Intervet International B.V. v E.I. du Pont de Nemours and Company
[2017] APO 11
•3 March 2017
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Intervet International B.V. v E.I. du Pont de Nemours and Company [2017] APO 11
Patent Application: 2008268321
Title:Animal pest control method
Patent Applicant: E.I. du Pont de Nemours and Company
Opponent:Intervet International B.V.
Delegate:Dr A. Lim
Decision Date: 3 March 2017
Hearing Date: Written submissions finalised on 08 February 2017
Catchwords: PATENTS – whether to rely on information pursuant to regulation 5.23 –the information sought to be relied on being evidence that is part of a statutory declaration – whether the evidence is likely to be crucial to the delegate’s decision – regard had to the nature and significance of the information – whether the information filed as evidence is of high probative value that it is likely to significantly affect the outcome of the substantive opposition – the party filing the evidence must make a compelling case in favour of the evidence being considered – regulation 5.23 not invoked
Representation: Applicant: Houlihan2
Opponent: Spruson & Ferguson
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2008268321
Title:Animal pest control method
Patent Applicant: E.I. du Pont de Nemours and Company
Date of Decision: 3 March 2017
DECISION
Regulation 5.23 is not invoked in relation to the identified paragraphs of the statutory declaration of Dr Steven Rodney Kopp, dated 07 October 2016, and accompanying Exhibits SRK-19, SRK-20 and SRK-22 (herein collectively referred to as condensed Kopp No. 3).
REASONS FOR DECISION
This matter concerns a request made under regulation 5.23 of the Patents Regulations (the Regulations) as amended on 15 April 2013 by the Intellectual Property Legislation Amended (Raising the Bar) Regulation 2013 (No 1) (the Amendment Regulation).
Background
Patent application 2008268321 in the name of E.I. du Pont de Nemours and Company (Du Pont) was examined and accepted by the Commissioner, and subsequently opposed under section 59 of the Patents Act 1990 (the Act) by Intervet International B.V. (Intervet).
The parties relied upon evidence by several declarants. Evidence in support consists of declarations by Bryce Alan Peters (Peters No. 1), Penelope Jane Linnett (Linnett No. 1) and Petr Fisara (Fisara No. 1). Evidence in answer consists of declarations by Peter Alexander Taylor (Taylor No. 1) and Steven Rodney Kopp (Kopp No. 1). Evidence in reply consists of declarations by Petr Fisara (Fisara No. 2), Ronald Kaminsky (Kaminsky No. 1), Bryce Alan Peters (Peters No. 2) and Penelope Jane Linnett (Linnett No. 2). The Evidence in reply was completed on 14 October 2015.
On 20 October 2015 Du Pont wrote to the Commissioner advising that it considered that Kaminsky No. 1 (which also introduced new Exhibits RK-4 and RK-5) filed as evidence in reply was actually evidence in support filed out of time. On 03 November 2015 Intervet wrote to the Commissioner submitting that Kaminsky No. 1 and accompanying Exhibits RK-4 and RK-5 are properly evidence in reply. On 23 November 2015, after several exchanges of correspondence between the Commissioner and both parties, a delegate of the Commissioner considered that Kaminsky No. 1 and Exhibits RK-4 and RK-5 are properly evidence in reply.
On 23 February 2016, Du Pont made a request under regulation 5.23 of the Regulations requesting the Commissioner to consult an additional statutory declaration by Steven Rodney Kopp (Kopp No. 2), with accompanying Exhibits SRK-14 to SRK-18, for the purposes of deciding the substantive opposition. On 01 March 2016, a delegate of the Commissioner notified both parties that he proposed to rely on the documents filed by Du Pont and, pursuant to paragraph 5.23(2)(c) of the Regulations, on 08 March 2016, Intervet wrote to the Commissioner submitting that Kopp No. 2 with accompanying Exhibits SRK-14 to SRK-18 should not be consulted under regulation 5.23. On 05 April 2016 Du Pont made further submissions to the Commissioner regarding the significance of Kopp No. 2 and Exhibits SRK-14 to SRK-18.
On 18 April 2016, the delegate of the Commissioner notified both parties that he intended to rely on portions of Kopp No. 2 and Exhibits SRK-14 to SRK-18 and directed Du Pont to file a condensed version of Kopp No. 2 (condensed Kopp No. 2). Pursuant to paragraph 5.23(2)(c) of the Regulations, the delegate gave Intervet an opportunity to respond about condensed Kopp No. 2. Condensed Kopp No. 2, dated 28 April 2016, was file by Du Pont on 29 April 2016.
In response to condensed Kopp No. 2, Intervet filed, on 14 June 2016, a further statutory declaration by Ronald Kaminsky (Kaminsky No. 2) with accompanying Exhibits RK-6 and RK-7. On 20 June 2016, a delegate of the Commissioner acknowledged that Kaminsky No. 2, dated 13 June 2016, with Exhibits RK-6 and RK-7 completed the evidence in response to condensed Kopp No. 2 relied on under regulation 5.23.
On 11 October 2016, Du Pont filed another statutory declaration by Steven Rodney Kopp (Kopp No. 3), dated 07 October 2016, with accompanying Exhibits SRK-19 to SRK-23 requesting, pursuant to paragraph 5.23(2)(c) of the Regulations, that the delegate of the Commissioner consider the new documents and Du Pont’s submissions as a response to Kaminsky No. 2 and Exhibits RK-6 and RK-7. In the alternative, Du Pont requested Kopp No. 3 and Exhibits SRK-19 to SRK-23 be considered pursuant to regulation 5.23.
On 14 October 2016, the delegate stated in a letter to Du Pont that paragraph 5.23(2)(c) is not intended to allow the parties to enter into an endless loop of responding to evidence. The delegate was also not satisfied that Kopp No. 3 and Exhibits SRK-19 to SRK-23 should be considered under regulation 5.23.
On 09 December 2016 Du Pont wrote to the delegate and requested that only parts of Kopp No. 3 be considered rather than the whole of Kopp No, 3. Du Pont also requested that only Exhibits SRK-19, SRK-20 and SRK-22 be considered. Du Pont made a request for the Commissioner to consult identified paragraphs of Kopp No. 3, Exhibits SRK-19, SRK-20 and SRK-22 (herein collectively referred to as condensed Kopp No. 3) pursuant of subregulation 5.23(1).
On 15 December 2016, the delegate suggested that Du Pont request a hearing in relation to the request for condensed Kopp No. 3 to be considered under regulation 5.23. On the 19 December 2016, Du Pont requested a hearing. On 21 December 2016, the delegate directed a hearing be conducted by written submissions.
Du Pont filed written submissions on the 31 January 2017. In a letter to the Commissioner, dated 01 February 2017, Intervet stated:
“Internet International B.V. will not object to consideration of Kopp No. 3 if permitted to respond with information already to hand, supported by expert comment in the form of a Statutory Declaration which could be prepared, finalised, executed and filed within a reasonably short time period.”
The framework of the Regulations
Regulation 5.8 sets up a three stage procedure for the filing of evidence with the relevant evidentiary timeframes. The opponent files evidence in support. This is followed by the applicant's evidence in answer, and finally the opponent can respond with evidence in reply. Where an opposition commenced before 15 April 2013, a party seeking to adduce evidence outside the evidentiary timeframes may seek leave to file the evidence as further evidence under subregulation 5.10(4) as in force immediately before 15 April 2013. There are no provisions for further evidence in an opposition commenced on or after 15 April 2013.
However, in order to protect the public interest the Commissioner retains 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 regulation 5.23 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."
The application of Regulation 5.23
Regulation 5.23 was considered by a delegate of the Commissioner in Merial Limited v Bayer Intellectual Property GmbH[1] (the Merial decision). In this decision, the delegate noted that[2]:
“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.”
[1] [2015] APO 16.
[2] [2015] APO 16 at [24]-[25].
In the Merial decision, regulation 5.23 was considered in the context of information that was contained a prior art citation, and whether the prior art citation sought to be consulted under regulation 5.23 was more relevant than any of the other prior art citations already filed.
In a recent decision, Reflex Instruments Asia Pacific Pty Ltd v Minnovare Limited[3] (the Reflex decision), the delegate considered regulation 5.23 in the context of information that was contained in statutory declarations. In the Reflex decision, the delegate adopted an approach based on decisions of the Trade Marks Office relating to an equivalent provision provided under the Trade Marks Regulation 1995, this provision being Trade Marks regulation 21.19. The delegate in the Reflex decision noted the following practice of the Trade Marks Office as set out in the Trade Marks Examiner Manual[4]:
“The delegate will not consider out of time evidence as a matter of routine. The party filing the evidence must make a compelling case in favour of it being considered.”
[3] [2017] APO 8.
[4] [2017] APO 8 at [50], referring to Trade Marks Examiner Manual, part 51, paragraph 2.6.
The delegate in the Reflex decision stated[5]:
“I am satisfied that the approach taken by the Trade Marks Office is consistent with the Merial decision, and is a useful framework. Thus in order for me to determine if I should invoke regulation 5.23, I must form a broad view of the circumstances and potential implications should I decide to invoke or not to invoke regulation 5.23.
To form this view, I will do so by considering the following matters:
1.The circumstances leading up to the evidence not being filed earlier
2.What does the evidence show
3.Is the information likely to be crucial to the delegate’s decision
4.The public interest in having the information considered
5.The balance of convenience of the parties if the information is considered”
[5] [2017] APO 8 at [51]-[52].
I will consider the above-quoted matters to the extent that they are material to the facts of the present case.
Should the evidence be relied upon under regulation 5.23?
As mentioned above, the relevant evidence sought to be relied upon under regulation 5.23 consists of certain paragraphs of Kopp No. 3, identified by Du Pont in their request filed 09 December 2016 and accompanying Exhibits SRK-19, SRK-20 and SRK-22 (condensed Kopp No. 3).
The circumstances leading up to the evidence not being filed earlier
From a history of the present case outlined above, Du Pont requests the condensed Kopp No. 3 be relied upon under regulation 5.23 in order to respond to Kaminsky No. 2, Exhibits RK-6 and RK-7. Kaminsky No. 2, Exhibits RK-6 and RK-7 were filed by Intervet as part of an opportunity available to Intervet to respond a direction of the Commissioner’s delegate to rely on evidence (condensed Kopp No. 2 and Exhibits SRK-14 to SRK-18) filed by Du Pont in a previous request under regulation 5.23 (Du Pont’s first regulation 5.23 request).
I consider Du Pont’s present request under regulation 5.23 (Du Pont’s second regulation 5.23 request) relating to the condensed Kopp No. 3 has been made at the appropriate time. A consideration of the circumstances leading up to the evidence not being filed earlier is immaterial to the present fact scenario.
What does the evidence show?
Du Pont submitted[6]:
[6] Du Pont’s submissions, dated 31 January 2017, on page 2.
“As stated above, the Applicant [Du Pont] apprehends that the Opponent [Intervet] will seek to rely on Kaminsky No. 2 to support an argument that the choice of administration route is a matter of routine that would be tested as a matter of course. This is disputed by the Applicant.
More particularly, the Applicant submits that Kaminsky has raised the following four major propositions in Kaminsky No. 2, which are directed to the above issue. He has done so using as support Exhibits RK-6 and RK-7, being new documents which the Applicant has not had the opportunity to address, and by referring to particular examples of compounds said to support those propositions. The four propositions will be addressed below in turn.
Proposition 1: The administration route is much more a matter of user convenience than the location of the parasite.
…..
Proposition 2: Both ectoparasites and endoparasites can be treated with parasiticides administered internally or externally, and vice versa.
…..
Proposition 3: Compounds with good in vitro activity would as a matter of course be further tested for their potential in vivo by carrying out all relevant tests.
…..
Proposition 4: Having carried out all the relevant tests, a compound with good, safe and long-term activity would not be missed.
…..”I accept that the opportunity to address Kaminsky No. 2 and respond with counter arguments is important to DuPont. However, regulation 5.23 is not a provision for parties to enter into unlimited exchanges of filing evidence or submissions. A consideration I will take into account is whether the party filing the evidence (DuPont) has made a compelling case in favour of the evidence being considered under regulation 5.23. In order to do this I will firstly need to consider what the evidence shows.
On 9 December 2016, Du Pont submitted a table, which limited the parts of Kopp No. 3 sought to be relied upon under Regulation 5.23 (Table of Parts). A copy of the Table of Parts accompanied Du Pont’s written submissions dated 31 January 2017 and is reproduced in Annex 1.
Du Pont submitted:
“The identified parts of Kopp No. 3 address the factors and considerations that bear upon the route of administration and dosage form when developing a treatment involving the use of an active compound, as well as the other propositions raised by Kaminsky listed above.”[7]
and
“The nature and significance of the material in the above identified parts of Kopp No. 3 is set out in more detail in the accompanying Table of Parts. …
Among other things, Exhibit SRK-20 contains material of particular significance. It provides a table of parasiticides with specific details, including their chemical structures, mode of action, route of administration and their efficacy against certain ectoparasites.”[8]
[7] Du Pont’s submissions, dated 31 January 2017, on page 2.
[8] Du Pont’s submissions, dated 31 January 2017, on page 3.
The written submissions of Du Pont, including the Table of Parts, point me to what Du Pont considers new and significant information in Kopp No. 3, and why Du Pont considers this information to be significant in the determination of the substantive opposition. Du Pont’s written submissions have been helpful in assisting me assess the nature and significance of condensed Kopp No. 3.
I have considered each of the paragraphs of condensed Kopp No. 3 and have found the information to be responsive to Kaminsky No. 2, and in particular paragraphs [6], [8] and [18] of Kaminsky No. 2. The information in condensed Kopp No. 3 clearly refutes the propositions advanced in Kaminsky No. 2 by providing statements in regard to various factors and considerations that bear upon the route of administration and dosage form when developing a treatment involving the use of an active compound. These factors and considerations include selective toxicity of the active compound, systemic efficacy of the active compound, different therapeutic behaviour of the active compounds against fleas, ticks and mites, contrasting therapeutic activity of the active compound via different routes of administration and the half-life of the active compound.
I consider that the statements in condensed Kopp No. 3 are of a nature that can be generally characterised as refuting a proposition that there can be any expectation of achieving therapeutically meaningful efficacy of an active compound which has been found to have activity in an in vitro test. The following statement in Kopp No. 3 is consistent with this characterisation[9]:
“Accordingly, the process that needs to be followed in the selection of which compounds to take to further testing once contact activity has been demonstrated, is a complex, step-wise task, which is not as simple as Kaminsky makes out. One needs to proceed first through testing to see if a compound is active through direct contact, i.e. following topical administration in vivo on either a pest/parasite or a mammal. If the compound is found to exhibit contact activity then one might consider conducting further testing, but this could never be done with any expectation of achieving therapeutically meaningful efficacy. One might then proceed to investigate whether the compound is also systemically active, but again this would be done without any expectation of finding efficacy. For example, if topical in vivo testing proves to be unsuccessful and/or produces unfavourable reactions on or in the mammal, this would prevent a researcher from taking any further steps.”
[9] Kopp No. 3, dated 07 October 2016, at paragraph [9].
Is the information likely to be crucial to the delegate’s decision?
I will now need to ask whether the information in condensed Kopp No. 3 is likely to be crucial to the delegate’s decision in the substantive opposition such that regulation 5.23 should be invoked. Following the approach in the Reflex decision of adopting the principles from the Trade Marks Office, I will consider whether the information filed as evidence is of high probative value that it is likely to significantly affect the outcome of the substantive opposition (see Fed Square Pty Ltd v Federation IP Pty Ltd[10], TWG Tea Company Pte Ltd v Tsit Wing International Company Ltd[11]). This approach is consistent with principles in the Merial decision[12].
[10] [2015] ATMO 42; (2015) 113 IPR 453 at [50]-[[51].
[11] [2015] ATMO 64 at [45].
[12] [2015] APO 16 at [24]-[25].
Du Pont submitted:
“The fact that there is already support in the Applicant's evidence for the general proposition that the choice of administration route is not a matter of routine, does not mean that the additional information in Kopp No. 3 lacks the necessary significance.”[13]
and
“Kopp No. 3 provides more detailed and specific evidence, which directly addresses the new material contained in Kaminsky No. 2. It does so in a way that both supports the Applicant's proposition (that the choice of administration route is not a matter of routine) and refutes the four contrary propositions advanced by Kaminsky, as outlined above. Moreover, it does so by addressing the details of specific examples and particular active compounds, such as to enable the issues in the Opposition to be considered by reference to hard facts, rather than general assertions of the kind made by Kaminsky. The table of parasiticides with details in Exhibit SRK-20 provides an example of the specific information in Kopp No. 3.”[14]
[13] Du Pont’s submissions, dated 31 January 2017, on pages 3-4.
[14] Du Pont’s submissions, dated 31 January 2017, on page 4.
I have considered Exhibit SRK-20 which Du Pont submitted as providing specific examples of parasiticides that are of particular significance to Du Pont’s evidence. I have found Exhibit SRK-20 to be a collation of information about eleven specific parasiticides, and the paragraph references that are provided in the exhibit point to where the information about the specific parasiticides is found in the statutory declarations of the expert witnesses. Since the statutory declarations are already on file as evidence for the present case, I consider the information in Exhibit SRK-20 as largely repeating information about the specific parasiticides that is already in evidence.
I consider that the information regarding ivermectin in Exhibit SRK-20 and paragraphs [17] of Kopp No. 3 as largely repeating information already in evidence. I also note that condensed Kopp No. 2 also contains statements, which are already in evidence, regarding the ineffectiveness of ivermectin against fleas which Du Pont advances [15].
[15] Condensed Kopp No. 2, dated 28 April 2016, at paragraphs [7] and [10].
I consider the information regarding spinosad in Exhibit SRK-20 and paragraphs [18] of Kopp No. 3 as largely repeating information already in evidence. The references relating to spinosad provided in Exhibit SRK-20 point to statements in Taylor No. 1 — Dr Taylor being an expert witness of Du Pont — and these statements are already in evidence to contest the availability of spinosad at the priority date of the patent application[16].
[16] Taylor No. 1, dated 11 August 2015, at paragraphs [42] and [107].
I consider the information regarding selamectin and the explanation of tests in the Zakson-Aiken et al. paper (Exhibit SRK-14) in paragraphs [21]-[26] of Kopp No. 3 as largely repeating information already in evidence in condensed Kopp No. 2[17].
[17] Condensed Kopp No. 2, dated 28 April 2016.
I consider the information regarding US2007/0066617 (‘The Mita Patent’ exhibited as Exhibit PJL-10) in paragraphs [31]-[33] of Kopp No. 3 as largely repeating information already in evidence in Kopp No. 1[18].
[18] Kopp No. 1, dated 12 August 2015, at paragraphs [172]-[183].
I find that the information provided in condensed Kopp No. 3 to be largely repetitive of information already in evidence for the present case. Condensed Kopp No. 3 does not provide new information that is significantly better than what is already in evidence.
Du Pont submitted:
“Referring to AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30; (2015) 323 ALR 605 at [15] and [67], the relevant enquiry for inventive step may be rephrased as follows:
‘Whether the notional skilled person at the relevant date in all the circumstances, which include the common general knowledge considered separately or together with prior art information publicly available in a document relevant to the problem, would have directly been led as a matter of course to try the invention as claimed in the expectation that it might well produce a useful result.’
In particular, the Applicant submits that the new information in Kopp No. 3 refutes the proposition that there can be a reasonable expectation that a compound which has been found to be active by contact upon topical application against a parasite in an in vitro test, would also be found to be systemically active (in vivo) in a mammal against an ectoparasite residing on a mammal following oral administration to the mammal.
That issue will plainly be of real significance in the determination of the Opposition.
Accordingly, the Applicant respectfully submits that the identified parts of Kopp No. 3 meet the relevant test and should be taken into account under Regulation 5.23.” [19]
[19] Du Pont’s submissions, dated 31 January 2017, on page 4.
I have previously characterised the nature of statements in condensed Kopp No. 3 as generally refuting a proposition that there can be any expectation of achieving therapeutically meaningful efficacy of an active compound which has been found to have activity in an in vitro test. The evidence sought to be filed as condensed Kopp No. 3 addresses considerations that were taken into account in the development towards successfully producing a therapeutically efficacious compound for various parasiticides. Whilst the information in condensed Kopp No. 3 may be relevant, it does not add significantly to an enquiry whether certain steps are of a routine character or tried as a matter of course for the present invention as claimed in the opposed application.
In summary, I find the information in condensed Kopp No. 3 to be largely repetitive of information already in evidence for the present case, and does not add significantly to an enquiry regarding inventive step. Therefore, I consider the information is not of high probative value that it is likely to significantly affect the outcome of the substantive opposition. I conclude that the information in condensed Kopp No. 3 is not likely to be crucial to the delegate’s decision in the substantive opposition.
The public interest in having the information considered
The procedures for consulting documents provided under regulation 5.23 can introduce delay to the opposition. Whilst unnecessarily protracted opposition proceedings are clearly undesirable, this is balanced against the principle of ensuring invalid patents are not granted.
In the present case, since I have found the information in condensed Kopp No. 3 not likely to be crucial to the delegate’s decision in the substantive opposition, not invoking regulation 5.23 means that the opposition is dealt with appropriately and efficiently.
The balance of convenience of the parties if the information is considered
Given my findings in regard to condensed Kopp No. 3, it appears unlikely that either of the parties will be inconvenienced by proceeding to a hearing to decide the substantive opposition.
Other matters submitted by Du Pont
Du Pont submitted the following in response to a letter from a delegate of the Commissioner:
“In the letter of 15 December 2016, the Senior Examiner said the following[20]:
‘It is preferable that all procedural issues (including Reg 5.23) are resolved before the substantive hearing.’
The Applicant readily accepts that it is preferable if procedural issues can be resolved before the substantive Hearing. However, Regulation 5.23 confers a discretion to consider information in a document ‘for the purposes of deciding an opposition’. The Applicant respectfully submits that the question of the exercise of that discretion arises in the course of deciding the Opposition, and that, as a result, a final decision on that question would properly be made by the Delegate of the Commissioner of Patents who is to hear the Opposition, in the light of all of the evidence and submissions made at the substantive Hearing. The Applicant respectfully submits that this is not merely a procedural issue.
….. Accordingly, if the Senior Examiner is not able to conclude now that the identified parts of Kopp No. 3 will meet the relevant standard, and thus should be expected to be taken into account, the Applicant respectfully submits that the question as to whether those parts of Kopp No. 3 should be considered under Regulation 5.23 should be dealt with by …… the Hearing Officer for the substantive Hearing.”
See, by way of comparison, the comments by Dr. Barker in Merial v Bayer at [7], referring to Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp [2001] APO 13, for the proposition that the only time that a final determination of whether evidence is actually in reply is made is during the substantive Hearing of the Opposition.”
[20] Du Pont’s submissions, dated 31 January 2017, on page 4.
The above-quoted submissions suggest that a delegate of the Commissioner other than the hearing officer for the substantive opposition is not able to decide whether in condensed Kopp No. 3 should be consulted under regulation 5.23.
It is the practice of the Patent Office to resolve matters regarding regulation 5.23 before the hearing of the substantive opposition to ensure that the hearing is not unduly complicated by having material served at the hearing. This practice ensures an efficient and orderly processing of matters before the Patent Office. A delegate of the Commissioner with delegated power to exercise the Commissioner’s discretion under Regulation 5.23 is able to do so — the delegate does not necessarily need to be the hearing officer of the substantive opposition[21].
[21] See the Merial decision, [2015] APO 16, and the subsequent decision of the substantive opposition, [2016] APO 16.
Du Pont submitted[22]:
“Finally, the Applicant notes that one of the documents referred to in the parts of Kopp No. 3, which are no longer pressed, is the Opponent's own Australian Patent No. 2008290581. As this document is already available in the Patent Office, there is no need for it to form part of the material in Kopp No. 3 in order for it to be considered under Regulation 5.23.
For avoidance of doubt, the Applicant contends that AU 2008290581 should be considered under Regulation 5.23, independently of Kopp No. 3, and that it meets the test set out above.”
[22] Du Pont’s submissions, dated 31 January 2017, on page 5.
Australian Patent No. 2008290581 (AU2008290581) has been filed by Intervet as part of its evidence in support. Intervet alleges that the opposed application is not entitled to its claimed priority date, and therefore AU2008290581 is a relevant citation for the enquiry of novelty. AU2008290581 forms Exhibit BAP-12 and Peters No. 1 contains statements regarding the patent[23]. AU2008290581 also forms Exhibit PJL-12 and Linnett No. 1 contains statements regarding the patent[24]. As the patent is already in evidence for the present case, AU2008290581 will be considered as part of the substantive opposition. Kopp No. 3 contains statements about AU2008290581 in paragraphs [36]-[43] and Du Pont no longer presses these paragraphs to be considered under regulation 5.23. I find that AU2008290581 does not need to be consulted under regulation 5.23[25].
[23] Peters No. 1, dated 11 May 2015, at paragraphs [126]-[130].
[24] Linnett No. 1, dated 11 May 2015, at paragraphs [123]-[129].
[25] Pursuant paragraph 5.23(1)(b), AU2008290581 is not a document that may be consulted under regulation 5.23. This is because AU2008290581 is a document that has been filed, in the present substantive opposition, under chapter 5 of the Regulations.
Conclusion
Having considered the above matters, I conclude that Du Pont has not made out a compelling case in favor of the evidence being consulted under regulation 5.23. Therefore, I will not invoke regulation 5.23 in relation to condensed Kopp No.3.
Costs
It is normal for cost to follow the event. However, Intervet has played no active role in the present matter. I consider it appropriate to make no award of costs.
Dr A. Lim
Delegate of the Commissioner of PatentsAnnex 1
TABLE OF PARTS OF KOPP DECLARATION NO. 3, DATED 7 OCTOBER 2016, PRESSED
Para(s) of Kopp No. 3 Part Pressed Reasons for adducing evidence/ new information provided 1, 2 Whole Introductory/formal paragraphs 3,4 Not pressed 5-9 Whole Comments on Kaminsky No. 2 (13 June 2016), para 6, giving examples of various active compounds and stating that the administration route and dosage form used is much more a matter of user convenience than the location of the parasite
Provides evidence of the various factors and considerations that bear upon the route of administration and dosage form when developing a treatment involving the use of an active compound
10 First sentence and Exhibit SRK-19
onlyComments on Kaminsky No. 2, para 6 (see above)
Provides evidence as to selective toxicity considerations in the above context
11 Last two
sentences onlyComments on Kaminsky No. 2, para 6 (see above)
Provides evidence that it is necessary to have shown systemic efficacy of a compound first before a decision to administer it orally or parenterally can be made
12 Whole Comments on Kaminsky No. 2, para 6 (see above)
Provides evidence that an active compound needs to concentrate sufficiently in the target tissues where the parasite resides and that the parasite needs to take a blood meal in order for treatment to be effective
13 First three
sentences and
Exhibit SRK-20
onlyComments on Kaminsky No. 2, para 6 (see above)
Provides evidence that parasiticides in the same chemical class may not behave in the same way and while they may be active against ticks, they may not be active fleas and vice versa
14 First two lines Comments on Kaminsky No. 2, para 6 (see above)
Provides an example of the contrasting therapeutic activity of Selamectin via different routes of administration
15 Not pressed 16 Whole Comments on Kaminsky No. 2, para 6, giving the example of Praziquantel
Provides evidence as to the therapeutic activity of Praziquantel, including having regard to the half-life of the active compound in blood, commenting on the example given by Kaminsky
Para(s) of Kopp No. 3 Part Pressed Reasons for adducing evidence/ new information provided 17 First two
sentencesComments on Kaminsky No. 2, para 6, giving the example of Ivermectin
Provides evidence that Ivermectin has no relevance to companion animals, such as dogs or cats, and it is ineffective against fleas
18 First three lines
and last lineComments on Kaminsky No. 2, para 6, giving the example of Spinosad
Provides evidence that Spinosad was not available in orally administered form at the priority date, but rather was still in research and development at that time
19 Whole Comments on Kaminsky No. 2, para 6, giving examples of various active compounds and stating that the administration route and dosage form used is much more a matter of user convenience than the location of the parasite
Asserts the position that administration route cannot be "a matter of user convenience", using Selamectin as an example. A different spectrum of activity of Selamectin is observed when the administration route has been changed. For example, a gastrointestinal parasite, Ancylostoma caninum (dog hookworm), is no longer affected when Selamectin is administered topically. For this reason (and others), Canex® is given orally with topically administered Selamectin to make up for the shortfall in the spectrum of activity against gastrointestinal parasites. Accordingly, depending on the companion animal, for example, dogs, the route of administration of Selamectin affects its activity.
20 Lines 7-13 Comments on Kaminsky No. 2, para 6, giving examples of various active compounds and stating that the administration route and dosage form used is much more a matter of user convenience than the location of the parasite
Provides evidence that the relationship between topical/transdermal deliverability and the parasiticide is highly dependent on the physico-chemical properties of that parasiticide. These properties also dictate its pharmacokinetic and pharmacodynamic properties. Thus, it cannot be assumed that an orally-administrable parasiticide can be given topically and still achieve the same effect because each parasiticide will behave differently based on these properties, i.e., not all orally effective parasiticides will be topically effective (and vice versa). A parasiticide cannot be administered using any route as "a matter of user convenience", since it may not be compatible with that route.
Para(s) of Kopp No. 3 Part Pressed Reasons for adducing evidence/ new information provided 21-26 Whole Comments on Kaminsky No. 2, para 8, discussing the ZaksonAiken et al. paper (Exhibit SRK-14)
Provides evidence explaining tests reported in the paper and why Selamectin has poor activity and would not be considered further in light of those findings
27, 28 Not pressed 29 First two lines Comments on Kaminsky No. 2, para 6, giving examples of various active compounds and stating that the administration route and dosage form used is much more a matter of user convenience than the location of the parasite
Provides evidence that, even though Fipronil is a good topical parasiticide, it induces vomiting if given orally
30 Whole, including
Exhibit SRK-2231-33 Whole Comments on Kaminsky No. 2, para 18, discussing Mita (D3) Example 19
Provides evidence as to the skilled person's understanding of Example 19, including the limitations on the disclosure
34-46 Not pressed
5
7
0