Syngenta Participations AG v Monsanto Co - [2005] APO 36

ABSTRACTS OF DECISIONS
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Application : No. 720095 in the name of Syngenta Participations AG

Title: Process for the control of weeds

Action: Opposition to the grant of a patent by Monsanto Co.

Decision: Issued 15 August 2005.
Abstract

The opposition succeeds on the basis of section 40, but fails on the other grounds.
Full description: The specification describes the invention in terms that leave the reader without guidance of where success is likely, or even where success is possible. As such, the specification clearly fails to disclose a manner of carrying out the invention, and consequently does not fully describe the invention.
Novelty: Actual or potential synergy is a feature of the claims. The claims are novel because the citations do not teach the presence of synergy between the components.
Inventive step: The evidence shows that people in the art knew how to carry out the optimisation of herbicide compositions, but would not have been able to do this in relation to herbicide-resistant plants due to lack of access to modified plants. It follows that the optimisation of compositions for such plants could not have been a matter of routine as a practical matter. Consequently an inventive step exists.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Patent Application No. 720095 by Syngenta Participations AG, and an opposition to the grant of a patent by Monsanto Co.

BACKGROUND

Patent application number 720095 in the name of Syngenta Participations AG was advertised accepted on 25 May 2000. A notice of opposition was filed by Monsanto Company on 21 August 2000. Evidence was served by both parties, and the matter was heard in Melbourne on 28 April 2005. Syngenta was represented by Mr Ross Macaw QC of Counsel, Mr Adrian Ryan of Counsel, Mr Michael Caine and Dr Kathryn Morris, patent attorneys of Davies Collison and Cave. Monsanto was represented by Mr Bruce Caine SC of Counsel, and Mr Bruce Wellington, patent attorney of E.F.Wellington & Co.
Grounds of opposition
The grounds of opposition are:
i)novelty;
ii)inventive step;
iii)manner of manufacture; and
iv)section 40.
All grounds were the subject of submissions at the hearing.
The evidence
The evidence in support consists of declarations by Bruce Wellington (three declarations), Ronald Brinker and Christopher Preston. The evidence in answer consists of declarations by Willy Ruegg, Rakesh Jain, Peter O’Connell and John Cameron. The evidence in reply consists of declarations by Ronald Brinker and Christopher Preston. The evidence will be referred to where relevant.
DECISION
The invention relates to herbicidal compositions. The key issue in this opposition is synergy. The specification asserts that the compositions are synergistic, and the claims incorporate this feature. The specification does not demonstrate synergy for any of the compositions. Prior art documents disclose very similar compositions, but do not demonstrate synergy.
The description
The invention as described is a process for the control of weeds in useful plant cultivations, as well as compositions for the control of weeds. The nature of the invention is summarised on page 2 of the specification:
“It has now surprisingly been found that a quantitatively variable combination of phospho-herbicides selected from the group comprising glufosinate and glyphosate with at least one of the above-listed other herbicides exhibits a synergistic effect which is capable of controlling the majority of weeds occurring preferably in useful plant cultivations that are resistant to glufosinate or glyphosate, both in pre-emergence and in post-emergence, without significantly damaging the useful plants.”
The herbicides used are all known substances, and are known to be useful as herbicides. Useful plants are commercial crops, such as maize, soya, cotton, rape, beet and sugar cane.
The specification states at page 3 that it is highly surprising that the combination of a phospho-herbicide and at least one of the other listed herbicides gives a synergistic effect (i.e. the effect is greater than the additive effect expected). The advantages arising from the synergistic effect are then explained:
“On the one hand, the application amounts of the individual compounds applied are reduced, whilst maintaining a good level of activity. On the other hand, the composition used according to the invention still achieves a high rate of weed control where the individual substances have become no longer agronomically useful in small application amounts. The consequence of this is a considerable widening of the weed spectrum and an additional increase in selectivity for useful plant cultivations, which is necessary and desired in the case of an unintentional overdose of active ingredient. In addition, the composition according to the invention allows greater flexibility of subsequent cultivations whilst maintaining the outstanding control of weed in useful plants.”
I interpret this passage as stating that the compositions are able to achieve effective weed control at low application rates. A wider spectrum of weeds is controlled because the two herbicides control different groups of weeds.
The ratio of the active ingredients that achieves a synergistic effect appears to be very broad. At page 2 the specification states:
“It has now surprisingly been found that a quantitatively variable combination of phospho-herbicides selected from the group comprising glufosinate and glyphosate with at least one of the above-listed other herbicides exhibits a synergistic effect which is capable of controlling the majority of weeds occurring preferably in useful plant cultivations that are resistant to glufosinate or glyphosate, both in pre-emergence and in post-emergence, without significantly damaging the useful plants.
At page 7 the specification states:
“The active ingredient combination used according to the invention contains glufosinate or glyphosate and at least one of the other herbicides in any ratio of the mixture, normally with an excess of one component over the other. Preferred ratios between glufosinate or glyphosate and the components in the mixture lies between 1:100 and 1:0.001.
It is possible that this passage is referring to the ratio of the active ingredients to each other, or the ratio of the phospho-herbicide to the total composition. However, given that the passage starts by referring to the “active ingredient combination”, the plain meaning must be a reference to the ratio of the active ingredients. Clearly an extremely wide range of ratios is contemplated.
The specification discusses the application rate of the composition and the ratio of the active ingredients at page 10:
“The amount applied may vary within a wide range, and depends on the nature of the soil, the type of application (pre- or post-emergent; seed disinfecting; usage in the seed drill; no tillage application etc), the plant cultivated, the weed to be controlled, the prevalent climatic conditions and other factors determined by the type of application, the time of application and target cultivation. In general, the active ingredient mixture used according to the invention may be used at an application rate of 0.3 to 4.0 kg active ingredient per hectare.
In the composition used according to the invention, glufosinate or glyphosate is preferably present in a weight ratio of 1:10 to 1000:1 in relation to the other herbicide(s).”
This passage also confirms the wide range of active ingredient ratios that is possible. The description ends with a series of preferred formulations (on pages 14 to 18). None of these formulations identify the specific active ingredients, or the amounts or ratios of the ingredients. As an example, the first preferred formulation is given as:
“Emulsifiable concentrates:
active ingredient mixture:  1 to 90% preferably 5 to 20%
surface active composition:  1 to 30%, preferably 10 to 20%
liquid carrier:  5 to 94%, preferably 70 to 85%”
Testing methods to determine the effect of the compositions on weeds and cultivated plants are given on pages 18 and 19. The specification does not record the results of testing any specific composition, except for the throw-away line:
“In these tests, the herbicide mixtures used according to the invention show good control of the weeds.”
The claims
The specification ends with 17 claims. At the hearing, attention was focussed on claim 1:
1. Process for the control of weeds in cultivations of useful plants which are resistant to a phosphor-herbicide, characterised in that a herbicidally effective amount of a composition containing, in addition to the usual inert formulation assistants, a phospho-herbicide selected from the group comprising glufosinate and glyphosate and a synergistic amount of at least one further herbicide selected from the group comprising prosulfuron, primisulfuron, dicamba, pyridate, dimethenamide and its S-enantiomer, metolachlor and its S-enantiomer, fluometuron, propaquizafop, atrazine, clodinafop, norflurazone, ametryn, terbutylazine, simazine, prometryn, NOA-402989, as well as the compounds of fourmulae
is allowed to take effect on the cultivated plant or its habitat, wherein said synergistic amount is also an amount which allows control of weeds without significantly damaging the useful plants, with the provision that compositions containing glufosinate and metolachlor, glufosinate and atrazine, glufosinate and metolachlor and atrazine, as well as glufosinate and atrazine and dicamba are not used in glufosinate-resistant maize, and further that compositions containing glyphosate and atrazine are not used in glyphosate-resistant maize, and compositions containing glyphosate and metolachlor or glyphosate and dimethenamide are not used in glyphosate-resistant soya.
There are also two claims directed to the herbicidal compositions per se:
14. Herbicidal composition, characterised in that it contains, in addition to the usual inert formulation assistants, glufosinate and a synergistic amount of at least one further herbicide selected from the group comprising prosulfuron, primisulfuron, pyridate, dimethenamide and its S-enantiomer, the S-enantiomer of metolachlor, fluometuron, propaquizafop, clodinafop, norflurazone, ametryn, terbutylazine, simazine, prometryn, NOA-402989, as well as the compounds of formulae
15. Herbicidal composition, characterised in that it contains, in addition to the usual inert formulation assistants, glyphosate and a synergistic amount of at least one further herbicide selected from the group comprising prosulfuron, primisulfuron, dicamba, pyridate, the S-enantiomer of dimethenamide, the S-enantiomer of metolachlor, fluometuron, propaquizafop, clodinafop, norflurazone, ametryn, prometryn, NOA-402989, as well as the compounds of formulae
The specification ends with two omnibus claims.
What is a “synergistic amount”
The invention is described and defined as the use of a phospho-herbicide in conjunction with “a synergistic amount” of a co-herbicide. The plain meaning of this expression is an amount that will produce a synergistic result when applied to weeds. In claim 1 the amount is further qualified by the requirement that “said synergistic amount is also an amount which allows control of weeds without significantly damaging the useful plants”. This is a practical qualification - you do not want to kill the useful plant as well as the weeds.
Synergy is established by comparing the effect of each of the components individually with the effect of the mixture of components. If the effect of the mixture is greater than the sum of the individual components, then there is synergy. Whether a composition will produce a synergistic effect depends on the quantities of the active ingredients, the application rate of the composition, the nature of the weed and a range of environmental factors.
I note that the application rate that achieves a synergistic effect would be likely to be the same as the optimal application rate - the minimal amount that will kill the weeds without damaging the useful plant. The fact that the weed killing is the result of synergy rather than the standard additive effect of the herbicides is immaterial.
Does the specification fully describe the synergistic amount
The compositions must contain a “synergistic amount” of the co-herbicide. The specification states that the determination of a weed killing effect involves carrying out greenhouse tests, and rating the effect on weeds and cultivated plants after 3 weeks. In order to determine the presence of synergy, this test would need to be carried out using the herbicides separately and in combination.
The specification indicates that the ratio of the active ingredients is preferably in the range of 1 : 100 to 1 : 0.001. There is no suggestion whether any ratio within the range is more likely to be synergistic. No examples of a synergistic amount are given in the specification, and no compositions involving a synergistic amount are described. A person seeking to work the invention is confronted with the need to undertake a potentially huge amount of experimentation in order to find a suitable composition.
The specification describes the invention in terms that leave the reader without guidance of where success is likely, or even where success is possible. As such, the specification clearly fails to disclose a manner of carrying out the invention, and consequently does not fully describe the invention.
Is synergy a part of the invention as claimed
Claim 1 defines the process by reference to the amounts of each component, with the amount of co-herbicide defined as “a synergistic amount”. The synergistic amount depends on the amount of the first herbicide that is applied, the weed in question, the application rate of the composition and a variety of environmental factors. The claim is specifying not just the composition, but also its application in a way that allows synergy to manifest (i.e. appropriate application rate, etc). Consequently, the claim defines a process in which the two herbicides produce a synergistic effect. If synergy does not occur, then the process is not within the scope of claim 1.
Claims 14 and 15 define compositions that contain a synergistic amount of the second herbicide. This means that the composition is formulated in such a way that synergy can be achieved when the composition is applied at an application rate, on appropriate weeds and under environmental conditions that allow the synergistic effect to be detected. As such, the synergy is an inherent feature of the composition.
The term “comprising”
The claims use the term “comprising” in relation to the group of phospho-herbicides:
“a phospho-herbicide selected from the group comprising glufosinate and glyphosate” [emphasis added]
The plain meaning of the claims is that the phospho-herbicide can be glufosinate or glyphosate, but could also be other substances. The description only relates to glufosinate and glyphosate, so claims directed to the use of other phospho-herbicides lack fair basis. Mr Macaw stated that Syngenta was prepared to amend this aspect of the claim.
Novelty
Monsanto alleged that there was a lack of novelty in the light of two patent documents: US 4769061 (the Calgene patent) and AU 46648/96 (the Ciba-Geigy application). It is well established that the general test for anticipation 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) 137 CLR 228, at page 235:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at page 517; 16 IPR 545 at page 549). 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 (see definition of "prior art base" in Schedule 1 of the Act).
In relation to claim 1, it is necessary to show synergy in the process. In the case of claims 14 and 15, it is necessary to show the potential for synergy.
(i) The Calgene patent
The Calgene patent discloses the production of glyphosate resistant plants. The patent states that these plants can be protected from weeds using a variety of herbicide formulations. Listed in column 7 are the herbicides metolachlor, atrazine and dicamba (amongst others). Clearly this patent teaches the use of glyphosate in combination with these herbicides for the control of weeds in glyphosate-resistant crops. The patent does not discuss synergy, and it is not established that the compositions are capable of synergy. Consequently all claims are novel in the light of the Calgene patent.
(ii) The Ciba-Geigy application
The Ciba-Geigy application discloses the use of glyphosate or glufosinate in combination with other herbicides. The application does not discuss synergy, and it is not established that the compositions are capable of synergy. Consequently, all claims are novel in the light of the Calgene patent.
(iii) Conclusion
All claims are novel in the light of the citations since it has not been demonstrated that any of the compositions in the citations possess synergy. This conclusion may need to be reconsidered if the applicant provides an example of the invention. If an identical composition is disclosed in either citation, then it would follow that there would be a lack of novelty (synergy being an inherent feature of compositions of the present application).
Inventive step
Monsanto alleged a lack of inventive step in the light of six documents:
US 4769061 (the Calgene patent)
AU 46648/96 (the Ciba-Geigy application)
J.L.Flint and M.Barrett “Effects of Glyphosate Combinations with 2,4-D or Dicamba on Field Bindweed (Convolvulus arvensis)” Weed Science (1989) 37(1), 12-18 (the Flint article)
L.J.Moshier and O.G.Russ “Response of Honeyvine Milkweed to Herbicides” North Central Weed Control Conference (1978) 33, 108 (the Moshier abstract)
L.J.Moshier “Response of Honeyvine Milkweed (Ampelamus albidus) to Herbicide Applications” Weed Science (1980) 28(6), 722-724 (the Moshier paper)
WO 92/08353 (the Hoechst application)
The test for inventive step is laid out in section 7(2): an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art. The relevant prior art is the common general knowledge, considered on its own or together with information in a document that could reasonably have been expected to be ascertained, understood and regarded as relevant.
The normal approach to obviousness is the problem-solution approach. Once the problem has been formulated, and the common general knowledge and the prior art base has been determined, the question of whether the claimed solution is obvious must be addressed. The test for obviousness is whether it would have been a matter of routine to proceed to the claimed invention.
“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.”
[Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd (1981) 148 CLR 262 286]
I note that the test is “would” have taken the steps, rather than could have taken the steps. This means that the question is a practical one (involving consideration of practical constraints), rather than a theoretical question of what might have been done.

Mr Macaw suggested that the problem solution approach is not appropriate in this case. I understand his concern to lie with the fact that at the priority date, phospho-herbicide resistant plants were not available in Australia, so there was insufficient knowledge of the properties of these plants for workers to formulate a problem. However, the specification is clear on its face in identifying a problem, and that problem is one that would reasonably be expected to arise once genetically modified plants became available. If the applicant believed that the art in Australia was different to that in other parts of the world, they would have drafted their application for Australia to reflect this difference. Consequently it is reasonable to use the problem-solution approach as suggested by the specification.
(i) The problem
The identification of the problem is the key step in the problem-solution approach to inventive step. In University of Georgia Research Foundation, Inc v BioChem Pharma, Inc (2000) 51 IPR 222 at 247, (2001) AIPC 91-676 at 39,227 I suggested that the problem can generally be read out of the specification. For example, the explanation of the prior art and the stated problems that existed provide a reasonable starting point for the problem. The specification opens with these words:
“The present invention relates to a new process for the control of weeds in useful plant cultivations, for example in the cultivation of maize, soya, cotton, rape, beet and sugar cane, which are resistant to phospho-herbicides.”
At its broadest, the specification relates to new processes for control of weeds in useful plants. However, the specification only discusses phospho-herbicide resistant plants, so I think the problem should be viewed as finding a process for the control of weeds in phospho-herbicide resistant useful plants
(ii) Ascertained
The argument was made that patent documents were not consulted in the art, so the citations would not have been ascertained. Mr Cameron stated that he used journal articles as a resource, but did not search the patent literature (para 41). Mr Cameron stated that he did not believe many people working in the art would have searched the patent literature. Dr Preston stated that he regularly consulted Chemical Abstracts for abstracts of patents (Preston 1 at para 3.1.4). Mr Brinker made a similar statement (at para 4.1.4). The test laid down in section 7 is whether the skilled person “could … be reasonably expected to have ascertained”. It is clear from the material served in evidence in this opposition that this is an art where there is intense patent activity. While it may be true that the patent literature is not consulted by all workers in the art, it seems reasonable to conclude that the skilled person could reasonably have been expected to consult the patent literature.
(iii) Matters of routine
The key issue is whether it was a matter of routine to prepare a composition having synergy. My reading of the evidence is that it is routine to determine the optimal formulation and application rate. Where there is synergy between the active ingredients, the optimal formulation will most likely be a synergistic mixture of the active ingredients as it requires less active agent to achieve the same result.
The key evidence on this point is the first Preston declaration at para 8.1 (c ), which says “it was a routine procedure to test a mixture of glyphosate with at least one other herbicide for a synergistic result, in order to obtain the economic benefit of reducing rates of application of individual herbicides while maintaining herbicidal effectiveness”. The same comment is made at para 8.4.1. This passage suggests to me that it was routine to determine the optimal ratio of components and application rate for a composition, regardless of whether there is synergy. If the optimal application involves synergy, then that is just a bonus.
However, the optimisation of compositions for application to glyphosate or glufosinate-resistant plants appears to be a different matter. The evidence is unequivocal that glyphosate and glufosinate-resistant plants were not routinely available in Australia at the priority date. For instance, Cameron states at para 34: “Crops resistant to either glyphosate or glufosinate were not commercialised and were indeed at best in highly secure research programs covered in entirety or in the majority by secrecy agreements or commercial in confidence contracts. Thus the number of people with access to, or knowledge of the trial outcomes of such research was highly limited.” There is no evidence that modified plants were otherwise routinely available. It is clear that people in the art knew how to carry out an optimisation, but would not have been able to do it due to lack of access to modified plants. It follows that the optimisation of compositions for such plants could not have been a matter of routine as a practical matter.
I conclude that the optimisation of compositions for use on glyphosate or glufosinate-resistant plants was not a matter of routine.
(iv) Obviousness
My conclusion above effectively disposes of the issue of inventive step. Since it was not routine to optimise compositions for use on glyphosate or glufosinate-resistant plants, the claimed invention could not have been a matter of routine in the light of the common general knowledge alone. Similarly, all of the citations also require the step of optimising, so the invention is not obvious in the light of any single citation. This result is similar to that in Kiren-Amgen Inc v Board of Regents of University of Washington (1996) 33 IPR 557, where the Deputy Commissioner found that a DNA sequence was not obvious because it depended on knowledge that could not have been obtained due to scarcity of supply of erythropoietin. I will elaborate briefly in relation to each citation.
a)   The Calgene patent is clearly relevant to the problem, and discusses the use of glyphosate in combination with other herbicides in glyphosate-resistant plants. However, the optimisation of the active ingredients would not be routine, so the claimed invention is not obvious.
b)   The Ciba-Geigy application is clearly relevant to the problem, and discusses the use of glyphosate or glufosinate in combination with other herbicides in resistant plants. However, the optimisation of the active ingredients would not be routine, so the claimed invention is not obvious.
c)   The Flint article describes the control of bindweed using a combination of glyphosate and another herbicide. There is no suggestion of applying the composition to glyphosate-resistant crops. It is questionable whether this document would have been regarded as relevant. However, optimisation in the case of resistant crops would be required, and this is not a matter of routine.
d)   The Moshier abstract describes the control of honeyvine milkweed by glyphosate and another herbicide. There is no suggestion of applying the composition to glyphosate-resistant crops. It is questionable whether this document would have been regarded as relevant. However, optimisation in the case of resistant crops would be required, and this is not a matter of routine.
e)   The Moshier paper describes the control of honeyvine milkweed by glyphosate and another herbicide. There is no suggestion of applying the composition to glyphosate-resistant crops. It is questionable whether this document would have been regarded as relevant. However, optimisation in the case of resistant crops would be required, and this is not a matter of routine.
f)   The Hoechst application describes the control of monocotyledonous and dicotyledonous weeds by glufosinate or glyphosate and another herbicide. There is no suggestion of applying the composition to resistant crops. It is questionable whether this document would have been regarded as relevant. However, optimisation in the case of resistant crops would be required, and this is not a matter of routine.
(v)       Conclusion
The invention is not obvious in the light of the common general knowledge or any of the citations.
Manner of manufacture
It was argued that the invention is no more than the new use of a combination of known herbicides to control weeds in known plants in a manner for which the known properties of those herbicides make them suitable. The case of Commissioner v Microcell Limited (1959) 102 CLR 232 was relied on in this regard. Claim 1 does not relate to the new use of a known composition as the composition is novel (as evidenced by the fact that claims 14 and 15 are novel. Consequently this ground of opposition fails.
Section 40 matters
Monsanto raised the issue of clarity. In construing the claims I have not been left with any clarity issues, so this ground of opposition fails.
I raised the issue of whether the specification fully describes the invention. Mr Caine said that Monsanto did not raise this issue because they believed that this ground was essentially unavailable following the High Court decision in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58. This aspect of section 40 is not addressed by the Lockwood case, and the present specification fails to fully describe the invention for the reasons already given.
Conclusion
I have found that the specification suffers from several deficiencies:
i)The specification does not fully describe the invention in relation to the synergistic amount.
ii)The claims are not fairly based in so far as they use the term “comprising glufosinate and glyphosate”
These are straight forward matters to rectify. I allow the applicant 30 days to propose amendments to address these issues.
Costs
The opposition succeeds on two matters arising under section 40, and fails completely on the major grounds of novelty and inventive step. The matter of full description was not argued by the opponent. Consequently, the opponent has been successful on a very minor part of its opposition, and it is appropriate that costs should not follow the event. I award costs in accordance with Schedule 8 against Monsanto.
Dr S.D.Barker
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : Davies Collison Cave
Patent attorneys for the opponent : E.F.Wellington & Co