Nufarm Australia Limited v Dow AgroSciences LLC
[2017] APO 52
•19 October 2017
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Nufarm Australia Limited v Dow AgroSciences LLC [2017] APO 52
Patent Application: 2010239445
Title:High-strength, herbicidal compositions of glyphosate and 2,4-D salts
Patent Applicant: Dow AgroSciences LLC
Opponent: Nufarm Australia Limited
Delegate: K. Wagg
Decision Date: 19 October 2017
Hearing Date: 8 June 2017
Catchwords: PATENTS -Opposition successful-costs awarded against the Applicant-Concentrated co-formulations of glyphosate and 2,4-D-the person skilled in the art would be directly led as a matter of course to try the amine salts claimed-Claims 1-5 and 9 do not involve an inventive step in the light of the common general knowledge-Opportunity to amend.
Representation: Counsel for the Applicant: Craig Smith
Patent attorneys for the Applicant: Dr Tom Gumley and Dr Karen Bentley of FPA Patent Attorneys Pty Ltd
Counsel for the Opponent: Ben Fitzpatrick
Patent attorney and Legal Practitioner for the Opponent: Virginia Beniac-Brooks of Arcadia Intellectual Property
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2010239445
Title:High-strength, herbicidal compositions of glyphosate and 2,4-D salts
Patent Applicant: Dow AgroSciences LLC
Date of Decision: 19 October 2017
DECISION
Claims 1-5 and 9 do not involve an inventive step in the light of the common general knowledge. The claims are inventive over the prior art documents cited. The invention is sufficiently described.
Opposition successful. The Applicant is given 60 days to file suitable amendments.
Costs awarded against the Applicant.
REASONS FOR DECISION
Background
Patent application number 2010239445 was filed on 20 April 2010. The request for examination in relation to the application was filed on 7 April 2013. Consequently, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) do not apply to the present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. Any subsequent references to sections of the Patents Act relate to the Patents Act 1990 prior to amendment by the Raising the Bar Act. A similar qualification applies to references to the Patents Regulations 1991.
The applicant is Dow AgroSciences LLC (the Applicant). The application was examined and advertised as accepted by the Commissioner on 13 August 2015. Nufarm Australia Limited (the Opponent) filed a notice of opposition to grant on 13 November 2015. A hearing was held on 8 June 2017 in Melbourne to decide the opposition.
The Statement of Grounds and Particulars
The Statement of Grounds and Particulars (SG&P) was filed on 15 February 2016. The applicant filed a Request to Dismiss the Opposition on 15 March 2016. This resulted in dismissal of certain grounds and further amendments to the SG&P with the current version being that allowed on 14 March 2017. A delegate of the Commissioner confirmed with the letter of 7 July 2016 that the grounds of opposition of Manner of manufacture, novelty, usefulness and secret use were dismissed. The delegate directed that the only grounds that remained are the following:
·Not an invention within the meaning of NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) CLR 655
·Insufficiency under ss 40(2)(a)
·Lack of inventive step under ss 18(1)(b)(ii)
The Opponent’s summary of submissions included submissions on the grounds of clarity and utility. At the hearing this was discussed, along with the delegate’s letter of 7 July 2016, and consequently these grounds were not heard.
Standard of Proof
The onus of proof in this opposition proceeding rests with the Opponent, who must demonstrate that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [67]; 50 IPR 305; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18]; 79 IPR 426).
Evidence
The evidence is summarised in the table below:
Evidence Declarant Exhibits Date Reference In Support Phillip Maxwell Hay PMH-1 to PMH-22 16 May 2016 Hay #1 Gottfried Lichti GL-1 16 May 2016 Lichti Virginia Ann Beniac-Brooks 13 May 2016 Beniac-Brooks In Answer Holger Tank HT-1 to HT-15 18 August 2016 Tank In Reply Phillip Maxwell Hay PMH-23 to PMH-27 19 October 2016 Hay #2 The Specification
The specification is entitled “High-strength, herbicidal compositions of glyphosate and 2,4-D salts”.
The specification starts with background and then discusses the current invention and provides 5 examples, and ends with 9 claims. Claim 1 is the only independent claim and is directed towards the composition along with claims 2-7. Claim 8 is directed towards a method of controlling undesirable vegetation in crops using the composition of claims 1-7. Claim 9 is an omnibus claim to the composition of claim 1.
What is the invention as described?
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139]:
"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date."
The field of the invention
The field of the invention can be gleaned from the specification (page 1 lines 4-5):
“The present invention relates to high-strength, liquid compositions containing salts of N-(phosphonomethyl)glycine (glyphosate) and (2,4-dichlorophenoxy)acetic acid (2,4-D).”
The person skilled in the art
The person skilled in the art (PSA) was considered in Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70]:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”
However, the person is not a real person, but an artificial construct that is used as a tool of analysis with which the court uses to make the determination. This concept was established in AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”
Our understanding of the person skilled in the art is based on evidence from persons with knowledge of the art as to the things they know and do, and what they understand to be commonly known and done. The weighing and evaluating of this evidence to decide the characteristics of the person skilled in the art is part of the normal work of a delegate of the Commissioner.
The Opponent relied on expert evidence from Mr Phillip Hay and Dr Gottfried Lichti. Both have extensive careers in formulation science with Mr Hay working for Dow Chemical Australia Ltd as a Research Chemist before joining the Opponent’s company, Nufarm, as a development chemist and then Formulation Development Manager between 1994 and 2003 (Hay #1 at 5). Dr Lichti worked at Daratech Pty Ltd as Director of Controlled Release Formulations and during that time founded the graduate programme in formulation science at Monash University (Lichti at 6). His work at Daratech was focussed on agricultural formulations. Dr Lichti set up his own consultancy company in 1994 and has consulted on a wide range of herbicide formulations since then (Lichti at 8).
The Applicant relied on evidence from Dr Holger Tank who, after completing work as a Postdoctoral Fellow at the University of Auckland, New Zealand, worked for Dow AgroSciences LLC (the Applicant’s company) in New Zealand from 1989-1999 (Tank at 4-5). Dr Tank relocated to Dow AgroScience headquarters in Indianapolis, Indiana, USA in 1999 where he worked on a large range of herbicide formulations (Tank at 7). Dr Tank has been managing Dow’s formulation development laboratories in Shanghai, China since 2015 (Tank at 10).
The Opponent took issue with the fact that Dr Tank was not based in Australia and, given Australia’s unique conditions, would not be aware of issues specific to Australian agriculture. To this the Applicant submitted that he was based in New Zealand and his work there was for the entire Asia Pacific region, including Australia.
I am satisfied that given the global nature of the field and the fact that the company Dr Tank worked for is indeed a global company, Dr Tank would be aware of the state of the art as it existed in Australia at the priority date.
Principles of Construction
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 at [118] – [120]:
"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification"
The background to the invention
On page 1, lines 7-10 the specification notes that both glyphosate and 2,4-D are known and that there are various formulations on the market that can be used as is or diluted prior to use with both compounds exhibiting sufficiently high solubility in water.
The specification notes that the known pre-mix formulations are typically used in burn-down applications. The total active ingredient loading in the commercially available formulations is limited to less than 320 grams acid equivalent per litre (gae/L) of both compounds if the glyphosate to 2,4-D ratio is between 1:2.3 to 2.3:1 (page 1 line 13-15). It is important to note that the specification mentions that the commercially available formulations use the isopropylamine salts of both glyphosate and 2,4-D.
The aim of the invention
The specification discusses that higher strength (greater than the known 320 gae/L) is desirable for both environmental and economic reasons (page 1 lines 16). The specification states that the high-strength formulation would reduce packaging and reduce shipping and handling costs (page 1 lines 71-81).
The specification then goes on to say that the formulation should be stable and remain homogeneous (page 1 line 20). Followed by stating that the high-strength formulation should be a homogeneous liquid that is stable at temperatures at least as high as 50 ºC and should not exhibit any precipitation at temperatures at least as low as 0 ºC (page 1 lines 20-22).
These desirable features were not in dispute at the hearing and I therefore conclude that the aim of the invention is to provide a formulation which possesses these desired features.
The invention as described
The specification states that it (page 1 lines 23-25):
“has been found that the mixture of certain amine salts of glyphosate and 2,4-D allows the preparation of high-strength liquid compositions containing up to or greater than 450 gae/L of total active ingredient loading if the pH is adjusted to 6.0 to 8.0”
Further clauses are added to this on the following pages, notably that amines salts are used and:
“are independently primary, secondary, tertiary or quaternary alkylamine, alkanolamin or alkylanolamine salts, wherein the alkyl and alkanol groups are saturated and contain C1-C3 carbon atoms individually, with the proviso that no more than one of the amine salts in the composition can be a primary amine salt, (ii) the composition contains a total active ingredient loading of at least 350 gae/L of the glyphosate amine salt and the 2,4-D amine salt, (iii) the weight ratio of the glyphosate amine to the 2,4-D amine salt is from 1:2.3 to 2.3:1 and (iv) the pH is from 6.0 to 8.0. Furthermore, one or more cosolvents and/or efficacy-enhancing surfactants can optionally be incorporated into the high-strength composition while still maintaining the high loading.”
The examples achieve this with table 1 and table 2 showing the solutions of glyphosate and 2,4-D amines. The amines used in the examples are dimethyl amine (DMA), isopropylamine (IPA), dimethylethanolmaine (DMEnolA), diethylethanolamine (DEEnolA), choline hydroxide (choline) and tetramethylammonium hydroxide (TetraMA).
Table 4 shows the formulations made up including the total active content, weight ratio and storage stability at both ambient temperature and at -10 ºC.
Table 5 then shows the compositions with added surfactants. Further viscosity was measured for composition 54, which was shown in table 6.
Claim 1
Claim 1 is the claim directed to the composition. It reads
“A homogeneous, stable, high-strength aqueous herbicidal concentrate composition comprising:
(a) water,
(b) a glyphosate amine salt, and
(c) a 2,4-D amine salt,in which (i) the glyphosate amine salt and the 2,4-D amine salt are independently primary, secondary, tertiary or quaternary alkylamine, alkanolamine or alkylalkanolamine salts, wherein the alkyl and alkanol groups are saturated and contain from C1-C3 carbon atoms individually with the proviso that no more than one of the amine salts in the composition can be a primary amine salt, (ii) the composition contains a total active ingredient loading of at least 350 gae/L of the glyphosate amine salt and the 2,4-D amine salt, (iii) the weight ratio of the glyphosate amine salt to the 2,4-D amine salt is from 1:2.3 to 2.3:1, and (iv) the pH is from 6.0 to 8.0.
The claim is to a herbicidal composition. The composition is aqueous and contains amine salts of both glyphosate and 2,4-D.
The composition is said to be “homogenous”, which means it is one phase and that the two herbicides are both dissolved in the water and not present as precipitates.
The composition is said to be “stable”, when read with the specification as a whole it is clear that this means that the composition remains homogenous, and precipitates do not form, within the working range of temperatures.
The terms “high-strength” and “concentrate” are clarified by the claim itself with the total active ingredient loading being at least 350 gae/L.
The amines salts are defined, but include a proviso such that the composition cannot contain two primary amine salts. Instead there can be a primary amine of one and a secondary amine of the other or two secondary amines.
The weight ratio of the glyphosate amine salt to 2,4-D is defined and the pH of the composition is also defined.
Inventive step
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art. A document is prior art for this purpose if "a skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded [the document] as relevant" (subsection 7(3)).
The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12 at [45], 148 CLR 262 at 286 Aickin J stated:
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."
The High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59, 212 CLR 411 approved this approach. the High Court accepted the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at [187] where Graham J posed the reformulated Cripp’s question:
“Would the notional research group at the relevant date, in all the circumstances, .... directly be led as a matter of course to try [the claimed combination] in the expectation that it might well produce a [useful or better result]?” (emphasis in original)
Where the invention is a combination of integers (as in the present case), obviousness is to be determined by reference to the combination as a whole and not each integer individually. As stated in Alphapharm at [41]:
“The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step. It is the selection of the integers out of ‘perhaps many possibilities’ which must be shown by Alphapharm to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers.”
In AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99; 107 IPR 177 (AstraZeneca), the court held that in formulating the problem it is not permissible to incorporate information that is not available to the person skilled in the art either as common general knowledge or information available under subsection 7(3).
In the present opposition the Opponent submitted that the claims of the opposed application lacked an inventive step when compared to the common general knowledge alone (section 7(2)) and when the common general knowledge is taken together with prior art.
Before deciding the question of inventive step it is useful to determine the common general knowledge in Australia at the priority date.
The Common General Knowledge
The common general knowledge was considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc [1999] FCA 345; 45 IPR 577 at [112]:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled worker’s mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
· standard texts and handbooks;
· standard English dictionaries;
· technical dictionaries relevant to the field;
· magazines and other publications specific to the field.”
Both sides agreed that both glyphosate and 2,4-D compositions were well known in Australia and indeed that is acknowledged in the opposed specification. There were a range of products available, including ones containing both 2,4-D and glyphosate. However, none of these contained both 2,4-D and glyphosate both present as amine salts with the proviso that both of them cannot be primary amine salts. Nor did that achieve the high-strength concentration as claimed.
Glyphosate formulations
Monsanto was first to market glyphosate in a composition under the ROUNDUP trademark (Hay #1 at 21). Most glyphosate compositions available from the late 1970s until about 1998 were based on the mono-isopropylamine salt (Hay #1 at 26). Mr Hay stated in evidence that there were other salt forms available, including the Glyphosate CT, Glyphosate 360 which also contained the IPA salts. DAVISON GLYPHOSATE 300D HERBICIDE was another herbicide containing the DMA salts (Hay #1 at 25-26). Mr Hay also noted that ROUNDUP MAX and ROUNDUP POWERMAX had the monoethanolamine salt and potassium salts respectively. Mr Hay went on to discuss high-load formulations that used the mono-ammonium salt and isopropylamines together which were called Weedmaster Duo and Credit Herbicide (Hay #1 at 28).
Dr Tank stated that he was aware of the glyphosate formulations presented to him in HT-3 before the priority date (Tank at 34). These included the formulations I have mentioned above.
2,4-D formulations
Mr Hay states that the most common form of 2,4-D before 2000 was the dimethylamine salt (Hay #1 at 34) and after 2000 it was in combination as dimethylamine and diethanolamine. BATON is a solid DMA salt form. SURPASS 300 and Nufarm Surpass are both isopropylamine salts (Hay #1 at 36), AMICIDE 625 Selective Herbicide and SURPASS 475 contain the dimethylamine and diethanolamine salts and AMICIDE 625 contains the diethanolamine and triethanolamine salts (Hay #1 at 38). Estercide Xtra 680 is the ethyl hexyl ester of 2,4-D.
Dr Tank stated that he was aware of the 2,4-D formulations I have listed above before the priority date (Tank at 34).
Co-formulations, premix concentrates, tank mixes and high-load concentrates.
Co-formulations can come in a variety of forms. A tank mix formulation is concentrated to a degree to allow for dilution once added to a tank for spraying (Tank at 18). To make a co-formulation in a tank mix one can either add two formulations separately and dilute or use a premix concentrate (Tank at 23). Given that the current claims are directed towards a concentrate with both herbicides present, premix concentrates are of particular relevance.
Dr Tank states that (Tank at 40). :
“Premix concentrates as discussed here are a mixture of both 2,4-D and glyphosate with the ratios of them between 1:5 and 5:1 but preferably 1:1.”
Dr Tank stated some considerations as follows (at 41):
“Another consideration specific to the formulation of premix concentrates is the difference in the solvent power of water for homogenous dissolution of A or homogenous dissolution of B (thereby forming a high-load concentrate of A, or of B), as compared with the solvent power of a high-load concentrate of A for homogenous dissolution of herbicidal compound B. In the former, water has a higher solvent power for the dissolution of compound A, or for the dissolution of compound B. Therefore, it is much easier to load large amounts of compound A, or compound B into water to obtain the types of high-load concentrates seen in 2009 such as Glyphosate 360 or Surpass 475. In contrast, in the latter, a solution already having a large amount of, say compound A dissolved in it will have a lower solvent power for the dissolution of large amounts of compound B. Therefore it is much harder to load large amounts of compound B into a solution that already contains large amounts of compound A. In the case of 2,4-D and glyphosate, in 2009, it was much harder to load large amounts of 2,4-D into a solution that contains large amounts of glyphosate and vice versa.”
There were two premix formulations presented as common general knowledge by the Opponent. These are Tillmaster and Tillmaster CT (Exhibits PMH-12 to PMH-13 relate to these). Hay noted these in his first declaration at 48-50 and when they were presented to Tank he stated that he was aware of them (Tank at 38).
Tank went on to state that no-one had been able to produce “high-load” premix concentrates of both 2,4-D and glyphosate with Tillmaster being the best that could be achieved (Tank 43).
Tillmaster contains glyphosate 90 gae/L as the IPA salt and 2,4-D 180 gae/L as the IPA salt (HT-4). The APVMA label for Tillmaster CT is dated 6 November 1997 and expired on 30 June 2006 (PMH-13).
Tillmaster CT contains glyphosate 100 gae/L as the IPA salt and 2,4-D 100 gae/L as the IPA salt (HT-4). The APVMA label for Tillmaster CT is dated 30 October 1997 and expired on 30 June 2006 (PMH-13).
I note that these were taken off the market before the priority date.
Given that both Tillmaster and Tillmaster CT use IPA salts and that the current application also discusses commercially available co-formulations with IPA salts I consider that formulations containing IPA salts of both glyphosate and 2,4-D were part of the common general knowledge.
Conclusion on CGK
There was no dispute that glyphosate and 2,4-D formulations were known. There was, however, some arguments as to how well known particular formulations were which affects whether or not that formulation would be considered to be part of the common general knowledge. This included Davidson Glyphosate 300D which was the DMA salt. In my view, it is clear the most common formulations of glyphosate were the IPA salt forms and these would form part of the CGK.
2,4-D was known to be sold as both the IPA and DMA salt forms and these form part of the CGK.
The premix co-formulations of Tillmaster and Tillmaster CT were known by the experts on both sides and in my view are examples of the premixes formulated with IPA stated in the specification. If you recall that the specification states on page 1 line 11 that glyphosate IPA and 2,4-D IPA formulations were known in the industry and typically used in burn-down applications. Therefore premixes using IPA were part of the CGK.
Determining the Problem
The specifications states (page 1 lines 12-15):
“…the total active ingredient loading (grams acid equivalent per liter [gae/L] glyphosate IPA + gae/L 2,4D IPA) in the commercially available formulations is limited to less than 320 gae/L if the ratio of glyphosate (gae/L) to 2,4-D (gae/L) is between the desired ratio of 1:2.3 to 2.3:1.”
The specification then goes on to state how making a more concentrated product would be desirable and have benefits as follows (page 1 lines 15-19):
“A higher-strength formulation is desirable to provide a high strength-strength formulation to reduce shipping and handling costs to reduce the amount of packaging material that must be disposed. The high-strength formulations should be stable and retain potency during storage and shipping.”
The Opponent put forward a similar problem citing Hay at 29:
“Before 2009 there was always a desire to increase the loading of herbicides including both glyphosate and 2,4-D. A concentrated form was more efficient to transport because of the reduction in the amount of weight. This was particularly important given the geographical spread of end-users. Furthermore, higher loading reduced the amount of packaging and therefore costs. The packaging for herbicides was expensive given the contents and the risk of loss of containment, and reduced the potential for inadvertent exposure during the mixing operation.”
The Applicant submitted that the Opponent failed to show that there was a relevant problem to be solved by commenting that if the Tillmaster products were in such widespread use in Australia then surely this problem has been solved. I disagree with this submission because neither of the Tillmaster products achieved a total active ingredient loading of at least 350 gae/L as claimed.
Furthermore I note that although Tank’s declaration does not set out a problem, he does state at 14:
“I was asked how I would have approached a particular problem as of 22 April 2009.”
Tank’s declaration discusses many of the issues with formulating herbicides and indeed he discusses the issues with high-load and concentrated pre-mixes, for example at 40 he states:
“within the desired weight ratio range, there may be a barrier to achieving higher loadings. This is because the solubility limit of an active is influenced by other species in solution”.
Tank discusses these issues further through 41-44. This is clear to me that he was addressing a similar problem to the one set out in the specification and proposed by the Opponent.
In my view it is clear from the disclosures of the specification which were similar to the problem set out by Hay and issues raised by Tank the problem was to make a higher strength formulation that is stable and homogeneous of both glyphosate and 2,4-D.
Inventive Step when compared to the CGK
As set out above the test for inventive step is to determine whether a person skilled in the art would be directly led as a matter of course to try the claimed invention with a reasonable expectation of success in all of the circumstances (Aktiebolaget Hassle v Alphapharm Pty Ltd [2002]).
In the present case when faced with the problem of increasing the concentration of the formulation Mr Hay states that (Hay #1 at 78):
“I would have been motivated to increase loading of Tillmaster because of the well known problems…”
He then goes on to state that:
“For 2,4-D the most used amine salt forms were secondary amines and therefore I would have considered this to be a worthwhile option and a matter of routine.
Furthermore, he states that:
“I would have had a reasonable expectation that using secondary amines would increase the loading and achieve the result given the known successful use of secondary amines with increased 2,4-D loading. I would have also been confident that the solubility and compatibility issues would not arise with the use of a secondary amine given it was already known to use a secondary amine salt with glyphosate and such formulations were widely available in the Australian market before April 2009. One such example is Davison Glyphosate 300D Herbicide.”
The Applicant stated that Mr Hay’s evidence must be treated with caution as he worked for the Opponent. Furthermore, in his instructions he stated before giving evidence on CGK that he was informed that:
“…this proceeding concerns Australian patent application 2010239445”.
He was therefore not naïve when giving evidence and his statements about how widespread secondary amine salts of glyphosate, such as Davison Glysphosate 300D Herbicide were disputed.
The evidence on how widely available glyphosate secondary amines were limited to statements in Mr Hay’s evidence such as the one above. I therefore give little weight to the statements that a secondary amine of glyphosate would be one of the first formulations to try with a reasonable expectation of success.
However, it was accepted that the Glyphosate IPA formulations, such as Roundup, were well known and this was not disputed. Furthermore, the specification sets out the limitations of formulations with IPA salts of both 2,4-D and glyphosate.
Of the known 2,4-D formulations, Mr Hay stated that the most common was the dimethylamine salt (Hay #1 at 34). However, when faced with the problem, he states that he would have considered using more than one salt (Hay #1 at 80). These included the dimethylamine and diethanolamine salts or the diethanolmain and trienthanolmaine salts in the AMICIDE products.
Dr Tank responds to Mr Hay’s evidence on this by stating the following (Tank at 73-75):
“Mr Hay seems to indicate that it would have been useful to use 2,4-D with glyphosate IPA in the premix concentrate arising from addition of 2,4-D DMA to Tillmaster, because it was known that glyphosate is soluble with DMA from the DAVISON GLYPHOSATE 300D product. In my view, all that one can draw from the Davison glyphosate product specification sheet is that glyphosate can be formulated as a high strength DMA concentrate, and can be tank mixed with 2,4-D DMA. This is what the Davison specification sheet says. Notably it makes no mention of the stability of high loaded glyphosate with high loaded 2,4-D or stability when other cations, i.e., other than DMA, are present.
My understanding of the implication of Mr. Hay’s declaration is that there was no difficulty in going from a low load glyphosate/2,4-D premix concentrate to high load glyphosate/2,4-D premix concentrate. However, given that the three glyphosate/2,4-D premix concentrates that Mr. Hay relies upon were all manufactured by Nufarm and all provided glyphosate and 2,4-D as the IPA salts, this begs the question why Nufarm didn’t follow the steps Mr. Hay sets out to prepare a high load glyphosate/2,4-D premix concentrate?
At paragraph 80, Mr. Hay makes certain comments that he would have considered using more than one salt, and he refers to certain high loading concentrates of 2,4-D. Again it is unclear to me why anyone would consider the knowledge regarding high load concentrates relevant to a reasonable expectation of success for forming a high load premix concentrate.” His emphasis.
From this I am not convinced to the level of practical certainty that the DMA salt of glyphosate would be used to address the problem. It appears that the PSA would use the IPA salt of glyphosate and work from there to address the problem.
Dr Lichti stated (Lichti at 29) that:
“The dimethylamine (DMA) salt of 2,4-D is one of the commercially important amine salts of 2,4-D herbicide globally, including Australia. DMA is a secondary alkyl amine.”
In the evidence, Dr Lichti was tasked to set out the steps a formulator would take to develop a co-formulation of glyphosate and 2,4-D in water as at April 2009 (Lichti at 32). He further stated that the formulator would be motivated to achieve as high a loading as practically possible (Lichti at 35).
He states that the formulator would look at prior art and information about both mono-active and multiple-active formulations (Lichti at 36).
He then states that (Lichti at 39):
“Consistent with my previous comments on common salts used in glyphosate and 2,4-D formulations, the formulator would first consider using glyphosate salt cations and 2,4-D salt cations that are independently primary, secondary or tertiary alkylamine, alkanolamine or alkylalkanolamine cations because these cations are typically chosen to achieve high loading in glyphosate mono-formulations and also 2,4-D mono-formulations.”
He said that (Lichti at 40):
“Having identified salt (cation) candidates that provide highest mono-formulation loadings, the formulator would take a set of these (say 5-10) and would develop a co-formulation matrix based on these various salts. An initial set might consist of singly-salt formulations and another set might contain mixed salts (one chosen for providing high glyphosate loading and another (different) salt chosen for high 2,4-D loadings).”
He mentions that the pH would be between 5-8 and that surfactants could also be added (Lichti at 41-42).
Lichti then goes on to state that (Lichti at 43):
“When a formulator prepares a range of formulations (a formulation matrix) in order to identify liquid compositions of favourable stability, a typical strategy is to make a series of stock solutions (e.g. a stock of solution of aqueous glyphosate salt, and a separate stock solution of aqueous 2,4-D salt). Various weights of the stock solution are added to a series of pre-labelled uniformly sized glass vials (or small lidded glass jars) and a brief agitation step is carried out after the additions have been carried out.”
The vials or jars are left at different storage temperatures for a set period of time and they are checked for signs of instability (inhomogeneity such as sediment formation, crystallisation or the formation of other types of separate phase (Lichti at 44).
He states that (Lichti at 44):
“Typically, the formulations would be made and left at 0ºC overnight in a fridge. This is because the likely failure mechanism for a concentrated-salt formulation in water is poor performance (e.g. phase separation or high viscosity) under cold conditions. It will generally be found that some formulations in the matrix will be more stable (or otherwise suitable) than others, and a subsequent experiment(s) may be carried out where a revised formulation matrix is set up to fine-tune the formulation.”
Lichti states that:
“This screening process is routine and is both easy and inexpensive.”
The Applicant disputed the steps set out by Dr Lichti for a number of reasons. Firstly, that they appear to be initial screening tests and that there is no “reasonable expectation of success”. Although not expressly stated, it is clear from Dr Lichti’s evidence that he is setting out the steps to achieve a higher-loading co-formulation of both glyphosate and 2,4-D. He states which salts he would look at using, if he was trying to achieve this goal. It is clear he had a reasonable expectation that these salts would work.
Dr Tank accepts the screening assay at 81 and states that they might be routine at 82. However he states that he would not be sure why one would choose DMA. However, he does not talk about the fact that 2,4-D DMA salts were known and avoids discussing why it would not be obvious to use what was known to work in single herbicide formulations.
The Applicant took further issue with Dr Lichti’s assays and screens, submitting that they are proposed experiments and not actual experiments. The Applicant cited Glaxosmithkline Consumer Healthcare Investments (Ireland) (No 2) Ltd v Apotex Pty Ltd (2016) IPR 1 at [984] where Beach J commented on the experts approach in that case for a number of reasons including that:
“Seventh, Dr Mooney’s [the expert] approach was of course hypothetical. The respondents conducted no experiments, not even in vitro dissolution ones, notwithstanding that they assert that it is ‘inevitable’ that Dr Mooney’s development work would have resulted in a formulation falling within claim 1 of the Patent.”
Indeed in the present case Dr Lichti’s approach is also hypothetical, however, in this case he is not providing full experimental detail of development work he was conducting instead he is setting out what steps he would have taken. It is merely a statement of routine steps.
The Applicant also submitted that Dr Licthi’s “proposed experiments” do not consider all of the parameters, that there are in fact a very large number of different formulations and why would you limit your choice to the amine salts that conveniently arrive at the claims.
This argument is supported by the fact that Dr Lichti does not discuss the possible use of 2,4-D esters. They are known to exist in concentrated formulations such as Estericide 800 and Estericide Xtra 680 which are stated to be able to be missed with glyphosate IPA (Weedmaster Duo) and Glyphosate 360 in tank mixes (Hay #1 at 28).
The Opponent stated in their submissions that an ester would be rejected because of expense and disadvantages put forward in reply by Mr Hay. I accept that there may be disadvantages to using the ester, however, there are also advantages in achieving a higher load. Dr Lichti does not discuss these disadvantages when he is setting out the steps he would take.
Furthermore, the Applicant stated that Dr Lichti failed to extrapolate on the surfactants and cosolvents. Indeed this is true, however, these are not features of claim 1 and therefore do not affect its validity.
Unlike the Mr Hay, Dr Lichti was provided with a copy of the Federal Court’s Guidelines for Expert witnesses which Dr Lichti had read and understood and stated that his declaration complies with those requirements (Lichti #1).
In my view, however, the most common forms of both glyphosate and 2,4-D available at the priority date would be trialled as a matter of routine, as set out by Dr Lichti, with a reasonable expectation of success. These were the IPA and potassium salts of glyphosate and the DMA salt, ester and diethanolamine salts of 2,4-D. This is only a small number, but would arrive at the current claims as a matter of routine.
The IPA salt of glyphosate, such as in Roundup would be mixed with the DMA salt of 2,4-D such as in AMICIDE and SURPASS when attempting to increase loading and would arrive at the current claims. This is particularly true given pH range and ratios also appeared to be the standard.
100. Therefore a person skilled in the art would be directly led as a matter of course to try the invention of claim 1 when compared to the common general knowledge of glyphosate IPA formulations, 2,4-D DMA and diethanolamine formulations and the glyphosate IPA and 2,4-D IPA premix formulations.
101. Claim 2 is directed towards the composition of claim 1 but has a total active ingredient loading greater than 450 gae/L. This includes within its scope glyphosate IPA and 2.4-D DMA formulations. The person skilled in the art would be motivated to increase the loading and therefore this claim also does not involve an inventive step.
102. Claim 3 is dependent on claims 1 or 2 but specifics the weight ratio of glyphosate to 2,4-D be 1:1. This is within the desired ratio that the person skilled in the art would be aiming for and therefore does not involve an inventive step.
103. Claim 4 is dependent on the preceding claims but limits the pH to between 6.5 and 7.5 this is also within the desired range the person skilled in the art would be aiming for and therefore this claim does not involve an inventive step.
104. Claim 5 is dependent on anyone of the preceding claims but lists the choice of amines and these include dimethylamine, isopropylamine and diethanolamine. As a consequence this claim does not involve an inventive step.
105. Claim 6 and 7 include cosolvents and surfactants. My Hay mentions that Tillmaster CT includes dipropylene glycol as a co-solvent (Hay #1 at 86) and Dr Lichti mentions synergising surfactants (Lichti at 42). The Opponent further cited some general texts on detergents and surfactants in their submissions. However, I have no evidence that the amounts between 20 g/L and 200 g/L, as specified in these claims, would be routine when co-formulating concentrated herbicides. I am therefore not satisfied to the level of practical certainty that these claims do not involve an inventive step.
106. Claim 8 is directed towards using the composition of any of the preceding claims to control undesirable vegetation in crops that are resistant to both 2,4-D and Glyphosate. The Opponent submitted that this claim was obvious and at the hearing discussed that “roundup ready” crops were well known. However, I do not have any evidence that the formulation of this type would routinely be applied to resistant crop varieties and no evidence that suggest that it was a routine to make formulations for resistant varieties at the priority date. Instead the product labels all discuss weed control in general or for application before sowing or tillage; there is no mention of use on resistant crops. Furthermore the specification states that the commercially available premixes with IPA salts were used for burn-down applications. Therefore the evidence does not establish that this claim lacks an inventive step.
107. Claim 9 is an omnibus claim, it states:
“A composition of claim 1, substantially as hereinbefore described.”
108. It therefore is a claim directed to the examples described which fall within the scope of claim 1. Given my findings above, there is one example which falls within the scope of claim 1 and does not involve an inventive step. This is Formulation ID number 38 which contains glysphosate IPA and 2,4-D as the DMA salt. It follows that claim 9 does not involve an inventive step.
109. In summary, claims 1-5 and 9 do not involve an inventive step in the light of the common general knowledge.
Inventive Step when compared to D1
110. The Opponent alleges that the claims do not involve an inventive step when the common general knowledge is combined with D1.
D1: WO 2006/127501
111. D1 is directed towards compositions that improve compatibility of herbicides when mixed, for example in a spray tank (see [0002] of D1).
112. The document then goes on to discuss problems with the potassium salt of glyphosate at paragraphs [0006]. It does mention that:
“a range of surfactants are compatible with glyphosate IPA salt, fewer have been found to be compatible with glyphosate potassium salt”
113. At paragraph [0007] formulations with 2,4-D and their challenges are discussed:
“a second herbicide that is also in a form of salt, for example a phenoxy-type herbicide salt such as an organic ammonium, illustratively dimethylammonium (DMA) salt of 2,4-dichlorophenoxyacetic acid (2,4-D), to form a tank mixture. Such tank mixtures of glyphosate and phenoxy-type herbicides are widely used, but their use can be limited by a tendency, under certain conditions, for precipitation of solids that can settle and clog filters or nozzles of field spraying equipment. This is evidence of physical incompatibility of the glyphosate and the phenoxy-type herbicide salt under such conditions.”
114. It then states at [0011] that:
“There is an especial need for formulations having high glyphosate loading, for example at least about 400 gae/L, that are compatible when tank mixed with phenoxy-type herbicide salts under a wide range of field conditions.”
115. D1 then discusses the invention that it discloses and at [0013] states:
“It has now surprisingly been found that a small increase in the molar excess of cations in a glyphosate potassium salt formulation can result in improved tank-mix compatibility of such a formulation with a phenoxy-type herbicide salt.
116. Further information on the invention disclosed in D1 can be found at paragraph [0017]:
“In an embodiment of the invention, the composition comprises a mixture of potassium and low molecular weight organic ammonium salts of glyphosate wherein the mole ratio of potassium to low molecular weight organic ammonium cations is about 55:45 to about 99:1.
117. From this it clear to me that D1 is focused on the potassium salt of glyphosate. It goes on to state in paragraph [0018]:
“In a further embodiment, the composition comprises glyphosate potassium salt having no more than a pH adjusting amount of low molecular weight organic ammonium cations.
118. The invention is about using a potassium salt of glyphosate and adding small amounts of ammonium salts to adjust the pH. The pH adjusting amount is further defined:
“A “pH adjusting amount” in the present context means an amount sufficient to raise the pH of a glyphosate potassium salt solution, as determined by a method substantially as taught herein, by up to about 0.5 pH unit.”
119. At the hearing I was taken to page 4 in paragraph [0019]:
“A tank-mix herbicidal composition, prepared by admixing a glyphosate salt composition as provided above”
120. However, I note that what is provided above is the glyphosate potassium salt with a small amount of a low molecular weight ammonium cation added to adjust the pH.
121. D1 further states in paragraph [0019] that the glyphosate is accompanied by low molecular weight non-amphiphilic cations and that:
“a major amount to substantially all of the low molecular weight non-amphiphilic cations are potassium cations”
122. This line is repeated at [0024] under “Detailed Description”.
123. At the hearing I was taken to example 7 which uses the glyphosate potassium salt with a small amount of an organic amine base added. In this example the glyphosate potassium salt was added to 2,4-D amine (Agrisolution) and the results in table 1 showed the length of time it took to form a precipitate. It showed that precipitation occurred and then the examples moved on to focus on adding a surfactant to mitigate that issue.
124. The Opponent submitted that the person skilled in the art would have been motivated to consider using the IPA salt form of glyphosate in the place of the potassium salt used in D1. Stating that it was well known that the potassium salt challenges the compatibility profile of 2,4-D and that the potassium salt is not compatible with a number of surfactants.
125. I disagree with the position because these problems are recognized in D1 and it goes about solving them while still using the potassium salt.
126. When the teachings of D1 are considered in full there is no motivation, or direction to use the IPA salt or any other salt of glyphosate other than the potassium salt.
127. Therefore in my view, the claims involve an inventive step when compared to D1 and the common general knowledge.
Inventive step: the common general knowledge and the Dow patent
128. The Opponent alleged that the claims lack an inventive step when the common general knowledge is combined with WO 2009/006169 A3 (the Dow patent) also referred to as D9 in the evidence.
129. The Dow patent is directed towards the synergy that occurs when two pesticides are combined. 2,4-D and glyphosate are used as two examples where synergy occurs (see page 2 and examples).
130. The Dow patent mentions that several different salts can be used including stating on page 5 lines 5-9:
“Preferred amine salts are those derived from ammonia, methylamine, dimethylamine, trimethylamine, isopropylamine, monoethanolamine, diethanolamine, triethanolamine, triisopropanolamine” etc.
131. Although this list does include secondary and tertiary amines there is no direction to use them over any of the others.
132. On page 13 the Dow patent gives broad ranges for the concentration of the formulation:
“The concentration of the active ingredient in the synergistic composition of the present invention is generally from 0.001 to 98 per cent by weight. Concentrations from 0.01 to 90 percent by weight are often employed. In compositions designed to be employed as concentrates, the active ingredients are generally present in a concentration from 5 to 98 weight per cent, preferably 10 to 90 weight percent. Such compositions are typically diluted with an inert carrier such as water, before application.”
133. Dr Tank noted (at 104) that:
“this broad range of actives covers Tank mixtures.”
134. Dr Tank notes that (at 102):
“There is nothing to suggest, and no motivation in [the Dow patent], to prepare a concentrate of 2,4-D and glyphosate.” His emphasis.
135. Dr Tank also states that (at 103):
“I consider that the teaching of [the Dow patent] is not in relation to selecting compound salts”…”[the Dow patent] teaches tank mixtures of glyphosate and 2,4-D and evaluating the efficacy of such mixtures when applied to target vegetation. Therefore when read in context, [the Dow patent] describes herbicidal mixtures of glyphosate and 2,4-D without being limited to any particular salt(s), or indeed without being limited to salts.”
136. Given the disclosures of the Dow patent I have noted above I agree that there it appears to be directed to solving a different problem to the current application. Furthermore, there is no motivation in the Dow patent to try the particular amine salts claimed and without both being primary amines. Therefore the claims do involve an inventive step when compared to the Dow patent and the common general knowledge.
Conclusion on inventive step
137. Claims 1-5 and 9 do not involve an inventive step in the light of the common general knowledge.
Sufficiency
138. The test for sufficiency of description is set out in the High Court decision in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25]:
"… will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions of prolonged study of matters presenting initial difficulty?"
139. The Opponent’s argument was that the composition is made up and in aqueous solution. If there were two different salts such as starting from a primary amine of glyphosate and then mixing it with a secondary amine of 2,4-D that the amine salt will dissociate and there will be an equilibrium of various salts in solution. There was no sufficient disclosure of a solution where the salts did not dissociate. This was stated in Mr Hay’s first declaration at 115 as “Other matter”.
140. The Opponent then proposes that a suitable amendment would include that the primary amine salt and non-primary amine salts are prepared separately before mixing.
141. The Applicant took a prosaic analogy to this in their submissions stating that:
“a ‘chocolate cake comprising eggs, flour, chocolate and milk’ can be sensibly understood without requiring that the ‘composition’ be capable of dissection so as to isolate something that is recognisably any of those ingredients.”
142. I agree with the Applicant’s submission that this is indeed a construction issue and on reading the claim the person skilled in the art would recognise that the salts dissociate in solution and therefore it is clear that the a primary amine and a non-primary amine would be added before dissociation.
143. In my view would a composition comprising separate amine salts in aqueous solution, that do not dissociate, is a construction that would be rejected by the person skilled in the art.
144. Therefore the invention as claimed is fully described.
Conclusion
145. Claims 1-5 and 9 do not involve an inventive step in the light of the common general knowledge.
146. The Applicant is given 60 to file suitable amendments.
Costs
147. The parties submitted that costs should follow the event. I see no reason to depart from that result. Costs should be awarded against the Applicant under Schedule 8.
K. Wagg
Delegate of the Commissioner of Patents
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