Abbey Laboratories Pty Ltd v Bayer Australia Ltd
[2020] APO 25
•4 June 2020
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Abbey Laboratories Pty Ltd v Bayer Australia Ltd [2020] APO 25
Patent Application: 2014280848
Title:Ectoparasitic treatment method and composition
Patent Applicant: Bayer Australia Ltd
Opponent: Abbey Laboratories Pty Ltd
Delegate: Cathy Douglas
Decision Date: 4 June 2020
Hearing Date: 27 February 2020 in Sydney
Catchwords: PATENTS – opposition to the grant of a patent – lack of support – lack of novelty by inevitable result – lack of inventive step – dose determination by routine steps – opposition succeeds
Representation: Counsel for the applicant: Andrew Fox
Patent attorney for the applicant: Jenny Park of Griffith Hack Patent Attorneys
Counsel for the opponent: David Larish
Solicitor for the opponent: Jane Owen and Rebecca Currey of Bird & Bird
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014280848
Title:Ectoparasitic treatment method and composition
Patent Applicant: Bayer Australia Ltd
Date of Decision: 4 June 2020
DECISION
Claims 1-10 are not supported according to subsection 40(3). Claims 1 and 4-11 are not novel in view of D1. Claims 1-3, 6 and 7 lack an inventive step in view of D1 and the common general knowledge in the art.
Bayer Australia Ltd is allowed two months from the date of this decision to file amendments to overcome these deficiencies.
I award costs according to Schedule 8 against Bayer Australia Ltd
REASONS FOR DECISION
1. Patent application 2014280848 (the application) was filed on 12 June 2014 by Bayer Australia Ltd (the applicant) and derives priority from AU 2013902122 filed 12 June 2013. The application was advertised accepted on 10 May 2018.
2. Abbey Laboratories Pty Ltd (the opponent) filed a Notice of Opposition under section 59 of the Patents Act 1990 (the Act) on 9 August 2018. A statement of grounds and particulars was filed dated 9 November 2018. Subsequently a request to amend the statement of grounds and particulars was filed on 13 November 2018, and this request was allowed on 29 November 2018. The amended statement identifies the following grounds: Lack of clear enough and complete enough disclosure, lack of support, lack of clarity, lack of novelty and inventive step, and secret use.
3. The evidence filed during the evidentiary periods is summarised in the table below:
Evidence Declarant Exhibits Date of declaration Reference In Support Jane Margaret Frances
OwenJO-1 – JO-4
5 February 2019
Owen
Matthew Charles Playford MCP-1 – MCP-11 2 February 2019 Playford 1 In Answer Edward Lionel Bruce
WhittemELBW-1 – ELBW-8
8 May 2019
Whittem 1
Nicholas Charles Sangster NCS-1 – NCS-8 9 May 2019 Sangster In Reply Matthew Charles Playford MCP-12 – MCP-13 9 July 2019 Playford 2 Phil Waterford 15 July 2019 Waterford 4. Prior to the hearing, the applicant filed further evidence for consideration under Regulation 5.23. Following this, the opponent filed a declaration and further documents to be considered under Regulation 5.23. Finally, the applicant filed another declaration. This evidence is summarised in the Table below.
Date of letter Party Declarant Name Exhibits 19 September 2019 Applicant Edward Lionel Bruce Whittem dated 18 September 2019, ‘Whittem 2’ ELBW-9, ELBW-10 19 December 2019 Opponent Matthew Charles Playford dated 18 December 2019, ‘Playford 3’ MCP-14 11 February 2020 Applicant Edward Lionel Bruce Whittem dated 10 February 2020, ‘Whittem 3’ NONE 5. In a letter to the parties dated 24 September 2019, a delegate noted that the matters relating to Regulation 5.23 should be decided as a part of the hearing and substantive opposition. This was confirmed in a later letter by the delegate dated 12 February 2020.
6. A hearing was held on 27 February 2020 in Sydney. At the hearing, the following grounds were pressed:
a)Lack of support;
b)Absence of clear enough and complete enough disclosure;
c)Lack of novelty over the “Trade Advice Notice on Thiacloprid in the product Piranha dip for sheep, APVMA product number 63766” (Trade Advice Notice, D1) and/or US 2003/0162773 (Sirinyan 2003, D2); and
d)Lack of inventive step over the Trade Advice Notice, D1 or Sirinyan 2003, D2 when combined with the common general knowledge.
7. At the hearing I asked the parties if they were satisfied that they had been given sufficient opportunity to provide representations in relation to the Regulation 5.23 material as a part of the hearing process, should I decide to consult this material. Both the opponent and applicant confirmed that they had.
Regulation 5.23
8. Regulation 5.23 of the Patents Regulations provides as follows:
(1)For the purposes of deciding an opposition, the Commissioner may consult a document that:
(a) is relevant to the opposition; and
(b) has not been filed under this Chapter; and
(c) is available in the Patent Office.
(2) If the Commissioner proposes to rely on the document, the Commissioner must give the parties:
(a) notice of the Commissioner’s intention to do so; and
(b) a copy of, or access to, the document; and
(c) an opportunity to give evidence or make representations about the document.
9. Noting that Regulation 5.23 is a discretionary provision, the delegate in Reflex InstrumentsAsia Pacific Pty Ltd v Minnovare Limited[1] listed a number of factors relevant to whether this regulation should be invoked:
a)the circumstances leading up to the evidence not being filed earlier;
b)what the evidence shows and whether the information is likely to be crucial to the delegate’s decision;
c)the public interest; and
d)the balance of convenience of the parties if the information is considered
[1] [2017] APO 8 at [52].
I will consider each of these factors, whilst keeping in mind that the key determinant, as stated in Merial Limited v Bayer Intellectual Property GmbH ,[2] is whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.
The circumstances leading up to the evidence not being filed earlier
[2] [2015] APO 16 at [24].
10. No unusual circumstance leading up to the filing of Whittem 2 is evident from the file; the declaration appears to be an attempt to respond to the opponent’s evidence in reply. That is, it appears to be an attempt by the applicant to file further evidence beyond the stipulated evidentiary stages.
11. Playford 3 and Whittem 3 follow the filing of Whittem 2 and appear also to be attempts by the opponent and the applicant, respectively, to respond to the previously filed declaration. I note that the subject matter of Playford 3 paragraphs 11 and 12, although referencing paragraph 2.11 of Whittem 2, is somewhat different in that it appears to provide information not previously covered, as I discuss below.
12. However, each of the Regulation 5.23 requests are evidence filed out of time without a clear reason indicating that this is necessary. Consequently, this factor weighs against allowing the Regulation 5.23 requests.
What the evidence shows and whether the information is likely to be crucial to the delegate’s decision?
Whittem 2
13. The first part of this declaration consists of comments on Playford 2. Professor Whittem restates his concerns about the accuracy of the “rule of thumb” and provides a hypothetical example of a dose calculation. These comments are further repetition of Professor Whittem’s concerns about the accuracy of the “rule of thumb”. I am mindful of these concerns, as already expressed in Whittem 1, as will be evident from my discussion below. However, I do not consider that these additional comments add further insight and thus are not likely to be crucial to my decision.
14. The second part of the declaration is about whether inferences can be drawn from the structural similarity of various actives. The exhibits are related to this point. I do not consider that this material is likely to be crucial to my decision.
15. The final part of the declaration consists of comments on the Waterford Declaration. There is no new evidence in this section which is likely to be crucial to my decision.
Playford 3
16. The first section of this declaration is further discussion of the “rule of thumb” controversy. I have already been made aware of the main issues related to this point, and I do not consider that these furthers comments are likely to be crucial to my decision.
17. The second part of this declaration at paragraphs 11 and 12 discusses how the skilled person would go about determining an appropriate dosage of an active. MCP-14 is an attached exhibit containing three supporting documents. Comments about practices in the art for working out dosage of known actives have not been specifically provided in the previously filed evidence, nor have previous supporting documents been provided. The first of the attached supporting documents, a document published in a veterinary journal, titled “World Association for the Advancement of Veterinary Parasitology (W.A.A.V.P.) guidelines for evaluating the efficacy of ectoparasiticides against biting lice, sucking lice and sheep keds on ruminants” (W.A.A.V.P. article), is the most likely of the three to be relevant. The second is post priority date and the third is related to the requirements of a European agency.
18. I consider that it is likely that the ground of lack of inventive step will be significantly impacted by the above mentioned paragraphs and W.A.A.V.P. article; without it, I do not consider that it is likely that the ground would be made out.
19. Therefore, I consider that the second part of this declaration at paragraphs 11 and 12, and W.A.A.V.P. article, are likely to be crucial to my decision.
Whittem 3
20. This declaration contains comments that Professor Whittem has stated previously regarding the need for experimentation to determine the properties of actives. I do not consider that these furthers comments are likely to be crucial to my decision.
21. However, I am mindful of the need to ensure that the applicant has sufficient opportunity to respond to the relevant parts of Playford 3 as required by Regulation 5.23 (2)(c). Whittem 3 paragraphs 2.2-2.5 are relevant in this respect.
The public interest
22. The public interest lies in the efficient resolution of matters before the Commissioner, but also in assuring the validity of granted patents. In the present case, since I have found the information in paragraphs 11 and 12 of Playford 3 is likely to be crucial to my decision in the substantive opposition, the public interest weighs in favour of including it. It is unfortunate that this material was not provided at an earlier stage. However, if I do not invoke Regulation 5.23 regarding these paragraphs, the public interest in assuring the validity of granted patents would not be served.
23. As I have found that the rest of the material is not crucial to my decision, the public interest weighs against including it.
The balance of convenience of the parties if the information is considered
24. In relation to this factor, there is no inconvenience to the parties should the relevant paragraphs from Playford 3 and the supporting document be included in the opposition. The material has been filed and the applicant has already had a chance to respond. I consider that this factor weighs in favour of including the above mentioned paragraphs and document from Playford 3 and the response in Whittem 3.
Conclusion on Regulation 5.23
25. Taking into consideration all the above factors I consider that, on balance, it is appropriate for the Commissioner to grant the Regulation 5.23 request made by the opponent insofar as it relates to paragraphs 11 and 12 of Playford 3 and the W.A.A.V.P. article. I will consult this evidence in my decision. I will also consult the response to those paragraphs in Whittem 3 paragraphs 2.2-2.5 to ensure that the requirements of Regulation 5.23(2)(c) are met. However, I will not invoke Regulation 5.23 in regard to the remaining parts of Playford 3 and Whittem 3. Also, I will not invoke Regulation 5.23 in regard to Whittem 2.
Onus
26. The application was filed on 12 June 2014 and consequently the amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) apply to the present application. This includes section 60(3A) of the Act, which provides that the Commissioner may refuse an application if satisfied on the balance of probabilities that a ground of opposition exists.
27. Both parties provided submissions on the issue of onus and the standard of proof required. In response I note the following:
28. It is the traditional position that the onus lies on the opponent to lead evidence to demonstrate to the requisite standard that a patent, if granted, would not be valid.[3]
[3] F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [67].
29. As a consequence of the Raising the Bar Act the standard of proof is the “balance of probabilities”. However, there is nothing in the words of section 60 that alters the requirement for the opponent to establish the facts supporting the grounds of opposition.[4] The opponent still bears the onus of proof.
[4] Voestalpine Schienen GmbH v Nippon Steel & Sumitomo Metal Corporation [2017] APO 32 at [10].
30. The opponent referred to a comment in the Explanatory Memorandum (EM) to the Raising the Bar Act, Item 8, stating that “the onus of establishing that the invention is described in enough detail lies with the applicant”. This statement concludes with the words "see item 14". Item 14 relates to acceptance of standard patents, and relevantly says:
“Where the Commissioner identifies a problem this is raised with the applicant. The applicant then bears the onus of providing the Commissioner with information sufficient to satisfy her that the issue has been resolved.”
31. Clearly, once an objection has been raised on the balance of probabilities, the onus moves to the applicant to satisfy the Commissioner that the objection should be withdrawn. Item 8 of the Explanatory Memorandum is thus referring to the examination process and is not altering in any way the requirement that the opponent must make their case in an opposition proceeding.
32. On the other hand, the applicant submits the difficulties encountered by the applicant if the opposition is successful (potential refusal) should be compared with ongoing opportunities provided to the opponent to continue to press their case (such as by re-examination) if the opposition is unsuccessful, and that this comparison should impact the standard of proof applied.
33. This argument is somewhat akin to the rationale noted in the EM for the previous standard of proof under the Patents Act prior to the Raising the Bar Act, discussed in item 14.
“whereas refusal of acceptance is final, acceptance is not. An application may be opposed after acceptance, and if a patent is granted, its validity can be challenged in proceedings for infringement or for revocation.”
34. The EM rejects this rationale, stating it is no longer persuasive.
“… a decision to refuse by the Commissioner can nowadays be more easily challenged as an applicant has a right of appeal to the Federal Court under section 51. (Prior to the establishment of the Federal Court the only route was directly to the High Court).”
35. Finally, the comment of Bennett J in AustalShips Pty Ltd v Stena Rederi Aktiebolag,[5] referred to by the applicant, also does not seem to me to be relevant to the present inquiry when the quotation is read including the line immediately after the section quoted by the applicant.
“… where there are two opposing expert views that are conclusive on obviousness, both presented bona fide by witnesses of accepted expertise, unless one set of views can be rejected on proper grounds, the legal burden to establish a ground of opposition is not discharged; the Court cannot be practically certain that obviousness or lack of inventive step is established.” (emphasis added)
[5] [2005] FCA 805 at 12.
36. This comment is clearly in the context of an earlier standard of proof required by previous legislation (“practically certain”) which is not relevant in the present matter.
37. In summary, I am satisfied that the standard of proof applying to oppositions is the balance of probabilities, and the opponent bears the onus of establishing the facts supporting the grounds of opposition.
The specification
38. The specification is directed to an ectoparasitic treatment method, and in particular relates to the treatment of biting lice on sheep. The specification ends with 11 claims.
39. In relation to construction, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd:[6]
“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.”
[6] [2013] FCA 214; 100 IPR 451 at [139].
The person skilled in the art
40. 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].
41. 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 at [70]-[72].
42. The specification relates to a chemical compound, thiacloprid, used to control lice on sheep and other animals. The description states that a particular problem for farmers in Australia is parasite infestation on sheep.[9] Accordingly, I consider that a range of skilled people would have an interest in this field, and that the person skilled in the art is best represented by a team. The skilled team would include veterinarians with an interest in sheep health, formulation chemists interested in the identification and development of ectoparasitic treatments and farmers interested in administering treatments to their animals.
[9] Page 1 lines 11-12.
43. The key declarants in this matter are Dr Matthew Charles Playford, Mr Phil Waterford, Professor Edward Lionel Bruce Whittem and Professor Nicholas Charles Sangster.
44. Dr Playford is a veterinary surgeon with 33 years’ experience including in livestock parasitology. For the last 10 years he has been managing Director of Dawbuts Pty Ltd which provides parasitology diagnostic services and advice in relation to parasite management in livestock,[10] and prior to this he was the Technical Manager at Bovine services[11]. These roles included conducting the ‘Lice Sense’ program during 2009 and 2010 to educate sheep farmers in Australia in the correct management and treatment of lice.[12] He also developed sheep lousicide products during his work at Intervet Australia during 1998-2004.[13]
[10] Playford 1 at [1]-[2].
[11] Playford 1 [9].
[12] Playford 1 at [30]-[31].
[13] Playford 1 [8].
45. Mr Waterford is the owner of a sheep plunge dipping service and has 32 years’ experience conducting sheep dipping for farmers.[14]
[14] Waterford at [1]-[2].
46. Professor Whittem is a professor at the University of Melbourne in the faculty of veterinary and Agricultural Sciences. From 2001-2008 he was head of Research and Development at Jurox, where he worked on a range of new veterinary products including a pour-on lousicide for sheep, a pour-on acaricide for cattle and a triflumuron treatment for biting lice on horses.[15]
[15] Whittem 1 at [2.1]-[2.5].
47. Professor Sangster is currently the Program Manager, Grassfed Productivity, at Meat and Livestock Australia. He has extensive university teaching experience, with expertise in veterinary parasitology. He is an authority on anthelmintic resistance and pharmacology, and in nematode parasites of sheep, cattle and horses.[16]
[16] Sangster [2.2]-[2.8].
48. I am satisfied that Dr Playford, Professor Whittem and Professor Sangster have backgrounds that enable them to understand the specification and provide evidence as to what a person skilled in the art knew or would have done at the relevant date. Where there is conflicting evidence, I will decide which evidence to give greater weight. I also consider that Mr Waterford’s specific experience in the practice of sheep plunge dipping, while not qualifying him to comment on matters of pharmacology or veterinary health, would qualify him to provide information about how a skilled person would perform plunge dipping.
The invention as described
Background
49. The description indicates that in Australia, lice and blowflies are the two most significant external parasites to affect sheep and are the cause of extensive production losses. Lice are species specific, meaning that generally sheep lice only live on sheep , and “goats, cattle, pigs and horses are each affected by their own species of lice.”[17] The most prevalent species to affect sheep is the biting louse, Bovicola ovis.[18]
[17] Description page 1 lines 14-20.
[18] Description page 1 line 23.
50. The control of lice requires effective chemical treatment of the whole flock.[19] External administration of ectoparasiticides may be used. Treatment by backlining (pour-on or spray) is recommended within 24 hours of shearing (off-shears), or within 7 days for some products. Treatment using ‘dipping’ administration methods – plunge, shower or cage dipping - can be used on longer wool, such as up to 6 weeks after shearing. Treatment of sheep with long wool may require hand-jetting or a specialised long-wool backlining treatment.[20] Not all types of parasiticidal actives are suitable for all different types of administration.[21]
[19] Description page 3 line 1.
[20] Description page 3 lines 5-14.
[21] Description page 3 line 16.
51. The use of lower concentration of actives is desirable to reduce cost and to reduce residue on the animal and in the environment, provided the active maintains efficacy at lower concentration.[22]
[22] Description page 3 lines 20-27.
52. A range of categories of chemical parasiticides are available for the treatment and prevention of sheep lice such as insect growth regulators, spinosyns, macrocyclic lactones, organophosphates, and synthetic pyrethroids. Various disadvantages are listed for these categories.[23]
[23] Description page 4 lines 1-23.
53. The neonicotinoid imidacloprid is also used for the control of lice on sheep. The product AvengeTM contains 3.5% w/v imidacloprid; when applied as a backline treatment within 24 hours of shearing it provides up to four weeks of persistent activity against reinfestation by lice.[24]
[24] Description page 4 lines 25-30.
54. The description indicates that there is a need for alternate methods of controlling ectoparasites such as sheep lice. The preference is for actives having high potency and high persistency to allow for reduced quantities to be used, and for methods that are useful for both short and long wool treatments.[25]
Disclosure of the invention
[25] Description page 5 lines 1-5.
55. The description states that the invention is based upon the discovery that thiacloprid, [3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene]cyanamide, an insecticide of the neonicotinoid class, has high potency and suitability for the control of lice when applied externally to an animal.[26] The description goes on to state that although the invention is to be described in relation to the control of biting lice on sheep (Bovicola ovis), the principles disclosed could apply in other situations, such as for controlling biting lice on goats (Bovicola caprae)[27], since “Many of the problems associated with sheep are also present in goats having regard to their long hair and related physiological systems.”[28]
[26] Description page 6 lines 1-6.
[27] Description page 8b lines 9-12.
[28] Description page 9 lines 1-2.
56. The description provides preferred quantities of thiacloprid to be administered. These amounts are listed in terms of various units:
a)0.0001% to 3.5% w/v, preferably 0.1% to less than 3.5% w/v, more preferably 0.5% to 2% w/v, particularly preferred is a composition of about 1% w/v thiacloprid;[29]
b)1 to 45 mg/kg, more preferably 5-40 mg/kg, even more preferably 10 to 30 mg/kg thiacloprid by weight of the animal,[30] and from 5 to 40 mg/kg by weight of the animal wherein the thiacloprid is administered by localised topical application to the back of the animal;[31]
c)1 to 200 mg/L (ppm), more preferably 5 to 100 mg/L (ppm), even more preferably about 48 mg/L (ppm) thiacloprid.[32] Immediately after these ppm amounts the description states that preferably the composition is administered as a dip treatment;[33]
d)100 mg/L (ppm) to 1000 mg/L (ppm), more preferably 200 mg/L (ppm) to 600 mg/L (ppm), preferably as a jetting treatment.[34]
[29] Description page 9 lines 10, lines 19-23; page 11 line 10, page 14 line 29.
[30] Description page 9 lines 12-17.
[31] Description page 14 lines 22-23.
[32] Description page 9 line 26-page 10 line 1.
[33] Description page 10 line 4.
[34] Description page 10 lines 12-19.
57. The description states that the active composition can be administered to the animal by any suitable means including backlining, dipping or jetting. The composition is applied to all or most of the fleece or hair of the animal, or by localised application, such as to the back of the animal.[35]
[35] Description page 11 line 27-page 12 line 2.
58. The description goes on to outline the application methods of dipping, jetting and backlining. These application methods are considered common general knowledge before the priority date of the application, that is 12 June 2013, by Professor Whittem[36] and by Professor Sangster[37]. The description explains that these methods are described with reference to sheep because this is the most typical species that is treated, but it emphasizes that the person skilled in the art would be able to adapt the administration means to other animals.[38]
[36] Whittem 1 [3.14].
[37] Sangster [3.2]-[[3.4].
[38] Description page 12 lines 17-20.
59. The description states that thiacloprid has “high efficacy” in the control of lice on sheep; four weeks of persistency has been measured when thiacloprid is administered as a plunge-dip or pour-on.[39] It notes that thiacloprid has superior potency compared to imidacloprid, and states “…thiacloprid has been demonstrated as effective when used as a pour-on treatment at a dose as low as 5 mg/kg thiacloprid.”[40]
The Examples
[39] Description page 14 lines 4-9.
[40] Description page 14 lines 14-18.
60. The description concludes with two formulation examples and 10 trial examples.
61. The first formulation example contains 48% thiacloprid which according to this example would be diluted to around 48 ppm (mg/L) for dipping. The second formulation contains 1% thiacloprid which is said to be useful for backlining.
62. Trial examples 1 and 2 involved treatment of 6 sheep by hand jet with a 400 mg/L solution of thiacloprid which used about 4L and 5L of solution respectively per sheep. Example 1 reduced live lice on the sheep at 166 days after treatment by 96.4%, and for example 2 lousicidal efficacy was 99.5% at 104 days after treatment.
63. In trial example 3, various concentrations of thiacloprid (300ppm-20ppm) were assessed for lousicidal efficacy when applied by hand jet to infested sheep. A positive correlation between thiacloprid concentration and efficacy was observed.
64. In trial example 4, sheep with natural lice infestation were treated by plunge dip, using various concentrations of thiacloprid ranging from 500-125ppm. Sheep treated at all dose levels were found to be lice free after 20 weeks. Trial example 5 was similar, using various concentrations of thiacloprid from 120-15 ppm. Efficacy was rated as “high” at all concentrations.
65. Trial example 6 was a dose-titration plunge dip study using six thiacloprid concentrations of around 15, 8, 4, 2, 1, 0.5 ppm. The three highest concentrations were rated as providing “acceptable” levels of efficacy. Trial example 7 used a concentration of 48 ppm, which was said to eliminate live lice from detection “when the sheep were assessed over a period of 12 months”.
66. Trial example 8 was an in vitro comparison of the relative potencies of imidacloprid versus thiacloprid. The latter was found to be six times more potent against a field strain of B. ovis when compared at the lethal concentration 50%.
67. Trial example 9 was a plunge dip treatment at 48ppm. The introduction of lice to treated sheep up to 4 weeks after treatment did not establish new infestations, demonstrating persistent lousicidal efficacy.
68. Finally, in trial example 10, four groups of sheep were dosed at different dose rates using a 10g/L pour on formulation. The example states that the formulation controlled sheep lice when applied at a dose level as low as 0.5mL per kg bodyweight (also measured as about 200 mg thiacloprid per square metre of sheep body surface area), and at 22 weeks after treatment there was an absence of lice on all three groups.
The invention as claimed
69. The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:[41]
“…the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. Words used in a specification are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification … This applies to words used in the claims. … the construction of a specification, including the claims, is ultimately a question of law …
…While the claims define the monopoly claimed in the words of the patentee’s choosing, the specification should be read as a whole …
It is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification ...”
[41] [2009] FCAFC 70; 81 IPR 228 at [118]- [120].
70. The cautions provided by Middleton J on several occasions are also helpful.
“…the use the [decision maker] can make of the body of a specification will vary from case to case. As Apotex submitted, there is a fine line between using the specification to construe the claim, and using the specification in such a way that adds an impermissible gloss to the claims.”[42]
“Above all, the [decision maker] should approach the task of patent construction with a generous measure of common sense.”[43]
[42] Eli Lilly and Co Ltd v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [144].
[43] Ranbaxy Laboratories Ltd v AstraZeneca AB [2013] FCA 368; (2013) 101 IPR 11 at [108].
71. By way of example, Stephen J in Interlego A.G. v Toltoys Pty. Ltd[44] considered the meaning of “lateral face” in the claim, a term which in the evidence had no special meaning known to experts in the art. The specification provided several types of lateral face. Stephen J refused to read down the meaning of the term to exclude an internal lateral face, stating this was not a case where “it is necessary to introduce into every claim limitations dictated by common sense after a perusal of the whole of the specifications.”
[44] (1973) 130 CLR 461 at [22]-[26].
72. There are three independent claims reproduced below. The whole claim set of the application is reproduced at Annex A.
1. A method of controlling lice on an animal, characterised by the step of administering externally a pharmaceutically effective amount of thiacloprid, wherein the amount of thiacloprid administered to the animal is from 1 to 45 mg/kg by weight of the animal.
6. A method of providing persistent control of lice on an animal, characterised by the step of administering externally a pharmaceutically effective amount of thiacloprid, wherein the amount of thiacloprid administered to the animal is from 1 to 45 mg/kg by weight of the animal.
9. Use of thiacloprid in the manufacture of a composition for controlling lice on an animal, wherein the amount of thiacloprid administered to the animal is from 1 to 45 mg/kg by weight of the animal, and wherein the composition is administered externally to the animal.
An animal
73. The description does not provide a definition of “animal”. However, it states that sheep, goats, cattle, pigs and horses are each affected by their own species of lice.
74. At the hearing, I asked the parties what they considered to be the appropriate meaning of the word “animal” as it appears in the claims. Counsel for the applicant stated the term referred to domesticated animals, whereas counsel for the opponent did not consider the term to be restricted to any sub-group of animals.
75. The claims are directed to “a method of controlling lice on an animal”, so as a matter of common sense, I consider it is appropriate to read the word “animal” in the context of the whole claim, and limit the word “animal” to those particular classes of animal which may be in need of treatment for lice infestation.
76. The thrust of the present description is the treatment of sheep, however at the very start of the description it is stated that:
“…the present invention relates to the treatment of biting lice on sheep, although it should be appreciated that aspects of the present invention can be extended to related matters.”[45]
[45] Description page 1 lines 5-7.
77. I therefore do not consider that this is a case where the whole thrust of the specification dictates that the word “animal” in the claims should be read down to exclude any species, other than to say as I have done above that it is animals that are or may be in need of lice treatment that are encompassed. I am therefore not satisfied that the claim can be limited to domesticated animals.
78. I therefore construe “animal” to mean any animal that may be in need of treatment for lice infestation.
79. I also note here that ‘an animal’ is singular, therefore the method is applicable to individual animals.
Controlling
80. Professor Whittem states that controlling lice and control of lice means that “an extremely high percentage of live lice and viable eggs (i.e. at least around 95%) are eliminated from treated animals. The terms do not mean, or require, that there is 100% eradication of all lice and eggs.”[46]
Professor Sangster says something very similar.[47] Dr Playford does not disagree with this definition.
[46] Whittem 1 [5.12.1].
[47] Sangster [5.6].
81. The description does not provide a definition of the term “control” or “controlling”. However, Trial examples 1 and 2 state that the average numbers of live lice on the treated sheep were reduced by 96.4%, and that “lousicidal efficacy” was 99.5%, respectively. This is consistent with Professors Whittem and Sangster’s views. I therefore conclude that “controlling” or “control of” lice means that at least around 95% of live lice and viable eggs are eliminated from treated animals.
Administering externally
82. Professors’ Whittem and Sangster understand this phrase to mean applied to the exterior of the animal, that “topically administering” has the same meaning as “administering externally”, and that typical external methods of application include dipping, jetting and backlining (pour-on) methods.[48] Dr Playford understands external administration to include dipping, jetting, backlining, dressings and ear tags containing an insecticide.[49] However, he considers “topically administering” more specifically to refer to application of a spot of liquid to a portion of the animal’s skin, and considers that backlining is an example but states that jetting and plunge dipping are not topical application methods.[50]
[48] Whittem 1 [5.12.2], [5.12.5]; Sangster [5.6].
[49] Playford 1[20].
[50] Playford 1 [51].
83. The specification is most consistent with Dr Playford’s understanding. It states:
“In some embodiments, the composition is applied to all or a majority of the fleece or hair of the animal. In some embodiments, the composition is applied by localised topical application to part of the fleece or hair of the animal, e.g. to the back of the animal.”[51]
[51] Description page 11 line 28 – page 12 line 2.
This is also consistent with general claims construction principles that claims should be construed against redundancy.[52]
[52] Parkinson v Simon (1894) 11 RPC 493 at page 502 lines 57-59.
84. I therefore construe “administering externally” to encompass all methods of applying medicaments to the outside of an animal, and that “topically administering” is a sub set of these administration methods in which the medicament is applied only to a part of the outside of an animal.
85. Further, the phrase “administering externally” should also be considered in terms of how it affects the understanding of the amount of active that is administered. Dr Playford calculates the administered dose based on a range of “take-off” volumes[53] - the volume of liquid removed from the dip by a sheep in the dipping process. In their evidence, Professors Whittem and Sangster comment[54] that the take-off volume is not the same as the volume that remains on the sheep, as some of the dip liquid will drip off the sheep as it emerges from the dipping pool. They therefore conclude that the dose delivered to the sheep is less than the dose calculated from using the volume of dip take-off. Professor Sangster states that the only way to know how much active is administered is to weigh a sheep before and after dipping, ensuring that the second weighing is done after allowing excess dip to drip off the sheep.[55] Dr Playford comments regarding his use of take-off volume to determine dose:
“…given the nature of the plunge dipping method of administration, there is no other technique available…to calculate the amount of any active per sheep…”[56]
[53] Playford 2 [21].
[54] Whittem 1 [7.8.4]; Sangster [7.17].
[55] Sangster [7.17].
[56] Playford 2 [15].
86. I appreciate the concerns of the professors that in order to determine a precise dose, precise sheep weights and dip volumes would need to be determined. However, I am mindful that the nature of this art is not technologically complex, and occurs in the context of farming, rather than a laboratory. I note also that the specification itself does not say that you need to weigh sheep after dipping to determine the dose delivered. This is consistent with Dr Playford’s view.
87. Returning to the wording of the claim, it specifies “…administering externally … wherein the amount of thiacloprid administered to the animal is from 1 to 45 mg/kg by weight of the animal.”.
88. Therefore, I consider that what is administered to the animal, in the case of a plunge dip, is the volume of dip liquid that the animal removes from the dip trough. What remains on the animal may well be less than what is initially administered, but the claim is only concerned with the administered amount. This is consistent with the description, which only discusses the dip concentration and contains no suggestion that a dip volume that is retained on the sheep should be measured by weighing each dipped sheep individually after allowing excess dip liquid to drain off. This construction is also consistent with a common sense understanding of the nature of the art in question.
Persistent Control
89. “Persistent control” is not defined in the description.
90. Both the applicant and the opponent substantially agree that “persistent control” is the ability of the active compound to prevent re-infestation for a time period. The opponent refers to a “certain period of time” and the applicant, an “extended period of time”.[57]
[57] Applicant submissions [76]; Opponent submissions [37].
91. The experts also concur. Professor Whittem states that “‘Persistence of control’ is the ability of the active compound to prevent re-infestation for a certain period of time, e.g. by staying on the animal long enough to keep having the effect. In my opinion, ‘persistent control of lice’ is different from ‘controlling lice’.” Professor Sangster says that “persistence of control” means prevention of re-infestation for an “extended period of time”. Both experts mention the time period of “at least two weeks” specified in claim 7 as an example of such a time period.[58] This is consistent with Dr Playford’s statement that “Persistent control means that the method provides a protection from re-infestation for a period of weeks after application.”[59] Therefore I find that “persistent control” means prevention of re-infestation of lice for a period of at least two weeks.
Pharmaceutically effective amount
[58] Whittem 1 [5.12.6]; Sangster 12 [5.6].
[59] Playford 1 [62].
92. Professors Whittem and Sangster agree that “pharmaceutically effective amount” refers to a sufficient amount of thiacloprid to provide control or persistent control of lice on the animal.[60] As the amount of thiacloprid is specifically stated in the independent claims, I do not consider that this term requires any further discussion.
[60] Whittem 1 [5.12.3]; Sangster 12 [5.6].
Support
93. The delegate in CSRBuilding Products Limited v United States Gypsum Company[61] (CSR) set down the following steps to determine whether the claims are supported by the description.
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.
[61] [2015] APO 72 at [95].
94. Drawing on UK jurisprudence, the delegate also elaborated on the meaning of “technical contribution to the art.” I note in particular his reference to the following principles.
a) “…the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art. Consequently, a technical feature which is described and highlighted in the description as being an essential feature of the invention, must also be a part of the independent claim or claims defining this invention."[62]
b) “The invention's technical contribution to the art is concerned with the evaluation of its inventive concept – how far forward has it carried the state of the art?”[63]
c) “An important question will often be whether the technical contribution to the art is a general principle or the specific examples in the specification. Lord Hoffmann gave some examples in Biogen at page 49:
“Thus if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect. On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them.’ [citations omitted].”[64]
[62] Ibid at [110].
[63] Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12; [2009] RPC 13 at [30].
[64]CSR Building Products Limited v United States Gypsum Company [2015] APO 72 at [113].
95. The opponent submits that the claims lack support for either of two reasons:
a) The specified ranges of amount of thiacloprid to be administered to an animal is wider than the amounts of thiacloprid disclosed in the specification as effective; and
b) The only support for the administration of thiacloprid is in relation to administration for the treatment of sheep.[65]
[65] Opponent submission [39].
What is the invention as claimed?
96. I have previously discussed the construction of certain words in the claims. In view of the construction, I will summarise the scope of the independent claims.
97. I construe claim 1 to be directed to a method of controlling (eliminating around 95% of live lice and viable eggs) lice on animal (any animal in need of lice treatment) by the step of administering externally (to the outside of the animal) a pharmaceutically effective amount of thiacloprid (sufficient amount to control lice), wherein the amount of thiacloprid administered to the animal (the amount initially administered in the process of external application) is from 1 to 45 mg/kg by weight of the animal.
98. Claim 6 is the same as claim 1 except that it is a method of providing “persistent control”. In line with my previous construction of this phrase, I construe this claim to be a method as for claim 1 except that it additionally provides control of lice upon an animal for a period of at least two weeks.
99. Claim 9 is directed to the use of thiacloprid (a method using thiacloprid) in the manufacture of a composition for controlling lice on an animal. It also specifies external administration and the same dosage as claims 1 and 6. The only difference between claim 9 and claims 1 and 6 is that claim 9 specifies the manufacture of a composition comprising thiacloprid.
What is the technical contribution to the art?
100. I have previously discussed the disclosure of the description. In particular, the description states that the invention is based upon the discovery that thiacloprid, [3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene]cyanamide, an insecticide of the neonicotinoid class, has high potency and suitability for the control of lice when applied externally to an animal.[66] To my mind, this is the beginning point for understanding the technical contribution to the art. Previously, a related neonicotinoid, imidacloprid, had been used.[67] However, the description notes that thiacloprid has superior potency compared to imidacloprid.[68]
[66] Description page 6 lines 1-6.
[67] Description at page 4 line 25.
[68] Description page 14 line 14.
101. The invention is described in relation to sheep, but the description suggests that it could also apply other animals.[69] The description notes that goats present similar challenges in relation to their long hair, and have similar physiological systems.[70] Only sheep have been tested in the examples.
[69] Description page 8b lines 9-12; page 12 lines 19-20.
[70] Description page 8b line 12-page 9 line 2.
102. I therefore need to answer the question as to whether the discovery of thiacloprid as a useful neonicotinoid insecticide represents a general principle that can be applied to the whole class of species covered by the term “animal”, or whether the technical contribution represented by the use of thiacloprid is more limited.
103. Professor Whittem states:
“The efficacy of an insecticide product will depend partly on the amount of product used and the mode of delivery. This is difficult to predict without comprehensive testing. Whether a product is effective in any animal species can only be determined by a range of studies.”[71]
[71] Whittem 1 [3.21].
104. The applicant submits[72] that the opponent has taken this evidence out of context, the context being the difficulties of taking an insecticide known in plants and applying it to animals, as he discussed in the previous paragraph. However, I do not find the submission compelling. The paragraph immediately after the one quoted is clearly discussing the transferability of insecticide treatments between species[73]. I agree that this following paragraph is primarily about the legalities involved, but it shows that this section of evidence is more than simply a discussion of whether crop insecticides can be used on animals. Paragraphs [3.20]-[3.24] of Professor Whittem’s evidence seem to me to be making separate points.
[72] Applicant submission [121].
[73] Whittem 1 [3.22].
105. In addition, earlier in his declaration Professor Whittem stated:
“While some antiparasitic agents are useful to kill parasites through a particular mode of action in any animal, it cannot be expected that the same antiparasitic agent will have the same efficacy, potency or safety in different animal hosts.”[74]
[74] Whittem 1 [3.7].
106. This statement is clear that it is not predictable whether an insecticide effective in one species will also be effective in another, even if the mechanism of action is known. This corroborates the previous statement that studies are required to demonstrate efficacy in different species.
107. The statement in the description that “one skilled in the art will be aware of suitable adaptions and means for administering to other animals” thus seems to be at odds with the evidence. Professor Whittem says that “comprehensive testing” and a “range of studies” will be required. Therefore, the use of thiacloprid as an insecticide on all “other animals” is not, to my mind, at “the disposal of the person skilled in the art”; the present description does not conduct any studies on other species. Further, there is no disclosure of a general principle that explains why this particular neonicotinoid could be used without extensive testing on all other lice affected species.
108. I do note that the description indicates that goats have related physiological systems, which provides some basis for an expectation that thiacloprid will be effective in this species. According to Professor Whittem, other neonicotinoids have been used successfully on goats.[75]
[75] Whittem 1 [3.12].
109. This art has been advanced, then, only to the extent that it is now known that sheep lice can be treated with thiacloprid, and it is likely that the method will also work on goats due to their similar physiology. However, the applicant has not demonstrated a general principle by which lice on all animals will be controlled when treated with thiacloprid, irrespective of species or physiology. Therefore, insofar as it relates to the types of animals that can be treated in the method, the technical contribution to the art is limited to the treatment of sheep and goats.
110. In relation to support for the range of amounts of thiacloprid administered, the examples disclose the testing of a significant range of concentrations of thiacloprid on sheep and disclose the use of several external application methods.
Hand jet
400 mg/L (ppm) in trial examples 1-2, 300-20 ppm in example 3, positive correlation between thiacloprid concentration and efficacy was observedPlunge dip
500-125 ppm in example 4; 120-15ppm in example 5; 15-4ppm in example 6; 48 ppm in example 7Pour on
10g/L in example 10, dose level down to 0.5 mL/kg bodyweight which equates to 5 mg/kg as calculated by the opponent[76][76] Opponent submission [27].
111. The applicant further notes in their submission that the skilled person could calculate the dose of thiacloprid in mg/kg bodyweight having regard to the information in the disclosed in the specification.[77] For example, the applicant submits[78] that the dose of thiacloprid in mg/kg body weight may be calculated from the volume administered and the weight of the animal, and provides the following table showing the range of active that would be administered assuming 4L or 5L of formulation is used as per examples 1 and 2, on a sheep of 60kg.
[77] Applicant submission [111].
[78] Applicant submission [112].
112. I note that this method of estimating the dosage corresponds to Dr Playford’s method previously referenced[79], and thus is confirmed by the evidence. The above table demonstrates that dosages of between about 1-33 mg/kg are shown to be effective in the examples. In one embodiment in the description the dosage range is stated as 5 to 40 mg/kg.[80] The examples also suggest that higher concentrations will also be effective[81]. However, the description indicates that it is desirable to use lower quantities of actives where possible,[82] and notes that the previously used product for lice control on sheep is about 49 mg/kg of sheep body weight.[83] The claimed dosage of 1 to 45 mg/kg body weight of the animal is thus consistent with the overall disclosure of the description including the examples in relation to dosage.
[79] Playford 2 [21].
[80] Description page 14 line 22.
[81] Description page 16 line 22.
[82] Description page 3 line 26.
[83] Description page 14 line 16.
113. I therefore conclude that the technical contribution to the art of the described invention is a method of controlling lice by external administration of thiacloprid to sheep and goats wherein the amount of thiacloprid administered is in the range of 1 to 45 mg/kg by weight of the animal.
114. Claims 1-10 do not specify that the method is applicable to sheep and goats only. I therefore find that claims 1-10 are not supported according to subsection 40(3).
Clear enough and complete enough disclosure
115. Section 40(2)(a) requires that the complete specification must disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art. The provisions of section 40(2)(a) have been considered in detail in CSR and Evolva SA (Evolva)[84].
[84] [2017] APO 57.
116. In CSR the delegate adopted a three-step test for determining whether the specification provided a clear enough and complete enough disclosure of the claimed invention as follows:
i.construe the claims to determine the scope of invention as claimed,
ii. construe the description to determine what it discloses to the person skilled in the art, and
iii. decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.[85]
[85] [2015] APO 72 at [95].
117. An expanded approach was taken in Evolva, wherein the third consideration of enablement was assessed according to the following criteria:
Is it plausible that the invention can be worked across the full scope of the invention?
Can the invention be performed across the full scope of the claims without undue burden?[86]
[86] [2017] APO 57 at [45].
118. The opponent submits under this ground that the specification does not disclose how to apply the claimed invention in the context of dipping or jetting, and that the only example which measures dose by mg/kg of the animal is trial example 10 which discloses backlining.[87]
[87] Opponent submission [56]-[57].
119. I have previously construed claim 1 to be directed to a method of controlling (eliminating around 95% of live lice and viable eggs) lice on animal (any animal in need of lice treatment) by the step of administering externally (to the outside of the animal) a pharmaceutically effective amount of thiacloprid (sufficient amount to control lice), wherein the amount of thiacloprid administered to the animal (the amount initially administered in the process of external application) is from 1 to 45 mg/kg by weight of the animal.
120. I have already found that the description discloses a range of external application methods including the use of hand jetting and plunge dipping. The applicant has included calculations in their submission under the support heading showing how the dosage can be determined from the amount of formulation expected to be used in each of these methods, which correspond to the method used by Dr Playford in calculations that he describes as “standard”. I consider therefore that it is clearly plausible that the invention can be worked over the scope of application methods encompassed by the claim, and that the disclosure can be considered enabling.
121. All the experts concur that jetting, dipping and backlining were all well known methods of external administration before the priority date.[88] I note Professor Sangster’s comment that preparing formulations of actives for a range of application methods would require skill and time.[89] However, I note that the disclosure of an invention is not incomplete merely because the skilled person would have to use a reasonable degree of skill, so long as “prolonged inquiry”[90] is not required. Given that the above application methods are all well known in the art, and that the description contains some instruction as to each of these methods, I am satisfied that no undue burden is imposed upon the skilled addressee to practice the invention using application by dipping or jetting.
[88] Whittem 1 [3.14]; Sangster [3.2]-[3.4]; Playford 1 [20].
[89] Sangster 7.40.
[90] Eli Lilly & Co. v Human Genome Sciences, Inc. [2008] EWHC 1903 (Pat); [2008] RPC 29 at [241].
122. Consequently, I find that this ground of opposition has not been made out.
Novelty
123. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) provides that an invention is taken to be novel unless it is not novel in light of the prior art base. Prior art information made publicly available in a document or through the doing of an act forms part of the prior art base for the purpose of novelty if it was published before the priority date of a claim.
124. It is well established that the general test for lack of novelty is the reverse infringement test, as set out by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd[91](Meyers Taylor):
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement…”
[91] [1977] HCA 19 at [20]; 1A IPR 181 at 186.
125. For this test to be satisfied, the alleged anticipation must disclose all the essential features of the invention as claimed, as stated in Nicaro Holdings Pty Ltd v Martin Engineering Co. [92]
“A prior publication does not amount to an anticipation of an invention claimed as a combination if it discloses some but not all of the integers of that combination…”
[92] [1990] FCA 40 at [21].
126. The disclosure of a feature in an alleged anticipation need not always be explicit. Bennett J sets out principles to be considered in such cases in H Lundbeck A/S v Alphapharm Pty Ltd:[93]
“Where the prior publication discloses exactly what is claimed, there is anticipation. This can be objectively determined and, apart from an understanding of terms of art, the evidence of the skilled addressee is not likely to be of much further assistance. However, this does not always occur and many of the authorities contain discussions of the extent to which a disclosure less than the entirety of the claim constitutes an anticipation of a product or a process to deprive the claimed invention of novelty.
If the prior art discloses some but not all integers of a claimed patent to a product, such as a combination, there is anticipation if the skilled addressee would add the missing information as a matter of course and without the application of inventive ingenuity or undue experimentation (Nicaro at 530-531).
It may be that the prior disclosure is of a method that produces the claimed product. If that method leads inexorably to the product, there is anticipation (General Tire at 138). If it may or may not result in the claimed product, there is no anticipation.”
[93] [2009] FCAFC 70 at [180]-[182].
127. The level of disclosure that is required in cases where a feature is not explicitly disclosed is set out in General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd:
“…If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor’s publication will inevitably result in something being made or done which, if the patentee’s patent were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented. A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”[94]
[94] General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 457 at 485-486 (citations omitted).
128. Jessup J comments as follows on this passage in Novozymes A/S v Danisco A/S[95]:
“Although General Tire is part of Australian jurisprudence in the relevant area, it must be accommodated to the terms of s 7(1) of the Patents Act, upon which everything depends. That is to say, the inevitability of outcome to which General Tire refers must be such as would arise from recourse to the information referred to in the section. At the expense of repetition, it is here useful to remind ourselves of what the Court of Appeal said in that case ([1972] RPC at 485-486):
… if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated. [Emphasis added]
This proposition is explicitly hypothetical. It is concerned not with what has happened or with what could have happened, but with what would have happened if the directions were carried out. As such, the proposition is in complete harmony with s 7(1), and with every other presently relevant aspect of the jurisprudence in this area. It is not the doing of it, nor even the ability to do it, that amounts to anticipation: it is the content of the information. If the information contains directions which, if carried out, would constitute an infringement of the patent in suit, the invention under the latter is not novel.”[96]
[95] Novozymes A/S v Danisco A/S [2013] FCAFC 6; (2013) 99 IPR 417.
[96] Ibid at [177].
129. He then elaborates on the case before him.
“…In my reasons so far, the only respect in which I have departed from the primary Judge is that which relates to inevitability of outcome. I have agreed with her Honour that the Novo patent would not have disclosed to the skilled addressee the generation of a second functional ingredient. But I have taken the view that that deficiency would not compromise the appellants’ inevitability case, since I have held that a second functional ingredient would inevitably have been generated in the enzymatic reaction referred to…
In my view, the General Tire approach, if taken at all, may be taken only with respect to the whole of any claim asserted to have been anticipated. The “precise destination” at which the flag must have been planted is one which includes every integer of the claim. The approach cannot, in my view, be taken for some integers only, leaving others to be dealt with by reference to the understanding of the skilled addressee. In the present context, what this means is that, to the extent that the appellants’ case is based on General Tire, it is not sufficient that they be able to point to passages in the Novo patent from which it would appear to the skilled addressee that inactivation was contemplated or intended by the earlier inventors. It is necessary that they show that, if Example 20 were worked as directed, it would inevitably, as a matter of hard fact, have involved inactivation of the enzyme (to the standard set up under Claims 1 and 7 of the patent in suit as identified by the primary Judge) at the baking stage.
Was the evidence below sufficiently categorical for those purposes? Here the appellants have the benefit of findings by the primary Judge that “the baking conditions would have caused inactivation” and that ‘[t]here can therefore be little doubt that, following the directions in example 20 of the Novo patent, the enzyme would be denatured or inactivated to the extent that no significant or material amount of active enzyme remains in the foodstuff.’ These findings related to what would have happened in fact, not merely to the understanding which the skilled addressee would have derived from the terms of the Novo patent.”[97]
[97] Ibid at [186]-[188].
130. I particularly note the conclusion above drawn by Jessup J that although the citation in question did not disclose to the skilled addressee the generation of the functional ingredient which was a feature of the claim, that deficiency did not compromise the inevitability case. In other words, I understand this decision to demonstrate that in an inevitability case, it is not required that the skilled person appreciate a particular result would be generated in a disclosed process; rather, the question is whether that result is generated inevitably, as a “matter of hard fact”.
131. A further decision about determining lack of novelty by inevitable result referred to me by the applicant is SNF (Australia) Pty Limited V BASF Australia Ltd[98]in which Beach J stated:
“It is not sufficient to demonstrate that a prior publication is capable of being carried out in a manner which would equally infringe or not infringe the particular claim. In such a case there would not be the relevant anticipation. To elaborate, if the prior art is a document and there is ambiguity in the sense that the disclosure can be read in two or more ways, such that one way would, if carried out, infringe, and one or more other ways would not, then there has been no anticipation. Anticipation must not merely be a possibility or even a likely consequence of performing the invention disclosed by the prior art, but it must necessarily be entailed in or an inevitable result of carrying out the disclosure.”[99]
[98] [2019] FCA 425.
[99] Ibid at [1724].
132. The opponent submits that the Trade Advice Notice (D1) and Sirinyan 2003 (D2) anticipates the present claims.[100]
Trade Advice Notice (D1)
[100] Opponent submission at [63].
133. It is not disputed by the parties that D1 was published before the priority date of the present claims.
134. D1 is a Trade Advice Notice published by the Australian Pesticides and Veterinary Medicines Authority (APVMA) in relation to thiacloprid in the product Piranha® Dip for sheep. The introduction section indicates that the product contains the active thiacloprid at a concentration of 480 g/L, and that the product is a plunge dip intended for the control of the sheep body louse (Bovicola ovis) on short wool sheep.
135. In the use pattern section at 2.1, the dose rate is indicated for plunge dip. Under the headings “Dose Rate” and “Nominal”, it states that the product is to be diluted at a rate of 10mL product in 100L of water, which is equivalent to 48 mg thiacloprid/L water.
136. Thus, D1 discloses a method of controlling lice on an animal (sheep) by externally administering (plunge dip) thiacloprid. D1 does not disclose that the amount of thiacloprid administered is from 1-45 mg/kg by weight of the animal. However, D1 does disclose the concentration of thiacloprid to be used in the dipping solution.
137. The opponent’s submission is that carrying out the method disclosed in D1 will inevitably result in something being made or done that would fall within the scope of the present claims.[101]
[101]Opponent submission [72].
138. In considering this submission, I have found it helpful to highlight several principles from the authorities stated above and consider how they apply to the method defined in claim 1 as I have construed it.
139. The basic test for anticipation is the same as that for infringement and the question to be asked is whether the alleged anticipation would, if the patent were valid, constitute an infringement.
140. I return to the construction of claim 1. It is a method of controlling lice on “an animal” singular, not a method of controlling lice on multiple animals such as a flock or a herd. It follows that this claim is anticipated if one animal is inevitably treated according to the method.
141. It is also a method of “administering externally” an amount of thiacloprid, the amount administered being 1 to 45 mg/kg by weight of the animal. I have previously found that the amount of thiacloprid administered corresponds to the amount found in the dip liquid that is initially provided to the animal in the form of the take-off liquid the animal removes from the dip.
142. For the purposes of finding anticipation by inevitable result, I need to find, on the balance of probabilities that, as a matter of fact, the claimed dose would be administered to at least one animal, and it is irrelevant whether or not it is appreciated by the skilled person that the claimed dose is administered when the dip is used.
143. However, I note the caution that where the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the claim will not have been anticipated. Anticipation must be necessarily entailed, and not just a possibility or a likely consequence of performing the prior art disclosure.
What is the inevitable result of plunge dipping sheep with the thiacloprid dip disclosed in D1?
144. The experts agree that some amount of liquid will be removed from the dip in a plunge dipping process[102] and this is reflected in the applicant submissions[103].
[102] Whittem 1 [7.8.4]; Sangster [7.9].
[103] Applicant submissions [173].
145. Dr Playford explains that when a sheep is dipped, each sheep will “take off” a certain volume of the dipping liquid in the dipping process, depending on its weight and the amount of wool it carries. He states that “The rule of thumb used in the industry is that dipping each 60 kg sheep with up to 6 weeks of wool would take off between 2L and up to 6L from the dip”.[104] Thiacloprid is a non-stripping dip, which means that the active does not adhere to the wool and “strip” the dip of active. He therefore notes that “…a constant concentration of active is depleted from the plunge dip after each sheep dipped. This way you can calculate at a constant rate the amount of active in each ‘take off’ – so what has been applied to the sheep.”[105]
[104] Playford 1 [22].
[105] Playford 1 [23].
146. In his second declaration, Dr Playford calculates the amount of thiacloprid administered in mg/kg for sheep of various weights, using both the bottom (2L) and top (6L) of the range for take-off that he considers would cover variations in take-off produced by wool length, wool density, breed and size of sheep.[106] I have reproduced his table below.
[106] Playford 2 [19] and [21].
Sheep weight (kg) Thiacloprid applied (mg/kg)
20 4.8 - 14.4
30 3.2 - 9.6
40 2.4 - 7.2
50
1.92 - 5.76 60 1.6 - 4.8
147. The applicant’s experts do not dispute the range of sheep weights that are used by Dr Playford. Professor Sangster comments that “a 60kg sheep is a large sheep” and that “a small sheep weighing about 20kg … will be expected to take off much less dip…”[107]. This suggests that he is in general agreement with the range of sheep sizes that Dr Playford has used in his calculations. That is, Professor Sangster’s use of comparative language “small” and “large” here suggests to me that usually sheep will fall within the top and bottom limits proposed by Dr Playford. Professor Whittem also refers to a 60kg sheep as a “big sheep”.[108]
[107] Sangster [7.11].
[108] Whittem 1 [7.8.4].
148. The area of disagreement is the estimate of take-off that is used to calculate how much dip will be administered to a sheep in the course of plunge dipping.
149. In particular, the applicant submits[109] that:
·any “rule of thumb” is flawed and does not form part of common general knowledge.
·“rules of thumb” are locally developed for each local group of variable factors, and therefore they vary widely.
·“rules of thumb” are no more than a very rough guide.
·the range of variables to be considered cannot ever be sensibly accounted for in any single “rule of thumb”.
·The literature references provided by the opponent for take off measurements widely vary and are not consistent.
·Some of the literature references disclose take offs of lower than Dr Playford’s bottom limit of 2L.
[109] Applicant submissions [170]-[180].
150. Firstly, as stated above, for the purposes of finding anticipation by inevitable result, I need to find, on the balance of probabilities, the claimed dose would be administered. It is irrelevant whether or not the skilled person would appreciate that this dose in mg/kg is administered. It is therefore not relevant for this test whether any “rule of thumb” is common general knowledge since I do not need to determine what the skilled person would understand about the dose. Rather, I need to determine what would actually occur.
151. As to the amount “take-off” that can be expected, the experts comment as follows.
152. Professor Whittem states that “rules of thumb” are “not reliable for making precise or accurate calculations of doses in mg/kg of an active compound delivered to each sheep (or goat) by plunge-dipping”.[110] He also states:
“I am not prepared to accept that take-off for most sheep is always, or reliably, in the range of the ‘rule of thumb’ described at [Playford 1 paragraph 22]…”[111]
[110] Whittem 1 [7.10].
[111] Whittem 1 [7.9].
153. Professor Sangster states “…I am not certain, and could not be certain, that the take-off from dips would always fall in the ‘rule of thumb’ range of ‘between 2L and up to 6L’ for a 60 kg sheep with two to six weeks of wool…in my opinion, the ‘rule of thumb’ … cannot be used to make a sensible and reliable mathematical calculation of the dose of active compound administered in mg/kg body weight of an animal following plunge dipping.”[112]
[112] Sangster [7.11]-[7.12].
154. Dr Playford acknowledges that the rule of thumb will not provide an exact figure.[113]
[113] Playford 2 [16].
155. The primary objection to the use of Dr Playford’s take-off amounts on the part of Professors Whittem and Sangster seems to be that they are estimates rather than “reliable” mathematical calculations. I acknowledge that Professor Whittem does not accept that the take-off for most sheep is always in the range of the rule of thumb. However, I do not read his, or Professor Sangster’s evidence as saying that the take-off will never be within Dr Playford’s estimated range. I do not accept that simply because the take-off values are estimates, and may vary from practitioner to practitioner, that these estimates should be accorded no weight in determining what would happen when sheep are dipped using the product of D1. It seems to me that the disagreement as to the validity of the calculations is about the appropriate bottom and top ends of the ranges rather than the bulk of the calculations. See for example Professor Whittem’s comment that a 20 kg sheep could take off less than 2L from the dip.[114]
[114] Whittem 1 [7.8.5].
156. I am mindful that Dr Playford has field experience in advising farmers about lice treatment of livestock, and I am inclined to give considerable weight to his evidence. All the calculations in Dr Playford’s table reproduced above fall within the dose range claimed in claim 1. Dr Playford’s estimated range of take-off of 2-6L is criticised by the applicant as being “… so wide…that this rule of thumb cannot contribute any useful or reliable information….” [115] However, on the contrary, the width of the range would make this estimate more likely to cover the variables identified by the experts, and therefore more useful.
[115] Applicant submission [173].
157. Mr Waterford, based on his considerable experience of conducting sheep dipping as a contractor, considers that generally “take-out” (which I understand to mean the same thing as “take-off”) is 3-4L per sheep, with 2L possible as a lower limit. Whilst he may never have measured the take off for an individual sheep, I consider that in the course of a days’ work he would have needed to ensure he provided enough dip liquid for the number of sheep being treated, which would necessarily entail a reasonable estimate of how much liquid an individual sheep would remove. For this reason, I consider his evidence to be credible. His estimates are narrower than Dr Playford’s, but to my mind this does not make them inconsistent. On the contrary, as stated above, Dr Playford’s estimate is deliberately broad to catch as many variations as possible. To my mind, therefore, I consider that Mr Waterford’s evidence lends further weight to Dr Playford’s calculations.
158. Dr Playford’s evidence is also consistent with the present specification. Trial examples 1 and 2 used approx. 4L and 5L of solution per sheep for a hand jet application. At the hearing, I asked counsel for the applicant how the skilled person would practice the invention by applying the dose when plunge dipping was used as the application method. Counsel confirmed that the volume estimates found in these examples of hand jet application could similarly be used as estimates of the volume used (take off) for plunge dip application. The applicant submissions confirm this, stating:
“The dose of thiacloprid in mg/kg body weight of the animal may be calculated from knowing the volume of formulation administered and the weight of the animal. The applicant submits that a person skilled in the art would be able to conduct that calculation having regard to the information disclosed in the specification.”[116] (emphasis added)
[116] Applicant submission [111].
159. It is clear to me, then, that Dr Playford’s take off estimates are entirely reasonable.
160. I accept, based on Professors’ Whittem and Sangster evidence, that there could be outliers not covered by Dr Playford’s calculations that represent animals that do not receive the claimed dose. However, I do not read their evidence as saying that when a group of animals is treated, it is possible that all individuals within that group could receive a dose outside the claimed range. Therefore, this is not a case where the prior publication contains a direction which is capable of being carried out in a manner which would infringe, but would be at least as likely to be carried out in a way which would not do so. For this to be the case, all the sheep in the dipped group would need to be outliers. I reiterate that if one sheep is dipped according to the claimed method, infringement will have occurred.
161. I also do not consider that this is a case where there is ambiguity in the prior art document such that the disclosure can be read in two or more ways, one that way would, if carried out, infringe, and one or more other ways would not. There is no ambiguity in understanding what D1 teaches. It teaches a dip of a particular concentration. It is what will happen when a dip of that concentration is used that is in issue.
162. Rather, I read the evidence as saying that whilst it is possible that some sheep within a dipped flock will not be administered the claimed dose, the bulk of animals in the group will be administered that dose. I consider that the weight of evidence favours a conclusion that, on balance, when the D1 dip is used as directed, at least one sheep in any group will satisfy the assumptions behind Dr Playford’s calculations, and therefore at least one sheep will inevitably be administered a dose of thiacloprid falling within the claimed dosage range of present claim 1.
Conclusion on novelty for claim 1
163. It follows that claim 1 is anticipated by the disclosure of D1.
Conclusion on novelty for claims 2-11
164. Claim 2 is directed to topical administration methods. D1 is directed to plunge dipping. I have found that this is not a topical method. Therefore claim 2 is novel in view of D1.
165. The opponent accepts that claim 3 is not anticipated by D1. I find that claim 3 is novel in view of D1.
166. Claim 4 is appended to any of claims 1 to 3 and specifies diluting a composition containing from 30%-60% w/v of thiacloprid with water prior to administration. Professor Whittem accepts that these features are disclosed, since 30% w/v is equivalent to 300 g/L (30g/100mL), and therefore 480 g/L thiacloprid, as disclosed in the Introduction to D1, is within the claimed range.[117] Also, the dilution step is clearly disclosed under “Dose rate”. Claim 4 is not novel in view of D1.
[117] Whittem 1, Table at page 22.
167. Claim 5, appended to claim 4, specifies that the dilution provides a composition having 1 to 200 ppm of thiacloprid. This is disclosed in D1 which states that the dilution provides 48 mg thiacloprid/L, equivalent to 48 ppm. Claim 5 is not novel in view of D1.
168. Claim 6 requires that the method provides “persistent control” of lice on an animal. I have previously found that persistent control means prevention of re-infestation of lice for a period of at least two weeks. D1 does not specifically disclose persistent control. However, as I have previously discussed, when considering whether a feature is disclosed by inevitable result, it is not necessary that the person skilled in the art appreciates that the result is achieved. All that is required is that as a matter of fact, when the disclosure is practised, the result inevitably occurs. The present specification provides evidence in Trial Example 9 of persistent control of lice on sheep treated with a plunge dip of thiacloprid at 48 ppm (the same concentration as advised in D1); the introduction of lice to treated sheep up to four weeks after treatment did not result in establishment of new infestations. I therefore conclude that the use of such a treatment inevitably provides persistent control of lice as a result of the properties of the compound itself. Therefore, I find that claim 6 is not novel in view of D1. The same reasoning applies for claim 7; claim 7 is not novel in view of D1.
169. Dipping is specifically disclosed by D1, therefore claim 8 is not novel in view of D1.
170. I have previously found that the only difference between claim 9 and claims 1 and 6 is that claim 9 specifies the manufacture of a composition comprising thiacloprid. D1 discloses a product, Piranha® Dip for sheep, having thiacloprid as the active constituent. This therefore discloses the manufacture of a composition for the required use as specified by claim 9. Claim 9 is therefore not novel in view of D1. It follows also that claim 10, appended to claim 9, is not novel as D1 discloses dipping.
171. Claim 11 specifies that the method is applicable to a sheep or goat. D1 discloses the use on sheep, and therefore claim 11 is not novel in view of D1.
Conclusion on novelty in view of D1.
172. Claims 1, and 4-11 are not novel in view of D1.
Sirinyan 2003 (D2)
173. D2 relates to aqueous formulations for the dermal control of parasitic insects on animals. Examples of insects that may be controlled are fleas, lice or flies.[118] The active compounds that can be used in the formulation are identified by way of a broad “Markush” style formula which encompasses a very broad range of compounds.[119] More than forty specific compounds are listed that fall within the general formula. The second mentioned compound is imidacloprid. Thiacloprid is mentioned toward the end of the list, as a compound that may be “particularly emphasized”.[120] All the examples relate to the use of imidacloprid.
[118] D2 at [0003].
[119] D2 at [0012].
[120] D2 at [0064]-[0066].
174. The amount of the active is stated to be “about 0.5 to about 50 mg, preferably from 1 to 20 mg, of active compound per body weight per day”.[121] In this paragraph it is not stated whether the animal body weight is measured in kilograms or pounds.
[121] D2 at [0068].
175. The description lists a wide variety of animals that can be treated by the disclosed compounds. Sheep and goats are specified in the list.[122]
[122] D2 at [0096]-[0098].
176. I agree with the opponent that the test for novelty is the Meyers Taylor reverse infringement test quoted earlier. However, for the appropriate level of disclosure, I return to the well-known statement in the General Tire case previously quoted.
“To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented. A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”
177. Thiacloprid is disclosed as one of a large range of possible actives that could be used in the D2 method. A large variety of insects upon a wide range of animals are contemplated by D2, each of which potentially could be controlled by one or more of the many disclosed actives. One would have to select from each of these lists of possibilities to arrive at the method of present claim 1. Therefore, I consider that there is no specific disclosure that equates to “planting the flag” at the precise destination of the claim 1 method.
178. The opponent has not made out this ground.
Inventive step
179. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art (subsection 7(3)).
180. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd[123] (Wellcome) Aickin J stated:
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."
[123] [1981] HCA 12 at [45]; (1981) 1A IPR 268 at 281.
181. In Aktiebolaget Hassle v Alphapharm Pty Ltd (Alphapharm)[124] the High Court endorsed the use of the reformulated "Cripps question":
"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts … directly be led as a matter of course to try [the invention as claimed] in the expectation that it might well produce a useful alternative…”[125]
[124] [2002] HCA 59; (2002) 56 IPR 129.
[125] Ibid at [53].
182. Further elaboration is found in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft (Generic Health):
“We do not think that the plurality in Alphapharm were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited [1981] HCA 12; (1981) 148 CLR 262, at 280281, 286, per Aickin J). We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.”[126]
[126] [2014] FCAFC 73 at [71].
183. The Full Federal Court decision in AstraZeneca AB v Apotex Pty Ltd (AstraZeneca) [127] addresses the question of the level of expectation required by the skilled person, particularly in relation to determining dosage. (I note the High Court dismissed the appeal).
“In my view, in this state of the evidence, it was no error for the primary judge to have found that the s 7(2) skilled person would have been led directly, and as a matter of course, to try S‑4522 at a dosage of 5-10 mg daily in the expectation that it might well be an efficacious treatment for a patient suffering from hypercholesterolemia. It is not necessary that he or she would have known, before the event, that the compound or method notionally being further investigated would in fact satisfy that test: the requirement is that it “might well” do so.”[128]
[127] [2014] FCAFC 99; 107 IPR 177.
[128] Ibid at [542].
184. AstraZeneca also addresses the effort that may be expected on the part of the skilled person.
“For an invention to be obvious, it is not necessary that the single source of information admitted under s 7(3) disclose a completed invention to the extent that the notional skilled person would have little or nothing further to do. That he or she would need to work towards the invention is not inconsistent with the conclusion that the invention was obvious, in the sense of falling within the range of destinations that he or she would expect to reach after the investigations, tests, trials and the like that would be carried out as a matter of course.”[129]
[129] [2014] FCAFC 99; 107 IPR 177 at [547].
185. What is meant by common general knowledge was considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·standard texts and handbooks;
·standard English dictionaries;
·technical dictionaries relevant to the field;
·magazines and other publications specific to the field.”[130]
[130] [1999] FCA 345; 45 IPR 577 at [112].
186. The common general knowledge must be established by evidence as stated by Emmett J in Dynamite v Aruze:
“It is necessary to establish common general knowledge by appropriate evidence. Evidence that consists of generalised and sweeping statements of opinion or recollection, unsupported by secondary materials such as text books, trade journals and technical publications, should be treated with caution and given little weight.”[131]
[131] [2013] FCA 163 at [104].
187. I have already found that claim 1 is not novel in view of D1. However, as the opponent has also submitted[132] that claims 1, 3 and 6-7 lack an inventive step when the common general knowledge is combined with either of two section 7(3) documents, D1 or D2, I will consider the claims in view of this ground separately.
The Problem
[132] Opponent submission [112].
188. The problem addressed by the specification, as previously stated, is the need for alternative methods for controlling lice using actives of high potency and high persistency that allow for the use of relatively low quantities of actives for short and long wool treatments.
189. The opponent states more specifically that “the problem at which the Application is directed is the appropriate dose of thiacloprid to use to control lice”.[133] I understand the context of this submission is the opponent’s reliance on D1 (disclosing thiacloprid, but not the dose in mg/kg) plus common general knowledge as the basis of their inventive step argument.
[133] Opponent submissions [116].
190. The applicant does not specifically identify a problem for the inventive step consideration, but states “a person skilled in the art would not directly be led as a matter of course to try externally administering to an animal thiacloprid in an amount from 1 to 45 mg/kg by weight of the animal.”[134] Although I accept the applicant’s submission that the question is whether the invention as claimed, rather than a particular feature, is inventive, it is clear that both the applicant and opponent view the issue of the dose of thiacloprid as a key part of the inventive step analysis.
D1 plus common general knowledge
[134] Applicant submission [261].
191. I have previously discussed the disclosure of D1 and found that it is novelty destroying for claim 1 based on an inevitable result. However, for inventive step, the question changes from “what would have happened when D1 was put into practice?”, to “what would the person skilled in the art do as a matter of routine armed with the disclosure of D1 and faced with the same problem of finding alternative methods for controlling lice using actives that allow for the use of relatively low quantities of actives?”.
192. The disclosure of D1 provides the PSA with the knowledge that thiacloprid is useful for the control of lice on sheep. D1 also provides the PSA with the knowledge that thiacloprid can be provided in the form of a plunge dip formulation using the active at 48 mg/L. Using the words of the test in Wellcome, I need to determine whether the PSA, faced with the same problem, would have taken as a matter of routine whatever steps might have led from this prior art to the invention, whether they be the steps of the inventor or not.
193. This test for inventive step requires that the PSA has a reasonable expectation of success. According to the Generic Health decision, it is “implicit in the characterisation of steps as routine” that there is “an expectation that an experiment might well succeed”.
194. The applicant also referred me to the decision in Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2)[135](Bayer Pharma). In this decision (upheld on appeal) I note the comment of Jagot J that it is not enough to show that the skilled person would have an expectation of finding “some other useful result”; the expectation of the skilled person in the context of obviousness must be an expectation of producing the claimed invention.[136]
[135] [2013] FCA 279.
[136] Ibid at [68].
195. The decision in Nichia Corporation v Arrow Electronics Australia Pty Ltd further discusses the meaning of “useful alternative” in the context of the test for inventive step.
“It will be apparent from these decisions that the prior art and the claimed invention in the context of the specification as a whole are relevant to the appropriate formulation of the Cripps question in a given case. A “useful alternative” is one which is useful compared to the prior art in the field of the invention…”[137]
[137] [2019] FCAFC 2 at [80].
196. In the present case, the prior art includes methods of treating lice using externally administered actives at certain dosages. The invention claimed is a method of externally administering thiacloprid at a certain dosage. I understand, then, that the expectation of the skilled addressee must include the expectation of producing a useful dosage for the treatment of lice by external administration of thiacloprid.
What is the common general knowledge regarding determination of dosage for a known active?
197. Dr Playford states that “once an active compound is known to be efficacious in the treatment of a particular parasite, determining the appropriate dosage range at which treatment with the active compound will result in persistent control of a parasite is a matter of routine trial. By conducting such trials, I would expect to be able to determine an appropriate dosage range.”[138] He states that “in such trials, a sheep is treated with different dosages of the investigational product and then tested at 7 days, 14 days and 28 days…”[139].
[138] Playford 3 [11].
[139] Playford 3 [12].
198. He explains that he is familiar with such trials and conducted them during the time he worked for Intervet. I am inclined to give considerable weight to this statement; Dr Playford’s declaration states that during his time as Scientific Manager at Intervet Australia he was responsible for the development of sheep lousicide products[140], which I consider would entail determining the appropriate dosage.
[140] Playford 1 [8].
199. Professor Whittem states that those skilled in the field “would not rely upon dose extrapolations between different formulations of the same active compound, nor between different active compounds having different physicochemical properties, but would rely on experimentation to determine appropriate dose rates for a given active compound.”[141] Professor Sangster also refers to “experimental data” and “experimental studies” being required to determine the properties of active agents.[142] They do not specifically comment on whether or not these experiments are routine. However, these statements do appear to corroborate Dr Playford’s statement that conducting experimental trials is the way the skilled person would determine the dose.
[141] Whittem 1 [7.36.2].
[142] Sangster 1 [7.29]-[7.31].
200. Dr Playford provides a document in support of his contention that dosage trials are well known which outlines the types of testing that should be conducted, and in particular specifies testing of lice treatments for sheep by dose determination and dose confirmation studies, and field studies. This document is the “World Association for the Advancement of Veterinary Parasitology (W.A.A.V.P) guidelines for evaluating the efficacy of ectoparasiticides against biting lice, sucking lice and sheep keds on ruminants” (W.A.A.V.P article)[143], and is dated 2006.
[143] Veterinary Parasitology 136 (2006) 45-54, provided in Exhibit MCP-14.
201. This document appears to be particularly significant in the field of dose determination for ectoparasiticides. The abstract states that the document is specifically intended to “assist investigators on how to conduct specific experimentation” and to “facilitate the world-wide adoption of standard procedures”; further, its authors are associated with various veterinary bodies around the world. Given this stated aim, and the widespread locations of the authors, it would seem clearly to be material that the skilled worker “would refer as a matter of course”. Its date, some seven years before the present priority date, is ample time for the information to be circulated such that it becomes “technical background” to a skilled worker in the field.
202. The document states that for the dose determination studies the dosage rates should be selected based on an approximate effective dose (from a pilot study), and that four groups of adequately infested animals are used: negative control, 0.5, 1 and 2 times the anticipated effective dose.[144]
[144] W.A.A.V.P article at 3.4.1.
203. Professor Whittem does not question the relevance of this paper; rather, he appears to endorse its methods when he refers to the statements in the paper about field trials.[145]
[145] Whittem 3 [2.4].
204. I am therefore satisfied that this document is representative of common general knowledge in the field, and that the tests outlined in this document – dose determination studies, dose confirmation studies and field trials – can all be characterised as routine. This document, then, corroborates Dr Playford’s statement that dosage trials are well known and provides information about how standard trials are conducted.
205. I will briefly comment on the applicant’s submission that the opponent’s evidence is tainted by hindsight analysis[146] because Dr Playford was provided with the application and the prior art documents at the same time without any instruction as to the order in which they should be read. I do not find this submission relevant to the evidence I have mentioned above. The reason Dr Playford gives for saying he would conduct trials to determine dosage is his past experience in product development.[147] In other words, his evidence regarding conducting trials flows directly from his prior experience, rather than from any documents he has read.
[146] Applicant submission [254]
[147] Playford 3 [12].
206. To my mind it is clear, then, that the skilled person would undergo routine tests to determine an appropriate dosage of thiacloprid for controlling lice in sheep; I find Dr Playford’s evidence convincing on this point, and it is corroborated by the applicant’s experts at least to the extent they agree that experimental trials are necessary.
What is the expectation of the skilled person when conducting tests and trials?
207. Professor Whittem responds to Dr Playford’s comments on conducting trials by stating the following:
“It is essential to conduct experiments and trials to determine whether an active compound will be useful for, or result in, persistent control of a parasite…without conducting trials, I would have no certainty that the results of such experiments and trials will inevitably show that the active compound is useful for, or result in, persistent control of the parasite…whether a product containing an active compound will have persistent control of a parasite cannot be reliably predicted without conducting experiments.”[148]
[148] Whittem 3 [2.3].
208. I understand Professor Whittem to be saying here that prior to conducting trials, he would have “no certainty” that the active is useful and that a product will show persistent control cannot be “reliably predicted”. This is not to say, however, that there is no reasonable expectation of success.
209. As confirmed in the AstraZeneca decision, it is not necessary for the skilled person to be certain before the event that the use of a particular compound, or a particular dose of that compound, will produce an efficacious result. The expectation needs only to be that it “might well” do so. I further note from that decision that some degree of effort on the part of the PSA to determine an appropriate dose, such as by conducting dose studies and field trials, is not inconsistent with a finding of lack of inventive step.
210. Furthermore, I consider that because thiacloprid is identified in D1 as useful in the control of lice in sheep, there is clearly a reasonable expectation on the part of the PSA that conducting trials “might well succeed” in producing an external administration method of treating lice on sheep at an appropriate dosage to be determined by the routine trials.
What is the relevance of Dr Playford’s table of doses based on estimated take-off?
211. I do not accept the opponent’s submission that that the skilled person would try the dosages calculated in Dr Playford’s table of estimates that I have previously discussed[149]. The tests for novelty and inventive step are distinct. I have considered that these estimates are useful in determining what amounts would be administered to sheep when D1 is used as directed; I do not find this table directly relevant to the question of what the PSA would do armed with D1 and faced with the problem of finding alternative treatments for sheep lice using low quantities of active. It is important to note that the experts say they would conduct experimental trials to determine dose.
[149] Opponent submission [115].
212. However, D1 does indicate to the skilled person that a plunge dip concentration of 48 ppm of thiacloprid is effective in controlling lice. Further, the applicant has submitted that for a known concentration of thiacloprid “a person skilled in the art could calculate the dose of thiacloprid in mg/body weight of the animal from knowing the volume of formulation administered and the weight of the animal”[150]. It follows that the skilled person would be able to use the plunge dip concentration from D1 in this way to determine an approximate dose (akin to a dose from a “pilot study” mentioned in the W.A.A.V.P article) for an experimental trial.
Conclusion on claim 1
[150] Applicant submission [71].
213. Thus, the skilled person, armed with D1, has the knowledge that thiacloprid is useful in controlling lice on sheep. D1 also provides a general indication of a useful concentration of active from which to begin dosage studies – a starting point. The skilled person therefore has a reasonable expectation of generating a successful treatment regime for lice on sheep.
214. The common general knowledge teaches the skilled person to conduct routine testing and trials to determine effective dosages of the active. Furthermore, motivated by the problem of achieving the use of lower quantities of active, the skilled person would seek to optimise the dose of thiacloprid towards the lowest effective amount as a matter of routine. I am therefore satisfied that the skilled person would arrive at the claimed method of controlling lice on sheep using a dose within 1 to 45 mg/kg by routine steps. It follows that claim 1 lacks an inventive step in view of D1 and the common general knowledge in the art.
Consideration of dependent claims
215. Claim 3 further narrows the dosage range to 10 to 30 mg/kg. I have found that experimentation to determine dose is a matter of routine. To my mind, further refining of the dose amounts to no more than additional dose optimization. I have noted above that the skilled person would seek to optimise towards the lowest effective dose. However, 10 mg/kg is still towards the lower end of the dosage range. For comparison, I note that in trial example 10, dosages of 10 mg/kg and 15 mg/kg were part of that dosage trial.[151] I am therefore satisfied that the skilled person in the course of undertaking standard experimentation would arrive at the matter claimed in claim 3 by routine steps. It follows that claim 3 lacks an inventive step in view of D1.
[151] See opponent submission [27] for conversion to mg/kg.
216. Claims 6 and 7 further specify that the method is characterized by providing persistent control of lice. I have previously found that “persistent control” means prevention of re-infestation of lice for a period of at least two weeks.
217. I have quoted above Dr Playford’s evidence that “determining the appropriate dosage range at which treatment with the active compound will result in persistent control of a parasite is a matter of routine trial.”[152] The W.A.A.V.P article sets out the nature of studies required to demonstrate persistent efficacy, supporting Dr Playford’s statement that such studies would be a matter of routine.
[152] Playford 3 [11].
218. Professor Whittem, commenting on the W.A.A.V.P article, notes that several field trials are required in addition to initial dose determination and confirmation studies to establish a persistency claim.[153] However, according to the AstaZeneca decision quoted above, it is not necessary that “the notional skilled person would have little or nothing further to do” in order for lack of inventive step ground to be made out. “That he or she would need to work towards the invention is not inconsistent with the conclusion that the invention was obvious…”
[153] Whittem 3 [2.4].
219. I therefore conclude that the skilled person would arrive at the matter of claims 6 and 7 by routine steps. It follows that claims 6 and 7 lack an inventive step in view of D1.
220. The opponent has submitted that only claims 1, 3 and 6-7 need to be addressed in their arguments for lack of inventive step because “if claim 1 is invalid, claims 2, 4, 5 and 8-11 are also disclosed by the Trade Advice Notice”[154]. I understand this submission to mean that the opponent wishes to address any claims that are found to be novel under the lack of inventive step ground.
[154] Opponent submission [112].
221. I have found claim 2 to be novel in view of D1. I will therefore consider whether claim 2 lacks an inventive step in view of D1 and the common general knowledge.
222. Claim 2 is appended to the method of claim 1 and is characterised by the step of “topically administering” the composition of claim 1. The claim 2 method also specifies that the composition administered contains from 0.0001% to 3.5% w/v of thiacloprid.
223. I have previously found that topical administration is a subset of external administration methods in which the medicament is applied only to a part of the outside of an animal. Plunge dipping is not “topically administering” using this definition. The question for inventive step then becomes whether the skilled person, armed with D1 and in view of the problem, would formulate topical applications of thiacloprid as a matter of routine.
224. Dr Playford comments that “… it is a matter of taking routine steps to formulate the same active ingredient for topical application…Given that numerous ectoparasiticides are available in both pour on (ie a topical application) and dip formulations, it is well understood how to produce a product for topical administration without further inventive input. It is standard course to produce efficacious formulations of the same active for multiple administration methods.”[155]
[155] Playford 1 [83]-[84].
225. Although Professors’ Sangster and Whittem have a different view of the meaning of “topically administering”, their comments are still applicable. Professor Sangster states:
226. “In my opinion, it would not be "a matter of taking routine steps to formulate the same active ingredient" for any topical administration, at this time or before 12 June 2013. Topical administration includes localised application and general application, e.g. pour-on, spot-on, plunge dip, spray dip and jetting. In my opinion, preparing formulations of the same active compound which are suitable for a range of topical administration methods would not be trivial or be "a matter of taking routine steps". Various factors must be taken into account, such as formulating to ensure suitable dissolution and long shelf-life, and ensuring that the formulation is not light sensitive, as well as aspects such as the effective dosage range, potency, field utility and the potential for persistent control, which would not be routinely or readily ascertained. In my opinion, the steps required to formulate new compositions comprising the same active compound, which are suitable for a range of topical administration methods, are not trivial and would require considerable skill, experience, effort and time.”[156]
[156] Sangster [7.39]
227. Professor Whittem makes a similar comment.[157]
[157] Whittem 1 [7.39].
228. I am mindful of these comments, however I have noted previously from the decision in AstraZeneca that the “need to work towards the invention is not inconsistent with the conclusion that the invention was obvious”. A step that is routine may still require some degree of effort on the part of the PSA; routine is not synonymous with “trivial”. I agree that the skill and effort required to overcome difficulties in formulating thiacloprid referred to by the professors is not trivial, but nevertheless can be categorised as routine steps working “towards the invention”. The fact that all the experts agree that backlining (pour on) was common general knowledge at the priority date[158] supports the conclusion that making such a formulation would also be a matter of routine, well known steps.
[158] Sangster [3.2], [3.8]; Whittem 1 [3.14]; Playford [20].
229. I have already found above that determining a dosage is a matter of undergoing routine testing. A similar conclusion applies to the concentration of thiacloprid specified in claim 2. I consider that finding the appropriate concentration range specifically for a topical application method is likewise a matter of routine optimization.
230. Therefore, I consider that the skilled person, armed with the teaching of D1, and seeking alternative methods for controlling lice including using varied application methods would formulate thiacloprid for topical application using the common general knowledge in the art, thus arriving at the matter of claim 2 by routine steps. It follows that claim 2 lacks an inventive step.
Conclusion on inventive step for D1 plus common general knowledge.
231. Claims 1-3, 6 and 7 lack an inventive step.
D2 plus common general knowledge
232. I have already found that claims 1-11 are novel in view of D2. The opponent submits that dependent claims 4, 5, 8 and 10 are not inventive in view of D2[159]. However, in order to consider this, I need to determine whether the independent claims to which these claims are appended lack an inventive step.
[159] Opponent submission [136], [138].
233. As previously discussed, D2 discloses active compounds for the control of insects on animals, selected from a “Markush” style formula which encompasses a very broad range of compounds.[160] More than forty specific compounds are listed. Thiacloprid is mentioned toward the end of the list, as a compound that may be “particularly emphasized”.[161] All the examples relate to the use of imidacloprid, which is the second mentioned compound, even though this compound is not in the list that are said to be “particularly emphasized”, which leads me to the conclusion that little weight should be placed on the quoted phrase for the purposes of determining which of the listed compounds are most preferred. The only use examples in D2 are in relation to fleas on dogs. I therefore conclude that the skilled person seeking a solution to the problem of finding treatments for lice, and armed with D2, would as a matter of routine, select imidacloprid for testing on lice. However, I am not satisfied that the skilled person would continue down the list of possibilities and select thiacloprid for testing as a matter of routine. There is no evidence from the opponent that this would be the case. It follows that claims 1, 6 and 9 are inventive in view of D2.
[160] D2 at [0012].
[161] D2 at [0064]-[0066].
234. Since claims 4, 5, 8 and 10 are appended to either of claims 1, 6 or 9, claims 4, 5, 8 and 10 are inventive in view of D2 and the common general knowledge. The opponent has not made out this ground.
Conclusion
235. The opposition is successful.
236. Claims 1-10 are not supported according to subsection 40(3). Claims 1 and 4-11 are not novel in view of D1. Claims 1-3, 6 and 7 lack an inventive step in view of D1 and the common general knowledge in the art. I will allow the applicant an opportunity to file amendments to overcome the deficiencies.
Costs
237. It is usual in matters before the Commissioner that costs follow the event. I see no reason to depart from this approach and so I will accord costs according to Schedule 8 against the applicant.
Cathy Douglas
Delegate of the Commissioner of PatentsAnnex A
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