Aspen Pharma Pty Ltd v H Lundbeck A/S

Federal Court of Australia|2013-04-09|Before: Yates J

the application for a stay 30 Section 44A(2) of the AAT Act provides that: Where an appeal is instituted in the Federal Court of Australia from a decision of the Tribunal, that Court or a Judge of that Court may make such order or orders staying or otherwise affecting the operation or implementation of either or both of the following: (a) the decision of the Tribunal or a part of that decision; and (b) the decision to which the proceeding before the Tribunal related or a part of that decision; as that Court or Judge considers appropriate for the purpose of securing the effectiveness of the hearing and determination of the appeal. 31 In considering applications for a stay under s 44A(2) of the AAT Act, this Court has applied principles akin to those involved in granting interlocutory injunctive relief: see, for example, Minister of State for Education and Youth Affairs v Bracken (1984) 6 FCR 197 at 200; Broadbent v Civil Aviation Safety Authority [1999] FCA 1871 at [6]; Catena v Australian Securities and Investment Commission [2010] FCA 598 at [12]; Citrus Queensland Pty Ltd v Sunstate Orchards Pty Ltd [2008] FCA 1867 at [39]-[40]. In some cases, it has been said that the discretion conferred by the provision should only be exercised where "special circumstances" justify departure from the rule that a successful litigant is entitled to the fruits of judgment pending appeal: see, for example, Secretary, Department of Families, Housing, Community Services and Indigenous Affairs v Mouratidis [2010] FCA 880 at [20]. It has also been said that the purpose of the provision is to ensure that the subject matter of the appeal is not rendered nugatory by the implementation or coming into effect of the decision under appeal: see, for example, Theo v The Secretary, Department of Family Services [2004] FCA 1748 at [5]; Hartnett v Migration Agents Registration Authority [2003] FCA 998 at [4]-[6]; Mouratidis at [20]. 32 The first of these qualifications may simply reflect the fact that a favourable exercise of the discretion involves a change from the prima facie position under s 44A(1) of the AAT Act that an appeal to the Court does not affect the operation of the decision or prevent the taking of action to implement it. The second qualification exemplifies why the discretion might be exercised favourably in given circumstances. However, neither qualification should be grafted onto the clear words of the provision so as to limit the occasions on which the broad discretion it confers should be exercised. 33 On the hearing of the present application, the first respondent raised a threshold matter: it contended that the application did not engage s 44A(2) of the AAT Act because the failure to grant a stay would not render the applicants' appeal nugatory. As an abstract proposition, that contention might be correct. If a stay is not granted, the applicants will still be entitled to prosecute their appeal and, if successful, obtain the relief they seek. However, the first respondent's submission does not, itself, engage the terms of s 44A(2), which are directed to securing the effectiveness of the hearing and determination of the appeal. As will become apparent when dealing with the applicants' contentions, a significant plank in their application is that, if the appeal is determined in their favour, the occasion will not arise for the Commissioner to determine the first respondent's extension of term application. The effectiveness of the hearing and determination of the appeal, if determined in the applicants' favour, would be to avoid what will have been shown to have been an unnecessary proceeding before the Commissioner under Part 3 of Chapter 6 of the Act. 34 I am satisfied, therefore, that the applicants' application for a stay is of a kind that would fall within s 44A(2) of the AAT Act. The real question is whether, in the particular circumstances of this appeal, the discretion should be exercised in favour of granting the stay that is sought.

The applicants' contentions 35 The applicants submit that their notice of appeal reveals a substantial basis for their challenge to the decision under appeal. They submit that a number of important questions of law are raised which involve complex and significant issues that have not previously arisen. 36 The applicants advance four additional contentions in support of a stay. 37 First, if a stay is not granted, the Commissioner, the parties and, potentially, others, will be required to proceed with the extension of term application. So far as the Commissioner is concerned, this would involve the Commissioner publishing a notice in the Official Journal that an extension of term application has been made; considering whether the requirements of ss 70 and 71 of the Act are satisfied; publishing a notice of acceptance in the Official Journal (if the application for an extension of term is accepted); and conducting opposition proceedings in relation to the extension of term application. 38 In this latter connection, the applicants have made clear that, should the Commissioner accept the extension of term application, they will lodge notices of opposition. They observe that others with a similar interest may do likewise. The applicants then say that this will lead to parallel proceedings before the Commissioner, while the appeal is pending in this Court. In the anticipated opposition proceedings, the opponents will be required to prepare notices of opposition, pay filing fees and prepare evidence in support of their oppositions. 39 The applicants submit that if their appeal is successful - such that the decision under appeal is set aside - the steps undertaken in the parallel opposition proceedings will have been unnecessary. Although an order for costs can be made against the first respondent in those proceedings, the scale of fees that would apply is such that it is unlikely that they (and other opponents) will be adequately compensated for the costs that they will actually (and ex hypothesi unnecessarily) incur. 40 Secondly, the appeal and the Commissioner's consideration of the extension of term application will raise a common question, namely, whether the requirement of s 70(4) of the Act can be satisfied in the instant case. 41 In this connection, it will be recalled that s 70(4) provides that it is a precondition to an extension of term that the patent must not have been previously extended under Part 3 of Chapter 6 of the Act. The applicants contend that, in the instant case, this particular precondition cannot be satisfied as a matter of fact. They rely on the fact that the Commissioner had, on 27 May 2004, originally extended the term of the patent. The applicants say that it makes no difference that this decision was found to be invalid and that the Register was rectified accordingly. The applicants' case is that, as a matter of construction, s 70(4) speaks only of an historical act regardless of its legal effect. Indeed, the applicants accept that the first respondent could not sue for infringement based on an extension of term that had not been validly granted. On their argument, it is enough that the term of the patent was purportedly extended. 42 The construction of s 70(4) of the Act arises in the appeal because the applicants say that, as a matter of discretion, the Commissioner should not have acceded to the first respondent's request for an extension of time in which to apply for an extension of term of the patent. This is because, on their argument, an application to extend the term of the patent would itself be futile in light of s 70(4) properly construed and applied in the instant case. I observe that, having regard to the delegate's reasons, this does not appear to have been an argument that the applicants advanced before the Commissioner when opposing the first respondent's application to extend time. 43 The applicants contend that any decision in the opposition proceedings will necessarily involve the Commissioner construing s 70(4) of the Act and that this will be tied to how that provision is construed in the appeal. Thus, they say, it would be far better for the Full Court to determine that question of construction first so that the Commissioner can then apply that construction when considering the extension of term application. They note that an inconsistent result or interpretation of s 70(4) by the Commissioner will give rise to further proceedings by way of an appeal from the Commissioner's decision in the extension of term application. 44 Thirdly, the applicants submit that if a stay is not granted, and the ultimate outcome of the appeal is delayed (including by way of application for special leave to the High Court), it is possible that the Commissioner may hand down a decision on the extension of term application before the correctness of the extension of time decision has been finally determined. 45 Fourthly, the applicants submit that the first respondent cannot complain about the delay in the prosecution of the extension of term application which would result from the grant of a stay, because the first respondent itself unreasonably delayed in making its extension of time application.

The first respondent's contentions 46 The first respondent challenges the significance of the matters raised by the applicants in support of a stay. It also advances a number of additional considerations. Foremost amongst these is the undoubted proposition that it has been successful, over opposition, before the Commissioner and the AAT in seeking an extension of time within which to make the extension of term application. It submits that, as the successful party, it is "entitled to the fruits of its judgment". If, however, a stay is granted, it argues that it will almost certainly lose the benefit of those decisions, based on the following reasoning: • If the term of the patent is extended, it will be in a position to commence infringement proceedings in respect of the sales of "generic" escitalopram products made between 13 June 2009 and 12 December 2012: s 79 of the Act. • The benefit to it of the AAT's decision is properly to be seen as its ability to pursue such proceedings. However, s 120(4) of the Act requires infringement proceedings to be commenced within six years of a relevant infringing act. • If a stay is granted, and assuming an extension of term is ultimately granted, it is almost inevitable that the first respondent will start losing its right to sue for infringement in the relevant period. This is because, on a predicted time scale taking both of these events into account, it is unlikely that the Commissioner will issue a decision with respect to the extension of term application earlier than July 2015. It submits that, in the language of s 44A(2) of the AAT Act, the "effectiveness of the hearing" will not be "secured". 47 I should say at once that the last-mentioned submission is based on a misreading of s 44A(2) of the AAT Act. This is because s 44A(2) is aimed at securing the effectiveness of the hearing and determination of the appeal, not the effectiveness of the hearing and determination of the proceeding before the AAT. Nevertheless, the point made by the first respondent is one of substance and, in my view, constitutes a significant consideration to be taken into account in determining how the discretion should be exercised in the present application. It is a consideration to which I will return. 48 The first respondent also challenges a number of bases on which the appeal has been brought. It submits that, subject to two exceptions, the applicants' notice of appeal does not raise questions of law. The two exceptions are questions 1 and 2, which raise, respectively, the proper construction of s 223(2)(a) (considered with s 223(11) of the Act and reg 22.11(4)(b) of the Regulations) and the proper construction of s 70(4) of the Act. Even so, it submits that these questions were correctly determined by the AAT in its favour. It submits that, although not unarguable, the appeal does not enjoy good prospects of success and that this is a relevant consideration in determining how the discretion should be exercised in the present application.

consideration 49 The critical issue in the appeal is whether s 223(2)(a) of the Act, read in light of s 223(11) and reg 22.11(4)(b), confers the power to extend time for filing, during the term of the patent, an application for an extension of term under s 70(1) of the Act. I am satisfied, for the purposes of this application, that this question is raised as a question of law by the notice of appeal and that the construction for which the applicants contend is arguable. I am satisfied that the appeal has some prospect of success. In saying this, I do not wish to be taken as implying that, in my view, the construction favoured by the Commissioner and the AAT is wrong. It is a construction that is available, for the reasons expressed by the AAT. It will be a matter for the Full Court to determine the correctness of that construction. 50 It is not necessary for me to discuss each and every one of the other questions that are said to arise on the appeal, beyond noting, in a summary way, that I am not persuaded that, considered cumulatively, those grounds substantially add to the applicants' prospects of success in the appeal. It seems to me that the fate of the present application really rests in balancing the other considerations which the parties have advanced for and against the granting of a stay. 51 At face value, the contention that there should not be parallel proceedings before the Commissioner while the appeal to this Court is pending, is persuasive. Absent other considerations, the taking of further steps in the extension of term application - dependent as that application is upon the proper exercise of the power under s 223(2)(a) of the Act - may be undesirable, to the extent that it is possible that unnecessary and irrecoverable costs will be incurred. However, the following matters should be noted. 52 First, insofar as the applicants rely on prejudice to themselves, they have placed no evidence before the Court as to the likely quantum of the costs that will be incurred. Thus, their concerns find no material expression beyond the construct of their contention. 53 I accept that if the anticipated opposition proceedings take their course, the steps which the applicants have identified will need to be taken and that, as a consequence, costs will be incurred. However, the preconditions for an extension of term largely involve the fulfilment of somewhat prosaic requirements on the part of the patentee which, normally, do not admit of significant debate. The costs of bringing an opposition proceeding should not be substantial. 54 In oral submissions, the applicants foreshadowed that they propose to advance an additional argument arising under s 70(2)(a) of the Act concerning the identification of the relevant pharmaceutical substance that is disclosed and claimed in the patent. They submit, therefore, that the oppositions will not be limited to straightforward grounds. Be that as it may, the applicants have not sought to show the extent to which the oppositions they propose to run will result in substantial additional costs. Certainly the limited evidence before me does not show that the issues to be determined will have a factual complexity that will lead to the incurring of substantial costs over and above what might otherwise be incurred in a "straightforward" opposition. 55 Furthermore, and importantly, the applicants are able to exert a real measure of restraint over the costs they will incur in the anticipated oppositions. It is not apparent to me why it is necessary to have multiple oppositions in relation to what appears to be, in substance, a single controversy. Even if the applicants wish to fileindividual notices of opposition, the prudent and economical conduct of those oppositions should at least include consideration of filing common evidence and engaging common representation. This should result in a significant saving of costs, which can then be shared. Whether the applicants choose to exercise restraint of that kind is entirely a matter for them. The point is that they have choices in this regard which are realistic and practical and which would be likely to lead to a significant lessening of the risk of the prejudice they advance absent the stay they seek. 56 Secondly, insofar as the applicants rely on inconvenience or prejudice to the Commissioner, no concern of that kind has been expressed by the Commissioner. There is no evidence before me that the steps that the Commissioner is now obliged to take under the Act will be onerous or involve any significant wastage of time or resources within the Australian Patent Office. 57 Thirdly, insofar as the applicants rely on prejudice to third parties, I do not propose to speculate on whether the costs to be incurred by other potential opponents to the extension of term application will be either burdensome or irrecoverable. 58 Fourthly, although the proper construction of s 70(4) will arise in both the appeal and the anticipated opposition proceedings, I do not see this as being a significant consideration in support of a stay. For one thing, I doubt that the construction advanced by the applicants is correct. The AAT had little difficulty in rejecting it. In any event, the Commissioner routinely deals with questions of statutory construction arising under the Act. In the present case, the question is purely one of law that is not enlivened by disputed facts. It will not cause embarrassment if the Commissioner is called upon to construe s 70(4) in the context of the extension of term application before that question is determined in the appeal. Moreover, as the applicants' submissions recognise, they will retain their right to appeal against any unfavourable decision in their anticipated opposition proceedings. 59 The undesirability of parallel proceedings before the Commissioner must be balanced against the risk that rights that would be granted to the first respondent in a successful extension of term application will be lost should a stay be granted. I accept the applicants' submission that the timelines relied upon by the first respondent are based on a number of assumptions and variables which might readily change. I am satisfied, however, that these timelines provide a workable, albeit broad, standard against which the discretionary factors in the present application can be weighed. The first respondent's assessment that, if a stay is granted, it is unlikely that the Commissioner will issue a decision with respect to the extension of term application earlier than July 2015 seems to be soundly based. I also accept the applicants' submission that, independently, the first respondent's potential patent rights might be eroded in any event by the bringing of appeals against any extension of term decision made by the Commissioner. That submission, however, only persuades me that the first respondent's concern about the loss of patent rights is real and that the extension of term application should be progressed expeditiously and not delayed. This is especially so in circumstances where the first respondent has the benefit of two decisions in its favour, which it has achieved in the face of the applicants' opposition. Moreover, I have no doubt that the rights that the first respondent will acquire should the patent term be extended will be of significant commercial value to it. The history of the litigation between the parties with respect to the patent, including with respect to the present appeal, supports that general conclusion. 60 It seems to me, therefore, that, in balancing the discretionary considerations, the potential economic loss to the first respondent, represented by a loss of rights to sue for damages for patent infringement, far outweighs the potential economic loss to the applicants, represented by the possibility of irrecoverable costs of opposition proceedings before the Commissioner. Naturally, any loss of the first respondent's patent rights by the effluxion of time can only work to the benefit of the applicants and to the prejudice of the first respondent. It follows that unnecessary delay in the prosecution of the extension of term application has the potential to result in significant injustice to the first respondent. 61 As to the remaining matters raised by the applicants, I accept that there is a prospect that the Commissioner might give a decision in the foreshadowed opposition proceedings before the parties have exhausted their rights arising out of the AAT proceedings. The likelihood of this happening also depends on a number of imponderables, including the forensic decisions that the parties might choose to make in the protection of their own legal and commercial interests. This consideration, however, can be regarded as an aspect of the applicants' main contention about the incurring of unnecessary costs. 62 Finally, I am not persuaded by the applicants' submission that any delay resulting from the grant of a stay is a matter that lies at the feet of the first respondent because it was dilatory in making its extension of time application. Significantly, the AAT made a finding of fact on unchallenged evidence that it was reasonable for the first respondent to defer making its application to extend time until the decision of the Full Court had been given in the earlier proceedings: see Re Aspen Pharma Pty Ltd and Commissioner of Patents [2012] AATA 851 at [91]. For completeness, I note that the Commissioner's delegate came to the same conclusion: see Alphapharm Pty Limited & Ors v H. Lundbeck A/S [2011] APO 36; 92 IPR 628 at [75]. Although the applicants seek to challenge the correctness of the AAT's finding in the appeal, it is not a finding that I should ignore, still less interfere with, for the purpose of determining the present application. 63 Taking all these matters into account, I am not persuaded that a stay should be granted.

Disposition 64 The application for a stay is refused with costs. I certify that the preceding sixty-four (64) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Yates.

Preliminary facts 17 Citalopram is a racemate comprising two enantiomers in equal measure. It is the active substance (in the form of a hydrobromide salt) of a pharmaceutical product called Cipramil, which was included in the ARTG on 9 December 1997. 18 The patent relates to one of the enantiomers, called "escitalopram". Escitalopram is the active substance of a pharmaceutical product called Lexapro, which was included in the ARTG on 16 September 2003. The 20 year initial term of the patent expired on 13 June 2009. 19 Citalopram and escitalopram are different chemical entities with different physical properties and different pharmacological activities. 20 On 22 December 2003, the first respondent applied for an extension of the initial patent term, based on the date that Lexapro was included in the ARTG. On 27 May 2004, this application was granted by the Commissioner, without opposition. The term of the patent was extended to 13 June 2014, and an entry to that effect was duly made in the Register of Patents (the Register). 21 In circumstances that it is not necessary for me to recite, the Commissioner subsequently determined, first, that the extension of term should have been based on the date that Cipramil was included in the ARTG and, secondly, that, as a consequence, the term of the patent should be extended only to 9 December 2012. 22 In subsequent proceedings in this Court, Lindgren J found that the correct regulatory approval date for the application for the extension was the inclusion of Cipramil in the ARTG. However, the consequence of this finding was not merely that the term of the extension should be more limited, as the Commissioner had determined. The first respondent's application for an extension of term was out of time: the first respondent had only until 9 June 1998 to apply for an extension. As the time requirement of s 71(2) of the Act had not been met, Lindgren J ordered that the Register be rectified by removing the recordal that the Commissioner had made: Alphapharm Pty Ltd v H Lundbeck A/S (2008) 76 IPR 618 at [544]; see also [28] to [33]. A subsequent appeal to a Full Court against this judgment was unsuccessful: H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 at [111], [247] and [250]. 23 Final orders were made by the Full Court on 12 June 2009, the day before the initial term of the patent expired. Later on 12 June 2009, the first respondent made an application pursuant to s 223(2) of the Act for an extension of time within which to file an application to extend the term of the patent. The extension sought was 121 months (just over 10 years). 24 Each of the applicants launched their own generic products containing escitalopram in mid-June 2009, shortly after the initial patent term expired. 25 On 9 July 2009, the first respondent filed an application for special leave to appeal to the High Court. The application was refused on 11 December 2009: Alphapharm Pty Ltd v H Lundbeck A/S [2009] HCATrans 324 (11 December 2009). 26 On 9 February 2010, the Commissioner amended the Register by removing the recordal relating to the extension of term. 27 The applicants opposed the first respondent's application for an extension of time. Four oppositions were filed and heard together. On 1 June 2011, the Commissioner's delegate granted the extension of time: Alphapharm Pty Limited & Ors v H. Lundbeck A/S [2011] APO 36; 92 IPR 628. This was the decision affirmed by the AAT (Re Aspen Pharma Pty Ltd and Commissioner of Patents [2012] AATA 851) from which the applicants bring their present appeal.

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