Norwood Immunology Ltd v Regeneus Pty Ltd

[2012] APO 26

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Norwood Immunology Ltd v Regeneus Pty Ltd [2012] APO 26

Patent Application:                   2009201915

Title:Therapeutic methods

Patent Applicant:  Regeneus Pty Ltd

Opponent:  Norwood Immunology Ltd

Delegate:  Dr B. Akhurst

Decision Date:  24 February 2012

Hearing Date:  By written submissions filed on 25 January 2012 and 1 February 2012

Catchwords:  PATENTS - subregulation 5.10(2) - request for an extension of time to serve evidence in reply - the balance of considerations support the extension - application granted - no award of costs

Representation:  Patent applicant:  Dr Martin O’Brien, patent attorney of Spruson & Ferguson, Sydney.

Opponent:Dr Ian Rourke, patent attorney of FB Rice, Melbourne.

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2009201915

Title:Therapeutic methods

Patent Applicant:  Regeneus Pty Ltd

Date of Decision:  24 February 2012

DECISION

I grant Norwood Immunology Ltd an extension of time until 19 March 2012 in which to serve evidence in reply.  I make no award of costs.

REASONS FOR DECISION

Background

1.   Patent application 2009201915 in the name of Regeneus Pty Ltd (‘Regeneus’) was advertised as accepted on 17 September 2009.  On 17 December 2009, Norwood Immunology Ltd (‘Norwood’) filed a notice of opposition to grant of a patent, followed by a statement of grounds and particulars on 17 March 2010. 

2.   Evidence in support was served on 17 November 2010 and evidence in answer on 19 September 2011.  Evidence in reply was due on 19 December 2011, on which date Norwood applied under regulation 5.10(2) for an extension of time until 19 March 2011 in order to serve the evidence.  Regeneus objected on 23 December 2011 and requested a hearing. 

3.   On 4 January 2012, the Commissioner advised the parties that in the circumstances an oral hearing was not required and the hearing would be based on written submissions.  Both parties were invited to file written submissions, on whether the extension of time should be allowed. 

4.   Both parties provided submissions.  Norwood’s included a statutory declaration by attorney Ian Jeffrey Rourke dated 25 January 2012.

The law on extensions of time

5.   The time for serving evidence can be extended under subregulation 5.10(2) of the Patents Regulation 1991 which provides that:

(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.

6.   The above provision must be read in conjunction with subregulation 5.10(5) which relevantly provides that:

(5) The Commissioner must not … grant an application under subregulation (2) … 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

(c) … :

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

(ii) is reasonably satisfied that … an extension of time … is appropriate in all the circumstances.

7.   I am satisfied that the applicant has been notified of the extension request, and both parties have had an opportunity to make representations. 

8.   The extension can only be granted if the Commissioner is reasonably satisfied that it is appropriate in all the circumstances.  In exercising this discretion, I am guided by the decisions of Burchett J in Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981; 28 IPR 243, Sackville J in A Goninan & Co Ltd v Commissioner of Patents [1997] FCA 424; 38 IPR 213 and Goldberg J in National Starch & Chemical Co v Commissioner of Patents [2001] FCA 33; 50 IPR 398. The general principles that flow from these decisions are as follows:

a)The power is discretionary: Regulation 5.10 confers a broad discretion, which cannot be reduced to imperative compliance with particular requirements.  It is necessary to give genuine and proper consideration to all relevant considerations. (Ferocem FCA at [11]; IPR at 247-8, Goninan IPR at 220)

b)Explanation of delay: The reasons why the evidence was not served earlier are a relevant consideration, but a satisfactory explanation is not a mandatory requirement. (Ferocem FCA at [10]; IPR at 247).

c)The public interest: The public interest in determining a serious opposition on its merits is a relevant consideration (Goninan IPR at 222). It is necessary for the Commissioner to form a view as to the nature of the evidence that is sought to be adduced, and the significance of that evidence for the opposition proceedings (Goninan IPR at 225-6). The significance of the evidence is assessed having regard to any relevant material available, not just the evidence itself (National Starch FCA at [33]; IPR at [33]). The public interest is not protected merely because some evidence has already been served (Goninan IPR at 225).

d)The interests of the parties: The interests of the party seeking the exercise of discretion are a relevant consideration (Ferocem FCA at [11]; IPR at 247). It is also relevant to consider the disadvantage to the other party of delays in determining the opposition, and the effect of delays on the efficient and orderly administration of the Patent Office. (Ferocem FCA at [11]; IPR at 247, Goninan IPR at 222).

The application for an extension of time

9.Norwood’s application is as follows:

“The circumstances in which, and the grounds upon which, this application is made are as follows:-
Following receipt of the Evidence-in-Answer, efforts were made to contact the expert who assisted the Opponent with the preparation of the Evidence-in-Support, namely Dr Rodney James Dilley.  Our efforts to contact Dr Dilley at the Bernard O’Brien Institute of Microsurgery in Melbourne were unsuccessful.  Following contact with other members of the Bernard O’Brien Institute of Microsurgery, we were advised that he had left this Institute.
We finally tracked down Dr Dilley at the Department of Surgery of the University of Western Australia.  Dr Dilley advised that he was able to assist with the preparation of the Evidence-in-Reply.  As a result, copies of all documents relating to the Opposition were forwarded to Dr Dilley at his new address in Perth.
Dr Dilley has advised that his review of the Evidence-in-Answer is progressing; however, further time is required for Dr Dilley to complete his review to enable the preparation of a Statutory Declaration to be served as at least part of the Evidence-in-Reply.”

10.In his declaration, Norwood’s attorney Dr Rourke expanded on the circumstances leading up to the extension request, as follows:

“BACKGROUND

3. On 17 September 2011 the Applicant filed its Evidence-in-Answer after seeking and obtaining extensions of time totalling seven months.  The reasons provided for these extensions included the quantum and complexity of the Opponent’s Evidence-in-Support.  The Evidence-in-Answer consisted of four declarations and 16 exhibits.  The Evidence-in-Answer included a 51 page declaration by Dr Richard Mollard which provided detailed comments on a declaration filed by Dr Rodney Dilley as part of the Evidence-in-Support and on many of the 39 prior art documents cited in the Statement of Grounds and Particulars.

4. On 20 September 2011 the Evidence-in-Answer was forwarded to Mr Peter Hansen instructing on behalf of the Opponent.  On 11 October 2011 instructions were received by phone from Mr Hansen to file Evidence-in-Reply and re-engage Dr Dilley.

5. On 11 October 2011, the Opponent filed and served an Intention to Serve Evidence-in-Reply.

6. On 11 October 2011 I tried to contact Dr Dilley by telephone to ascertain whether he was able to assist in the preparation of the Evidence-in-Reply and left a message on his answering machine for him to return my call,

7. After having not received a response from Dr Dilley, on or about 19 October 2011 I called the reception at The Bernard O'Brien Institute in Melbourne to determine if they might be able to shed light on my inability to get hold of Dr Dilley.  To my surprise I was advised that Dr Dilley had left the Institute.  I spoke with another person at The Bernard O'Brien Institute (I did not write down their name) who gave me Dr Dilley's new address in Perth.

8. On 19 October 2011 I was finally able to speak with Dr Dilley in Perth.  He agreed to assist with the Evidence-in-Reply.  I advised I would send him the relevant material and asked him to review the entire matter, particularly his declaration and the Evidence-in-Answer paying particular attention to the Mollard declaration because that document appeared to be most relevant to his declaration.  I requested Dr Dilley to provide his detailed comments regarding the Evidence-in-Answer, following which we could work together to prepare a new declaration.

9. On 24 October 2011, all documents relating to the Opposition were sent by courier to Dr Dilley.  I printed and sent all documents relating to the opposition because Dr Dilley gave the impression that because of the move to Perth he may struggle to locate the material he had previously been sent including his declaration and the many documents referred to therein.

10. On 25 October 2011 I received an Email reply from Dr Dilley stating “Documents arrived this morning, will get back to you when I have had a chance to read through in the next week.”

11. On 17 November 2011 I sent an Email to Dr Dilley enquiring about progress.

12. On 17 November 2011, I received a reply from Dr Dilley stating “Some progress in reading the Mollard section, hope to get more done through this week.”

13. On 19 December 2011 I received instructions from Mr Peter Hansen to obtain an extension to file the Evidence-in-Reply.  Considering the extension period included the Christmas, New Year and January summer school holiday season, and that comments on the Evidence-In-Answer had not yet been received from Dr Dilley, it was determined that at least a 3 month extension would be necessary.

14. On 19 December 2011 the Opponent applied for a three month extension of time to complete its Evidence-in-Reply.  This application has been objected to by the Applicant.

15. On 19 December 2011 I sent a further Email to Dr Dilley enquiring about progress.

16. On 19 December 2011, I received an Email reply from Dr Dilley stating “very busy with grant writing and papers etc.  The review is going OK, more than halfway through the Mollard part.  Lots to consider ... ”.

17. On 11 January 2012 I telephoned Dr Dilley to seek his advice as to when he expected to have completed his review of the documents.  He indicated to me that he was close to completing his review of the materials and expected to complete this process shortly.

18. On 24 January 2012 I again telephoned Dr Dilley to seek his advice as to when he expected to have completed his review of the documents.  He said to me that he is close to completing detailed written comments on at least the Mollard declaration and he would attempt to provide me with the written comments by late evening Wednesday 25 January 2012.  Once Dr Dilley has provided his comments, I will proceed as outlined above in paragraph 8.  In particular, I expect that lengthy discussions will occur between myself and Dr Dilley, following which a draft declaration will be prepared for his consideration.”

Explanation of the delay

11.Much of Regeneus’ arguments in respect of the delay were based on case law that predates and is inconsistent with the Federal Court decisions summarised above at [8]. Notwithstanding, Regeneus’ submissions were to the effect that Norwood’s application for an extension does not provided an adequate explanation of the delay in serving evidence in reply.

12.In its submissions, Regeneus pointed out that Norwood’s application was based primarily on the difficulty in contacting its expert as the reason for needing the extension.  Regeneus submitted that this difficulty does not constitute special circumstances that would warrant exercise of the Commissioner’s discretion, noting that it had been able to quickly and easily determine Dr Dilley’s whereabouts, simply by using the internet and making enquiries by phone.  Regeneus’ contention that the application does not adequately explain the delay is supported by Dr Rourke’s declaration which establishes that he was able to contact Dr Dilley within 8 days of first attempting to do so. 

13.Regeneus noted that Norwood did not attempt to contact their expert until 3 weeks after the evidence in answer was served and a follow-up phone call was not made until 8 days after that.  As a result, Regeneus submitted that the delay in the evidence process appeared to be due to delays in attempting to contact the expert rather than the difficulties experienced in doing so.

14.Regeneus’ concerns as to the adequacy of the information in Norwood’s application for an extension appear justified.  However, Norwood has now in its submissions for the hearing provided additional information in respect of the delay. 

15.In its submissions, Norwood claims that it has made significant progress in preparing the evidence in reply with little, if any, delay.  It noted that the evidence in answer was substantial and complex, consisting of four declarations (one being a 51 page declaration) and 16 exhibits.  Summarising Dr Rourke’s declaration, Norwood initially spent 3 weeks reviewing the evidence in answer before providing instructions to prepare and file evidence in reply by Dr Dilley.  Then, after an 8 day delay in contacting their expert, Dr Dilley received the documents 6 days later on 25 October 2011.  Norwood claims that, despite having been busy with his work activities, Dr Dilley has made substantial progress in reviewing the documents and providing detailed written comments.  As at 25 January 2011 Dr Rourke expects Dr Dilley to complete his review of the evidence in answer shortly, following which his declaration will be prepared.

16.There is a substantial amount of evidence in answer to be considered and I believe there is a degree of complexity such that the time taken by Norwood to review it, and the time taken by Dr Dilley to consider the evidence, has not been unreasonable.  I am satisfied that in its submissions for the hearing, Norwood has provided a reasonable explanation of the delay.  

The public interest

17.In determining the public interest, the expeditious disposal of the opposition by the Patent Office must be balanced with the need to determine a serious opposition on its merits.  The latter consideration is assessed by considering the nature and significance of the evidence that will be served (Goninan IPR at 225-6).

18.Regeneus submitted that Norwood’s actions were not consistent with a serious opposition in that Norwood has not kept up-to-date contact details for their expert witness and they have not been diligent in preparing the evidence in reply.  However, I have found above at [16] that Norwood’s have adequately explained the delay in serving the evidence in answer.  Furthermore, as it was not anticipating Dr Dilley’s move to WA, I see no reason why Norwood should have sought his contact details earlier.

19.In order to demonstrate that a serious opposition is underway, Norwood pointed to its statement of grounds and particulars and evidence in support.  Norwood’s statement as amended on 20 September 2010, particularises 40 documents under the grounds of novelty and inventive step, and its evidence in support consists of 3 declarations and 43 exhibits.  Prima facie, a serious opposition is in train.

20.Regeneus argued that Norwood has not explicitly explained the evidence to be filed and as a result the Commissioner cannot determine its nature and significance.  However, Norwood has  indicated Dr Dilley’s evidence will respond to the assertions and criticisms made by Regeneus’ witnesses, particularly that of Dr Mollard, and will comment on the design and experimental data described in two other declarations filed as evidence in answer.  Prima facie, the evidence in preparation will be important in the opposition and would contribute to a more just and correct outcome of the opposition.

21.   I am satisfied that the public interest supports the extension of time in this case.

The interests of the parties

22.Norwood submitted that if the extension were not allowed, it would be significantly disadvantaged in having no evidence to challenge or properly qualify Regeneus’ evidence in answer.  Consequently, Norwood has a strong interest in their application being allowed.

23.Regeneus submitted that it is a small Australian biotechnology company seeking timely and appropriate IP protection and it has expeditiously prosecuted this application, gaining acceptance only 4 months after the filing date.  Regeneus is concerned that the opposition process to date has delayed grant of its patent by more than 2 years, and if the extension request is allowed, this will result in further delay.  Clearly, Regeneus’ interests are against allowing the extension.

24.As is usual in proceedings of this type, the interests of the parties lie in opposing directions and are largely offsetting.  The Patent Office has an interest in the orderly processing of oppositions.

The balance of considerations

25.The power to grant an extension of time under regulation 5.10(2) is discretionary.  In exercising this discretion, I am mindful of the provisions of regulation 5.10(5)(c)(ii) which states that the Commissioner must not grant an extension of time unless reasonably satisfied that the extension is appropriate in all circumstances.

26.In this case, Norwood has provided a reasonable explanation of the delay.  The public interest supports allowing the extension, and the interests of the parties are largely offsetting.  On balance, I consider it appropriate in the circumstances to grant the application for an extension of time.

Conclusion

27.I am satisfied that the extension of time is appropriate in all the circumstances.  I grant Norwood an extension of time until 19 March 2012 to serve evidence in reply.

Costs

28.Regeneus sought costs in this proceeding, while Norwood submitted that costs should follow the event. 

29.Although Norwood has been successful, its application did not adequately explain the delay and did not fully support its request for an extension of time.  On this basis Regeneus was justified in commencing its objection to the extension of time.  Norwood has been successful because it provided the missing information in its submissions for the hearing, after Regeneus objected.  In these circumstances, I consider it appropriate to make no award of costs.

Dr B. Akhurst
Delegate of the Commissioner of Patents