Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd

National Practice Area: Intellectual Property

Sub-area: Patents and associated Statutes

Date of last submissions: 13 April 2021

Date of hearing: 30 March 2021

Counsel for the Prospective Applicants: Mr D Shavin QC with Ms C L Cochrane

Solicitor for the Prospective Applicants: DLA Piper Australia

Counsel for the Prospective Respondent: Mr J S Cooke with Mr D B Larish

BETWEEN: PFIZER IRELAND PHARMACEUTICALS First Prospective Applicant

PFIZER AUSTRALIA PTY LTD Third Prospective Applicant

AND: SAMSUNG BIOEPIS AU PTY LTD ACN 611 890 094 Prospective Respondent

order made by: BURLEY J DATE OF ORDER: 18 November 2021

1. The parties confer and, by 25 November 2021, provide to chambers short minutes of order giving effect to these reasons marked-up to indicate any areas of disagreement.
2. In the event there is any disagreement as to the appropriate form of short minutes: (a) the prospective applicants file and serve, by 2 December 2021, written submissions of no more than five pages; and (b) the prospective respondent file and serve, by 9 December 2021, responsive written submissions of no more than five pages; in support of the form of the proposed short minutes sought.
3. Pursuant to s 37AI of the Federal Court of Australia Act 1976 (Cth) and on the ground that it is necessary to prevent prejudice to the proper administration of justice, the text of the reasons for judgment published today is to be published and disclosed only to the external legal representatives of the parties.
4. The parties confer and provide to chambers, by 2 December 2021, an agreed form of the reasons for judgment that is suitable for publication, with redactions noted.
5. The proceedings be listed for a case management hearing at 9.30am on 13 December 2021. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT 1 INTRODUCTION [1] 1.1 Background [1] 1.2 Summary of conclusions [10] 1.3 The evidence [12] 1.4 The May 2019 Orders [25] 1.5 Different processes for making etanercept [31] 1.6 The documents now sought [36] 1.7 The entities who manufacture etanercept for the Brenzys products [38] 2 RELEVANT LAW [42] 3 THE DISPUTES [55] 4 CONSIDERATION [65] 4.1 Introduction [65] 4.2 Request 2 [68] 4.3 Request 4 [116] 4.4 Request 6 [138] 4.5 Continuing discovery and FCR 7.23 [139] 4.6 Sabre-style orders [151] 5 DISPOSITION [157]

1.1 Background 1 The prospective applicants, Pfizer Ireland Pharmaceuticals, Wyeth LLC and Pfizer Australia Pty Ltd (collectively, Pfizer) received on 17 June 2019 preliminary discovery documents from the prospective respondent, Samsung Bioepis AU Pty Ltd (SBA). In its present interlocutory application, Pfizer contends that it is entitled to the production of further documents pursuant to r 7.23 of the Federal Court Rules 2011 (Cth) (FCR), continuing discovery and orders that SBA be compelled to request the production of documents from third parties. SBA opposes the orders sought. 2 The parties have not moved swiftly in these proceedings. That is in part because of their inherent complexity. The prospective proceedings that Pfizer may bring against SBA concern the infringement of claims in three patents: (1) patent no. 2005280036 entitled "Production of TNFR-Ig fusion protein" (036 patent) which is said in the specification to provide an improved system for large scale production of proteins and/or polypeptides in cell culture; (2) patent no. 2005280034 entitled "Production of polypeptides" (034 patent) which has substantially the same specification as the 036 patent, but differently worded claims; and (3) patent no. 2008242632 entitled "Use of low temperature and/or low pH in cell culture" (632 patent) which is said to provide methods of improving protein production by cultured cells, especially mammalian cells. The methods claimed in these patents relevantly relate to the production of the biological medicine etanercept, which is used in the treatment of autoimmune diseases. Pfizer suspects that the processes used to make the etanercept in SBA's product "Brenzys" (Brenzys process) may infringe those patents. To the complexity of the underlying science must be added that caused by the fact that the process used to make etanercept for the Brenzys products is highly confidential. Furthermore, neither party has taken a backward step in the protection of its legal interests, as the range of disputes ventilated in the present application will demonstrate. 3 In 2017 I dismissed Pfizer's originating application seeking preliminary discovery: Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285 (Pfizer No 1). That decision was overturned by the Full Court in Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCAFC 193; 257 FCR 62 (Allsop CJ, Perram and Nicholas JJ) (Pfizer FFC). The Full Court ordered SBA to give preliminary discovery and remitted the matter for me to determine the final form of orders providing for discovery and any questions of confidentiality and costs. 4 The parties were able to agree the scope of the discovery then to be given, but not to other issues, and outstanding matters going to the confidentiality regime to be applied and costs were addressed in Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (No 2) [2019] FCA 657 (Pfizer No 2). I made orders going to the scope of discovery on 20 May 2019 (May 2019 Orders). 5 These reasons assume familiarity with Pfizer No 1, Pfizer FFC and Pfizer No 2. 6 On 17 June 2019 SBA gave discovery verified by an affidavit given by Sung Soo Jun, Director of SBA, and inspection of some 52 listed documents comprising about 4,000 pages followed. A further dispute developed between the parties as to the terms of a confidentiality undertaking, and in September 2019 Pfizer filed an interlocutory application seeking to vary the May 2019 Orders. During a hearing in December 2019 the parties resolved their differences. No substantive change was made to the classes of documents that were required to be discovered, although other aspects of the May 2019 Orders were varied by consent in orders made in December 2019 (December 2019 Orders). 7 The present interlocutory application was filed on 7 September 2020 and has been amended twice, most recently on 16 November 2020. The orders sought by Pfizer are, in broad terms: (1) that SBA provide further preliminary discovery responsive to requests identified in an annexure to the application; (2) that SBA give continuing discovery and inspection to Pfizer of any documents meeting the definition of "Discovery Documents" in paragraph 1 of Annexure A to the December 2019 Orders; and (3) that SBA take all reasonable steps available to obtain copies of any of the documents in (1) that are not in its possession, custody or control from each of Samsung Bioepis Co Ltd (SBK), Biogen MA Inc, Fujifilm Corporation and Fujifilm Diosynth Biotechnologies Denmark ApS (Fujifilm Denmark). These orders are said to be in a form first used by Lockhart J in Sabre Corporation Pty Ltd v Russ Kalvin's Hair Care Company (1993) 46 FCR 428. 8 SBA opposes orders (1) and (2), and opposes order (3) except insofar as it concerns the taking of reasonable steps to obtain documents from SBK (assuming either of orders (1) or (2) are made). 9 It is not in dispute that most of the documents in the proceedings are highly confidential containing, as they do, information owned or possessed by SBA or its affiliates going to their secret processes for the manufacture of etanercept. As a consequence, not only most of the evidence, but substantially all of the written and oral submissions are confidential. Accordingly, although regrettable, the present case is a rare example where parts of these reasons must remain confidential.

1.2 Summary of conclusions 10 For the reasons set out below I have: (1) found that Pfizer is entitled to further preliminary discovery in a narrower form than that sought; (2) confined the further preliminary discovery to documents arising from four commercial batches of etanercept (defined below as the process A and process B batches); (3) found that Pfizer is not entitled to continuing discovery under FCR 7.23; and (4) declined to make any Sabre-style order. 11 I will direct that the parties provide short minutes of order reflecting the conclusions that I have reached within seven days of the provision of these reasons.

1.3 The evidence 12 The evidence relied upon by Pfizer is as follows. 13 Four affidavits affirmed by Neysi Ibarra, Director and Group Leader, Process Development, Manufacturing Science and Technology at Pfizer Ireland Pharmaceuticals on 5 January 2017, 31 January 2017, 6 February 2017 and 8 February 2017 in support of the application referred to in Pfizer No 1. 14 Four affidavits affirmed by Nicholas Tyacke, solicitor on the record for Pfizer. In Mr Tyacke's first affidavit, dated 7 September 2020, he exhibits correspondence between the parties and sets out, in a series of lengthy confidential attachments, evidence addressing Pfizer's application as it stood at that date. Of most immediate relevance is his evidence concerning Professor Hearn, the independent expert retained by Pfizer who has been provided with access to the discovery documents. Mr Tyacke records that he is informed by Professor Hearn, and believes, that by reason of Professor Hearn's knowledge and experience, Professor Hearn is able to express the opinions that Mr Tyacke refers to in his affidavit and its annexures. Mr Tyacke does not set out the instructions given to Professor Hearn, but in the many pages of evidence that follow it may be deduced that Professor Hearn was broadly asked to offer his opinion as to whether the discovery documents supplied by SBA were sufficient to enable him to express an opinion as to whether the process by which the etanercept in SBA's Brenzys products is manufactured falls within the claims of the patents and whether it is likely that SBA or SBK have those documents in their control. 15 Mr Tyacke's second affidavit, dated 6 October 2020, addresses Pfizer's application for continuing discovery. 16 Mr Tyacke's third affidavit, dated 16 November 2020, provides evidence in support of Pfizer's contention that documents are in the hands of Biogen, Fujifilm and/or Fujifilm Denmark. 17 Mr Tyacke's fourth affidavit, dated 26 February 2021, responds to the evidence filed by Professor Mahler and Mr D'Aloisio. In relation to Professor Mahler, Mr Tyacke responds by providing further evidence on information and belief from Professor Hearn. It is curious that Professor Hearn did not provide an affidavit himself. No explanation is provided for the course adopted by Pfizer. However, an application for preliminary discovery is interlocutory in character: Pfizer FFC at [79] (Allsop CJ); Aristocrat Technologies Australia Pty Limited v Ainsworth Game Technology Limited [2018] FCA 1511 at [27] (Yates J). Accordingly, evidence given on information and belief may be admissible pursuant to s 75 of the Evidence Act 1995 (Cth). No objection was taken to the reception of Mr Tyacke's evidence in this form. 18 As I have noted, Professor Hearn did not provide affidavit evidence. On 23 February 2021 he did, however, give a report (Hearn Report) addressed to Mr Islam of Pfizer, in which he says that he was asked to provide his opinion regarding whether: (1) the processes used to manufacture the etanercept in the Brenzys products may be within the scope of the claims of the patents; (2) whether one or more of SBA, SBK, Biogen or Fujifilm Denmark is likely to have documents in their control that are not yet discovered and which are directly relevant to the processes used in the Brenzys process; and (3) whether it is likely that SBA would be able to obtain such documents upon request from SBK, Biogen and Fujifilm Denmark. The Hearn Report records that confidentiality orders do not permit him to disclose the contents of confidential material in his report to Pfizer. The opinions that he gives are as follows: 30. In my opinion, based on the information available to me, and my knowledge and experience outlined in Section 2, above, the process(es) used to manufacture the etanercept in the Brenzys Products may be within the scope of the claims of the Patents. 31. I have considered the Second Mahler Affidavit carefully. I disagree with opinions expressed in the Second Mahler Affidavit. I am unable to discuss the substance of these differences of opinion in this report as it is to be provided to Pfizer and I am significantly constrained by the Court's Orders as to what material I can disclose from the Discovery Documents, as I have discussed at paragraph 7 above. Notwithstanding matters contained in the Second Mahler Affidavit, I maintain my opinion set out in paragraph 30 above. 32. The Discovery Documents omit information and data that are directly relevant to whether the process(es) used to manufacture the etanercept in the Brenzys Products are within the scope of the claims of the Patents, with the result that it has been necessary for me to base my opinion expressed in paragraph 30, above, in part, upon theoretical assumptions made by me and inferences drawn by me from the Discovery Documents. 33. In my opinion, based on the information available to me and my own knowledge and experience, one or more of the Prospective Respondent, SBK, Biogen, and/or Fujifilm is likely to have documents in its control that have not yet been discovered that: a. are directly relevant to whether the process(es) used to manufacture the etanercept in the Brenzys Products are within the scope of the claims of the Patents; and b. could cause me to change my opinion expressed in paragraph 30, above, because they could contain information and data that may confirm or undermine, wholly or partly, the theoretical assumptions I have made and the inferences I have drawn from the Discovery Documents. 34. In my opinion, based on the information available to me and my own knowledge and experience, it is likely that the Prospective Respondent would be able to obtain such documents upon request from SBK, Biogen and Fujifilm. 19 It may be seen that these opinions are not supported by reasoning, but represent conclusions. To the extent that reasoning is available, it is apparently to be gleaned from the opinions of Professor Hearn supplied, on information and belief, in evidence from Mr Tyacke. There is no dispute that Professor Hearn is an experienced and qualified expert in the field relevant to the patents. 20 In an affidavit affirmed by Shahan Islam, senior corporate counsel at Pfizer Inc., the parent company of each of the prospective applicants, Mr Islam identifies himself as being the person with relevant authority to make the decision to commence proceedings against SBA. He exhibits the Hearn Report and gives evidence that, on the basis of Professor Hearn's opinions set out therein at paragraphs 30, 31 and 36, he believes that Pfizer may have the right to obtain relief from SBA. He gives evidence that in order to make a decision to commence proceedings or not it is necessary for him to assess the likelihood of SBA having defences to patent infringement allegations in the form of complete or partial answers to Professor Hearn's opinion that the Brenzys process(es) may be within the scope of the claims, and in doing so it is also necessary for him to assess the potential costs and risks of the litigation. He refers to paragraphs 30-34 of the Hearn Report and gives evidence that in circumstances where he is unable to see the discovery documents (because of confidentiality orders), he relies on the skill, knowledge and experience of Professor Hearn and the opinions given by Professor Hearn as providing the basis for his belief that he does not have sufficient information to make the decision. He contends that without the additional information sought by Professor Hearn, he is unable to assess the likelihood of SBA having defences to patent infringement allegations and the potential costs and risks of the litigation. He relies on Professor Hearn's opinion that SBA may have, or could obtain upon request, additional documents directly relevant to Pfizer's right to obtain relief. He further relies on Professor Hearn's opinion to support his view that the documents sought in the application would assist in making the decision to commence proceedings. 21 The evidence relied upon by SBA is as follows. 22 An affidavit affirmed by Young-Phil Lee, head of cell engineering at SBA, on 26 January 2017. This affidavit was relied upon for the purposes of Pfizer No 1. 23 Affidavits affirmed by Stuart D'Aloisio, solicitor on the record for SBA, on 27 September 2019, 18 December 2020 and 17 March 2021. In the first of these Mr D'Aloisio provides the history of the discovery given by SBA. In his affidavit of 18 December 2020, he provides some evidence on information and belief from Dr Son, Senior Legal Counsel - Intellectual Property Group of SBK, and responds to the affidavits of Mr Tyacke of 7 September 2020, 6 October 2020 and 16 November 2020. In his affidavit of 17 March 2021, Mr D'Aloisio responds to the final affidavit of Mr Tyacke. 24 Affidavits affirmed by Professor Stephen Mahler on 27 January 2017, 18 December 2020 and 17 March 2021. Professor Mahler's qualifications are identified in Pfizer No 1 and were not called into question in this application. His affidavit of 27 January 2017 was made in opposition to the application the subject of Pfizer No 1. In his affidavit of 18 December 2020 Professor Mahler responds to instructions to set out his understanding of aspects of the claims of the 034 and 036 patents. He was supplied with the discovery documents and gives evidence that they provide him with sufficient information to reach a conclusion as to whether or not the Brenzys process would fall within the aspects that he addresses. In his affidavit of 17 March 2021 Professor Mahler responds to the evidence given in the fourth affidavit of Mr Tyacke concerning Mr Hearn's opinions in answer to Professor Mahler's earlier affidavit.

1.4 The May 2019 Orders 25 Order 1(a) of the May 2019 Orders required SBA, within 28 days, to give verified discovery and inspection of copies of parts of four identified submodules of the Common Technical Document (CTD) submitted to the Therapeutic Goods Administration (TGA) in relation to the Brenzys products the subject of two registrations on the Australian Register of Therapeutic Goods (ARTG), defined as the CTD Submodules Extracts. Discovery under order 1(a) was to be in respect of eight different types of information that were then identified in sub-paragraphs 1(a)A-H of the May 2019 Orders, defined collectively as the Relevant Matters. 26 Included within the Relevant Matters are: C. the nature and point in time of any change that is applied to the culture conditions (for example, pH, temperature, osmolality, chemical inductant level) up until the time when the supernatant is harvested from the cells and the viable cell density when the change is applied; D. initial cell density and viable cell density for the duration of the culture; and F. pH and temperature at all times up until the time when the supernatant is harvested from the cells. 27 Order 1(b) required production of the following, defined as the Batch Record Extracts: a copy of those parts of all drug substance batch records insofar as they concern the Relevant Matters for the cell culture process used as part of the manufacture of all batches of etanercept drug substance for the Brenzys Products produced for the Australian market (Batch Record Extracts). 28 It may be inferred that the parties agreed that the production of the CTD Submodules Extracts and Batch Record Extracts would assist Pfizer to make a decision whether or not to commence proceedings for patent infringement of one or more of the three patents in respect of which the preliminary discovery application was made. 29 The May 2019 Orders did not require SBA to discover or produce documents relating to batches of etanercept produced for the purposes of gaining regulatory approval in Australia, although the documents produced made reference to such batches. 30 Order 3 provided that should the documents discovered not provide sufficient information in Pfizer's reasonable opinion for it to determine whether to commence a patent infringement proceeding then, absent agreement to further production, it may approach the Court for further orders.

1.5 Different processes for making etanercept 31 The evidence adduced by SBA enables the following findings to be made for the purposes of the present interlocutory application. 32 The etanercept manufactured for the Brenzys products has been produced for the Australian commercial market (commercial batches) using two different cell culture processes which are referred to as process A and process B. 33 By the time that the discovery documents were produced in June 2019 four batches of etanercept had been produced and used in the Brenzys products. Two batches were produced using process A, and two using process B. The documents produced provide Batch Record Extracts for these four batches (the process A and process B batches). SBA does not intend to use process A in the production of future batches of etanercept. 34 By the time of the hearing there had been 13 more batches made using process B (further commercial batches). There is a dispute about whether SBA should be required to give production in relation to those additional batches. 35 The CTD Submodules Extracts produced form part of the documents that were supplied to the TGA prior to discovery being given on 17 June 2019. They include information about batches of etanercept that have not been incorporated into the Brenzys products supplied in Australia. Those batches are identified as regulatory batches because they were made and used as part of the product development process or as part of a process validation run (PVR). There is a dispute about whether SBA should produce documents relating to such regulatory batches in this application.

1.6 The documents now sought 36 The documents sought by Pfizer are identified in a confidential annexure to its further amended interlocutory application, as amended in its written submissions in reply. Initially it sought six categories of documents which were winnowed down to three categories by the time argument was heard. Requests 2 and 4 seek documents concerning the cell culture processes used to prepare the etanercept used in the Brenzys products. Request 6 seeks seven specific documents, and any counterpart or corresponding documents, identified by Professor Hearn of which, he contends, the discovery documents demonstrate the existence. 37 In addition, Pfizer seeks the production of batch records and later CTD submodules relating to the further commercial batches.

1.7 The entities who manufacture etanercept for the Brenzys products 38 There is a dispute between the parties as to whether or not SBA should be required to request documents from one or other of Biogen, Fujifilm and Fujifilm Denmark. The evidence as to the relationship between SBA (and SBK) and those companies may be summarised as follows. 39 Mr D'Aloisio gives evidence that he is informed by Dr Son and believes the following matters: (a) since November 2018, Biogen Therapeutics Inc., a subsidiary of Biogen Inc., has had a 49.9% shareholding in SBK, but the Samsung Bioepis group of companies (being SBK and its subsidiaries) conduct themselves as separate corporate groups and are independently managed; (b) the Samsung Bioepis group operates at arm's length from the Biogen group; (c) the Biogen group of companies worked with the Samsung Bioepis group on the etanercept cell culture process development, but that work was completed in 2015; (d) Biogen (Denmark) Manufacturing ApS, under the control of Biogen Inc., manufactured all commercial batches of etanercept prior to August 2019, after which manufacturing was carried out at Biogen's manufacturing facility in Denmark; (e) in August 2019, Biogen's manufacturing facility in Denmark was transferred to the Fujifilm group of companies after Fujifilm acquired Biogen (Denmark) Manufacturing; and (f) if a request were to be made by SBA or SBK to any companies within the Biogen group to produce documents responsive to Pfizer's requests, none of the companies would be "under any contractual or other obligation to produce such documents". 40 Mr D'Aloisio also gives evidence on information and belief from Matthew Swinn, a partner of King & Wood Mallesons (KWM), the solicitors who act for Biogen, that Biogen is under no contractual or other obligation to SBA to provide any of the documents now sought by Pfizer, including requests 2, 4 and 6. In a letter dated 3 November 2020, KWM wrote to DLA Piper, the solicitors representing Pfizer, informing them that since manufacture passed to Fujifilm, Biogen is no longer involved in the process. It says: Biogen believes that much of the detailed information sought by Requests 2 - 5, such as continuous data about conditions such as temperature, pH, or lactate and ammonium levels taken from probes within the bioreactors used to manufacture the etanercept products, would be in the possession of Fujifilm Denmark as the manufacturer of the etanercept products. As mentioned above, Biogen no longer has possession, custody, power or control over the documents held by Fujifilm Denmark, nor does it have any basis for believing that Fujifilm Denmark would be prepared to provide Biogen with documents responsive to Requests 2 - 5 upon request. 41 When it was informed of the manufacturing arrangements for the etanercept used in the Brenzys products, Pfizer wrote to Fujifilm. Fujifilm responded on 28 January 2021 saying: [SBA] and Fujifilm Denmark are two entirely separate entities, whose relationship is that of customer and supplier. Even if Fujifilm Denmark were to identify documents in its possession relevant to Pfizer's requests and notwithstanding the execution of the confidentiality undertakings, it would be inappropriate for Fujifilm Denmark to voluntarily provide such documents when, as we understand it, [SBA] is contesting Pfizer's entitlement to receive them.

2. RELEVANT LAW 42 FCR 7.23 is contained within "Part 7-Orders before the start of a proceeding" and provides: 7.23 Discovery from prospective respondent (1) A prospective applicant may apply to the Court for an order under subrule (2) if the prospective applicant: (a) reasonably believes that the prospective applicant may have the right to obtain relief in the Court from a prospective respondent whose description has been ascertained; and (b) after making reasonable inquiries, does not have sufficient information to decide whether to start a proceeding in the Court to obtain that relief; and (c) reasonably believes that: (i) the prospective respondent has or is likely to have or has had or is likely to have had in the prospective respondent's control documents directly relevant to the question whether the prospective applicant has a right to obtain the relief; and (ii) inspection of the documents by the prospective applicant would assist in making the decision. (2) If the Court is satisfied about matters mentioned in subrule (1), the Court may order the prospective respondent to give discovery to the prospective applicant of the documents of the kind mentioned in subparagraph (1)(c)(i). 43 FCR 7.21 defines a "prospective respondent" as: a person, not presently a party to a proceeding in the Court, against whom a prospective applicant reasonably believes the prospective applicant may have a right to obtain relief. 44 The law relevant to FCR 7.23(1)(a) was considered in Pfizer FFC. In that case, the Full Court determined that Pfizer had established that it reasonably believes that it may have the right to relief from SBA. As Perram J observed, Pfizer put forward a case that rested on six circumstantial steps and a final deductive step yielding a conclusion that there were grounds to think that the Brenzys products had been produced using the patents: Pfizer FFC at [127]. Notably, the circumstantial steps did not involve close analysis of the claims potentially in suit. The case advanced by Pfizer was that because there was a reasonable basis for the belief that SBA was using the same manufacturing process in the second phase of its etanercept production as Pfizer (the sixth step), and because Pfizer's process fell within the scope of the claims, it must follow that the process used to make the etanercept for the Brenzys products also uses the processes described in the patents (the deduction): Pfizer FFC [127(vi)]-[127(vii)]. It is not incumbent upon a prospective applicant to establish every element of a relevant cause of action but, instead, that it may have the right to the relief alleged: see also Optiver Australia Pty Ltd v Tibra Trading Pty Ltd [2008] FCAFC 133; 169 FCR 435 at [48] (Heerey, Gyles and Middleton JJ). 45 In this application, SBA attempts at various times to reanimate the debate on the subject of FCR 7.23(1)(a). However, in my view, such attempts are inappropriate, except where they are made by reference to specific factors that support the contention that the circumstances have changed such that the basis for the Full Court's conclusion that FCR 7.23(1)(a) was satisfied is obviated. 46 Whereas FCR 7.23(1)(a) is addressed to the belief of a prospective applicant to a right to relief, FCR 7.23(1)(b) is addressed to the information required by the prospective applicant. It provides that a prospective applicant may apply to the Court if, after making reasonable inquiries, it does not have sufficient information to decide whether to start a proceeding in the Court to obtain the relief referred to in FCR 7.23(1)(a). There is no dispute in the present case that Pfizer has made all reasonable inquiries. The question in the present case focussed on whether Pfizer has sufficient information. 47 The leading authority going to the sufficiency of the information is Optiver in which the Full Court considered the equivalently worded Federal Court Rules 1979 (Cth) O 15A r 6(b). In that case the Full Court rejected the primary judge's characterisation that a party is entitled to limit production to those documents that would be sufficient to supply a prospective applicant with enough information to meet the threshold of "a bare pleadable case", observing that a case may be pleadable even if the evidence supporting it is dubious or vulnerable to contradiction: Optiver at [35]. The characterisation of the primary judge by reference to such language served to place a gloss on the language of the rule. 48 The Full Court noted at [36]: ...The policy behind the rule is that even where there is a reasonable cause to believe that a person may have a right to relief, nevertheless that person may need information to know whether the cost and risk of litigation is worthwhile. As Hely J pointed out in St George Bank Ltd v Rabo Australia Ltd (2004) 211 ALR 147 at [26], the question does not concern the right to relief but rather "whether to commence proceedings". Inspection of documents in the possession of the proposed defendant may enable a properly informed decision to be made whether to commence a proceeding to obtain the relief... 49 This passage serves to illustrate the different roles played by FCR 7.23(1)(a) and (b). While FCR 7.23(1)(a) provides a test going to the necessary belief as to a right to relief, FCR 7.23(1)(b) concerns the question of sufficiency of information to know whether the cost and risk of litigation is worth the candle. This to be tested objectively: Hooper v Kirella Pty Ltd [1999] FCA 1584; 96 FCR 1 at [40] (Wilcox, Sackville and Katz J); Optiver at [32]. 50 Various decisions provide further guidance as to the requirement that a prospective applicant does not have sufficient information. The purpose of preliminary discovery is to provide what is reasonably necessary to enable the decision to commence a proceeding to be made: McFarlane as Trustee for the S McFarlane Superannuation Fund v IOOF Holdings Limited [2018] FCA 692 at [65] (Gleeson J); Aristocrat Technologies Australia Pty Limited v Ainsworth Game Technology Limited [2018] FCA 1511 at [43] (Yates J). The question is whether the prospective applicant has sufficient information to enable it to decide whether to commence proceedings. However, the purpose is not to provide comfort in taking the decision which it already has sufficient information to take: Alphapharm Pty Ltd v Eli Lilly Australia Pty Ltd [1996] FCA 391 (Lindgren J); McFarlane at [65]-[66]. Put another way, a prospective applicant must demonstrate as an objective fact that it lacks sufficient information to decide whether to start a proceeding. The purpose of preliminary discovery is not to require the production of material that strengthens or enhances a decision to commence a proceeding, where that decision can reasonably be made on already existing material: Aristocrat at [43]. 51 None of these formulations supplants the language of the rule which, I note, focuses on the question of whether, on the facts as established, the applicant has demonstrated that it "does not have sufficient information to decide whether to start a proceeding in the Court". 52 Furthermore, it is not enough for a prospective applicant merely to assert or state a belief that insufficient information is held. The Court must be satisfied that the prospective applicant in fact does not have sufficient information to make the relevant decision: HQ Insurance Pty Limited v Stonehatch Risk Solutions Limited (No 2) [2020] FCA 1010 at [9] (Thawley J). 53 The special and intrusive nature of preliminary discovery and the fact that, ordinarily, the prospective respondent will not know or be in a position to expose the information known to the prospective applicant, oblige the prospective applicant to be forthcoming and not hold back information: Reeve v Aqualast Pty Ltd [2012] FCA 679 at [65(f)] (Yates J). It must place before the Court all of the evidence already available to it relevant to the sufficiency of the information it possesses to enable a decision to be made whether to commence a proceeding. It is not logically possible to assess whether a prospective applicant has sufficient information to make a decision whether to start a proceeding without knowing what information the prospective applicant already has: HQ Insurance at [55]. 54 Like FCR 7.23(1)(a), FCR 7.23(1)(c) requires the Court to consider whether Pfizer "reasonably believes" certain matters. Those matters are that: (1) SBA has or is likely to have or has had or is likely to have had in its control documents directly relevant to whether Pfizer has a right to obtain relief; and (ii) that inspection of such documents would assist in making the decision to start a proceeding. This requires, first, that Pfizer have an actual subjective belief of each of the specified matters. Relevantly, belief is more than "suspicion"; it is not merely an "apprehension" or even a "fear"; it is an actual "inclination of the mind": George v Rockett [1990] HCA 26; 170 CLR 104 at 115-116 (Mason CJ, Brennan, Deane, Dawson, Toohey, Gaudron and McHugh JJ). Second, the subjective belief must be one formed by reference to objectively reasonable circumstances. The relevant objective circumstances are those known to, and taken into account by, the person forming the belief: Prior v Mole [2017] HCA 10; 261 CLR 265 at [23]-[24] (Gageler J); Poole v Australian Pacific Touring Pty Ltd [2017] FCA 424 at [43]-[53] (Bromwich J).

3. THE DISPUTES 55 Pfizer submits that the evidence of Professor Hearn, Dr Ibarra and Mr Islam is sufficient to satisfy the requirement in FCR 7.23(1)(a) that Pfizer reasonably believes that it may have the right to obtain relief in the Court from SBA. It submits that Mr Islam believes, based on the evidence of Dr Ibarra and Professor Hearn, that Pfizer may have a right to obtain relief from SBA within FCR 7.23(1)(a). It notes that there is a disagreement between the evidence of Professor Hearn and Professor Mahler but maintains that Dr Ibarra and Professor Hearn's views are capable of giving a reasonable basis for Pfizer's belief given the Court would be slow to prefer one body of expert evidence to another under FCR 7.23(1)(a), citing Pfizer FFC at [81] and [84] (Allsop CJ), [120] (Perram J) and [180] (Nicholas J). Mr Islam is the person within Pfizer who is responsible for making the decision whether or not to commence proceedings for patent infringement, however, he is not permitted to see the documents that have been discovered because a confidentiality regime does not permit him to do so. Accordingly, he is reliant on information within the Hearn Report as the basis for his belief. Mr Tyacke, who has had the benefit of access to the confidential documents, deposes to not being aware of anything that would cause him to form a view that Mr Islam's beliefs are not reasonable. 56 In relation to FCR 7.23(1)(b), Pfizer contends that it has made reasonable inquiries but does not have sufficient information to decide whether to start a proceeding in the Court. It refers to requests for information that it has made of SBA, Biogen and Fujifilm. It relies on the opinions expressed by Professor Hearn in the Hearn Report, and also evidence given on information and belief from him in the affidavits of Mr Tyacke, to form the basis for Mr Islam's view that he does not have sufficient information to decide whether or not to commence a proceeding. 57 In relation to FCR 7.23(1)(c), Pfizer contends that it reasonably believes that SBA is likely to have, or has had, or is likely to have had, in its control documents directly relevant to the question of its right to relief, and that inspection of such documents would assist it in making its decision. In this regard it contends that SBA has or could obtain upon request from SBK, Biogen or Fujifilm Denmark the documents sought in the present application. It further contends that the Court should exercise its discretion under FCR 7.23(2) to order the discovery sought. 58 Pfizer also submits that Sabre-style orders against SBA are appropriate, requiring it to take all reasonable steps to obtain copies of documents containing the information sought from SBK, Biogen and Fujifilm Denmark. 59 Pfizer further submits that SBA has a continuing discovery obligation under order 1 of the May 2019 Orders by reason of the operation of FCR 20.20. 60 SBA submits that Pfizer's approach to this application is generally misconceived. It contends that the Hearn Report does not lay the foundation for Mr Islam's satisfaction that the requirements of FCR 7.23(1)(a) are met because the justification for the opinions expressed in the Hearn Report are not set out with sufficient reasoning. It also makes a general submission that discovery ought not be required to be given in respect of potential infringement of the 034 or 036 patents [redacted text]. It submits, based on the evidence of Professor Mahler, that [redacted text], the claims of the 034 or 036 patents are not infringed. As a result, SBA submits that Pfizer cannot satisfy the requirements of either FCR 7.23(1)(a) or (b) [redacted text]. 61 SBA next submits, by specific reference to each of requests 2 and 4 and the evidence of Professor Mahler, that Pfizer has not established as a matter of objective fact that there is insufficient information in the material already discovered for Professor Hearn to provide an opinion to Pfizer for it to decide whether to commence a proceeding within FCR 7.23(1)(b). 62 SBA also submits that many of the documents sought by Pfizer are not sufficiently within its control (for the purposes of FCR 7.23(1)(c)) or power (for the purposes of the Sabre-style orders). It also contends that Sabre-style orders are generally not appropriate in preliminary discovery proceedings. 63 In relation to request 6(a)-(c) and (g)-(j) (the only parts of request 6 pressed at the hearing), SBA submits that as they fall within requests 2 and 4 any requirement of disclosure will follow rulings in relation to those requests. SBA also submits that, in any event, request 6 concerns only regulatory batches that should not have to be disclosed. Finally, it makes separate submissions in relation to each of the subparagraphs as to why, for the particular document identified, Pfizer has not established the requirements of FCR 7.23. 64 I refer further to the submissions made by the parties in section 4 below.

4.1 Introduction 65 The outcome of the Pfizer FFC decision was that Pfizer had, by the evidence of Mr Silvestri assisted by the evidence of Dr Ibarra, established that it reasonably believed that it may have the right to obtain relief from SBA within FCR 7.23(1)(a): see Pfizer FFC at [84] (Allsop CJ), [163] (Perram J) and [180] (Nicholas J). The remaining issues remitted to this Court concerned the scope of documents to be supplied and satisfaction of the balance of the requirements of FCR 7.23. The discovery categories in the May 2019 Orders were by consent and, it may be inferred, represented a compromise solution between the parties as to the form and scope of preliminary discovery to be given by SBA, subject to an agreed mechanism in order 3 whereby Pfizer could seek the production of further documents either by agreement or by application to the Court. The present contest concerns whether Pfizer can establish that it is entitled under FCR 7.23 to the further documents sought. 66 SBA makes a general objection to the present application on the basis that the evidence adduced by Pfizer is insufficient to satisfy the requirements of FCR 7.23(1)(a). In that regard, it submits that the opinions of Professor Hearn, through his report to Mr Islam and through Mr Tyacke's information and belief evidence, do not provide an appropriate basis for Pfizer to reasonably believe that the Brenzys process may be within the claims of the three patents under consideration. The generality of this objection runs into the immediate difficulty that the Full Court has reached the opposite conclusion having regard to the evidence then before the Court. It is antithetical to the efficient disposition of applications for preliminary discovery if a prospective respondent, absent a change in circumstances, is able to turn back the clock on each occasion a further request for production is made to revisit the threshold question posed by FCR 7.23(1)(a). Pfizer has satisfied the Full Court that it is entitled to the production of documents and the present application must be considered on that basis. 67 In this regard SBA next submits that, as a result of specific information supplied to Pfizer in the documents discovered so far, it must now be apparent that the basis for its belief pursuant to FCR 7.23(1)(a) is not reasonable. SBA also contends that Pfizer has not demonstrated that it has insufficient information within FCR 7.23(1)(b) for it to make its decision. Nor, SBA submits, has Pfizer established that SBA has within its control as per FCR 7.23(1)(c)(i) the documents sought by request 2. I address these submissions and the more detailed submissions advanced, and evidence relied upon, by the parties where they arise in the context of each of the requests.

4.2 Request 2 68 Before turning to request 2, it is necessary to refer to claim 1 of the 034 and 036 patents. 69 In broad terms, claim 1 of each of the 034 and 036 patents is for a method of producing, respectively, polypeptides or the TNFR-Ig fusion protein, in a large-scale production cell culture comprising the steps of providing a cell culture comprising: (1) mammalian cells that contain a gene encoding TNFR-Ig or a polypeptide of interest, which gene is expressed under condition of cell culture; (2) a medium containing glutamine with certain characteristics (the medium integer); (3) maintaining said culture in an initial growth phase under a first set of culture conditions for a first period of time sufficient to allow said cells to reproduce to a viable cell density within a range of 20%-80% of the maximal possible viable cell density if said culture were maintained under the first set of culture conditions (viable cell density integer); (4) changing at least one of the culture conditions so that a second set of culture conditions is applied; and (5) maintaining the culture for a second period of time under the second set of conditions and for a second period of time so that the polypeptide/TNFR-Ig accumulates in the cell culture. 70 Claim 36 of the 034 and 036 patents is for "the method of claim 1, wherein glycylglutamine is substituted for glutamine in said culture". 71 Request 2 is as follows: 2. Information relating to the cell culture process(es) used to prepare the Brenzys Products regarding: (a) results and analyses of any tests or studies performed in relation to the viable cell density of the cell culture, including the maximum viable cell density achieved under each set of conditions applied to the cell culture; and (b) any paper exercises, in silico exercises, modelling procedures, projections and simulations (and their assumptions), modelling design studies (quality by design studies), and process characterisation studies, relating to maximum viable cell density of the cell culture (e.g. calculations or projections and simulations (and their assumptions) of the average growth rate of cells under particular conditions). Where two or more documents record the exact same data, only one of those documents need be produced. This must be understood as being a request for documents insofar as they contain information of the type specified. 72 Pfizer submits that request 2 is directed to an assessment of the viable cell density integer in the production bioreactor used in the Brenzys process as exemplified in claim 1 of each of the 034 and 036 patents. 73 SBA contends that Pfizer is not entitled to the documents in request 2 [redacted text] because Pfizer has not established a reasonable belief within FCR 7.23(1)(a) that [redacted text] required for claims 1 or 36 of the 034 and 036 patents to be infringed. SBA refers to the evidence of Professor Mahler in this regard to the effect that, based on his review of the discovery documents, he considers that the cell culture media [redacted text] does not fall within any of the claims of the 034 or 036 patents. 74 I reject SBA's submission for the following reasons. 75 The construction of the integers of the relevant claims of the 034 and 036 patents is in dispute. Pfizer contends for a construction of those claims that does not require [redacted text]. It is not appropriate to consider, let alone determine, a disputed question of construction in the present application. Professor Hearn gives evidence that, notwithstanding the opinions of Professor Mahler with regard to the medium integer, he is of the opinion that [redacted text]. Whilst I accept that Professor Hearn's evidence on this point does not descend into the same detail provided by Professor Mahler, it is not appropriate to prefer one body of evidence over the other in this application: Pfizer FFC at [180] (Nicholas J). Although the evidence of Professor Mahler on this topic may, at least on one view, be seen to demonstrate that Professor Hearn's evidence is contestable, this does not sufficiently undermine the reasonableness of Pfizer's belief that it may have a right to relief: Pfizer FFC at [121] (Perram J). Put another way, I do not consider the evidence of Professor Mahler in relation to the medium integer demonstrates that Professor Hearn's views as to [redacted text] are not ones capable of being held: Pfizer FFC at [84] (Allsop CJ). 76 Accordingly, I am satisfied that Pfizer has established the requirements of FCR 7.23(1)(a). 77 Next, SBA submits that Pfizer has sufficient information within FCR 7.23(1)(b) to obviate the need for production in accordance with request 2. 78 The arguments presented relied, respectively, on information and belief evidence of the opinions of Professor Hearn and the direct evidence of Professor Mahler. 79 Professor Hearn's opinion is that the discovery documents indicate that there is an "expected range" for viable cell density for each day of the production bioreactor. [redacted text]. He concludes that whether or not the viable cell density integer is met may be ascertained by reference to the uppermost limits given of that range. He expresses the view that if the cell culture were left to grow [redacted text], the viable cell density of the cell culture could be expected to reach at least the upper limit of the expected ranges recorded in the discovery documents. [redacted text]. On this basis I understand Professor Hearn's view to be that the upper limits of the expected viable cell density ranges in the discovery documents could represent an underestimate of the maximum viable cell density that would be achieved in the hypothetical scenario where [redacted text]. 80 Given Professor Hearn's approach to assessing the viable cell density integer, he wishes to examine the underlying basis for the expected ranges supplied. As he puts it, on the one hand, the numeric values for the ranges included in the discovery documents may be based on reasoned scientific bases, in which case the viable cell density integer may be present. On the other hand, the values for the ranges may have been included solely for regulatory purposes (e.g. the ranges might represent parameters advised to regulators) such that they are not particularly helpful in assessing the hypothetical maximum viable cell density. 81 Professor Hearn also expresses the view that in calculating the "average growth rate of the cell culture, additional data concerning viable cell density recorded at more frequent intervals, or across different batches using the same process" may change the outcome of that calculation. His opinion is that the "average growth rate of the cell culture is directly relevant to his Provisional Opinion…because [it] can be used…to indicate the viable cell density trend from a particular point where no actual data have been recorded". On this basis he gives evidence that he requires access to actual viable cell density data points recorded at more frequent intervals than those provided in the discovery documents, and also across different batches of etanercept produced using the Brenzys process. 82 SBA relies on the evidence of Professor Mahler in answer. He commences by giving evidence about the construction of the viable cell density integer. It is to the effect that the viable cell density integer describes a culture phase, being the "initial growth phase", which occurs after inoculation of a large-scale production bioreactor under "a first set of culture conditions". His evidence is that this initial growth phase is to continue until a sufficiently high viable cell density is obtained, being "sufficient to allow said cells to reproduce to a viable cell density within a range of [about] 20%-80% of the maximal possible viable cell density". Professor Mahler understands from reading the specification that, for instance, the temperature of the cell culture may be selected during the initial growth phase to optimise cell growth and viability and that, at the end of the initial growth phase, the temperature can be changed to cause a metabolic shift in the cell culture. He considers that the viable cell density integer requires that the initial growth phase be maintained for a period of time sufficient to result in a viable cell density of between about 20%-80% of the "maximal possible cell density" if said culture were maintained under the first set of culture conditions, and that "maximal possible viable cell density" is the viable cell density that would have been achieved if the cell culture process had continued in a large-scale bioreactor without a change in culture conditions; that is, maintaining the culture at the first set of culture conditions. Accordingly, Professor Mahler understands the viable cell density integer to involve a comparison between the hypothetical scenario of the viable cell density that would have been achieved if there had been no change in the culture conditions (or metabolic shift) and the viable cell density actually achieved in the bioreactor. 83 Professor Mahler takes a different approach to the question of infringement to that taken by Professor Hearn. He says: (1) [redacted text]. (2) To assess whether [redacted text] satisfies the viable cell density integer, a key question is whether or not, [redacted text], the viable cell density falls within a range of about 20%-80% of the maximal possible viable cell density that would have been achieved under the first set of culture conditions. This may be determined by plotting a graph of the actual recorded data for viable cell density on each day of the cell culture, which Professor Mahler did and demonstrated in tables included in his affidavit. (3) This analysis confirms that the cell culture [redacted text]. (4) No further documents or data are necessary because there is sufficient information in the discovery documents [redacted text]. (5) The results of tests and studies performed during bioprocess development whereby the [redacted text] would not provide any assistance in establishing whether the viable cell density integer is satisfied in the Brenzys process itself, namely, because the discovery documents already provide sufficient information. (6) The discovery documents establish that viable cell density integer is absent [redacted text]. 84 It may be seen that Professors Hearn and Mahler take different approaches to the application of the viable cell density integer. SBA submits that Professor Mahler's approach is correct and that, accordingly, Pfizer has sufficient information. 85 Pfizer advances a case theory based on the opinions of Professor Hearn that the uppermost limits of the "expected range" set out in the discovery documents may supply the basis for his conclusion of infringement. However, he needs to have a better understanding of the basis upon which those ranges have been calculated to reach that conclusion. Professor Hearn also advances the view that documents recording the viable cell density recorded at more frequent intervals or across different batches using the same process may change the outcome of the average growth rate calculation. 86 Although the arguments presented by the parties might suggest that I am here conducting a patent infringement suit, that is not the case. To determine whether Pfizer has "sufficient information" within FCR 7.23(1)(b) it is necessary to consider the information it presently has in the context of the case theory it propounds. Although Professor Hearn may ultimately be incorrect in his reliance on the expected viable cell density ranges in the discovery documents and the relevance of further recordings of viable cell density (I express no view about this), it cannot be said that he, as an expert in the field, has not advanced a reasonable basis for contending for its relevance. On this case theory, in my view, Pfizer has demonstrated that it does not have sufficient information in order to decide whether to start a proceeding. 87 This leads to consideration of FCR 7.23(1)(c), which requires that Pfizer "reasonably believes that": (i) the prospective respondent has or is likely to have or has had or is likely to have had in the prospective respondent's control documents directly relevant to the question whether the prospective applicant has a right to obtain the relief; and (ii) inspection of the documents by the prospective applicant would assist in making the decision. 88 Five points may be noted. First, the reasonable belief is that of Pfizer, which here is that of Mr Islam. Where information is confidential, Mr Islam's view is based on his proxy of Professor Hearn upon whose opinion he relies. In my view that was an appropriate course to take. Secondly, the belief is of the same character as that for FCR 7.23(1)(a) as elucidated in Pfizer FFC and as set out in section 2 at [44] and [54] above. Thirdly, the documents must be "directly relevant to the question of whether [Pfizer] has a right to obtain the relief" referred to in FCR 7.23(1)(a) and (b). Fourthly, a component of Pfizer's belief must be that SBA has, or is likely to have, or has had, or is likely to have had, in its "control", the documents. Fifthly, it is necessary to consider whether the documents sought would assist Pfizer in making the decision referred to in FCR 7.23(1)(b). 89 For substantially the same reasons as set out above in my consideration of FCR 7.23(1)(b), I consider that the evidence of Professor Hearn provides a reasonable basis for Pfizer's belief that the information underlying the expected viable cell density ranges recorded in the discovery documents is directly relevant to the question of whether Pfizer has a right to relief against SBA. I am also satisfied that access to such information would overcome the insufficiency of information it has identified and, therefore, assist Pfizer in making its decision. Similarly, I accept that Professor Hearn's evidence provides a reasonable basis for Pfizer's belief that additional data concerning viable cell density recorded at more frequent intervals is directly relevant to Pfizer's right to relief and would assist it in making its decision. I do not consider that Professor Mahler's evidence in this regard undermines the reasonableness of Pfizer's belief. 90 However, I do not consider that the requirements of FCR 7.23(1)(c) are satisfied insofar as request 2 seeks the production of documents containing information about the further commercial batches or the regulatory batches. Although I note that the later CTD submodules and batch records relating to the further commercial batches were pressed for separately by Pfizer, it is convenient to deal with them here because for similar reasons I do not consider that Pfizer should be entitled to the production of those documents. 91 In relation to the further commercial batches, Pfizer relies on the opinion of Professor Hearn that the cell culture conditions used in the production of the etanercept for the Brenzys products are not exactly replicated by each batch produced (even between batches produced using the same process) but fall within ranges, and additional data would enable him to form an opinion as to likely infringement of future batches. 92 In relation to the later CTD submodules, Pfizer relies on the opinion of Professor Hearn that process B may have undergone changes that, whilst not deeming the process to be "a 'different' process for regulatory purposes", may reflect a change in the process relevant to his provisional opinion. In response to evidence given by Mr D'Aloisio on information and belief from Dr Son of the reasons that different versions of the CTD submodules were submitted to the TGA, Mr Tyacke accepts that such changes do not necessarily indicate a change in process conditions, but relies on the opinion of Professor Hearn who points specifically to what he considers to be a change in the pH range between two process B batches to demonstrate that there are relevant changes in the cell culture manufacturing process including within process B. It is this change upon which Pfizer places specific reliance. 93 SBA has given discovery in relation to the Relevant Matters described in order 1(a) of the May 2019 Orders. That includes discovery in respect of the two process B batches. The evidence is that process B has not changed since SBA gave discovery on 17 June 2019 and that the process uses the same parameters, including temperature and pH and the same viable cell density expected ranges as the two process B batches that form part of the discovery documents. Although Mr Tyacke reports Professor Hearn's opinion that the discovery documents indicate that a different pH range within the production bioreactor was used for the two process B batches the subject of the discovery documents to support the proposition that the cell culture conditions vary between batches, that opinion appears to be based on a factual error. Professor Mahler explains that Professor Hearn appears not to have compared like with like. He observes that Professor Hearn compared the pH action limit range in one document [redacted text] with the pH operating range in the other document [redacted text]. Professor Mahler's evidence, which I accept, is that the operating ranges and action limits for the two process B batches are the same. Having regard to the tightly controlled regulatory environment in which the Brenzys process must operate, I am not persuaded that the production of additional documents in respect of batches produced using the same process would assist Pfizer in making its decision whether to start a proceeding. In this context I am not persuaded that assessing average viable cell density growth rates across different batches, including the further commercial batches, is sufficiently relevant. 94 The position is similar in relation to the later CTD submodules. Mr D'Aloisio gives evidence on information and belief from Dr Son that there is no material difference in the information in the later CTD submodules lodged with the TGA and, indeed, that process B has not changed, including with respect to temperature and pH process parameters and viable cell density ranges, since SBA gave discovery in June 2019. He gives evidence that the later CTD submodules do not contain any different temperature, pH and viable cell density information from that disclosed in the discovery documents, and that the further commercial batches of etanercept produced using process B were produced using the same temperature and pH process parameters and the same viable cell density ranges as the two process B batches the subject of discovery documents. Consequently, I am not persuaded that the later CTD submodules are relevantly different to those already provided to Pfizer. It is impermissible for a prospective applicant to use preliminary discovery for the purpose of simply seeking additional comfort: McFarlane at [66]-[67]; Alphapharm; Matrix Film Investment One Pty Limited v Alameda Films LLC [2006] FCA 591 at [25] (Tamberlin J). 95 I am fortified in this conclusion having regard to the way in which Pfizer put its case. Whilst submitting, generally, that it was entitled to preliminary discovery to enable it to determine the extent of SBA's breach and the likely quantum of any damages, it did not submit that it would not commence proceedings unless it were shown that the further commercial batches were infringing, or that it required production of documents relating to those batches to ascertain the likely quantum of damages. This tends against the view that production of such documents would assist Pfizer to make its decision. 96 In relation to the regulatory batches, the evidence of Mr Tyacke indicates that Professor Hearn considers that the data in the regulatory batches is likely to be replicated in the commercial batches. Professor Hearn's opinion is that data from the regulatory batches is nevertheless relevant because the regulatory batch data will allow the "whole picture" to be understood and that the results achieved in the regulatory batches may indicate what is likely to occur in future batches of etanercept. 97 However, there is no suggestion that the regulatory batches will be the subject of suit. Data collected in relation to those batches is tangential to any prospective proceedings. I do not consider that the production of documents containing information within request 2 insofar as they concern regulatory batches should be required. 98 Having regard to the above observations, in my view, request 2 should be modified as follows: 2. Documents concerning the process A and process B batches containing information relating to the cell culture process(es) used to prepare the Brenzys Products regarding: (a) results and analyses of any tests or studies performed in relation to the viable cell density of the cell culture, including the maximum viable cell density achieved under each set of conditions applied to the cell culture; and (b) any paper exercises, in silico exercises, modelling procedures, projections and simulations (and their assumptions), modelling design studies (quality by design studies), and process characterisation studies, relating to maximum viable cell density of the cell culture (e.g. calculations or projections and simulations (and their assumptions) of the average growth rate of cells under particular conditions). Where two or more documents record the exact same data, only one of those documents need be produced. (modified request 2) 99 This then leaves for consideration the question of whether Pfizer reasonably believes that the documents in modified request 2 are within SBA's "control". 100 In his first affidavit Mr Tyacke identifies relevant passages of the Therapeutic Goods Act 1989 (Cth) (TG Act). Section 25(1)(g) provides that the Secretary must evaluate goods for registration including, if a step in the manufacture of goods has been carried out outside of Australia, whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable. Mr Tyacke gives evidence that the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (GMP Code) applies to biologicals such as etanercept and that Professor Hearn informs him that the requirements of the GMP Code would cause the manufacturer of the Brenzys products to record and retain information responsive to the requests. Moreover, he gives evidence that paragraph 23 of the Standard and Specific Conditions applying to Registered or Listed Therapeutic Goods, determined under s 28(2) of the TG Act, states: Where the registered/listed goods are imported goods which if manufactured in Australia would be required under the provisions of the Act to be manufactured in licensed premises, the sponsor of the goods shall, upon request at any time by the Secretary or the Secretary's delegate appointed for the purposes of section 31 of the Act, provide to the National Manager, Therapeutic Goods Administration, an acceptable form of evidence which establishes the standard of manufacture of the goods. If this is not available, the sponsor shall pay the costs of an inspection of the principal manufacturer of the goods by Australian inspectors where this is considered necessary by the Secretary or the Secretary's delegate referred to in this paragraph. (Emphasis added) 101 In addition, s 31(1)(e) of the TG Act provides that a sponsor is required, if requested by the Secretary, to provide information or documents relating to the formulation, composition, design specifications and quality of the goods and also "the method and place of manufacture or preparation of the goods and the procedures employed to ensure that proper standards are maintained in the manufacture and handling of the goods". 102 The opinion of Professor Hearn is that these requirements would cause the manufacturer of the Brenzys products to record information responsive to requests 2 and 4 and to have retained those documents. Pfizer submits that, having regard to the regulatory requirements, SBA is likely to have within its power such documents even if they are held by Biogen or Fujifilm Denmark, given that Biogen was the manufacturer until August 2019 and Fujifilm Denmark since August 2019. 103 SBA relies on the affidavit evidence of Mr D'Aloisio who says, on information and belief from Dr Son, that: (a) in respect of commercial batches, SBA and SBK do not have in their control any documents recording or evidencing the information sought in Request 2, including documents recording studies to determine the maximum VCD achieved under each set of conditions applied to the culture, apart from the Discovery Documents already provided; (b) in respect of regulatory and commercial batches, SBA and SBK have not conducted and do not have in their control any documents recording or evidencing tests, studies, calculations, simulations and/or projections concerning the maximum VCD that would be achieved in the etanercept cell culture process in the absence of [redacted text]; and … SBA and SBK are not aware of any other person, including Biogen and Fujifilm, having documents in their control recording or evidencing the information sought in Request 2 in respect of commercial batches… 104 The language of FCR 7.23(1)(c) requires that the prospective applicant reasonably believes that the prospective respondent has or is likely to have or has had or is likely to have had in its control documents directly relevant to the question of the prospective applicant's relief. 105 SBA submits that there can be no utility in requiring discovery of such documents that are subject to Dr Son's evidence and that the Court would not order preliminary discovery in those circumstances, citing United Voice v Accolade Wines Australia Limited [2013] FCA 285 at [29] (Lander J). In the passage relied upon by SBA Lander J said: [28] Rule 7.23(1)(c)(i) was relevant in this application because the prospective applicants had, before bringing this application, sought almost all of the documents contained in the application and had been advised by the prospective respondent that some of those documents did not exist. [29] I will refer later to that correspondence, but it is enough at this stage to note that if a prospective applicant has been told by a prospective respondent that documents of the kind sought in the application do not exist or are not in the prospective respondent's possession, custody or power, it is hard to think that the prospective applicant could thereafter reasonably believe that the documents did exist, unless the prospective applicant could point to other evidence apart from the prospective respondent's denial that would support that belief. In this passage Lander J directs attention to that part of FCR 7.23(1)(c)(i) that concerns whether the prospective applicant has a reasonable belief that the prospective respondent "has or is likely to have" documents in its control. His Honour makes no reference to the question posed as to whether the prospective respondent "has had or is likely to have had" such documents. The reasoning of Lander J is best understood in the context, also, of the exercise of the discretion under FCR 7.23(2). The ultimate exercise of power to order preliminary discovery is subject to the exercise of discretion under FCR 7.23(2). That discretion is unconstrained, save that it must be exercised in accordance with the policy and purpose of the rule in the context of the FCR generally. In my view, in the face of an assurance that the prospective respondent does not have documents in its control (regardless of whether it may once have had them), the Court would not ordinarily make an order for preliminary discovery. That is because, in the face of such an assurance, regardless of whether FCR 7.23(1)(c)(i) is satisfied, ordering discovery would be a waste of time. 106 In light of the relevant authorities, having regard to the content of Mr D'Aloisio's evidence, I must be satisfied that Pfizer has "point[ed] to other evidence apart from the prospective respondent's denial that would support that belief": United Voice at [29]. Such evidence must include "the existence of facts that are sufficient to induce that belief in a reasonable person": Sandhurst Trustees Ltd v Clarke [2015] FCAFC 21; 321 ALR 1 at [20] (Dowsett, Davies and Wigney JJ); see also Paperlinx Limited v McConnell [2016] FCA 450 at [12] and [37] (Middleton J). 107 For the following reasons I am satisfied that Pfizer has done so in relation to documents falling within modified request 2 insofar as those documents are in the possession of Fujifilm Denmark, but not SBA, SBK, Biogen or Fujifilm. 108 First, SBA and SBK have given unequivocal evidence that they do not have in their control documents within request 2 with respect to the commercial batches. Although there is a dispute as to the legal meaning to be attributed to the word "control", which I address below, I accept that, at the least, this evidence should be understood to mean that those companies have conducted a search and can assure the Court that documents within request 2 are not in their possession or custody. The evidence given is sufficient to engender the view, which I hold, that whilst SBA may be in a position to require a third party manufacturer to provide it with documents, they do not hold the documents themselves. Accordingly, whether or not it is for failure to satisfy FCR 7.23(1)(c)(i) or in the exercise of the discretion under FCR 7.23(2), I would not require those companies to conduct a fruitless search for documents that they have said they do not have. 109 Secondly, until August 2019 Biogen was the manufacturer of the etanercept for the Brenzys products. The evidence indicates that after that date the manufacturing facility in Denmark was transferred to the Fujifilm group of companies and that Biogen is under no contractual or other obligation to SBA to provide any documents responsive to the requests. The letter from KWM of 3 November 2020 indicates that such documents as are sought are likely to be in the possession of Fujifilm Denmark. The evidence indicates that such documents that Biogen may have been obliged to retain as the manufacturer of the Brenzys products were passed to Fujifilm Denmark upon the sale of the business. 110 Thirdly, the evidence indicates that Fujifilm Denmark, and not Fujifilm Corporation, is the only Fujifilm entity that may have possession, custody, power or control of documents relating to the process used to manufacture the etanercept contained in the Brenzys products. 111 Fourthly, with respect to Fujifilm Denmark, the evidence establishes that it regards its relationship with SBA as one "of customer and supplier" of the etanercept used in the Brenzys products. The question arises as to whether or not Pfizer reasonably believes that SBA is likely to have or have had "control" over documents held by Fujifilm Denmark concerning the manufacture of the etanercept in its Brenzys products. 112 "Control" is defined in Schedule 1 to the FCR as follows: control, if referring to a document, means possession, custody or power. 113 A person has "power" over a document when it has a presently enforceable legal right to obtain it from whomever actually holds the document without the need to obtain the consent of anyone else: Lonrho Ltd v Shell Petroleum Co Ltd [1980] 1 WLR 627 at 635 (Diplock LJ). Conversely, a document is not within a party's power even if it is merely likely that, if requested, the non-party would agree to produce the document to the litigating party: Bova v Avati [2009] NSWSC 921 at [360]-[365] (Ward J); Australian Competition and Consumer Commission v Prysmian Cavi E Sistemi Energia S.R.L. (No 8) [2014] FCA 376 at [17] (Besanko J). 114 The provisions of the TG Act, GMP code and similar instruments to which I have referred provide a sound basis for Pfizer to have the reasonable belief required within FCR 7.23(1)(c)(i), namely, that SBA is, or is likely to be, or has been, in a position to oblige Fujifilm Denmark to produce documents to it upon request. I am not persuaded that the evidence given on information and belief from Dr Son, who says that relevant documents are not within the "control" of SBA, addresses the breadth of the concept of control as provided for in the definition in the FCR and the cases. To supply a therapeutic good in Australia, the sponsor is obliged to provide documents to the regulator upon request. No evidence has been supplied by SBA or SBK to gainsay the proposition that it could do so by requiring Fujifilm Denmark to produce documents. Furthermore, the letter from Fujifilm Denmark of 28 January 2021 does not suggest otherwise. It merely states that "it would be inappropriate for [it] to voluntarily provide such documents when….[SBA] is contesting Pfizer's entitlement to receive them". 115 Accordingly, I am satisfied that Pfizer has satisfied the requirements of FCR 7.23(1)(c)(i) insofar as they concern documents apparently in the possession of Fujifilm Denmark. I consider it appropriate in the exercise of the discretion under FCR 7.23(2) to require that SBA give preliminary discovery of documents within modified request 2.

4.3 Request 4 116 Claim 1 of the 632 patent is as follows: 1. A method of producing a protein in a cell culture comprising: (a) growing cells in the cell culture at a reduced temperature, wherein the reduced temperature is in a range of 27.0°C to less than 30.0°C; and (b) growing cells in the cell culture at a reduced pH, wherein the reduced pH is in a range of 6.80 to less than 7.00; to reduce production of misfolded proteins and/or aggregated proteins. (Emphasis added) 117 Request 4 is as follows: 4. In relation to the cell culture process(es) used to prepare the Brenzys Products: (a) the precise temperature of the cell culture at all times in the production bioreactor up until the time when the supernatant is harvested from the cell, including any and all temperature results recorded by the online temperature probes, and any offline measurements; and (b) the precise pH of the cell culture at all times in the production bioreactor up until the time when the supernatant is harvested from the cell, including any and all pH results recorded by the online pH probes, and any offline measurements, for commercial batches of the Brenzys Products manufactured for Australia, and for process validation run (PVR) batches manufactured to support regulatory approval of the Brenzys Products in Australia (being those PVR batches [redacted text] Process A and [redacted text] Process B). Where two or more documents record the exact same data, only one of those documents need be produced. 118 Pfizer contends that request 4 is directed to ascertaining the pH and temperature of the cell culture at all times during the production bioreactor step. It is said by Pfizer to be relevant to a number of claims, including claim 1 of the 632 patent. 119 SBA first contends that Pfizer has not met the requirements of FCR 7.23(1)(a). It notes that claim 1 of the 632 patent contains two integers, one (broadly) concerning the growing of cells in a cell culture at a temperature range of 27.0°C to less than 30.0°C and, the other concerning growing cells at a reduced pH in a range of 6.80 to less than 7.00. It refers to evidence given by Professor Mahler on the construction of this integer and submits that the "and" in the claim should be construed as requiring the temperature and pH to be reduced concurrently. It also relies on the evidence of Professor Mahler to support the proposition that there is sufficient information in the discovery documents, including temperature and pH set points, operating ranges and action limits for the commercial batches, as well as graphs showing the pH and temperature measured over the [redacted text] cell culture, to support the conclusion that the temperature/pH integers are not present in either process A or process B and, accordingly, the threshold question posed in FCR 7.23(1)(a) is not met. 120 Pfizer contends for a different construction of the claim that does not require "and" being understood conjunctively. Mr Tyacke gives evidence, on information and belief from Professor Hearn, that notwithstanding Professor Mahler's views, Professor Hearn considers that the discovery documents indicate that the pH/temperature integers may be present in both process A and process B. He notes that graphs in the discovery documents recording pH and temperature in the batch records [redacted text]. He further observes that the operating ranges and action limit ranges referred to in the discovery documents [redacted text], a fact which he notes was also recognised by Professor Mahler in his evidence. 121 SBA's challenge on the basis of a construction argument as to the likelihood of infringement should be rejected. As noted above, an application for preliminary discovery is not the occasion for a prospective party to ventilate, as if in a final hearing, questions of claim construction. The fact that Professor Mahler posits a particular construction of claim 1 of the 632 patent does not, in my view, undermine the reasonableness of Pfizer's belief. The construction of the claim is an issue for trial. 122 Accordingly, Pfizer has established the requirements of FCR 7.23(1)(a). 123 Pfizer submits that it does not have sufficient information within FCR 7.23(1)(b). 124 Professor Hearn's opinion regarding the insufficiency of information is to the following effect: (1) the discovery documents contain no actual temperature data at any point in time during the production bioreactor, and only minimal pH data; (2) for the integers relating to temperature, it has been necessary for him to base his opinions on the only information available in the discovery documents which are set points, operating ranges and action limits for temperature in the production bioreactor, as well as the high level trend visible in the graphs provided; (3) for the integers relating to pH, the discovery documents provide similar minimal information about pH, in addition to some data which is provided only for one point in time for each day of the production bioreactor step; and (4) Professor Hearn's opinion is that whilst graphs in the discovery documents [redacted text], because the data plots on the graphs have been overwritten with thick lines that somewhat obscure the underlying data points, he has concerns that the plots shown in the discovery documents are insufficient to ascertain what raw temperature and pH data was actually acquired. 125 SBA relies on the evidence of Professor Mahler set out at [119] above that he has sufficient information from the discovery documents to form a view as to infringement. On this basis, SBA submits that no further documents are necessary within FCR 7.23(1)(b) and, accordingly, Pfizer cannot need the information sought. 126 However, a contested and contestable claim construction dispute does not provide a basis for concluding, even on the objective standard required in FCR 7.23(1)(b), that the request should be refused. Professor Hearn's opinion is that in light of particular information recorded in the discovery documents (for example, certain graphs, operating ranges, set points and action limits) the pH/temperature integers may be present in the Brenzys process. It is by reference to this case theory that the submissions of the parties regarding the sufficiency of information possessed by Pfizer must now be assessed. Furthermore, it is apparent from claim 1 of the 632 patent that the temperature and pH of the cell culture within the production bioreactor is relevant to the question of infringement on either case theory. 127 From the evidence summarised above, it is tolerably clear that Professor Hearn's approach to assessing the presence of the pH/temperature integers relies on him having access to actual pH and temperature data recorded within the production bioreactors. I am satisfied that Pfizer does not have sufficient information to enable it to make its decision to start a proceeding. 128 This leads to consideration of FCR 7.23(1)(c). 129 For substantially the same reasons set out above in my consideration of the evidence regarding FCR 7.23(1)(b), I am satisfied that the opinion of Professor Hearn provides a reasonable basis for Pfizer's belief that actual pH and temperature data recorded at frequent intervals within the production bioreactors is directly relevant to the question of whether it has a right to relief and would assist it in making its decision whether to start a proceeding. 130 However, for the reasons set out in [90]-[97] above, I am not satisfied that the production of documents containing information as set out in request 4 in relation to the further commercial batches or the regulatory batches is appropriate. 131 Having regard to the foregoing, in my view request 4 should be modified as follows: In relation to the cell culture process(es) used to prepare the process A and process B batches Brenzys Products: (a) the precise temperature of the cell culture at all times in the production bioreactor up until the time when the supernatant is harvested from the cell, including any and all temperature results recorded by the online temperature probes, and any offline measurements; and (b) the precise pH of the cell culture at all times in the production bioreactor up until the time when the supernatant is harvested from the cell, including any and all pH results recorded by the online pH probes, and any offline measurements, for commercial batches of the Brenzys Products manufactured for Australia, and for process validation run (PVR) batches manufactured to support regulatory approval of the Brenzys Products in Australia (being those PVR batches [redacted text] Process A and [redacted text] Process B). Where two or more documents record the exact same data, only one of those documents need be produced. (modified request 4) 132 This then leaves for consideration whether Pfizer reasonably believes that SBA has in its "control" documents within modified request 4. SBA disputes that this aspect of the rule has been met. 133 Pfizer relies on the requirements set out in the TG Act and GMP code to which I have referred in [100]-[101] above. 134 SBA relies on the evidence of Mr D'Aloisio to the following effect: I am informed by Dr Son and I believe, that SBA and SBK do not have in their control any documents recording temperature and pH levels in the production bioreactor continuously captured by online probes, whether in regulatory or commercial batches. 135 It will be noted that this statement does not address the entirety of request 4, but concerns only documents regarding temperature and pH levels in the bioreactor continuously captured by online probes. I am not satisfied that this denial addresses the scope of modified request 2. Consequently, I am satisfied that Pfizer reasonably believes that documents falling within modified request 2 are in the possession or custody of SBA. 136 The question then arises whether documents that are likely to be or have been in the hands of other companies are within SBA's "control". For the reasons set out in [109]-[110] above, I do not consider that this requirement has been satisfied in relation to Biogen or Fujifilm. However, it has been satisfied in relation to Fujifilm Denmark. For the reasons set out in [111]-[115] above, I am satisfied that Pfizer reasonably believes that documents falling within modified request 4 that may be in the hands of Fujifilm Denmark are in SBA's control within FCR 7.23(1)(c)(i). 137 I consider it appropriate to exercise the discretion in FCR 7.23(2). The result is that I will order that SBA give preliminary discovery within modified request 4.

4.4 Request 6 138 The evidence of Mr D'Aloisio is that the documents sought in request 6 concern regulatory batches only. Having regard to my conclusions above as to the relevance of the regulatory batches to Pfizer's right to relief, request 6 must be refused.

4.5 Continuing discovery and FCR 7.23 139 In paragraph 2A of its interlocutory application Pfizer seeks an order that SBA "give continuing discovery and inspection to [it] of any documents meeting the definition of Discovery Documents" in the May 2019 Orders (as amended by the December 2019 Orders) not previously discovered. This concerns the discovery of the following additional documents: (a) those identified in order 1(b) of the May 2019 Orders insofar as they concern the further commercial batches of etanercept manufactured for the Brenzys products; and (b) a later set of CTD submodules filed with the TGA in relation to the Brenzys products (the later CTD submodules). 140 Pfizer contends for this order on two bases. First, that the additional documents satisfy the requirements of FCR 7.23. I have considered this argument in the context of my reasons specific to each of requests 2 and 4. For the reasons set out there, I am not satisfied that Pfizer has separately met the requirements of FCR 7.23 to warrant a conclusion that production of documents should be supplied insofar as they concern the further commercial batches or the later CTD submodules. 141 Secondly, FCR 20.20 provides: (1) A party who has been ordered to give discovery is under a continuing obligation to discover any document: (a) not previously discovered; and (b) that would otherwise be necessary to be discovered to comply with the order. (2) However, a party is not obliged to discover any document that has been created after the proceeding was started, if the party is entitled to claim privilege from production for the document. 142 Pfizer submits that FCR 20.20(1) imposes an obligation upon SBA to provide continuing discovery of documents required to be discovered pursuant to FCR 7.23 for so long as Pfizer's existing application for preliminary discovery is on foot. It submits that, as a matter of construction, the obligation under FCR 20.20 applies to all discovery required under the FCR. It submits that other obligations in Part 20 such as the requirements applicable to supplying a verified list of documents in FCR 20.16, 20.17 and 20.22 apply in preliminary discovery proceedings and have in fact been observed by SBA in giving discovery in these proceedings. It submits that the continuing discovery obligation applies to documents that come within a party's control after the date of original discovery. 143 I do not accept that FCR 7.23 imposes an automatic obligation of continuing discovery upon a prospective respondent akin to that found in FCR 20.20(1). The text and structure of FCR 7.23 does not support Pfizer's contention. The express obligation in FCR 20.20(1) is absent from Part 7 of the FCR, in which FCR 7.23 is found. Nor does FCR 7.23 contain any cross-reference to FCR 20.20, although where other rules intend to import by cross-reference other aspects of Division 20.2 of the FCR, they do so expressly. For example, FCR 7.25 cross-references FCR 20.17, to make it clear that a person ordered to give preliminary discovery must file a list of documents in the same way as a party ordered to give discovery. 144 Furthermore, FCR 20.20 provides that it is a party who has an obligation to give continuing discovery. This is to be contrasted with the obligation to give discovery under FCR 7.23 which applies only to a prospective respondent, defined as being "a person, not presently a party to a proceeding": FCR 7.21. 145 In addition, the policy considerations underlying preliminary discovery, on the one hand, and discovery, on the other, are quite different. As I have noted, preliminary discovery is a form of relief available to a prospective applicant against a prospective respondent. It takes place at a time when substantive proceedings have not been commenced and may never be: Pro-Pac Packaging (Aust) Pty Ltd v Penn (No 2) [2020] FCA 710 at [13] (Burley J). The purpose of FCR 7.23 is "to enable a person who believes he, she or it may have a right to seek relief to obtain information to make a responsible decision as to whether to commence proceedings": Pfizer FFC at [4] (Allsop CJ). Applications for preliminary discovery are summary in nature, and not mini-trials: Pfizer FFC at [2]. Tied up with this concept is the notion (not apparent from the present proceedings) that preliminary discovery applications are to be relatively quick and cheap such that it is unlikely that continuing discovery obligations would arise. 146 What is more, unlike discovery, which takes place after proceedings have been commenced and after the point in time when a respondent has had an opportunity to understand the nature of the case made against it and to respond in the form of a defence or an affidavit (see FCR 20.13(3)), preliminary discovery takes place before proceedings are commenced, and before any substantive pleading has been filed. Such proceedings are constrained by the requirements of FCR 7.23 which confine a prospective applicant's ability to only seek documents that are "sufficient" to make a decision. That decision is to be taken at a particular point in time, namely when the application is brought, that being the time when the prospective applicant must hold its reasonable belief: Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648; 158 IPR 1 at [20] (Burley J). 147 It was no doubt in recognition of the more limited role of preliminary discovery that, in United Voice, Lander J observed that FCR 7.23 should be read as not imposing any greater obligation on a prospective respondent in giving discovery before a proceeding is started than a prospective respondent would have as a respondent after the proceeding is started (at [24]). 148 The limited and specific purpose of FCR 7.23, which is simply to enable a prospective applicant to obtain access to information required to make a decision to start proceedings, is to be contrasted with the broader purpose underlying discovery in proceedings which has been said to reflect the fact that litigation is to be conducted to ensure that the ultimate result is just and correct: Davies v Eli Lilly & Co [1987] 1 All ER 801 at 804 (Donaldson MR); Trade Practices Commission v Santos Ltd [1993] FCA 292; 42 FCR 203 at 205 (Heerey J); Brookfield v Yevand Products Pty Ltd [2004] FCA 1164 at [367] (Lander J). 149 For these reasons, I do not consider that an automatic obligation to provide continuing discovery arising from FCR 20.20(1) applies to a prospective respondent in proceedings brought pursuant to FCR 7.23. Of course, a Court may within FCR 1.32 make orders for preliminary discovery that in express terms require that continuing discovery be given, but such orders will be assessed on a case by case basis and would not be lightly made. They were not made in the present case. 150 Accordingly, I do not consider that SBA has been under such an obligation to give continuing discovery in relation to the further commercial batches or the later CTD submodules.

4.6 Sabre-style orders 151 In paragraphs 2, 5 and 5A of its interlocutory application Pfizer seeks orders that to the extent that any of the documents sought in requests 2, 4 and 6 are not in the possession, custody, power or control of SBA (the unavailable documents), that SBA take all reasonable steps to obtain the unavailable documents which are in the possession, custody, power or control of SBK, Biogen and Fujifilm Denmark. SBA has agreed to take such steps insofar as they concern SBK. 152 The form of orders sought are characterised in submissions as those arising from the decision of Lockhart J in Sabre Corporation. In that case, Lockhart J explained (at 431-432): In my opinion the Court has power to direct a party to take steps to obtain access to and discover documents which are in the possession, power or control of a third party where there is a real likelihood that the party to the proceeding would be given access to the documents upon request. Section 23 of the Federal Court of Australia Act 1976 (Cth) confers ample power upon the Court to make orders of the kind sought in par (2) of the notice of motion, namely, an order that the applicant be required to request Joico to take steps to obtain access to and discover documents in the possession, power or control of Joico (the third basis relied on by the respondents and mentioned earlier). Section 23 provides: "The Court has power, in relation to matters in which it has jurisdiction, to make orders of such kinds, including interlocutory orders, and to issue, or direct the issue of, writs of such kinds, as the Court thinks appropriate." This power may be exercised where there is a real likelihood that the party to the proceeding against whom the order is made would be given access to the documents by the third party upon request. (Emphasis added) 153 This power has been exercised many times since then: see, for instance, Kraft Foods Group Brands LLC v Bega Cheese Limited (No 4) [2018] FCA 1055 at [18] (O'Callaghan J); Vringo Infrastructure Inc v ZTE (Australia) Pty Ltd [2014] FCA 525 at [35] (Yates J). However, the researches of counsel in this case have not turned up a case where such an order has been made in support of an application under FCR 7.23. 154 In Prysmian Besanko J declined to make a Sabre-style order, contrasting the facts in Sabre Corporation. His Honour noted at [24]: In that case, Lockhart J indicated that he would make an order requiring an Australian distributor of products manufactured by a United States corporation to request the manufacturer to provide it with certain documents. Critically, his Honour found on the facts, including a clause in a distributorship agreement, that there was a real likelihood that the United States corporation would provide the documents to the Australian distributor. Although the parties in this case are related, I am not able to find such a real likelihood on the facts of this case and I refuse to make the order sought in paragraph 3. (Emphasis added) 155 In Vringo the Court distinguished Pyrsmian on the basis that the respondent corporation was not only a member of the same corporate group as the overseas third party (ZTE Corp), it was also established to be the Australian sales arm of ZTE Corp: Vringo at [24]-[25]. Furthermore, the Court found that although ZTE Corp had declined an informal request made by the applicant through the respondent for the production of documents, the Court did not regard this to be a matter of any significant weight, that being the background common to most, if not all, applications for Sabre-style orders: Vringo at [26]. 156 SBA correctly withdrew a submission that the Court did not have the power to make a Sabre-style order under s 23 of the Federal Court of Australia Act 1976 (Cth) in preliminary discovery proceedings. The power under that section is not so circumscribed. Nevertheless, I do not consider that the principles developed by reference to Sabre Corporation extend to preliminary discovery applications. Those principles apply where one party has pleaded a case against another party. The distinction between preliminary discovery and discovery that I have identified above in [144]-[148] serves to demonstrate that the Court would be slow to accept that mechanisms developed to aid discovery processes should automatically be applied where there have been no pleadings and proceedings proper have not been commenced. Furthermore, it may be inferred that FCR 7.23 provides what might ordinarily be considered to be the limits of pre-commencement relief available to a prospective party. I have determined that Pfizer is entitled to some such relief. I am not persuaded that Pfizer is entitled to more.

5. DISPOSITION 157 I have found that SBA must give additional preliminary discovery in relation to modified requests 2 and 4. Otherwise, the interlocutory application must be dismissed. In my view, it is appropriate that the preliminary discovery proceedings also be dismissed. They have been ongoing since 2016 and, although there may be extenuating circumstances, in my view preliminary discovery applications ought not to provide a prospective applicant with repeated opportunities to extend and expand its demands. 158 No doubt the parties will wish to argue about costs. My preliminary view is that an enormous amount of the evidence filed by Pfizer, and particularly the very lengthy affidavits of Mr Tyacke, was irrelevant to the application argued. Pfizer had a modest degree of success and SBA undoubtedly entered the fray raising numerous arguments in opposition to production: see Pfizer No 2 at [25] and [27]. The logistics of the process of the further preliminary discovery were understandably not debated at the hearing. My preliminary view is that the following orders should be made: (1) Pursuant to r 7.23 of the Federal Court Rules 2011 (Cth) (FCR), by 4.00 pm on the date that is 28 days after the date of these orders, to the extent not already provided, the Prospective Respondent give discovery on affidavit by a director having knowledge of the facts, and inspection, to the Prospective Applicants of documents within the description of modified requests 2 and 4 set out in the confidential annexure to these orders. (2) That SBA pay 40% of Pfizer's costs of the further amended interlocutory application. (3) The proceedings filed on 14 December 2016 be dismissed. 159 However, I will provide the parties with the opportunity to endeavour to agree to the form of orders giving effect to these reasons, including as to the appropriate form and duration of any final suppression orders. I will order that the parties confer and within seven days provide to my chambers short minutes of order marked-up to indicate any areas of disagreement. In the event there is any disagreement as to the appropriate form of orders, I will direct that Pfizer file and serve written submissions of no more than five pages within seven days thereafter and for SBA to file and serve responsive written submissions within seven days after that. I will also direct that until the appropriate form of final suppression order is determined, the text of these reasons only be published and disclosed to the external legal representatives of Pfizer and SBA. I will also order that the parties confer and provide to chambers, within 14 days, a copy of these reasons where any confidential material has been identified for redaction. Thereafter the proceedings will be listed for a case management hearing at 9.30am on 13 December 2021 to determine what, if any, further steps are required. I certify that the preceding one hundred and fifty-nine (159) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Burley.