Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 2)
[2013] FCA 554
•7 June 2013
FEDERAL COURT OF AUSTRALIA
Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 2) [2013] FCA 554
Citation: Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 2) [2013] FCA 554 Parties: OTSUKA PHARMACEUTICAL CO., LTD and BRISTOL-MYERS SQUIBB COMPANY v GENERIC HEALTH PTY LTD ACN 110 617 859 File number: NSD 121 of 2012 Judge: YATES J Date of judgment: 7 June 2013 Catchwords: DISCOVERY – claim for infringement of patent and cross‑claim for revocation of relevant claims – allegation that invention as claimed is invalid as it is not useful – discovery sought of broad category of documents to support allegation of inutility – whether allegation of inutility is speculative – whether order for discovery would facilitate the just resolution of the proceeding as quickly, inexpensively and efficiently as possible Legislation: Federal Court of Australia Act 1976 (Cth)
Federal Court Rules 2011 (Cth)
Patents Act 1990 (Cth)Cases cited: Hatmaker v Joseph Nathan & Co. Ltd (1919) 36 RPC 231
In the Matter of Alsop’s Patent (1907) 24 RPC 733
Kraft, Kraft Cheese Company (Incorporated) and Kraft Walker Cheese Company Proprietary Ld. v McAnulty (1931) 48 RPC 536
O’Sullivan v Parkin and Others (2008) 169 FCR 283
Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (2012) 291 ALR 763
WA Pines Pty Ltd v Bannerman (1980) 30 ALR 559Date of hearing: 22 May 2013 Place: Sydney Division: GENERAL DIVISION Category: Catchwords Number of paragraphs: 58 Solicitor for the Applicants: Mr P Kerr of Allens Counsel for the Respondent: Mr A Ryan SC with Mr A Fox Solicitor for the Respondent: K&L Gates
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
NSD 121 of 2012
BETWEEN: OTSUKA PHARMACEUTICAL CO., LTD
First ApplicantBRISTOL-MYERS SQUIBB COMPANY
Second ApplicantGENERIC HEALTH PTY LTD ACN 110 617 859
Cross-ClaimantAND: GENERIC HEALTH PTY LTD ACN 110 617 859
RespondentOTSUKA PHARMACEUTICAL CO., LTD
Cross-RespondentBRISTOL-MYERS SQUIBB COMPANY
Cross-Respondent
JUDGE:
YATES J
DATE OF ORDER:
7 JUNE 2013
WHERE MADE:
SYDNEY
THE COURT ORDERS THAT:
The parties bring in draft orders giving effect to these reasons and proposing orders for the discovery that has been agreed to be given by them respectively.
Note:Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY
GENERAL DIVISION
NSD 121 of 2012
BETWEEN: OTSUKA PHARMACEUTICAL CO., LTD
First ApplicantBRISTOL-MYERS SQUIBB COMPANY
Second ApplicantGENERIC HEALTH PTY LTD ACN 110 617 859
Cross-ClaimantAND: GENERIC HEALTH PTY LTD ACN 110 617 859
RespondentOTSUKA PHARMACEUTICAL CO., LTD
Cross-Respondent
JUDGE:
YATES J
DATE:
7 JUNE 2013
PLACE:
SYDNEY
REASONS FOR JUDGMENT
A question has arisen concerning the scope of discovery to be given in this proceeding.
Introduction
The proceeding concerns, amongst other things, the alleged infringement and threatened infringement by the respondent of Patent No. 2002226752, entitled “Substituted carbostyril derivatives as 5‑HT1A receptor subtype agonists” (the patent). The complete specification of the patent describes the invention as relating to a method of treating a patient suffering from a disorder of the central nervous system associated with the 5-HT1A receptor subtype. It describes a “potent, partial 5‑HT1A receptor agonist” that is said to be useful for various disorders of the central nervous system associated with the 5-HT1A receptor subtype that induces a number of conditions. Relevantly for present purposes, the disorder is depression, including major depression (the 752 Patent Disorder).
Claim 1 of the patent is as follows:
Use of a carbostyril compound of [a particular formula]; and a pharmaceutically acceptable salt or solvate thereof, for the production of a medicament effective in the treatment of disorders of the central nervous system associated with 5-HT1A receptor subtype, selected from depression; cognitive impairment caused by Alzheimer's disease or Parkinson's disease; autism; Down's syndrome; attention deficit hyperactivity disorder (ADHD); Alzheimer's disease; Parkinson's disease; panic; obsessive compulsive disorder (OCD); sleep disorders; sexual dysfunction; alcohol abuse; drug addiction; emesis; motion sickness; obesity; and migraine.
Aripiprazole is a carbostyril compound that falls within the formula referred to in claim 1.
Claim 2 of the patent is as follows:
The use of Claim 1 wherein the disorder is depression.
Claim 3 of the patent claims:
The use of Claim 2 wherein the depression is selected from endogenous depression, major depression, melancholia or treatment-resistant depression.
Claim 8 of the patent is as follows:
A method for treating a patient suffering from a disorder of the central nervous system associated with 5-HT1A receptor subtype selected from depression; cognitive impairment caused by Alzheimer's disease or Parkinson's disease; autism; Down's syndrome; attention deficit hyperactivity disorder (ADHD); Alzheimer's disease; Parkinson's disease; panic; obsessive compulsive disorder (OCD); sleep disorders; sexual dysfunction; alcohol abuse; drug addiction; emesis; motion sickness; obesity and migraine, comprising administering to said patient a therapeutically effective amount of carbostyril compound of [a particular formula]; and a pharmaceutically acceptable salt or solvate thereof.
Claim 9 claims:
The method of Claim 8 wherein the disorder is depression.
Claim 10 claims:
The method of Claim 9 wherein the depression is selected from endogenous depression, major depression, melancholia or treatment-resistant depression.
The applicants allege that the respondent has infringed, and threatened to infringe, claims 1, 2 and 3 of the patent by, amongst other things, offering to sell the products known as ARIPIPRAZOLE GENERICHEALTH and ARIPIPRAZOLE GH. The applicants allege that these products are medicaments produced using a form of aripiprazole and that they are effective in the treatment of the 752 Patent Disorder.
The applicants also allege that the respondent has infringed, and threatened to infringe, claims 8, 9 and 10 of the patent by offering to supply ARIPIPRAZOLE GENERICHEALTH in circumstances where it has reason to believe that the product would be used to treat patients suffering from the 752 Patent Disorder. Further, the applicants allege that the respondent has infringed, and threatened to infringe, those claims by offering to supply the product with an instruction to use it, or with an inducement to use it, to treat patients suffering from the 752 Patent Disorder.
The respondent, in substance, denies these allegations of infringement and also alleges that the relevant claims are invalid on a number of grounds, including that the invention, as claimed, is not useful. It has cross-claimed seeking revocation of claims 1, 2 and 3 and claims 8, 9 and 10 of the patent. The respondent has particularised its allegation of inutility in its Particulars of Invalidity filed on 10 February 2012 (the particulars) as follows:
(a)Claims 1 and 8 are not limited as to dosage amount, dosage regimen or the time period of administration of the medicament;
(b)Claim 1 does not identify the amount of the compound required to make the compound “effective in the treatment of” the alleged disorders;
(c)Claim 8 does not identify the therapeutically effective amount of the compound required for treating the alleged disorders;
(d)The method claimed in claim 8 is not useful or effective for treating the alleged disorders.
It is to be observed that the particular provided in (d) is no more than a bare statement of the inutility of the method claimed in claim 8. The particulars provided in (a) to (c) appear to be more apposite to other possible grounds of invalidity.
In the particulars, the respondent also alleges that the specification of the patent does not comply with s 40(2)(a) of the Patents Act 1990 (Cth) (the Act) in that it does not describe the invention fully, including the best method by which it is to be performed. It also alleges that the specification does not comply with s 40(3) of the Act in that the claims are not clear and succinct.
The proceeding also concerns the alleged infringement and threatened infringement by the respondent of Patent No. 2005201772 (the 772 patent). The 772 patent is directed to the use of, relevantly, aripiprazole for cognitive impairment caused by treatment-resistant and other forms of schizophrenia. The respondent has alleged that the relevant claims of the 772 patent are invalid on various grounds and has cross-claimed for revocation accordingly.
At an early stage of the proceeding, the parties agreed that no orders should then be made regarding a timetable for discovery and that they should proceed, respectively, with the filing of their affidavit evidence in support of the claim and cross‑claim.
The present question
The respondent seeks discovery of the following category of documents:
Documents brought into existence before the date of grant of [the patent] which record any research, development, test or experimental work in respect of the alleged invention disclosed and claimed in [the patent] insofar as those documents relate to the “752 Patent Disorder” and the treatment of the “Extended Indication” (as those terms are defined in the Amended Statement of Claim filed 22 February 2012) (the statement of claim).
The definition of the “752 Patent Disorder” is set out in [2] above. The meaning of “Extended Indication” in the statement of claim is taken from the respondent’s registration of the ARIPIPRAZOLE GENERICHEALTH product on the Australian Register of Therapeutic Goods (the ARTG) as follows:
Acute treatment of manic or mixed episodes associated with Bipolar 1 Disorder in adults as monotherapy and in combination with lithium or valproate; Maintenance treatment of manic or mixed episodes in Bipolar 1 Disorder in adults as monotherapy.
A mixed episode of bipolar disorder is a condition during which symptoms of mania and clinical depression occur simultaneously.
In summary, the respondent seeks discovery of certain documents directed to the use of aripiprazole in the treatment of:
depression, including major depression;
the acute treatment of manic or mixed episodes of bipolar 1 disorder in adults, whether as monotherapy or combination therapy; and
the maintenance treatment of manic or mixed episodes of bipolar 1 disorder in adults as monotherapy.
The respondent originally sought discovery by reference to a broader category of documents. It articulated the present, narrower category of documents in written submissions dated 20 May 2013. The applicants resist giving discovery in relation to this category of documents (the disputed category of documents).
There is an additional matter to note. As I understand it, the respondent’s case will be that, even though a mixed episode of bipolar 1 disorder comprises a mix of manic and depressive symptoms and signs, the depressive symptoms and signs of bipolar 1 disorder are not a disorder in and of themselves. They are symptoms of a subtype of bipolar 1 disorder which coexist with manic symptoms. Thus, the respondent will argue that when claim 8 refers to depression, it is referring to a separate disorder of depression and not to the symptoms of bipolar 1 disorder. The denouement of this argument would appear to be that the indication for which the ARIPIPRAZOLE GENERICHEALTH product is registered on the ARTG (that is, the Extended Indication) cannot be treated as an instruction or inducement by the respondent to use the product for the 752 Patent Disorder. This is an argument directed to the respondent’s defence that it has not infringed, or threatened to infringe, the patent by reason of the operation of s 117(1) of the Act as invoked by s 117(2)(c). It is not an argument directed to the validity of claim 8 of the patent.
Significantly, the respondent’s case will be that claim 8 does not claim a method of treating the depressive episodes of bipolar disorder. That question of construction is not one that I am called upon to decide now. Nevertheless, it can be seen that, if the respondent’s construction of claim 8 be correct, the utility of aripiprazole for the treatment of the depressive episodes of bipolar disorder simply does not arise as an issue in the proceeding because inutility as a ground of revocation can only be addressed to the invention as claimed: see s 18(1)(c) of the Act.
The submissions
The parties have provided written submissions, supplemented by oral argument. Although the written submissions touch on a number of matters, the substance of the parties’ positions, as reflected principally in oral submissions, is as follows.
The respondent submits that the disputed category of documents is principally directed to discovery to support the allegation that the invention as claimed in claim 8 of the patent is inutile. Nevertheless, it submits that documents in this category are also adjectivally relevant to the allegation that the complete specification of the patent fails to comply with s 40(2)(a) and s 40(3) of the Act.
I should say at once that I would not make an order for discovery in respect of the disputed category of documents in aid of the allegation of non-compliance of the complete specification with s 40(2)(a) or s 40(3) of the Act. No proper foundation has been laid in this case for discovery on that basis. The real question is whether discovery in respect of the disputed category of documents should be ordered in aid of the allegation that the invention claimed in claim 8 is inutile. This was the focus of the respondent’s submissions, both written and oral.
In essence, the applicants submit that discovery by reference to the disputed category of documents should not be given because the respondent’s allegation of inutility is speculative. The applicants developed this submission in the following way.
First, they submit that the respondent was ordered to file its evidence in chief in support of its claims of invalidity by 2 November 2012. The respondent filed three affidavits from Dr O’Dea and an affidavit from Professor McGorry. The applicants submit (and the respondent did not challenge) that these affidavits do not address the utility of the challenged claims of the patent; indeed, the applicants say that these affidavits do not address any challenge to the validity of the patent.
Secondly, the applicants submit that a party must not apply for an order for discovery unless the making of the order will facilitate the just resolution of the proceeding as quickly, inexpensively and efficiently as possible: r 20.11 of the Federal Court Rules 2011 (Cth). This objective mirrors the overarching purpose set out in s 37M of the Federal Court of Australia Act 1976 (Cth).
Thirdly, the applicants submit that the respondent is not entitled to engage in a “fishing expedition” for documents, where it has made only bare allegations that are unsupported by evidence, particularly where the respondent has been afforded the opportunity to file such evidence. In this connection, the applicants rely on the acceptance by the Full Court in O’Sullivan v Parkin and Others (2008) 169 FCR 283 of the following observations of Brennan J (when in this Court) in WA Pines Pty Ltd v Bannerman (1980) 30 ALR 559 at 567:
Though the power to require discovery be acknowledged, how should it be exercised? It depends upon the nature of the case and the stage of the proceedings at which the discovery is sought. In the present case, discovery is sought before there is a tittle of evidence to suggest that the Chairman did not have the requisite cause to believe which para 6 of the statement of claim would put in issue. Some assistance was sought to be derived from cases where discovery had been given to a party before he was required to give particulars of his claim: cases such as Ross v Blake's Motors [1951] 2 All ER 689, but in cases of that kind there is either an anterior relationship between the parties which entitles one to obtain information from the other, or sufficient is shown to ground a suspicion that the party applying for discovery has a good case proof of which is likely to be aided by discovery. This is not such a case. This is a case where a bare allegation is made by para 6 of the statement of claim and, the paragraph being denied, the applicant seeks to interrogate the Chairman and ransack his documents in the hope of making a case. That is mere fishing. As Smithers J said in Melbourne Home of Ford Pty Ltd v Trade Practices Commission, supra (5 TPC at 35; ATPR at 18,087: “In the absence of such evidence the proceeding is essentially speculative in nature. In such circumstances for the Court to assist the applicants by making available to them the processes of interrogatories and discovery would be to assist them in an essentially fishing exercise and from this the Court on established principles should refrain.” …
In O’Sullivan, the Full Court considered the observations of Brennan J in WA Pines to be directed to the question of discovery in the context of an application for judicial review of an administrative decision. Be that as it may, his Honour’s observations also have resonance when considering whether discovery in respect of a particular category of documents should be ordered in other cases, especially in light of the requirements of r 20.11.
The applicants’ position is encapsulated in the following submission:
As the evidence currently stands, the respondent has no case on inutility. The respondent is not entitled to seek documents to see if it can support a claim of inutility in circumstances where it otherwise has no case.
The applicants also submit that discovery in relation to this category would be burdensome. They have referred to the fact that it would take some months to have documents translated from Japanese into English. No evidence was adduced in support of this submission, but the respondent did not seek to challenge it. It accords with my general understanding of the likely position, gleaned from my experience of another case in my docket involving the same patentee in respect of another patent concerning aripiprazole.
In response, the respondent points to evidence intended to be given by Professor Iain McGregor. Professor McGregor made an affidavit on 4 April 2013 which responds to an affidavit made by Associate Professor Trevor Norman, which has been filed on behalf of the applicants in their case on infringement. In general terms, Associate Professor Norman’s affidavit deals with the process of neurotransmission in the brain and the role of receptors in that process. More specifically, his affidavit deals with whether, in his view, the 5-HT1A receptor is associated with cognitive impairment in schizophrenia and depression, including major depression.
In dealing with the association between the 5-HT1A receptor and depression (including major depression), Associate Professor Norman refers to the fact that medications that interact with the 5-HT1A receptor have been used in various therapeutic applications. In this connection, he refers to the use of atypical antipsychotic agents, such as aripiprazole, in low doses to augment the antidepressant effect of selective serotonin reuptake inhibitors.
In his affidavit, Professor McGregor refers to this evidence and says, with respect to the use of antipsychotic drugs as agents in depressive episodes of bipolar disorder, that the efficacy of aripiprazole as an agent for treating depressive episodes of bipolar disorder is “in doubt”. In this connection, Professor McGregor refers to a paper by Tsai et al entitled “Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature” (the Tsai et al paper). In his affidavit, Professor McGregor says that this paper:
… highlights the very few studies that support the use of aripiprazole in bipolar disorder and also notes in the abstract that the main supportive study (1) was of insufficient duration to demonstrate maintenance efficacy; (2) was of limited generalizability due to its enriched sample; (3) involved possible conflation of iatrogenic adverse effects of abrupt medication discontinuation with beneficial effects of treatment; and (4) had a low overall completion rate …
It is to be noted that Professor McGregor’s affidavit was not filed in support of the respondent’s challenge to the validity of the patent, but in response to the applicants’ affidavit evidence filed on the question of infringement. So viewed, it arrives as something of a side wind to the respondent’s challenge to the validity of claim 8 of the patent. Beyond reciting the findings of Tsai et al which I have quoted immediately above, Professor McGregor does not elaborate on his statement that the efficacy of aripiprazole as an agent for treating depressive episodes of bipolar disorder is “in doubt”.
I was taken by the respondent to parts of the Tsai et al paper in the course of oral argument. The paper seeks to critically review the evidence supporting the use of aripiprazole in the maintenance treatment of bipolar disorder and to examine how that evidence has been disseminated in the scientific literature. Specifically, the paper identifies a trial by Keck et al (the Keck trial) which was conducted with respect to participants that met certain criteria for bipolar 1 disorder, and evaluates how that trial has been, and should be, interpreted.
The Tsai et al paper describes the treatment of bipolar disorder as being divided into three phases: acute treatment lasting about two months to achieve remission; continuance treatment from two to six months to prevent relapse; and long-term maintenance treatment to prevent recurrence. The Tsai et al paper addresses the last-mentioned form of treatment.
The methodology used by Tsai et al which led them to appraise the Keck trial is described by the authors as follows:
We systematically searched multiple databases to identify double-blind, randomized controlled trials of aripiprazole for the maintenance treatment of bipolar disorder while excluding other types of studies, such as open-label, acute, and adjunctive studies. We then used a citation search to identify articles that cited these trials and rated the quality of their citations. Our evidence search protocol identified only two publications, both describing the results of a single trial conducted by Keck et al., which met criteria for inclusion in this review.
In discussing the Keck trial, the Tsai et al paper provides a flow chart which includes data in relation to a cohort of patients that was randomised and assigned to either the use of a placebo or continued treatment with aripiprazole. The flow chart provides some data on relapsed patients, including their symptoms.
In this connection, the flow chart records that, in the 26 week double-blind phase of the Keck trial, 11 out of 83 patients assigned to placebo (with aripiprazole abruptly discontinued), and nine out of 78 patients assigned to continued treatment with aripiprazole, relapsed with depression. The flow chart also records that, in the 74 week extension phase of the Keck trial, two out of 27 patients assigned to placebo, and two out of 39 patients assigned to continued treatment with aripiprazole, relapsed with depression.
The Tsai et al paper also references another paper (Goodwin GM, Evidence‑based guidelines for treating bipolar disorder: revised second edition – recommendations from the British Association for Psychopharmacology (2009) 23 J Psychopharmacol 346-388), amongst a number of other papers, and includes an extract from it in which the following is stated:
Aripiprazole was more effective than placebo after acute and continuation treatment of mania with aripiprazole: no effect on depression was discernable. Acute withdrawal of the active agent did not produce an excess of early relapse in this study.
On the basis of these matters, counsel for the respondent submitted that, in relation to depressive episodes associated with bipolar disorder, aripiprazole “appears to be no better than the placebo”. He continued:
We say it does have utility probably, for the manic difficulty associated with bipolar, but that with the depressive condition the jury is out. It doesn’t appear to [be] better than the placebo.
Tsai et al described the significance of their own evaluation in the following terms:
This evaluation of the evidence base supporting the use of aripiprazole for the maintenance treatment of bipolar disorder shows that the justification for this practice relies on the results of one published trial. Moreover, the methodology and reporting of this trial mean that its results cannot easily be generalized to inform the treatment of most patients with bipolar disorder. Worryingly, the researchers’ citation search indicates that the Keck trial has been cited uncritically in the ensuing scientific literature. Although the unique features of bipolar disorder make it hard to undertake controlled studies of treatment options, the researchers express concern that “the publication and apparently uncritical acceptance of this trial may be diverting patients away from more effective treatments”.
Consideration
The method claimed in claim 8 of the patent is one limited by result. It is directed to administering, relevantly, aripiprazole in a therapeutically effective amount for the treatment of one of the selected disorders. For this reason, the respondent’s case on inutility can only be that the result promised by claim 8 (therapeutic efficacy), as it applies to the administration of aripiprazole for the treatment of depression, including major depression, is simply unattainable: see the discussion in Blanco White TA, Patents for Inventions (Fifth Edition, Stevens & Sons) 4-413; Hatmaker v Joseph Nathan & Co. Ltd (1919) 36 RPC 231 at 237; Kraft, Kraft Cheese Company (Incorporated) and Kraft Walker Cheese Company Proprietary Ld. v McAnulty (1931) 48 RPC 536 at 550-551; In the Matter of Alsop’s Patent (1907) 24 RPC 733 at 752-753.
It is, of course, the respondent who bears the onus of establishing that claim 8 of the patent is inutile. The applicants bear no onus in that regard. In the course of oral argument, the respondent made clear that it seeks to make good its case on inutility by what might be shown if discovery is ordered by reference to the disputed category of documents. In this connection, the respondent accepted that the affidavits of its experts to be called in chief in its case on invalidity – Professor McGorry and Dr O’Dea – do not deal with the use of aripiprazole in the treatment of depressive disorders. Indeed, counsel for the respondent pointed to the fact that, in one of his affidavits, Dr O’Dea says that he does not prescribe aripiprazole to treat depressive disorders or depressive symptoms of disorders. Dr O’Dea did not say that this was due to reasons concerning its utility. Counsel positively asserted that Dr O’Dea was not in a position to give evidence on the efficacy of aripiprazole in the treatment of depressive disorders or depressive symptoms.
Thus, taking its stated position at face value, the respondent seeks discovery by reference to the disputed category of documents in the hope that it might find that which the evidence presently available to it apparently does not show – that it has been established that aripiprazole is not useful in the treatment of depression, including major depression. Such an application has all the hallmarks of “fishing” in the context of what appears to be a largely speculative allegation that the method of claim 8 of the patent is inutile. As I have noted in [13] above, the relevant particular provides only a bare allegation of inutility.
The respondent’s present application is based primarily on the Tsai et al paper. As I have noted, the paper is an evaluation of a particular clinical trial concerning the use of aripiprazole for the maintenance treatment of bipolar disorder. It advances four limitations, which it characterises as critical limitations, on the trial’s interpretation and overall utility.
Significantly, so far as I am aware, the Tsai et al paper does not engage the question of the therapeutic efficacy of aripiprazole in the acute treatment of bipolar disorder or in the treatment of depression, including major depression, at least to the extent that depression is unrelated to the depressive episodes of bipolar disorder. Moreover, it does not descend to any specific finding concerning the utility of aripiprazole in the treatment of depressive episodes associated with bipolar disorder, beyond showing data included in the flow chart to which I have referred.
I do not know how the respondent would seek to deploy the Tsai et al paper at the hearing for final relief. As the sequence of filing of the affidavit evidence indicates, it has not been advanced in the respondent’s case in chief on invalidity. Moreover, if at the hearing for final relief the paper is admitted into evidence, I do not know what the respondent would contend its evidential value to be. I was not taken to any intended evidence that discusses the Tsai et al paper or, indeed, the Keck trial. The respondent’s intended evidence does not appear to address whether the paper’s evaluation and conclusions are themselves valid. The present application is not, of course, the occasion on which to make findings on issues that are to be determined on a fully contested hearing for final relief. However, the absence of intended evidence about these matters is significant when regard is had to the broad scope of discovery to which the disputed category of documents is directed: see [20] above. The Tsai et al paper appears to stand simply as a published critique of the conclusions that have been drawn from a particular published clinical trial dealing with the administration of aripiprazole in maintenance therapy for bipolar disorder.
The evidence intended to be adduced from Professor McGregor does not materially advance matters for the purpose of the present application. I was not taken to any evidence that Professor McGregor has personal experience of the use of aripiprazole in the treatment of depression, including major depression, or in the treatment of the depressive episodes of bipolar disorder. Moreover, Professor McGregor’s consideration of the Tsai et al paper appears to be limited to identifying, without further elaboration or discussion, its principal findings and to stating, without further reference, that the efficacy of aripiprazole as an agent for treating the depressive episodes of bipolar disorder is “in doubt”.
The respondent’s reliance on the Tsai et al paper in the present application sits somewhat oddly with its own registration of ARIPIPRAZOLE GENERICHEALTH on the ARTG for the maintenance treatment of manic or mixed episodes of bipolar 1 disorder in adults as monotherapy. Objectively, this registration signifies, contrary to the concerns expressed in the Tsai et al paper, that aripiprazole is effective in the maintenance treatment of bipolar disorder. It would certainly appear that the Therapeutic Goods Administration is satisfied of that fact. It would also appear that the respondent itself is satisfied of that fact; otherwise, presumably, it would not have sought that registration and thereby manifested its intention to market the product for that purpose. As I have noted, the registration extends to the treatment of mixed episodes of bipolar disorder. In the absence of evidence directed to these matters, there is no reason why, at the present time, I should not proceed on the basis that, outside the present proceeding, the respondent has recognised, presumably for sound scientific reasons, that aripiprazole is effective in the maintenance treatment of mixed episodes of bipolar 1 disorder. The apparent contradiction presented by these facts was not addressed by the respondent in evidence to support its present application.
The respondent’s approach in this application has been to “cherry pick”, by way of submission only, aspects of the data shown in the Tsai et al paper to support the discovery it seeks. I was not taken to any evidence intended to be adduced at the hearing for final relief that discusses this data or its significance, or which shows that this data can be considered in isolation from other data. As I have said, Professor McGregor’s evidence does not purport to do so. I am certainly not prepared to draw my own uninformed conclusions about these matters for the purpose of deciding the present application.
I also take into account the fact that it arises in the context of the respondent contending in its intended evidence in chief that claim 8 of the patent, on its proper construction, does not even claim a method of treating the depressive episodes of bipolar disorder.
Additionally, discovery of the kind sought is likely to require the applicants to translate documents from Japanese into English, involving what I would understand to be significant cost and inconvenience. This task will also inevitably involve some delay – said to be months – in the preparation of the case for final hearing.
In all the circumstances, I am not persuaded, on the basis of the materials relied upon in this application, that the respondent has shown a sufficient foundation for discovery by reference to the disputed category of documents. More specifically, I am not satisfied at the present time that discovery by reference to the disputed category of documents will facilitate the just resolution of the proceeding as quickly, inexpensively and efficiently as possible.
Disposition
The respondent’s application for discovery by reference to the disputed category of documents is refused with costs. I am aware, however, that the parties have agreed that discovery by reference to other categories of documents should be given. The parties are to bring in draft orders giving effect to these reasons and proposing orders for the discovery that has been agreed to be given by them respectively.
I certify that the preceding fifty-eight (58) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Yates.
Associate:
Dated: 7 June 2013
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