Novartis Vaccines & Diagnostics, Inc. v Wyeth Holdings Corporation
[2014] APO 65
•22 September 2014
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Novartis Vaccines & Diagnostics, Inc. v Wyeth Holdings Corporation [2014] APO 65
Patent Application: 2012202916
Title:Novel immunogenic compositions for the prevention and treatment of meningococcal disease
Patent Applicant: Wyeth Holdings Corporation
Opponent: Novartis Vaccines & Diagnostics, Inc.
Delegate: Dr N.R. Madsen
Decision Date: 22 September 2014
Hearing Date: Written submissions completed on 28 August 2014
Catchwords: PATENTS – extension of time to file evidence in answer – Regulation 5.9 – whether the applicant has acted promptly and diligently at all times – extension of time granted
Representation: Patent applicant: Shelston IP
Opponent:FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2012202916
Title:Novel immunogenic compositions for the prevention and treatment of meningococcal disease
Patent Applicant: Wyeth Holdings Corporation
Date of Decision: 22 September 2014
DECISION
I allow an extension of the time for filing evidence in answer until 20 August 2014.
For the purposes of regulation 5.8(4), this decision represents notice that all of the evidence in answer has been filed. The time for filing evidence in reply is 2 months from the date of this decision.
I award costs according to Schedule 8 against Novartis Vaccines & Diagnostics, Inc.
REASONS FOR DECISION
This matter relates to patent application 2012202916 in the name of Wyeth Holdings Corporation (Wyeth). The application was advertised as accepted on 1 August 2013 and a notice of opposition to the grant of a patent was filed by Novartis Vaccines & Diagnostics, Inc. (Novartis) on 1 November 2013.
Novartis filed a statement of grounds and particulars on 3 February 2014. Evidence in support was completed on 5 May 2014. Evidence in answer was due to be filed by 6 August 2014. Wyeth requested an extension of the time for filing evidence in answer until 6 September 2014.
The Commissioner advised on 29 July 2014 that she was satisfied with the reasons in support of the application, and Novartis asked for a hearing. The hearing was conducted by means of written submissions.
Wyeth filed complete evidence in answer on 20 August 2014.
The law
On 15 April 2013, the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1) (the Amendment Regulation) commenced. The Amendment Regulation significantly amended the Patents Regulations (the Regulations) as they apply to patent oppositions. The law governing extensions of time to file evidence in a patent opposition depends upon the date on which the opposition commenced. Where the evidentiary period commenced on or after 15 April 2013 (as in the present case), the extension is governed by regulation 5.9 of the Regulations as in force on 15 April 2013. This follows from regulation 23.36(2), item 2, of the Regulations.
Subregulation 5.9(2) states:
The Commissioner may extend the period only if the Commissioner is satisfied that:
(a) the party who intended to file evidence in the period:
(i)has made all reasonable efforts to comply with all relevant filing requirements under this Chapter; and
(ii)despite acting promptly and diligently at all times to ensure the appropriate evidence is filed within the period, is unable to do so, or
(b) there are exceptional circumstances that warrant the extension.
Exceptional circumstances are defined in subregulation (5):
In this regulation:
exceptional circumstances includes the following:
(a) a circumstance beyond the control of a party that prevents the party from complying with a filing requirement under this Chapter;
(b) an error or omission by the Commissioner that prevents a party from complying with a filing requirement under this Chapter;
(c) an order of a court, or a direction by the Commissioner, that the opposition be stayed pending the completion of a related proceeding or action under the Act.
These provisions have been considered by the Commissioner in TRED Design Pty Ltd v Julie-Anne McCarthy and Bradley McCarthy [2013] APO 57 (the TRED decision) and Merial Limited v Novartis AG [2013] APO 65 (the Merial decision). The principles applied in those decisions, which I accept as correct, are that I must ask myself the following questions:
1. Has the party (and their attorney or agent) made all reasonable efforts to comply with all relevant filing requirements?
2. Was the failure to file the evidence in time despite the party (and their attorney or agent) acting promptly and diligently at all times to ensure the evidence is filed in time?
3. Were there exceptional circumstances that warrant the extension?
I can extend the time for filing evidence only if I am satisfied that the answer to questions 1 and 2 is YES, or if I am satisfied that the answer to question 3 is YES. If I am so satisfied, then I must consider whether there are any discretionary reasons why the extension should not be granted.
10. As noted in the Explanatory Statement accompanying the Amendment Regulation:
"The Commissioner will not be able to extend time periods unless one of these conditions was made out. The party seeking the extension will bear the onus of convincing the Commissioner of this. Once the conditions in subregulation 5.9(2) are met, the Commissioner still has the discretion to consider whether or not it is appropriate that an extension of time be granted. In applying the test, the Commissioner will not be required to give a direction to extend a period solely because of delays caused by a legal representative failing to act promptly or diligently, by difficulties in obtaining expert evidence that could have been anticipated and acted on or by attempts to settle the proceedings.
Where a party cannot satisfy the Commissioner that an extension is justified under the test, the Commissioner will not have the power to give a short extension to allow the filing of evidence immediately available or to validate evidence filed out of time."
11. If the Commissioner is satisfied that an extension is appropriate, the Commissioner must then determine the length of the extension (subregulation (3)):
The Commissioner must determine the length of the extended period having regard to what is reasonable in the circumstances.
The application for extension of time
12. The relevant parts of the application for an extension of time are reproduced within this decision. The following general chronology was provided by Wyeth as part of the applicant’s written submissions.
| Time period | Tasks |
| 5-30 May | Review of evidence and substantial prior art by Applicant and its attorneys Comments sought from inventors Collation of relevant documents commenced Plan for evidence collection prepared Advice regarding strategy provided to by attorneys to Applicant |
| 2-5 June | Applicant reviews advice and provides instructions |
| 6-26 June | Four interviews conducted with two potential experts Experts carried out further investigations Ongoing consideration as to appropriateness of each expert Selection of expert made Declaration drafting commenced |
| 30 June | Prior art documents provided to expert Declaration drafting continued |
| 7-11 July | Meetings scheduled to discuss prior art which could not take place because of illness of expert Declaration drafting continued |
| 14-18 July | Expert uncontactable. Plans had been made to provide expert with patent application during this period, but this could not take place because prior art had not been discussed due to illness set out above Declaration drafting continued |
| 21 July - 6 August | Seven further interviews held Declaration drafting continued |
| 6 - 20 August | Five further interviews held Declaration drafting continued |
Has the party made all reasonable efforts to comply with all relevant filing requirements?
13. In the TRED decision at [28], the delegate of the Commissioner noted that:
“I would expect that often where a person has acted reasonably, they will also have acted promptly and diligently”
14. Additionally, the Deputy Commissioner noted in Merial at [16]:
“that the requirement in paragraph 5.9(2)(a)(i) is intended to import a consideration of the reasonableness of the relevant party’s conduct over the totality of the opposition proceedings rather than its compliance with the particular evidentiary period in question – here the period for filing evidence in answer – which is addressed by the more specific requirement of paragraph 5.9(2)(a)(ii).”
15. In this decision, where the only filing requirement is evidence in answer itself, the reasonableness of Wyeth's behaviour is best understood by analysing whether they acted promptly and diligently. If the applicant and their attorneys have acted promptly and diligently at all times, then it follows that all reasonable efforts to comply have been made.
Was the failure to file the evidence despite acting promptly and diligently?
16. In relation to the demonstration of prompt and diligent action the delegate in TRED noted at [76] that:
“An attorney does not need to account for every minute of their day, but they must provide enough information to enable a delegate of the Commissioner to form their own opinion on whether the party has acted reasonably, promptly and diligently. The kind of information that could be provided is a brief account of actions taken (for instance, an outline of what was done, when it was done, how it was done, by whom it was done, as appropriate to the case) covering the period in question.”
17. Further guidance is present in Fugro Airborne Surveys Corp v Geotech Airborne Limited [2014] APO 23 (Fugro) at [20] where the delegate stated that a chronology of the steps taken is usually a good starting point to assess whether a person has acted promptly and diligently:
"A party seeking an extension of time will assist the Commissioner (and advance their own cause) if they provide information about what they did, when they did it, and how long those actions took. When considering such information, it is relevant to consider whether there have been any significant unexplained delays. The presence of significant delays without a reasonable explanation is the antithesis of acting promptly and diligently. "
18. However, it is clear that there can be no absolute measure upon how much information is required to be satisfied that a person has acted promptly and diligently. In Osmose New Zealand v Zelam Limited [2014] APO 49 (Osmose) at [18] and [22] respectively, the delegate noted when considering the time taken to engage an expert:
“The fact that some activities took place over several months does not automatically mean that Zelam have not been prompt and diligent.”
“While it might have been possible to carry out some activities faster, the time taken is not outside the range of prompt and diligent given the work that was involved.”
19. There are a number of issues raised by the opponent in regard to the information provided in the extension of time application and chronology of events. I will assess the relevant actions chronologically, and refer to the parties submissions as necessary.
The period prior to 5 May 2014
20. Regarding the period before the filing of evidence in support, the application for an extension of time discusses the following actions:
“Prior to the Opponent's Evidence-in-Support being filed, the Applicant instructed its attorneys to identify suitably qualified technical experts to provide evidence in the matter. Five possible experts were identified and their qualifications and experience reviewed. Two experts were identified as having potentially suitable credentials as a result of this process.
The Applicant's attorneys conducted preliminary interviews with the two potential experts. After reviewing the proposed experts' curriculum vitae, both experts were retained for further discussions. Given that the Evidence-in-Support had not yet been received it was not possible to make a final determination as to which of the experts would be most suitable. It was decided that it was best to retain both experts at this stage, also as a contingency against availability or other issues that might arise during the course of the opposition proceedings.
Thus, prior to the Opponent's Evidence-in-Support being filed, the Applicant had engaged two suitable experts to act on its behalf for the above opposition.”
21. In relation to this work, the opponent largely submits that there is no detail in regards to dates and content of the discussions/interviews with experts. The opponent points out that there is no indication of any difficulties in obtaining experts, and that there is no indication of any substantive analysis of the prior art documents contained in the Statement of Grounds and Particulars.
22. The opponent adds that Statement of Grounds and Particulars “clearly and concisely refers to those parts of the prior art documents that are considered to be relevant to the opposed claims”, and therefore the applicant’s attorneys “cannot reasonably argue that they were unable to start to prepare their evidence between 3 February 2014 (when the SGP was filed) and 5 May 2014 (when the Evidence in Support was filed)”. The opponent also adds that the applicant was already aware of the relevant prior art documents.
23. In Shelford Services Pty Limited v Baylor Research Institute [2014] APO 20 (Shelford) at [18], the delegate of the Commissioner noted that:
“In many cases it may be reasonable for an applicant not to start work on defending an application until the evidence in support is filed. This could include the applicant waiting until the evidence in support is filed to then determine appropriate experts to seek in defending the application. The deferral of costs of this type of firm action by the applicant until the evidence in support is filed would be quite reasonable. A reasonable expectation also is that an applicant, seeking an extension of time to file evidence in answer, should nonetheless demonstrate that it had started considering or thinking about how it would defend its case at an early stage.”
24. The delegate in Shelford made it clear that a reasonable expectation of an applicant is that they begin considering an evidence strategy before evidence in support is filed. Similarly, the delegate in Sportingbet Australia v Tabcorp International Pty Ltd [2014] APO 21 (Sportingbet) at [28] recognised that there are significant costs involved in the preparation of evidence and that it was often appropriate that actions be deferred until the receipt of evidence in support.
“… an applicant should start to think about and consider its case in answer before the EIS is completed. If the party could demonstrate it had done so at an early stage, this would assist the Commissioner when considering an extension request under regulation 5.9. Notwithstanding, steps such as engaging experts and drafting relevant declaratory evidence is costly and, in general, it may be reasonable for an applicant to defer the cost of these actions until after the EIS is filed.”
25. The applicant identified and engaged two experts before the receipt of evidence in support and points out in their submissions that the experts indicated their “generally available during the relevant period”. In accordance with the above decisions of the Commissioner, I am satisfied that this is entirely reasonable action in the circumstances. It was reasonable that the applicant waited until the totality of the case to answer was clear before expending considerable resources on substantive preparations of evidence.
26. In regards to the submissions of the opponent, I do not require any further information to be satisfied that the applicant has been prompt and diligent in this period. There does not appear to be a clear basis to indicate that the opponent’s case was particularly straight forward such that evidence in answer could or should have been further progressed before the filing of evidence in support. While the applicant may have had an understanding of the opposition and prior art, I am satisfied it is reasonable to wait until the filing of the evidence in support before further progress is made. In short, any further action at this stage in the present case appears to go beyond that which may be considered reasonable, prompt and diligent.
The period 5 May 2014 – 6 June 2014
27. Regarding the period from 5-30 May 2014, the application for an extension of time discusses the following actions:
“The prior art documents included with the Evidence-in-Support were substantial and amounted to over 2,500 pages. The Evidence-in-Support referred in detail to the prior art documents. Evidence-in-Support was immediately forwarded to the Applicant for its review. At the same time our attorneys also reviewed Prof. Paton's declaration and the associated prior art documents. As a result of the size of the evidence submitted it was necessary for the Applicant's attorneys to devote a substantial amount of time to reviewing the Evidence-in-Support, determining the strategy for answering such evidence and communicating with the Applicant concerning such matters. During this period the Applicant itself also reviewed the evidence and commenced collation of relevant documents and comments.”
28. The applicant adds further information in their submissions indicating that within this period:
“A detailed plan of the topics which needed to be discussed with the expert witnesses was prepared”.
29. The applicant and their attorneys have adopted a particular approach in the gathering of evidence whereby the attorneys have waited until the filing of evidence in support before initially spending time reviewing the evidence and formulating an evidence strategy. At the same time the applicant also reviewed the evidence. This was followed by the provision of advice to the applicant. Such an approach enables experts to be able to spend their time wisely focussed on the issues of the opposition. A similar approach was endorsed by the delegate in Shelford. I am satisfied that this approach is entirely reasonable in the circumstances.
30. The opponent generally argues that a period of four weeks should not be required in the present circumstances, and that the applicant has not provided a particularly detailed account of what was done, when it was done, how it was done and by whom it was done, with this four week period.
31. It is clear that the opposition comprises a reasonably substantial volume of evidence being over 2500 pages. In this regard I would expect that a diligent party would carefully assess this information and that this process may be accelerated to a degree using prior knowledge of the aspects of the case. However I see no clear basis in the present opposition to conclude that the applicant and their agents should have completed the relevant tasks faster. In this period the applicant’s attorneys have reviewed the evidence in support, determined a strategy for answering the evidence and formulated a detailed plan of the topics to be discussed with expert witnesses. This information was then communicated to the applicant who was, at the same time, reviewing the evidence. There are no significant unexplained delays within this reasonable period. Given the completion of these substantial tasks within the period I am satisfied that the action is within “the range of prompt and diligent” contemplated in Osmose.
32. The period of four weeks from 5 – 30 May was immediately followed by one week of further action of the applicant as follows:
“During the week starting 2 June 2014, the Applicant reviewed the information provided by the attorneys and subsequently provided instructions to the attorneys to proceed with interviewing both the engaged experts.”
33. In accordance with the discussion of the action taken in the previous four weeks, it appears entirely prompt and diligent for the applicant to take one week to review advice from attorneys and reply with instructions. I also consider that there is no lack of prompt and diligent behaviour on the part of the attorneys in awaiting said instructions.
The period 6 June 2014 – 26 June 2014
34. Regarding this period the application for an extension of time discusses the following actions:
“…our Attorneys conducted four detailed interviews with our two experts, that is, two interviews with each expert, to obtain evidence in relation to the common general knowledge in the relevant field in Australia at the priority date of the Opposed Application and further assess the suitability of each expert to give evidence in light of the specific issues raised in the Evidence-in-Support.
During this period the Applicant was also collating a number of additional documents and information to form part of the evidence and to put to the expert witnesses.”
35. In addition to noting that the final selection of one of these experts occurred within the period, the submissions filed by the applicant also add that:
“..the Applicant confirms that the dates of the interviews were spread over the period indicated. This permitted discussion with the two experts, further inquiries to be made by them as to certain matters, as well as time to assess the suitability of each expert in light of the issues raised in the Evidence-in-Support. Specifically, the interviews were carried out on 6 June 2014, 10 June 2014, 23 June 2014, and 26 June 2014”
…
“A full statement of the common general knowledge as understood by the experts was obtained and it was not necessary to revisit the common general knowledge after this process was carried out.”
…
“[the additional documents collated by the applicant] were sent to the applicant’s attorneys during this period and in addition to conducting the interviews set out above, the attorneys also reviewed these documents.”
36. Similarly to my findings above, I am satisfied that the approach to gathering evidence was entirely reasonable in the circumstances. The attorneys have waited until after they have reviewed evidence, formulated an evidence plan, and received instruction from the applicant, before beginning interviews with the experts. Within a three week period the attorneys have obtained full statements of common general knowledge from both of the experts (by way of two interviews with each expert), while the applicant has also continued to prepare documentation to put to the experts and provided these documents to the attorneys for review. There were no significant delays within this period and therefore, I am satisfied that the action in this period is within the range of prompt and diligent.
The period 27 June 2014 – 30 June 2014
37. Regarding this period the application for an extension of time discusses the following actions:
“Both experts had advised that they would be unavailable for a period of time in July 2014. In particular, one of the experts advised that they would not be available for a full 2 weeks during the school holidays. Following the interviews, one expert was selected to provide Evidence-in-Answer. One of the factors in selecting this expert was the extended period of unavailability of the other expert.
On 30 June 2014, the prior art documents cited in the Opponent's evidence were forwarded to the expert. At this time, a detailed plan was established for the taking of the evidence during the remainder of the evidence period.”
38. The expert that was selected was unavailable for a 10 day period from 11 July 2014 to 21 July 2014. With this in mind the plan for taking evidence from this expert was established as follows:
“…conduct two interviews with the expert during the week starting 7 July 2014 to discuss the prior art documents. As the expert was to be on leave, on a sailing boat with no access to telephone or email from 11 July 2014, it was intended to provide the expert with the opposed patent application before that time (after the prior art had been discussed) and to discuss the opposed patent application with them early in the following week of 21 July 2014. It was then intended to provide and discuss the declaration of Prof. Paton and some further documents during the remainder of that week and the beginning of the week of 28 July 2014, allowing a further week to finalise the declaration with the expert, which was being prepared in tandem with the interviews with the expert.”
39. I remain satisfied that the approach to gathering evidence was entirely reasonable. It was appropriate for the applicant’s attorneys to interview the expert as to common general knowledge before providing documents to him, and before formulating a detailed plan for continued evidence gathering.
40. I earlier noted that the experts had indicated general availability throughout the period, when initial discussions were conducted with the attorneys before the filing of evidence in support. The selected expert later advised that he would be unavailable for 10 days in July. I do not believe that such an absence imposes any additional requirement to anticipate and plan for at an earlier stage of proceedings. Importantly, the period of absence is relatively insignificant. The degree of planning around this relatively short absence, once known, demonstrates prompt and diligent action on the part of the applicant’s attorneys. This is particularly the case given the absence appears insufficient to warrant a search for a new expert. Thus I am satisfied of prompt and diligent action in this period.
The period 1 July 2014 – 21 July 2014
41. As discussed above, the intention was for the expert to review the documents sent on 30 July 2014 with review being followed by two interviews during the week starting on 7 July 2014. These meetings were to be conducted before the expert left on their boat trip from 11 July to 21 July 2014. It transpired that the expert was ill in the period before the boat trip and could not review the prior art documents and take part in interviews with the attorneys. This delay could not have been avoided by the attorneys. As I am satisfied that the attorneys had reasonably planned for the absence of the expert due to his boat trip, it follows that I am satisfied that there is no lack of prompt and diligent action in this period.
The period from 22 July 2014 to filing of the declaration on 20 August 2014
42. Regarding this period the application for an extension of time discusses the following actions:
“The expert had advised that during the week starting 21 July 2014, he would be in the US for a work-related matter. Notwithstanding, our expert advised us that he would be available to discuss the prior art. Accordingly, on 22 July 2014 (21 July 2014, US time), which was the first opportunity after the expert travelled to the US for him to speak, our attorneys conducted a first discussion with our expert in relation to the prior art cited in the Opposed Application. Our attorneys also arranged to speak with our expert again on 24 July 2014. However, despite all efforts by our attorneys, the expert was not contactable on 24 July 2014.
It was intended after the arranged call on 24 July 2014 to provide the expert with the opposed patent application and speak with him about it on 26 July 2014 (Saturday). Subsequently, a further call with the expert has taken place today (25 July 2014) with further calls scheduled for 26 July 2014 as well as next week. However in light of the two week period lost as a result of the expert's unexpected illness, the Applicant does not consider that it will have sufficient time for the expert to review the remaining documents, discuss these with the attorneys and complete the declaration before the due date of 6 August 2014.”
43. In addition, the submissions filed by the applicant also add that:
“Further interviews took place with the expert on 25 July, 26 July, 28 July, 29 July, 30 July and 31 July during which time the prior art and the Opposed Application, as well as other documents provided by the Applicant were discussed. Despite all of these efforts to make up the time lost due to the expert's illness it was not possible to complete the evidence before the deadline of 6 August.
Further interviews have been conducted with the expert in the period since then on 8 August, 12 August, 15 August, 18 August and 19 August during which time the Paton declaration has been discussed and the declaration finalised.”
44. I also note that the applicant’s chronology of events indicates that drafting of the declaration continued throughout this period. This culminated in the filing of the declaration on 20 August 2014.
45. The opponent generally submits that there is no explanation as to why so many interviews were required, what the content of these interviews was, and why the evidence couldn’t be completed by 6 August 2014.
46. While it may have been possible to conduct less interviews and draft a declaration sooner, it is clear that the attorneys have conducted a number of interviews in a short period of time. These interviews were shortly followed by a number of further interviews which enabled the declaration to be discussed and filed. There are no significant unexplained delays in regard to this period. Therefore, I am satisfied that the actions of the applicant’s attorneys in this period are within the range of prompt and diligent required by Regulation 5.9.
Were there exceptional circumstances?
47. In the TRED decision the delegate of the Commissioner stated at [64] that exceptional circumstances were:
"…matters outside the normal evidentiary process, and outside the control of the party, where it would be unreasonable to insist on a party filing their evidence"
48. The applicant submits that the illness of the applicant was an exceptional circumstance.
49. I do not consider it possible to regard the short illness (in this case a period of 5 days) of the expert as an exceptional circumstance for the purpose of Regulation 5.9(2)(b). People involved in opposition matters often experience short periods of illness and in this regard it cannot be considered unreasonable to expect evidence to be filed when such a short period of illness has occurred.
Conclusion
50. I am satisfied that there are no significant periods of delay and that the information provided by the applicant demonstrates that action has been prompt and diligent. Thus, I am satisfied that an extension of time is appropriate.
51. Finally, I need to consider what length of extension is reasonable in the circumstances. The extension was sought until 6 September 2014 however the relevant evidence was filed on 20 August 2014. Given this, I consider it reasonable that the extension be granted until 20 August 2014.
Costs
52. It is normal for costs to follow the event. In this case, Wyeth has been successful and I can see no reason depart from the norm. I will award costs against Novartis.
Dr N.R. Madsen
Delegate of the Commissioner of Patents
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