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.