Colin Leslie Young v Arthur Yates & Co Ltd and W. Neudorff GmbH

[2001] APO 68

OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application  :          No. 689399and Petty Patent No. 697781 in the name of Colin Leslie Young

Title:          Stomach-action molluscicides

Action:          Two oppositions to the grant of application no 689399, and two notices under section 28 in relation to petty patent no 69781, both by Arthur Yates & Co Ltd and W.Neudorff GmbH KG

Decision:          Issued            .

Abstract

The opposition succeeds on the grounds of novelty, inventive step and section 40.

Construction:  The invention as described and claimed has a pH of above about 7.  This is construed as above 7, within the limits of experimental accuracy.  The pH may be measured by any reasonable method.  The measurement of pellets at the dough stage or by dissolving the pellets is reasonable.  A person would be able to determine whether a pH was above 7, but would not know the exact pH.

Priority date:  The earlier provisional applications do not disclose the significance of pH, so priority cannot be claimed from them.

Novelty:The application is not novel in the light of a US patent.  The replacement of the carrier by bone meal is sufficiently clearly indicated, and would produce a product having a pH of above 7.  A prior use was not established because the earlier product did not have a pH of above 7.

Inventive step: The application is not inventive in the light of the US patent.  It would have been a matter of routine to replace the carrier by bone meal, as this is stated in the citation to be an alternative carrier.  The prohibition on the use of bone meal in different molluscicides would not have dissuaded a person from trying bone meal in a metal complexone composition.

Section 40:As there is no description or definition of how to determine pH values other than 7, there is an ambiguity and a lack of full description.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 689399 by Colin Leslie Young, and two oppositions to the grant of a patent by Arthur Yates & Co Ltd and W.Neudorff GmbH KG;  and

Petty Patent No. 697781 by Colin Leslie Young, and two notices under section 28 by Arthur Yates & Co Ltd and W.Neudorff GmbH KG

BACKGROUND

Patent application number 12203/97 was filed on 17 January 1997 by Colin Leslie Young.  The application is associated with provisional applications PN 7757 and PO 1708 (filed on 25 January 1996 and 19 August 1996).  The application was examined by the Commissioner, and advertised accepted under the serial number 689399 on 26 March 1998.

W.Neudorff GmbH KG (hereafter referred to as Neudorff) filed a notice of opposition on 22 June 1998.  A statement of grounds and particulars was served on 21 September 1998.  The evidence stages were completed on 20 December 2000.

Arthur Yates & Co Ltd (hereafter referred to as Yates) filed a notice of opposition on 26 June 1998.  A statement of grounds and particulars was served on 28 September 1998.  The evidence stages were completed on 1 March 2001.

On 16 July 1998 Professor Young filed petty patent application number 77420/98 as a divisional application of patent number 689399.  The petty patent application was examined by the Commissioner and sealed on 15 October 1998 with the serial number 697781.  An extension of term was requested on 5 August 1999.

Neudorff filed a notice under section 28 on 9 August 1999, accompanied by evidence in support.  Evidence in response was completed on 19 June 2000.  On 22 January 2001 Neudorff filed further evidence which they asked the Commissioner to consider under section 28(3).

Yates filed a notice under section 28 on 15 September 1999, accompanied by evidence in support.  Evidence in response was completed on 19 June 2000.

The oppositions to the parent application and the objections to the extension of term of the petty patent were heard in Melbourne on 16 and 17 August 2001.  Professor Young was represented by Mr Michael Houlihan and Dr Elizabeth Houlihan, patent attorneys of Callinan Lawrie.  Neudorff was represented by Mr Raymond Evans, patent attorney of Phillips Ormonde & Fitzpatrick.  Yates was represented by Mr Paul Kilborn, patent attorney of F.B.Rice & Co.  Also present at the hearing were Professor Colin Young, Mr Ron Pearce and Dr George Puritch.

Following the hearing, further evidence was served and all parties provided written submissions in relation to the further evidence.

The opposition to 689399

The grounds of the Yates opposition are:

1.  the nominated person is not entitled to the grant
2.  manner of manufacture
3.  novelty
4.  inventive step
5.  section 40 matters

The evidence in support of the opposition consists of declarations by Paul Anthony Kilborn, Robert Whitmill Prince, Drew Matthew Ward, Lindsay Ronald Showyin and Ngaire Ann Pettit-Young.  The evidence in answer consists of declarations by Robert Hardy, Rosemary Henderson, David Morton and Colin Leslie Young.  Evidence in reply consists of declarations by Lindsay Ronald Showyin and Paul Anthony Kilborn.

At the hearing, ground 1 was not pressed.

The grounds of the Neudorff opposition are:

1.  novelty
2.  inventive step
3.  manner of manufacture
4.  section 40 matters

The evidence in support of the opposition consists of declarations by Roderick Bradbury, Raymond Lewis Evans, Bernd Nowack, Alison Kilford, Andreas Prokop, Geoffrey A. Derrick, Susan Carpenter and Gottfried Lichti.  Evidence in answer consists of declarations by Colin Leslie Young, David Morton, Rosemary Henderson and Robert Hardy.  Evidence in reply consists of declarations by Robertson Matson, Susan Carpenter, Gottfried Lichti, Andreas Prokop and Bernd Nowack.

The objection to 697781

The grounds of objection raised in the section 28 notice by Yates are:

1.  the nominated person is not entitled to the grant of a patent
2.  manner of manufacture
3.  novelty
4.  inventive step
5.  section 40 matters

The notice was accompanied by a declaration from Paul Anthony Kilborn dated 15 September 1999.  Evidence in response consisted of declarations by David Morton, Rosemary Henderson, Robert Hardy and Colin Leslie Young.

At the hearing, ground 1 was not pressed.

The grounds of objection raised by Neudorff are:

1.  the patentee is not entitled to the grant of a patent
2.  section 18(1)(a) or (b)
3.  section 40(2) or (3)

The notice was accompanied by a declaration from Gottfried Lichti and Raymond Lewis Evans.  Evidence in response consisted of declarations by Rosemary Henderson, David Morton, Robert Hardy and Colin Leslie Young.

At the hearing, ground 1 was not pressed.

The evidence

The evidence in relation to petty patent 697781 is the same as the evidence in support and answer to the oppositions to the parent application 689399.  The evidence in reply in relation to the opposition to the parent application is not formally part of the evidence in relation to the petty patent.  However, Neudorff have attempted to place before me their evidence in reply for consideration under section 28(3).

The evidence in relation to the opposition to the parent application is clear-  it is the evidence as filed.  I note that Yates' evidence includes copies of some of the Neudorff evidence.  The evidence in relation to the petty patent is more of a problem  The parent application and the petty patent are very similar documents.  The evidence in support and answer to the parent application are the same as the evidence in relation to the petty patent.  It is overwhelmingly likely that the evidence in reply to the parent application will also be highly relevant to the objection to the petty patent.  In order to properly determine the objection to the petty patent I must have regard to the evidence in reply to the parent application.

The evidence processes that apply to an extension of term action were carefully considered by the Commissioner in Re Applications by Yamazaki Mazak Corporation (1992) 24 IPR 321. It is clear that evidence in reply is not a normal part of the extension of term process. The only way that the information in the evidence in reply can be part of the extension of term case is if I raise the matter under section 28(3). On 20 July 2001 I informed the parties in writing that I considered that the evidence in reply to the parent application by both opponents may affect the validity of the petty patent. Consequently I intend to rely on that evidence in reply in deciding the extension of term.

At the hearing Mr Houlihan raised the issue of whether the use of bone meal in a composition was permissible under Australian law.  This matter was not part of the evidence on file.  Given the significance of this matter to the grounds of anticipation, I directed that this issue should be made the subject of formal evidence.  The opponents did not oppose further evidence provided they had the opportunity to respond.  I directed that a formal application for further evidence be made, and that the opponents would have the opportunity to respond.  Further evidence in the form of a declaration by Mr Armstrong was filed on 2 October 2001 (in both oppositions).  Responding evidence was filed by both opponents:  Neudorff filed a declaration by Dr Lichti on 17 October 2001, and Yates filed a declaration by Mr Kilborn on 17 October 2001.

Abbreviations used in this decision

Due to the nature of the art, it is convenient to use a number of abbreviations in this decision:

EDTA................................................ ethylenediaminetetraacetic acid

Fe(III)EDTA..................................... ferric EDTA mono anion (the iron(III) complex of EDTA)

[Fe(OH)EDTA]^2-............................... hydroxy form of Fe(III)EDTA
[EDTA-Fe-O-Fe-EDTA]^4-................. oxy-dimer form of Fe(III)EDTA

THE SPECIFICATIONS

Both the petty patent and the parent application relate to compositions for controlling molluscs, particularly slugs and snails.  The invention in both cases is said to include a metal chelate, in which the chelating ligand is a complexone.  These compounds are stated to act as  stomach-action poisons.

The term complexone is defined in both specifications in identical terms:

"The term 'complexone' as used herein refers to an organic ligand containing at least one iminodiacetic acid group -N(CH₂CO₂H)₂ or two aminoacetic groups -NHCH₂CO₂H, or a derivative of either of these where the -CH₂ group is substituted, which form complexes with most cations.  Suitable complexones include those disclosed in Wilkinson, G., 'Comprehensive Coordination Chemistry', Volume 2, Chapter 20.3, pp 777-792 which is incorporated herein by reference."

The preferred metal is iron.  Preferred forms of the complexone include EDTA.  The prime focus of both specifications is the compound Fe(III)EDTA.

A number of examples demonstrate the molluscicidal activity of Fe(III)EDTA compositions, and compare the activity to commercially available molluscicides, as well as to different metal complexes.

The claims

There are two independent claims in the parent application:

1.  A stomach-action molluscicide including a metal complexone and a suitable non-liquid carrier therefor, wherein the molluscicide has a pH above about 7.

26.  A metal complexone when used as a stomach-action molluscicide, wherein the pH of the molluscicide is above about 7.

The claims of the petty patent are:

1.  A stomach-action molluscicide comprising a metal complexone and a suitable non-liquid carrier therefor, wherein the molluscicide has a pH above about 7.

2.  A stomach-action molluscicide according to claim 1, wherein the metal of the metal complexone is selected from a group comprising aluminium, manganese, iron, copper or zinc.

3.  A stomach-action molluscicide according to claim 1 or 2, wherein the metal complexone is an hydroxy-metal complexone.

DECISION

In this decision I am concerned with both the parent application and the petty patent.  The discussion will focus on the parent application, but the comments are equally applicable to the petty patent unless specifically indicated.

In deciding this matter, I recognise what was said in F Hoffman-La Roche AG v New England Biolabs Inc (2000) 50 IPR 305. After reviewing a large number of authorities, Emmett J concluded at 319 [67]:

"I consider that, before the court would uphold an opposition to the grant of a patent, the court should be clearly satisfied that the patent, if granted, would not be valid."

The question that I must ask myself is the same:  whether I am clearly satisfied that the patent, if granted, would be invalid.

1. The evidence of the declarants

It seems to me that some objection was raised against the evidence of almost all of the declarants in this matter.  I will deal quickly with this issue before considering the evidence of the declarants.

Professor Young is the inventor in respect of both cases (and of other applications).  Professor Young declared that he is the only person skilled in the relevant art in Australia because the person skilled in the art has a complex mixture of skills:

"I believe that to be a person skilled in the art in relation to the subject matter of the Opposed Application, one needs to be a physical chemist, who understands the competing equilibria involved when ferric EDTA in the presence of water is subjected to an increase in pH;  a biologist, who understands the anatomy and behavioural characteristics of snails;  a manufacturer of pesticides in general and in particular, of molluscicides;  and a person capable of conducting trials and interpreting the results obtained therefrom."
[paragraph 14 of declarations in answer to both oppositions]

It is a well established principle of patent law that a person skilled in the art is a hypothetical person who can possess the skills of a number of different people (for instance, see General Tire & Rubber Co Ltd v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 482). Consequently, a person may give evidence even if they do not themselves have all of the skills of a person skilled in the art. I do not believe that any of the declarants should be disregarded as they all have some relevant experience.

As an example, Mr Ward is challenged on the basis that he is not a person skilled in the art:

"Ward, an employee of the Opponent, carries out routine testing of the Opponent's products to see if they meet specifications.  He is not knowledgeable in the area of the chemistry of metal complexones, nor in the areas of the biology and anatomy of molluscs and is not conversant with the development of molluscicidal formulations."
[paragraph 26.17 of Young declaration in answer to the Yates opposition]

Mr Ward holds a BSc. App. Chem. degree.  He is employed as a quality assurance chemist, and carried out pH tests on commercially available molluscicides.  I consider that Mr Ward is a person with a suitable background to give evidence in this opposition.  The fact that he is not skilled in all aspects of the present application does not prevent him giving evidence on those matters that are within his area of experience.  I accept that Mr Ward can give evidence.  Equally, all other declarants have a background that makes it appropriate for them to give evidence (and I will not detail each declarant in turn).

A further point is that Mr Ward is employed by one of the opponents.  There is no principle that this automatically disentitles a person from giving evidence.  In the case of any conflict in the evidence, it may be a matter that goes to the weight of the evidence.  I note that a similar criticism could be directed to Dr Morton, who has published many papers jointly with Professor Young.  I consider that I should still have regard to Dr Morton's evidence.  I will have regard to the evidence of all declarants.  If there is conflict between the evidence, it may be necessary to consider whether the weight of any declarant's evidence should be reduced due to a lack of independence.

On a further point, Professor Young characterised most of the evidence for the opponents as tainted through reliance on the evidence of Mr Bradbury.  Mr Bradbury carried out pH measurements of baits said to have been prepared according to the Puritch patent.  Professor Young explained his objection to the Bradbury evidence as follows:

"Bradbury's procedures are flawed.  Bradbury purports to follow the procedure outlined in the Puritch patent and from there he supposedly determines the pH of the resultant formulations.  …  Bradbury only follows the Puritch patent part-way since he only produces doughs and not pellets.  The pH testing is only conducted on doughs, not doughs that are subjected to the final heat treatment step of the Puritch patent and then from which pellets are formed.  Bradbury should have prepared pellets and then conducted pH tests, not simply follow the Puritch patent up to a point, miss an entire step and then test a different composition."
[Young declaration in answer to the Yates opposition, paragraph 26.9]

Many declarants accept without reservation the results obtained by Mr Bradbury.  Professor Young argues that since Mr Bradbury was in error in how he determines the pH of the Puritch baits, then the declarants who accept Mr Bradbury's results cannot be relied upon on this or other points of evidence.  The short answer to this is to ask whether Mr Bradbury followed the correct pH testing procedure.  As I note later in this decision, the specification does not state how the pH test should be conducted, and it is open to a person to use any reasonable test for determining pH.  The measurement of the pH of the dough is a reasonable method of determining the pH of the bait (see my discussion below).  Consequently Mr Bradbury has used a reasonable method for determining pH, so his evidence is not invalidated, and the evidence of those who rely on his evidence is not tainted.

1. The invention as described in the specification

Molluscicides for use against snails and slugs can be divided into three categories:

(i)  irritants:  which are powders that act by being taken up in the snail or slug's locomotion mucus;
(ii)  contact-action:  which are applied as sprays or dusts, and are taken up passively when the snail or slug moves in the area;  and
(iii)  stomach-action:  which are ingested by the snail or slug.

The stated aim of the invention is to provide an improved stomach-action molluscicide.

The specification states that the invention is a metal complexone composition (as previously defined) with a specific pH.  There are several key questions that need to be resolved:  what is the pH limitation, how is the pH measured, how does the invention work, what is the nature of the metal species, and what is the nature of the complexone.

a)  What is the pH limitation

The pH limitation is described on page 8 at lines 19 to 21:

"wherein the pH of the molluscicide is above 7.  Preferably the pH of the molluscicide is between about 7 and 10.  More preferably, the pH of the molluscicide is about 8."

This is the only general statement regarding pH in the description.  Examples are provided that demonstrate formulations with a wide range of pH values.  For instance, the pH values of the examples range from 4.92 (for formulation Z) to 10.3 (for formulation Q).  It is not immediately clear from the examples whether some of the examples fall outside the scope of the invention. 

I note that the examples in the specification are the subject of an implied criticism by Ms Henderson:

"However, my observations on Examples 1 to 5 in the Opposed Application need to be reviewed very carefully because it is not only the pH which has been varied.  In my experience, it is usual when assessing efficacy data for regulatory purposes to only have one variable for example, concentration or pH.  In this way, the results can be attributed to that one selected factor.  However, in some of the Examples, the concentration of Fe(III)EDTA has been changed or has been replaced by Fe(II)EDTA, as well as the pH having been changed.  In Example 1, the concentrations of Fe and pH have changed and it is therefore difficult to categorically say what has altered the efficacy.  …  In my opinion, what the inventor was trying to illustrate was the fact that pH does have an effect on the efficacy rather than pinpointing the optimum pH."

[paragraph 16 of the declaration in the Neudorff opposition;  a similar passage appears at paragraph 15 of the declaration in the Yates opposition]

I agree that it is not easy to draw conclusions from the examples, but I will analyse the examples none the less (since I have nothing else to guide me).  The examples that compare formulations against prior art molluscicides are given in Tables 3 and 5.  These Tables show that 9% Fe(III)EDTA, formulations K, L and M, and [EDTA-Fe-O-Fe-EDTA]^4- (concentration unstated) are more effective than the prior art.  These formulations do not appear in any of the other tables of results.

The other tables of results show:

Table 1:  "The results from Examples 1 show that a formulation of higher pH is much more effective than one of lower pH" (page 16).  This is a reference to formulation A, which has a pH of 9.5 and an efficiency of 92%.  However, the table also shows that formulation C, having a pH of 6.5, is also much more effective (83%) than formulations of pH 6.8 (67%) and 7.8 (54%).

Table 2:  "Example 2 shows that iron (II) formulations are far more effective that those containing aluminium" (page 16).  However, the pH of the aluminium complexones is not specified, so it is not clear whether this results from the metal ion or the pH of the compositions.

Table 4:  A comparison of some aluminium and iron (III) complexones shows "that the kill rate is dependent on the choice and amount of metal used in the formulation and the pH of the formulation" (page 18).  The description does not explain how it is dependent.  It appears to me that the aluminium chelates give higher kill rates than iron (III) chelates.  Focussing on the aluminium chelates, an increase in pH at similar metal concentrations seems to decrease efficacy (comparing formulation R against U, and T against S).  A higher amount of aluminium seems to decrease efficacy at similar pH.  Focussing on the iron chelates now, the metal concentrations are all very similar.  The highest and the lowest pH both give the same efficacy (46%).  Better efficacy is achieved with a pH between these limits.  My conclusion is that kill rate is dependent on a variety of factors, but it is not clear that it is predictable in what way it is dependent.

Table 6:  A comparison of some iron (III) chelates and one iron (II) chelate shows that "the more alkaline the bait formulation for a particular metal chelate, the more palatable the bait and the higher the resulting kill rate" (page 20).  When looking at the iron (III) complexes, it is apparent that formulations with pH values of 7.58 and 8.01 have superior efficacies to formulations having pH values of 6.14 and 6.68.  However, an iron (II) complex with a pH of 4.92 also has a superior efficacy.  I think it can be said that alkaline compositions are effective, but it cannot be said that acidic compositions are not effective.

The data seems to show that variations in pH, metal ion type and concentration lead to differences in efficacy.  Alkaline compositions seem to be generally effective, and on average a bit more effective than acidic compositions.  However, it is apparent that the relationship between pH and efficacy is not linear.  There is no magic pH at which the molluscicide becomes effective, and the detailed examples do not suggest any particular point at which to draw the line.  In this regard, I agree with the comments of Ms Henderson quoted above:  "In my opinion, what the inventor was trying to illustrate was the fact that pH does have an effect on the efficacy rather than pinpointing the optimum pH".

I believe that the description has chosen to place the pH cut off at alkaline values, i.e. at pH values above 7.  I infer this from the following statements:

"the pH of the molluscicide is above 7"  (page 8, line 19-20)
"a stomach poison having an alkaline pH has proved to be more efficacious than one having an acidic pH"  (page 9, line 29 to page 10, line 1)

I conclude that the specification relates to pH values of greater than 7.  As any measurement process inevitably involves an error, results of around 7 may still be properly regarded as greater than 7.  The term "about 7" reflects the practical nature of the cut off.

I note that Professor Young declared that the "pH of the Opposed Application is about above 7 meaning that a pH of 7 is included" (Neudorff, 24.5).  This is correct if read as I have suggested above.

Interestingly, I also have before me information about the pH of a product that appears to be the commercial embodiment of the present application.  I do not believe that it is legitimate to use this information to construe the specification.  The information relates to Multicrop Multiguard Snail and Slug Killer (referred to for convenience as the Multiguard Snail Killer), a product bearing NRA approval number 50312/0698.  This product contains [EDTA-Fe-O-Fe-EDTA]^4-, and is apparently made according to the international application corresponding to the parent application.  It seems a fair conclusion that the Multiguard Snail Killer is a product within the scope of the present application.  Ms Carpenter measured the pH of this product, and found the pH to be 6.32 immediately on mixing, and 6.58 after standing (Carpenter declaration in support of the Neudorff opposition, Exhibit SC-1).  This would suggest that the commercial embodiment of the invention has a pH of about 6.5.  This is an observation only and does not influence my interpretation of the specification or the claims.

A final question is how to interpret a pH result which is different depending on the measurement method used (see discussion of measurement below).  It seems from the description that a single pH measurement was carried out using an undisclosed method, and that pH value is accepted without question.  This suggests that what is described is a pH measurement of above about 7 by any reasonable method, regardless of what may be determined by another method.

b)  How do you measure the pH of a molluscicidal composition

Measurement of pH is a key aspect of the present invention.  However, it must be understood that the main purpose of the measurement is to determine whether the pH is above about 7.

The significance of a pH of 7 is that this is the pH of neutral solution (i.e. pure water).  A pH of above 7 is an alkaline solution, and a pH of below 7 is an acidic solution.  The way that a pH measurement is carried out can influence the pH value obtained, but it would not be expected that a solution would change from acid to alkaline (or vice versa).  For instance, an alkaline solution retains a pH of above 7 at any concentration, but the exact pH value will change with concentration.

The specification does not explicitly state how the pH of the composition is determined.  It is apparent that the compositions are prepared as dry pellets (this is clear from the method of preparation at the bottom of page 10).  The pH of a dry composition cannot be measured directly.  It is necessary for water to be present to form a solution, suspension or paste that can be tested.  However, there is no evidence that there is a recognised protocol for the determination of the pH of molluscicidal pellets (see paragraph 17 of the Showyin declaration in support).

The next question is whether the skilled reader would have understood how to carry out a pH determination without this information.  When I consider the evidence of the parties it is apparent to me that there are several methods that could be used, and that all declarants were able to identify at least one method to determine the pH of pellets.  The evidence shows some disagreement as to whether there is one correct method, with all other methods being incorrect.  This may be an academic matter.

The methods of pH determination suggested by the declarants essentially fall into two types:  dissolution of the pellets in water, and testing of the pellets before they have been dried (this is known as the dough stage of their production).  To my mind both of these approaches have a logical basis.  Since the specification makes no special issue of the method of determining the pH, it follows that the reader may assume that it may be done in any reasonable manner.  In the case of dissolution of pellets in water there is evidence that the pH reading depends on the concentration of the pellets in the water, and how long the mixture is allowed to stand.  I think that the only fair conclusion is whatever seems reasonable.  Mr Bradbury, who carried out pH tests for Neudorff, followed what was called the Bread Test.  In summary, 10 grams of dough was broken into small pieces and placed in 100 ml of water, and the pH of the solution was measured.  Mr Bradbury also used a different approach of measuring the pH of the dough directly, by using a device called an ion sensitivity field effect transistor (ISFET) sensor.  Ms Carpenter also dispersed the dough in water and measured the pH using a normal pH meter.

Dr Lichti in his declaration in support says:  "As there is no requirement for the molluscicide to contain water let alone sufficient water to measure pH by studied methods, I would understand that water would need to be added.  It is not clear, however, how much water should be added or what technique is to be used for measurement"  (paragraph 6.3).  Dr Lichti considered that both the methods used by Mr Bradbury are reasonable:  "any of these methods or indeed other similar methods would be reasonable but are likely to provide significant differences in pH" (paragraph 6.6 of his evidence in reply).

I note that Professor Young declares that there would be no difficulty in assessing the pH of soil (paragraph 26.6 of the Yates evidence;  paragraph 24.7 of the Neudorff evidence).  I would have expected Professor Young to explain how he would have determined the pH of a snail pellet, rather than soil.  However, it is interesting to note the method that Professor Young suggests:  the sample is mixed with a minimum of water.  When Mr Freeman tested a sample of Escar-Go! for Professor Young (paragraph 22 of Professor Young's evidence in answer to the Yates opposition;  paragraph 22.9 of Professor Young's evidence in answer to the Neudorff opposition) he suspended 1 part of bait in 10 parts of water and allowed it to equilibrate for 30 minutes ( paragraph 5 of Mr Freeman's declaration, which is Exhibit CLY-8).  A 1 in 10 suspension does not sound like a minimum amount of water.  Professor Young appears to accept the accuracy of the pH test carried out by Mr Freeman using a method different to that which Professor Young appears to be suggesting in paragraphs 26.6 and 24.7 of his own declarations.  This suggests to me that even Professor Young considers that there is some flexibility in how a pH test can be carried out.

So which method or methods are reasonable methods of measuring the pH of the compositions?  No declarant took the view that dissolving pellets is unreasonable.  The disagreement was over whether testing the dough is reasonable.  No declarant provided a credible argument why an alkaline dough would become acidic simply by drying, which is the critical question.  Drying is the loss of neutral water molecules, not the loss of negative ions.  The measurement of the pH at the dough stage might logically give a different pH value to measurement of the dried pellets, but there is no reason to believe it would change from alkaline to acid.  Testing the dough seems an entirely reasonable method of determining whether the pH is above about 7.

I note that Mr Matson gave evidence in reply to the Neudorff opposition that is relevant to this point.  He tested the pH of the dough and the dried pellets of example 7B of the Puritch patent (discussed more fully below).  In both cases the material was dispersed in water for testing.  Mr Matson's results are:

Dough	7.47
Pellets (3 min)	7.61
Pellets (30 min)	7.26

While not producing identical results, the dough and the pellets gave very similar results that are consistently above 7.  Evidently there was very little change in pH produced by drying the pellets.  This agrees with the view that I had already reached, that testing the dough is a legitimate method of determining the pH of a composition.

I recognise that the Matson evidence was served as evidence in reply, and it is open to question whether it is properly reply evidence (or further evidence in support).  I do not rely on the Matson evidence in reaching my decision, I merely note that it is consistent with the view that I had already formed.

At the hearing there was discussion of the question of whether the specification provided a reference point for the determination of pH.  Mr Houlihan pointed out that on page 13 there is a specific composition of 9% Fe(III)EDTA described, and at page 16 there is a pH value of 7.5 given for 9% Fe(III)EDTA.  The suggestion was that the pH on page 16 refers to the composition on page 13, which provides a means to calibrate any pH determination.  I note that at page 16 it is not made clear that the 9% Fe(III)EDTA is the same as that prepared on page 13.  However, it is more likely than not that it is the same composition.  The difficulty with using this as a calibration example is that the composition contains components that have a pH that varies depending on their source.  The example cited is wheat flour, which is the major component of the composition.  Different sources of wheat flour can have different pH values, and without knowing the pH of the wheat flour it is not possible to use the example as a means to calibrate the pH measuring process.  The evidence supports this interpretation -  Dr Morton, a declarant for the applicant, states that the pH of flour can vary from 6.0 to 6.8, and is an important factor in the pH of a composition (paragraph 23 of declaration in answer to the Yates opposition).  I conclude that there is no calibration information in the specification. 

To the extent that calibration is needed, the reference point for measurement is a pH of 7 (since the question is whether the pH is above about 7).  Pure water has a pH of 7, so can be used to calibrate any test equipment.

I turn now to the question of the determination of pH values other than 7.  The significance of this lies in the fact that some of the claims refer to pH values other than 7:  for instance, claim 2 refers to a pH of "about between 7 and 10", and claim 3 refers to a pH of "about 8".  If a pH determination is carried out using a reasonable method, as discussed above, then a pH value will be obtained, and this pH value can be accepted.  Of course, if the pH determination was carried out in a different (and also reasonable) manner, a different pH would probably be obtained.

This brings me to the question of the accuracy of the pH measurement.  There is necessarily an error in any measurement process, and it was suggested by Mr Houlihan that the term "about" reflects this experimental error.  In the present case I have evidence from people involved in carrying out pH determinations.  Ms Carpenter (declarant for Neudorff) stated in paragraph 7 of her evidence in support that the error is no more than 0.1 pH units.  Mr Freeman (declarant for Professor Young) stated at paragraph 7 of his declaration that the error is no more than 0.2 pH units.  This is one point on which there is reasonable agreement between the declarants for both sides.  I believe that it is safe to conclude that the error inherent in pH testing is no more than ± 0.2 pH units.

c)        How does the invention work

The specification asserts that the compounds produce their increased efficacy as a result of increased palatability.  As examples of where this assertion is found, I note the following passages of the text:

"The major problem to be overcome with stomach action molluscicides is that in order to be effective they must be sufficiently palatable to the mollusc to enable a sufficient quantity of the active ingredient to be eaten to cause the death of the mollusc."
[page 8, lines 15 to 17]

"The results illustrate the variability in the kill rate obtained with the alteration of metal ion and pH which both affect the palatability of the resultant bait formulation.  In general, the more alkaline the bait formulation for a particular metal chelate, the more palatable the bait and the higher the resulting kill rate."
[page 20, lines 12 to 15]

Mr Showyin declares that there is no evidence of palatability:  "the examples of molluscicide formulations given in the specification of the opposed application … do not support the assertion made in the opposed specification that the palatability of molluscicide comprising a metal complexone in a non-liquid carrier is improved by having a pH above 7" (paragraph 25 of his declaration in support).  I agree that there is no evidence in the specification that the applicant has determined that the baits are more palatable to molluscs.  The specification establishes that the baits are effective at killing molluscs, and draws the implication that this is the result of increased palatability. 

However, it could be that the active component is more toxic, as suggested by Dr Morton:

"It is important to remember that the efficacy of a Fe(III)EDTA molluscicide is related to the amount of chelated Fe(III) which is present.  For every molecule of the oxo-dimer present there are two molecules of Fe(III) present within its structure.  Therefore, the concentration of Fe(III) associated with the hydroxy and oxo-dimer species is 0.15 M, with the concentration of Fe(III) associated with the [Fe(III)EDTA]^- species being 0.085 M.  Therefore, at a pH of 7, the amount of chelated Fe(III) remaining in the [Fe(III)EDTA]^- form would be 36%, while 64% exists as the hydroxy and oxo-dimer form i.e. the amount of Fe(III) present as [Fe(III)EDTA]^- is substantially in the minority at a pH of 7."
[paragraph 20 of the Morton declaration in answer to the Yates opposition]

Yet another mode of action seems to be suggested by Mr Hardy:  "the connection between the palatability of the bait and the adjustment of the pH with a metal carbonate to aid in the passage of ferric ions into the blood stream of molluscs"  (paragraph 11 of his declarations in answer to both oppositions).

On a fair reading of the specification, it teaches that the metal complexones are more effective molluscicides, and it is suggested that this is due to increased palatability.  However, there is no evidence that satisfies me how the invention works.  If the rationalisation of the mode of action of the baits is in error, it remains the case that they are effective molluscicides.  It is not necessary for me to resolve the mechanism by which the baits cause the death of the molluscs.

d)        Speciation

One of the assumptions of the application is that the nature of the metal complexone species depends on the pH of the system.  This assumption is based on the article "Determination of the Reaction Quantum Yield for the Photochemical Degradation of Fe(III)-EDTA:  Implications for the Environmental Fate of EDTA in Surface Water" by Kari et al.  This paper shows how the nature of a dissolved iron EDTA species is effected by the pH of the aqueous system, based on calculations using stability constants.  Figure 1 of the Kari article (reproduced below) shows that at a pH of about 8 Fe(III)EDTA has been almost totally replaced by [Fe(OH)EDTA]^2-.

Dr Nowack also carried out calculations of the speciation of 0.05M Fe(III)EDTA and 9% Fe(III)EDTA with 2% CaCO₃.  The results are in Figures 1 and 2 of his declaration (which is part of the evidence in support of the Neudorff opposition).  While Dr Nowack's figures are not identical to those in the Kari article, they show that speciation is effected by pH, and that at a pH of about 8 to 9 the Fe(III)EDTA has been largely replaced by hydroxy species (as noted by Professor Young in his declaration in answer to the Yates opposition at paragraph 26.12).

Professor Young takes great exception to Dr Nowack's calculations (declaration in answer to the Neudorff opposition, paragraph 25), but some of his criticisms are equally applicable to the calculation of Kari.  I note that both Kari and Dr Nowack use a computer program to carry out their calculations, and both make a number of assumptions.  If Dr Nowack's calculations are invalid and should be rejected, then it is likely that the Kari calculations (that are the basis of the speciation arguments relied on by Professor Young in the present applications) are also unreliable.  Both parties accept that speciation occurs, and that Fe(III)EDTA is substantially replaced by [Fe(OH)EDTA]^2- and [EDTA-Fe-O-Fe-EDTA]^4- as the pH is increased.  The disagreement is in the detail, and seems somewhat academic in the present case.  I do not think that too much weight should be attached to Professor Young's criticisms of Dr Nowack.

Dr Morton also addressed this point (paragraph 15 of the Morton declaration in answer to the Yates opposition;  paragraph 16 of the Morton declaration in answer to the Neudorff opposition):

"The speciation diagrams for Fe(III)EDTA complexes clearly show the dominant species within the pH range 7-10 are [Fe(OH)EDTA]^2- and [EDTA-Fe-O-Fe-EDTA]^4-.  Provided water is used as a solvent in the preparation of the stomach action molluscicide the reactions responsible for the formation of these species from [FeEDTA]^- must occur."

Dr Morton disagrees with Dr Nowack's calculations, and comes up with a different set of values.  However, it seems that he agrees with Dr Nowack on the critical point that there should be negligible amounts of Fe(III)EDTA when the pH is 7-10 (paragraph 18 of the Morton declaration in answer to the Yates opposition).  Again it seems that the disagreement over speciation are matters of fine detail, and not of general principle.

Dr Lichti commented that speciation "is an inherent property of Fe EDTA" (paragraph 14.3 of his declaration in support).  I accept that speciation of iron-EDTA complexes is inevitable and is pH dependent.  There could be some doubt as to the precise pH at which the speciation changes occur.  I note that the specification does not prove the nature of the species present in the bait for any of the examples.  Rather, the Kari article is used as the basis for inferring which species should be present.  It seems to be implicit in the specification that other metal complexones would also demonstrate speciation.  I think that the teaching of the specification is of baits with a specified pH, which it is predicted will contain the species suggested by the Kari article.

Dr Morton stated that Fe(III)EDTA and the hydroxy form are not to be regarded as technical equivalents (paragraph 30 of the declaration in answer to the Yates opposition;  paragraph 19 of the declaration in answer to the Neudorff opposition):

"Both the chemical and physical properties of all the different Fe(III)EDTA species, which can exist, are distinct and different from each other and are not just technical equivalents of [FeEDTA]^-"

I accept that the different species are not equivalents.  Although there is no direct evidence that the hydroxy species exist in the pellets, it is fair to proceed on the assumption that they are likely to exist at alkaline pH values.  To my mind this returns to the question of pH measurement, because the species present depends on the pH.  While I am satisfied that a person could determine whether the pH was above about 7, it is more problematic whether a person could determine whether the pH was such as to produce the [Fe(OH)EDTA]^2- species in the dry composition, i.e no more than 12 (which is the point where the Kari article suggests the [Fe(OH)EDTA]^2- species reduces to zero).  As I have already discussed at length, it would be possible to determine whether a composition has a pH of above about 7, and to give a pH value to any composition by using a reasonable method of testing.  However, in order to relate any results to the information in the Kari article, it would be necessary to use a testing method that equates to the Kari conditions.  The evidence does not address the question of whether any of the testing methods give results that can be directly related to the Kari information.  This inevitably means that a reader would be very unsure of the nature of the species present in a composition.

e)        What is the complexone

The definition of the term complexone ends with the words "which form complexes with most cations".  The declaration of Mr Showyin questions whether this requirement to form complexes with most cations is an inherent property of a complexone or an additional limiting feature (paragraph 12 of the Showyin declaration in support).  If it is viewed as a limiting feature it is almost certainly of no effect -  ligands having an iminodiacetate or two aminoacetate groups would inherently be capable of complexing a range of cations.  This is a distinction without a difference, and the term is unambiguous.

1. The invention as claimed in the claims

The claims are directed to a "molluscicide comprising a metal complexone and a suitable non-liquid carrier".  Clearly this is a composition of at least two components.

There are a number of questions posed in relation to the claims, which are similar to those raised by the description.

The metal:There is no limitation on the metal, except that it must be capable of forming a complex with the complexone.

Complexone:   The specification clearly sets up a dictionary that defines this term.  The meaning ascertained in the body of the description applies to this term as used in the claim.

pH:the pH that is relevant is that of the complete composition, not just of a single component.  While the definition of pH is well known to any person who has studied chemistry, what is less certain is how to determine the pH of a bait.  The pH of a solid composition cannot be directly measured, so there is an uncertainty regarding how this is to be carried out.  In the situation of an ambiguity in a claim, it is legitimate to resort to the body of the description for assistance (see Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at 476). As discussed above, the description does not place any restrictions on how the pH determination is carried out, so any reasonable method can be used.

Assuming that a reasonable method gives a result of above about 7, then that composition falls within the scope of claim 1.  I can see no necessity in the claim or the description for the pH to be above 7 as measured by more than one method.

About:This term is inherently imprecise.  Mr Showyin expressed the view that he was uncertain as to the effect of this term:  "it is not clear to me if this includes a pH of 7 or how much below 7 the pH may fall and still be considered 'above about 7'"  (Showyin declaration in support, paragraph 18).  In situations of ambiguity, it is legitimate to refer to the body of the description (see Interlego v Toltoys, supra).  I previously determined that the cut off value as described is 7, within experimental error.  I believe that this is the correct construction to apply to the claims.

Non-liquid carrier:     This term is essentially self-explanatory.  The carrier component must not be a liquid.  The carrier must be such that the resultant composition is suitable for use as a stomach-action molluscicide, which is an extremely broad limitation.  Other than this, there is no limitation on the nature of the carrier.

Reference to specific species: Looking at the appended claims, some of the claims refer to specific species:  claims 8, 17 and 18 refer to [Fe(OH)EDTA]^2-.  Reading the specification as a whole, I consider that these claims should be construed as referring to Fe(III)EDTA under conditions of pH such that the Kari article would predict that [Fe(OH)EDTA]^2- should be present.  I note from Figure 1 in the Kari article that at pH values between 5 and 12 the species [Fe(OH)EDTA]^2- is present, and represents the predominant species at about pH 8.  Consequently, these claims are restricted to compositions where the pH ranges from 7 to 12.  This means that it is necessary to determine with accuracy whether the pH of a composition is below about 12.  In all probability, the testing method ought to be that which reflects the Kari approach.

Claim 7 refers to a hydroxy-metal complexone.  This must also be a reference to the pH conditions necessary to produce this species.  However, the Kari article only provides information for the formation of hydroxy complexones when the metal is iron and the complexone is EDTA.  A meaning can be given to the claim when iron-EDTA is the metal complexone, and that meaning is a pH up to 13 (i.e up to the extinction of [Fe(OH)₂EDTA]^3-).  However, it is not possible to ascribe a meaning to the claim when the metal complexone is other than iron-EDTA.

Reference to a specific pH:    Looking at the appended claims, some of the claims refer to specific pH values above 7:  claim 2 refers to a pH between 7 and 10;  claim 3 refers to a pH of about 8.  This terminology refers to a composition where the pH is of the value specified when measured by a reasonable method.

When used:Claim 26 is directed to a metal complexone "when used" as a stomach-action molluscicide.  I consider that this is another way of defining a process for using a composition containing a metal complexone as a molluscicide.  There is a limitation on the pH which is the same as that used in claim 1.  I consider that the incorporation of a carrier in the composition is inherent, making this claim equivalent to a process of using the composition of claim 1 as a molluscicide.

The invention defined by claim 1 thus includes a metal complexone, and the composition has a pH of above 7.  In the case of the petty patent, claim 1 is the same as claim 1 of the parent application.  Claim 2 is self-explanatory.  Claim 3 is directed to the instance where the metal complexone is an hydroxymetal complexone.  This is a reference to the speciation issue, and indicates a pH such that the hydroxymetal species is present.  Consistent with claim 7 of the parent application, the pH must be in the range of 7 to 13 when the metal complexone is iron-EDTA.

1. Novelty

Novelty was argued on two bases.  First, a United States patent is alleged to anticipate the invention.  Second, the sale of a commercial product is also alleged to anticipate the invention.

It is well established that the general test for anticipation is the reverse infringement test.  The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228, at page 235:

"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement"

This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at page 517; 16 IPR 545 at page 549). A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim (see definition of "prior art base" in Schedule 1 of the Act).

It is relevant to have regard to the recent decision of the Federal Court in Bristol-Myers Squibb Co v F H Faulding & Co Ltd (2000) 46 IPR 553. The Court noted that in the case of a paper anticipation, the reverse infringement test cannot be applied literally. This is because the infringement arises because someone hypothetically does what is suggested by the document. After reviewing the traditional authorities, the majority concluded (at page 576):

"What all those authorities contemplate, in our view, is that a prior publication, if it is to destroy novelty, must give a direction or make a recommendation or suggestion which will result, if the skilled reader follows it, in the claimed invention.  A direction, recommendation or suggestion may often, of course, be implicit in what is described and commonly the only question may be whether the publication describes with sufficient clarity the claimed invention or, in the case of a combination, each integer of it."

The Court recognised that not everything published in a document is an anticipation.  For instance, information that is a speculation or a proposal for a trial would not be an anticipation.  The judges drew a distinction between a teaching of useful things in relation to a subject matter, and a teaching of the invention as claimed.

Turning to prior use, an invention also lacks novelty if it is anticipated by information made publicly available through doing a single act (section 7(1)(a)).  The question is whether an article that would infringe the claim has been made public, even if it was not realised that it would infringe (Evans Medical Ltd's Patent [1998] RPC 517). It is immaterial whether any member of the public had analysed the product to determine its constitution (Bristol-Myers Co v Beecham Group Ltd [1974] 1 All ER 333). I note that the evidence of prior use must be very clear:

"It is essential that an allegation of prior public use should be strictly proved.  Evidence which is uncorroborated is undoubtedly suspect and should be scrutinised with particular care.  The Court must be satisfied that the proof is sufficient in the circumstances, having regard to the gravity of the allegation."
[Windsurfing International Inc v Petit (1984) AIPC 90-135 at 38,924]

a)  Priority date of the claims

The parent application is associated with two provisional applications, and thus is prima facie entitled to claim priority from these earlier documents.  Professor Young declared (and Mr Houlihan accepted) that the application is not entitled to priority from the provisional applications because the critical feature of the importance of pH was not suggested in either of the provisional applications.  I will refer to a passage of Professor Young's evidence in the Yates opposition (an equivalent passage appears in the evidence in the Neudorff opposition):

"The Opposed Application is entitled: 'Stomach-action Molluscicides' and was filed in Australia on 17 January 1997.  Two prior documents, namely PN 7757/96 (Exhibit RLE-3) and PO 1708/96 (Exhibit RLE-4), while disclosing the incorporation of a metal complexone(s) in general as the active ingredient in the molluscicide are not here relied upon for claiming priority in relation to pH.  The improved effect resulting from pH adjustment was discovered after the filing of these prior documents"
[paragraph 15]

I have studied the specifications of the provisional applications, and they contain no reference to pH, or the effect of alkalinity on the molluscicide.  I agree that the parent application is not entitled to priority from either of the provisional applications, and takes the date of filing of the parent application as its priority date.

I note that the presence of inaccurate priority information on the patent request form is undesirable, and should be deleted by amendment.

b)  The Puritch patent

The United States patent number 5,437,870 in the name of George Puritch et al was raised as a novelty citation in the statements of grounds and particulars of both opponents.  The patent was published in the United States on 1 August 1995 (according to information appearing on the patent itself).

The Puritch patent states that it relates to ingestible compositions for the control of terrestrial molluscs.  The patent states that there was a need to develop an ingestible molluscicide that is palatable to molluscs and does not pose a threat to the environment, crops, animals and other non-pests.  The solution provided by the Puritch patent is a composition wherein the constituent compounds do not themselves pose a threat to the environment.

1. Is Puritch directed to stomach-action molluscicides?

As an aside, I note that there was some conjecture at the hearing about whether the Puritch compositions were stomach-action molluscicides or contact-action molluscicides.  The Puritch patent says they are ingestible (i.e. stomach-action).  The opposed application refers to a family member of this patent, and says "it is believed that the efficacy claimed is possibly due to the formulation acting as a contact poison rather than an ingestible poison" (page 7, lines 12-13).  Professor Young reiterates this view in his declaration in answer to the Yates opposition (paragraph 26.13).  While it is open to speculate on the mode of action of the Puritch compositions, I consider this to be an argument of no importance.  So long as the citation discloses the same composition, it is immaterial how it kills the snails.  Puritch identifies his composition as an ingestible poison, which limits the nature of the composition to pellets, rather than a powder or solution.  Also, Puritch clearly states (at column 5, line 45) that the composition can be formulated as pellets or granules.  The compositions of the Puritch patent are of a type that can properly be described as stomach-action molluscicides.

1. What are the Puritch compositions?

The Puritch patent presents an embodiment in which an iron compound and a component such as EDTA (or a salt of EDTA) are used (column 2, lines 44 to 50).  The patent suggests that this mixture only becomes toxic to molluscs on ingestion (column 2, lines 50 to 54).  In a second embodiment, there is a single active ingredient such as Fe(III)EDTA (column 2, lines 61 to 65).

The bait also contains an inert component (column 4, line 25).  The parties disagreed on whether an inert component had to be chemically inert or biologically inert.  The reason for this disagreement centres on whether an alkaline material could be used as an inert component.  If an alkaline component is used, then a formulation falling within the scope of the claims of the parent application would likely be produced.

The bait may also include other components, such as preservatives, phagostimulants, water-proofing agents and taste altering additives.

The general method of producing the bait is described at column 5, lines 31 to 45:

(i)  the active ingredient is mixed with a bait (such as wheat flour) in dry form;
(ii)  other dry ingredients are mixed with the bait;
(iii)  liquid additives are added to form a dough;
(iv)  the dough is covered with a plastic wrap and heated;
(v)  the dough is processed to strands;  and
(vi)  the dough is dried and converted to powder, pellets or granules.

The examples demonstrate the preparation of baits from Fe(III)EDTA, a combination of iron sugar and sodium edetate, and a combination of iron chloride and sodium edetate (examples 7 and 8 being the most relevant).  There are no examples using a carbonate ingredient.

1. What is inert?

Professor Young interpreted the term "inert" as implying "that it should and will not react with the active ingredient/s" (paragraph 21 of the declaration in the Yates opposition;  paragraph 24.10 of the declaration in the Neudorff opposition).  The inert component is discussed immediately following a long discussion of the active ingredients, which could suggest that it is inert as opposed to biologically active.  Bone meal is listed in Puritch as an example of an inert component, and bone meal is an alkaline material.  Professor Young believes that bone meal cannot be inert:

"If as shown by Bradbury and Carpenter on their dough products an effect on the pH of the active ingredient is due to the carrier, then that single carrier or blend of ingredients forming that carrier is contrary to the 'inert' requirement of the Puritch patent.  Bone meal cannot be regarded as an inert carrier as it reacts with the Ferric edetate."
[paragraph 28.3 of the declaration in the Neudorff opposition]

Professor Young is saying that adjusting the pH of the overall composition represents a reaction with the Fe(III)EDTA.  There is a sense in which this is true.  Professor Young's interpretation leads to the necessity to revise the teaching of the Puritch patent in respect of bone meal:

"bonemeal, if selected as the carrier, would have to be chemically treated to be rendered 'inert', before it is added to the active ingredients"
[paragraph 21 of the declaration in the Yates opposition]

This seems to me to be a strained interpretation of the Puritch patent.  Puritch does not suggest the need to modify the inert components to guarantee they are completely inert.  As an example, the carrier used in the example in Puritch is wheat flour.  According to Dr Morton, who is a declarant for Professor Young, wheat flour has a pH of 6.0 to 6.8.  Clearly this would produce a change in the pH of the composition, as it is not of exactly neutral pH.  However, Puritch does not indicate that the wheat flour was treated so as to render it chemically inert.  Puritch simply uses wheat flour as it comes, and there is no need to inactivate it.  There is no suggestion that Puritch teaches inactivation of this, or any other, carrier.  Professor Young does not raise an objection to the examples using wheat flour.

Dr Prokop gives a different interpretation to inert:

"In the field of pest control in agriculture in the US, Germany and in my experience, other countries, including Australia, the term, 'inert', is well understood to refer to the pesticidal activity rather than chemical activity.  Thus 'active' means pesticidally active and 'inert' means pesticidally inactive."
[Prokop declaration in reply to the Neudorff opposition, paragraph 12]

This seems to be the view of Mr Showyin:  "In my opinion, a person skilled in the art would understand the term 'inert' as referring to all the non-actives in the formulation"  (paragraph 9.5 of the declaration in reply).

I think the correct interpretation of Puritch is that you can use bone meal as an additive without the need to make it chemically inert.

1. What is the pH of Puritch?

The Puritch patent does not specify the pH of any of the compositions prepared.

Professor Young obtained a sample of "Escar-Go! Slug and Snail Bait", which he believes is made according to the Puritch patent.  Professor Young declared that this product has been offered for sale outside of Australia, in particular in the United States of America (Neudorff evidence, paragraph 22;  Yates evidence, paragraph 22).  It is clear from the copy of the packaging of this product attached to Professor Young's declarations that the material was manufactured for sale in the United States.  The package has a US patent number on the back, which could be the same as that of the Puritch patent (the copy exhibited to Professor Young's declarations is very unclear).  The active ingredient is stated to be "iron phosphate".  I note that iron phosphate and EDTA are used in the formulations in example 4 of the Puritch patent.

A sample of Escar-Go! was analysed by Mr Paul Freeman, whose declaration appears as Exhibit CLY-8 of Professor Young's declarations.  Mr Freeman suspended a powdered sample in water and allowed the material to stand for 30 minutes.  The pH of the sample was measured as 3.7.  This value is well below 7.

Dr Prokop stated that the material analysed by Mr Freeman could not have been Escar-Go!.  The sample of Escar-Go! analysed by Mr Freeman was green, but Dr Prokop says that Escar-Go! is actually light brown (Prokop evidence in reply to the Neudorff opposition, paragraphs 6 to 8).  I personally examined the Escar-Go! box produced at the hearing, and noted that the pellets in the box were clearly light green.  I am satisfied that the material in the box labelled as Escar-Go! is light green.  Dr Prokop's evidence is inconsistent with what I have seen directly, and I place no weight on his evidence that the material purchased by Professor Young was not Escar-Go!.  I note in passing that it could be that the records of the production of Escar-Go! as sold in the United States at this time were not part of the product records consulted by Dr Prokop in the preparation of his declaration.  I accept that it is most likely that the Escar-Go! was made from iron phosphate and EDTA according to the Puritch patent.  The evidence is that this product has a pH of 3.7, which is clearly not above about 7.

I turn now to example 7B of the Puritch patent.  Example 7B is prepared from 2232 ppm of iron from iron sugar and 16,400 ppm of sodium edetate (which is the tetrasodium salt of EDTA, according to the Merck Index, 11^th edition).  This example is one of the few to use sodium edetate (rather than EDTA itself), and uses the highest level of edetate or EDTA.  Consequently, a significant excess of sodium edetate would be expected.  Given that sodium edetate is alkaline (according to the Merck Index [11^th edition], a 1% solution of sodium edetate has a pH of 11.3), it would not be unexpected for this to lead to an alkaline composition.  Three people prepared and tested samples made according to example 7B:  Ms Carpenter, Mr Bradbury and Mr Matson.  Ms Carpenter tested the dough dispersed in water, Mr Bradbury tested the dough, and Mr Matson tested the dough and dried pellets.  The three independently prepared samples gave results of:

Carpenter (on mixing)	6.68
Carpenter (on standing)	6.56
Bradbury (glass electrode)	7.29
Bradbury (ISFET)	7.50
Matson (3 min standing)	7.47

The evidence is inconsistent on whether the dough of example 7B has a pH of above about 7.  Given that wheat flour is the major component of the composition, and wheat flour has a variable pH (Morton declaration in the Yates opposition, paragraph 23), it is probable that the samples used different types of wheat flour, and so had different pH values.  It follows that a person following example 7B would have produced a product having a pH of above about 7 if they had used a less acidic wheat flour.  The test for novelty is stricter than this:  there is a lack of novelty only if the instructions will result in an infringement.  As there is no suggestion in Puritch to use a less acidic wheat flour it does not fairly teach how to prepare a composition of example 7B having a pH of above about 7.  I conclude that the invention claimed is novel in light of example 7B of the Puritch patent.

1. What else does Puritch teach?

It was suggested that a reader of the Puritch patent could easily have made a composition with a pH greater than 7 in two other ways.  Starting from the general method of preparation in column 5, a reader could use a carbonate additive, or they could use a bone meal additive.  Carbonate would clearly lead to a more alkaline pH, but there is no indication in the Puritch patent to use carbonate.  No declarant has stated that they would have read Puritch as teaching the inclusion of carbonate.  I consider that Puritch does not teach the inclusion of carbonate in a pellet.

The second possibility relates to bone meal.  If bone meal is used as a carrier, then the pH of the composition will be higher than it would otherwise be.  This is confirmed by the work of Mr Bradbury (declaration in support of the Neudorff opposition, and Exhibit LRS-5 of the Showyin declaration in support of the Yates opposition).  At paragraph 10 of his declaration, Mr Bradbury reports the pH of doughs prepared in accordance with the Puritch patent, but using different carriers.  Mr Bradbury's results from testing the dough are:

Carrier composition	pH (glass electrode)	pH (ISFET)
100% bone meal	8.52	7.48
50:50 bone meal : flour	7.89	7.39
90:10 bone meal : flour	8.28	7.52

In addition, Ms Carpenter prepared material in accordance with the Puritch patent and measured the pH of the dough when dispersed in water.  A pH of greater than 7 is recorded for three compositions which were prepared according to example 8 when using bone meal as an ingredient (Carpenter declaration in support of the Neudorff opposition).

pH immediately on mixing	pH after 40 min
8A (bone meal)	7.23	7.39
8C (bone meal)	9.04	9.15
8D (bone meal)	7.26	7.41

Example 8C is a control example, containing no Fe(III)EDTA.  It seems clear that if the Puritch patent is followed using bone meal as the carrier, a composition with a pH of above 7 would inevitably have been produced.  Bone meal is clearly specified in Puritch as an example of an inert bait component, but is not a preferred bait component, and is not used in any of the examples.  The question then is whether the Puritch patent describes a composition prepared from an iron source, EDTA and bone meal "with sufficient clarity" (to use the language of Bristol-Myers) to deprive the present invention of novelty.  To assess this, I will quote in full the relevant text from columns 3 and 4 of Puritch:

"In another embodiment the molluscicidal composition combines an inert, edible mollusc bait with an active ingredient such as ferric edetate or a ferric hydroxyethyl derivative of edetic acid."

"The inert bait component of the molluscicidal composition of the invention is one that must be readily consumed by molluscs.  A variety of mollusc baits are well known and may be used in the compositions of the present invention.  Such baits include agar, potato dextrose agar, gelatin, oil cake, pet food, wheat, soya, oats, corn, rice, fruits, fish by-products, sugars, coated vegetable and cereal seeds, casein, blood meal, bone meal, yeast, fats, and a variety of cereals, including wheat cereal.  A preferred bait is wheat cereal which is commercially available from various sources."
[emphasis added]

Is the inclusion of bone meal in this list of inert components a speculation or a direction?  Puritch teaches that the inert component carries out no special function, and it follows that the inert components can be used interchangeably.  Bone meal is specifically identified as a suitable inert component, and there is a method of formulation given that could be used to prepare a bone meal containing composition.  I believe that a reader of Puritch is entitled to view a bone meal containing composition as made public.  This is analogous to the conclusion that I reached in Pharmacia Aktiebolag v Ueno Fine Chemical Industry Ltd (1995) 34 IPR 445 (in relation to the teaching of the citation US 4131738).

An argument that was not advanced by the parties is that the Puritch patent should not be regarded as teaching compositions that would not be legal for sale in Australia (assuming knowledge of this fact was common general knowledge).  This is analogous to the argument of teaching away that was presented under the heading of inventive step (see below).  While I am not aware of any authority for this notion, it is a logical extension of reading a citation in the light of the common general knowledge.  However, I have come to the conclusion that bone meal is not a prohibited additive in Fe(III)EDTA based molluscicides (see the discussion under inventive step), so this argument would not aid Professor Young's case.

It is clear that claim 1 is not novel in so far as it includes a composition of Fe(III)EDTA and bone meal.  Such a composition would have a pH of about 7.5 to 8.5, based on the data of Mr Bradbury and Ms Carpenter.  Puritch discloses that the composition also contains a water-proofing agent, a phagostimulant, a preservative and other additives.  The amount of the active ingredient appears to be less in Puritch and there is no calcium carbonate in Puritch.  It follows that the following claims are also lacking in novelty:  2, 3, 4, 5, 6, 7, 8, 9, 20, 26.

For the same reasons, claims 1, 2 and 3 of the petty patent are not novel.

c)  Sale of the Multiguard Pellets

It was alleged that a product sold under the name "Multicrop Multiguard Snail and Slug Pellets" fell within the scope of the claims.  I will refer to this product simply as the Multiguard Pellets.

(i)  When were Multiguard Pellets  sold in Australia?

Before a snail killer can be legally sold in Australia, it is necessary to obtain the approval of the National Registration Authority (known as the NRA).  When a product is approved, it is given an NRA number that appears on the packaging of the product.

The Multiguard Pellets was approved by the NRA on 6 September 1996 and received the number 48504.  A box of Multiguard Pellets was purchased from Mitre 10, Camden Timber and Hardware, Maxwell Place, Narellan, NSW by Mr Geoffrey Derrick on 9 January 1997.  Mr Derrick executed a declaration in support of the Neudorff opposition establishing this fact.

(ii)  What is the active ingredient in Multiguard Pellets?

The information on the NRA database in relation to Multiguard Pellets states that the active ingredient is FERRIC EDTA.  The packaging of the Multiguard Pellets box states that the active constituent is "90g/kg IRON-EDTA COMPLEX".  The package also states that "PATENT APPLIED FOR NO. PN 7757/96".

The first question is whether Multiguard Pellets contains Fe(III)EDTA.  Professor Young declared in the Neudorff evidence that "a number of chemicals are accurately described by using the generic name iron-EDTA complex" (paragraph 27.2).  It appears from the packaging of the Multiguard Pellets that it is made according to provisional application PN 7757.  Mr Houlihan seemed to agree with this interpretation.  There seems to be only one pellet composition disclosed in PN 7757.  At page 8 the composition is given as

670 g/kg  wheat flour;
160 g/kg  bran;
20 g/kg  calcium stearate;
90 g/kg  ferric sodium EDTA;
20 g/kg  sodium benzoate;
0.2 g/kg  bitrex (denatonium benzoate);  and
40 g/kg  white oil

This suggests that the Multiguard Pellets contains Fe(III)EDTA.

(iii)  What is the pH of Multiguard Pellets?

The next question is whether the pH of the Multiguard Pellets was above about 7.  At the hearing there was some discussion of assertions made in correspondence to the Commissioner during the prosecution of the application.  These assertions relate to a commercial product (which is probably Multiguard Pellets) corresponding to the present application.  Inferences as to the pH of Multiguard Pellets were sought to be drawn from these assertions.  This is very indirect evidence which requires a number of inferences to be drawn.  In this situation I prefer to rely on the direct evidence of the pH.

Professor Young declared that he reviewed the formulation for Multiguard Pellets, and that it does not contain "a component or a sufficient concentration of one or more components that result in the final and marketed composition having a pH above about 7" (paragraph 22.6 of the declaration in the Neudorff opposition;  paragraph 24.9 of the declaration in the Yates opposition).  However, this evidence does not establish what the pH value of Multiguard Pellets is, was, or should be.

In this case I am fortunate to have evidence of direct tests made on samples of Multiguard Pellets.  Mr Derrick sent a sample of the material that he purchased to Ms Carpenter for analysis.  Ms Carpenter prepared a report of her analysis on 22 February 1999 (Carpenter declaration in support of the Neudorff opposition).  The report gives the pH of this material as:

immediately on mixing	6.18
after agitation and standing	6.38
after agitation and standing for 20 hours	6.99

Ms Carpenter crushed the pellets and dissolved (or suspended) them in water.  The difficulty in using this information lies in two questions:  was the material tested by Ms Carpenter still in a fresh state; and was the measurement done correctly.

Mr Houlihan suggested that it was impossible to know whether the Multiguard Pellets had been stored properly at the store prior to purchase, how it had been handled since its purchase, and whether it was past its use by date.  I agree that I do not know how the product was handled prior and subsequent to sale, but the product does not carry any statement that it must be stored or handled in a particular way.  The product, on its face, indicates that no special handling is required.  Mr Houlihan cannot argue that the opponent was in error in following the implicit information on the packaging, so this point is of no significance.  The suggestion that the product was past its "use by date" when it was tested is similarly lacking in evidence.  It is not clear from the box that there is a "use by date".  There is no evidence from the applicant that the product has a set shelf life, or what that life span is.  Having been presented with detailed information about the purchase and testing of the Multiguard Pellets, it is not sufficient for Mr Houlihan to suggest that the test results might not be accurate because the product might have been too old.  However, given my interpretation of the results of the pH measurement (see below), it is not necessary to resolve the "use by date" issue.  In passing I note that there are five different pH measurements carried out on samples of Multiguard Pellets in the evidence, and that all gave results that are very similar (see the declarations of Carpenter, Young and Ward).

I turn now to interpreting the results obtained.  On mixing and standing the pH value obtained is well below 7.  However, after standing for 20 hours the pH is effectively 7.  If allowing the sample to stand for 20 hours is a reasonable method for carrying out the pH determination, then the Multiguard Pellets has a pH of 7.  Professor Young declared that standing for 20 hours is not a reasonable test method (Neudorff evidence at paragraph 28.8).  The Lichti declaration in reply explains that changes in pH are due to "interaction of the carrier with the water" (paragraph 19).  My reaction to this evidence is that allowing a sample to stand for 20 hours is not a reasonable test method, and this result should not be considered.  The other evidence is consistent in specifying that the Multiguard Pellets have a pH of less than 7.  The pH is sufficiently below 7 that it is not reasonably considered as above about 7.

Finally, I note that a product with an alkaline pH was given approval by the NRA under the number 49636.  This product was called NO FRILLS SNAIL AND SLUG PELLET.  The information in relation to this product is that it contains Fe(III)EDTA, but in the manufacturing process the pH has been raised to just above neutral (7.5-8.0).  The active ingredient is described as iron oxo EDTA.  This is made clear in the Henderson declaration in answer to the Yates opposition, at page 8.  The NO FRILLS product was apparently never released commercially, and its place was taken by a later product containing iron oxo EDTA which received NRA approval on 20 October 1997 (given the number 50312/1097).  This product was manufactured in September 1998.  Professor Young declares that since this product containing [Fe(OH)EDTA]^2- was not manufactured until September 1998, that no other product containing Fe(III)EDTA and having a pH of above 7 could have been manufactured before September 1998 (Young declaration in answer to the Yates opposition, paragraphs 24.10 to 24.15).  With respect, this is consistent with the Multiguard Pellets having a pH of less than 7, but it does not prove the pH of any material that was sold in 1997.

I conclude that the Multiguard Pellets do not have a pH above about 7, so they do not anticipate the claimed invention.

1. Inventive step

It was argued that the invention is obvious in the light of the Puritch patent and another article.

Section 7(2) provides a definition of inventive step for the purposes of the Patents Act.

"(2)  For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, whether that knowledge is considered separately or together with either of the kinds of information mentioned in subsection (3), each of which must be considered separately.
  (3)  For the purposes of subsection (2), the kinds of information are:

(a)prior art information made publicly available in a single document or through doing a single act;  and

(b)prior art information made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;

being information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant to work in the relevant art in the patent area."

[The prior art base is defined in Schedule 1 of the Act.]

It is clear that inventive step is a matter that is presumed, unless it is demonstrated that the invention is obvious.  The assessment of obviousness can be made against the common general knowledge alone, or the common general knowledge together with a document (or act) of the type covered by section 7(3).  Section 7(3) documents must satisfy several requirements:  the document must be publicly available inside or outside Australia (see the definition of "prior art base");  and the document would have reasonably been expected to have been ascertained, understood and regarded as relevant.

The normal approach to obviousness is the problem-solution approach:  for instance, see Rhone-Poulenc Rorer S.A.'s Application [1995] APO 50. I note in passing that the problem-solution concept is evident in judicial decisions such as Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 (e.g. at 298: "this solution to the known problem") and Winner v Ammar Holdings Pty Ltd (1993) 113 ALR 63 (e.g. at 67: "The problem and the solution were readily apparent"). Once the problem has been formulated, and the common general knowledge or prior art base has been determined, the question of whether the claimed solution is obvious must be addressed. The test for obviousness is whether it would have been a matter of routine to proceed to the claimed invention.

"It is still correct to say that a valid patent may be obtained for something stumbled upon by accident, remembered from a dream or imported from abroad, if it otherwise satisfies the requirements of the legislation.  What is important is that the patent itself should involve an inventive step, whether or not it was consciously taken by the patentee and whether or not it appeared obvious to the patentee himself.  The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."
[Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd (1981) 148 CLR 262 286]

The question of what would be routine can be considered using the "obvious to try" approach.  This approach is well explained in Beecham Group Ltd's (Amoxycillin) Application [1980] RPC 261 (which has been approved in Coopers Animal Health Australia Ltd v Western Stock Distributors Ltd (1986) 67 ALR 390 at 410 and W R Grace & Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481 at 492 - 494) at 290 - 291:

"It is clearly established that, for a particular step or process to be obvious for the purpose of either section, it is not necessary to establish that its success is clearly predictable.  It will suffice if it is shown that it would appear to anyone skilled in the art but lacking in inventive capacity that to try the step or process would be worthwhile.  Worthwhile to what end?  It must, in my opinion, be shown to be worth trying in order to solve some recognised problem or meet some recognised need."
[citations omitted]

This approach suggests that an invention is obvious if it would have been considered well worth trying, with the likelihood of success being sufficient to warrant the actual trial.  However, it must always be remembered that there is an unclear line between normal trial and error and an inventive step:

"However, the test of whether something was 'worth trying' involves questions of degree  …  If the expectation of success is sufficiently predictable, and the effort involved is not going to be very great, it may well be that there is no inventive step.  On the other hand, if the expectation of ultimate success is doubtful and the effort involved is great, the person undertaking the work should be entitled to a monopoly.  A patent monopoly is awarded, not to reward genius but to encourage the disclosure of information which is of value to the public in that it takes the store of knowledge ahead by the requisite 'inventive step'."
[ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc (1999) 45 IPR 577 at 600-601, citations omitted]

a)  The problem

The specification discloses the problem at page 7, lines 16 to 18:

"Accordingly, it is an object of the present invention to provide an improved stomach-action molluscicide containing a metal chelate, which is substantially more palatable and therefore more efficacious"

Unfortunately I cannot adopt this formulation of the problem, as there is no evidence that the formulations of the application are more palatable to snails and slugs.  There is evidence that the formulations are more effective at killing snails and slugs, and palatability is presented as a rationalisation of their effectiveness.  However, without some evidence that the invention as claimed has solved the problem of palatability, I cannot use it as the problem.  On the other hand, increased effectiveness in killing snails and slugs is an acceptable formulation of the problem that is supported by the specification.  I will use this broader formulation of the problem for my analysis.

The specification goes on to suggest a further object of the invention:

"It is a further object of the present invention to provide a more palatable stomach-action molluscicide, whilst also retaining the beneficial aspects of such a molluscicide being both environmentally-friendly and non-toxic to non-target organisms."
[page 7, lines 18 to 20]

The notion of reduced toxicity to non-target organisms is picked up by Professor Young in his evidence:

"In my expert opinion therefore, the Opposed Application provides a molluscicidal formulation that is efficacious, while being harmless to non-target organisms"
[paragraph 28 of the declaration in answer to the Yates opposition]

Again, there is no evidence in the specification that the composition is selective for molluscs.  However, there appears to be a theoretical basis put forward for believing that the compositions would be selective:

"Selected complexones are considerably less toxic to mammals than methiocarb or metaldehyde.  Indeed, they are used in medicinal applications to relieve anaemia.  Such complexones are often used in trace-element mixes in situations where a plant is suffering from an iron deficiency."
[page 7, lines 27 to 29]

Given that there is a reasonable basis for believing that the compositions would solve the problem of toxicity to non-target organisms, it is appropriate to include this in the formulation of the problem.  For the purpose of this decision, I will formulate the problem as:

To provide an improved molluscicide which is non-toxic towards non-target organisms.

b)  Common general knowledge

The evidence contains a large number of statements of what the declarants consider to be common or well known.  I will refer here only to these matters that are relevant to the determination of inventive step.

One of the key questions is whether it was common general knowledge, or routine practice, to use an alkaline additive in large quantity.  The important alkaline additives are bone meal and calcium carbonate.  I will deal with the evidence in relation to these points.

(i)There are molluscicides on the market with a range of pH values (Henderson declaration in the Yates opposition, page 10).

(ii)Molluscicide formulations with a pH of greater than 7 were known in Australia according to Mr Showyin (Showyin declaration in support, paragraph 37), but would not have been preferred according to Professor Young (Young declaration in the Yates opposition, paragraph 25.4).

(iii)It was commonly believed that alkaline materials behaved as irritants to molluscs and were not ingested by molluscs (Young declaration in the Yates opposition, paragraph 16).

This evidence suggests that alkaline compositions were not likely to have been a matter of routine in molluscicidal compositions.  Turning now to the specific instance of molluscicides containing calcium carbonate:

(i)There are products on the market with a range of pH values (Henderson declaration in the Yates opposition, page 10).

(ii)Calcium is important for snails (Showyin declaration in reply, paragraph 9.22), and snails are likely to be attracted to calcium containing materials (Showyin declaration in support, paragraph 38).  Snail farmers feed calcium carbonate to snails (Lichti declaration in reply, paragraph 122).  On the other hand, it is not clear why snails are attracted to calcium containing materials (Young declaration in the Yates opposition, paragraph 26.18).

(iii)It was commonly believed that alkaline materials behaved as irritants to molluscs and were not ingested by molluscs, and deterred the mollusc from ingesting the poison (Young declaration in the Yates opposition, paragraph 16, based on Exhibit RH-2 of the Hardy declaration which states that certain alkaline substances have been used as irritants in slug control).

(iv)Edible carriers used in molluscicides include flour and bone meal (Lichti declaration in reply, paragraph 117).

(v)Additives in molluscicides include calcium carbonate (Lichti declaration in reply, paragraphs 117 and 120).

This evidence suggests to me that snails need calcium as a part of their diet.  However, there is insufficient evidence that it was standard practice to include calcium carbonate in molluscicides.

Finally, the use of bone meal in molluscicides is not suggested to be common general knowledge by any of the declarants.  At best it appears that bone meal can be used as a carrier.

I conclude that it has not been established that alkaline compositions were routine in the molluscicide art.  Further, it has not been shown to be routine to include either calcium carbonate or bone meal in molluscicidal compositions.

A final important point is that it was common general knowledge that Fe(III)EDTA was not toxic to non-target organisms.  The evidence of this is found in the specification itself:

"Selected complexones are considerably less toxic to mammals than methiocarb or metaldehyde.  Indeed, they are used in medicinal applications to relieve anaemia.  Such complexones are often used in trace-element mixes in situations where a plant is suffering from an iron deficiency.  …  They are neither insecticides nor acaricides and snail and slug pellets based on such compounds will not kill earthworms or the (mainly beneficial) carabid beetles.  The term 'metal complexone' is used in its broadest sense and refers to a chelate of a metal with at least one ligand of the complexone type."
[page 7 to 8]

While this discussion occurs under the heading "Summary of the Invention", it appears to be a recitation of the known properties of metal complexones.  This is reinforced by the fact that there is no independent verification of these properties in the specification.  It is settled law that information that the specification asserts is generally known can be accepted as part of the common general knowledge:

"If a patent application, lodged in Australia, refers to information derived from a number of prior publications referred to in the specification or, generally, to matters which are known, in our view the court - or the commissioner - would ordinarily proceed upon the basis that the knowledge thus described is, in the language of s 7(2) of the 1990 Act, part of 'the common general knowledge as it existed in the patent area'."
[Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 46 IPR 553 at 564, paragraph 30]

c)  Puritch

Puritch is addressing the same problem as the present application (as noted by Dr Lichti in his declaration in support at paragraph 13.3).  The Puritch patent discloses Fe(III)EDTA containing molluscicides.  I believe that Puritch is a document that would have been ascertained, understood and regarded as relevant.  The Puritch patent discloses compositions that are very similar to those of the present application. 

Since Puritch discloses Fe(III)EDTA compositions, a person would have understood that they would be non-toxic to non-target organisms.  The key question is whether it would be a matter of routine to vary the Puritch compositions to include either calcium carbonate or bone meal.

It can be argued that it would be a matter of routine to vary the Puritch process to use bone meal, as this is suggested by the Puritch patent itself as an alternative inert component. If bone meal is used as an inert component, then the pH of the composition will almost certainly be above 7 (see the earlier discussion under the heading of novelty). The further evidence of Mr Armstrong goes to the question of whether it would have been a matter of routine to incorporate bone meal in a molluscicidal composition. Mr Armstrong declares that he is aware of the Agricultural and Veterinary Chemicals Code Act and its associated Regulations. Mr Armstrong carried out a search of SCALEplus, the web based legal information retrieval system provided by the Australian Attorney General's Department ( His search of the term "molluscicide" led him to regulation 9 of the Agricultural and Veterinary Chemicals Code Regulations. This regulation reads:

9.        (1)       For the purposes of paragraph 14(3)(d) of the Code (which deals with the grant or refusal of applications), an agricultural chemical product of a kind specified in the subregulation (2), (3) or (4) must comply with the requirements prescribed by this regulation in relation to that product.

(2)       A molluscicide in the form of a bait and of which the active constituent is metaldehyde:

(a)must contain sufficient green pigment or dye to colour the bait a distinctive green colour;  and

(b)must not contain, in the bait, any bone meal or other product of animal origin.

(3)       A molluscicide in the form of a bait and of which the active constituent is methiocarb:

(a)must contain sufficient blue pigment or dye to colour the bait a distinctive blue colour; and

(b)must not contain, in the bait, any bone meal or other product of animal origin.

(4)       An agricultural chemical product that is to be applied to seeds that are to be stored before planting or sowing must contain sufficient pigment or dye to colour the seed to which the product is applied so as to enable that seed to be readily distinguished from seed to which the product has not been applied.

Mr Armstrong declares that this regulation came into force on 21 February 1995.  Mr Armstrong considers that this regulation would have dissuaded anyone from using bone meal in a molluscicidal composition:

"I am aware that metaldehyde and methiocarb were the only two chemicals in common use in commercial molluscicidal formulations in Australia prior to the registration of a molluscicidal formulation incorporating a metal complexone as referred to in Australian Patent No. 689399 and Australian Petty Patent No. 697781.

Regulation 9 was in force as of 17 January, 1997.  Accordingly, I believe that anyone wishing to prepare a molluscicidal formulation for use in Australia before 17 January, 1997 would have been aware that the use of bone meal or any other product of animal origin in such a formulation would have been prohibited by Regulation 9"
[paragraphs 9 and 10 of the Armstrong further evidence in relation to both oppositions]

This evidence raises two problems.  First, was this regulation known to workers in the art.  Mr Armstrong does not state that this regulation was known to him prior to his search on the SCALEplus site.  In the absence of clear evidence, it seems unlikely that regulation 9 was well known to Mr Armstrong.  I note that Professor Young discusses the bone meal issue in his evidence in answer, but does not mention this point.  Professor Young considers himself to be a person skilled in the art, and his silence on this issue suggests that he was not aware of this problem.  Secondly, would a person consider that the prohibition on the use of bone meal extended beyond baits containing metaldehyde or methiocarb as the active constituent.  While the regulation is clear in limiting its operation to baits containing metaldehyde or methiocarb, Mr Armstrong regards the prohibition as extending to other molluscicidal baits.  Regrettably Mr Armstrong does not explain why he would extend the scope of the regulation.  Dr Lichti in his declaration responding to the further evidence in the Neudorff opposition stated that he disagreed with this position (paragraph 8).  Dr Lichti also does not provide a satisfying reason for his belief.

It is clear from the evidence that bone meal is not a prohibited additive in Fe(III)EDTA based molluscicides.  Further, I can see no reason why a skilled person, even assuming that they were aware of the regulation, would have considered that they should imply a prohibition.  Consequently the Puritch patent should be accepted on its face as clearly providing an indication that bone meal is an equivalent carrier that is well worth trying.  Puritch discloses that the composition also contains a water-proofing agent, a phagostimulant, a preservative and other additives.  The amount of active ingredient appears to be less in Puritch, but I do not believe that this can be regarded as inventive.  On the other hand, Puritch does not disclose the use of calcium carbonate, which I found was not a routine ingredient in molluscicides.  Consequently, the compositions containing carbonate are not obvious, but the other compositions are obvious.  Thus claims 1 to 9, 11 to 14, 16 to 18, 20 to 26 lack an inventive step.  Claim 19 relates to a composition containing an additional molluscicide.  I have no evidence that it was common general knowledge to include an additional molluscicide.

Looking at the claims of the petty patent, the same logic applies and renders claims 1 to 3 lacking in inventive step.

The other possibility is to incorporate calcium carbonate into the Puritch composition, which would undoubtedly lead to a higher pH.  However, it has not been shown to be a matter of routine to incorporate calcium carbonate.  Consequently obviousness on this basis is not established.

d)  Henderson article

The article "Control of slugs with contact-action molluscicides" in the Annals of Applied Biology (1990) 116, 273-278 by Henderson et al was raised as an inventive step citation.  This document was available to the public in Australia on 4 September 1990 (Pettit-Young declaration).

The Henderson article lies in the field of molluscicides, particularly contact-action molluscicides.  One of the active agents investigated is Fe(III)EDTA, which is reported on favourably (see particularly page 277).  Mr Showyin comments about this document:

"The disclosure in this document concerning the activity of Fe(III)EDTA as a molluscicide immediately raises in my mind the possibility of incorporating that chelate in a bait formulation."
[paragraph 42 of declaration in support]

Mr Showyin declared in his declaration in support that the selection of carriers was a matter of choice:

"I believe the selection of these well known carrier(s) in the formulation of stomach-action molluscicides represent mere formulation choices available to the persons skilled in the field in Australia before 25 January 1996  …  I therefore believe that a person skilled in the art wishing to produce a stomach action molluscicide, and having read any one of the prior art documents referred to above, would produce a molluscicide composition that would, with equal probability, either have a pH at or below 7 or have a pH above 7."

[paragraph 48 of declaration in support]

Mr Showyin goes on to reinforce this point by reiterating his view that there is no evidence that a pH above 7 produces an increase in palatability:

"It seems to me that that pH feature emphasised in the opposed specification is in reality a mere formulation choice that was available to a person skilled in the field having the common general knowledge in Australia before 25 January 1996."
[paragraph 49 of declaration in support]

There is no doubt that the Henderson article is relevant to work in the area of molluscicides, and it would be expected to have been ascertained and understood by workers in the art.  The reader would have understood that the Fe(III)EDTA discussed would be less toxic to non-target organisms, as this was common general knowledge.  However, I am not satisfied that it was a matter of routine to prepare alkaline molluscicidal compositions.  Consequently the claimed invention is not obvious in the light of this article.

1. Manner of manufacture

The law on manner of manufacture has been examined in a number of recent decisions by Australian courts:  the High Court in NV PhilipsGloelampenfabriken v Mirabella International Pty Ltd (1995) 183 CLR 655 and Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171, the Federal Court in Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 46 IPR 553.

In the Bristol-Myers case, the majority summarised the effect of the Philips case as:

"Philips stands for the proposition (as a matter of construction of the 1990 Act) that if, on the basis of what was known, as revealed on the face of the specification, the invention claimed was obvious or did not involve an inventive step -  that is, would be obvious to the hypothetical non-inventive and unimaginative skilled worker in the field (Minnesota at CLR 260 per Barwick CJ) -  then the threshold requirement of inventiveness is not met."
[page 564]

It is clear that I must consider whether there is an inventive step in the light of what the specification states is known.  What is known is not everything that is stated in the specification:

"Some elaboration, however, is required in relation to what the specification reveals as 'known'. If a patent application, lodged in Australia, refers to information derived from a number of prior publications referred to in the specification or, generally, to matters which are known, in our view the court - or the commissioner - would ordinarily proceed upon the basis that the knowledge thus described is, in the language of s 7(2) of the 1990 Act, part of 'the common general knowledge as it existed in the patent area'."
[Bristol-Myers at page 564]

The assessment is based on the common general knowledge as it is presented on the face of the specification.  If information is stated to be common general knowledge or can reasonably be inferred to be common general knowledge, then the Commissioner can accept that conclusion without any further evidence.  It is not correct to say that every piece of prior art referred to in the specification is part of the common general knowledge.

In the present case the argument is quite simple.  The Puritch patent is admitted prior art in the specification (it is referred to on page 7 by the number of the corresponding international application -  WO 96/05728).  The specification states that Puritch discloses a "mollusc stomach poison", although there is some doubt whether it works as a stomach-action or contact-action molluscicide.  The Puritch molluscicide is said to use an active agent which can be Fe(III)EDTA.  There is a reference to the pH of the Puritch molluscicides at lines 11 to 12:

"tests carried out on these formulations by the present inventors revealed the acidic and hence possibly unpalatable nature of these formulations"

On the face of the specification there is no suggestion that Puritch discloses an alkaline molluscicide.  I consider that the ground of manner of manufacture has not been made out.

1. Section 40 matters

A number of section 40 matters were included in the statements of grounds and particulars.

a)  Clarity

A claim is lacking in clarity if a third party could not ascertain whether an act would fall within the scope of the claim (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59). A number of clarity issues were raised in relation to the claims. All of these matters were discussed earlier under the heading of the construction of the claims. One matter that is ambiguous is the determination of the pH when it is defined as other than 7. I have construed this requirement as meaning that the pH is of the specified value when measured by any reasonable method. However, a person may need to carry out measurements by all possible reasonable methods in order to know whether a composition would fall within the scope of the claim; the fact that a composition did not fall within the scope of the claim when the pH is measured by one reasonable method does not guarantee that the composition will not fall within the scope of the claim when the measurement is carried out by a different reasonable method. Thus claims 2, 3, 7, 8 and 17 are not clear. A second matter of clarity relates to claim 7, where the pH requirement is such as to form a hydroxy-metal complexone. As previously noted, the pH at which hydroxy-metal complexones other than of iron-EDTA are produced have not been disclosed, and is entirely uncertain. Claim 3 of the petty patent is unclear for similar reasons.

b)  Fair basis

When considering the issue of fair basis, "the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification" (Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 11 IPR 289 at 304). A number of fair basis issues were raised in the statements, and I will deal with them briefly.

EDTA is the only complexone exemplified:  The specification refers to complexones generally, and specifically exemplifies EDTA.  In my opinion, EDTA can properly be regarded as a reasonable example of a complexone, so there has been a real and reasonably clear disclosure of complexones generally.  However, if it was necessary, the specification also exemplifies the use of additional complexones with aluminium (see page 14).

pH limitation is not described:  The specification states in general terms that the pH limitation is above about 7.  As I discussed previously, the value of 7 is an arbitrary choice and is not a cut off value.  However, the fact that the invention may still work at pH values of less than 7 does not mean that there ceases to be a real and reasonably clear disclosure of compositions with a pH of above about 7.

The claims are not limited to compositions that are more palatable to molluscs:  As I have already discussed, there is no evidence that the compositions are more palatable, and this is only a rationalisation of the mode of action of the invention.  Consequently, the specification provides a real and reasonably clear disclosure of compositions, regardless of their mode of action.  It is not necessary for the claims to be restricted to palatable compositions.

Iron and aluminium are the only metals exemplified:  This point is similar to the complexone point.  The specification refers to metals generally, and iron and aluminium are exemplified.  I consider that this is sufficient to provide a real and reasonably clear disclosure of metals generally.

Upper limit on pH:  The specification discloses that if the bait is too alkaline this deters feeding (page 9, lines 28 to 29), but the claims have no upper limit on pH.  I note that the specification demonstrates formulations with a pH of 10.0 and 10.3 (formulations P and Q).  These compositions still retain a reasonable efficacy, suggesting to me that although they may be less palatable, they retain sufficient efficacy to be regarded as part of the invention.  I consider that there is a real and reasonably clear disclosure of effective compositions at least up to pH 10, and it is not clear that an upper limit is taught.

I conclude that none of the claims are lacking in fair basis.  The same conclusion applies to the petty patent.

c)  Full description

The requirement for full description is a requirement to disclose the invention to a technical person.

"The specification contains a full description if it makes the nature of the invention plain to persons having reasonably competent knowledge of the subject and also makes it plain, to persons having reasonable skill, how to perform the invention"
[Patent Gesellschaft AG v Saudi Livestock Transport and Trading Co (1996) 37 IPR 523 at 530]

The main issue of full description relates to the issue of how to carry out the pH testing.  I have discussed this point at length above, and concluded that a person would understand how to determine whether or not a composition had a pH of above about 7.  However, a person would not be able to determine whether a composition had any specific pH above 7.  Specific pH values are a part of the invention defined by claims 2, 3, 7, 8 and 17.  The specification does not fully describe the invention so far as these claims are concerned.

I recognise that my conclusion appears different to that in Colgate-Palmolive Co v Cussons Pty Ltd (1993) 26 IPR 311. In the Colgate-Palmolive case a critical issue was the flowability of a granular detergent composition, which was defined as "at least 70 per cent of that of clean dry sand".  Evidence was presented that the test of flowability was not sufficiently explained, and was not understood.  Additionally, experts showed that different results were achieved depending on how the test was done.  The evidence also showed that the patentee had detailed instructions that it used within the company for measuring flowability.  The present case differs in that readers were able to identify methods to measure the pH, and the evidence does not suggest that different results would be obtained in relation to claim 1 (different absolute pH values would be obtained, but they do not vary between above and below 7).  There is one example in the evidence of different measurements giving values above and below 7 (the Carpenter measurement of example 7B of Puritch).  In that case it is not certain that the samples were identical, so it cannot be concluded that the difference is due to the test method.  However, in claims 2, 3, 7, 8 and 17 there is a further pH value to be considered, and it is that value that cannot be accurately determined (and is analogous to the 70 per cent flowability).

The grounds also raise the question of whether the specification describes the best method of performance in relation to carrying out the pH measurement.  Under section 40(2)(a), the applicant is required to describe the best method of performing the invention.  In patent law the invention is defined by the claims, which in this case is a composition having a pH of above about 7.  The purpose of the corresponding provision in the Patents Act 1949 (UK) 12, 13 & 14 Geo 6 was described as:

"The Act is intending to protect the public against a patentee who deliberately keeps to himself something novel and not previously published which he knows of or has found out gives the best results"
[American Cyanamid Co v Ethicon Ltd [1979] RPC 215 at 269]

While the applicant has kept to himself his preferred method of determining the pH of the compositions, he has disclosed a number of specific compositions which are stated to have a pH of above between 7 and 10, and of about 8.  I consider that this has made public the best method of performing the compositions that are claimed.  The same conclusion applies to the petty patent.

1. Evidence in reply

Mr Houlihan objected that several pieces of evidence in reply were not properly in reply.  Specifically, paragraphs 117 - 123 of the Lichti declaration, the Matson declaration and the Carpenter declaration.  I have not relied on the evidence in the Matson or Carpenter declarations.  I have referred to paragraph 122 of the Lichti declaration, but it did not influence my decision.  Since the contested evidence does not impact on my decision it is not necessary to decide this issue, and nothing flows from it.

1. Conclusion

I have found that the opposition succeeds on the grounds of lack of novelty (claims 1 to 9, 20 and 26), lack of inventive step (claims 1 to 26), lack of clarity (claims 2, 3, 7, 8 and 17) and lack of full description (of the determination of pH values).  The opposition is not successful on the ground of manner of manufacture.

The specification is deficient in that the composition as claimed can include bone meal, and there is no method for determining pH.  I consider that it is likely that these problems can be rectified by amendment.  I allow Professor Young 8 weeks from the date of this decision to propose amendments in order to overcome these deficiencies.

The objection to the extension of term of the petty patent also succeeds as the petty patent is invalid on the grounds of lack of novelty (claims 1 to 3), lack of inventive step (claims 1 to 3), lack of clarity (claim 3) and lack of full description (of the determination of pH values).  According to section 69(4), I must not refuse to grant an extension of term of the petty patent without giving the patentee a reasonable opportunity to amend the specification for the purpose of removing the grounds of invalidity.  Accordingly I allow Professor Young 8 weeks from the date of this decision in which to file a request to amend the complete specification for the purpose of removing the grounds of invalidity that I have found.  In the absence of such a request being filed I will formally refuse to grant an extension of term.

I note that there was an objection under section 64(2) raised during the examination of the petty patent application.  This issue is not a part of the present opposition or extension, and I make no finding in relation to it.  However, the issue of section 64(2) remains relevant to the parent application, and will have to be considered by the Commissioner before the parent can be sealed.  Consequently, the matter of section 64(2) should be taken into account in preparing any proposed amendments to the specifications.

1. Costs

I allow the parties 4 weeks from the date of this decision to file submissions in relation to costs.

Dr S.D.Barker
Delegate of the Commissioner of Patents

Patent attorneys for the applicant and petty patentee  :  Callinan Lawrie, Melbourne

Patent attorneys for Neudorff  :  Phillips Ormonde & Fitzpatrick, Melbourne

Patent attorneys for Yates  :  F.B.Rice & Co, Melbourne