Merial, Inc. v Bayer New Zealand Limited - [2018] APO 14

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial, Inc. v Bayer New Zealand Limited [2018] APO 14

Patent Application: 2014201152

Title:Tablet Formulation

Patent Applicant:                   Bayer New Zealand Limited
Opponent:  Merial, Inc.
Delegate:  Dr A. Lim
Decision Date:  22 February 2018
Hearing Date:  09 November 2017 in Melbourne

Catchwords: PATENTS – section 59 – opposition to the grant of a patent – opposition governed by the Patents Act as amended by the “Raising the Bar” provisions –the specification does not disclose the best method known to the applicant at the filing date of the application – the best method requirement is not satisfied – the evidence does not establish that the work involved in preparing a tablet having improved bioavailability properties would amount to an undue burden –the disclosure in the specification is sufficient – the scope of all the claims correspond with the technical contribution to the art – all the claims are supported –the evidence does not establish any of the claims lack utility – the claims meet the promise as derived from the whole of the specification– a lack of inventive step has not been established – a lack of a manner of manufacture has not been established – the opposition succeeds on the ground of paragraph 40(2)(aa) – opportunity provided to attempt to overcome the deficiencies in the specification.

Representation: Patent attorney for the applicant: Dr Andrew Scott from James & Wells
Counsel for the opponent: Mr Christian Dimitriadis, SC, Ms Clare Cunliffe
Patent attorney for the opponent: Dr David Herman from FB Rice

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014201152

Title:Tablet Formulation

Patent Applicant: Bayer New Zealand Limited
Date of Decision: 22 February 2018
DECISION
The opposition is successful on the ground of paragraph 40(2)(aa).
I allow Bayer New Zealand Limited a period of two months from the date of this decision in order to attempt to overcome the deficiencies in the opposed specification.
Costs according to Schedule 8 are awarded against Bayer New Zealand Limited.
REASONS FOR DECISION

Patent application number 2014201152 (the opposed application) was filed on 04 March 2014 as a divisional application from 2007334747 (the parent application), which claims priority from NZ 552293 (the basic application) filed on 21 December 2006. The applicant is Bayer New Zealand Limited (Bayer NZ).
The opposed application was examined and advertised accepted by the Commissioner on 30 July 2015. The application was subsequently opposed under section 59 of the Patents Act 1990 (the Act) by Merial, Inc. (Merial). Merial filed a notice of opposition on 30 October 2015 and filed a Statement of Grounds and Particulars (SGP) on 01 February 2016.
Bayer NZ filed amendments to the accepted claims under section 104 of the Act on 03 August 2016 and 08 September 2016. The amendments were allowed on 23 December 2016. Consequently, these amendments form part of the specification. A hearing was held in Melbourne on 09 November 2017. Bayer NZ represented by Dr Andrew Scott, patent attorney, did not attend the hearing and relied solely on written submissions. Merial was represented by Mr Christian Dimitriadis, Senior Counsel, Ms Clare Cunliffe, counsel and Dr David Herman, patent attorney.
1 The opposition
The grounds of opposition pressed at the hearing were:
·no disclosure of the best method,
·lack of a clear and complete enough disclosure in the specification,
·lack of support,
·lack of utility,
·lack of inventive step, and
·claimed invention is not for a manner of manufacture.
The evidence is summarised in the table below.

Evidence Declarant Exhibits Date Reference

In Support David Herman DAJH-1 to DAJH-9 29 January 2016 Herman #1

Karen Hapgood KH-1 to KH-21 29 April 2016 Hapgood #1

David Herman DAJH-10 to DAJH-23 02 May 2016 Herman #2

Joe Pippia JRP-1 to JRP-22 02 May 2016 Pippia #1

In Answer Craig Bunt CB-1 to CB-3 02 August 2016 Bunt

Karthigeyan Nanjan KN-1 to KN-4 03 August 2016 Nanjan

In Reply Karen Hapgood KN-22 to KN-24 15 December 2016 Hapgood #2

Joe Pippia JRP-23 to JRP-26 23 December 2016 Pippia #2

The request for examination of the opposed application was filed on 27 May 2014. As a consequence, the amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 apply to the present application. This includes section 60(3A) of the Act which states:
(3A) If the Commissioner is satisfied, on the balance of probabilities, that a ground of opposition to the grant of the standard patent exists, the Commissioner may refuse the application.
The standard of proof that applies to the present opposition is the balance of probabilities, and Merial carries the onus of proof.
2 Regulation 5.23
Before the hearing, Bayer NZ filed new documents and requested it be considered under the provisions of regulation 5.23. A delegate considered the filed documents and found nothing of significance that would change the outcome of the opposition in a significant way. Consequently, the delegate declined Bayer NZ’s request that the Commissioner consult the new documents under regulation 5.23.[1]
[1] Letter from IP Australia dated 03 May 2017.
Bayer NZ submitted in their written submissions that it remains open to me to consult the new documents under regulation 5.23 if I believe the further information is relevant to the opposition.[2]
[2] Bayer NZ’s written submissions dated 02 November 2017 at [14] – [28].
I have viewed the new documents very briefly. The documents the applicant seeks to rely on consists of a declaration of Dr Andrew Scott providing submissions in relation to the request under regulation 5.23 accompanied by declarations of the opponent’s expert witnesses in relation to an opposition regarding NZ 604032 (a New Zealand patent application in the name of Bayer new Zealand Limited), a copy of the decision of the New Zealand Assistant Commissioner of Patents in relation to NZ 604032 and a copy of NZ 604032.
The decision of the New Zealand Assistant Commissioner of Patents is not evidence. The evidence of the opponent’s declarants that Bayer NZ seeks to rely upon are in relation to the significance of WO 2008/075984 (the international application from which the parent application of the current opposed application is derived) in matters relating to novelty and inventive step in the New Zealand opposition. It is not apparent to me that this new evidence would significantly alter the outcome of the present opposition. Therefore, I consider there is no justification to invoke regulation 5.23. Consequently, I will not consult the new documents.
3 The specification
The specification relates to a tablet formulation with anthelmintic activity for administration to an animal. The specification has 35 claims. There are two independent claims: claims 1 and 19. The full claim set is reproduced in Annex A to this decision.
3.1 Principles of construction
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:
“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.”[3]
[3] [2013] FCA 214 at [139]; 100 IPR 451.
3.2 The field of the invention
The specification states the following in regard to the technical field:
“The invention relates to a tablet formulation. More specifically, the invention relates to a tablet formulation containing at least one macrocyclic lactone compound with anthelmintic activity dissolved in at least one organic solvent along with levamisole and optionally at least one further anthelmintic compound for use in treatment of animal parasites.”[4]
[4] The specification at page 1.
3.3 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.”[5]
[5] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]; 177 ALR 231.
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.”[6]
[6] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; 89 ALJR 798.
An 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. In this opposition there are declarations by a number of people. Professor Hapgood has 20 years’ experience in pharmaceutical manufacturing processes, especially granulation processes of powders, tablets and capsules, and many years’ experience as a process engineer in tablet process development.[7] Mr Pippia has over 23 years’ experience in laboratory and pharmaceutical manufacturing environments, and many years’ experience in the development of topical and oral veterinary products for the Australian and New Zealand markets.[8] Mr Nanjan has over 16 years’ experience in the development of pharmaceutical formulations and drug delivery.[9] Dr Bunt has over 21 years’ experience working as a pharmaceutical formulation scientist.[10]
[7] Hapgood #1 at [1] – [15]; Annexure KH-1.
[8] Pippia #1 at [1] – [12]; Annexure JRP-1.
[9] Nanjan at [3]; Annexure KN-2.
[10] Bunt at [4]; Annexure CB-3.
Mr Nanjan is named as an inventor of the opposed application.[11] Merial submitted that:
[11] Bayer NZ filed a request on 20 March 2017 to add Mr Nanjan as an inventor of the opposed application. The amendment to add Mr Nanjan as an inventor was advertised and subsequently allowed on 17 July 2017.
“By his [Mr Nanjan] own account, he was directly involved in arriving at the alleged invention in the opposed application. Mr Nanjan’s evidence also sets out the rationale of the alleged invention, and asserts certain advantages in relation to the alleged invention. As will become clear, many of his comments in his declaration refer to a tableting process not disclosed in the Opposed Application at the complete filing date (Exhibit KN-4). The opponent also submits that Mr Nanjan cannot be characterised as an independent witness. This has ramifications for the weight to be given to Mr Nanjan’s evidence. The opponent submits that the Commissioner should be cautious in giving weight to Mr Nanjan’s evidence. However, his comments on his preferred method of manufacturing the claimed tablets are highly relevant to this opposition.”[12]
[12] The written submissions of Merial, dated 27 October 2017, at [17].
I consider that all of the declarants mentioned above are in a position to provide evidence as to what the person skilled in the art knew and would have done. The weighing and evaluating of the evidence to decide the characteristics of the person skilled in the art is part of the normal work of a delegate of the Commissioner.
3.4 Technical background that forms part of the common general knowledge
Before analysing the specification it is important to review what was already known in the art about anthelmintic formulations and conventional methods for manufacturing tablets before the priority date, 21 December 2006.
Common general knowledge (CGK) is the background knowledge and experience available to all those working in the relevant art:
“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.”[13]
[13] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 at [115]; 144 CLR 253 at page 292.
Anthelmintic formulations
A range of different classes of anthelmintic agents including a macrocyclic lactone compound (such as abamectin and ivermectin), an imidazothiazole compound (such as levamisole) and a benzimidazole compound (such as albendazole) were used for controlling parasitic worms which infest animals before the priority date.[14] It was routine to use a broad spectrum anthelmintic treatment before the priority date by using a combination of anthelmintic agents either sequentially, concurrently or combined into a single formulation.[15]
[14] Pippia #1 at [40].
[15] Pippia #1 at [51].
Macrocyclic lactone compounds (MLs) are lipophilic molecules with limited solubility in aqueous solutions.[16] MLs are soluble in many organic solvents, a property exploited in commercial injection, pour-on and drench applications.[17]
[16] Pippia #1 at [42]; Nanjan at [19].
[17] Pippia #1 at [42].
The acid form of levamisole (Lev), Lev hydrochloride (Lev HCl), is highly soluble in water and the form that is most widely used, particularly for oral and injectable administration.[18]
[18] Pippia #1 at [48].
A combination of ML and Lev in an aqueous formulation is not stable because the pH required for maintaining stability of each compound is vastly different.[19]
[19] Exhibit CB-1 at [15.1] - [15.2].
Methods for manufacturing tablets
Tablets can be manufactured by a process of wet granulation, dry granulation or direct compression.[20] The properties of the active ingredient (active) and excipients in a pharmaceutical composition typically dictate the type of granulation selected.[21]
[20] Hapgood #[34] - [47]; Pippia #1 at [62] - [72].
[21] Hapgood at [40].
Where an active is required in low dosage, wet granulation is routinely used in order to uniformly distribute the low-dose active throughout the granule.[22] MLs are very potent and require only a small unit dose amount.[23] In tablet manufacture, MLs are typically dissolved in the granulation solution, which could be an organic solvent or a mixture of organic solvents, and subsequently added to tableting excipients and dry active constituents during the wet granulation process.[24]
[22] Hapgood #1 at [54], [73].
[23] Pippia #1 [42]; Hapgood #1 [73].
[24] ibid.
Lev and benzimidazole (Benz) have a lower potency and therefore a relatively high unit dose amount of each active would typically be added to the mixture of dry tableting excipients—as opposed to dissolving each active in the granulation solution.[25]
[25] Pippia #1 at [46], [48].
The wet granulation processes
In written submissions, Merial provided the following diagram summarising the principle steps in the manufacture of tablets using wet granulation:[26]
[26] Merial’s written submissions dated 27 October 2017, at [75] which references Hapgood #1 [45], [46], [54], [55], [56], [57], [59], [68], [70], [86], [97]; Pippia #1 [57] - [60], [63] - [65], [94], [98].
The granulating liquid is commonly a solvent which could be water or an organic solvent.[27] Where an aqueous based liquid is used as the granulating liquid, this is typically water as water is non-toxic and easily regulated.[28] Where the active is susceptible to hydrolysis or is heat sensitive, organic solvents (such as ethanol) are used.[29] The solvents known to be used include alcohol, isopropyl alcohol (another name for isopropanol) and propylene glycol.[30] Where the active is heat sensitive, it is known that the use of organic solvents reduce the time needed for drying during tablet manufacture.[31]
[27] Hapgood #1 at [57].
[28] ibid.
[29] ibid.
[30] Hapgood #1 at [87].
[31] Hapgood #1 at [57].
It was known that the choice of solvents required a consideration of the properties of the active, and the avoidance of a significant amount of organic solvent is typically desirable, otherwise the final granules would need to be screened for residual organic solvents which would be an extra step in quality control.[32]
[32] Hapgood #1 at [65].
Where a low-dose active (MLs) and high-dose active (Lev, Benz) are both required in a tablet, it was routine to incorporate the low-dose active (MLs) in the granulating liquid, and to incorporate the high-dose active with excipients as part of the powder mixture/blend prior to addition of the granulating liquid containing the low-dose active.[33]
[33] Pippia #1 at [46], [65]; Hapgood #1 at [73], [92], [93].
Excipients routinely incorporated in the powder mixture/blend include binders, fillers and diluents.[34] It was commonly known to include binders in a tablet formulation to assist holding together the constituents in the tablet.[35] Common binders include polyvinyl pyrrolidone (another name for povidone).[36]
[34] Hapgood #1 at [55], [56], [67] - [69], [73]; Pippia #1 at [57] - [60].
[35] Pippia #2 at [27].
[36] Hapgood #1 at [68].
Normal tableting processes include a drying step to remove excess liquids or solvents used in the wet granulation processes.[37] Typically, the granules that are formed by wet granulation are transferred into a dryer (a fluidised bed dryer or a tray dryer) and excess water or solvent is evaporated to obtain a composition suitable for tableting.[38] The drying process is known to create solid bridges between the powders in the granules to make the granule strong as the liquid is removed.[39]
[37] Hapgood #1 at [46], [57], [70], [86]; Pippia #1 at [64], [94], [98]; Pippia #2 at [36]; Nanjan at [50], [59].
[38] Hapgood #1 at [70]; Pippia #1 at [94].
[39] Hapgood #1 at [86].
It is routine for the dried granules to be blended and mixed with additional excipients including disintegrants, lubricants and glidants to assist and aid in final tablet compression.[40] Following the blending of the additional excipients with the dried granules, it was routine to compress the final mixture into tablets.[41]
[40] Hapgood #1 [68], [70], [86].
[41] Hapgood #1 [86].
What does the drying step that forms part of a conventional tableting procedure achieve?
As discussed above a drying step to remove excess liquids in a wet granulation process was a routine step in conventional tableting procedures.
Mr Pippia stated that the drying step used in conventional wet granulation methods removes substantially all of the solvents.[42] He also states:
[42] Pippia #2 at [36].
“On some occasions, for example where the solvent used has a low boiling point, it may be possible to dry the mixture at lower temperature, but regardless of the exact conditions the normal procedure would be to remove essentially all of the organic solvent (i.e. some traces may remain).”[43]
[43] ibid.
Mr Nanjan stated that in a conventional drying process solvents would be substantially removed.[44]
[44] Nanjan at [50].
I am satisfied that the drying step used in a conventional wet granulation method removes substantially all of the solvents.
3.5 The aim of the invention
The specification describes that many anthelmintic compounds are extremely insoluble in aqueous environments such as extracellular fluids and need to be formulated to ensure they are bioavailable.[45] The MLs, which include abamectin and ivermectin, are described to present a challenge as these compounds are lipophilic and largely insoluble in aqueous environments.[46] Therefore, it is a challenge to formulate a tablet that includes one or more anthelmintic compounds that are lipophilic, require specific conditions in which to dissolve, and may lose viability when stored over time.[47]
[45] The present specification at page 1.
[46] The present specification at page 2.
[47] ibid.

The specification describes an aim of the opposed application is to provide a tablet formulation containing at least two different anthelmintic compounds ideally from different families of anthelmintic activity.[48]
[48] The present specification at page 1.
A problem, described as specific to tablets, is ensuring the tablet dissolves on administration and releases the active compounds in a form that is bioavailable and does not simply pass through the animal without achieving the desired therapeutic effect.[49]
[49] ibid.
The specification also states:
“….it is desirable to have a formulation:
·for delivery of parasiticidal compounds including lipophilic agents,
·which stabilises these agents so that they may be stored over time with minimal physical or chemical degradation, and
·delivers a consistent dose of the agents on administration to an animal.
It is an object of the present invention to address the foregoing problems or at least to provide the public with a useful choice.”[50] (emphasis added)
[50] The present specification at pages 2 - 3.
The specification states that it would be advantageous to provide a tablet formulation comprising multiple anthelmintic actives where a blood level of each anthelmintic active—a measurement used to indicate bioavailability level—is achieved which is comparable to the level achieved if the animal was administered a liquid-based oral drench comprising the same single anthelmintic active.[51] However, the specification notes that a tablet formulation having a lower bioavailability level may still be of commercial value given advantages offered by tablets.[52] The advantages include cost efficiency to small farms which have an option of purchasing small number of tablets instead of costly liquid-based drenches that are packaged in large containers.[53]
[51] The present specification at page 14.
[52] ibid.
[53] The present specification at page 10.
Therefore, I conclude that the aim of the invention is to provide a multiple anthelmintic formulation, in the form of a tablet, which is an alternative to an oral drench. I also conclude that whilst it is desirable to formulate an improved tablet having an anthelmintic bioavailability level comparable to an oral drench, a tablet having a lower bioavailability level is an alternative formulation that is still a useful choice.
3.6 The invention as described in the specification
Under the heading “Disclosure of invention”, the specification sets out the invention in the following terms:
“According to one aspect of the present invention there is provided a tablet formulated for administration to an animal characterised in that the tablet includes:
(a) at least one macrocyclic lactone compound having anthelmintic activity and;
(b) at least one levamisole compound with anthelmintic activity; and,
wherein the macrocyclic lactone compound or compounds are dissolved in at least one organic solvent.”[54]
[54] The present specification at page 3.
and
“According to a further aspect of the present invention there is provided a tablet formulated for administration to an animal including:
(a) at least one macrocyclic lactone compound or compounds with anthelmintic activity;
(b) at least one levamisole compound;
(c) at least one substituted or unsubstituted benzimidazole compound with anthelmintic activity; and,
wherein the macrocyclic lactone compound or compounds are dissolved in at least one organic solvent.”[55]
[55] The present specification at page 7.
The specification describes that in a preferred embodiment, the macrocyclic lactone compound or compounds are subsequently mixed with at least one second organic solvent (termed a ‘co-solvent’ for the purposes of the specification).[56]
[56] The present specification at page 7.
The first organic solvent or solvents are described to be preferably selected from an alcohol, a glycol, an ether, a pyrrolidone compound with two or more carbon atoms, or a combination thereof.[57] In a more preferred embodiment, the solvent is benzyl alcohol as this solvent is described to not only dissolves the ML, but acting with the co-solvent stabilises the ML increasing the overall stability of the product.[58]
[57] ibid.
[58] The present specification at pages 7 - 8.
The co-solvent is described to be preferably an alcohol or ether compound with three or more carbon atoms.[59] In a more preferred embodiment, the co-solvent is a propylene glycol compound such as monopropylene glycol.[60]
[59] The present specification at page 8.
[60] ibid.
An advantage of the solvent and co-solvent chosen is described as providing improved bioavailability whereby it is suggested that the solvents and co-solvents assists in transfer of the ML from the gut and into the animal bloodstream.[61]
[61] ibid.
Another advantage described is:
“By dissolution and mixing with solvents and co-solvents, the macrocyclic lactone anthelmintic compound(s) are made absorbable and can be mixed with levamisole and other anthelmintic agents without risk of reducing efficacy or tablet stability.”[62]
[62] The present specification at page 8.
In regard to the method of preparing the tablet, I consider the statement quoted above to describe that the solvents are being used to dissolve the ML prior to addition of the Lev. Mr Pippia arrives at the same interpretation.[63]
[63] Pippia #1 at [200].
The Examples
Example 1 describes three different formulations, referred to as reformulation 1, reformulation 2 and reformulation 3. The complete components of these formulations are set out in Annex B of this decision. All formulations include three anthelmintics compounds — abamectin (ML), Lev HCl and albendazole (Benz). Of particular relevance, the following solvents are described to be used to dissolve the ML:

Formulation Solvent(s)

Reformulation 1 monopropylene glycol

Reformulation 2 monopropylene glycol

benzyl alcohol

Reformulation 3 monopropylene glycol

The formulations were administered to animals and the blood levels of each anthelmintic active measured post-administration over time (Figures 1-9). The blood level of the anthelmintic compound was used as a measure of the degree of absorption of the active and therefore an indicator of bioavailability level.
Reformulations 1, 2 and 3 were administered to sheep at a dose sufficient for a 60 kg animal and using a standard dose regime of 0.2 mg/kg, 3.75 mg/kg and 7.5 mg/kg for abamectin, albendazole and Lev HCl, respectively.[64] The blood level of each anthelmintic compound was compared to a reference oral drench comprising the same single anthelmintic compound — Nilverm™ (Lev), Genesis™ (abamectin) and Valbazen™ (albendazole).[65]
[64] The present specification at page 13.
[65] The present specification at page 14.
The specification states in regard to reformulation 3 that:
·the degree of absorption of Lev was comparable to the reference Nilverm™;
·the degree of absorption of abamectin was not comparable to the reference Genesis™; and
·the degree of absorption of albendazole was not comparable to the reference Valbazen™.[66]
[66] The present specification at page 15.
The specification states in regard to reformulation 2 that:
· the degree of absorption of Lev compared well against the reference Nilverm™;
·the degree of absorption of abamectin approximated to half that of the reference Genesis™; and
· the degree of absorption of albendazole compared well against the reference Valbazen™.[67]
[67] The present specification at pages 15 – 16.
Example 2 describes the bioavailability of anthelmintic compounds, administered in the absence of excipients, in animals. Separate gelatine capsules containing a single anthelmintic compounds — abamectin, albendazole or Lev HCl — were administered to sheep using the standard dosage regime as described in Example 1. The blood level of each anthelmintic compound was measure post-administration over time (Figures 10 - 11).
The results of Example 2 were described to demonstrate that tablet formulations containing excipients are an important factor for improving drug bioavailability.[68] The specification describes the results of Example 2 show that the blood level of:
[68] The present specification at page 18.
·     abamectin was just above the detection threshold and this indicated that abamectin was not absorbed;
·     albendazole was lower than expected and suggested that the formulation of the tablet appeared to have an effect on albendazole bioavailability; and
·     Lev showed a delay in reaching the maximum concentration (C_max) and suggested the delay may be due to the active passing through the mucosal layer between the gut and blood stream.[69]
[69] The present specification at pages 17 - 18.
Example 3 describes another formulation, reformulation 4, that includes abamectin, albendazole and Lev HCl. The abamectin was described to be dissolved and mixed with two organic solvents, monopropylene glycol and benzyl alcohol, during manufacturing. The complete components of reformulation 4 are set out in Annex B of this decision. Of relevance, the dose of abamectin and albendazole, as a percentage of the tablet, was increased — described in the specification as approximately doubled —compared to reformulations 1-3. Reformulation 4 was formulated for cattle weighing 160 kg and administered to cattle.
The blood levels of each anthelmintic active achieved by administering reformulation 4 were described to be equivalent to the levels observed for the corresponding reference oral drench. The blood levels of each anthelmintic active over time were measured post-administration and shown on Figures 12-14.[70]
[70] Figures 12-14 are reproduced in Annex C of this decision.
Example 4 describes tests conducted to determine the storage stability of tablets of reformulation 2. The tablets were tested for:
·General visual description
·Disintegration time
·Average weight
·Weight variation
·Concentration of abamectin
·Hardness
The specification describes that the tablets were remarkably stable, did not breakdown when stored at 40°C or below and at a relative humidity of 75% over a significant time period.[71]
[71] The specification at pages 20 - 21, Tables 5 and 6.
Example 5 describes tablets formulated for cattle with other macrocyclic lactones. Table 7 describes tablets formulated with ivermectin, doramectin, eprinomectin or moxidectin. Table 8 describes tablets formulated with abamectin or moxidectin and oxfendazole.
Example 6 describes a kit comprising a blister pack of tablets as described in the specification and a pill applicator for administration of the tablets. The pill applicator is described to be a mechanical device, such as a pill popper device, or a swallowing-enhancing coating, such as a dough composition, which encases the pill and masks the pill from the animal.[72]
[72] The specification at page 23.
3.7 The invention as claimed
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd.:
“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”[73]
[73] [2009] FCAFC 70 at [118] - [120]; 81 IPR 228.
Claim 1
Claim 1 is the first independent claim of the present application. It reads:
“A tablet formulated for administration to an animal, the tablet including:
(a)at least one macrocyclic lactone compound having anthelmintic activity
and;
(b)at least one levamisole salt having anthelmintic activity and
wherein the at least one macrocyclic lactone compound is dissolved in at least one organic solvent and;
then subsequently mixed with at least one co-solvent prior to the addition of levamisole and subsequently tablet formation;
and wherein the solvent(s) and co-solvent(s) are different compounds and are non-aqueous compounds.”
What does claim 1 define?
Reading the words of claim in the context in which they appear, claim 1 is directed to a tablet framed by reference to both the features of the tablet and the process by which the tablet is manufactured. The tablet comprises at least one ML and at least one Lev salt. The method of producing the tablet comprises:
·dissolving the ML in at least one organic solvent (step 1);
·and then mixing another solvent, the co-solvent, with the ML-organic solvent mixture from step 1 (step 2);
·and then adding the Lev salt to the ML-organic solvent-co-solvent mixture from step 2 (step 3);
·and then forming the tablet (step 4).
The plain meaning of the words “subsequently” and “prior to” require that steps 1, 2, 3 and 4 be done sequentially. This interpretation is consistent with the statements of the various declarants that the method of producing the tablet is one involving series of sequential steps.[74]
[74] Nanjan at [38] - [40], [46], [49] - [56]; Hapgood #2 at [7]
Does claim 1 define a drying step prior to the addition of the Lev salt?
A question I must ask, for reasons that will become evident when assessing the claimed invention in light of the prior art, is whether there is a drying step after dissolving and mixing the ML in the organic solvent and co-solvent, and before addition of the Lev salt. Whilst the words of claim 1 do not preclude a drying step before addition of Lev salt, it would seem counter-intuitive to have a method where there is a dissolution step to get the ML into solution, and then dry off the solvents before adding the Lev salt if the ML could simply be added in a dry form to the Lev salt. From my previous discussion about the invention as described in the specification, there is a clear implication from the body of the specification that different solvents are used to get the ML into solution before addition of the Lev salt and subsequent tablet formation. Therefore, I consider it is a reasonable interpretation that there is no drying step prior to the addition of the Lev salt.
I will now consider the meaning of several other terms of claim 1.
“Tablet”
The specification states:
“For the purposes of this specification, the term 'tablet' refers to the formulation being administered orally and in a consistency able to be administered as a granular material, discrete tablet or capsule, or alternatively expelled by device such as a 'pill popper', stomach tube or other delivery device.”[75]
[75] The present specification at page 3.
The specification therefore provides a dictionary meaning for interpretation of the term “tablet” of the claims.
“formulated for administration to an animal”
The terms mean that the tablet must be suitable for administration to an animal.
“at least one macrocyclic lactone compound”
The claim defines the tablet to comprise an anthelmintic compound that is from the ML family. The specification describes the ML family to include abamectin, ivermectin, moxidectin, eprinomectin, doramectin, or a combination of the mentioned MLs.[76]
[76] The present specification at page 4.
“at least one levamisole salt”
The claim defines the tablet to comprise another anthelmintic compound that is a Lev salt. The specification describes the Lev salt to include Lev HCl.[77]
[77] The present specification at page 5.
“co-solvent”
The specification provides a dictionary meaning for the term “co-solvent”.[78] The “co-solvent “is an organic solvent. Claim 1 defines that the solvent and the co-solvent are different compounds. Therefore, claim 1 defines at least two different organic solvents in the method of formulating the tablet.
[78] The present specification at page 7.
As a matter relevant to claim construction, and for reasons that will become evident when assessing matters in regard to section 40 of the Act, I must ask whether the co-solvent is one that is simply subsequently mixed after the ML has been dissolved in the first organic solvent, or whether the claim includes a co-solvent that is being used to dissolve the ML after the first organic solvent has partially dissolved the ML.
Whilst the words of claim 1 itself specifically defines a co-solvent that is subsequently mixed with the ML-organic solvent mixture, I consider that it is reasonable to interpret the co-solvent (which is a second organic solvent) as another solvent that is being used to assist dissolution of the ML. As previously discussed, the method of preparing reformulation 2 is described in the specification to involve dissolving the ML in two solvents while the method of preparing reformulation 4 is described to involve dissolving and mixing the ML with two solvents.[79] Therefore, I consider it is a reasonable interpretation that the scope of claim 1 includes (a) a co-solvent that is being used to dissolve the ML after the first organic solvent has partially dissolved the ML, and (b) a co-solvent that is simply subsequently mixed after the ML has been dissolved in the first organic solvent.
[79] The present specification at pages 12 and 18.
“non-aqueous compounds”
The Macquarie dictionary defines “aqueous” to be “of, like, or containing water; watery”.[80] It follows that a plain meaning of “non-aqueous compounds” is compounds that do not contain water. This interpretation is consistent with the description in the specification that MLs are lipophilic and largely insoluble in aqueous environments.[81]
[80] Macquarie Dictionary Publishers, 2017 (An on-line version).
[81] The present specification at page 2.
Summary
Claim 1 defines a tablet comprising a ML and a Lev salt produced by a method that includes the use, in a sequential manner, of at least two different organic solvents to get the ML in solution before adding the Lev salt and subsequent tablet formation. The scope of claim 1 includes (a) dissolving the ML in a first organic solvent and subsequently mixing a second organic solvent (a co-solvent) to the ML solution; and (b) partially dissolving the ML in a first organic solvent, and subsequently mixing a co-solvent to fully dissolve the ML. Apart from defining the sequence of mixing different ingredients—organic solvents and anthelmintic active compounds—the method of claim 1 does not define other limiting steps. Apart from defining that the solvent and co-solvent are different organic solvents and do not contain water, claim 1 does not define further limitations to the solvents used to manufacture the tablet.
Claim 5
Claim 5 reads:
“The tablet as claimed in any one of claims 1 to 3 wherein the at least one macrocyclic lactone compound and levamisole salt included in the tablet are at a concentration sufficient to provide the animal with a dose of the at least macrocyclic lactone compound or levamisole salt equivalent to that which would be obtained from an oral drench containing the same compounds.”
What is a dose of “ML compound or levamisole salt equivalent to that which would be obtained from an oral drench containing the same compounds”?
I interpret the phrase to define a blood level concentration of ML or Lev salt that is achieved in an animal when tablets having the dosage range defined in the claim are administered to the animal. In other words, the claim defines a bioavailability limitation for the tablet.
Mr Pippia stated that when developing an anthelmintic tablet, he would note the actives contained in oral drenches with market authorisation, or were commercially available, in order to develop a tablet that could deliver an equivalent amount of actives per animal body weight.[82] Professor Hapgood mentions a similar approach.[83] I consider that the skilled person would understand the scope of the dosages defined in claim 5 by reference to known oral drenches.
[82] Pippia#1 at [81].
[83] Hapgood #1 at [212].

I consider reformulation 4 which comprises 68 mg abamectin, 1200 mg Lev HCl and 1200 mg albendazole to fall within the scope of claim 5.[84]
[84] The present specification at page 8, lines 30 - 38 and Table 4 which describes the components and method of making reformulation 4.
Claims 11
Claim 11 reads:
“The tablet as claimed in any one of the above claims wherein the at least one macrocyclic lactone compound and levamisole salt dissipate from the bloodstream of the animal in a similar manner as an oral drench.”
Similar to claim 5, I interpret claim 11 defines a bioavailability limitation for the tablet. The dosages of the ML and Lev salt are defined in claim 11 with reference to the time the actives are cleared from the bloodstream of an animal and by comparison with an oral drench. I consider that the skilled person would understand the scope of the dosages by reference to known oral drenches.
I consider reformulation 4 to fall within the scope of claim 11 because of the drug profiles of the formulation shown in Figures 12-14.
Claim 19
Claim 19 reads:
“A tablet formulated for administration to an animal including:
(a)   at least one macrocyclic lactone compound with anthelmintic activity;
(b)   at least one levamisole salt with anthelmintic activity; and
(c)   at least one benzimidazole compound with anthelmintic activity; and
wherein the macrocyclic lactone compound or compounds have been dissolved in at least one organic solvent and;
then subsequently mixed with at least one co-solvent prior the addition of levamisole salt subsequent to tablet formation;
and wherein the solvent(s) and co-solvent(s) are different compounds and are non-aqueous compounds.”
Like claim 1, claim 19 is directed to a tablet framed by reference to both the features of the tablet and the process by which the tablet is manufactured. The tablet of claim 19 comprises at least one ML, at least one Lev salt and at least one Benz compound. The method defined in claim 19 includes the same method steps defined in claim 1, that being the use of at least two different organic solvents, in a sequential manner, to get the ML into solution before adding Lev salt and subsequent tablet formation. Apart from defining the sequence of mixing different ingredients—organic solvents and anthelmintic active compounds—the method of claim 19 does not define other limiting steps. Apart from defining that the solvent and co-solvent are different organic solvents and do not contain water, claim 19 does not define further limitations to the solvents used to manufacture the tablet.
Claim 35
Claim 35 reads:
“A kit containing a pill administration device or pill administration composition and one or more tablets as claimed in any one of claims 1 to 30.”
Adopting a plain meaning of the words, the claim defines a collection of components collocated in a kit. The components are a tablet as claimed in claims 1-30, a device to administer a pill or a composition to administer a pill.
I consider that a skilled person would understand the devices and compositions used to administer a pill. Professor Hapgood states these to be routine means for administering tablets.[85] The specification describes a pill popper or a gas actuated applicator and a dough in which tablets are encased to mask the tablet from the animal.[86]
[85] Hapgood #1 at [246].
[86] The present specification at page 10.
4 The invention from the perspective of the inventor
I note here Mr Nanjan makes an overarching statement in his declaration, dated 03 August 2016, that his opinions are based on his knowledge and experience as at 21 December 2006 in Australia.[87] Therefore, I consider his evidence is to be evaluated in the context of this statement.
[87] Nanjan at [16].
Rationale of the invention
Mr Nanjan stated that at the time of filing of the opposed patent application, since it was known in the industry that MLs were are not compatible with Lev, it was important that any useful composition which contains both ML and Lev must separate the actives to ensure stability and effectiveness of the composition.[88] As a solid, abamectin can react with oxygen from the atmosphere, and in an aqueous solution abamectin is hydrolysed by water.[89] Abamectin also reacts with acidic compounds like Lev.[90] Mr Nanjan stated that the instability of a composition comprising abamectin and Lev salt is understood to lead to poor bioavailability of abamectin primarily due to breakdown of the active, and consequently lower effectiveness of the treatment due to insufficient dosing.[91]
[88] Nanjan at [19] - [20].
[89] Nanjan at [25].
[90] ibid.
[91] Nanjan at [26].
Mr Nanjan stated that at the time the project commenced to develop a tablet comprising a combination of ML and Lev, he was aware other manufacturers had overcome some of the stability problems by partitioning incompatible actives in separate phases of an emulsion or micro-emulsion. [92] Mr Nanjan stated he was aware of the several multi-active formulations that were administered in liquid form.[93] Examples of these liquid formulations are Switch™ Oral Drench for Sheep (which contains abamectin and levamisole) by Merial Ancare, and Q-Drench TM Multi-Combination Drench for Sheep (which contains abamectin, levamisole, albendazole and closantel) by Jurox Pty Limited.[94]
[92] Nanjan at [27].
[93] ibid.
[94] ibid.
Mr Nanjan stated that at the time of filing the opposed application, there was no commercially available tablet that included ML and Lev, nor was he aware of any disclosure of such a product in any publication.[95] The literature also indicated that combinations of ML and Lev were formulated as liquids.[96]
[95] Nanjan [29].
[96] Nanjan at [30].
Mr Nanjan stated that it is likely that why no one in the industry had, at the time of filing the opposed application, been able to provide a stable tablet containing abamectin and Lev, nor provide a manufacturing process for such a tablet composition was because having the two actives being in contact with each other, as well as the exposure of abamectin to oxygen, would result in an unstable combination.[97]
[97] Nanjan at [32].
Mr Nanjan stated that after 2-3 years of research and development a method of manufacturing a single tablet with incompatible actives was devised, and this method involved phase separation of the actives.[98]
Mr Nanjan stated:
“Claim 1 defines the key features of the composition which act together synergistically to provide a unique and clever phase separation between the two actives and, more-so, a process which avoids the need for a substantial drying step at high temperatures, providing further key advantages discussed below. When we arrived at the present invention we immediately recognised the importance of our discovery and, in particular, the advantages outlined below.”[99] (emphases added)
The process devised, which I will now describe, avoided the need for a substantial drying step, and also avoided the excess use of solvents to get the ML into solution before the addition of Lev.[100]
Manufacturing Processes
Current manufacturing instructions
[98] Nanjan at [34] - [35].
[99] Nanjan at [68].
[100] Nanjan at [54], [69], [72], [98].

100. Mr Nanjan stated:
“Current manufacturing instructions in accordance with the invention as claimed are annexed as ‘KN-4’”.[101]
[101] Nanjan at [37]; I discuss what is meant by “current manufacturing instructions” later in my decision.

101. I reproduce the manufacturing method of KN-4 below for convenience, and will subsequently outline some of the important aspects of the manufacturing process from an inventor’s perspective.
“1. Dissolve the abamectin in benzyl alcohol then mix in the monopropylene glycol.
2. Mix with levamisole hydrochloride, povidone and corn starch.
3. Dry at 40°C.
4. Mix with sodium starch glycolate, aerosil 200 and magnesium state [sic] and granulate.
NOTE: tablets were pressed from this granulation using rotate punch machine.”

Phase separation of the actives
102. The organic solvents are used to keep the ML in solution, and since Lev salt is insoluble in organic solvents, there is phase separation of the actives. Mr Nanjan stated:
“Since levamisole will not dissolve in the ML/solvent solution, the two actives are effectively kept separate in different phases. Therefore, a delicate phase separation between the two actives is achieved whereby each active is kept in an isolated environment in which it is stable and isolated from the other active(s).”[102]
[102] Nanjan at [48].

103. Mr Nanjan stated that it was important to find a way not to disturb the delicate phase separation during the subsequently tableting step.[103] Mr Nanjan stated:
“It was clear to us at the time that if one were to substantially dry such a mix as per normal tableting processes, the delicate phase separation would be affected as the solvents protecting the ML would be substantially removed through the conventional drying process. This would expose the ML to the levamisole, and also to oxygen in which it is unstable.”[104] (emphases added)
[103] Nanjan at [49].
[104] Nanjan at [50].

104. Mr Nanjan explained that the “substantial drying step” that he refers to is:
“… the removal of the main solvents in a composition by drying at high temperatures; for instance if one were to remove a solvent (e.g. benzyl alcohol) and co-solvent (e.g. monopropylene glycol).”[105]
[105] Nanjan at [59].

Use of a minimum volume of solvents
105. Mr Nanjan stated that in the method of KN-4 abamectin is dissolved, or at least partially dissolved, in the first organic solvent and then a co-solvent, different to the first solvent, is added to the mixture.[106]
[106] Nanjan at [37] - [38].
106. Mr Nanjan also stated that the use of different organic solvents in the manufacturing process resulted in avoidance of use large volumes of solvents to solubilise the ML.[107] The consequence of using relatively lower volumes of solvents resulted in the mixture of ML and Lev having a consistency which is highly beneficial for subsequent tableting procedures, and also provided the particular advantage that a substantial drying step is avoided.[108]
[107] Nanjan at [69], [72].
[108] Nanjan at [72].
107. I understand Mr Nanjan’s statements regarding solvents to indicate that the use of a combination of different solvents minimises the total volume required to get the ML into solution. I also understand Mr Nanjan’s statements to mean that the volumes of benzyl alcohol and monopropylene glycol that are used to dissolve the ML are so low that there is no need to remove excess solvents by a substantial drying step before tabletting.
The nature of the drying step
108. After mixing Lev to the ML solution, Mr Nanjan stated that povidone is then added to the ML/Lev mixture to act as a binding agent without which the ML/Lev mixture would not sufficiently hold together for tableting.[109]
[109] Nanjan at [57].
109. Mr Nanjan stated:
“The only drying that is employed is to remove the isopropanol (IPA) that is a carrier for the povidone component. This drying step is carried out at a low temperature of 40°C as opposed to the much higher temperatures that would be required to remove the main solvents (e.g. benzyl alcohol and monopropylene glycol) in the composition. This drying step does not disturb the delicate phase separation previously referred to in my declaration.”[110]
[110] Nanjan at [58].

110. Mr Nanjan also stated that the drying step to remove IPA is:
“…not actually essential, and if it is omitted it has no substantial influence on the outcome of the composition's success. This drying step is utilised in the preferred wet granulation process used to produce the tablets. However, less preferred direct compression methods could be used that would avoid this drying step.”[111]
[111] Nanjan at [61].

111. I note that whilst there is no mention of the use of IPA in the method of KN-4, I consider Mr Nanjan’s statement at paragraph 58 of his declaration, quoted above, to strongly indicate IPA is used as a carrier to dissolve povidone. Mr Pippia arrives at a similar conclusion.[112]
[112] Pippia #2 at [12].
112. I consider Mr Nanjan’s statements in regard to the low temperature 40°C drying step need to be understood in the context of the nature of any drying steps in a wet granulation process and the importance of maintaining phase separation between the ML and Lev.
113. I understand Mr Nanjan’s statements to mean that where the wet granulation process, as outlined in KN-4, is used the only drying step in the process is the 40°C drying step which is used to remove IPA. This is because, as previously discussed, the relatively lower volumes of benzyl alcohol and monopropylene glycol used to dissolve the ML are such that there is no need to remove excess solvents by a high temperature drying step. The fact that IPA is a low boiling point solvent means that the temperature needed to evaporate IPA is low, 40°C, and drying at a low temperature will not disturb the phase separation between the ML and Lev.
When was the method of KN-4 known to the applicant?
114. Mr Nanjan stated:
“Despite the avoidance of a substantial drying step, I consider the tableting steps referred to in the manufacturing instructions (KN-3) [sic] after the addition of levamisole were conventional tableting procedures known at the time of filing the patent application.”[113] (emphasis added)
[113] Nanjan at [63]; I consider that Mr Nanjan intended to refer to KN-4 rather than KN-3 because manufacturing instructions are found in KN-4 and not in KN-3.

115. I previously noted that Mr Nanjan’s evidence is to be considered in the context that his overarching statement that his opinions are based on his knowledge and experience as at 21 December 2006. Therefore, I understand Mr Nanjan’s evidence, in particular at paragraphs 33-36, 50, 63 and 68, to be evidence based on his knowledge as at the priority date, 21 December 2006, or at the latest by the time of filing of the parent application—this being 20 December 2007. This is because I understand the process of making an anthelmintic tablet is the subject matter of the “project” which Mr Nanjan refers to in his evidence, and the process is the subject matter of both the parent and opposed applications. Whilst Mr Nanjan refers to the manufacturing instructions of KN-4 as “current manufacturing instructions”, I consider Mr Nanjan’s evidence indicates he knew of the importance of using a minimum volume of solvents and the nature of any drying step in the manufacture of the anthelmintic tablet by 20 December 2007. I consider the process Mr Nanjan refers to in KN-4 is a process that was developed based on that understanding.
116. I am satisfied that the process of KN-4 had already been established by the applicant by the filing date of the parent application, 20 December 2007.
5 Best method of performance
117. Paragraph 40(2)(aa) of the Act reads:
A complete specification must:
….
(aa) disclose the best method known to the applicant of performing the invention

118. Prior to the changes introduces by Raising the Bar the best method of performance requirement was found in paragraph 40(2)(a):
A complete specification must:
(a) describe the invention fully, including the best method known to the applicant of performing the invention;

119. The requirement of paragraph 40(2)(aa) is closely related to the requirement of paragraph 40(2)(a), and the relevant principles for the best method of performance requirement are set out in in the decision of the Full Federal Court in Les Laboratoires Servier v Apotex Pty Ltd (Servier).[114]
[114] [2016] FCAFC 27; 117 IPR 415.
120. The Court in Servier stated:
“While it cannot be held to be definitive or directory, it is worth a passing observation that in the Explanatory Memorandum for the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth) (the Explanatory Memorandum) at Item 8 concerning s 40 of the Act, it is stated that the existing requirement for a complete specification to include the best method known to the applicant of performing the invention remains unchanged. This was in connection with a proposal, subsequently enacted, to separate the requirements of s 40(2)(a) into two distinct paragraphs….”[115]
[115] Servier at [107].

121. The Court in Servier confirmed that the best method of performance requirement is separate and additional to the requirement of sufficiency:
“It follows that the courts have recognised the necessity for a patentee to include in the specification not only sufficient instruction to work the invention but also the best method of performing the invention known to him, her or it. This requirement has been developed by the courts over time and has been reflected in statutory provisions, such as in s 40(2)(a). Where the best method question has been addressed by the courts, the separate or additional nature of the requirement has been confirmed, including by the Full Court.”[116]
[116] Servier at [109].

122. The basis of the obligations of disclosure is to provide members of the public with the knowledge on how practically to obtain the benefit of the invention when the patent is expired. The Court in Servier stated:
“… a patentee was held to be bound to give the best information in his (or her) power as to how to carry out the invention. This was an element of the required good faith on the part of the patentee and the requirement to give to the public the consideration of knowledge of the best method that corresponds with the obtaining of the benefit of monopoly.”[117]
[117] Servier at [75].

123. In order to appreciate what is required of an inventor by way of disclosure in the specification, it is necessary to understand the invention itself.[118] This understanding requires taking into account the nature of the invention being described and claimed, and involves a question of fact, that being knowledge of the patent applicant.[119]
[118] Servier at [103].
[119] Servier at [59].
124. The Court in Servier noted the approach of Bennett J in Expo-Net Danmark A/S v Buono-Net Australia Pty Ltd (No 2) (Expo-Net).[120] In Expo-Net Bennett J stated:
“… it must be established that there was a better method known to the applicant as at the date of filing of the patent than the one described in the specification. This is clearly a subjective question.”[121]

and
“… it is necessary first to understand what the invention is. Indeed, this is perhaps the first question that needs to be answered.”[122]
[120] [2011] FCA 710.
[121] Expo-Net at [15].
[122] Expo-Net at [16].

125. Her Honour went in to recite the approach adopted by the Supreme Court of South Africa Transvaal Provincial Division in Enka BV v E I Dupont De Nemours & Co,[123] and stated it was a useful analysis:
“(a) the method which the patentee failed to disclose is a method of performing the invention;
(b) the method is in fact a better method of performing the invention than the method disclosed in the specification;
(c) the method was known to the patentee at the time when the application for the patent was lodged at the Patent Office;
(d) the method is not disclosed in the specification; and
[123] (1987) BP 13 (TPD).
(e) the patentee knew that the method was better than the method(s) described in the specification.”

126. In other words, it is necessary to determine what method is disclosed in the specification, and then to ask whether there is any evidence that the applicant was aware of a better method of performing the invention.
127. The construction of the specification is a task undertaken through the eyes of the person skilled in the art. It is not necessary for the specification to describe those things that the skilled person would understand and be able to supply from a reading of the specification.[124]
[124] CCOM Pty Ltd v Jeijing Pty Ltd (1993) 48 FCR 41; 27 IPR 577 at 614-615.
128. I conclude the approach I am to take includes the following three considerations which were stated by the Deputy Commissioner of Patents in Kineta, Inc.:

“1. what is the invention for which a best method must be provided;
2. what method is described in the specification; and
[125] [2017] APO 45 at [29].
3. was the applicant aware of a better method?” [125]

What is the nature of the invention?
129. I consider the opposed specification describes a tablet comprising a ML and a Lev salt prepared by a method where a combination of different organic solvents are used to obtain ML in solution before the Lev salt (which is insoluble in the organic solvents) is added to the ML solution. Whilst the opposed specification does not explicitly describe phase separation between the ML and Lev, I consider the use of different organic solvents to dissolve the ML prior to adding Lev described in the specifiation is an implicit disclosure of the phase separation concept described by Mr Nanjan in evidence.
130. I conclude from Mr Nanjan’s evidence that the use of a minimum volume of organic solvents by utilising a combination of different solvents, and the nature of any drying steps used in the manufacture of the tablets are important aspects for maintaining phase separation.
131. I consider that in order for the public to have the full benefit of the invention the applicant must provide the best method known to the applicant for how the ML is put into solution, and how the ML is kept separated from the Lev salt during the manufacturing process.
What does the specification disclose?
132. Under the heading “Best mode for carrying out the invention”, the specification discloses four examples of formulations comprising abamectin, Lev salt and albendazole. Reformulation 4 is disclosed in the specification to provide an animal with a dose of abamectin, Lev salt and albendazole which is the bioavailable equivalent of an oral drench with the corresponding active. Whilst the examples disclose that abamectin was dissolved in one solvent or two solvents, they do not disclose any further details regarding how the tablets are made.
133. I note that the examples do not explicitly disclose the step-wise addition of the two different organic solvents, or that the dissolution of the ML in the organic solvents takes place prior to addition of the Lev. However, as discussed above the specification does have a more general description that different organic solvents are used to dissolve and mix the ML prior to addition of the Lev salt, and that in a preferred embodiment the co-solvent is subsequently mixed after a first organic solvent is used to dissolve, or partially dissolve, the ML. Therefore, I consider there is clear implication in the specification that benzyl alcohol and monopropylene glycol are added sequentially to put the ML in solution during the preparation of reformulation 2 and reformulation 4—these formulations being the preferred embodiments.
134. Apart from describing the sequence of mixing the organic solvents and anthelmintic actives, and the types of organic solvents that can be used, I consider the specification does not disclose further details in regard to the method of making the anthelmintic tablet. I consider with the limited disclosure in regard to the method of making the anthelmintic tablet, a skilled person would understand that conventional tableting methods are used to make the tablet, and that all methods are equivalent.
Did the applicant know anything better?
The date for the purposes of assessing the best method requirement
135. The date by which the best method known to the patentee must be disclosed is unclear from the case law. The Court in Servier provided a summary of various dates considered in previous court decisions to be the relevant date by which the best method known to the patentee must be disclosed.[126] In the present opposition, it seems that the parties agree that the best method requirement is the best method known to the patentee at the filing date of the application.[127] However, the parties disagree on what is the relevant filing date of the opposed application.
[126] Servier at [113].
[127] Both parties have cited Rescare Ltd v Anaesthtic Supplies Pty Ltd (1992), 25 IPR 119, and Pfizer Overseas Pharmaceutical v Eli Lilly & Co, [2005] FCAFC 224, 68 IPR 1.
136. Merial submitted that since the opposed application is a divisional application, the best method requirement is assessed on the basis of the applicant’s knowledge at the time of filing of the complete specification of the parent application.[128] In this case, that date is 20 December 2007.
[128] Merial’s written submissions dated 27 October 2017 at [114].
137. Bayer NZ submitted that the opposed application was filed on 04 March 2014, and that this date is the relevant filing date by which the best method known to the applicant must be disclosed.[129] Bayer NZ submitted:
“……, the requirement for a divisional application to disclose its best method when the divisional application is filed is entirely consistent with the present post-RTB Patents Act 1990. Although s 102 of the new legislation prohibits the amendment of the specification to ‘claim or disclose matter that extends beyond that disclosed in’ the specification as filed, there is absolutely no prohibition on filing a divisional specification that discloses matter that extends beyond that disclosed in the specification of its patent application.
By this measure, the applicant of a divisional application can supplement the disclosure only at filing, and the only problem that may arise is where that supplemental information is not clearly disclosed in the parent application and is relied upon for the priority date of a claim.” [130]
[129] Bayer NZ’s written submissions dated 02 November 2017 at [523] - [530].
[130] Bayer NZ’s written submissions dated 02 November 2017 at [531] - [532].

138. I have previously found that Mr Nanjan’s evidence is based on what he knew as at 21 December 2006, or at the latest by 20 December 2007. There is no evidence that the applicant’s knowledge at 04 March 2014 is different to its knowledge at 20 December 2007. Therefore, in the circumstances of the case, I do not need to decide whether the best method requirement is assessed based on knowledge at the actual filing date of the divisional application or knowledge at the filing date of the parent application. The relevant question is whether the best method of performing the invention known to the applicant is disclosed in the opposed specification.
139. I have viewed the specification of the parent application, 2007334747, and find that the body of the parent specification very similar, if not identical to the body of the opposed specification. Therefore, if I find that the best method known to the applicant was not disclosed by 04 March 2014, this best method would also not have been disclosed by 20 December 2007.
What did the applicant know about how the ML is put into solution?
140. From Mr Nanjan’s evidence discussed above, the applicant knew of the method outlined in KN-4. In the method, the ML is dissolved, or at least partially dissolved, in benzyl alcohol and monopropylene glycol is then added to the mixture.[131] I have previously concluded that the use of a combination of the different organic solvents minimised the total volume of solvents required to get the ML into solution such that there is no need to remove excess solvents by a substantial drying step before tabletting. I also note that the two different solvents of KN-4 are used in a particular order in the method.
[131] Nanjan at [37].
141. Therefore, I conclude that the applicant knew that use of a combination of solvents, where the solvents are added in a step-wise order to dissolve the ML, would keep the total volume of solvent to a minimum and effectively remove the necessity to dry off excess solvents.
What did the applicant know about how the ML is kept separate from the Lev salt?
142. From Mr Nanjan’s evidence discussed above, the applicant knew it was important not to disturb the phase separation between the ML and Lev salt during the manufacturing process. The applicant knew that the use of high temperature drying to remove benzyl alcohol and monopropylene glycol—substantial drying step— would disturb the phase separation, and therefore should be avoided.
143. As discussed above, it was part of the CGK before the priority date that a drying step to remove substantially all of the organic solvent was a routine step included in a wet granulation process.
144. I conclude that the applicant knew that the high temperature drying step used routinely in conventional tableting methods would disturb the phase separation between the ML and Lev salt and therefore it was critical that the drying step be avoided.
145. Bayer NZ submitted:
“….. The specification does expressly teach the avoidance of a substantial drying step when it states that the solvent ‘dissolves the macrocyclic lactone compound, but also, acting with the co-solvent, stabilises the compound increasing the overall stability of the product’. [emphasis added] Notably the statement refers to the state of the product – not an intermediate in the formation of a tablet.”[132]
[132] Bayer NZ’s written submissions dated 02 November 2017 at [472].

146. Bayer NZ also submitted that information regarding the importance of avoiding the substantial drying step has always been present in the opposed specification since the filing date of the parent of the opposed application because the advantages of the stability and improved bioavailability can only be provided by the tablet if there is no substantial drying step to remove the very solvent and co-solvent that provides the function.[133]
[133] Bayer NZ’s written submissions dated 02 November 2017 at [473] - [475].
147. I understand the submissions of Bayer NZ to mean that the nature of the drying step required to make the anthelmintic tablet can be inferred by the skilled person from a reading of the opposed specification without explicit disclosure. Since it was part of the CGK to remove substantially all of the organic solvent during the drying step, I consider that a skilled person reading the opposed specification would not understand the specification to be teaching a drying step that removes solvents only to the extent where there was still sufficient solvents to maintain phase separation between the ML and Lev.
148. I conclude that the applicant knew that it was important not to use a high temperature drying step when manufacturing the anthelmintic tablet in order to keep the ML separate from the Lev salt, and this information is not disclosed in the opposed specification.
What did the applicant know about the nature of any drying step that could be used?
149. As discussed above, the preferred method described in KN-4 includes a drying step carried out at a low temperature of 40°C to remove the isopropanol (IPA) that is a carrier for the binder, povidone.[134]
[134] Nanjan at [61]; KN-4.
150. The question is whether the use of IPA, a low boiling point solvent, to dissolve povidone will inevitably mean that a low temperature drying step is used in the manufacturing process and therefore the phase separation between the ML and Lev will inherently be achieved.
151. Professor Hapgood and Mr Pippia made statements that the use of IPA or any other solvent as a carrier for the binder is not discussed in the opposed specification. [135] I agree.
[135] Hapgood #2 at [19]; Pippia #2 at [17].
152. Professor Hapgood also stated that there is no mention in the opposed specification of the need to carry out a special (e.g. 40°C) drying step, or of the need to avoid carrying out any drying step. [136] I agree.
[136] Hapgood #2 at [20].
153. I have previously found the drying step used in a conventional wet granulation method achieves removal of substantially all of the organic solvents. Therefore, even if a low temperature drying step is used in a conventional tableting method, I consider it reasonable to conclude that conventional drying would be done to remove substantially all of the solvents, and not only to an extent that where there was still sufficient solvents to maintain phase separation between the ML and Lev.
154. I conclude that the applicant knew that use of IPA, a low boiling point solvent, in the manufacturing process would mean that only a low temperature 40°C drying step is needed to dry off the IPA and this is a special drying step that would maintain the phase separation between the ML and Lev.
Conclusion on the best method requirement
155. In summary, I find that the following knowledge in regard to the method was known to the applicant by the filing date of the parent application and was not disclosed in the opposed application:
·keeping the total volume of solvent to a minimum by using a combination of different solvents, where the solvents are added in a step-wise manner to dissolve the ML, and consequently effectively removing the necessity to dry off excess solvents;
·maintaining the phase separation between the ML and Lev salt by avoidance of a high temperature drying step when manufacturing the anthelmintic tablet; and
·use of IPA, a low boiling point solvent, in the manufacturing process so that only a low temperature 40°C drying step is needed to dry off the IPA and this is a special drying step that would maintain the phase separation between the ML and Lev.

156. As part of their evidence, Professor Hapgood and Mr Pippia each provided a hypothetical method of manufacturing a veterinary tablet containing two anthelmintic actives.[137]
[137] Hapgood #1 at [80] - [100]; Pippia #1 [77] - [102].
157. In his evidence Mr Nanjan compared the hypothetical methods to the preferred method of KN-4, and stated that the hypothetical methods provided by the opponent’s experts would not lead to the composition the applicant developed nor have the stability/bioavailability profiles observed by the applicant primarily because the delicate phase separation between the ML and Lev would not be achieved.[138]
[138] Nanjan at [92], [93], [100].
158. Mr Nanjan stated that the preferred method of making tablets that he describes in evidence would produce a composition with better stability and/or bioavailability because of the phase separation achieved in the method:
“….. Our process is advantageous because no substantial drying step is needed (partly because of the lower volumes of solvent used) and this means the solvents remain with the ML to protect it”[139]

and
“From this comparison, my conclusion is that our process is both different and simpler (e.g. easier solubilisation of the ML and lack of substantive drying step) and would produce a composition with better stability and/or bioavailability because of the phase separation it achieves.”[140] (emphasis added)
[139] Nanjan at [94.5].
[140] Nanjan at [95].

159. I conclude that Mr Nanjan knew of a better method of making tablets, one that would produce a composition with better stability and/or bioavailability. I am satisfied that the method that Mr Nanjan refers to in KN-4 is the method that would produce a composition with better stability and/or bioavailability.
160. Therefore, I conclude that Mr Nanjan, and by implication the applicant, knew of a better method and did not disclosed this better method in the opposed application. Consequently, I conclude the opposed specification does not disclose the best method known to the applicant, and does not satisfy best method requirement of paragraph 40(2)(aa) of the Act.
The relevance of the disclosure in PCT/NZ 2008/000190
161. PCT/NZ 2008/000190 is a patent application having an international filing date of 29 July 2008, that is filed in the name of Bomac Research Limited which subsequently amalgamated into Bayer New Zealand Limited. PCT/NZ 2008/000190 names Mr Nanjan as an inventor, and relates to manufacturing methods of tablets comprising a combination of anthelmintic compounds.
162. Merial made comparisons of Reformulation 4 of the opposed application with Reformulation 4 of PCT/NZ 2008/000190 and submitted:
“The compositions of Reformulation 4 in Table 4 of PCT/NZ2008/ 000190 and the Opposed Application are identical. Figures 12-14 of PCT/NZ2008/000190 and the Opposed Application, which show pharmacokinetic profiles for Reformulation 4, are also identical. Prima facie, it appears that the Opposed Application and PCT/NZ2008/000190 contain different experimental write-ups for the same experiment concerning the same tablet formulation.”[141]

“Reformulation 4 must have been made by the time the Opposed Application was filed (since it was included in the specification)….”[142]
[141] Merial’s written submissions dated 27 October 2017 at [164] which references Mr Pippia who came to the same conclusion, Pippia #2 at [34].
[142] Merial’s written submissions dated 27 October 2017 at the unnumbered paragraph between [164] and [165].

163. I have viewed PCT/NZ 2008/000190 (the PCT application) and am satisfied that the composition and pharmacokinetic profiles of Reformulation 4 of the PCT application are identical to those of the opposed application. Therefore, I infer Reformulation 4 of the opposed application was most likely made by the method disclosed in the PCT application which was known to the applicant by the filing date of the PCT application, that is, by 29 July 2008.
164. I reproduce the composition and the method used to manufacture reformulation 4 of the PCT application in Annex D of this decision. I note that the method of making Reformulation 4 as disclosed in the PCT application is very similar to that outlined in KN-4. I consider the only difference between this method and that of KN-4 is the explicitly mention of mixing with albendazole. Importantly, the specification of the PCT application describes step-wise solvent addition with abamectin, sequential addition of Lev to the abamectin which had been dissolved in the organic solvents and a low temperature drying step at 40°C. The similarity of the method of making Reformulation 4 in the PCT application to that of KN-4 suggests that the method of KN-4 or something very similar to this method had been established by 29 July 2008. This inference is not inconsistent with my previous finding that applicant knew of a better method of performing the invention by 20 December 2007 and did not disclose this better method in the opposed application.
6 Disclosure and support
165. The Raising the Bar Act introduced two new requirements to section 40: a requirement for disclosure and a requirement for support. The two concepts are closely connected.
166. The disclosure requirement is found in paragraph 40(2)(a) which states the complete specification must:
(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art

167. The Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (the Explanatory Memorandum) explained that the item that sought to amend paragraph 40 (2)(a) was intended to:
“to modify the wording of paragraph 40(2)(a) of the Act so as to require enablement across the full width of the claims, while adopting language that is consistent with that used in other jurisdictions. The wording in the amendment is similar to s 14(3) of the UK patents legislation, which has been interpreted as imposing this requirement. The wording is also similar to art 83 of the European Patent Convention, which has been interpreted with similar effect. The intention is that paragraph 40(2)(a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention.”[143]
[143] Explanatory Memorandum, item 8.

168. The support requirement is found in subsection 40(3) which states:
The claim or claims must be clear and succinct and supported by matter disclosed in the specification.

169. The requirement of “supported by matter disclosed” was introduced as a replacement for the former requirement of fair basis. The purpose of this change is explained in the Explanatory Memorandum:

[165] Hapgood #2 at [12], [14].
[166] Pippia #2 at [13].
205. As previously discussed, the specification describes the types of organic solvents which are preferable for manufacturing the tablet. I consider the description in the specification to be teaching the skilled person that these organic solvent are those which fall within the scope of solvents in which the ML can be dissolved prior to addition of Lev. Therefore, I consider that the specification provides a general principle of using an organic solvent which dissolves a ML (not only the two exemplified solvents) in order to keep the ML separate from the Lev salt when manufacturing an anthelmintic tablet. I also note, as previously discussed, organic solvents which are suitable for dissolving anthelmintic actives that are susceptible to hydrolysis or heat are known to the skilled person.
206. I conclude that the technical contribution to the art is a tablet comprising a combination of ML and Lev salt made by a process where the ML is kept separate from the Lev salt (phase separation between the actives) by using different organic solvents in a step-wise manner to get the ML into solution before adding the Lev salt to the ML solution.
Are the claims supported?
207. As previously discussed, the claims are limited to an anthelmintic tablet a comprising a ML and a Lev salt made by a process where the ML is dissolved, or partially dissolved, in an organic solvent, subsequently mixed with a different organic solvent prior to the addition of the Lev salt to the ML solution.
208. I consider the scope of the all of claims correspond with the technical contribution to the art. Consequently, I conclude all of the claims are supported by the technical contribution to the art.
7 Utility
209. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be useful. The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd (Lundbeck).[167] Emmett J stated:
“A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility…”[168]
[167] [2009] FCAFC 70; 81 IPR 228.
[168] Lundbeck at [81].

210. In Apotex Pty Ltd v AstraZeneca AB (No 4) Jagot J pointed out that lack of utility requires evidence, not just speculation:
“Ultimately, an asserted lack of utility must be established by appropriate evidence, not by mere speculation that the invention will not work or meet the promise set out in the specification.”[169]
[169] [2013] FCA 162; 100 IPR 285 at [352].

211. In Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd., Greenwood J (Rares J concurring) stated an assessment of the utility requirement involves an analysis of what the specification itself says is the promise of the invention, and whether by following the teaching of the specification the claimed invention does attain the result promised:
“Put another way, the two questions are: first, what is the promise of the invention derived from the whole of the specification?; second, by following the teaching of the specification, does the invention, as claimed in the patent, attain the result promised for it by the patentee?...”[170]
[170] [2016] FCAFC 29; 117 IPR 210 at [121].

212. Merial submitted that if I accept that the particular method developed by Mr Nanjan overcomes the difficulties he outlined in his evidence, then the invention claimed in claims 1-35 is not a patentable invention because although tablets that fall within the scope of the claim could be made by other methods, the tablets would not be useful.[171] At the oral hearing Merial submitted that, for example, an anthelmintic tablet that degrades would not be a useful choice.
[171] Merial’s written submissions dated 27 October 2017 at [220].
213. I have previously found that the aim of the invention is to provide an alternative anthelmintic formulation—a tablet with multiple anthelmintic actives. The promise of the invention is therefore not to provide a better anthelmintic tablet. Since the promise of the invention is derived from the specification itself, the skilled person following the teaching of the specification needs only to produce a tablet as claimed in the claim in order to fulfil the utility requirement—the tablet need only be an alternative formulation and not necessarily a better formulation. The skilled person does not need to produce the better anthelmintic tablet described by Mr Nanjan in his evidence in order for the claimed invention to be useful.
214. I have found that following the teaching of the specification the skilled person can prepare a tablet claimed in claims 1 and 19 using routine tableting methods. I have also found that the specification discloses a method to make reformulation 4, and discloses several different types of organic solvents that are preferred as solvents and co-solvents.
215. Whilst I can accept that certain tablet formulations may degrade more than others, Merial has merely speculated that the claimed invention will not work or meet the promise as set out in the specification. Merial has not provided any evidence that an alternative anthelmintic tablet cannot be produced.
216. Consequently, I conclude the opponent has not established ground of lack of utility for any of the claims of the opposed specification.
8 Inventive step
217. 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 an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art:
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 (whether in or out of the patent area) before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).

218. Subsection (3) prescribes the information that may be considered as:
The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.

219. Once the common general knowledge and relevant information has been identified, 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 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.”[172]
[172] [1981] HCA 12 at [45]; 148 CLR 262 at 286.

220. An expectation of success is not an additional requirement over and above matters of routine:
“It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.”[173]
[173] Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 (Generic Health); 314 ALR 91 at [71].

221. The High Court in Hassle has also endorsed the use of the well known “Cripps question”.[174] The Cripps question and the matter of routine approach are alternative ways of analysing obviousness.[175]
[174] Hassle at [53].
[175] Generic Health at [71].
222. The High Court in Hassle stated that the test of obviousness does not import a criterion of whether a particular avenue of research was obvious to try so that the result claimed therefore was obvious:
“In so expressing the critical question and then proceeding to answer it favourably to Alphapharm, the Full Court fell into various errors of law. Several points are to be made. First, the statute does not ask whether a particular avenue of research was obvious to try so that the result claimed therefore is obvious; the adoption of a criterion of validity expressed in terms of ‘worth a try’ or ‘obvious to try’ and the like begs the question presented by the statute. In a sense, any invention that would in fact have been obvious under the statute would also have been worth trying. Paragraph (e) of s 100(1) of the 1952 Act, applied to the present case, asks whether the combination claimed in claim 1 was obvious. The paragraph does not fix upon the direction to be taken in making efforts or attempts to reach that particular solution to the problem identified in the Patent. Nor does it direct an inquiry respecting each integer of the claimed combination. The paragraph asks whether ‘the invention . . . as claimed’, here the combination, was obvious, not each of its integers.”[176]
[176] Hassle at [72].

8.1 The problem
223. The problem addressed by the opposed application is the preparation of a tablet formulation containing at least two different anthelmintic compounds ideally from different families of anthelmintic activity.
8.2 Obviousness in light of D1 considered together with CGK
224. Merial submitted that each of claims 1-35 of the opposed specification lacks inventive step on the basis of CGK together with CN 1522706 (D1).[177]
[177] Merial’s written submissions dated 27 October 2017 at [197].
225. D1 was published on 25 August 2004. Consequently, D1 is part of the prior art base.
226. I have previously discussed what forms the CGK. Of particular relevance for the present purposes, I note that a conventional wet granulation method includes a drying step to remove substantially all solvents before subsequent tableting processes.
227. D1 discloses the preparation of a solid dispersion comprising a macrolide-based anthelmintic, using a water-based carrier as a dispersion medium.[178] Polyethylene glycol (PEG) is disclosed to be a particularly preferred carrier material.
[178] A macrolide-based anthelmintic is disclosed in D1 to include abamectin, ivermectin, doramectin, moxidectin, eprinomectin and emamectin.
228. Example 1 of D1 discloses ivermectin is dissolved in ethanol (an organic solvent), and then mixed with molten PEG to form a mixture which was subsequently cooled and dried to form a solid. The drying step was performed to remove the solvent. The resulting solid was crushed and screened to give a solid dispersion containing ivermectin and PEG.
229. D1, more generally, discloses that the solid dispersion containing the macrolide-based anthelmintic is useful for the preparation of a compound solid preparation or liquid preparation by combination with other anthelmintics. The other anthelmintics disclosed include tetramizole-based anthelmintics. The abstract of D1 discloses that the solid dispersion is combined with levamisole hydrochloride.
230. Professor Hapgood and Mr Pippia considered the molten PEG of D1 to be a solvent.[179] Whilst I accept the statements of the opponent’s declarants that molten PEG is a solvent, it is unclear to me whether the molten PEG of D1 is a solvent that falls within the scope of the claims of the opposed specification. This is because in the context of the method steps of claims 1and 19, and the plain meaning of the term “co-solvent”, it would appear that a co-solvent is a solvent that is a liquid at room temperature. However, for reasons that will follow, I can decide the issue of lack of an inventive step without deciding whether molten PEG is a solvent for the purposes of claims 1 and 19.
[179] Pippia #1 at [242], Hapgood #1 at [105].
231. I have previously construed the method of claims 1 and 19 to be one that includes the use of at least two different organic solvents, in a sequential manner, to obtain a solution of ML before adding Lev salt and subsequent tablet formation. I have also previously construed that there is no drying step to remove the solvents before adding the Lev salt in the method of claims 1 and 19.
232. The relevant question in regard to lack of inventive step is whether it would have been a matter of routine for the skilled person to take away the drying step that removes the solvents in light of the teaching of D1. There is no evidence that it would have been a matter of routine for the skilled person, following the teaching of D1 and seeking to prepare an anthelmintic tablet comprising ML and Lev, to take away a drying step that removes the solvents. I conclude that the evidence does not establish that claim 1, or any other claim of the opposed application, lacks an inventive step in light of D1 considered together with CGK.
9 Manner of manufacture
233. Subsection 18(1) of the Act relevantly reads:
Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies;

234. In Ramset Fasteners (Aust) Pty Ltd v Advanced Building Systems Pty Ltd and Another, the court found that the claimed invention was a mere collocation of well-known integers, rather than a true combination patent, and therefore not for a manner of new manufacture.[180]
[180] (1996) 66 FCR 151; 34 IPR 256 at 272.
235. Where one of the integers is new and otherwise patentable, the inclusion of such an integer in a collocation forms a patentable combination. In British United Shoe Machinery Co Ltd v. Fussell & Sons Ltd, (1908) Fletcher-Moulton LJ stated:
“......if a patentee could rightly claim a general grant, but he limits that grant in any way - limits it, not extends it - no such limitation can destroy the validity of his grant. Supposing the Patentee was entitled to claim this first group by itself, i.e., generally, and he chose only to claim it when used in combination with a special operating mechanism, his so claiming it has limited, and not extended, his grant; and no such limitation which amounts to a present to the public of his invention, excepting when used under such circumstances, can possibly injure the validity of the grant, though it may prevent doubts arising as to the validity of the grant.”[181]
[181] 25 RPC 631 at page 649.

236. Merial submitted that claim 35 of the opposed application is not for a manner of manufacture because the claim is to a kit that is a collocation of integers with no working interrelation between the integers.[182]
[182] Merial’s written submissions dated 27 October 2017 at [223] - [224].
237. I have previously found the evidence does not establish that the tablet of claims 1-30 of the opposed application lacks an inventive step. There is no evidence to show that the tablet is not novel either. Therefore, the kit defined in claim 35 is not a collocation of well-known integers. Consequently, I conclude that the opponent has not established that claim 35 does not comply with the manner of manufacture requirement.
10 Conclusions
238. The opposition succeeds on the ground of paragraph 40(2)(aa), and fails on all other grounds.
239. It is not clear to me how the deficiencies in the opposed application may be overcome since it appears that any proposed amendments would result in adding new matter that was not present in the originally filed specification, and therefore would not be allowable under section 102 of the Act. However, since this matter was not discussed at the hearing, I will allow Bayer NZ a period of two months from the date of this decision in order to attempt to overcome the deficiencies.
11 Costs
240. The opposition is successful. It is normal that cost should follow the event. I find no reason to depart from that result. Cost should be awarded against Bayer NZ.
Dr A. Lim
Delegate of the Commissioner of Patents
Annex A: The claims of the opposed specification
1. A tablet formulated for administration to an animal, the tablet including:
(a) at least one macrocyclic lactone compound having anthelmintic activity
and;
(b) at least one levamisole salt having anthelmintic activity and;

wherein the at least one macrocyclic lactone compound is dissolved in at least one
organic solvent and;
then subsequently mixed with at least one co-solvent prior to the addition of levamisole
and subsequent tablet formation;
and wherein the solvent(s) and co-solvent(s) are different compounds and are non-aqueous
compounds.
2. The tablet as claimed in claim 1 wherein at least one macrocyclic lactone compound
is selected from: abamectin, ivermectin, moxidectin, eprinomectin, doramectin and
combinations thereof.
3. The tablet as claimed in claim 1 or claim 2 wherein the levamisole salt is levamisole
HCI.
4. The tablet as claimed in any one of the above claims wherein the at least one
macrocyclic lactone compound and levamisole salt included in the tablet are at a dose
sufficient to: prevent growth of parasites; reduce parasite numbers; kill parasites; kill
incoming parasite larvae; lower the number of surviving incoming parasite larvae; kill or
reduce the number of hypobiotic state parasites; and combinations thereof.
5. The tablet as claimed in any one of claims 1 to 3 wherein the at least one macrocyclic
lactone compound and levamisole salt included in the tablet are at a concentration
sufficient to provide the animal with a dose of the at least macrocyclic lactone compound
or levamisole salt equivalent to that which would be obtained from an oral drench
containing the same compounds.
6. The tablet as claimed in any one of the above claims wherein the at least one
macrocyclic lactone compound includes abamectin or ivermectin in a dosage amount of
0.2 mg to 0.6 mg of abamectin or ivermectin per kg of animal body weight.
7. The tablet as claimed in any one of the above claims 1 to 5 wherein the at least one
macrocyclic lactone compound includes abamectin or ivermectin in a dosage amount of
0.4 mg of abamectin or ivermectin per kg of animal body weight.
8. The tablet as claimed in any one of the above claims wherein the at least one
levamisole salt is included in a dosage amount of approximately 5 to 9 mg levamisole
salt per kg of animal body weight.
9. The tablet as claimed in any one of the above claims wherein the at least one
macrocyclic lactone and levamisole salt are rapidly released on oral administration.
10. The tablet as claimed in any one of the above claims wherein the at least one
macrocyclic lactone compound and levamisole salt remain present in the bloodstream of
the animal for at least 24 hours.
11. The tablet as claimed in any one of the above claims wherein the at least one
macrocyclic lactone compound and levamisole salt dissipate from the bloodstream of the
animal in a similar manner as an oral drench.
12. The tablet as claimed in any one of the above claims wherein the tablet also includes
at least one benzimidazole compound with anthelmintic activity.
13. The tablet as claimed in claim 12 wherein the benzimidazole compound has the
structure:

where n = 1 or 2;
where R1 which may be the same or different at each occurrence = H, Cl,
-SC₃H₇, -SOC₃H₇, -SC₆H₅, -SOC₆H₅, -C₄H₉, or –OC₆H₃Cl₂; and,
where R₂ = -NHC0₂CH₃ or -SCH₃.
14. The tablet as claimed in claim 12 or claim 13 wherein the benzimidazole compound
is selected from: albendazole, ricobendazole, fenbendazole, oxfenbendazole,
parbendazole, triclabendazole and combinations thereof.
15. The tablet as claimed in any one of claims 12 to 14 wherein the benzimidazole raw
material is a dry micronised particulate powder.
16. The tablet as claimed in any one of claims 12 to 15 wherein the benzimidazole

compound is albendazole or oxfendazole included at a rate of at least 1 mg of
albendazole or oxfendazole per kg of animal body weight.
17. The tablet as claimed in any one of claims 1 to 16 wherein the levamisole salt is
present in a proportion of at least approximately 35% w/w.
18. The tablet as claimed in any one of claims 12 to 17 wherein the benzimidazole is
present in a proportion of at least approximately 35% w/w.
19. A tablet formulated for administration to an animal including:
(a) at least one macrocyclic lactone compound with anthelmintic activity;
(b) at least one levamisole salt with anthelmintic activity;
(c) at least one benzimidazole compound with anthelmintic activity; and,
wherein the macrocyclic lactone compound or compounds have been dissolved in at
least one organic solvent and;
then subsequently mixed with at least one co-solvent prior the addition of levamisole salt
subsequent to tablet formation;
and wherein the solvent(s) and co-solvent(s) are different compounds and are non-aqueous
compounds.
20. The tablet as claimed in any one of the above claims wherein organic solvent or
solvents are selected from: an alcohol, a glycol, an ether, a pyrrolidone compound with
two or more carbon atoms, and combinations thereof.
21. The tablet as claimed in any one of the above claims wherein the organic solvent or
solvents used are selected from: ethyl alcohol, benzyl alcohol, phenethyl alcohol, ethyl
benzyl alcohol and other aromatic monohydric alcohols; glycols, glycol ethers, glycol
ether acetates, C₁ to C₈ alkyl pyrrolidones, and combinations thereof.
22. The tablet as claimed in any one of the above claims wherein the organic solvent is
benzyl alcohol.
23. The tablet as claimed in any one of the above claims 1 to 22 wherein the solvent or
co-solvents used are selected from: dial alcohols including glycols, aromatic monohydric
alcohols, glycol ethers, glycol ether acetates, and combinations thereof.
24. The tablet as claimed in any one of the above claims 1 to 23 wherein the co-solvent
used is a propylene glycol compound.
25. The tablet as claimed in any one of the above claims 1 to 24 wherein the co-solvent
used is monopropylene glycol.
26. The tablet as claimed in any one of the above claims 1 to 25 wherein the tablet
remains stable with a less than 10% w/w loss in active concentration during storage for
at least 6 months at a temperature of less than 40°C and relative humidity of less than
75%.
27. The tablet as claimed in claim 26 wherein the tablet remains stable for at least 18
months.
28. The tablet as claimed in claim 26 or 27 wherein the tablet is chemically stable
whereby the active agent concentration remains at within 10% of initial levels and is
physical stable such that no physical alteration is observed in the tablet during storage or
at the time of administration.
29. The tablet as claimed in any one of the above claims wherein the tablet contains
mineral sources selected from: cobalt, copper, iodine, selenium, zinc and combinations
thereof.
30. The tablet as claimed in any one of the above claims 1 to 29 wherein the tablet
contains inert excipients selected from: binders; fillers; bulking agents; carriers;
disintegration agents; glidants; lubricants; and combinations thereof.
31. A method of treating non-human animals for parasite infestation by administration of
a tablet as claimed in any one of the above claims 1 to 30.
32. The method as claimed in claim 31 wherein the animal is a ruminant animal.
33. The method as claimed in claim 31 or 32 wherein the animal is of ovine or bovine
species.
34. The method as claimed in any one of claims 31 to 33 wherein the parasites are
endoparasites.
35. A kit containing a pill administration device or pill administration composition and one
or more tablets as claimed in any one of claims 1 to 30.
Annex B: The composition of reformulation 1-4 of the opposed specification
Table 1: Reformulation 1 Composition

Component Quantity per tablet[%] Quantity per tablet (mg)

Abamectin 1.35 12.0

Monopropylene glycol 12.13 108.0

Levamisole hydrochloride 51.45 457.9

Albendazole 25.63 228.1

Polyvinyl pyrrolidone 0.26 2.35

Corn starch 3.24 28.86

Sodium starch glycolate 3.95 35.19

Aerosil 200 0.88 7.82

Magnesium stearate 1.10 9.78

Total: 100% 890mg
Table 2: Reformulation 2 Composition

Component Quantity per tablet[%] Quantity per tablet (mg)

Abamectin 1.43 12.0

Monopropylene glycol 5.14 43.0

Benzyl alcohol 1.43 12.0

Levamisole hydrochloride 54.71 457.9

Albendazole 27.25 228.1

Polyvinyl pyrrolidone 0.28 2.35

Corn starch 3.45 28.86

Sodium starch glycolate 4.20 35.19

Aerosil 200 0.93 7.82

Magnesium stearate 1.17 9.78

Total: 100% 837mg
Table 3: Reformulation 3 Composition

Component Quantity per tablet[%] Quantity per tablet (mg)

Abamectin 1.35 12.0

Monopropylene glycol 6.52 58.0

Sodium Lauryl Sulphate 5.62 50.0

Levamisole hydrochloride 51.45 457.9

Albendazole 25.63 228.1

Polyvinyl pyrrolidone 0.26 2.35

Corn starch 3.24 28.86

Sodium starch glycolate 3.95 35.19

Aerosil 200 0.88 7.82

Magnesium stearate 1.10 9.78

Total: 100% 890mg
Table 4: Reformulation 4 Composition

Component Quantity per tablet[%] Quantity per tablet (mg)

Abamectin 2.12 68.0

Monopropylene glycol 7.17 230.0

Benzyl alcohol 1.99 64.0

Levamisole hydrochloride 37.38 1200.0

Albendazole 37.38 1200.0

Polyvinyl pyrrolidone 0.39 12.55

Corn starch 4.80 154.07

Sodium starch glycolate 5.84 187.4

Aerosil 200 1.30 41.76

Magnesium stearate 1.63 52.22

Total: 100% 3210Mg
Annex C:
Figure 12 of the opposed specification: A graph of abamectin blood levels measured post administration of reformulation 4 compared to a reference abamectin oral drench.

Figure 13 of the opposed specification: A graph of albendazole sulfoxide blood levels measured post administration of reformulation 4 compared to a reference albendazole oral drench.
Figure 14 of the opposed specification: A graph of levamisole blood levels measured post administration of reformulation 4 compared to a reference levamisole oral drench.
Annex D:
Reformulation 4 of PCT/NZ2008/000190
Table 4: Reformulation 4 Composition

Component Quantity per tablet[%] Quantity per tablet (mg)

Abamectin 2.12 68.0

Monopropylene glycol 7.17 230.0

Benzyl alcohol 1.99 64.0

Levamisole hydrochloride 37.38 1200.0

Albendazole 37.38 1200.0

Polyvinyl pyrrolidone 0.39 12.55

Corn starch 4.80 154.07

Sodium starch glycolate 5.84 187.4

Aerosil 200 1.30 41.76

Magnesium stearate 1.63 52.22

Total: 100% 3210Mg
Method of manufacturing reformulation 4 of PCT/NZ2008/000190
1.Dissolve the abamectin in benzyl alcohol
2.Mix with monopropylene glycol
3.Mix with levamisole, albendazole, polyvinyl pyrrolidone and corn starch
4.Dry the mixture at 40°C
5.Mix the dried mixture with sodium starch glycolate, aerosil 200 and magnesium stearate
6.Press into a tablet

Evidence	Declarant	Exhibits	Date	Reference
In Support	David Herman	DAJH-1 to DAJH-9	29 January 2016	Herman #1
	Karen Hapgood	KH-1 to KH-21	29 April 2016	Hapgood #1
	David Herman	DAJH-10 to DAJH-23	02 May 2016	Herman #2
	Joe Pippia	JRP-1 to JRP-22	02 May 2016	Pippia #1
In Answer	Craig Bunt	CB-1 to CB-3	02 August 2016	Bunt
In Answer	Karthigeyan Nanjan	KN-1 to KN-4	03 August 2016	Nanjan
In Reply	Karen Hapgood	KN-22 to KN-24	15 December 2016	Hapgood #2
In Reply	Joe Pippia	JRP-23 to JRP-26	23 December 2016	Pippia #2

Formulation	Solvent(s)
Reformulation 1	monopropylene glycol
Reformulation 2	monopropylene glycol
Reformulation 2	benzyl alcohol
Reformulation 3	monopropylene glycol

Component	Quantity per tablet[%]	Quantity per tablet (mg)
Abamectin	1.35	12.0
Monopropylene glycol	12.13	108.0
Levamisole hydrochloride	51.45	457.9
Albendazole	25.63	228.1
Polyvinyl pyrrolidone	0.26	2.35
Corn starch	3.24	28.86
Sodium starch glycolate	3.95	35.19
Aerosil 200	0.88	7.82
Magnesium stearate	1.10	9.78
Total:	100%	890mg