Merial, Inc. v Bayer New Zealand Limited - [2017] APO 27

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial, Inc. v Bayer New Zealand Limited [2017] APO 27
Patent Application: 2009304000

Title:Anti-infective formulation and methods of use

Patent Applicant: Bayer New Zealand Limited

Opponent:Merial, Inc.

Delegate:Dr A. Lim

Decision Date: 7 June 2017

Hearing Dates: 03 and 04 April 2017, in Canberra

Catchwords: PATENTS – section 59 – opposition to the grant of a patent – grounds of novelty and inventive step – construction of “when used” claims – invention relates to a process for the prevention of mastitis by administration of a single formulation –when assessing novelty, whether an antiseptic is present in sufficient quantity to act effectively as an antiseptic is a question of fact – claims lack novelty in light of cited prior art –subsection 7(3) – one document disregarded for the purposes of inventive step – claims lack inventive step in light of cited prior art –opposition succeeds – costs awarded against the applicant

Representation: Counsel and patent attorney for the applicant: Mr Ian Finch from James & Wells
Counsel for the opponent: Mr Christian Dimitriadis, SC, and Ms Clare Cunliffe
Patent attorney for the opponent: Dr Marcus Caulfield from FB Rice

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2009304000

Title:Anti-infective formulation and methods of use

Patent Applicant: Bayer New Zealand Limited

Date of Decision: 7 June 2017

DECISION
The opposition is successful on the grounds of novelty and inventive step. Each of claims 1 and 7-13 lacks novelty in light of cited prior art. Each of claims 1-4 and 7-13 lacks an inventive step in light of cited prior art and the common general knowledge.
I allow Bayer New Zealand Limited a period of two months from the date of this decision to propose amendments to the specification.
Costs according to Schedule 8 are awarded against Bayer New Zealand Limited.
REASONS FOR DECISION

Patent application number 2009304000 (the opposed application) was filed on 15 September 2009 under the provisions of the Patent Cooperation Treaty. The applicant at the time of filing the opposed application was Mastitis Research Centre Limited which subsequently amalgamated with Bomac Industries Limited, Bomac Laboratories Limited and Bomac Research Limited to become Bayer New Zealand Limited (Bayer NZ). A request to amend the applicant name to Bayer NZ was filed on 11 May 2015 and recorded. The opposed application claims priority from the application NZ571347 (the priority document) which was filed on 17 September 2008.
The opposed application was examined and accepted by the Commissioner, and subsequently opposed under section 59 of the Patents Act 1990 (the Act) by Merial, Inc. (Merial) and Zoetis LLC (Zoetis). Zoetis and Bayer NZ subsequently reached a settlement, and Zoetis withdrew their opposition on 23 December 2016. The present matter concerns the opposition by Merial. Merial served a notice of opposition on 06 November 2015 and filed a statement of grounds and particulars (SGP) on 05 February 2016. An application to amend Merial’s SGP was filed on 05 May 2016 and subsequently allowed on 26 May 2016. The claims and description as accepted on 16 July 2015 comprise the opposed application. The amended SGP identified five grounds of opposition: manner of manufacture, novelty, inventive step, best method of performing the invention and fair basis. A hearing was held on 03 and 04 April 2017 in Canberra to decide the opposition. Bayer NZ was represented by Mr Ian Finch, counsel and patent attorney. Merial was represented by Mr Christian Dimitriadis, Senior Counsel, Ms Clare Cunliffe, counsel and Dr Marcus Caulfield, patent attorney.
The opposition
At the hearing the opposition was limited to the grounds of novelty and inventive step.
The parties relied upon evidence by several declarants. Evidence in support was completed on 05 May 2016 and consists of declarations by:
- Dr Stephen W Page with Exhibits SWP-1 to SWP-39, dated 03 May 2016;
- Professor Darren Trott with Exhibits DT-1 to DT-3, dated 04 May 2016;
·Mr John Landells with Exhibits JSL-1 to JSL-17, dated 05 February 2016; and
·Dr Marcus Julian Caulfield with Exhibits MJC-1 to MJC-30, dated 05 May 2016 where Exhibit MJC-23 is a copy of a declaration by Professor Edward Lionel Bruce Whittem, dated 13 December 2011, Exhibit MJC-24 are copies of declarations by Ms Elizabelth Clare Veber, dated 04 November 2011 and 21 December 2011, and Exhibit MJC-27 is a copy of a declaration by Professor Edward Lionel Bruce Whittem, dated 03 May 2016. Professor Whittem and Ms Veber are declarants of Zoetis, which have withdrawn as a party opposing the present application. Merial made submissions that relied on Professor Whittem’s evidence.
Evidence in answer was completed on 03 August 2016 and consists of declarations by:
·Dr Craig Bunt with Exhibits CB-1 to CB-3, dated 02 August 2016;
·Dr Kiro Petrovski, with Exhibits KP-1 to KP-11, dated 03 August 2016 where Exhibit KP-3 consists of a declaration by Dr Kiro Petrovski, dated 25 May 2015, made in support of New Zealand patent application No. 571347 and accompanied with seven Exhibits;
·Dr William Francis Grayson, with Exhibit FWG-1 (AU), dated 21 June 2016 where Exhibit FWG-1 (AU) consists of declaration by Dr William Francis Grayson, dated 25 May 2015, made in support of New Zealand patent application No. 571347 and accompanied with Exhibits FG-1 and FG2; and
·Mr Imtiaz Ahmed, with Exhibit IA-1 (AU), dated 04 July 2016 where Exhibit IA-1 (AU) consists of declaration by Mr Imtiaz Ahmed, dated 25 May 2015, made in support of New Zealand patent application No. 571347.
Evidence in reply was completed on 05 October 2016 and consists of a declaration by:
·Dr Stephen W Page with Exhibits SWP-40 to SWP-49, dated 05 October 2016.
Onus of proof, and standard of proof
The request for examination in relation to the present application was filed on 26 February 2013. As a consequence, the substantive amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present application. The onus of proof in this opposition rests with Merial, who must demonstrate that it is clear that a valid patent cannot be granted.[1]
[1] F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [67]; 50 IPR 305, Commissioner of Patents v Sherman [2008] FCAFC 182 at [18]; 79 IPR 426.
The standard of proof of evidence leading to a conclusion of lack of novelty or lack of inventive step as stated by Besanko J. in Aspirating IP Limited v Vision Systems Limited is proof to a level of practical certainty:
“The primary facts are to be established on the balance of probabilities, but the ultimate facts – the facts leading directly to a conclusion of a lack of novelty or a conclusion of obviousness – must be proved to the level of practical certainty. In Austal Ships, Bennett J said (at 423 [12]):
‘I can accept that a lower standard may apply to proof of evidence such as whether a document has been published or, indeed, whether a prior art vessel was well-known. I do not accept that it properly applies to the factual question that itself is the test for obviousness or lack of inventive step. Where the factual question is itself the legal test, as set out in s 7(3) of the Act, it seems to me that it should be determined at the higher standard. That means that where there are two opposing expert views that are conclusive on obviousness, both presented bona fide by witnesses of accepted expertise, unless one set of views can be rejected on proper grounds, the legal burden to establish a ground of opposition is not discharged; the court cannot be practically certain that obviousness or lack of inventive step is established.’ ”[2]
[2] [2010] FCA 1061 at [35]; 88 IPR 52.
The specification
The specification relates to a formulation that has anti-infective properties and methods of using the formulation to prevent or ameliorate mammary gland infections, including mastitis. The specification has 18 Tables, 10 Figures and 16 claims. Claim 1 is an independent claim. Claims 14, 15 and 16 are omnibus claims. The full claim set is reproduced in Annex A to this decision.
Principles of construction
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”[3]
[3] [2013] FCA 214 at [139]; 100 IPR 451.
The field of the invention
The specification states that:
“The invention relates to an anti-infective formulation and methods of use.
More specifically, this invention relates to an anti-infective formulation and methods of use to prevent or ameliorate mammary gland infections, including mastitis.”[4]
[4] The present specification at page 1.
The person skilled in the art
It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”[5]

[5] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]; 177 ALR 231.

However, the person skilled in the art is an artificial construct that is used as a tool of analysis, and there is a danger in trying to identify them as an actual person or persons:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”[6]
[6] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; 89 ALJR 798.
Our understanding of the person skilled in the art is based on evidence from persons with knowledge of the art as to the things that they know and do, and what they understand to be commonly known and done. In this opposition there are declarations by a number of people. The most important are Dr Page, Professor Trott, Professor Whittem, Dr Bunt, Dr Petrovski, Dr Grayson and Mr Ahmed. Dr Page is a consultant specialising in the area of veterinary pharmacology with more than 35 years of experience in the use and development of veterinary medicines for livestock animals including dairy cattle, particularly intramammary products for cows.[7] Professor Trott is a veterinarian and microbiologist with over 25 years of research experience in zoonotic, companion and production animal bacterial diseases.[8] Professor Trott has conducted numerous contract research projects, mainly focused on MIC (Minimum Inhibitory Concentration) determinations using CLSI (Clinical and Laboratory Standards Institute) methodology for veterinary pharmaceutical companies registering new products as well as investigating the antimicrobial activity of new compounds.[9] Professor Whittem is a veterinary practitioner and specialist in veterinary pharmacology with many years of experience in veterinary research and product development.[10] Dr Bunt is an Associate Professor in animal science with over 21 years’ experience as a pharmaceutical formulation scientist.[11] Dr Petrovski has 19 years of experience working as a veterinary practitioner, researcher, lecturer in lactational physiology and bovine mastitis and senior lecturer in ruminant health.[12] Dr Grayson is the director of a chemical consultant company which provides services including analytical services in the field of chemistry and microbiology as well as obtaining approval for agricultural compounds and veterinary medicines in New Zealand.[13] Mr Ahmed is a sterile products testing manager employed by AMS Laboratories Pty Ltd., a provider of analytical and consulting services in microbiology.[14]
[7] Page#1 at [3]-[5] and Exhibit SWP-1.
[8] Trott at [1]-[3] and Exhibits DT-1 and DT-3.
[9] Exhibits DT-1 and DT-3.
[10] Professor Whittem is an expert witness of Zoetis which have withdrawn as a party opposing the present application. A copy of Professor Whittem’s declaration and curriculum vitae has been filed as Exhibit MJC-27 in the present opposition.
[11] Bunt at [3]-[7] and Exhibit CB-2.
[12] Petrovski [9]-[22] and Exhibit KP-2.
[13] Grayson and Exhibit FWG-1 (AU).
[14] Ahmed and Exhibit IA-1 (AU).
Merial submitted that Dr Petrovski cannot be characterised as an independent witness because on his own account, he was closely involved with the Mastitis Research Centre which originally filed the opposed application at the time it developed the opposed invention.[15] Merial also submitted that Dr Petrovski conducted field trials for the opposed invention, his PhD seems to have been the starting point of the opposed invention and the applicant was his largest source of funding from 2006-2012.
[15] The opponent’s written submissions, dated 20 March 2017, at [17]-[18] which refer to Dr Petrovski’s declaration and Exhibit KP-2.
I consider that all of the declarants mentioned above are in a position to provide evidence as to what the person skilled in the art knew and would have done. The weighing and evaluating of the evidence to decide the characteristics of the person skilled in the art is part of the normal work of a delegate of the Commissioner.
Technical background
Before analysing the specification it is useful to review some concepts of what was already known in the art.
Anatomy of a cow’s udder and susceptibility to infection
A cow’s udder consists of four separate quarters, each drained by a separate teat.[16] The anatomical structures of the cow’s teat are shown in Figure A below. This figure has been taken from Dr Page’s declaration which reproduced the figure from the text book entitled “Mastitis Control in Dairy Herds: An Illustrated and Practical Guide” by Roger Blowey and Peter Edmondson, Farming Press Books, Ipswich, United Kingdom, 1995.[17]
[16] Page #1 at [33].
[17] A copy of Chapter 2 of the text book: Structure of Teats and Udder and Mechanism of Milk Synthesis has been filed as Exhibit SWP-3 in the present opposition.
Figure A. Structure of the udder and teat
Most infections of the mammary gland of the dairy cow enter through the teat canal.[18] The teat canal provides an important barrier to infection since its exterior surface is frequently exposed to a very contaminated environment.[19]
[18] Page #1 at [35]; Bunt at [10.1.1].
[19] Page #1 at [35].
Infection of the mammary glands by pathogenic bacteria and other infectious agents (including fungi, yeasts and occasionally algae) can lead to inflammation of the mammary gland which is often referred to as mastitis.[20] Mastitis is generally caused by bacterial infection and the clinical signs include local pain, redness, swelling and heat of the mammary gland.[21] Different bacteria have been identified to cause mastitis in dairy cattle, and these bacteria include Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus, Streptococcus uberis and Escherichia coli (and other faecal coliforms).[22]
[20] Page #1 at [35].
[21] Page #1 at [35].
[22] Page #1 at [36]-[38].
Methods of treating mastitis in cows
DCT (dry cow therapy) is a method used to treat new outbreaks of mastitis where all cows (healthy and mastitis positive) are treated with an infusion of a long acting antibiotic at the start of the dry off period to cover the dry period.[23] Whilst effective, the use of antibiotics in DCT is highly undesirable because antibiotic residues can be absorbed by the cow, can be excreted in the milk and therefore the milk needs to be withheld for a period of time following antibiotic administration.[24] The use of antibiotics in DCT can lead to increased risk of the mastitis causing micro-organisms developing resistance to the antibiotic.[25]
[23] The present specification at pages 1-2.
[24] The present specification at page 2.
[25] The present specification at page 2.
To overcome the problems associated with DCT, artificial external and internal teat seals were developed to provide a physical barrier to prevent micro-organisms from gaining access into the teat or udder.[26]
[26] The present specification at page 2.
The aim of the invention
Bayer NZ submitted:
“The invention is an improved formulation to prevent or ameliorate mammary gland infections, including mastitis, in animals; especially, yet not solely, for cows. For expediency the rest of these submissions will discuss the invention in the context of preventing mastitis in dairy cows.”[27]
[27] The applicant’s submissions, dated 24 March 2017, at [16].
At the oral hearing, Merial submitted:
- the invention of the opposed application is not an improved formulation, but rather an alternative formulation, to prevent or ameliorate mammary gland infections, including mastitis;
- if the formulation merely needs to be equivalent to an existing formulation without an anti-infective, it is apparent on any view that the prior art products containing acriflavine will anticipate;
- the description provides no support for the proposition that the antiseptic effect of the antiseptic compound actually improved the efficacy of the formulation in preventing mastitis; and
- if the opposed invention is interpreted to be an improved formulation, the opposed invention will fail for lack of utility because the embodiments described in the specification do not perform better than TeatSeal^TMproduct and the opposed application will fail for insufficiency, lack of fair basis and clarity because the specification does not teach what amount of antiseptic must be included in the opposed formulation to provide improved efficacy of the formulation over existing formulations.[28]
In order to assess whether the opposed application must provide an improved formulation it is necessary to start with what the specification says. The specification states:
“A drawback of a seal is that microbes which may already be present in the teat are sealed inside and without natural challenges may become infectious. In addition, the natural sealing process may also be disrupted, slowed or otherwise altered, which may cause harm to the animal.
It should therefore be appreciated that a product which prevented new infection by pathogenic micro-organisms during the dry period and also avoids altering natural teat sealing processes would be advantageous.
It is an object of the present invention to address the foregoing problems or at least
[29] The present specification at pages 5-6.
to provide the public with a useful choice.”[29]
From the quote above, the opposed application formulates an object of the invention as the provision of a teat seal formulation that is a “useful choice”. The description of the invention in the body of the specification (as I will outline below) is consistent with a description of an alternative teat seal formulation. I conclude that the aim of the opposed application is to at least provide an alternative to existing formulations to treat mammary gland infections, including mastitis.
The invention as described

Under the heading “Disclosure of the invention” the specification sets out the invention in the following terms:
“According to first aspect of the present invention there is provided a formulation, for administration to the teat canal or/and lower portion of teat cistern of a mammary gland of an animal, wherein the formulation prior to delivery is in the form of a paste, the formulation including:
an oil-based physical barrier material which is able to form a cohesive mass in the teat canal and/or the lower portion of the teat cistern, and
at least one antiseptic compound mixed with the barrier material.
According to a further aspect of the present invention there is provided a use of a formulation as substantially described above, in the manufacture of a medicament to prevent or ameliorate mastitis.
According to a further aspect of the present invention there is provided a use of a formulation as substantially described above, in the manufacture of a medicament to prevent or ameliorate infection within the teat cistern of a mammary gland.
The term 'infection' or grammatical variations thereof refers to the invasion of an animal's body by micro-organisms.
The term 'prevent' or grammatical variations thereof refers to keeping, averting or hindering an infection from occurring.”[30]
[30] The present specification at pages 6-7.
I consider the definition of “prevent” quoted above to be the plain meaning of the word. A plain meaning of “ameliorate” is “to make better; improve; meliorate”.[31] I consider that the opposed application indicates that whilst it is desirable to ameliorate (improve) mastitis with the use of a formulation, it is sufficient that the formulation prevents (keeps or averts or hinders from occurring) mastitis.
[31] Macquarie Dictionary online.
The specification states that the inventors consider it important to be able to use a formulation that does not contain an antibiotic to prevent and/or ameliorate mastitis in the dry period.[32] The use of antiseptics is described to enable broad spectrum activity against micro-organisms and overcome the problems associated with use of antibiotics.[33]
[32] The present specification at page 11.
[33] The present specification at pages 11-12.
The specification states that the formulation of the opposed application:
“ .. overcomes problems with existing formulation/chemical preparations by providing an antiseptic which is targeted to and limited to the area between the formulation and the side of the teat canal or/and lower portion of teat cistern. This is advantageous as it provides a consistent and effective barrier, both physical and chemical across the entire teat canal or/and lower portion of teat cistern, either preventing the passage of micro-organisms into the teat cistern or treating those that are present in the cistern. Limiting the antiseptic to this small area decreases the amount of antiseptic required to provide an effective concentration. This lowers the cost of the formulation, and as the antiseptic is limited to one area of relatively high concentration, the possibility of the microorganisms becoming resistant to the antiseptic is significantly reduced.”[34]
[34] The present specification at page 18.
From the quote above, I consider the opposed application seeks to provide a formulation with an antiseptic where the formulation functions as an effective physical and chemical barrier across the teat canal or/and lower portion of the teat cistern by either preventing the passage of micro-organisms into the teat cistern or treating those that are present in the cistern.
The specification describes an embodiment, referred to as ATS-Barium, which comprises barium sulphate as the physical barrier material and chlorhexidine as the antiseptic. The components of ATS-Barium are outlined in Table 2. The Tables referred to in this decision are reproduced in Annex B to this decision. The specification describes in vivo studies done in cows where ATS-Barium is compared with Teatseal^TM, an internal teat seal product marketed by Pfizer Animal Health.[35] The specification does not describe the contents of Teatseal^TM. Dr Page in his declaration states that Teatseal^TM has been registered by Pfizer Animal Health, under registration number A7294, for sale in New Zealand since 8 January 1997.[36] Teatseal^TM A7294 contains bismuth nitrate in an oily base. Dr Page also states that, the Australian equivalent product, Teatseal^TM, has been registered by Zoetis Australia Pty Ltd, under the product number 51357, since 19 December 2001.[37] Dr Page stated that Pfizer changed the name of its animal health division to Zoetis.[38] I understand Teatseal^TM that is used in the specification to contain bismuth nitrate in an oily base.
[35] Examples 5 and 6 of the present specification.
[36] Page #1 at [85] which refers to a copy of the products details from “The New Zealand Index of Veterinary Specialities Annual” 2007 Edition that has been filed as Exhibit SWP-21(i).
[37] Page #1 at [90] which refers to a copy of the product information from the Australian Pesticides and Veterinary Medicines Authority (APVMA) that has been filed as Exhibit SWP-21(ii).
[38] Page #1 at [300].
Bayer NZ submitted that the results from Figures 7 and 10, and Tables 11, 12 and 14 show that ATS-Barium is an improved formulation compared to Teatseal^TM. The Figures referred to in this decision are reproduced in Annex C to this decision.
The specification states that:
“Figure 7 shows examination scores for clinical Mastitis on days post treatment (i.e. during the dry period). Tables 9 to 14 below outline various data from the assessments made……. Table 11 shows a summary of microbiological culture results of all quarters including those previously treated, post-calving. Table 12 shows a summary of microbiological culture results, all quarters including those previously treated post-calving……. Table 14 shows an average Somatic Cell Counts, all quarters including those previously treated at calving”[39]
and
“Figure 10 shows the average clinical score per group”[40]
[39] The present specification at page 37.
[40] The present specification at page 21.
In regard to Figure 7, the combined udder mean scores have been assessed by an experienced dairy technician[41] using the parameters outlined in Table 8 — these being ratings for pain and distress of the cow. The specification states:
“A score of 3 was determined to be the score for calling an udder as mastitic. Allowance was made by the experienced person during examinations for any udder enlargement taking place as part of the normal drying-off process.
Any affected quarter that was found with a score of 3 or over was determined to be clinical mastitis and subsequently treated.” [42] (Emphasis added)
[41] The present specification at page 34.
[42] The present specification at page 35.
At the oral hearing Bayer NZ observed, in regard to Figure 7, that the graph for ATS-Barium showed combined udder mean scores that was reduced compared to Teatseal^TM, and therefore it was submitted that ATS-Barium is an improved formulation compared to Teatseal^TM. The submission was said to be supported by the greater number of negative results for ATS-Barium observed from microbiological culture results post-calving as shown in Tables 11 and 12. Bayer NZ also observed that the average somatic cell counts (SCC) as shown in Table 14 was lower for ATS-Barium compared to Teatseal^TM and submitted that the lower SCC is an indication of lower subclinical mastitis infection.
In regard to Figure 10, Bayer NZ observed that the graph for ATS-Barium showed average daily clinical scores per group that was reduced compared to Teatseal^TM and therefore it was submitted that ATS-Barium is an improved formulation compared to Teatseal^TM. At the oral hearing, Bayer NZ informed me that the bar graphs from the outermost graph to the innermost graph represent cows treated with barium and chlorhexidine (ATS-Barium), bismuth and chlorhexidine, Teatseal^TM and control (untreated).
I note Figures 7 and 10 show scores that are well below one — that is, scores that are well below those described in the specification for calling an udder as mastitic, or for a finding of clinical mastitis. I consider the results of Figures 7 and 10 describe ATS-Barium as an alternative formulation to Teatseal^TM for the prevention of mastitis.
Merial submitted in response that (1) the results shown in Tables 9 and 10, suggested no superiority of ATS-Barium compared to Teatseal^TM, (2) the results shown in Table 11 suggested that ATS-Barium is broadly equivalent to Teatseal^TM, and (3) the greater number of negative results in Table 12 for ATS-Barium compared to Teatseal^TM is undermined by the number of contaminated cultures.
I consider the results in Tables 9, 10 and 12 describe ATS-Barium as an alternative formulation to Teatseal^TM for the prevention of mastitis.
Merial also submitted that the results shown in Table 16:
“suggests that the rates of clinical mastitis up to 30 days post calving were actually higher for the cows treated with the claimed invention (although the test group was smaller). Dr Page concludes that:
the ATS-Barium product did not perform in a superior way to Teatseal™, in fact it was numerically inferior to the commercial product.
As found in two studies, one a challenge study and one a field study, which compared the invention with a commercial teat seal, Teatseal™, no advantage with respect to reduced incidence of mastitis was observed.
It is also important to note that there were no cases of clinical mastitis during the dry period in any of the three groups i.e. ATS-Barium, Teatseal™ or control (no treatment).”[43]
[43] The opponent’s written submissions, dated 20 March 2017, at [50] which refers to the evidence of its expert witness, Dr Page, Page #1 [254]-[256].
I also note that under the heading ‘Results — incidence of clinical mastitis’, the specification states:
“The incidence of clinical mastitis per group and in total up to 30 days post calving is shown in Table 16 and Figure 8. The number of cows with clinical mastitis between ATS-Barium and Teatseal did not differ significantly (p=0.176), while there is a statistical difference between the ATS-Barium and non-treated control group (p=0.044). The data of clinical mastitis is based on cases occurring in the early period post-calving. There were no cases of clinical mastitis during the dry period in any of the groups.”[44] (Emphasis added)
[44] The present specification at page 41.
From the quote above, I understand the inventors considered that the results in Table 16 and Figure 8 show no statistically significant difference for the incidence of clinical mastitis when ATS-Barium is compared to Teatseal™. I understand that the period analysed in Table 16 and Figure 8 includes up to 30 days post calving — that is, a period that includes time extending past the dry period — and that there was no clinical mastitis during the dry period for cows using ATS-Barium and Teatseal™.
I am satisfied that the specification describes ATS-Barium as an alternative formulation to Teatseal^TM for the prevention of mastitis.
The invention as claimed
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification”[45]
[45] [2009] FCAFC 70 at [118] – [120]; 81 IPR 228.
Claim 1 is an independent claim. It reads:
“A single formulation when used for administration to the teat canal or/and lower portion of the teat cistern of a mammary gland of an animal for the prevention of mastitis, wherein the formulation is in the form of a paste, the formulation including:
an oil-based physical barrier material which is able to form a cohesive mass in the teat canal and/or the lower portion of the teat cistern, and
at least one antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic.”
Is claim 1 a product claim or a process claim?
Bayer NZ submitted that claim 1 is a product claim.[46] At the oral hearing, Merial endorsed the characterisation of Bayer NZ that claim 1 is a product claim, and submitted that claim 1 may be anticipated by a description of a prior art product, whether or not that description described the application of the product . Whilst both parties construe claim 1 as a product claim, they differ in their interpretation of the amount of antiseptic that is included within the scope of “sufficient quantity to act effectively as an antiseptic”.
[46] The applicant’s written submissions, dated 24 March 2017, at [29].
The first question I need to ask is whether claim 1 is directed to a formulation (and therefore, a product itself) that is being used in the process recited in the claim, or directed to a process of using the formulation. In other words, what is the meaning of the “when used” part of claim 1.
Merial submitted at the oral hearing that the “when used” language means that the formulation must be suitable for the use identified. I do not agree. The High Court considered the scope of a "when used" claim (without using that term) in Wellcome Foundation Ltd v Commissioner of Patents,[47] which came before the Court as a special case stated by the Chief Justice. The Court stated at 529:
“… there is no distinction between the claim to the process and the claim to the substance when the substance claim is limited to its use in the process.”
[47] [1980] HCA 21; 145 CLR 520.
The term “when used” read in the context of claim 1 limits the formulation to use in the environment where the specified use is taking place — that is in the animal when the formulation is administered. I consider that the acts that would fall within the scope of a claim to a formulation of present claim 1 when used for the prevention of mastitis, are the same as the acts that fall within a claim to a process for the prevention of mastitis by using the formulation. I consider that claim 1 (and all the appended claims that are directed to a formulation) define a process for the prevention of mastitis by administration of a formulation to the teat canal or/and lower portion of the teat cistern of a mammary gland of an animal.
Does claim 1 require any limitation to the extent of prevention of mastitis?
Now I will consider the phrase “for the prevention of mastitis”. Merial submitted that since the word “prevent” encompasses hindering the spread of infection, the scope of claim 1 includes cases where prevention of the infection is not entirely effective — that is, an infection may merely be hindered but not averted.[48] Adopting the definition of “prevent” provided in the specification (a definition I previously found to be a plain meaning of the word), I agree that claim 1 includes within its scope cases where use of the formulation merely hinders mastitis infection but is not entirely effective in preventing the infection. However, claim 1 does not require any limitation to the extent of prevention of mastitis. Therefore, I consider that claim 1 encompasses within its scope cases where an infection is averted to various degrees including ameliorating the infection.
What feature of claim 1 prevents mastitis? Is it the overall formulation, or the antiseptic compound?
[48] The opponent’s written submissions, dated 20 March 2017, at [35].
Merial submitted that even if the “when used” language imposes a requirement that there be an effect in vivo in terms of the prevention of mastitis:
- Claim 1 requires that it is the overall formulation that must have that effect; and
- Claim 1 does not require that the antiseptic effect must be responsible for, or must contribute to any particular extent to, the prevention of mastitis.
I will consider what claim 1 defines to provide the effect of preventing mastitis: is it the overall formulation or the antiseptic compound of the formulation?
Claim 1 defines use of a “single formulation”. Adopting a plain meaning of the words, the term is construed to mean all the components of the formulation are combined together into one formulation. Claim 1 defines a single formulation that includes the following two components: an oil-based physical barrier material, and at least one antiseptic compound. The antiseptic compound is mixed with the physical barrier material. Since it is the single formulation of claim 1 that is administered to the animal, I interpret that claim 1 requires the overall formulation to provide the effect of preventing mastitis in an in vivo environment of the animal. This interpretation is consistent with the description in the specification that the opposed invention provides an effective physical and chemical barrier across the teat canal or/and lower portion of the teat cistern — this barrier described to either prevent the passage of micro-organisms into the teat cistern, or treat those that are present in the cistern. My interpretation also means claim 1 does not require the antiseptic compound to contribute to any particular extent to the prevention of mastitis.
An oil-based physical barrier material which is able to form a cohesive mass in the teat canal and/or the lower portion of the teat cistern
Now I will consider the phrase “an oil-based physical barrier material which is able to form a cohesive mass in the teat canal and/or the lower portion of the teat cistern”. The “physical barrier material” is a technical term that the person skilled in the art would understand in the context of a function of a component included to make a formulation. The specification describes the formulation to provide an effective barrier which prevents the passage of micro-organisms through the teat canal and/or teat cistern. Therefore, construing the phrase in the context of the specification, the physical barrier material is an oil-base material which is able to be moulded into a cohesive mass to seal off the teat canal and/or lower portion of the teat cistern.
How is the assessment made as to whether a quantity of antiseptic compound acts effectively as an antiseptic?
Now I will consider the phrase “at least one antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic”. The question I need to ask myself is how an assessment would be made as to whether a quantity of antiseptic compound acts effectively as an antiseptic. Would the quantity of antiseptic be an amount assessed:
·using experiments on animals where the formulation is administered to the teat canal and/or lower portion of the teat cistern of the animal — that is, in vivo in the animal? or
·using in vitro methods where the formulation is assessed using in vitro methods relied on by a person skilled in the art to determine what amount of antiseptic in a paste formulation constitutes an amount that acts effectively as an antiseptic— that is, in vitro by methods known to the skilled person? or
·using either in vivo experiments in the animal or in vitro by methods known to the skilled person?
Having regard to the context of the words in the claim, I consider both in vivo and in vitro methods of assessment equally valid because:
·since I have previously found claim 1 to be a process claim, it is a reasonable construction that the scope of claim 1 includes a quantity of antiseptic that acts effectively as an antiseptic as assessed in vivo in the animal; and
·the arrangement of the words in claim 1 can be read with an emphasis placed on the formulation itself having an antiseptic property, and the quantity of antiseptic that is “sufficient quantity to act effectively as an antiseptic” is determined by the skilled person using in vitro methods known to them— these methods include in vitro microbiological plate assays which mimic the conditions in vivo.
The question of what amount of antiseptic is encompassed within the scope of “sufficient quantity to act effectively as an antiseptic” is a question of fact.

The specification of the opposed application itself uses in vitro assays to assess the antiseptic effect of chlorhexidine on bacteria— these being, an agar diffusion test[49] (which uses a zone of inhibition observed on agar to assess the extent of bactericidal effect) and the direct inoculation[50] (which uses the viability of bacteria cultured in vitro to assess the extent of bacteriostatic effect). The methods that the expert witnesses of both parties used for determining whether a particular quantity of antiseptic is a sufficient quantity to act effectively as antiseptic included in vitro microbiological plate assays which mimic the conditions in vivo.[51]
[49] Example 3 and Figure 1 of the present specification.
[50] Example 3 and Tables 4 and 5 of the present specification.
[51] A sandwich agar test plate is described in a journal article authored by A. J. Bradley, entitled “A Study of the Anti-infective Properties of TeatSeal™ Formulations in the Presence and Absence of Acriflavine” and filed in this opposition and referred to as D7. The configuration of the sandwich agar test plate is discussed below in this decision. A study done by Professor Trott and commissioned by Dr Page (an expert witness of Merial) uses agar tests plates identical to that described in D7. Dr Grayson and Mr Ahmed (expert witnesses of Bayer NZ) use the agar diffusion tests plates (zone of inhibition) described in the opposed application. The configuration of the agar diffusion tests plates (zone of inhibition) is discussed below in this decision.
Therefore, I conclude that the quantity of antiseptic compound defined in claim 1 includes a quantity that provides an antiseptic effect in an in vivo environment of the animal, or a quantity determined by a skilled person using in vitro methods known to them. My conclusion is consistent with my previous findings that (1) claim 1 requires no limitation that the antiseptic compound contributes to any particular extent to the prevention of mastitis, (2) claim 1 requires no limitation to the extent of prevention of mastitis and (3) it is the overall formulation of claim 1 that provides an effective physical and chemical barrier to either prevent the passage of micro-organisms into the teat cistern, or treat those that are present in the cistern.
What is the extent of antiseptic effect required?
Merial submitted that the definition of “antiseptic” in the specification does not require the antiseptic to have a bactericidal action, and a bacteriostatic action is sufficient to hinder (which is included within the scope of “prevent”) the spread of infection:
“Although the claims use the phrase ‘to act effectively as an antiseptic’, its meaning is not clearly defined by or apparent from the claims. Some guidance is provided in the body of the specification, at page 7, lines 19-23, which states:
The term 'antiseptic' or grammatical variations thereof refers to any agent that kills or prevents the spreading of infectious organisms in order to prevent the spread of infections. Antiseptics are generally applied to the external surface tissue. Whereas the term 'antibiotic' refers to a drug that treats infections internally within the body.
This definition of antiseptic does not require that the antiseptic have bactericidal action (that is, that that [sic] the antiseptic kills and prevents the spreading of infectious organisms). The antiseptic may only have bacteriostatic action (that is, it may simply prevent, or hinder, the spread of infectious organisms). The actual quantity of antiseptic required to act effectively as an antiseptic will depend on the properties of the antiseptic and whether bactericidal or bacteriostatic effect is intended. The applicant’s expert, Dr Bunt, construes the term similarly.
The claims do not provide any guidance on what might constitute a ‘sufficient quantity’ of antiseptic, but it is apparent from Table 1 that the exemplified antiseptic, chlorhexidine, is included in the invention in the amount of 0.15 – 0.5% w/w (equivalent to 1500-5000 μg/mL). The Application on page 25, lines 18 to page 26, line 2 states:
Chlorhexidine at higher concentrations (>100 μg/ml) acts as a bactericide to most of the bacteria. At lower concentrations chlorhexidine (1-100 μg/ml ) acts as a bacteriostatic agent (European Medicines Agency: EMEA).
Ideally, the formulation should contain such amount of chlorhexidine that after administration into the teat canal or / and lower portion of teat cistern, it will have a bactericidal concentration. An excessive higher concentration should be avoided as it will cause tissue irritation along with adding to the cost of the formulation.
It is apparent from this wording that a bactericidal concentration is a preferred but not essential feature of the invention, and that a composition which contains a bacteriostatic concentration will also fall within the scope of the claims. That is also apparent from Example 3, and the formulations described in Table 3. Page 29 of the Application explains that formulations made with chlorhexidine salt (including, for example, formulation F16-1) produced a bacteriostatic rather than a bactericidal effect. It follows, therefore, that an antiseptic which is present in a quantity sufficient to produce a bacteriostatic effect will be an “antiseptic compound … in sufficient quantity to act effectively as an antiseptic”. Dr Petrovski’s contrary reading (that the agent must kill bacteria) is not supported by the language of the definition or the specification.”[52]
[52] The opponent’s written submissions, dated 20 March 2017, at [37]-[40].
Bayer NZ submitted the following:
“‘Sufficient quantity to act effectively as an antiseptic’ means that the amount of antiseptic in the formulation and rate at which it is released is such that, once released to the area adjacent to the formulation, it is able to exert either a bactericidal (ie killing) or bacteriostatic (ie inhibiting) effect upon microbes at or very near the site of administration. In the case of a cow that site is the teat canal and/or lower portion of the teat cistern. [references are made to Bunt at [15.6], Petrovski at [43.4]]
The amount at or very near the site of administration will depend on the choice and concentration of antiseptic compound and how easily (and at what rate) it is released from the teat seal formulation. [reference is made to Bunt at [15.7]]
The critical consideration is whether a therapeutically effective bactericidal or bacteriostatic effect can be observed in vivo and that will depend on the above factors (ie type and concentration of antiseptic, amount of release and rate of release from the teat seal formulation) as well as the extent to which the antiseptic may be rendered ineffective by the environment into which it is released and or by its subsequent distribution around the body. [reference is made to Bunt at [15.11], Petrovski at [51.1][53]]
There is no inconsistency between the evidence of Dr Bunt and Dr Petrovski on this issue. Construed purposively, this integer of claim 1 requires the teat seal to exhibit a meaningful antibacterial effect on pathogens which cause mastitis so that their growth is prevented or inhibited to produce a therapeutic outcome. In preferred embodiments the effect will be bacteriostatic.”[54]
[53] There appears to be a typographical error in the paragraph reference to Dr Petrovski’s declaration, and the appropriate reference is Petrovski at [54.1].
[54] The applicant’s written submissions, dated 24 March 2017, at [30.7]-[30.10].
From the quotes above, I understand both parties accept the scope of “sufficient quantity to act effectively as an antiseptic” includes an amount of antiseptic that has a bactericidal (kills bacteria) effect and a bacteriostatic (inhibits bacteria) effect. This interpretation is consistent with the statements regarding chlorhexidine (antiseptic) of Example 3, acting as a bactericide at higher concentrations, and as a bacteriostatic agent at lower concentrations. Therefore, I am satisfied the scope of the amount of antiseptic in the formulation of claim 1 includes an amount that is bactericidal and an amount that is bacteriostatic against bacteria.
In regard to Example 3, page 25 of the specification states that chlorhexidine at the higher concentrations acts as a bactericide to most of the bacteria. I interpret the statement to mean that a particular amount of antiseptic can produce a bactericidal effect on one or more types of bacteria but not necessarily on all types of bacteria. In other words, I understand that the effectiveness of a particular amount of the antiseptic depends on the types of bacteria being acted upon. My interpretation is consistent with the statement in regard to Example 3 on page 30 of the specification that S. pyogenes is more sensitive to chlorhexidine than S. aureus. Therefore, I consider that claim 1 includes within its scope an amount of antiseptic that provides a bactericidal effect on one or more bacteria types but not necessarily all bacteria types.
Does the scope of claim 1 include a formulation that performs better than an existing formulation?
At the oral hearing Merial submitted that:
- the quantity of antiseptic that provides a preservative effect in the formulation is an amount that is “sufficient quantity to act effectively as an antiseptic”;
- Claim 1 does not state that the effects of the antiseptic must be “therapeutically meaningful” to the animal, does not identify any standard as to what would be therapeutically meaningful, and the description does not enable any way of assessing what would constitute a therapeutically meaningful amount;
- the claim does not require that the formulation must perform better than the formulation that does not contain an antiseptic compound — that is, there is no requirement in the claim that the formulation of the opposed application is an improved formulation;[55] and
- The “purposive” construction of the claims submitted by Bayer NZ is unclear, indeterminate and not open to principles of construction, and if adopted would lead to one or more of lack of utility, insufficiency, lack of fair basis, and lack of clarity which the Commissioner can have regard to under s 60(3) of the Act.
From Bayer NZ’s submissions quoted above at [61], I understand Bayer NZ contends for an interpretation that the quantity of antiseptic encompassed within the scope of claim 1 is an amount that must provide an antiseptic effect in the in vivo environment of the animal in order to be “therapeutically meaningful”. On the other hand, I understand Merial contends for an interpretation that the quantity of antiseptic encompassed within the scope of claim 1 only needs to act as a preservative of the formulation.
As discussed above, the effectiveness of a particular amount of the antiseptic compound depends on the types of bacteria being acted upon. I accept, from the following statement of Dr Bunt, that the effectiveness of the amount of antiseptic is also affected by the environment the antiseptic is placed in:
“The critical consideration is whether a bactericidal or bacteriostatic effect can be observed in vivo and that will depend on the above factors (ie type and concentration of antiseptic, amount of release and rate of release from the teat seal formulation) as well as the extent to which the antiseptic may be rendered ineffective by the environment into which it is released. Since antiseptics are charged they will adhere to the surface of oppositely charged particles rendering them ineffective. In the teat canal such oppositely charged particles will include milk, plasma, tissue cells and proteins. Experimenting with different types and concentrations of antiseptics to achieve a particular release profile / rate form [sic] a particular medium is within the skill set of most formulators and would not be a difficult task once the idea of using an antiseptic within an internal teat seal for its antiseptic effect has been conceived.”[56]
[56] Bunt at [15.11].
From Dr Bunt’s statement above I am satisfied that the person skilled in the art would understand how to vary the formulation of claim 1 to modify the effectiveness of antiseptic effect in vivo. I can see no reason why the scope of claim 1 cannot include a formulation that performs better (that is, more efficacious) than an existing formulation. The words of claim 1 do not require any such limitation. The efficacy of preferred embodiments does not limit the scope of claim 1. I consider that it would be reasonable to expect a person skilled in the art to desire a formulation that performs better, but it would be acceptable to them if they could provide an alternative formulation that has equivalent efficacy compared to existing formulations. This consideration is consistent with my previous finding that the opposed application aims to provide at least an alternative formulation. I am satisfied that the scope of claim 1 includes a formulation that has equivalent efficacy, or performs better, compared to an existing formulation.
Claim 1
In summary, claim 1 is directed to a process. The process defines the use of a single formulation in the environment of the teat canal or/and lower portion of the teat cistern of a mammary gland of an animal for the prevention of mastitis. The single formulation includes an oil-based physical barrier material and at least one antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic. It is the single formulation that provides the effect of preventing mastitis in an in vivo environment of the animal. The scope of prevention includes cases where use of the formulation merely hinders mastitis infection but is not entirely effective in preventing the infection. The quantity of antiseptic in the formulation required by the words of the claim is a quantity that provides a bacteriostatic or bactericidal effect, as assessed either in an in vivo environment of the animal or by an in vitro assay. The scope of claim 1 includes an amount of antiseptic that provides a bactericidal effect on one or more bacteria types but not necessarily all bacteria types.
Omnibus claims
I will now consider the interpretation of the omnibus claims.
Claim 14 reads:
“The formulation substantially as herein described with reference to Tables 1-3 of the ‘Best Modes’ section.”
Claim 14 is directed to a formulation as recited in the claim. Claim 14 is therefore a product claim. The scope of the formulations of claim 14 is limited to the formulations described in Tables 1-3 of the specification. These formulations have chlorhexidine (base or hydrochloride salt) as the antiseptic and barium sulphate as the physical barrier material.
Claim 15 reads:
“The use of a formulation substantially as herein described with reference to and as illustrated by Examples 3-6 of the ‘Best Modes’ section.”
Claim 15 is directed to the use of a formulation as recited in the claim and is a process claim. The process is limited to processes exemplified in Examples 3-6 of the specification. The formulations used in these examples have chlorhexidine (base or hydrochloride salt) as the antiseptic and barium sulphate as the physical barrier material.
Claim 16 reads:
“A method substantially as herein described with reference to and as illustrated by Examples 1 and 2 of the ‘Best Modes’ section.”
Claim 16 is directed to a process that is limited to processes that use the formulation exemplified in Examples 1 and 2. The formulations used in these examples have chlorhexidine (base or hydrochloride salt) as the antiseptic and barium sulphate as the physical barrier material.
Novelty
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 taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd:

“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”[57]

[57] [1977] HCA 19 at [20]; 137 CLR 228 at 235.

This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed.[58]
[58] Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] 91 ALR 513 at 517; 16 IPR 545.
Australian courts have often identified the principles of the UK Court of Appeal in The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited[59] (the General Tire case) as the criteria for determining anticipation by a prior publication. Most relevantly, to anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented.
[59] [1972] RPC 457 at 485 – 486.
The disclosure necessary to support the ground of lack of novelty has also variously been described as “planting the flag” (ICI Chemicals & Polymers Ltd v The Lubrizol Corporation Inc[60]), "the accuracy of a sniper, not the firing of a 12 gauge shotgun" (Apotex Pty Ltd v Sanofi-Aventis[61]) or "what a prior art document teaches" as distinct from "what might be 'included' or 'encompassed in' a prior art document" (Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3)[62]). These various descriptions of the disclosure necessary to support lack of novelty emphasised that there is a degree of specificity that is required.
[60] [2000] FCA 1349 at [51]; 106 FCR 214, citing the General Tire case at [485]-[486].
[61] [2008] FCA 1194; 78 IPR 485 at [91].
[62] [2011] FCA 846; 92 IPR 320 at [180].
Merial relies on the following five citations to allege lack of novelty:
1. GB 2,273,441 (D1);
2. NZ 258199 (D1A);
3. GB 1,441,747 (D3);
4. Meaney, W. J. Effect of a dry period teat seal on bovine udder infection, Ir. J. Agric. Res. 16: 293, 1977 (D5);
5. AJ Bradley, A Study of the Anti-infective Properties of TeatSeal™ Formulations in the Presence and Absence of Acriflavine (D7).
Before analysing the disclosure of the citations, it is worthwhile considering the question of inherency. A consideration of inherency is important because the parties differ on whether there is sufficient disclosure in the prior art in regard to an antiseptic “in sufficient quantity to act effectively as an antiseptic”. It is sufficient to establish lack of novelty if the working of the process of the prior art disclosure would in fact carry out the process of the claims of the opposed application, even if that fact is not apparent on the face of the prior art disclosure.[63] It is a question of fact whether the amount of antiseptic disclosed in a prior art citation is sufficient to have bacteriostatic or bactericidal effect, as assessed either in an in vivo environment of the animal or by an in vitro assay. Since the answer to this factual question is one that leads directly to a conclusion of lack of novelty, the facts must be proved to a level of practical certainty.[64]
[63] Novozymes A/S v Danisco A/S [2013] FCAFC 6 as per Jessup J; 99 IPR 417.
[64] Aspirating IP Limited v Vision Systems Limited, [2010] FCA 1061 at [35]; 88 IPR 52.
GB 2,273,441 (D1) and NZ 258199 (D1A)
D1A is the New Zealand equivalent of D1. The disclosure of D1 and D1A is similar even though the claim set of each citation is different. D1 was published on 22 June 1994. D1A was published on 29 January 1997. Consequently, both D1 and D1A are part of the prior art base.

Each of D1 and D1A, separately, disclose a veterinary composition for treating mastitis in dry cows. The composition is disclosed to comprise an antibiotic composition which is infused into the udder of the cow, and a teat seal formulation which is sequentially administered to seal the teat canal. The teat seal formulation is disclosed to provide a physical barrier in the teat canal to prevent the ingress of pathogens. In some embodiments, the teat seal formulation was administered without the administration of the antibiotic. The teat seal formulation, injector type 2A, used in study 1 and study 2 (of both D1 and D1A) are examples where an antibiotic was not administered. Injector type 2A is disclosed to be co-administered with an antibiotic in study 3.
Each of D1 and D1A disclose three teat seal formulations that are termed injector type 2A. Each of the three formulations is a gel having a different yield value (a measure of fluidity relative to the gel) and comprises liquid paraffin, aluminium monostearate, bismuth subnitrate and acriflavine. Acriflavine is included at a concentration of 0.1% w/w in all three formulations. Acriflavine is disclosed to be a pigment in D1 or D1A. Both citations do not make an explicit disclosure that acriflavine is an antiseptic.
Dr Bunt and Dr Petrovski state that acriflavine is not present in sufficient concentrations in D1 and D1A to act as an antiseptic and is being used as a pigment or preservative.[65]
Does 0.1% (w/w) acriflavine in the teat seal formulations of D1 and D1A fall within the scope of “sufficient quantity to act effectively as an antiseptic” of claim 1?
[65] Bunt at [39]; Petrovski at [65].
The question relevant for the issue of novelty in the context of the opposed application is this: does a concentration of 0.1% (w/w) acriflavine in the teat seal formulations of D1 and D1A fall within the scope of “sufficient quantity to act effectively as an antiseptic” of claim 1. If the answer is ‘yes’ then claim 1 is anticipated even if acriflavine has not been disclosed in the citation as an antiseptic, and even if an antibiotic is used at the same time. This is because it is a question of fact whether acriflavine at a concentration of 0.1% w/w in the teat seal formulations of D1 and D1A is sufficient to have a bacteriostatic or bactericidal effect, as assessed either in an in vivo environment of the animal or by an in vitro assay. I will therefore consider what the expert witnesses say regarding the antiseptic effect of acriflavine on bacteria.
In vitro assays: Trott Study and Bayer NZ’s study
Dr Page states:
“The minimum inhibitory concentration and minimum bactericidal concentration of acriflavine against Staphylococcus aureus has been well documented. See for example, the article by Gavini et al., Mucoadhesive vaginal tablets as veterinary delivery system for the controlled release of an antimicrobial drug, acriflavine; AAPS Pharm Sci 2002, 3(3) Article 20. Now shown to me and marked Exhibit SWP-18.
Table 2. MIC (MBC) Values in μg.mL^-1.*

(Exhibit SWP-18, page 3, Table 2)
Staphylococcus aureus (S aureus) identified in this table is one of the most common causes of mastitis in dairy cattle. This fact has been common general knowledge for more than 50 years. This is further reinforced by numerous other publications, see for example Noguchi et al., Antiseptic susceptibility and distribution of antiseptic-resistance genes in methicillin-resistant Staphylococcus aureus; FEMS Microbiology Letters, 172(2), 247-253, (1999). Noguchi et al. found that the minimum inhibitory concentration (MIC) of acriflavine against methicillin resistant Staphylococcus aureus (MRSA) was as low as 3.13 mg/L. Now shown to me and marked Exhibit SWP-19 is a copy of this document.”[66]
[66] Page #1 at [82]-[83].
Bayer NZ submitted at the oral hearing that the MIC of acriflavine against S. aureus, this being 19 µg/ml, was not part of common general knowledge (CGK).
Merial submitted at the oral hearing that it is not necessary for Merial’s case that the MIC of acriflavine be information that is part of the CGK. Merial relies on the MIC not as information that was available to the person skilled in the art, but rather as a scientific fact that supports a finding that the concentrations of acriflavine in the prior art teat seal formulations, including formulations disclosed in D1, are “antiseptically effective”. Merial submitted that since the concentration of acriflavine disclosed in D1 is more than 50 times higher than both the MIC and MBC against the common mastitis causing pathogen, S. aureus, the amount of acriflavine disclosed in D1 would on any view be “antiseptically effective”.[67]
[67] The 0.1% w/w concentration of acriflavine disclosed in D1 is equivalent to 1000 µg/ml. Using a MIC or MBC of 19 µg/ml — this value obtained from Gavini et al., AAPS Pharm Sci 2002, 3(3) Article 20 — against the common mastitis causing pathogen, S. aureus, D1 was therefore calculated to disclose an acriflavine concentration more than 50 times higher the MIC or MBC against S. aureus.
At the oral hearing Bayer NZ referred me to the study commissioned by Dr Page[68] and done by Professor Trott. In this study the growth of bacteria on agar plates which included commercially available TeatSeal^TM was compared to the growth of bacteria on agar plates which included TeatSeal^TM and 0.1% (w/w) acriflavine.[69] Referring to Table 1, which is reproduced below, Bayer NZ submitted that the Trott study showed 0.1% (w/w) acriflavine in a teat seal formulation produced no inhibition of growth of S. aureus and S. uberis isolates. I note that the S. aureus isolate used in the Trott study has an MIC of 16 µg/ml which is a similar MIC to the one reported in the above-mentioned Gavini et al. article.
The plates were scored as follows:
[68] Page #1 at [129].
[69] A report of a study entitled “Determination of antimicrobial activity of acriflavine when mixed with a commercial teat seal product” undertaken by Professor Darren Trott of the University of Adelaide, South Australia, was filed as Exhibit SWP-34 in this opposition.
Merial submitted that of the 18 isolates the study reported on, five isolates were inhibited by TeatSeal^TM with acriflavine and there was no inhibition with TeatSeal^TM alone. On the basis of the Trott study, Dr Page concluded that acriflavine is a very potent antimicrobial agent against all tested isolates which included three species isolated from cattle with mastitis (Streptococcus uberis, Corynebacterium spp. and coagulase negative staphylococci (CoNS)) and two reference species (Staphylococcus aureus and Escherichia coli).[70]
[70] Page #1 at [144].
Dr Bunt stated that the test agar plates used in the Trott study are less suited to determining whether acriflavine would have a bactericidal or bacteriostatic effect in vivo compared to the agar diffusion test (zone of inhibition) used in the opposed application and by the expert witnesses of Bayer NZ.[71]
[71] Bunt at [38.4].
An illustration of the test agar plates used in the Trott study, reproduced from Professor Trott’s report, is shown below:[72]
I note that the configuration test agar plates used in the Trott study are identical to those disclosed in the prior art citation (D7) authored by A. J. Bradley, entitled “A Study of the Anti-infective Properties of TeatSeal™ Formulations in the Presence and Absence of Acriflavine”.
[72] Figure 1 of Exhibit SWP-34.
Dr Page states the following in regard to the test agar plates of D7:[73]
“Conventional microbiological techniques to assess the antimicrobial activity of the two test preparations were applied on test agar plates. A series of plates were inoculated with individual mastitis pathogens and the plates were incubated for twenty-four hours followed by inspection to look for growth characteristics. It was observed that the commercially available TeatSeal^TM that contained no acriflavine did not prevent the growth of any of the pathogens. However, many of the plates containing TeatSeal^TM combined with 0.1% w/w acriflavine had obvious zones of inhibition of each of the mastitis pathogens. I consider that the methods used to investigate the antimicrobial activity are minor modifications of conventional methods well known to the assessment of antimicrobial ointments, pastes, and other semi-solid dosage forms.”
[73] Page #1 at [110].
From Dr Page’s statements quoted above, I understand that the test agar plates used in the Trott study (and D7) would be considered a minor modification of a conventional method that a person skilled in the art would use to assess the antiseptic effect of a paste formulation.
The following is an illustration of the agar diffusion test agar plates of the opposed application:
Dr Bunt states that because the teat seal formulation is spread thinly and widely on the test strip of the agar test plates of the Trott study, the method is likely to use a greater volume of teat seal formulation compared to the agar diffusion test agar plates. In the latter method, a disc was cut from the agar and the teat seal formulation is dispensed into the well.[74] The diameter of the zone of inhibition was measured to the first bacteria colonies observed around the disc. Dr Bunt states that in the tests of the Trott study:
“the surface area is significantly increased making diffusion from the material easier and likely to occur much more rapidly than from a plug of material with a smaller surface area as would be used in zone of inhibition testing. In vivo internal teat seals are applied as a solid plug making the zone of inhibition test a better approximation of how the sample will perform in vivo;…”[75]
[74] Present specification at pages 26-27.
[75] Bunt at [38.1]. I note that in this paragraph Dr Bunt refers to the sandwich agar test plates disclosed in D7. The configuration of the agar test plates of D7 is very similar to the test agar plates used in the Trott study. At [38.4], Dr Bunt states that the issues that arise with the Trott study are the same as those he states for the sandwich agar test plates of D7.
I accept that the above-mentioned differences exist in the configurations of the test plates. However, I consider that both configurations of test plates described above are approximations a person skilled in the art would use to mimic in vivo conditions to test the antiseptic effect of acriflavine of a paste formulation. I consider the agar test plate of the Trott study and the agar diffusion tests (zone of inhibition) of the opposed application (and Bayer NZ’s expert witnesses) are both suitable methods that inform me whether a quantity of antiseptic provides a bacteriostatic or bactericidal effect, as assessed by an in vitro assay.
The agar diffusion tests (zone of inhibition) commissioned on Bayer NZ’s behalf are detailed in the declarations of Dr Grayson and Mr Ahmed (Bayer NZ’s agar test study). The tests were done using Pfizer’s TeatSeal^TM product that is marketed in New Zealand. Acriflavine hydrocholoride or acriflavine base was added to Pfizer’s TeatSeal^TM product to a concentration of 0.1% (w/w). The test organism used was described as Streptococcus uberis. The test showed no antiseptic effect from samples containing either form of acriflavine on the test organism used.
Merial submitted that the results detailed by Dr Grayson and Mr Ahmed are deficient for several reasons, of which I consider the following most relevant:
- there are no experimental details of the acriflavine used other than a product number, batch number and the supplier. In particular, it is not clear whether the acriflavine used had some antimicrobial effect when tested directly on the test organisms, and without this information the test is not validated or reliable;[76]
- the documentation does not properly identify the bacterial isolate tested; or seek to identify the sensitivity of the isolate tested, although this is critical to establishing the validity of the test;[77] and
- only one test organism is used and one that is uncharacterised as to source and microbiological properties. No meaningful conclusion can therefore be reached from these studies as any results, either negative or positive, may have been influenced by the particular test organism i.e. presence of antimicrobial resistance.[78]
[76] Page #2 at [11], [14].
[77] Page #2 at [14], [19(i)], [19(ii)].
[78] Page #2 at [19(ii)].
I observe from Table 1 of the Trott study that some bacteria isolates, including those within the S. uberis species, are more susceptible to acriflavine than others. The Bayer NZ results are not inconsistent with the Trott results since the Trott results show variability in acriflavine susceptibility between bacteria isolates. I am satisfied that the Trott study informs me that 0.1% (w/w) acriflavine in a teat seal formulation provides a bactericidal effect on mastitis-causing bacteria as assessed in vitro.
In vivo studies: Flynn Study
Both parties made submissions in regard to field trials conducted by Mr Jim Flynn (Flynn study).[79] The Flynn study reports on experiments done in cows where the performance of Pzifer’s TeatSeal^TM product is compared with a formulation of Pzifer’s TeatSeal^TM + 0.1% (w/w) acriflavine. The experiments used Streptococcus dysgalactiae as the challenge bacteria strain because this strain causes less damage to the udder tissue, thereby limiting stress and discomfort to the animal.
[79] A copy of the Flynn study has been filed in this opposition as Exhibit SWP-33.
Dr Page states:
“The development of new clinical infection (i.e. mastitis) in udder quarters infused with either teat seal + 0.1% acriflavine or teat seal alone after deliberate challenge with Streptococcus dysgalactiae Type M was described in Table 1 as follows:
From these results, I see that the prevalence of new clinical infections for udders treated with Teat Seal alone was 52% whereas with Teat Seal + 0.1% acriflavine there was 40%. The % difference is (52-40)/52 * 100 = 23%. In other words, the inclusion of 0.1% w/w acriflavine (an antiseptic) in the teat seal formulation provides a numerical 23% increase in the effectiveness of the teat seal
[80] Page #1 at [127]-[128].
formulation in preventing the development of mastitis.”[80]
Bayer NZ submitted that a 23% increase in the effectiveness of Pzifer’s TeatSeal^TM + 0.1% (w/w) acriflavine is an extremely selective assessment of the findings in the Flynn study.[81] Dr Bunt and Dr Petrovski both observe that the authors of the Flynn study reached a different conclusion to Dr Page.[82] The authors of the Flynn study state as their conclusions:
“The results of this trial show that, despite the absence of the anti-infective material acriflavine from the test teat seal formulation, its performance in dairy cows was equivalent to the performance of the control teat seal containing 0.1% acriflavine”.
[81] The applicant’s written submissions, dated 24 March 2017, at [120.2].
[82] Petrovski at [82]; Bunt at [38.6].
Bayer NZ submitted that:
“Bayer’s experts believe that Dr Page may have (euphemistically) ‘fallen into error’ by focussing on Table 1 (which reports on a challenge with S. dysgalactiae) and disregarding the results in Table 2 (sub-clinical infections caused by S. dysgalactiae), Table 4 (daily incidence rate for new clinical infections caused by all bacteria types) and Table 5. Table 2 is important because, if the sub-clinical infection establishes in the quarter during the dry period, it may flare-up and show as clinical mastitis during the next lactation (after calving). Table 4 is important because it takes into account infections caused by ‘wild’ strains of bacteria and therefore reports on all infections not just those caused by the challenge strain. This more accurately reflects what is likely to happen on the farm. Table 5 tallies the results of all infections
Taking these results into account both experts agree that the authors of Flynn were correct to conclude as they did and that the study demonstrates that 0.1% acriflavine is unlikely to provide any therapeutically meaningful bactericidal or bacteriostatic effect in vivo when incorporated into a teat seal product.”[83]
[83] The applicant’s written submissions, dated 24 March 2017, at [121]-[122] which refers to Petrovski at [82] and Bunt at [38.6].
I consider that it is reasonable to place greater weight on the conclusions of the authors of the Flynn study that their experiments found teat seal formulation with 0.1% (w/w) acriflavine was equivalent to teat seal formulation without acriflavine when tested in vivo in cows. The Flynn study informs me that the teat seal formulation with 0.1% (w/w) acriflavine does not provide any bactericidal or bacteriostatic effect in vivo in some cases. However, the effectiveness of acriflavine depends on the bacteria species (as shown by the Trott study), so the Flynn study does not conclusively indicate that teat seal formulation with 0.1% (w/w) acriflavine does not provide any bactericidal or bacteriostatic effect in vivo at all.
In vivo studies: Professor Whittem’s evidence
At the hearing, Merial referred me to the declaration of Professor Whittem,[84] an expert witness of Zoetis. Zoetis has withdrawn as a party opposing the present application. Merial submits Professor Whittem is an independent expert and the weight of his evidence is not undermined because he was retained by a different party. Where it is relevant to the issues in the present opposition, I can consider the evidence of Professor Whittem.
[84] A copy of Professor Whittem’s declaration, dated 03 May 2016, has been filed as Exhibit MJC-27 in the present opposition.
In the context of analysing the quantity of acriflavine contained in a teat seal formulation disclosed by GB 1,441,747 (D3), Professor Whittem stated:
“The Example on page 2 includes acriflavine, a well-known antiseptic. The quantity of acriflavine taught in the example is 0.075% which is clearly a sufficient quantity to act effectively as an antiseptic (see for example A.W. Stableforth et al. ‘Entozon and Acriflavine for the Treatment of Chronic, Contagious Bovine Mastitis’, The Veterinary Record, 1938, volume 50, pages 663 to 676 that teaches 0.01 % acriflavine is a sufficient quantity to act effectively as an antiseptic, and S.D. Johnson ‘Observations on the treatment of mastitis with acriflavine’, Cornell Vet. 1941, volume 31, pages 127 to 148 that teaches 0.025% acriflavine is a sufficient quantity to act effectively as an antiseptic for the treatment of bovine mastitis attached to this declaration as Exhibit ELBW1-8).”[85]
[85] Exhibit MJC-27 at [79].
The relevant issue for me to consider here is a question of fact: does 0.1% (w/w) acrifavine in a teat seal formulation provide a bacteriostatic or bactericidal effect in vivo in an animal? The Stableforth et al. article[86] referenced by Professor Whittem describes infusion of a 1:10,000 acriflavine solution (this being a 0.01% solution) and a 1: 1000 solution (this being a 0.1% solution) into udder quarters of cows to treat mastitis. When a 1:10,000 acriflavine solution was used, the infusion was left in the udder quarter for 24 hours (in dry cows) or 5-10 minutes (in lactating cows) before being taken out. A second method described by the article involved using a 1:10,000 acriflavine solution as outlined, followed by infusion of a 1: 1000 acriflavine solution where half of the infusion was left in the udder quarter for 2-3 minutes before being taken out and the other half left in the udder quarter for 3-4 hours before being taken out.
[86] A copy of the Stableforth et al. article has been filed as Exhibit SWP-17 in the present opposition.
The Stableforth et al. article reported when cows were treated with 1:10,000 acriflavine solution (1) 26 out of 29 quarters (nearly 90%), representing 17 out of 19 cows treated, either during the lactation or dry period, were cured for latent mastitis, and (2) 9 out of 12 quarters, representing five out of eight cows treated during the lactation period were cured for clinical mastitis. Use of a 1:10,000 acriflavine solution followed by 1:1000 acriflavine solution was reported to be too severe on the udder tissue. The article also reports that in five out of seven quarters treated this way milk secretion was stopped and all quarters showed considerable atrophy.

Since the commercially available teat seal formulation in Australia and New Zealand was a reformulation of Osmonds Teat Seal with no acriflavine, I see no reason for a person skilled in the art at the priority date of the opposed application to reintroduce an antiseptic into commercial teat seal formulations.
Dr Page states that many veterinarians would be reluctant to recommend use of a non-antimicrobial intramammary teat sealant by itself because of the concern of inadvertently introducing infectious agents during administration of the teat sealant due to suboptimal udder hygiene.[134] Dr Page, referring to the review article by Crispie et al., entitled "Dry Cow therapy with a non-antibiotic intramammary teat seal – a review", Irish Veterinary Journal 57(7) 2004 412-418,[135] stated that the authors concluded that there would be advantages associated with incorporating an antimicrobial agent into the teat seal preparation for combined single administration. I note that Mr Meaney is an author to the Crispie et al article. I note that the article discusses the incorporation of antibiotics into the teat seal preparation and does not mention use of an antiseptic.
[134] Page #1 at [91].
[135] A copy of the Crispie et al article has been filed in this opposition as Exhibit SWP-22.
I conclude that the evidence does not establish it would have been a matter of routine for a skilled person to incorporate an antiseptic into a commercially available teat seal formulation in Australia at the priority date of the opposed application. It has not been shown that claim 1, or any other claim of the opposed application, lacks inventive step in the light of common general knowledge alone.
Ascertained, understood and regarded as relevant
Subsection 7(3) states that before information in a publicly available document or through the doing of an act can be considered for the purposes of inventive step, it is necessary to decide whether the person skilled in the art "could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant" the information.
“Ascertained” means discovered or found out (Lockwood v Doric (No.2)).[136]
[136] [2007] HCA 21 at [132]; 235 CLR 173.
“Understood” means that, having discovered the information, the skilled addressee would have “comprehended it” or “appreciated its meaning or import” (Lockwood v Doric (No.2)).[137]
[137] [2007] HCA 21 at [132]; 235 CLR 173.
The High Court stated in Lockwood v Doric (No.2):
“…the phrase ‘relevant to work in the relevant art’ should not be construed as meaning relevant to any work in the relevant art, including work irrelevant to the particular problem or long-felt want or need, in respect of which the invention constitutes an advance in the art. The phrase can only be construed as being directed to prior disclosures, that is publicly available information (not part of common general knowledge) which a person skilled in the relevant art could be expected to have regarded as relevant to solving a particular problem or meeting a long-felt want or need as the patentee claims to have done.”
and
“[t]he question of what a person skilled in the relevant art would regard as relevant, when faced with the same problem as the patentee, is to be determined on the evidence”.[138]
[138] [2007] HCA 21 at [152]-[153]; 235 CLR 173.
Merial relies on the following seven citations to allege lack of inventive step:
1. GB 2,273,441 (D1);
2. GB 2,273,443 (D2);
3. GB 1,441,747 (D3);
4. NZ 531618 (D4);
5. Meaney, W. J. Effect of a dry period teat seal on bovine udder infection, Ir. J. Agric. Res. 16: 293, 1977 (D5);
6. US 4,472,374 (D6);
7. AJ Bradley, A Study of the Anti-infective Properties of TeatSeal™ Formulations in the Presence and Absence of Acriflavine (D7).
Dr Page stated:
“I was provided with a copy of prior art documents D1 to D6 during preparation of evidence for the corresponding New Zealand patent opposition. At the time, I had not seen the New Zealand or the corresponding Australian patents [sic] applications. I have now also been provided with an additional prior art document, designated D7, which I have been advised by FB Rice was identified during a routine prior art search conducted in relation to the present opposition. I consider each of these documents to be directed towards the treatment and prevention of bovine mastitis. I reiterate my comments on these documents below with respect to the present Australian opposition.
I would have expected to have identified each of these documents by no more than routine literature searches when identifying relevant prior art in the field directed toward the prevention and treatment of bovine mastitis. I would have understood their contents, and regarded these documents as being relevant to such formulations.”[139]
[139] Page #1 at [100]-[101].
In regard to D7, Dr Page further stated:
“I have been informed by FB Rice that this document was identified during a routine prior art search conducted for the purposes of the present proceedings. I have been further advised that this document was published on the European Patent Register on 13 February 2007.
It is my understanding that the register is maintained by the European Patent Office (EPO) and contains a copy of all correspondence filed with the EPO relating to a European patent application. I am also advised that documents on the European Patent Register are available online, 24 hours a day, 7 days a week to anybody with access to the internet. I have previously accessed documents from the register during the prosecution of European patent applications for which I have been involved in. In the present case, I have been advised that the prior art document was submitted as part of an opposition to a European patent application, EP 0971690. I have also been advised that this European patent application was directed towards a teat sealant composition. During my time at Pfizer, we would routinely monitor the patent filings of competitors and if a patent application of relevance was identified, Pfizer would instigate an ongoing watch of that application to see whether the competitor was able to obtain claims that might be relevant to Pfizer’s commercial interests and oppose such applications, if deemed necessary. I understand that this is standard industry practice and that other animal healthcare companies, such as Merial, routinely maintain such watches. I consider that given EP 0971690 is directed towards similar subject matter as Pfizer’s own product, Teatseal®, that it would certainly have been an application of interest to those developing new teat sealant formulations and if tasked with developing a new teat seal formulation I would certainly have looked at this application and its files history during the development phase.”[140]
[140] Page #1 at [103]-[104].
Dr Bunt stated:
“Mr Page's 3 May 2016 declaration next analyses certain prior art documents relied upon by Merial in this proceeding. As Mr Page notes at paragraph 100 of his declaration, six of these documents were cited in the corresponding New Zealand opposition. A seventh document, Bradley, was not. Mr Page says this document was located during a routine literature search. The fact that it did not come to light when similar searches were carried out for the New Zealand opposition casts some doubt on this statement. The short point is that not every document which is publically available would or could be found by a researcher and I question whether Bradley is one such document. I was not able to locate Bradley by performing a Google search of its title. I also question whether researchers would make use of patent documents to the extent implied by Mr Page.”[141]
and
“In paragraph 104 of his declaration Mr Page states that he has been advised that Bradley was submitted as part of an opposition to European Patent No EP 0971690 and that, because this Register is open to the public, people in the field would inevitably have found it. I don't agree. There is a very large amount of literature about the causes and means for prevention of mastitis in dairy cows. Researchers and formulators have limited time and financial resources and I doubt whether those resources extend to looking for information in secondary sources such as patent opposition files. Certainly it would never occur to me to look there for relevant literature and I was not personally able to locate the document on the European website even after having been alerted by Mr Page's evidence that it is available.”[142]
[141] Bunt at [32].
[142] Bunt at [35].
Bayer NZ submitted:
“Particular concerns are raised in respect of D7. D7 was filed in support of an opposition to Bimeda’s EP 0971690. It is not indexed or otherwise locatable. Dr Page’s evidence confirms that D7 was located after he had been provided with and analysed D1 – D6. It was not cited in the original SGP. It was not cited in the corresponding New Zealand opposition until 27 May 2016¹⁷² which is some six years after that opposition was launched (and, it is presumed, searches for relevant art were first conducted by FB Rice). It is a reasonable inference that D7 is not a document which would be discovered or found out by a skilled addressee since it was not a document which was discovered by FB Rice¹⁷³. Dr Bunt was unable to locate D7 even after being alerted to its existence and questions whether it is the sort of document a skilled addressee would have the resource or time to locate.”[143]
[143] The applicant’s written submissions, dated 24 March 2017, at [172].
It seems to be agreed by the declarants that it is reasonable to expect a skilled person would conduct literature searches that included patents and journal articles when identifying relevant prior art in the field directed toward the prevention and treatment of bovine mastitis. Therefore, I conclude that the skilled person could reasonably be expected to have ascertained, understood and regarded as relevant D1-D6 in their area of work. Therefore D1-D6 are available as information in a document under s7(3).
However, I consider that D7 could only be found by extending literature searches to include patent opposition files. I agree with Dr Bunt that limited time and financial resources of the skilled person would suggest against extending literature searches to patent opposition files. D7 is not indexed on the opposition file available on European Patent Register, and Dr Bunt was unable to locate the document with a Google search of its title. I am satisfied D7 could not have been reasonably ascertained by the skilled person. Therefore, D7 is not available as information in a document under s7(3).
Obviousness in light of D1 considered together with common general knowledge
Claim 1
Whilst D1 does not disclose acriflavine to be an antiseptic, this is of no consequence because I have previously found the teat seal formulation of D1 contains acriflavine in sufficient quantity to act effectively as an antiseptic. The question for the purposes of inventive step is what would a skilled person have done as a matter of routine in light of the teaching of D1? I have previously found it was part of the CGK to use an artificial teat seal formulation to provide a physical barrier to seal off the teat canal. Therefore, I conclude that it would have been a matter of routine for a skilled person to follow the teaching of D1 and administer the teat seal formulation of D1 to seal the teat canal or lower portion of the teat cistern of an animal for the prevention of mastitis. Therefore, I conclude claim 1 lacks inventive step in light of D1 considered together with CGK.
The claims appended to claim 1
I will now consider the claims appended to claim 1.
Claim 2: The question here is whether it would have been a matter of routine for a skilled person to use a physical barrier material that includes barium.
Dr Page stated:
“As discussed above, claim 1 (in conjunction with claim 15) of D1 is directed towards an intramammary use of an antibacterial and seal formulation which includes a non‐toxic heavy metal salt. As there are only a select few ‘non‐toxic heavy metal salts’, I believe it would been obvious to a person skilled in the field to include selected barium salts within the family of non‐toxic heavy metal salts, as these along with bismuth salts are the only heavy metal salts that have found a valuable role in medicine that continues to the current day. Barium sulphate immediately comes to mind as a suitable barium salt as it has a long history of safe use in medical and veterinary applications. In particular, as a radiographic contrast medium.”[144]
[144] Page #1 at [317].
Dr Bunt stated:
“It cannot be denied that alternatives to bismuth subnitrate would are [sic] obvious. Indeed it was well known in the field that bismuth subnitrate could be irritant towards biological tissues. One alternative well known at the time was bismuth sulphate. The inert properties of the heavy metal salt barium sulphate were routinely used for internal diagnostic procedures. Nor can it be denied that antibiotics and non-antibiotic antimicrobials such as bacteriocins were known. However antiseptics such as chlorhexidine were mostly known as agents for external application or application internally as infusions to treat an infection (in much the same way as a mouth wash) prior to the application of an inert teat seal. As I will discuss in more detail below, antiseptic infusions were observed to cause severe irritancy and, in some cases, tissue damage. Their use was discontinued many decades ago and I believe there would be a clear prejudice against reinstating the internal use of antiseptics to treat or prevent mastitis. The combination of a teat seal forming heavy metal salt and an antiseptic is in my opinion inventive and is in no way suggested by any of the documents I have considered - either alone or in combination.”[145]
[145] Bunt at [29].
I am satisfied that the evidence shows that barium sulphate was commonly known to the skilled person as a heavy metal salt with inert properties and suitable for medical, veterinary and diagnostic applications. Therefore, I consider it would have been a matter of routine for a skilled person to use barium sulphate as an alternative to bismuth subnitrate. Therefore, I conclude claim 2 lacks inventive step in light of D1 considered together with CGK.
Claims 3 and 4: It follows from the discussion above on barium sulphate that each of claims 3 and 4 lacks inventive step in light of D1 considered together with CGK.
Claim 5: The claim is appended to claim 3 or claim 4, with the additional qualification that the barium is micronised. Adopting a plain meaning of the word, “micronized” means breaking a substance into fine particles. From Dr Page’s statement quoted above, barium sulphate has a long history of use as a radiographic contrast medium. This use is consistent with an interpretation that using barium salts in the form of fine particles in diagnostic applications was known to the skilled person. I consider the use of barium salts as fine particles in a teat seal formulation and the use in a radiographic contrast medium to be use of the fine particles in different environments. Therefore, I consider the evidence does not establish that it would be a matter of routine for the skilled person to use micronised barium salts in teat seal formulations. I conclude that the evidence does not establish claim 5 lacks inventive step in light of D1 considered together with CGK.
Claim 6: This claim is appended to any one of claim 1 to 5, with the additional qualification that the antiseptic is in the form of chlorhexidine or a salt thereof. The issue to consider here is whether it would have been a matter of routine for a skilled person to use chlorhexidine in a teat seal formulation.
Merial submitted:
“Chlorhexidine is an antiseptic which is administered to cows to prevent or control bacterial infection. [A reference to D29 — Product information for Rudducks Antiseptic intra-uterine pessary — was provided.]
By 2008, chlorhexidine was used on cow’s udders in Hibitane, Coppers Hibitane Teat Dip & Spray, Udder Mate Ready-to-Use Glycerine Enriched Teat Dip & Spray, Hibitane Antiseptic Dairy Cream, Hibitane Plus, Teatshield, Teatcare, Teatcare Plus, Teatguard Plus ajd[sic] Teatspray Plus. [A reference is made to Page #1 at [55]]”[146]
[146] The opponent’s written submissions, dated 20 March 2017, at [76 (g)].
At the oral hearing, Merial confirmed the above-mentioned products listed in Dr Page’s declaration are products that are used externally on cow’s udders. I consider these products to be used to disinfect the external surfaces of the animal’s udder and teat. The antiseptic intra-uterine pessary is a formulation that is infused into the uterus of the animal and not used in the mammary gland of an animal.[147]
[147] The opponent’s written submissions, dated 20 March 2017, at [167] and associated footnote.
I have previously found it was not part of the CGK that acriflavine was used in a teat seal formulation to provide an antiseptic effect in the animal. Therefore, I consider that it would not be a matter of routine to use chlorhexidine to provide an antiseptic effect in the teat canal or teat cistern of the animal.
Dr Page stated:
“The difference from what is required by claim 6 and what is described in D1 is the choice of antiseptic. As previously mentioned, there are a limited number of antiseptics that have a history of use in the dairy industry, the list includes acriflavine (most recently used in the teat seal formulations), chlorhexidine, iodine based antiseptics and cetrimide. These antiseptics are different chemical entities with their own physico-chemical properties. Having said that, however, all of these antiseptics have a long history of use in the dairy industry. For example, as discussed above, chlorhexidine was routinely used in the dairy industry before the priority date as a disinfectant on inanimate surfaces and as an antiseptic for cattle, in particular, it is routinely included in preparations used to clean the udder prior to milking and included in teat dips that may be used before or after milking. Given the fact that there is a limited choice of antiseptics approved for use in dairy cattle and it is unlikely that cetrimide would be antiseptically effective in the presence of milk, in my opinion it is clearly obvious to a person skilled in the field that either chlorhexidine or iodine based antiseptics would be suitable for inclusion in a teat seal formulation in exchange for the acriflavine used in Teatseal and described in D1. I consider that chlorhexidine and iodine based antiseptics would definitely be worth trying and their suitability could be assessed by routine testing. I therefore consider that the subject matter of claim 7 [sic] is obvious to a person skilled in the field and therefore in my opinion lack any inventive step in light of D1.”[148]
[148] Page #1 at [321].
As discussed above, the test of obviousness does not import a criterion of whether a particular avenue of research was obvious to try so that the result claimed therefore was obvious. The evidence does not establish that it would be a matter of routine that a skilled person would use chlorhexidine as an alternative to, or in addition to, acriflavine in a teat seal formulation. Therefore, I conclude the evidence does not establish claim 6 lacks inventive step in light of D1 considered together with CGK.
Claim 7: This claim is appended to any one of claims 1 to 6, with the additional qualification that the formulation includes a carrier. Dr Page stated that the commercially available TeatSeal^TM in Australia and New Zealand comprises bismuth subnitrate 65% (w/w) in a paraffin oil gel base.[149] Dr Page also stated that aluminium stearate has been used as a gelling agent in many medical applications including injectable antibiotics since the 1940’s.[150] Dr Bunt also stated that paraffin and aluminium stearate are common constituents of mastitis treatments.[151] Therefore, I consider it would have been a matter of routine for a skilled person to use a carrier such as paraffin oil or aluminium stearate in a teat seal formulation. I conclude claim 7 lacks inventive step in light of D1 considered together with CGK.
[149] Page #1 at [84].
[150] Page 31 at [360].
[151] Bunt at [10.4.1] and [10.4.2].

Claims 8-11: Each of these claims is appended to claim 7, with the additional qualification that the carrier is an oil, paraffin oil, a gelling compound or aluminium stearate. From the discussion above on paraffin oil and aluminium stearate, each of claims 8-11 lacks inventive step in light of D1 considered together with CGK.
Claim 12: The teat seal formulation of D1 is disclosed as a veterinary formulation that has been prepared for treating mastitis in dry cows. I consider it would be a matter of routine for a skilled person at the priority date to use the teat seal formulation of D1 to provide a physical barrier to prevent or ameliorate mastitis. Therefore, I conclude claim 12 lacks inventive step in light of D1 considered together with CGK.
Claim 13: The teat seal formulation of D1 is disclosed to be administered into the teat canal of a cow to provide a physical barrier to prevent the ingress of pathogens. I consider it would be a matter of routine for a skilled person at the priority date to use the teat seal formulation of D1 to provide a physical barrier for treating or preventing infection within the teat cistern of a mammary gland by administration of the formulation into the teat canal or lower portion of the teat cistern. Therefore, I conclude claim 13 lacks inventive step in light of D1 considered together with CGK.
The omnibus claims
Claim 14-16: The formulations, use or method, defined in each of claims 14-16 have chlorhexidine (base or hydrochloride salt) as the antiseptic and barium sulphate as the physical barrier material. The formulations have the limitations described in the specified tables and examples of specification. I have previously found that the evidence does not establish that it would be a matter of routine that a skilled person would use chlorhexidine as an alternative to, or in addition to, acriflavine in a teat seal formulation. Furthermore, I consider the evidence does not establish that it would be a matter of routine for a skilled person to combine the constituents of the formulations in the manner or quantities described in the tables and examples of the specification. Therefore, I conclude the evidence does not establish each of claims 14-16 lacks inventive step in light of D1 considered together with CGK.
I conclude claims 1-4 and 7-13 lack an inventive step in light of D1 considered together with CGK.
Obviousness in light of D2 considered together with common general knowledge
D2 was published on 22 June 1994. Consequently, D2 is part of the prior art base. The disclosure of D2 is similar to that of D1. Relevant for the current purposes, D2 discloses a teat seal formulation used to provide a physical barrier for the prevention of mastitis in dry cows. The teat seal formulation disclosed comprises liquid paraffin, a polyethylene gel, 0.1% (w/w) acriflavine and bismuth subnitrate.
The reasoning discussed above in regard to D1and the claims of the opposed application applies equally to D2. I consider that it would have been a matter of routine for a skilled person to follow the teaching of D2 and administer the teat seal formulation of D2 to seal the teat canal or lower portion of the teat cistern of an animal for the prevention of mastitis.
I conclude claims 1-4 and 7-13 lack an inventive step in light of D2 considered together with CGK.
Obviousness in light of D3, or alternatively, D5 considered together with common general knowledge
The disclosure of each of D3 and D5 has been discussed above. Relevant for the current purposes, each of D3 and D5 discloses a teat seal formulation used to provide a physical barrier for the prevention of mastitis in dry cows. The teat seal formulation disclosed comprises 0.075% (w/w) acriflavine, 25% bismuth subnitrate and a paraffin/wax base.
The reasoning discussed above in regard to D1 and the claims of the opposed application applies equally to D3 and D5, each citation considered separately. I consider that it would have been a matter of routine for a skilled person to follow the teaching of D3 or D5 and administer the teat seal formulation of the citation to seal the teat canal or lower portion of the teat cistern of an animal for the prevention of mastitis.
I conclude claims 1-4 and 7-13 lack an inventive step in light of each of D3 and D5 considered together with CGK, each citation considered separately.
Obviousness in light of D4 considered together with common general knowledge
D4 was published on 24 March 2005. Consequently, D4 is part of the prior art base.
D4 discloses a method for preventing contamination of a teat canal during administration of a teat sealant comprising the steps of delivering a sterilising agent into the teat canal and subsequently delivering the teat sealant into the teat canal. The teat sealant is disclosed to be administered to prevent mastitis. The sterilising agent is disclosed to be administered ahead of the teat sealant to ensure that accidentally introduced micro-organisms are killed and do not cause mastitis. The sterilising agent is disclosed to include antiseptics such as chlorhexidine. The teat sealant is disclosed to comprise an oil-based component with bismuth subnitrate. A separating device, such as a frangible membrane, is disclosed to provide a physical and chemical separation of the sealant and sterilising agent.
D4 does not disclose a single formulation comprising an oil-based physical barrier material and an antiseptic. The citation teaches the oil-based physical barrier component is separated from the sterilising agent for the purpose of administering the sterilising agent first to kill inadvertently introduced mastitis-causing micro-organisms.
Dr Bunt stated that:
“The clear teaching of this document is to keep the sterilising agent and teat sealant separate and distinct. For this reason the preferred embodiment uses two separate injectors. While Figure 2 shows a version in which the sterilising agent is injected from the same tube as the teat seal the sterilising agent and seal are separated by a frangible barrier. Neither embodiment shown in the Figures at paragraph 198 of Mr Page's Declaration is a ‘single’ formulation as I understand that term to be used in the claims of Bayer's patent application and have discussed above.”[152]
[152] Bunt at [43].
I consider D4 teaches away from providing a single formulation comprising an oil-based physical barrier material and an antiseptic. The evidence does not establish it would have been a matter of routine for a skilled person, following the teaching of D4 and seeking to prepare a teat seal formulation, to combine an oil-based physical barrier material and an antiseptic in a single formulation. I conclude that the evidence does not establish that claim 1, or any other claim, lacks an inventive step in light of D4 considered together with CGK.
Obviousness in light of D6 considered together with common general knowledge
D6 was published on 18 September 1984. Consequently, D6 is part of the prior art base.
D6 discloses a veterinary composition for reducing mammary infections in cattle during their dry period. The composition is administered to the teat canal to provide an effective teat seal. The composition comprises a “siloxane elastomer” which is defined in the citation as an elastomer comprising an elastic polymer of silicon containing repeating -Si-O- units. The siloxane elastomer is described as being of “sufficiently low viscosity to allow application to the teat by infusion and must remain sufficiently elastic during the period of use in order to retain the elastomer in place.” In some embodiments, the composition further comprises an antibacterial agent which is described to be in the form of a solution or suspension and comprises an oil vehicle.
Dr Petrovski stated:
“The sealant in the invention described in D6 is silicone elastomer of specific viscosity to facilitate infusion of the antibiotics and maintenance throughout the dry period. The sealant in Bayer's invention is an oil based physical barrier material and is preferably a heavy metal salt in a mineral oil. The table in Mr Page's paragraph [376] states that D6 discloses at col 2 line 12 an oil based physical barrier material. It does not. The lines referenced by Mr Page describe an embodiment of the invention where the antibacterial agent is infused into the mammary gland as an oily solution or suspension prior to injection of the siloxane elastomer. This isn't an oil based physical barrier material or, for that matter, a description of a single formulation.”[153]
[153] Petrovski at [76].
I consider the siloxane elastomer of D6 to be an elastic polymer and not an oil-based physical barrier which is able to be moulded into a cohesive mass to seal off the teat canal. D6 therefore teaches the use of elastic properties of a silicon polymer rather than physical moulding of a material in oil to seal the teat canal. The evidence does not establish that it would be a matter of routine for the skilled person, following the teaching of D6 and seeking to prepare a teat seal formulation, to substitute the elastic properties of the siloxane elastomer of D6 with properties of an oil-based physical barrier material. I conclude that the evidence does not establish that claim 1, or any other claim, lacks an inventive step in light of D6 considered together with CGK.
Conclusion on inventive step
I conclude that a lack of inventive step has been established for claims 1-4 and 7-13 of the opposed application.
Conclusion
Each of claims 1 and 7-13 lacks novelty in light of cited prior art. Each of claims 1-4 and 7-13 lacks an inventive step in light of cited prior art considered together with CGK. These deficiencies can be overcome by amendment, so I will allow Bayer NZ a period of two months from the date of this decision in which to file amendments.
Costs
The opposition is successful. It is normal that cost should follow the event. I see no reason to depart from that result. Cost should be awarded against Bayer NZ.
Dr A. Lim
Delegate of the Commissioner of Patents
Annex A: The claims
1. A single formulation, when used for administration to the teat canal or/and lower portion of the teat cistern of a mammary gland of an animal for the prevention of mastitis, wherein the formulation is in the form of a paste, the formulation including:
an oil-based physical barrier material which is able to form a cohesive mass in the teat canal and/or the lower portion of the teat cistern, and
at least one antiseptic compound mixed with the barrier material in sufficient quantity to act effectively as an antiseptic.
2. A formulation as claimed in claim 1 wherein the physical barrier material includes barium.
3. A formulation as claimed in claim 2 wherein the barium is in the form of a barium salt.
4. A formulation as claimed in claim 3 wherein the barium is in the form of barium sulphate.
5. A formulation as claimed in either claim 3 or claim 4 wherein the barium is micronised.
6. A formulation as claimed in any one of claims 1 to 5 wherein the antiseptic is in the form of chlorhexidine or salt thereof.
7. A formulation as claimed in any one of claims 1 to 6 which includes a carrier.
8. A formulation as claimed in claim 7 wherein the carrier is in the form of oil.
9. A formulation as claimed in claim 8 wherein oil is paraffin oil.
10. A formulation as claimed in claim 7 wherein the carrier is a gelling compound.
11. A formulation as claimed in claim 10 wherein the gelling compound is aluminium stearate.
12. The use of formulation as claimed in any one of claims 1 to 11 in the manufacture of a medicament to prevent or ameliorate mastitis.
13. A method of treating or preventing infection within the teat cistern of a mammary gland characterised by the step of administering a formulation as claimed in any one of claims 1 to 11 into the teat canal or/and lower portion of teat cistern of the mammary gland of a non-human animal.
14. The formulation substantially as herein described with reference to Tables 1- 3 of the "Best Modes" section.
15. The use of a formulation substantially as herein described with reference to and as illustrated by Examples 3 - 6 of the "Best Modes" section.
16. A method substantially as herein described with reference to and as illustrated by Examples 1 and 2 of the "Best Modes" section.
Annex B: The tables
Annex C: The figures
Figure 7
Figure 8
Figure 10