Merial Limited v Bayer Intellectual Property GmbH - [2015] APO 16

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merial Limited v Bayer Intellectual Property GmbH [2015] APO 16

Patent Application: 2007341647

Title:Agents for controlling parasites on animals

Patent Applicant:                   Bayer Intellectual Property GmbH
Opponent:  Merial Limited
Delegate:  Dr S.D. Barker
Decision Date:  14 April 2015
Hearing Date:  Written submissions finalised on 26 March 2015

Catchwords: PATENTS – whether evidence is evidence in reply – whether to rely on information pursuant to regulation 5.23 – regard had to the nature of the information and whether the information is likely, if not certain, to change the outcome of the opposition in a significant way

Representation: Patent applicant: Davies Collison Cave
Opponent:FB Rice

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2007341647

Title:Agents for controlling parasites on animals

Patent Applicant: Bayer Intellectual Property GmbH
Date of Decision: 14 April 2015
DECISION
Paragraphs [50] – [52] of the declaration of Dr Clark are not evidence in reply, and do not form part of the evidence in the opposition.
The references to D18 in the declaration of Dr Witchey-Lakshmanan are not evidence in reply, and do not form part of the evidence in the opposition.
Regulation 5.23 is not invoked in relation to D18 or paragraphs [50] – [52] of the Clark declaration.
REASONS FOR DECISION

This matter concerns material filed as evidence in reply and is determined under the Patents Regulations (the Regulations) as amended on 15 April 2013 by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1) (the Amendment Regulation).
Background
Patent application 2007341647 in the name of Bayer Intellectual Property GmbH (Bayer) is under opposition by Merial Limited (Merial). Evidence in reply was completed on 5 February 2015. On 20 February 2015 Bayer wrote to the Commissioner advising that it considered that portions of the evidence filed in reply was actually evidence in support filed out of time. A delegate of the Commissioner advised the parties on 2 March 2015 that he considered that the evidence was prima facie in reply, except those matters that related to a document designated as D18. The delegate then stated that he was not satisfied that D18 should be relied upon under regulation 5.23. Merial objected to this conclusion, and both parties were allowed time to file written comments in relation to the delegate's findings. I have considered those comments.
The framework of the Regulations
Regulation 5.8 sets up a three stage procedure for the filing of evidence. The opponent files its evidence in support, followed by the applicant's evidence in answer, and finally the opponent can respond with evidence in reply. It is well established that evidence in reply is restricted to evidence rebutting the applicant's evidence in answer. Evidence that merely bolsters the evidence in support or opens up new matters that should have been raised in evidence in support is not in reply (see Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp and Schering Aktiengesellschaft [2001] APO 13 (the Sonus decision)).
Where evidence is not properly in reply, that evidence is not automatically disregarded. Under the Regulations as they applied prior to 15 April 2013 (i.e. prior to the commencement of the Amendment Regulation), evidence that was not strictly in reply could be served as further evidence (subject to the admissibility criteria in regulation 5.10), and the applicant would have the opportunity to serve responding evidence. However, for oppositions commenced on or after 15 April 2013, it is no longer possible for a party to file further evidence. Consequently, evidence that is not strictly in reply cannot be brought into evidence by the opponent.
However, in order to protect the public interest the Commissioner retains a discretion to rely on documents that are not formally in evidence. This power is found in regulation 5.23:
5.23 Commissioner may consult documents
(1) For the purposes of deciding an opposition, the Commissioner may consult a document that:
(a) is relevant to the opposition; and
(b) has not been filed under this Chapter; and
(c) is available in the Patent Office.
(2) If the Commissioner proposes to rely on the document, the Commissioner must give the parties:
(a) notice of the Commissioner's intention to do so; and
(b) a copy of, or access to, the document; and
(c) an opportunity to give evidence or make representations about the document.
The intent of this provision is explained in the Explanatory Statement accompanying the Amendment Regulation:
"parties will be able to provide any document to the Patent Office at any stage under new regulation 5.23. The Commissioner will be able to consider the document and then have the discretion to determine the most appropriate course of action in light of the information contained within the document. However, it is not intended that regulation 5.23 is to be used as a substitute for the repealed further evidence provisions."
Is the evidence in reply?
At the outset I repeat what I said in the Sonus decision at page 8:
"The only time that a final determination of whether the evidence is actually in reply is made is during the substantive hearing of the opposition. However, that does not mean that I cannot form a view of the question, and indeed it is essential for me to do so in order to decide the matter before me. However, it is only possible to form a preliminary view. If there is a reasonable basis for believing that evidence fits the definition of evidence in reply, then I believe that I should treat that evidence as reply evidence at this time unless Sonus can satisfy me that that conclusion is not appropriate. It may be that a different conclusion would be reached after detailed analysis of the declarations, such as during the substantive opposition. It clearly would have been easier to determine these issues as a part of the substantive opposition, but that option is not available. I am required to make a preliminary assessment, and to base my decision on that assessement."
In the present case it is necessary to form a view of whether the evidence is in reply in order to make a decision whether to invoke regulation 5.23. The applicant raised concerns in relation to the following material filed in reply:
- the entire declaration by Dr Jeffrey N. Clark dated 2 February 2015;
- at least paragraphs [20] to [27] of the declaration of Mr Joe R. Pippia dated 5 February 2015; and
- paragraphs [73] to [79] of the declaration of Dr Leonore C. Witchey-Lakshmanan dated 3 February 2015 (which refer to the newly cited document D18).
On 2 March 2015 a delegate wrote to the parties advising:
"With respect to the declaration of Dr Clark and the declaration of Mr Pippia, although some parts of these declarations do not explicitly address the declaration of Dr Rowe submitted as evidence in answer, the matter discussed in these parts is, prima facie, closely related to the matter discussed in Dr Rowe’s declaration. Therefore, I consider these two declarations to be, prima facie, proper evidence in reply in their entirety and that they should not be excluded from the opposition proceedings. If the Applicant disagrees, they might wish to consider bringing the issue to the attention of the Hearing Officer at the hearing.
With respect to the declaration of Dr Witchey-Lakshmanan, I consider the discussion of document D18 contained in paragraphs 73 to 79 to be unrelated to the evidence in answer. The French equivalent of this document was indeed mentioned in paragraph 7 of Dr Rowe’s declaration, however this was done in relation to a different matter which does not appear to be discussed in paragraphs 73 to 79 of Dr Witchey-Lakshmanan’s declaration. Therefore, prima facie, I consider that the discussion in paragraphs 73 to 79 of this declaration does not constitute evidence in reply and that it should be excluded from the opposition proceedings. If the Opponent disagrees, they might wish to consider bringing the issue to the attention of the Hearing Officer at the hearing."
I will consider each of these pieces of evidence in turn.
The evidence of Dr Clark
Bayer states that the evidence of Dr Clark was largely made in the absence of having read the opposed application or the evidence of Dr Rowe. Dr Clark states that he was asked to address several questions:
·whether it would be fair to say that the veterinary industries in Australia and New Zealand are similar to those in the United States and other countries (paragraph [35]) – this can be seen as responsive to comments that Dr Rowe makes about differences between overseas information and knowledge in Australia (for instance, paragraphs [31] and [91]); and
·what he considered to be common general knowledge with respect to N‑phenylpyrazoles or fiproles (paragraph [39]) – this appears to be generally responsive to Dr Rowe's evidence at paragraphs [24] – [35].
Dr Clark then addresses two questions that he appears to pose for himself after reading the specification:
·is there evidence of systemic delivery of fipronil following topical application of Frontline^® Top Spot formulations (paragraph [50]); and
·are the experimental results in the opposed specification consistent with other studies (paragraph [50]).
Dr Clark draws the conclusion that there is no advantage to the formulations of the application compared to a product called Frontline^® Top Spot (paragraph [50]). Dr Clark does not say that this conclusion is responding to any portion of the evidence in answer, and I have not been able to identify any part of the evidence in answer that this might be responding to. I am not satisfied that the information at paragraphs [50] – [52] is responding to the evidence in answer.
At paragraph [53] Dr Clark begins to directly address the declaration of Dr Rowe. I am satisfied that this portion of his evidence directly responds to the evidence in answer.
Consequently I am satisfied that the evidence of Dr Clark is evidence in reply, except for paragraphs [50] – [52].
The evidence of Mr Pippia
Bayer raised concerns with paragraphs [20] to [27] of Mr Pippia's evidence. These paragraphs address the following questions:
·what sources of information would you use if asked to research and develop a veterinary formulation for topical administration (paragraph [21]);
·what sources of information would you use to gather information regarding existing products (paragraph [23]); and
·conduct a search to determine the composition of a commercial topical formulation which includes fipronil as an active agent (paragraph [26]).
These questions appear to be generally responsive to comments made by Dr Rowe as to how he would go about developing a formulation from an existing active agent and the common general knowledge (paragraphs [10] – [35] of his declaration). Consequently I am satisfied this is evidence in reply.
Evidence of Dr Witchey-Lakshmanan
Dr Witchey-Lakshmanan discusses a new document GB 2 334 888, which is designated D18. D18 is discussed as a citation. D18 claims priority from a French document FR 1996-11446 A. The French document is mentioned on page 1 of the present application, and a copy is attached to the evidence in answer of Dr Rowe. Dr Rowe does not discuss the French document as a citation.
D18 and the French document are different documents, and they are used in the evidence in very different ways. The French document is presented to show what was previously known about the use of formulations having a high content of DEE. D18 is presented as a citation against the claims. There can be no doubt that this new citation does not arise in response to the evidence in answer. The references to D18 in the declaration of Dr Witchey-Lakshmanan are not evidence in reply.
This leads to the question of whether D18 should be relied upon under regulation 5.23.
Should the evidence be relied upon under regulation 5.23?
There is no previous decision on the operation of regulation 5.23. Merial provided a submission that D18 should be relied upon because it "is in the public interest and will lead to a more correct and expeditious result in the opposition."
Guidance as to the interpretation of this regulation can be drawn from both the Explanatory Statement and the context of the Patents Act and the Regulations. Regulation 5.23 is not the only provision dealing with information brought to the attention of the Commissioner. Under section 97, the Commissioner can carry out re-examination on her own initiative. Re‑examination is available either before or after grant, whereas regulation 5.23 can only operate while an opposition is proceeding. It is in the public interest for highly significant information to be considered within an existing opposition and not wait for re-examination after the opposition is concluded. Less significant information should be allowed to wait until after the opposition has been concluded (considering that amendments resulting from the opposition may overcome the deficiency).
The question is simply how significant does new information need to be? The Explanatory Statement makes it clear that "it is not intended that regulation 5.23 is to be used as a substitute for the repealed further evidence provisions". Further evidence under the former regulation 5.10 was assessed having regard to the nature and significance of the evidence as one of several considerations (for instance, see Norwood Immunology Ltd v Regeneus Pty Ltd [2012] APO 132). It follows that regulation 5.23 is intended to import a stricter requirement than this. It is also necessary to remember that the standard of proof that applies in oppositions commenced before 15 April 2013 is that it must be clear that a ground has been made out (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [67]; 50 IPR 305).
I conclude that a decision under regulation 5.23 must have regard to the nature of the information and whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.
If the new information is not likely to change the outcome of the opposition in a significant way, there is little advantage gained by bringing it into the opposition. The procedures for evidence laid down in regulation 5.23 will introduce delay to the opposition. On the other hand, if the new information is not relied on in the opposition the Commissioner can reconsider the information at the conclusion of the opposition, and re-examine the application if any amendments resulting from the opposition have not already addressed the issue. In other words, the new information needs to be significantly better than what is already in evidence. Where the new information is a new citation, it should be considered whether it is likely that the ground of lack of novelty or lack of inventive step in the light of the citation would be made out, and whether the ground would not otherwise have been made out.
The Regulations do not mandate a procedure that the Commissioner must follow when a party provides new information. The Explanatory Statement says:
"The Commissioner will be able to consider the document and then have the discretion to determine the most appropriate course of action in light of the information contained within the document."
Regulation 5.23 is clearly based on the former regulation 5.11, which is referred to in the Explanatory Statement:
"This power is discretionary – the patents legislation does not provide parties with a right to urge the Commissioner to make use of this power. As a result, the power in current regulation 5.11 cannot be used as a mechanism to delay opposition proceedings."
While it is clear that a party can bring new information to the attention of the Commissioner and ask that it be relied upon under regulation 5.23, the procedure cannot be used as a delaying tactic. It is appropriate for the Commissioner to form a view of the significance of the new information, and invite comment on her proposed action (to either rely on the document or not) before finalising her decision. That process has been followed in this case.
Consideration of the facts
D18 is directed to the control of parasites in small mammals. The present application claims a composition for controlling parasites in animals. D18 discloses two examples that are similar to what is claimed in the present application – Example 3 and Example 5. The delegate of the Commissioner said:
"Having considered the disclosure of document D18 with regards to the invention defined in the broadest claim of the specification under opposition (claim 1), I note that one of the components of the composition (an aliphatic cyclic carbonate) is not disclosed or obviously suggested in D18."
I think that Merial accepts this finding:
"Thus, D18 teaches very similar compositions to those claimed by the opposed application for the same purpose as that proposed by the opposed specification." [emphasis in the original]
but argues that it would have been a matter of routine to add the missing component:
"The use of an aliphatic cyclic carbonate, such as propylene carbonate, as a carrier for topical ectoparasiticidal formulations was well-known to the skilled person and forms part of his or her common general knowledge."
It is clear that D18 is not advanced as a novelty citation. D18 will only be a successful citation if Merial can establish that the inclusion of an aliphatic cyclic carbonate in addition to the other components in D18 would have been a matter of routine. Dr Witchey-Lakshmanan does not make this claim – she merely says at paragraph [79] that the missing component is known in another document (D11), and thus "all the elements outlined in the opposed specification are provided for in the prior art".
I am not satisfied that the ground of lack of inventive step is likely to be made out in the light of D18. However, even if I were satisfied, I have no basis to believe that the ground would not otherwise be made out. The statement of grounds and particulars lists 17 pieces of information that are relevant to the ground of inventive step. There is no suggestion that D18 is more relevant than any of the other 17 documents.
I have no basis for concluding that reliance on D18 would be likely to change the outcome of the opposition in a significant way. I will not rely on D18 pursuant to regulation 5.23.
I have also considered whether it would be appropriate to rely on paragraphs [50] – [52] of the evidence of Dr Clark. As discussed above, this evidence relates to a product called Frontline^®. It is not clear to me that this information even relates to a ground of opposition. The nature of this information does not satisfy me that it is likely to make out a ground of opposition.
Costs
In the present case each party challenged the findings made by the delegate. I have only departed from the conclusions of the delegate with regard to paragraphs [50] – [52] of the evidence of Dr Clark, which I consider to be a small variation. I consider it appropriate to make no award of costs.
Dr S.D. Barker
Delegate of the Commissioner of Patents