Clarus Therapeutics, Inc. v Lipocine, Inc

[2014] APO 56

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Clarus Therapeutics, Inc. v Lipocine, Inc. [2014] APO 56

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:  5 August 2014

Hearing Date:  Further submissions completed 25 July 2014.

Catchwords:  PATENTS – extension of time to file evidence in support – reg 5.9 – whether applicant has acted promptly and diligently at all times –– further evidence considered – extension of time granted.

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:  5 August July 2014

DECISION

The time for filing evidence in support is extended to 12 October 2014.

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. On 11 July 2014 I issued a decision, Clarus Therapeutics, Inc. v Lipocine, Inc. [2014] APO 50 (my previous decision), finding that the opponent Clarus Therapeutics, Inc. (Clarus) had not demonstrated that it had failed to file its evidence in support despite acting promptly and diligently at all times. Nevertheless I allowed Clarus further time to provide declaratory evidence clearly addressing the deficiencies I identified. These were:

   • 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; and
   • That it was 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.

3. Clarus filed further evidence as directed on 18 July 2014 comprising a declaration by their Australian attorney Mathew Lucas with exhibits MAL-1 to MAL-15. The patent applicant Lipocine, Inc. (Lipocine) filed its submissions in response on 25 July 2014.

   Does the evidence demonstrate that the failure to file the evidence was despite Clarus acting promptly and diligently at all times?

4. I am satisfied on the evidence that Clarus has acted promptly and diligently at all times. In this I accept that it was reasonable to approach the evidence gathering process as indicated in Mr Lucas’s declaration and that the Schedule of Events (MAL-1) indicates that the exercise was pursued with reasonable diligence. The nature of the evidence and reasons for delay in obtaining evidence from the Australian and US experts is apparent from this information.

5. I also accept that it was reasonable in the circumstances to delay further steps with the European expert until evidence to be obtained from the other experts had been clarified. This is particularly the case in light of new evidence about the engagement of the European expect.

6. Consequently I am satisfied as to the matters specified in regulation 5.9(2)(a).

   Should I exercise the Commissioner’s discretion under regulation 5.9(1) to extend the evidentiary period?

7. The evidence in support was due by 10 May 2014 or the next business day 12 May 2014 when Clarus requested the present extension of time. A full and frank disclosure of the circumstances on which the extension could be determined was only made by the evidence filed on 18 July. This has significantly protracted the resolution of this matter and more broadly of the opposition. I expect that it has also resulted in Clarus imposing on itself unnecessary cost and effort.

8. Normally I would consider such conduct to weigh heavily against the granting of the extension. However as discussed in my previous decision there are potentially mitigating circumstances which in my view required me to allow Clarus a further opportunity to file evidence supporting its case. Clarus fully complied with my direction and consequently I now find it appropriate to extend the evidentiary period. Nothing in the submissions from Lipocine convince me that I should decide otherwise.

   What length of extension in reasonable in the circumstances?

9. Having determined that an extension is justified I am required under regulation 5.9(3) to determine the length of the extended period having regard to what is reasonable in the circumstances. As a consequence of amendments filed then withdrawn by Lipocine and the potential for a stay, the delegate examining the extension request at first instance considered that a period to 12 August would be appropriate. Lipocine filed its objection and request for hearing on 4 June 2014 resulting in a period of uncertainty of approximately two months in which Clarus could not determine whether the extension would be granted. That being the case I will extend the evidentiary period to 12 October 2014.

   Conclusion

10. I am satisfied that the evidence in support was not filed in the prescribed period despite Clarus acting promptly and diligently at all times. In the circumstance set out in my previous decision I consider the Commissioner’s discretion should be exercised to extend the evidentiary period to 12 October 2014.

    P M Spann
    Deputy Commissioner of Patents