Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited - [2016] APO 86

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited [2016] APO 86
Patent Application: 2008322739

Title:Use of anti-bacterial compounds having an anaesthetic effect

Patent Applicant: Reckitt Benckiser Healthcare (UK) Limited

Opponent:Sanofi-Aventis Healthcare Pty Limited

Delegate:Dr A. Lim

Decision Date: 8 December 2016

Hearing Date: Written submissions completed on 27 September 2016

Catchwords: PATENTS - opposition to the allowance of amendments –amendments allowable according to subsection 102(1) and subsection 102(2) – amendment allowed – costs awarded against the opponent

Representation: Applicant: Madderns Patent & Trademark Attorneys
Opponent:Watermark Patent & Trademark Attorneys

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2008322739

Title:Use of anti-bacterial compounds having an anaesthetic effect

Patent Applicant: Reckitt Benckiser Healthcare (UK) Limited

Date of Decision: 8 December 2016

DECISION
The opposition fails on all grounds.
I allow the amendments.
I award cost according to Schedule 8 against Sanofi-Aventis Healthcare Pty Limited.
REASONS FOR DECISION
Background

This matter relates to patent application 2008322739 in the name of Reckitt Benckiser Healthcare (UK) Limited (the applicant). The application was advertised as accepted on 10 July 2014. A notice of opposition to the grant of the patent was filed by Sanofi-Aventis Healthcare Pty Limited (the opponent) on 10 October 2014.
Amendments were filed on 28 September 2015, and leave to amend was advertised on 12 November 2015. The opponent filed a notice of opposition to the amendments on 06 January 2016. It is that opposition that is the subject of this decision.
Grounds of opposition
The statement of grounds and particulars specifies the following matters: subsection 102(1), paragraphs 102(2)(a) and 102(2)(b) of the Patents Act 1990 (the Act).
Evidence and submissions
Both the opponent and the applicant have not filed evidence in relation to the opposition to the amendments, and have sought to address the allowability of the amendments by written submissions.
The matter was heard by means of written submissions. The opponent filed submissions on 30 August 2016. The applicant filed reply submissions on 13 September 2016, and the opponent filed further submissions in response to the applicant’s reply submissions on 27 September 2016.
The Law
As the request for examination of the patent application was filed before 15 April 2013, substantive amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent application.
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).
As set out in subsection 102(2A) the "relevant time" is after the specification has been accepted. Therefore, as the present specification had been accepted when the amendments were requested, the requirements of subsection 102(2) apply.
Relevant principles applying to subsections 102(1) and 102(2) are conveniently laid out by Yates J in Bristol-Myers Squibb Company v Apotex Pty Ltd[1] (Bristol-Myers Squibb):
"38. Consideration of the prohibition in s102(1) of the Act requires a comparison between what would be claimed as a result of the proposed amendment and what is disclosed in the specification as filed. The steps involved in this comparison were described in RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458 at 466C-E. As there emphasised, the key point is that the words 'as a result of the amendment' in s102(1) are not to be confused with the expression 'after the amendment'. The amendment is identified by considering the specification as it stands with how it would stand after the proposed amendment. It is only by that step that one can determine what matter results from the amendment. Once that is determined, the next step is to read the specification as a whole (that is, amended in the manner proposed) and to compare it with what is 'in substance disclosed' in the specification as filed. If by reason of the amendment proposed, and for no other reason, the specification would then claim matter not in substance disclosed in the specification as filed, the amendment would not be allowable.
39. As to the notion 'in substance disclosed', the Full Court in ICI Chemicals & Polymers Ltd v The Lubrizol Corporation Inc (2000) 106 FCR 214 at [118] referred to the close relationship between that notion and the test for fair basis, saying that it would be a rare case where a claim which claims matter in substance disclosed in the specification as filed is not, equally, fairly based on the matter described in the specification: see also Gambro Pty Ltd v Fresenius Medical Care South East Asia Pty Ltd (2000) 49 IPR 321 at [18] where the two requirements were said to be 'very similar'. In Ethyl Corporation's Patent [1972] RPC 169 at 195, Lord Denning MR said that the requirements were 'virtually the same', although in Lubrizol the Full Court thought it unnecessary to go that far. It is thus expedient to test whether matter is 'in substance disclosed' in the specification as filed by asking whether there is a 'real and reasonably clear disclosure' of that matter.
40. Consideration of the prohibition in s 102(2)(a) requires a comparison between the proposed new claims and the claims of the specification immediately before amendment. Once again the prohibition is conditioned on a state of affairs existing as a result of the amendment, namely that a claim would not in substance fall within the scope of the claims before amendment. Thus the identification of the amendment is, once again, an important first step. Moreover, the reference to 'within the scope of the claims' before amendment is significant. The comparison is not between a particular amended claim and that claim before amendment. The expression 'within the scope of the claims' directs attention to all the claims. For this reason a practical test is to ask whether an amendment makes anything an infringement which would not have been an infringement before the amendment. If the answer is 'yes', the amendment is proscribed by s102(2)(a) of the Act: AMP Incorporated v The Commissioner of Patents (1974) 3 ALR 283 at 289-290; Fina Research SA v Halliburton Energy Services Inc (No 2) (2003) 127 FCR 561 at [29]; W J Voit Rubber Corp 's Application, Re (1965) AOJP 1752 at 1754-1755."
[1] [2010] FCA 814; (2010) 87 IPR 516 at [38]-[40]
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 nature of the amendments
The claims and the description were amended, and a marked-up version of the amendments is reproduced in Annex 1. Briefly, amendments to the claims consist of amendments to previous claims and the addition of new claims. Amendments to the description consist of the addition of text. I will discuss the amendments in more detail below within the context of the requirements of section 102.
Are the amendments allowable under subsection 102(1)?
As noted in the Bristol-Myers Squibb case, subsection 102(1) requires a comparison between what would be claimed as a result of the proposed amendment and what is disclosed in the specification as filed. When determining whether matter is in substance disclosed in the specification as filed the courts have basically applied the test for fair basis. Thus it is necessary to ask whether there is a “real and reasonably clear disclosure” of the matter claimed in the amended claim.
The opponent's objections with the proposed amendments are best summarised in paragraphs 3.1.1- 3.1.3 of the statement of grounds and particulars which state[2]:
[2] The opponent’s statement of grounds and particulars, filed 05 February 2016, in support of the opposition to the amendments.
“Proposed amendments to the description begin on page 3, last paragraph, extend onto pages 4 to 4e and insert subject matter relating to medicament/composition formulations comprising detailed embodiments of:
• specific concentrations, weight ranges or weights,
• specific formulation types (e.g. liquid or solid form),
• specific dosage forms (e.g. chewable (masticable) or suckable form, and
• excipients.
The subject matter inserted is not disclosed in the specification as filed.
The subject matter that is newly inserted has a material effect on the scope of the claims as exemplified by the table below in which newly inserted subject matter relating to medicaments/compositions of AMC [amylmetacresol] and DCBA [2,4-dichlorobenzyl alcohol] is highlighted. As a consequence the amendment would result in the claims claiming matter not in substance disclosed in the specification as filed.”
The table provided by the opponent and referenced in the above-mentioned quote is reproduced in Annex 2.
The opponent also submitted[3]:
“The table below summarises the fact that pages 3 and 4 of the specification as originally filed broadly and generally described preferred embodiments of the alleged invention. However, nowhere else in the specification as accepted were the embodiments exemplified, let alone were there explicit or implicit disclosures of medicaments/compositions comprising DCBA and/or AMC in any particular amounts. There was simply no description of the best method known for performing the invention claimed, or any disclosure that would enable a person skilled in the art to produce something within each claim.
Rather, the focus of the description from page 5 is in vitro testing to establish whether specific compounds have the capacity to modulate action potentials in a voltage gated sodium channel (Na_V1.2) as a surrogate to assessing the generation of a local anaesthetic effect. Again, the in vitro tests used 1 M stock solutions of DCBA, AMC, CPC, HR and HT with ethanol from which dilutions were prepared (see page 6, line 30).
If it is the case that the basis for making the amendments to the description to include embodiments of compositions with AMC and DCBA in particular amounts/ranges is derived from common general knowledge (such as for example the Applicant’s use of AMC and DCBA in lozenge form marketed under the trade mark STREPSILS), the Applicant has not provided any evidence to support such a proposition. Further, there is no information in the specification as filed that would lead skilled addressee to such knowledge.
On this basis, the proposed amendments contravene s 102(1) of the Act as the specification, compared before and after amendment (consistent with the decision of RGC v Wimmera), now claims matter not in substance disclosed in the specification as filed.”
[3] The opponent’s written submissions, dated 30 August 2016, at [75]-[78].
The opponent appears to contend that because more specific embodiments of the medicament have been added in the form of additional text to the description, the amended specification would now claim matter not in substance disclosed in the specification as filed.
In regard to the test for allowability of amendments under s102(1) in RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd[4], the opponent submitted[5]:
“The first stage is to compare the specification before and after the amendment so as to identify what matter results from the amendment. Notably, the comparison required by s102(1) at this first stage is a comparison of the specification before and after the amendment, rather than a comparison of the claims as amended with the specification as filed (Fina Research SA v Halliburton Energy Services Inc (2003) 127 FCR 561; 59 IPR 91; [2003] FCA 251 at [37]; Kornelis' Kunsthars Producten Industrie BV v WR Grace & Co (1994) 28 IPR 471).
In the second stage, a determination of whether the newly inserted matter is in substance disclosed in the specification as filed is made.”
[4] (1998) 89 FCR 458; 42 IPR 353
[5] The opponent’s written submissions, dated 30 August 2016, at [18].
The applicant submitted[6]:
“The Opponent's reference to RGC v Wimmera in paragraphs 78 and particularly paragraph 18 of the Opponent's submissions is misconceived in that the court in RGC v Wimmera actually considered the test for allowability of amendments under section 102(1) to be a comparison between:
·‘the matter’ which ‘the specification would claim’, ‘as a result of the amendment’; and
·‘the matter’, disclosed ‘in the specification as filed’. [emphasis added]
Particularly, at paragraph 18, the Opponent appears to have overlooked the importance of the matter being tested being matter that the specification would claim.”
[6] The applicant’s written submissions, dated 13 September 2016, at [95]-[96].
As stated above, subsection 102(1) requires a comparison between what would be claimed as a result of the proposed amendment and what is disclosed in the specification as filed. A comparison between the existing claims and the proposed amended claims needs to be made to determine what matter would be claimed as a result of the amendments. The approach of comparing the existing claims with the proposed amended claims is consistent with the following definition of ‘claim’ provided in Schedule 1 of the Act:
(c) when used as a verb—to claim in a claim (including a dependent claim) of a complete specification.
The amendment would be not allowable only if, “as a result from the amendment”, the specification would claim matter not in substance disclosed in the specification as originally filed.
Claim 1
A marked-up copy of the proposed amendments to claim 1 is shown below:
1. The use of 2,4-dichlorobenzyl alcohol in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol for the preparation of a medicament for the provision of an anaesthetic effect~~, wherein 2,4-dichlorobenzyl alcohol is in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol.~~
The applicant submitted that[7]:
“Amended claim 1 has been rearranged such that the statement that ‘2,4-dichlorobenzyl alcohol [is] in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol’ was moved from a wherein statement to the claim preamble. Both prior to and following the amendments, claim 1 clearly states that the medicament is ‘for the provision of an anaesthetic effect’; and further, both prior to and following the amendment, the medicament clearly contains 2,4-dichlorobenzyl alcohol ‘in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol’. Claim 1 was amended to increase clarity of the claim and ensure it was properly construed, which is considered desirable by the High Court. The substance of this claim is unchanged by the amendments. In particular, this claim has not been broadened in scope by the amendments.”
[7] The applicant’s written submissions, dated 13 September 2016, at [20].
The opponent submitted that[8]:
“Claim 1 as amended is now directed to the use of DCBA [2,4-dichlorobenzyl alcohol] in combination with one of AMC [amylmetacresol], CPC [cetylpyridinium chloride] , HT [hexetidine] or HR [hexylresorcinol] in the manufacture of a medicament, wherein said medicament (i.e. the combination) is for the provision of an anaesthetic effect.
Amended claim 1 is to be contrasted with claim 1 as accepted as discussed above (i.e. when read in connection with claim 6 it is the DCBA alone in claim 1 which is purported to provide the anaesthetic effect). This interpretation of claim 1 as unamended is justified in view of amended claim 7 (previous claim 6) and new claim 12 (discussed below) both of which expressly state that DCBA exhibits the anaesthetic effect.
As a result of the amendment, claim 1 is directed to a combination which provides the anaesthetic effect. This is broader in scope than claim 1 as originally accepted wherein, as discussed above, DCBA alone provided the anaesthetic effect. As a result of the amendment, claim 1 would not fall within the scope of the claims before amendment. Claim 1 as amended thus contravenes s102(2)(a) of the Act.
In addition, claim 1 as amended encompasses general anaesthesia by any route of administration, which is inconsistent with the description of the invention in the specification as filed in light of the focus on local anaesthesia the treatment of sore throats and other areas of the mouth, and peroral administration.”
[8] The opponent’s written submissions, dated 30 August 2016, at [80]-[82], [84].
I will firstly determine the difference (if any) between existing claim 1 and proposed amended claim 1. Where there is a difference, I will then determine what matter would be claimed as a result of the amendment.
The existing claim 1 and the proposed amended claim 1 are drafted in the form of a Swiss type claim[9]. Yates J in Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) stated[10]:
“In my view, an invention defined by a Swiss type claim is appropriately characterised as method or process. For the purpose of this analysis, no useful distinction exists between the words ‘method’ and ‘process’. In the Act, the words ‘method’ and ‘process’ are not defined. In my view, neither word has a meaning that is different from its ordinary English signification. My conclusion reflects, therefore, what I consider to be an apt use of the words ‘method’ and ‘process’ when applied as ordinary English words to describe the content and subject matter of the generalised form of the claim to which I have referred.”
Therefore, the proposed amended claim 1 is directed to a method.
[9] The generalised form of a Swiss type claim is “the use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use”: see Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] 253 CLR 284 at [248] and Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) (2015) 113 IPR 191 at [101].
[10] [2015] FCA 634; (2015) 113 IPR 191 at [120]
The opponent submitted that existing claim 1 is not in the form of a classic Swiss type claim and therefore, it is legitimate to refer to the rest of the specification to resolve ambiguities in the construction of claims[11]. I consider that existing claim 1 is clearly intended to be a Swiss type claim and so will construe the claim in that way.
[11] The opponent’s written submissions, dated 27 September 2016, at [15]-[20].
In the present case, I can understand the meaning of the words of existing claim 1 from the language of the claim itself. Considering the arrangement of words as they appear in existing claim 1, I interpret that the claim defines the use of 2,4-dichlorobenzyl alcohol (DCBA) for the preparation of a medicament. In the preparation of the medicament, I interpret that DCBA is used in combination with a compound selected from the group consisting of amylmetacresol (AMC), cetylpyridinium chloride (CPC), hexetidine (HT) and hexylresorcinol (HR). I am satisfied that in this method, (a) it is the medicament that provides an anaesthetic effect, and (b) in the preparation of the medicament, DCBA is combined with a compound selected from the recited group. I consider this to be a more reasonable interpretation of existing claim 1 compared to the opponent’s interpretation that DCBA alone provides the anaesthetic effect.

Similarly, I am satisfied that proposed amended claim 1 defines a method of (a) using DCBA in combination with a compound selected from the recited group for the preparation of a medicament, and (b) it is the medicament that provides an anaesthetic effect.
When I compare the subject matter claimed by existing claim 1 to the subject matter claimed by proposed amended claim 1, I find that there is no difference in what matter is claimed as a result of the proposed amendment.
The opponent submitted that[12]:
“Thus as a result of the amendment the matter discussing the invention around which the claims are drawn is greatly expanded – by the introduction of description of embodiments of that invention – as compared to the specification as accepted. Consequently the proposed amended claim 1 contravenes s 102(1).”
[12] The opponent’s written submissions, dated 30 August 2016, at [87].
I disagree. In construing existing claim 1 and proposed amended claim 1, it has not been necessary for me to refer to the description to interpret the meaning of the claims. The amendments that introduce more specific embodiments of the medicaments to the description do not result in an expansion of the scope of proposed amended claim 1.
I am satisfied that there is no change in the scope of claim 1 as a result of the amendment to claim 1. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore the proposed amendment to claim 1 is allowable under s 102(1).
Claim 2
Proposed claim 2 is a new claim that has been introduced as a result of the amendment. New proposed claim 2 is directed to the use of DCBA in combination with AMC for the preparation of a medicament for the provision of an anaesthetic effect. New claim 2 is therefore of a narrower scope compared to existing claim 1. Consequently, introducing new proposed claim 2 does not result in the specification claiming additional matter. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to introduce new claim 2 is allowable under s 102(1).
Claims 3 and 4
As a result of the amendments proposed to claims 3 and 4, there is a change of claim dependency — each proposed claim being dependent on claim 1 or claim 2. The change of claim dependency has not broadened the scope of each proposed claim. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendments to claims 3 and 4 are allowable under s 102(1).
Claim 5
A marked-up copy of the proposed amendments to claim 5 is shown below:
45. The use as claimed in any one of the preceding Claims, wherein ~~the base of~~ the medicament has a base ~~which contains the anti-bacterial agent~~ that comprises one or more components selected from sucrose, glucose, isomalt, maltitol, xylitol, mannitol.
The applicant submitted that[13]:
“Amended claim 5 has been clarified to ensure a correct interpretation. The words ‘which contains the anti-bacterial agent’ were deleted from the phrase ‘the medicament which contains the anti-bacterial agent’ by the amendment as there was no antecedence for the words ‘anti-bacterial agent’. This had no effect on the scope of the claim as this feature was redundant. Specifically, amended claim 5 depends from claim 1. Claim 1, both prior to and after the amendments, requires that the medicament contains 2,4-dichlorobenzyl alcohol ‘in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol’ as outlined above in paragraph 18. The specification as originally filed relevantly discloses that ‘typically the one or more anti-bacterial compounds can be selected from 2,4-dichlorobenzyl alcohol, amylmetacresol, cetylpyridinium chloride, hexetidine, lidocaine, hexylresorcinol and benzocaine’ as detailed in paragraph 39. Accordingly, it is immediately clear that ‘the anti-bacterial agent within the medicament’ recited in dependent claim 4 as accepted are the compounds already recited in claim 1 from which claim 4 depends. This amendment is clearly of no consequence. This approach has been endorsed by the High Court when considering deletion of a phrase from a claim as described in paragraph 18 above.
Secondly, the phrase ‘wherein the base of the medicament…’ in claim 4 as accepted was amended to read ‘the medicament has a base’ in amended claim 5. This amendment was made because the term ‘the base’ lacked antecedence, and the amendment ensures that ‘the base’ is correctly introduced in the claim using the phrase ‘the medicament has a base’. Both prior to and following the amendments, the claim requires that the base comprises one or more components selected from sucrose, glucose, isomalt, maltitol, xylitol, mannitol. Plainly, the scope of the claim has not changed. Accordingly, this claim is in substance disclosed at least by claim 7 and page 3, lines 27 to 20 of the specification as filed.”
[13] The applicant’s written submissions, dated 13 September 2016, at [42]-[43].
The opponent submitted that[14]:
“Amended claim 5 is derived from claim 4 of the unamended specification. Previous claim 4 states that the medicament of claim 1 contains a base which, in turn, contains the antibacterial agent and one or more further components. This is identical language to that on page 3, fourth paragraph, and also new paragraph 2 on page 4. Prior to amendment the claim required the base to include both the antibacterial agent (e.g. DCBA) and one or more selected components. There is no basis for a broadening of claims in the unamended specification.
The language of amended claim 5 has been broadened in scope as the reference to the ‘base containing the anti-bacterial agent’ has been deleted. Post amendment (as a result of the amendment) the antibacterial agents mentioned in claim 1 need not be included in the base component. The antibacterial agent could be, for example, a liquid inside a solid base or in another layer to the base. These forms would not fall within old claim 4. Amended claim 5 therefore as a result of the amendment contravenes s 102(2)(a) of the Act.
Further, given the inconsistency of language between amended claim 5 and page 3, fourth paragraph, and page 4, paragraph 2, the subject matter of amended claim 5 travels beyond the specification as filed, and thus also contravenes s 102(2)(b) of the Act (i.e. consistent with the decision in Coopers Animal Health as the claim defines a different invention from that described in the specification).”
[14] The opponent’s written submissions, dated 30 August 2016, at [90]-[92].
The issue here in regard to existing claim 4 (which after amendment becomes proposed claim 5) is one of claim construction. Considering existing claim 4, the question is whether it is the medicament which contains the anti-bacterial agent, or the base.
I consider that the arrangement of the words as they appear in existing claim 4 qualifies that (a) it is the medicament which contains the anti-bacterial agent, and (b) the base of the medicament comprises one or more components selected from sucrose, glucose, isomalt, maltitol, xylitol, mannitol. I consider that this is a more reasonable construction compared to the alternative which is to interpret that the base comprises the anti-bacterial agent and one or more further components. I am satisfied that existing claim 4 does not limit the anti-bacterial agent to be included only in the base of the medicament.
Proposed claim 5 is dependent on any one of claims 1 to 4. Although the phrase “which contains the anti-bacterial agent” has been deleted from proposed claim 5, the “anti-bacterial agent” feature is now imported by way of dependency on proposed claim 1 or proposed claim 2. As I have previously found, a combination of DCBA and a compound selected from the group consisting of AMC, CPC, HT and HR is used in the preparation of the medicament of proposed claim 1. DCBA, AMC, CPC, HT and HR are described to be anti-bacterial compounds in the specification as originally filed. In proposed claim 2, AMC is an anti-bacterial compound. Therefore, I conclude proposed claim 5 defines a medicament which contains an anti-bacterial compound. The arrangement of the words of proposed claim 5 now makes it clear that it is the base that comprises one or more components selected from sucrose, glucose, isomalt, maltitol, xylitol, mannitol.
There is no difference in the matter that is claimed as a result of the amendment proposed to claim 5. The scope of proposed claim 5 has not broadened as a result of the amendment. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to claim 5 is allowable under s 102(1).
Claim 7
A marked-up copy of proposed amended claim 7 is shown below:
67. A method of obtaining a local anaesthetic effect in a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect, wherein 2,4- dichlorobenzyl alcohol is in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol.
As a result of the amendment proposed, there is a change to the claim numbering. The change has not broadened the scope of the proposed claim. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to claim 7 is allowable under s 102(1).
Claims 8, 13 and 18
A marked-up copy of the proposed amendments to claims 8, 13 and 18 is shown below:
8. A method of obtaining a local anaesthetic effect in a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol which exhibits an anaesthetic effect, wherein 2,4- dichlorobenzyl alcohol is in a combination with amylmetacresol.
13. A method of locally anaesthetising a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol and amylmetacresol, wherein the 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect.
18. A method of locally anaesthetising the throat of a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol in a combination with amylmetacresol, wherein 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect, and wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet.
Proposed claims 8, 13 and 18 result in new claims all of which are directed to a method of providing a local anaesthetic effect by administering a composition comprising a combination of DCBA and AMC. The method of proposed claim 18 is limited to locally anaesthetising the throat of a patient. Importantly, each of proposed claims 8, 13 and 18 is narrower in scope than proposed claim 7 (existing claim 6). It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendments to introduce new claims 8, 13 and 18 are allowable under s 102(1).
Claims 12 and 17
A marked-up copy of the proposed amendments to claims 12 and 17 is shown below:
12. A method of locally anaesthetising a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol, wherein the 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect.
17. A method of locally anaesthetising the throat of a patient comprising administering a composition comprising 2,4-dichlorobenzyl alcohol in a combination with a compound selected from the group consisting of amylmetacresol, cetylpyridinium chloride, hexetidine and hexylresorcinol wherein 2,4-dichlorobenzyl alcohol exhibits an anaesthetic effect, and wherein the composition is in a form of a lozenge, gel, spray, capsule, pastille, gum, dissolving granules, gargle, drink, liquid-shots, or tablet.
Proposed claim 12 is a new claim that has been introduced as a result of the amendment. Using the plain meaning, I interpret the method defined in proposed claim 12 to be of the same scope as the method defined in proposed claim 7 (existing claim 6). It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to introduce new claim 12 is allowable under s 102(1).
Proposed claim 17 is a new claim that has been introduced as a result of the amendment. Importantly, proposed claim 17 is narrower in scope than proposed claim 12. Since I have previously found proposed claim 12 to be of the same scope as the method defined in proposed claim 7 (existing claim 6), it follows that proposed claim 17 is narrower in scope than proposed claim 7. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to introduce new claim 17 is allowable under s 102(1).
Claims 10 and 11
Proposed claims 10 and 11 are new claims that have been introduced as a result of the amendment. Proposed claims 10 and 11 are dependent on proposed independent claim 7 or 8. I have previously found that as a result of the amendment proposed, there is no broadening of the scope of proposed claim 7 (compared to existing claim 6). I have also previously found that proposed claim 8 is narrower in scope than proposed claim 7. I conclude that it follows that proposed claims 10 and 11 are also narrower in scope than proposed claim 7. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendments to introduce new claim 10 and 11 are allowable under s 102(1).
Claims 14 and 15
Proposed claims 14 and 15 are new claims that have been introduced as a result of the amendment. Proposed claims 14 and 15 are dependent on proposed independent claim 12 or 13. I have previously found proposed claim 12 to be of the same scope as proposed claim 7, and found proposed claim 13 to be narrower in scope than proposed claim 7. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendments to introduce new claims 14 and 15 are allowable under s 102(1).
Claim 19
Proposed claim 19 is a new claim that has been introduced as a result of the amendment. Proposed claim 19 is dependent on proposed independent claim 17 or 18. I have previously found that proposed claims 17 and 18 are each narrower in scope than proposed claim 7. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to introduce new claim 19 is allowable under s 102(1).
Claims 6, 9 and 16
As a result of the amendment proposed, there is a change to the claim numbering of proposed claim 6. The change has not broadened the scope of the proposed claim. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to claim 6 is allowable under s 102(1).
Proposed claim 9 results in the claim being dependent on existing claim 6 (now proposed claim 7) or new proposed claim 8. The scope of proposed claim 9 has not broadened as a result of the amendment. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to claim 9 is allowable under s 102(1).
Proposed claim 16 is a new claim that has been introduced as a result of the amendment. Proposed claim 16 is dependent on proposed independent claim 12 or 13. I have previously found proposed claim 12 to be of the same scope as proposed claim 7, and found proposed claim 13 to be narrower in scope than proposed claim 7. It follows that, as a result of the amendment, the specification does not claim matter not in substance disclosed in the specification as filed. Therefore, the proposed amendment to introduce new claim 16 is allowable under s 102(1).
I conclude that as a result of the amendments proposed, the specification would not claim matter not in substance disclosed in the specification as filed. The proposed amendments to the description and claims are therefore allowable under s 102(1), and the opposition is unsuccessful in relation to s 102(1).
Are the amendments allowable under paragraph 102(2)(a)?
As noted in the Bristol-Myers Squibb case, paragraph 102(2)(a) requires a comparison between the proposed new claims and the claims of the specification immediately before amendment. The comparison is not between a particular amended claim and that claim before amendment because the expression “within the scope of the claims” directs attention to all the claims. As a practical test I need to ask whether an amendment makes anything an infringement which would not have been an infringement before the amendment. If the answer is “yes”, the amendment contravenes s 102(2)(a).
I will now look at whether as a result of the amendments, the proposed claims would not in substance fall within the scope of the claims before the amendment.
Claim 1: I have previously concluded that as a result of the amendment, the scope of proposed claim 1 has not been broadened. Since the scope of proposed claim 1 has not been broadened, there cannot be anything that would be an infringement as a result of the amendment. Therefore, the proposed amendment to claim 1 is allowable under s 102(2)(a).
Claim 2: I have previously concluded that new proposed claim 2 is narrower in scope compared to existing claim 1. Therefore, the proposed amendment to introduce new claim 2 is allowable under s 102(2)(a).
Claims 3 and 4: I have previously concluded that as a result of a change in the dependency of claims 3 and 4, the scope of each claim has not been broadened. Therefore, the proposed amendments to claims 3 and 4 are allowable under s 102(2)(a).
Claim 5: I have previously concluded that as a result of the amendment, the scope of proposed claim 5 has not been broadened. Therefore, the proposed amendment to claim 5 is allowable under s 102(2)(a).
Claims 6 and 7: I have previously concluded that as a result of a change in claim numbering, the scope of proposed claims 6 and 7 has not been broadened. Therefore, the proposed amendments to claims 6 and 7 are allowable under s 102(2)(a).
Claims 8-11 and 13-19: I have previously concluded that as a result of the amendments, proposed claims 8-11 and 13-19 are narrower in scope compared to existing claim 6 (now proposed claim 7). Therefore, the proposed amendments to claims 8-11 and 13-19 are allowable under s 102(2)(a).
Claim 12: I have previously concluded that new proposed claim 12 is of the same scope as existing claim 6 (now proposed claim 7). Therefore, proposed amendment to introduce new claim 12 is allowable under s 102(2)(a).
I conclude that the proposed amendments to the claims are allowable under s 102(2)(a), and the opponent is unsuccessful in relation to s 102(2)(a).
Are the amendments allowable under paragraph 102(2)(b) with regard to subsection 40(2)?
The relevant question to ask here in relation to s 102(2)(b) and s 40(2) is whether, “as a result of the amendment”, the specification would not describe the invention fully, including the best method known to the applicant of performing the invention.

The opponent submitted that[15]:
“The Applicant seeks impermissibly to cure deficiencies in the accepted specification by substantially amending the description of the invention. The specification as accepted does not describe any method known to the Applicant for performing the invention and hence also lacks sufficiency. The Applicant seeks to remedy these deficiencies by adding five pages containing descriptions of embodiments of the invention.”
[15] The opponent’s written submissions, dated 30 August 2016, at [2].
The proposed amendments to the description do not remove any text from the description. Rather, the proposed amendments insert additional text which describes more detailed and specific embodiments of the medicament. Therefore, as a result of the amendments, the specification better describes the invention.
I conclude that the proposed amendments are allowable under s 102(2)(b) with regard to s 40(2), and the opponent is unsuccessful in relation to this ground.
Are the amendments allowable under paragraph 102(2)(b) with regard to subsection 40(3)?
The opponent submitted that the proposed amendments result in the claims being not clear and not fairly based on the description.
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)[16]:
"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."
[16] [2009] FCA 1019; (2009) 83 IPR 42 at [28]
Therefore, 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.
I have previously concluded that the existing claims and the proposed amended claims are clear from a reading of the words of the claims themselves. Therefore, I am satisfied that a lack of clarity to the proposed claims has not arisen as a result of the amendments.
I have previously concluded that the proposed amendments to the specification do not result in the specification claiming matter not in substance disclosed in the specification as filed. Therefore, I am satisfied that a lack of fair basis has not arisen as a result of the amendments.
I conclude that the proposed amendments are allowable under s 102(2)(b) with regard to s 40(3), and the opponent is unsuccessful in relation to this ground.
Other matters
The opponent made submissions on a document, provided in Annexure 1, entitled “Topical antiseptics for the treatment of sore throat block voltage-gated neuronal sodium channels in a local anaesthetic-like manner” by Buchholz et al. and published as Naunyn-Schmied Arch Pharmacol 2009, 380:161-168[17]. This document was not filed as evidence and cannot be relied on as evidence. However, I will note that even if the document was properly filed in evidence, I have not needed to rely on it in the considerations of the current opposition. Therefore the document is immaterial to the current opposition.
[17] The opponent’s written submissions, dated 30 August 2016, at [60]-[61].
Conclusion
The opposition is unsuccessful on all grounds. 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. Costs should be awarded against the opponent.
Dr A. Lim
Delegate of the Commissioner of Patents
Annex 1

Annex 2