H Lundbeck A/S v Alphapharm Pty Ltd
[2016] APO 45
•8 July 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
H Lundbeck A/S v Alphapharm Pty Ltd and Ors [2016] APO 45
Patent:623144
Title:(+)-Enantiomer of citalopram and process for the preparation thereof
Applicants for
Licences: (1) Alphapharm Pty Ltd
(2) Apotex Pty Ltd
(3) Aspen Pharma Pty Ltd
(4) Sandoz Pty Ltd
Patentee and
Opponent: H Lundbeck A/SHearing Officer: P M Spann, Deputy Commissioner of Patents
Decision Date: 8 July 2016
Hearing Date: 14 May 2016 by written submissions
Catchwords: PATENTS – Applications for licences to exploit – opposition to applications – request for stay – request for determination of threshold issues – requests refused – directions for filing of evidence for determination of all issues.
Representation: Licence Applicants: C Dimitriadis SC and N R Murray Counsel instructed by King & Wood Mallesons
Patentee:S Stern, Corrs Chambers Westgarth
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent:623144
Title:(+)-Enantiomer of citalopram and process for the preparation thereof
Patentee: H Lundbeck A/S
Date of Decision: 8 July 2016
DECISION
Request for stay refused
Request for determination of threshold issues refused
I direct that (subject to any application for review of this decision):
i.The Licence Applicants file evidence in support of their applications within 3 months from the date of this decision; and
ii.The patentee file any evidence in answer within 3 months of the day the Commissioner gives it a copy of the evidence in support of the applications and notifies it that all the evidence has been filed; and
iii.The Licence Applicants file any evidence in reply within 2 months of the day the Commissioner gives them a copy of the evidence in answer and notifies them that all the evidence has been filed.
REASONS FOR DECISION
Patent application number 623144 (the patent) was filed on 13 June 1989, and granted on 31 August 1992 to H Lundbeck A/S (Lundbeck). It has had an exceptionally complex litigation history which I will summarise below. The present matter however concerns directions under r. 5.12 which the Commissioner may make for the practice and procedure to be followed in the oppositions by Lundbeck to applications under r. 22.21 for licences to exploit the patent. These were filed by each of Alphapharm Pty Ltd (Alphapharm), Apotex Pty Ltd (Apotex), Aspen Pharma Pty Ltd (Aspen) and Sandoz Pty Ltd (Sandoz) (together, the Licence Applicants). The requests for licences and oppositions thereto have been joined in a single proceeding.
In making directions for the further conduct of the proceedings I will more specifically consider:
a)a request made by the Licence Applicants for the proceedings to be stayed pending final determination of the infringement proceedings brought by Lundbeck against them; and
b) a request by Lundbeck that the Commissioner proceed to decide a number of threshold questions which in its view will result in the applications for licences being dismissed.
The history of the present matter
Citalopram is a compound belonging to the therapeutic category of selective serotonin re-uptake inhibitors. Citalopram is a racemate, meaning that the molecule exists as two mirror-image forms in equal amounts.
The racemate of citalopram is covered by patent 509445 which ceased on 5 January 1993. The racemate was marketed as CIPRAMIL, which was registered on the Australian Register of Therapeutic Goods (ARTG) on 9 December 1997.
The (+)-enantiomer of citalopram, also known as escitalopram, is the active enantiomer. Escitalopram is the subject of the present patent 623144. The normal 20 year term of the patent expired on 13 June 2009.
Escitalopram is marketed under the brand name LEXAPRO. LEXAPRO received ARTG registration on 16 September 2003.
An extension of the term of the patent based on the registration of LEXAPRO was granted on 27 May 2004.
Alphapharm requested rectification of the Register on the basis that the extension of term was wrongly calculated. The Commissioner found that the extension of term should have been based on CIPRAMIL rather than LEXAPRO and recalculated the extension accordingly (Alphapharm Pty Ltd v H Lundbeck A/S [2006] APO 18, 69 IPR 629).
On appeal, Lindgren J held that the extension of term should be removed from the Register (Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559, 76 IPR 618). The Full Court upheld this decision (H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228). The High Court refused special leave to appeal (Alphapharm Pty Ltd v H Lundbeck A/S [2009] HCATrans 324).
On 12 June 2009 (the day after the decision of the Full Court of the Federal Court) Lundbeck filed a new application for an extension of term based on the CIPRAMIL registration, and an application under s. 223 for an extension of time to make the application for an extension of term. The patent expired on 13 June 2009 at the end of its normal 20 year term and shortly after the Licence Applicants launched generic products containing escitalopram.
The extension of time was opposed by Alphapharm, Apotex, Sandoz and Sigma Pharmaceuticals (Australia) Pty Limited. The extension of time was granted by the Commissioner on 1 June 2011 (Alphapharm Pty Limited v H Lundbeck A/S [2011] APO 36, 92 IPR 628). On appeal, the Administrative Appeals Tribunal (AAT) upheld the decision of the Commissioner (Aspen Pharma Pty Ltd and Commissioner of Patents [2012] AATA 851). The decision of the AAT was upheld by the Full Court of the Federal Court (Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCAFC 129). The High Court granted special leave to appeal that decision but the appeal was dismissed on 5 November 2014 (Alphapharm Pty Ltd v H Lundbeck A-S [2014] HCA 42).
In the meantime, the extension of term application had been accepted and opposed by the Licence Applicants (a stay was refused in Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCA 324). On 18 and 20 December 2013 the Licence Applicants filed their applications under r. 22.21 and Lundbeck filed the oppositions on 28 January 2014 resulting in the current proceedings. On 5 March 2014 a delegate of the Commissioner stayed the proceedings pending the outcome of the extension of time and extension of term applications.
The oppositions were heard and the extension of term based on CIPRAMIL was granted by a delegate of the Commissioner on 25 June 2014 (Alphapharm Pty Ltd, Apotex Pty Ltd, Aspen Pharma Pty Ltd, Sandoz Pty Ltd v H Lundbeck A/S [2014] APO 41). The following day Lundbeck commenced infringement proceedings in the Federal Court against the Licence Applicants. The term of the extension granted was to 9 December 2012.
Ultimately the grant of the extension of term was upheld on appeal (Alphapharm Pty Ltd v H Lundbeck A/S [2014] FCA 1185; Alphapharm Pty Ltd v H Lundbeck A/S [2015] FCAFC 138) with the High Court ultimately refusing special leave to appeal on 14 March 2016 (Alphapharm Pty Ltd & Ors v H Lundbeck A/S [2016] HCATrans 52).
The extension of term being finally determined, the delegate notified the parties that the stay of the proceedings had expired and this led to the parties being heard on the future conduct of the proceedings.
The co-pending claims for infringement are before Justice Jagot in Federal Court proceedings NSD 643/2014, NSD 644/2014, NSD 645/2014 and NSD647/2014. Apotex in proceeding NSD 644/2014 has cross-claimed for revocation of the patent.
The nature of the proceedings
As indicated above, on 18 and 20 December 2013 the Licence Applicants filed applications for licenses under r. 22.21. These applications are filed in relation to the extension of time granted to Lundbeck to apply for its extension of term and as a consequence of ss. 223(9). This provides that:
“(9) Where the Commissioner grants:
(a) an extension of more than 3 months for doing a relevant act; or
(b) an extension of time for doing a prescribed relevant act in prescribed circumstances;the prescribed provisions have effect for the protection or compensation of persons who, before the day on which the application for extension of time is advertised under subsection (4), exploited (or took definite steps by way of contract or otherwise to exploit) the invention concerned because of the failure to do the relevant act within the time allowed, the lapsing of the patent application or the ceasing of the patent, as the case may be.”
The ‘prescribed provisions’ are set out in r. 22.21:
“22.21 Protection or compensation of certain persons
(1) The following provisions of this regulation are prescribed for subsections 41(4), 150(4) and 223(9) of the Act.
(2) Persons who availed themselves of or exploited, or took definite steps by contract or otherwise to avail themselves of or exploit, inventions:
(a) in the case of inventions to which subsection 41(4) of the Act applies—in the period mentioned in paragraph 41(4)(c) of the Act; and
(b) in the case of inventions to which subsection 150(4) of the Act applies—after the lapse of the applications and before the day on which their restoration was notified in the Official Journal; and
(c) in the case of inventions to which subsection 223(9) of the Act applies—within the period of time extended under that subsection;
may apply, in the approved form, to the Commissioner for the grant of licences to exploit the inventions.
(3) The Commissioner must give a copy of the application to:
(a) a person whose application was restored under section 150 of the Act; or
(b) a patent applicant or patentee of the application or patent for which an extension of time was granted under section 223 of the Act; or
(c)the patent applicant or patentee of the application or patent to which subsection 41(4) of the Act applies;
and to any other person the Commissioner believes to have an interest in the application.
(4) A person mentioned in subregulation (3) may oppose the grant of the licence to which the application relates.
(5) The Commissioner, if reasonably satisfied that the application should be granted, must grant a licence to the applicant on such terms as the Commissioner thinks reasonable.”
The amendment to s. 223(9) brought about by the Patents Amendment (Innovation Patents) Act 2000 expanded the effect of the section to further ‘prescribed relevant acts’ however these are not relevant for current purposes. Otherwise the section is as enacted in the Patents Act 1990 and the Explanatory Memorandum stated:
“310. Subclause (9) provides that the prescribed provisions have effect for the protection or compensation of persons who exploited an invention in the period between the lapsing of a patent application or ceasing of a patent, and its restoration by virtue of an extension of time for more than 3 months. It is envisaged that the regulations will provide for the granting of a licence under the patent in appropriate circumstances.”
These provisions have been substantially considered by the Commissioner twice - in HRC Project Design Pty Ltd v Orford Pty Ltd [1997] APO 12; (1997) AIPC 91-362; 38 IPR 121 where a licence was granted and in Garden City Planters Pty Ltd v Vivre Veritas Pty Ltd [2012] APO 133 where a licence was refused. Both cases involve circumstances where a patent ceased for failure to pay a renewal fee and was subsequently restored.
In Law v Razer Industries Pty Limited [2010] FCA 1058 Bennett J was considering an application for a stay of infringement proceedings pending the determination of a licence application before the Commissioner. She noted at [15]:
“It is not in dispute that it is for the Commissioner rather than the Court to decide whether or not to grant a licence under s 223(9) of the Act and Reg 22.21 of the Regulations and to determine the terms of such licence as she thinks reasonable. The parties both submit that the Court does not have original jurisdiction to entertain the application for a licence. That is, until the licence application has been determined by the Commissioner, the Court does not have jurisdiction to determine the licence application. Razer submits that Mr Law’s rights as patentee to exploit the Patent, as provided for in s 13 of the Act, are ‘subject to’ the Act such that if Razer has a right to a licence under s 223 of the Act or the Regulations, Mr Law’s rights are subject to Razer’s rights.”
Ultimately she refused the stay on the basis that the alleged infringer did not fall within the scope of s. 223(9) having not acted on knowledge of the ceasing of the patent. Her Honour stated at [27]:
“Section 223(9) of the Act is not designed to protect a person who by happenstance takes steps to exploit a patent during a period in which it is ceased. It cannot be that a person who manufactures and sells products within the scope of the claims of a patent can be protected simply because that person is lucky enough to have commenced those steps while that patent was not in force through an error or omission of the patentee. There must be a link between the fact that the particular patent has ceased and reliance upon that fact by the person seeking to obtain the protection. Regulation 22.21 of the Regulations does not refer to that necessary link but the regulation can rise no higher than the subsection to which it refers and for which it is prescribed.”
The Act and Regulations do not state any grounds for opposition to a licence but the considerations apparent from the cases above appear to be:
· was there relevant exploitation of the invention?
· did the applicant have knowledge of the status of the patent at all material times?
· did the applicant exploit the invention because of the failure to do the relevant act within time?
· should a licence be granted? and, if so
· on what terms?
These factors also appear to be relevant to the present matter however there are a number of unique issues and disputes not arising in previous cases. For example, the applications and the parties’ submissions raise a number of questions of statutory construction concerning s. 223(9) and r. 22.21(2) in the unique circumstances of this case. These include whether ceasing is required to enliven ss. 223(9), if so whether the patent ceased in a relevant sense and what is the effect of “within the period of time extended” in r. 22.21(2). I will not comment on the merits of the arguments made, however these issues are relevant to the directions that I am requested to make in the sense that they may suggest threshold issues of law that might need to be resolved. They also create uncertainty as to the relationship between the current proceedings and matters currently before the Federal Court.
By virtue of the definition in r. 5.2 and r. 5.10(3) the opposition to a licence application is a procedural opposition. The power to determine the conduct of a procedural opposition is provided by r.5.12.
“5.12 Practice and procedure
The Commissioner may:
(a) decide the practice and procedure to be followed in a procedural opposition; and
(b) direct the parties accordingly.”When introduced by the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No. 1), the Explanatory Statement indicated that:
“Under new regulation 5.12, the Commissioner will have the ability to direct, on a case-by-case basis, the appropriate practice and procedures for procedural oppositions – this will include directing evidential timeframes.”
To the extent that the dealing with the licence applications might be considered distinct from the oppositions then r. 22.24 is applicable and applies equivalent powers for the Commissioner to determine practice and procedure:
“22.24 Practice and procedure other than for opposition proceedings
(1) Subject to these Regulations:
(a)if the Act or these Regulations authorise the Commissioner to hear and decide an application or matter that is not an opposition; or
(b)in a matter being decided on the motion of the Commissioner;
the practice and procedure to be followed for the purposes of enabling the application or matter to be decided is to be determined by him or her.
(2)A person to be heard at a hearing may apply to the Commissioner in respect of the practice and procedure in relation to the hearing to be determined by the Commissioner.”
Consequently the Commissioner has broad discretion in determining the practice and procedure of the present proceedings and this is the context in which the requests for a stay and determination of threshold questions are made.
Should a stay be granted
The relevant provisions above do not set out a statutory period in which a licence application must be filed. Therefore it may have been possible for the Licence Applicants to delay seeking a licence until the outcome on infringement is known. However they consider they were obliged to apply due to uncertainty about the requirements of the legislation and the possibility that delay would be taken into account in any discretionary consideration. Consequently the Licence Applicants have made their applications on a ‘without admissions’ basis. They do not concede exploitation but reserve their position should exploitation be found in the co-pending infringement proceedings. They also indicate that failing a stay they could withdraw the applications if they were assured that would be without penalty and without prejudice to any future application. It is not entirely clear how prejudice would arise for the Licence Applicants however I note that, to the extent it is relevant, Lundbeck has refused to give such assurances.
The legislation makes clear that only a person who exploited or took definite steps has a right to apply for a licence. Here the Licence Applicants have applied but do not want to admit exploitation and thereby have a procedural bind of their own making. They however argue that further consideration of the applications is pointless unless a finding of infringement is made and they could only proceed on an assumption of infringement.
It is true that if they are found not to infringe, or the patent is found invalid, the Licence Applicants will not require a licence. However it is not correct to suggest that determination of infringement is a necessary prerequisite to the considerations of their applications. Nothing in s. 223(9) and r. 22.21(2) suggests that an infringement finding or even the existence of infringement proceedings is necessary for the grant of a licence. It might be argued conversely that determination of licence applications is a prerequisite for infringement proceedings given a licence would likely exclude any infringement claim. The previous cases mentioned above appear to have proceeded on this basis.
Rather than a prerequisite it seems more correct to say that, depending on the resolution of questions of statutory interpretation, the Court may make some findings of fact that are relevant to the present proceedings, that is, whether the invention has been exploited. This however does not lead automatically to the conclusion that a stay should be granted (see Cadbury UK Ltd v Registrar of Trade Marks [2008] FCA 1126 and RGC Mineral Sands Limited v Wimmera Industrial Minerals Pty Ltd [1999] FCA 17).
In Cadbury a decision by a delegate of the Registrar of Trade Marks to stay an opposition until resolution of related Federal Court proceedings was overturned because of at least two reasons:
“The first is that to delay opposition proceedings for an indeterminate period, a period that could stretch out to three, four or even more years, amounts to a refusal by the delegate to hear those proceedings. The second reason is that the delegate was asked (and appears to have been prepared) to give too much significance to findings of fact made by the Federal Court.”
On the first of these reasons Finckelstein J expressed his view in relation to opposition proceedings under the Trade Marks Act that:
“[13] In my view the effect of the Trade Marks Act and the Regulations is that the Registrar must take all necessary steps to get opposition proceedings ready for hearing as soon as practicable and thereafter hold the hearing. The merits are determined on the evidence before the Registrar and on the law as it is when the hearing takes place.”
and
“[16] In my view, the suspension of the opposition proceedings for an indefinite period amounted to a denial of justice and a refusal by the delegate to perform her duty to hear and determine those proceedings: R v Whiteway; Ex parte Stephenson [1961] VicRp 26; [1961] VR 168, 170; compare Thornton v Repatriation Commission (1981) 35 ALR 485.”
His Honour however did not entirely preclude the staying of opposition proceedings further stating in relation to the second issue that:
“[21] Sometimes there will be circumstances in which it is appropriate to delay opposition proceedings and await a court’s resolution of disputed facts that may be relevant in opposition proceedings. It is not possible to say with any precision what those circumstances might be. They would include (a) the degree of similarity of the issues involved, (b) the significance of the issues to the opposition proceeding, (c) whether the Registrar has more evidence than the trial judge, (d) the likelihood of the judge’s findings being challenged, and (e) whether it may be unfair (ie a breach of the rules of natural justice) to rely on the judge’s findings or the evidence on which those findings were based. In particular cases other matters will be taken into account.”
While the circumstances considered are different I do not consider that Cadbury is distinguished as suggested by the Licence Applicants. It is relevant because it addresses principles for considering a stay in opposition proceedings before the Commissioner or Registrar. The first of these is the general obligation for the Commissioner to promptly decide a matter properly before her for determination. In this regard, nothing has been submitted nor have I been informed of any orders of the Court that would suggest a definite timeframe for the proceedings to be recommenced on a finding of exploitation. Rather how the further conduct of these proceedings would be accommodated within the infringement proceedings is unclear. In this light, and based on the history of litigation between the parties, it is apparent that any finding by the Federal Court and then resolution of appeals will likely take a very extensive and indeterminate period of time.
To address this point the Licence Applicants suggest staying the proceedings for a fixed period, say 12 months, and then reassessing the position. However this offers only the pretence of a definite stay with no rational justification. There is no certainty that anything will occur within 12 months or subsequently that would make a stay of that length meaningful. Consequently I can only conclude that, if granted, any stay would be prolonged and indeterminate.
Turning next to the potential findings of fact and law by the Federal Court. If the licence applications need to be determined it appears possible that no finding of the Court will be relevant but, if relevant, will not address all matters before the Commissioner. For example, the Court will not need to determine what acts are relevant to the grant of a licence and whether the Licence Applicants exploited the invention because of the failure to do the relevant act within time. Evidence of non-infringing acts of exploitation or definite steps might be put only before the Commissioner and it remains the case that findings of the Court about the same acts, if potentially persuasive, are not binding (SNF (Australia) Pty Ltd v Ciba Specialty Chemicals Water Treatments Limited [2016] APO 8). Given this, and that the alleged acts of exploitation appear factually straightforward (at least prima facie), I do not consider that there is a strong basis for granting a stay to allow some future finding of fact and law by the Court to be taken into account.
There remains the question of whether a stay would otherwise be appropriate when considering the competing public and private interests involved. In relation to the public interest, I agree that this in part may lie in the Commissioner not wasting resources by determining matters that are ultimately moot, for example, if the Licence Applicants are found not to infringe. On the other hand it is at least equally likely that after a long indefinite period the licence applications will need to be determined and there is a strong public interest in the prompt and orderly administration of the legislation which would not be met. The obligation to decide as discussed in Cadbury is also a reflection of this public interest.
By contrast the interests of Lundbeck appear all against a stay. It would very likely add complexity to the infringement proceedings and, if Lundbeck ultimately prevails, would have very substantially delayed final orders providing the remedies for infringement that it has been found entitled to. Determining the Licence Applicants’ eligibility for a licence first would clarify its position and promote earlier resolution of the infringement proceedings even if this was by providing the opportunity for an appeal of the Commissioner’s decision to be heard concurrently.
The prejudice against the Licence Applicants in refusing the stay is less clear. Primarily they are concerned that pursuing the applications would amount to admitting infringement. I do not see that this is necessarily the case. The Court and the Commissioner will consider different matters under the Act and the extent of the relationship between the proceedings is yet to be determined. Normally I would have expected that prompt determination of a licence would also favour a licence applicant in resolving any liability for infringement and potentially avoiding more expensive infringement proceedings. This however is clearly an exceptional case and the Licence Applicants have apparently decided that a stay best serves their interests. That may be so but I do not consider they have presented a compelling argument for a stay that outweighs the considerations already discussed above.
The fact that the Licence Applicants may have the option of withdrawing the present applications and reinstating them at a later time also does not support a stay. That they may have means to preserve their position without being answerable to other interests does not mean that they should then obtain the further benefit of a stay if not otherwise justified. Ultimately it is the Licence Applicants who have instigated the current proceedings and they must weigh up the risks of continuing or withdrawing and seeking to reinstate the proceedings at a later date if necessary. The proceedings cannot be managed for their convenience against interests plainly favouring resolution of the present applications.
Neither does it assist by saying that the provisions of s. 223(9) are beneficial. If so it does not mean that any rights available should remain undetermined at the convenience of the Licence Applicants. The interests of the patentee also need to be considered particular in having the extent of its patent rights clarified without delay.
On balance I consider that I should refuse the Licence Applicants’ request for a stay. The likelihood that a stay would resolve or avoid consideration of matters before the Commissioner is insufficient to justify an indefinite suspension of the proceedings. On the contrary there is significant risk that a stay would unnecessarily delay the resolution of matters encompassed by the licence applications to the prejudice of Lundbeck.
Direction for the further conduct of proceedings
Having decided that the proceedings should not be stayed I must consider how they may be further progressed and make directions accordingly. Lundbeck seeks directions that three threshold issues be decided first. These are the exploitation issue (including what it says is the Licence Applicants’ refusal to acknowledge exploitation), the casual connection issue (the linkage between the failure to do the act and any subsequent exploitation) and the expiry not cessation issue (whether the patent ceased). It asserts that consideration of these issues will result in refusal of the applications.
In the alternative to a stay, or the ability to withdraw without prejudice, the Licence Applicants propose that directions be given to allow determination of all issues save the question of exploitation.
Therefore both parties seek determination of some matters material to the resolution of the applications and oppositions but not all. If I was disposed towards a part determination I consider that it may be more appropriate, as a starting point, to address only the relevant issues of law referred to above rather than the other factual matters identified by the parties. This could clarify significantly the future progress of the oppositions, including evidentiary requirements, and the extent of the linkage with the concurrent infringement proceedings.
However there are difficulties with pursuing a partial determination on any basis. To begin with it might be uncertain whether such a determination is a reviewable decision under r 22.26(2)(vi) which provides review by the AAT of decisions to grant or not grant a licence (see Stylis and Commissioner of Patents [2014] AATA 796). Nevertheless, whether by the AAT or by judicial review it would seem inevitable that a challenge would be made leading to very lengthy delays in reaching a final determination of the proceedings which would also be subject of appeal. Having multiple decisions and lines of appeal suggests very significant inefficiencies in resolving the current proceedings that would provide no better advantage than a stay.
Lundbeck might argue that its proposed course would lead to prompt dismissal of the applications, at least on the failure to concede exploitation. While perhaps giving it a tactical victory this however does not account for the possibility of further licence applications being made at a later stage when exploitation is either found or conceded. There would therefore be a significant likelihood that the question of the availability of licences would not be finally resolved. In the alternative while the Licence Applicants’ proposal has the benefit of at least allowing more of the proceedings being determined it still will result in substantial delay and fragmentation of the proceeding without clear advantages.
Otherwise, contrary to Lundbeck’s submissions, it is unusual for the Commissioner to separately determine questions in opposition matters. Dismissals of an opposition because of inadequate particularisation, or final determination after an opportunity to amend, are very different to what is proposed here. Rather, the practice is to hear and determine all issues at one time. This appears to be consistent with the approach in the Federal Court where the “ordinary course” is for all issues of fact and law in a proceeding to be decided at the same time (Latteria Holdings Pty Ltd v Corcoran Parker Pty Ltd (No 2) [2014] FCA 1378 and Reading Australia Pty Ltd v Australian Mutual Provident Society [1999] FCA 718).
Departure from that approach requires that it be “just and convenient” to do so (Shape Shopfitters Pty Ltd v Shape Australia Pty Ltd [2016] FCA 610). The circumstances of this case and the matters already referred to do not suggest any partial determination will promote early and efficient determination of proceedings and consequently I will not make directions of that type.
I will rather make directions for the filing of evidence toward the determination of all issues together. This presents a clear choice for the Licence Applicants on whether they intend to proceed with the applications but in my view it is appropriate that it falls to them to resolve the difficulty of filing the applications while not admitting circumstances that are a prerequisite for those applications to be made.
In the circumstances of this matter I consider that it is more appropriate for the Licence Applicants to first file evidence in support of their applications, followed by any evidence in answer that Lundbeck intends to rely on. Based on the submissions and the relative complexity of the matter I will permit the same periods for the filing of evidence that applies to substantive oppositions.
Conclusion
I refuse the Licence Applicants’ request for a stay of the proceedings. I also refuse Lundbeck’s request for a determination of “threshold” issues.
Rather I will make directions for the filing of evidence towards the determination of all issues.
Costs
To the extent that Schedule 8 Part 1 is relevant to the hearing of the present matter I make no award of costs.
P M Spann
Deputy Commissioner of Patents
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