Gilead Pharmasset LLC v AbbVie Ireland Unlimited Company
[2016] APO 53
•16 August 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Gilead Pharmasset LLC v AbbVie Ireland Unlimited Company [2016] APO 53
Patent Applications: 2013201406, 2013201532, 2013201585, 2013201758
Title:Methods for treating HCV
Patent Applicant: AbbVie Ireland Unlimited Company
Opponent: Gilead Pharmasset LLC
Delegate: Dr B. Akhurst
Decision Date: 16 August 2016
Hearing Date: Written submissions filed by both parties on 6 July 2016 and 13 July 2016
Catchwords: PATENTS – Reg 5.9 – extension of time to file evidence in reply – whether opponent has made all reasonable efforts to comply with the filing requirements and acted promptly and diligently at all times – whether circumstances beyond control – extension of time granted – costs awarded against the patent applicant
Representation: Patent attorney for the patent applicant: Griffith Hack.
Patent attorney for the opponent: FB Rice.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2013201406, 2013201532, 2013201585, 2013201758
Title:Methods for treating HCV
Patent Applicant: AbbVie Ireland Unlimited Company
Date of Decision: 16 August 2016
DECISION
I grant an extension of time until 9 June 2016 for filing evidence in reply in each of the four oppositions.
I award costs according to Schedule 8 against AbbVie Ireland Unlimited Company.
REASONS FOR DECISION
This matter concerns requests for an extension of time to file evidence in reply and is determined under regulation 5.9 of the Patents Regulations as amended on 15 April 2012 by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1).
Background
This matter relates to four patent applications filed in the name of AbbVie Inc. and subsequently assigned to AbbVie Ireland Unlimited Company (collectively AbbVie). These are patent applications 2013201406 (’406), 2013201532 (’532), 2013201585 (’585) and 2013201758 (’758). These applications were advertised as accepted between 2 October 2014 and 27 November 2014 and subsequently opposed by Gilead Pharmasset LLC (Gilead).
Gilead filed Statements of Grounds and Particulars within the required time in each opposition. After gaining an extension of time in which to do so in each case, Gilead completed its evidence in support of each opposition (EIS) on 23 September 2015. Evidence in answer (EIA) was filed on 24 March 2016. On 30 May 2016, the day evidence in reply (EIR) was due, Gilead filed the majority of its evidence and requested firstly, a direction that additional material that it sought to file as evidence should not be open to public inspection and secondly, an extension of time in which to file it. Gilead subsequently filed the additional material on 9 June 2016, after the Deputy Commissioner invoked reg 4.3(2)(b) to direct that it should not be open to public inspection.
On 14 June 2016, the parties were advised that the Commissioner intended to grant Gilead’s request for an extension of time to file evidence in reply. AbbVie requested a hearing, which was conducted by way of written submissions filed by both parties on 6 July 2016 and 13 July 2016.
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 opposition 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.
Subregulation 5.9(1) gives the Commissioner the discretionary power to extend the evidentiary time periods:
(1) The Commissioner may extend an evidentiary period mentioned in regulation 5.8:
(a) if requested in writing by a party; or
(b) on the Commissioner’s own initiative.
This power is qualified by subreg 5.9(2), which states:
(2) 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 subreg 5.9(5):
(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.
9. If the Commissioner is satisfied that an extension is appropriate, the Commissioner must then determine the length of the extended period having regard to what is reasonable in the circumstances (subreg 5.9(3)).
These provisions have been considered by the Commissioner in TRED Design Pty Ltd v Julie-Anne McCarthy and Bradley McCarthy [2013] APO 57 (TRED) and Merial Limited v Novartis AG [2013] APO 65 (Merial). The principles applied in those decisions, which I accept as correct, are as follows:
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. (TRED [2013] APO 57 at [34]-[35], Merial at [2013] APO 65 at [14])
The application for an extension of time
As indicated above, Gilead’s application on 30 May 2016 for an extension of time to complete its EIR was filed with a request that the additional evidence be kept confidential. The relevant parts of Gilead’s correspondence are as follows:
“Our client’s evidence in reply in the oppositions is due to be filed today. As part of that evidence, our client wishes to file certain portions of the transcript and exhibits from the deposition of one of the named inventors, Dr Amit Khatri, taken on 30 October 2015 (Khatri Material).
The purpose of this letter is to seek a direction from the Commissioner pursuant to Regulation 5.22 that the Khatri Material be treated as confidential and not made publically available. That direction is sought on the following grounds:
1. The Khatri Material has been designated as confidential by AbbVie Inc. and, as such, is subject to a Stipulated First Amended Protective Order made by Judge Sleet on 24 April 2015 in U.S. District Court Proceeding C.A. No. 13-2034-GMS (Delaware Proceeding).
2. By stipulation dated 14 January 2016 (Stipulation), AbbVie Inc. allowed our client to share the Khatri Material with its foreign counsel, including its Australian lawyers.
3. Pursuant to paragraph 3 of the Stipulation dated 14 January 2016, our client may use the Khatri Material in the present oppositions, provided that the parties each take all available steps to maintain the confidentiality of that material.
Please note that our client also relies upon Regulation 4.3(2)(a) and (b) and section 55(2)(a) of the Patents Act 1990 (Cth) in support of the direction sought in respect of the Khatri Material.
…
In light of the fact that our client’s evidence in reply is due today, our client also seeks an extension of time to file the Khatri Material (together with a statutory declaration annexing that material). That extension of time is sought in order to allow the Commissioner time to consider our client’s request. Its request for an extension of time is made under Regulation 5.9(2)(a) and (b).
The extension is sought in respect of the Khatri Material only, the balance of our client’s evidence in reply will be filed today.
In its letter, Gilead also explained that it had written to AbbVie the previous week seeking its consent to the direction for confidentiality that it sought, but it had not received consent until the day the EIR was due. Gilead also advised that it could file the Khatri Material within 3 business days of the Commissioner’s decision on the confidentiality issue.
Has the party made all reasonable efforts to comply with all relevant filing requirements?
Paragraph 5.9(2)(a)(i) requires 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, the latter being addressed by the more specific requirement of paragraph 5.9(2)(a)(ii) (Merial [2013] APO 65 at [16]). In deciding whether a party has made all reasonable efforts to comply with all relevant filing requirements, it is necessary to understand the actions that they have taken (for instance, what was done, when it was done, how it was done, by whom it was done) covering at least the period in question, and the nature of the evidence that they are preparing (TRED at [40]).
A chronology of the relevant events is apparent from the Patent Office file and the parties’ submissions, and is summarised below:
Date Actions 24 April 2015 The US District Court makes a Stipulated Protective Order with respect to the Khatri material. 23 September 2015 EIS completed by Gilead. 14 January 2016 By stipulation, AbbVie allows Gilead to share the Khatri material with its foreign counsel, including its Australia lawyers, providing that all available steps are taken by the parties to maintain its confidentiality. 24 March 2016 EIA completed by AbbVie. 29 March 2016 Gilead is notified that EIR is due 29 June 2016. 29 March - 29 May 2016 Gilead prepares evidence by 5 declarants. 24 May 2016 Gilead writes to AbbVie seeking its consent to directions by the Commissioner regarding confidentiality of the Khatri material to be filed in evidence. 25 May 2016 AbbVie’s attorneys advise that they expect their client to consent to the confidentiality direction and request a copy of Gilead’s proposed letter to the Commissioner. 26 May 2016 Gilead sends AbbVie a draft letter and requests confirmation of AbbVie’s consent to the letter being filed with IP Australia. 27 May 2016 (Friday) AbbVie advises Gilead that it is not in a position to respond that day. 30 May 2016 (Monday)
Evidence in reply due
Gilead files the majority of its evidence in reply.
AbbVie’s Australian attorneys advise Gilead that it consents to the direction for confidentiality.
Gilead requests a direction from the Commissioner that the Khatri material remain confidential and requests an extension of time in which to file the evidence.
8 June 2016 The Deputy Commissioner invokes reg 4.3(2)(b) with respect to the Khatri material, directing that it not be open to public inspection. 9 June 2016 Gilead filed the Moore declaration exhibiting the Khatri material. Consideration
Gilead filed a substantial amount of evidence within the extended period it had for filing EIS. AbbVie did not dispute, and I accept, that Gilead made all reasonable efforts to comply with the requirements for filing evidence during this earlier evidentiary period. It remains to be determined whether Gilead has made all reasonable efforts to comply with the filing requirements for EIR.
AbbVie submitted that Gilead has not made all reasonable efforts due to the unexplained delay in seeking a direction for confidentiality in order for it to be able to file the Khatri material. AbbVie submitted that Gilead had permission to share the Khatri material with its Australian lawyers and attorneys for use in the opposition proceedings so long as confidentiality measures were taken, and that Gilead did not seek consent before it filed the Khatri material in other non-US jurisdictions well before 24 May 2016. However, in view of its obligations under the US Stipulated Protective Order, I consider the caution exercised by Gilead’s attorneys in seeking AbbVie’s consent and ensuring confidentiality for the Khatri material before filing it in Australia was reasonable in the circumstances.
AbbVie further submitted that no explanation has been provided as to why, when the Khatri material was available to it on 14 January 2016, Gilead had delayed until 24 May 2016 before seeking its consent and requesting a confidentiality direction from the Commissioner. In this regard, I accept Gilead’s submission that it was not in a position to determine whether it would file the Khatri material with its reply evidence until it had received and reviewed AbbVie’s EIA, which was filed on 29 March 2016. Gilead subsequently prepared and filed 6 declarations by 5 people within the 2 month period for EIR. It was in this context that Gilead left the relatively simple task of gaining AbbVie’s consent, then requesting a confidentiality direction for the Khatri material, until 6 days before the EIR was due to be filed.
Prima facie, it was reasonable for Gilead to think that it could obtain AbbVie’s consent and the confidentiality direction within 6 days, enabling it to complete its EIR within the two month deadline. This conclusion is consistent with AbbVie’s submission that there was “very little actual work needed to be performed in order to file the Khatri material as evidence”. Although it subsequently transpired that this time frame was optimistic and more time was necessary, I am of the view that this does not detract from the reasonableness of Gilead’s conduct during the evidentiary period.
On balance, I am satisfied that Gilead took all reasonable efforts to comply with all relevant requirements for filing EIR.
Was the failure to file the evidence despite acting promptly and diligently at all times?
Relevant to the present circumstances, in Merial the Deputy Commissioner stated:
“in my view when considering whether a party has acted promptly and diligently at all times I need to consider all the actions of the party in relation to compliance with the evidentiary period”
Thus, the question of whether a party has been prompt and diligent at all times is assessed by looking at the behaviour of the party as a whole. In order to establish its promptness and diligence during the two month period for filing EIR, Gilead relied on the substantial body of evidence it had prepared and filed within this time. In this context, I have found above that it was not unreasonable for Gilead to seek AbbVie’s consent for a confidentiality direction 6 days before the deadline for filing EIR.
On 30 May 2016, the due date for EIR, AbbVie advised Gilead that it consented to the confidentiality direction. The same day, Gilead wrote to the Commissioner requesting a direction that the Khatri material be treated as confidential and not made publicly available. Gilead also requested an extension of time to file the Khatri material as evidence pending consideration of its request for confidentiality.
Considering its actions as a whole during this evidentiary period, I am of the view that Gilead’s actions have been prompt and diligent at all times in seeking to complete its EIR in time.
Were there exceptional circumstances?
In TRED at [64], the delegate stated 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”. Specific examples are those explicitly identified in subreg 5.9(5).
Applying the dictionary definition of “exceptional”, Gilead described the Khatri material as “extraordinary material” that ought, in the public interest, to be considered in the opposition. Notwithstanding, Gilead’s submissions do not establish that any matters occurred that were 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. I conclude that there are no relevant exceptional circumstances in this case.
Discretionary matters
Once the mandatory requirements of paragraphs 5.9(2)(a) or 5.9(2)(b) have been met, an extension is not automatic. The Commissioner “may” extend the period for filing evidence.
AbbVie submitted that the Commissioner should exercise her discretion to refuse the extension for two reasons. Firstly, because Gilead “did not appear to make any formal application for an extension of time” and did not pay the fee, and secondly in view of false and misleading conduct on the part of Gilead in prosecuting this matter.
Regarding Gilead’s application, earlier in this decision I have reproduced parts of Gilead’s correspondence on 30 May 2016, from which it is clear that Gilead requested an extension of time to file evidence in reply. On 31 May 2016, Gilead paid the necessary fee.
Regarding Gilead’s conduct, AbbVie submitted that its letters to the Commissioner on 30 May 2016 and 14 June 2016 “were plainly carefully worded and appear designed to mischaracterise AbbVie’s position and mislead the Commissioner”. Gilead denied this, noting that it had provided all of the correspondence that AbbVie asserts it mischaracterised such that the Commissioner can make her own assessment.
In Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2014] APO 74 at [34], the hearing officer stated:
“… where a party deliberately misleads the Commissioner in order to obtain an extension, either by explicit statement or omission, I consider that the Commissioner would be entitled to take that into account in exercising her discretion.”
In this case, I am not satisfied that Gilead has deliberately sought to mislead the Commissioner in its submissions for an extension of time to file evidence. Parties in proceedings such as this, generally provide submissions in a manner favourable to their case, and I consider Gilead’s submissions go no further than this. Therefore, I see no reason to refuse Gilead an extension of time on discretionary grounds.
Conclusion
I am satisfied that an extension of time to file evidence in reply is appropriate. Therefore, I need to consider what length of extension is reasonable in the circumstances. The Khatri material was filed on 9 June 2016. I consider it reasonable to extend the time until that date.
COSTS
Gilead has been successful in this matter. I award costs according to Schedule 8 against AbbVie Ireland Unlimited Company.
Dr B. Akhurst
Delegate of the Commissioner of Patents
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