Danisco A/S v Novozymes A/S (No 2)

[2011] FCA 282

FEDERAL COURT OF AUSTRALIA

Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282

Citation:

Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282

Parties:

DANISCO A/S and DANISCO AUSTRALIA PTY LTD (ACN 096 139 392)   v NOVOZYMES A/S and NOVOZYMES AUSTRALIA PTY LTD 
(ACN 001 420 677)

File number:

NSD 1968 of 2008

Judge:

BENNETT J

Date of judgment:

29 March 2011

Catchwords:

PATENTS – construction of claims – clarity – claim narrower than specification – meaning of “an enzyme” – meaning of “generated from” – meaning of “functional ingredient” – meaning of “inactivating or denaturing the enzyme” – construction difficult – not render claim invalid – clear construction available

PATENTS – construction of claims – based on language of independent claim, second constituent does not include water – water stated as a second constituent in specification and dependent claim – patentee says reference to water is a “mistake” – whether water can be constituent of independent claim

PATENTS – construction of claims – limitation by result – inactivated or denatured enzyme – standard of inactivation – workable standard – no significant or material amount of active enzyme

PATENTS – invention – relevance of Invention Disclosure Statement to construction of claims – relevance of Invention Disclosure Statement to inventive step – relevance of Invention Disclosure Statement to characterisation of invention

PATENTS – infringement – whether infringement by supply of product pursuant to Patents Act 1990 (Cth) s 117 – ss 117(2)(a), (b) and (c) – whether indirect infringement as joint tortfeasor

PATENTS – validity – novelty – understanding of skilled reader following directions in prior publication – whether following directions would disclose the process – whether following directions would disclose the results of the process being essential integers of the claims – whether there was disclosure of products of the process as functional ingredients – whether information in prior publication discloses the integers of the claimed process

PATENTS – validity – novelty – anticipation by use –
whether anticipation by “inevitable result” – inherent activity of enzyme disclosed – whether clear and unmistakable directions to the process of the claims where claims include specified result and meaning of prior information – whether, where disclosure is incomplete in prior publication, completion by following directions must be publicly available prior to priority date – whether anticipation by “inevitable result” where resulting information not available prior to priority date – enzyme and clone deposited – hypothetical use – whether enzyme could in fact have been obtained for use prior to priority date – whether information equating to the result was disclosed prior to the priority date – whether skilled addressee would know that result of use of enzyme in prior art document was claimed process – whether necessary for anticipation by inevitable result for directions in prior art document to have been able to be followed by skilled addressee before priority date of the patent

PATENTS – validity – novelty – “whole of contents” citation pursuant to paragraph (b)(ii) of “prior art base” definition – identification of “information” under paragraph (b)(ii) of “prior art base” definition – drafting of notional claims – whether permissible to draft notional claims with hindsight – notional claims alter words used in consistory clause – whether notional claims fairly based – whether notional claims contain information that anticipates the claims of the patent

PATENTS – validity – obviousness – inventive step – “problem and solution” approach – whether material in specification is part of problem or solution – whether necessary for lack of inventive step to prove  skilled addressee would try each integer of process – whether reference in specification to enzyme from unpublished specification made enzyme part of common general knowledge

PATENTS – manner of manufacture – whether lack of manner of manufacture apparent on face of specification – whether new substance, new characteristic of a known substance, new use or new method – cross-reference to unpublished priority application – statement of incorporation by reference – whether whole of unpublished priority application can be taken into consideration – whether reference to nature and characteristics of enzyme incorporated the whole of the prior document – whether disclosures of unpublished priority application describe invention

Words & phrases:

“an enzyme”, “functional ingredient”, “generated from”, “inactivating or denaturing the enzyme”

Legislation:

Patents Act 1990 (Cth) ss 7(1), 7(2), 13(1), 18(1)(a), 18(1)(b), 40(3), 117(1), 117(2)(a), 117(2)(b), 117(2)(c)
Patents Regulations 1991 (Cth) reg 3.25

Cases cited:

AbbottGMBH and Co KG v Apotex Pty Ltd (No 2) (2010) 87 IPR 561 cited
Aktiebolaget Hassle v Alphapharm Pty Ltd (2002) 212 CLR 411 applied
Alcatel NV v Commissioner of Patents (1996) 68 FCR 8 cited
Apotex Pty Ltd (formerly GenRx Pty Ltd) v Sanofi-Aventis (2008) 78 IPR 485 cited
Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416 applied
Bristol-Myers SquibbCo v FH Faulding & Co Ltd (1998) 41 IPR 467 cited
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524 cited
British United Shoe Machinery Co Ltd v A Fussell & Sons Ltd (1908) 25 RPC 631 cited
Caterpillar Inc v John Deere Ltd (1999) 48 IPR 1 cited
Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 cited
Collins v Northern Territory (2007) 161 FCR 549 cited
Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 cited
Decor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 cited
Dura-Post(Aust) Pty Ltd v Delnorth Pty Ltd (2009) 177 FCR 239 applied
E I Du Pont de Nemours & Co v ICI Chemicals & Polymers Ltd (2005) 66 IPR 462 applied
Flexible Steel Lacing Company v Beltreco (2000) 49 IPR 331 cited
General Tire & Rubber Co v Firestone Tire & Rubber Co Ltd (1971) 1A IPR 121 applied
Gibson and Campbell v Brand (1841) 1 WPC 631 cited
Gillette Safety Razor Company v Anglo-American Trading Co Ltd (1913) 30 RPC 465 cited
HLundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151
Henriksonv Tallon Ltd [1965] RPC 434 cited
Hill v Evans (1862) 1A IPR 1 applied
ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc (2000) 106 FCR 214 cited
Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd (2008) 78 IPR 20 cited
Inverness Medical Switzerland GmbH v MDS Diagnostics Pty Ltd (2010) 85 IPR 525 cited
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 1) (2004) 217 CLR 274 cited
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173
Martin v Scribal Pty Ltd (1954) 92 CLR 17 cited
Memcor Australia Pty Ltd v GE Betzdearborn Canada Company (2009) 81 IPR 315 cited
Merck & Co Inc v Arrow PharmaceuticalsLtd (2006) 154 FCR 31 cited
Minnesota Mining& Manufacturing Co & 3M Australia Pty Ltd v Beiersdorf (Aust) Ltd (1980) 144 CLR 253 cited
Mölnlycke AB v Procter & Gamble Ltd(No 4) [1992] 4 All ER 47 cited
Morgan & Co vWindover& Co (1890) 7 RPC 131 cited
National Research Development Corp v Commissioner of Patents (1959) 102 CLR 252 applied
Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 cited
Northern Territory v Collins (2008) 235 CLR 619 considered
NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 cited
Ramset Fasteners (Aust) Pty Ltd v Advanced Building Systems Pty Ltd (1999) 164 ALR 239 cited
Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 65 IPR 605
Welch Perrinand Co Pty Ltd v Worrel (1961) 106 CLR 588 cited
Welcome Real-Time SA v Catuity Inc (2001) 113 FCR 210 cited
Wellcome Foundation Ltd vVR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 applied

Industrial Property Advisory Committee, Patents, Innovation and Competition in Australia (Industrial Property Advisory Committee, Canberra, 1984)

Date of hearing:

August 30 - 3 September and 1 - 5 November 2010

Date of last submissions:

10 March 2011

Place:

Sydney

Division:

GENERAL DIVISION

Category:

Catchwords

Number of paragraphs:

378

Counsel for the Applicants:

Mr D Catterns QC with Mr C Dimitriadis and Mr C Burgess

Solicitor for the Applicants:

Wrays Lawyers

Counsel for the Respondents:

Ms K Howard SC with Mr P Flynn and Mr R Schaffer

Solicitor for the Respondents:

Shelston IP Lawyers

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION	NSD 1968 of 2008

BETWEEN:

DANISCO A/S
First Applicant/Cross Respondent

DANISCO AUSTRALIA PTY LTD (ACN 096 139 392)
Second Applicant

AND:

NOVOZYMES A/S
First Respondent/Cross Claimant

NOVOZYMES AUSTRALIA PTY LTD (ACN 001 420 677)
Second Respondent

JUDGE:	BENNETT J
DATE OF ORDER:	29 March 2011
WHERE MADE:	SYDNEY

THE COURT ORDERS THAT:

1.The parties submit draft orders to give effect to these reasons, including as to reserved costs and the future conduct of the proceedings, by 4 p.m. on 31 March 2011.

2.The parties notify Bennett J’s chambers by 4 p.m. on 30 March 2011 if there are confidentiality concerns as to [141] and [163] of the reasons.

3.The matter be stood over for directions to 9:30 a.m. on 1 April 2011.

Note:Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
The text of entered orders can be located using Federal Law Search on the Court’s website.

IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION	NSD 1968 of 2008

BETWEEN:

DANISCO A/S
First Applicant

DANISCO AUSTRALIA PTY LTD (ACN 096 139 392)
Second Applicant

AND:

NOVOZYMES A/S
First Respondent

NOVOZYMES AUSTRALIA PTY LTD (ACN 001 420 677)
Second Respondent

JUDGE:	BENNETT J
DATE:	29 March 2011
PLACE:	SYDNEY

REASONS FOR JUDGMENT

1. The applicants (together Danisco) sue the respondents (together Novozymes) for infringement of Australian Patent No 752215 entitled “Foodstuff” (the Patent).  The Patent relates to a process for preparing a foodstuff comprising certain steps which involve the use of, inter alia, an enzyme.  Lipopan Xtra is a Novozymes product said by Danisco to infringe the Patent.  The important claims for the purpose of Danisco’s infringement case are claims 1, 2, 7 and 14, although Novozymes’ cross-claim for revocation is broader.

2. Novozymes’ cross-claim seeks revocation of the Patent on the grounds set out in its Fourth Further Amended Particulars of Invalidity, being that:

   (a)the alleged invention, as claimed in claims 1 to 9, 14 and 15 of the Patent is not a manner of new manufacture (s 18(1) of the Patents Act 1990 (Cth) (the Act));

   (b)the alleged invention, as claimed in claims 1 to 9, 14 and 15 of the Patent is not novel (s 18(1)(b)(i) of the Act) in light of:

   (i)US Patent no. 3,386,903 (the Johnson patent);

   (ii)International Patent Application no. WO 94/04035 (the Qi Si patent);

   (iii)International Patent Application no. WO 98/26057 (the Novo patent); and

   (iv)International Patent Application no. WO 98/45453 (the Poulsen patent);

   (c)the alleged invention did not involve an inventive step when compared with the prior art base (s 18(1)(b)(ii) of the Act); and

   (d)the claims of the Patent are unclear (s 40(3) of the Act).

3. In its written submissions filed after the completion of the hearing, Novozymes raised the question of fair basis and indicated reliance on this ground as an alternative.  No application was made to amend the Fourth Further Amended Particulars of Invalidity to raise fair basis as an alternative ground.  It was clear that Danisco did not consent to any such ground being relied on.  Indeed, Danisco says, and it is not disputed, that it ran its case on the understanding that lack of fair basis was not relied on.  I shall not consider it further as a ground for revocation.

4. The present hearing is concerned with issues of liability only, issues of the quantum of any pecuniary relief having been reserved for later determination.

5. The Patent was granted on an application filed on 20 July 1999. As such, relevantly, the provisions of the Act as in force prior to the amendments effected by the Patents Amendment Act 2001 (Cth) apply.

6. The parties have agreed upon the contents of a primer which sets out technical background relevant to the litigation.  The primer, with some amendment, is Annexure A to these reasons.

7. In addition to their oral submissions, both parties provided several sets of written submissions after the hearing.  The positions taken in these written submissions were not always consistent with the parties’ earlier oral submissions or with other written submissions that were provided to the Court.  As a result, setting out each party’s submissions in their entirety is neither practical nor desirable.  I have, however, endeavoured to summarise the position taken by each party where appropriate.

8. These reasons are divided into the following sections:

THE PATENT........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[9]
The Specification........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[10]
The state of the enzyme at the end of the reaction........ ........ ........ ........ ........ ........	[21]
The description of the enzyme........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[25]
The functional ingredients and the constituents........ ........ ........ ........ ........ ........ ...	[26]
THE EXPERTS........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .....	[32]
Professor Small........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[33]
Professor Hoseney........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[34]
CONSTRUCTION OF CLAIMS 1 AND 7........ ........ ........ ........ ........ ........ ........ ........ ..	[37]
Legal Principles........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[37]
The Claims........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[42]
General comments........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .....	[49]
Construction of Claim 1........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[52]
Does claim 1 encompass the use of more than one enzyme?........ ........ ........ ........	[56]
Single and/or more than one reaction?........ ........ ........ ........ ........ ........ ........ ........ .	[61]
The submissions........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[66]
Consideration........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[73]
What is the meaning of “generated from”?........ ........ ........ ........ ........ ........ ........ ...	[78]
The submissions........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[80]
Consideration........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[84]
Can the second constituent be water?........ ........ ........ ........ ........ ........ ........ ........ ....	[87]
The submissions........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[88]
Consideration........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[90]
Can the second constituent be a fatty acid ester?........ ........ ........ ........ ........ ........ ..	[100]
What is a “functional ingredient”?........ ........ ........ ........ ........ ........ ........ ........ ........	[101]
What is the standard of the inactivation or denaturation of the enzyme?........ ...	[107]
Construction of Claim 7........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[114]
INFRINGEMENT BY LIPOPAN XTRA........ ........ ........ ........ ........ ........ ........ ........ ....	[118]
Lipopan Xtra characteristics........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[127]
The use of Lipopan Xtra........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ...	[130]
Integers of claims 1 and 2........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .......	[133]
Integers of claim 7........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[133]
Non-infringement arguments........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .	[133]
Can the second constituent in claim 1 be a fatty acid ester?........ ....	[135]
The extent of inactivation of the Lipopan Xtra enzyme........ ........ .....	[139]
Infringement by Supply – Section 117 of the Act........ ........ ........ ........ ........ ........ ...	[145]
Legal Principles........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[145]
Application of s 117(1)........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[148]
Application of s 117(2)(a)........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .......	[150]
Application of s 117(2)(b)........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .......	[153]
Application of s 117(2)(c)........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .......	[156]
Indirect Infringement as a Joint Tortfeasor........ ........ ........ ........ ........ ........ ........ ...	[159]
Legal Principles........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[159]
Application........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[162]
Indirect Infringement pursuant to s 13(1) of the Act........ ........ ........ ........ ........ .....	[169]
Legal Principles........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[169]
Application........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[170]
NOVELTY........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[174]
Legal Principles........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[178]
The Johnson patent........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[179]
The second constituent........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ...	[182]
Use of a single enzyme........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[183]
Generation of an emulsifier........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ...	[187]
A second functional ingredient generated from a second constituent........ ........ .	[190]
Inactivating or denaturing the enzyme........ ........ ........ ........ ........ ........ ........ ........ ..	[192]
The Qi Si patent........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .	[193]
The second constituent........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ...	[199]
Use of a single enzyme........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[200]
A second functional ingredient generated from a second constituent........ ........ .	[202]
Inactivating or denaturing the enzyme........ ........ ........ ........ ........ ........ ........ ........ ..	[205]
The Novo patent........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .	[212]
A single enzyme........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .......	[225]
The use of an enzyme to produce the second functional ingredient........ ........ ....	[227]
Inactivating or denaturing the enzyme........ ........ ........ ........ ........ ........ ........ ........ ..	[241]
Inherency........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[248]
Is there anticipation by inevitable outcome?........ ........ ........ ........ ........	[252]
Is there anticipation by reason of the inherent activity of the enzyme disclosed in the Novo patent?........ ........ ........ ........ ........ ........ ......	[254]
Is there anticipation by reason of the use of Lipopan F in example 20 of the Novo patent?........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[260]
Could the disclosure have been complete before the priority date?........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ...	[269]
The Poulsen patent........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[283]
Notional Claims........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[289]
Are the notional claims fairly based?........ ........ ........ ........ ........ ........ .....	[303]
Do the notional claims contain information that anticipates the claims of the Patent?........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ....	[307]
Conclusion on novelty........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[322]
INVENTIVE STEP/OBVIOUSNESS........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[323]
Legal Principles........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[326]
The common general knowledge........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[331]
The submissions........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .	[334]
Consideration........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .....	[343]
MANNER OF MANUFACTURE........ ........ ........ ........ ........ ........ ........ ........ ........ ........	[350]
Legal Principles........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ..	[355]
The face of the specification........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[357]
The Poulsen Priority Application........ ........ ........ ........ ........ ........ ........ ........ ........ .....	[366]
Consideration........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ .....	[367]
CONCLUSION........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ......	[377]

THE PATENT

1. The Patent claims priority from two basic applications filed in the United Kingdom, the earlier of which was filed on 21 July 1998.  There is no dispute in this proceeding that the claims of the Patent are entitled to that priority date.

   The Specification

2. The specification of the Patent provides a dictionary of some relevant terms.  “Functional ingredient” means any one of a number of constituents of the foodstuff which performs a specific function in the foodstuff, including an emulsifier, preservative, antioxidant, colouring and flavouring.  This is a wide class.  Preferably, the term “functional ingredient” is said to mean ‘a constituent of the foodstuff which has one or more of surface active properties, antioxidative effect, anti-bacterial effect including bacteriostatic effect and/or bactericidal effect and viscosity modifying effect, preferably viscosity improving effect’. 

3. “Functional” is not otherwise defined in the specification.  It is, however, relevantly defined in the Macquarie Dictionary (rev 3^rd ed, Macquarie, 2003) to mean ‘of or relating to a function or functions’.

4. “Foodstuff” means a substance which is suitable for human or animal consumption.

5. The invention described and claimed in the Patent is said to have application in relation to the preparation of foodstuffs generally but more particularly in the context of baking and the production of baked products.  The description in the Patent commences with a general statement of the field of the invention in the conventional way.  This indicates that the invention relates to a foodstuff, and more particularly a foodstuff comprising at least one functional ingredient which has been generated in situ by a conversion agent.  That is, the reference is to an enzyme and at least one (which includes one) functional ingredient. 

6. A discussion of the background to the invention is then provided. The background is said to be a desire to prepare foodstuffs meeting quality requirements while minimising the number of additives in the final foodstuffs.  Developments in the industrial preparation of food are noted, including the use of functional ingredients such as emulsifiers, hydrocolloids, preservatives, antioxidants, colourings and flavourings.  The Patent refers to recent demand from consumers to reduce the number of additives in foodstuffs, such as functional ingredients.

7. Reference is then made to various journal articles and patent specifications reporting the use of lipases in food production.  Various prior art publications are cited which teach the use of a lipase for the production of emulsifiers.  One of the publications refers to the use of a lipase for the hydrolysis and ester exchange of triglyceride, where the triglyceride is partially hydrolysed to free fatty acid and the partially hydrolysed triglyceride product is used for production of margarine.  Another refers to the transesterification of two oils or fats; another to rearrangement by transesterification of the fatty acid components of a fat or oil.  Each of the latter two publications are said to be relevant to use of the process in the production of margarine.

8. A further cited publication relates to the production of mayonnaise.  There, a lipase is added to a mixture of water and oil; the oil is degraded to free fatty acid or fatty acid salts (soap) and glycerol, which may provide the emulsifying properties.  In this context, the pH dependency is noted and the statement made that at low pH free fatty acid is present in the acid form, which has low emulsification properties, whereas at alkaline pH free fatty acid is available as a soap, which has good emulsification properties.  Whether or not this is a problem depends on the foodstuff to be produced.

9. The invention is said to address the problems of the prior art.

10. The specification then describes the invention.  As is not uncommon, the invention is described in the specification with increasing particularisation.

11. The invention as described in the first, second and third aspects of the invention does not correspond to claim 1.  For example, the conversion agent of these aspects is not necessarily an enzyme.  It is only three pages later that the specification states that preferably the conversion agent is a catalyst and that in a preferred or particularly preferred aspect the conversion agent is an enzyme.  As a further example of the breadth of those earlier described aspects of the invention, there is no reference to the requirement in claim 1 that the enzyme be denatured or inactivated, since the conversion agent of the second aspect of the invention is not limited to an enzyme.

12. The specification says that the invention utilises a conversion agent, such as an enzyme, to generate one or more functional ingredients such as emulsifiers, antioxidants or preservatives from a constituent or ingredients of a food material from which the foodstuff is prepared.  Instead of adding food additives produced by traditional chemical synthesis, this enables the in situ synthesis of a required functional ingredient.  This is said to overcome disadvantages that may arise with chemical synthesis, such as extreme conditions.  It also means that there is one less additive in the foodstuff.  This is advantageous because the reduction or elimination of additives is desirable to consumers and because additives often must be declared as ingredients by listing on the foodstuff.  The specification also states that, provided the conversion agent is suitably chosen so that it is compatible with the foodstuff in the sense of being edible, further processing of the foodstuff may not be necessary.  However, the invention encompasses foodstuffs which have been further processed.

    The state of the enzyme at the end of the reaction

13. Following this discussion, the specification turns to the use of a catalyst and preferably an enzyme as a conversion agent.  It explains that enzymes are particularly preferred because they are readily available, may be chosen to convert a specific constituent of the food material and/or may be chosen to generate a specific functional ingredient.  Yet further, the specification says, they 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.

    The use of enzymes is advantageous because denatured enzymes are considered, particularly under food labelling regulations, to constitute a processing aid.  Inactivated enzymes are not considered to be additives; the addition of additives to foodstuffs is undesirable to many consumers.

    Inactivation of the conversion agent, in particular denaturation of the enzyme, is advantageous because it allows one to control the amount of functional ingredient generated.  For example, the generation of the functional ingredient may be monitored (for example by measurement of the functional properties of the food material) or the rate thereof determined.  One may then terminate the generation of the functional ingredient, when a suitable amount of functional ingredient has been generated, by heating the food material.  Thus the amount of the functional ingredient and the properties of the food material/foodstuff may easily be controlled.

14. Thus the use of the enzyme is beneficial because, relevantly to its state after the reaction:

    ·Enzymes are denatured by heat.

    ·The foodstuff or food material is heated after generation of the functional ingredient.

    ·The enzyme will be denatured.

    ·The enzyme may then constitute protein.

    ·The denatured enzyme need not be declared.

    ·Inactivated enzymes are not considered to be additives and additives may be considered undesirable.

    ·Denaturation of the enzyme allows control of the amount of functional ingredient generated by heating the food material.  That is, a denatured enzyme has no activity.

15. The specification later states that the conversion agent is preferably present in the foodstuff, more preferably in an inactive form or in a denatured form.

16. No measure of inactivation is given in the specification of the Patent.  The examples for the preparation of margarine say that the mixture is ‘shortly heated to 100°C to denature the enzyme’.  For sponge cake, the specification says that the reaction mixture is ‘shortly treated at 100°C in order to inactivate the enzyme’.   The recipe for sponge cake includes baking for 35 minutes at 180°C.

    The description of the enzyme

17. The specification states that ‘preferably the enzyme is an enzyme as described in and/or as claimed in Danish Patent Application No 0400/97’, that is, the Priority Application for the Poulsen patent (Poulsen Priority Application).  The enzyme is also said to be preferably capable of exhibiting lipase activity.  The specification provides that the enzyme comprises at least one amino acid sequence selected from a group of three sequences provided.  In a further aspect, the enzyme may be an enzyme as described in and/or as claimed in International Patent Application No PCT/IB98/00708 filed 6 May 1998.

    The functional ingredients and the constituents

18. The specification is very general in its description of possible functional ingredients and constituents.  It is stated that ‘the at least one’ functional ingredient may be generated from ‘the at least one’ constituent by two or more conversion agents.  It is said that preferably, ‘the at least one’ constituent of the food material is selected from a large class of compounds, including esters, mono-, di- and triglycerides, fats, fatty acid esters, various oils, proteins, amino acids, a constituent comprising a hydroxy group, polyvalent alcohols, including glycerol, water, ethanol and sugars.  Indeed there seems to be a repetition of proteins and amino acids in the list.

19. A more detailed description is given of the meaning of the term “triglyceride” to mean a triester of an alcohol, preferably glycerol and a fatty acid.

20. A number of preferred aspects of the integers of the invention are then described:

    ·The triglyceride of the first constituent is selected from triglycerides of specified fatty acid chain lengths.

    ·The functional ingredient is generated from at least two constituents of the food material where at least two constituents of the foodstuff may interact and/or react and/or combine together to generate at least one functional ingredient.

    ·The functional ingredient is generated from a first constituent and a second constituent of the food material.

    ·The first and second constituents are constituents of the foodstuff.  The functional ingredient is generated from a first and a second constituent of the food material and these constituents are also present in the foodstuff.  That is, the constituents/ingredients are only partially used.

    ·The first constituent of the food material/foodstuff is hydrophobic and/or lipophilic.

    ·The first constituent of the food material/ foodstuff is selected from a broad class of compounds including esters, mono-, di- and triglycerides and various oils, derivatives and mixtures thereof.  More preferably, the first constituent of the food material/foodstuff comprises or is an ester or a triglyceride.

    ·The second constituent is hydrophilic and may be selected from proteins, amino acids, mixtures and derivatives.

    ·The second constituent is selected from a constituent comprising a hydroxy group including glycerol, water and ethanol, more preferably glycerol.  This preferred group does not include fatty acid esters.

    ·The first constituent is an ester, preferably a triglyceride and the second constituent is a constituent comprising a hydroxy group, preferably an alcohol, more preferably a polyvalent alcohol and yet more preferably glycerol.

    ·In a highly preferred embodiment, the first constituent is a triglyceride and the second constituent is a sugar or a sugar alcohol.  These constituents interact on contact with the conversion agent to generate an ester derived from the first constituent with a lower degree of esterification than the first constituent, and a sugar ester.  Each of the ester and the sugar ester may act as a functional ingredient such as an emulsifier.  Thus, two functional ingredients may be generated from two constituents of the food material/foodstuff by a conversion agent.  This describes a single reaction, known as interesterification.  In that highly preferred embodiment, the second constituent is preferably ascorbic acid.

    ·In a further broad aspect of the invention, the foodstuff comprises at least two functional ingredients which have been generated from a first constituent of the food material (preferably a triester, more preferably a triglyceride) and a second constituent of the food material (preferably a sugar or sugar alcohol and more preferably ascorbic acid) by a conversion agent.

    ·In a further preferred aspect of the invention, the food material/foodstuff further comprises greater than two constituents, preferably a third constituent.  This is selected from the constituents listed for the first and second constituents, preferably one that comprises a hydroxy group, including glycerol and water. Preferably, it is selected from sugars.

    ·The provision of one or more of the constituents in liquid form may significantly increase the reaction velocity of the generation of ‘the at least one’ functional ingredient.

    ·The conversion agent may be contacted with all of or a portion of the food material.  An example is described in the specification and in Figure 1, resulting in margarine.

    ·Preferably, the functional ingredient is generated by a reaction selected from alcoholysis, preferably glycerolysis, hydrolysis, interesterification and combinations thereof, more preferably alcoholysis, preferably glycerolysis. 

    ·The ‘at least one’ functional ingredient is selected from emulsifiers, hydrocolloids, preservatives, antioxidants, colourings and flavourings.  Preferably, at least one functional ingredient comprises or is selected from a group including emulsifiers and, more preferably, is an emulsifier.  The emulsifier may comprise or be selected from mono- and diglycerides, derivatives and mixtures thereof.

    ·The food material and/or the food material contacted with the conversion agent and/or the conversion material is substantially free of water.  An example of this aspect of the invention is where a lipase carried in glycerol is contacted with a triglyceride.  Mono- and diglycerides and preferably sugar esters are generated as functional ingredients.  Two single reactions are exemplified, one an interesterification using a lipase where the constituents are triglyceride and glycerol, the other using triglyceride and glycerol/sugar, that is three constituents, and a lipase.  It is possible to select the ‘at least one constituent’ to provide a required functional ingredient.  Where it is an emulsifier being a mono-, di- or triglyceride, ‘the at least one’ constituent may be, for example, a triglyceride and a polyvalent alcohol.

    ·The foodstuff provided may be selected from a very wide range of goods including baked goods.  In one aspect of the invention, it is other than mayonnaise.  A preferred embodiment is margarine.

21. The specification contains 16 examples which illustrate the invention.  These examples relate to the production of a variety of foodstuffs, including where the foodstuff is full fat margarine, 60% fat spread with protein, 40% fat spread with whey powder, filling cream, ice cream and various other forms of margarine.  Example 14 relates to the production of sponge cake, a baked product.

22. It is not in dispute that there are reactions described in the specification that are single reactions.  The specification also describes a reaction in which the first and second constituents are contacted with the conversion agent under conditions of controlled water activity.

23. The relevant claims of the Patent are set out later in these reasons.

    THE EXPERTS

24. Two experts gave evidence at the hearing.  Danisco adduced evidence from Professor Darryl Small.  Novozymes adduced evidence from Professor Russell Hoseney.  There was no dispute that both experts were skilled in the relevant art now and as at the priority date, that is, in the preparation of baked goods (in particular, bread), including the use of enzymes in the preparation of bread.

    Professor Small

25. Professor Small obtained a Bachelor of Agricultural Science with Honours from the University of Sydney in 1974.  In 1981, he obtained a PhD from the University of Sydney, studying metabolism of storage polysaccharides.  From 1978 to 1982, Professor Small worked as a Scientific Research Officer at the Biological and Chemical Research Institute, NSW Department of Agriculture.  Professor Small was then employed by the Australian Wheat Board (AWB) from 1982 to 1992, first as Chief Chemist and subsequently as Manager of the Grain Quality Laboratory.  In 1989, he was appointed Assistant Director of the AWB’s Academy of Grain Technology, the responsibilities of which involved baking, the testing of wheat and flour and protein and enzyme analysis.  From 1993 to 1995, Professor Small held the position of Senior Food Technologist with the National Food Authority in Melbourne.  From 1995 to 2002, he lectured at Victoria University in Food Science and Technology.  During this time, Professor Small became involved in various projects and publications relating to enzymes. Since 2002, Professor Small has been employed by the Royal Melbourne Institute of Technology University (RMIT), first as a Senior Lecturer in Food Chemistry and, since 2009, as an Associate Professor.  Professor Small’s research at RMIT has involved investigations into the practical outcomes of the use of enzymes in food production and food processing, including the use of enzymes in baking.

    Professor Hoseney

26. Professor Hoseney obtained a Bachelor of Science in 1957 and a Master of Science in 1960, both from Kansas State University (KSU), specialising in Grain Science and Chemistry.  From 1956 to 1970, Professor Hoseney worked as a chemist and subsequently as a research chemist at the United States Department of Agriculture.  He was awarded a PhD in 1968, his thesis being entitled the “Determination of Biochemical and Bread Making Properties of Wheat Flour Components”.  Professor Hoseney accepted a position as an Associate Professor in the Department of Grain Science and Industry at KSU in 1970.  Professor Hoseney was promoted to full professorial status in 1975 and held this position until retiring in 1997, upon which he was appointed a Professor Emeritus, an appointment which he continues to hold.  During his time at KSU, Professor Hoseney researched and published papers in matters relevant to cereal chemistry, as well as teaching courses such as “Wheat and Flour Quality” and “Advanced Cereal Chemistry”.  Since 1971 Professor Hoseney has also operated a consultancy business through which he regularly consults with various milling companies and baking companies on a range of different matters relating to the milling of grains and the preparation of baked goods.

27. Professor Hoseney has attended the annual conferences of the American Association of Cereal Chemists since 1961.  Australian researchers have been prominently represented at this conference each year.   Professor Hoseney has also attended and presented at a number of meetings of the Cereal Division of the Royal Chemical Society of Australia, including meetings in 1986, 1991, 1995, 1998 and 2006.  Through these meetings, he came to know and maintain regular correspondence with many researchers in the field of cereal chemistry working at various Australian institutes, universities and companies. 

1. Neither Professor Hoseney nor Professor Small was familiar with the carrying out of molecular biology techniques.  Professor Hoseney was unfamiliar with a number of terms used in molecular biology, as used in the Novo patent.

   CONSTRUCTION OF CLAIMS 1 AND 7

   Legal Principles

2. It is not necessary to set out the basic principles of claim construction which are well-known, accepted and not in issue.  The construction of the claims is determined by the Court, assisted, where relevant, by the evidence of persons skilled in the relevant act.  The parties draw attention to various statements that are, they say, particularly apposite to the construction of the claims in this case.  It is therefore helpful to record some of the directions in earlier cases:

   ·A patent is not a written instrument operating inter partes but a public instrument which must, if it is to be valid, define a monopoly in such a way that is not reasonably capable of being misunderstood (Welch Perrinand Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610).

   ·The invention is ascertained from a fair reading of the specification of a whole.  If it is impossible to do so that ‘is an end of the matter’ (Welch Perrin at 610).

   ·If a verbal or grammatical question can be resolved according to the ordinary rules of construction, that does not leave uncertain the ambit of the monopoly claimed (Welch Perrin at 610).

   ·It is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification (Welch Perrin at 610).

   ·If a claim is clear it is not to be made obscure simply because obscurities can be found in particular sentences in other parts of the document (Welch Perrin at 610).

   ·The meaning of the claims and the terms used in the claims may be made clear by using the specification as a dictionary of the jargon of the claims (Welch Perrin at 616).

   ·Once the nature of the invention has been appreciated, it is not to be ‘demolished’ by finding that particular phrases used could, out of context, be ambiguous (Welch Perrin at 617).

   ·The specification must be read as a whole (Welch Perrin at 610; Decor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 410).

   ·If words are used in a particular way in a specification whether or not by way of a formal dictionary and thereby it is shown that the draftsman used such words to have a particular meaning, that meaning must be given to those words in the claims (Decor Corporation at 410; Flexible Steel Lacing Company v Beltreco (2000) 49 IPR 331 at [76]–[77]).

   ·There is a fine line between reading down the words of a patent claim to reflect how a person skilled in the art would understand it in a practical and common sense way and impermissibly limiting the clear words of the claim because the reader skilled in the art would be likely to apply those wide words only in a limited range of all of the situations that they would describe (Sachtler GmbH & Co KG v RE Miller Pty Ltd (2005) 65 IPR 605 at [42]).

   ·An essential part of the process of construction involves understanding the nature of the invention described and claimed and the way in which the patentee has used words or phrases describing and then claiming the invention.  It is appropriate to try to understand what the patentee seeks to convey by the words used, especially where those words convey matters of biological or technological complexity (Inverness Medical Switzerland GmbH v MDS Diagnostics Pty Ltd (2010) 85 IPR 525 at [15]).

   ·The patentee must define the invention with sufficient precision to permit the monopoly to be determined and to allow the general public to identify from the words of the claims the conduct prohibited (British United Shoe Machinery Co Ltd v A Fussell & Sons Ltd (1908) 25 RPC 631 at 650–651; Clorox Australia Pty Ltd v International Consolidated Business Pty Ltd (2006) 68 IPR 254 at [18]).

   ·If the monopoly as defined by the claims is reasonably capable of being misunderstood, it is open to the Court to conclude that the terms of the specification are so ambiguous that a proper construction must always remain a matter of doubt.  In such circumstances the duty of the Court would be to declare the patent void (Martin v Scribal Pty Ltd (1954) 92 CLR 17 at 59 per Dixon CJ).

   ·The fact that there are alternative constructions of a claim does not mean that the claim is invalid for want of clarity (Welcome Real-Time SA v Catuity Inc (2001) 113 FCR 210 at [167]-[168]).

3. It is accepted that a claim is not to be construed with an eye to the infringing article, nor should it be construed with an eye to the prior art.  However, it is a fact and is well understood that patentees may draft a claim with knowledge of the prior art and in order to avoid anticipation.

4. Danisco emphasises that HLundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 at [118]–[120] per Bennett J (Middleton J agreeing) reiterates that the words used in a claim are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification, that is in the context which they appear. Further, the claims are part of the specification, which must be read as a whole.

5. As to the construction of the Patent, Danisco points out that:

   ·The Patent’s specification is broader than the Patent’s claim and many embodiments of the invention are not claimed. 

   ·The boundaries of the Patent’s claimed monopoly should not be expanded by reference to broad disclosures of the specification that are not claimed.

   ·There is no dispute that the claims are fairly based.

   ·A claim is not ambiguous or lacking clarity because it uses inexact expressions or is difficult to construe, as long is it provides a “workable standard” suitable to the intended use (Henriksonv Tallon Ltd [1965] RPC 434; Minnesota Mining& Manufacturing Co & 3M Australia Pty Ltd v Beiersdorf (Aust) Ltd (1980) 144 CLR 253 at 274).

6. Novozymes submits that in order to find the claims unambiguous and in order to adopt Danisco’s submissions on construction, it is necessary to ignore the entire specification.  Novozymes submits that on Danisco’s construction, the claims exclude the only thing described in the specification as the invention. 

   The Claims

7. The claims define the subject matter of the claimed monopoly.  The Patent contains 17 claims which define the invention.  Danisco asserts infringement of claims 7 and 14, as appended to claims 1 and 2.

8. Claim 1 is to:

   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.

9. Claim 2 is to:

   A process according to claim 1 wherein the fatty acid ester comprises at least two ester groups.

10. Claim 7  is to:

    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.

11. Claim 9 is dependent on the preceding claims, including claim 1 and claim 7.  It provides that the second constituent is selected from a constituent comprising a hydroxy group, including ethanol, water and glycerol.  While Danisco does not press claim 9 for the purposes of infringement or validity, Novozymes relies upon the claimed characterisation of the second constituent and, specifically, the inclusion of water to submit that claim 1, the independent claim, should be similarly construed to include water as a second constituent.

12. Claims 10 to 12 denote as the second constituent glycerol, a sugar or sugar alcohol and ascorbic acid respectively.  Claim 13 denotes, generally speaking, proteins as the second constituent.  No submissions were made as to whether or not the second constituents of these claims are inconsistent with the parties’ construction of claim 1 or claim 7.

13. Claim 14 is to, inter alia:

    A process according to any one of the preceding claims wherein the foodstuff is selected from baked goods, including breads, cakes, muffins, doughnuts, biscuits, crackers and cookies …

    General comments

14. Although the construction of claim 1 and claim 7 is a matter for the Court, the experts gave evidence, without objection, of their reading of the claims.  I have had regard to that evidence to the extent that it relates to the skilled addressee’s understanding of the terminology and the reactions described.

15. The construction of the claims of the Patent has been particularly difficult.  This can, in part, be attributed to the use of the expression “generated from” and the fact that the specification describes more than is claimed.  However, as stated in Blanco White TA, Patents for Inventions (5^th ed, Stevens, 1983) at [4-701]:

    Certainly a claim is not invalid merely because it might have been better drafted, nor merely because the patentee puts forward a construction that the court is not prepared to adopt; nor merely because it is capable of more than one construction, even though it be difficult to decide which is the right one.

16. Despite the difficulties associated with the construction of the Patent I have found, as detailed below, that there is a clear construction available. Accordingly, the claims of the Patent cannot be revoked for lack of clarity under s 40(3) of the Act.

    Construction of Claim 1

17. The foodstuff that is prepared by the process of claim 1 comprises, in the sense of includes, an emulsifier.  The claimed process comprises, that is consists of, three steps:

    (i)        starting with 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;

    (ii)inactivating or denaturing the enzyme to provide the foodstuff comprising, that is including:

    ·          the emulsifier;

    ·          the fatty acid ester; and

    ·          the enzyme in an inactive or a denatured form

18. It can be seen that claim 1 is to a more specific process than many of the more general processes described in the specification.  The conversion agent is an enzyme, the process is for preparing a foodstuff which includes an emulsifier, and the first constituent of the food material is a fatty acid ester.

19. The main issues in construing claim 1 are:

    ·Is the enzyme a single enzyme, or does the claim encompass the use of more than one enzyme?

    ·Does the claim describe a single reaction, two reactions or both?

    ·What is meant by the phrase “generated from” the second constituent?

    ·Are there any limitations on the “second constituent”?  Can the second constituent include water?

    ·What is meant by a “functional ingredient”?

    ·Must the enzyme be completely or only substantially denatured?

20. The fatty acid ester is a substrate for the enzyme.  The claim provides that an emulsifier is generated by an enzyme from the fatty acid ester.   As a result of contacting the food material with the enzyme, the emulsifier is generated from the fatty acid ester and a second functional ingredient is generated from the second constituent.  This leads to a number of further questions, some of which are interrelated in outcome:

    ·Is the second constituent a substrate for the enzyme?

    ·Does the claim describe a second reaction, being the reaction between the second constituent and the enzyme, or is the second functional ingredient also a product of the reaction where the first constituent is a substrate for the enzyme?

    ·Accepting that the emulsifier is generated by the enzyme from the fatty acid ester, does the claim require that the second functional ingredient is generated by the enzyme from the second constituent or simply that it come from the second constituent?  Does this affect the question of whether the second constituent must be a substrate for the enzyme?

    Does claim 1 encompass the use of more than one enzyme?

21. The experts were asked, for the purposes of a joint experts’ report, to comment on the use of one enzyme or two enzymes in the process of claim 1.  The experts agreed that claims 1 and 7 (I shall return to the latter) covered the use of one enzyme to catalyse two reactions to create an emulsifier and a functional ingredient.

22. Professor Small interpreted claim 1 as referring to the use of a single enzyme only.  However, Professor Hoseney read claim 1 to indicate, further, the use of a single enzyme to catalyse one reaction and two enzymes to catalyse two reactions, each to create an emulsifier and a functional ingredient.  Thus, Professor Hoseney interpreted claim 1 as also referring to a number of enzymes.  He did not read this from the claim but interpreted the claim as not excluding multiple enzymes.  He drew a distinction between “an enzyme” and “a pure enzyme” and noted that an enzyme may have some side activity.  He also relied upon a reference in the specification to the enzyme being preferably selected from ‘lipases, esterases, derivatives or mixtures thereof’.

23. In my view, in the context of the claims the reference to “an enzyme” means “the enzyme”, that is, a single enzyme.  The enzyme of claim 1 is a single enzyme and not a mixture of enzymes.  Claim 1 refers to “an enzyme” and “the enzyme” in the singular, the latter on three occasions.  There is no reference to the plural, “enzymes”.  Inactivation or denaturation is of “the enzyme”.

24. The reference in the specification to a mixture of enzymes does not change the meaning of the claim to include a mixture of enzymes.  Rather, as Danisco submits, the specification refers to a single enzyme isolated from a mixture of various enzymes produced by the relevant microorganism.  In coming to his conclusion, Professor Hoseney referred to a statement in the specification that two or more enzymes may be involved in the reaction that produces ‘the at least one’ functional ingredient.  Importing that broader description into the clear wording of the claims to alter their meaning is not permissible.

25. Nothing in the specification changes my conclusion.

    Single and/or more than one reaction?

26. I repeat for convenience step (ii) of claim 1:

    (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.

27. The possible reaction schemes encompassed by claim 1 are:

    A.One enzyme to catalyse one reaction to create an emulsifier and a functional ingredient.

    B.One enzyme to catalyse two reactions to create an emulsifier and a functional ingredient.

    C.Two enzymes to catalyse two reactions to create an emulsifier and a functional ingredient.

28. Professor Small read claim 1, initially apart from the body of the specification, as describing two reactions catalysed by the one enzyme.  He conceded in cross-examination that the claim does ‘not specifically’ preclude the possibility of one enzyme/one reaction and that this remains a ‘very narrow possibility’.  Professor Small, I observed, was not given to speak in absolutes or to preclude possibilities.  He remained of the view that claim 1 was to the use of one enzyme to catalyse two reactions to create an emulsifier and also a functional ingredient.  Professor Small’s opinion was based in part on his grammatical reading of the claim and the wording ‘such that’.  He maintained that view after reading the whole of the specification. 

29. Professor Hoseney accepted that claim 1 encompasses all three schemes: one enzyme/one reaction, one enzyme/two reactions and two enzymes/two reactions.  Professor Hoseney’s evidence was based on his reading of the claims in light of the specification.  He drew his conclusion as to the two enzymes/two reactions possibility not from his reading of the claim but from his reading of the specification.  He then decided that it was not precluded from the claim.  He said that in his view claim 1 did not actually state or set out the two enzymes/two reactions possibility.

30. As I determined above, claim 1 refers to the use of a single enzyme; therefore the two enzymes/two reactions scheme is not within the claim.

    The submissions

31. Novozymes contends that claim 1 must include one reaction and that, on one view, is limited to one reaction.  Such a reaction may be depicted as:

    +

     

    +

     

               

32. Novozymes points out that the reaction which it contends is described by claim 1 is a single reaction in which each of the reactants and products are identified.  That is, the reactants are the fatty acid ester and the second constituent and the products are the emulsifier and a second functional ingredient.  Claim 1 does not specify any additional reactants.  This is despite the fact that the specification refers to an aspect of the invention where the foodstuff comprises greater than two constituents and then expressly identifies those constituents.  Novozymes contends that the specification does not contemplate the involvement of missing reactants in claim 1.

33. Novozymes also characterises step (ii) of claim 1 as providing for a limitation by result.  That is, step (ii) involves contacting the food material with an enzyme with the result that an emulsifier is generated from the first constituent and a second functional ingredient is generated from the second constituent.  On this basis, the claim encompasses and arguably is limited to a single reaction whereby two functional ingredients are generated from two constituents of the food material.

34. This is in contrast to Danisco’s contention that claim 1 only refers to two reactions catalysed by one enzyme, whereby the enzyme acts on the fatty acid ester to produce the emulsifier and other products and also acts on the second constituent to produce the second functional ingredient and other products.  For each reaction this would necessitate a second reactant.  Such a reaction may be depicted as:

35. Novozymes points out that claim 1 does not identify reactants additional to the fatty acid ester and the second constituent in the reactions contended for by Danisco, nor does it identify the products of those two reactions, other than the emulsifier of the first reaction and the second functional ingredient of the second reaction. 

36. Danisco’s construction of claim 1 is that it claims the use of a single conversion agent to catalyse the hydrolysis of two different fatty acids and describes no other reaction.  However, Danisco denies that it has characterised the invention, or that the invention should be characterised, as a “dual activity enzyme”.  This term was used, however, as a convenient shorthand.

37. Novozymes submits that Danisco’s construction ignores the specification which, it says, does not specifically describe or exemplify the use of a single conversion agent to catalyse the hydrolysis of two different fatty acid esters.  Novozymes contends that it is unlikely that the specification is silent about the very thing which Danisco submits is the invention.  Novozymes points out that, on Danisco’s construction, the claim is limited to hydrolysis reactions which must involve two different types of fatty acid esters and that claim 1 excludes transesterification reactions.  This, Novozymes says, supports its construction of claim 1 as a single reaction whereby the enzyme catalyses the reaction or interaction between the fatty acid ester and the second constituent.  Danisco’s construction, Novozymes says, is one advanced ‘with an eye to the allegedly infringing article’ and with ‘an eye to the prior art’, which is impermissible.

    Consideration

1. Professor Small and Professor Hoseney agreed that the one enzyme/two reactions scheme is within the claims, where an emulsifier and a second functional ingredient are generated from their respective constituents by a single enzyme by way of two hydrolysis reactions.  That is, claim 1 is not limited to the use of an enzyme in a single reaction.

2. Each expert agrees that if there were two reactions whereby the enzyme acted on two separate substrates, in each case another reactant would be necessary to produce, for example, the emulsifier.  This could, according to Professor Small, be water, glycerol or ‘a number of possibilities’.  Novozymes contends that if there are two reactions, the second reactants in each case are not identified.

3. There is no evidence that the skilled reader such as Professor Hoseney or Professor Small, in carrying out a reaction whereby an enzyme acted on a fatty acid ester to produce an emulsifier, would have difficulty in determining what separate reactant would be necessary or useful to achieve that outcome. For example, it could be said that in a hydrolysis reaction, water as a second reactant is “a given”. The evidence is silent as to the skilled reader’s understanding from the specification as to how to achieve the two reactions Danisco contends for. This may be because neither fair basis nor lack of sufficient description under s 40 of the Act are pleaded grounds of invalidity. There is no basis on which to contend that the skilled reader would have difficulty in working the claimed process as a one enzyme/two reactions scheme. The skilled reader does not need the second reactants to be identified.

4. The next question is whether the one enzyme/one reaction scheme is also included in claim 1.

5. The assumption that the unspecified reactants of a “dual reaction” scheme are water for a hydrolysis reaction or glycerol for a glycerolysis reaction does not provide a complete answer to Novozymes’ submission that the claim also describes a single reaction, because the claim is not limited, for example, to hydrolysis reactions.  I accept that, in addition to describing two reactions catalysed by the one enzyme, claim 1 may also, as a matter of grammatical construction, describe a single reaction in which the enzyme acts on the fatty acid ester to generate the first functional ingredient.  In the same reaction, a second functional ingredient is generated from the second constituent.  This would depend on the nature of the second constituent.  In one way, the second functional ingredient could be seen as a by-product of the action of the enzyme on the first constituent.

   What is the meaning of “generated from”?

6. The meaning to the skilled reader of “generated from” was a topic of much evidence.

7. Professor Hoseney said that he read “generated from” simply to mean “comes from”.   His view was that everything on the right side of an equation is “generated from” everything on the left side of the equation.  Professor Hoseney said that in a single reaction parts of the product material “come from” each reactant; that is, in the single reaction A + B = C + D, each of C and D “come from” each of A and B.    However, if the claim uses “generated from” in that simple sense, there would be no need to spell out that the first functional ingredient came from the first constituent and the second functional ingredient came from the second constituent.  Indeed, it is inconsistent with the requirement of the claim that certain products on the right side of the equation are “generated from” specific constituents on the left side.  The claim must mean something different.

   The submissions

8. Novozymes relies on a passage in the specification of the Patent which states:

   Preferably, the functional ingredient is generated from at least two constituents of the food material.  In this aspect at least two constituents of the food material may interact and/or react and/or combine together to generate at least one functional ingredient.

9. This, Novozymes says, is a “dictionary” for the meaning of “generated from” which must be incorporated into the claims.  That means, Novozymes contends, that the term “generate” describes the generation of at least one functional ingredient as a result of two constituents interacting or combining together in a single reaction.  Novozymes gives as an example the generation of an emulsifier and a second functional ingredient from a fatty acid ester and water.  Professor Small accepted the view that the use of “generated from” in that particular passage means that the production of a second constituent involves the interaction/reaction/combining of two molecules.

10. Danisco counters this reliance on that particular passage in the specification by saying, in summary, that:

    ·The text of claim 1 uses the word “generated” twice, indicating two reactions.

    ·The experts both read claim 1 as describing (at least including) two reactions catalysed by a single enzyme.

    ·The specification covers more than the subject matter of the claims.

    ·The specification describes both:

    1.glycerolysis reactions, which occur in a non-aqueous environment where two substrates interact, react or combine in the presence of an enzyme to produce a functional ingredient; and

    2.hydrolysis reactions, wherein the language of the skilled addressee is to say the functional ingredient is generated from the respective constituent or substrate by which the enzyme is defined by the International Union of Biochemistry and Molecular Biology (IUBMB) classification system.  For example, a lipase acts on lipids and a phospholipase acts on phospholipids.

    ·The one enzyme of the claims cannot catalyse both the non-aqueous glycerolysis and the aqueous hydrolysis.  If the enzyme is a lipase, it is a hydrolase which catalyses a hydrolysis reaction, in the presence of water.

    ·The passage relied on by Novozymes is not a definition but a description of what may occur.  Even if it were a definition, the context of the claims must prevail (Memcor Australia Pty Ltd v GE Betzdearborn Canada Company (2009) 81 IPR 315 at [60], upheld on appeal).   First, the incorporation of that definition would render the second use of “generated” in the claim redundant.  Secondly, it introduces incorrect terminology if it means that the functional ingredient is “generated from” water.  Thirdly, it contradicts the skilled reader’s reading of the claim as describing the use of one enzyme to catalyse two reactions.

11. Danisco submits that the language of the claims, in particular the requirement that the emulsifier and the functional ingredient be “generated from” the fatty acid ester and the second constituent, must be read the same way each time the term is used; it means that the enzyme must act on each of those constituents as a substrate.  The enzyme is a lipase which is a hydrolase.  Danisco says that this single enzyme therefore catalyses a hydrolysis reaction in each case.  It cannot be said, Danisco contends, that the enzyme acts on water as a substrate in a hydrolysis reaction.  Therefore, according to this logic, there must be two reactions with the substrates being a fatty acid ester (a triglyceride) which produces the emulsifier and a second lipid on which the lipase can act.

    consideration

12. In any reaction involving two reactants combining to yield a product or products, the products “come from” both reactants – yet the claims speak of a product being “generated from” one reactant.  The claim is using “generated from” in conjunction with “functional” to mean other than the broader notion that something in the product comes from each of the reactants.  Professor Hoseney agreed that chemists would not normally use the terminology of “generated from water”.  Certainly Professor Small would not do so.  In context, where the product is a functional ingredient, the claim is saying that the functional ingredient comes from, or takes its functional part from, the named constituent, generated by the enzyme. 

13. Functionality, that is, the functional part of the product, is relevant.  For example, in the reaction:

    where ^R1 and ^R2 are functional groups, assume that only ^R2 conveys functionality.  It is correct to say that C “comes from” A and B.  So too does D.  However, if C is the functional ingredient and ^R2 confers that functionality, while it is strictly correct to say that C “comes from” or is “generated from” A and B, the functional ingredient of C can be said to have been generated by the enzyme from B.  In my view, this is the meaning conveyed in the claims by the requirement that the functional ingredient be generated from the constituent by the enzyme.

14. Claim 1 requires that there be generation of a second functional ingredient from the second constituent as a result of the action of the enzyme on the fatty acid ester as a substrate of the first constituent (in a single reaction) or on the second constituent as a substrate (in a second reaction).

    Can the second constituent be water?

15. Professor Small could not accept that a functional ingredient could be said to be generated from water.  Professor Hoseney was also clearly uncomfortable with such terminology.  Professor Small did not read the claims as including water as a constituent from which a functional ingredient would be generated.  He said that due to its small size, the fact that it is a component present in virtually all foods and because the products of the reaction are large molecules, he would not talk of water being converted into one such large molecule.  Specifically, he could not think of a large molecule such as a mono- or diglyceride being generated from water.  In this regard, Professor Small said water is distinguishable from other small molecules such as ethanol and glycerol because the latter contain carbon atoms.  This distinction did not cause a problem to Professor Hoseney because of his view that part of a mono- or diglyceride, the products of the hydrolysis of fatty acid esters, that is the –OH groups, “came from” water.

    The submissions

16. Novozymes asserts that water is not only included as a second constituent in a hydrolysis reaction, it is also specifically included as a second constituent in the specification and in claim 9, which is dependent on claim 1.  Danisco maintains that, where the selected reaction is hydrolysis, water is not a second constituent.  Recognising that claim 9 specifies water as a second constituent, Danisco simply says that the claim is ‘erroneous’ and consents to an order for its revocation. 

17. Danisco’s submissions can be summarised:

    ·There is no doubt that the emulsifier is generated from the fatty acid ester.

    ·There is no doubt that water is part of the reaction.

    ·The skilled reader would not consider water in a hydrolysis reaction to be “interacting”, “reacting” or “combining” with the substrate to form the second functional ingredient.  It is not the normal language of the skilled addressee to say that the second functional ingredient is “generated from” water.

    ·Therefore, the claim describes another reaction involving the same enzyme.  As a lipase is a hydrolase, this is another hydrolysis reaction.  Professor Hoseney described a hydrolase as an enzyme that splits molecules, or acts on molecules, in the presence of water.  In a hydrolysis reaction, Professor Hoseney said water is ‘taken for granted’.

    ·The experts agreed that part (ii) of claim 1 appears to disclose the use of one enzyme to catalyse two reactions to create an emulsifier and a functional ingredient.  In such a case, where one normally speaks of an enzyme acting on a substrate (such as a lipase acting on a lipid in the presence of water), the skilled reader would not consider water as the second constituent from which the second functional ingredient is generated in the second reaction. 

    ·While, chemically, some part of the second functional ingredient “comes from” water, that ingredient has to have a functional element and it is not appropriate and would not be read to encompass water (H₂O) as the substrate for generation.  For example, as Professor Hoseney said, ‘you cannot just take water and convert it over to monoglyceride’.  Professor Hoseney also said that it would be ‘wrong’ or ‘alchemy’ to speak of a second functional ingredient as being “generated from” water.

    ·While the fatty acid ester and water are participants in the reaction sensibly read, the claim describes two reactions where water is part of both reactions but the functional ingredients are generated from a fatty acid ester and another constituent, not water, such as a triglyceride, diagalactosyl diglyceride (DGDG) or phosphatidyl choline (PC).  This is supported by the description in the specification of the reactions of the claims, whereby the mechanism of action is hydrolysis by way of the action of a hydrolase as a combination of hydrolysis reactions (that is, two hydrolysis reactions).  The presence of water does not need to be specified in the claims and it cannot be described as some ‘undisclosed reactant’.

    ·The language of “generation” from two interacting, reacting or combining constituents in the presence of an enzyme is apt to cover transesterification, which is described in the specification but not claimed.  The specification also describes the generation of one or more functional ingredients by the action of an enzyme on one or more constituents.

    ·As stated by Professor Small, water is a small molecule.  The other constituent and the functional ingredients are much larger molecules.  It is not appropriate nor normally understood by the skilled addressee to talk of water being converted into large molecules, such as mono- or diglyceride, which are the products of the claimed reaction, even assuming it to be a single reaction.

    Consideration

18. There is no restriction in claim 1 or claim 7 on the second constituent.  The specification describes a very broad class, which may include the class of the first constituent.  It provides that ‘the at least one’ constituent is selected from a class that includes esters and fatty acid esters, as well as compounds containing a hydroxy group.  While in preferred embodiments the second constituent is not selected from esters or fatty acid esters but from proteins or hydroxy containing compounds or sugars, there is no specific restriction.

19. Claim 1 is the primary claim, the independent claim on which not only claim 7 depends but also other dependent claims in which the second constituent is a compound that cannot be a substrate for a lipase, such as glycerol, a sugar or ascorbic acid (claims 10 to 12).  If the specification is read as a whole or if resort is had to the body of the specification, it is apparent that the second constituent may include a compound with a hydroxy group, including water.  That is, the second functional ingredient may be generated by the action of the enzyme on a second substrate or may come from a second constituent of the food material as a result of the reaction in which the enzyme acts on the first constituent as a substrate.

20. The skilled reader would understand the enzyme responsible for catalysing the reaction whereby a fatty acid ester is the substrate and an emulsifier is the product to be a lipase.  This is confirmed by the specification, which states that the enzyme responsible is preferably selected from a group including lipases.  Lipases are classified, as a matter of nomenclature, within class 3 of the IUBMB classification system, that is as a class of hydrolases.  Hydrolases are enzymes that split molecules in the presence of water, liberating the hydroxyl (or –OH group) from water through the process of hydrolysis.  A lipase is a hydrolase that acts on a lipid as a substrate and reacts with water.  This would be understood by the skilled reader.  As noted by Professor Small, lipases are typically able to catalyse hydrolysis and transesterification reactions.

21. As Professor Hoseney pointed out, claim 1 does not explain how the second functional ingredient is generated.  From Professor Hoseney’s and Professor Small’s evidence, the skilled reader would not understand the claims to be referring to a functional ingredient in a hydrolysis reaction such as a monoglyceride being “generated from” water.  As Professor Small said, he could not think of a molecule which might be a mono- or diglyceride being generated from water.  While the –OH or hydroxy group of the monoglyceride may have come from water in the reaction in which the lipase acts on a triglyceride, it is not normal language to describe a functional ingredient such as a monoglyceride (the second functional ingredient in the context of the claims) as having been “generated from” water.  That, according to Professor Hoseney, would be to bring up something ‘magical’ rather than applying chemistry.  However, he also said that, if the reaction were a hydrolysis reaction where a di- or triglyceride was hydrolysed, that is where water was a reactant, it would not be correct to say that one product was generated from the di- or triglyceride and the other from water.  The products are each generated from the combination rather than one from one reactant (the substrate) and the other from the second reactant, the water.  It follows that it is not correct to say that a monoglyceride is generated from either the diglyceride or from water; it is generated from the triglyceride and water.

22. In such a context, the skilled reader would not need to be told that water was a necessary constituent.  The presence of water is, as Professor Hoseney acknowledged, ‘a given’ and ‘taken for granted’ in hydrolysis reactions.  The specification describes the generation of one functional ingredient, such as an emulsifier, from one constituent, such as a fat, by the enzyme without needing to state that water participates in the reaction.

23. However, although it is not appropriate or the normal language of the skilled addressee to say that the water “generates” the functional ingredient, water is a reactant, as Professor Hoseney emphasised, even though it is not something from which the functional ingredient is “generated”.  On this basis, water would not be the second constituent as it does not provide the functional groups, nor is it a substrate for the lipase, the enzyme of the claim that acts on the fatty acid ester.  Water is not, in the words of Professor Small, ‘acting to generate’ the second functional ingredient. 

24. If the specification and claim 9 of the Patent were silent, it would follow that water would not be considered a second constituent of the claims.  However, the specification and claim 9 specify water as a possible second constituent.  The reference to “second constituent” of the food material in claim 1, on which claim 9 is dependent, has no limitation.   It is not in dispute that water is an ingredient of most foods and would be expected to be an ingredient of the food material of the claims.  Indeed, as the enzyme that acts on the fatty acid ester is a lipase, water would be required for its action.

25. It may be that claim 1 seeks to encompass a variety of reactions, including simple hydrolysis in a single reaction.  The specification describes single reactions, including where a single functional ingredient is generated from a first constituent and a second constituent.  An example is interesterification between a fatty acid and a proteinaceous second constituent; another is the conversion of triglyceride and glycerol/sugar by a lipase to mono-, di- and triglyceride plus sugar esters.  This is generation of two functional ingredients from first and second constituents in the general sense described by Professor Small in a single reaction. 

26. It does not assist Danisco to assert during these proceedings that the reference to water in claim 9 is a “mistake” and that it accepts revocation of claim 9.  There has been no application to amend the specification to delete the reference to water, nor has the basis for the “mistake” been explained.  It is not only the claim that nominates water as a second constituent but also the specification.  Consenting to an order for revocation of claim 9, which is dependent on claim 1, may mean that that claim is not taken into account in construing the claims as a whole.  However, it is not suggested that claim 9 is not fairly based on the specification.  The specification remains unamended and describes water as a second constituent.  Accepting that claims 1 and 7 do not claim all that is described in the specification, the question is how the skilled reader would understand the claims.

1. Further, in regard to the essential integer of inactivation by heat, it is not to the point that the skilled worker knew that enzymes could be inactivated by heat or that baking of dough normally inactivated a lipase.  The relevance of the inactivation step was set out in the specification.  In order to show that the claimed process was obvious, Novozymes needed to demonstrate that the hypothetical skilled worker would try each integer of that process.  It has not done so.  There is no evidence that such a person would have taken or tried the steps in (i) and (ii) of claim 1.  There is no evidence that step (iii) would have been tried or ascertained or that the skilled person would have had a reason for taking it.

2. Novozymes also asserts that further factual matters relating to knowledge of free fatty acids and the capability of free fatty acids, mono- and diglycerides to act as emulsifiers in baked goods were part of common general knowledge.  Many of these were disputed by Danisco.  It is not necessary to canvass the detail of those matters.  Even if they did form part of common general knowledge, the claimed processes of claims 1 and 7 were not obvious.

3. Novozymes has not established that the hypothetical skilled worker would have been led to try the claimed process of the Patent as a matter of course.  Novozymes has not established that the invention would have been obvious to a person skilled in the art in light of the common general knowledge as it existed in 1998.  Novozymes has not established that the relevant claims of the Patent are invalid for want of inventive step.

   MANNER OF MANUFACTURE

4. As pleaded, Novozymes alleges that:

   The alleged invention, as claimed in claims 1 to 9, 14 and 15 of the Patent, is not a patentable invention within the meaning of section 18(1) of the Act, in that it is apparent on the face of the Specification that what is claimed in claims 1 to 9, 14 and 15 is not a manner of new manufacture.

5. Both parties’ submissions centred on claims 1 and 7.

6. Novozymes submits that if the Court:

   ·accepts Novozymes’ construction of the claims of the Patent, that is, that they at least include the use of a single enzyme to catalyse a single reaction, there can be no question that the claimed invention is not a patentable invention as it is not a manner of new manufacture;

   ·finds that the invention is a “dual activity enzyme”, there is no manner of new manufacture as the Patent discloses no new substance, no new characteristics of a known substance, no new use and no new method.

7. Novozymes’ submissions, which are directed towards the second ground, characterise the invention as a “dual activity enzyme”.  Danisco rejects that characterisation and urges reference to the claims as defining the invention.

8. Novozymes relies principally on the disclosure in the specification of the Poulsen Priority Application which, it says, is incorporated in its totality in the Patent.  Danisco’s response is that:

   ·The Poulsen Priority Application was not published before the priority date and is therefore not to be taken into consideration as it was not known or available.

   ·The nature and quality of the cross-reference to the Poulsen Priority Application in the specification did not incorporate the Poulsen Priority Application’s specification as a whole.

   ·Even if the Poulsen Priority Application was incorporated as a whole, it cannot be demonstrated that the invention is not a manner of new manufacture.

   Legal principles

9. There is no real dispute as to the principles to be applied to the alleged lack of manner of manufacture on the face of the specification of the Patent.  The parties agree that the question is whether a manner of new manufacture appears on the face of the specification properly construed (National Research Development Corp v Commissioner of Patents (1959) 102 CLR 252 at 261-2 (NRDC); NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 at 664; Merck & Co Inc v Arrow PharmaceuticalsLtd (2006) 154 FCR 31 at [62]).

10. Relevantly, the question posed by s 18 of the Act (as relevant at the time) is whether, as a threshold requirement, there is a patentable invention, being an invention as defined in terms of a manner of manufacture within the meaning of s 6 of the Statute of Monopolies (Philips at 663; Merck at [63]). That requirement will not be met, relevantly to the allegation in this case if, on the face of the specification, the subject matter lacks the necessary quality of inventiveness under the Statute of Monopolies or is not new (Philips at 664-5; Merck at [63]). A new use of an old substance is not an invention if its known properties make it suitable for that use; the new purpose is then no more than analogous to the purposes for which the utility of the substance is already known (NRDC at 262; Merck at [63]). However, Danisco says, the ground of the new use of an old substance is not available as a basis of invalidity as it was not pleaded.

    The face of the specification

11. The parties agree that in order to determine whether the Patent discloses a manner of manufacture it is necessary to understand the claimed invention and the specification properly construed.  That includes understanding the disclosures in the specification relied on in context.

12. Claim 1 is to a process for preparing a foodstuff including an emulsifier.  The process involves providing a food material containing a fatty acid ester and a second constituent and contacting it with an enzyme so that an emulsifier is generated from the first constituent and a second functional ingredient is generated from the second constituent.  The effect of my construction of claim 1 is that this could be brought about by a single reaction or by two reactions.  That is, the enzyme could act on each constituent as a substrate in two reactions, or it could act only on the fatty acid ester, with the second functional ingredient being a product of the single reaction between the fatty acid ester and the second constituent, catalysed by the enzyme.  As part of the claimed process, the enzyme is inactivated or denatured and the foodstuff contains the emulsifier, fatty acid ester and the enzyme in an inactive or denatured form.

13. I have concluded that claim 7 narrows the process of claim 1 by stipulating that the emulsifier has been generated by the enzyme from the fatty acid ester and that the second functional ingredient has been generated by the enzyme from the second constituent in two reactions.

14. The invention that must be a manner of manufacture is the process as claimed in the claims.

15. The broad description of the invention in the specification is of a process that utilises the constituents to produce the functional ingredients in the foodstuff.  This is brought about by the action of an enzyme which is not present in an active form in the foodstuff and so does not need to be listed as an additive.  That is achieved by inactivation or denaturation of the enzyme, which also allows control of the amount of functional ingredient generated and therefore control of the properties of the foodstuff. 

16. The specification says that lipases are one of the preferred class of enzymes.  The specification then states with respect to the Poulsen enzyme:

    Preferably the enzyme is an enzyme as described in and/or as claimed in [the Poulsen Priority Application].  In other words preferably the enzyme is a polypeptide in glycosylated or non-glycosylated form capable of exhibiting lipase activity wherein the polypeptide comprises at least one amino acid sequence selected from the group consisting of:

    [specified polypeptide sequences]

17. The specification not only provides the partial amino acid sequences taken from the Poulsen Priority Application but also tells the reader  that the preferred enzyme is ‘as described in and/or as claimed in’ that application.  There is no other reference to, or description of, such an enzyme that can carry out the reactions of the claims.  The specification later states that ‘all publications mentioned in the above specification are herein incorporated by reference’.

18. Danisco submits that the reference to the Poulsen Priority Application incorporates that document only to the extent of and for the purpose of identification of the Poulsen enzyme and does not extend to disclosures relating to the use of the Poulsen enzyme.  Danisco says that when the Patent is properly construed, the reference to the Poulsen Priority Application should be limited accordingly.

19. In my view, the reference to the Poulsen Priority Application at page 7, which directs the reader to the document in order to ascertain the description and characterisation of the preferred enzyme, is sufficient to include so much of the document that describes or claims the Poulsen enzyme.  The description includes the relevant activity of the Poulsen enzyme in the different methods of use.  It is not limited to the DNA or the amino acid sequence.  An enzyme may also be described in terms of its activity and the expression of activity in different circumstances.  That is so whether or not the statement of incorporation by reference itself serves to include the entirety of the Poulsen Priority Application.

    The Poulsen Priority Application

20. The Poulsen Priority Application relevantly describes an invention that relates to a polypeptide having lipase activity.  As well as relating to the DNA sequences coding for the polypeptide, the invention relates to ‘the use of the polypeptide in fat-free flour dough for baked products and a method for preparing such baked products’.  The Poulsen Priority Application also says, relevantly and in summary:

    ·Lipases are very important enzymes that hydrolyse fats to produce glycerol and fatty acids but can also function in synthetic mode in esterification and transesterification reactions.

    ·Within the baking industry it is well known to use enzymes such as amylases, xylanases, oxidases and proteases for the improvement of dough, retarded staling and greater softness.  The use of lipases as a baking additive is also known.

    ·A purified lipase preparation when added to bread dough significantly retarded the tendency of bread to become stale.  There are other descriptions of its utility in bread making by reference to volume, softness and anti-staling.  On the basis of the prior art, lipases as well as their functional properties are highly variable when used in dough for baked products.

    ·The inventors have purified a polypeptide exhibiting lipase activity which imparts positive characteristics without deteriorating properties. 

    ·The polypeptide has unexpected and useful properties when used in a fat-free flour dough or baked products.  The baked products have smaller average pore diameter and greater pore homogeneity with unchanged crumb porosity.  The product is more sliceable and resistant to physical handling.

    ·The polypeptide is very stable at pH 5 where it retains 100% of its activity after 48 hours at room temperature.  To be practically useful it is essential that the polypeptide has good thermotolerance and optimum temperature for activity.

    ·An interesting characteristic is the Poulsen enzyme’s capability of hydrolysis of endogenous galactolipids present in wheat flour to the corresponding galactosyl monoglycerides.

    ·The invention relates in a particular aspect to improving the stability of the gluten network in a fat-free flour dough and to impart improved pore homogeneity and reduced pore diameter to the baked product.

    ·The major ingredients of the dough are, inter alia, flour and at least one further dough additive such as an emulsifying agent, a starch-degrading enzyme or a cellulose or hemicellulose-degrading enzyme.

    ·Using the polypeptide according to the invention in fat-free dough provides baked products with a fortified crumb structure.

    ·It is believed that the improved pore homogeneity of the bread crumb using the polypeptide of the invention is caused by the formation of the more surface active glycerides (MGMG and DGDG) in combination with liberated fatty acids in ionised form.

    ·The purified lipase had good thermostability and maintained 60% of activity after 1 hour at 60°C.  It was also very stable at pH 5.

    ·An example is given for a baking procedure for Danish toast bread where the dough was proofed and baked for 40 min at 220°C and the crumb was evaluated.  A baking procedure for Danish rolls is also exemplified where the dough was baked for 18 min at 220°C and the volume of the rolls measured. 

    ·Another example is given where the lipase was tested in Danish toast bread and Danish rolls and volume, firmness, resultant fatty acids and mono-, di- and triglycerides measured.

    ·The results of adding the lipase were a not significant decrease in volume, improved bread crumb homogeneity and reduced crumb pores.

    ·Analyses showed hydrolysis of triglycerides and modification of glycolipids, MGDG and DGDG.  This was linked to surface activity and improved crumb cell structure and homogeneity.

    ·It is apparent that the lipase had a significant effect on the hydrolysis of DGDG whereas the effect of two commercial lipases was negligible.

    ·Free fatty acids were produced when the lipase was added to a dough.  The Poulsen enzyme not only catalysed the hydrolysis of triglycerides but also ‘it was surprisingly found’ that ethyl ester of fatty acids was also formed.  This might explain the finding that lipase added to a dough is able to mask the “old” taste of bread made from stored flour.

    ·The claims are variously to the polypeptide, its DNA sequence and organisms from which it was produced.  The claims are also, relevantly, to the use of the polypeptide in baked product to improve the stability of the gluten network and to impart pore homogeneity and reduced pore diameter of the baked product.

    Consideration

21. Novozymes says that the specification of the Patent (including the Poulsen Priority Application) discloses as known:

    (a)the use of a lipolytic enzyme in the preparation of bread (a foodstuff) from dough (a food material);

    (b)an enzyme that acts in situ:

    (i)to hydrolyse triglycerides (fatty acid esters) naturally present in flour to produce mono- and diglycerides (each of which are emulsifiers); and

    (ii)simultaneously with (i), to hydrolyse galactolipids (second constituents) naturally present in flour to produce MGMG and DGMG (each of which is an emulsifier, that is, a second functional ingredient);

    (c)that the enzyme does not hydrolyse all of the triglycerides or galactolipids; some of them remain in the final baked product;

    (d)baking of the dough to produce bread; and

    (e)that enzymes, in general, may be inactivated by heating.

22. Novozymes submits that, therefore, the Patent ‘discloses no new substance, no new characteristic of a known substance, no new use and no new method’ as follows:

    (a)no new substance disclosed – the preferred enzyme, the Poulsen enzyme, is disclosed in the Poulsen Priority Application;

    (b)no new characteristic of a known substance – the “dual activity” of the Poulsen enzyme is identified in the Poulsen Priority Application, while it is apparent from the specification that inactivation of enzymes by heat is known;

    (c)no new use – the use relevantly is for the in situ generation of functional ingredients, which is disclosed in the Poulsen Priority Application; and

    (d)no new method – a method of preparing a foodstuff, that is, the preparation of bread from dough, is described in the Poulsen Priority Application.

23. I have set out the disclosures in the Poulsen Priority Application that relate to the characterisation and description of the enzyme in some detail.  These disclosures fall short of describing the invention of the claimed combination of the integers of the Patent, which includes the limitation by result of inactivation or denaturation of the enzyme.  Even if it were accepted that the unpublished Poulsen Priority Application and the ability of the Poulsen enzyme to catalyse the described reactions were “known” for the purposes of assessing whether the Patent discloses a manner of manufacture, the Poulsen Priority Application is silent both as to the relevant utility of the Poulsen enzyme and as to the necessary inactivation of the Poulsen enzyme.  The references to temperature in the Poulsen Priority Application are in the context of the stability and activity of the Poulsen enzyme, not to denaturation or inactivation.  Although the Poulsen Priority Application contains examples of baking which would inactivate the Poulsen enzyme, the document is silent as to that fact and as to the importance of such inactivation.  Therefore, there is no admission in the Patent that the relevant utility of the Poulsen enzyme and the necessary inactivation of the Poulsen enzyme were known, either expressly, by implication or when the specification is properly construed in the light of common general knowledge.

24. Further, in context, while the Poulsen Priority Application does disclose a “dual activity enzyme”, this is not accompanied by any suggestion that it may be advantageous to avoid the requirement to list additives in the products of the process or to use the Poulsen enzyme in the process of the claims of the Patent.  The integer of inactivation as a part of and result of the process is an essential integer of the claimed invention.  It has a function and purpose as described in the specification.  It cannot be said that, on the face of the specification, the use and then inactivation of the enzyme to achieve the required functional ingredients and its subsequent inactivation or denaturation so that there is no requirement to list the enzyme as an additive in the final product is no more than an analogous use of the enzyme of the Poulsen Priority Application (NRDC at 262).  It is not a “mere” new use (cf Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232). The process of the invention of the Patent takes advantage of the activity of the enzyme and its subsequent inactivation. As in Dura-Post(Aust) Pty Ltd v Delnorth Pty Ltd (2009) 177 FCR 239 at [32], the specification does not admit that the invention is nothing but a new use of the enzyme for a purpose for which its properties made it suitable, nor is there support for drawing such an inference. There is, for example, no reference in the Poulsen Priority Application to the features of the first and second functional ingredients being generated from the fatty acid ester and second constituent respectively or to the need to inactivate or denature the Poulsen enzyme. Rather, the Poulsen Priority Application emphasises the thermostability of the Poulsen enzyme.

25. There is no suggestion that the contents of the Poulsen Priority Application formed part of common general knowledge.  Indeed, the evidence of Professor Small was to the effect that he had no knowledge of the Poulsen Priority Application or of any enzyme capable of carrying out the two reactions said to be a surprising discovery in that document.  No issue of the extent of common general knowledge of the skilled reader was raised in the context of manner of manufacture.  It follows that there is no need to consider the relevance or otherwise of the knowledge of the skilled addressee in determining this ground of invalidity.

26. It is true that the properties of the Poulsen enzyme and its ability to act on the different substrates were disclosed in the Poulsen Priority Application.  However, there was no relevant discussion in that document of the advantages or disadvantages of those properties such that it could be said that it was well-known or well-understood, nor can it be said that it constituted an analogous use, as was considered in the judgment of Lord Halsbury LC in Morgan & Co vWindover& Co (1890) 7 RPC 131, which was cited with approval in Merck at [67] and relied on by Novozymes.

1. The Patent specification, on its face, does not disclose or claim a new enzyme but it does disclose and claim a new process for a new purpose. 

2. The description in the specification of the Patent gives context to the integers of the claims and explains in particular the reason for inactivation of the enzyme. Even if the whole of the Poulsen Priority Application was incorporated into the specification, it does not deprive the Patent or the claims of the Patent from disclosing an invention, being a manner of manufacture within the meaning of s 18(1) of the Act. I do not accept Novozymes’ assertion that the invention as claimed in the claims of the Patent was, on the face of the specification, known or admitted to have been known in the sense of being well-known or as forming part of common general knowledge. The same applies to its properties.

3. It is unnecessary in reaching my conclusion on manner of manufacture in this case to decide whether the fact that the Poulsen Priority Application was not published as at the priority date of the Patent makes its contents unavailable for consideration in determining whether or not there is a manner of manufacture disclosed in the Patent.  Danisco contends that it is not available for that reason.  I am of the view that, as set out in the specification, the Poulsen Priority Application is available.  The question is not whether the Poulsen Priority Application was made available to the public or had become part of common general knowledge.  It is whether, on the face of the specification itself, taking all of the information in the specification into account, including directions to include and incorporate other information, the subject matter of the claims is disclosed as an invention within the specification itself.

4. Novozymes does not rely on any other reference for this ground of alleged invalidity.  There is no admission in the specification, nor is it apparent on the face of the specification, that there is no invention or no sufficient inventiveness described or claimed.  Revocation on the ground of lack of manner of manufacture is not made out.

   CONCLUSION

5. Claims 1 to 9 and 14 to 15 of the Patent are not invalid on the bases of lack of manner of manufacture, lack of novelty or lack of an inventive step.  The claims of the Patent are not invalid for want of clarity.  Novozymes’ cross-claim should be dismissed.

6. Novozymes has infringed claims 7 and 14 of the Patent pursuant to s 117(1) of the Act and as a joint tortfeasor.

I certify that the preceding three hundred and seventy-eight (378) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Bennett.

Associate:

Dated:       29 March 2011

ANNEXURE A: PRIMER

It is useful to set out some background technological information relevant to the understanding of the Patent and the issues for determination before the Court.

Lipids

1.   Lipids are a broad group of naturally occurring molecules such as fats, oils and waxes.  They are generally composed of carbon (C), hydrogen (H) and oxygen (O) and sometimes other elements such as nitrogen (N), phosphorus (P) and sulphur (S) and are vital to all living cells for both structure and energy. Examples of fats are glycerides (including triglycerides, diglycerides and monoglycerides), phospholipids and glyceroglycolipids (which will be referred to as “glycolipids”).

Triglycerides, diglycerides and monoglycerides

2.   A triglyceride (also referred to as a triacyl glycerol) is a fat comprising a single unit of glycerol, combined with three fatty acid groups.  Triglycerides are the major components of vegetable oils and animal fats. They are also naturally present in flour. A general schematic of a triglyceride is shown below.

3.   Glycerol is a compound with a “backbone” of three carbon atoms and three oxygen-hydrogen (OH) groups protruding from the backbone, one OH group from each of the three carbons. The OH group is known as a hydroxyl group. A compound that contains an OH group bound to a hydrocarbon group is an alcohol. Glycerol is a polyvalent alcohol, that is, an alcohol with more than one OH group. It may also be referred to as a sugar alcohol.

4.   Fatty acids are compounds comprising a chain of carbon atoms (referred to as a “hydrocarbon chain”) bound to a carboxylic acid group.  The carboxylic acid group is formed of an oxygen atom bound to a carbon atom and an OH group bound to the same carbon atom to form a COOH group.  Fatty acids can have a hydrocarbon chain with varying numbers of carbon atoms, ranging from as little as about four up to twenty or thirty.

5.   Esters are organic compounds formed by reaction between acids and alcohols.  This reaction is known as esterification. In Figure 4, the –COR component is derived from the acid and the R’O from the alcohol.  The R and R’ groups may be hydrocarbons or hydrocarbon chains.  A fatty acid ester is an example of an ester, and a triglyceride is an example of a fatty acid ester. 

6.   A triglyceride is formed by replacing the hydrogen (H) atoms of the OH groups on the glycerol with fatty acids.  In Figure 5, an example of a triglyceride is shown. The three carbon atoms in the vertical line form the glycerol backbone, and the three chains of carbons atoms extending to the right comprise the fatty acids. 

7.   Due to the long chains of carbon atoms on the fatty acids, triglycerides in oils and fats do not interact with water and are collectively termed ”hydrophobic” (water-hating).  The stratification of oil and water into two distinct layers when they are brought together is an example of this behaviour.

8.   A diglyceride (also referred to as a diacyl glycerol) is a fat comprising a single unit of glycerol, combined with only two fatty acid groups. A monoglyceride (also referred to as a monoacyl glycerol) is a fat comprising a single unit of glycerol which has only one fatty acid group on the glycerol backbone. Both diglycerides and monoglycerides are examples of fatty acid esters and are naturally present in flour.

9.   A diglyceride may have the fatty acid groups on the first and second or the first and third carbons of the glycerol backbone as shown in Figures 6(a) and 6(b) respectively. A monoglyceride may have the fatty acid group on the first or second carbon of the glycerol backbone as shown in Figures 7(a) and 7(b) respectively.

10. A diglyceride may be formed by removing one fatty acid group from a triglyceride. A monoglyceride may be formed by removing one fatty acid group from a diglyceride or by removing two fatty acid groups from a triglyceride. In each case, the reaction is referred to as alcoholysis or hydrolysis, depending on whether the reaction involves the breaking of a bond by the addition of an alcohol (alcoholysis) or the breaking of a bond by the addition of water (hydrolysis).

11. As shown in Figures 6 and 7, monoglycerides and diglycerides have one or two free OH groups. Because the OH groups are hydrophilic (water-loving), diglycerides and monoglycerides have both a hydrophilic part (OH groups) and a hydrophobic part (fatty acid groups). Overall, diglycerides and monoglycerides are more hydrophilic than triglycerides, which do not have any free OH groups. 

12. Triglycerides, diglycerides and monoglycerides are generally referred to as “non-polar” lipids.

Phospholipids

13. Phospholipids are fats with a similar structure to triglycerides, except they comprise a phosphate group in place of one of the fatty acid groups.  In some phospholipids, an organic molecule, such as an amine, may be further bonded to the phosphate group as shown in Figure 8.  Amines are organic compounds that contain a nitrogen atom with up to three other groups attached.  In the case of phospholipids most commonly found in foods, as depicted in Figure 8, two fatty acid groups are bound to two of the carbon atoms of the glycerol backbone and a phosphate group is bound to the third carbon atom.  An amine group is further bound to the phosphate group.  Due to the presence of the two fatty acid groups on the glycerol and the ester links between the fatty acids and the glycerol, phospholipids are examples of fatty acid esters.  Phospholipids are major lipid components of cell membranes and are naturally present in flour.

14. The phosphate and amine groups of a phospholipid are able to interact with water, i.e. they are ‘hydrophilic’ (‘water-loving’) and the fatty acid groups are hydrophobic (‘water-hating’).  Phospholipids are generally referred to as “polar” lipids.

15. A common phospholipid is phosphatidyl choline (Figure 9).  It is a phospholipid composed of two long chain fatty acids, a phosphate group and an amine group in the form of acetyl choline (Figure 10) attached to a glycerol backbone.

16. Phosphatidyl choline is naturally present in flour. It may be referred to by the common name “lecithin”.

17. Phosphatidyl choline may be appreciated if the molecule is imagined as a balloon with two long paper streamers attached.  The balloon or "head" region corresponds to the polar, hydrophilic portion of the molecule, comprising the negatively-charged phosphate group and the positively charged choline, which readily dissolve in water.  The streamers or "tails" represent the non-polar, hydrophobic part, the long chains of 12 to 18 carbon atoms in each of the two fatty acids, which are insoluble in water.  Due to the presence of the two fatty acid groups on the glycerol, phosphatidyl choline may be termed a fatty acid ester.  Phosphatidyl choline is naturally present in flour. 

18. Removal of one of the fatty acid groups from phosphatidyl choline generates lysophosphatidyl choline (sometimes referred to as lysolecithin), which has the general structure shown in Figure 11.  The remaining fatty acid group in lysolecithin may be attached to the first or second carbon atom of the glycerol backbone, as shown in Figures 11(a) and (b) respectively.

Glycolipids

19. Glycolipids are fats with a similar structure to a triglyceride except they comprise one or two sugar groups in place of one or two of the fatty acid groups, in the same way that phospholipids have a phosphate group. 

20. A sugar is a compound made up of one or more organic compounds called saccharides.  Simple sugars comprise one or two saccharide units with more complex sugars comprising up to ten saccharide units bound together.  Monosaccharides generally contain a chain of about three to six carbon atoms or more commonly a ring of five or six carbon atoms.  All sugars contain a number of hydroxy groups.  Examples of saccharide units include glucose (also known as dextrose), fructose or galactose; whilst examples of disaccharides include sucrose (a glucose linked to a fructose), lactose (a glucose linked to a galactose) and maltose (two glucoses linked together). 

21. Glycolipids can interact with both water and fat.  The non-polar fatty acid group(s) will interact with fats, and the polar sugar group(s) will interact with water. Glycolipids are also referred to as “polar” lipids.

22. A class of glycolipids is galactolipids, in which the sugar group(s) include galactose.  An example of a galactolipid is digalactosyl diglyceride (DGDG), which comprises a glycerol backbone, with two fatty acid groups and one sugar group (Figure 14).  As is apparent from the names, the sugar group comprises two galactose saccharides.  Due to the presence of the two fatty acid groups on the glycerol, DGDG is an example of a fatty acid ester.  DGDG is naturally present in flour.

23. One of the fatty acid groups on DGDG can be removed to generate digalactosyl monoglyceride (DGMG), which has the general structure shown in Figure 15. 

24. DGMG has one fatty acid group, which can be attached to either the first or the second carbon of the glycerol backbone, and one sugar group formed by two galactose saccharide units, as shown in Figure 15(a) and (b) respectively.

Emulsifiers

25. Oil and water are immiscible liquids, that is, they generally do not mix.  However, they may be caused to mix by the formation of an emulsion wherein one liquid is dispersed in another.  Examples of oil/water emulsions include butter and margarine, milk and cream, and vinaigrettes.  In butter and margarine, fat surrounds droplets of water (a water-in-oil emulsion).  In milk and cream, water surrounds droplets of fat (an oil-in-water emulsion).  Emulsification is the process by which emulsions are prepared.

26. Emulsifiers are agents comprising a water-hating hydrophobic component and a water-loving hydrophilic component and can interact with both oil and water to form stabilised emulsions.  Phospholipids, glycolipids, diglycerides and monoglycerides all have emulsifying properties.

27. An emulsifier acts by spanning the interface between the oil and the water phases. In Figure 16, it can be seen that the hydrophilic ends of the emulsifier are located in the water environment, whilst the hydrophobic ends are located in the oil environment.  Emulsifiers are vital in the food production industry, as well as in the manufacture of detergents and a wide variety of other applications.

28. The emulsifying properties of monoglycerides and diglycerides are vital to a vast range of food production techniques.  They allow, for example, the formation of foods such as mayonnaise (oil droplets in water), margarine (water droplets in oil) and are important in improving the quality of baked products such as breads and cakes. 

29. Emulsifiers are incorporated into bread mixtures to improve dough handling and the products overall quality. They result in significant improvements in qualities such as dough conditioning and shelf life extension or "crumb softening."

30. Emulsifiers function as dough conditioners. Dough conditioners provide a number of benefits during bread making, such as: compensating for variations in raw materials (e.g., variations in flour quality); increasing gas retention leading to increased bread volume; better bread texture; and improved symmetry of baked bread.

31. Emulsifiers used in baking include DATEM (Diacetyl Tartaric Acid Ester of Monoglyceride), SSL (sodium stearoyl lactylate), DMG (distilled monoglyceride) and lecithin.

Enzymes

32. Proteins (also known as polypeptides) are organic compounds made of a chain of amino acids.  Proteins are molecules essential to all cells (including bacterial, fungal, plant and animal cells).  They may serve a structural role (e.g. they are the basic component of hair, skin, cartilage etc) or be required for the functioning and regulation of cells, tissues and organs. 

33. Examples of proteins include whole classes of important compounds, among them enzymes, some hormones, and antibodies.  Enzymes are proteins that catalyse (i.e. increase the rate of) chemical reactions.   

34. In enzymatic reactions, the molecules at the beginning of the process are called substrates.  The enzyme helps to convert them into different molecules, called products.  Enzymes are usually very specific to the type of reactions they catalyse and the substrates that are involved in the reactions.

35. Although enzymes differ when it comes to the processes they catalyse, they all have one feature in common, viz, a high catalytic capacity.  Typically, the presence of enzymes will accelerate a biochemical process several million times.  Thus, an enzyme is best characterised as a biological catalyst, since it can accelerate processes (for this purpose, biochemical reactions) that normally would not occur by themselves, or at any rate would proceed only very slowly.

36. Like other catalysts, enzymes are characterised by supporting and increasing the rate of biochemical reactions without undergoing any permanent change themselves.  Thus, a salient feature of enzymes is that they can catalyse an indefinite amount of chemical change without themselves being diminished or altered by the reaction.  At the end of a reaction, the enzyme is ready to catalyse a new reaction process.  Unless the enzyme gradually loses its activity, is removed or is deactivated, it will continue to catalyse the reaction for as long as any substrate is present and a suitable environment is present for activity of the enzyme, or until an equilibrium has been reached between the substrate of the enzyme and the product that is the result of the biochemical process in question.

Lipase

37. A lipase is a type of enzyme that hydrolyses the ester bonds in lipids, for example triglycerides. A lipase degrades triglycerides by cleaving the ester bond that attaches the fatty acid chain to the glycerol backbone.  In the presence of water, this cleavage reaction is referred to as hydrolysis.  This yields monoglycerides and diglycerides and free fatty acids.

38. Quite commonly and more specifically, the term lipase refers to enzymes that break the bond between a fatty acid and the rest of a lipid molecule. 

Phospholipase

39. A phospholipase is a type of enzyme that hydrolyses the ester bond in phospholipids, for example phosphatidyl choline.

Glycolipase

40. A glycolipase is a type of enzyme that hydrolyses the ester bond in glycolipids, for example digalactosyl diglyceride.

CONFIDENTIAL ANNEXURE

[This material is confidential]