Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V
[2020] FCA 1333
•17 September 2020
FEDERAL COURT OF AUSTRALIA
Boehringer Ingelheim Animal Health USA Inc. v Intervet International B.V. [2020] FCA 1333
Appeal from: A decision of a delegate of the Commissioner of Patents: Merial, Inc. v Intervet International B.V. [2018] APO 52 (17 August 2018) File number: VID 1127 of 2018 Judgment of: MOSHINSKY J Date of judgment: 17 September 2020 Catchwords: PATENTS – appeal under s 60(4) of the Patents Act 1990 (Cth) – novelty – combination injectable formulation for controlling parasites in animals – where opponent contended that alleged invention lacked novelty based on Chinese patent application – where Chinese patent application did not describe the type of formulation intended to be made or any manufacturing steps – where the relevant example in the Chinese patent application specified a concentration of 5% w/v levamisole hydrochloride but the patent application in suit specified a range between 10-35% w/v
PATENTS – appeal under s 60(4) of the Patents Act 1990 (Cth) – inventive step – obviousness – combination injectable formulation for controlling parasites in animals – where opponent contended that alleged invention lacked an inventive step based on common general knowledge alone, or common general knowledge and the Chinese patent application – where the alleged invention was a combination injectable formulation in a non-aqueous solvent system where the macrocyclic lactone was in solution and the levamisole was a salt in particulate form – where there were no known injectable formulations of levamisole in particulate form in an oily formulation – where it was common general knowledge that levamisole and macrocyclic lactones are chemically incompatible
PATENTS – appeal under s 60(4) of the Patents Act 1990 (Cth) – utility – where opponent contended that alleged invention lacked utility – promise of the patent application – whether the patent application promised stability for six months under accelerated conditions – whether, in the alternative, the patent application promised stability for three months under accelerated conditions – whether lack of utility established by stability study data in later patent application
Legislation: Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)
Patents Act 1952 (Cth), s 100
Patents Act 1990 (Cth), ss 7, 18, 59, 60
Patents Amendment Act 2001 (Cth)
Cases cited: Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411
Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618
AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324
AstraZeneca AB v Apotex Pty Ltd (2015) 257 CLR 356
Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420
Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524
Commissioner of Patents v AbbVie Biotechnology Ltd (2017) 253 FCR 436
Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232
Commissioner of Patents v Sherman (2008) 172 FCR 394
Esco Corporation v Ronneby Road Pty Ltd (2018) 358 ALR 431
F Hoffman-La Roche AG v New England Biolabs Inc (2000) 99 FCR 56
General Tire & Rubber Company v Firestone Tyre & Rubber Company Ltd (1971) 1A IPR 121
Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft (2014) 222 FCR 336
H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173
Meat & Livestock Australia Limited v Cargill, Inc (2018) 354 ALR 95
Merial Inc v Intervet International BV (No 3) (2017) 122 IPR 128
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253
Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (2020) 380 ALR 582
Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513
Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2
Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157
Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (2008) 77 IPR 449
Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79
Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262
Division: General Division Registry: Victoria National Practice Area: Intellectual Property Sub-area: Patents and associated Statutes Number of paragraphs: 336 Date of hearing: 16, 17 March 2020, 1, 2, 23 April 2020 Counsel for the Appellant: Mr C Dimitriadis SC with Ms C Cunliffe Solicitor for the Appellant: Ashurst Australia Counsel for the Respondent: Mr CH Smith Solicitor for the Respondent: Spruson & Ferguson Lawyers ORDERS
VID 1127 of 2018 BETWEEN: BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
Appellant
AND: INTERVET INTERNATIONAL B.V.
Respondent
order made by:
MOSHINSKY J
DATE OF ORDER:
17 SEPTEMBER 2020
THE COURT ORDERS THAT:
1.By 4.00 pm on 21 September 2020, the parties provide minutes of proposed orders to give effect to the Court’s reasons.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
REASONS FOR JUDGMENT
MOSHINSKY J:
Introduction
On 23 June 2011, the respondent (Intervet) filed in Australia an application for a standard patent titled “Injectable formulation of a macrocyclic lactone and levamisole” (Application AU 2011268899 C1) (the Patent Application). The invention described in the application relates to injectable formulations comprising a macrocyclic lactone and levamisole for controlling parasites in animals, and the use of such formulations in the preparation of a medicament for controlling parasites.
The Patent Application claims priority from two earlier applications pursuant to the Paris Convention for the Protection of Industrial Property. The Patent Application’s entitlement to priority is not challenged in this proceeding. The priority date of the Patent Application is 24 June 2010 (the priority date).
Examination of the Patent Application was requested on 11 April 2013.
It is common ground that the amendments to the Patents Act 1990 (Cth) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) do not apply to the application. Any subsequent references to the Patents Act relate to the Patents Act prior to those amendments.
On 7 October 2016, the appellant, then called Merial Inc but now called Boehringer Ingelheim Animal Health USA Inc (Boehringer), filed a notice of opposition to the Patent Application. Following the filing of evidence and a hearing, on 17 August 2018 a delegate of the Commissioner of Patents decided to dismiss the opposition and directed the Patent Application proceed to grant.
Boehringer ‘appeals’ to this Court against the delegate’s decision pursuant to s 60(4) of the Patents Act. Although called an ‘appeal’, the proceeding is in the original jurisdiction of this Court and involves a hearing de novo on the grounds and evidence before the Court. On two occasions since the commencement of the proceeding, Intervet sought to amend the Patent Application. On 5 March 2019 and on 18 February 2020, orders were made by consent amending the Patent Application. Subsequent references in these reasons to the “Patent Application” are to the Patent Application as so amended.
By its amended notice of appeal, Boehringer relies on nine grounds, which can be summarised as follows:
(a)Lack of novelty. Boehringer contends that the alleged invention claimed in each of claims 1, 2, 4, 5, 6, 7, 12, 13 and 15 of the Patent Application is not novel in light of Chinese patent application CN 1375291A (CN 291).
(b)Lack of inventive step. Boehringer contends that the alleged invention claimed in each of the claims does not involve an inventive step because it was obvious in the light of the common general knowledge considered alone, or the common general knowledge combined with CN 291.
(c)Lack of utility. Boehringer contends that the alleged invention claimed in each of the claims is not useful, in that the claims of the Patent Application include embodiments that do not achieve the promise of a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole.
Boehringer, as the opponent, bears the onus in relation to each ground of opposition. The authorities establish that, for an opposition to be upheld, it must be “clear” (or “practically certain”) that the patent, if granted, would not be valid.
For the reasons that follow, I have decided that none of the grounds relied on by Boehringer is made out. It follows that the appeal is to be dismissed.
The Patent Application
The introductory page of the Patent Application states that the “present invention relates to injectable formulations for controlling parasites and the use of such formulations in the preparation of a medicament for controlling parasites”.
It is further explained on the introductory page that:
Endoparasites commonly cause clinical disease in [sic] especially in livestock animals and have significant adverse economic effects on farming economies when present at subclinical levels. The most frequently encountered endoparasites are the group of worms referred to as nematodes. The nematodes are found in the intestinal tract, heart, lungs, blood vessels and other body tissues of animals and are a primary cause of anemia, weight loss and malnutrition in the infected animals. The nematodes most commonly found to be the infecting agents of ruminants include Haemonchus and Ostertagia generally found in abomasum; Cooperia, Trichostrongylus and Nematodirus generally found in the intestinal tract, and Dictyocaulus found in the lungs.
Treatment of animals to prevent infestation by any of the above-mentioned parasites, or to reduce or control the proliferation of these parasites in animals is thus important.
Meanwhile the problem has arisen that some parasites develop a resistance to antiparasitic drugs like ivermectin. The resistance occurs when a strain of a parasite is able to tolerate doses of an active ingredient that is efficacious against other populations of parasites of the same species. This characteristic is inheritable.
After the use of macrocyclic lactones (ML) for almost two decades in cattle in Brazil several reports on resistant endoparasites in sheep, cattle and goats were published.
The discovery of novel anti-parasitics with equal or better qualities than macrocyclic lactones seems to be a distant reality in the veterinary pharmaceutical industry.
Therefore, the chemical groups available nowadays must be used in a rational way, with a view to achieving high percentages of efficacy against endoparasites, especially in ruminants and delaying the occurrence of resistant strains.
Therefore a stable formulation for a combination of a macrocyclic lacone [sic] ad [sic] levamisole would be desirable[.] However, such combinations have been difficult to formulate.
Accordingly, there is a need for a stable suspension formulation capable of including macrocyclic lactone compounds together with levamisole.
(Emphasis added.)
As discussed later in these reasons, the problem identified in the above passage, namely that some parasites develop a resistance to anti-parasitic drugs, was common general knowledge as at the priority date. Further, it was common general knowledge that it would be desirable to develop an injectable formulation for a combination of a macrocyclic lactone and levamisole.
Parasiticides was an overarching term for products that treated parasites, and parasiticides that acted on helminths (a type of parasite) were referred to as anthelmintics. Common anthelmintics in use as at the priority date included macrocyclic lactones (such as ivermectin and abamectin) and imidazothiazoles (such as levamisole).
Under the heading “Statement of Invention” on page 2, it is stated that “[h]erein disclosed is a macrocyclic lactone solution formulation comprising levamisole in a particulate form in a non-aqueous solvent system”. It is stated that the non-aqueous solvent system may comprise oil and an organic solvent, and that the formulation may be suitable for injectable administration. A consistory clause for claim 1 is then set out:
According to a first aspect of the present invention, there is provided 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 a salt in a particulate form, and wherein the levamisole salt is present in the range of between 10-35% w/v.
I note the following aspects of the invention claimed in claim 1, which will feature in the expert evidence discussed later in these reasons:
(a)the formulation adopts a non-aqueous solvent system comprising oil and an organic solvent;
(b)the macrocyclic lactone is in solution; and
(c)the levamisole is a salt in a particulate form.
As discussed later in the reasons, it was common general knowledge as at the priority date that:
(a)levamisole and macrocyclic lactones are chemically incompatible and tend to react with each other when combined;
(b)levamisole and macrocyclic lactones are stable under different pH conditions (levamisole requires a pH of about 3.0-4.0 to be stable, while macrocyclic lactones require a pH of around 6.0-7.0); and
(c)levamisole salts are soluble in water, whereas macrocyclic lactones are not water soluble but are soluble in organic solvents, and are commonly formulated in oils and organic solvents.
The invention claimed in claim 1 addresses these issues by adopting a non-aqueous solvent system comprising oil and an organic solvent, in which the macrocyclic lactone is in solution, and the levamisole is a salt in particulate form (that is, in suspension). This type of formulation achieves a separation of the macrocyclic lactone and the levamisole, thus addressing the issue of chemical incompatibility.
Levamisole could be administered as levamisole base or as a salt. Two types of levamisole salt referred to in the evidence are levamisole hydrochloride (levamisole HCl) and levamisole phosphate.
There follows a series of consistory clauses for the other claims.
The detailed description commences on page 3. This includes the following statement (on page 3):
The macrocyclic lactone solution formulation comprising levamisole in a particulate form in a non-aqueous solvent system is advantageous as it provides stable formulations including an avermectin or milbemycin in combination with levamisole.
The complicated nature of prior art formulations is 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.
The formulations of the present invention exhibit desirable properties which are useful characteristics for the administration of relatively high concentrations of levamisole. The formulations are physically and chemically stable. In addition, as the formulation excludes water, the issue of incompatible pH requirements is alleviated. Enabling the two actives to stability [sic] co-exist in a single phase.
The formulations of the present invention must be stable to be of commercial use. In this specification, a commercially acceptable anthelmintic formulation is one which is stable at room temperature for a period of at least 6 months. In conditions of accelerated testing, at 40°C., this requires the potency of the actives within the formulation to remain within specified and acceptable limits for 3 months.
In the last sentence of the third paragraph set out above, the word “stability” should presumably read “stably”. The fourth paragraph set out above is relevant to the lack of utility ground.
The following paragraphs of the detailed description refer to different types of macrocyclic lactones, that is, the avermectin and milbemycin series of compounds. One particularly contemplated macrocyclic lactone parasiticide is ivermectin. Other macrocyclic lactone parasiticides are listed on pages 3 to 4.
On page 4, it is stated that levamisole as used in the specification “includes levamisole base, levamisole hydrochloride, levamisole phosphate together with other salts and forms”. It is stated that, in one embodiment, levamisole HCl is used. It is stated:
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[.]
Good results were obtained with a formulation comprising 1.6 - 4% w/v ivermectin and 15.04 - 18.8% w/v levamisole hydrochloride.
The following explanations are provided of terms used in the specification (on page 4):
By “particulate form” it is meant mobile, un-dissolved, solid matter suspended in a liquid. The liquid may be aqueous, oily, or both.
A solution is a mixture of two or more components that form a single phase that is homogeneous down to the molecular level.
A suspension consists of insoluble solid particles dispersed in a liquid medium, with the solid particles accounting for about 0.5% to about 30% of the suspension.
By “w/v” is meant weight/volume, i.e. “1% w/v” means 1 g in 100 ml of the formulation. “v/v” means volume per volume, and 1% v/v means 1 ml, in a total of 100 ml.
“Non-aqueous solvent system” means a solvent or a mixture of solvents that essentially consisting [sic] of liquid(s) other than water. The non-aqueous solvent system comprises at least one oil and at least one organic solvent.
There follows, on pages 4 to 5, a description relating to oils that can be used in the formulations. On page 5, reference is made to the organic solvent and to additional pharmaceutical excipients.
Preferred components and their concentration ranges are set out on page 6.
It is stated, on page 6, that in a preferred embodiment, the formulations according to the invention are used to treat a helminth infection, such as an infection caused by one or more of the helminths listed on that page. It is stated that, in cattle, the major production limiting parasite species is Ostertagia spp, and that another important cattle parasite is Cooperia spp.
The Patent Application provides some example formulations, including instructions for their manufacture, on pages 8 and 9. The example formulations are referred to as F1, F2, F3 and F4. Stability data in relation to these formulations is set out in Table 2 on page 10. I note that the heading to that table is inaccurate in that it refers only to “Formulation 3”, whereas the data presented in the table covers all four formulations. I also note that, somewhat confusingly, the data in the table is not presented in the numerical order of the four formulations, but rather presented in the following order: F1, F2, F4 and F3. As indicated in the sub-heading appearing immediately above the table, the data is based on accelerated stability studies, as distinct from studies conducted at room temperature, a matter that is relevant to the lack of utility ground.
Data from efficacy testing is set out in Table 3 on page 11.
The claims in the Patent Application are as follows:
1.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 a salt in a particulate form, and wherein the levamisole salt is present in the range of between 10-35% w/v.
2.The formulation as claimed in claim 1, wherein the levamisole is present in the range of between 12-25% w/v.
3.The formulation as claimed in claim 1 or claim 2, wherein the oil comprises castor oil and a medium chain triglyceride or a mixture of medium chain triglycerides.
4.The formulation as claimed in any one of claims 1 to 3, wherein the organic solvent is dimethylacetamide.
5.The formulation as claimed in any one of claims 1 to 4, wherein the macrocyclic lactone compound is present in the range of between 0.01-10% w/v.
6.The formulation as claimed in any one of claims 1 to 5, wherein the macrocyctic lactone compound is selected from the group comprising abamectin, doramectin, eprinomectin, ivermectin and moxidectin.
7.The formulation as claimed in any one of claims 1 to 6, wherein the levamisole is levamisole hydrochloride.
8.The formulation as claimed in any one of claims 1 to 6, wherein the levamisole is levamisole phosphate.
9.The formulation as claimed in any one of claims 1 to 8, wherein the non-aqueous solvent system comprises dimethylacetamide and an oil, wherein the oil comprises castor oil and a medium chain triglyceride or a mixture of medium chain triglycerides.
10.The formulation as claimed in any one of claims 1 to 9, wherein the formulation additionally includes at least one further medicament selected from the group of anthelmintics, dietary supplements, vitamins, minerals.
11. The formulation as claimed in claim 1, comprising:
•about 1.5-4% w/v ivermectin,
•about 15-18.8% w/v levamisole salt, and
wherein the levamisole salt is particulate and the ivermectin is substantially dissolved in a non-aqueous solvent system comprising dimethylacetamide and an oil, wherein the oil comprises castor oil and a medium chain triglyceride or a mixture of medium chain triglycerides.
12.A method for treating or preventing helminth infection of cattle with Cooperia or Ostertagia spp. by injecting an animal in need thereof with a formulation as claimed in any one of claims 1 to 11.
13.Use of a formulation according to any one of claims 1 to 11 for the manufacture of a medicament for the treatment of parasitoses caused by helminth infestations.
14A method of preparing an injectable formulation as claimed in any one of claims 1 to 11 comprising the steps of:
•mixing an organic solvent with the macrocyclic lactone
•mixing the macrocyclic lactone solution with an oil
•add levamisole salt and mix until complete homogenisation
•mill to get a homogeneous suspension of levamisole salt.
15.The method as claimed in claim 12 or the use as claimed in claim 13, wherein the macrocyclic lactone compound is selected from the group comprising abamectin, doramectin, eprinomectin, ivermectin and moxidectin, and the levamisole is levamisole hydrochloride or levamisole phosphate.
16.An injectable formulation of a macrocyclic lactone and levamisole salt as defined in claim 1, substantially as hereinbefore described with reference to the Example Formulations.
17.The formulation according to claim 16, wherein said formulation is Formulation F3 as described in the Example Formulations.
18.A method as defined in claim 14 of preparing an injectable formulation, said method being substantially as hereinbefore described with reference to the Example Formulations.
19.The method according to claim 18, wherein said formulation is Formulation F3 as described in the Example Formulations.
I note that the above quotation of the claims takes into account the deletion of certain words from claim 11 effected by the orders dated 18 February 2020.
Claim 1 is the broadest claim, and defines an injectable formulation having the features there set out. Claims 2 to 11 are dependent claims that also define injectable formulations, adding various features relative to claim 1. Claim 12 relates to a method for treating or preventing helminth infection of cattle with Cooperia or Ostertagia spp, by injecting an animal in need with the injectable formulation of claims 1 to 11. Claim 13 is a so-called ‘Swiss type’ claim (see Commissioner of Patents v AbbVie Biotechnology Ltd (2017) 253 FCR 436 at [58]). Claim 14 is to a method of preparing an injectable formulation. Claim 15 depends on claims 12 and 13, and specifies a smaller group of macrocyclic lactones and levamisole. Claims 16 to 19 are limited by reference to the examples.
Applicable principles in relation to an appeal under s 60(4)
As noted by Heerey, Kenny and Middleton JJ in Commissioner of Patents v Sherman (2008) 172 FCR 394 at [18], the fundamental principles governing an appeal against a decision of the Commissioner of Patents on an opposition to a grant of a patent are well settled. Their Honours stated (at [18]-[22]):
18… First, an appeal under s 60(4) of the Patents Act is not an appeal in the strict sense. Rather, it is a proceeding in the original jurisdiction of the Court and is conducted as a rehearing (sometimes referred to as a hearing de novo): see Jafferjee v Scarlett (1937) 57 CLR 115 at 119 per Latham CJ; and Kaiser Aluminum & Chemical Corporation v Reynolds Metal Company (1969) 120 CLR 136 at 142 per Kitto J. The Court upholds the opposition only if clearly satisfied that the patent, if granted, would be invalid: see Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 at 251 per Dixon CJ, McTiernan, Fullagar, Taylor and Windeyer JJ; and Denison Manufacturing Company v Monarch Marking Systems Inc (1983) 76 FLR 200 at 201 per Smithers J and 215 per Franki J. An appeal under s 60(4) of the Patents Act is different from some other “appeals” (as referred to in some other enactments) against administrative decisions that may be brought to this Court, where the Court decides whether the decision was correct in law, having regard to the evidence that was before the decision-maker at the time of making the decision. In an appeal under s 60(4) of the Patents Act, the Court does not ask this question.
19Secondly, on an appeal under s 60(4) of the Patents Act, subject to the Court’s direction, the parties may lead evidence-in-chief. The position of the opponent is relatively clear. As Emmett J said in F Hoffman-La Roche AG v New England Biolabs Inc (2000) 99 FCR 56 at [30], “[i]t would … be open to an opponent simply to tender the material that was before the Commissioner” and the “Court could, subject to all proper objections, admit that evidence”, although the opponent is not bound to this course.
20Thirdly, the only evidence to be taken into account at the hearing of an appeal under s 60(4) will be the evidence tendered or admitted at the hearing: see Caroma Sales Pty Ltd v Philmac Pty Ltd (1972) 46 ALJR 324 at 324; [1972-73] ALR 427 at 428; Brickwood Holdings Pty Ltd v ACI Operations Pty Ltd [1983] 2 VR 587 at 588-589 per King J; European Community v Commissioner of Patents (2006) 68 IPR 539 at 543 per Young J; and Cadbury Schweppes plc v Effem Foods Pty Ltd (2006) 69 IPR 584 at 586 per Lindgren J. This is the evidence on which the Court acts. As Kitto J said in Kaiser Aluminum 120 CLR at 142-143, in relation to the same kind of proceeding under the former Patents Act 1952 (Cth), the outcome of a proceeding such as this “must be decided upon the evidence adduced before [the] Court”, even if a different case than that made before the Commissioner. We return to this proposition below, which is virtually decisive of the outcome of this appeal.
21Fourthly, whilst the Court will make its own decision on the basis of the evidence before it, in deciding whether the applicant (here, Mr Sherman) has made out his case on the balance of probabilities, the Court will take into account the nature of the proceeding and the fact that the proceeding concerns the decision of an expert administrative decision-maker: see Commissioner of Patents v Emperor Sports Pty Ltd (2006) 149 FCR 386 at [24]; EI Du Pont de Nemours and Company v ICI Chemicals & Polymers Ltd (2003) 128 FCR 392 at [28] per Emmett J; EI Du Pont de Nemours and Company v ICI Chemical Industries plc (2002) 54 IPR 304 at [17] per Branson J; Neumann v Sons of the Desert SL [2008] FCA 1183 at [2] per Ryan J; and s 140 of the Evidence Act. The Full Court in Emperor Sports 149 FCR 386 at [24] explained that:
The Commissioner is an administrative decision-maker equipped with technical expertise. Subject to the rules of natural justice both common law and statutory … he or she is entitled to make use of that expertise, and draw inferences that may be rationally drawn from technical knowledge, including how skilled persons of various descriptions may act in their respective occupations … On an appeal by way of hearing de novo the judge would not be a person credited with technical expertise of his or her own. In such an event the judge may be able to take into account conclusions of the Commissioner based on his or her expertise, subject of course to the rights of other parties to call rebutting or supporting evidence.
Also in Emperor Sports 149 FCR 386 at [33], the Full Court noted that, when the identification of the relevant prior art is in dispute, “it is necessary to have either evidence or, which amounts to the same thing, reliance by an administrative decision-maker of expertise appropriate to the office”. Naturally enough, the weight given by the Court to the Commissioner’s findings will be affected by the extent to which the Court permits evidence to be adduced before it that was not before the Commissioner: see Du Pont 128 FCR 392 at [28] and Du Pont 54 IPR 304 at [17]. We return to these matters on the question of the admissibility of the evidence in question under the Evidence Act.
22Fifthly, where a ground of opposition depends on proof of a fact, the onus of proof lies on the party seeking to make out the ground. Usually the party bearing this onus will be the opponent, but sometimes, as in the present case, it will be the Commissioner: see Titan Mining & Engineering Pty Ltd v Arnall’s Engineering Pty Ltd (1988) 12 NSWLR 73 at 75 per McLelland J.
(Emphasis in original.)
The grounds on which the grant of a standard patent may be opposed are set out in s 59 of the Patents Act. These in turn require consideration of other provisions of the Act, including s 7 (in relation to novelty and inventive step) and s 18 (in relation to novelty, inventive step and utility).
The opponent bears the onus in relation to each ground of opposition. The authorities establish that, for an opposition to be upheld, it must be “clear” (or “practically certain”) that the patent, if granted, would not be valid: Commissioner of Patents v Sherman at [18]; F Hoffman-La Roche AG v New England Biolabs Inc (2000) 99 FCR 56 (F Hoffman-La Roche) at [29], [67] per Emmett J; see also Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 at 244-245, 251 per Dixon CJ, McTiernan, Fullagar, Taylor and Windeyer JJ. In F Hoffman-La Roche, Emmett J stated at [67]:
The language employed in the cases to which I have referred suggests that it should appear clear to the Court that no patent granted in respect of the specification would be valid. I consider that, before the Court would uphold an opposition to the grant of a patent, the Court should clearly be satisfied that the patent, if granted, would not be valid.
See also Austal Ships Pty Ltd v Stena Rederi Aktiebolag (2005) 66 IPR 420 at [12] per Bennett J; Merial Inc v Intervet International BV (No 3) (2017) 122 IPR 128 (Merial) at [13]-[16]; and Meat & Livestock Australia Limited v Cargill, Inc (2018) 354 ALR 95 at [11] per Beach J.
The hearing
At the hearing, Boehringer led evidence from the following witnesses:
(a)Mr Giuseppe (Joe) Robin Pippia (a chemist);
(b)Mr Kai Kin Lau (a pharmaceutical expert, whose evidence focussed on pharmaceutical formulation);
(c)Dr Paul John Martin (a pharmaceutical expert, whose evidence focussed on issues of parisitology);
(d)Mr Rodney Ian Lindsay Cruise (a patent attorney);
(e)Ms Melanie Kitchin (a solicitor); and
(f)Mr Marmikkumar Mohanlal Patel (an analytical chemist).
Mr Cruise, Ms Kitchin and Mr Patel were not required to attend for cross-examination.
Intervet led evidence from the following witnesses:
(a)Mr Mark Colin Vickers (a pharmaceutical expert); and
(b)Mr Matthew Blair Stewart (a patent attorney).
Mr Stewart was not required to attend for cross-examination.
Joint reports were prepared as follows:
(a)a joint report of Mr Lau and Mr Vickers addressing eight questions, which largely focussed on issues of pharmaceutical formulation (the Lau/Vickers Joint Report); and
(b)a joint report of Dr Martin and Mr Vickers addressing seven further questions (numbered 9 to 15), which covered issues relating to the administration of veterinary pharmaceuticals, in particular issues relating to the safety and efficacy of parasiticides (the Martin/Vickers Joint Report).
The hearing of the proceeding took place over five days. Due to the COVID-19 pandemic, days 3, 4 and 5 of the hearing took place using video-conferencing software (Microsoft Teams), with counsel and witnesses appearing remotely. While there were occasional issues with the quality of the audio, the overall quality of the video and audio was good, and the hearing was able to proceed in a satisfactory manner. The parties were given the opportunity to review the transcript and provided an agreed list of corrections. In a small number of cases, a party requested that I review the recording of the hearing to check the transcript. The transcript was subsequently amended and re-issued to incorporate the corrections arising from those processes.
The oral evidence at the hearing was structured as follows. On day 1, Mr Pippia gave evidence and was cross-examined. Mr Lau and Mr Vickers gave evidence concurrently on days 2 and 3 of the hearing. The subject matter of their evidence reflected the subject matter of their joint report, namely pharmaceutical formulation issues. Dr Martin and Mr Vickers gave evidence concurrently on day 4. Their evidence also dealt with the subject matter of their joint report, in particular issues relating to the safety and efficacy of parasiticides.
In the period between day 4 and day 5, the parties filed written outlines of closing submissions. (I note for completeness that the page and line references to the transcript in those documents are based on the transcript as originally issued, rather than the re-issued versions.) The parties’ counsel presented oral closing submissions on day 5.
The witnesses
The principal evidence led by Boehringer was that of Mr Lau and Dr Martin. The principal evidence led by Intervet was that of Mr Vickers. I will make some observations about the evidence of these witnesses, and then refer to the other witness who gave oral evidence, Mr Pippia.
Mr Lau
Mr Lau is a technical consultant at Woodlink Consulting Services Pty Ltd, which is his own consultancy business and provides consulting services to animal health companies in relation to quality systems and formulation development. Mr Lau has qualifications in science and more than 30 years’ experience in the field of pharmaceutical formulation, particularly the formulation and chemical and physical analysis of medicaments for animals.
Between 1985 and 1993, Mr Lau held positions as a research chemist, a quality control manager and senior formulation scientist as detailed in his affidavit dated 24 May 2019 (Mr Lau’s first affidavit).
In 1993, Mr Lau joined Jurox Pty Ltd (Jurox) in New South Wales, as a quality manager. In 2003, he became the Head of Chemistry at Jurox. He remained in that position until mid-December 2014. While at Jurox, he carried out and supervised the formulation and development of more than 30 veterinary products, including a number of injectable anthelmintic products. Mr Lau is a (or the) named inventor for about 16 patent applications or patents relating to his work at Jurox. From 2006 to 2008, Mr Lau was a PhD supervisor for the Department of Pharmacy of the University of Newcastle.
Mr Lau’s qualifications and experience, as detailed in his first affidavit, establish that (as stated in that affidavit) he has developed specialised knowledge in the field of pharmaceutical formulation, in particular the formulation and chemical and physical analysis of veterinary products.
In his oral evidence, Mr Lau demonstrated his deep expertise in matters of chemistry and the formulation aspects of the development of pharmaceutical products. Subject to the matters discussed below, I generally accept his evidence.
In some instances, Mr Lau made concessions during his oral evidence. This bolstered his credibility as a witness whose evidence was directed to assisting the Court. To the extent that there were differences between his oral and written evidence, I prefer his oral evidence.
Mr Lau quite properly acknowledged the limits of his expertise during his oral evidence. For example, when asked to comment on certain oral evidence given by Mr Vickers concerning the relative speed at which macrocyclic lactones and levamisole act on parasites, Mr Lau indicated that this was not his area of expertise. Later in his oral evidence, he confirmed that issues of efficacy were outside his expertise.
In matters of formulation chemistry, Mr Lau has a greater level of expertise than Mr Vickers. I do not consider this to be controversial; I took Mr Vickers to accept that to be the case. Accordingly, to the extent that there were differences between Mr Lau and Mr Vickers regarding matters of formulation chemistry, I prefer the evidence of Mr Lau.
Dr Martin
Dr Martin is the director of PJM Scientific Pty Ltd, which is his own consultancy firm providing services to the Australian and New Zealand animal health industries. He has qualifications in science and more than 25 years’ experience in the field of animal health research and product development, including parasitology and the development of parasiticides for animals.
In 1968, Dr Martin began working as a lab technician with the Commonwealth Scientific and Industrial Research Organisation (CSIRO). In 1979, he completed a Bachelor of Science with Honours at the University of New England. Dr Martin worked as an experimental scientist and subsequently as a senior research scientist at CSIRO. Between 1983 and 1989, he undertook a PhD at the University of Melbourne. This focussed on understanding the genetics and population biology of parasite populations and their ability to become resistant to treatment.
In 1991, Dr Martin commenced employment at Pitman-Moore Australia Limited (later Mallinckrodt Veterinary Limited) as a senior research and development scientist. He progressed to the position of Product Development Manager (Australia and New Zealand).
In 1995, Dr Martin commenced employment as Director of Research and Development at Virbac (Australia) Pty Ltd (Virbac). In this role, he was involved in the formulation, chemistry, registration, clinical studies and quality control of products, as well as the development of parasiticides, antibiotics, dermatological products and vaccines for agricultural and companion animals. His responsibilities included oversight of the Research and Development teams in both Australia and New Zealand.
Virbac is part of a multinational group of companies. At Virbac, the development of large animal parasiticide products took place in Australia. Much of Dr Martin’s work at Virbac was on the development of products for cattle.
Dr Martin left Virbac in 2008 to start his own consultancy firm, PJM Scientific. PJM Scientific provides consulting services in relation to animal health research and development, product registrations, project management, animal parasitology, expert scientific writing, education and training. His work at PJM Scientific is focussed on the design and stability testing, as well as safety and efficacy testing, of products that his clients intend to have registered and put on the market.
In addition to authoring or co-authoring a large number of peer-reviewed journal articles, Dr Martin is named as an inventor in a number of patent applications and patents relating to parasitic treatment of animals.
Dr Martin’s qualifications and experience, as detailed in his affidavit dated 24 May 2019 (Dr Martin’s first affidavit), establish that he has developed specialised knowledge in the field of parasitology and the development of parasiticides for animals.
In his oral evidence, Dr Martin demonstrated his expertise in the matters about which he gave evidence. There were no substantial points of disagreement between Dr Martin and Mr Vickers, and I generally accept Dr Martin’s evidence.
Mr Vickers
Mr Vickers is the Managing Director of Seacrest Farms Limited, a New Zealand company. In this position, he works as a regulatory and product development consultant for a range of clients in veterinary medicines, in particular anthelmintics. His role includes the registering of animal health products in Australia and New Zealand, the on-farm investigation of adverse effects of registered products, including anthelmintics, and the management and development of new products, including veterinary anthelmintic products in the Australian and New Zealand markets.
Mr Vickers obtained a Bachelor of Veterinary Science in 1979 from Massey University in New Zealand. From 1979 to 1990, he worked as a Veterinary Investigation Officer within the Animal Health Laboratory network of the Ministry of Agriculture and Fisheries in New Zealand. Mr Vickers states in his affidavit, and I accept, that the New Zealand and Australian animal health laboratories worked closely together, including holding joint workshops, exchanging newsletters and sometimes staff to facilitate staff development and ongoing training, and to facilitate a greater trans-Tasman/Australasian understanding of disease and disease trends.
Mr Vickers states in his affidavit, and I accept, that in his role as a Veterinary Investigation Officer he was trained (including ongoing internal training) across all laboratory disciplines, including gross and microscopic pathology, chemistry and toxicology, biochemistry, haematology, virology and serology and parasitology, and in the on-farm investigation of diseases.
From 1990 to 1994, Mr Vickers was a consultant with Ruakura Animal Health Laboratory.
From 1994 to 1997, Mr Vickers held the position of Australasian Regulatory Affairs, Research and Development Manager with Bomac Laboratories Ltd (Bomac), a pharmaceutical company. At this time, two New Zealand companies – Bomac and Ancare Limited – emerged as large players within both the New Zealand and the Australian animal health markets; they also marketed their products internationally. Mr Vickers was based at Bomac’s manufacturing site in South Auckland, and had direct contact with those in production, as well as formulation and analytical chemists. Mr Vickers personally supervised the development of a range of products, including skin, nutritional, metabolic, antibiotic and anti-parasitic preparations for a range of animal species, including managing clinical trials conducted both in Australia and New Zealand.
From 1997 to 2001, Mr Vickers held the position of Australasian Regulatory Affairs and Development Manager with Nufarm Limited/Captec, located at the Nufarm manufacturing site in South Auckland. Mr Vickers’s role included, initially, the marketing and technical support of the sales staff for anthelmintic products, both in Australia and New Zealand. In his development role, he chaired the development meetings and was responsible for overseeing the entire development process, with formulation chemists, analytical chemists, product staff and regulatory affairs staff reporting directly to him. Mr Vickers routinely travelled to Australia around six times per year, often one to two weeks at a time. This included meeting with various business and technical staff in relation to the product development and trials.
Between 2001 and 2003, Mr Vickers was the Project Manager for Veterinary Medicines and Animal Health at AgriQuality, a State-owned enterprise, and also the national Manager of the animal health laboratories for AgriQuality. His role included responsibility for over 60 laboratory staff, including parasitology staff.
In 2003, Mr Vickers established his consultancy company, Seacrest. In this role, he acts as an independent consultant, working with a number of national and international clients to evaluate new products in animal health, pest control and environmental products. This work continues to the present day.
Between 2008 and 2009, in addition to performing his role at Seacrest, Mr Vickers was employed as the Quality Assurance Manager of Alpha Laboratories (NZ) Limited (Alpha), a large contract manufacturing company of human health products/complementary medicines. Its product range spanned animal, plant, bee and marine products. Mr Vickers’s role included management of both Quality Assurance and Quality Control aspects, as well as overseeing areas including Australian and New Zealand regulatory affairs, formulation, production and technical staff. His role included developing new products and manufacturing processes and maintaining commercial relationships in Australia and New Zealand. From 2009 to 2010, Mr Vickers was the Technical and Regulatory Affairs, New Product Development Manager for Alpha. In this role, his focus was on the formulation, production and regulatory affairs of new products, including overseeing 10 to 12 technical staff.
During the period of time up to and including June 2010, a focus of Mr Vickers’s consulting work for Seacrest was investigating the benefit of combining levamisole and macrocyclic lactones in cattle, and in developing a formulation of combination injectable anthelmintics, particularly combinations of levamisole phosphate and ivermectin or abamectin.
Mr Vickers is named as an inventor for a number of patents and patent applications, including patents and patent applications relating to anthelmintics.
Over the course of Mr Vickers’s career, including as set out above, he had worked in Australia and New Zealand and with organisations and regulatory bodies in Australia, New Zealand and other countries around the world. Based on his experience in interacting with colleagues in Australia, he considered that what was known in the field in New Zealand as at June 2010 was also known in Australia at that time. International journals, particularly veterinary journals, often contained articles on, and also product advertisements, that related to anthelmintic products. There was also movement of veterinarians in practice between the USA, UK, Australia and New Zealand.
Subject to what I say below, I accept that, as a result of his training, study and experience, Mr Vickers has developed specialised knowledge of:
(a)the interpretation of laboratory results including pathology and parasitology results and a knowledge of various disease control programs;
(b)veterinary pharmaceuticals, and the development and manufacture of such pharmaceuticals (including antibiotics and anti-parasitic preparations) for a variety of animal species;
(c)designing, planning and conducting farm trials;
(d)formulation, production (manufacture) and regulatory affairs in Australia and New Zealand of new veterinary pharmaceutical products;
(e)the benefits of combining levamisole and macrocyclic lactones in agricultural animals such as cattle and sheep, and in developing a formulation of combination injectable anthelmintics; and
(f)common parasites, their effects on agricultural production animals and the resistance prevalent in these parasites.
During his oral evidence, Mr Vickers accepted that he had never been a formulation chemist. He said that, while he might have input into formulations, and might also have evaluated formulations, he did not do the day-to-day formulating. Mr Vickers accepted that Mr Lau had done more formulation chemistry work than him. In response to a question as to how he would describe himself, if not a formulation chemist, Mr Vickers said that product development manager or regulatory affairs were the areas in which he worked.
In the Lau/Vickers Joint Report, Mr Vickers referred to US patent 4096271 to support his view that the levamisole HCl in Example 3 of CN 291 existed as a solution. However, in oral evidence he accepted that the patent was teaching that it was a levamisole base and other bases of formula 1 that were soluble in the benzyl benzoate solvent, and that the corresponding salts, including levamisole HCl, were not soluble because they would precipitate out. This portion of the oral evidence tends to support the approach that I am taking, that is, to prefer the evidence of Mr Lau on matters of formulation chemistry.
Notwithstanding the preceding paragraph, Mr Vickers impressed me as having considerable knowledge and experience in relation to the development of veterinary pharmaceutical products, in particular in relation to safety and efficacy issues. Thus, while I prefer Mr Lau’s evidence in relation to matters of formulation chemistry, I otherwise generally accept Mr Vickers’s evidence. To the extent that there were differences between Mr Vickers’s written and oral evidence, I prefer his oral evidence.
Mr Pippia
Mr Pippia is the Managing Director of Pia Pharma Pty Ltd, which provides analytical, manufacturing, regulatory and consulting services to the pharmaceutical, animal health and agrochemical industries. He has 28 years’ experience in laboratory-based research and analysis of veterinary pharmaceutical products. Mr Pippia’s qualifications and experience are set out at [7]-[17] of his affidavit. I accept that he has expertise in relation to the analytical and formulation aspects of the development of veterinary pharmaceuticals.
Mr Pippia’s evidence concerned the design, conduct and results of a study that he undertook to prepare and determine the properties of the formulation described in Example 3 in CN 291. I accept Mr Pippia’s evidence.
The lack of novelty ground
The issue
Boehringer contends that the alleged invention claimed in each of claims 1, 2, 4, 5, 6, 7, 12, 13 and 15 of the Patent Application is not novel in the light of CN 291, being a Chinese patent application. This ground is set out in grounds 2 and 3 of Boehringer’s amended notice of appeal:
2.The Delegate erred in finding that the invention as claimed in the [Patent] Application is a patentable invention within the meaning of s 18(1)(b)(i) of the Act and that the alleged invention was novel in light of [CN 291] as published on 23 October 2002.
3.In making the finding referred to in paragraph 2 above, the Delegate erred in:
(a)finding that [CN 291] does not provide clear and unmistakable directions to use levamisole in a range of 10-25% (w/v) ([78] to [81] of the Decision); and
(b) further or in the alternative, finding that the range of 10-35% levamisole as claimed in claim 1 of [CN 291] was not arbitrary ([57] and [78] of the Decision).
In brief summary, Boehringer submits that Example 3 of CN 291 discloses a formulation with macrocyclic lactone in solution and levamisole HCl in particulate form. Boehringer submits that, although Example 3 does not describe the levamisole HCl as being in particulate form (or in a suspension), the experimental evidence of Mr Lau and Mr Pippia, which is consistent with Mr Lau’s understanding, based on his common general knowledge, demonstrates that the levamisole HCl is in particulate form in a suspension. Accordingly, Boehringer submits, CN 291 anticipates at least claim 1 of the Patent Application. Boehringer also submits that a number of the other claims are anticipated by CN 291.
Applicable principles
Section 18(1)(b)(i) of the Patents Act requires that an invention be novel when compared with the prior art base as it existed before the priority date of each claim. Novelty is to be assessed in accordance with s 7(1) of the Act, which provides that an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the kinds of information identified in s 7(1). Relevantly, these include information made publicly available in a single document.
The principles for the assessment of novelty are well established. The key decisions include: Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513, Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524 (Bristol-Myers), H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 (Lundbeck) and AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324 (AstraZeneca FC).
In Lundbeck, Bennett J (with whom Middleton J agreed) set out, at [173], a series of general propositions relating to novelty that emerge from the cases, including:
•Commonly the only question may be whether the prior publication describes the claimed invention with sufficient clarity (Bristol-Myers 97 FCR 524 at [67]).
•The disclosure is assessed by reference to the skilled addressee, a person of ordinary skill in the art.
•The question is whether the prior publication is sufficient to make the claimed invention apparent to the skilled addressee (Nicaro Holdings Pty Ltd v Martin Engineering Company (1990) 91 ALR 513 at 529).
•A prior publication does not invalidate a patent unless it supplies sufficient information to enable a person of ordinary skill to produce the product subsequently claimed (Acme Bedstead Company Ltd v Newlands Brothers Ltd (1937) 58 CLR 689 at 707). A specification is not to be read as in a vacuum but by the reader having at least the common knowledge of the art (Acme Bedstead 58 CLR at 701; Nicaro 91 ALR at 530).
•The requirement is that a person of ordinary knowledge of the relevant subject would be able practically to apply the prior published discovery without the necessity of making further experiments (Hill v Evans 1A IPR at 6-7).
•The further experiments do not include those that formed part of standard procedure or common general knowledge. They are experiments with a view to discovering something not disclosed (Van der Lely 1A IPR at 90).
•The further experiments do not mean ordinary methods of trial and error (Van der Lely 1A IPR at 90).
…
•Something less than a full description of the invention allegedly anticipated may be sufficient to invalidate it for want of novelty (Nicaro 91 ALR at 529).
…
•A direction, recommendation or suggestion may be implicit in what is described (Bristol-Myers 97 FCR 524 at [67]).
•A disclosure that describes an effective means by which a claimed invention may be produced falls short of anticipation if it requires the exercise of inventive ingenuity or the taking of any inventive steps (Nicaro 91 ALR at 531).
Further, at [181], Bennett J stated:
If the prior art discloses some but not all integers of a claimed patent to a product, such as a combination, there is anticipation if the skilled addressee would add the missing information as a matter of course and without the application of inventive ingenuity or undue experimentation (Nicaro 91 ALR at 530-531).
In AstraZeneca FC, Besanko, Foster, Nicholas and Yates JJ stated at [293] that the touchstone for determining whether a prior publication, such as the patent relied on in that case, anticipates a claimed invention, was stated in General Tire & Rubber Company v Firestone Tyre & Rubber Company Ltd (1971) 1A IPR 121 (General Tire) at 138 as follows:
When the prior inventor’s publication and the patentee’s claim have respectively been construed by the Court in the light of all properly admissible evidence … the question whether the patentee’s claim is new … falls to be decided as a question of fact. If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor’s publications will inevitably result in something being made or done which, if the patentee’s patent were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented … [a] signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
After setting out that passage, Besanko, Foster, Nicholas and Yates JJ continued:
294The metaphor of planting the flag has been taken up in this Court. For example, in ICI Chemicals, the Full Court at [51], after noting the metaphor, remarked that, in that case, the appellant’s argument involved the skilled addressee rummaging through a “flag locker” to find a flag which the prior art document possessed and could have planted. In Apotex Pty Ltd v Sanofi-Aventis (2008) 78 IPR 485 (Sanofi-Aventis (2008)), Gyles J at [91] adopted a different metaphor, remarking that “[a]nticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun”. Each metaphor underlines the importance of the specificity required in order for a prior art document to anticipate an invention as claimed.
…
298Here, relying only on the disclosures of the 471 patent, and not imputed common general knowledge concerning the administration of prior art statins, the person skilled in the art might seek to use one or any number of different dosages and dosage regimens for administering a pharmaceutical composition containing either the sodium salt or the calcium salt of rosuvastatin to treat hypercholesterolemia. It is possible that, out of a very large number of possibilities, the person skilled in the art might, based only on the disclosures of the 471 patent, use the dosage and dosage regimen of claim 1 or claim 2 of the 051 or low dose patent. But it is at least equally possible that such a dosage and dosage regimen might not be used. It cannot be said, therefore, that, by following the directions — such as they are — in the 471 patent, the person skilled in the art would inevitably do something that would inevitably infringe either claim 1 or claim 2 of the 051 or low dose patent.
299It is here that the true setting for using the notion of reverse infringement in assessing anticipatory disclosure must be recognised. In Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 Aickin J (at 235) said:
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.
300But it is important to note that the reverse infringement test is not applied by simply asking whether something within the prior art document would, if carried out after the grant of the patent, infringe the invention as claimed. In Flour Oxidizing Company Ltd v Carr & Company Ltd (1908) 25 RPC 428, Parker J (at 457) observed:
… where the question is solely a question of prior publication, it is not, in my opinion, enough to prove that an apparatus described in an earlier Specification could have been used to produce this or that result. It must also be shown that the Specification contains clear and unmistakable directions so to use it.
301These observations are the wellspring of a long line of cases that recognise that, in order for a prior art document to be anticipatory, there must be (to adopt the language in General Tire) a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent. In Bristol-Myers Squibb Company v FH Faulding & Company Ltd (2000) 97 FCR 524 (Bristol-Myers), Black CJ and Lehane J reviewed the relevant authorities and concluded (at [67]):
What all of those authorities contemplate, in our view, is that a prior publication, if it is to destroy novelty, must give a direction or make a recommendation or suggestion which will result, if the skilled reader follows it, in the claimed invention. A direction, recommendation or suggestion may often, of course, be implicit in what is described and commonly the only question may be whether the publication describes with sufficient clarity the claimed invention or, in the case of a combination, each integer of it. But in this case medical practitioners hardly needed to be told that it was possible to infuse a particular dose of taxol over three hours, or how to do it. Nor, equally obviously, is that the point of the claims. The claims of the earlier of the petty patents are for a method for administration of taxol to a patient suffering from cancer; the claims of the later one are for a method of treating cancer. In each case the method involves a particular regimen for the infusion of taxol. The context was that great difficulties had been encountered in using taxol, despite its known anti-carcinogenic properties, in the treatment of cancer, because of the drug’s side effects. Each of the trials reported in the articles referred to was an investigation directed towards finding a solution of the difficulties: directed, particularly, to ascertaining safe dosage levels. But, though methods falling within the claims of the patents were used in each trial, none of the reports can be said to teach (a word which in this context encompasses direct, recommend and suggest) that which the petty patents claim.
302Sufficiency of disclosure is a cardinal anterior requirement in the analysis of whether a prior art document anticipates a claimed invention. It is only after the stage of assessing the sufficiency of disclosure — which involves a determination about whether a prior document has “planted the flag” as opposed to having provided merely “a signpost, however clear, upon the road” or, perhaps, something less — that the notion of reverse infringement comes into play as the final and resolving step of the required analysis. It is not the first step of the required analysis; nor is it the only step.
See also the discussion of the principles in AstraZeneca FC at [345]-[352].
The person skilled in the art
In Boehringer’s outline of closing submissions, it submits that: the skilled person to whom the Patent Application is directed is a team with experience in the field of animal health, including the development of injectable dosage forms for drug delivery for use in the treatment of animals (including cattle); and the team consists of a pharmaceutical formulator, instructed by a parasitology expert or experts with knowledge of the possible modes of administration, active ingredients and their concentration and the dose volume. Intervet did not dispute that the person skilled in the art was a team comprising these persons, but also placed some emphasis in its evidence and submissions on the process of obtaining regulatory approval of new products. However, I am not persuaded that the notional team need include a person with such skills, which relate to processes after development of a product. I accept Boehringer’s description of the notional skilled team.
CN 291
No issue has been raised as to the publication and public availability of CN 291 before the priority date. Further, Intervet admits that the English translation in the Court Book is accurate.
CN 291 is a patent application published on 23 October 2002 for an invention titled “Veterinary Compound Injection Containing Levamisole or Salts thereof”. The abstract set out on the first page is as follows:
The present invention relates to a veterinary compound injection containing levamisole or salts thereof, which comprises the following formula components: 1-25% (W/V) of levamisole or salts thereof and 0.1-20% (W/V) of other anthelmintic. The compound preparation has the following prominent features: 1) the compound preparation has a remarkable synergistic action of repelling and killing nematodes in bodies of pigs, cattle and sheep, and can repel ectozoic parasites, therefore expanding the parasite controlling spectrum and overcoming the defect that levamisole cannot repel and kill ectozoic parasites; 2) the compound injection is extremely effective to nematodes which have single drug-resistance; 3) a compound oil injection has both quick-acting and long-acting efficacies, is good in absorbability and small in irritation, and is a very excellent injection.
I note that the last part of the above passage refers to a “compound oil injection”. Of the three examples set out later in the patent application, only Example 3 has an oil component. It may be, therefore, that the last part of the abstract is referring to Example 3. Mr Vickers in oral evidence said that he thought this was the case.
The claims, which are set out on the next two pages of the application, are as follows:
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.
2.The compound injection according to claim 1, characterized in that the dispersion media include water, vegetable oil, mineral oil or other organic liquid media; preferred organic media include ethanol, 1,2-propylene glycol, glycerol, isobutanol, isopropanol, polyethylene glycol, benzyl alcohol, glycerol formal, dimethylacetamide, benzyl benzoate, ethyl oleate, oleic acid, Miglyol 840 (dicaprylate/dicaprate of propylene glycol), sorbitan fatty acid esters, glyceryl dicaprylate/dicaprate, and pentaerythritol dioleate; in a formula, two or more of the liquid dispersion media above can be combined to form composite media for use; the vegetable oil includes corn oil, peanut oil, soybean oil, castor oil, rapeseed oil, sesame oil, cottonseed oil, apricot kernel oil, peach kernel oil, coconut oil, tea-seed oil and olive oil; two or more of the vegetable oils added into the formula can be combined for use, and the vegetable oil can also be combined with other dispersion media to form a co-solvent for use; the suspending agent added if necessary is medicinal suspending agent; preferred suspending agent includes xanthan gum, carboxymethyl cellulose (sodium), ethylcellulose, polyvinyl alcohol, polyvinyl pyrrolidone, sodium alginate, aluminum stearate and hydrogenated vegetable oil; the surfactant added if necessary is medicinal surfactant, including anionic surfactant, cationic surfactant, non-ionic surfactant and ampholytic surfactant; preferred surfactant is non-ionic surfactant, including polyoxyethylene sorbitan fatty acid ester, sorbitan fatty acid ester, alkylphenol ethoxylates, polyoxyethylene castor oil and ester compounds synthesized from glycerol. One kind of the surfactant can be used for forming the preparation, and two or more of the surfactants can also be mixed for use.
3.The compound injection according to claim l, characterized in that preferred formula components include:
(a) levamisole or hydrochloride thereof 10-20% (W/V);
(b) abamectin or ivermectin 0.5-2% (W/V);
(c) dispersion media added to 100% (V/V);
(d) other adjuvants which can be added if necessary.
4.The compound injection according to claim 3, characterized in that further preferred formula components include:
(a) levamisole or hydrochloride thereof 10% (W/V);
(b) abamectin or ivermectin 1% (W/V);
(c) 1,2-propylene glycol 50-80% (V/V);
(d) glycerol formal 20-50% (V/V).
5.The compound injection according to claim 3, characterized in that further preferred formula components include:
(a) levamisole or hydrochloride thereof 12% (W/V);
(b) abamectin or ivermectin 1% (W/V);
(c) dimethylacetamide 10% (V/V);
(d) Tween-80 10% (V/V);
(e) 1,2-propylene glycol 20% (V/V);
(f) water for injection added to 100% (V/V).
6.The compound injection according to claims 4 and 5, characterized in that the injection is used for prevention and treatment of nematodes and ectozoic parasites in animal body, and is administered orally or by injection, with a dosage of 1-2ml per 20kg of weight for pigs, cattle or sheep.
I note that it is common ground that the reference to a “macrolide anthelmintic” in paragraph (b) of claim 1 is to a macrocyclic lactone.
The detailed description in the specification commences with a description of the properties of levamisole, followed by a description of macrolide anthelmintics (macrocyclic lactones). It is then stated (specification, page 1):
Therefore, the preparation provided by the present invention has the feature that levamisole and the macrolide anthelmintic such as abamectin are combined to form a compound preparation which can be used for controlling drug-resistant nematodes. In addition, the compound injection provided by the present invention not only has a fast-acting efficacy, but also has a long-acting efficacy, therefore not only reducing both dosing times and dosing cost but also thoroughly repelling parasites.
The specification then sets out certain formula components and a description of the dispersion media. On page 2 of the specification, there is a table headed “Parasite controlling spectra of levamisole, ivermectin and compound preparations thereof”.
On page 3 of the specification, in a passage that corresponds with claim 3, it is stated:
Preferred formula components of the present invention include:
(a) levamisole or hydrochloride thereof 10-20% (W/V);
(b) abamectin or ivermectin 0.5-2% (W/V);
(c) dispersion media added to 100% (V/V);
(d) other adjuvants which can be added if necessary.
On pages 4 and 5, three examples are set out. Boehringer relies on Example 3, which is as follows:
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)
It is convenient to note at this point that, while the concentration of levamisole HCl in Example 3 is 5% w/v, the concentration of levamisole salt in claim 1 in the Patent Application is in the range 10-35% w/v. Thus, on its face, Example 3 does not fall within claim 1 of the Patent Application.
In oral evidence, Mr Lau accepted that CN 291 makes no reference to chemical degradation issues between levamisole and macrocyclic lactones. He also accepted that CN 291 makes no mention of the issue of stability or of stability tests having been conducted.
Mr Lau accepted during oral evidence that CN 291 does not state whether any of the Examples had been made or tested. Mr Lau accepted that none of the Examples sets out any manufacturing steps, or any description of what is intended to be made. The following exchange took place during the oral evidence, with reference to Mr Lau undertaking the task of formulating a combination injectable comprising a combination of a macrocyclic lactone and levamisole:
[COUNSEL FOR INTERVET]: In practical terms, though, if you were actually undertaking this task in 2010, there is nothing in CN291 that would have provided you with any practical assistance, is there?
MR LAU: Could you repeat your question?
[COUNSEL FOR INTERVET]: Yes. So as a practical matter, had you actually been undertaking that task in June 2010? There’s nothing in CN291 that would have provided you with any practical assistance.
MR LAU: Okay. I would be using my experience to make up those formulations.
[COUNSEL FOR INTERVET]: But you could have used your experience based on the description you have already given in your affidavit. You don’t get any additional assistance from anything that’s in CN291, do you?
MR LAU: Sorry, I didn’t quite understand your question.
[COUNSEL FOR INTERVET]: So you had a set of knowledge as at June - - -
MR LAU: Yes.
[COUNSEL FOR INTERVET]: - - - 2010, as you’ve - - -
MR LAU: Yes.
[COUNSEL FOR INTERVET]: - - - described previously, in earlier parts of this affidavit.
MR LAU: Yes.
[COUNSEL FOR INTERVET]: And what I am saying – suggesting to you that in approaching this combination [injectable] exercise at that time, there is nothing in CN291 that would provide you with any additional assistance.
MR LAU: Correct.
[COUNSEL FOR INTERVET]: Sorry?
MR LAU: Yes, there is not.
Thus Mr Lau conceded in oral evidence that, if he had been given the task of formulating a combination injectable comprising a combination of a macrocyclic lactone and levamisole, CN 291 would not have provided him with assistance.
The experimental evidence
Mr Lau was asked to design and conduct experiments to demonstrate how he would prepare an injectable combination formulation containing a macrocyclic lactone and levamisole based on:
(a)Example 3 in CN 291, assuming he had been directed to include levamisole HCl at 15% w/v and ivermectin at 0.4% w/v (Formulation 1); and
(b)Mr Lau’s optimised version of Example 3 of CN 291, following the approach described in his first affidavit at [114]-[118], also assuming he had been directed to include levamisole HCl at 15% w/v and ivermectin at 0.4% w/v (Formulation 2).
In each case he was instructed to use only his knowledge as at June 2010.
The concentrations of levamisole HCl and ivermectin that Mr Lau was instructed to incorporate in his experiments reflected the adjustments that Dr Martin would have made to the concentrations of each active ingredient in Example 3 of CN 291 in order to produce a formulation with an effective dose of each active ingredient for cattle (see below).
The final experimental protocol for Mr Lau’s experiments, a copy of which was included in the Court Book, reflects the approach that Mr Lau would have taken based on the information in CN 291, in light of his knowledge before June 2010, having regard to the instructions given to him.
The Experimental Protocol describes:
(a)Mr Lau’s preparation of Formulations 1 and 2 at bench scale (referred to in Mr Lau’s first affidavit as Experiments 1 and 4, respectively);
(b)Mr Lau’s pre-formulation tests for Formulation 2, which involved:
(i)determining the solubility of levamisole HCl in medium chain triglycerides (MCTs) (referred to in Mr Lau’s first affidavit as Experiment 2); and
(ii)determining a suitable matrix of MCTs and aluminium stearate (referred to in Mr Lau’s first affidavit as Experiment 3); and
(c)the stability tests conducted on Formulations 1 and 2 over a three month period, as well as the conditions under which samples of Formulations 1 and 2 were stored.
Experiments 1 to 4, which include the making of Formulations 1 and 2, took place on 4 and 5 April 2019. The experiments are described in Mr Lau’s first affidavit. In relation to Experiment 1 (Formulation 1), the steps taken by Mr Lau were described at [153] of his first affidavit:
(a)I weighed out 4.4046 grams of ivermectin on an analytical balance using a weighing dish. I tared a 600 mL beaker on the balance and transferred the sample of ivermectin into that beaker. 4.3947 grams of the ivermectin was transferred into the beaker.
(b)I measured out 100 mL of benzyl alcohol using a measuring cylinder, ensuring that the bottom of the meniscus was at the 100 mL mark. I waited until the bubbles reached the surface and left the solution before I measured the meniscus. I transferred the benzyl alcohol into the beaker containing the ivermectin. I placed the beaker onto a magnetic stirrer plate. I added a magnetic stirrer bar, and began stirring the mixture until the ivermectin dissolved.
(c)I measured out 400 mL of benzyl benzoate using a measuring cylinder, waiting until the bubbles reached the surface and left the solution before I measured the meniscus. I poured the benzyl benzoate into the ivermectin-benzyl alcohol solution while the mixture was being stirred.
(d)I weighed out 150.6 grams of levamisole HCl and transferred it into the precalibrated 2 L beaker. In transferring the levamisole HCl, I dropped an insignificant amount on the analytical scale (I estimated would have been less than 0.5 grams, and so less than 0.5% of the overall levamisole HCl content), I do not consider the small amount would have reduced the amount of levamisole HCl present in any meaningful way.
(e)I measured out 300 mL of soybean oil using a measuring cylinder. I waited until the bubbles reached the surface and left the solution before I measured the meniscus. I poured the soybean oil into the pre-calibrated 2 L beaker containing the levamisole HCl.
(f)I mixed the soybean oil-levamisole HCl solution using an IKA homogenizer, in order to break up any agglomerated particles of levamisole HCl and to produce a uniform suspension. I inserted an electronic thermometer into the formulation so that I could measure the temperature and ensure that it did not increase above 35°C during homogenisation. I chose 35°C as the limit of an acceptable temperature rise, because ivermectin is not stable at high temperatures.
(g)As the blade was stirring, I used a spatula to ensure that the soybean oil could reach any compacted levamisole HCl and incorporate it into the suspension. I also occasionally moved the beaker around on the homogeniser base to ensure that the homogeniser blade was reaching all of the levamisole HCl.
(h)I began homogenising the dispersion at 9:33am, and stopped homogenising the dispersion at 9:42am. I set the homogeniser at a speed of 11,440 RPM, which I considered to be sufficient to homogenise the dispersion without generating excessive heat. At the end of the homogenising period, the temperature of the dispersion was 30.4°C.
(i)Once I was satisfied that all of the levamisole HCl was uniformly dispersed, I added the ivermectin-benzyl alcohol-benzyl benzoate solution into the levamisole HCl suspension. I made the formulation up to volume with more soybean oil, until the meniscus of the formulation was at the mark.
(j)I strapped the 2 L beaker back into the homogeniser. I inserted an electronic thermometer into the formulation so that I could measure the temperature and ensure that it did not increase above 35°C.
(k)I set the homogeniser at a speed of 14,000 RPM, which I considered to be sufficient to homogenise the dispersion without generating excessive heat. I began homogenising at 10:55am, and stopped the homogeniser at 11:06am. During this time, the temperature did not reach or exceed 35°C. At this stage, the formulation appeared as a smooth, white suspension.
(l)I unstrapped the 2 L beaker from the homogeniser. I moved the beaker of Formulation 1 to the side, and placed foil over the top to prevent any contamination or evaporation whilst I ran other experiments.
(m)I washed the homogeniser in MCT, in preparation for its use in preparing Formulation 2.
As noted above, Experiment 4 (Formulation 2) involved Mr Lau following the approach described in [114]-[118] of his first affidavit. In those paragraphs he explained that, in order to formulate the combination injectable using the information contained in Example 3 of CN 291, he would optimise the formulation by swapping out the soybean oil and benzyl benzoate for MCT (for the reasons given in his affidavit). He stated that he would also swap the benzyl benzoate for more MCT because he was more familiar with the use of MCTs in injectable products than benzyl benzoate. Mr Lau stated that he would also add a suspending agent to a sample of MCT, to create a matrix that had a viscosity suitable for the suspended levamisole HCl (it being Mr Lau’s expectation that the levamisole HCl would be present in suspension). He stated that he would run some preliminary tests to confirm his expectation that the levamisole HCl would be present in suspension. Mr Lau summarised the steps he would take at [118] of his first affidavit:
(a) I would begin by dissolving the ivermectin in benzyl alcohol.
(b) I would sterilise the solution through a 0.22 micron filter.
(c)In a separate vessel, I would make up a matrix using pre-sterilised suspending agent and some of the MCT, which I would have pre-sterilised. The amount of suspending agent I would use would be dictated by the preliminary tests I describe in paragraph 117 above.
(d)I would mix pre-sterilised, micronised levamisole HCl with the MCT-suspending agent matrix.
(e)I could either purchase pre-micronised levamisole HCl, or I could micronise sterilised levamisole HCl in some MCT using a ball mill. If I were micronising the levamisole HCl myself, I would run some preliminary validation tests to determine the duration and speed at which the levamisole HCl would need to be milled for a given canister with a given number of balls. If I were using pre-micronised levamisole HCl, I would homogenise the levamisole HCl-MCT suspension in order to break up and disperse any agglomerated particles.
(f)I would add the ivermectin solution to the levamisole HCl suspension, and top it up with the remaining sterilised MCT.
(g)Unlike the Example 1 formulation, in relation to the Example 3 formulation I would not add a preservative, because benzyl alcohol is a very good preservative and fulfils that role. I also would not add a buffer, given that the formulation is non-aqueous.
(h)I would homogenise the formulation as a final step in order to break up and disperse any agglomerated particles, and to evenly disperse the suspension.
Later in his first affidavit, at [158], Mr Lau described the steps he undertook in conducting Experiment 4 (Formulation 2).
Stability tests were carried out on the following dates: 5 April, 6 May, 5 June and 3 July 2019.
The results of the stability tests (contained in Mr Lau’s second affidavit) can be summarised as follows:
(a)in both Formulations 1 and 2, the levamisole HCl was present in suspension in particulate form;
(b)the experimental results confirmed Mr Lau’s expectation that the formulation set out in Example 3 of CN 291 contained levamisole HCl in particulate form;
(c)the experimental results confirmed the validity of Mr Lau’s approach of optimising Example 3 of CN 291, to produce Formulation 2; and
(d)Formulations 1 and 2 fell within the scope of claim 1 of the Patent Application.
In addition to the experiments conducted by Mr Lau, Boehringer relies on experiments conducted by Mr Pippia for the purposes of the opposition proceeding below. This evidence did not originally form part of Boehringer’s evidence-in-chief. However, after the filing of Mr Vickers’s affidavit, Boehringer sought and was granted leave to rely on evidence of the experiments conducted by Mr Pippia in the opposition proceeding. Boehringer then filed Mr Pippia’s affidavit, which set out details of his earlier experiments.
Boehringer contends, in summary, that the alleged invention claimed in each of the claims is not useful, in that the claims of the Patent Application include embodiments that do not achieve the promise of a physically and chemically stable suspension formulation of a macrocyclic lactone and levamisole. This ground is set out in grounds 6 to 8 of the amended notice of appeal:
6.In the alternative to paragraphs 2 to 5 above, the Delegate erred in finding that the invention claimed in the [Patent] Application is useful within the meaning of s 18(1)(c) of the Act.
7.In making the finding referred to in paragraph 6 above, the Delegate erred in finding that the Opponent had not proved that the promise of a physically and chemically stable suspension formulation of a macrocyclic lactone levamisole was not met by the claimed invention ([149] and [150] of the Decision).
8.Further, claims 1 to 19 of the [Patent] Application include embodiments that do not achieve the promise referred to in paragraph 7 above. The Opponent relies upon the fact that Respondent’s International Patent Publication No. WO 2017/108954 A1 published on 29 June 2017 discloses that Formulations C1, C2, C3, C4, S1 and S2 described in that publication are not physically and chemically stable suspensions (at pages 22 to 28).
Although ground 8 refers to Formulations C1, C2, C3, C4, S1 and S2 in Intervet’s patent application WO 2017/108954 A1 (WO 954), in Boehringer’s closing submissions it relies only on Formulations S1 and S2. Accordingly, I take Boehringer’s lack of utility case to be confined to Formulations S1 and S2.
Boehringer contends, in summary, that:
(a)the Patent Application promises that the formulations will be stable for 6 months under accelerated testing conditions;
(b)alternatively, the Patent Application promises that the formulations will be stable for 3 months under accelerated testing conditions;
(c)Formulations S1 and S2 in WO 954 fall within the scope of the claims in the Patent Application;
(d)the stability data in WO 954 demonstrates that S1 and S2 are not chemically stable when tested under accelerated stability testing conditions (either for 6 months or 3 months); and
(e)accordingly, not all formulations falling within the scope of the claims of the Patent Application will be physically and chemically stable.
Applicable principles
Section 18(1)(c) of the Patents Act requires that the claimed invention be “useful”. In Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC (2008) 77 IPR 449, the Full Court (Emmett, Weinberg and Bennett JJ) stated at [141]:
Under ss 138 and 18(1)(c) of the [Patents 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) (see Rehm Pty Ltd v Webster’s Security Systems (International) Pty Ltd [(1988)] 81 ALR 79 at 96; 11 IPR 289 at 305–6; Welcome Real-Time SA v Catuity Inc (2001) 113 FCR 110; 51 IPR 327; [2001] FCA 445 at [157]–[161]; and Fawcett v Homan (1896) 13 RPC 398 at 405). As to the first aspect, the invention as claimed must attain the result promised by the patentee (Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd (1998) 194 CLR 171; 152 ALR 604; 40 IPR 243; [1998] HCA 19 at [21]–[26]).
Thus, the requirement regarding utility is two-fold: the claimed invention must do what it is intended by the applicant to do, and the end obtained must itself be useful.
As to the first of those requirements, the invention as claimed must obtain the result promised in the specification. In Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79, Gummow J stated (at 96):
The basic principle has been formulated as follows in Fawcett v Homan (1896) 13 RPC 398 at 405 per Lindley LJ: “If an invention does what it is intended by the [P]atentee to do, and the end attained is itself useful, the invention is a useful invention.”
What the invention is intended to do is a matter to be gathered from the title and the whole of the specification: Blanco White, Patents For Inventions, §4-403.
Later in the judgment, Gummow J stated that the promise of the invention in the patent under consideration was concerned with a particular aspect of security, which his Honour described. His Honour then continued (at 97):
It is in the light of this that one has to consider the question of utility, and the question is whether in the sense of patent law the device is useless for that purpose.
Thus, as the Full Court of this Court stated in Esco Corporation v Ronneby Road Pty Ltd (2018) 358 ALR 431 (Esco Corporation) at [199], “[t]he analytical process involves identifying the promise of the invention”: see also at [200], [208].
As with other grounds of invalidity, an allegation of inutility is to be tested against the breadth of the claims. In Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618, Lindgren J stated at [468]:
There is a principle that all that is within the scope of a claim must be useful if the claim is not to fail for inutility, or, to express the matter differently, a claim is bad if it covers means that will not produce the desired result even if a skilful person would know which means to avoid: WM Wrigley Jr Co v Cadbury Schweppes Pty Ltd (2006) 66 IPR 298; [2007] FCA 1035 at [138] and authorities there cited.
This statement of principle was approved on appeal: Lundbeck at [217], [250]. See also Esco Corporation at [235].
WO 954
Before considering the lack of utility ground directly, it is convenient to refer to the stability testing data in WO 954 and some of the evidence and admissions relating to that data.
WO 954 is a patent application filed by Intervet under the Patent Cooperation Treaty. The title is “Injectable formulation of a macrocyclic lactone and levamisole”. Under the heading “Field of Invention” it is stated (in part):
This invention relates to injectable formulations with enhanced stability for combating parasites in and on animals, comprising a macrocyclic lactone and levamisole and methods for eradicating, controlling, and preventing parasitic infections and infestations in or on an animal comprising administering the compositions of the invention to the animal in need thereof.
The “Summary of the Invention” commences with the following statement:
An embodiment of the invention is an injectable pharmaceutical formulation comprising a macrocyclic lactone and levamisole, and triacetin as carrier wherein the macrocyclic lactone is in solution and the levamisole is in suspension and has an average effective particle size (D50) ≤ 250 μm.
Commencing on page 22, a number of example formulations are set out. These include, relevantly, “Formula S1” and “Formula S2”. (Consistently with Boehringer’s submissions, I will refer to these as Formulation S1 and Formulation S2.) It is unnecessary for present purposes to set out the details of these formulations.
Table 4 on page 26 of WO 954 is headed “Stability data (Formulations F1-F4, C1-C4, S1-S2 and P1)”. It sets out the results of stability testing for each of these formulations, in relation to levamisole HCl and ivermectin, at the following times: initial; 1st month; 2nd month; 3rd month; and 6th month.
It is apparent from the description at the top of page 28 of WO 954 that the stability testing in Table 4 was conducted under accelerated conditions. On page 28, at lines 1-10, it is stated:
Formulas F1-F4 proved to be the formulations with both superior stability (see Table 3) and superior syringeability (see Table 4). Each of these formulas survived the accelerated stability test at 40°C± 2°C / 75% RH ± 5% without significant degradation of either of the active ingredients. Moreover, these formulations were able to be syringed without clogging using the smaller 40x1.2 mm syringe. Formulation C3 had acceptable stability but could only be syringed without clogging using a larger needle (40x1.6 mm). Formulations S1, S2 and P1 were syringed acceptably by the smaller needle but were unstable for their active ingredients which degraded more than 5% during the 6 month accelerated stability study.
(Emphasis added.)
The letters “RH” refer to relative humidity.
Included in the evidence, as annexure “MBS-1” to the affidavit of Mr Stewart, is an annotated version of Table 4 of WO 954. A copy of the annotated version of Table 4 is annexed to these reasons for judgment. In that document, Mr Stewart has added, in green and red, the percentage change in value for each data point, compared with the initial concentration value for that active ingredient in the relevant batch. Green has been used where the percentage change is positive (that is, a gain); red has been used where the percentage change is negative (that is, a loss). The red numbers appear in bold where the loss is greater than 5%.
In relation to Formulation S1, the annotated version of Table 4 shows that, after a period of 6 months under accelerated stability testing, the percentage change in levamisole HCl was a loss of 6.0%. In relation to Formulation S2, after a period of 6 months under accelerated stability testing, the percentage change in levamisole HCl was a loss of 5.6%.
On or about 8 February 2019, Boehringer’s predecessor, Merial Inc, served a notice to admit in this proceeding. Subsequently, on or about 1 March 2019, Intervet served a response in which it admitted certain facts for the purposes of the proceeding. The following statements, included in the notice to admit, were admitted by Intervet:
Formula S1
84.Formula S1 has each and every integer of claims 1 to 7 of the [Patent Application].
…
89.In the Experiments, [Intervet] prepared Formula S1 according to a method that has each and every integer of claims 14 and 15 of the [Patent Application].
…
Formula S2
101.Formula S2 has each and every integer of claims 1 to 7 of the [Patent Application].
…
106.In the Experiments, [Intervet] prepared Formula S2 according to a method that has each and every integer of claims 14 and 15 of the [Patent Application].
…
Experimental results
…
108.Table 4 on page 26 of WO 954 is a true and accurate report of the results of the Experiments conducted by [Intervet].
109.The stability tests reported in Table 4 on page 26 of WO 954 were carried out at 40°C ± 2% and 75% relative humidity ± 5%.
110.Page 28 at lines 1 to 10 of WO 954 is a true and accurate report of results of the Experiments conducted by [Intervet].
In Mr Lau’s first affidavit, he referred to the 6 month results for Formulations S1 and S2 in Table 4 of WO 954 and expressed the view that, according to these results, Formulations S1 and S2 were not chemically stable.
In Mr Vickers’s affidavit, he stated that accelerated stability testing (40°C and 75% relative humidity) of a formulation involves the exposure of that formulation to abnormal conditions which may then be used to claim a longer shelf life at normal ambient conditions; however, this data does not necessarily reflect the data that would be obtained from testing the formulation under normal ambient conditions (25-30°C and 65% relative humidity). He stated that if the loss of stability is temperature dependent, then under normal conditions, the stability loss may not occur at all, or may occur at a significantly slower rate. He stated that he had had experience of products that failed stability under accelerated conditions, but had the required stability when tested under real-time conditions.
Mr Vickers referred in his affidavit to the data in Table 4 of WO 954 and expressed the view that Formulations S1 and S2 were stable. This view was based on the trend in the data over time. Mr Vickers noted that, at various points, there were increases in the amount of levamisole and ivermectin, which may reflect overall measurement errors or loss of solvent due to evaporation. This impacted, he stated, on the reliability (or accuracy) of the data presented in Table 4.
In his third affidavit, Mr Lau responded to Mr Vickers’s affidavit evidence. Mr Lau stated that, according to the APVMA guidelines, which have been harmonised with the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines, VICH GL-3 defines a “significant change” for a drug substance to include a 5% change in assay from its initial value.
In the Lau/Vickers Joint Report, the experts stated that they agreed that there was more than 5% degradation of S1 and S2, but they differed in their interpretation of this; both experts agreed that there was insufficient data to comment on physical stability. Each of Mr Lau and Mr Vickers provided a precis of the evidence on this issue in their affidavits.
The oral evidence established that there cannot be an increase in the amount of an active ingredient over time. Thus, to the extent that Table 4 shows a gain in the amount of an active ingredient (the green percentages in the annotated version), this represents some form of an error in the testing or inaccuracy in the data. Likewise, to the extent that the table shows a reduction in the loss over time (and thus an implicit gain), this also represents some form of error in the testing or inaccuracy in the data.
In oral evidence, Mr Vickers stated that he was not aware of there being a requirement for a product to obtain registration in Australia that it satisfy 6 months under accelerated stability testing. Mr Lau said that in his experience this was a requirement, and referred to the APVMA having adopted the VICH guidelines. On the basis of the evidence, I am not satisfied that there is a requirement, as distinct from a guideline, for registration in Australia that a product satisfy 6 months under accelerated stability testing.
In oral evidence, Mr Lau accepted that the level of degradation that might be observed over time under ambient conditions would differ from the level of degradation under accelerated conditions. He also accepted that, where one uses accelerated conditions to predict stability under ambient conditions, that prediction may be correct or it may be incorrect. He accepted that it is possible to have a product that has good stability under ambient conditions, but poor stability under accelerated conditions.
The overall tenor of Mr Vickers’s oral evidence on this issue was that it would be necessary to conduct stability testing under ambient conditions to reach a view on stability under ambient conditions. Mr Vickers accepted that whether there is a change of more than 5% is the “threshold” for stability.
Consideration
The starting point in considering Boehringer’s lack of utility case is to analyse the relevant promise of the Patent Application. The specification as a whole must be reviewed to determine what is the promise of the invention: see Esco Corporation at [239].
The Patent Application has been described at [10]-[31] above. On page 3 of the Patent Application, as part of the detailed description, it is stated:
The formulations of the present invention must be stable to be of commercial use. In this specification, a commercially acceptable anthelmintic formulation is one which is stable at room temperature for a period of at least 6 months. In conditions of accelerated testing, at 40°C., this requires the potency of the actives within the formulation to remain within specified and acceptable limits for 3 months.
The Patent Application also includes stability data in Table 2. This data relates to the four example formulations described earlier in the Patent Application. The sub-heading to the table indicates that the studies were accelerated stability studies carried out at 40°C and 75% relative humidity. The data is provided for a 6 month period.
Boehringer’s primary position, based on the data in Table 2, is that the promise of the Patent Application is stability for 6 months under accelerated conditions. Boehringer submits that the only stability data in the Patent Application is accelerated stability data, and that Table 2 represents that the formulations will be stable under accelerated conditions for 6 months. Boehringer submits that the promise of stability for 6 months under accelerated conditions is consistent with the expert evidence that generally for anthelmintic products it is desirable to have a shelf life of at least 12 months.
I am not satisfied that the promise of the Patent Application is stability for 6 months under accelerated conditions. While it is true that Table 2 present stability data for 6 months under accelerated conditions, this does not necessarily equate with the promise of the invention. There is no statement to the effect that the claimed invention will have a stability of 6 months under accelerated conditions; indeed, the passage on page 3 set out above contains a different statement about the issue of stability. In light of these matters, I reject Boehringer’s primary position as regards the promise of the Patent Application.
Boehringer’s alternative position, based on the third sentence of the passage on page 3 of the Patent Application set out above, is that the promise of the Patent Application is stability for 3 months under accelerated conditions.
Although the matter is not free from doubt, I accept that stability for 3 months under accelerated conditions forms part of the promise of the Patent Application. The second sentence of the passage states that, in the specification, a commercially acceptable formulation is one that is stable at room temperature for a period of at least 6 months. While it would be possible to read that sentence as the entire promise on the subject of stability, with the third sentence merely being some form of indication, I consider the better view to be that the Patent Application promises both stability for 6 months at room temperature and stability at 3 months under accelerated conditions at 40°C. The third sentence is expressed as a requirement (“requires”). It is not inconsistent with the statement in the second sentence. There is no grammatical or other difficulty in reading both the second sentence and the third sentence as representing the promise of the Patent Application in relation to stability. I note that the third sentence of the passage on page 3 refers to the formulation remaining within “specified and acceptable limits” for 3 months. In light of the expert evidence discussed above, I will proceed on the basis that degradation of more than 5% would be outside acceptable limits.
The next issue is whether Boehringer has established that Formulations S1 and S2 (or either of them), being formulations that are admitted to fall within the scope of the claims 1-7, 14 and 15 of the Patent Application, fail to meet to promise of stability, and thus lack utility.
Boehringer relies on the data regarding Formulations S1 and S2 in Table 4 of WO 954, and Intervet’s admissions in response to the notice to admit, as set out above. In particular, Boehringer relies on the data in Table 4 for 2 months, which shows a loss of 5.7% for levamisole HCl for Formulation S1, and a loss of 5.0% for levamisole HCl for Formulation S2.
There are a number of difficulties with Boehringer’s contentions. First, the figures in Table 4 for 3 months – this being the relevant period for the purposes of the promise – do not show a loss of more than 5%. After 3 months, the loss of levamisole for Formulation S1 was 4.6%, and the loss of levamisole for Formulation S2 was 4.6%. Accordingly, the data in Table 4 does not establish that Formulations S1 and S2 (or either of them) failed to meet the promise of stability (that is, stability for 3 months under accelerated conditions).
Secondly, the data in Table 4 is inherently unreliable. As noted above, the oral evidence established that there cannot be an increase in the amount of an active ingredient over time. However, in many instances, Table 4 contains increases in the amount of an active ingredient (the green percentages). This calls into question the reliability of the testing. For this reason alone, even if Table 4 had shown a loss of more than 5% as at 3 months, I would not have been satisfied that Formulations S1 and S2 failed the promise of stability. I note for completeness that I do not regard Intervet’s admissions to stand in the way of this conclusion. Intervet has admitted (in its response to the notice to admit) that Table 4 is a “true and accurate” report of the results of the experiments, and that page 28 at lines 7-10 is a “true and accurate report” of the results of the experiments. In my view, these admissions relate to the data in the table (that is, the data in the table accurately records the results of the experiments), rather than the reliability of the testing process.
For these reasons, it is not established that Formulations S1 and S2 (or either of them) failed to meet the promise of stability in the Patent Application (that is, stability for 3 months under accelerated conditions). It follows that the lack of utility ground is not made out.
Conclusion
It follows from the above that the appeal is to be dismissed. It would appear to be appropriate to make orders to the effect that: (a) the appeal be dismissed; (b) the Patent Application proceed to grant; (c) Boehringer pay Intervet’s costs of the proceeding, as agreed or assessed. However, I will give the parties a short period of time to prepare minutes of proposed orders in case there is a need for any ancillary orders.
I certify that the preceding three hundred and thirty-six (336) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Moshinsky. Associate:
Dated: 17 September 2020
ANNEXURE
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