Nufarm Australia Ltd. v Monsanto Technology LLC
[2013] APO 66
•10 December 2013
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Nufarm Australia Ltd. V Monsanto Technology LLC [2013] APO 66
Patent Application: 2004232335
Title:Herbicidal compositions containing glyphosate and a pyridine analog
Patent Applicant: Monsanto Technology LLC
Opponent: Nufarm Australia Ltd
Delegate: Karen Ayers
Decision Date: 10 December 2013
Hearing Date: 26 September 2013
Catchwords: PATENTS –– opposition to the grant of the patent under s 59 –– opposition partly successful on novelty and inventive step –– key features can be readily inferred from disclosure –– generic disclosure will not always deprive a later more specific claim of novelty ––documents cannot be combined under novelty unless they would be treated as a single source of information –– starting point for inventive step was potential benefit of a combined herbicide treatment –– not all documents would have been ascertained and regarded as relevant in light of this problem –– results with combination herbicides have been varied (and unpredictable) ––skilled worker would not be directly led to use a combined herbicide approach without specific incentive––a list of possible herbicidal combinations without any further guidance is merely obvious to try –– only difference being a particular concentration was a mere choice from known alternatives
Representation: Patent applicant: Ian Horak of Counsel instructed by Bruce Wellington (patent attorney of EF Wellington & Co, Melbourne)
Opponent:Warwick Rothnie of Counsel instructed by Adrian Crooks (patent attorney of Phillips Ormonde Fitzpatrick, Melbourne)
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2004232335
Title:Herbicidal compositions containing glyphosphate and a pyridine analog
Patent Applicant: Monsanto Technology LLC
Date of Decision: 10 December 2013
DECISION
The opposition is partly successful.
The opponent has established that the Milne results (1987, 1990 and 1992) deprive claims 9, 15, 17, 18, 21, 25, 27, 31-34 and 36 of their novelty and that the PowerMax® label deprives claims 16-18, 21, 22, 31, 34 and 35 of their inventive step.
The opponent has not established that any of the remaining claims lack novelty or an inventive step.
There is patentable subject matter within the patent application and I therefore allow the applicant 60 days in which to propose amendments to address the above deficiencies.
Costs awarded according to Schedule 8 against the patent applicant, Monsanto Technology LLC.
REASONS FOR DECISION
Background
Patent application 2004232335 was filed under the provisions of the PCT by Monsanto Technology LLC on 22 April 2004. It claimed priority from US basic application 60/496031 filed on 22 April 2003.
The Australian application was published accepted on 23 December 2010 and a notice of opposition was filed on 23 March 2011 by Nufarm Australia Ltd. Evidence in support was completed on 26 October 2011. The applicant filed section 104 amendments on 20 June 2012 with their evidence in answer. These amendments were finally allowed on 21 March 2013. Evidence in the opposition was completed on 25 June 2013 and the case was set for hearing in Melbourne on 26 September 2013.
Evidence
The parties have filed the following evidence filed in this matter:
Evidence in support
Statutory Declaration from Phillip Maxwell Hay dated 24 October 2011 together with exhibits PMH-1 to PMH-32 (Hay-1)
Statutory Declaration from Scott Gardiner dated 24 October 2011 together with exhibit SG-1
Evidence in answer
Statutory Declaration from Daniel R. Wright dated 14 June 2012 together with exhibits DWR-1 to DWR-6
Evidence in reply
Statutory Declaration from Phillip Maxwell Hay dated 25 June 2013 together with exhibits PMH-33 to PMH-43 (Hay-2)
Preliminary Matters
Amendment to the SGP
The opponent filed a request to amend the Statement of Grounds and Particulars (SGP) on 12 September 2013 (shortly before the hearing date). Both parties were advised that the Commissioner would deal with the amendment request at the hearing.
The proposed amendment to the SGP introduces additional novelty citations which had already been served in Evidence in Reply. As the applicant has conceded, the new citations by Milne (the 1987, 1990 and 1992 results) are the closest prior art in the opposition (particularly in regard to the post-amended claims). The public interest therefore dictates that this highly relevant material should be admitted into the current proceedings (even though none of these documents were properly evidence in reply).
The applicant has been aware of this highly relevant material since at least June 2013 and their written submissions have addressed the new citations. I consider that the applicant has had sufficient time to consider and respond to this material. Given this, I allow the further evidence into these proceedings and the consequential amendment to the SGP.
Onus of Proof
The request for examination in relation to the patent was filed on 9 July 2007. As a consequence, substantive amendments of the Patents Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent application. This includes the amendment to subsection 59(3A) that allows the Commissioner to refuse an opposed patent application if satisfied on the balance of probabilities that a ground of opposition exists.
It therefore appears that the former standard for opposition proceedings applies and the opponent must establish that it is clear or practically certain that the patent is invalid (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; 50 IPR 305; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; 79 IPR 426; Genetics Institute Inc v Kirin-Amgen Inc [1999] 92 FCR 106 at [17]).
The opponent argued that this standard of proof actually changed as a result of the Patents Amendment Act 2001. This amending Act introduced a higher threshold test for novelty and inventive step in examination in which the Commissioner must be satisfied that an invention was novel and inventive (rather than conferring the 'benefit of the doubt' to the applicant). The relevant amendment only applied to acceptance and no related amendment was made to Chapter 5 of the Act (which deals with the determination of oppositions). Nonetheless the opponent argued that the same test should apply to opposition because opposition and examination are both pre-grant considerations.
10. However, as discussed by the Deputy Commissioner (Philip Spann) in Micromass Ltd v Varian Inc [2002] APO 31 (at [23]-[30]), these amendments have not introduced a new evidentiary test. There are only two standards of proof recognised under Australian law – the criminal and the civil standards of proof (Murray v Murray (1960) ALJR 521, Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336). In proceedings before the Commissioner, it is the civil standard of proof which applies sometimes referred to as the "balance of probabilities" test.
11. Moreover the Deputy Commissioner noted that the “balance of probabilities” test is not a mere comparison of probabilities but requires the tribunal to be reasonably satisfied that an allegation is made out. In this regard "the seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding" have been found to be relevant factors as to whether the issue has been proved to the satisfaction of the tribunal.
12. It follows that the courts in pointing out the consequences of the refusal of a patent application were not proposing a new standard of proof for opposition matters but merely applying that standard in those circumstances and in particular taking into account the consequences of an adverse finding on the applicant. This standard would not change as a result of the Patents Amendments Act 2001 as was acknowledged by the Court in Aristocrat Technologies Australia Ltd v IGT (Australia) Pty Ltd (2007) 71 IPR 259; [2007] FCA 37 at [10].
13. As a consequence, the “Microcell test”[1] continues to apply in the current patent opposition. In order to discharge their onus, the opponent will need to establish that the patent is “clearly invalid”.
[1] As per the test provided by the High Court in Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 (at 244-245):
“The Commissioner ought not to refuse acceptance of an application and specification unless it appears practically certain that letters patent granted on the specification would not be upheld”
Specification
14. The specification (as amended) relates to herbicidal compositions containing glyphosate (N-phosphonomethyl-glycine). The specification notes that although glyphosate is very effective in killing unwanted plants, its uptake and translocation through a plant is relatively slow with few early visual symptoms in a plant to indicate successful treatment. To overcome this problem, the prior art applied a mixture of herbicides containing glyphosate and a contact herbicide such as a pyridine analog (such as triclopyr).
15. The specification notes that in contrast to these earlier compositions, the current invention discloses herbicidal compositions with higher ratios of glyphosate:triclopyr and/or include a surfactant. A summary of the admitted prior art compositions (and how they differ from the current claims) is provided in the table below:
| Admitted prior art | specification page reference | components | w/w ratio (glyphosate:pyridine) |
| R.K. Howell et al Southern Weed Society Proceedings 195-197 (1998) | p2, line 7 | Surfactant TL90, Roundup Pro® and Garlon ™4 (triclopyr) | 1.3:1 |
| G.M Wright et al North Central Control Conference Proceedings vol 38, 139 (1983) | p2, line 11 | Tank mixture of glyphosate and triclopyr (no surfactant) | 1.5:1 |
| M.L. McCormack et al Northeastern Weed Society Proceedings vol. 36: 209-214 | p2, line 16 | Tank mixture of glyphosate and triclopyr (no surfactant) | 1.4:1 |
| J.Lawrie et al Weed Research 33: 25-34 (1993) | p2, line 20 | Tank mixture of glyphosate, triclopyr and surfactant | 1.67:1 |
| W.Harahap et al Biotrap Special Publication 24: 317-324 (1986) | p2, line 24 | Tank mixture of glyphosate and triclopyr or glyphosate and picloram (no surfactant) | glyphosate:triclopyr 9.5:1 or 11.5:1 glyphosate:picloram 7.7:1 |
| S.H. Kay et al Southern Weed Society Proceedings 291 (1992) | p2, line 30 | Tank mixture of glyphosate and triclopyr (no surfactant) | 1:1 |
| A Roundup Pro® supplemental label EPA Reg No. 524-475 | p2, line 34 | Roundup Pro® and Garlon ™4 (triclopyr) | Varying |
| GB 2 267 825A | p3, line 18 | IPA-glyphosate and butoxyethyl ester of triclopyr (as a microemulsion concentrate with surfactant) | 1.6:1 |
16. The specification as amended after acceptance ends with 46 claims of which 12 are independent (claims 1, 5, 9-12, 16, 19, 24, 31, 37 and 42). The essential features of each independent claim are summarised in Annex 1. Claims 1, 5 and 37 relate to aqueous herbicide concentrates and claim 19 relates to a herbicide particulate concentrate. Claim 24 relates to a method of killing plants using an aqueous herbicide concentrate. Claims 9-12, 16, 31 relate to herbicidal compositions and claim 42 relates to a method of killing plants using a hand sprayer containing a herbicidal composition.
17. The most relevant claims for the current decision (claims 1, 9, 16, 24 and 42) are outlined in full below.
1. An aqueous herbicidal liquid concentrate which may be diluted with water to provide an aqueous herbicidal application mixture for application to the foliage of a plant, the concentrate comprising:
glyphosate or a herbicidal derivative thereof in a concentration of at least about 50 grams acid equivalent per liter;
a pyridine analog selected from the group consisting of triclopyr, clopyralid, dithiopyr and thiazopyr, or a herbicidal derivative thereof; and,
at least one surfactant;
wherein (i) the glyphosate (acid equivalent basis) and the pyridine analog (acid equivalent basis) are present in a weight ratio between 8:1 and 20:1,glyphosate being in excess, and
(ii) when the glyphosate is predominantly in the form of a salt, said salt is selected from the group consisting of a sodium salt, an ammonium salt, an alkylammonium salt, a C3-C16 alkanolammonium salt, a diammonium salt, an alkylamine salt, a C3-C16 alkanolamine salt, an alkylsulfonium salt, a sulfoxonium salt, and combinations thereof.
9. An aqueous herbicidal composition useful for killing or controlling the growth of unwanted plants comprising:
glyphosate or a herbicidal derivative thereof;
a pyridine analog selected from the group consisting of triclopyr, clopyralid, dithiopyr and thiazopyr, or a herbicidal derivative thereof; and,
at least one surfactant;wherein the glyphosate (acid equivalent basis) and the pyridine analog (acid equivalent basis) are present in a weight ratio between 8:1 and 20:1, glyphosate being in excess, and further wherein when the glyphosate is predominantly in the form of a salt, said salt is selected from the group consisting of a sodium salt, an ammonium salt, an alkylammonium salt, a C3-C16 alkanolammonium salt, a diammonium salt, an alkylamine salt, a C3-C16 alkanolamine salt, an alkylsulfonium salt, a sulfoxonium salt, and combinations thereof.
16. An aqueous herbicidal composition useful for killing or controlling the growth of unwanted plants comprising:
at least one glyphosate salt predominantly in the form of potassium glyphosate, monoethanolamine glyphosate, or a mixture thereof;
a pyridine analog selected from the group consisting of triclopyr, clopyralid,
dithiopyr and thiazopyr, or a herbicidal derivative thereof; and at least one surfactant;
wherein (i) the glyphosate salt is present in a concentration less than 320 grams acid equivalent per liter and the glyphosate salt (acid equivalent basis) and the pyridine analog (acid equivalent basis) are present in a weight ratio between 8:1 and 20: 1, glyphosate being in excess; (ii) the glyphosate salt is present in a concentration less than 324 grams acid equivalent per liter and the glyphosate salt (acid equivalent basis) and the pyridine analog (acid equivalent basis) are present in a weight ratio between 9:1 and 20:1, glyphosate being in excess; or (iii) the glyphosate salt is present in a concentration less than 326 grams acid equivalent per liter and the glyphosate salt (acid equivalent basis) and the pyridine analog (acid equivalent basis) are present in a weight ratio between 10:1 and 20:1, glyphosate being in excess.
19. A herbicidal particulate solid concentrate which may be dissolved or dispersed in water to provide an aqueous herbicidal application mixture for application to the foliage of a plant, the concentrate comprising:
glyphosate or a herbicidal derivative thereof;
pyridine analog or a herbicidal derivative thereof; and
at least one surfactant;wherein the glyphosate (acid equivalent basis) and the pyridine analog (acid equivalent basis) are present in a weight ratio between 8:1 and 20:1, glyphosate being in excess.
24. A method of killing or controlling weeds or unwanted plants comprising:
diluting an aqueous herbicidal concentrate composition in an amount of water to form an application mixture; and
applying a herbicidally effective amount of the application mixture to foliage of the weeds or unwanted plants,
wherein the weeds or unwanted plants comprise poison ivy, poison oak, kudzu, multiflora rose, golden rod, blue fescue, red maple, and/or red oak, and the aqueous herbicidal concentrate composition comprises glyphosate or a herbicidal derivative thereof; a pyridine analog selected from the group consisting of triclopyr, clopyralid, dithiopyr, thiazopyr and picloram, or a herbicidal derivative thereof; and,
at least one surfactant,
wherein the glyphosate (acid equivalent basis) and the pyridine analog (acid equivalent basis) are present in a weight ratio between 8:1 and 20:1, glyphosate being in excess.
42. A method of killing or controlling weeds or unwanted plants comprising: applying a herbicidally effective amount of an application mixture to the foliage of the weeds or plants via a hand sprayer, said application mixture comprising:
a salt of glyphosate selected from the group consisting of a sodium salt, a potassium salt, an ammonium salt, an alkylammonium salt, a C3- C16 alkanolammonium salt, a di-ammonium salt, an alkylamine salt, a C3-C15 alkanolamine salt, an alkylsulfonium salt, a sulfoxonium salt, and combinations thereof;
a pyridine analog herbicide selected from the group consisting of triclopyr, clopyralid, dithiopyr, thiazopyr, and the salts and esters thereof; and
a surfactant,
wherein the salt of glyphosate (acid equivalent) and the pyridine analog (acid equivalent) are present in a weight ratio between 8:1 and 20:1, glyphosate being in excess, provided that when the glyphosate is predominantly in the form of the potassium salt thereof, the concentration of glyphosate acid equivalent is less than 320 g/L.
18. The claim set is very complex. Thus, while most of the claims refer to specific glyphosate salts (Na, ammonium, alkylammonium, C3-C4 alkanolammonium salt, diammonium salt, akylamine salt, C3-C16 alkanolamine salt, alkylsulfonium salt, sulfoxonium salt, and combinations thereof), claims 16, 31, 37 and 42 also include potassium and claims 19 and 24 are not claimed as a glyphosate salt at all. Further while most of the independent claims refer to the specific pyridine analogs triclopyr, clopyralid, dithiopyr and/or thiazopyr, claim 24 also includes picloram as an option.
19. This means that the only common features of the compositions defined in each of the independent claims is as follows:
a. Glyphosate (regardless of salt form);
b. a specific pyridine analog (triclopyr, clopyralid, dithiopyr or thiazopyr in most of the independent claims but claim 24 also includes picloram);
c. at least one surfactant;
d. where the weight ratio of glyphosate to pyridine analog (acid equivalent basis) is between 8:1 and 20:1 (with glyphosate being in excess).
20. At the hearing, neither party agreed that my decision should be limited to a consideration of these features. However they both accepted that given the complexity of the claim set, it was reasonable for me to concentrate on these features in my decision (at least in the first instance).
Common General Knowledge
21. Glyphosate is a well-known post-emergence herbicide generally applied to the foliage of target plants[2]. Because glyphosate is relatively insoluble, it is commonly formulated as a water-soluble anionic salt (with a metal or an amine derived cation)[3]. Glyphosate was originally (and is still most commonly) formulated as the isopropylamine (IPA) salt in commercial herbicides. This is an alkylamine salt which is included in the list of glyphosate salts defined in claim 1.
[2] Franz et al: “Glyphosate: A unique Global Herbicide” (1997) ACS Monograph 189, American Chemical Society, Washington, DC (1997) (Chapter 7) (PMH-4)
[3] Hay-1 at [25]
22. Glyphosate is typically provided as liquid concentrate and metered as a volume dosage rather than weight. Thus the concentration of herbicidal active ingredients is often presented as weight per unit volume (ie: grams per litre or pounds per gallon)[4]. In addition, the concentration of glyphosate tends to be expressed in terms of the free acid portion of glyphosate (ie: acid equivalent) per litre of solution rather than grams of the active ingredient itself (ie: the grams of the glyphosate salt) per litre of solution[5].
[4] Hay-2 – PMH-43 at page 7, lines 18-22
[5] Hay-1 at [26]
23. Commercial glyphosate products also often contain adjuvants (such as surfactants) to increase glyphosate retention on the foliage and enhance its uptake[6]. An example is the well known commercial product Roundup® which contains the surfactant MONO818 (a polyethoxylated tallowamine surfactant) present at 7-8%[7].
[6] Over 70% of commercial glyphosate formulations contained at least one adjuvant in 1997 - See Franz at page 187.
[7] Hay-1 at [23]
24. A review (by Franz et al[8]) published in 1997 (which both parties referred to for common general knowledge) noted that many herbicides have been tested in combination with glyphosate primarily in an effort to further broaden the weed-control spectrum or add residual activity. Franz teaches that that one of the most common combinations is a mixture of a broad leaf herbicide such as 2,4-D or dicamba with glyphosate[9].
[8] Franz at page 188
[9] Franz at p211
25. Franz also reports that combinations of glyphosate with other post-emergence, broad spectrum herbicides have been studied including the pyridine analog herbicides, triclopyr and fluroxypyr[10]. Pyridine analog herbicides are synthetic auxins and are widely sold in Australia (typically to control woody plants such as blackberry or ivy). Three of the most common pyridine analogs are triclopyr, clopyralid and fluroxypyr.
[10] Franz at p 212 and 213
26. The labels on a number of commercial herbicidal products explicitly discussed “tank mixing” of glyphosate and a pyridine analog. One of these (a Roundup Pro® supplemental label EPA Reg No. 524-475) was referred to in the admitted prior art.[11] The mention of glyphosate and pyridine analog mixtures on commercial herbicide labels is particularly significant because (as the opponent has argued) all claims for efficacy and use on herbicide labels are reviewed and approved by the national regulators[12]. This suggests that the combination of glyphosate and pyridine analogs was “generally regarded as a basis for further action”[13] and hence the combination was (at least at a broad level) part of the CGK.
[11] Opposed specification page 2, line 34.
[12] Opponent’s submissions at [87]
[13] As per Lindgren J’s comments in Alphapharm (2008) 76 IPR 618; [2008] FCA 559, (at 667 [221]) regarding CGK:
[I]t was held in Astra that information recorded in a document, even a document widely circulated within the art, is not part of general common knowledge merely because the skilled addressee could be expected to locate it. The question is whether it is “‘generally accepted without question” or “generally regarded as a good basis for further action” by the bulk of those in the art.
27. However Franz also teaches that the results with combination herbicides have been varied (and unpredictable). Some herbicide combinations are incompatible (or antagonistic) where other combinations are additive or even synergistic. In some cases, a particular combination can even be antagonistic in one type of application and synergistic in another. It is therefore generally accepted that while there is a recognised potential in combining herbicides, there is also a high level of unpredictability in this art with regard to specific combinations and their application.
Novelty
Relevant Law
28. The question of novelty is determined under the provisions of subsection 7(1) of the Patents Act (Cth) which relevant reads as follows:
(1) For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a) prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;
(b) prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information;
(c) ……
29. The basic test for novelty is the "reverse infringement test" as set out in Meyers Taylor Pty Ltd v Vicarr Industries [1977] HCA 19; (1977) 137 CLR 228 at page 235 where Aickin J stated:
"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 invention would if the patent were valid, constitute an infringement."
30. Infringement is said to occur where "each and every one of the essential features of that claim have been taken" (Rodi and Wienenberger AG v. Henry Showell Ltd (1969) RPC 367).
31. However, as noted in Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224 (see paragraphs 311 et seq), it is not sufficient for a citation to contain all the essential features of the claim, there must be “clear and unmistakable” directions to the claimed invention. In that regard, the Full Court referred to three key decisions:
(a) Canadian General Electric Co v Fada Radio Limited [1930] AC 97:
“...it is not enough to prove that an apparatus described in an earlier specification could have been used to produce this or that result. It must also be shown that the specification contains clear and unmistakeable directions to use it.”
(b) General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 45:
“a signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee”
(c) ICI Chemicals v Lubrizol Corp [2000] FCA 1349; (2000) 106 FCR 214
‘... skilled addressees are not required to rummage through the prior patentee’s "flag locker" to find a "flag which the [prior patentee] possessed and could have planted".’
Novelty can however be found where a feature is not explicitly mentioned but is nonetheless inherently present as an inevitable result of the disclosure. As noted in General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [supra]at page 486:
"if in carrying out the directions contained in a prior inventor's publication will inevitably result in something being made or done which, if the claim of the opposed specification were a claim of a valid patent, would constitute an infringement of that claim, then that claim would have been anticipated".
However as also observed by the same Court:
“ If ... the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way that would not do so, the patentee's claim will not be anticipated."
In addition, as noted in the Pfizer decision, a citation to deprive a claim of its novelty must be the same as the claimed invention for the purposes of “practical utility”. In other words, the citation has to “enable” the skilled worker to produce the invention from the written disclosure. The basic principle is explained in Hill v Evans (1862) 4 De G F & J 288; 45 ER 1195be where the court noted
“...the antecedent statement must be such that a person of ordinary knowledge in the subject would at once perceive, understand, and be practically able to apply the discovery without the necessity of making further experiments and gaining further information before the invention can be made useful. If something remains to be ascertained which is necessary for the useful application of the discovery that affords sufficient room for another valid patent”.
Cited art
At the hearing, the opponent relied on the following documents to establish a lack of novelty:
Document Citation Abbreviation Exhibit Date of publication D1 K.Little et al ICFR Bulletin Series No 02/1998 Little (1998) PMH-22 2/07/98 D2 K. Little et al ICFR Bulletin 03/ 2000 Little (2000) PMH-23 14/11/2001 D3 B Milne, 1987 Results – Weed Research & Demonstration Unit, Agricultural Research & Veterinary Centre, orange published by the NSW Agriculture &Fisheries 1987 Results PMH-35 19/04/1988 D4 B Milne, 1990 Results – Weed Research & Demonstration Unit, Agricultural Research & Veterinary Centre, orange published by the NSW Agriculture &Fisheries 1990 Results PMH-38 1990 (exact publication date not provided) D5 B Milne, 1992 Results – Weed Research & Demonstration Unit, Agricultural Research & Veterinary Centre, orange published by the NSW Agriculture &Fisheries 1992 Results PMH-39 6/07/1993 D6 WO 00/30452 in the name of Monsanto Co WO 00/30452 PMH-43 2 June 2000 D7 Australian Product information sheet or product label for “Roundup® PowerMax” Roundup® PowerMax guide PMH-6 Prepared in November 2002 and approved by the Australia Pesticides and Veterinary Medicines Authority on 10 January 2003 D8 The Lontrel® Product Label (Dow AgroSciences Product Guide Book 2000 pp 111-119) Lontrel Label PMH-10 2000
Little (1998)(D1)
36. Little (1998) investigated the control of Eucalyptus cut stumps after a process known as “coppicing”. In coppicing, a young tree stem is cut down to near ground level to generate a stump from which many new shoots can generate.[14] These shoots have to be selectively thinned to make sure the most robust shoots remain on the original stem (stool). The authors found that the most effective control of coppice shoots was by using chemical herbicides and in particular, the pyridine analogs imazapyr, triclopyr and picloram.
[14] There were 3 treatments described in the citation (E, J and O) which combined triclopyr and glyphosate (see pages 10 and 11). Each of these treatments is said to contain “triclopyr (ester) as a 2% mixture with glyphosate (IPA salt) at 144 g/L”. This statement doesn’t specify the source (or starting concentration) of the triclopyr (ester) and hence (on its own) does not provide the concentration of triclopyr used in the treatments. However the opponent argued that this could still be determined from an earlier part of the citation (page 4) which only lists one commercial product containing the ester form of triclopyr (Garlon®4)[15]. Based on the known concentration of triclopyr in Garlon®4, the opponent calculated that the composition used in treatments E, J and O would contain 9.6 g triclopyr/L[16]. This equates to a ratio of 15:1 (glyphosate:triclopyr) on an acid equivalent basis (based on 144 g/L glyphosate) in the treatment compositions[17] which falls within the currently claimed range (8:1-20:1)[18].
[15] or in the Vermeulen (1993) reference itself (Hay-2, PMH-34)
[16] 2% mixture of Garlon®4 is equivalent to 20mls of Garlon®4 per litre or 0.02 x 480g/L =9.6 g/L.
[17] 144/9.6 = 15
[18] Opponent’s submissions at [58]-[61]
38. The applicant argued that the skilled worker would not necessarily import the information from the earlier part of the citation into the later treatments[19]. However, the earlier discussion outlines the general methodology used in the later treatments and the two sections are clearly intended to be read in conjunction with each other. I therefore agree with the opponent that the skilled worker would understand that Garlon®4 was used as the commercial source of triclopyr (ester).
[19] The applicant also argued that Timbrel®3A (containing at 360g/L triclopyr) was also mentioned on page 4 and could have been used as the source of triclopyr. However this product contains the amine salt (not the ester) and would not have been used in the later treatments. In any event, even if Timbrel®3A was used, the ratio of glyphosate:triclopyr would be 20:1 and still fall within the claimed range.
39. The applicant argued that even if this was the case, the reference to “triclopyr (ester) as a 2% mixture with glyphosate (IPA salt) at 144g/L” in treatments E, J and O (pages 10-11) could still mean 2% triclopyr relative to the glyphosate content (which would lead to a ratio well above 20:1). However all the formulations on pages 10 and 11 are expressed in terms of a % mixture whether (or not) the formulation also contained glyphosate. The only reasonable interpretation of the term “2% mixture” is therefore as a percentage of the total formulation as the opponent has argued.
40. Finally, the applicant questioned the opponent’s assumption that the term “active ingredients per litre” was actually a measurement of the “acid equivalents per litre”. I note that this term is only mentioned in reference to the concentration of the active ingredients in a commercial product so any potential ambiguity in this term can easily resolved from the commercial labels themselves. These clearly demonstrate that the “active ingredient” levels of triclopyr listed in the tables on page 4 for Garlon®4 are consistent with the ingredient measured in terms of its “acid equivalent” as argued by the opponent[20].
[20] The Garlon®4 label measures the levels of triclopyr in terms of its acid equivalent and notes that the formulation contains 4lb/gallon triclopyr (Hay-2 PMH-33). This measurement can be converted into metric values (g acid equivalent /L) as follows:
4lb/gal = (4 x 453.6g)/3.785 = 479.3 g acid equivalent/L
(based on the product containing US liquid gallons (1 US gal liquid being 3.785 litres - see Hay-2 at [13]) and that 1lb is equivalent to 453.59 grams) (see
41. Given this, I accept that the assumptions made by the opponent in calculating the glyphosate:triclopyr ratio are all inferences which a skilled worker would readily draw from reading the citation. The citation clearly teaches that glyphosate and triclopyr should be mixed in certain proportions (15:1). The opponent has merely calculated how much of each component would have been present in the final treatment and to match this to the units of measure used in the current claims.
42. In contrast, I note that Little (1998) does not explicitly mention the presence of surfactant in their mixed herbicide formulations. The opponent has argued that Roundup® contains a tallow amine surfactant[21] and hence a surfactant is nonetheless inherently present as an additive of Roundup®. However as the applicant argued[22], not all Roundup® formulations available to Little in 1998 would have contained a surfactant. Further, the citation does not limit the commercial brands of glyphosate to the Roundup® formulation of glyphosate. Thus the generic brands of glyphosate referred to in the table on page 4 may not all have contained surfactants[23].
[21] Hay-1 at [18]
[22] Wright EIA at [67]
[23] See discussion above under common general knowledge
43. As a consequence, while the citation is capable of being carried out in a manner which would infringe the patentee’s claim, it would be at least as likely to be carried out in such a way that would not do so (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1971) 1A IPR 121 at 138). There are therefore no “clear and unmistakable directions” to add a surfactant to the 15:1 glyphosate:triclopyr mixtures disclosed in Little (1998) (as per Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [314]; [2005] FCAFC 224; (2006) 68 IPR 1 at 67 [314]). Hence none of the claims are anticipated by Little (1998).
Little (2000)(D2)
44. Little (2000) is a continuation of the earlier work (discussed above) on the control of Eucalyptus stools of a multi-stem origin. The citation tested the cost-effectiveness of using two herbicidal compositions on Eucalyptus stumps and compared treatments using mixtures of glyphosate and triclopyr with applications using either herbicide individually.
45. Scenario 2 (table 2) contains triclopyr (amine) @ 1% with glyphosate @ 3% and 0.5% Actipron® Super[24]. Because the paper doesn’t provide the initial concentrations (or the commercial source) of either the glyphosate or triclopyr, the percentage values do not provide enough information for the skilled worker to calculate the level of triclopyr or glyphosate present in the treatment compositions. Hence the feature of the weight ratio of glyphosate:triclopyr between 8:1-20:1 is not disclosed in Little (2000).
[24] Actipron® is a self-emulsifying adjuvant oil which acts as a surfactant in the herbicidal compositions
46. Further, even if it is assumed that the authors used the commercial formulations from their earlier paper, the ratios used in Little (2000) fall well outside the claimed range (8:1-20:1):
Glyphosate @ 3% x 360g/L = 10.8g
Triclopyr (amine) @ 1% x 360g/L[25] = 3.6g
Glyphosate:triclopyr (acid equivalent basis) = 10.8:3.6 = 3:1[25] The only triclopyr commercial formulation containing amine in Little (1998) was Timbrel®3A (containing 360g/L triclopyr)
47. As a consequence, Little (2000) does not disclose a composition containing a ratio of glyphosate:triclopyr of between 8:1-20:1 and does not deprive any of the claims of their novelty.
The 1987, 1990, and 1992 Results (Milne Results)(D3-D5)
48. The 1987, 1990 and 1992 Milne Results are all reports produced by the NSW Department of Agriculture based on results of a testing program conducted by officers from the Weed Research and Demonstration Unit in Orange, NSW. There is no evidence that the Milne Results were openly published but they were provided to a range of interested people and companies without any fetter of confidence. I therefore accept (and this was not disputed) that these documents are all part of the prior art base for novelty.
49. The 1987 Results describe a trial conducted in Bathurst, NSW which tested Roundup® (360g/L) in combination with 3 different herbicides (dicamba, Lontrel® and 2,4-D ester) for the control of blue heliotrope in pasture. Relevant to this decision is the treatment using Roundup® and Lontrel® with the latter containing clopyralid (one of the herbicides listed in the current claims). This treatment also used 200 mls of a non-ionic organic surfactant (Agral®). The herbicides were applied with a handheld boom at 100L per hectare. All the treatments were successful in the trials with no apparent advantage with any wetting agent or herbicide mixture. In the treatment using Roundup® and Lontrel®, the rate of product per hectare was 2L of Roundup® and 200 mls of Lontrel®. These products were applied in a 100L volume (per hectare). The concentration of each component in a 100L volume would therefore be 7.2g/L glyphosate and 0.6 g/L clopyralid [a ratio of 12:1 glyphosate:clopyralid (grams acid equivalent per litre)][26].
[26] Opponent’s submissions at [71]-[73]. Glyphosate (Round up®) is present at (360g/L x 2L)/100 = 7.2 grams per litre acid equivalent. Clopyralid (Lontrel®) is present at (300g/L x 0.2L)/100 = 0.6g per litre acid equivalent. The ratio of glyphosate:clopyralid is therefore 7.2:0.6 = 12:1
50. The 1990 Results describe a trial which tested treatments using Roundup®CT alone and in mixture with different herbicides (2,4-D ester, Lontrel® (clopyralid) and Velpar®[27]) for the control of Sifton bush. There were two specific treatments which are relevant to the current decision:
(a) 2 Litres of Roundup®CT with 300 mls of Lontrel® L and 2 L of D-C-Trate®[28];
(b) 4 litres of Roundup® CT with 300 mls of Lontrel® and 2 litres of D-C-Trate®.
[27] Velpar® is a broad spectrum herbicide manufactured by DuPont®. Its active ingredient is hexazinone which is a member of the triazine class of herbicides.
[28] D-C-Trate® is a low surfactant spray oil/wetting agent specifically designed as an adjuvant or carrier for application of herbicides.
51. These concentrated components were diluted so they could be applied at 100L per hectare with a handheld boom. The concentration of each component in the 100L volume would be 9g/L glyphosate and 0.9 g/L clopyralid (treatment a) and 18g/L glyphosate and 0.9g/L clopyralid (treatment b)[29]. The ratio of glyphosate:clopyralid in treatment (a) was therefore 10:1 and in treatment (b) 20:1. A surfactant was also present in both treatments with the addition of D-C-Trate®[30].
[29] Roundup®CT contains 450g/L glyphosate. Lontrel® contains 300g/L clopyralid. Applied at 100 L per hectare, treatment (a) contains (450g/L x 2L)/100 = 9g glyphosate and (300g/L x 0.3)/100 = 0.9g clopyralid. The ratio of glyphosate to cloryralid is therefore 9:0.9 = 10:1. For treatment (b), the amount of glyphosate is doubled (18g) compared to clopyralid and the ratio is therefore 18:0.9 = 20:1.
[30] Note that Roundup®CT also contains 10% surfactant as part of its formulation.
52. The 1992 Results describe a trial which evaluated Roundup®CT alone and in mixture with 2,4-D ester 80, Starane®[31] and Lontrel® for the control of nightshade and yellow burr-daisy. Roundup®CT (either 1 or 2 litres) was combined with either 300 or 75 mls of Lontrel® in the presence of the surfactants CSO or BS1000. The relevant mixtures are as follows:
[31] Starane® contains the pyridine analog Fluroxypyr which is not claimed in the opposed specification
night shade
(a) 1 L Roundup®CT + 0.3 L Lontrel® + 1 L CSO
(b) 2 L Roundup®CT + 0.3 L Lontrel® + 1 L CSO
yellow burr daisy
(c) 1 litre Roundup® CT + 75 mls Lontrel® + 200 mls BS1000
53. Applied in a volume of 100L/ha, treatment (a) would contain 4.5 g/L glyphosate and 0.9 g/L clopyralid (a ratio of 5:1), treatment (b) would contain 9 g/L glyphosate and 0.9g/L clopyralid (a ratio of 10:1) and treatment (c) would contain 4.5 g/L glyphosate and 0.225g/L clopyralid (a ratio of 20:1).
54. For convenience, I have presented a summary of the key Milne results in the table below:
Milne Results Glyphosate source Glyphosate
(g a.e/L)Clopyralid
(g a.e/L)Glyphosate:
Clopyralid (g a.e)surfactant
1987 Roundup® 7.2 0.6 12:1[32] Agral® 1990 Roundup®CT 9 (a)
18 (b)0.9 (a)
0.9 (b)10:1 (a)
20:1 (b)[33]D-C-Trate® 1992 Roundup®CT 4.5 (a)
9 (b)
4.5 (c)0.9 (a)
0.9 (b)
0.225(c)5:1 (a)
10:1(b)
20:1(c) [34]CSO or BS1000 [32] Opponent’s submissions at [71]-[73]. Glyphosate (Round up®) is present at (360g/L x 2L)/100 = 7.2 grams per litre acid equivalent. Clopyralid (Lontrel®) is present at (300g/L x 0.2L)/100 = 0.6g per litre acid equivalent. The ratio of glyphosate:clopyralid is therefore 7.2:0.6 = 12:1
[33] Roundup® CT contains 450g/L glyphosate. Lontrel® contains 300g/L clopyralid. Applied at 100 L per hectare, treatment (a) contains (450g/L x 2L)/100 = 9g glyphosate and (300g/L x 0.3)/100 = 0.9g clopyralid. The ratio of glyphosate to cloryralid is therefore 9:0.9 = 10:1. For treatment (b), the amount of glyphosate is doubled (18g) compared to clopyralid and the ratio is therefore 18:0.9 = 20:1.
[34] Roundup® CT contains 450g/L glyphosate. Lontrel® contains 300g/L clopyralid. Applied at 100 L per hectare, this treatment contains (450g/L x 1L)/100 = 4.5g glyphosate and (300g/L x 0.075)/100 = 0.225g clopyralid which is a ratio of 20:1.
55. All the Milne results contain glyphosate as the IPA salt (an alkylamine) and use a surfactant in the mixture. Most also have a glyphosate:clopyralid weight ratio between 8:1-20:1. The opponent argued that these results deprived claim 9, 25 and 27 of their novelty. The opponent also noted that the citations disclose a clopyralid concentration of between 0.4 to 6 grams per litre (claims 15, 31-33, 36) or a clopyralid concentration of between 0.4 to 3 grams per litre (claims 34, 36), a glyphosate concentration of between 4 to 25 grams per litre (claims 17, 31-34), a specific surfactant (claim 18) and a method of controlling the growth of unwanted plants (claim 21).
56. The applicant argued that none of the Milne Results explicitly discussed “tank mixing” of the herbicides before application and that it was therefore possible that the two herbicides were applied consecutively rather than as a mixture[35]. The consecutive approach (multiple applications) is clearly much less efficient than applying both herbicides at the one time. I find it difficult to believe that the skilled worker would follow a consecutive approach without a clear reason (which the applicant failed to provide). In any event, the rates of product per hectare are expressed in terms of additive volumes of the different components (eg: 2 litres of Roundup® + 0.3 litres of Lontrel® + 1 litre of surfactant). Surfactants enhance the activity (or uptake) of herbicides and therefore have to be applied at the same time as the herbicide. By inclusion of this ingredient with the active ingredients, the clear implication is that all the ingredients are combined (ie: mixed) before application. The 1987 results even referred to the herbicide treatment as a “mixture” [see point (iv) on page 50]. I therefore agree with the opponent that the combined ingredients were tank mixed before being applied.
[35] Applicant’s submissions at [88]
57. At one point in their submissions (in relation to the herbicide labels), the applicant also argued that there is a difference between short term tank mixes and the stable compositions of their invention[36]. However if this feature is intended to distinguish the claims from the prior art, it is not present in the claims as currently drafted.
[36] Applicant’s submissions at [132]
58. Finally, the applicant questioned the salt form of glyphosate used in the Milne results[37]. Roundup®CT was used in at least 2 of their treatments which contains the IPA (an alkylamine) salt. However the applicant noted that the glossary of the herbicides provided in the report generically refers to Roundup®CT as “Roundup®CT and (generally) glyphosate 450g/L”. According to the applicant, this broadens the construction of the term Roundup®CT so it could include a glyphosate product with a different type of salt. However this is an over-strained construction. I think the skilled worker would clearly understand Roundup®CT as meaning the commercial product containing IPA salt (exactly as it says).
[37] Applicant’s submissions at [90]
59. In my view, the Milne results disclose the application of a herbicide mixture containing glyphosate (IPA salt), clopyralid and at least one surfactant. As summarised in the table above (and not disputed by the applicant), the exemplified glyphosate:clopyralid ratios include 12:1 (Milne 1987), 10:1 and 20:1 (Milne 1990 and 1992) which fall within the 8:1 to 20:1 range encompassed by the current claims. This deprives claims 9, 15, 17, 18, 21, 25, 27, 31-34 and 36 of their novelty.
60. There is no disclosure in the Milne results of either a herbicide concentrate, a composition containing glyphosate as a potassium or MEA salt, a specific surfactant or a surfactant with less than 9.3 g/L concentration, a method using a handsprayer, targeting specific plants or a particular application rate of glyphosate. Hence claims 1-8, 10-14, 16, 19, 20, 22-24, 26, 28-30, 35, 37-46 are novel in light of the Milne results.
WO 00/030452 (D6)
61. Patent application WO 00/30452 by Monsanto Co. (US) has an international publication date of 2 June 2000. It discloses a highly concentrated herbicidal composition containing glyphosate as an active ingredient predominantly in the form of the monoethanolamine (MEA) salt. MEA is a C2-alkanolammonium salt[38] which is not one of the glyphosate salts listed in independent claims 1, 5, 9, 10-12, 31, 37 and 42 (see annex 1). The citation was therefore only raised as a novelty citation against claim 16.
[38] Commonly also known as a C2-alkanolamine salt (even though this is separately defined in the claims)
62. While the citation mainly focuses on the single herbicidal concentrate, it also mentions that the MEA salt could be mixed with a second (anionic) herbicide in a ratio from about 1:1 to about 30:1 (see page 20, lines 24-25). It specifically mentions the anionic herbicides clopyralid, picloram, triclopyr and imazapyr (see page 20, lines 24-30) but amongst a long list of alternatives from a number of different classes of herbicides. The disclosure is therefore a generic one and there are no worked examples of any combination herbicide. .
63. Generic disclosures such as this will not necessarily anticipate a later, more specific claim. As noted in Apotex Pty Ltd v Sanofi-Aventis [2008] FCA 1194 at [91]:
“Anticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun.”
64. Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214 (at [272] and [273]) explained this in the context of a chemical formulae emphasising that for anticipation to be made out, a clear and precise disclosure of the subject matter of the claim is required:
“The view I have reached in this proceeding is that even if the prior art theoretically includes all of the integers of the invention (among other possible combinations), this is not necessarily to anticipate a later patent. Such a view is particularly apt where the prior art discloses a class of chemical compounds, often by way of a generic formula, as in the present case. Everything will depend upon the extent of disclosure in the prior art document, and the context in which that disclosure appears. It will be necessary to consider the disclosure in its entirety to determine what it clearly and unmistakably discloses. It is true to say as a matter of logic that a very generalised prior description in a prior art document does not necessarily disclose a specific item falling within that generalised description.”
65. In the current case, the disclosure on page 20 are not specific examples of the same general teaching but rather a list of possible combinations which the skilled worker could investigate further. This is not a clear and precise disclosure to any particular combination. As a consequence, this citation does not deprive any of the claims (including claim 16) of their novelty.
Roundup® PowerMax label (D7)
66. The Roundup® Powermax product was launched in Australia on 1 March 2003 (around 7 weeks before the priority date of the current application). This product contains Glyphosate (540g acid equivalent/L) as well as 10% tallow amine surfactant[39]. Because Powermax® contains glyphosate as the potassium salt, this citation was only raised against claims 16-18, 31, 34 and 35.
[39] Opponent’s submissions at [101]
67. Powermax® label contains a worked example of a composition containing glyphosate and triclopyr clearly directing the skilled worker to mix glyphosate and triclopyr for the treatment of Prickly Paddy melon. The skilled worker would understand the product to be useful for this stated purpose (particularly as the product undergoes a regulatory approval process to determine both its safety and efficacy)[40]. The specific teaching within the general disclosure is therefore a clear and precise disclosure to a composition containing glyphosate (potassium salt) and triclopyr.
[40] Hay-2 at [46]
68. The Roundup® PowerMax Product label (at page 7) teaches that 640ml-1275mls PowerMax® (540g/L) should be combined with 80ml Garlon®600 (600g/L triclopyr) per hectare for the treatment of Prickly Paddy melon. This equates to 345.6-688.5 grams of glyphosate and 48 grams of triclopyr per hectare and results in a glyphosate:triclopyr ratio of between 7.2:1 and 14.3:1 on an acid equivalent basis.[41]
[41] Powermax® contains 540g glyphosate acid equivalent/L; Garlon®600 contains 600g/L triclopyr. Glyphosate is therefore present at between (0.640Lx540ae/L)=345.6 a.e and (1.275Lx540ae/L)=688.5ae. Triclopyr is present at (0.08Lx600ae/L)=48ae; This equates to glyphosate:clopyralid ratios of (345.6:48) =7.2:1 and (688.5:48)=14.34
69. This is clearly included within the claimed range (8:1 to 20:1). However there are additional limitations in independent claims 16 and 31 which also need to be found in a citation for a novelty objection to be successful. Thus claim 16 has an upper glyphosate concentration limit:
(i)Glyphosate is present in a concentration less than 320g/L and weight ratio of between 8:1 and 20:1;
(ii)Glyphosate is present in a concentration less than 324g/L and weight ratio of between 9:1 and 20:1; or
(iii)Glyphosate is present in a concentration less than 326g/L and weight ratio of between 10:1 and 20:1.
70. Claim 31 has an upper and lower concentration limit for both glyphosate and triclopyr:
(a) Glyphosate to be present in a concentration of between 4 and 25 g/L; and
(b) A pyridine analog selected from triclopyr in a concentration between 0.4 and 6 grams/L.
71. As originally mixed, PowerMax® and Garlon® mixture would have a concentration of between 480 and 508 g/L of glyphosate[42] and between 67g/L and 35.4g/L of triclopyr[43] which is well above the concentration values defined in both claims 16 and 31. Mr Hays suggested in his evidence that this mixture would be further diluted (tank mixed) before use (as recommended on page 12 of the PowerMax® label). He suggested that the rate of application would be 80L per hectare in a broad acre boom spray application[44] and this would produce a mixture of between 4.3-8.6 g acid equivalents glyphosate and 0.6 triclopyr[45]. If correct, this (diluted) mixture would fall within the concentration limits of both claims 16 and 31 (as summarised in the table below):
[42] Mixing 640mls glyphosate with 80 mls of triclopyr makes 720 mls. Mixing 1.272L with 80mls is 1.355 litres. Glyphosate concentration in the lowest mix would be 345.6g/0.72L=480 g/L. In the highest mix it would be 688.5g/1.355L=508g/L. At the lowest mix, triclopyr would have a concentration of 48 g triclopyr/0.72= 67g/L. At the highest mix, it’s 48g triclopyr/1.355=35.4g/L
[43] 48 g triclopyr/0.72= 67g/L and 48g triclopyr/1.355=35.4g/L
[44] Hays-1 at [49]
[45] Hays-1 at page 18 and Hays-2 at [72]. Note that Hays-1 seems to have miscalculated the concentration of triclopyr as 0.7g/L (for 80L) but this is corrected to 0.6 g/L in Hays-2 and this is clearly the right value (48/80).
Glyphosate concentration (g/L) Triclopyr concentration (g/L) Claim 16 (broadest option) Less than 326 No explicit limit defined Claim 31 4-25 0.4-6 No dilution 480-508 35.4-67 80L dilution 4.3-8.6 0.6 72. However, as the applicant observed[46], the concentration of the triclopyr and glyphosate is dependent on the volume of the tank mixture (and assumes that one would be prepared). Page 12 of the PowerMax® label merely provides a general recommendation to use a spray volume of 80L/ha or less for optimum performance of a broad acre spray. There are no clear instructions directing the skilled worker to dilute the mixture to 80L in the specific circumstances of treating the Prickly Paddy melon with triclopyr and glyphosate. Although I accept that the skilled worker would dilute the original mixture to apply it in a boom spray, there are not “clear and mistakable directions” to a composition containing less than 326g/L glyphosate or 4-25/L glyphosate and 0.4-6g/L triclopyr.
[46] Applicant’s submissions at [106]-[108]
73. As a consequence, claims 16 and 31 (and their dependent claims 17, 18, 34 and 35) are novel in light of the PowerMax® label.
Lontrel® Label (D8)
74. Lontrel® is a commercial herbicide formulation manufactured by Dow AgroSciences. Its active constituent is 300 g/L clopyralid[47] present as the triisopropanolamine salt. The Lontrel® label is a guide of how a skilled worker would use this product in field applications. While the Lontrel® label contains generic information about the product, it also includes an explicit recommendation to tank mix glyphosate and Lontrel® (clopyralid) for a specific purpose (pre-sowing treatment of capeweed in WA). The label even provides specific directions about how this combination should be applied (including the rate of application of Lontrel® being 150 mL/ha)[48]. Given the amount of specific direction and detail in a commercial (and regulated) product guide, the skilled worker would understand this to be clear and unmistakeable directions to mix clopyralid and glyphosate for its stated purpose.
[47] Although the label does not explicitly state that the measurement is in terms of grams acid equivalent per litre, this would have nonetheless have been understood by the skilled worker because the measurement in expressed in terms of clopyralid which the label clearly distinguishes from its salt form.
[48] Lontrel® label at page 112 and note opponent’s submissions at [89], Hay-1 at [45] and Hay-2 at [51]
75. Although the citation teaches how much clopyralid should be added in the treatment, it is silent about the exact levels of glyphosate and hence does not disclose a particular ratio of glyphosate to clopyralid. The opponent argued that this could be determined from information on commercial glyphosate labels. According to the opponent, a common glyphosate composition used in Australia prior to 2004 was Roundup®CT label (containing 450 g glyphosate acid equivalent /L in the form of the IPA salt) and about 10% w/w tallow amine surfactant). The Roundup®CT label directs the use of Roundup®CT on page 9 at 800ml-1.2 litres/hectare which would equate to ratio of 8:1 to 12:1 glyphosate:clopyralid (if combined with the recommendations contained in the Lontrel® label)[49].
[49] Clopyralid is present at (0.15Lx300ae/L)=45ae (per hectare); glyphosate is present at (0.8Lx360ae/L)=360a.e (per hectare) and (1.2Lx360ae/L)=540ae (per hectare). This equates to glyphosate:clopyralid ratios of (360:45) =8:1 and (540:45)=12:1.
76. However this novelty argument relies on the combination of two documents. This is only possible under section 7(1)(b) of the Patents Act (Cth) if the two documents are related such that a person skilled in the relevant art would treat them as a single source of that information[50]. In this case, both labels mention the other commercial product but there are no clear directions from either label to directly import information from the other document. Hence the two documents are separate prices of information and cannot be combined for the purposes of novelty.
[50] As per section 7(1)(b) of the Patents Act 1990 (Cth)
77. As a consequence, the Lontrel® label does not deprive any of the claims of their novelty.
Inventive Step
Relevant Law
The question of inventive step is determined under the provisions of subsections 7(2) and 7(3) of the Patents Act (Cth). For applications with examination requests filed before 15 April 2013, a claimed invention will lack an inventive step if it is obvious in the light of:
(a)common general knowledge; or
(b)common general knowledge considered together with information in a single document or through doing a single act, provided that the document or act could reasonably be expected to have been ascertained, understood and regarded as relevant to work in the relevant art in the patent area by the person skilled in the art.
79. The general principles regarding inventive step were recently discussed in the Ranbaxy Laboratories Ltd v AstraZeneca AB [2013] FCA 368 (23 April 2013) ([203]-[218]). In that decision, Justice Middleton cited Jagot J’s comments in Apotex Pty Ltd v AstraZeneca AB (No 4) [2013] FCA 162 with approval:
“in Danisco at [326] one principle which Bennett J identified as orthodox having regard to the reasons “as enunciated by the High Court in Aktiebolaget, Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; (2007) 235 CLR 173 [(Lockwood v Doric (No 2)] and Wellcome and by the Full Court in Lundbeck [H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 ; [2009] FCAFC 70] and Apotex”, and which was not disturbed in Novozymes A/S v Danisco A/S [2013] FCAFC 6, is that:
In assessing obviousness, it is necessary first to determine the nature of the claimed invention and the inventive step described in the Patent. This may involve ascertaining the “starting point” of the inventive step, sometimes described in terms of an existing problem for which the inventor found a solution. The obviousness of the invention as claimed is then assessed by reference to common general knowledge in Australia at the priority date.
80. Justice Middleton then concluded that a key element of the test for inventive step is that the required comparison is between the relevant prior art base and the “invention, so far as claimed in any claim” (rather than each of the individual integers thereof). This was emphasised in Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59; (2002) 212 CLR 411 at 441 [72] in the context of discussing the relevant section of the Patents Act 1952 (Cth) (this passage was cited in Eli Lilly [2013] FCA 214 at [460]):
“[The relevant provision does not] direct an inquiry respecting each integer of the claimed combination. The paragraph asks whether “the invention ... as claimed”, here the combination, was obvious, not each of its integers.”
81. As noted by the High Court in Aktiebolaget Hässle [2002] HCA 59; (2002) 212 CLR 411, referring to Diplock LJ’s comments in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 at 362 (at 423 to 424 [21]):
“Once an invention has been made it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention that he claims in his specification if he started from something that was already known. But it is only because the invention has been made and has proved successful that it is possible to postulate from what starting point and by what particular combination of steps the inventor could have arrived at his invention. It may be that taken in isolation none of the steps which it is now possible to postulate, if taken in isolation, appears to call for any inventive ingenuity. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but, even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to that result.”
82. Of course as noted above, the onus of proof in opposition proceedings lies with the opponent who must establish 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 [29], [67]; [2000] FCA 283; (2001) 50 IPR 305 at 311 [29], 319 [67]; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; [2008] FCAFC 182; (2009) 79 IPR 426 at 430 [18], 432 [22]).
What is the starting point of the invention?
83. The admitted prior art in the opposed specification acknowledged that herbicidal mixtures containing glyphosate and pyridine analogs were already known. However the applicant argued that this was not the correct “starting point” for determining inventive step because these mixtures were not part of the CGK.[51] According to the applicant, the majority of the documents produced by the opponent containing combined herbicide mixtures merely describe preliminary results. The herbicidal art was unpredictable and there was no evidence that a commercial product had been developed containing dual active ingredients. The applicant also noted that even if such statements were true at a general level, it does not follow that these can be routinely or predictably applied[52]:
“Experience tells us different combinations of compounds behave differently even when they might be in the same class. It follows that the person skilled in the art will know that each composition may behave differently and, where a new composition is proposed, its physical, chemical and performance properties can only be assessed with a trial. Even then, the usefulness of a composition combining plural herbicides (ie whether there is incompatibility or antagonism) may depend on the further step of determining optimum concentrations which cannot be predicted.”
[51] Relying on Rambaxy Laboratories Ltd v AstraZeneca AB [2013] FCA 368 at [203] and Apotex Pty Ltd v AstraZeneca AB (No. 4) [2013] FCA 162 at [207]
[52] Applicant’s submissions at [40] and [47]
84. As a consequence, the applicant considered that the correct “starting point” for formulating an improved herbicidal composition was a single glyphosate formulation. From that “starting point”, their view was that there was no motivation to move directly to a glyphosate and a pyridine analog much less the particular compositions claimed. The glyphosate market was well-established and the evidence showed that researchers were concentrating on many different aspects of herbicides for improving the properties of glyphosate not simply combining it with different types of herbicides.[53]
[53] Applicant’s submissions at [128]
85. However, while I accept that there are problems with predicting the effectiveness of specific combinations and applications[54], this problem has not been solved by the current claims. There is no suggestion that the claimed ratio or the presence of (any) surfactant solves the unpredictability problems acknowledged in the prior art. Therefore, while the problem provides relevant context for determining whether there is an inventive step, it doesn’t change the “starting point” of the invention.
[54] Discussed in detail above in the section on CGK
86. As discussed above, the common general knowledge had broadly recognised the potential benefit of combining glyphosate and pyridine analogs in a single herbicide treatment (to target a wider range of weeds). This concept is therefore the correct starting point for the current invention.
What is the problem to be solved?
87. The opposed specification distinguishes the claimed composition from the admitted prior art specifying a particular ratio of glyphosate to pyridine analog (8:1 to 20:1) and by including a surfactant. There was no suggestion that the current claimed ranges have any advantage (or solve any problem) compared with the prior art combined formulations nor did the art teach away from the specifically claimed ranges.
88. Therefore, the only problem that can be derived from the specification is to provide an alternative or improved herbicide formulation (or concentrate) containing glyphosate and a pyridine analog.
Who is the skilled worker?
89. The skilled worker is a commercial herbicide formulator with knowledge of the preparation and application of herbicides.
Which documents are part of the prior art base for inventive step?
90. Under section 7(3)(b) of the Patents Act (Cth) as it applies in this case[55], a claimed invention will lack an inventive step in light of the common general knowledge considered together with information in a single document, provided that the document or act could reasonably be expected to have been ascertained, understood and regarded as relevant to work in the relevant art in the patent area by the person skilled in the art.
[55] The opposed application has an examination request filed before 15 April 2013
91. The opponent relied on the same documents for both novelty and inventive step. However (as the applicant has argued), it is not clear that all these documents are part of the prior art base for inventive step under section 7(3). The opponent suggested[56] that the skilled worker would regularly conduct searches of information on herbicides including glyphosate herbicides across a range of publications including:
(a)Journals;
(b)Patents and patent applications; and
(c)Well-known reference material.
[56] Opponent’s submissions at [145]
92. The skilled worker is a herbicide formulator in a competitive commercial industry and I accept that would be interested in new developments in herbicide compositions by competitors. This means that they would be clearly interested in patent applications from key commercial players (including WO 00/30452 by Monsanto). These types of documents are widely published and readily searchable on publicly available electronic data bases. Faced with the problem of providing new combinations of glyphosate and pryridine analogs, the skilled worker would have ascertained and regarded this document as relevant.
93. I also agree that the Lontrel® and Roundup® labels are part of the prior art base for inventive step under section 7(3). A skilled worker would monitor current market developments and be interested in commercial formulations. They clearly would have ascertained these documents which are product labels from well-known herbicides. Since both labels discuss combinations of glyphosate and pyridine analog herbicides, the skilled worker would also have considered these documents relevant to their problem.
94. In contrast, the Milne results (1987, 1990 and 1992) are reports produced by the NSW Department of Agriculture. They were provided to a range of people known to have an interest in the field but do not appear to have been otherwise published or available from any searchable data base. Without specific evidence explaining why these documents would be ascertained, I cannot infer that these documents (D3-D5) would have been ascertained by the skilled worker at the priority date.
95. I am also not convinced that the skilled worker would have regarded any of the Milne documents as being particularly relevant to solving their problem with improved or alternative combination herbicides even if these documents had been ascertained. None of the Milne results suggest that that a combination treatment would be a particularly useful avenue to pursue. The (1987) results suggest that there was no apparent advantage with any wetting agent or herbicide mixture in the trial. The (1990) results recommend the use of Velpar L®[57] rather than the combination treatment and the (1992) treatments were all reported as “disappointing”. These results provide no real incentive for the skilled worker to pursue the combination herbicide treatment avenue further. As a consequence, the Milne 1987, 1990 and 1992 results are not part of the prior art base for inventive step under section 7(3).
[57] The active ingredient of Velpar® L is hexazinone which is a member of the triazine class of herbicides
96. The Little (1998) and (2000) documents are Bulletins published by the Institute for Commercial Forestry Research in South Africa on their internal research. They are publications about internal research results in what appears to be a relatively obscure (and non-peer reviewed) journal. The opponent did not provide any information about where this journal was published, how widely read it was or whether it is searchable on a publicly available data base. I am also not sure that a skilled worker interested in herbicide formulations would necessarily consult a journal on forestry research to obtain useful information about their field. Even the articles themselves concern coppice control (which kills coppice shoots but not the plant itself) rather than weed treatment. As a consequence, without specific evidence explaining why these documents would be ascertained and regarded as relevant, I cannot infer that either of these documents would have been ascertained and regarded as relevant by the skilled worker at the priority date.
97. Hence the opponent has not established that either of the Little documents are part of the prior art base for inventive step under section 7(3).
Inventive step based on CGK plus a document
98.As a result of the analysis above, there are only 3 documents raised by the opponent which are part of the prior art base for inventive step under section 7(3). These are listed in the table below and discussed in detail in the following sections.
Number Citation Abbreviation Exhibit D6 WO 00/30452 in the name of Monsanto Co WO 00/30452 MH-43 D7 Australian Product information sheet or product label for “Roundup® PowerMax” Roundup® PowerMax label PMH-6 D8 The Lontrel™ Product Label (Dow AgroSciences Product Guide Book 2000 pp 111-119) Lontrel™ Label PMH-10 WO 00/030452 (D6)
99.Patent application WO 00/30452 by Monsanto Co. (US) relates to highly concentrated herbicidal compositions containing glyphosate as an active ingredient predominantly in the form of the monoethanolamine (MEA) salt. The citation broadly discloses that the MEA salt could be mixed with a second (anionic) herbicide including the anionic herbicides clopyralid, picloram, triclopyr and imazapyr. However this generic disclosure did not provide a clear and precise disclosure of the specific combinations defined in the current claims and hence did not deprive any of the claims of its novelty.
This lack of a clear and precise disclosure also means that document fails to deprive any of the claims of their inventive step. The general disclosure on page 20 is simply a list of possible combinations which a skilled worker might want to research further. Given the unpredictability in the art, there is no reasonable expectation[58] that any of these combinations would actually work and the skilled worker would need to try every combination of listed herbicide to determine its efficacy.
[58] As per Middleton J’s comments in Rambaxy referred to in applicant’s submissions at [118]
This “obvious to try” approach was criticised by the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59 [referring to the comments of Judge Rich in the US decision of re O’Farrell 853 F 2d 894 at 903 (1988)].
"The admonition that 'obvious to try' is not the standard under §103 has been directed mainly at two kinds of error. In some cases, what would have been 'obvious to try' would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. ... In others, what was 'obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it." (my emphasis)
In the current case, the skilled worker would need to try numerous possible combinations from the long list of herbicides provided without any guidance from the citation about which combination would work. As a consequence, the skilled worker is not “directly led” to the specific combinations now claimed. The disclosure in patent citation WO 00/30452 therefore does not deprive any of the claims of their inventive step.
Roundup® PowerMax label (D7)
As discussed above under novelty, the PowerMax® label contains a clear and precise disclosure of a composition containing glyphosate (potassium salt):triclopyr within the range 7.2:1 to 14.35:1 for the treatment of Prickly Paddy melon. However it did not disclose a particular concentration (g/L) of glyphosate and/or triclopyr in a tank mixture and hence did not deprive claims 16-18, 31, 34 and 35 of their novelty.
The opponent argued that it was common general knowledge to dilute herbicidal concentrates depending on the intended application and that this was reinforced in the current specification (at page 42, lines 17-36)[59]. Further they suggested the deployment of herbicides with different strengths was common place at the priority date and varying the individual ratios would therefore be no more than routine optimisation[60]. In such cases, the choice of a particular concentration claimed ratio over other possible concentrations appears to a simple workshop variation from a known field. As noted in Elconnex Pty Ltd v Gerard Industries (1993) AIPC 90-984, at page 39-326, this is not inventive:
"this is not a case of a new combination, although of old integers, but of an old combination which has been, at most, subjected to slight variations. The question must be whether those variations are other than obvious."
[59] Opponent’s submissions at [127]
[60] Opponent’s submissions at [130]
I note that the PowerMax® label recommends applying 640-1276 mls of PowerMax® with 80mls of Garlon® 600 as a “boom rate per hectare” for the treatment of Prickly Paddy melon. This equates to an application rate of 345.6-688.5 grams glyphosate/ha and 48 grams triclopyr/ha. The concentration of the mixture (g/L) which is then applied does not affect this application rate. The skilled worker would simply adjust the volume of whatever solution available to them to deliver the recommended amount of active ingredients (in grams) per hectare. In other words, they would apply less of a concentrated solution and more of a dilute solution to achieve the same outcome.
The concentration of the original mix is therefore simply a matter of choice and primarily determined by the method of delivery. In the current case, the label refers to the application rate as a “boom rate per hectare”. The skilled worker would understand this to mean that the mixture should be applied in a boom sprayer. The original mixture of PowerMax® and Garlon®600 only contains 0.72-1.355L (per hectare) and would need to be diluted (tank mixed) for use in a boom sprayer to ensure an effective spray distribution. General mixing instructions are provided on page 11 of 13 of the label for this purpose. A skilled person would routinely select a volume that suited their equipment and conditions and adjust the concentration and spray rate to deliver the correct level of herbicide per hectare.
As noted in the table below, all application rates above 5L/ha will produce a concentration that falls within the scope of claim 16 and all dilutions between 40L/ha and 80L/ha (the maximum recommended rate) will produce a concentration that falls within claim 31. These are all standard volumes which would be routinely used by the skilled person in a boom spray. As a consequence, the claimed concentrations are all within the normal range which the skilled worker would be expected to apply.
Glyphosate Triclopyr Application rate/HA (g/ha) 345.6-688.5 48 Volume of original mix (L) 0.72-1.355 0.72-1.355 No dilution (g/L) 480-508 35.4-67 Diluted to: 1.5L (g/L) 230-459[61] 32[62] 2L (g/L) 173-344 24 5L (g/L) 69-138 9.6 10L (g/L) 35-69 4.8 20L (g/L) 17.3-34 2.4 40L (g/L) 8.6-17 1.2 50L (g/L) 6.9-13.8 0.96 60L (g/L) 5.8-11.5 0.8 80L (g/L) 4.3-8.6 0.6 Claim 16 (broadest option) Less than 326 g/L No explicit limit defined Claim 31 4-25 g/L 0.4-6 g/L [61] All calculations for glyphosate are based on application rate (345.6-688.5)g/ha divided by the litres diluted to (in this case 1.5L) ie: (345.6/1.5) =230g/L and (688.5/1.5)=459g/L
[62] All calculations for triclopyr are based on application rate 48 g/ha divided by the litres diluted to (in this case 1.5L) ie: (48/1.5)=32g/L
The applicant argued that the skilled worker is not directly led to the specifically claimed concentrations. However, the concentration of the active ingredients (g/L) in a mixture have no bearing on the final outcome [which as noted above is measured as an application rate (g/ha)]. The skilled worker would simply use the concentration of the original mixture to determine how much to apply per hectare. This would be either to calculate the volume of solution required or to adjust (dilute) the mixture to suit the preferred method of delivery.
Using a boom sprayer (as in this case), the original solution will need to be diluted and the claimed concentrations are within normal range which the skilled worker would expect to apply. With no advantage over other concentrations[63], the selection of one over another is a mere choice of alternatives in a known field and is therefore routine optimisation. I therefore find that the herbicide compositions of claims 16-18, 31, 34 and 35 for the treatment of Prickly Paddy melon are obvious in light of the PowerMax® label.
[63] Opponent’s submissions at [126]
The opponent did not argue that the treatment methods using the composition of claim 16 (claims 21, 22) were obvious but this is clearly the intended purpose of the herbicide mixture. Hence these claims also fail for lack of inventive step.
The citation doesn’t mention clopyralid (or any other pyridine analog) and there is also no evidence to establish that replacing one glyphosate salt form with another was routine. Hence I am unable to conclude that claims 1-15, 23-30, 32, 33, 36, 38, 39, 41, 43-45 are obvious in light of the PowerMax® label.
The remaining claims (claims 19-20, 37, 40, 42, 45, 46) all include triclopyr (the active ingredient in Garlon® 600) and the potassium salt of glyphosate. These are discussed in point form below:
·Claims 19-20 relate to a particulate solid concentrate. This is not disclosed in the PowerMax® label and there is no evidence to suggest that this is a routine variation of the liquid formulation. Hence I am unable to conclude that claims 19-20 are obvious in light of the Powermax® label.
·Claims 37 and 40 define a herbicidal concentrate with [glyphosate] between 100 and 400 g/L and [triclopyr] of between 8 and 20 g/L. From the table above, these do not appear to be routine concentrations that a skilled worker would use in a boom spray application of Prickly Paddy melon. Hence this concentration does not amount to a mere choice amongst alternatives and the skilled worker would otherwise not be directly led to this claimed concentration. I am therefore unable to conclude that claims 37 and 40 are obvious in light of the Powermax® label.
·Claim 42 is a method using a hand sprayer where the Powermax® label refers to boom rate. There is no evidence to establish that the same application rate would apply with this different delivery method. I am unable to conclude that claim 42 is obvious in light of the Powermax® label.
·Claims 45 and 46 are both dependent on claims 21 and 22 but are further limited by particular application rates of the herbicides (at least about 3657 grams glyphosate/acre (claim 45) and at least about 195 triclopyr/acre (claim 46). Converting these values to their metric equivalents[64], the application rates are (3657/2.471) = 1480g glyphosate/ha and (195/2.471)=78g triclopyr/ha. This is well above the rates recommended in the PowerMax® label for the treatment of Prickly Paddy melon (345.6-688.5 g/ha glyphosate and 48 g/ha triclopyr). Hence these application rates are inventive in light of the PowerMax® label.
[64]1 hectare is equivalent to 2.471 acres (
In summary, based on the analysis above, claims 16-18, 21, 22, 31, 34 and 35 (for the treatment of Prickly Paddy melon) are obvious in light of the PowerMax® label. However the opponent has not established that the remaining claims lack an inventive step.
Lontrel® label (D8)
As discussed above under novelty, Lontrel® is a commercial herbicide formulation containing 300 g/L clopyralid present as the triisopropanolamine salt. The Lontrel® label contains a clear recommendation to mix glyphosate and Lontrel® (clopyralid) for a specific purpose (pre-sowing treatment of capeweed in WA). The only difference between the citation and the current claims are the exact ratio of glyphosate to clopyralid (8:1 to 20:1) and the presence of a surfactant (neither of which is explicitly mentioned in the Lontrel® label).
The opponent’s expert (Mr Hay) argued that the skilled worker would be directly led to obtain this information from the glyphosate product guides and in particular the Roundup®CT label (which contains 450g/L glyphosate as the IPA salt along with a surfactant). His basic reasoning is as follows.
(a) The problem faced by the skilled worker is to provide an an alternative or improved herbicide formulation containing glyphosate and a pyridine analog.
(b) The skilled worker would find the product Lontrel® label relevant to their problem because it recommends mixing this product with glyphosate for the specific purpose of treating capeweed.
(c) The Lontrel® recommends applying the product at 150 ml/ha for pre-sowing treatment of capeweed which equates to 45 g a.e./ha clopyralid[65];
(d) There are no instructions to indicate how much glyphosate should be added so the skilled worker would be directly led to commercial glyphosate products to obtain this information (including the product Roundup®CT).
(e) The product label Roundup®CT recommends an individual application rate of 800 mls - 1.2 Litres/hectare for pre-sowing treatment of capeweed. Roundup® CT contains 450g/L glyphosate as the IPA salt along with a surfactant and so this application rate equates to 360-540 g glyphosate a.e per hectare.[66]
(f) Combining the two individual application rates would be 360-540 g a.e. per hectare of glyphosate and 45 g a.e. per hectare clopyralid which is a ratio of 8:1-12:1.[67] Because Roundup®CT contains a tallow amine surfactant, this would also inevitably be present in the final mixture.[68]
[65] 0.15 x 300g/L clopyralid = 45 g a.e per hectare
[66] 0.8 x 450g/L glyphosate = 360 g a.e per hectare; (1.2 x 450g/L) = 540 g a.e per hectare
[67] Opponent’s submissions at [148] – note that the opponent’s submissions suggest that the calculation is 10:1. This may be an average of 800-1.2L which Hay’s evidence refers to (Hay-1 at [44]-[45]). Hay himself uses the lowest rate of application (800ml) and concludes that the ratio is 8:1.
[68] Opponent’s submissions at [98]
The applicant argued that Mr Hay had retrospectively combined the disparate teachings of PMH-5 (the glyphosate label) and PMH-10 (the Lontrel® labels) according to the complex set of inferences drawn with the benefit of information from the opposed application[69]. According to the applicant, Mr Hay (at most) demonstrates that it could have been possible to derive the claimed composition and methods from the instructions in these references but not that it would have been obvious to do so.
[69] EIA – Wright at [31]
I note that the “disparate” teachings of the two documents are actually linked by a common and specific treatment regime (pre-sowing treatment of capeweed). This provides a clear context for combining the two documents in the way Mr Hay suggests. The only gap in Mr Hay’s logic is whether Lontrel® would necessarily be combined with Roundup®CT (rather than any other commercial source of glyphosate). Mr Hay argued that Roundup® CT was a very common glyphosate product used in Australia at the priority date.[70] However this does not necessarily mean that the skilled worker would be directly led to combine this product with Lontrel® when other products were also available.
[70] Hay-2 at [52]
The opponent did not establish that either Roundup® CT would have been the clear product of choice for the skilled worker or that all commercial glyphosate products would have produced the same result.[71] Therefore while the skilled worker could derive the claimed composition, I am not convinced that they would have derived it at the priority date without the benefit of hindsight. As a consequence, I am unable to find that any of the claims lack an inventive step in light of the Lontrel® label.
[71] There is however evidence that other glyphosate products will produce the claimed composition. The label for Roundup® PowerMax (540 g a.e/L), for example, certainly does produce the same result (see PMH-6). This product is applied to capeweed at 630-990ml per ha which equates to 340-535g glyphosate/ha. Compared to 45 g clopyralid, this would be a ratio of 7.6:1 to 11.9:1 (glyphosate:clopyralid)
Inventive step based on CGK alone
The opponent argued that the admitted prior art was evidence that combination herbicide mixtures containing glyphosate and a pyridine analog were well known at the priority date. According to the opponent, the primary difference between the current claims and the admitted prior art was that the ratio of glyphosate to a pyridine analog was 8:1-20:1 (glyphosate in excess). However this ratio would be a common result of mixing commercial products (containing glyphosate and pyridine analogs) according to their individual recommended application rates[72].
[72] Calculations provided in Hay-1
I note that acknowledgement of prior art in a specification is an admission which carries considerable weight. As stated in Bristol-Myers Squibb Co v F H Faulding & Co Ltd [2000] FCA 316; 170 ALR 439; 46 IPR 553 at [30]:
“If a patent application, lodged in Australia, refers to information derived from a number of prior publications referred to in the specification or, generally, to matters which are known, in our view the Court – or the Commissioner – would ordinarily proceed upon the basis that the knowledge thus described is, in the language of s 7(2) of the Act, part of “the common general knowledge as it existed in the patent area”. In other words, what is disclosed in such terms may be taken as an admission to that effect.”
In this case however although there seem to be a number of documents using a combination herbicide containing glyphosate and a pyridine analog, the only citation which provided evidence of any real success was Little (2000) (D2)[73]. Even then, this document was in an obscure journal and only reported preliminary success with coppice control. This is not evidence of CGK and does not support the general proposition that combination herbicides were commonly used in weed control.
[73] In fact, the only citation referred to at the hearing which reported any real success with combination herbicides was Little (2000). This citation reported preliminary success with a combination of triclopyr and glyphosate in controlling Eucalyptus grandis stools of a multi-stem origin. The combination of the glyphosate and triclopyr meant that less of the (more expensive) triclopyr needed to be applied in combination compared to the individual treatment (see page 5). This resulted in a cost savings of 48% compared to the triclopyr treatment alone.
I accept that the commercial labels (Lontrel® and PowerMax®) would be well known. These labels include examples of combined herbicide treatments but these are still limited to very specific weeds (capeweed and prickly paddy melon). As Franz[74] (discussed above) notes, the results with combination herbicides have been varied (and unpredictable). Success in one or two isolated examples can therefore not be extrapolated to a general teaching.
[74] Franz et al: “Glyphosate: A unique Global Herbicide” (1997) ACS Monograph 189, American Chemical Society, Washington, DC (1997) (Chapter 7) (PMH-4)
The test for obviousness requires not only that individual integers are known but also that it was obvious to combine them in the context of solving the problem (as per Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Limited (1980) 144 CLR 253 at page 293). Although there was a clear appreciation in the CGK that combining herbicides could be a useful approach, the opponent has provided little documentary evidence to show that the combined approach was routinely successful.
As a consequence, the opponent has failed to establish that the combined herbicide treatment was a well-known approach (apart from specific examples). Without a clear motivation in the CGK, it is difficult to say that a skilled worker would generally be directly led to use a combined herbicide approach let alone routinely optimise one. I am therefore unable to conclude that the claims lack an inventive step based on the CGK alone.
CONCLUSION
The opposition is partly successful. The opponent has established that the Milne results (1987, 1990 and 1992) all disclose a herbicide mixture containing glyphosate (IPA salt) and clopyralid with a weight ratio between 8:1 to 20:1 (glyphosate in excess) together with at least one surfactant. This deprives claims 9, 15, 17, 18, 21, 25, 27, 31-34 and 36 of their novelty.
The PowerMax® label discloses the use of glyphosate (potassium salt) and triclopyr for the treatment of Prickly Paddy melon. The difference between this disclosure and claims 16-18, 21, 22, 31, 34 and 35 is in the concentration of the applied herbicide. However the concentration and has no impact on the rate of application (grams/ha) and is within a routine range which the skilled worker would be expected to use. This is a mere choice amongst known alternatives which is not inventive.
Based on the other evidence before me, none of the other documents provided by the opponent deprive any of the claims of their novelty or inventive step. I consider that there is patentable subject matter within the patent application and I therefore allow the applicant 60 days in which to propose suitable amendments to overcome the deficiencies noted above.
COSTS
The Opponent has been partly successful with their opposition in relation to both novelty and inventive step. While the negative novelty findings are based on documents provided in EIR, the new documents were raised in response to amendments made after evidence in support had been filed.
Accordingly I award costs in accordance with Schedule 8 of the Patents Regulations 1991 against the applicant Monsanto Technology LLC.
Karen Ayers
Delegate of the Commissioner of PatentsAnnex 1
Essential Features of each independent claim
Claim Subject preamble [Glyphosate] Specific glyphosate salts Pyridine analog Weight ratio surfactant 1 Aqueous herbicidal liquid concentrate 50g acid equiv/L Yes* Triclopyr, clopyralid, dithiopyr or thiazopyr 8:1 – 20:1 At least one 5 As above Not greater than 165 g acid equiv/L Yes* As above As above As above 9 Aqueous herbicidal composition Not specified Yes* As above As above As above 10 As above Not specified Yes* As above As above less than 3.9 g/l in concentration 11 As above Not specified Yes* As above As above Not greater than 6.6 g/l in concentration 12 As above Not specified Yes* As above As above Not greater than 9.3 g/l in concentration 16
-3 separate options (a),(b) and (c)As above (a) Less than 320 g acid equiv/l;
(b) Less than 324 g acid equiv/l; or
(c) Less than 326 g acid equiv/l
Potassium and/or monoethanolamine (MEA) As above (a) 8:1 – 20:1;
(b) 9:1 – 20:1; or
(c) 10:1-20:1
At least one 19 Herbicidal particulate solid concentrate Not specified Not claimed as a salt Any analog 8:1-20:1 At least one 24 Method of killing or controlling (specific**) weeds Not specified Not claimed as a salt Triclopyr, clopyralid, dithiopyr, thiazopyr or picloram 8:1-20:1 At least one 31 Aqueous herbicidal composition 4-25g acid equivalent/l Yes* plus potassium Triclopyr or clopyralid between 0.4 and 6 g acid equivalent/l 8:1-20:1 At least one 37 Aqueous herbicidal composition 100-400g ae/l*** Yes* plus potassium Triclopyr or clopyralid between 8 and 20g acid equivalent/l 8:1-20:1 At least one 42 Method of killing or controlling weeds Not specified except as a proviso with respect to potassium*** Yes* plus potassium Triclopyr, clopyralid, dithiopyr or thiazopyr 8:1-20:1 A surfactant *Na, ammonium, alkylammonium, C3-C4 alkanolammonium salt, diammonium salt, akylamine salt, C3-C16 alkanolamine salt, alkylsulfonium salt, sulfoxonium salt, and combinations thereof;
**poison ivy, poison oak, kudzu, multiflora rose, golden rod, blue fescue, red maple and/or red oak
***with the proviso in claims 37 and 42 is that when glyphosate is in the form of a potassium salt, the concentration of glyphosate is less than 320 g ae/lAnnex 2
Commercial Products and their Active ingredients
Active ingredient Chemical name Commercial Products Triclopyr (3,5,6-trichlor-2-pyridinyl) oxyacetic acid Garlon®4 (butoxy ethyl ester)
Garlon® 3A
Timbrel®3A (amine salt)Clopyralid 3,6-dichloro-2-pyridine carboxylic acid Lontrel® Picloram 4- amino-3,5,6-trichloropicolinic acid Tordon® 101 Imazapyr 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1-H-imidazol-2-yl]-3-pyridinecarboxylic acid Arsenal® (IPA salt)
Chopper®Fluroxypyr (not claimed) 4,5-amino-3,5-dichloro-6-fluoro-2-pyridinyloxyacetic acid (meptyl ester) Starane™ Glyphosate N-(phosphonomethyl)glycine [DMA (dimethylammonium) salt] Accord® Glyphosate N-(phosphonomethyl)glycine as the IPA(isopropylamine) salt Roundup®, Round up®CT Glyphosate N-(phosphonomethyl)glycine as the MEA (monoethanolamine) salt Roundup®Max
Glyphosate N-(phosphonomethyl)glycine as the Potassium salt Roundup® Powermax Glyphosate N-(phosphonomethyl)glycine as the Trimesium (trimethylsulfonium) salt Touchdown®
0
6
0