Warner-Lambert Company v Dynogen Pharmaceuticals, Inc

Case •

[2007] APO 34

•

2 October 2007

ABSTRACTS OF DECISIONS

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application  :          No.  779262 in the name of Warner-Lambert Company

Title:          Method for the Treatment of Incontinence

Action:          Request by Warner-Lambert Company for an Official Direction under Regulation 5.10(1) to file Evidence in Answer and an objection thereto by Dynogen Pharmaceuticals, Inc.

Decision:          Issued 2 October 2007.

Abstract

The applicant has sought a direction by the Commissioner under regulation 5.10(1) to extend the time for service of evidence in answer to one month after the final allowance or refusal of the request to amend.

The present opposition is unusual in that the evidence in support has focussed on section 40 issues and the opponent has stressed the importance of these grounds to their case.  As a consequence any amendments addressing such issues can only be viewed as being non-trivial in the context of the evidence to be adduced.  Evidence in relation to these section 40 matters will also be significant in the context of the opposition being pursued.

The interests of the parties are not entirely at odds.  A prima facie consideration of the evidence suggests that the nature of the amendments is such that they are likely to have a significant effect on the type of evidence that needs to be adduced.  If this is indeed the case then the parties should be able to focus on the key issues of dispute in the substantive hearing, thereby ensuring a more efficient evidentiary process and hearing.  The time taken to file the proposed amendments does appear excessive, but a satisfactory explanation has been provided for the delay.

On balance the direction sought has been considered appropriate under all the circumstances.

Both parties submitted that costs should follow the result, but the opponent further submitted that in view of “the dilatory approach of the applicant to the present proceedings and the consequent offence to the public and private interests in an expeditious manner” the opponent should be awarded costs if their submissions were successful in any of these issues.  As the opponent has been unsuccessful in this regard costs in accordance with Schedule 8 have been against the opponent.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 779262 by Warner-Lambert Company and Request by Warner-Lambert Company for an Official Direction under Regulation 5.10(1) to file Evidence in Answer and an objection thereto by Dynogen Pharmaceuticals, Inc.

BACKGROUND

  1. Patent application 779262 for an invention titled “Method for the Treatment of Incontinence” was filed on 17 January 2000 in the name of Warner-Lambert Company (hereinafter referred to as the applicant).  The application was advertised accepted on 13 January 2005, and a notice of opposition was filed on 13 April 2005 by Dynogen Pharmaceuticals Inc. (hereinafter the opponent).  A Statement of Grounds and Particulars (SGP) was served on 13 July 2005 which set out grounds of opposition under manner of manufacture, novelty, inventive step, best method of performance, clarity and fair basis.  Part evidence in support (EIS) was served on 21 October 2005 and 5 January 2006, and following two extensions of time (13 April 2006 and 13 July 2006) EIS was completed on 17 May 2006 without additional evidence being served.

  2. The applicant sought, and was granted, 5 extensions to file evidence in answer (EIA).  The most recent of these extends the time to serve EIA until 17 October 2007.  None of the extensions were opposed, but the opponent provided comments in relation to the fourth extension request.

  3. On 6 July 2007 the applicant filed a request to amend the specification under Section 104.  On the same day they also requested an official direction by the Commissioner under regulation 5.10(1) to extend the time for service of EIA to one month after the final allowance or refusal of the request to amend.  The opponent objected to this request on 25 July 2007.

  4. The hearing was held in Canberra on 4 September 2007.  The applicant was represented by Dr Linda Govenlock and Ms Shahnaz Irani of Spruson & Ferguson.  The opponent was represented by Dr Thomas Boyce and Mr Lars Koch of Pizzeys.

    Relevant Law

  5. Regulation 5.10(1) allows the Commissioner to make directions in relation to the conduct of opposition proceedings under Chapter 5 of the Act.  This includes “stopping the clock” for filing evidence in answer where a request to amend the specification has been filed.  This power is subject to subregulation 5.10(5) which sets out that the Commissioner must be satisfied that the direction “is appropriate in all the circumstances”.  The law relating to regulation 5.10 has been thoroughly considered in Ferocem Pty Ltd v Commissioner of Patents (1994) 28 IPR 243 and A Goninan & Co Ltd v Commissioner of Patents (1997) 38 IPR 213 which set out that regulation 5.10 confers a broad discretion that cannot be reduced to imperative compliance with particular requirements. On the contrary, it is necessary to give proper, genuine and realistic consideration to all relevant aspects of the case.

  6. Some guidance on relevant considerations in relation to the application of Regulation 5.10 are provided by the following decisions:

    • An extension should only be granted if the amendments are non-trivial, and it is inappropriate for the applicant to unnecessarily protract opposition proceedings by filing trivial amendments [Stena Rederi Aktiebolag v Danyard A/S (1996) 34 IPR 111]
    • However even if the amendments are non-trivial a direction may not be appropriate if there has been an excessive delay in filing the request to amend [Exxon Chemical Patents Inc v Lubrizol Corporation (1998) 41 IPR 126].
    • Whether a proposed amendment will expedite the opposition may be a relevant consideration, but not where there is marked disagreement between the parties as to the likelihood of the amendments leading to a resolution of the opposition [Exxon Chemical Patents Inc v Lubrizol Corporation (supra)].
    • Proceedings before the Commissioner should be conducted in an efficient and expeditious manner (Genetics Institute v Kirin Amgen Inc. 44 IPR 257).
    • Applicants may be put to unnecessary time and expense in preparing what may well prove to irrelevant evidence if they were required to file evidence in answer without being certain of the final form of the amendments, and in such cases it may be appropriate to stay matters pending the determination of amendments (University of Georgia Research Foundation Inc v BioChem Pharma [2001] FCA 688).

  7. The delegate in Affymax Technologies N. V. v Diversa Corporation [2001] APO 52 reviewed these decisions and articulated a number of key factors to be considered when determining requests under Regulation 5.10. These were further elaborated recently by the delegate in Wm. Wrigley Jr. Company v Cadbury Schweppes Pty Ltd [2007] APO 8 to comprise the following:

    • the nature of the amendments;
    • whether there were any undue delays in proposing (or processing) the amendments. 
    • the interests of the parties, including the expeditious disposal of proceedings before the Commissioner;
    • the nature and significance of the evidence to be served by the applicant.   

    I will consider each of these in turn below.

    Nature of the Amendments

  8. A consideration in such requests is whether or not the amendments are non-trivial in the sense that they are likely to have a significant effect on the evidence required in the main opposition [Affymax (supra)].  Despite making substantial submissions in relation to the amendments not overcoming the grounds of opposition, the opponent cautioned against a predetermination of the substantive matters of the opposition and consequential prejudice of Dynogen’s case.  They particularly argued that:

    “Warner-Lambert invites the Commissioner to determine the merits of the amendments in advance of, and independently of proper examination and opposition proceedings (if any).  Acceptance of this invitation would prejudge substantive grounds of opposition and thereby prejudice Dynogen’s case…if a stay is granted, it must be made clear that it is not justified by any agreement or inference that the proposed amendments would substantively resolve the opposition.”

  1. I agree that any consideration under Regulation 5.10 does not require the evidence to be scrutinized in the same way as would occur at a hearing on the merits, but it does not preclude any consideration of the evidence and amendments.  Rather, I need only form a prima facie view of the evidence and whether the nature of the amendments is likely to result in a significant difference in the evidence to be adduced.  In any case the “merits” of the amendments is not under consideration here.  Consideration of the amendments by the Commissioner will be dealt with in examination, and will only consider the allowability of the amendments and not whether they overcome any issues under opposition.  Pursuant to that consideration, the opponent has been given the opportunity to make comments and may oppose the amendments if they wish.

  2. As noted above, the SGP set out grounds of opposition under manner of manufacture, novelty, inventive step, best method of performance, clarity and fair basis.  A single prior art document: the Physician’s Desk Reference entry for Neurotonin® (Gabapentin Capsules), pages 2110 et seq, January 1997 (hereinafter D1); was particularised under the grounds of novelty and inventive step. The evidence in support comprises declarations by Dr Karl Thor and Dr Kate Moore.  A third declaration by Dr Boyce entered D1 into evidence.  A prima facie consideration of these declarations suggests that only section 40 issues are addressed by the experts, an assessment which was not disputed by the parties.  This is highly unusual in an opposition, and when questioned at hearing the opponent submitted that despite the absence of evidence they were not abandoning the grounds of novelty and inventive step.  I acknowledge that even though this document has not been discussed by the experts it will be available for consideration at hearing.  However as an aside I note that the absence of evidence in relation to D1, or indeed in relation to the common general knowledge in the art, means that any subsequent consideration of novelty and inventive step can be made only on the face of the document. 

  3. The proposed amendments may be summarized as follows.  The applicant’s comments in relation to which aspects of the evidence in support are addressed by the amendments are also given:

    1. Pages 3 to 5 are amended to correct minor typographical errors and revise the consistory statements to maintain consistency with the claims.
    2. A brief description of new Figures 1 and 2 has been inserted on new page 5.
    3. Definitions of urge urinary incontinence, stress urinary incontinence and mixed urinary incontinence, as known in the art at the priority date, have been inserted on new page 6.  (This is relevant to paragraph 15 of the Moore declaration).
    4. The biological mechanisms associated with urge, stress and mixed urinary incontinence have been further elucidated in new page 6a.  (This is relevant to paragraphs 21-23 of the Moore declaration and paragraphs 24-28 of the Thor declaration).
    5. New Examples 1 and 2 have been inserted which provide in vivo data for Gabapentin and Pregabalin.  New Figures 1 and 2 which are associated with these examples have also been inserted.  (This is relevant to paragraphs 30-32 of the Thor declaration and paragraph 25 of the Moore declaration).
    6. Some changes have been made to the wording of independent claims 1, 7, 13 and 17. (This is relevant to Ground 2 of the SGP).
    7. New claims 2, 3, 8, 9, 14 to 16 and 18 to 20 have been inserted and specify the type of urinary incontinence to be treated.  (This is relevant to paragraphs 27 and 29 of the Moore declaration, and paragraphs 22-23 of the Thor declaration).
    8. Former Claim 11, an omnibus claim directed to the previously absent examples, has been deleted.  (This is relevant to Ground 2 of the SGP).

  4. The applicant submitted in their request that the direction was appropriate in that:

    “The proposed amendment is substantive and has been proposed by the Applicant in order to address what the Opponent alleges to be deficiencies in the patent specification.”

  5. The opponent disputed the applicant’s submissions, arguing that the amendments did not overcome all grounds of opposition given in the SGP and that it was therefore unlikely that they would overcome the opposition.  I do not find the opponent’s submissions in this regard persuasive since evidence in answer should be limited to matters that are responsive to the evidence in support.  The key consideration is therefore whether the amendments are trivial in the sense that they address some or all of the matters raised in the evidence in support and significantly change the evidence to be adduced.

  6. Referring to the summary of amendments given above, items (iii) to (v) (to the description), and (vii) (to the claims) have been proposed in response to the evidence in support.  The amendment referred to in item (vii) inserts new claims 2, 3, 8, 9, 14 to 16 and 18 to 20 which are dependent on Claims 1, 7, 13 and 17 and further specify the type of urinary incontinence defined in these independent claims.  With the exception of some minor clarifications, the scope of the independent claims remains substantially unchanged and the proposed changes would be unlikely to significantly affect the evidence to be adduced (Solstice Neurosciences, Inc v Allergan Inc. [2006] APO 2). Accordingly, even though the amendments are intended to address clarity issues raised in the evidence in support and SGP, I consider these amendments are relatively trivial.

  7. The proposed amendments to the description referred to in points (iii) to (v) are intended to address issues of full description and best method of performance that were raised in evidence in support.  Such deficiencies can be rectified by amendment at any time up to grant subject only to compliance with the requirements for amendments (Eli Lilly v Pfizer Overseas Pharmaceuticals [2005] FCAFC 224). To this end the proposed amendment inserts two new examples and a brief description of the various types of urinary incontinence. In the ordinary course of a hearing such section 40 matters might be considered of lesser significance in evidence than matters related to novelty and inventive step. However, in the present case section 40 matters are essentially the sole focus of the evidence in support, and at hearing the opponent stressed the importance of these grounds in their case. As a consequence I consider that any amendments addressing such issues can only be viewed as being non-trivial in the context of the evidence to be adduced.

    Were there any undue delays in proposing the amendments?

  8. The onus lies with the applicant to justify the need for the direction, including an explanation of any delay in filing amendments [Exxon Chemical Patents Inc v Lubrizol Corporation, (supra)].  However while this may be a relevant consideration, a satisfactory explanation is not a mandatory requirement under Reg. 5.10 (Ferocem at IPR 247).  In the present case the amendment was filed about 14 months after the completion of evidence in support.  The opponent claimed that the amendments to the claims were trivial in nature and noted that Example 1 as proposed to be inserted was available to the applicant well before the opposition commenced.  I was referred to a document dated 6 September 2004 which was filed in the corresponding application before the European Patent Office (Exhibit A) and gave the experimental details of proposed Example 1.  However, the applicants noted that the proposed amendments inserted a new example which was not described in Exhibit A and the opponent’s submissions did not fully set out the situation in this regard. 

  1. The opponent further argued that the need to amend was clear at least as early as receipt of the SGP, or at the latest as of the service of evidence in support.  Under the circumstances they claimed that the proposed amendments should have been made much earlier.  The applicant disputed these submissions, noting that they needed to know the full case against them, inclusive of a detailed review of the expert evidence, before a proper assessment of the weight of submissions and nature of the opposition could be made.  They argued that rather than protract the proceedings, the applicant had “instead filed a single substantive amendment at the earliest time achievable in an effort to expedite, if not resolve, the substantive ground in the opposition,” and provided a detailed chronology of their activities since evidence in support was completed.  It is clear from that chronology that the applicant has pursued a strategy of addressing the opponent’s evidence by amendment and there have been a number of meetings and communications with an expert and with the applicant in this regard.  However the opponent argued that an assessment of diligence was not an assessment of activity, and delays in filing the amendments could be seen as being a lack of diligence on the part of the applicant.        

  2. I am sympathetic to the concerns of the opponent as the time taken to prepare relatively straightforward amendments does seem excessive.  In particular, a draft amendment was first sent to the applicant on 27 September 2006, but it took a further 10 months to finalise the amendments and Sprusons was provided with additional material to consider as late as May 2007.  However, the delay was primarily the result of a number of changes in the in-house counsel for the applicant which necessitated several briefings on the application and status of the opposition.  I also note that an expert was engaged early in the process and has provided advice on the draft amendments throughout the process.  Such actions are consistent with a serious defence of the application and a clear intention to overcome the issues raised in the evidence in support by amendment.  On balance I consider that the applicant has provided a satisfactory explanation of the delay in filing the amendments.

    The interests of the parties

  3. The interests of the opponent lie in having the opposition dealt with expeditiously, and as a consequence lie against allowing the extension.  The interests of the applicant lie in gaining time to prepare a defence against the opposition without spending time and expense on evidence that may be irrelevant as a result of the amendments.  The public interest calls for a balance between the requirements that the Commissioner deal with opposition matters expeditiously and economically and that a serious opposition is dealt with on its merits [Ferocem (supra) and Goninan (supra)]. 

  1. In the present case these competing interests are not entirely at odds.  A prima facie consideration of the evidence suggests that the nature of the amendments is such that they are likely to have a significant effect on the type of evidence that needs to be adduced.  If this is indeed the case then the parties should be able to focus on the key issues of dispute in the substantive hearing, thereby ensuring a more efficient evidentiary process and hearing [Affymax (supra)].  On balance, I consider that it is in the interests of all parties to finalise the amendments before continuing with the evidence. 

    The nature and significance of the evidence

  2. The public interest in determining a serious opposition on its merits is a relevant consideration.  In order to consider this, the Commissioner must form a view as to the nature of the evidence that is sought to adduce and the significance of that evidence for the opposition proceedings [Goninan (supra)].  In forming this view, the significance of the evidence to be adduced is assessed in the context of the opposition and a prima facie view of the evidence in support, rather than being an assessment of the merits of the opponent’s case. 

  1. The applicant submitted that the central issue for consideration by their expert related to non-compliance with Section 40. At hearing they stated that while they have pursued a strategy of overcoming the substantive matters raised in the evidence in support by amendment, they have also progressed the preparation of evidence in answer.  The opponent highlighted the involvement of the expert during the formulation of the amendments, and argued that as a consequence of that involvement the applicant had evidence at hand in relation to the amended specification.  They did not address the significance of the amendments to the description, instead concentrating on the amendments to the claims which they asserted would have no substantive effect on the evidence to be adduced.

  2. The circumstances of the present opposition are unusual in that the evidence in support has focussed on section 40 issues, so evidence in relation to these matters will be significant in the context of the opposition being pursued.  Moreover, the amendments proposed by the applicant are likely to impact on the evidence in answer, and indeed it could be argued that the amendments might obviate the need for any evidence in answer.  On balance I am satisfied that the nature and significance of the evidence to be adduced justifies the direction sought. 

    CONCLUSION

  3. The applicant has sought a direction by the Commissioner under regulation 5.10(1) to extend the time for service of evidence in answer to one month after the final allowance or refusal of the request to amend.

  1. The present opposition is unusual in that the evidence in support has focussed on section 40 issues and the opponent has stressed the importance of these grounds to their case.  As a consequence I consider that any amendments addressing such issues can only be viewed as being non-trivial in the context of the evidence to be adduced.  Evidence in relation to these section 40 matters will also be significant in the context of the opposition being pursued.  

  2. The interests of the parties are not entirely at odds.  A prima facie consideration of the evidence suggests that the nature of the amendments is such that they are likely to have a significant effect on the type of evidence that needs to be adduced.  If this is indeed the case then the parties should be able to focus on the key issues of dispute in the substantive hearing, thereby ensuring a more efficient evidentiary process and hearing.

  3. The time taken to file the proposed amendments does appear excessive, but I am satisfied that a satisfactory explanation has been provided for the delay.

  1. On balance I consider that the direction sought is appropriate under all the circumstances.  I therefore intend to make the following direction:

    “The time for serving evidence in answer will expire 1 month after the date the Commissioner notifies the parties of the allowance or refusal of the request for leave to amend filed on 6 July 2007 or if that request is withdrawn, 1 month after the date of withdrawal.

However, as the time taken for processing the amendments is largely in the hands of the applicant, the applicant will need to apply for extensions of time (if needed) under Regulation 5.10(2) up until you are advised that leave to amend has been granted.  The grant of an extension will need to be justified by appropriate progress of the amendments under all the circumstances.”

  1. I will make this direction after 21 days from the date of this decision unless the Commissioner is served with a notice of appeal from this decision or a stay.

    COSTS

  2. The power to award costs is based on section 210 and regulation 22.8.  Both parties submitted that costs should follow the result, but the opponent further submitted that in view of “the dilatory approach of the applicant to the present proceedings and the consequent offence to the public and private interests in an expeditious manner” the opponent should be awarded costs if their submissions were successful in any of these respects.

  1. I consider that the opponent has been unsuccessful in this regard and accordingly I award costs in accordance with Schedule 8 against the opponent.

L. F. McCaffery
Delegate of the Commissioner of Patents

Patent attorneys for the applicant: Spruson & Ferguson

Patent attorneys for the opponent: Pizzeys

Actions
Download as PDF Download as Word Document
Cases Citing This Decision

0

Cases Cited

6

Statutory Material Cited

0

Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981
Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981
Ferocem Pty Ltd v Commissioner of Patents [1994] FCA 981