Merial, Inc v Intervet International B.V
[2018] APO 52
•17 August 2018
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial, Inc v Intervet International B.V. [2018] APO 52
Patent Application: 2011268899
Title:Injectable formulation of a macrocyclic lactone and levamisole
Patent Applicant: Intervet International B.V
Opponent: Merial, Inc
Delegate: K. Wagg
Decision Date: 17 August 2018
Hearing Date: 22 May 2018, in Canberra
Catchwords: PATENTS - – s59 – grounds of novelty, inventive step, fair basis and utility –all grounds unsuccessful – variation in costs due to amendment
Representation: Patent attorneys for the Applicant: David Myers & Matthew Stewart
Counsel for the Opponent: Christian Dimitriadis SC & Clare Cunliffe
Patent attorneys for the Opponent: Marcus Caulfield & Corrine Porter
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011268899
Title:Injectable formulation of a macrocyclic lactone and levamisole
Patent Applicant: Intervet International B.V.
Date of Decision: 17 August 2018
DECISION
The Opposition is unsuccessful. Subject to appeal, I direct the application proceed to grant.
Costs according to Schedule 8 are awarded against the applicant until the date of advertisement of allowance of the amendment to the specification (9 October 2017) and against the opponent thereafter.
REASONS FOR DECISION
Background
Patent application 2011268899 (the application) is the Australian national phase entry of PCT/EP2011/060535, which was filed on 23 June 2011 and claims a priority date of 24 June 2010. Examination was requested on 11 April 2013. Consequently, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) do not apply to the present application. 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. Any subsequent references to sections of the Patents Act relate to the Patents Act 1990 prior to amendment by the Raising the Bar Act. A similar qualification applies to references to the Patents Regulations 1991.
The applicant is Intervet International B.V. (the Applicant). The application was examined and advertised as accepted by the Commissioner on 7 July 2016. Merial Inc. (the Opponent) filed a notice of opposition to grant on 7 October 2016. After evidence in support was filed, the Applicant sought leave to amend the specification, including the claims, on 19 June 2017. Those amendments were allowed on 9 October 2017. The Statement of Grounds and Particulars was substantively amended in response on 27 September 2017 (Amended SGP)
A hearing was held on 22 May 2018 in Canberra to decide the opposition. The Opponent was represented by Christian Dimitriadis of counsel, accompanied by Clare Cunliffe, with Marcus Caulfield and Corrine Porter of FB Rice. The Applicant was represented by David Myers of Spruson & Ferguson, accompanied by Matthew Stewart.
The Amended SGP identified 8 grounds of opposition. At the hearing the following grounds were pressed:
oLack of Novelty
oLack of Inventive Step
oInutility
oLack of Fair Basis
Standard of Proof
The onus of proof in this opposition proceeding rests with the Opponent, who must establish that it is clear or practically certain that the patent is invalid.[1]
[1] 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], Genetics Institute Inc v Kirin- Amgen Inc [1999] FCA 742; [1999] 92 FCR 106 at [17]
Evidence
The evidence presented is summarised in the following table:
Evidence Declarant Date Reference Exhibits In support Marianne Repacholi 6 January 2017 Repacholi #1 MR-1 – MR-42 MR-1 is referred to as D1 herein
MR-1a is referred to as D1a herein
MR-2 is referred to as D2 hereinMarilyn Domney 7 November 2016 Domney #1 MD-1 – MD-13 Brittany Howard 6 April 2017 Howard #1 BH-1 – BH-8 Gottfried Lichti 23 March 2017 Lichti #1 GL-1 – GL-20 GL-19 is a declaration by Joe Pippia (referred to as Pippia #1) Toby Thompson 21 December 2016 Thompson #1 TAT-1 – TAT-9 In Answer Ray Simms 26 July 2017 Simms #1 RS-1 – RS-3 Stanley Shepherd 26 July 2017 Shepherd #1 SS-1 – SS-9 In Reply Gottfried Lichti 26 September 2017 Lichti #2 GL-21 – GL-24 Joe Pippia 26 September 2017 Pippia #2 -
The declarations of Repacholi, Domney, Howard and Thompson provide evidence on the availability and publication dates of documents mentioned in the Amended SGP. The declarations of Lichti, Pippia, Simms and Shepherd constitute evidence of expert witnesses.
What is the invention as described?
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:
"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.” [2]
[2] [2013] FCA 214, 100 IPR 451 at [139]
The specification
The specification is entitled “Injectable formulation of a macrocyclic lactone and levamisole”. The specification describes formulations comprising the anthelminthic agents: levamisole and a macrocyclic lactone such as ivermectin, in non-aqueous solvents comprising an organic solvent and an oil. The levamisole does not dissolve in this solvent and is in a particulate form. Several formulations and tests for stability and efficacy against nematodes are disclosed.
The specification ends with 19 claims. Claim 1 is the only independent claim.
The field of the invention
The field of the invention is drawn to
“… injectable formulations for controlling parasites and the use of such formulation in the preparation of a medicament for controlling parasites”[3]
[3] Description, page 1 lines 3-5. All unattributed references in footnotes are to the description.
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:
“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.” [4]
[4] [2000] FCA 980; 49 IPR 225 at [70]
However, the PSA is not a real person, but an artificial construct that is used as a tool of analysis by the Court to make a determination. This concept was established in AstraZeneca AB v Apotex Pty Ltd:
“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 stepage” [5]
[5] [2015] HCA 30 at [23]
The understanding of the PSA is based on evidence from persons with knowledge of the relevant art, experts, as to the things they know and do, and what they understand to be commonly known and done. The weighing and evaluating of this evidence to decide the characteristics of the PSA is part of the normal work of a delegate of the Commissioner.
The key expert declarants in this opposition are Dr Lichti, Mr. Pippia, Mr Shepherd, and Mr Simms. Each of the declarants are formulation scientists with experience in the field of veterinary medicine.[6] It was noted during the hearing that these declarants exhibited significant points of agreement in respect to the common general knowledge in the art. The parties did not challenge the relevance of the statements by the expert declarants.
[6] Opponent’s Submissions at 15-17, Applicant’s Submissions at 14
I therefore consider that each declarant is able to comment on what would be known and understood by the PSA. I will refer to the content of these declarations where appropriate throughout the decision.
The aim of the invention
The specification describes that in the field of veterinary antiparasitic formulations, drug resistance is a problem.[7] Drug resistance can be reduced by providing combination formulations of different antiparasitics with different modes of action.[8] The specification states that it would be desirable to provide a combination formulation of a macrocyclic lactone and levamisole,[9] however the specification then states that:
“such combinations are difficult to formulate … Accordingly there is a need for a stable suspension formulation capable of including macrocyclic lactone compounds together with levamisole”.[10]
[7] page1 line 18
[8] Lichti #1 at 34
[9] page 1 line 29
[10] page1 lines 30-33
The detailed description defines the difficulty of combination formulations as being
“due in part to the different formulation requirements of the actives. Avermectins and milbemycins being substantially insoluble in water whereas levamisole is water soluble. In addition levamisole has previously been found to require a pH of less than about 4 for stability while avermectins and milbemycin require a pH of about 6.6”.[11]
[11] page 3 lines 5-9
This problem is corroborated by the evidence of the experts. Mr Shepherd states that a stable formulation would be a formulation with a shelf life of usually 12 months or longer at 25ºC or 30ºC. [12] However, co-formulations can be problematic because levamisole is chemically incompatible with macrocyclic lactones[13] and that levamisole and a macrocyclic lactone are pH incompatible. Mr Shepherd provides further details on this problem at the priority date:
“it was well known before June 2010 that levamisole is stable at around pH 4-5, whilst macrocyclic lactones are unstable and begin degrading at this pH range, preferring a pH range of approximately 6-8 for stability”.[14]
[12] Shepherd at 26
[13] Shepherd at 35
[14] Shepherd at 36
Along with pH solvent incompatibility is also a problem:
“levamisole salts being water soluble while macrocyclic lactones are insoluble in water, although soluble in polar solvents”.[15]
[15] ibid
The evidence of Mr Simms and Dr Lichti is consistent with this. [16] Dr Lichti gives further details on this and points out in his second declaration that pH incompatibility issues occur in aqueous rather than non-aqueous formulations. [17]
[16] Simms at 34, Lichti at 38.
[17] Lichti #2 at 27, 78
Shepherd at 38 concludes that “In my experience, when considering formulation of levamisole with a macrocyclic lactone, the primary consideration is in relation to chemical stability, although physical stability is also important.” Disadvantages associated with physical stability include “issues such as product settling, incomplete mixing when injecting leading to incorrect dosing, and bio incompatibility”.[18]
[18] Shepherd at 39
The detailed description of the invention indeed discloses an object of the invention as providing for the administration of relatively high concentrations of levamisole, being physically and chemically stable, and enabling the actives to co-exist in a single phase.[19]
[19] page 3 lines 10-14
I therefore conclude, that the specification when read by the PSA, gives the aim of the invention as to provide a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole that avoids disadvantages such as those identified above.
The invention disclosed in the specification
The specification discloses in the “statement of invention”[20]a general statement that in one aspect the invention relates to a macrocyclic lactone solution formulation comprising levamisole in particulate form in a non-aqueous solvent system. A number of other aspects of the invention are described and at the end of page 2 bridging page 2a the specification states:
“There is provided a method of preparing an injectable formulation of the invention as described above comprising the steps of:
·mixing an organic solvent with the macrocyclic lactone
·mixing the macrocyclic lactone solution with an oil
·add levamisole and mix until complete homogenisation
·mill to get a homogeneous suspension of levamisole”.
[20] page 2 line 1
The formulations disclosed are then said to be stable and are broadly disclosed as:
“comprising a macrocyclic lactone compound and levamisole and wherein levamisole being suspended in a non-aqueous solvent and is therefore in a particulate form in the formulation”.
By “stable” the specification states that it is to be stable at room temperature for a period of at least 6 months.[21] In conditions of accelerated testing at 40 ºC with the actives staying at acceptable limits for 3 months.[22]
[21] Page 3 lines 15-17
[22] Page 3 lines 16-19
Particulate form is defined as:
“mobile, un-dissolved, solid matter suspended in a liquid.”[23]
[23] Page 4 line 26
A suspension is also defined as:
“[consisting] of insoluble solid particles dispersed in a liquid medium, with the solid particles accounting for about 0.5% to about 30% of the suspension.”[24]
[24] Page 4 lines 30-31.
More detailed preferred embodiments of the invention are set out on page 3 lines 3-5. It is stated that preferably levamisole is present in the range of between 0.1-40% w/v, 10-35% w/v, 12-30% w/v, 15-25% w/v.[25] Detailed preferred formulations and uses for treatment are then given.[26]
[25] page 4 lines 22-23
[26] Pages 6-7
Relevantly injectable formulation is said to be given by injection:
“… the pharmaceutical formulation according to the current invention is preferably administered parenterally, e.g. by intravenous, intramuscular or subcutaneous injection …”[27]
[27] page 7 lines 26-27
The specification concludes with four example formulations, along with instructions for preparation of the formulations. This is done by sequential mixing of N,N-dimethylacetamide and ivermectin (a macrocyclic lactone), with castor oil, caprilic/capric triglyceride, and butylated hydroxytoluene, followed by addition of levamisole hydrochloride, homogenisation and milling to produce a homogenous suspension.[28] The four formulations had different concentrations of ivermectin (1.2% - 4%) and levamisole HCl (15.04% or 18.8%).[29] Formulation 3 was tested and demonstrated accelerated stability at 40 degrees C and 75% relative humidity, and tested and demonstrated efficacy against nematodes.[30]
[28] Page 8 lines 1-18
[29] Page 8 lines 21- page 9 line 5.
[30] Page 10
Construction
The principles for the construction of claims have been conveniently summarised by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:
"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".[31]
[31] [2009] FCAFC 70, 81 IPR 228 at [118] – [120]:
Claim 1 is an independent claim directed to:
“An injectable formulation of a macrocyclic lactone and levamisole in a non-aqueous solvent system comprising oil and an organic solvent, wherein the macrocyclic lactone is in solution and the levamisole is in a particulate form, and wherein the levamisole is present in the range of between 10- 35% w/v.”
Claims 2-11 specify further features of the formulation.
Claims 12-13 and 15 are claims to methods and uses of the formulations claimed in claims 1-11.
Claim 14 is a claim to:
“A method of preparing a formulation as claimed in any one of claims 1-11, comprising the steps of:
·mixing an organic solvent with the macrocyclic lactone
·mixing the macrocyclic lactone solution with an oil
·add levamisole and mix until complete homogenisation
·mill to get a homogeneous suspension of levamisole.”
Claims 16-19 are omnibus claims.
I will consider each of the elements of claim 1 in turn.
“An injectable formulation”
The plain meaning of “injectable” is capable of being administered by injection. The specification does not specifically define the term except to specify that the organic solvent must be pharmaceutically acceptable.[32]
[32] Page 5 lines 26-27
Necessary properties that the skilled worker would assume of injectable formulations are chemical and physical stability, the suitable concentration to deliver an effective dose in an injectable volume, not too thick or viscous, and sterile.[33]
[33] Lichti #1 at 40, concurred with by Simms at 64, Shepherd at 71, 73.
The necessity of physical stability, however,is provided by the experts::
“[the issue of settling out] was generally not prohibitive”[34] “However I note that there are such formulations available now, such as antibiotic suspensions, although the physical stability of these known formulations is not ideal as they usually need to be shaken well before use”[35] … “… I agree that the physical stability of a product (such as product settling) is a relevant consideration when formulating a suspension. However, it is possible to develop an injectable formulation with particulates notwithstanding these concerns, and I am aware that there were a number of injectable suspensions registered with the APVMA before June 2010”[36] and “… I agree that the issue of settling was not prohibitive.”[37]
[34] Simms at 37
[35] Simms at 39
[36] Lichti #2 at 15 addressing Simms at 37
[37] Lichti #2 at 81, addressing Simms at 39
In Mr Shepherd’s opinion, physical instability causes “issues such as product settling, incomplete mixing when injecting leading to incorrect dosing, and bio incompatibility” and in his opinion an injectable formulation should ideally be a clear liquid and the presence of particulates in an injectable formulation is not desirable.[38] However this is a statement of desirability only, and to the extent that the instant specification demonstrates the feasibility of an injectable particulate formulation, I will disregard it.
[38] Shepherd at 39
Therefore I will construe an injectable formulation as one which is capable of being effectively administered by injection; it must contain an effective dose of active ingredient(s) in a relatively small volume of carrier, it must not be so viscous as to prevent injection, it must be chemically stable, it must be physically stable at least insofar as it can be reconstituted by shaking into an even mixture, and must be safe, sterile and biocompatible so as to avoid injection site reactions.
“A macrocyclic lactone”
Macrocyclic lactones were known as part of the common general knowledge to be a class of structurally related broad spectrum anthelmintic actives derived from Streptomyces with similar properties such as poor water solubility and instability in acidic environments.[39] Preferred macrocyclic lactones are listed as “abamectin, doramectin, eprinomectin, ivermectin and moxidectin”[40] which correspond with those listed in Dr. Lichti’s declaration. I consider that the skilled worker would recognize a macrocyclic lactone to be a member of this known class, not necessarily limited to the listed examples.
[39] Lichti #1 at 31(iii)) and page3 line 20 – page4 line 16 of the description
[40] page 2 line 14
“Levamisole”
Levamisole is an imidazothiazole anthelmintic and is the most commonly used member of this class.[41] The term is defined in the specification to include levamisole base, levamisole hydrochloride, levamisole phosphate, or other salts and forms.[42]
[41] Lichti #1 at 31(ii
[42] page 4 lines 19-20
“A non-aqueous solvent system”
The specification defines “non-aqueous solvent system” as a solvent or mixture of solvents that essentially consists of liquid(s) other than water.[43] I construe this to mean that there is no significant amount of water in the system.[44]
[43] page 4 lines 35-36
[44] see also page3 lines 12-13, Lichti at 135, Simms at 75
“Oil”
Suitable oils are defined in the specification as being natural, e.g. vegetable, semisynthetic or synthetic mono, di- or tri-glycerides.[45] This is a non-exclusionary definition and I consider the skilled worker would take this term to mean the dictionary definition of an oil: a viscous liquid that is insoluble in water but soluble in organic solvents[46] as long as the oil is suitable for injection.
[45] page 4 lines 38-39
[46] The Oxford English Dictionary
“An organic solvent”
The specification limits this term to a pharmaceutically acceptable organic solvent such as DMA or DMSO,[47] however the skilled reader would understand other organic solvents could fall within the scope of the claim e.g. propylene glycol, polyethylene glycol (PEG), glycol ethers, pyrrolidones or benzyl alcohol.[48]
[47] page 5 lines 26-27
[48] Simms at 45
“Wherein the macrocyclic lactone is in solution and the levamisole is in a particulate form”
As noted above, “particulate form” is defined as mobile, undissolved solid matter suspended in a liquid.[49] Notably, this does define particulate form to be a suspension.
[49] page 4 lines 26-27
All macrocyclic lactone must be dissolved and all levamisole must be in particulate form. This is supported by the reference to “undissolved” in the definition of particulate and is consistent with the declarations of the experts.[50]
[50] See e.g. Lichti at 146, Lichti #2 at 25 and 62, Simms at 75 and Shepherd at 148 discussing the possibility of partial dissolution of levamisole base as going against the teaching of the application.
“Wherein the levamisole is present in the range of between 10- 35% w/v”
The Opponent submitted that this is an arbitrarily imposed limitation that cannot confer novelty, with reference to Otsuka.[51]
[51] Otsuka Pharmaceutical Co. Ltd v Generic Health Pty Ltd (No 2) (2016) 120 IPR 431 at 110-112 and 176. (Opponent’s Submissions at 56)
The context of the Otsuka decision related to a method of treatment using antipsychotic drugs and the “arbitrarily imposed” limitation was that the method be conducted on a patient who fails to [respond] to other antipsychotic drugs listed in the claim. This was construed as referring to a “third line” treatment where two or more other antipsychotic drugs had failed.[52] The appeal decision qualifies that it is not entirely clear whether the primary judge set aside the limitation altogether.[53] When answering the appellants submissions that this feature is not arbitrary, the appeal decision states:[54]
“The primary judge was aware that switching of antipsychotics could lead to a worsening of symptoms and of a patient’s diminishing response rate. However, he made clear findings of the practice at the priority date of switching antipsychotics in an attempt to improve cognitive impairment in schizophrenic patients. Neither of the matters identified by the appellants overcomes the primary judge’s finding that there would be no reason to read down the prior art to exclude any particular line of treatment, including third or later line treatment, where the patient fails to respond to two or more of the identified antipsychotic drugs”.
[52] Otsuka at 44
[53] Otsuka at 103
[54] Otsuka at 111
My reading of this passage is that their Honours found that the feature of third line treatment was found in the prior art when read in light of common general knowledge and there was no reason to exclude the known possibility of third line treatment from the prior art disclosure. This would seem to apply whether the limitation in suit was “arbitrary” or not.
This was succinctly summarised by Beach J.
“I agree that novelty is not conferred merely by … (c) claiming a narrower use of an old product, where that narrower use fits within the broader use for the old product already described in the prior art”[55]
[55] Otsuka at 176
This is consistent with the principle that "a given specification is not to be read in a vacuum. The reader must be regarded as having at least the common knowledge of the art."[56] Given that the present claims concern an allegedly new formulation, it is difficult to see how the guidance of Otsuka is directly applicable here. I do not consider that specification of a concentration range of a drug is an example of “claiming a narrower [method] use of an old product” in the sense of Otsuka.
[56] Acme Bedstead v Newlands (1937) 58 CLR 689 at page 704
The specification refers to the need to administer relatively high concentrations of levamisole[57] and Mr Shepherd’s evidence is that the claimed range is consistent with the examples of the description.[58] Furthermore, Mr Shepherd considered that a levamisole concentration of 12% is consistent with an acceptable injection volume but concentrations below 10% are not.[59] Therefore I am satisfied that the claimed range of 10-35% is a part of the invention and should not be disregarded for the purposes of determining novelty.
[57] page3 lines 10-12
[58] Shepherd at 145
[59] Shepherd at 88
The w/v is a weight/volume ratio measurement as is conventional in the art, and does not require any detailed consideration as to its construction.
Novelty
The opponent pressed grounds of lack of novelty over D1/D1a, and over D2.
Legal principles:
It is well settled that the general test for anticipation or want of novelty is the reverse infringement test,[60] and this test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed.[61]
[60] Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 19
[61] Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40; 16 IPR 545 at 19
Australian courts have often cited with approval the words of the UK Court of Appeal in General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited:
"To anticipate the patentee's claim the prior publication must contain clear and unmistakeable 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."[62]
[62] 1A IPR 121 at 138
More recently the Full Federal Court clarified the above proposition:
“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”... “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.” [63]
[63] Novozymes A/S v Danisco A/S [2013] FCAFC 6 at 177
The Opponent alleged that the claims lacked novelty when compared to two prior art documents. I will decide this below.
D1 (CN1375291) and D1a (English translation)
D1 is a Chinese-language patent publication. A verified translation has been provided as D1a.[64] The content of both D1 and D1a is considered part of the prior art base for determination of novelty. I will refer to D1a throughout this section.
[64] Exhibit MLR-1a
D1a relates to a Veterinary Compound Injection Containing Levamisole or Salts thereof.[65] The abstract of D1a discloses a compound injection of levamisole (1-25% W/V) and another anthelmintic. The compound is said to be synergistic, effective against nematodes which are single drug resistant, and that a compound oil injecting has both quick-acting and long-acting efficacies, is good in absorbability and is a very excellent injection.[66]
[65] Title of D1a
[66] Abstract of D1a
The claims of D1a are part of its disclosure; they are consistent with the statements in the remainder of the disclosure (i.e. the body of D1a). Claim 1 discloses:
1. A veterinary compound injection containing levamisole or salts thereof, characterized in that the veterinary compound injection comprises the following formula components:
(a) 1-25% (W/V) of levamisole or salts thereof;
(b) 0.1-10% (W/V) of macrolide anthelmintic (abamectin, ivermectin, eprinomectin, moxidectin and doramectin);
(c) balance of dispersion media;
(d) other adjuvants (such as suspending agent, surfactant and antioxidant) which can be added if necessary.Claim 2 provides a long list of options for the dispersion media, of claim 1 which can include, water, oil or other organic liquid media.
Claim 3 specifies that a preferred formulation of claim 1 comprises (inter alia) 10-20% levamisole or hydrochloride w/v.
Claims 4 and 5 specify formulations corresponding to Formula 1 and Formula 2 on pps 3-4 of D1a. These both comprise 10% or more levamisole or hydrochloride but do not comprise an oil.
Claim 6 specifies a dosing regime …”administered orally or by injection, with a dosage of 1-2ml per 20kg of weight for pigs, cattle or sheep”
As indicated, the body of D1a closely corresponds to the above claims, but ends with three Examples.
Example 1 corresponds exactly with preferred formula 2 and is aqueous. Example 2 is similar to preferred formula 1 with the notable addition of benzyl alcohol and glycerol triacetate. Neither of these examples disclose the presence of an oil.
The Opponent submitted that Example 3 anticipated claim 1 of the opposed application. Example 3 of D1a is repeated below:
“Example 3
This example is used for preparing an oil injection containing 0.5% of ivermectin and 5% of levamisole hydrochloride
Levamisole hydrochloride 5% (W/V)
Ivermectin 0.5% (W/V)
Benzyl alcohol 10% (V/V)
Benzyl benzoate 40% (V/V)
Soybean oil added to 100% (V/V)”Although Example 3 does not disclose that the levamisole is in particulate form, the Opponent submits that this is an inherent property.[67] Dr Lichti provided a declaration of Mr Joe Pippia[68] which Dr Lichti described as a study carried out to investigate whether the formulation of Example 3 of D1a was a solution or contained a particulate, and if a particulate was present, what active(s) it contained.[69]
[67] Opponent’s Submissions at 52
[68] Exhibit GL-18 (Pippia #1) at 9-13
[69] Lichti #1 at 161
The experiments by Mr Pippia involved sequential addition of benzyl alcohol, benzyl benzoate, ivermectin, levamisole HCl and soybean oil, with stirring at each step followed by heating at 40ºC to encourage dissolution. I do note that D1a does not disclose instructions for preparing the formulation, but the formulation method was not challenged during the proceedings so I will proceed on the basis that this formulation method would have been used by a skilled worker to prepare Example 3.
This formulation experiment revealed that the levamisole did not dissolve in either the non-aqueous solvent or the oil and remained in particulate form.[70] The formulation contained a particulate which settled after storage but could be redispersed on shaking.[71]
[70] Table 3.1 of Exhibit GL-20
[71] Table 3.2 and Figs 1-4 of Exhibit GL-20,
The Applicant addressed this by submitting that there is a difference between “undissolved” and “suspended”[72] and that a particulate needs to be sufficiently fine to remain suspended, that physical stability is important for injection and that the formulation of Example 3 is not stable, and arguably not an “excellent injection”.[73] However as I have previously found that it is sufficient for a particulate to be able to be resuspended by shaking to satisfy the stability requirement of an injectable composition; I am satisfied on the evidence presented from Pippia #1 that the composition of Example 3 would have comprised injectable particulate levamisole HCl.
[72] Applicant’s Submissions at 42
[73] .Applicant’s Submissions at 45 and 48
In my view, the difference between Example 3 of D1a and the opposed claim 1 is that the amount of levamisole used in Example 3 is 5 % (w/v) whereas the claimed is 10-35% (w/v). The Opponent submitted that the current claimed range of 10-35% of levamisole was arbitrary. In my construction above I found that the concentration of levamisole is not arbitrary and is indeed part of the claim and therefore Example 3 does not provide clear and unmistakable directions to arrive at the opposed claims.
The Opponent further submitted that Example 3 should be read in connection with claims 1-3 which teach levamisole concentrations of 1-25% or 10-25%. In response to this, the Applicant submits that D1a does not plant a flag at a formulation that falls within the scope of the claims and that if the skilled reader did contemplate increasing the levamisole concentration in Example 3, this would appear to exacerbate the settling out problem noted in the Pippia experiments[74] and therefore does not enable a formulation as claimed.[75]
[74] Applicant’s Submissions at 50
[75] Applicant’s Submissions at 53
Claim 3 of D1a states that levamisole can be used in a range of 10-25%, however, when this is read in the context of claims 1 and 2 a range of aqueous and non-aqueous solvents is disclosed. Furthermore, the preferred formulations (formulations 1 and 2, claims 4 and 5) falling within the scope of claim 3 in D1a do not contain oil. Therefore, when the claims are read in context I do not see the connection with Example 3 to the extent that it is clear and unmistakable directions to arrive at the opposed claims.
In my view the clear and unmistakable directions in D1a were those followed by Mr Pippia.[76] Those directions were to repeat example 3, using a concentration of 5 % levamisole, and not to combine it with any particular feature found in the claims of D1a. I am therefore not satisfied that D1a clearly anticipates the opposed claims.
[76] Pippia #1
I therefore find that the present claims do not lack novelty in view of D1/D1a.
D2 (NZ535644)
D2 relates to anthelmintic formulations including a combination of actives. It is titled “Anthelmintic formulations”. There are a number of formulations made in D2 and the Opponent argues that Formulations 1, 2 and 4 of Study 1, and Formulation R4 of study 7 are relevant to the current claims in terms of their components; however, they are used as a pour-on rather than as being injected.
The formulations 1, 2 and 4 of study 1 all use levamisole at 20 % w/v and abamectin (a macrocyclic lactone) with benzyl alcohol and soy bean oil.[77] However, further components, such as Capmul PG-8, Tween 80 and isopropyl palmitate are used. There is not much evidence provided to satisfy me that these formulations would provide the levamisole in particulate form which is stable and injectable. Simms provides some assistance and states that:
“they utilise Tween 80, which is a known surfactant for use in aqueous systems, and usually used in emulsion preparations”.[78]
[77] D2 page 6-7.
[78] Simms at 92
Study 7 of D2 uses a mixture of levamisole base and levamisole.HCl (15 and 5 g respectively) along with propylene glycol and glycerin formaldehyde and Capmul MCM (oil) up to 100 mL. The use of levamisole base and levamisole.HCl meant that some could be dissolved in solution, however, this was not clear from the evidence.
The Opponent does acknowledge that D2 is silent on whether these formulations contain levamisole in particulate form, but submits that the levamisole is particulate by analogy with the experiments in the Pippia declaration.[79] It is Dr Shepherd’s opinion[80] that the formulations of D2 all involved dissolved actives.
[79] Opponent’s Submissions at 60
[80] Shepherd at 94
Dr Lichti states the main focus of D2 is on DGBE/NMP-containing formulations and cites those argued by the Opponent.[81] Simms disagrees with Dr Lichti by stating that D2 is directed to pour-on formulations.[82] I note that D2 states that a stable pour-on veterinary formulation is disclosed in the abstract.
[81] Lichti #1 at 167
[82] Simms at 91
Simms further states:
“on my reading of D2, all the formulations of D2 that were considered to be unstable all comprised oil, suggesting that all oil-based formulations would be unstable, thereby teaching away from the oil-based injectable formulation of the patent application.”[83]
[83] Simms at 92
Indeed, in Study 1 of D2, which includes the cited formulations, D2 states that:
“All formulations exhibited significant degradation of the abamectin component. Animal studies also demonstrated an unexpected degree of skin irritancy when the formulation was topically applied, with hair loss occurring at the point of application. These results indicated that an oil-base to the product may be unsuitable both from an irritancy and stability perspective.”[84]
[84] D2 page 7 lines 7-12.
D2 then goes on to use the DGBE/NMP-containing formulations and on Study 7 states that:
“These results show that none of the test formulations showed great promise in stabilizing the abamectin component of the formulations.”[85]
[85] D2 page 14 lines 6-7.
In my view, the above passages from D2 do state that these formulations were unstable due to the degradation of the abamectin. Furthermore, it was clearly used as a pour-on as it caused skin irritancy and hair-loss when applied topically. The instability of the formulations and the irritancy shown when applied topically, in my view means that these are not injectable.
I have found above that stability, particularly chemical stability, is essential in order for a formulation to be injectable. All of the asserted formulations were described by D2 as being chemically unstable.[86]
[86] D2 at page 7 l 7-9 and page 14 lines 6-7
In terms of particulate form, I am not convinced that it is appropriate to rely on the results of the Pippia experiments by analogy, as the formulations in D2 appear significantly different from those tested in the Pippia declaration. They include further additives which might act as surfactants which could dissolve some of the levamisole into the oil or acid/base mixtures of the levamisole. Therefore I am not satisfied to the requisite level of certainty that the formulations of D2 had levamisole in particulate form.
In summary, I am not satisfied that Formulations 1, 2 and 4 of Study 1, and Formulation R4 of study 7 of D2 are injectable compositions or contain levamisole in particulate form. Consequently, on the evidence D2 does not provide clear and unmistakable directions to arrive at the current claims.
For these reasons I find the present claims do not lack novelty in view of D2. This ground of opposition fails.
Inventive step
At the hearing, the Opponent confirmed that it was not pressing the ground of lack of inventive step over common general knowledge alone, but only in view of D1/D1a.
Ascertained, understood, and regarded as relevant
Under the applicable law, for a document to be part of the prior art base for inventive step, it must have been ascertained, understood, and regarded as relevant by the skilled worker.
In Lockwood,[87] the High Court stated that “Ascertained” means discovered or found out.
[87] Lockwood v Doric (No.2) [2007] HCA 21 at [132] (“Lockwood”)
A document would be ascertained “if it was published in such a manner or form that it could reasonably have been expected to be found by a person skilled in the art”.[88]
[88] Nippon Kayaku Kabushiki Kaisha and Sankyo Company, Limited v Rohm and Haas Company [1997] APO 40
100. “Understood” means that, having discovered the information, the skilled addressee would have “comprehended it” or “appreciated its meaning or import”.[89]
[89] Lockwood at [132]
101. The High Court stated in Lockwood:
“…the phrase ‘relevant to work in the relevant art’ should not be construed as meaning relevant to any work in the relevant art, including work irrelevant to the particular problem or long-felt want or need, in respect of which the invention constitutes an advance in the art. The phrase can only be construed as being directed to prior disclosures, that is publicly available information (not part of common general knowledge) which a person skilled in the relevant art could be expected to have regarded as relevant to solving a particular problem or meeting a long-felt want or need as the patentee claims to have done.”
and
“[t]he question of what a person skilled in the relevant art would regard as relevant, when faced with the same problem as the patentee, is to be determined on the evidence”.
102. D1 is a Chinese language patent document. It was agreed by the parties at the hearing that as of the priority date, an English-language translation of the abstract of D1 would have most likely been available on English patent search databases. The Opponent submitted during the hearing that the abstract would have been ascertained by a skilled worker, as a skilled worker would routinely perform a patent database search.[90] Some of the keywords suggested by Simms were found in the abstract of D1, in particular, “levamisole” and “Veterinary Compound Injection” and English-language terms for macrocyclic lactones are used in the Chinese text. The Opponent submitted that this would provide enough detail to induce a full translation of the document.
[90] Lichti #1 at 57-58, Simms at 41, Shepherd at 13 & 45, Lichti #2 at 17
103. I find on the basis of the evidence that skilled workers would use patent searches and appropriate keywords such that at least the English abstract of D1 would have been ascertained, that is, reasonably expected to be found, and understood by the skilled worker.
104. The Applicant responded that a translation would be expensive and would not necessarily be carried out unless the skilled worker had already found that the abstract was relevant. The Applicant also pointed out that macrocylic lactones and the problem of stability were not mentioned in the abstract, and argued the Abstract would not have been considered relevant.
105. Lockwood makes it clear that the relevance of documents is to be determined in view of the problem addressed by the claimed invention. The aim of the present invention (as set out above) is to provide a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole.
106. In view of the fact that the abstract of D1 discloses compound levamisole formulations, a “very excellent injection” which the experts agree would imply a stable formulation, and the English names of macrocyclic lactones can be ascertained from the body of the Chinese text of D1, I consider that the skilled worker would have considered D1 relevant to the above problem and therefore would have also arranged for a translation.
107. D1/D1a therefore forms part of the prior art base for determination of inventive step.
Applicable Principles
108. In Alphapharm,[91] the High Court endorsed the use of the reformulated "Cripps question":
[91] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411
"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 solution to the problem."[92]
[92] Alphapharm at [53]
109. This has been elaborated on in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft:
“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) 148 CLR 262, at 280‑281, 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. “[93]
[93] 2014 FCAFC 73 at [71]
110. That is, it is equivalent to ask whether the variations were routine to be tried as a matter of course, because the expectation of success is implicit in the meaning of routine. Since the reformulated Cripps question seems to provide the most helpful structure for addressing the analysis of inventive step in the present case, I will use it here.
111. The key considerations for administering this test are establishing the problem, and then establishing what the skilled worker would do as a matter of course in response to this problem.
The problem, as previously stated, is to provide a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole.
112. The skilled worker or research group is a hypothetical construct, but each of the declarations of the three experts can be considered as evidence for determining what this construct would take into account or do. The determination of this is a matter for the Court, and it is not required for the parties to lead expert evidence echoing the terms of the question.[94]
[94] AstraZeneca AB v Apotex Pty Ltd (2015) 323 ALR 605 at [43]
113. Proceeding from the standpoint that example 3 of D1/D1a discloses a particulate formulation of levamisole, albeit with a lower concentration than that required by the present claims, the Opponent asserts that the skilled worker would have increased the concentration of levamisole in this formulation, based on the higher ranges disclosed in claim 3.
114. D1/D1a does provide its own indication of preferred dosage regimens. At the 3rd paragraph of D1a, it is disclosed that
“When the compound preparation (containing 5mg of abamectin or ivermectin and 50-60mg of levamisole) provided by the present invention is injected into cattle and sheep according to a dosage of 0.5ml per 10kg of weight, the repelling rate thereof to haemonchus and other various nematodes can still reach 95-100% (see Table 1).”[95]
[95] D1a page 3 paragraph 3
115. The Opponent noted that Shepherd[96] and Simms[97] said the amount of this formulation required for administration of a commercially effective amount of levamisole would require a large dose of 50 mL which could be difficult to administer and uncomfortable to the animal.
[96] Shepherd at 88
[97] Simms at 90
116. The Opponent submitted that increasing the concentration of levamisole would give you a smaller dose, which would be easier to administer and you would end up at the current claims as a matter of course.
117. Pippia states that at higher concentrations of levamisole:
“The only thing that would occur is that there would be more levamisole HCl particulate present in the formulation.”[98]
[98] Pippia #2 at 8
118. Dr Lichti also states that “the skilled person can readily adjust D1/D1a Example 3 to have up to 25% w/v levamisole HCI.”[99]
[99] Lichti #2 at 39
119. I note that the 50 mL dose, calculated for a 500 kg animal is based on a single component prior art drench, and is perhaps not directly comparable to a combination injection.[100]
[100] Shepherd at 88.2
120. The Applicant submitted that if the concentration of levamisole in Example 3 were to be increased, this would exacerbate the problem of settling observed in the Pippia experiments[101] and would increase the viscosity leading to syringeability issues.[102] The Applicant further submitted that the skilled worker, contemplating higher levamisole concentrations (such as those listed in claim 3), would apply the non-oily formulations as in examples 1 and 2 rather than attempting to increase the concentration in the oily formulation.[103]
[101] Applicant’s Submissions at 103 with reference to Simms at 44
[102] Simms at 54
[103] Applicant’s Submissions at 106
121. The Applicant also addressed the statement in the abstract of D1 that the oily formulation is a “very excellent injection”[104] by observing that the settled particulates observed in the first Pippia experiments are inconsistent with the evidence of Dr Lichti that suspension injections should be homogenous.[105] In my view the skilled worker, when producing Example 3 as evidenced by the Pippia experiments, would find it a less than optimal formulation in terms of physical stability as a result of the settling out of the particulate and that if they wanted a more concentrated formulation they would instead use either example 1 or 2 rather than combine Example 3 with claim 3.
[104] Applicant’s Submissions at 104
[105] Lichti #1 at 46
122. I therefore find that the skilled worker would not be directly led as a matter of routine, to increase the concentration of levamisole in example 3 of D1/D1a with the expectation of success.
123. This ground of opposition fails.
Fair Basis
Legal principles
124. Subsection 40(3) requires that the claims be fairly based. A claim will lack fair basis if it is not consistent with what the specification as a whole describes as the invention. The general principle for fair basis is:
“where the issue is one under a 40(3) of ‘fair basing’ of a claim, what the 1990 Act requires is a comparison between the matter described in the specification and the claim which defines the scope of the monopoly”.[106]
[106] Kimberly-Clark Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at 15
125. However the consideration of fair basis is not “a superficial test based solely on the presence or absence of words”.[107] Rather, a consideration must be made as to what the specification read as a whole discloses as the invention.[108]
[107] Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth (“Sigma”) [2011] FCAFC 132
[108] Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 at 87; (2004) 217 CLR 274)
126. The Opponent drew attention to Sigma where the Full Court concluded that a consistory clause could not provide fair basis for a claim where other matters disclosed in the specification showed that the invention is narrower than the consistory clause suggests.[109]
[109] Opponent’s Submissions at 88
127. The Applicant pointed to the principle that the specification must be read as a whole without pulling out parts in isolation,[110] and referred to a recent decision of the Full Federal Court in which examples were said to illustrate advantageous properties but not limit the invention thereto.[111] All these examples are consistent with the general principles identified above.
[110] Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 “Rhône-Poulenc”at 11
[111] GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v Generic Partners Pty Limited [2018] FCAFC 71
128. The Opponent’s submissions for lack of fair basis is that the only exemplifed formulations in the present application have a single salt of levamisole (HCl) a single species of macrocyclic lactone, a single oil and organic solvent formulation, and a narrow range of levamisole concentrations (15.04% and 18.8%).
129. With regards to the HCl salt Mr Shepherd commented that levamisole may need to be present as a salt in order to be particulate, but qualified this as he did not have any experience formulating levamisole in this solvent system.[112] Likewise, Dr Lichti was “not at all confident” that the examples could be extrapolated from the HCl salt to the free base form of levamisole in light of its much greater solubility in many organic solvents.[113] However, Mr Simms states that he expected free base levamisole not to significantly dissolve in the patent application formulation, but could be used in an appropriate particulate formulation.[114]
[112] Shepherd at 58 and 63
[113] Lichti #1 at 145
[114] Simms at 70
130. The Opponent drew attention to the evidence of Mr Simms, that he “would have expected the formulators that developed the formulations of the patent application to have iteratively narrowed to formulations described in the patent application through trial and error, in order to arrive at a preferred formulation that embodied the inventive concept (i.e., particulate levamisole in a non-aqueous base)”[115] to argue that only the exemplified formulations represent the inventive concept.
[115] Simms at 78
131. Although Mr Simms did expect that trial and error may have been used to narrow down to the claimed formulation, he also considered that “formulations of the patent application describe a broad principle of suspending levamisole in a non-aqueous solvent system, resulting in a stable formulation suitable for injection”[116] and “While there can be no guarantee that any oil combined with any organic solvent will provide a suitable solvent system for the purposes of the patent application, I consider that the knowledge and understanding of oils and organic solvents in the veterinary field is extensive, and I or another person working in this field would be able to determine suitable oil/solvent systems for use in the formulations of the patent application through no more than routine experimentation”.
[116] Simms at 73
132. The Applicant points to the statements in the description corresponding to the terms in the claim as evidence that the claimed invention is “broadly, that is in a general sense disclosed”. There is somewhat of a tension whenever a broad consistory statement is contrasted with a narrower set of working examples. However this can be addressed by considering the specification through the eyes of the skilled reader.
133. Dr Shepherd also states that a range of solvents were available to a formulator and that he could create other formulations within the scope of the claims without any great difficulty.[117]
[117] Shepherd at 127-128
134. I note that Dr Lichti did not express any confidence that the solvents used in the examples could be replaced with “any and all oils and organic solvents, in any proportions”.[118]
[118] Lichti #1 at 142
135. Dr Lichti generally has reservations that not all of the possible claim components would be expected to work all of the time. This is not inconsistent with the Applicant’s experts who phrase their evidence from the point of view that a variety of suitable formulations would present themselves to the skilled worker, albeit with no guarantees that any particular formulation would be suitable. However, in my view there is no requirement under the applicable law of fair basis that the skilled worker must be able to make formulations using any and all possible components. Rather, the test is whether there is a real and reasonably clear disclosure of the invention as claimed in the body of the specification.[119]
[119] Rhône-Poulenc at 11
136. I find that the disclosure of the specification as a whole is consistent with a broad principle of particulate levamisole and a macrocyclic lactone in an oily non-aqueous solvent, within a range of concentrations that encompass the examples while allowing for variation within the skill of the formulator. I can see no basis to conclude that the invention described is limited to the exemplified formulations.
137. The Opponent has therefore not established that the claims lack fair basis.
Utility
138. Section 18(1)(c) of the Act requires that for an invention to be patentable it must be useful. This requirement was expressed in the following manner:[120]
[120] Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC 2008 FCAFC 82 at 141:
“Under ss 138 and 18(1)(c) of the 1990 Act, it is a ground of invalidity if the claimed invention is not useful "so far as claimed in any claim". If the claimed invention does what it is intended by the patentee to do and the end obtained is itself useful, the invention is useful within the meaning of s 18(1)(c). As to the first aspect, the invention as claimed must attain the result promised by the patentee (citations omitted).
139. The recent Full Federal Court in ESCO Corporation v Ronneby Road Pty Ltd, after an extensive review of the case law of utility, sets out a number of classes of inutile cases:
where it is said that the invention as claimed achieves the result promised but the result itself is not useful
where each claim is said to lack utility because each claim asserts a monopoly over the useful and the nonuseful thus offending the “rule” that all that is within the scope of a claim must be useful. As to that, of course, the “rule” is tempered by the consideration that the specification and claims should not “be construed in a way that any sensible person would appreciate would lead to unworkability when by construction it could be given a more limited meaning
where each claim is said to be invalid because it contains “something that will not produce the desired result even [though] a skilled person would know which means to avoid [that something]” [121]
[121] [2018] FCAFC 46 at 235-237
140. Their Honours concluded (with reference to a composite promise of six different advantages set out in the opposed specification):
“if para 6 of the Patent Application, properly understood having regard to the whole of the Specification including the claims, contains a “composite” promise for the described invention, a failure to attain any one of the elements of the composite promise in any claim defining the invention renders the invention so far as claimed in any claim, inutile. The question then is – what is the promise for the invention?”
141. Neither party made written submissions as to the promise of the invention. At the oral hearing, the stability of the formulation was raised by the Opponent as being part of the promise of the invention.
142. I identified the aim of the invention (above) to be a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole. This can be equally construed as its promise or promises.
143. The Opponent’s submissions on utility effectively mirror those on fair basis, and consistent with Dr Lichti’s view: not all of the possible formulations in the scope of the claim would have stable, particulate levamisole or be injectable.[122]
[122] Lichti #1 at 143-145
144. The key point in all the authorities is whether something in the scope of the claim will not produce the desired result. As Jagot J pointed out in Apotex Pty Ltd v AstraZeneca AB (No 4)[123] that lack of utility requires evidence, not just speculation:
[123] [2013] FCA 162; (2013) 100 IPR 285 at [352]
“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.”
145. In the present case there appears to be a lot of speculation that “not all oils” work and that the levamisole base might not work. Dr Lichti states at 145:
“I would not be at all confident in extrapolating from levamisole HCl to the free base of levamisole.”
146. In my view Dr Lichti’s confidence does not weigh as much as experimental evidence would−of which I have none−and is instead speculative.
147. The Opponent cited D2. Indeed, as I have outlined above, D2 teaches compositions which contain levamisole, an organic solvent, an oil and a macrocyclic lactone. Furthermore, Study 1, with formulations 1,2 and 4 and Study 7 formulation 4 were said to be unsuitable. In fact D2 states:
“These results indicated that an oil-base to the product may be unsuitable both from an irritancy and stability perspective.” (my emphasis).
148. Here the Authors appear to be supporting the view that a levamisole-base was the cause of the instability and irritancy. I agree that the levamisole-base formulations of D2 might not be useful. However, in my view as outlined above for novelty, these formulations are not within the scope of the claims because the claims require the levamisole to be particulate (a feature D2 is silent on) and they were not formulated for injection but were instead pour-on. I therefore do not consider D2 compelling evidence of something within the scope of the claims not meeting the promise of the invention.
149. At the hearing the Opponent alleged that Example 3 of D1/D1a, as tested by Pippia was evidence of inutility of the current claims. One of the main reasons for this was that in Pippia #1 the particulate/precipitate settled. In my view settling of the precipitate does not destroy the formulations use as a stable formulation for injection. The issue of settling was said to not be prohibitive[124] and that it may have required shaking before use, however, this does not mean it is not useful.
[124] Lichti #2 at 81.
150. I am therefore not satisfied on the basis of this evidence that the opposed claims fail for want of utility.
Conclusion
151. The opposition fails under all grounds relied upon.
Costs
152. Costs normally follow the event. The Opponent submitted during the hearing that the amendment advertised as allowed on 9 October 2017 should be taken into account for determining costs. I had found above in respect to novelty and inventive step that claim 1 (and hence the remaining claims) is only novel and inventive in view of D1 by virtue of the levamisole concentration range that was introduced in the amendment.
153. I am therefore minded the opposition would have been successful on the grounds of lack of novelty and inventive step in view of D1/D1a but for this amendment.
154. I therefore award costs according to Schedule 8 against the Applicant for the period until 19 October 2017, and against the Opponent for the period after 9 October 2017.
K. Wagg
Delegate of the Commissioner of Patents
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