Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd

BURLEY J: 1 In proceedings commenced on 20 August 2018 the applicants (collectively, Sanofi) seek relief including declarations and orders restraining the respondent (Alphapharm) from infringing certain claims of Australian Patent No. 2009304105 entitled "Drug delivery device and method of manufacturing a drug delivery device" (patent). They also seek relief arising from claims under the Australian Consumer Law as contained in Schedule 2 of the Competition and Consumer Act 2010 (Cth). Interlocutory relief is sought in the originating application for orders to restrain Alphapharm from launching a product that is said to infringe certain claims of the patent (injunction application). The impugned device for the purpose of the injunction application is, I understand, an insulin glargine injector pen called SEMGLEE. The hearing of the injunction application has been set down for 2 November 2018. 2 Also on 20 August 2018, Sanofi filed an interlocutory application seeking orders pursuant to s 105 of the Patents Act 1990 (Cth), amending the claims of the patent (s 105 application). No date has been fixed for the hearing of the s 105 application. 3 Alphapharm has served a notice to produce (notice) in advance of the hearing of the injunction application in the following terms: (1) All documents, including correspondence, memoranda, reports and legal and patent attorney advices, created or brought into existence during the period following 17 November 2015, recording or evidencing an assessment of: (a) the invalidity of any of claim 1 to 4 of the Australian Patent AU 2009304105 (the Patent) having regard to the prior publication of DE 10 2005 032 705 A1 (Burren - D1) or GB 743 839 (Schofield - D2) or any equivalents thereof; (b) whether and how the proposed amendments sought in the First Applicants' application to amend the Patent dated 20 August 2018 (Amendment Application) would address any validity concerns in relation to any of claims 1 to 4 of the Patent. (2) All documents, including correspondence, memoranda, reports and legal and patent attorney advices, created or brought into existence during the period following 13 May 2013, recording or evidencing an assessment of: (a) the invalidity of any of claim 1 to 4 of European Patent Number 2346552 in the form of those claims as at the date of grant or pursuant to the first auxiliary request (as referred to in the European Patent Office (EPO) Oral Hearing on 17 November 2017) having regard to the prior publication of Burren - D1 or Schofield - D2 or any equivalents thereof; (b) whether and how any application or request to amend the abovementioned claims in terms or substantially in terms as the Amendment Application would address any validity concerns in relation to any of the abovementioned claims. (3) All documents, including correspondence, memoranda, reports and legal and patent attorney advices, created or brought into existence during the period following 17 November 2015, recording or evidencing an assessment of: (a) the invalidity of any claim in EP(FR) 2346552, EP (IT) 2346552 and US Patent Number 9,132,237 that correspond to any of claim 1 to 4 of the Patent having regard to the prior publications of Burren - D1 or Schofield - D2 or any equivalents thereof; (b) whether and how any application or request to amend the abovementioned claims in terms or substantially in terms as the Amendment Application would address any validity concerns in relation to any of the abovementioned claims. 4 Sanofi seeks orders setting aside the notice. In response, Alphapharm relies on an affidavit sworn by Robert Kelvin Cooper of MinterEllison, the solicitors representing Alphapharm, on 10 September 2018, and an affidavit affirmed by Lisa Anne Taliadoros of Jones Day, the solicitors representing Sanofi, on 7 September 2018. 5 There is some pressing need for resolution of the issue, given the proximity of the hearing date. Set out below are my short form reasons for acceding to Sanofi's application to set aside the notice. 6 The notice has been served in anticipation of the hearing of Sanofi's injunction application to restrain the sale of the SEMBLEE device. As I made clear during the course of the hearing, these reasons do not touch upon the relevance or suitability of the supply by Sanofi of documents relevant to its s 105 application, whether by way of discovery or otherwise. 7 Sanofi's injunction application will be determined having regard to whether it has established a prima facie case in the sense explained in Beecham Group Ltd v Bristol Laboratories Pty Ltd [1968] HCA 1; 118 CLR 618 at 622-623, and whether the balance of convenience and justice favours the grant of an injunction or the refusal of that relief. See generally Australian Broadcasting Corporation v O'Neill [2006] HCA 46; 227 CLR 57 (Gummow and Hayne JJ) at [65] and Samsung Electronics Co Ltd v Apple Inc [2011] FCAFC 146; 217 FCR 238 at [60] - [67]. 8 Alphapharm contends that the notice is appropriate in the circumstances of the present application because the documents sought are expected to demonstrate that Sanofi has known or suspected since at least November 2015 (when the first applicant sought to amend an equivalent European patent in substantially the same terms as now sought in the amendment application) that the relevant claims of the patent are or may be invalid. Broadly summarised, Alphapharm submits that the documents sought are relevant first, to the strength of its prima facie case that the claims asserted are invalid for want of novelty, and secondly because the delay in seeking to amend the patent may be characterised as "blameworthy conduct" on the part of Sanofi if it is shown that Sanofi deliberately stayed its hand in seeking to amend the patent prior to the current injunction application. In this latter regard, Alphapharm points to the evidence of Ms Taliadores, which indicates that two items of prior art were first relied upon in May 2013 to oppose the grant of the European equivalent patent in the EPO. Prior to the hearing before the EPO, Sanofi proposed a number of amendments to the patent application which it contended should be permitted in the event that its arguments concerning the irrelevance of the prior art documents were rejected. At the hearing on 17 November 2015, the EPO rejected Sanofi's arguments, but permitted Sanofi to amend the claims to a further form. Subsequently, Sanofi has filed applications to amend equivalent patents in France and Italy in May and June 2018 respectively. In August 2018, it sought to amend the patent in Australia. It also sought to amend the equivalent US patent in November 2015. 9 The first argument advanced by Alphapharm should be rejected. In the context of the application for an interlocutory injunction (as opposed, I emphasise, to the s 105 application), the subjective views of Sanofi as to the strength or weakness of the patent can have little rational role to play. The infringement and validity of a patent are to be determined objectively. The production of documents recording or evidencing an assessment of the validity of the claims on the part of Sanofi or its legal advisors are not likely reasonably to add, in some way or another, to the relevant evidence going to the question of prima facie case (to paraphrase the apparent relevance test set out in Seven Network Ltd v News Ltd (N0 11) [2006] FCA 174 at [6]). 10 The second argument tends to conflate aspects of evidence relevant to the injunction application with those relevant to the s 105 application and should also be rejected. In the injunction application, Sanofi's application is based on the patent in its current form. Questions of the strength of Sanofi's infringement case and Alphapharm's proposed invalidity case will be determined on the basis of that form of the patent. Sanofi has not sought to agitate its amendment application in advance of the interlocutory injunction application. Accordingly, the interlocutory rights of Sanofi will be considered, having regard to the unamended version of the patent. 11 The principles relevant to the grant of the s 105 application are well established and have been set out in Apotex v Les Laboratoires Servier and anor (No 4) [2015] FCA 104; (2015) 111 IPR 160 (Apotex); and on appeal in Les Laboratoires Servier and Another v Apotex Pty Ltd [2016] FCAFC 27; (2016) 247 FCR 61 at [243]. One material factor is the exercise of discretion to allow or refuse an amendment; see, for example Apotex at [161] ff. Matters of delay; knowledge of the need to amend; that a patentee has obtained substantive relief on the unamended form of the patent, without first amending; and knowledge of weaknesses in the patent as granted may be relevant in that context, but these are matters for another day. 12 For present purposes, the question of whether Sanofi has known or suspected that an amendment application "should" be made is not likely reasonably to add to the relevant evidence going to the question of balance of convenience. Such evidence could be speculative, because Sanofi's application to amend may not proceed or may ultimately be refused. 13 Further, it is to be noted that the origin of the amendment applications made in Europe and referred to in the affidavit of Ms Taliadores appear to lie in the decision of the EPO, applying the law of novelty as it is understood in the European Community. It is appropriate to be cautious as to the relevance of decisions made in jurisdictions which have different substantive and procedural laws concerning patentability; Neurim Pharmaceuticals (1991) Ltd v Generic Partners Pty Ltd [2018] FCA 1082 at [47]. The production sought in paragraphs 2 and 3 of the notice drifts yet further from relevance to the current interlocutory injunction application in that regard because they seek production of documents relevant to the amendment of European and US patents. 14 Alphapharm submits that if the injunction sought is granted on the current form of patent, but an amendment application is ultimately allowed, then that will cause it harm that cannot be recompensed because it could never test the validity of the unamended claims at final hearing. It adds that documents that show that Sanofi stayed its hand in amending could enhance its arguments during the hearing of the injunction application. However, Alphapharm's argument does not so much depend on deliberate conduct on the part of Sanofi, as the harm to Alphapharm consequent upon an amendment. The evidence of the chronology of events leading to the present s 105 application is present in Ms Taliadores' affidavit. I do not consider that the documents sought in the notice are likely materially to advance matters further such as to warrant the production of the type of documents now sought. 15 Finally, I should be inclined to consider the breadth of each paragraph in the notice to be too wide in the circumstances, seeking, as it does, all documents recording or evidencing the provision of the named assessments of validity. However, as I have concluded that the documents sought are not sufficiently relevant to warrant permitting production in accordance with the notice, it is not necessary to engage in a detailed consideration of this aspect of the notice. 16 Accordingly, the notice should be set aside. Alphapharm should pay Sanofi's costs of the application. I certify that the preceding sixteen (16) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Burley.