Merial New Zealand Limited v Jurox Pty Ltd
[2017] APO 5
•18 January 2017
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial New Zealand Limited v Jurox Pty Ltd [2017] APO 5
Patent Application: 2004210461, 2009201942 and 2012200544
Title:Anthelmintic composition
Patent Applicant: Jurox Pty Ltd
Opponent: Merial New Zealand Limited
Delegate: K. Wagg
Decision Date: 18 January 2017
Hearing Date: 17-18 October 2016, in Canberra
Catchwords: PATENTS – opposition under section 59 – opposition successful – all three applications do not contain the best method of performance known to the applicant at the filing date – priority date considered – claims are novel in view of the evidence – claims involve an inventive step in view of the evidence – the inventions are a manner of manufacture – on the face of the specifications the claims have utility – opportunity to amend – submissions on costs invited.
Representation: Counsel for the applicant: Julian Cooke (written submissions)
Patent attorneys for the applicant: FB
Rice
Counsel for the opponent: Christian Dimitriadis SC and Clare Cunliffe
Patent attorneys for the opponent: Denis Tuffery and Helen Bellchambers of AJ Park
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2004210461, 2009201942 and 2012200544
Title:Anthelmintic composition
Patent Applicant: Jurox Pty Ltd
Date of Decision: 18 January 2017
DECISION
Patent application numbers 2004210461, 2009201942 and 2012200544 do not contain the best method of performance known to the applicant at the filing date.
The applicant is given 60 days from the date of this decision to file suitable amendments.
The parties are given 2 weeks from the date of this decision to file submissions in relation to costs.
REASONS FOR DECISION
Patent application number 2004210461 (‘461) was filed on 4 February 2004. It claims the priority date of 5 February 2003. Patent application number 2009201942 (‘942) was filed on 15 May 2009 and claims divisional status from ‘461. Patent application number 2012200544 (‘544) was filed on 31 January 2012 and claims divisional status from ‘942. The applicant for all three applications is Jurox Pty Ltd (the Applicant).
The requests for examination for all three applications were filed prior to 15 April 2013. As a consequence, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent applications. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. I also note that any subsequent reference to the Patents Act relates to the Patents Act1990 (the Act), prior to amendment by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
The three applications were examined and accepted by the Commissioner. Acceptance of ‘461, ‘942 and ‘544 were advertised on 3 December 2009, 16 February 2012 and 20 November 2014, respectively. Merial New Zealand Limited (the Opponent) filed notices of opposition on all three applications on 1 March 2010, 15 May 2012 and 18 February 2015 for ‘461, ‘942 and ‘544, respectively.
A hearing was held on 17-18 October 2016 to decide all three oppositions. The Applicant appeared by written submissions prepared by Julian Cooke of Counsel. The Opponent was represented by Christian Dimitriadis SC, Clare Cunliffe of counsel and patent attorneys Denis Tuffery and Helen Bellchambers of AJ Park.
Standard of proof
The onus of proof in these opposition proceedings rests with the Opponent, who must demonstrate that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283; 50 IPR 305 at [67]; Commissioner of Patents v Sherman [2008] FCAFC 182; 79 IPR 426 at [18]).
The opposition ‘461
The Statements of Grounds and Particulars identified eight grounds of opposition:
(1) Lack of Manner of Manufacture
(2) Lack of Novelty
(3) Lack of Inventive Step
(4) Lack of Utility
(5) Secret Use
(6) Lack of Sufficiency
(7) Lack of clarity and that the claims do not define the invention
(8) Lack of Fair basis.At the hearing, the grounds of secret use, lack of clarity and fair basis were not pursued.
The parties relied upon evidence by several declarants.
Evidence in Support of the ‘461 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 8 February 2012 Paul John Martin Martin #1 23 13 February 2012 Gottfried Lichti Lichti #1 5 24 February 2012 Edwin Justin Hurst Hurst #1 4 3 February 2012 Ronald Peter Gogolewski Gogolewski #1 1 31 January 2012 Scott James Gardiner Gardiner #1 2
Evidence in Answer of the ‘461 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 12 December 2012 Kai Kin Lau Lau #1 5 25 November 2012 Edward Lionel Bruce Whittem Whittem #1 3 17 January 2013 Stanley Shepherd Shepherd #1 1
Evidence in Reply of the ‘461 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 17 May 2013 Gottfried Lichti Lichti #2 1 26 April 2013 Paul John Martin Martin #2 6 22 April 2013 Ronald Peter Gogolewski Gogolewski #2 3 22 May 2013 Denis Eng Tuffery Tuffery #1 1 22 May 2013 Marilyn Patricia Domney Domney #1 26 July 2013 Paul John Martin Martin #3
Further Evidence filed by the applicant on the ‘461 consisted of:
Date of Declaration Declarant Abbreviation 18 September 2013 Kai Kin Lau Lau #2
Opponent’s response to Further Evidence on the ‘461 consisted of:
Date of Declaration Declarant Abbreviation 18 October 2013 Paul John Martin Martin #4
Further Evidence filed by the opponent on the ‘461 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 12 August 2015 Gottfried Lichti Lichti #3 6 13 August 2015 Paul John Martin Martin #5 5 12 August 2015 Ray Simms Simms #1 4 12 August 2015 Helen Bellchambers Bellchambers #1 5
Applicant’s response to Further Evidence on the ‘461 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 19 December 2015 Stanley Shepherd Shepherd #2 4, includes Shepherd #5 as SS-A The opposition ‘942
The Statements of Grounds and Particulars identified eight grounds of opposition:
(1) Lack of Manner of Manufacture
(2) Lack of Novelty
(3) Lack of Inventive Step
(4) Lack of Utility
(5) Secret Use
(6) Lack of Sufficiency
(7) Lack of clarity and that the claims do not define the invention
(8) Lack of Fair basis.At the hearing, the grounds of secret use, lack of clarity and fair basis were not pursued.
Much of the evidence relied on in the submissions refers to the evidence on the ‘461 opposition. I have used those references in this decision. That evidence was filed as evidence on the ‘942 opposition as exhibits. I have provided the exhibit numbers where applicable.
Evidence in Support of the ‘942 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 13 September 2013 Paul John Martin Martin #6 8, includes Martin #1 as PJM-B 12 September 2013 Gottfried Lichti Lichti #4 3, includes Lichti #1 as GL-B 13 September 2013 Edwin Justin Hurst Hurst #2 4 16 September 2013 Ronald Peter Gogolewski Gogolewski #3 5, includes Gogolewshi #1 as RPG-A 12 September 2013 Scott James Gardiner Gardiner #2 1 16 September 2013 Denis Eng Tuffery Tuffery #2 2
Evidence in Answer of the ‘942 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 16 December 2013 Kai Kin Lau Lau #3 3 10 December 2013 Edward Lionel Bruce Whittem Whittem #2 3, includes Whittem #1 as TW-B 10 December 2013 Stanley Shepherd Shepherd #3 3, includes Shepherd #1 as SS-B
Evidence in Reply of the ‘942 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 17 March 2014 Gottfried Lichti Lichti #5 17 March 2014 Paul John Martin Martin #7 4 17 March 2014 Ronald Peter Gogolewski Gogolewski #4
Further Evidence filed by the opponent on the ‘942 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 12 August 2015 Gottfried Lichti Lichti #3 6 (identical to that filed on ‘461) 13 August 2015 Paul John Martin Martin #5 5 (identical to that filed on ‘461) 12 August 2015 Ray Simms Simms #2 4 18 August 2015 Helen Bellchambers Bellchambers #2 5
Applicant’s response to Further Evidence on the ‘942 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 23 December 2015 Stanley Shepherd Shepherd #4 4, includes Shepherd #5 as SS-A The opposition ‘544
The Statements of Grounds and Particulars identified eight grounds of opposition:
(1) Lack of Manner of Manufacture
(2) Lack of Novelty
(3) Lack of Inventive Step
(4) Lack of Utility
(5) Secret Use
(6) Lack of Sufficiency
(7) Lack of clarity and that the claims do not define the invention
(8) Lack of Fair basis.At the hearing, the grounds of secret use, lack of clarity and fair basis were not pursued.
Again, much of the evidence relied on in the submissions refers to the evidence on the ‘461 opposition. I have used those references in this decision. That evidence was filed as evidence on the ‘544 opposition as exhibits. I have provided the exhibit numbers where applicable.
Evidence in Support of the ‘544 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 24 July 2015 Paul John Martin Martin #9 2, includes Martin #1 as PJM-B 7 August 2015 Paul John Martin Martin #10 2, includes Martin #6 as exhibit PJM-2B 11 August 2015 Paul John Martin Martin #11 10, includes Martin #5 as PJM-3D and Martin #4 as PJM-3H. Lau #2 is also included as PJM-3F 13 August 2015 Paul John Martin Martin #5 5 (identical to that filed on ‘461) 12 August 2015 Gottfried Lichti Lichti #3 3 (identical to that filed on ‘461) 10 August 2015 Gottfried Lichti Lichti #6 3, includes Lichti #5 as GL-2A 23 July 2015 Gottfried Lichti Lichti #7 3, includes Lichti #1 as GL-C 18 August 2015 Gottfried Lichti Lichti #8 1, includes Lichti #2 as GL-4A 13 August 2015 Edwin Justin Hurst Hurst #3 1 13 August 2015 Ronald Peter Gogolewski Gogolewski #5 2, includes Gogolewshi #1 in RPG-2 12 August 2015 Ray Simms Simms #3 4 18 August 2015 Denis Eng Tuffery Tuffery #3 3 18 August 2015 Helen Bellchambers Bellchambers #3 5
Evidence in Answer of the ‘544 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 17 November 2015 Kai Kin Lau Lau #4 5 13 November 2015 Edward Lionel Bruce Whittem Whittem #3 18 includes Whittem #1 as TW-B 15 November 2015 Stanley Shepherd Shepherd #5 7 includes Shepherd #1 as SS-B
Evidence in Reply of the ‘544 consisted of:
Date of Declaration Declarant Abbreviation Exhibits 12 January 2016 Gottfried Lichti Lichti #9 10 January 2016 Paul John Martin Martin #12 1 13 January 2016 Ray Simms Simms #4 The ‘461 specification
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [139]:
"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."
The background to the invention
The ‘461 specification relates to a method of treating parasites, specifically helminths - small, often microscopic worms, in animals.
The specification outlines that such parasites have developed resistance to available drug treatments (page 1 lines 18-19, and page 1 lines 26-29).
It is then stated that the time it takes to develop new substances for use as anthelminths is substantial and expensive (page 1 lines 31-33).
Because of this reason, lines 4-7 of page 2 state:
“Rather than tackling the problem of resistance through the development of new substances, the present inventors have found that it is possible to circumvent resistance by combining specific classes of anthelmintics. The efficacy of this combination arises out of the finding that the combination is synergistic.”
The nature of the invention
The invention relates to a method directed to the use of a synergistic combination. This combination is a composition of at least 4 anthelmintic compounds and a therapeutic carrier (page 2, line 10).
The four compounds are selected from 4 different groups of anthelmintics. These are macrocyclic lactones, benzimidazoles, salicylanilides, and imidazothiazoles (page 2 lines 20-23).
The specification also states that the dosage form for the composition is preferably a drench (page 6 lines 18-20). It is stated on page 6a that a drench formulation will include a solvent system for the macrocyclic lactone, one or more dispersing and suspending agents for the benzimidazoles and salicylanilides, one or more surfactants, one or more preservatives, a buffering system and water as a carrier.
The composition is in the form of a micellar solution (page 4 line 24).
The method then involves administration of the composition to an animal prior to introduction to a land area. This prevents the land area from becoming infested with parasites (page 4 line 15).
The specification then states that (page 4 lines 19-20):
“Typically, animals such as sheep, will be isolated for at least 2 days after treatment before being placed on pasture.”
In more general terms the specification also states on page 5 lines 1-2 that the period of isolation is at least 24 hours for an animal prior to introduction into the land area.
The method is said to provide a 90 % reduction in macrocyclic lactone and closantel resistant strains of Haemonchus spp. when these resistant strains are known to be present (page 5 lines 3-5).
The aim of the invention
There is no specific aim mentioned in the specification but it can be gleaned from the background and the disclosure of the method itself.
I consider that the use of the anthelmintic composition with at least 4 anthelmintics present working synergistically and applied to an animal at least 24 hours before being introduced into a land area to be part of the aim.
The outcome of the treatment is 90% reduction of macrocyclic lactone and closantel resistant strains of Haemonchus spp, but only when resistance in known to be present.
The claims
The specification ends in 23 claims with claim 1 being the only independent claim. All of the claims relate to a method of treating parasite infections.
The ‘942 specification
The description of the ‘942 application is almost identical to that of the ‘461 application. However, rather than being directed to the method of treatment, the ‘942 application is directed at providing a synergistically effective drench composition per se (page 2 lines 5-9).
The composition of the ‘942 application also has four anthelmintics and is a micellar solution (page 2 line 9). The four anthelmintics include a macrocyclic lactone, a benzimidazole, an imidazolthiazole and closantel.
The composition is defined further in the ‘942 application compared with the ‘461 application and includes further features of water, polysorbate 80, colloidal silicon dioxide a phosphate buffer and one or more water miscible solvents (benzyl alcohol and propylene glycol). The ratio of the water miscible solvent to water is said to be from about 1:0.75 to about 1:2.5 (page 2 lines 11-16).
The ‘942 application also has the feature of providing 90% reduction in macrocyclic lactone and closantel resistant strains of Haemonchus spp, but only when resistance in known to be present (page 2 lines 19-21).
The ‘942 application ends in 28 claims with claim 1 being the only independent claim.
The ‘544 specification
The description of the ‘544 application is almost identical to that of the ‘461 and ‘942 applications. However, like the ‘942 application, the ‘544 application is directed at providing an effective drench composition per se (page 2 lines 5-9).
The major difference between them is that the ‘544 specification is silent on there being synergy.
The composition of the ‘544 application also has four anthelmintics and is a micellar solution (page 2 line 9).
The four anthelmintics include a macrocyclic lactone selected from abamectin, ivermectin, doramectin, moxidectin and milbemycin. The remaining three anthelmintics include a benzimidazole, an imidazothiazole and closantel. The composition has further features of water, polysorbate 80, colloidal silicon dioxide, a phosphate buffer and one or more water miscible solvents (benzyl alcohol and propylene glycol). The ratio of the water miscible solvent to water is said to be from about 1:0.75 to about 1:2.5 (page 2 lines 11-16).
The ‘544 application also does not include the feature of providing 90% reduction in macrocyclic lactone and closantel resistant strains of Haemonchus spp.
The ‘544 application ends in 28 claims with claim 1 being the only independent claim.
The person skilled in the art
The person skilled in the art (PSA) was considered in Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70]:
“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.”
However, the person is not a real person, but an artificial construct that is used as a tool of analysis with which the court uses to make the determination. This concept was established in AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”
The applicant submitted that the PSA in this case would be a formulation chemist with experience in formulating anthelmintic compositions for the treatment and/or prevention of parasitic infection in animals at the priority date.
Given the nature of the inventions relates to an anthelmintic composition and a method of treating helminths using the composition, the hypothetical PSA would certainly include a formulation chemist. However, I think the hypothetical PSA would also need knowledge of current products on the market as well as knowledge of resistance. To accommodate the full nature of the inventions, the hypothetical PSA would be a team of people who consult with each other; they would include a formulation chemist, and a parasitologist.
All the declarants, who provided expert evidence, would have an interest or working knowledge of this hypothetical team.
I will have regard to all the evidence provided by the declarants in these proceedings. Where there is conflicting evidence, I will use the normal practice of evaluating and weighing the evidence in order to resolve any conflict.
Construction
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [118] – [120]:
"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification".
Claim 1 of the ‘461 application
Claim 1 of the ‘461 application reads:
“A method of treating parasitic infections in an animal comprising administering to the animal a synergistic anthelmintically effective amount of a drench composition in the form of a swollen micellar solution comprising only four anthelmintic compounds and a therapeutically active carrier, wherein one anthelmintic compound is a macrocyclic lactone selected from the group consisting of abamectin, ivermectin, doramectin and milbemycin, one anthelmintic compound is selected from the group of benzimidazoles, one anthelmintic compound is closantel, and one anthelmintic compound is selected from the group of imidazothiazoles, wherein the benzimidazole and closantel are suspended in the composition, and
wherein the drench composition is administered to the animal prior to introduction to a land area so as to prevent the land area from becoming infested with parasites which may or may not be resistant to one or more compounds selected from the groups consisting of macrocyclic lactones, benzimidazoles, salicylanilides and imidazothiazoles,
wherein the animal is isolated for a period of at least 24 hours after treatment prior to introduction to the land area and,
wherein the method provides a greater than 90 % reduction of macrocyclic lactone and closantel resistant strains of Haemonchus spp. when the macrocyclic lactone and closantel resistant strains of Haemonchus spp. are present in the animal,
with the proviso that the animal has not previously been treated with naphthalophos.”This claim is clearly to a method involving a combination of features. Each feature is linked by the term “and” which means that the method has to involve every step.
Synergistic anthelmintically effective amount
The method is clearly to treating parasitic infections. It is carried out by using a “synergistic anthelmintically effective amount of a drench composition”.
Synergistic is not defined in the specification and it is followed by the words “anthelmintically effective amount of a drench composition”. This puts a limitation on the composition. The composition must be used in an amount that is anthelmintically effective and the composition must be synergistic.
Synergistic is a term known to the PSA to be the action of a combination of drugs being greater than the sum of their independent action (Martin #1 at [85]).
Swollen micellar solution
A swollen micellar solution is not defined in the specification. But this term is known to the PSA and according to exhibit GL-2 to Lichti #3, a swollen micellar solution is made with a surfactant wherein the size of the micelle is measured to be greater than the micelle formed where only the surfactant is added to water, and occurs when a non-aqueous material is added to the solution and this goes into the centre of the micelle and it swells.
Only four anthelmintic compounds
There are only four anthelmintics present. The term “only” means “exclusively” (Macquarie Dictionary), so there are no further anthelmintics present.
The macrocyclic lactone can only be selected from abamectin, ivermectin, doramectin and milbemycin. Because they are “selected from”, other macrocyclic lactones are not within the scope of this claim.
The clonsantel is a salicylanilide and is a specific compound. There are no other salicylanilides within the scope of the claim.
The benzimidazole and imidazothiazole are classes of anthelmintics. The specification does provide examples within these classes in table 2 on page 6.
Animal is isolated
The step of treating the animal is done “at least” 24 hours before introducing the animal into the land area. This means that time periods of greater than 24 hours are included.
Resistance strains
The reduction of greater than 90% of the macrocyclic lactone and closantel strains of Haemonchus spp. when that species is present could be due to the action of the two other anthelmintics, i.e. the benzimidazole and imidazothiazole. It is also limited to when a resistant strain of Haemonchus spp. is present. The claim also covers methods where no Haemonchus spp. is present or when non-resistant strains are present with no limitation on the percentage reduction.
Proviso
The claim also adds a proviso at the end that limits the animal to not being previously treated with naphthalophos.
Claim 1 of the ‘942 application
Claim 1 of the ‘942 application reads:
“A synergistic anthelmintically effective drench composition in the form of a micellar solution consisting of at least one compound selected from each of the following groups:
Macrocyclic lactones; benzimidazoles; imidazothiazole; and closantel; a therapeutically acceptable carrier comprising water; at least one surfactant comprising polysorbate 80; at least one dispersing agent comprising colloidal silicon dioxide; at least one phosphate buffer; and one or more water miscible solvent(s) selected from the group consisting of benzyl alcohol and propylene glycol, wherein the ratio of water miscible solvents to water is from about 1:0.75 to about 1:2.5 wherein the closantel and benzimidazole are suspended in the composition and wherein the synergistic anthelmintically effective drench composition provides a greater than 90% reduction of macrocyclic lactone and closantel resistant strains of Haemonchus spp. when introduced into an animal infected by the macrocyclic lactone and closantel resistant strains of Haemonchus spp.”
This claim is to a synergistic anthelmintically effective drench composition per se.
The term “synergistic anthelmintically effective drench composition” is similar to that in the ‘461 application and so it follows that it has the same meaning here.
The micellar solution, is not said to be swollen in this claim, but is broader and would include all micellar solutions including swollen ones.
The specification does not define “consisting of” to be exhaustive, however, it does define comprising to be non-exhaustive. If the drafter had wanted to choose a non-exhaustive word they would have used comprising. Therefore, the ingredients in the micellar solution are limited to those listed in the claim by use of the term “consisting of”.
The additives in the composition are specified, with the ratio of water to water miscible solvent also specified.
Claim 1 of the ‘544 application
Claim 1 of the ‘544 application reads:
“An anthelmintically effective drench composition in the form of a micellar solution comprising
only four anthelmintic compounds wherein one anthelmintic compound is a macrocyclic lactone selected from the group consisting of abamectin, ivermectin, doramectin, moxidectin and milbemycin; one anthelmintic compound is a benzimidazole; one anthelmintic is closantel; and one anthelmintic compound is an imidazothiazole;
a therapeutically acceptable carrier comprising water;
at least one surfactant comprising polysorbate 80;
at least one dispersing agent comprising colloidal silicon dioxide;
at least one phosphate buffer; and
one or more water miscible solvent(s) selected from the group consisting of benzyl alcohol and propylene glycol
wherein the ratio of water miscible solvent(s) to water is from about 1:0.75 to about 1:2.5 and
wherein the closantel and benzimidazole are suspended in the composition.”This claim is very similar to the ‘942 application, however, it does not require the composition to be synergistic and the macrocyclic lactones are defined. Furthermore, the composition of this claim has no requirement to be effective against resistant strains.
Novelty
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235:
"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".
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited (General Tire) [1972] RPC 457 at 486).
Firstly, I will decide the novelty case for the document published before the claimed priority date.
WO 2000/074489 A1 (NUFARM LTD) 14 December 2000 (The Nufarm Patent)
The Nufarm patent was the subject of litigation itself. Nufarm alleged that the product being sold by Jurox, Q-Drench, infringed the Nufarm patent. The opponent submitted that the Q-Drench product is the commercial embodiment of the patents in suit.
The opponent submitted that examples 1 to 4 of the Nufarm patent disclose micellar compositions of both abamectin and levamisole. I note that Middleton J noted the similarities in the formulations between examples 1 to 4 and Q-Drench (the commercial embodiment of the current claims) Nufarm Ltd v Jurox Pty Ltd [2008] FCA 178 at [84]. I accept that the similarities would provide for micellar solutions, Nufarm Ltd v Jurox Pty Ltd [2008] FCA 178 at [87].
Examples 1 to 4 of the Nufarm patent do not include a benzimidazole or salicylanilide (closantel) as required by the current claims. Instead the opponent has relied on the following disclosure of the Nufarm patent (page 9 line 4):
“Preferably a third active ingredient is included in the composition”.
This is then followed by:
“Preferably said third anthelmintic agent is selected from the group including benzimidazoles”… “salicylamides (eg; closantel)”.
I accept that there is a teaching of a third anthelmintic.
The opponent then relied on evidence by both Dr Martin (Martin #1 at [36] to [38] and Dr Lichti #1 [100], [101]. The two experts construed the Nufarm patent to be a disclosure of multiple anthelmintics and the use of up to four anthelmintics. I note that there are further examples in the Nufarm patent that use a different combination of four anthelmintics but these are not in a micellar solution.
I accept that the Nufarm patent discloses the use of multiple anthelmintics. I note, however, that the Nufarm patent itself only mentions a third and not a fourth anthelmintic in a micellar solution. The question then is: are there clear and unmistakable directions to the use of all four as claimed?
In response, the applicant cited Dr Whittem’s evidence where he discusses the disclosure of the third anthelmintic and the options for it given in table 2 of the Nufarm patent (Whittem #1 at [57]):
“When I look at table 2 I merely see a large array of anthelmintic agents. There is nothing to suggest that any one group might be preferred”.
In my view the disclosure of the Nufarm patent includes compositions, including micellar compositions, with multiple anthelmintics. I do not however see clear and unmistakable directions to the four particular anthelmintics in the current claims of all three applications in a micellar composition.
The current claims of all three applications are novel over the Nufarm patent.
The Q-Drench Label and sale of Q-Drench
The opponent submitted that the Q-Drench Label, which is an approved label for a multi-combination drench for sheep containing the four anthelmintics claimed, is the commercial embodiment of the patents in suit (including the ‘942 and ‘544 applications). This label was approved on 11 November 2003.
100. Further to this, the opponent alleged that the sale of the Q-Drench product itself amounted to prior use.
101. In order for both the Q-Drench label and sale to be part of the prior art base the priority date of 5 February 2003 must be invalid. The opponent made submissions on this issue. Therefore in order to decide these matters I will make a decision on the priority date.
Priority
102. Jagot J provided a good summary of the law on priority in Gilead Sciences Pty Ltd v Indenis Pharmaceuticals LLC (2016) 117 IPR 252 at 256 et seq. The test for priority is the same test as fair basis, that is, there must be a real and reasonably clear disclosure of the invention claimed. There are some subtle differences and because of this, priority is often referred to as external fair basis.
103. In F. Hoffman-La Roche & Co. Aktiengesellschaft v Commissioner of Patents 123 CLR 529 at 542, Gibbs J noted that compounds selected from a general disclosure in the priority document which have a special utility in the complete specification would not be fairly based.
104. The Full Federal Court also dealt with this issue in Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd and Others (Coopers) 11 IPR 20. In the Coopers case the patent in suit was a petty patent which claimed a pour-on formulation for sheep. The specification stated that the solvent DGBE “has been found to be particularly useful. It has minimal adverse effect on the skin in terms of mild epidermal shedding seen with other solvents in some sheep. It also exhibits good spreading over the skin and fleece of the sheep.” This advantage of DGBE was not stated in the provisional specification and Fox J notes at 29:
“The patent claim concerning DGBE is not simply a more specific application of what is claimed in the provisional specification. It is the result of further experimentation, and can properly be regarded as involving an inventive step. Indeed, the whole product is different from any which could be regarded as part of an invention disclosed in the provisional specification, but what has since been arrived at, although in a sense derived from various ingredients mentioned in the provisional specification, is itself a special product. A reading, or study, of the provisional specification would not lead readily, or by a process of selection, to what is set forth in the patent claim.”
105. The Full Court noted in Multigate Medical Devices Pty Ltd v B Braun Melsungen AG (Multigate) [2016] FCAFC 21 at 189 that the use of “disclosed” rather than “described” connotes greater flexibility in the test for external fair basis. They continued with the following at 190:
“In the context of external fair basis, the test of real and reasonably clear disclosure requires attention not on whether a subsequent claim had previously been made, but whether in the earlier specification there had been a real and reasonably clear disclosure of the invention that is claimed. Further, a real and reasonably clear disclosure in the prior specification need not be made only in the verbal description, but can appear from the accompanying drawings (CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 (CCOM) at 280 per Spender, Gummow and Heerey JJ; Leonardis at 137 per Burchett, Hill and Tamberlin JJ referring also to the fact that expert assistance may be necessary to interpret the drawings). Further, the relevant passage(s) from the prior specification need not be disclosed as part of the invention claimed therein. Further, the task of determining whether there has been a real and reasonably clear disclosure is not to be undertaken with an over-meticulous verbal analysis: Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 240 per Barwick CJ; approved in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 at [15] per Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ and in Lockwood No 1 at [57], [68] and [69]. Further, the relevant disclosure is not limited to the description of preferred embodiments.”
106. In Multigate at 229-330 the Full Court found that the aid of experts may be an aid in construction but the incorporation of externally made statements into a patent specification was not of assistance in that case and the consideration is to be made by the text alone of each specification.
107. The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58; 217 CLR 274 at 300 approved the words of Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95:
"the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification".
108. The micellar solution is a feature of the claims in all three applications. The opponent has argued that the specifications were all silent on micellar solutions until amendments. Furthermore the divisional applications were also not entitled to divisional status because of this.
109. The opponent argued that the amendment which added the micellar solution to the ‘461 application occurred on 21 October 2014 and amounted to a change in the nature of the invention. I note that examples 1-3 were deleted and examples 5-6 were added, however, example 4 was in the priority document and the specification as filed.
110. In my view, example 4 was one of a few worked examples in the priority document and there has not been a selection as a result of the amendments. It was one of a few exemplified examples.
111. The next question is whether or not there is a real and reasonably clear disclosure of a “micellar solution” or a “swollen micellar solution”?
112. The applicant’s response to this is that the original example 4 in the priority document was indeed a micellar solution and that this was impliedly disclosed and an inevitable consequence of carrying out the teaching in the priority document.
113. The question for me then becomes is example 4 a micellar solution?
114. The opponent argued that the application did not make mention of the micellar solution system and cited Dr Lichti in Lichti #2 at [48] where he stated:
“Even if the formulation of a micellar solution system with two suspended active agents is an essential part of the invention, there is nothing in the Jurox specification which identifies that the micellar solution system is a key to the formulation.”
115. He then goes on at [49]:
“If such a micellar solution could be considered as an essential feature of the invention, I would have thought that this would have been stated explicitly in the patent specification.”
116. He states at [51]:
“From my experience as a formulator, example 4 of the Jurox patent may well produce a micellar solution in which the closantel and albendazole are suspended.”
117. I note that Dr Lichti does not say that example 4 is not a micellar solution. He is more concerned that the PSA is not specifically told that it is a micellar solution.
118. The opponent also submitted that the named inventor, Dr Whittem, stated in his declaration that the formulation could be micellar. But this is a more general statement and he does not specifically discuss example 4.
119. In discussing the Q-drench formulation and example 4 in the Jurox patent Shepherd #1 at [28] noted that Q-drench (a micellar solution) had more abamectin than example 4 and noted:
“I note some variation in the quantity of propylene glycol, benzyl alcohol, polysorbate 80, colloidal silica and water. These variations would not result in one formulation exhibiting major different physical or chemical properties to the other. In my view, the formulations are both micellar solutions of abamectin with the levamisole hydrochloride dissolved in the aqueous micellar phase and hence should have similar pharmacokinetic profiles. Because the buffer salt concentrations are the same, both formulations should have the same pH and hence the same chemical stability. Likewise, the albendazole and closantel actives are actives suspended in the aqueous phase of both formulations at the same concentration. The antifoam A present in the Q-Drench is a manufacturing aid used to prevent foaming during manufacture as this formulation contains approximately 20% more water than Jurox (Example 4). In my opinion, from a formulation point of view, the formulations are essentially the same and I would expect them to exhibit similar physical and chemical stability profiles.”
120. To me this provides good reasoning as to why example 4 would be a micellar solution. Mr Shepherd discusses the concentrations of additives and pH and gives technical reasons why he thinks example 4 is a micellar solution. I also note that Mr Shepherd has worked as a professional product formulator in the field of veterinary products (Shepherd #1 at [8]) and so his evidence has weight.
121. There does not appear to be any evidence that clearly shows that example 4 is not a micellar solution, and instead I am compelled to accept Mr Shepherd’s view that it is.
122. The opponent further argues that the parasite resistance feature is not fairly based on the specification because the promise of the invention is 99 % reduction of certain resistant parasites and the claims allow for greater than 90 % reduction. However, the various examples range from 86 % to 99 % and the specification is not required to describe the exact limits of a range, rather disclose instances within that range (Ethyl Corporation’s Patent [1972] RPC 169). It is my view that this has been done and this feature is fairly based on the priority document through the examples.
123. The test for fair basis is that there is a real and reasonably clear disclosure of the invention. This can include the examples and figures. The priority document does not explicitly tell the reader that a micellar solution is part of the invention but it is impliedly disclosed in example 4 (Ethyl Corporation’s Patent [1972] RPC 169).
Conclusion on Priority
124. I am therefore satisfied, on the basis of the evidence, that all three applications are fairly based on the provisional specification and without any further evidence I conclude that the priority date claimed (5 February 2003) is validly claimed for all three applications.
Conclusion on Novelty
125. Given my conclusion on the priority date, the Q-Drench label and the sale of Q-Drench do not form part of the prior art base relevant to novelty.
126. This ground of opposition fails.
Inventive step
127. 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. A document is prior art for this purpose if "a skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded [the document] as relevant" (subsection 7(3)).
128. The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12; 148 CLR 262 at 286 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."
129. The High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 approved this approach.
130. The opponent made the following submissions on inventive step:
a)That the claims lack an inventive step when compared to the common general knowledge
b)That the claims lack an inventive step when compared to the Nufarm patent
c)That the claims lack an inventive step when compared to EP 0,045,655 (the Merck Patent)
d)That the claims lack an inventive step when compared to WO 1998/018463 (the Chemvet Patent)e)That the claims lack an inventive step when compared to the Q-Drench Label and
d)That the claims lack an inventive step when compared to the Q-Drench sale.
131. The Q-Drench label and sale occurred after the priority date of 5 February 2003 and it follows from my conclusion on the priority date above that these are not part of the prior art base and are not relevant to inventive step.
132. In order for a document to be relevant to the assessment of inventive step, it is a requirement of the Act that it be ascertained understood and regarded as relevant.
133. Both Dr Martin and Dr Lichti explain that searching patent literature is conducted by the PSA (Lichti #1 at [28] and Martin #1 at [20]). I accept that the patents b)-d) would be ascertained. Furthermore, they are directed towards similar subject matter and would be understood and regarded as relevant by the PSA.
134. The opponent did not rely on a starting point approach in their submissions as per AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 at [202] and [203].
a) The Common General Knowledge (CGK)
135. The common general knowledge was defined by Aickin J in Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 292 as:
"The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge."
136. The opponent has relied on two things being part of the CGK in their submissions. These are the product called Triton which was registered in New Zealand in November 2001 and the Triton tape which was registered on 12 December 2001 and then launched in Australia and New Zealand in February 2002 (Gogolewski #1 at [7], [9] and [13]).
137. Dr Martin gave evidence that the regulatory and technical people working in this field would monitor public data bases such as regulatory websites (Martin #1 at [23]). These would have included the approval of Triton (Martin #1 at [61]) including its launch in New Zealand. The registration date in Australia for Triton was 19 February 2003. So the opponent is therefore relying on the PSA checking the New Zealand approval (9 January 2002, Gogolewski #2 at [8]) before the priority date.
138. Dr Martin further declared that (Martin #1 at [103]):
“I believe that any company in Australia that was involved with manufacture and/or supply of anthelmintics to the Australian market would have been aware of that launch of the two products shortly thereafter.”
139. I accept what Dr Martin says that some people in the field would monitor databases and been aware of new product launches. I therefore accept that the PSA would be aware of Triton and Triton tape, but I am not convinced that the evidence shows that something so recently launched and registered had become part of the background knowledge and experience. I do not accept that these two products were part of the common general knowledge of the PSA at the priority date of the specifications in suit.
140. The opponent also submitted that combining anthelmintics was known and micellar solutions were also known. They note that this was the approach taken by the group working on the Nufarm patent. I will deal the Nufarm patent as a subsection 7(3) document.
141. I therefore conclude that the claims have an inventive step over the CGK provided.
b) Inventive step over the Nufarm Patent
142. The difference between the Nufarm patent and the current claims is outlined above for novelty. In summary it discloses very similar examples, which are micellar solutions, but teaches a composition with only 3 active compounds and not 4 compounds in a micellar solution.
143. In their submissions, the opponent combined the Triton CGK with the Nufarm patent in order to say that the person skilled in the art would be directly led as a matter of course to the micellar formulations of the current claims. This does not address the fact that neither Triton nor the Nufarm patent disclose all four anthelmintics claimed in micellar solutions.
144. In discussing the micellar solution in example 1 of the Nufarm patent the document states on page 20 line 27:
“This resultant formulation was physically stable but considered too thin”.
145. The authors tried to correct this deficiency by adding thickeners (in examples 2-4) however they then moved towards macro-emulsions (the further examples).
146. Dr Martin’s evidence states that he would try and create a work around to Nufarm, in Martin #1 at [53]:
“In the case of the Nufarm patent, the demonstration of multi anthelmintics formulations that were effective and stable, raises the question, can the same end be achieved by means not covered by the patent.”
147. However, this evidence does not deal with the teaching that the micellar formulations were too thin.
148. From the disclosure of the Nufarm patent, I cannot see why it would be routine to continue with micellar solutions based on the teachings of Nufarm. To go into further experiments to solve the problems in Nufarm appears to be going beyond what would be routine, i.e. finding a work around, and would be undertaking inventive endeavour.
149. Furthermore, as outlined above for novelty, the Nufarm patent does not suggest a fourth anthelmintic in a micellar solution.
150. I accept that multiple anthelmintics are taught in the Nufarm patent, but I do not see that the combination of four in a micellar solution would be routine when a formulation of 2 anthelmintics (example 1 of Nufarm) was too thin.
151. On the basis of the evidence, I therefore find that the claims of all three specifications involve an inventive step in the light of the Nufarm patent.
c) Inventive step over the Merck Patent
152. The Merck patent was said to be the first patent with a solution of ivermectin in a micellar solution (Lau #2 at [4]). It describes how this type of formulation is stable (Lau #2 at [5]).
153. The Merck patent does not provide any insight into the problem of resistance and the use of multiple anthelmintics (Lau #2 at [10]).
154. The opponent responded to this by agreeing that at the time of the Merck patent, resistance was not an issue, and that the use of multiple anthelmintics became known in the CGK later (Martin #4 at [7]).
155. Mr Lau then states that it was challenging to prepare formulations with multiple anthelmintics and that the Merck patent does not provide the guidance necessary to do it (Lau #2 at [17]).
156. Dr Martin responds that at the time of the Merck patent the cost of additional additives was a factor and it was only closer to the priority date that multiple anthelmintic formulations became cost effective (Martin #4 at [13]).
157. I accept that the Merck patent teaches the use of micellar formulations to stabilise a macrocyclic lactone and that multiple anthelmintics formulations would have been known to the PSA at the priority date. This issue arose in Merial New Zealand Limited v Jurox Pty Ltd [2016] APO 63 (Merial). In Merial at [155] the Delegate found that adding an additional anthelmintic to the micellar solution in Merck patent was obvious. This involved adding an imidazothiazole.
158. In the present case, however, there are more steps involved. There are four anthelmintics in the compositions of the current claims.
159. The need for a combination of anthelmintics had arisen as a result of resistance and there were products available that used multiple anthelmintics.
160. The opponent submitted that Dr Lichti’s evidence in Lichti # 5 at [99] notes that a second anthelmintic could be included in the formulation in the Merck patent. However, he does not set out the steps necessary to add three anthelmintics. However, they also relied on evidence from Dr Martin.
161. Dr Martin said that additions of this type were all in a day’s work as a formulator (Martin #6 at [45]):
“I am well aware that in a formulation of this type, the water-insoluble macrocyclic lactone is in the micelle core formed by the surfactant. The micelle is a micro-sized sphere with the hydrophilic outer surface and the hydrophobic core. The macrocyclic lactone resides within the aqueous phase by nature of its hydrophilic out surface. The micelle containing the macrocyclic lactone in water was formed by the use of benzyl alcohol as a solvent and a surfactant to make the micelle.”
162. He goes on at [47]:
“Suspending one or more water insoluble compounds, a benzimidazole and a salicylanide such as closantel (base) and oxyclosanide in the water phase and dissolving levamisole in the water phase is all prior art. Continuing with the use of a thickener, such as bentonite or veegum, to achieve the desirable physical characteristics for suspensibility, drenchability and flowability, and the use of buffers to control the pH for stability, is, I believe, all in a day’s work for the average formulator.”
163. Although Dr Martin does not work at the bench as a formulator (Martin #1 at [6]), I accept that these steps are routine. This statement does not explain why one would be directly led to carry out these steps with all four anthelmintics presently claimed.
164. The opponent’s submissions appear to suggest that the choice of all four was just random and any formulator could choose any four. Furthermore, they did not believe that the specifications in suit showed synergy. However, the opponents did not provide experiment evidence proving that synergy did not exist and I do not accept that the combination was random and not inventive.
165. In summary, the Merck document teaches a micellar formulation to stabilise the macrocyclic lactone, adding further anthelmintics would be carried out in order to tackle resistance, however, but there is no motivation to choose the combination of the four claimed. There is no evidence why all four anthelmintics claimed in combination would be obvious based on the disclosure of Merck.
166. I therefore find that the claims of all three applications in suit involve an inventive step when compared to the Merck patent.
d)Inventive step over the Chemvet Patent
167. The Chemvet patent was published on 7 May 1998. It discloses the use of a macrocyclic lactone stabilised in a micellar solution with a selenium additive.
168. The disclosure and the examples of the Chemvet patent generally relate to the use of a single anthelmintic. This is a similar disclosure to the Merck patent, there is a macrocyclic lactone in a micellar solution but here there is an additional additive. It follows that the Chemvet patent does not provide any direction to the PSA to produce a formulation with four anthelmintics.
169. The claims of the three applications in suit are considered to involve an inventive step when compared to the Chemvet patent.
Conclusion on Inventive Step
170. The evidence has not established that the claims of ‘461, ‘942 and ‘544 do not involve an inventive step.
Manner of manufacture
171. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.
172. The opponent’s argument focused on the general lack of quality of newness or inventiveness, citing NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 at 663-665 along with the summary of principles in Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31 at [63] and the reasons of Gageler and Nettle JJ in D’Arcy v Myriad Genetics Inc (2015) 325 ALR 100 at [125]-[131].
173. In assessing the newness and inventiveness, the opponent had the view that the common general knowledge was also relevant citing Commissioner of Patent v Microcell Ltd (1959) 102 CLR 232. I agree that the CGK is relevant to how the patent is construed and understood, Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31 at [64].
174. The opponent also submitted that the feature of “synergy” in the combination is merely a finding and not an invention. The Full Court of the Federal Court stated in Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142 at [16]:
“A mere collocation of parts, each performing its own separate function, is not patentable. However, a claim may validly combine a number of elements which interact with each other to produce a new result or product.”
175. However, the present combination has been shown to be effective and synergistic combinations are patentable. I therefore do not accept that the combination of four anthelmintics as claimed is not a manner of manufacture on the face of the specifications.
176. This ground of opposition fails.
Utility
177. It is a requirement of subsection 18(1)(c) of the Act that the invention, so far as claimed in any claim, must be useful:
Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim: …
(c) is useful.
178. The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228. Emmett J at 247 [81] stated:
"A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility."
179. In Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162; (2013) 100 IPR 285 at [352] Jagot J pointed out that lack of utility requires evidence, not just speculation:
"Ultimately, an asserted lack of utility must be established by appropriate evidence, not be mere speculation that the invention will not work or meet the promise set out in the specification."
180. The opponent argues that not every combination of anthelmintics covered by the claims will have a synergistic effect. This is relevant to the ‘461 and ‘942 applications. However, I have construed the claim to be to combinations that are synergistic and that means that combinations without synergy will be outside of the scope of the claims.
181. The opponent then cites evidence by Dr Martin that Q-Drench is not marketed for the treatment of Haemonchus contorus, Martin #1 at [71]-[72]. I do not consider how a product is marketed to be evidence that it does not work.
182. The opponent then cites the difficulty in the trials with egg count date (Martin #1 at [89]-[90]). They refer to the comparative efficacy in example 4 which does not give adequate comparisons. I accept that comparing a product containing abamectin to a product containing ivermectin is not the best scientific comparision. However, the opponent has not itself provided evidence that example 4 does not work.
183. I see no evidence to demonstrate that something within the scope of the claims of any of the applications does not work and therefore this ground of opposition fails.
Full Description and Best Method of Performance
184. The test for sufficiency of description is set out in the High Court decision in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25]:
"… will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions of prolonged study of matters presenting initial difficulty?"
185. The specification, in addition to fully describing the invention, must include the best method of performing the invention. In American Cyanamid Company v Ethicon Limited [1979] RPC 215 at page 269, it was stated:
"The Act is intending to protect the public against a patentee who deliberately keeps to himself something novel and not previously published which he knows of or has found out gives the best results, with a view to getting the benefit of a monopoly without giving to the public the corresponding consideration of knowledge of the best method of performing the invention."
186. Consequently, even if a manner of performing an invention is self-evident, applicants are nevertheless required to set out the best method of performing the invention known to them. This requirement was confirmed by the Full Court of the Federal Court in Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27.
187. The best method requirement is assessed on the basis of the applicant’s knowledge at the time of filing the complete specification (Rescare Ltd. v Anaesthetic Supplies Pty. Ltd., 25 IPR 119). If the applicant identifies a better method at a time subsequent to filing, there is no obligation to amend the specification to include that method.
188. The specification will fail for want of best method if it can be shown that the best method known to the applicant at the date of filing is not included, PfizerOverseas Pharmaceuticals v Eli Lilly [2005] FCAFC 224 at [366]-[379] (Pfizer). Section 102 allows for amendments to overcome a ground of objection and this includes adding the best method known at the filing date, Pfizer at [368].
189. The opponent submitted that the best method of performance is the Q-Drench product. The applicant did not contest this and I am compelled to accept that the commercial embodiment of the specifications is indeed the best method of performance.
190. Was the best method (Q-Drench) known to the applicant at the filing date?
191. The Q-Drench product had its label approved on 11 November 2003. This is before the filing date of all three applications. I am therefore confident that the method for producing Q-Drench was known to the applicant before the filing date.
192. The summary of the method for producing Q-Drench is given in evidence by Mr Shepherd in Shepherd #5 at [16]-[17]. He states:
“In summary, the manufacturing steps can be summarised as follows:
In steps 1 to 6, the buffers, benzyl alcohol and propylene glycol are mixed and dissolved prior to addition of abamectin.
Step 7 adds the insoluble actives albendazole and closantel prior to the addition of levamisole hydrochloride in step 9.
After step 9 there is a “Note: do not leave the product overnight before pH check and adjustment”.
In Step 10, the pH must be adjusted to 5.3-5.5 in the same day.”
193. Mr Shepherd goes on to say that:
“In my opinion, these instructions are indicative that the method of preparation of Q Drench (order of addition of ingredients and the narrow pH range) is critical in overcoming the inherent instability of combination drench products containing macrocyclic lactones and levamisole hydrochloride”.
194. Mr Shepherd then concludes at [18]:
“The parent ‘461 application, the first divisional application and the opposed ‘544 application disclose such formulations”.
195. Dr Martin responded to this evidence and pointed out the method in the current specification has only 6 steps (Martin #6 at [26]).
196. Example 4 is given as:
(1) Dissolve avermectin in benzyl alcohol and propylene glycol.
(2) Add polysorbate 80 to step 1.
(3) Add water to the solution from step 2 and mix until homogeneous.
(4) Dissolve sodium phosphate dibasic and sodium phosphate monobasic in the solution from step 3.
(5) Add closantel, albendazole and levamisole hydrochloride. Mix until fully dispersed.
(6)Add Cab-0-Sil M5 to the suspension and homogenise until the thickening agent fully is hydrated.
197. There are clear differences in the order of addition and the pH adjustment. These were not included in the specification as filed. Mr Shepherd does say that this is critical.
198. Dr Martin also is of the view that the pH range is very small (Martin #6 at [34]). In my view, a person skilled in the art would be able to adjust the pH accordingly, however, they would not know, based on the disclosure or common general knowledge, that this needs to be done to such a narrow range.
199. The applicant submitted that the state of mind of the applicant was not known to the opponent and that in any event, example 5 has now been added. However, I note that examples 5 and 6 include the order of addition of levamisole; they do not include the critical steps of pH adjustment to the narrow range.
200. All three applications lack critical steps (pH adjustment) which are part of the best method of performing the invention which was known to the applicant at the filing date.
Conclusion on Full Description and Best Method of Performance
201. The applications ‘461, ‘942 and ‘544 do not have the best method of performing the invention that was known to the applicant at the filing date. This can be added by amendment under section 104.
Conclusion
202. The opposition has been successful. The applicant is given 60 days to propose suitable amendments.
Costs
203. The opponent submitted that they would like to provide further submissions on costs after the outcome of the opposition. The parties have two weeks from the date this decision is issued to file submissions on costs.
K. Wagg
Delegate of the Commissioner of Patents
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