EnGene IC Pty Ltd v Vaxiion Therapeutics, LLC

Case

[2016] APO 40

28 June 2016


IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

EnGene IC Pty Ltd v Vaxiion Therapeutics, LLC [2016] APO 40

Patent Application:                   2008201082

Title:Minicell compositions and methods

Patent Applicant:  Vaxiion Therapeutics, LLC

Opponent:  EnGene IC Pty Ltd

Delegate:  Dr S.D. Barker

Decision Date:  28 June 2016

Hearing Date:  Written Submissions completed 19 April 2016 

Catchwords:  PATENTS – Extension of time to file evidence responding to further evidence – transitional provisions – regulation 5.10 applies – nature and significance of evidence supports allowance – extension of time granted – costs awarded against the applicant

Representation:  Patent Applicant:  Fisher Adams Kelly Callinans

Opponent: Gilbert + Tobin Lawyers

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2008201082

Title:Minicell compositions and methods

Patent Applicant:  Vaxiion Therapeutics, LLC

Opponent:EnGene IC Pty Ltd

Date of Decision:  28 June 2016

DECISION

I grant EnGene IC Pty Ltd an extension of time until 11 April 2016 to file responding evidence.  I award costs according to Schedule 8 against Vaxiion Therapeutics, LLC.

REASONS FOR DECISION

Background

  1. This matter relates to patent application 2008201082 in the name of Vaxiion Therapeutics, LLC (the applicant).  A notice of opposition to the grant of the patent was filed by EnGene IC Pty Ltd (the opponent).  Further evidence was filed by the applicant on 13 August 2015 and the opponent was allowed until 11 November 2015 to file responding evidence.

  2. On 11 November 2015, the applicant was served with a notice for the production of certain documents (the documents).   The documents would form part of the responding evidence.  On 25 November 2015, an extension of time to 11 February 2016 was granted for the opponent to file responding evidence.  On 20 November 2015, the applicant filed a request to maintain confidentiality of the documents.  The documents were filed with IP Australia on 10 December 2015 and an order under regulation 4.3(2)(b) was made by the Deputy Commissioner on 11 December 2015.  On 15 December 2015, the opponent agreed to the terms of confidentiality and was provided with a redacted and unredacted version of the documents.

  3. On 21 January 2016, the opponent filed comments regarding inspection of the documents by outside experts, and suggested that the applicant had not provided all material subject of the notice to produce.  A letter indicating this was sent to the applicant on 22 January 2016 who responded on 29 January 2016.  A further letter was issued by the Commissioner on 5 February 2016 with the matter resolved on 9 February 2016.  On 11 February 2016, the opponent filed part of the evidence in response and an application for an extension of time of one month to 11 March 2016 in which to complete its evidence. The extension of time was granted on 23 February 2016.

  4. On 25 February 2016, the opponent changed its representation from Spruson & Ferguson to Gilbert + Tobin Lawyers.

  5. On 9 March 2016, the opponent filed a further request for an extension of time of one month to 11 April 2016.  The applicant filed an objection to the extension.  The parties were heard by written submissions filed on 12 April 2016 and 19 April 2016.

    The law

  6. 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.  Significantly, the Amendment Regulation altered the provisions relating to extensions of time to file evidence.  However, the start date for the various amendments to the Regulations depends on the details of the case, and it is necessary to carefully determine which provisions apply to the present case.  The transitional provisions are found in regulation 23.36 of the Regulations.  Item 2 of subregulation (2) is the relevant provision for the present matter:

    (2) The amendments of these Regulations made by the items of Part 1 of Schedule 3 to the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No. 1) apply as set out in the following table.

Transitional provisions
Item Column 1
The amendments made by:
Column 2
apply in relation to:
1
2 item 2 (new subregulations 5.9(1) to (5)) and item 9 (new item 218 of Schedule 7) an opposition proceeding commenced before 15 April 2013 in which an extension of time is requested for a period that commences on or after 15 April 2013
However:
(a) a reference in subregulation 5.9(1) to regulation 5.8 is taken to be a reference to regulation 5.8 as in force immediately before 15 April 2013; and
(b) paragraph 5.10(1)(b) and subregulation 5.10(2), as in force immediately before 15 April 2013, are taken not to apply
  1. Since the opposition commenced before 15 April 2013, item 2 applies if an extension of time is requested for a "period" that commences on or after 15 April 2013.  The period that is referred to must be understood by reference to the context, which is that this item implements the amendment to regulation 5.9 (new regulation 5.9).  The new regulation 5.9 states:

    (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.

  2. It seems clear that the "period" mentioned in item 2 is the "evidentiary period" in the new regulation 5.9.  The "evidentiary period" in new regulation 5.9 is the periods mentioned in regulation 5.8 as in force immediately before 15 April 2013 (old regulation 5.8) - see part (a) of item 2), which are the periods for filing evidence in support, evidence in answer and evidence in reply.  Old regulation 5.8 does not relate to evidentiary periods in relation to further evidence.  Thus item 2 only applies when an extension of time is requested for the filing of evidence in support, answer or reply.  Item 2 does not apply when an extension of time is requested for the filing of evidence in response to further evidence (as in the present case).

  3. It follows that part (b) of item 2 does not apply, and regulation 5.10 as in force immediately before 15 April 2013 (old regulation 5.10) continues to apply in the present case.[1]  Old regulation 5.10 relevantly states:

    [1] I came to the same conclusion in relation to evidence in response to further evidence in Dyno Nobel Inc. v Orica Explosives Technology Pty Ltd [2014] APO 42.

    (2) The Commissioner may extend the time within which the party may take a step prescribed in this Chapter (not being a step that is taken under regulation 5.3 or 5.3AA, paragraph 5.4 (a), subparagraph 5.8 (1) (a) (i) or regulation 5.9A):

    (a) on the application of a party in the approved form; and
    (b) on such reasonable terms (if any) as the Commissioner specifies; and
    (c) after the party has served a copy of the application on the other party.

    ...

    (4) The Commissioner may:

    (a) on the application of a party; and
    (b) on such reasonable terms (if any) as the Commissioner specifies;

    permit the party to serve further evidence on the other party.

    (5) The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:

    (a)    if he or she proposes to grant an application by a party – is reasonably satisfied that the other party has been notified of the application; and

    (b)   if he or she proposed to act on his or her own motion – ensures that the parties are notified of the proposed action; and

    (c)    in either case:

    (i)give the parties a reasonable opportunity to make representations concerning the application or proposed action; and

    (ii)is reasonably satisfied that a direction, an extension of time or the serving of further evidence is appropriate in all the circumstances.

  4. Old regulation 5.10(2) gives the Commissioner the power to extend the time for taking a step prescribed in Chapter 5, and further evidence is a procedure prescribed in that Chapter (being found in regulation 5.10(4)).  The Commissioner must not grant an extension unless satisfied that the parties have been notified of the application for extension (regulation 5.10(5)(b)), has given the parties a reasonable opportunity to be heard (regulation 5.10(5)(c)(i)), and is reasonably satisfied the extension is appropriate (regulation 5.10(5)(c)(ii)).  In the present case the parties have been notified and have had an opportunity to be heard.  The only remaining question is whether it is appropriate to extend the time.  The considerations relevant to this question have been considered several times by the Federal Court.[2]  In summary, the power to extend time is discretionary, so it is necessary to give genuine and proper consideration to all relevant considerations.[3]  Relevant considerations include:

    a.          The reason why the evidence was not served earlier,[4]

    b.          The public interest in determining a serious opposition on its merits,[5] and

    [2] Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; 28 IPR 243 (Ferocem), A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; 38 IPR 213 (Goninan) and National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; 50 IPR 398.

    [3] Ferocem at page 247-8, Goninan at page 220.

    [4] Ferocem at page 247.

    [5] Goninan at page 222.

    [6] Ferocem at page 247.

    c.          The interests of the parties.[6]

    The request

  5. The history of the events surrounding the present situation is summarised below:

    ·On 11 November 2015, the applicant was served with a notice to produce the documents in relation to the further evidence;

    ·On 16 December 2015, the documents were provided to the opponent subject to terms of confidentiality;

    ·On 21 January 2016, the opponent sought clarification on whether the documents could be provided to an internal expert.  The applicant responded on 29 January 2016;

    ·On 5 February 2016, a further letter was issued by the Commissioner with the matter resolved in the applicant’s response on 9 February 2016;

    ·On 11 February 2016, the opponent filed part of the evidence in response and was granted an extension of time of one month to 11 March 2016;

    ·On 25 February 2016, the opponent changed its agent from Spruson & Ferguson to Gilbert + Tobin Lawyers;  and

    ·On 9 March 2016, the opponent filed a request for an extension of time of one month to 11 April 2016.  This was opposed by the applicant on 22 March 2016.

  6. The evidence to be filed relates to a declaration by Dr Brahmbhatt.  I note that a first declaration was filed on 11 February 2016 (Brahmbhatt #1) which was confined to matters set out in the further evidence without reference to the documents.  The subject of the present extension of time request relates to a second declaration by Dr Brahmbhatt (Brahmbhatt #2) now having reference to the documents.

    Explanation of the delay

  7. The opponent submitted that the reason for the delay in filing evidence can be reasonably explained by the opponent’s change in representation from its previous attorneys Spruson & Ferguson to Gilbert+Tobin Lawyers.  On 25 February 2016, the opponent instructed Gilbert + Tobin to formally take over conduct of the opposition.  The Commissioner was notified of this change in representation on the same day.

  8. The opponent did not provide any reasoning as to the situation surrounding this change in representation.  Instead, the opponent referred to Deckers Outdoor Corporation Inc v Luda Production Pty Ltd,[7] Minnesota Mining and Manufacturing Company v Glaxo Group Limited[8] and FB Licensing[9] to support its contention that this was a satisfactory explanation of the delay.  However as the applicant has pointed out in their submissions, in all of these decisions there were specific reasons for the change in representation.  No such reasons have been provided for the present situation.  Further, it cannot be inferred that a change of attorney is of itself a satisfactory explanation in all situations.

    [7] [2009] ATMO 75; 83 IPR 409.

    [8] [2000] APO 64.

    [9] [1981] APO 1.

  9. In order to provide a complete picture, I will also cover the other issues surrounding the delay.  After further evidence was filed by the applicant, a notice to produce was served upon the applicant to provide the documents.  The documents were provided to the opponent on 16 December 2015 in a redacted and an unredacted form with the condition that access to the unredacted documents was restricted to external experts.  On 21 January 2016, the opponent requested that the applicant provide clarification as to whether the redacted documents could be provided to an internal expert.  The public availability of the redacted documents was confirmed by the applicant on 9 February 2016.

  10. As the applicant pointed out in their submissions it has not been explained why it took 36 days from when the documents were provided, to when clarification was sought by the opponent as to whether the documents could be provided to an internal expert.

  11. The opponent has provided a basic explanation of the delay.  I consider that it is a neutral consideration.

    The public interest

  12. In order to determine the public interest, it is necessary to form a view as to the nature and significance of the evidence that is being prepared.[10]  The further evidence filed by the applicant relates to matters of sufficiency, best method, utility and fair basis.  The opponent submits that the evidence to be filed (Brahmbhatt #2) relates to differences between the disclosure of the opposed application and the disclosure of the redacted documents, and that the said changes would not involve routine steps and are supported by an experiment performed by the opponent.  Although evidence by the same expert has already been filed (Brahmbhatt #1), this evidence does not take into account the redacted documents.

    [10] Goninan at page 225-6.

  13. Disagreeing with the opponent, the applicant asserts that the further evidence of 11 April 2015 was a single piece of evidence that was very focused in scope and did not unduly delay the progress of this opposition.  Additionally, the opponent has already filed further evidence provided by three experts spread out over a six month evidentiary period.  It is also noted that one of the three experts, Dr Brahmbhatt, is also the declarant of the evidence to be filed.  The applicant submits that refusal of an extension of time to file Brahmbhatt #2 would not unduly prejudice the opponent.

  14. Upon reviewing Brahmbhatt #2, I am of the view that this evidence may present a serious challenge to the opposed application.  

  15. The public interest also includes a consideration of "the expeditious disposal of matters in the Patent Office, and questions of cost, of efficiency, and of insistence upon proper professional standards being maintained by those who deal with the office".[11]  These considerations are not sufficient to offset the relevance of Brahmbhatt #2 to the ground of section 40.  I conclude that the public interest supports the extension of time.

    [11] Ferocem at page 247.

    The interest of the parties

  16. The parties made submissions that indicate they have interests that lie in different directions.  I accept their assertions, but consider that they are essentially offsetting.

    Balance of considerations

  17. The public interest supports the extension.  The interests of the parties are largely offsetting.  On balance, I find that it is appropriate to grant the extension.

    Conclusion

  18. I am satisfied that the extension of time is appropriate in all the circumstances.  I will grant the extension of time until 11 April 2016 to file responding evidence.

    Costs

  19. It is normal practice for costs to follow the event.  In the present case, I can see no reason to depart from the normal practice.  I will award costs according to Schedule 8 against the applicant.

    Dr S.D. Barker
    Delegate of the Commissioner of Patents


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