Norbrook Laboratories Limited v Bayer New Zealand Limited
[2020] APO 31
•1 July 2020
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Norbrook Laboratories Limited v Bayer New Zealand Limited [2020] APO 31
Patent Application: 2015202929
Title:Anti-infective formulation and methods of use
Patent Applicant: Bayer New Zealand Limited
Opponent: Norbrook Laboratories Limited
Delegate: Felix White
Decision Date: 1 July 2020
Hearing Date: 26 February 2020, at IP Australia Melbourne Office
Further written submissions received on 28 February and 10 March 2020 (Opponent) and 6 March 2020 (Applicant)
Catchwords: PATENTS – teat seal formulation comprising povidone-iodine antiseptic – section 59 – opposition to grant of a patent – grounds of clarity, support, clear and complete disclosure, utility, inventive step – consideration of reg 5.23 – relationship between claims and examples - opposition unsuccessful – no grounds made out – application to proceed to grant – costs awarded to applicant
Representation: Counsel for the applicant: Ian Finch, James & Wells
Patent attorneys for the applicant: Andrew Scott and Wing Seow, James & Wells
Applicant’s representative: Dee Nicholls
Counsel for the opponent: Clive Elliott QC
Patent attorney for the opponent: Julie Ballance, In-Legal Limited
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2015202929
Title:Anti-infective formulation and methods of use
Patent Applicant: Bayer New Zealand Limited
Date of Decision: 1 July 2020
DECISION
The opposition fails.
I direct the application to proceed to grant.
Costs according to Schedule 8 are awarded against Norbrook Laboratories Limited
REASONS FOR DECISION
Background
Patent application 2012202929 (the application) was filed by Bayer New Zealand Limited (Bayer/the Applicant) on 29 May 2015 as a divisional application from patent application 2009304000 (the parent). The application claims the effective filing date of the parent (15 September 2009), and claims an earliest priority date of 17 September 2008).
The parent application is currently under appeal in the Federal Court regarding admissibility of an amendment. Notably, the parent was the subject of a successful opposition under s 59 of the Patents Act 1990 (the Act), and an amendment under s 104 in response to that successful opposition was in turn unsuccessfully opposed by Norbrook and another party. It is that decision that is currently under appeal. I provide this information for context, but the grounds of opposition and the evidence adduced in this case are somewhat different to those traversed in the parent.
The application was examined and advertised as accepted on 17 August 2017. The complete specification at issue is AU 2015202929 B2 (the specification). The application was filed with a specification identical to the PCT specification of the parent. In response to a first examination report which cited, inter alia, a document forming part of the prior art base for novelty only in that it disclosed barium teat seals comprising antiseptics such as chlorhexidine,[1] “substantially different”[2] claims were introduced under s 104 on 28 February 2017, directed to a teat seal formulation comprising povidone-iodine (PVP-I).
[1] Objection 3, examination report no. 1 dated 3 August 2016
[2] [sic] Examination report no. 2 dated 16 March 2017 p. 5 “New Documents”.
Norbrook Laboratories Limited (Norbrook/the Opponent) filed a notice of opposition under s 59 on 16 November 2017.
The statement of grounds and particulars (SG&P) was filed on 15 February 2018. The SG&P was accompanied by copies of eighteen citations (D1-D18).
Evidence
In addition to the citations filed with the SG&P, the parties relied upon evidence as set out in the table below.
| Evidence | Declarant | Date of Declaration | Reference | Exhibits |
| In support | Dr James Rowe | 14 May 2018 | Rowe #1 | JSR-1 to JSR-5 |
| Assoc. Professor Richard Laven | 15 June 2018 | Laven #1 | RAL-1 to RAL-2 | |
| Jane Calvert | 15 June 2018 | Calvert | JLC-1 to JLC-18A[3] | |
| In answer | Assoc. Professor Craig Bunt | 20 September 2018 | Bunt | CB-1 to CB-16 |
| Dee Nicholls (redacted) | 17 September 2018 | Nicholls Redacted | None | |
| In reply | Dr James Rowe | 21 December 2018 | Rowe #2 | JSR-1 [sic] to JSR-5 [sic][4] |
| Assoc. Professor Richard Laven | 21 December 2018 | Laven #2 | RAL-1 [sic] to RAL-13 [sic][5] | |
| Michael Dhar | 2 January 2019 | Dhar | MSD-1 | |
| Lillian Cromie | 21 December 2018 | Cromie | LC-1 |
[3] Each exhibit was accompanied by a document establishing its publication date – these were designated “A” exhibits
[4] To the extent I need to refer to these, I will refer to them as JSR-2.1 – JSR-2.5
[5] Likewise, I will refer to these as RAL2.1 – RAL-2.13
There was a significant amount of correspondence outside of the normal evidentiary period, as well as a dispute between the parties as to whether the Dhar and Cromie declarations constituted evidence in reply. For the avoidance of doubt, I have taken into account all of the evidence in reply, but I have not invoked Regulation 5.23 and not taken into account any of the information filed outside of the evidentiary period. The underlying reason for this is that none of that evidence would have changed any of my conclusions herein, but I will provide reasoning as to my decision making process at the end of this decision.
The opposition
Grounds of opposition
The grounds of opposition pressed by the opponent in the hearing were:
lack of clarity,
lack of sufficiency,
lack of support,
lack of utility, andlack of inventive step.
Onus
Examination of the application was requested after 15 April 2013. Consequently, the present opposition is governed by the Act and Patents Regulations 1991 (the Regulations) as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar Act). Amendments to sections 7, 40 and 60(3A) of the Act apply to the present case as a consequence of Schedule 1, items 55(1)(d) and 55(4)(a), and Schedule 6, item 133(7)(d) of the Raising the Bar Act.
The standard of proof that applies in the present case is the balance of probabilities. Under subsection 60(3A) of the Act, if I am satisfied, on the balance of probabilities, that a ground of opposition to the grant of a patent exists, I may refuse the application.
Field of the application.
The application is titled “Anti-infective formulation and methods of use”
The field of the invention relates to “… an anti-infective formulation and methods of use to prevent or ameliorate mammary gland infections, including mastitis.”[6]
[6] Description, p. 1 l. 4-5 (page references are to the description as accepted unless indicated otherwise)
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.”[7]
[7]Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70].
The hypothetical skilled person works in the field with which the invention is connected and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[8]
[8]ibid
Given the field of the invention above, the notional skilled team would have an interest in mammary gland infections such as mastitis, and skill in preparing veterinary anti-infective formulations for that purpose. The declarants essentially agree on this.[9]
[9] Rowe #1 [29], Laven #1 [25], Bunt [16], cf. Applicants Submissions (AS) [5.2] and Opponents Submissions (OS) [22]
The Opponent, in presenting two primary declarants, has briefed them differently and their testimony is focussed on different aspects. Dr Rowe was already familiar with the patent specification and was asked to provide evidence as to the ease or difficulty of formulating the claimed formulation. A/Prof Laven, on the other hand, was briefed in stages, and gave different testimony based on being cognisant of different parts of the specification.
Nevertheless, although expert evidence can shine some light on what the notional skilled team would have known at the priority date, care must be taken not to conflate the testimony of a declarant with the notional skilled team:
“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.”[10]
[10] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; 89 ALJR 798.
I note that there are number of points where the opinions expressed by the experts differ. I will discuss these disagreements throughout the decision as required, bearing in mind that the jobs of construction and consideration of sufficiency, support and inventive step are matters of law and are for the Delegate, and also that the role of the Delegate in considering evidence is to look at the substance of the opinion expressed in evidence and the reasons behind it.[11]
[11] Cf. Ocean Marine Mutual Insurance Association (Europe) OV v Jetopay Pty Ltd [2000] FCA 1463 at [21]–[23]
Background of the invention
Before construing the specification, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd.[12]
“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.”
[12][2013] FCA 214;100 IPR 451 at [139].
The decision in the opposition of the parent application[13] provides a very good overview of the background to the field and the disclosure of the specification, so I will only summarise the key points here. The specification addresses the problem of mastitis (infection of the udder or mammary gland) during the dry period when cows are not producing milk, and pathogens can access the teat. In nature, cows produce a keratin plug to seal the teat, but when this is not formed properly infection can occur. Strategies in the prior art to prevent infection include antibiotics, external teat seals and internal teat seals.
[13] Merial, Inc. v Bayer New Zealand Limited [2017] APO 27 “The parent opposition”
The specification specifically relates to internal teat seals. These are discussed as typically being a heavy metal salt in an oil or gel base, which forms a physical barrier in the teat canal.[14] The specification discusses two particular prior art formulations at p. 4: an internal seal known as Teatseal™ and a veterinary composition disclosed in New Zealand patent number 258199 which involves an antibiotic suspension to be administered at the same time as a heavy metal salt internal teat seal. The specification identifies problems with teat treatments both using antibiotics (resistance and need for withholding milk[15]) and lacking antibiotics (failure to act against pathogens already present in the teat or introduced with the seal[16]). The description also identifies that internal teat seals using bacteriocins have been developed to provide both a physical and chemical barrier.[17]
[14] p. 3 line 17- p.4 line 2
[15] p. 2 lines 7-17
[16] p. 4 lines 5-7
[17] The specification does not provide a citation for an internal teat seal comprising bacteriocins, but a representative publication discussing such a formulation is D4.
The invention as described
The specification identifies that a product that both provided a teat seal functionality as well as preventing new infections would be advantageous.[18] Notably, the specification then states that it is an object of the present invention to address these problems or at least provide the public with a useful choice.[19]
[18] p. 5 lines 23-25
[19] p. 6 lines 1-2
The specification then discloses that a first aspect of the present invention is a formulation comprising an oil-based barrier material and an antiseptic mixed with the barrier material.[20] The barrier material which provides a teat seal appears to be the same formulation as that known in the prior art, and I will concentrate my discussion on the disclosure relating to the antiseptic.[21] The specification gives a range of preferable properties for the antiseptic at p. 12, and states that preferably the antiseptic is chlorhexidine, which is known to be acceptable for veterinary use. However the specification specifically points out that any other antiseptic with the desired characteristics can be used in place of chlorhexidine, with ionised antiseptics having poor absorption characteristics (point d of the list on p. 12) being listed as the most preferred characteristic[22]. Examples of ionised antiseptics are given as quaternary ammonium compounds such as Cetrimide and BZK, and PVP-I which is also disclosed as being currently in use in the dairy industry.
[20] p. 7 lines 1-3
[21] There is some discussion on the need for an appropriate viscosity of the seal paste, primarily in terms of ease of administration and ability to form an effective seal. The specification speculates that a suitable viscosity may also provide appropriate dissolution capacity for the active agent (p. 9 lines 3-6). However the specification does not disclose any formulations with a viscosity outside of the preferred range (cf Table on p. 43) so there is no apparent significance associated with this speculation.
[22] p. 13 lines 8-24
The antiseptic is said to be released by the formulation by diffusion but not absorbed significantly into the body of the animal, thereby creating an “equilibrium concentration” near the seal.[23] However the specification had previously stated the mechanism may not necessarily work as the inventors described.[24]
[23] p. 14 lines 1-10.
[24] p. 10 lines 11-14
The specification then asserts some advantages of the present invention with respect to teat seals comprising bacteriocins, primarily that bacteriocin formulations may lack long-term stability due to the need to formulate the bacteriocins as an emulsion.[25] The invention is also said to provide advantages over existing formulations for treating mastitis at p. 18-19. To paraphrase them, the advantages relate to the use of an antiseptic which is not absorbed by the animal body in combination with a physical teat seal, such that the antiseptic can kill micro-organisms in the vicinity of the seal in a localised manner.
[25] p. 17 line 9 – p. 18 line 11, and also p. 14 lines 16-19
The specification ends with six[26] examples. Example 1 lists a range of formulations based on barium sulphate in paraffin providing the physical seal, with different concentrations of chlorhexidine as an antiseptic and aluminium stearate as a gelling agent, and methods for preparing the same.
[26] There is also a measurement of the viscosity of the pastes used in the examples, apparently appended to Example 6 at p. 43 lines 4-13. As mentioned in footnote 21, this demonstrates that all pastes tested fall with the preferred viscosity range for teat seal formulation.
Example 2 provides a more specific formulation comprising a thickening agent and preservatives, which is used for testing in the in vivo examples.
Example 3 discloses in vitro testing of formulations as set out in Example 1. Formulations were tested using different chemical forms of chlorhexidine (free base or hydrochloride salt), different chlorhexidine concentrations and different amounts of gelling agent. Antibacterial properties were tested by both an agar diffusion test and a solid culture inoculation test. The test bacteria were Staphylococcus aureus and Streptococcus pyogenes. Both these tests showed that the free base of chlorhexidine was effective at the highest concentration tested (0.5% w/w). Notably this was used in the formulation of Example 2 and the in vivo studies.
Example 4 discloses an in vitro assay of release kinetics of 0.5% chlorhexidine base from formulations with different aluminium stearate concentrations, measured by HPLC.
Example 5 is an in vivo challenge experiment which compares the chlorhexidine formulation of Example 2 (designated ATS Barium) against a commercially available formulation (TeatSeal™) and an untreated control. The study is summarised in Table 6 of the specification:
The specification describes the results of the study that both the ATS-Barium and Teatseal™ (“positive control[27]”) can significantly prevent S. uberis infection post challenge.[28] Each of ATS-Barium and Teatseal™ only had one animal classified as having mastitis. The specification describes that ATS-Barium did not show any evidence of irritability, and average somatic cell counts (a measure of irritability which can also be associated with subclinical infection[29]) was lower in the ATS-Barium than either untreated or Teatseal™.[30] The numerical results underpinning these conclusions are found in tables 9-14, but the statistical significance was not determined.
[27] [sic] p. 36 line 14
[28] p. 36 lines 14-15
[29] Bunt [119]
[30] p. 36 lines 20-24
Example 6 is a longer term study also comparing ATS-Barium, Teatseal™ and untreated control, but in normal grazing conditions without bacterial challenge.[31] In this model, no animals (including untreated) suffered clinical mastitis before calving, but after calving both ATS-Barium and Teatseal™ were significantly protective against mastitis, although not significantly different to each other.[32] The same pattern is seen for somatic cell counts post calving.[33]
[31] The text at p. 42 referring to challenge appears to be out of place – as it corresponds to the methodology used in Example 5
[32] p. 41 lines 7-14, Table 16.
[33] p. 42 lines 3-7, Table 17
This reading of the examples is consistent with the balance of the evidence of the declarants. A/Prof Bunt considered that the ATS-Barium outperformed Teatseal™ in terms of preventing mastitis overall[34], post-calving[35], and during the dry period in terms of having “significantly lower daily udder exam score” [36]. A/Prof Laven disagrees with this assessment in his evidence in reply, essentially stating that the protection results are very similar and unlikely to be significant and the difference in Tables 11-12 is due to sample contamination not product efficacy.[37] A/Prof Laven also refers to a post-published study of the data in Example 5[38] which concluded that there was no significant difference between ATS-Barium and Teatseal™ during the dry period but ATS-Barium provided better protection from intra-mammary infection after calving. There is no comment in this paper about the significance of the post-calving somatic cell counts.
[34] Bunt [114] with regard to Tables 8-9
[35] Bunt [115] with regards to Tables 11-12
[36] Bunt [117] with regards to Table 13
[37] Laven #2 [54-56].
[38][38] Exhibit RAL-2.7, “Petrovski et al”, conclusions summarised in abstract, however Table 7 of this document which refers to post-calving intra-mammary infection (IMI) does not appear to correspond to the relevant Tables 11-12 of the description.
A/Prof Bunt does state that he considers ATS-Barium to be an improved formulation “or in any event, no worse”[39] than Teatseal™. He also states that it is difficult to show a marked improvement since “you are talking about improving a formulation which does nothing”[40] and the existing commercial product is already highly effective. This is consistent with the stated problem in the specification of providing a “useful alternative”.
[39] Bunt [120]
[40] Loc cit
Taking all of the above into account, I find that the specification discloses that adding the antiseptic chlorhexidine to an internal teat seal provides some relative benefit compared to an unmedicated teat seal after calving in a challenge model in terms of somatic cell counts, and also provides in vitro tests (Example 3) that are consistent with the in vivo challenge model.
The claimed invention
The opposed application ends with 16 claims, of which claim 1 is independent.
Claim construction
The principles of construction have been well traversed by the courts, and a number of principles have been set down in various decisions. Principles most relevant to this particular case were summarised by the Full Court of the Federal Court in Kinabalu Investments Pty Ltd v Barron Rawson Pty Ltd[41]
“When determining the nature and extent of the monopoly claimed, the specification must be read as a whole. But as a whole it is made up of several parts which have different functions. The claims mark out the legal limits of the monopoly granted. The specification describes how to carry out the process claimed and the best method known to the patentee of doing that. Although the claims are construed in the context of the specification as a whole, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim, by adding to those words glosses drawn from other parts of the specification. If a claim is clear and unambiguous, it is not to be varied, qualified or made obscure by statements found in other parts of the document. It is legitimate, however, to refer to the rest of the specification to explain the background of the claims, to ascertain the meaning of technical terms and resolve ambiguities in the construction of the claims. See Flexible Steel Lacing Co vBeltreco Ltd (2000) 49 IPR 331 at [73] – [75] (Hely J).
[41] [2008] FCAFC 178 at [44] – [45]:
Other more specific principles of construction collected in Flexible Steel[42] at [81] are:
·a specification should be given a purposive construction rather than a purely literal one;
·the hypothetical addressee of the specification is the non-inventive person skilled in the art before the priority date;
·the words used in a specification are to be given the meaning the hypothetical addressee would attach to them, both in the light of the addressee’s own general knowledge and in the light of what is disclosed in the body of the specification;
·as a general rule, the terms of the specification should be according their ordinary English meaning;
·evidence can be given by experts on the meaning those skilled in the art would give to technical or scientific terms and phrases, and on unusual or special meanings given by such persons to words which might otherwise bear their ordinary meaning;
·however, the construction of the specification is for the court, not for the expert. In so far as a view expressed by an expert depends upon a reading of the patent, it cannot carry the day unless the court reads the patent in the same way.
[42] Flexible Steel Lacing Co vBeltreco Ltd (2000) 49 IPR 331 (cited supra)
Claim 1
I note that claims with similar terms have been considered in the two[43] decisions issued for the parent application. However as the grounds at issue are different in this case I will construe the claims from an independent standpoint. Claim 1 reads as follows:
[43] The parent opposition as well as the opposition to the amendment of the parent ([2019] APO 20)
A single formulation, formulated 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
povidone-iodine mixed with the barrier material; wherein the povidone-iodine is 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 barrier material includes barium or bismuth.
A Single Formulation
The claim is directed to a formulation which is a product. The word “single” is taken to exclude formulations where the actives are administered in separate compositions, such as in NZ258199 referred to supra. The formulation is in the form of a paste. The phrases “for administration” and “for prevention” are not specifically defined in the description or commented on by the declarants, however conventional claim construction before the Australian Patent Office is that these phrases only limit the composition to as to be suitable for the specified purpose.[44] That is, the composition must be suitable for application to a teat canal or cistern, and must be able to prevent mastitis. Compositions that are manifestly unsuitable for either of these purposes are not to be taken as being inside the scope of the claim. For example, formulations which caused irritancy due to excessive concentrations of antiseptic[45] would be excluded, as would be formulations which cannot be applied to a teat.
[44] For example, one definition provided by the Macquarie dictionary Online for the preposition “for” is “suit the purposes or needs of”.
[45] Cf Laven #1 [80-83], [93], [130] (discussed by Bunt at [301]), Rowe #1 [103]
Barrier material
The formulation includes a barrier material with an oil base, and which also includes barium or bismuth. The nature of the oil and the barium or bismuth is not particularly limited. Prof. Laven and Dr Rowe in particular were aware of barium and bismuth based barrier materials being commonly known,[46] including the Teatseal™ product used as a comparative example in the specification.
[46] Rowe #1 [38], Laven #1 [65]
The barrier material must be able to form a cohesive mass in the teat canal or cistern. This again is a statement of suitability, and any formulation which is unable to do so is not inside the scope of the claim. Effectively this means that the formulation is able to function as a teat seal.[47] Given that internal teat seals were commonly known, it does not appear difficult for the skilled worker to determine whether or not a formulation can function as a teat seal.
[47] Cf Bunt [81.20]
Povidone-iodine (PVP-I)
The formulation includes PVP-I mixed with the barrier material. The claim further specifies that PVP-I “is an antiseptic, to kill or prevent the spread of mastitis causing infectious organisms in the teat cistern of the animal following administration”. The fact that PVP-I is an antiseptic compound is not controversial. The remainder of this phrase appears to be a statement of intent or capability. A/Prof. Bunt understands this to mean that once released from the formulation the PVP-I is able to exert a bacteriostatic or bactericidal effect rather than merely act as a preservative, pigment or dye, and this may be dependent on the concentration, release rate and the environment into which it is released.[48]
[48] Bunt [81.10-14]
However, this is a statement of the ability of PVP-I to act in vivo and it is difficult to say with certainty whether a bacteriostatic or bactericidal effect is actually occurring in a cow. As A/Prof Bunt admitted, teat seals are already very effective barriers to infection, even in a challenge model. Indeed the specification did not show any effect attributable to the antiseptic until well after calving, and only then in a challenge model. However the specification does demonstrate in vitro tests showing measurement of release of an antiseptic from a formulation (Example 4) as well as measurement of bacteriostatic and bactericidal effects (Example 3) which have been validated (at least in terms of bactericidal levels of antiseptic) by the in vivo challenge model. Therefore it seems reasonable to construe this claim with a measure of common sense in reference to the description such that a formulation that demonstrates bactericidal effects in vitro according to Example 3 would be expected on the balance of probabilities to be able to kill or prevent the spread of mastitis causing infectious organisms in the teat cistern of the animal following administration.
The Opponent submitted during the hearing that there were effectively four concentration ranges of PVP-I: a low range where it has no antibacterial effect but is functioning as for example a dye; a higher range where it has bacteriostatic effects; a yet higher range where it is has bactericidal effects; and the highest range where it causes irritancy. I agree with this in principle. The description only shows that a formulation with bactericidal activity in vitro translated to in vivo activity. Therefore the available evidence leads me to conclude that only a formulation with a PVP-I concentration that is bactericidal in vitro will fall within the scope of the claims.
Clarity
Clarity was pressed by the opponent with respect to whether a third party could ascertain without difficulty whether or not a proposed formulation falls withing the scope of the claims,[49] particularly in regards to whether or not the antiseptic is killing or preventing spread of mastitis producing organisms in vivo. A claim will lack clarity if the standard specified by the terms of the claim would not permit a third party to ascertain whether an act would fall within the scope of the claim.[50] However for the reasons set forth above, I am satisfied that the specification provides a workable in vitro proxy for this.
Support
[49] SG&P [12.8]
[50] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60
Relationship between claim and examples (Bree)
The Opponent submitted during the hearing that this application presents an unusual situation where it exemplifies embodiment A (chlorhexidine as the antiseptic) but claims embodiment B (PVP-I as the antiseptic). The parties were unable to cite any Australian or UK case law that mimicked this fact pattern, although it appears not dissimilar from that considered in BASF Corporation [2019] APO 34.[51]
[51] See [15] and [17] in particular with reference to the lack of correspondence between the claims and the examples. Although I will not comment on this decision in detail as it primarily focused on the admissibility of post-filing evidence, the Delegate in that case also declined to find a perfect “squeeze” between obviousness and sufficiency: see [94].
The Opponent raised Bree[52] as being relevant to the situation where the claims do not encompass the examples. Bree concerned a New Zealand application which was found to lack support under s 39(2)(c) of the New Zealand Patents Act 2013, which has the same form of words as s 40(3) here:
The claim or claims must … (c) be supported by the matter disclosed in the complete specification.
[52] [2017] NZIPOPAT 16
The Assistant Commissioner in that case found that neither of the two examples disclosed an invention with all the features of claim 1. Claim 1 was directed to a modular foundation system, Example 1 disclosed a foundation that was not modular, and Example 2 disclosed a module with the features of claim 1 except it was not used in a foundation.
I am not satisfied that Bree can be applied directly to the present application. For one thing, the technical field is quite dissimilar, which is relevant seeing determination of support is a question of fact. Furthermore, Bree’s attorney accepted in that case that if the examples do not support the claims then the objection should be upheld.[53] Bayer has made no such concession here.
[53] Bree at [18]
Therefore I will analyse the present application in the normal way: are the claims provided with sufficient clear enough and complete enough disclosure, and support, from the specification as filed?
CSR test
To determine whether the requirements of support are satisfied post-Raising the Bar, the following steps were set out in CSR:[54]
i. construe the claims to determine the scope of the invention as claimed,
ii. construe the description to determine the technical contribution to the art, and
iii. decide whether the claims are supported by the technical contribution to the art.[55]
[54] CSR Building Products Ltd v United States Gypsum Co (“CSR”), [2015] APO 72
[55] CSR at [95]
The Opponent’s attack in terms of support was in two parts: the first was that the situation is analogous to Bree: as set out above, I am not convinced as to the relevance of that decision. The Opponent also argues that a single reference to PVP-I is a “mere mention” which therefore cannot form the technical contribution[56]. I disagree. I understand that the discussion of “mere mention” in Schering[57] simply to say that textual conformity is not sufficient for support.
The word "support" means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed[58]
[56] OS [55]
[57] Schering Biotech Corp.'s Application [1993] RPC 249
[58] Schering at 253 lines 3-4
The Opponents second line of attack principally rests on the assertion that the technical contribution of the application is a chlorhexidine-based teat sealant[59] and that there is no principle of general application (an indication of the extent of the technical contribution as set out in CSR) to extend this to PVP-I.[60] Their basis for this is principally the opinion of Dr Rowe that there is “… a contradiction between what is described and what is claimed”[61] and “… the claims of the Application do not correspond to and in fact are quite different to what is disclosed and taught in the specification”.[62]
[59] OS e.g. [60]
[60] OS [46]
[61] OS [58], Rowe #1 [44]
[62] OS [59], Rowe #1 [55]
However, I am not inclined to give significant evidentiary weight to Dr Rowe’s opinions in this matter. The test set out in CSR of construing the claims and description is one for the court (or in this case, the Commissioner). As set out in paragraph 23 points (3-5) in particular of his first declaration, Dr Rowe was asked to effectively do the job of the Commissioner in answering questions of law: identifying an inventive concept, the consistency of the claims with products or processes taught by the description, and whether the claims cover what is enabled. With full respect to Dr Rowe, even if these questions had been framed in terms of the CSR test (which they are not), his answers to these questions are merely opinion. Even with respect to the particular question of the comparison of chlorhexidine and PVP-I, Dr Rowe states on numerous occasions that they are different compounds with different modes of action but does not go into any detail on the nature of the differences.
Therefore, I am satisfied that the principle expressed on p. 13 of the specification - that antiseptics, particularly charged antiseptics, have poor absorption properties (corresponding to item 4 on p. 12) - is a technical contribution that is shared by teat seals comprising any such antiseptics. The Applicant submitted that merely narrowing the scope of the claims should not take away from the fact that the broad concept is supported, and I agree with that submission. The technical contribution disclosed can extend to other embodiments if it is a “principle of general application” and in such a case it is not necessary to have a worked example for each on. There does not need to be a separate technical contribution for any given embodiment within the scope of the claims. To require such would be to severely limit an applicant’s ability to amend the claims to exclude prior art, particularly “whole of contents” or accidentally anticipatory prior art that is not relevant for inventive step.
In the present application PVP-I is listed as one of a class of charged antiseptics that the specification contends have similar properties. I am satisfied that this is a principle of general application which applies to all embodiments. Therefore the monopoly claimed is indeed consistent with (albeit narrower than) the contribution provided by the description.
Sufficiency (clear enough and complete enough disclosure)
Sufficiency post-Raising the Bar was surveyed in Evolva.[63] The approach adopted by the delegate in that case was:
What is the scope of the invention as claimed?
What does the specification disclose to the skilled person?
Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:
(a) Is it plausible that the invention can be worked across the full scope of the claim?(b) Can the invention be performed across the full scope of the claim without undue burden?[64][63] Evolva SA [2017] APO 57 (14 November 2017)
[64] Evolva at [45]
Factors indicative of undue burden include the need for the skilled addressee to undertake a “research programme” to carry out the invention across the full scope.[65]
[65] Evolva at [33], [36], [44]
Factors indicative of sufficient disclosure include the presence of a “principle of general application” that can be applied across the full scope.[66]
[66] Evolva at [37], [38], [43]
The two step Evolva test requires that it both be plausible that the invention can be worked across the scope of the claims, and that it can be done without undue experimentation. At the hearing, the Opponent accepted that plausibility was a low bar and conceded that it was present.
The Opponent’s attack on sufficiency included submissions on the difference between a theoretical product and an actual formulation, the amount of testing required in terms of cost and effort required, the distinction between in vitro and in vivo work, and uncertainty associated with substitution of PVP-I for chlorhexidine. This is based on a large section of Dr Rowe’s first declaration which points out repeatedly that there is no specific information in the specification as filed regarding formulation of PVP-I into a teat seal.
However even Dr Rowe admits that such a formulation could be made, but that it would take effort and be expensive.[67] I do take issue with Dr Rowe’s repeated contention that the description provides no starting point for formulation of PVP-I in a teat seal. Seeing as it discloses teat seals with chlorhexidine, it would seem to me a reasonable reading to start by substituting chlorhexidine with PVP-I and keeping everything else constant. After all, the basic formulation for obtaining a deformable seal was accepted as being part of the common general knowledge and had not changed for decades.[68]
[67] Rowe #1 [77], Rowe #2 [13]
[68] Cf paragraph 82 below
Dr Rowe is skeptical about this starting point, considering it a “leap of faith”[69] that one antiseptic could simply be substituted for another, and that a skilled formulation team would have to do “an enormous amount of work”[70] because chlorhexidine and PVP-I have completely different structures and mechanisms of action.[71] However this latter point is not accompanied by any technical reasoning and is in conflict with the disclosure in the specification that chlorhexidine and PVP-I are both ionic antiseptics. Even taking into account that PVP-I and chlorhexidine may have different release characteristics, the specification provides in vitro assays to assess the bactericidal effect of released iodine, and these in vitro assays are backed up by in vivo demonstrations.
[69] Rowe #2 [149]
[70] Rowe #2 [152]
[71] Rowe #2 [128]
The evidence available as to the compatibility or otherwise of PVP-I with formulations in general and teat seal formulations in particular is:
Dr Rowe has a lot of hands-on experience making a variety of PVP-I formulations including liquids and pastes;
Dr Rowe had one experience where PVP-I destroyed flavour of a mouthwash;[72]
Dr Rowe has made “certain solid formulations similar to these and they just turn to liquid because the iodine is reacting with the organic chemicals in the base.”[73] Although the nature of the chemicals is not specified, this may refer to oils with double bonds;[74]
The Cromie declaration demonstrates that addition of 0.1% w/w PVP-I to a teat seal formulation had no detectable antibacterial activity in vitro;
PVP-I in an aqueous formulation is disclosed to be incompatible with bismuth salts;[75] and
Several iodine-based teat seals have been successfully formulated and brought to market after the priority date.[76]
[72] Rowe #2 [37]
[73] Rowe #2 [101]
[74] Rowe #2 [113]
[75] Rowe #1 [108] and exhibit JSR-5
[76] Laven #2 [120-123]
The test allows for the skilled worker to bring their common general knowledge to bear, and assumes they are trying to make the invention work. [77] Although Dr Rowe considers that the nature of the excipients is important, there is no evidence as to whether excipient compatibility or merely concentration is more important. Although there is one example of one concentration of PVP-I in a teat seal being ineffective (disclosed in the context of a negative control in the Cromie declaration) titrating different concentrations of antiseptic in vitro to establish effectiveness is explicitly disclosed in the specification, and does not seem like a research project in the meaning of Evolva.
[77] Evolva at [28] citing Kirin-Amgen Inc v Hoechst Marion Roussel [2005] RPC 9 at [118]
Much was made of the cost of developing a new formulation. This appears to be in reference to CSR where a key factor in the Deputy Commissioner’s finding of lack of sufficiency was the prohibitive cost of testing.[78]
[78] CSR at [106].
Nevertheless, the test advanced in CSR is the same as the one in Evolva: does the work involved in obtaining the claimed invention involve reasonable trial and error, or undue burden/research project.[79] The facts of this case appear to me to differ from CSR to the extent that:
[79] CSR at [101]
In CSR there were “a lot of process and starting material variables” and many claimed parameters.[80] In the present case, the starting material is a well characterised teat seal and the parameters are an effective teat seal with an effective antibacterial amount of PVP-I;
In CSR the Deputy Commissioner found that the bench tests were not a reliable indicator of fire resistance[81] whereas in the present case I am satisfied that there is an in vitro assay that appears to correlate with in vivo effectiveness;
The only variable apparently needing optimisation is the amount of PVP-I to obtain antibacterial activity; and
The question of appropriate excipients was raised[82] but there does not appear to be any evidence on file as to the actual difficulty of choosing appropriate excipients (if in fact any were needed).
[80] CSR at [102]
[81] CSR at [45]
[82] Rowe #1 e.g. [61], [108], [122]
I am not convinced that there is enough evidence that the formulation of PVP-I into a barium/oil teat seal was in fact difficult or required experimentation to tip the balance of probabilities in the Opponent’s favour.
Utility
The principles of utility have been summarised by the Full Court of the Federal Court in Artcraft Urban GroupPty Ltd v Streetworx Pty Ltd [2016] FCAFC 29 at [120]-[121] (with references omitted):
“The ‘basic principle’ of inutility is that if an invention ‘does what it is intended by the patentee to do, and the end attained is itself useful, the invention is a useful invention’. What the invention is ‘intended’ to do is a matter to be gathered from ‘title and the whole of the specification’.
Put another way, the two questions are: first, what is the promise of the invention derived from the whole of the specification?; second, by following the teaching of the specification, does the invention, as claimed in the patent, attain the result promised for it by the patentee? Further, ‘everything’ that is within the scope of a claim must be useful, that is, attain the result promised for the invention by the patentee.”
I have construed all claims as to be capable of performing as an effective teat seal and exhibiting antiseptic activity at least in vitro, the invention in all claims prima facie has utility. The only situation where the claims might not be useful is if there is in fact no subject matter at all in the claims, i.e. there is no situation where PVP-I provides a bacteriostatic/bactericidal affect without becoming an irritant or preventing the formation of a teat seal.
The Cromie declaration contains evidence that at least one PVP-I formulation is ineffective in vitro. However evidence of the existence of one inoperable formulation does not satisfy me on the balance of probabilities that no useful formulations exist.
Inventive step
The most commonly used approach to inventive step is the so-called “Modified Cripps Question” adopted by the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59:
“Would the notional research group at the relevant date in all the circumstances which includes a knowledge of all the relevant prior art and of the facts of the nature and success of [compound], directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce [the desired result]?”
The Opponent contends the problem to be solved is “to provide an improved teat sealant which provides a cohesive mass in the teat canal and/or the lower portion of the teat cistern, which teat sealant contains povidone iodine, which acts as an antiseptic and kills or prevents the spread of mastitis”.[83]
[83] OS [256]
If this were indeed the problem to be addressed, then it can only be used as a starting point for the analysis if it was already found in the common general knowledge and prior art information.[84] For the reasons set forth below, I do not agree with this proposition.
[84] As set out in AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99
A broader reading of the problem addressed by the specification comes from my paragraph 22 above: to provide a teat seal formulation which addresses infection, or at least to provide the public a useful choice. This is consistent with the experimental examples which demonstrate that some in vivo protection was attributed to the chlorhexidine formulation in a challenge model but no objective advantage was observed vis-à-vis unmedicated TeatSeal™ in normal conditions. I am satisfied that this problem was part of the common general knowledge, and will deal with the step of obviousness over the common general knowledge alone shortly.
The Opponent further made submissions as to the quantum of invention: “..there must still be “some difficulty overcome, some barrier crossed” (per Lockhart J in RD Werner & Co Inc v Bailey Aluminium Products Pty Ltd (1989) 25 FCR 565 at 574; 85 ALR 679 at 689; 13 IPR 513 at 523) or some contribution to the art “beyond the skill of the calling” (Allsop Inc v Bintang Ltd (1989) 15 IPR 686 at 701).’[85]
[85] OS [250]: Garford Pty Ltd v Dywidag Systems International Pty Ltd (2015) 110 IPR 30; [2015] FCAFC 6 at [44]
I agree with the proposition that this is a test additional to the Cripps Question. One way of looking at it is that if there is no barrier crossed then there can be no inventive step and therefore the Cripps Question is moot. An alternative perspective is that after commencing the Cripps analysis, if the claimed solution does not involve any difficulty overcome or barrier crossed, it is not necessary to determine what the skilled worker would have done, as inventive step cannot be present in such a situation. However in this situation, I am not satisfied that no barrier has been crossed: the specification provides evidence of in vivo protective activity for the chlorhexidine formulation; it provides a theory as to why this would also be achieved for the PVP-I formulations, and the declarants do agree that an effective PVP-I formulation could be made.
Inventive step in view of common general knowledge
Common general knowledge is the background knowledge and experience available to all those working in the relevant art:
"The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[86]
[86] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 144 CLR 253 at 292
Guidance on this consideration was provided in British Acoustic Films Ld v Nettlefold Productions (1936) RPC 221 at 250:
“In my judgement it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or a series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less merely because it is widely circulated. Such a piece of knowledge only becomes common general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.”
To summarise, if it can be demonstrated by evidence that something is generally accepted by the hypothetical skilled worker, then this can be treated as common general knowledge. Scientific papers can be used to support such evidence but they do not themselves constitute common general knowledge.
It was common ground between the parties that the common general knowledge included bismuth-based teat seals, the possibility of infection being introduced with said seals, the use of antibiotics to combat infection and the problem of antibiotic resistance, and the use of antiseptics at least for external use.[87] The Applicant did take issue with two points: the idea that internal use of antiseptics was common general knowledge[88] and with the idea that the problem of incorporating alternative anti-bacterial agents into teat seals was part of the common general knowledge:
“What is not acceptable is the advancement of a new theory that there was a common general knowledge need to incorporate some kind of alternative anti-bacterial agent to anti-biotics into internal teat seals in 2008 not because of antibiotic resistance but the “widely held” view in 2008 that it was not ideal to use antibiotics for prophylactic use (in other words, to prevent infection in non-infected cows)”[89]
[87] AS [139] and [143].
[88] AS [139]
[89] AS [145]
Regarding the former, I agree with the Applicant’s contention as will become evident from my discussion of the citation evidence infra. Regarding the latter, the Applicant specifically argues that A/Prof Laven’s evidence at paragraph [29] was tainted by hindsight “based as it is on a view formed after reading the Application and reviewing an artificial sub-set of the body of information available to the PSA.”[90] I am convinced by this line of argument. In paragraph [29] A/Prof Laven admits that on 12 June 2018 he had had a further telephone discussion with “legal counsel representing Norbrook” and had “become more acquainted with the matter”, i.e. after receiving and reading the full copy of the opposed specification and D1-D18 on 11 May 2018[91]. Although the declaration is candid as to the dates at which the questions were answered, it strikes me as somewhat mercurial or at least disingenuous that the points of paragraph [29] are presented under the heading of Stage 1 of A/Prof Laven’s briefing (no prior knowledge of the opposed application).
[90] AS [145]
[91] Laven #1 [57]
Thus, I do not find that the problem of providing a useful alternative to antibiotics in teat seals has been shown on the balance of probabilities to be part of the common general knowledge. As per AstraZeneca v Apotex[92], if the problem in the Applicant’s specification was not part of the common general knowledge, it cannot be used as the starting point for an attack for lack of inventive step. The ground of lack of inventive step over common general knowledge alone therefore fails.
[92] Cited in footnote 84 above
Inventive step in view of prior art citations
Lack of inventive step can arise in view of a single document when read in view of the common general knowledge (s 7(2) and s 7(3)(a) of the Act) or in view of multiple documents that could be reasonable expected to be combined (s 7(3)(b) of the Act).
In the SG&P, the Opponent raised five distinct inventive step rationales. For each of these, the Opponent submitted that to the extent the claims of the opposed specification might differ from the each of the citations taken alone, the differences are obvious. The SG&P did not raise any combinations of documents.
These five rationales are:
Substitution of PVP-I for acriflavine; prior art being an oil-based bismuth teat seal comprising acriflavine (D1-D3)
Substitution of PVP-I for bateriocin; prior art being an oil-based bismuth teat seal comprising a bacteriocin (D4-D7)
Substitution of oil-based bismuth barrier material: prior art being an internal teat seal comprising PVP-I (D8-D9)
Use of PVP-I in a teat seal barrier: prior art being teat dips or infusions comprising PVP-I (D10-D17)
Use of an oil-based bismuth paste comprising iodine as a teat seal (D18)
The SG&P submitted that making the above substitutions would be “lying in the road” or an ordinary “workshop alteration” to the skilled worker in the art.
The Opponent did not present any specific reasoning for any of the citations individually as to why the differences were obvious, for example as per the “Cripps Question”, in their written submissions.
Indeed, the only mention of a document in the context of inventive step in the Opponent’s written submission is D4.[93] I asked the Opponent at the hearing if there was a particular “closest prior art” that could be used for inventive step analysis, if only to allow the Applicant a chance to provide more detailed submissions on that piece of prior art. The Opponent declined to do so but did not resile from any of the citations set out in the SG&P.
[93] OS [259]
With this in mind, I will consider whether based on the available evidence the differences between the claimed invention and any of the citations taken individually, are indeed “lying in the road”.
The framework set out in the IP Australia Patent Manual of Practice and Procedure (2.5.3.3.3)[94] for determining whether a claimed solution is “lying in the road” or a workshop improvement is:
[94] This is a practical framework for examiners but has been drafted in accordance with the principles set out in Allsop v Bintang (1989) AIPC 90-615 and Elconnex Pty Ltd v Gerard Industries Pty Ltd (1993) AIPC 90-984.
Where a claimed solution:
· is one of several options that the person skilled in the art would consider in solving either the identified problem or any subsequent practical difficulty;
· the options would at once suggest themselves to the person skilled in the art, e.g. the options are part of the common general knowledge, or clearly indicated in the prior art;
· there is no practical difficulty in implementing the particular solution claimed; and
· neither the prior art, nor the common general knowledge, teaches away from the particular solution;
then an inventive step objection will apply.
In this situation, the claimed solution is said to be ob via, or "lying in the way":I will apply this framework to each of the rationales presented by the Opponent.
Substitution of PVP-I for acriflavine; prior art being an oil-based bismuth teat seal comprising acriflavine
D1: Meaney, WJ, Irish Journal of Agricultural Research, 16:293-299, 1977
D2 - Bradley, AJ, A Study of the Anti-infective Properties of Teatseal™ Formulations in the Presence and Absence of Acriflavine, MJC-20, EPO European Patent Register, 13 February 2007
D3 - GB 1441747, Lazonby, B
Each of these disclose teat seal compositions comprising acriflavine. In the case of D1, the consensus of the experts is that D1 does not disclose that acriflavine is acting as an antiseptic.[95]
[95] Laven #1 [100], Bunt [26] and [143]. Although A/Prof Laven later states that he thinks it is “highly plausible that acriflavine was being used for its antibacterial effect” (Laven #2 [65]) this is not sufficient in my view to tip the balance of probabilities. I am aware that in the Opposition of the parent case, the Delegate found that the acriflavine in D1 is in sufficient quantity to inherently act as an antiseptic (see the Parent Decision at [126]). However inherent unrecognised properties cannot be taken into account for an inventive step analysis which is being pressed here.
In the case of D2, A/Prof Laven considers that this paper demonstrating in vitro activity of acriflavine against bacteria shows that the idea of adding an antiseptic to teat sealant was being considered before the priority date. However the consensus of the experts is that D2 does not demonstrate the effectiveness of teat seal in vivo.[96] A/Prof Bunt in particular challenges the applicability of the diffusion assay used in D2 to the likely in vivo effectiveness of an antibacterial, and prefers the assays used in the instant application. To support this, A/Prof Bunt refers to a similar study (CB-14) in which addition of 0.1% acriflavine was stated to have no improved performance in vivo compared to TeatSeal™ alone,[97] which contradicts the conclusion of D2.[98] A/Prof Bunt also points to the differences in terms of structure and mode of action between acriflavine and PVP-I.[99] I understand this to be in the context of his discussion of the diffusion assay in D2, i.e. that acriflavine could be expected to diffuse through a layer of agar in a sandwich assay whereas PVP-I would not. As such this is not directly contradictory with his statement later that (in view of the disclosure of the opposed application) that it would be a routine amount of trial and error to substitute PVP-I for chlorhexidine.[100]
[96] Laven #1 [102] “I also note the Bradley study does not demonstrate that the product described is an effective sealant”; Bunt [157], [158]
[97] CB-14, last paragraph
[98] D2, last paragraph
[99] Bunt [157.2]
[100] Bunt [267]
In the case of D3, A/Prof Bunt also considers that the acriflavine is not acting as an antiseptic, but rather as a dye,[101] whereas A/Prov Laven does not particularly comment on this except to speculate that antiseptics were being considered.[102]
[101] Bunt [37-38]
[102] Laven #1 [103]
For D1 and D3, the problem addressed the presence of acriflavine appears to be providing a teat seal with a pigment. There is insufficient evidence on file to suggest that substituting PVP-I as a pigment would result in a product which fell within the scope of the claims.
For D2, the balance of the evidence suggests to me that although this is a proof of principle that acriflavine can diffuse out of a TeatSeal™ formulation in vitro, there would have been practical difficulty in translating this to an in vivo formulation with PVP-I for two reasons: one is that higher molecular mass PVP-I is less likely to have performed well in the diffusion assay of D2 and hence would have dissuaded the skilled worker from further development; the more significant reason is that the 0.1% acriflavine formulation of D2 was shown in CB-14 not to provide any improvement in vivo. This would have been the most logical step to take before making further modifications to D2, and would have made further research seem inadvisable. Although there is contention whether CB-14 was published before the priority date or not,[103] that point is moot because I am not using it as evidence of “teaching away” in the prior art but rather as evidence of difficulties that would have been encountered.[104]
Substitution of PVP-I for bacteriocin; prior art being an oil-based bismuth teat seal comprising a bacteriocin
D4 - Meaney, WJ et al., Proceedings of the British Mastitis Conference, 24-32, 2001
D5 - Crispie, F et al., Journal of Dairy Research, 72(2):159-67, 2005
D6 - Sérieys, F et al., Veterinary Research, 27(3):295-303, 1996
D7 - Merck Veterinary Manual, 2005
[103] Laven #2 [68] vs Bunt [159]
[104] As A/Prof Bunt pointed out, CB-14 was also considered in the Opposition of the parent case where the Delegate concluded that it did not rule out the possibility of inherent antibacterial activity against different bacterial species (see the Parent Opposition at [107]). This is not inconsistent with my analysis in terms of inventive step.
D4 and D5 both disclose bismuth-based teat seal formulations comprising the bacteriocin lacticin. D6 refers to the comparison of PVP-I and nisin in an external teat dip. D7 is a technical manual which lists PVP-I as an antiseptic for mastitis control.
The Opponent pressed each of these documents alone, in view of common general knowledge, as rendering the instant claims obvious. D6 and D7 are not directed to teat seal formulations so it would seem that they are being cited as evidence of the use of PVP-I in an analogous context to bacteriocins. I am satisfied that the disclosure of D7 would form part of the common general knowledge. A/Prof Laven considers that D6 was part of the peer-reviewed literature and hence would have been part of the common general knowledge.[105] However I am not satisfied that D6 would have been part of the common general knowledge – this would seem to be a much lower bar for entry into the common general knowledge than set in the authorities.[106]
[105] Laven #1 [106]
[106] Cf paragraph 80 above.
The problem addressed by D4 and D5 is to provide antibacterial properties to a teat seal in vivo. It has not been established that internal antibacterial use of PVP-I was part of the common general knowledge, and therefore the first part of the ob via analysis fails. Even if (as not apparently pressed by the Opponent) the disclosure of D6 was read in conjunction with D4 or D5, D4 explicitly discloses that nisin is unsuitable for internal use,[107] and therefore any teaching that PVP-I was comparable to nisin does not teach towards internal use of PVP-I.
Substitution of oil-based bismuth barrier material: prior art being an internal teat seal comprising PVP-I
D8 - NZ 201983, Beecham Group PLC
D9 - US 4931282, Minnesota Mining and Manufacturing Company
[107] Bunt [175]
D8 explicitly discloses a teat seal formulation of a siloxane elastomer of sufficiently low viscosity to facilitate release of an antibacterial agent.[108] Iodine (not PVP-I) is mentioned as one possible antibacterial agent. Bismuth-based teat seals are discussed in the prior art section of D8, and I agree with A/Prof Bunt’s assessment that D8 appears to be a superior alternative to a barium-based teat seal (the implication being that the elastomer of D8 provides superior release characteristics). Therefore at the very least, D8 teaches away from substituting a barium-based teat seal and so the last part of the ob via analysis fails.
[108] Paragraphs bridging p. 2-3 of D8
D9 discloses a pressure sensitive medical sealant comprising a crosslinked swellable polymeric matrix comprising inter alia N-vinyl lactam groups, which is capable of incorporating large concentrations of iodine. One potential use of the matrix is suggested as a teat seal for preventing mastitis in cows.[109] There is no evidence as to why the skilled worker would see a bismuth-based teat seal as being equivalently capable of incorporating large concentrations of iodine, and so the ob via analysis fails.
[109] D9 abstract, col 10 lines 5-15
I would note that A/Prof Laven’s commentary on these citations is merely that the idea of using iodine in a teat sealant is not new.[110] Even taking this at face value,[111] it does not tip the balance of probabilities that the claimed invention is not inventive and does not support the proposition that internal use of PVP-I was part of the common general knowledge.
[110] Laven #1 [108-109]
[111] As pointed out by A/Prof Bunt, neither document provides any exemplification of using iodine internally.
Use of PVP-I in a teat seal barrier: prior art being teat dips or infusions comprising PVP-I (D10-D17)
D10 - Hemling, TC, Proceedings of the British Mastitis Conference, 1-14, 2002
D11 - US 5409697, Novapharm Research Pty Ltd
D12 - Hopkirk, CSM, Proceedings of the New Zealand Society of Animal Production, 3:43-51, 1943 (Hopkirk)
D13 - McDougall, S, New Zealand Veterinary Journal, 50(3) supplement: 81-84, 2002 (McDougall)
D14 - Park, HM et al., Journal of Veterinary Medical Science, 64(8):739-741, 2002 (Park)
D15 - RU 2165261, Nita Farm AOZT
D16 - AU 60048/94, McConn-Stern, R
D17 - Veterinary Medicine, Elsevier, 2007 (Veterinary Medicine)
None of these documents disclose barrier compositions, but rather disclose compositions for acute or topical use.
The proposition that it would be “ob via” to take any of these formulations individually and substitute a persistent teat seal for a topical composition does not sit at all well with the test: “one of several options that the person skilled in the art would consider in solving either the identified problem or any subsequent practical difficulty”.
The Opponent’s line of reasoning in the SG&P that “It was common general knowledge in Australia as of 17 September 2008 that an antiseptic could be included into a teat sealant for its antimicrobial properties”[112] has not been made out (cf the discussion of D1-D9 above) so this cannot be used as a starting point for an attack on inventive step either. A more favourable analysis for the Opponent would seek to show that these citations may establish that intramammary use of PVP-I was in fact part of the common general knowledge. For the reasons set out below, I am not convinced by this.
[112] SG&P 8.90
D10 and D11 are external dip compositions and so are not relevant to this question.
Regarding D12, even A/Prof Laven admits that this document published in 1943 had been superseded as of the priority date[113]. Its only reference to iodine is that infusions of iodine in mineral oil “has also been used and perhaps has paved the way for numerous drugs being given in mineral oil”.[114]
[113] Laven #1 [112]
[114] D12 p. 49 2nd paragraph
Regarding D13, A/Prof Laven considers that this review article is representative of common general knowledge as of the priority date.[115] This review explicitly focuses on “the contribution of New Zealand researchers in understanding the epidemiology, bacteriology and control of mastitis in New Zealand herds”[116] so may not necessarily reflect the common general knowledge of any skilled worker. In any event, the only reference to iodine is in the context of a historical discussion of D12. In this context, the reference to iodine is merely one of historical interest and cannot be said to support the proposition that intramammary use of iodine (let alone PVP-I which is a different form of iodine) was part of the common general knowledge at the priority date.
[115] Laven #1 [113]
[116] D13, Introduction
D14 is directed to a biodegradable PVP-I release formulation. Neither of the experts consider that this paper is part of or representative of common general knowledge.
D15 and D16 are patent documents and neither of the experts consider that these are part of or representative of common general knowledge.
D17 is a textbook and I am happy to accept A/Prof Laven’s opinion that this would have formed part of the common general knowledge in the priority date[117]. The extent of disclosure relating to iodine in this document is: “… iodine in oil as an intramammary infusion, might be of value”[118] [as one of a number of options for treatment of fungal infections]. A/Prof Laven was specifically asked as to how “might be of value” might be read, and he considered that it was something worth doing if other treatments were not effective and that there was no particular bias against using it.[119] A/Prof Bunt points out that this is a reference to iodine in oil and not PVP-I.[120] On balance, this document is consistent with D12 in that iodine in oil had been used in the past and could be an option if other treatments were ineffective, but does not go so far in my view as to support the proposition that PVP-I would “at once suggest itself” to the skilled worker for internal use.
Use of an oil-based bismuth paste comprising iodine as a teat seal (D18)
D18- Bismuth Subnitrate, Iodoform and Paraffin Paste, Jar formula, Tube formula and Impregnated Gauze, B.I.P. Paste leaflet, published by MIMS/myDr August 2004
[117] Laven #1 [123]
[118] D17, p. 727 last paragraph
[119] Laven #1 [125-126]
[120] Bunt [251]
D18 discloses paraffin oil-based paste formulations for human surgical use that include bismuth subnitrate and an iodoform antiseptic. A/Prof Laven understands this to disclose that iodine and bismuth are not incompatible in the particular formulation of D18.[121] Given that this document discloses iodoform (CH3I) and not PVP-I or even elemental iodine, this narrow reading of D18 cannot be said to lead the skilled worker anywhere near the present claims. A/Prof Laven does refer to D18 later in the context of encouragement to combine iodine and bismuth,[122] however again the different form of iodine used in D18 considerably reduce the weight of this evidence.
Combinations of citations
[121] Laven #1 [127]
[122] Laven #1 [139]
Although lack of inventive step over combinations of citations was not pressed in either the SG&P or the hearing, A/Prof Laven was asked at the end of his briefing whether the skilled person would have been motivated to use PVP-I in a teat sealant in view of D1-D18 separately or together.[123] However I cannot give any significant weight to the answers which follow, not only because this is strictly a legal question for the Delegate, but also because by this stage the declarant was almost certainly infused with hindsight.
A/Prof Laven’s oral disclosure
[123] Laven #1 [136-137]
During the hearing the Opponent specifically pressed the additional ground of lack of inventive step over A/Prof Laven’s stated oral disclosure of the concept of incorporating a disinfectant into a teat seal in “about 2006”.[124] My consideration of this disclosure is as follows:
[124] Laven #1 [74]
A/Prof Laven provided evidence as to his recollection of the disclosure in response to the specific question of whether the claims of the opposed application were new and inventive.[125] Although it is possible that having the knowledge of the claims may have prompted the recollection of a specific conversation, there is a significant possibility that his recall may have been affected by the knowledge of the invention. This recollection may have carried more weight if it had occurred prior to being shown the opposed specification and claims.
[125] Laven #1 [64]
A/Prof Laven also states that the discussion between colleagues, both of whom were working on a confidential work project, was not in any way confidential. However it seems to me that the discussion was directly related to an improvement of the product under development and hence I do not find the statement that the discussion was not confidential to be prima facie plausible.
As there is no further evidence as to a) the date and content of this disclosure and b) its non-confidential nature, I am not convinced on the balance of probabilities that such an oral disclosure should be treated as part of the prior art base for assessing inventive step.
Admissibility of evidence
As indicated earlier, I have considered the Dhar and Cromie declarations as being proper evidence in reply, but I have not taken any subsequent evidence into account under Reg 5.23. My rationale for this is as follows:
Evidence in Reply
The legal principles for evidence in reply are that it “must be confined to rebutting the applicant’s case, and should not merely confirm the case in chief. Additionally, evidence in reply cannot raise matters that should have been raised in the evidence in support”.[126] Although it is not essential to refer directly to the evidence in answer, it must nevertheless be responsive thereto.
[126] Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp and Schering Aktiengesellschaft [2001] APO 13
The context of the Cromie declaration is to provide evidence of an in vitro study carried out by the Opponent in 2016 in which a teat seal formulation comprising 0.1% PVP-I shows no anti-infective activity against the bacterial strains tested.[127] This is explained as being responsive to A/Prof Bunt’s evidence at paragraph 269 that he sees no reason to suggest that PVP-I would not function as an antiseptic. Even though it adds material that could have been presented in the evidence in support, the same could be said for any evidence in reply. Since it is filed in rebuttal to A/Prob Bunt’s evidence, I have considered it.
[127] Cromie [7-9]
The Dhar declaration contains an (albeit rather nonspecific) comment about A/Prof Bunt’s declaration, and a more lengthy section, with attached evidence, responsive to evidence of commercial success in the (original, unredacted) Nicholls declaration. Given that actual indicators of commercial success have been removed from the Nicholls declaration, it would seem that there is nothing for the Dhar declaration to reply to, and hence I need not consider this further.
Reg. 5.23
Evidence filed outside of the normal evidentiary procedure consisted of:
Harwood #1 (29/7/2019);
Harwood #2 (22/11/2019);
Dhar #2 (31/7/2019);
Laven #3 (1/8/2019);
Rowe declarations from ‘000 filed by Bayer on 20/2/2020.
Under regulation 5.23, the Commission has the discretion to take such evidence into account. Principles for consideration regarding whether to refer to evidence under Reg. 5.23 have been set out in Reflex Instruments Asia Pacific Pty Ltd v Minnovare Limited [2017] APO 8, and are:
The circumstances leading up to the evidence not being filed earlier
What does the evidence show?
Is the information likely to be crucial to the delegate’s decision?
The public interest in having the information considered
The balance of convenience of the parties if the information is considered
The third consideration is strictly a “necessary” one: if the information would not change the decision then there is no value in considering it. In view of the fact that based on the evidence on file I have found in the Applicant’s favour, there is no advantage in considering further evidence from the Applicant. Likewise there is little advantage in considering evidence filed by the Opponent in response to such evidence.
Conclusion
The opposition is unsuccessful. I direct that the application proceed to grant.
Costs:
It is conventional that costs follow the event. I therefore award costs according to Schedule 8 against the Opponent. Although this proceeding was characterised by significant amount of correspondence outside of the normal evidentiary period, it appears to me that both parties engaged in this exercise with equal enthusiasm and I do not find that either party was made to incur disproportionate costs due to the action of the other, so I find no reason to vary costs.
Felix White
Delegate of the Commissioner of Patents
0
15
0