Dow AgroSciences LLC v Bayer Intellectual Property GmbH
[2021] APO 13
•2 March 2021
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Dow AgroSciences LLC v Bayer Intellectual Property GmbH [2021] APO 13
Patent Application: 2017204231
Title:Substituted picolinic acids and pyrimidine-4-carboxylic acids, method for the production thereof, and use thereof as herbicides and plant growth regulators
Patent Applicant: Bayer Intellectual Property GmbH
Opponent:Dow AgroSciences LLC
Delegate:Dr Leslie F. McCaffery, Deputy Commissioner of Patents
Decision Date: 2 March 2021
Hearing Date: Written submissions completed on 5 January 2021
Catchwords: PATENTS – allowability of amendments under subsections 102(1) and 102(2) – disclosure by Markush formulae – whether the skilled person would learn something from the specification as proposed to be amended that they would not learn from the specification as filed – amendments allowable – opposition unsuccessful – costs awarded.
Representation: Solicitors for the applicant: Davies Collison Cave Law
Patent attorney for the applicant: Davies Collison Cave Pty Ltd
Counsel for the opponent: Craig Smith
Patent attorney for the opponent: FPA Patent Attorneys Pty Ltd
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2017204231
Title:Substituted picolinic acids and pyrimidine-4-carboxylic acids, method for the production thereof, and use thereof as herbicides and plant growth regulators
Patent Applicant: Bayer Intellectual Property GmbH
Date of Decision: 2 March 2021
DECISION
The opposition is unsuccessful.
Costs awarded against the opponent, Dow AgroSciences LLC.
REASONS FOR DECISION
Australian application 2017204231 (the application) was filed by Bayer Intellectual Property GmbH (the applicant) on 22 June 2017. It is a divisional application of AU2012288895 and claims the earliest priority date of 27 July 2011. The application was accepted on 13 November 2018 and a notice of opposition was filed by Dow AgroSciences LLC (the opponent) on 28 February 2019. Evidence in the substantive opposition was completed on 4 February 2020.
The applicant filed a statement of proposed amendments on 3 April 2020. A further statement of proposed amendments was filed on 4 May 2020 to correct some minor typographical errors in the first statement. The opponent filed a notice of opposition to the proposed amendments on 14 August 2020. On 21 October 2020, the delegate issued directions that the opposition proceed by way of written submissions, with the opponent having 4 weeks to file submissions in support of their opposition (referred to as DOS), the applicant then having 4 weeks to file submissions in answer (referred to as BOS), and the opponent then having 2 weeks to file submissions in reply (referred to as DOR). The submissions by the parties were completed on 5 January 2021.
The grounds of opposition
The grounds of opposition raised by the opponent are that the proposed amendments are not allowable under:
Subsection 102(1) because, as a result of the amendments, the claims would claim matter that extends beyond that disclosed in the complete specification.
Subsection 102(2)(b) because, as a result of the amendments, the specification would not comply with subsections 40(2)(a) and 40(3).
The relevant legislation
The application was filed on 22 June 2017, and the amendment of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (RTB) therefore apply to the present application.
Subsections 102 (1) and (2) state that:
An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in the following documents taken together:
(a) the complete specification as filed;
(b) other prescribed documents (if any).
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), (3) or (3A).
Notably the legislation requires that the failure to meet the requirements of subsections 102(1) and (2) must be the result of the amendment.[1] If any of these matters was pre-existing then it will not result in an amendment being not allowable,[2] though they may be relevant to the substantive opposition under section 59.
[1] RGC Mineral Sands Ltd v Wimmera Industrial Minerals Pty Ltd [1998] FCA 1358; 42 IPR 353 at page 360.
[2] Apotex Pty Ltd v Les Laboratoires Servier (No 2) [2009] FCA 1019.
The complete specification as filed.
The invention is said to relate to substituted picolinic acids[3] and pyrimidine-4-carboxylic acids represented by the general formula (I) and their use as herbicides.
[3] Picolinic acid is pyridine-2-carboxylic acid.
Most variability in the compounds is in the A-group at the 6-position of the picolinic acid ring, which is substituted by various benzo-fused 5-membered rings (designated A1 to A20). These are linked to the picolinic acid group via a carbon atom in the benzo ring and can be further substituted by R5 to R8 in either the benzo ring or the 5-membered ring (see Annex A for the claims as filed).
There is actually little variability in the substituents on the remaining positions of the picolinic acid. The 4-position (NR3R4) must be amino (NH2) and the 3-position (R2) must be chlorine. The 2-carboxy group may be esterified by C1-C4-alkyl. The 5-position (X) is N, CH, CCl, CF or CBr.
10. The specification goes on to provide definitions for general terms used in the specification,[4] though a number of these are superfluous because the claims do not use the terms (eg. aryl and alkenyl), or the claims are not as broad as the terms (for example the term alkyl is illustrated with groups having up to 10 carbons, but the claims are limited to a maximum of 3 or 4 carbons). However, nothing turns on this point. Depending on the nature of the substituents the compounds may also form geometric or optical isomers or salts.[5] The compounds are said to be useful for pre- and post-emergent control of weeds. The compounds may be used to control weeds in crop species, including transgenic crops. The compounds can be formulated in typical excipients and can be applied in combination with other herbicides.[6] Some more specific formulation examples are subsequently provided,[7] as well as some biological examples which provide an indication for the pre- and post-emergent activity of several compounds.[8]
[4] Page 3, line 26 to page 6, line 25 of the specification.
[5] Page 6, line 26 to page 8, line 26 of the specification.
[6] Page 111, line 4 to page 125, line 13 of the specification.
[7] Page 128, line 3 to page 130, line 7 of the specification.
[8] Page 130, line 10 to page 131, line 5 of the specification.
11. The specification provides a general synthetic method to prepare the compounds of the invention which I understand to be a Suzuki coupling.[9] The reaction is illustrated with three specific examples and NMR data is provided for 27 compounds.[10] The reactions may also be performed by various automated, combinatorial, or solid- or liquid-phase techniques.[11] The specification then sets out 44 tables of compounds to which “preference is given”.[12] Tables 1 to 22 are picolinic acid derivatives and Tables 23 to 44 are pyrimidine-4-carboxylic acid derivatives.
[9] Page 8, line 31 to page 9, line 8 of the specification.
[10] Page 125, line 15 to page 127, line 8 of the specification.
[11] Page 109, line 3 to page 26, line 27 of the specification.
[12] Page 9, line 10 of the specification.
12. The specification as filed comprised 10 claims. Claim 1 claimed compounds of formula (I) as shown in Attachment B, most notably having one of groups A1 to A20 in the 6-position of the picolinic acid moiety. The claims included both picolinic acid and pyrimidine-4-carboxylic acid derivatives. Claims 2 to 6 defined herbicidal compositions comprising the compounds of formula (I) and Claims 7 to 10 defined methods of using the compounds as herbicides.
The complete specification as accepted.
13. Following a first examiner’s report, the applicant amended Claims 1 to 5 define herbicidal compositions comprising picolinic acid derivatives wherein the benzo-fused 5-membered heterocyclic group was limited to six of the original twenty alternatives: benzofuran, benzothiophene and indole rings, each linked through the 5 or 6-position. These correspond to groups A1 to A3 and A13 to A15 (the claims as accepted are shown in Annex B).
14. The amended claims were limited to picolinic acid derivatives, and no longer claimed pyrimidine-4-carboxylic acid derivatives. The other substituents on the picolinic and fused rings remained the same as at filing. Claims 6 to 9 defined methods of use as herbicides using these compounds.
15. Amendments were also made to the description to include a consistory statement corresponding to Claim 1 as amended, and to include boilerplate paragraphs relating to the term comprises and references to prior art in the specification.
16. The application was accepted including these amendments.
The specification as proposed to be amended.
17. The claims as proposed to be amended comprise 17 claims (see Annex C). Claim 1 (as accepted) has not changed in scope. Proposed independent Claim 2 defines herbicidal compositions comprising a compound of formula (I) in which the 6-position is substituted by a substituted 5- or 6-indolyl group. These correspond to groups A3 and A15 as follows:
18. Substituents on the picolinic acid and indole rings are the same as defined in Claim 1. Dependent claims 3 to 5 are limited to where X is CF (Claim 3), R5 is halogen (Claim 4) and R6, R7 and R8 are each hydrogen (Claim 5).
19. Proposed Claim 6 is also an independent claim and defines herbicidal compositions comprising a compound of formula (I) in which the 6-position is substituted by a 6-indolyl group (A15 as above). Like Claims 2 to 5, Claims 7 to 9 are limited to where X is CF (Claim 3), R5 is halogen (Claim 4) and R6, R7 and R8 are each hydrogen (Claim 5).
20. Proposed Claims 10 to 13 define herbicidal compositions comprising the compositions of Claims 1 to 9 together with auxiliaries, other active compounds and safeners. Proposed Claims 14 to 17 define the use of the compositions as herbicides.
21. As noted above a second statement of proposed amendments was filed to correct some typographical errors. These amendments did not change the subject matter of the claims. The introduction of Claims 2 to 9 was opposed by the opponent.
Submissions from the parties
22. The opponent’s primary submission[13] is that the proposed claims are narrower than existing Claim 1, but the subject matter of the proposed claims was not disclosed in the complete specification as filed because:
The proposed claims involve new combinations of chemical substituents where those combinations were not disclosed as “being an invention” in the application as filed; and,
The new combinations specifically “exclude from their scope” the subject matter that was highlighted in the complete specification as filed as establishing the beneficial herbicidal activity. That is, the specific examples provided in the description do not fall within the scope of the new independent claims.
[13] DOS at [3].
23. The opponent drew parallels between the present case and AstraZeneca,[14] where the Full Federal Court considered the priority date of a claim directed at formulations of rosuvastatin comprising inorganic salts. The specification as filed in that case stated that a range of different inorganic salts were useful, but dibasic calcium phosphate and tribasic calcium phosphate were said to be preferred and the examples used only tribasic calcium phosphate. An amendment was subsequently made to the claims that specifically excluded the use of phosphate as a counter ion in the inorganic salts. The Full Court considered that the specific exclusion of phosphate was inconsistent with what had been disclosed in the specification as filed, stating that:
“Not only does the specification before amendment not suggest that phosphate not be used as the counter ion in the inorganic salts used in the pharmaceutical compositions of the invention, it positively recommends that it be used for that purpose.”[15]
[14] AstraZeneca v Apotex Pty Ltd (2014) 226 FCR 324; 312 ALR 1; 107 IPR 177; [2014] FCAFC 99.
[15] AstraZeneca v Apotex Pty Ltd, ibid at [247].
24. The gist of the opponent’s argument is perhaps best reflected in their submission that:
“…what is disclosed in Bayer’s complete specification as filed is that:
(a) it made a discovery by reference to four specific compounds that it tested and found to have useful herbicidal properties; and
(b) it theorised that structurally related compound would also have those properties.”[16]
[16] DOR at [13].
25. The opponent noted that the changes brought about by RTB were intended to align Australian practice with European and UK law. The changes in relation to section 102 were recently considered in CSIRO,[17] a case in which, they submitted, a proposed narrowing of claims was found not to meet the requirements of subsection 102(1) because the amendments were to a different invention from that which is disclosed in the application.[18]
[17] Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2020] FCA 328.
[18] DOS at [18] to [21].
26. In this regard the opponent noted that in the present case only four compounds had been tested for herbicidal activity in the application as filed, and these contained fused rings corresponding to groups A1, A13 and A14. They submitted that the proposed claims specifically excluded the compounds that were demonstrated at filing to have herbicidal activity, as distinct from compounds for which, they asserted, herbicidal activity was predicted at that time. They argued that this exclusion was fundamentally inconsistent with what was disclosed in the specification as filed.[19]
[19] DOS at [32].
27. They further submitted that A1, A13 and A14 comprise benzofuran and benzothiophene rings whereas A3 and A15 comprise an indole ring, which they submitted constitutes a separate and distinct chemical class, and that there was no suggestion in the specification as filed that an indole group forms part of the disclosed invention.[20] They considered similar reasoning applied to the compounds defined by proposed Claims 3 and 7, which limited the compounds to those in which the group X was CF.[21] They noted that none of the compounds provided in the tables had this substitution and the claims therefore represent a stark departure from the disclosure in the application as filed.
[20] DOS at [33].
[21] DOS at [34].
28. The applicant submitted that the opponent’s assertions were misconceived because they proceed on a fundamental mischaracterisation of the invention described and claimed in the specification as filed. They argued that the opponent had not identified any disclosure in the specification that supported their assertions that the proposed claim encompass compounds that are not “the invention” or “a new invention”.[22]
[22] BOS at [55].
29. The applicant also noted that the AstraZeneca decision was considered by the Full Court of the Federal Court in Idenix.[23] This case involved a consideration of whether priority documents disclosing a Markush formula having 70 different possible substituents at a particular position of a molecule provided a real and reasonably clear disclosure of a compound having fluorine in that position. They submitted that Idenix taught that:[24]
The relevant question is whether there is a real and reasonably clear disclosure, “requiring a comparison between what is claimed and what has been described in the …application. Concepts of inventive step or merit have little to do with the inquiry.”[25]
The disclosure of substituents of a chemical compound by way of a Markush structure is precise and specific for each of the relevant substituents and commonly used and so understood by chemists.[26]
Assertions that the narrowing of claims are without a rational basis or arbitrary are not relevant to, and are inconsistent with, the test of real and reasonably clear disclosure set out in Lockwood (No 1).[27]
[23] Idenix Pharmaceuticals LLC v Gilead Sciences Pty Ltd [2017] FCAFC 196.
[24] BOS at [101].
[25] Idenix, ibid at [244].
[26] Idenix, ibid at [295].
[27] Idenix, ibid at [296].
30. The applicant submitted that the circumstances in the present case were not analogous to CSIRO, since the applicant had not sought to take a feature or integer from one context and introduce it into a claim deprived of that context (sometimes referred to as an intermediate generalisation). They argued that the amendment legitimately introduced a claim to a sub-class of the inventive concept disclosed in the specification as filed, whilst retaining claims to the class. They considered this to be consistent with the statements of Beach J in CSIRO, in as much as this form of claim is:
“…consistent with established practice in relation to patent claiming, where a patent will routinely include cascading claims directed to progressively narrower characterisations of the disclosed invention. A patent applicant is not limited to a single patent claim, directed to a preferred embodiment.”[28]
[28] CSIRO, ibid at [212].
31. The applicant also submitted that the situation here is consistent with that considered by Pumphrey J in Palmaz, wherein he stated that:
“If the specification discloses distinct sub-classes of the overall inventive concept, then it should be possible to amend down to one or other of those subclasses, whether or not they are presented as inventively distinct in the specification before amendment.”[29]
[29] Palmaz’s European Patents (UK) [1999] 47 at 71.
Consideration under Subsection 102(1).
32. The requirements of subsection 102(1) were recently considered by Beach J in CSIRO.[30] One approach to this consideration is to ask “whether a skilled person would, upon looking at the amended specification, learn anything about the invention which he could not learn from the unamended specification”.[31] To this end, a comparison is made between the specification as proposed to be amended and the unamended specification to determine whether subject matter relevant to the invention has been added. This comparison is a strict one. Subject matter will be added unless it is “clearly and unambiguously disclosed in the application as filed”, including matter which may have been disclosed both explicitly and implicitly. What is clearly and unambiguously disclosed by the specification cannot extend to matter that would have been obvious to the skilled reader.[32]
[30] CSIRO, ibid.
[31] Richardson-Vicks Inc’s Patent [1995] RPC 568 at [576].
[32] Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH ibid at [203].
33. I note there is no apparent dispute between the parties as to the difference between the specification as proposed to be amended and prior to amendment. In short, the difference lies in the inclusion of claims specifically directed to a subgenus of compounds having group A defined as A3 and A15 in proposed Claim 2, and A15 in proposed Claim 6. Dependent claims further limit X to CF, R5 to halogen and R6, R7 and R8 each to hydrogen. The opponent considered that these claims were directed to new “combinations of substituents” that were not disclosed as being an invention in the specification as filed.
34. Turning to the consideration of what was clearly and unambiguously disclosed in the specification as filed, I note the claims comprise Markush formulae, which as noted above are commonly used and well understood by chemists. A Markush formula is simply a shorthand means of representing a number of alternative compounds. It is not the Markush formula per se that is the invention. The invention – that is, what would be used in practice – is a compound. The individual compounds are linked by a common structural element and associated activity that unifies them as a single inventive concept. And while Markush claims can be broad in scope, there is generally a high degree of precision in this form of claim. The skilled person would be able to determine each of the compounds encompassed by the claim, even though in some cases the claim may encompass many millions of compounds.
35. That is not to say that all the compounds encompassed by a Markush formula will necessarily be disclosed by the specification. A shorthand representation could in some cases result in combinations of substituents which the skilled person would not glean from the specification. Or the prediction made by the applicant may exceed that which is justified by the disclosure. The question in such situations is whether the claims and specification meet the requirements of sufficiency and support or, in the case of amendments to define a narrower combination of substituents, whether the skilled person would learn something new about the invention from the combination.
36. Claim 1 prior to amendment disclosed a genus of related compounds represented by formula (I), which are said to be useful in herbicide compositions. The opponent’s line of argument places significant weight on the specific synthetic examples and the compounds for which herbicidal results have been provided, and to a lesser extent on the “preferred” compounds set out in the tables. I do not consider this argument to be determinative of whether there is a clear and unambiguous disclosure of the compounds of the proposed claims. It is not unusual for a Markush claim to include alternatives that are not exemplified or tested in the specification. For example, the applicant may predict that other compounds have similar properties based on the specific examples and what is known in the field of technology to which the invention relates. That is perhaps reflected here by the relatively limited variability in the substituents R1 to R4 on the picolinic acid moiety, but a greater amount of variability of substitution in the “new” A group.
37. In my opinion the inclusion of indolyl-substituted derivatives in the tables of “preferred” compounds is a clear disclosure of such compounds constituting an aspect of the invention. Furthermore, despite there being no illustration or exemplification of compounds having X as CF in the tables and examples, this alternative is included in the claims and it would seem incongruous that the general formula would include groups that would not be considered an aspect of the invention. There is otherwise no apparent basis for the specific examples to be given the weight suggested by the opponent and to conclude that the compounds claimed in the proposed claims but not tested are not disclosed in the specification as filed.
38. Ultimately the key consideration here is whether the skilled person would learn something from the specification as proposed to be amended that they would not learn from the specification as filed. To this end the specification as filed disclosed that the compounds having the formula (I) as defined by claim 1 are useful as herbicides. There is nothing in the specification as proposed to be amended that is inconsistent with that disclosure or that would teach the skilled person anything new. I agree with the submissions from the applicant that this is a different situation to that which arose in AstraZeneca. In that case the amendment incorporated a specific exclusion relating to the use of phosphate. The invention as a result of the amendment was characterised by the absence of phosphate, which the specification up to that point had indicated was an aspect of the invention. In this case, in line with the type of cascading claim sets referred to by Beach J in CSIRO, the claims are directed to a subgenus of the original claimed group of compounds. While the specific examples disclosed in the specification as filed do not fall within the proposed claims, there is no suggestion that the invention was limited only to those specific compounds, nor of any hitherto undisclosed property in the subgenus that is inconsistent with the original disclosure.
39. The arguments set out by the opponent appear to relate to issues that do not arise as a result of the amendments. The compounds set out in the proposed claims were already encompassed by the formula given in Claim 1. If there is an issue with the extent of the prediction made by the applicant in drafting their claims based on the compounds tested and found to have herbicidal activity, then that would seem to me to be a pre-existing issue under subsection 40(2)(a) or subsection 40(3). That is a matter for consideration in the substantive opposition rather than an opposition under subsection 102.
40. Therefore, I do not consider that the proposed amendments claim or disclose matter that extends beyond that disclosed in the specification as filed.
Consideration under Subsection 102(2)(b)
41. The opponent also submitted that as a result of the proposed amendments the proposed claims lacked support and sufficiency. However, they also acknowledged that consideration of those grounds would require detailed submissions to be made covering largely the same evidence and arguments as would be advanced in respect of the existing claims. On that basis they suggested that if the proposed claims were found to be allowable under subsection 102(1) then the allowability of the proposed claims under subsection 102(2)(b) should be deferred until the substantive hearing of the opposition.
42. The applicant considered this would be inconsistent with general principles of fairness, justice and finality in proceeding since it would mean that the opponent effectively has two separate and distinct opportunities to challenge the amendments.[33] They also noted that the opponent had been given fair opportunity to rely on any evidence it considered necessary to prosecute the amendment opposition but did not avail themselves of the opportunity. The acknowledgement that their subsection 102(2)(b) case requires consideration of evidence and the absence of such evidence, in their opinion, necessarily means that the opposition under subsection 102(2)(b) must fail.[34]
[33] BOS at [62].
[34] BOS at [63].
43. Given that the opponent has not provided any substantive submissions on this point I consider that this ground has not been made out. In any event, based on the material before me, this issue prima facie does not arise as a result of the amendments. If there is an issue under subsections 40(2)(a) and 40(3), then this is likely to be a pre-existing one more suited to consideration in the substantive opposition.
Conclusion
44. The opposition under section 102 is unsuccessful.
Costs
45. Costs generally follow the event. I see no reason to depart from that approach. I award costs against the opponent, Dow AgroSciences LLC.
Dr Leslie F. McCaffery, Deputy Commissioner of Patents
Annex A: Claims as filed
Annex B: Claims as accepted
Annex C: Claims as proposed to be amended (amendments dated 3 April and 4 May 2020)
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