Syngenta Crop Protection AG v Bayer Intellectual Property GmbH
[2018] APO 19
•9 March 2018
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Syngenta Crop Protection AG v Bayer Intellectual Property GmbH [2018] APO 19
Patent Applications: 2004290500 and 2011244912
Title:Combination of active substances with insecticidal properties
Patent Applicant: Bayer Intellectual Property GmbH
Opponent: Syngenta Crop Protection AG
Delegate: K. Wagg
Decision Date: 9 March 2018
Hearing Date: 17 October 2017
Catchwords: PATENTS –Section 59-Synergistic combination of insecticides-clarity-fair basis-utility-novelty-inventive step-common general knowledge and a document-common general knowledge solves the problem by using combination formulations-combinations are disclosed in a document-synergy and weight ratio would be determined as a matter of routine.
Representation: Counsel for the Applicant: Christian Dimitriadis SC
Patent attorneys for the Applicant: Dr Stuart Boyer and Claire Ramsey of Griffith Hack
Patent attorneys for the Opponent: Dr Aaron Olsen of Spruson and Ferguson
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2004290500 and 2011244912
Title:Combination of active substances with insecticidal properties
Patent Applicant: Bayer Intellectual Property GmbH
Date of Decision: 9 March 2018
DECISION
The opposition is successful.
Claims 1-8 of 2004290500 lack an inventive step and claims 1-6 of 2011244912 lack an inventive step. Bayer Intellectual Property GmbH is given 60 days from the date of this decision to file suitable amendments.
Costs awarded against Bayer Intellectual Property GmbH.
REASONS FOR DECISION
Background
Patent application number 2004290500 was filed on 30 October 2004 (the parent application). The application number 2011244912 (the divisional) was filed on 1 November 2011 and claims divisional status from the parent application. The earliest priority date claimed is 14 November 2003.
The request for examination of the parent application was filed on 14 November 2007 and the request for examination of the divisional was filed on 14 May 2012. Consequently, substantive amendments of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) do not apply to the parent application or the divisional. 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 Bayer Intellectual Property GmbH (the Applicant). The parent application was examined and advertised as accepted by the Commissioner on 4 August 2011. On 4 November 2011, Syngenta Crop Protection AG (the Opponent) filed a Notice of Opposition to grant. The divisional was examined and advertised as accepted by the Commissioner on 15 May 2014. The Opponent filed a Notice of Opposition to grant on 15 August 2014. In August 2015 both parties agreed to hear the Opposition on the parent application and the divisional at the same time. This resulted in a stay pending the outcome of amendments on the parent application.
A hearing was held on 17 October 2017 in Canberra to decide the opposition.
The Statement of Grounds and Particulars
The Statement of Grounds and Particulars identified 5 grounds of opposition, including lack of manner of manufacture and non-compliance with subsections 40(2) and (3). At the hearing the following grounds were pressed on both the parent application and the divisional:
·Lack of Clarity
·Lack of Fair Basis
·Inutility
·Lack of Novelty
·Lack of Inventive Step.
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). I must therefore be satisfied to a level of practical certainty that the patent is invalid.
Evidence
The evidence for the opposition on the parent application is summarised in the table below:
Evidence Declarant Date Reference Exhibits In Support Denis John Hamilton 1 August 2012 Hamilton #1 DJH-1 to DJH-2 Denis John Hamilton 1 April 2013 Hamilton #2 DJH-3 to DJH-5 In Answer Stuart James Boyer 17 March 2016 Boyer #3 SJB-1 to SJB-13 Philip Edward Pentland 21 March 2016 Pentland PEP-1 to PEP-12 In Reply Denis John Hamilton 21 June 2016 Hamilton #3 DJH-6 to DJH-12 Further Evidence by the Applicant Aaron Heath Olsen 21 June 2016 and subsequently 27 October 2016 Olsen #3 AO-1 to AO-22 Responding Further Evidence by the Opponent Ralf Nauen 27 January 2017 Nauen RN-1 to RN-6
The evidence for the opposition on the divisional is summarised in the table below:
Evidence Declarant Date Reference Exhibits In Support Aaron Heath Olsen 17 February 2015 Olsen #1 AAO-1 to AAO-2 In Answer Stuart James Boyer 19 May 2015 Boyer #1 SJB-A Stuart James Boyer 19 May 2015 Boyer #2 SJB-1 to SJB-13 In Reply Aaron Heath Olsen 20 July 2015 Olsen #2 AAO-3
The Hamilton declarations of 1 April 2013, together with exhibits DJH-3 to DJH-5 were filed as AAO-1.
What is the invention 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 Specifications
The divisional is largely identical to the parent application with the only differences being the claims, consistory clauses and examples F to I of the parent are not identical to examples F to J of the divisional. Both applications are entitled “Combination of active substances with insecticidal properties”. The parent application ends in 10 claims directed to insecticidal compositions comprising a synergistically active compound combination with one compound being from a list including 5 neonicotinoids and the other is an anthranilamide as defined in a Markush structure of formula (II-1). The divisional ends in 6 claims which are to a composition comprising a synergistically active compound combination. The divisional does not refer to an “insecticidal composition” in its claims.
The field of the invention
The field of the invention can be gleaned from the discussion of the invention at the very beginning of the applications and what it relates to (page 1 lines 1-6 in both the parent and divisional):
“The present invention relates to novel active compound combinations comprising, firstly, known compounds which act as insecticides on nicotinergic acetylcholine receptors as agonists and antagonists and, secondly, further known insecticidally active compounds, which combinations are highly suitable for the broad control of animal pests, such as insects.”
The field is therefore in combinations of insecticides and their formulations.
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 PSA is not a real person, but an artificial construct that is used as a tool of analysis by the Court to make a determination. This concept was established in AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”
The understanding of the PSA is based on evidence from persons with knowledge of the relevant art, experts, as to the things they know and do, and what they understand to be commonly known and done. The weighing and evaluating of this evidence to decide the characteristics of the PSA is part of the normal work of a delegate of the Commissioner.
The present cases involve combinations of insecticides. The PSA would therefore require knowledge about the insecticides themselves, including their development, manufacture and use, but also their formulation and in particular the formulation of insecticide combinations.
It is clear that the experts, Mr Hamilton, Mr Pentland and Mr Nauen, have experience in this area and would be able to comment on the PSA.
Aim of the invention
On page 1 lines 7-10 of both specifications the following is stated:
“It is already known that certain agonists and antagonists of the nicotinergic acetylcholine receptor have insecticidal properties. The activity of these compounds is good; however, at low application rates or with respect to the activity spectrum, they are sometimes unsatisfactory.”
Both specifications go on to mention prior art documents which disclose nitromethylenes and nitroimines and related compounds followed by benzoylureas and pyrethroids (pages 1-1a of the parent application and pages 1-2 of the divisional).
Both specifications then describe various aspects of the invention, each of which is a synergistic combination of two compounds. They include a neonicotinoid and an anthranilamide.
Based on these disclosures it is fair to say that the aim of the invention is to provide an insecticidal composition of the nicotinergic acetylcholine receptor modulators and anthranilamides with a better activity spectrum than the compounds have individually.
The invention described in the specification
The parent application
A first aspect of the invention is provided in the parent application on page 1a. This is a consistory clause which matches the wording of claim 1. It states the invention is said to provide an insecticidal composition comprising a synergistically effective active compound combination of one neonicotinoid compound selected from a list and an anthranilamide compound of formula (II).
The parent application then states on page 1b lines 23-32:
“It has now been found that mixtures of compounds of the nicotinergic acetylcholine receptor agonists and antagonists… and at least one active compound from the group of the anthranilamides of the formula (II) are synergistically effective and suitable for controlling animal pests”.
It goes on to describe in further detail the more preferred compounds and the combinations are emphasised on page 21.
The specification gives preferred ratios of the two active compounds (page 27 line 28 - page 28 line 10):
“If the active compounds in the active compound combinations according to the invention are present in certain weight ratios, the synergistic effect is particularly pronounced. However, the weight ratios of the active compounds in the active combination can be varied within a relatively wide range. In general, the combinations according to the invention comprise active compounds of the formula (I) and the mixing partner of the formula (II) in the preferred and particularly preferred mixing ratios given :
The preferred mixing ratio is from 250:1 to 1:50
The particularly preferred mixing ratio is from 25:1 to 1:10.The mixing ratios are based on weight ratios. The ratio is to be understood as meaning active compound of the formula (I): mixing partner of the formula (II).”
The following disclaimer is then given at page 28 lines 12-13:
“The mixing ratios required for finding the synergism are not necessarily the preferred mixing ratios relevant for 100% activity.”
The specification goes on to discuss the pests which can be controlled and then starts to discuss the formulations and mentions that they can be converted into customary formulations (page 30 line 11) which are produced in a known manner (page 30 line 16).
The formulations are said to comprise between 0.1% and 95% by weight of active compound (page 31 lines 15-16) and can be mixed with other active compounds.
The application then sets out the uses of the compounds and makes it clear what is meant by synergy for insecticide or acaricide in the following passage (page 42 lines 30-32):
“A synergistic effect in insecticides and acaricides is always present when the action of the active compound combinations exceeds the total of the actions of the active compounds when applied individually.”
On page 43 lines 1-17 of the parent the Colby formula for calculating synergy is provided and it is useful to set it out here:
“If
X is the kill rate, expressed as a percentage of the untreated control,
when employing active compound A at an application rate of m g/ha or in concentration of m ppm,
Y is the kill rate, expressed as a percentage of the untreated control, when employing active compound B at an application rate of n g/ha or in a concentration of n ppm and
E is the kill rate, expressed as a percentage of the untreated control, when employing active compounds A and B at applications rates of m and n g/ha or in a concentration of m and n ppm,Then
E = X + Y – X .Y
100
If the actual insecticidal kill rate exceeds the calculated value, the action of the combination is superadditive, i.e. a synergistic effect is present. In this case, the actually observed kill rate must exceed the value calculated using the above formula for the expected kill rate (E). After the desired period of time, the kill rate is determined as a percentage. In this case, 100% means that all animals have been killed. 0% means than none of the animals have been killed.”
The application then presents Examples A to I on pages 44 to 53h which include the combinations of the neonicotinoids and anthranilamides and provides the calculated and observed kill rate in their assays.
The divisional application
The body of the divisional application is identical to the parent, except that is does not include consistory statements identical to the claims and examples F to I of the parent are slightly different to examples F to J of the divisional.
The invention as claimed
The parent specification ends with 10 claims. The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 at [118] – [120]:
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification”.
Claim 1 of the parent application
Claim 1 is the broadest independent claim and it reads:
“An insecticidal composition comprising a synergistically effective active compound combination of one compound of formula (I) selected from the group consisting of:
(Ia),
(Ie),(Ig),
(Ik),(Im),
and one compound of formula (II-1)
(II-1)in which
R2 represents hydrogen or methyl,
R3 represents C1-C4-alkyl,
R4 represents methyl, trifluoromethyl, trifluoromethoxy, fluorine,
chlorine, bromine, or iodine,
R5 represents hydrogen, fluorine, bromine, iodine, trifluoromethyl, or
trifluoromethoxy,
R7 represents chlorine or bromine,
R9 represents trifluoromethyl, chlorine, bromine, difluoromethoxy, or
trifluoroethoxy,in a weight ratio of 25:1 to 1:10.
The compounds Ia to Im correspond to the known neonicotinoid imidacloprid (Ia), acetamiprid (Ie), thiamethoxam (Ig), thiacloprid (Ik) and clothianidin (Im).
Formula (II-1) is a Markush structure with a substituted anthranilamide on the left hand side of the structure.
The claim is to a composition per se. This comprises a “synergistically effective active compound combination”. Because the synergistically effect active compound combination is part of the composition it is a limiting feature of the composition and not merely descriptive of that composition.
Claim 2 is to an insecticidal composition according to claim 1, wherein the compound of formula (I) is selected from (Ia) and (Ik).
Claim 3 is to an insecticidal composition as claimed in claim 1 or 2, wherein the compound of formula (II-1) is one of 72 compounds set out in a table. These are the same compounds given “very particular preference” in the table on page 15-1.
Omnibus claim 4 is directed to the specific insecticidal compositions described in the
Examples.
Claim 5 refers to use of an insecticidal composition according to any one of claims 1 to 4, for controlling pests.
Claim 6 defines a process for preparing an insecticide “comprising mixing a composition according to any one of claims 1 to 4 with extenders and/or surfactants”.
Independent claims 7 to 10 are to various insecticidal compositions comprising a synergistically effective active compound combination of one compound of formula (I) selected from specific neonicotinoids, and anthranilamides (II-1-4) or (II-1-9), in a weight ratio between 25:1 to 1:10.
Claims of the divisional
The divisional has 6 claims these are annexed to the end of the decision in annex 1. They relate to compositions and synergistically effective active compound combinations. They do not refer to insecticidal combinations but are otherwise similar to the parent and show the same neonicotinoids and formula (II-1) of the anthranilamides.
The Opponent submitted the synergistically effective active compound combination part of the claims in both the parent application and divisional is unclear; the meaning of synergistically effective was the basis for the ground of lack of clarity. I will now address this ground of opposition.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain “whether or not what he proposes to do falls within the ambit of the claim” (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59).
The active compound combination means a combination of active compounds, in this case being the neonicotinoids of formula (I) and anthranilamides of formula (II-1) as claimed.
I accept the construction that the active compound combination refers to compounds of formulae (I) and (II) as submitted by the Applicant. These are shown to have insecticidal activity and the combination of the two is what is being claimed in a particular weight ratio.
I will now consider “synergistically effective” in the claims. The Opponent submitted that the boundaries of “synergistically effective” as used in the claims are uncertain. They submitted that this is because the synergy could occur or not occur depending on the circumstances.
To have a synergistic effect, the Applicant submitted, and to be synergistically effective, plainly requires application in amounts that will produce a synergistic result.
When asked if they understood the phrase “synergistic effect” both Mr Pentland and Mr Nauen said their understanding was consistent with the passages in the specification which refer to synergistic effect in insecticides and Mr Pentland further referred to the Colby formula (Pentland at 72-74 and Nauen at 34-35). The passage they referred to is as follows (page 42 lines 30-32 of the parent and page 42 lines 33-35 of the divisional):
“A synergistic effect in insecticides and acaricides is always present when the action of the active compound combinations exceeds the total of the actions of the active compounds when applied individually.”
The Opponent submitted that the synergistic effect described in the parent is instead described at page 41 of the parent specification at lines 7-16:
“Depending on the plant species or plant cultivars, their location and growth conditions (soils, climate, vegetation period, diet), the treatment according to the invention may also result in superadditive (“synergistic”) effects. Thus, for example, reduced application rates and/or a widening of the activity spectrum and/or an increase in the activity of the substances and compositions which can be used according to the invention, better plant growth, increased tolerance to high or low temperatures, increased tolerance to drought or to water or soil salt content, increased flowering performance, easier harvesting, accelerated maturation, higher harvest yields, better quality and/or a higher nutritional value or of the harvested products, better storage stability and/or processability of the harvested products are possible which exceeds the effects which were actually to be expected.”
In my view the passage above, in the description, is broad and general but it does not add definition to the claims. Instead it states that the treatment may have other effects. These effects do not form part of the synergy claimed. The claims relate to the insecticidal activity and the compounds in the claims are insecticides; the examples also relate to this activity. The passage identified by Mr Pentland and Mr Nauen is consistent with this because it also relates to the synergistic effect in insecticides.
Mr Pentland goes further to discuss synergy, and his interpretation of it based on the literature. He states that it occurs in way that is something like a bell curve (Pentland at 77) and states that (Pentland at 78):
“I would not expect to observe a synergy between all weight ratios between 25:1 and 1:10. I may have to conduct some routine trial and error experiments in order to determine appropriate weight ratios for the particular neonicotinoid and anthranilamide compounds I had selected for use with the particular pest and the particular crop of interest.”
Mr Pentland further states that:
“I would not expect such tests to be overly onerous or burdensome.”
In my reading of Mr Pentland’s construction of the claim, the PSA would be able to take a weight ratio of the two active compounds and test it for synergy for a particular pest in a particular crop and if no synergy existed then they would be confident that they did not infringe the claim.
Mr Hamilton responded to these passages of the Pentland declaration and agreed that synergy would have to be measured as it might not occur at every weight ratio, but he interpreted the claim to encompass compositions that might have synergy under any circumstance. This is clear from Hamilton #3 at 1.27:
“There is no mention in claim 1 of the conditions (application rate, pest type, etc.) under which the ‘synergy’ is required to be found to satisfy claim 1. It would therefore appear that claim 1 is not limited in this regard. Consequently, on the above interpretation [referring to Pentland’s interpretation], where a composition of compounds (I) and (II-1) in a weight ratio of between 25:1 and 1:10 would comply with claim 1 if there exists at least one set of conditions at which that composition is synergistically effective. Conversely, to fall outside of the requirements of claim 1, such a composition must not exhibit ‘synergy’ under any circumstance. While it is possible, in principle, to prove that ‘synergy’ does not exist for a given set of circumstances, it is not possible to prove that ‘synergy’ does not exist under all circumstances.” [His emphasis].
Mr Pentland had resolved this issue by turning to the examples of the specification and construing the specification as a whole, and states (Pentland at 161):
“I would expect to be able to extrapolate from the results in the examples to find other compositions comprising synergistically effective active compound combinations of other neonicotinoids of formula (I) and anthranilamides of formula (II-1).”
He also stated at 48 that:
“Once you have data on two chemical compounds which provides an indication of synergy, it is possible to make reasonable predictions as to whether other compounds will act synergistically with each other in a pesticide formulation. For example, it is often possible to substitute one functional group for another, similar group without affecting whether a synergy occurs.”
Indeed because this construction requires extrapolation from the examples the crops and insects involved would be those discussed in the specification.
Mr Hamilton disagreed with this way of predicting synergy and referred to the loss of activity when the position of a methyl group on a particular anthranilic diamide is changed, i.e. the toxicity increased by 25-fold (Hamilton #3 at 1.34).
I accept that changing a functional group on a compound can alter the activity of the compound; however, the PSA is predicting the synergy of a compound which already has a known activity. Both compounds in the claimed combination possess the required activity and the two actives act together in the organism to produce an overall synergistic effect. Mr Hamilton has not provided me with evidence that this synergistic effect is like a lock and key mechanism and dependent on the structure of each compound as the toxicity of a single compound is. Without evidence of the structure activity relationships involved in synergy, I cannot be satisfied that Mr Pentland is incorrect when he tells me he can make a reasonable prediction.
I am not practically certain that the scope of the claim 1 is unclear.
The Opponent ran the same argument for the dependent claims 2-6 and claims 7-10. It follows that these claims are also clear.
This ground of opposition fails for both the parent and the divisional.
Fair Basis
It is a requirement of subsection 40(3) of the Act that the claims must be fairly based on the matter described in the specification.
The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 at [69], [2004] HCA 58; 217 CLR 274 (Lockwood) at 300 approved the words of Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95:
“the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification”.
However, a claim that encompasses matter that travels beyond the invention disclosed in the body of the specification read as a whole it will not be fairly based (Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 240).
The Opponent submitted that the claims of the parent application failed for want of fair basis for three reasons. I will deal with each of them separately.
Firstly, the Opponent alleged that claims 1-10 of the parent lacked fair basis because they encompass any synergistic effect. The Opponent argues that the only synergistic effect disclosed is an alleged increased activity of compounds (I) and (II) and that there is no indication of how other “synergistic” effects are achievable. The other synergistic effects are mentioned on page 41 of the specification at lines 7-16:
“Depending on the plant species or plant cultivars, their location and growth conditions (soils, climate, vegetation period, diet), the treatment according to the invention may also result in superadditive (“synergistic”) effects. Thus, for example, reduced application rates and/or a widening of the activity spectrum and/or an increase in the activity of the substances and compositions which can be used according to the invention, better plant growth, increased tolerance to high or low temperatures, increased tolerance to drought or to water or soil salt content, increased flowering performance, easier harvesting, accelerated maturation, higher harvest yields, better quality and/or a higher nutritional value or of the harvested products, better storage stability and/or processability of the harvested products are possible which exceeds the effects which were actually to be expected.”
The Opponent alleges that the “synergistic” effects mentioned in the above passage cause the claim to cover synergistic effects which have not been exemplified and travel beyond the invention in the body of the specification. As I have construed the claims above to be limited to the synergistic effect of the two insecticides present in the claim this passage does not cause the claims to travel beyond the subject matter described.
Secondly, the Opponent submitted that claims 1-3, 5 and 6 of the parent lack fair basis because there is no real and reasonably clear disclosure in the specification for most of the compounds within the scope of formula (II-1) having a synergistic effect when combined with a compound of formula (I).
The Opponent argued that the only combinations in the examples are those including compounds (II-1-4) and (II-1-9), which are compounds of formula II-1, and are combined with the compounds of formula (I).
In response to this the Applicant stated that this is clearly a description of the synergy between the two compounds and this does not demonstrate a lack of fair basis. The Applicant further submitted that it is not necessary for the specification to prove, by example, that synergy exists in every embodiment of the invention described and claimed. I agree with that submission; all that is required is a real and reasonably clear disclosure of the invention.
The Opponent further submitted that the synergism is only mentioned a few times in the specification and submitted that if you take away the lens of the claimed embodiments, the subject matter disclosed is not limited to synergistic combinations. In my view, when applying the test for fair basis, the body of the specification must have a real and reasonably clear disclosure of the invention claimed and the claims must not travel beyond the subject matter in the body of the specification. I agree with the Opponent in that the body of the specification has parts which are broader than the claims. However, the claims are narrower in scope than the body of the specification the Opponent is relying on, in a sense it is the body of the specification which travels beyond the subject matter claimed not the other way round.
The Opponent raised the same points which I have discussed above for clarity, where Mr Pentland believes he can extrapolate from the examples and Mr Hamilton does not. I came to the conclusion that I did not have enough evidence to agree with Mr Hamilton. I have no evidence before me that synergy is related to the structure of a compound in the same way as toxicity. In this case the compounds themselves already possess activity. Consequently, this argument does not satisfy me that the claims lack fair basis.
Thirdly, the Opponent submitted that claims 1, 3 to 6 and 10 travel beyond the invention in the body of the specification because there is no real and reasonably clear disclosure in the description of a “synergistically effective” combination of compound Ig and II-1-9 in a weight ratio between 25:1 and 1:10.
The argument the Opponent put forward focuses on the fact that there is not an example in the specification of compound Ig and II-1-9 within the claimed ratio. This compound combination is disclosed on page 23 as combination 9c, however, a weight ratio is not provided.
The invention disclosed in the specification is not limited to the examples and one particular compound combination. It is broader and I consider the passage on page 23 to be part of the invention described. Furthermore the weight ratios of 25:1 to 1:10 are given as a particular preference (page 28 line 7). The invention as disclosed in the body of the specification does include the combination claimed and the weight ratio. In my view this satisfies the requirement of a real and reasonably clear disclosure. There is no scope within the law of fair basis to limit the claims to the examples as the Opponent is seeking to do.
The Opponent submitted that claims 1 to 6 of the divisional also lacked fair basis because they travelled beyond the subject matter of the description for the same reasons as the parent. As I am not satisfied that this is the case for the parent, it follows that I am not satisfied that this ground is successful for the divisional.
The Opponent further submitted that claims 1 to 4 of the divisional lacked fair basis because they encompass non-insecticidal compositions and that these claims encompass compositions where the concentration of active compound is too low or where there is antagonism. It is true that the term “insecticidal” is not present in these claims; however, the claims are to a synergistically effective active compound combination. The description does provide a real and reasonably clear disclosure of the active compound combinations with examples of synergy. It would be an incorrect approach for me to look for essential features, such as, insecticidal activity, and apply it to the current claims.
This ground of opposition fails.
Utility
It is a requirement of paragraph 18(1)(c) of the Act that the invention, so far as claimed in any claim, must be useful:
Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim: …
(c) is useful.The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228. Emmett J at 247 [81] stated:
“A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility.”
In Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162; (2013) 100 IPR 285 at [352] Jagot J pointed out that lack of utility requires evidence, not just speculation:
“Ultimately, an asserted lack of utility must be established by appropriate evidence, not be mere speculation that the invention will not work or meet the promise set out in the specification.”
An overview of utility, including areas for consideration, is provided by Nicholas J in Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) (2016) 122 IPR 17 at 164 et seq. The Applicant noted his Honour’s words at 168:
“…much depends upon the proper construction of the claim. Claims are not to be read through the eyes of a skilled addressee purposefully seeking to perform the claimed invention in a manner that would not provide a useful result: see Washex Machinery Corporation v Roy Burton & Co Pty Ltd (1975) 49 ALJR 12 at 19. Nor should claims be construed in a manner that the skilled addressee would appreciate would lead to unworkability if there is another construction that is equally open that avoids that result: Electric & Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23 at 39; Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 99.”
Furthermore, his Honour stated at 170:
“A claim may have utility even if a promised advantage cannot be achieved in all cases or with the same degree of success: Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 at 142-143 (Gummow J) and Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) (2011) 92 IPR 320 at [245], point 8 (Jagot J). Thus, if a claimed method of treatment for nausea was effective in a substantial proportion of patients experiencing nausea, the claim would not be invalid merely because a small proportion of patients experiencing nausea did not respond to the treatment. This is because the skilled addressee reading the specification would not expect (assuming he or she is not told otherwise) that the claimed treatment will be an effective treatment for every patient suffering nausea resulting from every conceivable condition.”
In order to determine whether I am satisfied there is a lack of utility I will first determine the desired result of the specification (promise of the invention) and then look to see if the evidence shows whether there is something within the scope of the claim that does not produce that desired result.
What is the promise of the invention?
The Opponent submitted that the promise of the invention is the provision of an active compound combination having a synergistically improved insecticidal activity. The Applicant responded by pointing to the “insecticidal” composition of the claims of the parent.
The specification discusses the problems with known nicotinoid compounds on page 1 lines 7-10 of the parent. It then discusses the invention on page 1a and a synergistically effective active compound combination is introduced (page 1a line 8). The combination of the nicotinoid and anthranilamide is said to be synergistically effective on page 2 line 16. The examples of the specification all relate to that combination and the synergistic effect is measured by way of the Colby equation (see examples). From these clear statements in relation to synergy I agree with the Opponent’s construction of the promise.
Does the evidence establish that something within the scope of the claim will not achieve the promise?
The Opponent argued that the scope of the synergistically effective active compound combination claimed includes within its scope synergistic effects which were not related to insecticidal activity by reference to page 41 lines 9-16. I discussed this passage above under the ground of Clarity and Fair basis and I have construed it to be a general statement that does affect the scope of the claims. The same construction applies here. Furthermore, this passage on page 41 lines 7-9 states:
“the treatment according to the invention may also result in superadditive (“synergistic”) effects.” [my emphasis]
This statement is a general statement of other possible benefits of the invention. It is not the promise of the invention and this is clear from the use of the words “may also result”, indicating that is not integral to the invention by the use of the term “may” and it is additional to what is actually the invention by the term “also”.
The thrust of both specifications is about the insecticidal compositions; this is also present in the claims of the parent. The statement on page 41, in my view, does not broaden the scope of the claims or the promise. The thrust of the specification is about insecticides, the two compounds in the composition are insecticides and the examples relate to insecticidal activity.
The Opponent did not submit evidence to establish that the promise of the invention could not be achieved as I have construed it. The Applicant, however, pointed to the evidence by Mr Hamilton in Hamilton #2 at 73-92. In his second declaration Mr Hamilton is asked to review the experimental data presented to the Commissioner during the prosecution of the patent (DJH-4) and experimental data used in the European Opposition Proceedings (DJH-5). I do not find this discussion helpful. He discusses the problems with comparing the different experiments, such as spraying vs dipping (Hamilton #2 at 76) and focusses on the synergy seen at weight ratios outside the claimed range (Hamilton #2 at 89 and 92).
The Applicant also discussed field trials carried out by the Opponent (AO-1) and notes the lack of experimental detail given and the fact that of the 309 trials, 59 showed an observed efficacy above the Colby calculated efficacy.
The Applicant then further notes that Mr Nauen was aware of a commercial product that contained thiamethoxam and chloranthraniliprole (compounds of the current claims) which has been commercialised in the US.
Indeed the examples in the specification and the trials conducted in DJH-5 show that synergy does exist outside of the claimed weight ranges, but this does not establish that synergistic insecticidal activity does not exist within the claimed weight ranges. The problems identified in comparing the examples do not establish that the claims do not meet the promise of the invention as the PSA would construe them. Furthermore, the claims are limited to the synergistically effective active compound combination and examples which are not synergistically effective would not form part of the claim.
The Opponent submitted that claims 1-6 of the divisional lacked utility for the same reasons as the parent and, as I have found this unsuccessful, it follows that this ground is also unsuccessful.
100. The Opponent further submitted that claims 1-4 of the divisional application lack utility because they do not require the synergistic combination to be insecticidal. I have no evidence, however, that these claims, with a combination of a compound of formula (1) and formula (II-1) in a defined weight ratio, encompass a combination that does not meet the promise of the invention. Indeed the claims still require there to be a synergistic combination. As a consequence I am not satisfied that these claims lack utility.
101. This ground of opposition fails.
Parametritis
102. Although not a ground of opposition, the Opponent submitted that the weight ratio of 25:1 to 1:10, present in both the claims of the parent and the divisional is “parametritis” and it related to their submissions for Novelty and Inventive step. Before deciding those grounds I will consider this submission.
103. The term parametritis was first used by Laddie J in Raychem Corp’s Patents [1997] EWHC 372; [1998] RPC 31 (Raychem). At page 37, he defines the concept:
“This is the practice of seeking to repatent the prior art by limiting claims by reference to a series of parameters which were not mentioned in the prior art. Sometimes it includes reference to parameters measured on test equipment which did not exist at the time of the prior art. The attraction of this to a patentee is that it may be impossible to prove now that the prior art inevitably exhibited the parameters and therefore it is impossible for an opponent to prove anticipation. Even if that is what has happened here, it does not alter the task of the court. It must decide whether the opponent has proved anticipation or some other statutory ground of invalidity. Parametritis may make the court’s task more difficult, but at the end of the day the test of invalidity must be the same, whatever the form of the claims.”
104. At page 46, he refers to the parameter (the S/D volume ratio) that is used in the claims as:
“essentially arbitrary and has little technical significance. The selection of a group of compositions by reference to such a parameter does not involve any inventive step. Although it may not be obvious, in the common use of that word, to limit a claim by reference to this particular meaningless and arbitrary parameter, that has nothing to do with patentability. Patents are not given for skill in inventing technically meaningless parameters.”
105. In Australia there have been several cases where the issue has arisen, and they provide useful understanding. In Williams Advanced Materials Inc v Target Technology Co LLC [2004] FCA 1405 [2004] FCA 1405;63 IPR 645 at 654, Bennett J considered claims to an optical storage medium having a reflective layer including a silver – palladium alloy. Her Honour noted that the parameters were selected without a purpose:
“there is nothing in the specification that suggests that the proportions or the ranges of the metals in the alloys are in any way part of the invention, other than the mere reference to them. It is a case of ‘parameteritis’.”
106. Her Honour then found that certain of the claims were not novel.
107. In Austal Ships Pty Ltd v Stena Rederi Aktiebolag [2005] FCA 805 at [108], [2005] FCA 805; 66 IPR 420 at 437, Bennett J referred to the Williams case, and distinguished it because:
“there is reference in the patent specification and evidence which supports the fact that the parameters have been carefully chosen, are part of the invention and are related to a claimed advantage as part of the combination of the design”.
108. The critical question is has the weight ratio been chosen to achieve a technical effect, or is it of arbitrary convenience?
109. The Opponent’s position is that the weight ratio is arbitrary because synergy is shown to exist outside of the ratio claimed.
110. Examples A, C, D and E of the parent application show that synergy exists at the ratio of 625:1. Mr Hamilton points this out in Hamilton #3 at 1.60:
“…it is not clear what purpose the claimed ratio serves in the context of the alleged invention. The opposed application appears to be directed to the provision of a ‘synergistically effective’ combination of compounds of formula (I) and (II-1)…it appears that synergy…is possible at a ratio of 625:1, which is outside the claimed range (see Examples A, C, D and E of the opposed application). Furthermore, I do not see any disadvantage associated with the ratio of 625:1. In fact, of the five original examples provided in the opposed specification, only one showed ‘synergy’ within the claimed range (i.e. Example B. Clearly the claimed range of 25:1 to 1:10 is not a necessary condition for ‘synergy’.”
111. The Opponent pointed out in their submissions that the Example D, which uses a ratio of 625:1 had an 80% better than calculated kill rate and compared this to Example B which has a 1:1 ratio (within the scope of the claims) which had a 20% better than calculated kill rate.
112. Mr Hamilton also took the view that there is no real advantage in the claimed ratio given that DJH-4 (evidence of trials presented to the Commissioner during examination) and DJH-5 (evidence of trials presented to the European office) also showed synergy at ratios of 625:1 and 250:1 (Hamilton #2 at 89-91).
113. Mr Pentland stated the following (Pentland at 229):
“The patentee has chosen to only claim combinations between 25:1 and 1:10. However, this does not mean that combinations outside the claimed range of 25:1 to 1:10 are not synergistic. I know, for example, that companies are often only interested in commercially viable ranges, not every possible range. For these reasons, I do not consider the claimed range of 25:1 to 1:10 to be a meaningless restriction.”
114. The Applicant also noted that there were commercial considerations in choosing the particular weight range in their submissions.
115. Here it is the case that there is synergy in other weight ratios, but there is also synergy in the claimed weight ratio. Therefore a technical effect exists for both the weight ratios claimed and some which are not claimed. It does not demonstrate there is no technical effect in the claimed weight ratio.
116. Mr Hamilton’s view that there is “no real advantage” over the claimed weight ratio against another does not answer the question as to whether there is a technical effect but merely shows that there is also a technical effect elsewhere.
117. Furthermore, the weight ratio does not appear to be an arbitrary parameter that has been added to something which did not exist in the prior art, a weight ratio is easily calculated. The questions of validity over the prior art cannot be answered without disregard to the parameter so I do not consider this to be case where I need to use the term coined by Laddie J in Raychem.
Novelty
118. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
119. The well-established general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”.
120. This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486 (General Tire)).
121. The Opponent relied on one document for the ground of Novelty and submitted that claims 1-10 of the parent and claims 1-6 of the divisional lacked novelty for the same reasons. I will deal with them together, the document is as follows:
D4: WO 2003/015519 A1
122. D4 is titled Arthropodicidal Anthranilamides and the abstract begins by stating that it is directed to various anthranilamides, their N-oxides and their use for controlling invertebrate pests comprising contacting the invertebrate pests with the compounds.
123. D4 defines the anthranilamides in a Markush structure on page 2 lines 1-8. Mr Hamilton states that (Hamilton #2 at 65):
“I have reviewed the definition for these compounds of Formula 1 in D4 and found that all of the compounds encompassed by the broadest description of Formula 1 provided in D4 (page 2 and Claim 1 of D4), fall within the scope of the compounds of formula (II-1) of the opposed application (page 14 and Claim 1 of the opposed application).”
124. Formula 1 of D4 as shown on page 2 is shown below:
125. Mr Hamilton then points out that the specific compounds of formula (II-1) of the parent and divisional are also disclosed in D4 (Hamilton #2 at 66-68). The synthesis of these compounds is provided for in example 1 on page 16.
126. This evidence is compelling and I am satisfied that the anthranilamides of formula (II-1) of claim 1 of both the parent and the divisional are disclosed in D4 as insecticidal compounds.
127. The opposed claims of both the parent and the divisional require the anthranilamide to be in a synergistic composition with a neonicotinoid compound in a particular weight ratio.
128. D4 states on page 2 lines 9-14:
“This invention pertains to a composition for controlling an invertebrate pest comprising a biologically effective amount of a compound for Formula 1 and at least one additional compound selected from the group consisting of surfactants, solid diluents and liquid detergents. This invention also pertains to a composition comprising a biologically effective amount of a compound of Formula 1 and an effective amount of at least one additional biologically active compound or agent.”
129. The Opponent submitted that the person skilled in the art would choose a neonicotinoid of the current claims as the at least one additional biologically active compound or agent.
130. D4 states on page 59 lines 4-5 that:
“Compounds of this invention can also be mixed with one or more other biologically active compounds or agents.”
131. This statement is then followed by broad classes of other compounds and agents including insecticides, but also fungicides, nematocides and bactericides.
132. The list of possible insecticides starts at line 14 on page 59 and ends on line 14 of page 60. The Applicant told me that there are a total of 91 insecticides listed here. The Opponent pointed out that claimed Compound (Ia) is “imidacloprid” and is disclosed at page 59, line 21. Compound (Ie) is “acetamiprid” and is disclosed at page 59, line 14. Compound (Ig) is “thiamethoxam” and is disclosed at page 59, line 27. Compound (Ik) is “thiacloprid” and is disclosed at page 59, line 27. Compound (Im) is “clothianidin” and is disclosed at page 59, line 17.
133. Preferred insecticides are then listed on page 60 lines 24-35. In that list there are 7 pyrethroids, 4 carbamates and the following on line 27:
“neonicotinoids such as clothianidin, imidacloprid and thiacloprid”.
134. This corresponds to compounds 1a, 1k and 1m of the current claims. D4 also claims mixtures of the anthranilamide with at least one additional biologically active compound or agent and lists compounds 1a, 1k and 1m in a list of 30 possible compounds or agents to choose from.
135. The Opponent submitted that the PSA would choose one of the neonicotinoids and take standard steps which would arrive at identifying the synergy and weight ratios as an inevitable result.
136. The Applicant submitted that D4 is concerned with the anthranilamides themselves and there are no clear and unmistakable directions to choose one of the neonicotinoids of claim 1. I agree. Although D4 mentions 3 neonicotinoids as preferred, it also mentions other classes of insecticides, and goes on to provide “most preferred” compounds on page 60 line 36. The neonicotinoids Ia and Ik of the current claims are two of 14 most preferred compounds. In my view there are no clear and unmistakable directions to choose those two out of the 14.
137. Furthermore, the examples of D4 on page 67 are all single compound trials using the anthranilamide. The choice of an additional compound is something the PSA might do, but there are many to choose from and the choice of one from many preferred compounds and most preferred compounds is not clear and unmistakable directions.
138. This ground of opposition fails.
Inventive step
139. 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)).
140. 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.”
141. 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)
142. 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.”
143. 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).
144. In the present opposition the Opponent submitted that the claims of both the parent and the divisional lacked an inventive step when compared to D4 and the common general knowledge.
The Common General Knowledge (CGK)
145. 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 workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
· standard texts and handbooks;
· standard English dictionaries;
· technical dictionaries relevant to the field;
· magazines and other publications specific to the field.”
146. The Opponent submitted that the compounds of formulae Ia, Ie, Ig, Ik and Im, the neonicotinoids, were part of the CGK. The Applicant did not dispute this. Mr Hamilton, Mr Pentland and Mr Nauen all recognised the compounds as insecticides that the skilled worker would also be aware of (Hamilton #1 at 22, Pentland at 66-68, Nauen at 22-24). Because of this consensus I am satisfied that the compounds with formulae Ia, Ie, Ig, Ik and Im, the neonicotinoids, were part of the common general knowledge.
147. The Opponent submitted that combinations of active compounds were well-known to provide improved insecticidal activity, broaden the spectrum of activity and minimise the development of resistance and that this may be due to synergy between the compounds.
148. The Applicant took the position that combinations could potentially provide improved insecticidal activity but synergy was certainly not a given and that it was not inevitable and there was no reasonable expectation on the part of the PSA that synergy would occur.
149. The Opponent referred to Mr Pentland’s experience in making synergistic combinations (Pentland at 54) and Mr Nauen’s knowledge that synergy may occur (Nauen at 26). However, I note that Mr Hamilton stated in Hamilton #1 at 26:
“Mixing an insecticide with another chemical compound can potentially produce one of three outcomes, they can assist each other, inhibit each other or have no effect. If the mixing of the two compounds results in an enhanced effect this may indicate synergy.”
150. The three possible outcomes described by Mr Hamilton supports the Applicant’s position that synergy could occur, but it was not a given and there is no reasonable expectation of success that it would occur given that one of the outcomes could be antagonistic, i.e. they inhibit each other.
151. The Opponent further submitted that bioefficacy testing of active compound concentrations and ratios was routine and that this testing would have identified synergy. The Opponent directed me to evidence by Mr Hamilton (Hamilton #1 at 29-31) and Mr Pentland. Mr Pentland stated the following (Pentland at 24):
“Much of formulation chemistry is done by a trial and error process. In this process, the formulation chemist will have a list of substances used to modify mixtures. For example, active compounds... The chemist will then go through a trial and error process to see what concentration of which compound will work best for a specific application… determining the optimum loading (that is, concentration) of the active compound and other constituents usually requires trial and error testing.”
152. And at 40:
“the bioefficacy of the combination of active compounds also needed to be considered. Bioefficacy is a measure of the biological efficacy of an active compound. For example, in the case of herbicides, the minimum dose required to completely kill a weed. It was necessary to test for and measure how bioefficacy was affected as a result of the combination of active compounds in a pesticide formulation.”
153. Then at 78:
“I may have to conduct some routine trial and error experiments in order to determine the appropriate weight ratio for the particular neonicotinoid and anthranilamide compounds I had selected for use with the particular pest and the particular crop of interest.”
154. Furthermore at 161 Mr Pentland states:
“I would conduct routine tests of the nature described above at paragraphs 115-142 to find exactly at what application concentration and weight ratio a synergy could be observed for a particular composition applied to a particular insect.”
155. In context this evidence suggests that making a formulation with a combination could provide improved insecticidal activity and broaden the spectrum of activity and help with resistance. It would be routine to make the formulation, including optimising the amounts of the ingredients, but choosing that combination is not. It is possible to identify that synergy once the person skilled in the art knows what combination they are using. However, the choice of that combination is unpredictable, as the compounds may assist each other, inhibit each other or have no effect.
The problem
156. The Opponent submitted that the problem to be solved was to identify new insecticide formulations having improved activity at low application rates or an improved activity spectrum compared with existing insecticides. This is taken from the parent and divisional (page 1 lines 1-10). The Applicant agreed with this statement of the problem but stated that the solution did not need to be synergistic and non-synergistic compositions would also be trialled. I agree with the latter construction as it is supported by the evidence and although synergy was known it is not a given.
Inventive step and D4
157. In order for D4 to be compared with the current claims the Act requires that the PSA could be reasonably expected to ascertain, understand and regard D4 as relevant.
158. The Opponent’s position was that when solving the problem of identifying new insecticide formulations having improved activity at low application rates or an improved activity spectrum over existing products they would have searched the patent literature and ascertained, understood and regarded D4 as relevant.
159. Searching patent literature was routinely conducted by the Applicant’s experts generally (Pentland at 115 and Nauen at 17). However, the Applicant stated this does not fulfil the threshold of ascertainment of D4 and regarding D4 as relevant. However, in conducting routine searches the title of D4 is Arthropodicidal anthranilamides and the abstract refers to methods for controlling invertebrate pests. In my view, given this information, D4 would have been ascertained, understood and regarded as relevant as it is directed towards new insecticide formulations.
Would the PSA be directly led as a matter of routine to try the current claims when compared to D4 and the CGK with the expectation of success?
160. The Opponent submitted that D4 directly leads the skilled reader to compositions comprising anthranilamides and a further insecticide as a solution to providing improved activity spectrum.
161. When faced with the problem of making a formulation with improved activity or an improved activity spectrum, compared with existing pesticide formulations, the CGK teaches that combinations could provide a solution to that problem. D4 clearly teaches a combination of an anthranilamide, within the scope of the current claims, and at least one other active compound, i.e. a combination. As I discussed above under Novelty, D4 is concerned with compositions which include compounds of formula (II-1) as currently claimed. Furthermore, D4 mentions states on page 59 lines 4-5 that:
“Compounds of this invention can also be mixed with one or more other biologically active compounds or agents.”
162. The Applicant submitted that there was no reasonable expectation of success in trying the compounds of formula (I) of the current claims (the neonicotinamides). Mr Hamilton states in reply that (Hamilton #3 at 1.57):
“Clearly if I was looking to prepare a composition having broad insecticidal properties I would have chosen to compound the compound of Formula 1 with a second insecticide, which would be chosen to control insects not controlled by the anthranilamides. Likewise, I would have chosen a second insecticide if I was formulating a composition for resistance management, the second insecticide being chosen for the same insects, but acting by a different mechanism. There would be little point choosing a fungicide or bactericide, for example, if the purpose of the composition was controlling insect pests. D4 also makes it clear that, of those 91 insecticides, compounds (Ia), (Ik) and (Im) are preferred insecticides (D4, page 60, lines 24-27) and that compounds (Ia) and (Ik) are among the 14 most preferred insecticides (D4, page 60, line 36 to page 61, line 2).”
163. In my view, Mr Hamilton is correct insofar as it would be obvious to try insecticide combinations based on D4. D4 does make a disclosure of using at least one or more other biologically active compounds and when presented with the current problem, which involves making further insecticidal compositions, it would be obvious to use an insecticide over a fungicide or bactericide. In doing so, in my view, the PSA would use the most preferred compounds when trying a combination as a solution. The document is singling these out as the most preferred compounds. These are the ones to be tried first. There is a group of 14; this is a small number I consider that it all of them would be investigated as a matter of routine. This includes the compounds Ia and Ik of the current claims.
164. I am satisfied that selecting the compounds Ia and Ik in D4 would be obvious. I am, however, not satisfied that going further down the list and choosing Ie, Ig or Im would have been obvious based on the disclosure of D4.
165. I accept that the evidence shows conducting experiments on the compositions for efficacy would be a matter of routine and that optimisation of a formulation would be routine as I have discussed above under CGK. Synergy would then be discovered as part of the routine steps that the PSA would follow using the most preferred compounds. The weight ratio would also be determined as part of these routine steps.
166. Claim 1 of the parent is directed towards the anthranilamides of D4 and a compound of formula (I). The compounds of formula (I) include the most preferred compounds in D4, namely Ia and Ik. The combination of two insecticides is obvious based on D4. The routine steps of optimisation would lead to the synergistic effect and the claimed weight ratio. I am therefore satisfied that the evidence shows that claim 1 lacks an inventive step.
167. Claim 2 of the parent is directed towards the insecticidal composition of claim 1 but the compounds of formula (I) are selected from (Ia) and (Ik). These are the most preferred compounds of D4 and it follows from what I have decided above that claim 2 of the parent lacks an inventive step.
168. Claim 3 of the parent is dependent on claim 1 but further defines the anthranilamides in a table, these include the compounds of D4, and it follows that this claim also lacks an inventive step.
169. Claim 4 of the parent is an omnibus claim directed towards the synergistically effective active compound combination of claim 1 with the weight ratio of 25:1 to 1:10 substantially as hereinbefore described with reference to the Examples. The examples in table F1 and F2 include anthranilamides of D4 and the compound Ia and Ik in the weight ratios which would be arrived at as a matter of routine. It follows that this claim lacks an inventive step.
170. Claim 5 of the parent is directed towards the use of an insecticidal composition of any one of claims 1 to 4 for controlling insect pests. D4 is directed towards controlling invertebrate pests and the compounds are listed as being insecticides. It is the same use as the claim. It follows that claim 5 of the parent does not involve an inventive step.
171. Claim 6 of the parent is directed towards a process of preparing an insecticide, comprising mixing the combination of any one of claims 1-4 with extenders and/or surfactants. D4 discusses formulations on page 51 lines 4-6 and includes liquid diluents, a solid diluent or a surfactant. It follows that the person skilled in the art would be directly led to use these in their formulation. Therefore claim 6 of the parent lacks an inventive step.
172. Claim 7 of the parent is directed towards an insecticidal composition comprising a synergistically effective active compound combination of a compound of formula (I) and the anthranilamide (II-1-4) in the same weight ratios mentioned. The compound II-1-4 is explicitly disclosed in D4 as compound 20 and this compound is synthesised in example 6 on page 23. It would be obvious to use this exemplified example in the combination. As a consequence, this claim lacks an inventive step.
173. Claim 8 of the parent is directed towards an insecticidal composition comprising a synergistically effective active compound combination of a compound of formula (I) and the anthranilamide (II-1-9) in the same weight ratio mentioned. The compound II-1-9 is explicitly disclosed in D4 as compound 2 and made in example 1 on page 16. It would be obvious to use this exemplified example in the combination. As a consequence, this claim lacks an inventive step.
174. Claims 9 and 10 are both independent claims. They are directed towards an insecticidal composition comprising a synergistically effective active compound combination of two specific compounds in the claimed ratios of 25:1 to 1:10. The compound claimed is compound Ig, as the compound of formula (I). They differ in the anthranilamide compound claimed with compound II-1-4 being in claim 9 and compound II-1-9 being in claim 10. Compound Ig is thiamethoxam. It is disclosed in D4 on page 59 line 27. It is listed as a possible other biologically active compound to be mixed with the anthranilamide. As I mentioned previously, this is part of a list of 91 compounds on page 59. There are then preferred and most preferred insecticides listed. Thiamethoxam is not listed as preferred or most preferred compound. There is no evidence which satisfies me that the PSA would be directly led to try thiamethoxam over the preferred and most preferred compounds. Therefore the Opponent has not established that these claims lack an inventive step.
175. Claims 1-6 of the divisional are identical to claims 1-6 of the parent except they do not refer to an insecticidal composition and only refer to a composition. It follows that the person skilled in the art would be directly led to the composition of the two insecticides in these claims as they would be in the parent. Consequently, claims 1-6 of the divisional lack an inventive step.
176. This ground of opposition is successful. I am satisfied that claims 1-8 of the parent and claims 1-6 of the divisional lack an inventive step.
Conclusion
177. The opposition is successful, claims 1-8 of the parent and claims 1-6 of the divisional lack an inventive step. The Applicant has 60 days from the date of this decision to file suitable amendments.
Costs
178. 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 PatentsAnnex1
0
16
0