Bayer New Zealand Limited v Jurox Pty Ltd - [2015] APO 90

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Bayer New Zealand Limited v Jurox Pty Ltd [2015] APO 90

Patent Application: 2010201490

Title:Anthelmintic formulation

Patent Applicant:  Jurox Pty Ltd
Opponent:  Bayer New Zealand Limited
Delegate:  Dr S.D. Barker
Decision Date:  23 December 2015
Hearing Date:  Written submissions filed on 16 September 2015 and 1 October 2015

Catchwords: PATENTS – opposition to the grant of a patent – grounds of novelty and inventive step not made out – not a matter of routine to prepare the compositions – clarity: use of dictionary, unusual language able to be understood – fair basis established because of dictionary definition of "micellar solution" – manner of manufacture – opposition fails on all grounds

Representation: Patent applicant: FB Rice.
Opponent:James & Wells Intellectual Property.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2010201490
Title:Anthelmintic formulation

Patent Applicant: Jurox Pty Ltd
Date of Decision: 23 December 2015
DECISION
The opposition fails on all grounds.
Subject to appeal, I direct that the application proceed to grant.
I award costs against Bayer New Zealand Limited.
REASONS FOR DECISION

The examination request for this patent application was filed on 24 September 2012. As a consequence, substantive amendments of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act2012 do not apply to the present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists.
Consequently the former standard for opposition proceedings applies and the opponent must establish that it is clear or practically certain that the patent is invalid (F Hoffman La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; 50 IPR 305 at 311, 319; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; 79 IPR 426; Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742; 92 FCR 106 at [17]).
Background
Patent application number 2010201490 was filed on 14 April 2010 and claims priority from provisional application 2009901599 filed on 15 April 2009. The applicant is Jurox Pty Ltd (the applicant). The application was examined and accepted by the Commissioner on 26 March 2014, and subsequently opposed by Bayer New Zealand Limited (the opponent). A hearing was held by written submissions filed by the opponent on 16 September 2015 and by the applicant on 1 October 2015 to decide the opposition. The applicant was represented by FB Rice. The opponent was represented by James & Wells Intellectual Property.
The opposition
The statement of grounds and particulars was filed on 16 October 2014 and amended on 16 January 2015. The statement identifies the following grounds of opposition: novelty, inventive step, subsection 40(3) (viz; clarity and fair basis), and manner of manufacture. In the opponent's written submissions for the hearing all grounds were pressed.

The parties relied upon evidence by several declarants. Evidence in support consists of declarations by Fadil Al Alawi, Gottfried Lichti, Barbara-Anne Finn and Shalini Manuja Jayaweera. Evidence in answer consists of declarations by Stanley Shepherd and Kai Kin Lau. Evidence in reply consists of further declarations by Fadil Al Alawi and Gottfried Lichti. I will refer to the relevant parts of the evidence where appropriate.
The specification
The specification relates to an anthelmintic drench formulation for the treatment of farm animals to remove parasites such as worms. The formulation contains multiple active ingredients.
The written description runs to page 15, followed by 4 pages of claims. There are 27 claims of which claim 1 is independent and claim 27 is an omnibus claim, referring only to the description and accompanying examples.
The invention as described
In approaching the task of construing the specification, it is worth noting what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [139]:
"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date."
The background to the invention
The invention relates to stable veterinary compositions containing three active ingredients which are combined into a single formulation, and the use of such compositions for the treatment of helminth infections in certain mammalian animals.
The veterinary formulation or composition of the invention is a drench, for oral administration, with the purpose of controlling the endoparasites or worms (helminths) which infest farm animals, primarily sheep.
The anthelmintic composition of the invention contains the three active ingredients; levamisole, albendazole, and a macrocyclic lactone, along with a carrier and surfactant in a stable micellar solution.
At the priority date of the invention it was known that certain compounds, called anthelmintics, were effective in eradicating or controlling endoparasites. It was also known that certain compounds show selectivity for particular parasites and not others. For example it was known that levamisole is active against nematodes but ineffective against tapeworm, liverfluke or worm eggs. It was known that macrocyclic lactones, while being ineffective against liverfluke and other trematodes affecting sheep, are active against nematodes and some ectoparasites (such as ticks). It was also known that some benzimidazoles such as albendazole have a broad spectrum of activity against endoparasites, while others do not.
At the priority date of the invention it was known that it was problematic to administer a single active ingredient to treat helminth infections as this can give rise to resistance and reduce the efficacy of the active ingredient over time. It was also known that administering multiple active ingredients to treat helminthiasis was generally more effective since this approach both eliminates a broader spectrum of parasites and reduces the likelihood of promoting resistance.
The prior art discloses several formulations combining two or more active components, aimed at increasing effectiveness and reducing resistance, while eliminating the inconvenience and inefficiency of requiring multiple applications, however these multi-active formulations are known to suffer from chemical and physical instability, with the incompatibility of the different actives leading to degradation.
In order to reduce chemical degradation, the different active components present in these multi‑active drench compositions require different carrier environments, such as hydrophilic or lipophilic (aqueous or organic) carriers and/or solvents, and also differences in other variables such as pH.
In an effort to improve chemical stability, prior art multi-active formulations have therefore employed multiple solution phases, suspensions and emulsions however these have suffered from physical instability, due to the tendency of the components to separate or settle out.
Attempts to improve physical stability of such compositions have involved the addition of viscosity modifiers to increase the viscosity of the suspension or emulsion and thereby slow down the process of separation or settling out. However, this can result in an undesirably high viscosity at low temperature, making it extremely difficult to administer the composition orally via the usual drench gun. It also introduces the problem that once separation of the components does occur, it is extremely difficult to redisperse them in the normal way by stirring or shaking the composition.
Against this background of prior art the opposed specification states, at page 4, line 13:
"The inventors have surprisingly found that an effective anthelmintic composition comprising three active ingredients may be prepared where the composition comprises a stable micellar solution."
The aim of the invention
The specification does not explicitly recite a problem to be solved, however the prior art is discussed in relation to the desirability of multi-active compositions and the problems they introduce in terms of chemical and physical instability as well as difficulty of handling, especially with reference to the prior art composition registered under the trade mark of Triton (to Merial), and described in PCT/NZ00/00087.
Mr Al Alawi says at paragraph [25] of his first declaration:
"Therefore it would appear to me that the problem to be overcome is the preparation of a multiple active composition that is easy to disperse (unlike the emulsion of Triton) and is stable."
Mr Shepherd, while not contradicting the opinion of Mr Al Alawi, further elaborates in his declaration at paragraph [36]:
"The problem as set out by Al Alawi while referring to stability does not reflect that, in my view, the major problem to be overcome is the inclusion of pH incompatible active agents to give a stable composition. Specifically, there is a major problem to overcome with combination products containing both levamisole and macrocyclic lactones, which are pH incompatible".
Mr Kin Lau sets out the problem as somewhat more multi-faceted at paragraph [22]:
"There are a few problems to be solved. These are:
a) the thermodynamic instability of the invention as described in PCT/NZ00/00087;
b) insufficient dosing of the animals due to non-uniform dispersion of actives during administration and settling during storage;
c) physical and chemical compatibility between active materials and excipient; between active materials themselves; and the compatibility of the formulation with the packaging materials;
d) crystallisation of the water soluble component of the actives at low temperature;
e) flowability of the product through the drench gun, in particular, at low temperature;
f) inferior effect on the physical property of the composition at both high and low storage temperature;
g) manufacturing without the requirement of using specialised equipment;
h) undesired foaming property which may cause (non) uniformity of dosing, difficulty in product manufacturing and filling into final containers;
i) minimise the quantity of surfactant in the formulation against an increase in surface area of albendazole due to micronisation. The increase in surface area due to micronisation normally requires an increase in surfactant to provide wetting of the solid actives. This shows that care must be taken when using surfactants in formulation."
While Mr Kin Lau sets out numerous problems to be solved, I find that some of these, such as manufacturing without the use of specialised equipment, are not explicitly mentioned in the opposed specification, while others such as minimising the quantity of surfactant, are generally referred to in the specification as beneficial side effects, rather than specific problems to be solved. See page 7, line 15:
"An advantage for the manufacturer of having less surfactant is a decrease in cost of the ingredient."
The remaining problems identified by Mr Kin Lau I regard as being a consequence of improved chemical stability (overcoming chemical incompatibility of components), improved physical stability (addressing physical incompatibility of components, thermodynamic instability, separation of components due to crystallisation, foaming or settling, leading to non-uniform dispersion and insufficient dosing) or improved handling properties (favourable viscosity or flowability across a useful range of operating temperatures and avoiding foaming).
Consequently I conclude that the aim of the invention is to provide a broad spectrum multi-active anthelmintic drench composition that is both chemically and physically stable and has improved handling properties compared to prior compositions of this type.
The nature of the invention
The specification has a consistory statement, at page 5, line 18, setting out the invention in terms substantially identical to claim 1:
"In a first aspect the present disclosure relates to a stable anthelmintic drench composition in the form of a micellar solution, comprising an anthelmintically effective amount of only three anthelmintic agents being albendazole, levamisole and one macrocyclic lactone selected from the group consisting of: abamectin, ivermectin, doramectin, moxidectin, milbemycin and/or avermectin; the composition further comprising a therapeutically acceptable carrier and at least one surfactant in amount of more than 120 to less than 200 g/L, wherein the albendazole is micronized and the composition is chemically stable for at least 6 months at 30 °C."
The specification also provides two further aspects to the invention, the first of which is recited on page 6 at line 17, and mirrors the language of claim 20:
"In a second aspect, the present disclosure relates to a method of treating helminth or suspected helminth infections in an animal comprising administering an anthelmintically effective amount of a composition according to the first aspect, to an infected animal or an animal suspected to be infected with at least one helminth."
The final aspect of the invention, which is not explicitly mentioned in any of the claims, relates to its formulation as stated on page 12 of the specification at line 5:
"In another aspect, the present invention provides methods for formulating a product."
A key feature of the described invention is that the composition comprises a “micellar solution”. This feature is recited in the consistory statement and in independent claim 1. On page 6 at line 22 the term "micellar solution" is explicitly defined:
"As used herein the term 'micellar solution' refers to a thermodynamically stable single phase system."
At page 12 of the specification are disclosed "Methods of formulation" of the invention, illustrated with examples 1 and 2. Example 1 of the formulation differs from example 2 only in that it contains 30 g/L more surfactant (Polysorbate 80), 100 g/L less water miscible solvent (propylene glycol) and 22g/L less anti-caking/suspension/viscosity agent (Aerosil 200).
The method of preparation clearly indicates (see lines 12-21 on page 12 and lines 5-12 on page 13 of the specification) that the order of addition of the various components of the composition is crucial in order to ensure that a stable micellar solution is formed.
The formulation of example 1 was subjected to an efficacy test on live sheep infected with fluke (see Trial 1 on page 13 of the specification). Example 1 was also subjected to a comparative efficacy test against five known anthelmintic compounds, administered from "currently registered sheep drench products" (see Trial 2 on page 14 of the specification). These tests showed that the composition of the invention was effective as an anthelminthic, and that it was substantially more effective than the known compositions it was compared to.
Example 1 of the formulation of the invention is subjected to a chemical stability test (see the table on page 14 at lines 27-30 of the specification), in which it is shown that each of the three active components of the formulation exhibit a high level of chemical stability after being held at 30 degrees Celsius for a period of 6 months.
Finally, example 1 of the formulation of the invention is tested for physical stability (see lines 30-31 on page 14 of the specification) whereby it is placed in a centrifuge and subjected to 4000 g for 1 hour, after which the formulation "did not separate but remained as a single phase", thereby demonstrating a high degree of physical stability.
The description concludes at page 15 with the statement:
"It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive."
The person skilled in the art
It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
"He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious."
Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 (Root Quality) at [70]
However, the person skilled in the art is an artificial construct that is used as a tool of analysis, and there is a danger in trying to identify them as an actual person or persons:
"The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step."
AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]
Our understanding of the person skilled in the art is based on evidence from persons with knowledge of the art as to the things that they know and do, and what they understand to be commonly known and done. The weighting and evaluating of this evidence to decide the characteristics of the person skilled in the art is part of the normal work of a delegate of the Commissioner.
In Root Quality at [71] Finkelstein J stated:
"Generally speaking the skilled addressee is the person who works in the art or science with which the invention is connected. In Plimpton v Malcolmson [1876] 3 ChD 531 Jessel MR said (at 556):
'What is meant is that if [the invention] is a manufacture connected with a particular trade, the people in the trade shall know something about it; if it is a thing connected with a chemical invention, people conversant with chemistry shall know something about it.' "
In the present case the art is the formulation of anthelmintic drench compositions. The person skilled in the art must have knowledge of the formulation of such compositions, and an understanding of the development of new anthelmintic drench compositions. Since the problem relates to stability and handling properties of the composition, the person skilled in the art must possess some level of knowledge of this subject. Since it is possible that a range of persons could provide useful evidence as to the characteristics of the skilled addressee, I will have regard to the evidence of all declarants. Where there is conflict in their evidence, I will resolve that conflict in the normal way.
Construction of the claims
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [118] – [120]:
"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification."
Claim 1 is the only independent claim. It reads:
A stable anthelmintic drench composition in the form of a micellar solution, comprising an anthelmintically effective amount of only three anthelmintic agents being albendazole, levamisole and one macrocyclic lactone selected from the group consisting of: abamectin, ivermectin, doramectin, moxidectin, milbemycin and/or avermectin; the composition further comprising a therapeutically acceptable carrier and at least one surfactant in amount an amount of more than 120 to less than 200 g/L, wherein the albendazole is micronized and the composition is chemically stable for at least 6 months at 30 °C.

Putting to one side two matters of potential lack of clarity (discussed below), the claim is directed to a stable anthelmintic drench composition containing the following components:
a therapeutically acceptable carrier,
at least one surfactant (at a level of between 120 to 200 g/L), and
no more than three active agents which are;
           albendazole (which must be micronized),
           levamisole, and
one macrocyclic lactone selected from abamectin, ivermectin, doramectin, moxidectin, milbemycin or avermectin,
and having the following properties:
in the form of a micellar solution, and
           chemically stable for at least 6 months at 30 °C.
Claims 2-26 are all ultimately dependent on claim 1, with claims 2-19 further defining the features of the composition and claims 20-26 being directed to the method or use of the composition to treat helminth infections.
Claim 27, the last claim of the opposed specification, is an omnibus claim which recites:
A composition, method or use substantially as hereinbefore described with reference to the accompanying examples.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain "whether or not what he proposes to do falls within the ambit of the claim" (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59).
The opponent raised three matters of potential lack of clarity: the term "micellar solution" and the phrase "in amount an amount of" in claim 1, and the term "method" in omnibus claim 27.
Turning first to claim 1, there appears to be agreement that components of the composition defined in claim 1 are all known and that their meaning is not disputed. However with respect to the properties of the composition defined in the claim, the opponent asserts that the term "micellar solution" is vague and/or ambiguous.
In the submissions of the opponent at [103], the opponent states:
"The term 'micellar solution' in claim 1 does not clearly define whether the composition is also a 'single phase system' as is clearly stated on page 6, lines 4-7 of the specification. Without this limitation, the composition could include single or multi-phase systems provided they include micelles, is broader than what is described in the specification, and leads to ambiguity."
I accept that when claim 1 is read in isolation, the term "micellar solution" could potentially include multi-phase systems, however in order to understand the scope of the monopoly the claims must be read in light of the specification as a whole. In the present case it is particularly significant to consider whether the specification has set up a dictionary.
The nature of the dictionary principle is reflected in British Thomson-Houston Company Ld. v Corona Lamp Works Ld. (1922) 39 RPC 49 at page 67, where Viscount Haldane stated:
"We have to scan the Specification with the closeness which is required in the case of any instrument conferring a monopoly, but, subject to this, all we can legitimately do is apply the ordinary rules for the construction of written instruments. One of these, which is relevant in the case before us, is that the instrument must be read as a whole. The Claiming Clauses, for example, are not to be taken as standing in complete isolation. For if the Patentee has used in these clauses expressions which he has already adequately interpreted in the body of his Specification, he is entitled to refer to the Specification as a dictionary in which the meaning of the words he uses has been defined."
The opposed application provides a clear dictionary definition of the term "micellar solution" at page 6, line 22 of the specification:
"As used herein the term 'micellar solution' refers to a thermodynamically stable single phase system."
Mr Al Alawi comes to the same conclusion at [66-67] of his first declaration:
"In Jurox's specification, the composition is discussed as being a single phase. It is understood this is meant to differentiate it from emulsions which clearly have two or more distinct phases.
However, it should be appreciated that micelles and emulsions exist as part of a continuum without distinct bounds. I interpret the definition of 'micelle' provided in Jurox's specification as indicating one end of this continuum which continuum also includes micelles, swollen micelles and microemulsions."
Consequently I consider that the specification has set up a dictionary, and as a consequence claim 1 is not unclear in regards to the term "micellar solution".
The other matter that the opponent alleges introduces a lack of clarity to claim 1 is the phrase "in amount an amount of more than …". In the statement of grounds and particulars at [80]:
"Claim 1 is unclear because the term 'in amount an amount of more than…' is grammatically incorrect. Amendment is necessary."
Although this phrase is not grammatically correct, that is not enough to make the claim unclear. In AMP v Utilux (1971) 45 ALJR 123 at 128 McTiernan J stated that:
"Specifications very frequently contain mistakes; they also have omissions. But if a man skilled in the art can easily rectify the mistakes and can readily supply the omissions, the patent will not be held to be invalid."
In the present case it seems to me that it is intended to say "in an amount of more than …", and I consider that this is the way that the words would be understood. The additional "amount" does not introduce any ambiguity or uncertainty as to the scope of the monopoly claimed. Consequently I consider that the claim is not unclear in this regard.
Turning now to the question of the clarity of omnibus claim 27, the opponent asserts that the term "method" in this claim is ambiguous because it is not clear whether the claim includes within its scope the method of preparation of the composition disclosed in the specification, or rather the method of treatment of helminth infections which is also disclosed in the specification.
I can see no problem with interpreting the term "method" in claim 27 in its' broadest scope to include both the preparation of the composition and the use of the composition to treat helminth infections. Consequently I consider that claim 27 is clear in scope.
The opponent has not shown that there is a lack of clarity.
Fair Basis
It is a requirement of subsection 40(3) of the Act that the claims must be fairly based, that is to say, consistent with the described invention, and not travelling beyond the subject matter of the disclosure.
In their submissions at [103], the opponent asserts that the claims are not fairly based because of the alleged uncertainty in the scope of the term "micellar solution":
"The term 'micellar solution' in claim 1 does not clearly define whether the composition is also a 'single phase system' as is clearly stated on page 6, lines 4-7 of the specification. Without this limitation, the composition could include single or multi-phase systems provided they include micelles, is broader than what is described in the specification, and leads to ambiguity."
However, as I have already discussed above, any potential uncertainty introduced by the use of this phrase in the claims is immediately resolved when the dictionary principle is applied. Therefore, I find that the ground of lack of fair basis has not been made out.
Novelty
It is required of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art. 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.
It is well established that the general test for lack of novelty 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] HCA 19 at [20]; 137 CLR 228 at 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."
The disclosure necessary to support the ground of lack of novelty has variously been described as "clear and unmistakeable directions" (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486), "the accuracy of a sniper, not the firing of a 12 gauge shotgun" (Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194; 78 IPR 485 at [91]) or "what a prior art document teaches" as distinct from "what might be 'included' or 'encompassed in' a prior art document" (Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) [2011] FCA 846; 92 IPR 320 at [180]). There is a degree of specificity that is required.
The opponent initially relied on two citations to allege lack of novelty in the statement of grounds and particulars:
D1: WO2004/069242 and
D2: Nufarm Ltd v Jurox Pty Ltd [2008] FCA 178.
These two documents are related in the sense that D1 pertains to a prior drench composition of the applicant's known by the trade name "Q-Drench", while D2 is a judgement in the Federal Court of Australia that considers whether the applicant's Q-Drench formulation infringes Australian Innovation Patent No. 2003101020.
In their written submissions, the opponent no longer refers to document D1 for the ground of novelty, and in relation to document D2 the opponent concedes at [41] that there are at least three key differences between the published disclosure of D2 and the claims of the opposed specification. These are that the claimed invention has three active components (not four), that one of the actives is micronized, and that the composition is a stable "micellar solution":
"At the level of abstraction described in the specification the formulation details of Q-Drench provided in the judgment anticipate the alleged invention described in claim 1 save that claim 1 has only three specified actives, include micronised albendazole, and specified the composition is stable. While claim 1 may not be anticipated at this level of abstraction, the relevant question becomes whether these three features as claimed involves an inventive step."
I agree with the opponent's concession, and will not consider the ground of lack of novelty any further.
Inventive Step
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that the invention must be obvious in the light of the common general knowledge as it existed in the patent area before the priority date, either on its own or together with information in a document, or combination of documents, that the person skilled in the art could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant and, where necessary, combined. "Obvious" means "very plain" (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; 72 IPR 447 at [51]).
The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262 at 286 Aickin J stated:
"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."
More recently, in Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 (Alphapharm) at [53] the High Court approved the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187 in which Graham J had posed the reformulated Cripp's question:
"Would the notional research group at the relevant date, in all the circumstances, directly be led as a matter of course to try [the claimed combination of integers] in the expectation that it might well produce a [useful or desired result]?"
Where the invention lies in a combination of integers, the question is not whether each individual integer is obvious but rather whether the combination as a whole is obvious, when compared to the prior art base. In Alphapharm at [41] the Court said:
"The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step. It is the selection of the integers out of 'perhaps many possibilities' which must be shown by Alphapharm to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers."
The Court noted the comments of Lord Diplock in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 at 362:
"Once an invention has been made it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention that he claims in his specification if he started from something that was already known. But it is only because the invention has been made and has proved successful that it is possible to postulate from what starting point and by what particular combination of steps the inventor could have arrived at his invention. It may be that taken in isolation none of the steps which it is now possible to postulate, if taken in isolation, appears to call for any inventive ingenuity. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but, even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to that result."
The opponent submitted that the claimed invention lacks inventive step in light of the common general knowledge and the following documents:
·   WO2004/069242   (designated D1)
·   Nufarm Ltd v Jurox Pty Ltd [2008] FCA 178 (designated D2)
·   WO2000/074489   (designated D3)
·   WO2004/043445   (designated D4)
·   Blodinger, J. "Formulation of Veterinary Dosage Forms" (1983)           (designated D5)
In their written submissions, the opponent alleges that the invention is obvious in light of the common general knowledge alone (at [65]). Alternatively the opponent alleges the invention is obvious compared to D2 when read in light of the common general knowledge (at [95]). Finally the opponent alleges the invention is obvious when the teaching of D3 is combined with the teaching of either of D2 or D1 and the common general knowledge (at [97]).
D4 is not directly discussed in the opponent's submissions on the ground of lack of inventive step but rather it is annexed as "Appendix 1", which outlines that although D4 describes multi-active anthelmintic in aqueous micellar form, it does not disclose the use of micronized albendazole, or formulations containing three actives (only two actives are present in D4 compositions), or an upper limit of 200 g/L surfactant.
D5, a text book, is also not directly discussed in the opponent's submissions on the ground of lack of inventive step, but is referred to by Mr Al Alawi for the opponent in his first declaration, and in the amended statement of grounds and particulars, as "a good overview of the common general knowledge on certain aspects of the alleged invention".
The problem
In the present case the problem addressed by the specification is to provide a broad spectrum multi-active anthelmintic drench composition that is both chemically and physically stable and has improved handling properties (reduced viscosity at lower temperatures).
The common general knowledge
The common general knowledge was defined by Aickin J in Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 144 CLR 253 (the 3M case) at 292 as:
"The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge."
The opponent asserts in their written submissions at [56] that 15 matters were all part of the common general knowledge. It is not necessary to consider each matter in detail.
Matters of routine: modifying existing anthelmintic drenches
There is much evidence in relation to what teams in the art would or would not do, including evidence that looks at what particular people in the industry do. This is helpful in so far as it sheds light on what the hypothetical person skilled in the art would have done.
Mr Al Alawi says in his first declaration at [37] that known drench compositions represent the starting point that the skilled addressee would take when faced with the present problem:
"Also, as a formulation chemist who had prepared previous oral drench anthelmintic compositions as an employee of a veterinary company, I would utilise my own knowledge (or that of my team or past colleagues) as a starting point or reference for development of new and/or related products. Indeed, I can see the sole inventor of the opposed application is Kai Kin Lau, who is also the first named inventor of Jurox's previous patent publication W0'242 relating to the Q-Drench product, which was published in 2004. Clearly the inventor of the opposed application was well aware of Q-Drench when formulating the present composition as shown in claim 1, and would almost certainly have used Q-Drench as a starting point for the present invention - especially when you compare how closely related the compositions are, as is shown further below."
Mr Lichti takes a similar view in his first declaration at [29.33]:
"As a commercial formulator in pursuit of a multi-active liquid anthelmintic formulation, I would make extensive use of previous commercial and academic formulation technology (e.g. previous micelle technology for making a water-based injectable ML formulation). This is because using prior art and prior formulation development concepts minimises the novelty required in formulation development, and minimises time and cost parameters associated with formulation development. This is particularly important in a multiactive co-formulation because of the large number of possible formulation failure mechanisms eg (i) chemical degradation (depending on pH and also on micellar robustness) of solubilised active agents (abamectin, levamisole), (ii) crystallisation of soluble active agents during storage, (iii) physical settling of dispersed active agents (albendazole), and (iv) formation of secondary aggregates (albendazole) by multiple mechanisms including unanticipated interactions with surface-active agents and viscosity-building agents (including fine silicas such as aerosol materials)."
Mr Shepherd disagrees with this view of the starting point, at [84]:
"In my opinion Example 1 of AU2010201490 would have been arrived at by a formulator without considering the prior art knowledge of the Q-Drench formulation as disclosed in Dl or D2. I understand that the novelty of the Q-Drench formulation resides in the synergistic efficacy of the four combined actives against resistant nematodes. However, the present invention resides in the provision of a stable micellar solution containing only three actives."
Mr Kin Lau also disagrees with the use of prior art formulations as an acceptable starting point at [33]:
"There was nothing in the prior art to suggest that it would have been possible to make the specific formulation of the present invention, let alone whether such a formulation would be stable. The prior art relied on by the Opponent demonstrates significant stability problems, suggesting to me that the formulation of a number of active agents is difficult and would not necessarily lead to a commercially viable product. In my view, this prior art actually teaches away from the combination of the three active agents in the form of a stable micellar solution as claimed in the present invention. In particular, the prior art relied on by the Opponent is silent on whether a stable three component micellar solution could be formulated, especially in the absence of a salicylanilide."

I accept the evidence of Messrs Al Alawi and Lichti, that previously known drench compositions could represent a useful starting point for the person skilled in the art faced with the problem of providing a drench composition with improved stability and handling properties. It seems reasonable that a skilled addressee might choose to start from a drench composition such as the Triton composition referred to in the specification and seek to improve on the problems it poses with regards to handling properties (in particular, high viscosity at lower temperatures). Similarly it seems reasonable that a skilled addressee might choose to start from a drench composition such as the Q-drench product disclosed in D1 and seek to improve on its stability problems.
As was stated in the 3M case at page 294:
"There may be some fields of endeavour in which those who work therein study and make themselves familiar with all patent specifications as they become available for inspection in one or in many countries so that what was contained therein becomes common general knowledge in that particular trade or field of manufacture in the country in question."
It is noteworthy that in the Federal Court decision published in D2, Middleton J found at [149] that patent literature raised in those proceedings formed part of the common general knowledge:
"In my view, the evidence establishes that the Merck patent with an earlier priority date was common general knowledge before 4 June 1999."
The opponent asserts in their submissions at [56.12], consistent with the evidence provided by Mr Al Alawi in his first statement at [35], that the Q-drench product of D1 and the associated Federal court decision of D2, represent common general knowledge.
I think this goes too far. While I accept that patent literature can be part of the common general knowledge, as the Merck patent was found to be, this does not mean that D1, D3 and D4 were part of the common general knowledge. I am not satisfied that in this case the evidence establishes that D1, D3 and D4 were common general knowledge. I also not satisfied that D2 was part of the common general knowledge of the hypothetical skilled addressee.
Matters of routine: stabilising multi-active anthelmintic drenches
It is clear from the evidence presented on both sides that in the area of anthelmintic drench compositions, the solving of one problem tends to lead to another. For instance, the problem of parasite resistance leads to the need to include multiple actives in a single composition. As Mr Lichti says in his first declaration at [29.13.5]:
"If two or more active agents with different modes of action are available, an effective strategy is to formulate combinations of active agents to minimise resistance."
However including more than one active ingredients in a composition introduces the problem of chemical incompatibility of the various actives, in terms of their differing solubility requirements, and the pH required by each in order to prevent their degradation. As Mr Kin Lau states in his first declaration at [32]:
"There are a number of difficulties involved to overcome in formulating a stable product with desirable physical characteristics in view of chemical incompatibility between the three classes of active ingredients. For instance, each of the three active ingredients vary in their solubility and require different pH environments."
Efforts to address this problem have involved various approaches to partitioning the incompatible actives into differing solvation environments through formulation as emulsions and suspensions however these have introduced the further problem of physical instability, due to their tendency towards phase separation and settling out of solid components. See for example the first declaration of Mr Al Alawi at [77.6] discussing D5 (Blodinger):
"Blodinger discusses the preparation and preferred features of suspensions and oral drenches at length. Page 151 discusses Stoke's Law in relation to suspensions and the concept of adding thickening agents to stabilise suspensions and avoid issues with sedimentation/caking when the solid concentration (e.g. concentration of suspended actives) increases. The two main approaches outlined in Blodinger to stabilising such high solid content suspensions are to reduce particle size (i.e. through micronisation as discussed before) and to increase the density/viscosity of the composition."
Finally, as noted in the above quote, attempts to prevent phase separation and settling have involved increasing the viscosity of the compositions which in turn introduces the problem of difficulties with handling and dosing. I therefore find that the stabilisation of a drench composition is a complex matter, involving interactions between the numerous aforementioned problems posed by the task.
As stated by Mr Shepherd in his declaration at [121]:
"As a formulation chemist embarking on a new product development, such as an oral drench for sheep, there are many things to consider such as; broad spectrum activity, narrow spectrum activity, dose rate, persistent efficacy, safety, withholding periods, residues, stability, and resistance to individual actives etc. Every active added to a particular formulation somewhat complicates things and increases the cost. Therefore it is desirable to use the minimum number of actives which will give the desired efficacy."
The opposed specification approaches the problem of achieving chemical and physical stability in the composition, by partitioning chemically incompatible actives via formation of a micellar solution. This allows the lipophilic (and pH sensitive) macrolactone component to be encapsulated within the micelles. This approach is not new, however based on the evidence it does not appear to be matter of routine to implement.
See for example the first declaration of Mr Al Alawi [77.16]:
"A typical formulation chemist would understand that formation of micelles occurs over a range of conditions, and depends on numerous factors including the type and concentration of the surfactant used, as well as the proportions of lipophilic and hydrophilic components."
See also the first declaration of Mr Lichti [29.33]:
"This is particularly important in a multiactive co-formulation because of the large number of possible formulation failure mechanisms eg (i) chemical degradation (depending on pH and also on micellar robustness) of solubilised active agents (abamectin, levamisole), (ii) cystallisation of soluble active agents during storage, (iii) physical settling of dispersed active agents (albendazole), and (iv) formation of secondary aggregates (albendazole) by multiple mechanisms including unanticipated interactions with surface-active agents and viscosity-building agents (including fine silicas such as aerosol materials)."
I conclude that micellar solutions were known in the art as an approach to physically partitioning chemically incompatible active components of a multi-active anthelmintic drench composition. There is sufficient basis to believe that the need to partition chemically incompatible active components of multi-active anthelmintic drench compositions, in order to obtain acceptable levels of stability, was common general knowledge in the art. However, the evidence falls short of establishing that it would have been a matter of routine to try the use of micellar solutions to achieve this result.
Obviousness in the light of the common general knowledge alone
It must be borne in mind that the invention is a drench composition which is a combination of physical integers. The opponent must show that it would have been obvious (i.e. a matter of routine) to combine that combination of integers into a single drench composition in order to solve the particular problem. Above I stated that it would not have been a matter of routine to try micellar solutions in a newly formulated drench composition, even though it was known that it had been used to improve stability. Consequently, it has not been shown that the invention lacks inventive step in the light of the common general knowledge alone.
Obviousness in the light of the citations
WO2004/069242 (D1): D1 discloses the Q-drench product, discussed above briefly in relation to the ground of lack of novelty. The differences between the disclosure of D1 and the claimed invention are that the claimed invention has three active components (not four as in D1), that one of the actives (albendazole) is micronized, and that the composition is a stable "micellar solution", with a requirement for the composition to be chemically stable for at least 6 months at 30 degrees Celsius. This document is considered fully in conjunction with D2.
Nufarm Ltd v Jurox Pty Ltd [2008] FCA 178 (D2): The disclosure of D2 was discussed above in relation to the ground of lack of novelty. D2 is a Federal court decision pertaining to D1. I do not consider that D2 adds anything to the disclosure of D1, other than to prove that although D1 does not explicitly disclose drench compositions that are micellar solutions, it does disclose such micellar solutions inherently.
I have some doubts as to whether D2 would have been ascertained by the skilled addressee faced with the problem at hand, however setting that matter aside, it is clear that D2 represents sound evidence to show that the compositions of D1 were single phase micellar solutions.
With the knowledge (from D2) that the compositions of D1 were in fact micellar solutions, then the question becomes; would it have been a matter of routine to remove one of the solid active components of D1 (closantel), and to micronize the other active component (albendazole), with a reasonable expectation that this would result in a composition with enhanced stability and improved handling properties?
With regard to the issue of micronizing the solid active components of anthelmintic compositions, Mr Al Alawi, in his first declaration at [52], refers to D5 and points out that it is routine in the art to micronize suspended solids in such formulations:
"The use of a micronised active is a conventional technique that was well known in the art to enhance the stability of a suspension. Chapter 3 (pages 135 to 173) of the 1983 textbook 'Formulation of Veterinary Dosage Forms' by Jack Blodinger discusses suspension formulations at pages 143- 144."
I accept that the micronisation of solid actives was routine and well known in the art, however this still does not explain what steps the skilled addressee would have taken, in light of the disclosure of D1 or D2, to arrive at the presently claimed invention.
Of particular note is the fact that the Q-Drench composition disclosed in D1 and D2 has more than one solid active component. It contains both closantel and albendazole. What motivation was there for the skilled addressee to micronise albendazole and remove closantel completely when faced with the present problem?
Mr Al Alawi, in his first declaration, sets forth that if the skilled formulator was seeking to reduce the viscosity of a known composition, he would look to reducing the amount of solids in suspension at [77.5]:
"Regardless, I would expect that removing closantel from Q-Drench would naturally lessen the burden for thickeners as less actives would be in suspension. I would imagine that some thickener (e.g. colloidal silica) would still be required in order to keep the albendazole in suspension, but less than would be required for two suspended actives as in Q-Drench."
However, even if we accept that with this goal of reduced viscosity in mind, the skilled formulator would look to reducing the solids, a competing concern would be a reduction in activity, and I must still ask what motivation was there to specifically remove closantel from the composition?
Mr Al Alawi states in his first declaration that sufficient motivation to remove closantel from Q‑Drench is provided by the fact that it has a narrow spectrum of activity, and a propensity to develop resistance (at [79]), however in the absence of further evidence in support of these assertions, I cannot give them any more weight than those made in response, for example by Mr Shepherd at [122]:
"While it may be true that there is emerging resistance to closantel, it is also true to say that there is resistance to levamisole, macrocyclic lactones and bezimidazoles (e.g. oxfendazole)."
The evidence does not satisfy me that it would have been a matter of routine to remove closantel when seeking an improvement to the formulation disclosed in D1 or D2. It has not been shown that the claims lack an inventive step in the light of D1 or D2.
WO2000/074489 (D3): This document discloses micellar compositions containing only two actives (abamectin and levamisole – see examples 1-4), however it teaches that these compositions are relatively unstable (page 22, lines 1-4) and moves to an approach involving emulsions rather than micellar solutions. In this sense I consider that D3 teaches away from the presently claimed invention.
Nevertheless, the opponent alleges that the claims of the opposed specification are obvious when the disclosure of D3 is combined with either one of D1 or D2. They argue in their submissions at [99] that the applicant was motivated by the need to avoid infringing the emulsions of the prior art, and that they would therefore combine the teaching of D3 to prepare micellar solutions with the disclosure of multi-active compositions in D1 or D2 and arrive at the presently claimed composition.
In considering the question of obviousness in relation to an invention that combines known integers, I find it useful to refer to the words of Aickin J in the 3M case at 239:
"In the case of alleged lack of an inventive step the question of making a mosaic must operate (if at all) in a very different matter. An allegation of want of inventive step is not made out by saying you may take one or two, or twenty-one or twenty-two, prior publications and then select from them appropriate extracts or pieces of information, which will add up to the invention claimed and so demonstrate that it was obvious. So to proceed is to mistake the nature of an invention and the nature of the objection of obviousness. The question is, is the invention itself obvious, not whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent. If this were not so, there could never be a valid patent for a new combination of old integers. The proper question is not whether it would have been obvious to the hypothetical addressee who was presented with an ex post facto selection of prior specifications that elements from them could be combined to produce a new product or process. It is rather whether it would have been obvious to a non-inventive skilled worker in the field to select from a possibly very large range of publications the particular combination subsequently chosen by the opponent in the glare of hindsight and also whether it would have been obvious to that worker to select the particular combination of integers from those selected publications. In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not of itself make an alleged invention obvious. It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious. It is in relation to this process that the misuse of hindsight is most common. When once an idea or an object or a process or a combination, admittedly novel, has been published, it is very easy to say after perhaps months of search and study in the Patent Office and the public libraries that the integers into which the patent might be dissected could be found scattered amongst the prior documents by a person who already knew the solution to the problem and therefore knew what to look for and what to discard. But that process does not demonstrate lack of an inventive step. The opening of a safe is easy when the combination has been already provided."
I find that one can only arrive at the presently claimed solution if one applies the kind of ex post facto analysis referred to by Aickin J. The evidence does not suggest that it would have been a matter of routine to arrive at the claimed invention without the glare of hindsight. Accordingly I find that the ground of lack of inventive step has not been made out.
Manner of Manufacture
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. This requirement has been discussed many times by the courts, and a range of different formulations have been advanced:
"a proper subject matter of letters patent according to traditional principles"
NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15; 183 CLR 655 at [10]
"on the basis of what was known, as revealed in the specification, the invention claimed was obvious or did not involve an inventive step"
Bristol-Myers Squibb Co v FH Faulding & Co Ltd [2000] FCA 316; 46 IPR 553 at [30]
The only argument that the opponent put forth in support of this ground is stated in their submissions at [104]:
"claim 1 lacks any features which can be considered a novel manner of manufacture, and thus are not an invention according to the Statute of Monopolies."
It appears that the opponent alleges that the claims are a mere collocation of known integers and therefore not a proper subject of letters patent. However, the fact that an article is made up of known integers does not mean that it is thereby a mere collocation in the patent sense:
"That is to say, what is described is a machine, the elements of which are all well known and simple mechanical integers, but combined so that they are not a mere collocation of separate parts, but interact to make up a new thing."
Welch Perrin & Co Pty Ltd v Worrel [1961] HCA 91; 106 CLR 588 at [8]
I do not find it reasonable to view the drench composition as a mere collocation. The components of the composition exhibit a clear working interrelationship, giving rise to a micellar solution. The composition is more appropriately viewed as an integrated whole, rather than a collection of integers. The better question is whether there is an invention in the combination of known integers. These matters have already been considered above. The ground of lack of manner of manufacture fails.
Conclusion
The opposition fails on all grounds.
Costs
I see no reason to depart from the normal outcome that costs should follow the event.
Dr S.D. Barker
Delegate of the Commissioner of Patents