Merial, Inc. v Bayer New Zealand Limited - [2019] APO 21

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial, Inc. v Bayer New Zealand Limited [2019] APO 21

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 May 2019
Hearing Date:  07 February 2019, in Canberra

Catchwords: PATENTS – opposition under section 104 – allowability under paragraph 102(2)(b) considered – opposition unsuccessful – amendment allowable – costs awarded against the opponent

Representation: Counsel for the applicant: Mr Ian Finch from James & Wells
Patent attorney for the applicant: Dr Andrew Scott 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 May 2019
DECISION
The opposition is unsuccessful. The proposed amendments comply with paragraph 102(2)(b) and I allow the amendments.
I award costs according to Schedule 8 against Merial, Inc.
REASONS FOR DECISION
Background

This matter relates to patent application 2009304000 (the opposed application) in the name of Bayer New Zealand Limited (Bayer NZ). The application was advertised accepted on 06 August 2015, and subsequently opposed under section 59 of the Patents Act 1990 (the Act) by Merial, Inc. (Merial). I issued a decision for the opposition under s 59 on 07 June 2017 and found certain claims of the opposed application lacked novelty and were obvious in light of cited prior art and the common general knowledge.[1]
[1] Merial, Inc. v Bayer New Zealand Limited [2017] APO 27 (Merial 2017).
Bayer NZ filed proposed amendments on 27 July 2017 (Bayer’s amendments) and leave to amend was advertised on 28 September 2017.
Merial filed a notice of opposition to the allowance of the amendments on the 27 November 2017. It is that opposition that is the subject of this decision.
The opposition
Merial filed a statement of grounds and particulars on 22 December 2017, specifying that the proposed amendments are not allowable under s 102(2)(b) because, as a result of the amendments, the specification would not comply with subsection 40(3). In particular, Merial alleged that, as a result of the amendments, the claims are not fairly based on matter described in the specification.
A hearing was held on 07 February 2019 in Canberra. Bayer NZ was represented by Mr Ian Finch, counsel and Dr Andrew Scott, patent attorney. Merial was represented by Mr Christian Dimitriadis, senior counsel and Ms Clare Cunliffe, counsel and Dr Marcus Caulfield, patent attorney.
The evidence that was filed is summarised in the table below.

Evidence Declarant Exhibits Date Reference

In Support Professor Mark Wainwright MW-1 to MW-9 14 March 2018 Wainwright #1

In Answer Dr Craig Bunt CB-1 to CB-15 25 June 2018 Bunt

In Reply Professor Mark Wainwright MW-10 to MW-16 22 August 2018 Wainwright #2

Dr Marcus Caulfield MJC-1 to MJC-6 24 August 2018 Caulfield

Bayer’s amendments are separately opposed by a third party, Norbrook Laboratories Limited (Norbrook opposition).[2]The Caulfield declaration of the present opposition (Merial opposition) consists of the evidence-in-support (MJC-1 to MJC-2), evidence-in-answer (MJC-3 to MJC-4) and evidence-in-reply (MJC-5 to MJC-6) filed in the Norbrook opposition. In a letter dated 22 November 2018, a Delegate of the Commissioner of Patents considered exhibits MJC-1 to MJC-4 to the Caulfield declaration not responsive to the evidence-in-answer of the Merial opposition. The Delegate also outlined the paragraphs of Dr James Stevens Rowe’s second declaration, dated 16 May 2018 (MJC-5), which she considered not properly in reply in the Merial opposition.[3] At the hearing both parties of the Merial opposition agreed that it was their common understanding that the remaining paragraphs of Dr Rowe’s second declaration (Rowe #2) are being relied on.[4] I considered it was reasonable to proceed on this basis.
[2] Norbrook Laboratories Limited v Bayer New Zealand Limited [2019] APO 20.
[3] The Delegate of the Commissioner of Patents considered paragraphs [21]-[30], [69]-[70], [72]-[76], [84], [87], [92]-[94], [96]-[99], the reference to Pseudomonas aeruginosa in paragraph [5] and the first three sentences of paragraph [91] of Dr James Stevens Rowe’s second declaration dated 16 May 2018 not properly in reply to evidence-in-answer of the Merial opposition.
[4] By inference, paragraphs [1]- [4], [5] except the reference to Pseudomonas aeruginosa, [6]-[20], [31]-[68], [71], [77]-[83], [85]-[86], [88]-[90], [91] except the first three sentences, [95] and [100] of Dr James Stevens Rowe’s second declaration dated 16 May 2018 are properly in reply to evidence-in-answer of the Merial opposition.
Merial submitted that paragraphs [5] to [15] of Dr Rowe’s first declaration (Rowe # 1), dated 21 February 2018 (MJC-1), are merely directed towards the education and experience of Dr Rowe, establish Dr Rowe is a person skilled in the art, and therefore are admissible.[5] Bayer NZ stated it did not object.[6] I have viewed the mentioned paragraphs of Dr Rowe’s first declaration, consider that the information is in relation to Dr Rowe’s qualifications, and therefore reasonable to admit as part of the evidence-in-reply.
[5] Merial’s written submissions, dated 23 January 2019, at [25].
[6] Bayer NZ’s written submissions, dated 31 January 2019, at [32].
The law
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 Amendments (Raising the Bar) Act 2012 (RTB 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 the amendment should not be allowed.[7]
[7] By analogy with 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.
Subsection 104(1) states that the applicant is entitled to request amendments:
(1) An applicant for a patent or a patentee, may, subject to this Act, and subject to and in accordance with the regulations, ask the Commissioner for leave to amend the relevant patent request or complete specification, or any other filed document, for any purpose including either or both of the following:
(a) removing a lawful ground of objection to the request or specification, whether that objection is raised in the course of an examination or re‑examination or otherwise;
(b) correcting a clerical error or an obvious mistake.
Subsection 104(4) provides for opposition to an amendment:
(4) The Minister or any other person may, subject to and in accordance with the regulations, oppose allowing an amendment.
Subsection 104(5) then sets out the criteria for allowablility of an amendment:
(5) The Commissioner must not allow an amendment that is not allowable under section 102.
Section 102 of the Act governs the allowability of amendments. It relevantly provides:
(1)   An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
(2)   An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
(a)   a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b)   the specification would not comply with subsection 40(2) or (3).
Subsection 102(2A) states that the “relevant time” means after the specification has been accepted. As the present specification had been accepted when the amendments were requested, the requirements of subsection 102(2) apply.
The relevant parts of subsections 40(2) and 40(3) are:
(2) A complete specification must:
(a) describe the invention fully, including the best method known to the applicant of performing the invention; and
(b) where it relates to an application for a standard patent – end with a claim or claims defining the invention.
…….
(3) The claim or claims must be clear and succinct and fairly based on the matter described in the specification.
The expression “as a result of the amendment” is a feature of section 102 and has been considered on many occasions. In RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd, Carr and Goldberg JJ discussed s 102(1) as it stood at the time:
“….. That subsection requires one first to identify precisely what is the amendment. In this case that is done by identifying the difference between the specification as accepted (and as it stood at the hearing of the motion at first instance) on the one hand and, on the other hand, as the specification would read if amended in the manner sought. ….. The subsection focuses on the amendment proposed and it must be that amendment which has the result of pushing the claimed matter over the line defined by the expression ‘matter not in substance disclosed in the specification as filed’. The key point to keep in mind is, as counsel for the respondent contended (in our view correctly), that the words ‘as a result of the amendment’ are not to be confused with the expression ‘after the
[8] 89 FCR 458 at page 466; 42 IPR 353.
amendment’”[8]
Pre-existing defects in the specification are not relevant to consideration of the allowability of amendments under s 102, as noted by Bennett J in Apotex Pty Ltd v Les Laboratoires Servier (No 2) (Apotex):
“There may be deficiencies in the (existing) complete specification or lack of compliance with s 40 which do not fall for consideration at this time. The question is whether, as a result of the introduction of the proposed new claims, the amendments are not allowable because of the requirements of s 102.” [9]
[9] [2009] FCA 1019 at [28]; 83 IPR 42.
Relevant to the s 102(2)(b) ground pressed in this opposition, Bennett J stated in Apotex:
“… s 102(2)(b) requires:
1. Identification of the precise amendment sought by identifying the difference between the specification as it stood immediately before the amendment and the specification as proposed to be amended; and
2. Determination whether, as a result of the amendment, the specification would not comply with s 40(2) or s 40(3)”[10]
[10] [2009] FCA 1019 at [34]; 83 IPR 42.
The nature of the amendments
Bayer NZ proposed amendments to claims 1, 12 and 13 of the opposed application. The marked-up version of the complete set of amendments is reproduced in Annex 1.
The substantive amendments are to claim 1. I reproduce a marked-up version of proposed claim 1 here:
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 for the antiseptic to act effectively as an antiseptic to kill
or prevent the spread of mastitis causing infectious organisms in the teat
cistern of the animal following administration;
and wherein the antiseptic is not an acridine.
The amendments proposed to claim 12 and claim 13 are minor in nature, and Merial submitted that these amendments need not be considered further.[11] I agree.
[11] Merial’s written submissions, dated 23 January 2019, at [11].
No amendments have been proposed to the description of the specification.
The specification
The specification of the opposed application relates to a formulation that has anti-infective properties and method of using the formulation to prevent or ameliorate mammary gland infections, including mastitis.[12]
[12] The opposed application at page 1.
As the new requirements of the proposed amendments relate to the properties of the antiseptic of the claimed invention, it is useful to review the parts of the specification which teach about the properties and choice of an antiseptic used for the working of the invention of the opposed application (present invention).
The specification defines the meaning of an antiseptic in the following manner:
“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.”[13](Emphasis added)
[13] The opposed application at page 7.
In the context of the purpose of the formulation described in the specification and from the definition provided above, I interpret an antiseptic for the working of the present invention to be an agent that kills or prevents the spreading of infectious organisms which relate to mammary gland infections, including mastitis. This interpretation is consistent with my considerations in Merial 2017 where I found the scope of unamended claim 1 to include (i) “cases where use of the formulation merely hinders mastitis infection but is not entirely effective in preventing infection”, and (ii) a quantity of antiseptic “that provides a bacteriostatic or bactericidal effect, as assessed either in an in vivo environment of the animal or by an in vitro assay.”[14]
[14] [2017] APO 27 at [68].
The specification explains the properties of antiseptics in the following manner:
“Ideally, the antiseptic is physiologically acceptable, and have a broad spectrum
activity. More preferably, the antiseptic may be at least active against the major
and minor pathogens associated with bovine mastitis. This allows the antiseptic to
be active against a wide range of micro-organisms, ….
Preferably, the antiseptic may have one or more of the following properties:
a) the chemical has antimicrobial activity at physiological pH, and the pH of
milk, and/or
b) addition of the antiseptic does not change the physical characteristics of the
formulation, and/or
c) the antiseptic has a release rate such that the concentration in the aqueous
channel is greater than the minimum inhibitory concentration (MIC) for at
least 2-4 weeks, and/or
d) the antiseptic is not readily absorbed by the cow's body, and/or
e) the antiseptic is reasonably stable, and/or
f) the antiseptic is non-irritant to the cow's body.” [15] (Emphasis added)
[15] The opposed application at page 12.
Adopting a plain meaning of the words “ideally”, “more preferably”, “preferably” and “may” used in the paragraphs reproduced above, I consider a described property of an antiseptic is desirable, but not crucial to the working of the present invention. I also consider the use of the terms “and/or” to mean that each described property is optional, and an antiseptic of the present invention does not need to possess all the properties described.
The specification states that chlorhexidine is a preferred antiseptic which has the advantage of being a compound that is acceptable for veterinary use and has been used in dairy practices for some time.[16] The specification also states that chlorhexidine is stable, non-toxic to an animal and not believed to be absorbed into the body of the animal.[17] The specification also exemplifies a formulation and a method of using a formulation having chlorhexidine as the antiseptic.[18]
[16] ibid.
[17] The opposed application at page 13.
[18] Examples, tables and figures of the opposed application.
The specification states that the use of chlorhexidine should not be seen as limiting:
“However, the use of chlorhexidine should not be seen as limiting, as any other antiseptic
[19] The opposed application at page 13.
with the desired characteristics may be utilised with the present invention. Antiseptic with poor absorption characteristics are preferred, these may include, for example ionised anti-septic. For example, quaternary ammonium compounds may be suitable, including, but not limited to Cetrimide and BZK. Similarly, povidone-iodine which is currently used in the dairy industry may be suitable.”[19] (Emphasis added)
I consider that the above-mentioned paragraph is telling the reader that any antiseptic with the properties described on page 12 of the specification (reproduced in paragraph [27]) is suitable for the working of the present invention. I also consider the above-mentioned paragraph to tell the reader that antiseptics with poor absorption properties, such as ionised antiseptics, are desirable. Quaternary ammonium compounds are described as examples of such ionised antiseptics. The specific examples of quaternary ammonium compounds provided are cetrimide and BZK (benzalkonium chloride).
The specification explains that some advantages of using an antiseptic with poor absorption properties are a decreased concentration of antiseptic required, specific localization and targeting of antiseptic and preventing the antiseptic getting into the milk flow. [20]
Technical background
[20] The opposed application at page 19.
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.”[21]

[21] 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.”[22]
[22] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; 89 ALJR 798.
Each party made submissions regarding the deficiencies in qualifications of the other party’s expert witnesses.[23]
[23] Merial’s written submissions, dated 23 January 2019, at [28]. Bayer NZ’s written submissions, dated 31 January 2019, at [26], [34]-[37] and [39].
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. Professor Wainwright is a Professor of Antimicrobial Chemotherapy at the School of Pharmacy & Biomolecular Sciences, Liverpool John Moores University in the United Kingdom.[24] He has many years’ experience in antimicrobial chemotherapy and many publications in the field of antimicrobial compounds.[25] Dr Rowe is a consultant specialising in the field of human and veterinary pharmaceuticals and other chemical formulations in Australia. [26] He has worked on the development of several significant veterinary projects, and for several companies. [27] He has a PhD in pharmaceutical chemistry from the School of Pharmacy at the University of London.[28] Dr Bunt is an Associate Professor in Animal Science, Lincoln University in New Zealand and has many years’ experience working as a pharmaceutical formulation scientist.[29] He has a PhD in pharmaceutics from the University of Otago in New Zealand.[30]
[24] Wainwright #1 at [1].
[25] Wainwright #1 at [3], [10].
[26] Rowe #1 at [5].
[27] Rowe #1 at [6]-[13].
[28] Rowe #1 at [14].
[29] Bunt at [3], [7].
[30] Exhibit CB-2.

I consider that all declarants mentioned above have advanced qualifications in chemistry and pharmaceuticals and can provide evidence as to what the person skilled in the art knew and would have done in relation to antiseptics. 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.
In the context of understanding the antiseptics used in the present invention, the opposing parties filed evidence and made submissions in relation to acridines and quaternary ammonium compounds. It is useful to review what acridines and quaternary ammonium compounds are.
Acridines
The parties agree that the person skilled in the art understands that:
·acridine is the name given to a class of compounds that share a common ring structure shown below:[31]
·acriflavine is an example of an acridine.[32]
[31] Wainwright #1 at [20]; Bunt at [30]-[31].
[32] Wainwright #1 at [24], [38]; Bunt at [71.8].
In Merial 2017, I found that it was part of the common general knowledge (CGK) that acriflavine has an antiseptic property.[33]
[33] [2017] APO 27 at [198].
Quaternary ammonium compounds (QACs)
There appears to be some disagreement between the expert witnesses about what compounds are included within the category of quaternary ammonium compounds, in particular whether or not acridines are quaternary ammonium compounds.
Dr Bunt stated that quaternary ammonium compounds, referred in the field as “QACs” or “quats”, have the structure shown below, where each R is selected from a carbon containing group— typically an alkyl or aryl:[34]
[34] Bunt at [52].
Dr Bunt also stated that:
“… a quaternary ammonium compound (QAC) is one in which the nitrogen centre is not protonated – namely that it is fully substituted with carbon bearing substituents such as alkyl, aryl. This quaternisation provides a cationic charge to the nitrogen centre which is effectively permanent. This category of compounds is distinguished from a compound bearing an amine substituent that can be protonated/deprotonated depending on pH, …”[35]
[35] Bunt at [108].
Dr Bunt considered that QACs are also defined by their mode of action. Dr Bunt stated that QACs act by disrupting cell-membrane activity based on their surfactant properties and he was not aware of acridines which operate exclusively by disrupting cell-membrane activity.[36] Dr Bunt stated that acridines act by intercalating DNA.[37]
[36] Bunt at [55].
[37] ibid.
Professor Wainwright stated that the general structure of a QAC which Dr Bunt provided, and which is reproduced above, is not broad enough to cover many compounds reported in this group, including acriflavine.[38] By his statement, Professor Wainwright indicated that he considered Dr Bunt’s definition of a QAC as having four carbon bearing substituents on a quaternised nitrogen was too restricted and should include compounds in which the nitrogen atom is attached to three R groups with one group attached via a double bond to the nitrogen atom. Dr Bunt’s evidence does not suggest to me that there must be four R groups on a quaternised nitrogen. Rather, I consider Dr Bunt’s definition to include compounds having three R groups on a quaternised nitrogen where one of the R groups is attached via a double bond to the nitrogen atom.
[38] Wainwright #2 at [31].
Professor Wainwright stated that acriflavine has a permanent positive charge through the quaternary substituted nitrogen and is a quaternary ammonium compound.[39] Therefore, I consider Professor Wainwright and Dr Bunt are not in disagreement that a QAC is a compound in which the nitrogen centre is fully substituted with carbon bearing substituents and the quaternisation provides a cationic charge to the nitrogen centre which is effectively permanent.
[39] Wainwright #1 at [27].
Dr Rowe agreed that technically QACs have the structure depicted by Dr Bunt, but Dr Rowe considered that in common usage the term QACs has an extended meaning and includes protonated amines.[40] I find nothing in the specification of the opposed application which suggests that the extended meaning for QACs is intended.
[40] Rowe #2 at [44].
Dr Rowe disagrees with Dr Bunt that mode of action forms part of the definition of QACs.[41] I agree that there is no evidence that mode of action is an accepted part of the definition of QACs. I consider it is more likely that Dr Bunt is merely indicating the manner in which QACs normally operate.
[41] Rowe #2 at [43].
Therefore, I conclude that a QAC is a compound having the structural formula shown above at paragraph [42], with a permanent positive charge on the nitrogen.
Dr Bunt acknowledged that BZK (benzalkonium chloride), cetrimide and acriflavine have a quaternary nitrogen centre.[42] BZK and cetrimide are two examples of QACs that are mentioned in the opposed application as ionised antiseptics.[43]
[42] Bunt at [59]-[60].
[43] The opposed application at page 13.
Dr Bunt provided the structures of BZK, cetrimide and acriflavine in evidence.[44] The structures are reproduced below:
[44] Bunt at [59].
From the structural representations above, it is clear acriflavine has an ionised nitrogen that is not protonated—in other words, the quaternisation provides a cationic charge to the nitrogen centre which is effectively permanent. Therefore, I conclude that acriflavine is a QAC. My conclusion is consistent with the view of other persons skilled in the art who understand acriflavine to be a QAC.[45] I also consider that any other acridine having a permanent positive charge on the ring nitrogen would be a QAC.
[45] Professor Wainwright’s first declaration and Dr Rowe’s second declaration mentioned journal articles which refer to acriflavine as a QAC. Exhibit MW-9 (Wainwright # 1 at [46]) is a copy of a journal article with the following citation details: Kawai, M. and Yamagishi, J-I., Microbiology and Immunology, 2009, Vol. 53, pp. 481-486. Exhibit-JSR-1 (Rowe #2 at [20]) is a copy of a journal article with the following citation details: Wainwright, M., Journal of Antimicrobial Chemotherapy, 2001, Vol. 47, pp. 1-13. Exhibit JSR-12 (Rowe # 2 at [43]) is a copy of a journal article with the following citation details: Rouquette-Loughlin, C., Dunham, S. A., Kuhn, M., Balthazar, J. T. and Shafer, W. M., Journal of Bacteriology, 2003, Vol. 185, No. 3, pp. 1101-1106.
Regarding BZK and cetrimide, a comparison of their structures with the general structure of acridine shows me that BZK and cetrimide do not have the common ring structure of acridine. Therefore, I consider BZK and cetrimide are QACs which are not acridines.
In summary, I consider that QACs are a class of compounds which includes acridines and non-acridines.
Are the amendments allowable under paragraph 102(2)(b) with regard to subsection 40(3)?
Merial submitted that:
“… the specification would not disclose the invention that would be claimed as a result of the amendments in a manner that is clear and succinct and fairly based on the matter described in the specification.” [46]
[46] Merial’s written submissions, dated 23 January 2019, at [18].
The relevant question to ask here in relation to s 102(2)(b) and s 40(3) is whether, as a result of the amendment, the claims would not be clear and succinct and fairly based on the matter described in the specification.
Merial did not point me to any lack of clarity of the proposed amended claims. I am satisfied that the proposed amended claims are clear from a reading of the words of the claims themselves.
The principles applicable to the assessment of fair basis were considered in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 1).[47] It is necessary to consider whether there is a real and reasonably clear disclosure in the body of the specification of the subject matter that is claimed in the relevant claim.
[47] [2004] HCA 58; 217 CLR 274.
Is there a lack of fair basis as a result of the amendments?
Merial submitted that:
“In the present case, the specification of the Opposed Application discloses to a skilled addressee that ionised antiseptics are preferred antiseptics, and that of the ionised antiseptics, quaternary ammonium compounds are particularly preferred.
The skilled addressee would know that some acridines are ionised quaternary ammonium compounds, and moreover that these have a long history of use as veterinary antiseptics, including in the treatment of mastitis. The skilled addressee would thus understand the description of antiseptics to include these acridines, and would understand that these acridines are particularly preferred antiseptics.
Further, the Opposed Application contains no disclosure that provides a basis for the exclusion of acridines generally or acriflavine specifically, especially in light of a preference for compounds having a quaternary ammonium. Indeed, given that ionised
antiseptics and, in particular, quaternary ammonium compounds, are positively recommended as preferred antiseptics, and given that acriflavine is a well-known
quaternary ammonium compound, the principles articulated in AstraZeneca are wholly
applicable. That is, the unamended specification does not contain a real and reasonably
clear disclosure of what would be claimed as a result of the amendments, which would
disclaim material which is positively recommended by the specification.
As was the case in AstraZeneca, the amended claims are not fairly based on the body of
the specification. A disclaimer of acridines generally or acriflavine specifically is
simply not based fairly on a specification that explicitly states a positive preference for
compounds having a quaternary ammonium. The proposed amendments should not be
allowed.
The Opponent submits that it is sufficient to decide this case on the basis of the
principles articulated by the Full Court in AstraZeneca, and by analogy with the facts
of that case which also involved a claim to a formulation. The decision is recent and of
[48] Merial’s written submissions, dated 23 January 2019, at [47]-[51].
high authority, being a decision of a five-member Full Court…”[48]
The court in AstraZeneca considered an amended specification that had excluded particular inorganic salts— inorganic salts where the counter anion is a phosphate—from the claimed pharmaceutical compositions. [49] These amendments were termed “the 2005 amendments”.[50] The Court explained:
“The pharmaceutical composition of the invention as described at page 2, lines 8 to 9 of the specification in the form it took at the time it was filed, and immediately before the 2005 amendments were made, was said to include with the active ingredient ‘an inorganic salt in which the cation is multivalent’. The specification includes a list of ‘multivalent cations’ and ‘counter anions’ which are suitable for the inorganic salt. The specification states at page 3, lines 1 to 7:
The counter anion in the inorganic salt may be selected from a phosphate, a carbonate, a silicate, an oxide and a metasilicate. Preferred counter anions are selected from a carbonate, a silicate, an oxide and a metasilicate. Especially preferred counter anions are selected from a silicate, an oxide or a metasilicate.
Individual aspects of the invention include an inorganic salt comprising a
multivalent cation selected from any of the above and a counter anion also selected from any of the above.
Accordingly, while the specification clearly indicated that phosphate may be used as the counter anion in the compositions of the invention, the claims in their amended form made it clear that compositions that use phosphate for that purpose are not within the scope of the claimed invention.” [51]
[49] AstraZeneca AB v Apotex Pty Ltd (AstraZeneca) [2014] FCAFC 99; 107 IPR 177 at [232].
[50] ibid.
[51] AstraZeneca at [233]-[234].
The court considered whether or not there was a real and reasonably clear disclosure in the unamended specification of what was claimed as a result of the 2005 amendments.[52]
[52] AstraZeneca at [244], [247].
The Court took into consideration the invention of the unamended specification as broadly described and what the specification stated as “possible substances that might be used as the counter anion” in the inorganic salts.[53] The Court also considered the inorganic salts described as preferred in the specification and the inorganic salts that were described in the examples.[54]
[53] AstraZeneca at [246].
[54] AstraZeneca at [247].
Based upon the facts of the case, a plurality of the Full Court observed:
“…. In each of these compositions the phosphate is the counter anion to the inorganic salt. This is fundamentally inconsistent with the revised form of claims and the additional matter introduced as a result of the 2005 amendments. Not only does the specification before amendment not suggest that phosphate not be used as the counter anion in the inorganic salts used in the pharmaceutical compositions of the invention, it positively recommends that it be used for that purpose. We are satisfied that the unamended specification does not contain a real or reasonably clear disclosure of what was claimed as a result of the 2005 amendments.” [55] (Emphasis added)
[55] AstraZeneca at [247], Besanko, Foster, Nicholas and Yates JJ; AstraZeneca at [447], Jessup J concurring.
I agree with Merial that the principles of AstraZeneca are applicable in the current opposition and the relevant question I have to ask is whether or not there is a real and reasonably clear disclosure in the amended specification of what is claimed as a result of Bayer’s amendments.
The relevant question is:
·what subject matter is claimed as a result of Bayer’s amendments, and
·whether there is a real and reasonably clear disclosure of that subject matter in the specification as amended.
As a result of Bayer’s amendments, the claims are now limited to formulations in which the antiseptic:
i. acts to kill or prevent the spread of mastitis causing infectious organisms in the teat cistern of the animal following administration; and
ii.the antiseptic is not an acridine.
Merial does not allege that, as a result of the amendments, there is lack of a real and reasonably clear disclosure in the specification of formulations in which the antiseptic acts to kill or prevent the spread of mastitis causing infectious organisms in the teat cistern of the animal following administration. Rather, Merial submitted that there is not a real and reasonably clear disclosure that the antiseptic is not an acridine.
I have previously found the specification to define an antiseptic as an agent that kills or prevents the spreading of infectious organisms which relate to mammary gland infections, including mastitis. I consider this broad definition of an antiseptic includes acridine and non-acridine compounds within the scope of unamended claim 1. My consideration is consistent with Professor Wainwright’s statements in his declaration that the specification of the opposed application provides a broad definition for the term “antiseptic” which encompasses acridine compounds.[56]
[56] Wainwright #1 at [37]-[38].
Merial relies on analogy with the facts of AstraZeneca to contend that amendments to disclaim acridines from claim 1 would result in disclaiming material which is positively recommended by the specification. According to Merial, the amendments are not allowable because a disclaimer of acridines generally, or acriflavine specifically, is not fairly based on a specification that explicitly states a positive preference for compounds having a quaternary ammonium.
Bayer NZ submitted:
“…. there is no explicit reference to the use of acridines for any purpose, including as an antiseptic in the claimed formulation. The term ‘acridine’, and chemical variants thereof such as acriflavine, is not used anywhere in the specification.”[57]
and
“There is no ‘fundamental inconsistency’ arising as a result of the amendments since the specification provides no disclosure that acridines are preferred or places any reliance on such compounds in any, let alone all, of the examples. The full bench of the Federal Court’s decision in Astrazeneca is entirely supportive of the amendments.”[58]
[57] Bayer NZ’s written submissions, dated 31 January 2019, at [1].
[58] Bayer NZ’s written submissions, dated 31 January 2019, at [3].
As discussed above, I found that it was part of the CGK that acriflavine has an antiseptic property in Merial 2017.[59] Therefore, I consider that a person skilled in the art would understand acriflavine to be one of a number of options of antiseptics taught by the specification of the opposed application.
[59] [2017] APO 27 at [198].
I have reviewed the specification and find it makes no mention of the terms “acridine” or “acriflavine”. The specification does mention QACs on page 13 and describes cetrimide and BZK as examples of QACs. As previously discussed, cetrimide and BZK are QACs that are not acridines.
The specification also exemplifies use of chlorhexidine as an antiseptic. I reproduce the structure of chlorhexidine shown in Professor Wainwright’s declaration below:[60]
[60] Wainwright #1 at [29], Exhibit MW-7, slide 18.
The structure representation shows that chlorhexidine does not have the common ring structure of acridine. Therefore, it is clear chlorhexidine is not an acridine.
I consider the specification of the opposed application provides a real and reasonably clear disclosure of formulations in which the antiseptic is not an acridine because the specification describes cetrimide and BZK as preferred antiseptics and exemplifies chlorhexidine—all three compounds are not acridines. I note that apart from Bayer’s amendments considered in this decision, no other amendments have been proposed or made to the opposed application after acceptance. I also note that no amendments have been made to the description of the specification after filing.
Bayer NZ made significant submissions as to the undesirability of acridines as an antiseptic for the formulation of the opposed application. These include submissions that acridines do not have broad spectrum antiseptic activity, the ionisation of a majority of acridines is pH dependent and a very small number of acridines are permanently ionised, acridines are strong colorants and may discolour animal tissue or milk, acridines have indeterminate and complex release rate, acridines are absorbed into the animal’s tissue, acridines are unstable, acridines are irritants, acridines are not QACs by structure and mode of action, acridines do not stay localised, and acridines have indeterminate water solubility and wide-ranging pKa.[61]
[61] Bayer NZ’s written submissions, dated 31 January 2019, at pages 31-48.
I understand Bayer NZ to be submitting that the use of acridines as antiseptics is undesirable because acridines have properties contrary to those stated on page 12 of the specification—the preferred properties. However, I find Bayer NZ’s submissions regarding the properties of acridines of little assistance in an assessment of whether there is a real and reasonably clear disclosure in the specification of formulations in which the antiseptic is a not an acridine.
Bayer’s amendments seek to exclude from the claims subject matter—formulations having an antiseptic that is an acridine—that is not mentioned and not exemplified in the present specification. In contrast, the amendments in AstraZeneca excluded from the claims subject matter—pharmaceutical compositions having an inorganic salt where the counter anion is a phosphate—that was described as preferred and also exemplified in the specification. The fact situation in the Merial opposition is very different and therefore distinguishable from that in AstraZeneca.
I consider that the subject matter of proposed claim 1, as a result of the amendment, is not fundamentally inconsistent with the specification. I am satisfied that the specification of the opposed application as filed, and the specification as proposed to be amended, do contain a real and reasonably clear disclosure of what is claimed as a result of Bayer’s amendments.

I conclude a lack of fair basis has not arisen as a result of the amendment. Consequently, the proposed amendments are allowable under paragraph 102(2)(b) with regard to s 40(3).
Conclusion
The opposition is unsuccessful. I find the amendments allowable under section 102.
Costs
The parties submitted that cost should follow the event. I see no reason to depart from that result. Cost should be awarded against the opponent.
Dr A. Lim
Delegate of the Commissioner of Patents
ANNEX 1:
WHAT WE CLAIM IS:
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 for the antiseptic to act effectively as an antiseptic to kill
or prevent the spread of mastitis causing infectious organisms in the teat
cistern of the animal following administration;
and wherein the antiseptic is not an acridine.
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 the 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 the 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.

Evidence	Declarant	Exhibits	Date	Reference
In Support	Professor Mark Wainwright	MW-1 to MW-9	14 March 2018	Wainwright #1
In Answer	Dr Craig Bunt	CB-1 to CB-15	25 June 2018	Bunt
In Reply	Professor Mark Wainwright	MW-10 to MW-16	22 August 2018	Wainwright #2
In Reply	Dr Marcus Caulfield	MJC-1 to MJC-6	24 August 2018	Caulfield