Clarus Therapeutics, Inc. v Lipocine, Inc

[2014] APO 50

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Clarus Therapeutics, Inc. v Lipocine, Inc. [2014] APO 50

Patent Application:                   2010203457

Title:Steroidal Compositions

Patent Applicant:  Lipocine, Inc.

Opponent:  Clarus Therapeutics, Inc.

Hearing Officer:  P M Spann, Deputy Commissioner of Patents

Decision Date:  11 July 2014

Hearing Date:  Written submission completed 18 June 2014.

Catchwords:  PATENTS – extension of time to file evidence in support – reg 5.9 – whether applicant has acted promptly and diligently at all times –– extension not sufficiently justified – further opportunity to support request.

Representation:  Patent applicant: Davies Collison Cave

Opponent:FB Rice

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2010203457

Title:Steroidal Compositions

Patent Applicant:  Lipocine, Inc.

Opponent:  Clarus Therapeutics, Inc.

Date of Decision:  11 July 2014

DECISION

The requested extension of time to file evidence in support is not sufficiently justified. Clarus Therapeutics, Inc. is allowed seven (7) days from the date of this decision to provide declaratory evidence clearly addressing the deficiencies identified together with any supporting submissions.

Lipocine, Inc. is allowed seven (7) days from the filing of the evidence and submissions (if any) to file submissions in response.

REASONS FOR DECISION

1. This matter concerns a request for an extension of time to file evidence in support and is determined under regulation 5.9 of the Patents Regulations as amended on 15 April 2013 by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1).

   Background

2. Patent application 2010203457 was filed by Lipocine, Inc. (Lipocine) on 8 January 2010 as PCT/US2010/020538.  The application was advertised as accepted on 8 August 2013 and a notice of opposition to the grant of a patent was filed in the name of Clarus Therapeutics, Inc. (Clarus) on 8 November 2013. A statement of grounds and particulars was filed on 10 February 2014 and consequently the period provided under regulation 5.8 (1) for the filing of evidence in support ended on 10 May 2014 although, being a Saturday, under s222A the evidence could be filed on the next business day, 12 May.  

3. Lipocine on 8 May 2014 filed a request for further and better particulars then, on the following day, a request to amend the claims of the complete specification. On 12 May 2013 Clarus filed declarations by Williams and Constantinides and further requested an extension of time for filing evidence in support of two months to 12 July 2014. The request cites the need to obtain further evidence from the Australian expert (Williams), the US expert (Constantinides) and a European expert. In relation to the European expert, the request states that discussions have taken place but that further time was required to finalise the declaration.

4. On 13 May 2014 a delegate of the Commissioner provided the parties with a proposed direction for further and better particulars. On the same date he requested further information in relation to the extension of time request and whether the opponent had been prompt and diligent. On 15 May further information was provided in the form of a list of actions said to have been taken by Clarus’ attorneys. The delegate was not satisfied and on 19 May 2014 issued a letter indicating an intention to refuse the extension subject to a request to be heard. 

5. On 20 May 2014 Clarus filed further supplementary information supporting the extension of time and also requested a stay of the proceedings based on Lipocine’s proposed amendments. On 22 May the delegate proposed a direction to stay the proceedings but the following day Lipocine requested that its proposed amendments be withdrawn. The stay was therefore not granted and on 28 May the delegate again advised of his intention to refuse the extension of time request, not being satisfied with information provided on the obtaining of evidence from the European expert. The same day Clarus provided further information and, on the basis of delays in resolving the question of a stay, requested a further month’s extension to 12 August 2014. On 29 May 2014 the delegate issued a letter indicating his intention to grant the extension subject to a request to be heard.

6. Lipocine filed its objection and request for hearing on 4 June 2014 and the Commissioner determined to hear the parties by written submissions. These were completed on 18 June when Clarus informed the Commissioner that it would not file further submissions. No further evidence in support has been filed.

7. On 16 June Clarus filed an amended statement of grounds and particulars partially to address the issues raised by the request for further and better particulars.

   The law

8. As the opposition was filed after 15 April 2013, this request is to be determined under regulation 5.9 as amended on 15 April 2013 by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1).

9. Subregulation 5.9(1) gives the Commissioner the power to extend the evidentiary time periods:

   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.

10. The power to extend time is discretionary, as evidenced by the use of the word "may".  This power is qualified by subregulation 5.9(2), which 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.

11. 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.

12. Consequently the relevant questions are :

    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?

13. I can extend the time for filing evidence only if I am satisfied that the answer to questions i and ii is YES, or if I am satisfied that the answer to question iii is YES.  If I am so satisfied, then I must consider whether there are any discretionary reasons why the extension should not be granted.

14. In considering the legislation I further note that the Explanatory Statement accompanying the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1) states at page 19 that:

    “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”

    The request

15. The circumstances relevant to efforts by Clarus to file evidence in support within the statutory period, to the extent discernible from the information available, can be summarised as follows:

    a)The statement of grounds and particulars was filed on 10 February 2014.

    b)Work with the US expert commenced before the statement of grounds and particulars and that during February 2014 discussions with that expert also included that evidence should be obtained from Australian and European experts.  It appears an Australian expert was contacted first on 24 February 2014 and the European expert on 28 March. The US expert appears to have been central to the opponent’s evidence gathering, for example, being responsible for reviewing the Australian expert’s evidence

    c)In relation to the European expert there appears to have been some difficulty in making time for telephone conferences due to unanswered calls and the conference finally occurred on 11 April. Tasks were allocated and follow up contacts were made during early May. Ultimately however a telephone conference was cancelled on 15 May 2014 because of Lipocine’s proposed amendments. At this time the expert apologised for lack of response explaining that emails sent from Opponent were being redirected to junk mail.

    d)Part evidence in support (Williams and Constantinides ) was filed on 12 May 2014 together with a request for a two months extension later extended to three months.

    e)Further time is requested to:

    ·obtain a further declaration from the Australian expert "for a full understanding of the lack of inventive step"

    ·obtain a further declaration from the US expert who has already provided evidence of experimental results

    ·finalise a declaration by the European expert

    Has Clarus made all reasonable efforts to comply with all relevant filing requirements?

16. It is clear 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 support, which is addressed by the more specific requirement of paragraph 5.9(2)(a)(ii).

17. Lipocine submit generally that no evidence is given as to actions before the filing of the statement of grounds and particulars and, in relation to the European expert, that no timeframes for the completion of tasks was set. These points go to whether Clarus was prompt and diligent in relation to the preparation of evidence in support and not whether there have been reasonable efforts to meet other filing requirements.

18. An issue that does appear relevant is effort by Clarus to comply with the requirement to file a statement of grounds and particulars. If a defective statement was filed requiring subsequent directions for further and better particulars, even if done within the statutory time, then this might indicate that reasonable efforts had not been made to meet a filing requirement. In the present case however the defects in the statement raised by Lipocine and potentially resolved by proposed amendments to the statement are relatively minor. Furthermore the addition of new items of prior art are explained as having come to the attention of the opponent through proceedings in the United States. Thus I am not in a position to say that Clarus has not made all reasonable efforts to comply with the requirement for filing the statement of grounds and particulars.

19. Consequently, I consider the requirement of 5.9(2)(a)(i) to be met in relation to filing requirements other than the filing of evidence in support. If I find that Clarus has been prompt and diligent in relation to the evidence in support it will also have made all reasonable efforts and therefore I do not need to consider further whether Clarus has made all reasonable efforts to comply with all relevant filing requirements.

    Was the failure to file the evidence despite acting promptly and diligently at all times?

20. The delegate in Fugro Airborne Surveys Corp v Geotech Airborne Limited [2014] APO 23 stated that:

    “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.”

21. Clarus on three occasions has provided lists of actions and dates which it says demonstrates its prompt and diligent action. Largely the actions referred to are merely of the nature “contact with US expert”. What is missing is a narrative that puts those actions into context. For example, that explains the objective of the evidence gathering activities to the extent that efforts toward and failure to achieve that result can be understood. In not providing this Clarus appears to be expecting the Commissioner to read between the lines and potentially does not appreciate that it bears the onus of satisfying the Commissioner.

22. Without further information I must agree with Lipocine that while there are details as to contacts with the experts "there is no detail as to the connection between that contact and the progression of the completion of the evidence".

23. The situation can be contrasted to that in Osmose New Zealand v Zelam Limited [2014] APO 49 where, while a list of actions or chronology was found to support the granting of an extension, the list and the request provided substantive additional information on the nature of the evidence being sought and the effort that had been undertaken.

24. The particular deficiencies in the case made by Clarus are in my view, firstly, a lack of information about the evidence to be obtained from the Australian and US experts in an extended period, what efforts were made to obtain that evidence so that it could be filed within the statutory period and the reasons it could not be obtained.

25. Secondly while it is apparent that there have been difficulties communicating with the European expert, it is not apparent why selection of a European expert was discussed with the US expert on 20 February 2014 but first contact was only made on 28 March.

26. Consequently I am not satisfied that the failure of Clarus to file all its evidence in support within the statutory period was despite acting promptly and diligently at all times.

    Were there exceptional circumstances that warrant the extension?

27. No exceptional circumstances were relied on by Clarus or otherwise are apparent that would justify the extension of time.

    Should Clarus be allowed any further time in which to support its request for an extension of time?

28. In its submissions Clarus states that the delegate was satisfied that its previous submissions justified the granting of the extension and that “having previously fulfilled the criteria for obtaining an extension to file evidence in support, the opponent does not consider it necessary to make submissions to further substantiate the request”. It further states “Nevertheless, the opponent reserves the right to be heard should the decision of [sic] the extension request be reversed”.

29. These submissions are misguided. Firstly it should be clear that the delegate in his letter of 29 May 2014, while expressing his opinion that the extension could be granted in the absence of objection, was not granting the extension. Indeed the highlighted note in the letter states that the extension can be opposed and the extension will not be granted until the objection period has expired and any objection determined. In considering the objection I am deciding for the first time whether the extension should be granted or refused. I am not bound by the views of the delegate and I am in no way reversing a decision made by him.

30. Secondly, Clarus had three opportunities to file information to satisfy the Commissioner and then, following the filing of an objection, was on 5 June 2014 invited to be heard in a reasonable period by way of written submissions. To suggest that it has some further right to be heard or to provide submissions is optimistic to say the least.

31. Nevertheless I consider that in this case there is a risk that the delegate’s communication with the attorney for Clarus may not have given sufficiently clear direction particularly in an environment where the Commissioner’s practices in relation to regulation 5.9 are still developing and are unfamiliar to members of the patent attorney profession. As a result it may have been able to file satisfactory evidence at an earlier date.

32. Consequently, I will allow Clarus seven (7) days from the date of this decision to provide declaratory evidence clearly addressing the particular issues identified above together with any supporting submissions. If evidence is not filed to my satisfaction I will refuse the extension of time.

33. It should be understood that further opportunities of this nature will not be given in normal circumstances. Parties seeking extensions of time are required to file comprehensive evidence at the time of their request and will at best be given one further opportunity if the delegate first considering the request identifies deficiencies that are capable of rectification. The need for extension of time requests to be promptly considered and determined should be readily apparent noting the public interest in the prompt conclusion of opposition proceedings.

34. Conversely, a failure to promptly provide evidence fully supporting a request for an extension of time risks refusal including on discretionary grounds.

    Conclusion

35. I am not satisfied that the evidence in support was not filed in the prescribed period despite Clarus acting promptly and diligently at all times. However in the circumstances of this case I am prepared to allow Clarus seven (7) days from the date of this decision to provide declaratory evidence clearly addressing the deficiencies I have identified above together with any supporting submissions. If not I will refuse the request.

36. I will further direct that Lipocine has seven (7) days from the filing of that material to file submissions in response.

    Costs

37. I award costs in accordance with Schedule 8 of the Patents Regulations against the opponent Clarus. While I have been prepared allow Clarus further time to satisfy me that an extension should be granted I have found that the extension is clearly not justified on the information previously provided and Lipocine’s objection is successful.

    P M Spann
    Deputy Commissioner of Patents