Danisco A/S v Novozymes A/S (No 2)  FCA 282
In a first instance decision the Federal Court recently considered what is required for a prior art document to inherently anticipate a later claim, finding that anticipation by inherent teaching requires not only the inevitable result later claimed but also a teaching or recognition of the desirability of the result. The Court’s analysis and findings potentially lead to the curious situation where performing a process described in the prior art may well constitute an infringement of a later patent.
FACTS OF THE CASE
At issue was Australian Patent No 752215 (the Patent), to Danisco A/S (“Danisco”). The Patent related to processes for producing foodstuffs, particularly baked goods, by using an enzyme to generate, in situ, an emulsifier and a second functional ingredient from constituents present in the starting food material, such as fatty acid esters (which include triglycerides, phospholipids and glycolipids) and subsequently inactivating the enzyme during the baking process. Such a process is considered advantageous since it minimizes the number of additives in the final product; desirable not only from a cost view point but also from a consumer view point. Danisco asserted infringement by Novozymes A/S (“Novozymes”) by virtue of their promotion and supply of their product Lipopan Xtra, for production of baked goods. Novozymes counterclaimed for revocation, asserting, inter alia, that the claims were anticipated by inherent teachings in the prior art of the claimed outcome.
It is useful to set out the particular claims of interest.
Claim 1 provided:
- A process for preparing a foodstuff suitable for consumption comprising an emulsifier, the process comprising the steps of
- (i) providing a food material containing a fatty acid ester and a second constituent;
- (ii) contacting the food material with an enzyme such that an emulsifier is generated by the enzyme from the fatty acid ester and a second functional ingredient is generated from the second constituent;
- (iii) inactivating or denaturing the enzyme to provide the foodstuff comprising the emulsifier, the fatty acid ester and the enzyme in an inactive form or a denatured form.
Claim 7 further specified:
- A process according to any one of the preceding claims wherein the foodstuff comprises at least the emulsifier and the second functional ingredient, and wherein the emulsifier and the second functional ingredient have been generated from the fatty acid ester and the second constituent of the food material by the enzyme.
In essence, Justice Bennett’s findings on anticipation turned on the construction of the term “functional ingredient” and whether the skilled person would recognise the presence and functional purpose of a product of the enzyme’s action in the prior art baking processes. In particular, Her Honour considered the meaning of the term “functional ingredient”, which included “emulsifier”, noting that the specification defined the term as a constituent that performs a specific function in the food stuff, and concluded that it is “the intention to provide a functional ingredient which performs a specific, desired function in the foodstuff.”
Upon consideration of the prior art documents alleged by Novozymes to anticipate the claims, Her Honour found that although the use of an appropriate enzyme in the preparation of baked goods was described, and it was acknowledged that products which would be formed in the described baking process were relevant functional ingredients, these documents did not provide the skilled reader with the requisite clear disclosure of the presence and purpose of the emulsifier and second functional ingredients so formed.
Her Honour did, however, acknowledge that even though the prior art did not explicitly disclose all the claimed features, anticipation could still be found if the publication contained a direction to use a process that inevitably resulted in something within the claim1.
Novozymes relied on one particular example in the WO98/26057 (the Novo patent) for baking bread, alleging that the directions to use the disclosed phospholipase of SEQ ID No 2 (which also had lipase activity) would result in the generation of both an emulsifier (from lecithin, a phospholipid) and a second functional ingredient (from triglycerides) in the dough.
However, although it was not disputed that the Novo patent disclosed an enzyme with dual phospholipase/lipase activity, no evidence was led by Novozymes that the amount of enzyme used in the example would result in a non-de minimis amount of a second functional ingredient being generated and Justice Bennett refused to find that the skilled addressee would inevitably produce the subject matter of the claims of the Patent.
Her Honour also made the point of distinguishing between the disclosure of the use of the enzyme and its properties, and the process and results claimed in the Patent. In particular, her Honour found that even if the Novo patent contained directions to use the enzyme which by reason of its inherent activity would result in the claimed process, this would not necessarily disclose to the public or the skilled reader the action of the enzyme on constituents of the foodstuff to generate an emulsifier and a second functional ingredient as per the claimed process. It was specifically noted that not only was such information not available from the disclosures of the Novo patent, no such information would be disclosed or become apparent by the use of the enzyme in baking as directed. In the sense of Hill v Evans2, it was not established that the skilled person would at once be able to perceive, understand and be able practically to apply the discovery without the necessity of making further experiments and gaining further information before the invention can be made useful.
At  Her Honour stated:
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.
Novozymes also relied on the “Gillette Defence” 3 in respect of Danisco’s initially alleged infringement by Novozymes’ product Lipopan F, the active ingredient of which is an enzyme with a sequence which appears in SEQ ID No 2, although Danisco later withdrew that claim. Novozymes argued that the skilled person using Lipopan F in baking would infringe the Patent and would be unable to practice the prior art. Her Honour rejected this approach, noting that although it is now known that Lipopan F has both lipase and phospholipase activity in the dosages presently recommended for use, that information was not available to the skilled addressee from the Novo patent.
Her Honour did however acknowledge that this finding leads to a potential situation where a person who now follows the directions of the Novo Patent infringes the claims of the Patent, and that, when put broadly in this manner, this seemed a somewhat strange result. However, this was deemed to be a consequence of the grounds of invalidity available and the evidence adduced. Her Honour also found that Novozymes’ case imported a measure of hindsight knowledge of the Patent as the emphasis in the Novo patent was not on the use of an enzyme with both phospholipase and lipase activity in baking, or the desirability of using such.
In any event, Her Honour found that even if following the instructions of the Novo patent would have inevitably resulted in and taught the claimed process, the disclosure could not have been completed before the priority date of the Patent. This was because the Novo patent was published only 32 days before the priority date of the Patent, and although a sample of the microorganism from which enzyme of SEQ ID No 2 was obtained had been deposited in accordance with the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, there were restrictions on its access and a person wishing to repeat the relevant example of the Novo patent would not have been able to do so before the priority date of the Patent.
Her Honour found no difficulty in concluding infringement by supply under section 117, finding that Novozymes supplied to bakers their Lipopan Xtra product, which was capable of only one reasonable use, with inducements to use the product in a manner which would fall within the scope of the claims of the Patent.
In reaching her conclusions, Justice Bennett has applied well established case law regarding anticipation, requiring that the prior art make the nature of the invention, either expressly or through the following of instructions, apparent to the skilled addressee. In a situation where the nature of the later claimed invention is apparent to the skilled addressee once the prior art instructions have been followed, the generally accepted approach to inherent anticipation would still seem to hold sway, provided, of course, that the subsequently claimed invention is inevitably achieved. Yet, somewhat incongruously, in a situation where the nature of the subsequent invention cannot be gleaned or recognised by performing prior art instructions, without knowledge of the subsequent invention, a potential situation arises where a person could follow prior art teachings and yet infringe a later patent, begging the question: does the Gillette defence have any application in such a situation? Her Honour would appear to think not. The decision is currently under appeal.