1PLU was measured like PHLU but in 20 mm citrate, pH 5 and at 37°C instead of 50 mm HEPES, pH 7 at 30°C
I shall return to this passage.
127 The next example to which the appellants referred was Example 20, headed, "Use of a phospholipase obtained from F. oxysporum as a bread improving agent." There followed a standard bread-making recipe, with a direction to bake rolls for 22 minutes and panned bread for 35 minutes, at 230°C in each case. The results, after baking, were evaluated by reference to a "specific volume index" and a "roll standing" index (the latter to evaluate "dough stickiness"). There were eight samples tested, namely, three samples with 500, 1500 and 3000 lipase units of the enzyme (respectively) added per kilogram of flour; three samples with 500, 1500 and 3000 lipase units of the enzyme (respectively), together with (in each case) one gram of a commercial lecithin preparation, added per kilogram of flour; a control; and a control with one gram of the commercial lecithin preparation added per kilogram of flour. The results were reported as follows:
The results show a clear volume increasing effect of the Fusarium oxysporum phospholipase on both rolls and panned bread, in the recipe not containing lecithin. If lecithin is included in the recipe, even better volume effects are obtained, although the lecithin does not contribute to volume itself. A statistical analysis (ANOVA, Α=0.05), performed in Statgraphics Plus, release 3.0, shows a significant positive synergy between the phospholipase and the lecithin.
Both with and without lecithin in the recipe, a significantly improved shape of rolls (roll standing) is obtained with the F. oxysporum phospholipase. In this example, the best roll standing was obtained by combining lecithin and phospholipase (1500 LU/kg flour).
128 Example 21 was the third example in the Novo patent on which the appellants relied. It was similar to Example 20, save that the characteristic of the bread being tested was staleness over a period of a week subsequent to baking. The results were reported as follows:
… the breads treated with phospholipase were slightly softer than the control up to 3 days of storage. In combination with lecithin, a significant anti-staling effect could be obtained through the whole storage (not obtainable with lecithin or phospholipase alone).
129 The appellants relied on the Novo patent for their anticipation case in two ways: first, as disclosing to the skilled addressee, and by reference to his or her understanding of the art as at the priority date, the process claimed in Claim 1 in the patent in suit, and secondly (ie alternatively), as disclosing, in Example 20, a method of baking that, if followed, would inevitably involve every integer of the process claimed in Claim 1 in the patent in suit. The evidence given by Prof Hoseney, in his affidavits of 8 October 2009 and 5 August 2010, provided support for the appellants' case in these respects. However, that case was controversial in a number of ways, and was not accepted by the primary Judge.
130 With respect to the first of the ways in which the appellants put their case below, it was contentious whether the Novo patent provided sufficient disclosure to constitute anticipation in three respects: the use of a single enzyme, the generation of a second functional ingredient, and the inactivation of the enzyme as a result of the industrial application referred to. Her Honour decided the first and third of these points in favour of the appellants, but the second in favour of the respondents, the result of which was a finding that the Novo patent was not anticipatory. All three conclusions have been challenged, either in the appellants' Notice of Appeal or in the respondents' Notice of Contention.
131 Commencing with the respondents' point that the Novo patent did not disclose the use of a single enzyme, her Honour held, rejecting the point, that "[t]his integer of the relevant claims of the [p]atent [in suit] is disclosed by the Novo patent". The integer to which her Honour was here referring was the requirement under the patent in suit that it be a single enzyme which catalysed the reaction, or the two or more reactions, with which Claim 1, and the claims dependent on that claim, were concerned. If that were the extent of the inquiry under the Novo patent, there seems to be little doubt but that the use of a single enzyme in the processes referred to was disclosed. There are, indeed, places where the specification allows for the use of additional enzymes, but that does not detract from the fairly unambiguous disclosure referred to. Indeed, I do not understand it to have been submitted - at least on appeal - that the Novo patent did not disclose the use of a process in which a single enzyme (as opposed to there being a requirement for two or more enzymes) was, to use the wording of the patent in suit, the conversion agent.
132 The respondents' point, rather, was that the Novo patent did not specify unambiguously the particular enzyme that was to be used in the processes to which it referred, but left it open to the addressee to select from a range of enzymes, or, more correctly in my view, from alternative polypeptides that were identified within the amino acid sequence by which the enzyme cloned by the inventors had been characterised. The amino acid sequence, as set out in the specification, was identified as "SEQ ID No 2". There were 346 positions in that sequence, and the respondents' submission was that "the phospholipase of the [invention] is not [SEQ ID No 2]; it's either the amino acids 31 to 346 or 31 to 303".
133 The respondents derived support for this submission from the way some of the (70 in total) claims in the Novo patent were expressed. The following claims were relevant in this context:
35. An isolated polypeptide having phospholipase A activity which is obtained from a strain of the genus Fusarium and has
i) PLA activity in the pH range 3-10, measured at 40°C;
ii) a molecular mass of 29 ± kDa, as determined by SDS-PAGE;
iii) an isoelectric point (pI) in the range 4.5-8;
iv) a temperature optimum for phospholipase activity in the range between 25-55°C, measured with lecithin as substrate at pH 5; and/or
v) a phospholipase activity pH optimum in the pH range between 6-12, measured with lecithin as substrate at 37°C.
36. An isolated polypeptide exhibiting phospholipase A and/or B activity selected from the group comprising of:
(a) a polypeptide encoded by the phospholipase A and/or B enzyme encoding part of the DNA sequence cloned into plasmid pYES 2.0 present in Escherichia coli DSM 11299;
(b) a polypeptide having an amino acid sequence as shown in positions 31-346 of SEQ ID NO 2;
(c) a polypeptide having an amino acid sequence as shown in position 31-303 of SEQ ID NO 2;
(d) a polypeptide which is at least 70% homologous with said polypeptide defined in (a), (b) or (c); and
(e) a fragment of (a), (b), (c) or (d).
….
58. Use of a phospholipase obtained from a strain of the genus Fusarium, such as a strain of F. culmorum, F. heterosporum, F. solani, or in particular a strain of Fusarium oxysporum, in a process comprising treatment of a phospholipid or lysophospholipid with the phospholipase so as to hydrolyze fatty acyl groups.
59. Use of the phospholipase according to any of claims 35-50 and 57 in a process comprising treatment of a phospholipid or lysophospholipid with the phospholipase so as to hydrolyze fatty acyl groups.
….
65. Use according to any of claims 58-61 in a process for making a baked product, comprising adding the phospholipase to a dough, and baking the dough to make the baked product.
66. A dough or baked product comprising the phospholipase according to any of claims 35-50 and 57.
Of these claims, in their written outline on appeal, the respondents said:
The claims that relate to the use of an enzyme in baking are claims 65 and 66. By way of example, claim 65 is a method claim which is dependent on claims 58 to 61. Of these, claim 58 is a method claim for the use of a phospholipase obtained from any strain of Fusarium. This covers a potentially large number of enzymes. Claim 59 is a method claim claiming the use of a phospholipase according to any one of claims 35 to 50 and 57. Of these, claims 35 and 36 are product claims which encompass whole families of isolated polypeptides defined in different ways (activity and other physicochemical properties in claim 35, and polypeptide sequence in claim 36). These claims, and by definition the baking claims 65 and 66, encompass a large number of potential enzymes, as Professor Hoseney also confirmed in cross-examination.
It was said that Examples 20 and 21, on which the appellants relied, did not specify that it was SEQ ID No 2, in toto, which was the enzyme that was required to be used, with the result that a number of options would have been open to the skilled addressee.
134 The primary Judge rejected the respondents' submission, even in this more sophisticated formulation. Her Honour said:
While the disclosure of the DNA sequence for the phospholipase includes sequences that encode parts only of a polypeptide and, Danisco says, it is not made clear whether the 'phospholipase encoding region' encodes for only one phospholipase, this does not mean that the Novo patent fails to disclose a purified phospholipase. Both of the witnesses understood that the enzyme disclosed in the Novo patent was the enzyme having the amino acid sequence identified as SEQ ID No 2. Professor Hoseney understood that the enzyme used in example 20 was in a substantially pure form and his opinion was not challenged in cross-examination. The specification, read as a whole, refers to and discloses the use of an isolated, purified enzyme, cloned and characterised.
With respect to Example 20, her Honour said:
It is not stated that the enzyme to be used is of the whole of the sequence of SEQ ID No 2. The Novo patent says that other fragments of that sequence may have phospholipase activity and that the use of 'a phospholipase' may have been intended to allow for the use of such fragments. However, I accept that the skilled reader, a baker and not a molecular biologist, would, as did Professor Small, assume that the enzyme was the enzyme of that sequence.
Her Honour also dealt with this question in that part of her reasons (to which I shall come) which concerned the appellants' point that Example 20 was anticipatory by inevitable outcome. It is useful to set out here what her Honour then said:
Danisco relies on the fact that example 20 says to use "a phospholipase" rather than specifying the enzyme of SEQ ID No 2. Other examples in the Novo patent do so specify. Danisco also contends that the precise polypeptide sequence of the enzyme to be used is not clear, because the Novo patent says that the active enzyme sequence is contained within SEQ ID No 2. However, for the purposes of both following example 20 and understanding the Novo patent to ascertain whether it anticipates the Patent, Danisco and Novozymes accept that the skilled addressee is not a molecular biologist but a baker. Professor Small read example 20 as referring to the enzyme the subject of the Novo patent: a phospholipase of the sequence SEQ ID No 2. Professor Hoseney also said this in an affidavit but conceded in cross-examination that he was not certain. I accept that the skilled addressee would know to use the enzyme of SEQ ID No 2 in the baking process of example 20.
135 Based as it substantially was on the reading of the Novo patent by both of the experts, her Honour's conclusion that the use of SEQ ID No 2 was disclosed in Example 20 would seem to be on fairly solid ground. Counsel for the respondents sought to challenge it, however, at two levels. First, with respect to the evidence of Prof Small, they submitted that the opinion that SEQ ID No 2 would be used was given in answer to leading questions under cross-examination, and was manifestly wrong. Secondly, with respect to the evidence of Prof Hoseney, they submitted that it was here that the true picture emerged, and it did so when they themselves cross-examined that witness. This was, it must be said, a somewhat unconventional way of making good an evidentiary case, but the respondents sought to do so, and I shall consider the point.
136 The single-enzyme aspect of the Novo patent was not mentioned by the experts in their joint report. In his affidavit sworn on 5 August 2010, Prof Hoseney had said that, on his understanding, the patent related to "a particular enzyme, with phospholipase activity, which may be used in a number of industrial applications", and that the inventors had cloned "a single enzyme which has phospholipase A activity". Under cross-examination, these understandings were not directly challenged. Rather, senior counsel for the respondents took Prof Hoseney to Claims 35 and 36, thence to Claim 59, and thence to Claims 65 and 66, of the Novo patent, the end result of which was that, in baking applications, different polypeptides were referred to in the claims, depending upon, for example, the selection that the addressee made under Claim 36. Where the subject was, as here, scientific discourse, I would not regard the answers which Prof Hoseney thus gave to counsel's questions as sufficient to qualify his clear evidence in chief that the Novo patent disclosed the use of a single enzyme. Prof Hoseney was not, in terms, invited to reconsider what he said in chief, and her Honour was, in my view, amply entitled to decline to join the dots of scientific propositions as apparently invited to do by the respondents. And no sufficient basis for the Full Court to overturn her Honour's conclusion has been established.
137 Professor Small also gave evidence on this subject when cross-examined by counsel for the appellants. As accepted by counsel for the respondents, the witness answered simply and unequivocally in the affirmative to a number of questions which sought to have him confirm that the enzyme used in baking - the "phospholipase of the invention" as referred to in the specification - in the Novo patent was SEQ ID No 2. So far as I can see, this was not the subject of re-examination by counsel for the respondents (although they did re-examine Prof Small briefly on the following day). In these circumstances, it was not open to counsel to submit, either before her Honour or on appeal, that Prof Small's answers under cross-examination were wrong.
138 In the light of the evidence before the primary Judge to which I have referred (both of Prof Hoseney and of Prof Small), and the way the respondents' case was then conducted, I would reject the respondents' challenge to her Honour's conclusion that the Novo patent disclosed the use of a single enzyme in the processes which were relevant to the appellants' novelty case.
139 The next point with which the primary Judge dealt under the Novo patent related to the question whether the patent disclosed the generation of a second functional ingredient in its description of the use of the enzyme in the context of foodstuffs, essentially in baking. Here her Honour accepted, favourably to the appellants, that the enzyme which was disclosed in that context was SEQ ID No 2 and that that enzyme had both phospholipase and lipase activities. However, her Honour held that there was no disclosure, in the context of baking, of use being made of the lipase activity of the enzyme. Thus, there was no disclosure of the generation of a second functional ingredient by the reaction catalysed by the enzyme. Her Honour said:
The specification does disclose an enzyme with dual phospholipase and lipase activity. However, no use of lipase activity and phospholipase activity of the enzyme is described in the production of a foodstuff and there is no disclosure of such a use. The use that is referred to in the context of the dual activity is 'in standard uses of a lipase, in particular for use in cleaning and detergent compositions'. The description of the use of the enzyme in a process for the preparation of a foodstuff, exemplified in the use in baking, is in terms of phospholipase activity. [Her Honour's emphasis]
….
From the evidence, the disclosure in example 20, in the context of the Novo Patent specification, teaches away from the disclosure of the generation of a second functional ingredient by the enzyme acting on a second constituent.
Novozymes draws attention to isolated parts of the extensive Novo patent specification, combining passages and information to support a submission of disclosure of the invention of the claims of the Patent. Many of these disclosures require the skilled reader to draw conclusions as to, for example, activity at different pHs and a comparison of the enzyme's activity as a phospholipase and a lipase. This is not straightforward. The evidence from Professor Hoseney and Professor Small was to the effect that if the level of lipase activity is too low, it is not a simple matter of increasing the level of enzyme to obtain more lipase activity because increasing the dose to increase the impact of a minor activity could result in problems in the resulting product from the major activity, as demonstrated in Example 20. There are also some general statements that the phospholipase may also exhibit lipase activity. Relying on and adding together the statements to which Novozymes draws attention requires the reader to ignore other observations in the specification, such as the statement that 'the bread- and/or dough-improving composition of the invention may further comprise another enzyme. Examples of other enzymes are… a lipase (useful for the modification of lipids present in the dough or dough constituents so as to soften the dough)' and the fact that the example of the use of the enzyme in baking refers only to its phospholipase activity.
During cross-examination, Professor Small was taken to some of these passages individually and together, and asked to agree on what they revealed. I did not find that helpful. There is no single linear protocol disclosed in the Novo patent that can be unambiguously followed in the knowledge that all steps are explicitly defined. No such route was put to Professor Small. I am not satisfied that the skilled reader, as at the priority date and, therefore, without having read the Patent or having been alive to the issues in these proceedings, would have put together the various references relied on such that they amounted to the process of the claims of the Patent or, indeed, the use of an enzyme to obtain the functional ingredients of the claims in the process of preparing a foodstuff such as in baking. As both Professor Hoseney and Professor Small said, the skilled addressee's focus is on the look and taste of the loaf produced. In example 20, it is assessed by reference to the use of varying levels of an enzyme with phospholipase activity together with varying levels of its substrate, a phospholipid.
Further, while there is disclosure of a "dual activity enzyme" in the Novo patent, there is no disclosure that mono- or diglycerides generated by lipase activity perform some desired function in a foodstuff, whether as an emulsifier or otherwise as a functional ingredient. There is no disclosure of the use of such an enzyme in the preparation of a foodstuff. The use of the enzyme in such a process refers only to its phospholipase activity.
140 The appellants submitted that the primary Judge was in error not to have held that the Novo patent disclosed, either expressly or in terms that would be so understood by the skilled addressee, a baking process in which the phospholipase of the invention had lipase activity sufficient to generate a functional ingredient. There was little doubt but that the reaction catalysed by the enzyme in its phospholipase activity generated an ingredient (or ingredients); nor, as I understand it, but that the ingredient so generated would be functional. Rather, the problem concerned the sufficiency of the disclosure of the lipase activity. To the extent that there was such activity, I do not understand any issue to have been taken with Prof Hoseney's evidence that, acting on triacyl glycerols (naturally present in flour) in the presence of water, the enzyme would produce (amongst other things) monoacyl glycerols, that is to say, emulsifiers. So, if the Novo patent was to be understood as disclosing to the skilled addressee a lipase activity in the baking context, that would line up with the integer of Claim 1 in the patent in suit which required the generation of a second functional ingredient.
141 The appellants did not draw our attention to any passage in the Novo patent specification in which a lipase activity of the enzyme in baking was in terms disclosed. They pointed out that the specification disclosed that the enzyme had a dual (ie phospholipase and lipase) activity, and that it was useful in baking. In terms, however, the specification goes no further than to disclose the phospholipase activity in baking. The appellants pointed to the data in Example 9 which demonstrated the existence of a significant lipase activity of the enzyme. So much may be accepted, but those data were not reported at the pH of baking (5-6). Unhelpfully for the appellants, where the specification dealt specifically with the lipase activity, it gave as the only "particular" instance an application which involved cleaning and detergent compositions. Equally unhelpfully, in the context of a discussion of the "bread- and or dough- improving composition of the invention", the specification suggested that another enzyme might be used in conjunction with the phospholipase, including a lipase. As her Honour pointed out, this tended to teach away from the anticipatory position for which the appellants contended. I agree with her Honour that, considered overall, there is no "single linear protocol disclosed in the Novo patent" with respect to the lipase activity of the enzyme in baking, and that the skilled reader would have "to draw conclusions as to … activity at different pHs and [make] a comparison of the enzyme's activity as a phospholipase and a lipase" if he or she were to come to such a position.
142 Turning to what the skilled addressee would readily have understood from the specification in the Novo patent (even if only implicitly), Prof Hoseney accepted that, in choosing a dosage of the enzyme which was sufficient to achieve a lipase effect, "it's difficult to be sure when you have two activities and you don't have a way of separating them". I understood the witness there to be dealing with the circumstance that, while the data reported under Example 9 did show the existence of lipase activity, that was not at the pH of bread making. Prof Hoseney took the view that the lipase activity would be somewhat less at pH 5-6, albeit still occurring. If, in the baking context, one wanted to be confident of obtaining lipase activity, one would adjust the dosage of the enzyme added, but that in itself may not be uncomplicated as it would, at the same time, increase the potential for phospholipase activity beyond what might be desired.
143 In the light of this and the other evidence to which I were referred, I consider that the primary Judge was well-justified in her conclusion that the Novo patent did not, even implicitly, disclose to the skilled addressee the generation of a second functional ingredient from the addition of a lipase to a bread making process. Such an addressee might well have thought that such an outcome was within the range of reasonable possibilities, but the specification did not give him or her a clear direction, even an implicit one, towards that outcome.
144 That brings me to what was probably the appellants' main challenge to the primary Judge's conclusion that the Novo patent did not anticipate Claim 1 of the patent in suit. It was that a skilled addressee, instructed by Example 20 of the Novo patent at the priority date, would inevitably have followed a process which would, had it been done after that date, have amounted to an infringement of Claim 1. If so, Example 20 was anticipatory: Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235. If such an outcome would have been inevitable, it would make no difference that the skilled addressee had not been expressly or implicitly instructed to seek it, or even that he or she did not understand what was being done: The General Tire and Rubber Co v The Firestone Tyre and Rubber Co Ltd [1972] RPC 457 at 485-486; Lundbeck 177 FCR at 192 [182].
145 Because of the importance of the concepts involved in the parties' cases on appeal under the Novo patent, it is useful to commence with what the UK Court of Appeal said on the subject of anticipation by inevitable outcome in General Tire ([1972] RPC at 485-486):
If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented: Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. (1908) 25 R.P.C. 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers Electrical Co. Ltd. (1928) 45 R.P.C. 1 at 24, line 1). A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
In Lundbeck, this was accepted as stating the law in Australia (177 FCR at 192 [182]) and, in the present case, was accepted as applicable to the present question by both parties.
146 Although her Honour observed that the present case was not, as was General Tire, concerned with a product patent, I do not understand her to have proposed that the Court of Appeal's statement was inapplicable to a patent that was one for a process. Neither did the respondents develop any argument that that statement was irrelevant to the circumstances of the present case on account of such a distinction. Indeed, in the terms employed by their Lordships to express the principle, "if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated" (emphasis added).
147 Turning next to the reasons of the primary Judge, having dealt with the three points of contention referred to above (single enzyme, generation of a second functional ingredient, and inactivation), under the heading "Inherency", her Honour said:
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 (see generally Lundbeck at [180]-[182] per Bennett J, Middleton J agreeing). 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 the claim (General Tire; Lundbeck at [181]-[182]).
Senior counsel for the appellants accepted this as a correct statement of the law. What might be noted at this stage is that the primary Judge treated the inclusion of an otherwise "missing integer" by reference to the understanding of the skilled reader and the inevitability of a particular outcome as but two examples of anticipation by "inherency".
148 After some other general observations under the heading "Inherency", her Honour proceeding to deal with the subject under the following subheadings:
• Is there anticipation by inevitable outcome?
• Is there anticipation by reason of the inherent activity of the enzyme disclosed in the Novo patent?
• Is there anticipation by reason of the use of Lipopan F in example 20 of the Novo patent?
• Could the disclosure have been complete before the priority date?
As I shall attempt to explain, the use of these subheadings did not involve the corollary that the subjects dealt with under each were separate and distinct bases for the examination of the question whether a relevant claim of the patent in suit was anticipated by the Novo patent.
149 Under the subheading "Is there anticipation by inevitable outcome?", the primary Judge first concluded that the skilled addressee would know to use the enzyme of SEQ ID No 2 in the baking process of Example 20. That followed upon her Honour's conclusion on the single enzyme point to which I have referred. She continued:
However, there is no information in example 20 concerning lipase activity and the testing for lipase activity that is reported in the Novo patent was not conducted under baking conditions. Novozymes has not established that even if the enzyme used in example 20 had both phospholipase and lipase activity, the use of the enzyme in each possible dosage would result in a non-de minimis amount of mono- or diglyceride being generated as a second functional ingredient. Novozymes led no evidence to establish that the skilled addressee, following example 20, would inevitably produce the subject matter of the claims of the Patent.
In the appellants' case on appeal, this was a critical passage in her Honour's reasoning, and I shall return to it. I should first, however, address the subjects dealt with under the succeeding subheadings in this part of her Honour's reasons, and how they related, if at all, to this passage.
150 Under the subheading "Is there anticipation by reason of the inherent activity of the enzyme disclosed in the Novo patent?", the primary Judge recorded that the appellants had submitted "that the disclosure of the enzyme of SEQ ID No 2 in the Novo patent with directions to use the enzyme in example 20 will, by reason of the inherent activity of the enzyme in baking, inevitably result in the process of the claims of the Patent." Her Honour's use of the word "inevitably" in this context appears not to be consistent with the thrust of the balance of the paragraph of her reasons where it appears, from which it is tolerably clear that she was dealing here with disclosure (express or implied) rather than with inevitability in the General Tire sense. Her Honour continued:
However, this would not necessarily disclose to the public or the skilled reader the claimed process. The disclosed enzyme is not the claimed process. Even if the use of the enzyme in baking disclosed an end result of a denatured or inactivated enzyme as I found above, it would not disclose the action of the enzyme to generate the emulsifier and the second functional ingredient by the enzyme in the claimed process. No such information was available from the disclosures of the Novo patent. No such information would be disclosed by the use of the enzyme. Novozymes' contention that the use of the enzyme as directed in example 20 equates to the disclosure of claim 1 of the Patent is therefore incorrect.
151 Her Honour next referred to the test for novelty under s 7(1) of the Patents Act, which invokes the concept of "information in a document made publicly available." Her Honour continued:
Where sufficient information is not present in a publicly available document and the party alleging the anticipation relies on the use of the information in that document, it must be shown that information equivalent to the claimed invention was publicly available prior to the priority date. Novozymes is relying on directions to use an enzyme in order to complete a disclosure of information that is of itself insufficient to anticipate the invention of the claims. It is not sufficient for the purposes of Novozymes' claim of anticipation by reason of the inherent activity of the enzyme only to provide information that enables the use of an enzyme in baking that will "inherently" result in the claimed process where, at the end of that use, the public will be none the wiser as to the integers of the claims.
Senior counsel for the appellant described the last sentence in this passage as being based on "a clear error of law", namely, the statement of a requirement, in a case involving so-called inherent disclosure, that the public must thereby become aware of the integers of the claims presumptively being anticipated.
152 The primary Judge next set out the well-known passage from the speech of Lord Westbury in Hill v Evans (1862) 1A IPR 1, 6-7, which senior counsel for the appellants accepted as stating the law in Australia so far as it went, but which, in the submission of counsel, did not "deal with this issue at all"; the issue, of course, being whether the relevant claims in the patent in suit were inevitably (in the General Tire sense) disclosed by Example 20 in the Novo patent.
153 The primary Judge continued:
The information disclosed in example 20 of the Novo patent is a direction to use an enzyme in baking. Even if the enzyme was the polypeptide of SEQ ID No 2 and had the requisite activity and would in fact have yielded two functional ingredients by generating them from the two constituents, there is no provision, disclosure or recognition of the reaction or of the fact that the products of the reaction had functionality in the foodstuff. This is not the case of an inevitably produced product of a disclosed process, as in General Tire, but of an alleged inevitable carrying out of a process with identified results. Where the Novo patent did not itself disclose the claimed process or the products of that process, there is no necessary disclosure of that information after the directions are followed. As discussed in Lundbeck at [180]-[190] per Bennett J (Middleton J agreeing), it is necessary for anticipation that the skilled addressee would add missing information as a matter of course, or that the prior disclosure of a process would lead inexorably to the product, or that a skilled addressee may observe on inspection sufficient to enable him or her to comprehend the complete invention. There is no sufficient evidence here that the performance of example 20 would necessarily infringe the claims of the Patent. In view of the limited information about any lipase activity of the phospholipase of the Novo patent, it cannot be said that the disclosure enables the skilled addressee to perceive, understand or apply that disclosure necessarily to obtain the claimed invention.
Put another way, the Novo patent does not contain clear and unmistakable directions to the process of the claims - a process with a specified result. The direction is to use the enzyme in baking. Without further direction, the skilled addressee who used that enzyme would not know that the result was the process. That information would not necessarily be made available to the skilled addressee or to the public. There is no suggestion in the Novo patent that the use of the enzyme in example 20 revealed that information to the inventors of the Novo patent.
Therefore, accepting for this aspect of consideration that:
• the use of the enzyme described in the Novo patent has inherent phospholipase, glycolipase and lipase activity;
• the Novo patent gives clear and unmistakable directions to use the enzyme of SEQ ID No 2 in baking; and
• the use of the enzyme in baking would give the results specified in the claims of the Patent;
I do not accept that this resulted in anticipation of the invention of the claims of the Patent prior to the priority date. Novozymes emphasises that the information is all contained in the Novo patent: that is, after obtaining the enzyme and following the direction to use it in baking, the skilled addressee would then obtain the foodstuff of the claims of the Patent. However, the information equating to the process of the claims was not disclosed in the Novo patent. There was no disclosure of the generation of the two ingredients or of two functional ingredients, one of which was an emulsifier. There is no prior information in the Novo patent as required to deprive the claims of the Patent of novelty under the Act. The skilled reader following example 20 would not inevitably obtain the products of the process of those claims. Even if, in the dosages used, the enzyme inherently generated those products, there is no evidence that this would have been ascertained or understood by the skilled addressee at the priority date. [Her Honour's emphasis.]
These passages were also criticised by counsel for the appellants as involving the importation by her Honour of "a requirement, in addition to inherency, that the public knows what is there." Counsel submitted that "the very point of inherency [is] that you don't see it on the page, but when you follow it, you end up doing it."
154 It is convenient here to return to the passage in her Honour's reasons set out at para 149 above, and to the appellants' criticism of it. In order to understand what her Honour - seemingly - meant by "non-de minimis", it is necessary to return to the treatment given in her Honour's reasons to Example 9 in the Novo patent.
155 I have set out the relevant extracts from Example 9 at paras 125-126 above. The tests, and the data, there referred to were the subject of the following passage in the reasons of the primary Judge:
The specification of the Novo patent then provides experimental results purporting to demonstrate dual activity by comparison with a commercial phospholipase and a commercial lipase. Professor Hoseney read those results as demonstrating that the enzyme had more lipase than phospholipase activity. Professor Small said that he would not accept the comparison quantitatively because different methods were used to measure the two activities. The Novo patent specification describes an enzyme which has 100 fold higher phospholipase than lipase activity at pH 7. There is no disclosure that, in the dosages used, the enzyme will generate mono- or diglycerides from any ester above de minimis.
It is the penultimate sentence, and the final sentence which seemingly flowed from it, in this passage that have become problematic.
156 The data from Example 9 were not to the effect that, at pH 7, the enzyme had 100 times more phospholipase activity than lipase activity. The reference to "100 fold higher activity" was to a comparison between the enzyme in question and a commercially-available phospholipase. To the extent that the data justified any comparison between the phospholipase activity and the lipase activity of the enzyme in question (a matter to which I shall turn in the next paragraph), it disclosed a ratio of 225 PHLU/mg : 1000 LU/mg. This was said, by the appellants, to disclose a more than fourfold higher activity of the lipase than the phospholipase. For their part, the respondents did not seek to defend her Honour's "100 fold higher phospholipase" statement, but contended that it was not central to her reasons on inevitability. To the extent that, in the submission of the respondents, anything could be derived from these data, it was that, compared with a commercially-available lipase, the enzyme had one-fifth of the lipase activity while, compared with a commercially-available phospholipase, the enzyme had 100 times the phospholipase activity.
157 In Example 9 of the Novo patent, assays of the activities of the enzyme as a phospholipase and as a lipase were set out. For this purpose, phospholipase units (PHLU) were a measurement of "the release of free fatty acids from lecithin" under conditions there defined, wherein "1 PHLU equals the amount of enzyme capable of releasing 1 Μmol of free fatty acid/min under these conditions". Lipase units (LU) were a measurement referred to in a publication of a company described as "Novo Nordisk" - presumably associated with the appellants - whereby "1 LU equals the amount of enzyme capable of releasing 1 Μmol butyric acid/min under standard conditions". In the proceeding below, there was extensive attention given to the question whether Example 9 justified the generalisation that, under conditions of pH 7 and 30°C, the activity of the Novo patent enzyme as a lipase was about 4.5 times (ie 1000/225=4.44) higher than its activity as a phospholipase. To put the matter as succinctly as the subject-matter permits, it was the project of counsel for the appellants to have Prof Small accept that this was a valid generalisation because, although different substrates were used for these assays, each was concerned with the amount of the enzyme required to release one micromole of a fatty acid per minute. Prof Small accepted that the words of the Novo patent seemed to be saying this, but he had quite serious reservations about the validity of the comparison. At the end of a lengthy period of cross-examination on this subject - which included an overnight adjournment - Prof Small expressed his position as follows:
So it's saying to me there is both lipase activity and there is also phospholipase activity. I would not be particularly keen to do the calculation and get 4.25 or whatever it was. I would say it has both activities based on the analyses. Now, if I was wearing a biochemistry enzymology hat, I would do what I did last night and look back at the methods and feel frustrated and think I'm not convinced I can do this comparison precisely, but it wouldn't change the fact that both activities are there and they may be useful to me if I'm a baker.
Senior counsel for the appellants pressed Prof Small to indicate whether he would agree that Example 9 showed "a higher lipase activity", even if not as the result of a precise comparison. At this point her Honour intervened by saying:
I think Professor Small has answered that. I mean, you've asked him that question on a number of occasions yesterday and today and I think he has answered it, Ms Howard. I don't think repeating it assists. He has given an answer. It's not susceptible to a yes, no, answer in his view, and he's given you an answer. I mean, you heard that last question, Professor Small, are you able to answer any more than you already have?
Prof Small was unable to answer any more than he had already. Asked (by her Honour) if he would be prepared to draw the conclusion that the Novo enzyme had far more lipase activity than phospholipase activity ("in other words, that those are directly comparable"), Prof Hoseney responded: "Within limits I would think yes, you have more lipase activity than you have phospholipase activity."
158 Returning to the passage from her Honour's reasons set out at para 149 above, several things need to be said. First, our attention was drawn to no place in the evidence where either of the experts used the term "de minimis". Whether the relevant field of science, like the law, does not concern itself with trivialities does not seem to have been the subject of attention. Secondly, assuming that her Honour's meaning was that there was no disclosure in the Novo patent of anything more than trivial lipase activity - and here it should be borne in mind that her Honour's de minimis finding was made in the context of a discussion of the results obtained under Example 9 - I would have to say that such a finding was contrary to the evidence. The point ultimately reached by the experts was that Example 9 disclosed an enzyme that had both activities. Prof Hoseney was prepared to make the limited observation that the lipase activity was more than the phospholipase activity. Prof Small was prepared only to say that there were both activities. Neither said, and neither was asked to accept, that the activity of the enzyme as a lipase was de minimis, or any relevant scientific equivalent of that.
159 Thirdly, as the respondents pointed out, the assays in Example 9 were carried out under specified conditions which were not, or at least were not necessarily, those found in baking, or in the preparation of foodstuffs of any kind. Amongst other differences, the assays were carried out at pH 7, whereas the typical range encountered by an enzyme used in baking would be between pH 5 and pH 6. It is at this point that the primary Judge, with respect, was on firmer ground in the conclusions which she expressed in the passage set out in para 149 above. However, on the appellants' case on appeal, her Honour declined to give effect to what was said to have been an admission by the respondents as to the lipase activity of the Novo enzyme in a baking context. It is now convenient to turn to the matters dealt with in her Honour's reasons under the third of the subheadings under "Inherency", namely, "Is there anticipation by reason of the use of Lipopan F in example 20 of the Novo patent?".
160 As the primary Judge pointed out in her reasons, originally the respondents had sued the appellants for infringement of the patent in suit by the distribution of a product called "Lipopan F", an enzyme produced by the appellants for use in baking. An aspect of the appellants' response to that was to contend that Lipopan F was the commercial embodiment of the enzyme described in the Novo patent, and that the respondents had thereby provided, by their own allegations, the basis for a successful defence of anticipation: Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465. In reaction to this development, according to the appellants, the respondents withdrew their allegations about Lipopan F, and focussed then on Lipopan Xtra. Notwithstanding that, the appellants' reliance upon the Novo patent, in their Fourth Further Amended Particulars of Invalidity, included the following particulars:
(e) the Fusarium oxysporum phospholipase described in [the Novo patent] is the Lypopan F enzyme …
(f) Lipopan F has lipase, glycolipase and phospholipase activity in dough in baking applications …
(g) [i]n the premises of (e) and (f) above, the process described in claims 1 and 7 of the Patent [in suit] would inevitably be performed by a person skilled in the art following the directions in [the Novo patent] to use the enzyme in baking ….
The subject covered by (f) was to have been supported by extensive evidence referred to in an earlier version of the appellants' particulars of invalidity, but the respondents admitted (f) and references to that evidence were excised from the particulars. This development was the subject of orders and directions made by the primary Judge on 30 September 2010, which were prefaced by a note to the effect that the respondents had confirmed that they admitted, for the purposes of the proceeding only, "that the commercial product Lipopan F has lipase, glycolipase and phospholipase activity in dough in baking applications".
161 The appellants also referred to a product sheet for Lipopan F which was before the primary Judge. It contained instructions to use a dosage of 400-900 LU of the enzyme for each kilogram of flour. Although it is not suggested that that sheet predated the priority date of the patent in suit, when read in conjunction with the admission referred to above, it would justify the conclusion that, when used at the dosages indicated, Lipopan F would have lipase, glycolipase and phospholipase activity. The appellants then pointed out that the three dosages used in Example 20 in the Novo patent were 500, 1500 and 3000 LU/kg. They submitted that it was therefore established that a skilled addressee, following Example 20 in 1998, would inevitably follow a process in which the enzyme was having lipase, glycolipase and phospholipase activity in baking.
162 On the appellants' case, the enzyme commercialised as Lipopan F was the enzyme disclosed in the Novo patent, and that patent disclosed, in Example 20, a standard baking application in which that enzyme was used in dosages known to be efficacious in baking, and, consistently with the admission referred to above, that enzyme would, in such an application, have lipase, glycolipase and phospholipase activity. In those circumstances, according to the appellants, it was not open for the primary Judge to reach the conclusion, as she did in the passage set out in para 149 above, that the appellants had not "established that even if the enzyme used in example 20 had both phospholipase and lipase activity, the use of the enzyme in each possible dosage would result in a non-de minimis amount of mono- or diglyceride being generated as a second functional ingredient."
163 How did the primary Judge deal with this aspect of the appellants' case? Her Honour's reasons under the subheading "Is there anticipation by inevitable outcome?" were relatively brief. Save for her treatment of the respondents' point about the identity of the enzyme, those reasons were confined to what is set out at para 149 above. It will be seen that that passage contained no reference to Lipopan F, to the respondents' admission, or to the development of the appellants' argument in the way described above. However, as noted above, her Honour did address these matters under the subheading "Is there anticipation by reason of the use of Lipopan F in example 20 of the Novo patent?". If one were to go by the subheadings only, one would get the impression that this section of the reasons was not concerned with inevitability in the General Tire sense, that being the required context for a consideration of this aspect of the appellants' anticipation case (it not being suggested that Lipopan F itself was introduced before the priority date for the patent in suit). But that would not be an accurate, or a fair, impression as to the scope of the matters with which her Honour dealt under this subheading.
164 The primary Judge said that the appellants relied on -
… the following admissions by and evidence of [the respondents]:
• SEQ ID No 2 is the enzyme identified as SP 972 in the Novo patent, although [the respondents qualify] this admission as accepting that the amino acid sequence identified as SP 972 appears in SEQ ID No 2.
• The only enzyme identified by its amino acid sequence is the enzyme SEQ ID No 2, which is the enzyme used in example 20 of the Novo patent.
• SP 972 is the enzyme present in the commercial product Lipopan F.
• Lipopan F has lipase, glycolipase and phospholipase activity in dough in baking applications.
• Example 20 of the Novo patent is a baking application involving common ingredients and a basic recipe.
• [The respondents] originally claimed infringement by the use of Lipopan F in baking. That allegation has not been withdrawn.
• Some of the documents relied upon to establish infringement by the use of Lipopan Xtra contain references to Lipopan F which are consistent with the characteristics of Lipopan F as set out above and evidence the inactivation of Lipopan F by baking.
• [The respondents] sought an admission from [the appellants], which was made, that Lipopan F is completely inactivated by baking.
Her Honour referred to the parties' submissions on the point, and noted her earlier conclusion that the skilled addressee would have understood that the reference to "a phospholipase" in Example 20 would be read as a reference to the enzyme of the amino acid sequence disclosed in SEQ ID No 2. However, her Honour said that, "[e]ven if that translated into an understanding that the enzyme was that identified as SP 972, that was the only information of the identity of the enzyme in the Novo patent." Her Honour said that it was now known that Lipopan F had both lipase and phospholipase activity in the dosages recommended for use, and that it was inactivated by the baking process. However, "that information was not available to the skilled addressee before the priority date." Her Honour concluded: "The necessary information was not disclosed in the Novo patent and the subsequently available information does not assist Novo to establish anticipation by reference to the prior art base."
165 To this point, the primary Judge was not concerned to address the appellants' case on inevitability. So much is clear from her Honour's references to the skilled addressee. It is clear also from the opening words of the next succeeding paragraph in her reasons:
As to [the appellants'] alternative submissions on inherency and inevitable result, even if the skilled reader were armed with the polypeptide sequence of SEQ ID No 2, there is no certainty that he or she would choose SP 972 to use in example 20. [The appellants point] out that the recommended dosage of Lipopan F in [the appellants'] literature ranges from 100 LU/kg to 750 LU/kg. Whether or not the reference to LU in example 20 in connection with phospholipase activity is an error (a matter as to which the experts were not certain), there is no information in example 20 that establishes that the skilled addressee before the priority date would have understood to use a dosage of the enzyme that would, inevitably, have provided the lipase activity to generate the functional ingredients of the process of the claims of the Patent or that the dosage chosen would inevitably have yielded the results of that process.
As it seems to me, it is in this paragraph that the primary Judge came to grips with, and rejected, the appellants' case that, because of what is now known about Lipopan F, a skilled addressee working Example 20 in the Novo patent (ie as at the priority date) would inevitably have followed a process described in Claims 1 and 7 of the patent in suit.
166 On the face of it, it is difficult to see, with respect, where the basis is for what lies at the core of her Honour's reasoning in the passage set out above, namely, that "there is no information in example 20 that establishes that the skilled addressee before the priority date would have understood to use a dosage of the enzyme that would, inevitably, have provided the lipase activity to generate the functional ingredients of the process of the claims of the Patent or that the dosage chosen would inevitably have yielded the results of that process". Her Honour's concern was with dosage, and dosages were set out explicitly in Example 20. They included dosages known to be, and apparently accepted by her Honour as being, efficacious in baking when Lipopan F was used. It is true that Example 20 set out a range of doses, but one of them (500 LU/kg) fell squarely within the range referred to in the appellants' product sheet for Lipopan F (400-900 LU/kg) and also within the range for Lipopan F referred to by her Honour (100-750 LU/kg). The proposition that, if followed at a dosage of 500 LU/kg, Example 20 would inevitably involve a baking process in which a single enzyme had both phospholipase and lipase activities would seem, in my respectful view, to have been made good by the appellants.
167 On appeal, the respondents made it clear that they did not seek to resile from their admission. Their main point related to the identity of the enzyme to which the skilled addressee would turn when working Example 20. What her Honour described, in the first bullet point in the passage set out in para 164 above, as a qualification to the respondents' admission was not, the respondents submitted, a qualification at all, but was, rather, what might be called a clarification. SP 972 was, it seems, the enzyme used in Lipopan F, and the respondents' point was that it was not the whole of the sequence identified as SEQ ID No 2 in the Novo patent. They submitted that the skilled addressee would not know which enzyme was the one to use under Example 20. This was the point which her Honour decided against the respondents, and in relation to which I would uphold her Honour's decision (see paras 131-138 above). I would hold, therefore, that the appellants' inevitability case, to the extent that it depended upon Lipopan F, was not compromised by any insufficiency of enzyme identification in the terms of Example 20. The same conclusion was at least implicit in the reasons of her Honour.
168 Senior counsel for the respondents submitted on appeal that his clients' admission did not cover a situation in which "the tiniest amount" of enzyme was used, but accepted that, if we were to hold that the admission covered "every possible amount", they would "lose on that point". For myself, I do not regard it as very fruitful to contemplate the circumstances of a skilled addressee who used only a "tiny amount" of the enzyme under Example 20, since the example itself provided dosages that fell within the range of efficacious use as shown in relation to Lipopan F. The admission was that Lipopan F had lipase, glycolipase and phospholipase activity in dough in baking, and clearly related to dosages which fell within those which a skilled addressee would use when working Example 20.
169 The respondents also pointed to the caution with which the expert witnesses expressed their conclusions about the lipase activity of the enzyme under the baking conditions prescribed in Example 20. The assays in Example 9 were not carried out under baking conditions, and neither Prof Small nor Prof Hoseney (although, it must be said, more obviously Prof Small) was prepared to express a quantitative view with respect to Example 20. That is true so far as it goes, but, in this aspect of their case, the appellants were not seeking to extract such a view from the expert evidence, or relying on it. Rather, they relied on the admission as such.
170 I am not, therefore, persuaded by the respondents' submissions that the conclusion which I provisionally expressed in para 160 above should not be drawn. There is only one further aspect of the matter that should be mentioned at this stage. Although in terms concerned with dosage, it may be that the critical passage in the reasoning of the primary Judge was intended (or intended also) to refer back to her Honour's earlier conclusion that the appellants had not established that the use of the enzyme disclosed in the Novo patent would result in a non-de minimis amount of mono- or diglyceride being generated as a second functional ingredient. With respect to the quantitative aspect of this proposition, I refer to what I have said at para 158 above. In the light of the admission, it was not for the appellants to establish that the lipase activity of Lipopan F was more than de minimis. With respect to her Honour's reference to the production of monoglycerides or diglycerides, it was not suggested by the respondents that the lipase activity of the enzyme, in a baking context, would not be such as would produce monoglycerides or diglycerides from fatty acid esters, nor that such monoglycerides or diglycerides, when produced, would not be functional in the relevant sense. Once it is accepted, as in my view it ought to be, that the respondents' admission was relevant to the appellants' case of inevitability under Example 20, it ought also be accepted that the lipase activity so admitted was such as to generate functional ingredients, and to do so to an extent that was relevant to that case.
171 Subject only to the final matter in this part of the primary Judge's reasons to which I shall next turn, I take the view that the appellants had done enough to demonstrate that, as at the priority date, if a skilled addressee had followed Example 20 in the Novo patent according to dosages of the enzyme there stated, he or she would inevitably have worked a process in which a single enzyme with a phospholipase activity and a lipase activity was generating two functional ingredients from the constituents being used.
172 That final matter related to the practical ability of the respondents, for example (or, for that matter, anyone else), to obtain the enzyme under the Novo patent in the limited period between the publication of that patent on 18 June 1998 and the priority date of the patent in suit, 21 July 1998. The respondents' point was that, in that period, it was fanciful to suggest that anyone beyond the Novo inventors and those with whom they worked, or with whom they were commercially associated, might have obtained the Fusarium oxysporum microorganism - which had been deposited on 25 November 1996 in Germany in accordance with the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, with a notation that until grant of a European patent, a sample was only to be provided to independent experts - cloned the enzyme of interest from it, and then applied that enzyme in the working of Example 20. This was said to be fatal to the appellants' inevitability case.
173 The primary Judge accepted the respondents' case in this respect. Her Honour said:
A patent is invalid for want of novelty if it has, by a prior publication, been given or disclosed to the public, prior to the priority date. Just as a prior existing document that has not been published before the priority date will not anticipate, a direction to use an enzyme which cannot be obtained prior to the priority date does not complete the necessary steps to have given the invention of the result of a process involving its use to the public. The disclosure, by way of the invention itself or the information that constitutes the invention, is not complete.
Even on a hypothetical basis, the hypothetical use of the enzyme is as directed in the prior publication. In this case, that is a direction to use an enzyme that was not commercially available at the relevant time. The information in the Novo patent would have required a person wishing to use the enzyme first to obtain the enzyme or to make the polypeptide of SEQ ID No 2 or of SP 972. That is, the only alternatives available to the skilled addressee were to seek to obtain the enzyme from the deposit as set out in the Novo patent or to attempt to make the enzyme of the amino acid sequence described in the Novo patent.
Her Honour said that it was for the appellants "to establish that the enzyme would have been available to the skilled worker seeking to follow example 20 prior to the priority date." But, according to her Honour, there was "no evidence as to whether the skilled addressee could simply produce a functional enzyme from the given DNA or amino acid sequence or whether he or she could obtain it in sufficient quantities to use it in baking." Her Honour continued:
[I]n this case, the fact is that the hypothetical skilled addressee had only 32 days in which to complete the disclosure by following the directions to use the required enzyme in baking. [The respondents assert] that the evidence is that it could not have been done. [The appellants have] not adduced evidence to demonstrate how a skilled addressee would follow the Novo patent teaching to obtain the process of the claims of the Patent before the priority date.
Her Honour's conclusion on this point was as follows:
It follows that even if I had found that the skilled addressee, following the instructions of example 20, would have been chosen to use the enzyme of SEQ ID No 2 and that such use would inevitably result in the process of the claims of the Patent [in suit], this disclosure could not have been complete before the priority date.
174 In my opinion, any consideration of the appellants' challenge to this aspect of her Honour's reasons must start in the terms of s 7(1) of the Patents Act, which provides:
For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a) prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;
(b) prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information;
(c) prior art information contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of prior art base in Schedule 1.
The "prior art base" is "information" of the kinds referred to in the definition of that term, and "prior art information" is defined correspondingly. For present purposes, it is sufficient to note that it was and is common ground that the Novo patent was information in the required sense and was "prior art information" as defined.
175 The point presently under discussion was not said by the respondents to be an answer to so much of the appellants' anticipation case as relied upon the terms of the Novo patent for the meaning they naturally conveyed to the skilled addressee (the appellants having failed on that case anyway). It was accepted by the respondents, therefore, that the Novo patent, although published only a little more than a month before the priority date of the patent in suit, was conventionally available as information for the purposes of s 7(1). But, at the point when the appellants contended that, even if the words of the Novo patent themselves did not convey, to the skilled addressee, a meaning which would anticipate the patent in suit, a working of Example 20 would inevitably give rise to a process which did so, the respondents rejoined that the General Tire approach was not available unless, as a practical matter, the example could in fact have been worked by someone whose first exposure to the subject had been a reading of the Novo patent on the day of its publication.
176 Her Honour accepted that the result which she was persuaded by the respondents to endorse was a "strange" one, in the sense that it would mean that any person who, at any time, did no more than follow the instructions in Example 20 would infringe the patent in suit, notwithstanding that he or she would be working according to information published before the priority date. It would also introduce a considerable area of uncertainty into the application of the General Tire test, in that it would require a judgment in each case on the question whether a sufficient time interval had passed between the prior publication and the priority date of the patent of interest to permit, in a practical way, the skilled worker to obtain the wherewithal to convert the published information into a realistic, working, artefact. As counsel for the appellants pointed out, the result of the application of the respondents' test in any particular case would also depend, to an extent, upon chance circumstances, such as the market availability of materials, reagents, spare parts, etc.
177 Although General Tire is part of Australian jurisprudence in the relevant area, it must be accommodated to the terms of s 7(1) of the Patents Act, upon which everything depends. That is to say, the inevitability of outcome to which General Tire refers must be such as would arise from recourse to the information referred to in the section. At the expense of repetition, it is here useful to remind ourselves of what the Court of Appeal said in that case ([1972] RPC at 485-486):
… if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated. [Emphasis added]
This proposition is explicitly hypothetical. It is concerned not with what has happened or with what could have happened, but with what would have happened if the directions were carried out. As such, the proposition is in complete harmony with s 7(1), and with every other presently relevant aspect of the jurisprudence in this area. It is not the doing of it, nor even the ability to do it, that amounts to anticipation: it is the content of the information. If the information contains directions which, if carried out, would constitute an infringement of the patent in suit, the invention under the latter is not novel.
178 In the view I take, the appellants' General Tire case was not compromised by the practical difficulties which would have confronted the skilled addressee putting Example 20 of the Novo patent into effect before the priority date of the patent in suit, and the primary Judge was in error to have held otherwise.
179 The remaining controversy with respect to the Novo patent relates to the requirement under the patent in suit that the enzyme be inactivated. The primary Judge decided this point favourably to the appellants, and the respondents have challenged that decision in their Notice of Contention. They relied on their submissions made in connection with the same point arising under the Qi Si patent, and I have said what needs to be said in that regard in paras 116-120 above. Additionally, the respondents directed some specific criticisms to her Honour's reasoning in relation to this aspect of the Novo patent.
180 The resolution of the inactivation issue with respect to the Novo patent required a comparison of what was disclosed by that patent with the terms of the patent in suit. As to the latter, the standard of inactivation, as determined by her Honour as a matter of construction, was that there be "no significant or material amount of active enzyme in the foodstuff". There was no challenge to that determination. As to the former, I would refer to what I have said at para 125 above as to the temperature stability of the enzyme under the Novo patent, and the statement, contained in Example 9, that "the active enzyme should not be expected in the final product in … baked products". The "baked products" context was given content by the directions in Example 20 (see para 127 above).
181 The primary Judge held that the information in the Novo patent was that, if desired, the enzyme may be inactivated, under heating conditions less stringent than those of Example 20. This was a reference to the disclosure in Example 9 that the enzyme was inactivated at pH 5 and 55°C and to the direction in Example 20 that baking should be carried out at 230°C for 22 minutes (rolls) or 35 minutes (panned bread). Her Honour accepted that "the baking conditions would have caused inactivation and that the skilled reader would, taking the whole of the disclosure of the Novo patent into account, have understood that the enzyme would have no phospholipase activity after the baking process." Her Honour was of the view that the Novo patent disclosed inactivation to the standard required, and that there was, in that patent, sufficient disclosure to the skilled addressee of the inactivation integer of the patent in suit.
182 The primary Judge continued:
The conditions of baking at which the enzyme is denatured are described variously in the specification, being in each case at lower temperatures and for shorter periods than as used in example 20. There can therefore be little doubt that, following the directions in example 20 of the Novo patent, the enzyme would be denatured or inactivated to the extent that no significant or material amount of active enzyme remains in the foodstuff.
Her Honour's references to what the patent in suit said about the details of the inactivation process seem to have been to two passages in particular. In the specification, it is said:
Yet further, enzymes may be denatured by heat. Thus in a further preferred aspect, the foodstuff/food material is heated after generation of the functional ingredient. The enzyme will be denatured and may then constitute protein. This is advantageous because the denatured enzyme need not be declared on the foodstuff/food material ingredients.
One of the examples - and the only one which relates to baking - in the patent in suit related to a sponge cake. That example directed the preparation of a mixture of sugar, glycerol, soya bean oil and "a lipase from Rhizopus arrhizus". That mixture was to be stirred for one day at 45°C, then "shortly treated at 100°C in order to inactivate the enzyme". Only then was the mixture used as an ingredient, with others, in a sponge cake recipe. Her Honour said:
The conditions for denaturing the enzyme in the Patent involve a lower temperature than that of example 20. There was no suggestion that baking for 22 minutes and 35 minutes as directed in the Novo patent were less rigorous than the timing of "shortly" in the Patent.
183 The respondents criticised her Honour for making a simple comparison between the baking instructions contained in the Novo patent and the requirements of the patent in suit. In particular, they emphasised that the sponge cake recipe in the patent in suit involved the heating of a premix at 100°C, such that the baking process itself was not relied on to inactivate the enzyme. By contrast, the baking example in the Novo patent contained no free-standing inactivation step and relied upon the centre of the dough of a roll or loaf becoming sufficiently hot, for a sufficient period of time, to achieve inactivation. The appellants responded to this by referring to the evidence mentioned by her Honour in the passage I have set out at para 119 above. They submitted that the skilled addressee would understand the baking example in the Novo patent as involving a sufficient temperature at the centre of the roll or loaf to avoid key-holing, and therefore to produce inactivation of the enzyme. However, while that kind of approach may well take the appellants to their required destination with respect to the quality of the Novo patent's disclosure of inactivation as such, it is no satisfactory answer to the respondents' criticism of her Honour's comparison between the Novo baking example and the sponge cake example in the patent in suit.
184 In my respectful view, the respondents' criticism is a valid one. The matter of anticipation is to be judged by reference to what the claims provide. If there is some element of uncertainty in the claims, recourse may be had to other parts of the specification to assist in the process of construction. But the question whether the claims had been anticipated by the Novo patent was not to be resolved by a comparison of the efficacy of inactivation steps proposed in particular examples in each. The only question for her Honour was whether inactivation to the extent required on a proper construction of Claims 1 and 7 of the patent in suit was disclosed in the Novo patent. The issues surrounding the temperature under which, and the time during which, the baking experiment in the Novo patent was to be carried out was undoubtedly relevant to that question, but I do not think it took the matter anywhere to point to an example in the patent in suit in which different baking conditions had been employed.
185 But that does leave the question which I have just identified. Here the debate differed only in immaterial respects from that carried on with respect to the Qi Si patent, with which I have dealt above. Stripped of the sponge cake comparison, the primary Judge's conclusion was that the Novo patent disclosed a process in which, in the eyes of the skilled addressee, the enzyme would be inactivated by the temperatures reached in baking. The experts would have so understood the direction given to bake in Example 20, and the references to inactivation in Example 9. I am not persuaded by the respondents that her Honour was in error in relevant respects.
186 That is not, however, the end of the matter apropos inactivation. In my reasons so far, the only respect in which I have departed from the primary Judge is that which relates to inevitability of outcome. I have agreed with her Honour that the Novo patent would not have disclosed to the skilled addressee the generation of a second functional ingredient. But I have taken the view that that deficiency would not compromise the appellants' inevitability case, since I have held that a second functional ingredient would inevitably have been generated in the enzymatic reaction referred to. The question arises: can the appellants piece together a complete case on anticipation by reference to express or implied disclosure for some integers, and inevitable outcome for others? Specifically in relation to inactivation, if they otherwise have to resort to General Tire to make good their case, can they rely on what the skilled addressee would have understood on the matter of inactivation, or do they also have to establish, in point of hard fact, that the enzyme would have been inactivated by baking at the temperatures, and for the times, set out in Example 20? In a case otherwise heavily laden with factual and legal questions, this particular one appeared to go almost unnoticed in the parties' submissions on appeal, although it was mentioned in passing by senior counsel for the respondents, who submitted, in relation to the passage in the Novo patent about "the low stability of the enzyme" (see para 125 above) that was "a better disclosure than the one in Qi Si … but it certainly does not establish the inevitability point". The sufficiency of the respondents' reliance on this point, if they are to be understood as relying on it, is something to which I shall return.
187 In my view, the General Tire approach, if taken at all, may be taken only with respect to the whole of any claim asserted to have been anticipated. The "precise destination" at which the flag must have been planted is one which includes every integer of the claim. The approach cannot, in my view, be taken for some integers only, leaving others to be dealt with by reference to the understanding of the skilled addressee. In the present context, what this means is that, to the extent that the appellants' case is based on General Tire, it is not sufficient that they be able to point to passages in the Novo patent from which it would appear to the skilled addressee that inactivation was contemplated or intended by the earlier inventors. It is necessary that they show that, if Example 20 were worked as directed, it would inevitably, as a matter of hard fact, have involved inactivation of the enzyme (to the standard set up under Claims 1 and 7 of the patent in suit as identified by the primary Judge) at the baking stage.
188 Was the evidence below sufficiently categorical for those purposes? Here the appellants have the benefit of findings by the primary Judge that "the baking conditions would have caused inactivation" and that "[t]here can therefore be little doubt that, following the directions in example 20 of the Novo patent, the enzyme would be denatured or inactivated to the extent that no significant or material amount of active enzyme remains in the foodstuff." These findings related to what would have happened in fact, not merely to the understanding which the skilled addressee would have derived from the terms of the Novo patent.
189 In his affidavit sworn on 8 October 2009, Prof Hoseney said:
In both cases [ie under Examples 20 and 21], as the bread is baked at 230°C …, the result of the process is a food stuff comprising an emulsifier, a fatty acid ester and the enzyme in a denatured and therefore inactive form.
In his affidavit sworn on 17 February 2010, Prof Small made no comment about this aspect of Prof Hoseney's evidence (although he dealt extensively with Prof Hoseney's affidavit in other respects), and, indeed, said nothing about inactivation in the context of the Novo patent. Possibly for that reason, the subject was not touched upon in Prof Hoseney's second affidavit of 5 August 2010; nor, for that matter, in the joint report of the two experts. Those circumstances, I infer, were responsible for the way the subject was dealt with in the cross-examination of Prof Small by senior counsel for the appellants. She pointed to the fact that he had said nothing about it in his affidavit, and that he had not noted it to be an issue in the joint report. However, the subject having been raised, Prof Small said that the question "brings us back to the discussion we've had on numerous occasions about what happens inside a loaf". Prof Small's attention was drawn to the stability data (and accompanying passage) in Example 9 of the Novo patent (see paras 125-126 above), and it was put to him that he would "understand the patent to be telling you that this enzyme used would be inactivated in baking". His response was, "It is, using the data provided, to indicate that they think it would be." There was no re-examination directed to this subject.
190 I desire to say something next about the approach which the respondents took to this point. In part that approach is implicit from the structure of the evidence of Prof Small, to which I have just referred. In their Notice of Contention, the respondents sought to uphold the primary Judge's conclusion under the Novo patent on grounds which included that the Novo patent did not "disclose the use of a process wherein the enzyme is inactivated or denatured". That very broad way of putting may have been sufficient to accommodate a challenge to the findings of her Honour to which I have referred in para 181 above. That it should be so understood was not, however, conspicuous. In their outline of submissions in support of their Notice of Contention, no challenge was advanced to those findings, and no indication was given that the appellants' inevitability case under the Novo patent should be regarded as compromised by their failure to establish, as a matter of fact, that the enzyme would necessarily be inactivated under Example 20. Neither was there any such indication given in the respondents' outline in response to the appellants' outline in support of their ground of appeal on inevitability. It is scarcely surprising, in the circumstances, that almost nothing was said about the point at the hearing of the appeal. This would have been consistent with a silent understanding that, if we were to uphold the primary Judge's view about inactivation as disclosed in the Novo patent, it would carry the appellants the distance required to defend her Honour's findings about inactivation in fact under that patent.
191 The position reached is, therefore, as follows. Prof Hoseney gave specific evidence on the subject of inactivation, in fact, under the Novo patent. No qualification to that was ventured by Prof Small until the matter was raised in the course of his cross-examination. That qualification was more negative than positive, and effectively left Prof Hoseney's evidence untouched. As mentioned above with respect to the Qi Si patent, there appeared to be little doubt but that any enzyme under contemplation for a baking application would be incapable of surviving conventional baking conditions. If it did, as her Honour pointed out, "key-holing" would be a problem. The enzyme described in the Novo patent was inactivated, at pH 5 and at a temperature of 55°C. It is true that this was under laboratory conditions rather than in the oven, but it was done at a pH which was relevant to baking. And there did not, in the evidence before her Honour, seem to be any real doubt but that such an enzyme, even in the centre of a loaf, could not survive conditions which would exist after the loaf had been subjected to baking at 230°C for 35 minutes. When this is added to the approach taken to the matter by the respondents on appeal, which was equivocal at best, I would conclude that they have not done enough to displace the findings made by the primary Judge to which I have referred in para 181 above.
192 In my opinion the appellants are entitled to rely on those findings as part of their inevitability case under the General Tire principle. It follows that they have made good that case.
193 For the reasons I have given, I am of the opinion that the invention in suit insofar as claimed in Claims 1 and 7 was not novel in the light of the information contained in the Novo patent.