Zoetis Services LLC v Elanco New Zealand - [2022] APO 4

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Zoetis Services LLC v Elanco New Zealand [2022] APO 4

Patent Application: 2015268626

Title:Injectable compositions for mastitis comprising an NSAID and an antibiotic in a non-aqueous solvent.

Patent Applicant:                   Elanco New Zealand
Opponent:  Zoetis Services LLC
Delegate:  K. Wagg
Decision Date:  28 January 2022
Hearing Date:  18 November 2020

Catchwords: PATENTS – All grounds of opposition fail—Selection Patents—lack of novelty by selection not established—costs awarded against the opponent.

Representation: Counsel for the Applicant: Ian Finch
Patent attorney for the Applicant: Wing Seow and Dr Andrew Scott of James and Wells.
Counsel for the Opponent: Patrick Flynn SC
Patent attorneys for the Opponent: Paul Johns and Katherine Hebditch of AJ Park

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2015268626

Title:Injectable compositions for mastitis comprising an NSAID and an antibiotic in a non-aqueous solvent

Patent Applicant: Elanco New Zealand
Date of Decision: 28 January 2022
DECISION
The opposition has been unsuccessful on all grounds. Subject to appeal, I direct the application to proceed to grant.
Costs are awarded against the opponent under Schedule 8.
REASONS FOR DECISION
Background

Patent application number 2015268626 (the Application or the Specification) was filed on 10 December 2015 by Elanco New Zealand (the applicant).Consequently, the substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) apply to the present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. Any subsequent references to sections of the Patents Act relate to the Patents Act 1990 as amended by the Raising the Bar Act. A similar qualification applies to references to the Patents Regulations 1991. The application claims a priority date of 20 January 2011. The application claims divisional status from parent AU2012207698. The parent lapsed on 7 January 2016 when it failed to gain acceptance within 21 months of the first examination report.
The application was examined and advertised as accepted by the Commissioner on 14 September 2017. Zoetis Services LLC (the opponent) filed a notice of opposition to grant on 13 December 2017 under section 59 of the Act. This decision concerns the opposition to grant under section 59 (this opposition).
After evidence was filed, the applicant sought leave to amend the specification on 8 February 2019. Further amendments were filed on 3 May 2019 and 11 July 2019. These amendments were allowed and incorporated into the application on 3 November 2019.
After the amendments were finalised, the Statement of Grounds and Particulars was amended, and the opponent filed evidence under regulation 5.23 to address the amended claims to which the applicant responded.
A hearing was held on 18 November 2020 to decide the opposition.
The Grounds of Opposition
The Statement of Grounds and Particulars identified all of the available grounds. These are:
·Lack of Manner of Manufacture
·Lack of Novelty
·Lack of Inventive Step
·That the application does not comply with s 40(2) and s 40(3), including a lack of clarity, a lack of a clear enough and complete enough disclosure and a lack of support
·That the invention is not useful.
At the hearing, the opponent pressed all grounds.
Onus and Standard of Proof
The onus lies with the opponent to satisfy me that a ground of opposition exists on the balance of probabilities. [1] If I am satisfied, then I may refuse the Opposed Application.[2]
[1] Section 60(3A).
[2] Ibid.
Evidence
The evidence in support comprises the following declarations:

Declarant Date Reference Exhibits

Dr Xiaobo Ding 2 May 2018 Ding XD-1 to XD 2

Alison Ann Gunn 11 June 2018 Gunn 1 AAG-1 to AAG-24

Raymond Nigel Simms 25 May 2016 Simms 1 RNS-1 to RNS-12

Dr Gottfried Lichti 15 February 2018 Lichti 1 GL1 to GL2

The evidence in answer comprises the following declarations:

Declarant Date Reference Exhibits

Associate Professor Craig Bunt 12 September 2018 Bunt 1 CB-1 to CB-37

. The evidence in reply comprises the following declarations:

Declarant Date Reference Exhibits

Alison Ann Gunn 13 November 2018 Gunn 2 AAG-2-1 to AAG-2-4

Raymond Nigel Simms 12 November 2018 Simms 2 RNS-2-1 to RNS-2-3

Dr Gottfried Lichti 9 November 2018 Lichti 2 GL2-1to GL2-3

. The material allowed under regulation 5.23 from the opponent comprises the following declarations:

Declarant Date Reference Exhibits

Raymond Nigel Simms 27 February 2020 Simms 3 RNS-3-1 to RNS-3-5

The applicant’s reply to the regulation 5.23 material comprised the following declaration

Declarant Date Reference Exhibits

Associate Professor Craig Bunt 30 July 2020 Bunt 2 No exhibits attached.
The Specification

Before commencing to construe the specification, I note what Middleton J said about approaching patent specifications in Eli Lilly 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 patent's subject matter. 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] Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139].
To properly construe the specification, it is essential to obtain an idea of the technology the invention relates to and obtain a picture of the person skilled in the art. A good starting point for this is the invention's field followed by whatever background the specification sets out.
The Field of the Invention
The Opposed Application begins by outlining the field of the invention as:
“The invention relates to a composition for the treatment of infection, and most preferably, although not specifically for the treatment of mastitis.”[4]
[4] Page 1 lines 3-4 (from here on in any reference to pages and line numbers refer to the application unless otherwise specified).
The above field is broad. The treatment of infection could be viral or bacterial and could be in any animal. No specific animal is mentioned; however, the preferred treatment is mastitis, which is an infection of the mammary glands in the breast or udder.
Background of the Invention
The Background begins with a statement that the invention concerns a means of treating an infection in an animal.[5] A statement follows that the specification will discuss farm animals' treatment, such as dairy cattle. Still, it could be applied to other animals, including humans.[6]
[5] Page 1 lines 6-7.
[6] Page 1 lines 8-10.
The specification then states that typically infections in animals are treated with antibiotics.[7] The use of antibiotics is expensive, and there are costs associated with withholding the sick animal and discarding the contaminated milk.[8]
[7] Page 1 line 18-20.
[8] Page 1 line 21-Page 2 line 13.
The specification then states that there is a need to find new treatments which are more convenient to administer but are still efficacious, which may give better outcomes and compliance.[9] Injectable antibiotics are said to have the advantage of treating all four quarters of the udder provided high enough concentrations of actives are achieved to cure the infection.[10]
[9] Page 2 lines 14-16.
[10] Page 2 lines 17-19.
The specification then goes on to discuss the concept of minimum inhibitory concentration (MIC).[11] This is the minimum concentration of antibiotics required to inhibit the specific bacteria involved in mastitis. It is the target concentration for mastitis treatment products.
[11] Page 2 lines 20-22.
The specification then discusses Staphylococcus aureus, which causes hard-to-cure mastitis, and for which the antibiotic tylosin is routinely prescribed.[12] However, little research has been done to establish the MIC for tylosin, and instead, most MICs use erythromycin as the antibiotic. The specification states that the MIC for tylosin is 2 μg/mL, whereas the MIC for erythromycin is 0.5 μg/mL.[13] With the MIC for tylosin being so high, it is said that even 20% of tylosin injectable preparations fail to reach the MIC.[14]
[12] Page 2 lines 23-25.
[13] Page 3 lines 3-6.
[14] Page 3 lines 7-8.
The co-administration of a non-steroidal anti-inflammatory drug (NSAID) with the antibiotic is said to treat both the infection itself and pain and inflammation.”[15] This combination is effective in improving antibiotic response.[16] The specification states that there have been difficulties combining these two actives in a stable composition, and they are typically administered separately, which is said to be generally inconvenient.[17] The specification states that the combination is relatively new in the industry.[18]
[15] Page 3 lines 25- Page 4 lines 2.
[16] Page 3 lines 19-20.
[17] Page 3 lines 20-24.
[18] Page 3 line 2.
The specification then discusses the NSAID, meloxicam, in a known composition with the antibiotic penethamate hydroiodide in US 2005/0277634.[19] This document provides a synergistic suspension formulation between the NSAID and antibiotic so that lower levels of antibiotics are needed to achieve a level above the MIC.[20]
[19] Page 3 lines 3-5.
[20] Page 3 lines 5-8.
The specification then states that there are disadvantages with using the suspension compositions, such as caking, dispersibility, difficulty in delivery, site reactions and pain, and poor absorption of the active.[21]
[21] Page 3 lines 10–13.
Tylosin is known to cause pain at the injection site[22] , and the specification sites a review article on how solvents and carriers can exacerbate this problem.[23] The specification states that veterinary chemists often use a low concentration/volume of solvent and that aqueous-based compositions are preferred to overcome this problem.[24]
[22] Page 4 line 20.
[23] Page 4 lines 21-25.
[24] Page 5 lines 1-7.
The pour-on or injectable compositions of WO 02/41899, which contain an antibiotic and an analgesic, are distinguished from the current invention, which uses beta-lactam and macrolide antibiotics.[25] It is then stated that beta-lactams and macrolide antibiotics are particularly unstable and likely to react with NSAIDs and that this document does not provide stability data.[26]
[25] Page 5 lines 14-18.
[26] Page 5 lines 19-20.
Aim of the invention and problem
The specification states that it is an object of the present invention to address the previous problems or provide the public with a useful choice.[27] This is quite vague, but in the context of the above discussion, the invention's aim can be gleaned from the statement that it would be preferable to provide an NSAID and antibiotic composition that is stable and where the NSAID is loaded to improve the effectiveness of the antibiotic.[28] There is a focus on beta-lactams and macrolides, and compositions suitable for treating mastitis. I consider that the provision of the composition with both an NSAID and an antibiotic that is stable is the problem to be solved.
[27] Page 6 lines 3-4.
[28] Page 4 lines 12-16.
The Person Skilled in the Art (PSA)
The concept of the person skilled in the art (PSA) has long been considered by the courts when construing patent specifications. Finkelstein J described the PSA with the following words:
“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.” [29]
[29] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70].
The PSA is not a real person but an artificial construct used as a tool of analysis by the court, and in this case, the Commissioner. This concept was established in AstraZeneca[30]:
[30] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30.
“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.”[31]
[31] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23].
Lord Diplock stated that the PSA is likely to have a practical interest in the subject matter:
“My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. ‘skilled in the art’)”[32]
[32] Catinc Industries Inc. v Hill & Smith Limited [1982] RPC 183 at 243.
In Australia, the Full Federal Court approved this approach with Heerey, Emmett and Dowsett JJ stating:
“The uninventive but skilled worker is likely to have a practical interest in the subject matter of the claimed invention.”[33]
[33] Minnesota Mining & Manufacturing Co v Tyco Electronics Pty Ltd [2002] FCAFC 315; 56 IPR 248 at [39], 257.
The field of the invention is related to the treatment of infections such as mastitis; however, it is clear from what the specification sets up in the background that a combination of an NSAID and a macrocyclic antibiotic or beta-lactam antibiotic for the treatment of mastitis in dairy cows is the main focus.
The expert witnesses in this case are:
·Alison Gunn—a consultant veterinarian and adjunct senior lecturer in ruminant health.[34]
[34] Gunn 1 at 2.1 and 3.1.
·Raymond Simms—an analytical chemist with experience in formulation and stability studies. [35]
[35] Simms 1 at 1.4-1.7.
·Dr Gottfried Lichti—a consultant formulation chemist[36]
[36] Lichti 1 at 2.1-2.9.
·Associate Professor Craig Bunt—who is an associate professor in animal science and works on formulations.
It is clear that veterinarians and chemists within formulation and stability studies would have a practical interest in the specification's subject matter. All of the experts appear to have relevant experience and qualifications that provide insights into the PSA. The opponent submitted that Associate Professor Bunt’s experience was more inclined towards more complex drug delivery routes. These are not reflected in the development described in the opposed application. I do not consider that his experience would rule him out from commenting on the current specification. Associate Professor Bunt has experience in antibacterial formulations for bovine health, including intramammary dosage forms, low viscosity liquids and high viscosity pastes.[37] Care needs to be taken when assessing someone with such experience that what they do is beyond that of the PSA and could be considered inventive. Furthermore, I note that Bunt was aware of the PSA concept and outlined his common general knowledge from the average but non-inventive technician's perspective.[38]
[37] Bunt 1 at [8] and Exhibit CB-2.
[38] Bunt 1 at 17-26.
The applicant made submissions about the specific experience of the opponent’s witnesses and that there might be hindsight bias. The weighing and evaluation of evidence are part of the normal work of a delegate of the Commissioner, and I will therefore weigh and evaluate the evidence from all of the declarants in my capacity as a delegate. If I find that evidence is tainted with hindsight, its weight will also be affected.
The Invention Described in the Specification
The specification provides what it calls the “disclosure of the invention” on page 6. The first aspect is an injectable composition when used for the treatment of a microbial infection in a mammary gland of an animal.[39] The composition is then said to comprise a non-steroidal anti-inflammatory drug (NSAID) and an antibiotic selected from the group consisting of a beta-lactam antibiotic and macrolide antibiotic.[40] The composition is characterised in that it includes a non-aqueous solvent in which the NSAID and antibiotic are dissolved.[41] The further aspects include the manufacture of a medicament for the treatment of a microbial infection and a method of preparing the composition.[42]
[39] Page 6 lines 21-23.
[40] Page 6 lines 1-3.
[41] Page 7 lines 5-8.
[42] Page 7 lines 13-15.
After that broad disclosure, there is a discussion of the advantages provided by the invention. The specification states that a synergistic interaction may result from the NSAID decreasing inflammation around the infection, allowing for effective distribution of the antibiotic.[43] It is said that the synergistic effect may be partially attributed to the NSAID binding endotoxins (endotoxaemia), which the inventors otherwise found hindered antibiotic effectiveness.[44]
[43] Page 8 lines 14-18.
[44] Page 8 lines 19-21.
The specification then discusses the advantages of the NSAID's effect by reducing fever and improving the animal's comfort by reducing inflammation and pain.[45] Furthermore, the provision of the two actives in a single combination formulation overcomes the need to deliver multiple compositions, storage of compositions, costs, packaging and so forth.[46] To formulate the two actives together:
[45] Page 9 lines 4-18.
[46] Page 9 lines 18-20.
“The inventors were able to identify a particular solvent type that aided the combination of the two actives, which previously were found to be very difficult to combine in a stable solution. In the past, suspensions were used in order to combine such actives together in a single composition.”[47]
[47] Page 9 lines 20-24.
The specification then discusses the doses and use of tylosin (10 mg/kg) at a concentration of 20% and ketoprofen at a concentration of 6 % w/v.[48] But this was not stable in an aqueous solution, so:
[48] Page 10 lines 6-11.
“To compensate for an increased concentration of NSAID, the inventors utilised a non-aqueous solvent system in an attempt to provide a stable composition in solution at various conditions (e.g. g. temperature above 4 C)”.[49]
[49] Page 10 lines 22-24.
The specification states that surprisingly site reaction/pain was not increased beyond that seen in commercially available compositions, which are aqueous-based.[50]
[50] Page 11 lines 3-5.
It is then said that unexpectedly, the inventors identified that an antibiotic and an NSAID could be included together in a stable composition in solution with an increased concentration of NSAID greater than that normally achievable when combined in an aqueous-based system.[51]
[51] Page 11 lines 11-14.
The specification then provides preferred embodiments with preferable NSAIDs[52] , preferable antibiotics, [53] and the solvent.[54] The solvent is said to be most preferably entirely non-aqueous. It states that methyl-2-pyrrolidone (NMP) and propylene glycol were particularly effective in stabilising the composition and allowing higher NSAID concentrations.[55] However, these are also known to be high irritants when injected. The specification says it was surprising when these did not lead to increased site reaction.[56]
[52] Page 12.
[53] Page 14.
[54] Page 16-
[55] Page 18 lines 20-21.
[56] Page 18 lines 22-24.
The specification then states that:
“More preferably, the liquid formulation includes a first and second non-aqueous based solvent, wherein the first solvent acts as a solubilising agent, and wherein the second solvent acts as a carrier solvent.”[57]
[57] Page 19 lines 1-3.

It is then stated that:
“For example, the inventors have identified that a combination of NMP and propylene glycol provide particularly stable actives in formulation. The inclusion of NMP, glycerine formal and/or benzyl alcohol may be used as a solubilising agent for the actives, whereas a solvent such as propylene glycol may be used as a carrier in the composition to provide improved stability.[58]
[58] Page 19 lines 4-8.
The first solvent ratio to the second solvent is said to be preferable between 1:10 and 1:1[59] and more preferably between 1:2 and 1:1
[59] Page 20 lines 1-2.
The specification has six worked examples. Example 1 provides eight formulations with tylosin and flunixin meglumine.[60] I note that F8 contains both NMP and propylene glycol, though the F5 formulation is the most stable.[61]
[60] Page 27-28.
[61] See table 1 and page 29 lines 11-13.
Example 2 makes two more formulations, F9 and F10, containing tylosin and either carprofen or meloxicam and NMP and propylene glycol.[62]
[62] Page 30-31.
Example 3 included formulation F11 with tylosin and ketoprofen but no NMP and included water.[63]
[63] Page 32.
Example 4 included formulation F12 with tylosin and ketoprofen with NMP and propylene glycol.
Example 5 was a test on reaction site side effects and pain on delivery using the formulation made in example 4 and compared them to the separate commercial formulations tylan (which contains 20 % w/v tylosin with a dosage of 10 mg/kg) and ketoprofen (which has 10% w/v ketoprofen with a dosage of 3 mg/kg), both are aqueous-based formulations.[64] The study was said to show that the formulation F12 was bioequivalent to the commercial formulations (administered separately) and no added site reactions or pain.[65]
[64] Page 36.
[65] Page 38 lines 1-15.
Example 6 is a stability trial conducted on the compositions of example 4. It showed that the formulation of example 4 was stable for at least 6 months at 25 C and 60% RH and at 30 C and 65% RH.[66]
[66] Page 39 lines 1-10.
The specification ends with 16 claims, with claim 1 being the only independent claim. Claims 1-11 are to compositions when used for the treatment of a microbial infection, claims 12-15 are to methods and claim 16 is to the use of the composition as claimed in claims 1-11 in the manufacture of a medicament for the treatment of a microbial infection.
The Claims and Clarity
The 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” [67]
[67] [2009] FCAFC 70, 81 IPR 228 at [118] – [120].
This approach of reading the specification as whole through the PSA's eyes with the CGK in mind provides context and the intention behind what is meant.[68] This is commonly referred to as a purposive construction.[69]
[68] Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 (HC).
[69] Technip France S.A.’s Patent [2004] RPC 46.
It is also a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain "whether or not what he proposes to do falls within the ambit of the claim".[70] Therefore if a construction of the claims where the monopoly is defined cannot be determined, then the claims must fail for want of clarity. Claim 1 as it currently stands is repeated below:
[70] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59.
An injectable composition when used for the treatment of a microbial infection in a mammary gland of an animal
wherein the composition includes
a. a non-steroidal anti-inflammatory drug (NSAID);
           b. an antibiotic from the group consisting of a beta-lactam antibiotic and macrolide antibiotic;
           c. N-Methyl-2-pyrrolidone (NMP); and
           d. Propylene glycol,
wherein the amount of propylene glycol in the composition is more than the amount of NMP in the composition; and
wherein the NSAID and antibiotic are dissolved in the NMP and propylene glycol.
The claim is directed to an injectable composition, meaning it must be capable of being injected using a syringe into an animal. The composition includes an NSAID, either a beta-lactam antibiotic or a macrolide antibiotic, two solvents, NMP and propylene glycol. There was no dispute about the meaning of non-steroidal anti-inflammatory drug (NSAID), beta-lactam antibiotics or macrolide antibiotics, N-methyl-2-pyrrolidone and propylene glycol. These were well known and understood by the declarants.[71]
[71] Gunn 1, paragraphs 8.6.5, 8.6.6, 8.7.4, 8.13.2, 9.3.4, 10.8, 10.25 Gunn 1, paragraphs 8.6, 8.7, 8.12 Lichti 1, paragraph 4.4.1; Simms 1, paragraphs 4.17; page 214, column 2; Lichti 1, paragraph 4.4.1; Simms 1, paragraphs 4.17 and 4.65;
The non-steroidal anti-inflammatory drugs (NSAIDs) are anti-inflammatory drugs that do not have a steroid group as part of their chemical structure. The specification provides preferable examples as:
“Preferably, the NSAID is selected from the group consisting of Carprofen, Naproxen, Ibuprofen, Ketoprofen, Piroxicam, Diclofenac, Etodolac, Flunixin, Deracoxib, Meloxicam, Celecoxib, Rofecoxib, and combinations thereof. Most preferably, the NSAID is selected from the group consisting of Flunixin, Carprofen, Ketoprofen and combinations thereof.”[72]
[72] Page 12 lines 18-22.
The macrolides are described as:
“Preferably, the macrolide-class antibiotic is selected from Azithromycin, Clarithromycin, Dirithromycin, Erythromycin, Roxithromycin, Telithromycin, Carbomycin A, Josamycin, Kitasamycin, Midecamicine/midecamicine acetate, Oleandomycin, Spiramycin, Troleandomycin, and Tylosin/tylocine. Most preferably, the macrolide antibiotic is tylosin.”[73]
[73] Page 14 lines 18-21
The beta-lactam antibiotic refers to a part of the antibiotics chemical structure essential for their mode of action. They are described as:
“Throughout this specification, the term beta-lactam antibiotic should be taken as meaning any antibiotic including a beta-lactam ring in its structure. For example, this may include penicillin derivatives (penams), cephalosporins (cephems), monobactams, and carbapenems. It is considered that the mode of action for beta-lactam antibiotics involves attacking bacterial cell walls. The beta-lactam antibiotics may be provided with beta-lactamase inhibitors such as clavulanic acid. Preferably, the beta-lactam antibiotic is penethamate. In a recent study, it was found that penethamate has a similar efficacy to tylosin (a particularly preferred type of antibiotic used for the present invention).”[74]
[74] Page 15 lines 14-23.
The term “includes” was not the focus of any construction issues in the evidence. Still, I note that the dependent claims 9-11 define an additional anti-oxidant to be “included”. Furthermore, the example formulations, such as example 4, also include the anti-oxidant BHT and benzyl alcohol. In this context and the plain English meaning of the word, I consider the use of the word “includes” is non-exhaustive. Other substances or solvents may be present in the injectable composition provided it remains injectable.
The claim states that the amount of propylene glycol is more than the amount of NMP in the composition. The opponent submitted this phase was unclear. I was not convinced as one solvent being in an amount more than another can easily be measured. Furthermore when read as a whole NMP is used as a solubilising agent or “the first non-aqueous based solvent” as described on page 19, lines 1-5. NMP is used to dissolve the NSAID and antibiotic, and then the formulation is made up to volume using propylene glycol (as described on page 19). Although the claim is not limited by this it is clear that following the specifications instructions use of propylene glycol is like that of a carrier, and I can see why when it is used like that, to make the formulation up to volume, then it will always be present in a greater amount than the NMP—which is used first to dissolve the actives. The opponent submitted that there is no limitation on how much more propylene glycol there is than NMP. Indeed this is true; however, the phrase “wherein the NSAID and antibiotic are dissolved in the NMP and propylene glycol” might influence the ratio. If NMP is being used as a first solvent to solubilise the actives and the amount of it is too low, then the actives will not be dissolved and would be outside of the scope of the claims.
The injectable composition is being claimed “when used” for the treatment of a microbial infection in the mammary gland of an animal. The opponent submitted that this was a claim to a method of treatment in disguise and conferred no novelty or inventive step. The opponent quoted Bennett J in Williams Advanced Materials, Inc. v Target Technology Company[75] where she uses the term “parameteritis”. Although this claim is parameter-free, they state that there is nothing specifically technical in treating mastitis. Indeed, mastitis has been treated for a long time. Still, the injectable composition is being claimed only when used to treat a microbial infection in the mammary gland of an animal. I construe “when used” to be limited to “when the injectable composition is used” as the plain English meaning is.
[75] [2004] FCA 1405 at [48]
Claims 2-7 state that the composition is non-aqueous and defines the NSAID as ketoprofen and the antibiotic as tylosin and its percentages.
Claim 8 is defined as:
“The composition as claimed in any one of claims 1-7 wherein the ratio of NSAID to antibiotic in the composition is approximately 1:3 w/v.”
The opponent stated that this was unclear because they did not know what was meant by the ratio w/v. The w/v is weight to volume. There was no evidence of experts having difficulty determining this, and I consider it clear that the claim's intention is the ratio of the NSAID to the antibiotic.
Claim 12 is a method of treating a non-human animal for an internal microbial infection characterised by the composition's administration. Indeed, this claim is not limited to infections of the mammary glands and includes all non-human animals. Previously claim 1 defined mammary gland in an animal, so would include any animal with mammary glands, including humans.
Claims 13-14 define subcutaneous injection (under the skin) and dosages. Claim 15 is to the method of claims 12-14 used to treat clinical mastitis or early-stage mastitis. Claim 16 is to the use of the composition of claims 1-11 in the manufacture of a medicament for the treatment of a microbial infection.
Conclusion on Clarity
It has not been established that stating the amount of propylene glycol is more than NMP is unclear, nor has it been established with evidence that the ratio w/v lead to a fatal lack of clarity. This ground of opposition has not been established.
Section 40(2)(a)
The amendments brought about by Raising the Bar introduced the following piece of legislation under s 40 (2):
“A 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;”
Perram J was the first Australian justice to consider this provision, where his honour stated that:
“the only requirement now in s 40(2)(a) relates to enablement.”[76]
[76] Encompass Corporation Pty Ltd v InfoTrack Pty Ltd [2018] FCA 421 at [167].
In that case, the Respondent did not advance a case that the specification did not enable the PSA to perform the invention, and so the ground was addressed without the need to determine a test for enablement.[77]
[77] Ibid.
In Merck Sharp & Dohme Corporation v Wyeth LLC (No 3[78]) (MSD), Burley J considered the law of support[79] and also considered s 40(2)(a). His honour consulted the explanatory memorandum, which discussed how the change brought about by Raising the Bar was intended to align the Australian disclosure requirements with those overseas.[80] His honour then considered s 40(2)(a) in comparison to the EPC and UK Act. He noted that s 40(2)(a) is expressed in terms that are virtually the same as in s 14(3) of the UK Act[81] but notes that the highest courts of the UK have emphasised the influential effect of the EPO Technical Board. I note that his approach is not inconsistent with the approach used by this in CSR Building Products Limited v United States Gypsum Company[82] (CSR) which involves the following three steps:
[78] [2020] FCA 1477.
[79] Ibid at [502]
[80] Ibid at [513]
[81] Ibid at [521]
[82] [2015] APO 72.
(1) Construe the claims to determine the scope of the invention as claimed,
(2) construe the description to determine what it discloses to the person skilled in the art, and
(3) decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.[83]
[83] Ibid at [89].
When deciding the third question the delegate in Evolva[84] included the following two questions:
[84] Evolva SA [2017] APO 57.
(4)Is it plausible that the invention can be worked across the full scope of the invention?
(5)Can the invention be performed across the full scope of the claims without undue experimentation?
In Cytec Industries Inc. v Nalco Company[85] Burley J cited this and appeared to state that this was the correct approach.In the current case, the opponent submitted that the description of the invention does not provide any information about which antibiotics (other than tylosin) or NSAIDs (other than ketoprofen) are useful to prepare an effective composition using the solvents encompassed by claim 1 or any dependent claim. They then submitted that the specification only provides examples of a small number of actives—tylosin (a macrolide antibiotic) with ketoprofen, carprofen or flunixin (NSAIDS). The opponent state that only F8, F9, F10 and F12 use solvents encompassed by Claim 1. Of these, the complete manufacturing procedure is only given for F12. Therefore, there are indeed a few examples within the scope of claim 1 that do use the solvent system, a macrolide and different NSAIDS. More than just tylosin and ketoprofen has been disclosed.
[85] [2021] FCA 970 at [145].
There is evidence that making these formulations is plausible and can be done without undue burden. Simms states in his evidence in support that:
“Any formulator as at the priority date would have known that NSAIDs were able to be combined with beta-lactam and/or macrolide antibiotics in injectable compositions”[86].
[86] Simms at [10.6].
Associate Professor Bunt confirms that
“the opposed application describes the invention in sufficient detail for numerous, different compositions to be prepared that fall within the claims. In particular, the specification describes various essential components of the claimed composition and various preferred components, as well as essential and preferred parameters for the final compositions. In my experience, after the team is provided with the opposed application, the team would be able to fully put the invention into practice without undue experimentation.”[87]
[87] Bunt 1 at [398].
There is no evidence that other formulations using other NSAIDs, macrolides or beta-lactams dissolved in NMP and propylene glycol where there is more propylene glycol than NMP could not plausibly be made or would require any undue burden on the part of the PSA.
The opponent submitted that all the Examples F8, F9, F10 and F12 all include benzyl alcohol and submitted that it had not been clearly and completely described how to make a formulation without benzyl alcohol. Their submission appeared to argue that benzyl alcohol was an essential part of the solvent system. Indeed at least claim 1 includes formulations without the use of benzyl alcohol. However, there is no evidence that the formulation without benzyl alcohol is implausible or could not be achieved nor is there any evidence that it would be an undue burden to remove the benzyl alcohol. Instead, there is only a submission. Furthermore, the evidence given at the evidence in support stage was based on a broader version of the claims and the experts then did not suggest that benzyl alcohol was essential to the invention.
Therefore, it has not been demonstrated that the invention defined in the claims is not disclosed in a manner that is clear enough and complete enough to be performed by a PSA. Therefore, this ground of opposition fails.
Section 40(3)
The amendments brought about by Raising the Bar introduced the following piece of legislation under s 40 (3):
“The claim or claims must be…supported by matter disclosed in the specification.”
Perram J discussed support in Encompass Corporation Pty Ltd v InfoTrack Pty Ltd[88] . He cited the explanatory memorandum and concluded that it did not allow for any continuity of the law of fair basis. Perram J did not elaborate on the approach to be taken in assessing support.
[88] [2018] FCA 421 at [168]-[172].
Burley J did discuss the law of support in MSD. His honour accepted the rationale outlined in the CSR decision.[89]
[89] [2020] FCA 1477 at [546].
In CSR the delegate provided a three-step approach:
(1) construe the claims to determine the scope of the invention as claimed,
(2) construe the description to determine the technical contribution to the art, and
(3) decide whether the claims are supported by the technical contribution to the art.[90]
[90] [2015] APO 72 at [110].
I note that the consideration of the technical contribution to the art also distinguishes classical insufficiency and Biogen insufficiency (which incorporates elements of support). The technical contribution may be a general principle:
“if [the patentee] has disclosed a beneficial property which is common to the class, [the patentee] will be entitled to a patent for all products of that class (assuming them to be new) even though [the patentee] has not himself made more than one or two of them.”[91]
[91] Biogen [1997] RPC 1 at 49 per Lord Hoffman.
I have construed the claims and description above. The opponent stated that claims lacked support for the same reasons as sufficiency (outlined above) and in the alternative that:
(i)There is no information given in the description on the solubility of any antibiotics or NSAIDs in the claimed solvent system, in particular there is insufficient information provided as to the effect of a greater proportion of propylene glycol on solubilities, or to achieve any of the aims of the invention;
(ii)there are repeated references to comparative information which is not provided
(iii) there are repeated references to the presence of a synergistic effect that is used to support the inventive merit of the compositions but that synergistic effect is already known
The applicant submitted the technical contribution to the art for the purposes of assessing section 40(3) is the identification of a particular two solvent system that allows a stable co-formulation of a beta-lactam/macrolide antibiotic and an NSAID to be used in the treatment of mastitis. They evidence this statement with the following statement by Associate Professor Bunt:
“I think the benefits of the composition are significant and represent a major improvement on what was commercially available at the time in terms of convenience (of storage and use as a single composition), overall animal welfare (as a result of only one injection being required), stability, and release profile”.
Indeed, the opponent’s point about the lack of information data on whether or not there is synergy is valid, and the only data provided is that in the examples. It does appear that the use of the non-aqueous solvent system allows for the co-administration of the NSAID and the antibiotic for the treatment of mastitis. Despite a lack of proven synergy, this co-formulation using a non-aqueous solvent system is still a contribution to the art. Furthermore, I note that the claimed invention does not mention synergy. The contribution does appear to lie in the solvent system.

As I have found above for sufficiency, I do not have any evidence that the scope of the invention defined in the claims is not justified.
This ground of opposition has not been made out.
Best Method of Performance section 40(2)(aa)
Even if a manner of performing an invention is self-evident, applicants are nevertheless required to set out the best method of performing the invention known to them. This requirement was confirmed by the Full Court of the Federal Court in Les Laboratoires Servier v Apotex Pty Ltd.[92]
[92] [2016] FCAFC 27
The requirement is assessed based on the applicant’s knowledge at the time of filing the complete specification (Rescare Ltd. v Anaesthetic Supplies Pty. Ltd.)[93] If the applicant identifies a better method at a time subsequent to filing, there is no obligation to amend the specification to include that method.
[93] 25 IPR 119.
The opponent submitted that the claims are broad, and the nature of the examples means that it appears that the applicant failed to provide the best method known to them and that nothing is expressly nominated as the “best method”. They also submitted that no example uses a beta-lactam.
The best method requirement only requires the best method known to the applicant at the time of filing (see Les Laboratoires Servier v Apotex Pty Ltd). I note that formulations F8 and F12 meet fall within the scope of the claims and formulation F12 described in detail in example 4 and worked through examples 5 and 6. There is no requirement to formally state what is the best method in the applicant and there is no evidence whatsoever that the applicant knew of a better method. Furthermore the best method requirement does not mean that the applicant is required to provide an example for each alternative in the claim, such as the use of a beta-lactam antibiotic.
Therefore this ground of opposition has not been made out.
Utility
It is a requirement of paragraph 18(1)(c) of the Act that the invention, so far as claimed in any claim, must be useful:
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: …
(c) is useful.
The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd.[94] Emmett J stated:
[94] [2009] FCAFC 70, 81 IPR 228.
“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.”[95]
[95] Ibid at [81]; [247].
In Apotex Pty Ltd v AstraZeneca AB (No 4),[96] Jagot J pointed out that lack of utility requires evidence, not just speculation:
[96] [2013] FCA 162; (2013) 100 IPR 285.
“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.”[97]
An overview of utility, including areas for consideration, is provided by Nicholas J in Apotex Pty Ltd v Warner-Lambert Company LLC (No 2)[98]. The applicant noted his honour’s statement:
“…much depends upon the proper construction of the claim. Claims are not to be read through the eyes of a skilled addressee purposefully seeking to perform the claimed invention in a manner that would not provide a useful result: see Washex Machinery Corporation v Roy Burton & Co Pty Ltd (1975) 49 ALJR 12 at 19. Nor should claims be construed in a manner that the skilled addressee would appreciate would lead to unworkability if there is another construction that is equally open that avoids that result: Electric & Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23 at 39; Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 99.”[99]
Furthermore, his honour stated:
“A claim may have utility even if a promised advantage cannot be achieved in all cases or with the same degree of success: Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 at 142-143 (Gummow J) and Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) (2011) 92 IPR 320 at [245], point 8 (Jagot J). Thus, if a claimed method of treatment for nausea was effective in a substantial proportion of patients experiencing nausea, the claim would not be invalid merely because a small proportion of patients experiencing nausea did not respond to the treatment. This is because the skilled addressee reading the specification would not expect (assuming he or she is not told otherwise) that the claimed treatment will be an effective treatment for every patient suffering nausea resulting from every conceivable condition.”[100]
[97] Ibid at [352].
[98] (2016) 122 IPR 17 at [164] et seq.
[99] Ibid at [168].
[100] Ibid at [170].

100. In Esco Corporation v Ronneby Road Pty Ltd [101] the Full Federal Court accepted that the starting point is to recognise that the utility depends upon whether, by following the teaching of the patent, the result claimed is produced and that process requires following the teaching of the complete specification to isolate the promise of the invention and whether that results in the promise being produced.[102]
[101] [2018] FCAFC 46
[102] Ibid at [233] and [279].
101. Therefore, in order to determine whether I am satisfied there is a lack of utility, I will first determine the desired result of the specification (promise of the invention) and then look to see if the evidence shows whether there is something within the scope of the claim that does not produce that desired result.
What is the promise of the invention?
102. The opponent quotes the following passage in their submissions:
“In the past, co-administration of an NSAID with an antibiotic treatment has been found to be effective in improving antibiotic response. However, difficulties with combining these actives in a stable composition have led to the actives typically to be delivered separately. This is a general inconvenience, and it would be preferred to provide a single composition with both NSAIDs and an antibiotic.”[103]
[103] Page 3 lines 16-20.

103. The opponent then suggests that stability appears to be the promise. They state that only 4 examples use the solvents as claimed, and stability is only given for F8 (apparently less stable than F5) and F12. The opponent suggests that the broad range in the claims, such as ratios of 99% to 1% of propylene glycol to NMP and the use of other solvents would adversely affect stability. This is not supported by any evidence and is merely stated as a submission. This does not satisfy me that the claims cover something that does not meet the promise.
104. The opponent further submitted that the synergistic effect is described as important however it is not enabled. Indeed, the specification discusses synergy in the broad sense. Indeed, it has not been shown if there is a synergistic effect or an additive effect; however, there are no submissions on this being the promise of the invention. Furthermore, as there is no evidence of synergy, neither is there any evidence that there is no synergy. I do not consider this submission to satisfy the tests that the claims are not useful.
105. No evidence has been submitted to show that the claims do not meet any alleged promise of the invention, and as such, this ground has not been made out.
Novelty
106. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is considered novel unless it is not novel compared to prior art information. The Act then states that prior art information can be information made publicly available in a single document.[104]
[104] ss 7(1)(a).
107. The well-established general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement".[105]
[105] [1977] HCA 19; 137 CLR 228 at 235.

108. This test is satisfied if the alleged anticipation discloses all the invention's essential features as claimed, see Nicaro Holdings Pty Ltd v Martin Engineering Co.[106] To meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited (General Tire)).[107] If it is an inevitable consequence of carrying out the directions in the prior art that the PSA would do something that falls within the claims' scope, then the claims will lack novelty.[108]
[106] (1990) 91 ALR 513 at 517.
[107] [1972] RPC 457 at 486.
[108] Novozymes A/S v Danisco A/S [2013] FCAFC at [145].
109. The opponent’s case argued that the correct test to apply in the current situation is that for “selection patents”, and argued that the “IG rules” apply.[109]
[109] Opponent’s submissions at 9.6.5
110. The “IG rules” I take are the three general propositions asserted by Justice Maugham of the UK High Court In the Matter of I.G. Farbindustrie A. G.’s Patent (I.G. Farbindustrie); these are:
“First, a selection patent to be valid must be based on some substantial advantage to be secured by the use of the selected members. (The phrase will be understood to include the case of a substantial disadvantage to be thereby avoided.) Secondly, the whole of the selected members must possess the advantage in question. Thirdly, the selection must be in respect of a quality of a special character which can fairly be said to be peculiar to the selected group.”[110]
[110] Reports of Patent, Design and Trade Mark Cases, Volume 47, Issue 9, 2 July 1930, Pages 322-323.

111. His honour went on to discuss the utility of the patent vs the originating patent before stating that:
“In a selection patent the condition that there must be a substantial advantage attributable to the use of the selected members is inherent in the so-called invention.”[111]
[111] Ibid.

112. Maugham J explained it as:
“If there are five thousand possible members of the group, and a hundred have been selected as possessing some new and definite advantage, it is not intended to assert that such a selection patent would be bad if it were shown as the result of further research that there existed another hundred members possessing the same advantage. If, on the other hand, it were to be established that there were a thousand unselected members which possessed the same advantage, I doubt very much whether the patent could be sustained.”[112]
[112] Ibid.

113. Maugham then states that:
“It should be obvious, after what I have said as to the essence of the inventive step, that it is necessary for the patentee to define in clear terms the nature of the characteristic which he alleges to be possessed by the selection for which he claims a monopoly.”[113]
[113] Ibid.

114. In Australia, the law on selection patents was reviewed by Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214.[114] After discussing I.G. Farbindustrie, he added:
“Another way to approach this issue is to seek to find “the field left open for subsequent researchers”: see Lord Wilberforce in EL Du Pont De Nemours & Co (Witsiepe’s) Application (1982) 1A IPR 297 at 303. In this way, to look for a compound amongst an earlier class of compounds (which compound will possess special characteristics) is to undertake the inventive approach. The earlier class may even have pointed the way, but the later inventor seeks to find the unrecognised special characteristics of a specific compound. Of course, the selected invention must possess qualities previously undiscovered, peculiar to the selected invention and not attributable to it by virtue of merely belonging to the earlier class.”
[114] Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214 at [371] et seq.

115. It would seem that selection patents would, therefore, only apply to specific cases where a genus is disclosed, and a later selection is made for a better compound. Middleton J then added:
“Notwithstanding the foregoing discussion, it is not settled that the concept of selection patents forms part of the current law of novelty in Australia.”

116. Indeed, the bulk of the case law on novelty discusses the quality of the disclosure: “clear and unmistakable directions”, “planting of the flag”, “accuracy of a sniper”, “inevitable consequence”—these metaphors and the language used is quite different to making a selection from what is, in fact, a broad disclosure that lacks specificity. Middleton J made the following point:
“It is clear from the judgment of Maugham J in Re IG Farbenindustrie (1930) 47 RPC 289 that the propositions concerning such patents technically pertain to whether an invention involves an inventive step, not to whether an invention is novel.”

117. Middleton J did, however, then acknowledge the appearance of selection patents in a number of Australian cases.[115] His honour then concluded:
“It is clear from the foregoing authorities that patents for selection inventions (if such patents form part of Australian law) are based on the discovery of particularly desirable properties arising from the use of a specific material that has been broadly encompassed by a prior disclosure of a family of related materials. The principle of a selection patent presupposes that there is no novelty in the process of manufacture, but that the novelty lies in the selection because it has particular merits (such as fresh or new advantages inherent in that selection: Re IG Farbenindustrie (1930) 47 RPC 289 at 303 per Maugham J). Thus analysed, selection patents encourage improvements.”
[115] For example ICI v Commissioner of Patents (2004) 213 ALR 399; [2004] FCA 1658 at 412 [64], [66]; Apotex v Sanofi-Aventis (2008) 78 IPR 485; [2008] FCA 1194 at 522-523 [79] and [82]; and on appeal in Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416; [2009] FCAFC 134 at 436, [117].

118. I note that Middleton J went on to apply the principles to Olanzapine and found it did have advantages over the prior disclosure, including related compounds of the same class.[116]
[116]
119. The opponent submitted that the current claims were not novel when compared to three prior art documents. I will first consider these documents in the usual way applying the test for novelty and I will consider the disclosure of each in turn including if there is a disclosure of a family or genus that encompasses the current claims.
D1: WO 2005/044254 A1 (IDEXX LABORATORIES, INC.) 19 May 2005[117]
[117] Exhibit AAG-13

120. D1 relates broadly to compositions containing at least two pharmacologically active ingredients. They comprise a proton-donating pharmacologically active ingredient and a proton-accepting pharmacologically active ingredient in the form of a neutral salt which can be dissolved in a solvent.[118] The two compounds can be an antibiotic and an anti-inflammatory. These are introduced on the first page of D1 with the following disclosure:
Known antibiotics include, for example, macrolides such as azithromycin, roxythromycin, tilmicosin, tetracyclines such as oxytetracycline and doxycycline, fluoroquinolones such as enrofloxacin, and beta-lactams such as cephalosporins and penicillins and aminoglycosides. Known non-steroidal anti-inflammatories (NSAIDs) include, for example, flunixin, carprofen, ibuprofen, naproxen and ketoprofen. A disadvantage of these compounds is that they are cleared from the patient's system relatively rapidly (i.e., they have short half-lives) and generally require multiple daily dosages in order to attain therapeutic effectiveness. For example, mastitis in cattle is treated with anti-infectives (single or multiple doses of appropriate antibiotic such as tilmicosin, oxytetracycline, doxycycline) accompanied by daily injections of flunixin (an anti-inflammatory) for 3-4 days. immediately following administration of a single dose of flunixin (at 1.1 mg/kg) dose), the serum concentrations rise to anywhere between 8-13 μg/ml but rapidly drop to sub micro gram /mL within 4 hours of administration and undetectable levels 6-12 hours post administration.
[118] See abstract.

121. With the above background, it is clear that D1 does relate to the treatment of mastitis using both an antibiotic and NSAID in a single formulation. The following statement is also made, which is similar to the opposed specification:
Medications, such as anti-inflammatories, are often concomitantly administered with anti-infectives to reduce suffering attributable to trauma and pain during pre and post surgical conditions.

122. D1 states that the proton-donating active is an NSAID in various embodiments,[119] and ketoprofen in the last example. I have repeated the disclosure below:
In various embodiments, the proton-donating, pharmacologically active ingredient is a non-steroidal anti-inflammatory (NSAID) such as, for example, flunixin, carprofen, naproxen, ibuprofen, diclofenac, or ketoprofen; the proton-accepting pharmacologically active ingredient is an antibiotic such as, for example, azithromycin, roxythromycin, tilmicosin, oxytetracycline or doxycycline. In one embodiment of the invention, the proton-donating pharmacologically active ingredient is flunixin and the proton-accepting pharmacologically active ingredient is tilmicosin. The compositions can be provided in a pharmaceutically acceptable carrier as an injectable composition or as a suspension. In a preferred embodiment, the composition further comprising a pharmaceutically acceptable organic solvent precipitates when injected into water. The injectable composition can be a true solution. In various embodiments, the composition is provided as a liquid, a suspension, or a solution form. The composition can also be provided as a solid (e.g., a crystal) or as an injectable formulation. Tilmicosin-flunixin is an example of a salt of the invention.[120]
[119] Page 3 last paragraph.
[120] Ibid and first paragraph of page 4.

123. D1 discusses the use of solvents on page 12 with the following disclosure I have repeated below:
“The salts disclosed herein can be provided in pharmacologically acceptable solvents, such as water miscible organic solvents. For example, the water miscible solvent can be pyrrolidone, N-methyl pyrrolidone, polyethylene glycol, propylene glycol (e.g., at about 10% in glycerol formal with or without stabilisers), glycerol formal, isosorbide dimethyl ether, ethanol, dimethyl sulfoxide, tetrahydrofurfuryl alcohol, triacetin, or any combination of these in any combined proportions, or another solvent found to have similar acceptable properties such as being non-toxic and soluble in water. The solvent can also be a water immiscible solvent. For example, the water immiscible solvent can be isopropyl myristate, ethyl lactate, castor oil, safflower oil, soybean oil, saw flower oil, castor oil, cottonseed oil, com oil, sunflower oil, arachis oil, olive oil, a medium or long chain fatty acid, ethyl oleate, linoleic acid, isopropyl palmitate, a glycerol ester, a polyoxyl hydrogenated castor oil, cod liver oil, a fish derived oil, coconut oil, or combinations thereof. Other water immiscible solvents can also be identified that will find use in the present invention. In one embodiment, the mixture of active compound and water immiscible solvent forms a clear, true solution at room temperature. In one embodiment, the combination of the salt and solvent result in a true injectable solution, but suspensions and other means of delivery are contemplated such as, for example, topical, oral or nasal delivery.” (My emphasis)

124. I note that the examples in D1 do use antibiotics and NSAIDs, however, they do not use the solvent system as claimed. Propylene glycol is used and stabilised and made to volume with glycerol in three formulations, and NMP is used in the others. The above disclosure in D1 lists the solvents and includes N-methyl pyrrolidone and propylene glycol and then states “any combination of these in any combined proportions”. The opponent’s argument is that “any this any combined proportions” of the solvents listed is what anticipates the claims. I note that none of the experts indicated that D1 anticipated the current claims. Given this disclosure, it is clear to me that D1 does not disclose clear and unmistakable directions to arrive at a formulation of an NSAID and antibiotic (beta-lactam or macrolide) dissolved in a solvent system NMP and propylene glycol where the propylene glycol is in excess. I do not consider the statement “or any combination of these in any combined proportions” to meet the level of disclosure required to destroy the claims of novelty.

125. Furthermore, the choice of using a combination as listed above is quite different to that of the selection patent scenario where there must be a disclosure of the family or genus—a subset of group or class of compounds is not being selected from a larger group; instead, two solvents are being chosen for a combination. NMP and propylene glycol must both be chosen as the “combination” and then used where the propylene glycol is used in excess. This is to decide to use a combination of two solvents listed and then choose what proportions to use. To me, this type of disclosure is best dealt with under the ground of inventive step where evidence on what the PSA would do as a matter of routine can assist the case.
126. The advantage is in the stability shown in examples that use both solvents with the propylene glycol being used in excess. D1 does not provide any assistance to solve the issue of stability. Furthermore, the opponent did not provide any evidence other than speculation on whether or not ratios at the extremes of 99:1 or 51:49 might not possess the advantage. I do not consider the step from this broad disclosure to be merely a selection from a family or genus but instead several choices are made, and proportions tweaked. The law of selection patents, to the extent that it may apply in Australia, is not suited to this case. This did not satisfy me that a lack of novelty existed.
127. The next document purported to be novelty destroying by way of selection is D2:
D2: WO 2002/041899 A1 (PHOENIX SCIENTIFIC, INC.) 30 May 2002[121]
[121] Exhibit AAG-4

128. Firstly, I would note that the examples of D2 make combinations of antibiotics and NSAIDs. The antibiotic florfenicol with the NSAID flunixin meglumine is often employed. However, I note that the solvent used is often NMP alone or as the major solvent with glycerol formal or polyethylene glycol 400.[122] Although there is evidence that formulations in D2 could be used to treat mastitis[123], it is not mentioned in the document. Given the evidence that the antibiotic/NSAID composition could be used to treat mastitis, it follows that it could be used to treat an infection in a mammary gland. The use of propylene glycol is not exemplified; also not exemplified a macrolide antibiotic nor a beta-lactam antibiotic.[124]
[122] See D2 examples 1-3; example 4 and example 5 respectively.
[123] Gunn 1 at 12.2.
[124] Bunt 2 at [16].
129. Mr Simms is the only declarant who thought that D2 anticipated the claims, and he relied on a list of 17 solvents and classes of solvents[125] where propylene glycol and NMP are listed. Similar to D1, that list is followed by a stated “or combinations thereof”. At the hearing, the opponent also drew my attention to the following passage:
“It will be understood that certain features and sub-combinations are of utility and may be employed without reference to other features and sub-combinations”.[126]
[125] D2 page 2; Simms 3 at [3.4]
[126] D2 page 8 lines 11-13.

130. As with D1, I do not consider that is disclosure meets the level of disclosure required for novelty. The picking and choosing of “sub-combinations” that may be employed from lists is not clear and unmistakable directions. Furthermore, D2 does not provide guidance on the issue of stability and apart from being an antibiotic there is no clear and unmistakable directions to treat mammary glands.
131. I do not consider that the use of both NMP and propylene glycol with the propylene glycol being resent in a greater amount than NMP to be a “selection” from the above passage, or the phase “or combinations thereof” to be a genus to which the current claims would be the species nor is the treatment of mammary glands disclosed. I, therefore, do not find that this document destroys the novelty of any of the claims for similar reasons as that of D1.
132. The third document purported to be novelty destroying is D3:
D3: CN1572301A (WANG YUWAN) 2 February 2005[127]
[127] Exhibit XD-2; AAG-23A

133. D3 is a Chinese language document that discloses a veterinary injection containing tylosin antibiotics.[128] The document does not appear to mention mastitis, but Gunn states that this antibiotic could be used to treat it. It follows that it could also be used to treat an infection in a mammary gland.[129] The document states that it has a significant effect on the prevention and treatment of mycoplasma infectious diseases in animals and calves are listed along with piglets, chickens and lambs.[130]
[128] See page 1 of the part labeled specification lines 28-29 under description of invention of AAG-23A (the translation provided in evidence)
[129] Gunn #1 at 13.2.
[130] Abstract of the translation AAG-23A.
134. Formulation (3) in claim 9 of D3[131] states the following:
“10% (W N) of acetyl isovaleryl tylosin or tilmican or tylosin or salts thereof formed with acids thereof; florfenicol 10% (WN), ketoprofen 1-2% (WN), triacetin or 1,2-propanediol or formaldehyde glycerol or one or more of them used together to 100% (V N); 10-30% of dimethylacetamide or N-methyl-pyrrolidone may also be added to the formulation; topical analgesics 0.5-2% (W /W), including benzyl alcohol, chlorobutanol, procaine or procaine hydrochloride may also be added to the formulation.”
[131] Page 3 of the claim pages in the translation provided as AAG-23A.

135. It is important to note that 1,2-propanediol, as used above, is another name for propylene glycol.
136. Gunn believed tilmican to be a misspelling,[132] however, tylosin and ketoprofen (the antibiotic and NSAID of the opposed specification) are present. The examples, however, do not mention the use of both propylene glycol and NMP, where the propylene glycol is used in a larger amount.
[132] Gunn #1 at 13.2.4.
137. The vague nature of this disclosure where NMP may also be added along with topical analgesics, and the fact that the treatment focus is mycoplasma in animals such as calves, is not, in my view, a disclosure of a family in which the current claims are selected and is not clear and unmistakeable directions to the current claims because it is not contain a disclosure of the treatment of mammary gland infections. Furthermore, no expert indicated that D3 disclosed clear and unmistakable directions to the opposed claims either. Thus, this document does not destroy the novelty of the current claims.
138. Given the evidence, the disclosures of the documents, and the opponent's submissions, I am not satisfied on the balance of probabilities that a lack of novelty exists.
Inventive Step
139. 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 (subsection 7(3)).
140. 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[133] 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."
[133] [1981] HCA 12; 148 CLR 262 at 286.

141. In Alphapharm,[134] the High Court endorsed the use of the reformulated "Cripps question":

"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts, directly be led as a matter of course to try the invention as claimed in the expectation that it might well produce a solution to the problem."[135]
[134] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411.
[135] Alphapharm at [53].

142. This has been elaborated on in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft:
“We do not think that the plurality in Alphapharm were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited (1981) 148 CLR 262, at 280‑281, 286, per Aickin J). We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. 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.“[136]
[136] [2014] FCAFC 73 at [71].

143. In AstraZeneca AB v Apotex Pty Ltd[137] (AstraZeneca), the court held that it is not permissible to incorporate information that is not available to the person skilled in formulating the problem in the art either as common general knowledge or information available under subsection 7(3).
[137] [2014] FCAFC 99; 107 IPR 177.
144. The opponent submitted that the claims lacked an inventive step when the common general knowledge is combined with either D1, D2, D3, D4 or US 5958888 (RNS3-5).[138] D1, D2 and D3 have been introduced above.
[138] Opponent’s submissions at 5 or 10.42 et seq.
D4 CN101658526 (RNS-12)

145. D4 discloses veterinary injection compositions, including the antibiotic tylosin (a macrolide antibiotic) and flunixin meglumine (NSAID) along with other antibiotics in organic solvents and water for injection.
US 5958888 (RNS3-5)

146. This document was raised by Mr Simms in his third declaration and disclosed water-miscible macrolide solutions, including erythromycin formulations. I note that this document only teaches single active formulations.[139]
[139] Bunt #2 at 24.

147. The common general knowledge was considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·           standard texts and handbooks;
·           standard English dictionaries;
·           technical dictionaries relevant to the field;
·           magazines and other publications specific to the field.” [140]
[140] [1999] FCA 345; 45 IPR 577 at [112].

148. The common general knowledge must be established by evidence as stated by Emmett J in Dynamite v Aruze:
“It is necessary to establish common general knowledge by appropriate evidence. Evidence that consists of generalised and sweeping statements of opinion or recollection, unsupported by secondary materials such as text books, trade journals and technical publications, should be treated with caution and given little weight.” [141]
[141] [2013] FCA 163 at [104].

149. When a claim is to a new combination of known integers, the invention may lie in the combination as a whole. Once the claim is known to the witness, cherry-picking features from the prior art to arrive at the combination is using impermissible hindsight.[142] In matters before the Commissioner when evidence is tainted with hindsight it is weighted accordingly.
[142] See Lockwood v Doric (No 2) (2007) 235 CLR 173 at [46]; Aktiebolaget Hässle v Alphapharm (2002) 212 CLR 411 at [72].
150. The opponent submitted the following points were common general knowledge:
(i) Beta-lactam and macrolide antibiotics including tylosin;
(ii) Non-steroidal anti-inflammatory drugs (NSAID) including ketoprofen;
     (iii) Treatment of microbial infections, in particular mastitis, with NSAIDs and antibiotics;
     (iv) The use of non-aqueous solvents NMP and propylene glycol to make injectable compositions;
(v) The use of propylene glycol to make injectable compositions with macrolide antibiotics;
(vi) Use of multiple solvents to dissolve combinations of actives in varying relative proportions depending on solubility, chemical stability, injection site acceptability and cost of goods.
(vii) The use of non-aqueous injectable formulations.

151. It is clear that many of the above points that are said to be common general knowledge are also contained in the documents used under s 7(3), and there is no dispute that beta-lactams, macrolides, NSAIDS and the solvents NMP and propylene glycol were known. I accept that these are common general knowledge.
152. At the hearing and in the opponent’s submissions the opponents argued that the solvent system used in the current claims was common general knowledge and could be combined with D1, D2 or D4. The opponent cited D15: NZ 210505, which uses ivermectin and is the patent related to the product IVOMEC (D16).[143] Ivermectin is a well-known insecticide and used to treat parasitic infections.[144] The opponent submitted it is a macrolide antibiotic; however, it is not an antibiotic(?).[145] The relevance of a formulation with an insecticide as in D15 to a co-formulation of a macrolide antibiotic and an NSAID (as in the current claims) has not been established in any evidence. Bunt stated:
“D15 discloses a parental formulation comprising a single active, ivermectin, in a solvent system of glycerol formal and propylene glycol. A variation of the formulation replaces glycerol formal with water.”[146]
[143] See also Opponent’s submissions at 10.46.
[144] See D15 or D16 or even Wikipedia.
[145] See D15 or D16; Bunt at 397.
[146] Bunt #1 at 395.

153. He went on to say that:
“D15 does not describe the use of an additional active agent in a dual active formulation, let alone an antibiotic active agent for treating mastitis”

154. Bunt then concluded his discussion that based on these reasons does not render claim 1 obvious.[147] I agree with Bunt’s statements here. I cannot see the relevance of this product to the current claims. It does use solvents in an injectable formulation for administering an insecticide but not an antibiotic and there is no suggestion this could be used for mastitis in the document.
D1
[147] Bunt #1 at 399
155. As outlined above for novelty, D1 does use antibiotics and NSAIDs, however, the examples do not use the solvent system as claimed. Propylene glycol is used and stabilised and made to volume with glycerol in three formulations, and NMP is used in the others. D1 does provide a list of solvents and includes N-methyl pyrrolidone and propylene glycol and then states “any combination of these in any combined proportions”.
156. The opponent’s main argument, which was repeated in their submissions on inventive step for the documents D1, D2 and D4 was that:
“It is common general knowledge of the skilled formulator that the amount of propylene glycol in the composition may be more than the amount of NMP. The common general knowledge discussed above does not direct a formulator to only consider compositions in which the amount of NMP is more than the amount of propylene glycol. The formulator will be guided by the properties of the active ingredients and known solvents of use. Propylene glycol is known as a very common solvent and is an obvious choice as a primary component of a solvent system. NMP is also known to be of use with the actives claimed in the opposed specification.”[148]
[148] Opponent’s submissions at 10.45; 10.60; 10.74

157. In my view, it appears that the solvent system sets the current claims apart from the prior art in that it allows for the stable injectable composition and, thus, the above submission requires exploration. Dr Lichti gave evidence for the opponent on some of these points. When asked the question “What would have been the most commonly used solvents to formulate injectable animal health products and why?” he discusses propylene glycol as a co-solvent in microemulsions[149], and when he provides a list of possible carrier solvents, it is also listed[150] as a carrier. NMP is not listed there, and neither is the mixture of two non-aqueous solvents as claimed. Dr Lichti states that the solvent would need to have low toxicity and low irritability, have the capacity to dissolve the active and be inert and not degrade the active.[151] He went on to say, in practice, it is common to search for injectable solvents and use them as they have been found to be acceptable.[152] Simms also stated that he would look at similar products on the market as well as the MSDS for the actives.[153] There was no naïve evidence that a formulator would use a mixture of propylene glycol and NMP with propylene glycol present in greater quantities.
[149] Lichti #1 at 4.2
[150] Lichti #1 at 4.4.1
[151] Lichti #1 at 4.5
[152] Lichti #1 at 4.6
[153] Simms 3.3

158. Dr Lichti also gave evidence for the opponent on the routine steps when making multi component formulations. He discussed stability issues that can arise with two actives, stating that different pHs might be required, or one might need a non-polar solvent while the other needs a polar solvent.[154] He went on to discuss reactions with water and to overcome issues with reactions and association with water that dispersion-type formulations could be used.[155]
[154] Lichti #1 at 6.3
[155] Lichti #1 at 6.6.9
159. Dr Lichti was asked to expand on the use of multiple solvents and carrier solvents and he stated:
A multi-component solvent system may provide adequate solubilisation of active agent at lower cost than a pure solvent (eg a combination of vegetable oil and benzyl alcohol may be cheaper than pure benzyl alcohol). The use of pure vegetable oil may not be an option because active agent may not be sufficiently soluble in this oil. However sufficient solubility in the solvent system may be obtained by dosing say 20% of the more expensive better solvent (benzyl alcohol) into the vegetable oil.
A mixed solvent system may have fewer undesirable tissue/site reactions than
[156]Lichti #1 at 7.2-3
a pure solvent. Consider again a mixed solvent system containing vegetable oil and benzyl alcohol. Pure benzyl alcohol (a very good solvent for many active agents) may be more irritant to tissues (for example because its solvency allows it to penetrate far into the tissue mass) than vegetable oil, but pure vegetable oil cannot be used because it cannot carry sufficient active agent (see above). However, a solvent system with (for example) 20% benzyl alcohol and 80% vegetable oil will have adequate carrying capacity for the active agent and will also have diminished tissue irritation.[156]

160. The use of vegetable oil and benzyl alcohol appears to be Dr Lichti’s primary focus. Propylene glycol and NMP do not appear to be obvious choices for a mixed solvent system based on Dr Lichti’s evidence.
161. Dr Lichti was then asked to comment on a combination of an NSAID and a macrolide, to which he states:
“The solvent of choice for injectable formulations is water. It is cheap and is the
[157] Lichti #1 at 8.2
least irritant. There is also a long history of patents/previous formulations with water to draw on.”[157]

162. Dr Lichti then discusses solubility and discusses the use of complex salts to improve water solubility or use a suspension or a solution of the two actives. On the solution, Dr Lichti states that:
“In relation to the solution option, both the actives would need to dissolve in the solvent system. This would avoid the physical stability issues of a suspension. However, there can be faster degradation of actives in solution, particularly if the actives react with each other or other components of the solvents system.”[158]

[158] Lichti #1 at 8.11

163. Dr Lichti states
“I am not aware whether there is likely to be reaction between a NSAID and a macrolide antibiotic. I would need to do further research and/or try putting them together in solution.”[159]
[159] Lichti #1 at 8.12

164. Based on this evidence, I do not find that it would have been routine for the person skilled in the art to arrive at the solvent system as claimed, i.e. NMP and propylene glycol with propylene glycol present in a greater amount than the NMP even when combined with the “combinations” disclosure in D1. The opponent’s expert outlined what he would do. This did not arrive at the current claims and instead acknowledged the possibility of stability issues and degradation and said that he would need further research. When Simms and Gunn read the opposed specification, which stated that these combinations were unstable, they merely stated that this should be referenced rather than offer evidence to the contrary.[160] Consequently, the approach of the experts using the common general knowledge and D1 does not lead to the current claims. The opponent also discussed combining (?) D15 with D1, D2 and D4 however, I do not consider D15 to be of any assistance in arriving at the current claims; it uses a different solvent system and a single insecticide. The current claims do not lack an inventive step when compared to D1 and the common general knowledge.
D2
[160] Simms at 4.5; Gunn #1 at 10.6
165. The opponent’s submissions for D2 were almost identical to that of D1. The examples of D2 make combinations of antibiotics and NSAIDs. The antibiotic florfenicol with the NSAID flunixin meglumine is often employed. I note that neither a macrolide antibiotic nor a beta-lactam antibiotic is exemplified.[161] However, I note that the solvent used is often NMP alone or as the major solvent with glycerol formal or polyethylene glycol 400.[162] However, the use of propylene glycol is not exemplified. The treatment of mastitis is not mentioned in D2, however, there is evidence that formulations in D2 could be used to treat mastitis[163]. It follows that it could be used to treat an infection in a mammary gland.
[161] Bunt 2 at [16].
[162] See D2 examples 1-3; example 4 and example 5 respectively.
[163] Gunn 1 at 12.2.
166. D2 lists 17 solvents and classes of solvents[164] where propylene glycol and NMP are listed. Similar to D1, that list is followed by a stated “or combinations thereof” and at the hearing, the opponent also drew my attention to the following passage:
“It will be understood that certain features and sub-combinations are of utility and may be employed without reference to other features and sub-combinations”.[165]
[164] D2 page 2; Simms 3 at [3.4]
[165] D2 page 8 lines 11-13.

167. As with D1, I do not consider that the use of both NMP and propylene glycol with the propylene glycol being present in a greater amount than NMP has been established as obvious. D2 does not provide guidance on the issue of stability in Dr Lichti’s evidence as I have outlined above for D1. As with D1 the evidence does not suggest that the choice required to arrive at the current claims would be obvious. Similarly, as with D1, D15 is of no assistance. Therefore, D2 is not prejudicial to the inventive step of the current claims.

D3
168. For D3 the opponent relied largely on their submissions made for novelty and the common general knowledge. As noted above, D3 teaches an antibiotic formulation of tylosin for the treatment of mycoplasma infection in piglets.[166] There is no mention of mastitis in D3, however, there was evidence from Gunn that the formulation of D3 could be used to treat a mammary gland infection.[167]
[166] See page 1 of the part labeled specification lines 28-29 under description of invention of AAG-23A (the translation provided in evidence)
[167] Gunn #1 at 13.2.

169. The examples cited in D3[168] do not mention the use of both propylene glycol and NMP nor is a system disclosed where the propylene glycol is used in a larger amount, instead it is said that NMP may also be added along with topical analgesics. Furthermore, the route of administration is not discussed in D3, however, Gunn appears to suggest that the mention of subcutaneous injection in the abstract and the serum drug analysis implies it is the same as the opposed claims.[169] In my view, this is not enough to lead the person skilled in the art to the current claims. There was no further extrapolation on the problem of co-administration or injection into mammary glands themselves.
[168] Page 3 of the claim pages in the translation provided as AAG-23A.
[169] Gunn #1 at 13.2.5.

170. The focus of D3 is not the treatment of mammary gland infections, despite using the same antibiotic, does not direct someone to the co-formulation and solvent system as claimed for treating mammary gland infections.
D4
171. D4 discloses veterinary injection compositions, including the antibiotic tylosin (a macrolide antibiotic) and flunixin meglumine (NSAID) in organic solvents and water for injection.[170] The opponent’s submissions for this document largely matched that for D1 and D2. Example 1 of D4 also uses water in its solvent system. Simms comments on the examples stating that:
“The stability results are also good, although I would have expected to see greater experimental uncertainty/variability in the results as some of the actives can be difficult to measure.”[171]
[170] See claim 1 of D4 and Simms #1 at 9.2.
[171] Simms #1 at 9.7.

172. The example and claims in D4 also includes the quinolone antibiotic enrofloxacin.[172] I note that the solvent system used in D4 does use water and the organic solvents are benzyl alcohol, ethanol, DMF (N,N-dimethylformamide) and α-pyrrolidone. There is no evidence that an expert would seek to change this solvent system to be propylene glycol in a larger amount than NMP. Furthermore, as with D1 and D2 I do not find that D15 is of any assistance in arriving at this solvent system with D4 either. It has not been established that the claims lack an inventive step when compared to this document.
US5958888 (RNS3-5)
[172] See claims and example of D4.
173. Mr Simms states that the solvent system taught in US 5958888 teaches the use of NMP as a solvent in concentration of 30-50% and propylene glycol as a carrier as the remainder of the solvent for an injectable formulation.[173] Simms then goes on to state that this, in combination with the common general knowledge, renders the current claims 1 obvious.[174] The only example in US5958888 is on column 6, and uses erythromycin (a macrolide antibiotic), glacial acetic acid, NMP and propylene glycol. There is no disclosure in US 5958888 about the addition of an NSAID to this formulation.[175] Furthermore, the document does not disclose the use of this formulation in the treatment of mastitis.[176] The issues of compatibility of the actives, the suitability of the solvents—including glacial acetic acid—and site reactions—for a multi-active formulation have not been addressed with this document.[177] The evidence does not satisfy me that a lack of inventive step exists for this document.
[173] Simms #3 at 9.3.
[174] Simms #3 at 9.4.
[175] Bunt #2 at 24.
[176] Ibid.
[177] Bunt #2 at 26.

174. The ground lack of inventive step fails.
Manner of manufacture
175. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.
176. The opponent’s argument focused on the general lack of quality of newness or inventiveness, citing Commissioner of Patent v Microcell Ltd:
“We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter for a patent.” [178]
[178] (1959) 102 CLR 232.

177. This concept with the law of manner of manufacture was developed further in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd:
“if it is apparent upon the face of the specification, when properly construed, that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further.”[179]
[179] (1995) 183 CLR 655 at 663-665.

178. Furthermore, in Bristol-Myers Squibb Co v FH Faulding & Co Ltd[180] , their Honours, Black CJ and Lehane J stated in the majority decision that:
“if, on the basis of what was known, as revealed on the face of the specification, the invention was obvious or did not involve an inventive step – that is, would be obvious to the hypothetical non-inventive and unimaginative skilled worker in the field – then the threshold requirement of inventiveness is not met.”[181]
[180] [2000] FCA 316; (2000) 46 IPR 553.
[181] Ibid at [30].

179. I note that the majority judgment of the Full Federal Court states that this is based on the face of the specification; however, in Advanced Building v Ramset[182] the High Court found that the lower court had erred in finding that the claims were not an invention within the meaning of the Patents Act 1952[183] because it placed decisive weight on prior art disclosures when it had the grounds of Novelty and Obviousness available but instead put them to one side.[184]
[182] [1998] HCA 19; 194 CLR 171; 152 ALR 604; 72 ALJR 673.
[183] In the Patents Act 1952 “invention” means any manner of new manufacture the subject of letters patent and grant of privilege within section six of the Statute of Monopolies and includes an alleged invention”.
[184] [1998] HCA 19; 194 CLR 171; 152 ALR 604; 72 ALJR 673 at [40].
180. The opponent’s submission is that there is no manner of manufacture on the face of the specification because page 6, line 5 states that “All references, including any patents or patent applications cited in the specification, are hereby incorporated by reference”.
181. The specification includes D2 (referred to on page 4, line 3 of the specification), D5 (referred to on page 5, line 14 of the specification and D7 (referred to on page 4, line 25). They argue that these deprive the claims of novelty, and by being incorporated by reference, the specification lacks novelty on its face. I have found that these documents do not deprive the claims of novelty above, so this submission fails.
182. The opponent also submits that these are to be taken together and that the NMP from D7 may be added to the disclosure of D2 and D5. I disagree. The lack of novelty would require clear and unmistakable directions, not adding material from one reference to another with no directions to do that.
183. This ground of opposition fails.
Conclusion
184. The opposition has been unsuccessful on all grounds. Subject to appeal, I direct the application to proceed to grant.
Costs
185. The opposition has been unsuccessful. Costs are awarded against the opponent under Schedule 8.
K. Wagg
Delegate of the Commissioner of Patents

Declarant	Date	Reference	Exhibits
Dr Xiaobo Ding	2 May 2018	Ding	XD-1 to XD 2
Alison Ann Gunn	11 June 2018	Gunn 1	AAG-1 to AAG-24
Raymond Nigel Simms	25 May 2016	Simms 1	RNS-1 to RNS-12
Dr Gottfried Lichti	15 February 2018	Lichti 1	GL1 to GL2