in vitro dissolution profile specified in the claims (with reference to Formulations A to D), and whether changes to the profile would have a meaningful effect within the context of the Patent. In cross-examination, Professor Davies variously explained:
The dissolution profiles as presented are well within the 10 per cent one would understand from an FDA perspective wouldn't - plus or minus 10 per cent which would not impact the pharmacokinetic data. …
If they meet the patent - if they meet the elements of claims of the patent, I would believe, based on the reading of the patent, that it will be - it will meet the pharmacokinetic parameters. …
If you mean that it's - the patent is teaching you that one can make formulations and if they fall within that range and they have the attributes as taught by the - the claim and the patent, then they should give you the [pharmacokinetic] attributes. … I'm relying on the whole patent. …
[T]he percentage ranges that are used within the 10 per cent again from a regulatory viewpoint that show that you don't have changes in [pharmacokinetic] data. So I think the patent is teaching you that you can use such formulations and they will be useful. They will achieve the result. …
[I]t's commonly understood that for such formulations plus the [sic] minus 10 per cent or beyond plus the [sic] minus 10 per cent will have an effect on the pharmacokinetic behaviour. That is at individual dissolution time points. … And that's why in setting a dissolution and IVIVC in the … guidelines, they talk about a biobatch and then having - having a slower dissolution by at least 10 per cent - having a faster dissolution by at least 10 per cent will produce a change. …
[T]he patent dissolution ranges were clearly set based on an understanding the relationship between the in vitro dissolution profile and the pharmacokinetic parameters. …
The ranges were set with an understanding from my perspective that the plus or minus 10 per cent would affect the - you know, the relationship between the dissolution profile and the pharmacokinetic parameters. And the fact that they're within that indicates to me that they have clearly been chosen around the mid points for C and D.
647 Further, the "10%" figures referred to in the 1997 FDA Report referred to "absolute" percentage points of total paracetamol released. In other words, if one was looking at 40% in vitro release after 15 minutes ± 10%, one would have a range of 30% to 50% (rather than a range of 36% to 44%).
648 In the JER, Professor Davies and Dr Mooney explained the relevance of the Formulations to the setting of the ranges and agreed that:
Based upon the pharmacokinetic behaviour of Formulations C and D, the % released values from the dissolution curves of C and D at 15 minutes and 60 minutes appear to have been chosen as the mid points of the ranges at 15 and 60 minutes. The third time point at 180 minutes is set at >85% to give a comfortable margin above that observed for Formulation B. The range at 15 minutes is set to exclude Formulation A and that at 60 minutes is set to exclude Formulation B and that at 180 minutes excludes Formulation B. In claim 1 we believe the first two windows were based on a +/-10% range as provided in guidance by the FDA.
649 Generally, the variance in paracetamol content and dissolution profile permitted by the claims and the regulatory guidelines were consistent with the skilled formulator's recognition of inherent variability associated with manufacturing and dissolution testing processes.
650 Let me now deal with Apotex's primary contention that the ranges in claim 1 were dependent upon a level A validated IVIVC, a contention that I also reject.
651 In my view, a skilled addressee would know that having regard to the accepted regulatory approach, formulations having a paracetamol content within ±10% of the ideal value or label claim and a dissolution profile within ±10 percentage points of the target, are likely to be for relevant purposes bioequivalent. Changes within these ranges are unlikely to have a significant clinical effect. Accordingly, even without an established level A IVIVC, there is a reasonable basis for the ranges specified in claim 1.
652 The dissolution specifications were set in accordance with FDA guidance. The relevant part of the FDA Report specifically concerns setting dissolution specifications "without an IVIVC". Further, it is stated therein that "[t]his approach is based on the use of the in vitro dissolution test as a quality control test without any in vivo significance".
653 In my view, the evidence demonstrates that a skilled formulator reading the Patent fairly with a view to making it work, with his common general knowledge (including relevant guidelines published by the FDA and regulatory practices) would understand that the patentee has, with reference to such common general knowledge, reasonably extrapolated from formulations shown to work (Formulations C and D) to specify the content, ratio and dissolution specifications in the claims. In my view, the respondents have not discharged their onus of establishing that there are formulations falling within the claims that do not meet the promise of the invention. They have only produced hypothetical speculations which were considered and rightly rejected by Professor Davies as not providing a basis to doubt the Patent's teaching.
654 Further, as explained by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 193:
Where, then, is the line to be drawn between a claim which goes beyond the consideration and one which equiparates with it? In my judgment this line was drawn properly by Sir Lionel when he very helpfully stated in the words quoted above that it depended upon whether or not it was possible to make a sound prediction. If it is possible for the patentee to make a sound prediction and to frame a claim which does not go beyond the limits within which the prediction remains sound, then he is entitled to do so. Of course, in so doing he takes the risk that a defendant may be able to show that his prediction is unsound or that some bodies falling within the words he has used have no utility or are old or obvious or that some promise he has made in his specification is false in a material respect; but if, when attacked, he survives this risk successfully, then his claim does not go beyond the consideration given by his disclosure, his claim is fairly based on such disclosure in these respects, and is valid.
655 Further, in Photocure ASA v Queen's University at Kingston (2005) 216 ALR 41 at [137], Merkel J explained:
[T]here is no reason why the inclusion in claims of some embodiments which have not yet been proven to work would fall foul of s 40(3). Even if some such embodiments are subsequently shown not to work, that does not invalidate the claims in respect of those embodiments on the ground of lack of fair basis.
656 Similarly, in Asahi Kasei Kogyo Kabushiki Kaisha v W R Grace & Co (1991) 22 IPR 491, Heerey J explained at 519 and 520:
It was said that there was insufficient support in the body of the specification for the claim that a film gave "reliable seals even when contaminated" in that no method of testing such ability or reference point for comparison was given. But the specification clearly gives examples of the invention which achieve that object (paras (27) and (29)).
A further objection was that the accuracy of the upper and lower limits of the specified range are not shown for either butene or octene, so that the specified weight range of comonomer was merely speculative and lacked scientific foundation.
But the applicant has not shown that the claimed invention is in a field of science where relevant properties suddenly emerge or disappear as a precise numerical point is reached. The boundary marked out by the claims includes only films of the invention. If the test of the specification is satisfied - viz improved combination of properties - it is irrelevant that the claims might have been slightly broader or narrower.
657 Finally, Apotex has challenged Professor Davies' evidence by asserting that the Patent does not itself disclose how the invention was arrived at or how or why the limits referred to above were set. But the Patent need only teach a skilled person how to perform the invention. Further, there is no need for the specification to identify the reasoning underpinning the selection of limits specified in the claims. As explained in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1992) 24 IPR 1 at 27 per Wilcox J:
[I]t is not a legitimate objection that the specification does not disclose the experimental and statistical basis for the chosen STD and e.n values. It does not have to. The obligation of the patentee is to instruct the skilled addressee how to perform the invention. The patentee is not obliged to explain how the invention was made or the theoretical basis underlying any stipulated integer.
658 Apotex's fair basis case amounts merely to speculation that the claims are likely to include within their scope formulations that do not possess the attributes identified in the Patent. Now, of course, such considerations might be relevant to any lack of utility allegation. But such an allegation, although initially made by the respondents, has now been abandoned, no doubt for good reason. It could not be proved. Indeed, it had no proper basis to be pursued once all the evidence was in. Apotex's nuanced back door argument through an asserted lack of fair basis also fails. Finally, if it was necessary to say so, I would also hold that fair basis has been established on the basis of the matching with the text of the consistory clauses.