Syngenta Crop Protection AG v Bayer Intellectual Property GmbH - [2015] APO 65

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Syngenta Crop Protection AG v Bayer Intellectual Property GmbH [2015] APO 65

Patent Application: 2004290500

Title:Combination of active substances with insecticidal properties

Patent Applicant:                   Bayer Intellectual Property GmbH
Opponent:  Syngenta Crop Protection AG
Delegate:  Dr S.D. Barker
Decision Date:  2 October 2015
Hearing Date:  Written submissions completed on 6 August 2015
Catchwords:  PATENTS – opposition to an amendment – construction of the claim considered – as a result of the amendment a claim would not in substance fall within the scope of the claims before amendment – amendments refused

Representation: Patent applicant: Griffith Hack
Opponent:Spruson & Ferguson

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2004290500

Title:Combination of active substances with insecticidal properties

Patent Applicant: Bayer Intellectual Property GmbH
Date of Decision: 2 October 2015
DECISION
The opposition succeeds. I refuse the amendments.
I award costs against Bayer Intellectual Property GmbH.
REASONS FOR DECISION

Patent application number 2004290500 was filed on 30 October 2004. The applicant is Bayer Intellectual Property GmbH (Bayer). The application was examined and accepted by the Commissioner, and subsequently opposed by E.I. du Pont de Nemours and Company (DuPont), and separately by Syngenta Crop Protection AG (Syngenta).
On 20 September 2013 Bayer filed a statement of proposed amendments. The Commissioner stayed both oppositions until the amendments were finalised. DuPont withdrew their opposition on 18 March 2014.
On 6 March 2014 the Commissioner advertised that leave to amend had been granted. On 6 May 2014 Syngenta filed a notice of opposition to the amendments. It is that opposition that is the subject of this decision. A hearing was held by way of written submissions filed by both parties. Submissions were completed on 6 August 2015.
1 The opposition
The statement of grounds and particulars identified three grounds of opposition: section 102(1), section 102(2)(a) and section 102(2)(b). All grounds were pressed at the hearing.
The parties relied upon evidence by several declarants. Evidence in support consists of a declaration by Aaron Heath Olsen. Evidence in answer consists of a declaration by Philip Edward Pentland. Evidence in reply consists of a further declaration by Aaron Heath Olsen. I will refer to the relevant parts of the evidence where appropriate.
2 The specification
The specification relates to insecticidal compositions. The specification as accepted ends with six claims. The specification as proposed to be amended would have 11 claims.
The compositions of the specification contain two components (page 1):
"The present invention relates to novel active compound combinations comprising, firstly, known compounds which act as insecticides on nicotinergic acetylcholine receptors as agonists and antagonists and, secondly, further known insecticidally active compounds, which combinations are highly suitable for the broad control of animal pests, such as insects."
The first component has formula (I) (page 1a), and the second component has formula (II-1) (page 1a – 1b). The second component belongs to a class of compounds called anthranilamides.
3 The relevant law
The amendment is governed by section 102 of the Patents Ac 1990 (the Act) as it stood immediately prior to 15 April 2013, since examination under section 44 was requested before that day (see item 55(9) of Schedule 1 of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012).
4 The amendments
The amendments make changes to several parts of the specification. For the purposes of this decision it is necessary to consider amendments that are proposed to page 13, page 53a, and to the claims.
4.1 The amendments – page 13
The amendments seek to delete a large passage of text from page 13 (the deleted paragraph). In order to place this amendment in some context, I will quote (selectively) the specification from page 9 to page 14. The deleted paragraph is shown as struckthrough text.
"The anthranilamides can be summarized under the formula (II):
in which
[there follows a recitation of the definition of the variables A1, A2, etc]
If (a) R5 represents hydrogen, C1-6-alkyl, C1-6-haloalkyl, C2-6-haloalkenyl, C2-6-haloalkynyl, C1-4-haloalkoxy, C1-4-haloalkylthio or halogen and (b) R8 represents hydrogen, C1-6-alkyl, C1-6-haloalkyl, C2-6-haloalkenyl, C2-6-haloalkynyl, C1-4-halalkoxy, C1-4-haloalkylthio, halogen, C2-4-alkylcarbonyl, C2-6-alkoxycarbonyl, C2-6-alkylaminocarbonyl or C3-8 dialkylaminocarbonyl, (c) at least one substituent selected from the group consisting of R6, R11 and R12 is present and (d), if R12 is not present, at least one R6 or R11 is different from C2-6-alkylcarbonyl, C2-6 alkoxycarbonyl, C2-6-alkylcarbonyl and C3-8-dialkylaminocarbonyl.
The compounds of the general formula (II) include N-oxides and salts.
Depending inter alia on the nature of the substituents, the compounds of the formula (II) may be present as geometrical and/or optical isomers or isomer mixtures of varying composition which, if appropriate, may be separated in a customary manner. The present invention provides both the pure isomers and the isomer mixtures, their preparation and use and also compositions comprising them. However, hereinbelow, for the sake of simplicity, only compounds of the formula (II) are referred to, although what is meant are both the pure compounds and, if appropriate, also mixtures having varying proportions of isomeric compounds.
Preference is given to active compound combinations comprising compounds of the formula (II-1)
in which
[there follows a recitation of the definition of the variables R2, R3, R4, R5, R7 and R9]"
4.2 The amendments – page 53a
The amendments seek to cancel page 53a, and replace it with new pages 53a to 53h. The text of the present page 53a seems to be repeated on the new page 53h. Consequently, the effect of this amendment is the addition of seven new pages. These pages contain four new examples, designated Example F, Example G, Example H and Example I.
Example F reports the spray application of compounds against Myzus persicae (the green peach aphid).
Example G reports the spray application of compounds against Phaedon cochleariae (mustard beetle).
Example H reports the spray application of compounds against Tetranychus urticae (two-spotted spider mite).
Example I reports the dip application of compounds against Aphis gossypii (cotton aphid).
4.3 The amendments – claim 1
Claim 1 of the specification as accepted is directed to compositions containing compounds of formula (I) and formula (II-1). A marked up copy of the claim as proposed to be amended is as follows:
A An insecticidal composition comprising a synergistically effective active compound combination of one compound of ~~the~~ formula (I) selected from the group consisting of:
[formulas (Ia), (Ie), (Ig), (Ik) and (Im) appear]
and one compound of ~~the~~ formula (II-1)
in which
R²       represents hydrogen or methyl,
R³       represents C1-C4-alkyl,
R⁴       represents methyl, trifluoromethyl, trifluoronethoxy, fluorine, chlorine, bromine, or iodine,
R⁵       represents hydrogen, fluorine, chlorine, bromine, iodine, trifluoromethyl, or trifluoromethoxy,
R⁷       represents chlorine or bromine,
R⁹       represents trifluoromethyl, chlorine, bromine, difluoromethoxy, or trifluoroethoxy, wherein said insecticidal composition is synergistic in at least one a weight ratio in the range of between 25:1 to 1:10.
It is clear that claim 1 (both as accepted and as proposed to be amended) does not contain any text matching the deleted paragraph. It is also apparent that there is no direct reference to the body of the specification.
5 Allowability of the amendments
Syngenta oppose the amendments on the basis that they would contravene subsections 102(1) and 102(2). These matters are interrelated, but need to be considered separately.
5.1 Section 102(1)
Section 102(1) says:
An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
The Dictionary in the Schedule to the Act says that "claim" when used as a verb means "to claim in a claim (including a dependent claim) of a complete specification".
It is well established that the question of what is in substance disclosed in the specification is virtually the same as that of fair basis: is there a real and reasonably clear disclosure of the relevant matter (for instance, see RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 42 IPR 353 per Burchett J).
Syngenta base their opposition on a view that the deleted paragraph limits the scope of formula (II) as it appears throughout the specification, and also limits the scope of formula (II-1) as it appears in both the description and the claims. As a consequence, they argue that removal of the deleted paragraph broadens both formula (II) and formula (II-1) as it appears in the claims.
Further, Syngenta argue that the addition of Examples F to I adds to the description compositions with new combinations of active compounds that extend beyond the combinations in the Examples A to E. They argue that this broadens the disclosure of the description, and also broadens the scope of the claims since the claims should be construed as limited by the description.
5.2 Construction of claim 1
Syngenta point out the well known proposition that a specification must be read as a whole (Rosedale Associated Manufacturers Ltd v Carlton Tyre Saving Co Ltd [1960] RPC 59 at 69; International Business Machines Corp v Commissioner of Patents (1991) 22 IPR 417 at 421). Syngenta also consider the decisions in Synthetic Turf Development v Sports Technology International [2005] FCA 69 and Synthetic Turf Development v Sports Technology International [2005] FCAFC 270 (the Synthetic Turf case) and conclude that
"the claims were construed by the Court as being limited to the subject matter that was in substance disclosed in the specification".
[submissions paragraph 66, emphasis in original]
This leads to their general proposition:
"as a general principle, embodiments within a broad construction of a claim that are not in substance disclosed in a specification may be legitimately excluded from the scope of that claim when applying a proper construction. Doing so is not adding a gloss from the specification, but is a 'proper inference' of a limitation based on the context of the specification as a whole. Applying this construction principle to the opposed application, it is appropriate to construe the claims as being limited to embodiments that are in substance disclosed in the specification."
[submissions paragraph 67]
In other words, even if a claim is clear, it is to be read down to exclude subject matter that is not in substance disclosed in the specification. This seems inconsistent with the statement of principle of the Full Court in the Synthetic Turf case (at paragraph 13):
"Claims are to be read in the context of the specification, not merely when ambiguity exists in a claim. However, integers not present in the claims are not thereby added. While the plain and unambiguous meaning of a claim cannot be varied or qualified by reference to the body of the specification, terms in the claim which are unclear may be defined or clarified by reference to the body of the specification. The question is what the person skilled in the art would have understood the patentee to be using the language of the claim to mean. [citations omitted]
In the Synthetic Turf case the Full Court concluded at paragraph 14 that:
"The specification as a whole confirms the natural meaning of claim 1".
I can see no support in the Synthetic Turf case for Syngenta's position. I will approach the construction of the claims in the same way as the Full Court in the Synthetic Turf case.
Claim 1 as accepted is clear on its face. It is directed to a composition of two substances of formula (I) and formula (II-1). Formula (II-1) is defined in clear language in the claim. There is no ambiguity to resolve by reference to the body of the specification.
Syngenta rely on the evidence of Denis John Hamilton, that appears as an Exhibit to the first Olsen declaration. Mr Hamilton says that the deleted text on page 13 "appear to me to be a strict requirement that compounds of formula (II) must meet." I doubt that this is correct. However, even if it was, it does not address the critical question of whether that limitation applies to the claims as accepted. The body of the specification, in particular the deleted paragraph on page 13, does not create a context that is so compelling that it can prevail over the clear words of the claims. The language of the deleted paragraph would have to be far more precise and emphatic to achieve that result. It follows that the removal of the deleted paragraph does not in itself lead to any change in the scope of the claims.
5.3 Examples F to I
In the case of the Examples F to I, the case is even more compelling. Syngenta submitted that the only combinations in the specification as accepted for which synergy is shown are the Examples A to E. They then argue that the combinations shown in these Examples are the only synergistic combinations that have been in substance disclosed in the specification as accepted, and that the addition of extra Examples results in new matter that was not in substance disclosed. Reference is made to the decision in Shionogi & Co. Ltd's Application [1967] RPC 623 in support of this proposition. However, this misses the point of section 102(1). It is only a ground of opposition if, as a result of the amendment, the claim would claim matter not in substance disclosed. This focuses attention on the effect of the amendment on the claims. The addition of four new Examples does not in itself lead to any change in the scope of claim 1 (or any other claim). There is no text in the specification that suggests that the Examples should be seen as the only forms of the invention, or otherwise limiting on the claims. The addition of the extra Examples does not lead to a change in the scope of the claims.
5.4 Section 102(2)
Section 102(2) says:
An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
(a) a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b) the specification would not comply with subsection 40(2) or (3).
The opposition relates to both of the legs of the section.
5.5 Section 102(2)(a)
Syngenta allege that as a result of the amendments one or more of the claims would not in substance fall within the scope of the claims before amendment. This question has been long understood as equivalent to asking whether the amendment would have the effect of making something an infringement when it would not have been before (see for instance The Distillers Co Ld's Application (1953) 70 RPC 221, AMP Inc v Commissioner of Patents (1974) 3 ALR 283).
Syngenta's principle arguments are essentially the same as those raised in relation to section 102(1), that the scope of the claims have been expanded due to the removal of a limitation found on page 13 of the description. It follows from what I have said above that the scope of the claims has not been altered by the amendments to the body of the description.
Syngenta also allege that the amendment to the text of claim 1 leads to a change in its scope. The relevant part of the claim, shown in mark up, is the final part of the claim:
wherein said insecticidal composition is synergistic in at least one a weight ratio in the range of between 25:1 to 1:10.
Remembering that the composition contains two components, the claim before amendment is limited to compositions in which the components are present in a weight ratio of 25:1 to 1:10.
After amendment, the claim would be directed to compositions which are "synergistic in at least one weight ratio in the range between 25:1 and 1:10". Syngenta argue that this does not require that the components are present in a weight ratio of 25:1 to 1:10. Rather, the claim only requires that the composition would be synergistic at a weight ratio between 25:1 and 1:10.
Bayer acknowledged this submission at paragraph [123] of their submissions. However, their response is essentially to argue that the description is very broad. At paragraph [124] of their submissions they say:
"The specification discloses a wide range of possible weight ratios which are synergistically effective, but only a narrow range is actually claimed."
At paragraph [125] they say that the claim is narrower than the disclosure:
"The Applicant has chosen only to claim combinations between 25:1 and 1:10 … It is common practice for a patentee to only claim ranges that are commercially viable, not every possible range."
This leads to the conclusion that the amendment is allowable because:
"the proposed amendments fall within the scope of the specification before amendment".
This overlooks that allowability under section 102(2)(a) involves a comparison of the claims before and after amendment.
The literal meaning of the text at the end of claim 1 as proposed to be amended is that the synergy is achieved in at least one weight ratio in the range of 25:1 to 1:10. But does the claim include the possibility that the composition contains the two compounds in a weight ratio outside the range 25:1 to 1:10 IF there is synergy at that ratio AND there would also be synergy in the range of 25:1 to 1:10? This seems to be the plain meaning of the words, and I can see no logical reason to depart from this construction. In this case, the claim would include matter that was not within the scope of the claim before amendment, and the amendment would not be allowable.
This leads me to a difficult question. Is this possibility real, or merely theoretical? If there are no combinations of compounds that could have synergy both within the weight ratio range of 25:1 to 1:10, and also outside this range, then there is in truth no change in the scope of the claim. It is a widely accepted fact that synergy is unpredictable. However, Bayer's submissions admit that synergy exists outside the range of the claim. In relation to compositions of the compounds (Ia) and (II-1-9) the specification as accepted says that at a weight ratio of 1:1 there is synergy in the application to Myzus persicae (see Table B), and at a weight ratio of 625:1 there is synergy in the application to Heliothis armigera (see Table A). The problem is real and not merely theoretical.
Thus, to the extent that claim 1 is not restricted to compositions in which the weight ratio of compound (I) to compound (II-1) is in the range between 25:1 to 1:10, the amendment is not allowable. The same applies to the other independent claims.
5.6 Section 102(2)(b)
Syngenta alleged that as a result of the amendment certain deficiencies arise under section 40. Specifically, the claims would not be clear and succinct and fairly based due to the introduction of the expression "wherein said insecticidal composition is synergistic" into claims 1 and 4, and the insertion of new claims 7 to 12 that also contain this expression.
This argument is presented in the following way. Synergy is an effect whereby two or more agents cooperate to produce a result that is greater than the sum of the effect of each operating alone. However, the claims refer to a single "composition" being synergistic. The absence of a second agent creates ambiguity. Further, there is no definition of what effect will demonstrate the synergy.
This ground is not made out. The composition is a mixture of two compounds of formula (I) and formula (II-1). The amendment inserts a requirement that it "is synergistic in at least one weight ratio in the range". The synergy is clearly related to the action of the two components. The composition is an "insecticidal composition". I doubt that there could be any confusion that the synergy relates to the insecticidal activity of the components.
5.7 Section 102(3)

Section 102(3) provides an exception to the provisions discussed above:
This section does not apply to an amendment for the purpose of correcting a clerical error or obvious mistake made in, or in relation to, a complete specification.
There is no suggestion that the present case represents the correction of either a clerical error or obvious mistake. Consequently it is not necessary to consider this possibility.
6 Conclusion
The opposition is successful. The amendments contravene section 102(2)(a).
7 Costs
The parties submitted that costs should follow the event. I see no reason to depart from that result. Costs should be awarded against Bayer.
Dr S.D. Barker
Delegate of the Commissioner of Patents