FEDERAL COURT OF AUSTRALIA

Troy Laboratories Australia Pty Ltd v Randlab Pty Ltd [2026] FCA 947

ORDERS

THE COURT ORDERS THAT:

1.    By 4:00pm on 3 August 2026 the parties are to provide to the chambers of Owens J agreed proposed orders giving effect to the reasons for judgment dated 20 July 2026, including as to costs, or, in the absence of agreement, competing proposed orders.

2.    By 4:00pm on 3 August 2026 the parties are to provide to the chambers of Owens J an agreed set of proposed redactions to the reasons for judgment dated 20 July 2026, or in the absence of agreement, competing proposed redactions, in order to ensure consistency with the orders made by Owens J on 9 March 2026.

3.    Subject to further order of the Court, the unredacted reasons for judgment dated 20 July 2026 are not to be published on the Federal Court of Australia website or otherwise published to any person other than the Prospective Applicant, the Prospective Respondent, and their legal representatives.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

OWENS J:

1 Troy Laboratories Australia Pty Ltd, the prospective applicant, conducts a business engaged in the research, development, manufacture and sale of innovator and generic veterinary chemical products, as defined in section 5 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) and registered by the Australian Pesticides and Veterinary Medicines Authority.

2 Randlab Pty Ltd, the prospective respondent, is a veterinary pharmaceutical company and a direct competitor of Troy.

3 Troy has separately commenced proceedings against Dr Yeakuty Jhanker, a research and development scientist formerly employed by Troy, who now works for Randlab. In those proceedings, Troy contends that Dr Jhanker improperly accessed and used Troy’s confidential information.

4 Troy is now contemplating whether it may be able to bring proceedings against Randlab, seeking relief for misuse of confidential information, copyright infringement, and involvement in Dr Jhanker’s alleged misuse of information contrary to section 183 of the Corporations Act 2001 (Cth). So that it may have sufficient information to make that decision, Troy filed an application seeking preliminary discovery pursuant to rule 7.23 of the Federal Court Rules 2011 (Cth).

EVIDENCE

5 On this application for preliminary discovery, Troy relies upon the following evidence:

(a)    two affidavits of Dr Dalemari Swanepoel, the Chief Technical Officer and Scientific Director at Troy, affirmed on 1 August 2025 and 18 December 2025;

(b)    two affidavits of Paul Simon Barnett, the Chief Executive Officer at Troy, sworn on 1 August 2025 and 16 September 2025;

(c)    an affidavit of Sanjiv Puri, the Chairman and Founder of Avet Health Limited (an Australian veterinary pharmaceutical company, which is a competitor of both Troy and Randlab), affirmed on 16 September 2025;

(d)    an affidavit of Rodney McKemmish, a consultant forensic technology specialist, sworn on 11 September 2025, including his independent expert report annexed as Annexure RM-2; and

(e)    an affidavit of Dr Fadil Alawi, a consultant pharmaceutical formulator, sworn on 19 December 2025, including his confidential report annexed as Confidential Annexure FA-4.

6 Randlab relies upon the following affidavits:

(a)    two affidavits of Bruce Bell, the General Manager of Randlab, affirmed on 22 October 2025 and 9 March 2026;

(b)    three affidavits of Thomas Anthony Haystead, a solicitor of Squire Patton Boggs (the solicitors for Randlab), affirmed on 22 October 2025, 10 February 2026 and 6 March 2026; and

(c)    two affidavits of Dr Jhanker, one sworn on 22 October 2025 (which annexes an earlier affidavit sworn by her on 29 July 2025 in the proceedings commenced against her by Troy), and another on 10 February 2026 (also filed in the related proceedings).

7 No witness was cross-examined.

APPLICABLE PRINCIPLES

8 Rule 7.23 provides:

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).

9 The following matters are relevant to the application of that rule:

(a)    Rule 7.23(1)(a) requires a reasonable belief that a claim may exist, not that it does exist: Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCAFC 193; (2017) 257 FCR 62 at [8] (Allsop CJ), and [101], [103], [108] (Perram J). A prospective applicant must show that they subjectively hold such a belief, and that the belief is objectively reasonably based: Pfizer at [107] (Perram J). A belief can be shown to be reasonably based “either by reference to material known to the person holding the belief or by other material subsequently placed before the Court”: Pfizer at [120(ii)] (Perram J).

(b)    A prospective respondent cannot show that a belief is not reasonably based merely because they disagree with it, or because some aspect of the material on which it is based is arguably wrong, or speculative: Pfizer at [121] (Perram J). Often, an application “will rest on case architecture which is circumstantial in nature”. It is not appropriate to interrogate the evidence in the manner of a “mini-trial”, but rather, to consider the force of the evidence as a whole, and whether it inclines one to believe that a case may exist: Pfizer at [2] (Allsop CJ), and [119], [120(iv)-(v)], [124] (Perram J).

(c)    Insofar as rule 7.23(1)(b) is concerned, whether reasonable inquiries have been made is assessed objectively, as is the question whether the prospective applicant has sufficient information to commence proceedings: HQ Insurance Pty Ltd v Stonehatch Risk Solutions Ltd (No 2) [2020] FCA 1010; (2020) 146 ACSR 159 at [7], [51] (Thawley J).

(d)    The latter question includes consideration of the prospective applicant’s circumstances, and whether there is sufficient information to consider whether the cost and risk of litigation is worthwhile: HQ Insurance at [7] (Thawley J); Poole v Australian Pacific Touring Pty Ltd [2017] FCA 424 at [38], [39(6)] (Bromwich J). To that end, a prospective applicant may be entitled to preliminary discovery in order to determine the existence and strength of any defences, or the extent of the prospective respondent’s breach and the likely quantum of damages: ObjectiVision Pty Ltd v Visionsearch Pty Ltd [2014] FCA 1087; (2014) 108 IPR 244 at [103] (Perry J), citing St George Bank Ltd v Rabo Australia Ltd [2004] FCA 1360; (2004) 211 ALR 147 at [26(f)] (Hely J).

(e)    However, preliminary discovery should not be ordered if it is not required to assist the prospective applicant to decide whether to commence proceedings, for example, if it would merely reinforce a decision which had already been made: see, e.g., Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (No 3) [2021] FCA 1428; (2021) 165 IPR 30 at [95] (Burley J); Telstra Corporation Ltd v Minister for Broadband, Communications and Digital Economy [2008] FCAFC 7; (2008) 166 FCR 64 at [60] (French, Weinberg and Greenwood JJ).

(f)    While the power to order preliminary discovery is discretionary, “[rule 7.23] is to be beneficially construed, [and] given the fullest scope that its language will reasonably allow”: Pfizer at [172] (Nicholas J), quoting St George Bank at [26] (Hely J).

10 As to the scope of the discovery that should be ordered:

(a)    The measure of preliminary discovery should be limited to those documents which are necessary to overcome the insufficiency of information already possessed by the prospective applicant relevant to the decision whether to commence proceedings: Reeve v Aqualast Pty Ltd [2012] FCA 679 at [65(d)] (Yates J).

(b)    It is often difficult to distinguish between documents which are “reasonably required” (or “reasonably necessary”) to make that decision, and documents which merely “would be good to have”: Aristocrat Technologies Australia Pty Ltd v Light & Wonder, Inc. [2024] FCA 439 at [32] (Nicholas J). Preliminary discovery should only be ordered over documents of the former kind.

(c)    The terms of rule 7.23 (and its operation by reference to the prospective applicant’s belief) make plain that it is no answer to a prospective applicant’s categories of document that the prospective respondent does not possess documents in those categories, unless that displaces the prospective applicant’s belief that the prospective respondent has, or is likely to have, documents relevant to the availability of relief: Sovereign Hydroseal Pty Ltd v Steynberg (No 2) [2020] FCA 1239 at [17] (McKerracher J) (the absence of documents may, however, be relevant to the exercise of the Court’s discretion under rule 7.23(2): Pfizer v Samsung (No 3) at [108] (Burley J)).

BACKGROUND AND RELATED PROCEEDINGS

11 Dr Jhanker was employed by Troy from 6 November 2019 to 6 January 2023. Dr Jhanker’s responsibilities included the development and formulation of new products, and assisting with regulatory submissions. On 20 November 2023, Dr Jhanker commenced employment with Randlab.

12 On 12 March 2025, Mr Barnett attended a meeting with Mr Puri at which Mr Puri stated that he had been informed that Dr Jhanker was attempting to sell Troy’s confidential information. On 8 May 2025, Mr Puri clarified to Mr Barnett that that information came from a colleague who did not wish to be named. In the meantime, on 28 March 2025, an anonymous email came to the attention of Mr Barnett which alleged that Dr Jhanker had been offering to assist rival companies to register products with the APVMA by using Troy’s confidential information. Specifically, it was alleged that Dr Jhanker was offering to assist with “item 7 applications”, being applications to register generic products with known active constituents. Such applications involve demonstrating comparability of the product sought to be registered with a closely similar (and already approved) reference product to establish that certain safety and efficacy criteria have been met.

13 It has now been ascertained that Mr Puri’s unnamed colleague was the same person who sent the anonymous email. That person had previously been employed by Randlab (although not, it would seem, at the same time as Dr Jhanker), and is now employed at Avet (Mr Puri’s company). Dr Jhanker denies ever having met or having had any dealings with that person.

14 In April 2025, Troy conducted investigations into applications filed by Troy’s competitors which could have used a Troy product as a reference. These investigations revealed that Randlab made successful item 7 applications for the following products, each registered after Dr Jhanker had left Troy:

15 The first three products used a Troy product as the reference product; the fourth used the same third-party reference product that Troy had used to obtain the registration of its product.

16 Troy says that the following products registered in its name are equivalent to the Randlab products set out above:

17 In May 2025, Troy engaged Mr McKemmish to conduct a forensic analysis of the laptop Dr Jhanker used while working for Troy. That analysis demonstrated that Dr Jhanker had connected USB devices to her work laptop and suggested (without being able to confirm one way or another) that she had copied files from Troy’s intranet on several occasions (I will return in due course to deal with Randlab’s contentions in relation to what Mr McKemmish’s analysis proves). The files in question included confidential formulation documents for Troy’s products, including in relation to the products the subject of this application.

18 On 8 July 2025, Troy commenced proceedings in this Court against Dr Jhanker. On 9 July 2025, Wigney J made discovery orders against Dr Jhanker, and imposed interim restraints which remain in effect to date by consent of the parties.

19 On 29 July 2025, Dr Jhanker filed an affidavit verifying the discovery she had provided. In that affidavit, Dr Jhanker admitted that she had copied some documents to USB devices, and said that she left the devices in a drawer at the Troy laboratory upon her departure (Troy has been unable to locate any such USBs). She denied Troy’s allegations that she had shared any documents with Randlab or other third parties. She said that she copied the documents because:

(a)    Troy’s laboratory staff used USB devices to transfer data between Troy’s computer systems and its high performance liquid chromatography machines, thus she thought it acceptable to use USB devices in the course of her work; and

(b)    she used the USB devices to transfer documents between her desktop computer in the laboratory and her work laptop because her laptop did not reliably connect with the Troy network via VPN. This made it easier for her to work remotely.

20 Troy now seeks preliminary discovery of the following thirteen categories of documents relating to the Randlab products and Troy products set out above, as well as an additional “Avenge + Fly” blowfly strike prevention product which Troy alleges may have been another subject of Dr Jhanker’s copying:

(1)    A copy of the Item 7 applications (and related material noted below) submitted to the Australian Pesticides and Veterinary Medicines Authority (APVMA) in relation to each of the products that are the subject of the following APVMA registrations:

(a)    Randlab Vitamin C Injection, 500 mg/mL ascorbic acid as sodium ascorbate, APVMA product no. 93665;

(b)    Randlab Frusemide Injection, 50 mg/mL furosemide, APVMA product no. 94504;

(c)    Randlab Meloxicam 40 Injection, 40 mg/ml meloxicam, APVMA product no. 94630; and

(d)    Randlab Xylazine 20 mg/mL Injection, 20 mg/ml Xylazine hydrochloride. APVMA product no. 95373,

(together, the Randlab Products), insofar as they concern:

(i)    The formulations used in the Randlab Products;

(ii)    Details regarding the specific active pharmaceutical ingredients (APIs) in the Randlab Products;

(iii)    The identity of any third parties that manufacture the APIs used in the Randlab Products;

(iv)    Manufacturing specifications that detail the processes and batch sizes used to manufacture the Randlab Products;

(v)    Finished product specifications for the Randlab Products as submitted to the APVMA, including any correspondence or requests for additional information with the APVMA as part of the application;

(vi)    Analytical methods used to test the Randlab Products and details of when they were developed; and

(vii)    Stability data for the Randlab Products;

(2)    A copy of all master batch manufacturing records used by Randlab to manufacture the Randlab Products;

(3)    Patent search requests to determine Randlab’s freedom to operate in relation to each of the Products;

(4)    Documentation collated by Randlab on the reference formulations for each of the Products as part of its preliminary research assessments;

(5)    A copy of results of comparative testing conducted in respect of the reference product relied upon for each Item 7 application submitted for the Randlab Products;

(6)    A copy of documents relating to the laboratory or pilot-scale batches produced in relation to each of the Randlab Products during development;

(7)    A copy of documents setting out the process of developing each of the Randlab Products, including development summaries, progress reports (including iterations of the formulations created through the development process) and milestone reports;

(8)    A copy of documents setting out the reverse engineering results in relation to each of the Randlab Products, including certificates of analysis or analytical work plans and raw data;

(9)    A copy of emails or other correspondence sent or received by Randlab comprising, or relating to, the bill of materials, correspondence with the APVMA, product specifications, formulations and/or master batch manufacturing records for the following Troy products:

(a)    Troy Vitamin C Injection, APVMA product no. 50272;

(b)    ilium Frusemide Injection, APVMA product no. 50268;

(c)    ilium Meloxicam 40 Anti-inflammatory Injection for Cattle, APVMA product no. 93900;

(d)    ilium Meloxicam 20 Anti-Inflammatory Injection for Cattle, Sheep, Pigs and Horses, APVMA product no. 62535;

(e)    ilium Xylazil-20 Analgesic, Sedative and Muscle Relaxant Injection, APVMA product no. 38653; and

(f)    Avenge + Fly Blowfly Strike Prevention and Lousicide for Sheep Spray-On Pour-On, APVMA product no. 62598,

(together the Troy Formulation Documents);

(10)    A copy of all documents in Randlab’s possession, custody or control that comprise:

(a)    the Troy Formulation Documents, including any one thereof;

(b)    the whole or any part of any and all information contained in the Troy Formulation Documents;

(11)    A copy of all documents that evidence or record research and development activities undertaken in respect of the Randlab Products that were prepared for the purpose of claiming the research and development tax incentive, including but not limited to research and development tax incentive schedules in relation to each of the Randlab Products.

(12)    A copy of all documents being, evidencing or recording communications sent prior to 20 November 2023 between Randlab and Ms Yeakuty Jhanker, including but not limited to communications that:

(a)    comprise, reproduce (whether whole or in part) or otherwise relate to the Troy Formulation Documents; and

(b)    relate to the Troy products listed in subparagraphs 9.a to 9.f.

(13)    A copy of all documents being, evidencing or recording communications from 20 November 2023 to date between Randlab and Ms Yeakuty Jhanker that:

(a)    comprise, reproduce (whether whole or in part) or otherwise relate to the Troy Formulation Documents; and

(b)    relate to the Troy products listed in subparagraphs 9.a to 9.f.

21 At the hearing, counsel for Troy indicated that Troy no longer pressed category 2.

ANALYSIS

Does Troy believe it may have the right to obtain relief from Randlab?

22 It was not in dispute that Troy has a subjective belief that it may have a claim against Randlab, and the evidence of Dr Swanepeol and Mr Barnett, who are respectively Troy’s Chief Technical Director and Chief Executive Officer, satisfies me that it does.

23 Dr Swanepoel deposed to her concerns about the registrations that Randlab had obtained against the background of the third-party tip-off about Dr Jhanker, the particular files which Mr McKemmish’s report indicated that Dr Jhanker could have copied and how those files could assist a competitor, and her opinion that developing products closely related to Troy’s would ordinarily involve substantial independent effort. Having set out those matters, she said this:

In light of my comments [about the above matters] I am concerned that [Dr] Jhanker has copied Troy’s sensitive commercial information on to USB devices and that copies of these files, or the confidential information in the files, have been provided by [Dr] Jhanker to Randlab and/or other suppliers of veterinary pharmaceuticals that compete with Troy. If this information has been provided to Troy’s competitors it will be significantly advantageous to them because it will enable them to launch competing products without having to undertake the development work that I described above.

24 Mr Barnett agreed with Dr Swanepoel’s concerns. He said:

I am concerned that [Dr] Jhanker has provided copies of Troy’s files, or the confidential information in these files, and copyright materials to Randlab. I believe that Troy may have the right to obtain relief from Randlab.

Is Troy’s belief reasonable?

25 Troy submitted that there was an objectively reasonable basis for its belief due to the combined force of the following circumstances:

(a)    There is no credible explanation for Dr Jhanker’s use of USB devices. In her second affidavit, Dr Swanepoel said that there was no reason for members of Dr Jhanker’s team to copy data from Troy’s intranet onto a USB device; Troy’s employees would only ever use USBs to transfer data from HPLC machines to Troy’s intranet, not vice versa; further, Troy’s VPN reliably supported remote work. The timing of some of the activity identified by Mr McKemmish was also inconsistent with Dr Jhanker having a legitimate work-related purpose for her conduct. She also said that Troy never found the devices which Dr Jhanker said she had left in an unlocked drawer at her desk.

(b)    After copying the files, Dr Jhanker ceased employment at Troy, and obtained employment at Randlab, contrary to the restraint provision in her contract. After Dr Jhanker left Troy, Randlab applied to register products similar to those that appeared in the material that had been copied (three such applications being made after Dr Jhanker started at Randlab, and another – for the Vitamin C injection product – before Dr Jhanker started at Randlab, but after she had left Troy).

(c)    Three of Randlab’s applications used a Troy product as the reference product; the fourth (the Meloxicam 40 product) used the same third-party reference product as Troy had for its equivalent application.

(d)    After Dr Jhanker left Troy, Randlab revised its formulations for the relevant products such that they became increasingly similar to Troy’s equivalent products, and has not provided an adequate explanation of how it did so.

26 In support of the reasonableness of its belief that Randlab may not have developed its applications through its own independent work, Troy relied on Dr Fadil Alawi’s report. Dr Alawi analysed material annexed to Mr Bell’s first affidavit, which Randlab relied upon to demonstrate that it developed its products independently. The material comprised formulation documents and APVMA applications for the relevant Randlab products, including formulation advices provided by Pia Pharma Pty Ltd, an external laboratory which Randlab engages to analyse samples of reference products upon which it intends to rely in an item 7 application. Dr Alawi’s opinion was that:

(a)    There are significant unexplained differences between the formulations proposed by Pia Pharma for Randlab’s Frusemide and Xylazine products and the formulations ultimately submitted to the APVMA. In particular:

(i)    As to the Frusemide product, by June 2023, Pia Pharma had not been able to determine a closely similar formulation to the reference product, and by August 2023, had only proposed three specific inactive ingredients (or “excipients”). Randlab’s APVMA application, however, included three further excipients in the same concentration as found in Troy’s formulation, and adjusted the concentration of two existing excipients in line with those found in Troy’s formulation.

(ii)    As to the Xylazine product, by August 2023, Pia Pharma had only proposed specific concentrations for the active constituent and three excipients. Randlab’s APVMA application, however, which bore Dr Jhanker’s name, contained two new excipients and had adjusted the concentration of two existing excipients, in each case bringing the concentrations in line with those in Troy’s formulation.

In each case, Dr Alawi had not identified any materials which would explain why those final adjustments had been made.

(b)    Although Mr Bell deposed that Randlab developed its Meloxicam 40 product by reference to its own Meloxicam 20 product which was registered in 2015, the higher strength product could not have been made simply by doubling the active ingredient and making obvious, proportional adjustments to the excipients. Instead, in Dr Alawi’s view, the formulation of the higher strength product was a “significant deviation” from, and “substantial reformulation of”, that of the lower strength product, but had “the same fundamental design” as Troy’s Meloxicam 40 product, including the same concentration of a number of excipients. Ordinarily, significant testing and work would be undertaken to achieve such a reformulation, but Dr Alawi had not seen any reports documenting such work.

(c)    Randlab’s application to the APVMA to register its Vitamin C product on 1 June 2023 listed a different concentration of its active ingredient compared to an earlier Randlab formulation sheet dated 20 January 2022. In Dr Alawi’s view, the concentration listed in the application was a typographical error, and the application would have been refused in that form. He expects that the APVMA would have queried the figure in correspondence with Randlab, and Randlab would ultimately have provided an updated figure, as shown in the details of Randlab’s registration on the public APVMA database. Troy submits that it has a reasonable basis to believe that, given Randlab’s delay between devising the original formulation sheet in 2022 and submitting the application in June 2023 (after Dr Jhanker had left Troy, but before she had formally joined Randlab), Randlab may have used Troy’s confidential information to correct the figure in its item 7 application, or at least to confirm the formulation that it had developed prior to applying for registration.

27 Further, in this regard, Troy relied on Dr Swanepoel’s evidence that she asked Pia Pharma about its reverse engineering capabilities in May and October 2025, and was told that Pia Pharma cannot determine the concentrations of all of a reference product’s ingredients with sufficient precision to achieve an item 7 registration.

28 Randlab, on the other hand, submitted that Troy’s belief was not reasonably based for the following reasons:

(a)    Randlab submitted that the evidence relied upon by Troy in support of the proposition that Dr Jhanker had copied the relevant files from Troy’s intranet was weak:

(i)    Randlab submitted that the evidence that third parties had informed Troy that Dr Jhanker had been approaching prospective employers who were competitors of Troy, and offering to assist with item 7 applications using Troy’s confidential information, was inadmissible hearsay. Randlab ultimately conceded that, by operation of section 75 of the Evidence Act 1995 (Cth), the evidence was not inadmissible. It contended, nonetheless, that the evidence was uncorroborated, baseless and flimsy. The evidence showed that the ultimate source of all of the allegations made to Troy was a colleague of Mr Puri, who was a former employee of Randlab. As a former employee of Randlab it was submitted that he “may have” a motive to make false accusations against Randlab. In any event, the fact that he had not sworn any affidavit to substantiate his claims was to be contrasted with Dr Jhanker’s sworn denials. Her explanation for using USBs as part of her work for Troy was said to be credible. The overall result, it was submitted, was that Dr Jhanker’s evidence should be preferred, or, at the very least, that the belief of Troy that Dr Jhanker had copied its confidential information was not reasonable.

(ii)    Randlab also emphasised that Mr McKemmish’s report established only that Dr Jhanker had connected USB devices to her work laptop that contained folder names and folder paths that were the same, or similar, to folders on Troy’s intranet; Mr McKemmish was not (with one exception) able to ascertain whether those folders (or their contents) had been copied from the intranet to the USB devices. The one file that could be directly established to have been copied from the intranet to a USB device attached to Dr Jhanker’s laptop was not related to the Troy products in issue. Randlab submitted that it did not necessarily follow from the similarity in folder names and structures that all the files in the folders with similar names were copied by Dr Jhanker, and that other inferences were available to explain the similarity.

(b)    Randlab submitted that the circumstances of Randlab’s product registrations were not capable of supporting any inference that Troy’s confidential information may have been used. It was said that the fact that Randlab’s products used a Troy product (or the same third-party product) as a reference product, and had similar active ingredients and other functional similarities, is to be expected given the nature of the item 7 regime and its requirements for “close similarity” to a chosen reference product. Further, Dr Alawi’s report indicated that there were some differences in the choice and concentration of particular excipients across some products. Randlab also disputed that the timing of Randlab’s registrations was in any way suspicious, because Mr Bell’s evidence indicated that Randlab was developing the relevant products before Dr Jhanker started at Randlab.

(c)    Mr Bell has denied that Randlab used or received any confidential information, and voluntarily provided Randlab’s own confidential information about its product registrations. Randlab attempted to resolve the preliminary discovery application through an open offer to provide documents in categories 12 and 13. Shortly before the hearing, Randlab also put on evidence that it had carried out searches of its premises and computer systems to identify whether it had any of the impugned USB devices or confidential information, and denied that it did. All of this was submitted to be inconsistent with Troy reasonably believing that it may have a claim against Randlab.

29 For the reasons that follow, I am satisfied that Troy’s belief that it may have a claim against Randlab in respect of the Frusemide, Xylazil and Meloxicam 40 products is objectively reasonable. However, I am not so satisfied in relation to any claim concerning the Vitamin C product, nor in respect of Troy’s Avenge + Fly product.

30 Randlab devoted considerable effort to demonstrating that Troy did not have a reasonable basis for believing that Dr Jhanker had copied its confidential information. In one sense the reason for that focus is obvious (in that initial copying by Dr Jhanker is a necessary premise for the case against Randlab). Troy, of course, already considers that it has a proper basis upon which to allege copying by Dr Jhanker (as evidenced by the fact that it has commenced proceedings against her). Troy’s uncertainty relates to what (if anything) Dr Jhanker may have done with that information in relation to Randlab. It follows that Troy does not believe that Dr Jhanker may have copied its confidential material; it believes that Dr Jhanker has copied its confidential material.

31 In any event, I am satisfied that, insofar as Troy’s belief that it may have a claim against Randlab depends on initial copying by Dr Jhanker, it is reasonably based.

32 I should emphasise, of course, that it is neither necessary nor appropriate for me to determine on this application whether the allegations that Dr Jhanker copied Troy’s confidential information are in fact true. I accept Randlab’s submission that all the allegations may ultimately be traced to one person, who has not given evidence on this application. The allegations were expressed in a conclusory way, without the detail or particularity that would be required to assess their credibility on their face. I would not have considered those allegations, on their own, to be sufficient to provide a reasonable foundation for Troy’s belief. Indeed, ultimately, I consider that this evidence is relevant primarily to explaining why it was that Troy set about investigating the possibility of Randlab’s use of its confidential information. The existence of a reasonable basis for Troy’s belief is principally to be found in the combined force of the results of those investigations, in the context of the fact of the allegations having been made. The allegations themselves do not add any independent weight to Troy’s case.

33 I should make clear, however, that I do not accept any submission (to the extent it was put) that it may be positively inferred that the allegations were deliberately fabricated in pursuit of some ulterior motive. While Randlab emphasised that the source was one of its former employees, and “may have” a motive for causing harm to Randlab, it did not identify any matters that would suggest that that person may in fact have such a motive. The existence of such a motive was nothing more than pure speculation.

34 What, then, of the matters revealed by Troy’s investigations upon which it relies?

35 In relation to Mr McKemmish’s report, it is true, as Randlab emphasised, that he did not express an opinion that Dr Jhanker had in fact copied Troy’s confidential documents (save in respect of one irrelevant instance). Rather, the critical conclusion of his report is that on various occasions:

(a)    a specified USB device was connected to Dr Jhanker’s laptop;

(b)    while so connected:

(i)    various folders on the Troy intranet were accessed;

(ii)    various folders on the USB device were either copied to, or created on, the device;

(iii)    the copied or created folders on the USB device were accessed.

(c)    the folder names that were copied to, or created on, the USB device were the same as (or similar to) folders located, and accessed, on the Troy intranet.

36 It is enough to describe the detail of one particular part of the analysis. The others relied upon by Troy fall into a similar pattern. That is, the analysis revealed that:

(a)    A “Verbatim STORE N GO” external USB device was connected to Dr Jhanker’s laptop on 3 January 2023 at 12:06am.

(b)    Troy’s intranet has a folder path entitled “X:\Regulatory Affairs\Australia & New Zealand\Australia\Products” (with various sub-folders relating to individual products contained within the “Products” folder).

(c)    Between 12:08am and 12:10am various folders in the “X:\Regulatory Affairs\Australia & New Zealand\Australia” folder were accessed.

(d)    At 12:10am a folder was created on the USB device entitled “RA-AU products”.

(e)    The “RA-AU products” folder on the USB device was then accessed 7 times in less than a minute.

(f)    Other activity then occurred on both Troy’s intranet, and the USB device, before the “RA-AU products” folder was accessed again at 12:28am.

(g)    The USB device was then disconnected from Dr Jhanker’s laptop at 12:29am.

37 Dr Swanepoel’s evidence was that the “X:\Regulatory Affairs\Australia & New Zealand\Australia” folder on Troy’s intranet contains all documents and correspondence relating to regulatory approvals for all Troy products sold in Australia. Those documents include the formulations for Troy’s products. It was not in dispute that such documents would be of considerable assistance in filing an item 7 application to secure registrations for products that are closely similar to the relevant Troy product.

38 The ultimate effect of Mr McKemmish’s evidence was that the activity he identified was consistent with copying, but did not establish that it had in fact occurred.

39 I did not understand there to be any genuine dispute about the validity of the observations contained in Mr McKemmish’s report. That is to say, there was no challenge to the correctness of his findings relating to the fact, or timing, of Dr Jhanker’s use of USB devices, or her accessing of particular folders on Troy’s intranet and her USB devices. It follows that Randlab’s submission that Mr McKemmish’s report was in some way tainted by the instructions he was given was difficult to understand. In any event, I do not consider that there was anything improper in the instructions that he was given, nor that those instructions in any way affected the reliability of the conclusions he reached.

40 I do accept, however, Randlab’s submission that Mr McKemmish’s analysis does not prove that Dr Jhanker had engaged in wholesale copying of Troy’s files, or transmitted any particular file to Randlab. But that does not seem to me to matter. The question is not whether Troy has proved that copying took place; the question is only whether Troy’s belief that it may have a claim against Randlab is objectively reasonable. In that regard, there can be no doubt that Mr McKemmish’s report lends considerable support to the reasonableness of Troy’s belief that Dr Jhanker has copied its confidential information (and all the more so when it is considered along with the other matters to which I will turn).

41 The sequence of events summarised above in relation to the “Regulatory Affairs” folder is no doubt consistent with a range of innocent activities by Dr Jhanker. It is also consistent, however, with the identification and copying of folders relevant to the regulatory approval of Troy’s products from Troy’s intranet to a USB storage device. That is to say, one of the available inferences is that Dr Jhanker:

(a)    Accessed various folders on Troy’s intranet relating to the regulatory approval of Troy’s products (perhaps for the purposes of identifying or confirming their contents, or for some other reason).

(b)    Created a folder on the USB device for the purpose of creating a destination to which files from the intranet could be copied, and giving it a name that would accurately and conveniently described the contents of the files to be copied. It is, for example, an available inference that the name of the newly created folder (“RA-AU products”) could mean “Regulatory Affairs – Australia – products”, which corresponds to the folder path from which the files were to be copied.

(c)    Copied files from the intranet onto the USB device.

42 The fact that that inference is available is also supported by other matters upon which Troy relied. For example:

(a)    Dr Jhanker provided two specific justifications for the use of USB devices for the purposes of her work at Troy:

(i)    to transfer documents between Troy’s computer systems and high performance liquid chromatography machines; and

(ii)    to transfer documents to her laptop to enable remote work, due to the unreliability of Troy’s remote access systems.

(b)    Dr Jhanker accepts that she was not working in Troy’s laboratory on 3 January 2023. She only returned to the laboratory after the Christmas break on 4 January 2023. It follows that neither of the specific justifications Dr Jhanker gave for using USB devices appears to be relevant to explain her conduct on 3 January 2023.

(c)    No specific work-related justification for accessing or copying the files in question has been identified by Dr Jhanker, particularly in circumstances where she had provided notice on 6 December 2022, and her last day at work was 6 January 2023. Indeed, Troy submits that there was no conceivable legitimate reason for Dr Jhanker to access some of the files that she did while a USB device was connected to her laptop. To take one example only:

(i)    On 5 January 2023 (that is, the day before her employment with Troy concluded) Dr Jhanker accessed the folder “X:\Regulatory Affairs\Australia & New Zealand\Australia\Products\Frusemide 50268”.

(ii)    That folder related to the regulatory approval of the Ilium Frusemide Injection. That approval was received on 17 December 1997. Dr Swanopoel’s evidence was that, in 2023, there was no work being performed in relation to that product, and no work being performed in relation to any other product to which that product might have been relevant. Dr Swanopoel thus stated that there was no reason why Dr Jhanker could have required access to those documents for the purposes of her employment with Troy.

(iii)    At the time Dr Jhanker accessed that particular folder on Troy’s intranet, the same USB device containing the folder “RA-AU products” was connected to her laptop.

43 Whether the inference that Dr Jhanker was copying Troy’s confidential documents to USB devices for purposes other than her employment by Troy is correct is not, I repeat, a matter to be determined on this application. The point is only that Mr McKemmish’s analysis (along with the full range of circumstances to which I have referred) provides some support for the reasonableness of one aspect of Troy’s belief that it may have a claim against Randlab. That is, it provides some support for the reasonableness of Troy’s belief that Dr Jhanker had copied its confidential information relating to the formulations of its products. Further support for that belief may be found in the matters, discussed below, tending to indicate that Randlab may have used that information (in circumstances where there is no suggestion that the information could have come into Randlab’s hands in any way other than via Dr Jhanker).

44 In any event, to demonstrate that Troy’s belief that it may have a claim against Randlab is reasonable it is, of course, necessary to do more than demonstrate that there is a reasonable basis for believing that Dr Jhanker copied Troy’s confidential files. Critically, Troy must show, in addition, that there is a reasonable basis for believing that its confidential information was used by Randlab.

45 Randlab advanced various arguments as to why Troy’s belief that its confidential information may have been used by Randlab was not reasonably based. None of them, though, seemed to me to be capable of denying the reasonableness of Troy’s belief. On the whole, they were arguments that either focussed on a single aspect of Troy’s case (and which thus failed to have regard to the evidence as a whole), or that sought to argue that the evidence as a whole was not capable of proving Troy’s case (and which thus failed to grapple with the real question, which is whether the evidence supported a reasonable belief that a claim may exist). Thus:

(a)    It is true that nothing nefarious may be inferred from the mere fact that Randlab used a Troy product as a reference product for its item 7 applications (or the same reference product that Troy had used for one of its applications). But Troy does not rely on that fact alone; it is one small piece of a total mosaic, and must be considered in light of the evidence as a whole.

(b)    Equally, it is unquestionably true that the fact that Randlab’s item 7 applications disclosed a close similarity between Randlab’s product and the reference product is to be expected. Once more, though, Troy does not rely on the fact of similarity alone; rather, it relies on the circumstances that indicate (so it is submitted) that similarity was only achieved by copying.

(c)    The fact that Randlab had already commenced working on its development of the products in question before Dr Jhanker started working for it does not mean that Troy’s belief cannot be reasonably based. Troy’s application acknowledges that fact, but points to the circumstance that Randlab had not, by that point, identified a closely similar formulation that would support an item 7 application. It is the rapid (and, on Troy’s case, unexplained) determination of such a formulation after the commencement of Dr Jhanker’s employment that provides the basis for Troy’s belief.

(d)    Nor can the fact that it was possible for Randlab to develop its own generic products without the use of Troy’s confidential information be determinative. It is not in dispute that Randlab is capable of developing generic products without using its competitors’ confidential information. The question is whether there is a reasonable basis for thinking that it might have done otherwise on these four occasions.

(e)    Finally, the denial of Mr Bell that Randlab has used information obtained from Troy (or any of its competitors) is not capable of negativing the reasonableness of Troy’s belief. It is enough to observe that Dr Jhanker’s use of Troy’s confidential information for the purposes of her employment with Randlab may have occurred without Mr Bell’s knowledge. Moreover, Mr Bell’s denial could never be conclusive; it is one piece of evidence that must be considered in the context of the evidence as a whole.

46 The effect of all that is that whether or not Troy’s belief that it may have a claim against Randlab is reasonably based requires consideration of the circumstances relied upon by Troy as indicating the possibility that Randlab’s development of the products in question utilised Troy’s confidential information. I will consider the evidence relating to each product separately.

47 In relation to the Randlab Frusemide Injection:

(a)    Randlab submitted its item 7 application for its Frusemide Injection on 23 January 2024, and the application was registered on 11 June 2024.

(b)    Mr Bell’s evidence was that Randlab developed “the formulation information in the Randlab Frusemide Injection registration in or around August 2023 using Randlab’s own knowhow and research and using external laboratory expertise from Pia Pharma”.

(c)    There was in evidence an advice dated 19 June 2023, and an advice dated 29 August 2023, each prepared by Pia Pharma for Randlab. Those advices represented Pia Pharma’s attempts to identify the formulation of the Troy Frusemide Injection that Randlab proposed to use as the reference product for its item 7 application.

(d)    [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].

(e)    [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].

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(i)    Dr Alawi observed that those differences had the effect of bringing Randlab’s formulation, with the one exception identified above, precisely into line with Troy’s formulation.

(j)    The result was that Troy emphasised the unexplained changes between the advice Randlab had received from Pia Pharma in August (in terms of both the ingredients in the formulation, and their quantities), and the formulation it submitted for its item 7 application. Troy did not suggest, of course, that it would not have been possible for Randlab to determine that formulation through its own independent work. Its point was that there was evidence of the work carried out to arrive at the August formulation, and then no evidence as to how the ultimate formulation was arrived at. The final formulation was, relevantly, identical to Troy’s formulation. And in the period between August 2023 and the submission of Randlab’s item 7 application in January 2024, Dr Jhanker had started her employment with Randlab.

(k)    I am satisfied that Troy’s belief that it may have a claim against Randlab in relation to the use of its confidential information concerning its Frusemide Injection is objectively reasonable. Randlab determined its formulation a short time after Dr Jhanker commenced work with it. Its formulation is relevantly identical to that of Troy. There is no evidence of the work that would have been necessary to independently arrive at that formulation being performed. Those matters in combination provide an objectively reasonable basis for Troy’s belief.

48 In relation to the Randlab Xylazine 20 Injection:

(a)    Randlab submitted its item 7 application for its Xylazine Injection on 23 September 2024.

(b)    Mr Bell’s evidence was that Randlab developed “the formulation information in the Randlab Xylazine 20mg/ml Injection registration application using Randlab’s own knowhow and research and using product formulation information using external laboratory expertise from Pia Pharma”. He said that “[p]rior to [Dr] Jhanker commencing her employment with Randlab in November 2023, Randlab had already developed the product formulation for the Randlab Xylazine 20mg/ml Injection registration”.

(c)    There was in evidence an advice dated 19 June 2023, and an advice dated 29 August 2023, each prepared by Pia Pharma for Randlab. Those advices represented Pia Pharma’s attempts to identify the formulation of the Troy Ilium Xylazil-20 Injection that Randlab proposed to use as the reference product for its item 7 application.

(d)    [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].

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(f)    Troy emphasised the unexplained changes between the advice Randlab had received from Pia Pharma in August (in terms of both the ingredients in the formulation, and their quantities), and the formulation it submitted for its item 7 application. Once again, Troy did not suggest that it would not have been possible for Randlab to determine that formulation through its own independent work. As with the Frusemide Injection, however, while there was evidence of the work carried out to arrive at the August formulation, there was no evidence as to how the ultimate formulation was arrived at. That final formulation was identical to Troy’s formulation. And in the period between August 2023 and the submission of Randlab’s item 7 application in September 2024, Dr Jhanker had started her employment with Randlab.

(g)    I am satisfied that Troy’s belief that it may have a claim against Randlab in relation to the use of its confidential information concerning its Xylazine Injection is objectively reasonable. Randlab determined its formulation after Dr Jhanker commenced work with it. Its formulation is relevantly identical to that of Troy. There is no evidence of the work that would have been necessary to independently arrive at that formulation being performed. Those matters in combination provide an objectively reasonable basis for Troy’s belief.

49 In relation to the Randlab Meloxicam 40 Injection:

(a)    Randlab had obtained APVMA approval for its 20mg/mL Meloxicam Injection on 22 April 2015.

(b)    Randlab submitted its item 7 application for its Meloxicam 40 Injection on 1 March 2024, and the application was registered on 11 June 2024.

(c)    Randlab’s item 7 application for its Meloxicam 40 Injection used the same reference product that Troy had used to obtain approval for its Meloxicam 40 Injection.

(d)    Mr Bell’s evidence was that the “formula used for the registration application for the Randlab Meloxicam 40 Injection APVMA application was developed by reference to its 20mg/mL Meloxicam Injection developed by Randlab in 2014, with some minor modifications to the excipients (being the inactive ingredients) because of the increased product strength”.

(e)    [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]

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(g)    Randlab did not provide any documents or other evidence to support Mr Bell’s statement that the new formulation was the product of “Randlab’s own knowhow and research”. Dr Swanepoel’s evidence was that Troy had invested a substantial amount of time in developing its Meloxicam 40 Injection, and had made three separate attempts (with different formulation iterations in between) to obtain registration.

(h)    [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].

(i)    [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].

(j)    Overall, therefore, the evidence showed that, in developing its Meloxicam 40 Injection, Randlab made changes to the formulation of its Meloxicam 20 Injection that had the effect of bringing its formulation largely into line with that of Troy’s Meloxicam 40 Injection. Troy did not suggest, of course, that it would not have been possible for Randlab to arrive at that new formulation independently; but to do so would have required considerable time, effort and testing. There was no evidence that demonstrated that Randlab had in fact undertaken that work.

(k)    I am thus satisfied that Troy’s belief that it may have a claim against Randlab in relation to the use of its confidential information concerning its Meloxicam 40 Injection is objectively reasonable. Randlab determined its formulation a short time after Dr Jhanker commenced work with it. Its formulation is largely identical to that of Troy. There is no evidence of the work that would have been necessary to independently arrive at that formulation being performed. Those matters in combination provide an objectively reasonable basis for Troy’s belief.

50 The position is, however, different in relation to Randlab’s Vitamin C product:

(a)    Randlab had determined a formulation for its Vitamin C product by 20 January 2022 (a date that preceded any suggestion of misconduct by Dr Jhanker).

(b)    [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].

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(d)    Troy advanced two independent bases for its case in relation to the Vitamin C product:

(i)    First, it was said that its belief that it may have a claim was reasonably based because the delay between the time when Randlab created its formulation (January 2022) sheet and when it ultimately submitted its application to the APVMA (June 2023) supported an inference that Randlab had waited to obtain Troy’s confidential information to “confirm” its formulation before submitting it to the APVMA.

(ii)    Secondly, it was submitted that the fact that there was a typographical error in Randlab’s original submission to the APVMA, which had apparently been corrected during the approval process, supported an inference that Randlab had relied upon Troy’s confidential information to correct its erroneous submission.

(e)    I do not accept that those hypotheses provide a reasonable basis for Troy’s belief:

(i)    In relation to the first, the evidence simply does not provide any reason to think that there was any perceived need for Randlab to seek “confirmation” of its formulation. I do not think that this theory amounts to anything more than pure speculation.

(ii)    In relation to the second, given the reasonably obvious nature of the error in question, and the fact that the concentration ultimately accepted for registration aligned with that which was specified in Randlab’s own formulation from January 2022, the natural inference is that (to the extent recourse to any material was required) Randlab resorted to its own formulation, not Troy’s, to correct the error. I can see no reason why Randlab would have needed to have regard to Troy’s confidential information, and there is nothing that suggests it did.

(iii)    In relation to both, of course, there is the additional difficulty that Randlab’s item 7 application for the Vitamin C product was made months before Dr Jhanker had commenced her employment at Randlab. In that context, Mr Bell’s evidence that at no time had Dr Jhanker communicated Troy’s confidential information to Randlab in respect of any of the products of concern in this application assumes greater significance. With applications submitted during Dr Jhanker’s employment with Randlab, that evidence may well be consistent with Dr Jhanker’s surreptitious use of the information for Randlab’s benefit. For the Vitamin C product, however, the only possible basis for a claim by Randlab would be if Dr Jhanker had provided Troy’s confidential information in advance of her employment to someone within Randlab. I am not satisfied that that possibility rises any higher than speculation.

51 It follows that I do not accept that Troy’s belief that it may have a claim against Randlab in relation to the Vitamin C injection product is reasonably based.

52 Neither do I accept that Troy has a reasonable basis for believing that it may have a claim in respect of the Avenge + Fly product.

53 The cornerstone of Troy’s case in respect of this product is that, on 3 January 2023, while the “Verbatim STORE N GO” USB device was connected to Dr Jhanker’s laptop, a folder entitled “Avenge + Fly 62598” was created. There is a folder on Troy’s intranet entitled “X:\Regulatory Affairs\Australia & New Zealand\Australia\Products\Avenge + Fly 62598”. There is, however, no evidence to suggest that Randlab has developed, or is developing, any product equivalent to Troy’s Avenge + Fly product, or that it has had access to any information concerning Troy’s product.

54 For the reasons given above, I accept that there is a reasonable basis for Troy’s belief that Dr Jhanker may have copied the contents of the folder relating to its Avenge + Fly product. I do not agree, however, that Troy’s belief that it may have a claim against Randlab in relation to the Avenge + Fly information is reasonably based. There is nothing to suggest that Randlab has ever had access to, let alone used, that information. I do not accept Troy’s submission that the combined force of a reasonable belief that the Avenge + Fly files were copied, and a reasonable belief that other copied files were used, is capable of sustaining a reasonable belief that the Avenge + Fly files were provided to Randlab or otherwise used. I consider that Randlab has not raised anything more than the “mere possibility” that Troy’s files have been used: see Pfizer at [172(d)] (Nicholas J).

Has Troy made reasonable inquiries?

55 I did not understand Randlab seriously to dispute that, assuming all else in Troy’s favour, it had made reasonable inquiries. In support of this aspect of its application Troy submitted that it had made extensive inquiries, including by engaging Mr McKemmish and Dr Alawi, and making requests of Randlab’s solicitors for information and documents.

56 I accept that submission, and am satisfied that Troy has made reasonable inquiries in order to decide whether or not to commence proceedings against Randlab. To the extent that it was suggested that Troy ought to have engaged in further solicitor correspondence, or engaged in conferrals following the commencement of proceedings, I do not accept it. The point had plainly been reached where no realistic further benefit was likely to be achieved.

Does Troy already have sufficient information?

57 Troy submitted that, without preliminary discovery, it does not have sufficient information to assess the likelihood that the confidential information that it believes was copied by Dr Jhanker was provided to, or used by, Randlab. In particular, Troy pointed to the following gaps in the information presently available to it:

(a)    While Mr McKemmish’s investigations identified that copies of Troy’s materials may have been made, they did not illuminate whether Dr Jhanker may have transmitted those copies to Randlab.

(b)    Dr Jhanker’s evidence in the related proceedings commenced against her does not contain information relevant to the decision to commence proceedings against Randlab, because Dr Jhanker had denied the allegations against her and said that she did not copy any confidential information.

(c)    The information provided by Randlab to date, in particular Mr Bell’s references to Randlab’s own “knowhow and research” and the documents set out in the annexures to his affidavit, is pitched at such a level that it does not sufficiently reveal how Randlab had replicated the reference products in the time that it did.

58 As the discussion above demonstrates, the process by which Randlab determined the ultimate expression of its formulations is essentially unknown to Troy. The mere fact that Randlab’s formulations correspond closely to those of Troy is not, in and of itself, even in all the circumstances, capable of illuminating whether or not Randlab had access to, and used, Troy’s confidential information. The categories of documents sought by Troy are thus directed at filling the lacuna in its knowledge that presently exists, and which prevents it from deciding whether or not to commence proceedings. Mr Barnett’s evidence was:

On the basis of the investigations that have been undertaken by, or on behalf of Troy, I do not currently have sufficient information to determine whether Troy’s copyright materials and/or confidential information were provided by Ms Jhanker to Randlab.

If it became apparent to me that Troy’s copyright materials and/or confidential information had been provided by Ms Jhanker to Randlab, then I would instruct Troy’s solicitors to commence proceedings in the Federal Court of Australia seeking relief against Randlab.

Copies of the documents sought by Troy in its preliminary discovery application would directly assist me with determining whether Troy has the right to obtain relief against Randlab for misuse of confidential information and copyright infringement.

59 Randlab’s submissions on this topic reduced, I think, to a submission that Troy had enough information to appreciate that it had no case against Randlab. Critically, Randlab submitted that the report of Dr Alawi demonstrated that Troy already had sufficient information to make its decision:

Tellingly, and significantly, there is no suggestion in the Alawi Report that the identified modifications are beyond the calling of a pharmaceutical formulator (or manufacturers of generic veterinary pharmaceutical products), such that Troy’s confidential information must have necessarily been used as part of the development process. In other words, while the Alawi Report suggests that pharmaceutical formulators in the position of Randlab might have performed additional ‘testing’ as part of the excipient selection to confirm the stability of the product, the Alawi Report does not suggest that the only way such modifications could have been made, or that the formulations could have been developed, was by misusing or copying the confidential information of Troy or a third party.

…

… [N]owhere in the Alawi Report does [Dr] Alawi suggest that his analysis and comparison of the formulations for the comparable Troy and Randlab products suggest to him that Randlab used any information or documents owned by Troy to secure the APVMA registrations.

60 The problem with that submission is that it equates a present inability to exclude innocent conduct on Randlab’s part (and a corresponding present inability positively to identify malfeasant conduct on Randlab’s part) with the existence of sufficient information to decide whether to commence proceedings. In truth, the very matters relied upon by Randlab support Troy’s case. To say that it cannot presently be said that “Troy’s confidential information must have necessarily been used” is to allow for the possibility that it may have been used. Similarly, the fact that it cannot be said that “the only way such modifications could have been made” is by using Troy’s information, is to recognise that they could have been made using that information. The fact that Dr Alawi did not say that “Randlab used any information or documents owned by Troy” must be viewed in the context that he equally did not say that Randlab did not use such information. The whole premise of Troy’s application is that it acknowledges the existence of competing possibilities on the information that it does possess, and it seeks further information to select between those possibilities.

61 In terms of other submissions that Randlab made in this regard:

(a)    The fact that Troy already has available to it evidence relating to the copying of its confidential information by Dr Jhanker is not to the point. Troy has already commenced proceedings against Dr Jhanker, and I accept that it has sufficient information to allow it to make a decision about whether it can properly allege copying by her. But, for the reasons I have already explained, before Troy can decide whether to commence proceedings against Randlab, it needs to know more.

(b)    The discussion above is sufficient to demonstrate why Mr Bell’s evidence (and the documents that Randlab has produced), publicly available information from APVMA, and Dr Alawi’s report, are not sufficient to allow Troy to decide whether to commence proceedings against Randlab. There is a critical lacuna in Troy’s knowledge. It knows enough to be able to say that it is possible that Randlab developed certain products using Troy’s confidential information. But the information that it presently possesses is not inconsistent with Randlab developing those products independently. It is that gap that preliminary discovery seeks to fill.

(c)    It is true that Troy has Dr Jhanker’s and Randlab’s denials of wrongdoing, and Randlab’s positive assertion that it used its own “knowhow and research”, along with the assistance of Pia Pharma. But Troy is not bound to accept Randlab’s assertions, particularly in circumstances where, as the discussion above makes clear, the totality of the information available to Troy leaves open the possibility that that explanation may not be accurate.

62 It follows that I accept that Troy does not have sufficient information to decide whether to commence proceedings against Randlab. I thus turn to consider whether the categories of document sought by Troy are reasonably necessary to overcome the insufficiency of information relevant to the decision whether to commence proceedings.

Are the documents sought reasonably necessary to allow Troy to make a decision?

63 I will consider each category in turn. As a general matter, however, in light of the conclusions I have reached above, I would not allow any category (other than category 12, for reasons I will explain) to the extent it related to the Vitamin C product or the Avenge + Fly product (and I will not repeat this limitation in connection with each individual category that I allow). Ultimately, I will direct the parties to agree on a form of wording for the categories of preliminary discovery consistent with these reasons.

Category 1

64 Category 1 seeks Randlab’s item 7 applications, and other related materials, submitted to the APVMA in respect of the impugned Randlab products (being Randlab’s Vitamin C, Frusemide, Meloxicam 40, and Xylazine products), insofar as they concern particular matters. Troy accepts that Randlab has already provided the applications themselves. It follows that category 1 is (subject to the matter to which I will turn next) not reasonably required to allow Troy to make its decision.

65 At the hearing, however, counsel for Troy emphasised that category 1 extends beyond the applications to associated correspondence, and said this:

[I]t’s not merely the application itself that is sought. What is sought are the associated correspondence and the process – documents indicating the process by which those – the applications were lodged …

…

… including any correspondence with the APVMA during the application process, the prospective respondent’s responses to any requests for additional information. And it’s that correspondence which is precisely where any mid-stream reformulation of the kind identified by Dr Alawi would be documented.

66 On Troy’s case, those additional documents would appear only to be relevant to a claim concerning the Vitamin C product (because it was in relation to that application that Dr Alawi expressed the view that there was likely to have been further correspondence with the APVMA relating to the typographical error in Randlab’s original application). Because I have found, however, that Troy does not have a reasonable basis for believing that a claim in respect of the Vitamin C product may be available, that cannot provide a justification for making an order in terms of category 1.

67 I am not otherwise persuaded that ordering the discovery of communications and documents generated during the application process is reasonably required to permit Troy to make its decision. For all products other than the Vitamin C product, I cannot see how later or other communications or documents are likely to shed any light on the question whether Randlab used Troy’s confidential information for the purposes of preparing its applications in the first place. So far as the evidence discloses, Randlab appears to have arrived at a complete, “closely similar” formulation by the time of making its application to the APVMA. Although counsel suggested that there may have been correspondence with the APVMA before those applications were lodged, indicating “the process by which” that was done, there is no evidence before me supporting a belief that relevant correspondence of that kind might exist.

68 It follows that I would disallow category 1.

Category 2

69 As I have already noted, Troy no longer presses category 2 (which sought copies of all Randlab’s master batch manufacturing records (which detail the process used to manufacture a given product) in respect of the impugned products).

Category 3

70 Category 3 seeks patent search requests used to determine Randlab’s freedom to operate in relation to each of the relevant products. Dr Swanepoel deposed that Troy’s own research and development and regulatory affairs teams would conduct patent searches as part of an initial literature search. To that extent, then, I accept that Troy has some basis for submitting that it “reasonably believes” that Randlab “has or is likely to have” (or at least, “had or is likely to have had”) in its control such patent search requests, at least in the scenario where (contrary to Troy’s prospective case) Randlab had independently formulated the relevant products: rule 7.23(1)(c)(i).

71 I am not satisfied, however, that knowledge of the existence or otherwise of patent search requests made by Randlab would relevantly assist Troy in making its decision. Any patent search requests would be made at a very preliminary stage in developing the relevant products. As I have explained, however, the crucial gap in the information available to Troy relates to the period between its early development of the relevant products and arriving at its final formulations. In other words, there is no suggestion that Randlab might have used Troy’s information to design its own product from scratch (in which case, the existence or otherwise of patent searches might have been relevant). The point at which Randlab may have used Troy’s confidential information is well after the development of the product had commenced. I do not see how the existence (or non-existence) of patent searches might be relevant to such a case.

72 Troy also submitted that the documents sought by category 3 may show “what knowledge [Randlab] did have of Troy’s products”, or at least of the field generally. I do not understand how that could assist Troy to make its decision. On any view, Randlab knew of Troy’s products.

73 It follows that I would disallow category 3.

Category 4

74 Category 4 seeks “documentation collated by Randlab on the reference formulations for each of the Products as part of its preliminary research assessments”. In this regard, counsel for Troy said:

That will reveal what information the prospective respondent will have about each of the applicant’s products at the start of the project and whether that information will go beyond what might ordinarily be expected to be held or might be derived from reverse-engineering alone … [W]e just want to know what it is that they had available. Now, that may – there may be some limited public information but if it extends well beyond information that might be available publicly to precise formulations, well, that will tend to tell us whether or not the prospective respondent had access to our confidential information.

75 I am satisfied that this category is reasonably required to enable Troy to make its decision. The information collected by Randlab about the formulation of the reference products at any stage of its product development is plainly capable of shedding light on the source of its knowledge about that topic at any later stage of development.

Category 5

76 Category 5 seeks a copy of results of comparative testing conducted in respect of the reference product relied upon for each item 7 application submitted for Randlab’s relevant products (where, for Frusemide and Xylazil, the reference product was a Troy product, and for Meloxicam 40, the reference product was the same third-party product chosen by Troy). Dr Swanepoel deposed that Troy, for its part, would conduct such tests “to attempt to identify the formulation used in the reference product”.

77 In short, the existence of such testing by Randlab would be consistent with Randlab having used its own knowhow and research to develop the products; the absence of such testing would increase the probability that Randlab had simply used Troy’s confidential information to derive its formulations. (Of course, there are intermediate possibilities, such that testing results shows the derivation of some parts of the ultimate formulation, while leaving unexplained how other components were derived).

78 As with Category 4, I am satisfied that this category is reasonably required to enable Troy to make its decision. The documents sought are plainly relevant to showing the way in which Randlab determined the formulation of its reference products, which is centrally relevant to the decision Troy must make. Randlab, however, submitted in relation to categories (such as Category 5) that sought “testing” or “analytical results”, that they could not be relevant, or assist Troy’s decision-making:

[T]he documentation comprising ‘testing’ or ‘analytical results’ relating to the selection of excipients identified as being absent from Bell in the Alawi Report … , is not likely to be ‘directly relevant’ to or to ‘assist’ Troy in relation to the question of the right to obtain relief. The Alawi Report rather indicates that such ‘testing’ and ‘analytical results’ are relevant to the stability of the commercial product. Such tests or analytical results going to product stability and shelf life will not be likely to reveal anything relevant to the question of the right to obtain relief.

79 With respect, I did not understand that submission. The fundamental question for Troy is whether it considers Randlab to have used its confidential information to derive the formulations for relevant item 7 applications. It is interested in the use of its confidential information to derive any part of the formulation, including those excipients promoting product stability and shelf life.

80 For those reasons I would allow category 5.

Category 6

81 Category 6 seeks documents relating to laboratory or pilot-scale batches produced in relation to each of the relevant products. Dr Swanepoel deposed that product development would ordinarily entail the preparation of such batches, “usually with slightly different formulation iterations to try to match the formulation of the reference product”. I accept that Troy has a reasonable belief that such documents are likely to be in Randlab’s possession or control, whether prepared in-house or by a third party on its behalf, and that such documents are relevant to the availability of relief. They could, for instance, reveal an unexplained leap between one iteration of Randlab’s formulations and another, which suddenly closely replicated Troy’s formulations.

82 It follows that I would allow category 6.

Category 7

83 Category 7 relates to documents setting out the process of developing each of the relevant Randlab products, including development summaries, progress reports (including as to iterations on the relevant formulations) and milestone reports. For the same reason as with category 6, I would allow category 7. The documentation sought is precisely what would illuminate any reasoning behind the choice of and adjustments to particular excipients which Dr Alawi could not explain on the material available to him. The fact that, in Dr Alawi’s view, significant work was required to take the relevant products from the stage evidenced by Mr Bell’s materials to the final formulations provides Troy a reasonable basis for believing that Randlab is likely to have such documents (at least assuming it is innocent), notwithstanding Randlab’s assertion to the contrary in solicitor correspondence: see Sovereign Hydroseal at [17] (McKerracher J).

Category 8

84 Category 8 seeks reverse engineering results in relation to the relevant Randlab products, including certificates of analysis or analytical work plans and raw data. Randlab’s written submissions appeared to misinterpret category 8 as seeking Randlab’s results of reverse-engineering its own products; at the hearing, counsel for Troy clarified that it was reverse engineering of third-party products that is concerned. In this regard, counsel for Troy said:

[T]hese documents will show what Randlab’s own analytical work actually established about the third-party products. Now, did they try to reverse engineer; did they get stuck at a certain point; did they suddenly arrive at the ultimate formulation having done no further work. And those reports will disclose whether or not the results are consistent with or diverge from the formulations that were ultimately submitted to the APVMA.

85 I agree that such documents would be relevant to the availability of relief, both in their existence and contents. That is, as counsel said, the absence of any reverse engineering endeavours would suggest that Randlab had obtained information about its reference products’ formulations by other means. Further, the degree of success of any reverse engineering results could also be probative, in that if Randlab only had inconclusive results and no other documents explaining the progress towards its ultimate formulations, that would support the view that Randlab was rather assisted by external information. Conversely, an implausibly successful reverse-engineering result authored by Dr Jhanker might evidence her transmission of confidential information to Randlab under the guise of legitimate work.

86 I would allow category 8.

Category 9

87 Category 9 seeks emails or other correspondence sent or received by Randlab that contain, or relate to, certain categories of Troy’s documents relating to its formulations for specified products. In short, Category 9 seeks direct evidence that Randlab had Troy’s confidential documents.

88 To the extent that the category relates to the Vitamin C and Avenge + Fly products, I would not allow it for reasons I have already given. Nor would I allow it in respect of Troy’s Meloxicam 20 product. I do not understand how that product could possibly be relevant to Troy’s decision. The reference product both for Troy’s and Randlab’s Meloxicam 40 product is a third-party product. Randlab’s contention is that it developed its Meloxicam 40 product by reference to its own Meloxicam 20 product. Troy’s prospective case is that Randlab’s Meloxicam 40 product is a significant deviation from Randlab’s Meloxicam 20 product, and is fundamentally similar to Troy’s Meloxicam 40 product (indicating that Randlab may have exploited confidential information in respect of that product to assist its development of its own). On no view does the evidence suggest any possibility that Randlab may have referred to Troy’s Meloxicam 20 product (which, on Troy’s case, would in any event provide an insufficient basis for developing a higher strength product without substantially more work).

89 As to the remaining products, I accept that any correspondence sent or received by Randlab comprising or relating to Troy’s confidential formulation information about those products would be, obviously enough, directly relevant to the question of transmission to, and misuse by, Randlab of that information.

90 Randlab submitted, however, that it is fatal to category 9 (and 10, which seeks similar material) that Randlab has given sworn evidence that they do not have the documents in their possession or control, because the Court will not order a company to conduct fruitless searches that it has said it does not have (referring to Pfizer v Samsung (No 3) at [108] (Burley J)). This submission was based on the evidence that Randlab did not have the USB devices, and Mr Bell’s second affidavit, in which he explained how Randlab had run searches of its cloud storage system, using search terms proposed by Randlab’s solicitors, to identify whether any of Troy’s confidential documents or copyright works were present, and found that they were not.

91 It is enough to deal with this submission to observe that there is a real dispute between the parties about whether Randlab’s searches were adequate to identify the existence of documents that would be captured by Categories 9 and 10.

92 The searches carried out were conducted in respect of each of the documents listed in Annexures B and C to Troy’s submissions on this application, which respectively listed files that Troy claimed were among its confidential documents and copyright works, stored within its secure intranet. For each such document, Randlab’s solicitors had identified brief keyword searches, typically comprising one- or two-word phrases specifying the subject of the relevant document (e.g., “Ilium Meloxicam”) along with another one- or two-word phrase focussing upon the type of document sought (e.g., “investigation report”). While these search terms are fairly general, in many instances, that appeared to be a product of the limited information provided about the relevant files, which in most cases comprised the subject product, the date of the document, and a high-level description which did not necessarily specify the exact file name (for example, “Product investigation report”, or “Spreadsheet titled ‘Lab Trials’”).

93 Overall, I am not satisfied that the searches documented in Mr Bell’s second affidavit constitute “unequivocal evidence” that Randlab does not possess correspondence “comprising, or relating to” the types of formulation documents specified in category 9 (cf. Pfizer v Samsung (No 3) at [108] (Burley J)). Accordingly, I agree that Troy still holds a reasonably based belief that Randlab may have information responsive to category 9 which would assist its decision whether to commence proceedings, and I would allow that category to the extent it seeks materials in respect of Troy’s Frusdemide, Xylazil and Meloxicam 40 products.

Category 10

94 Category 10 seeks all documents in Randlab’s possession, custody or control comprising any of the formulation documents sought by category 9, or the whole or any part of the information contained within such formulation documents. In other words, whereas category 9 seeks correspondence about particular formulation documents, category 10 seeks any document in Randlab’s possession or control (including, as Troy clarified in solicitor correspondence, documents Randlab could obtain from its external laboratories or third parties who assist in its product development, such as Pia Pharma) embodying that information.

95 For the same reasons as in respect of category 9, including as to the objection Randlab raised based on the searches undertaken thus far, I would allow category 10, insofar as the formulation documents and information concerned relates to Troy’s Frusemide, Xylazil and Meloxicam 40 products. Documents in Randlab’s possession or control embodying Troy’s confidential information would be direct evidence of misuse of that information, and I do not think that Randlab has given “unequivocal evidence” displacing Troy’s reasonable belief as to the likely existence of any such documents.

Category 11

96 Category 11 seeks records kept for the purpose of claiming the research and development tax incentive. Dr Swanepoel deposed that Troy, for its part, keeps such records “of the hours spent by employees on research and development and summary records of the work carried out … so Troy can prepare a schedule to claim the research and development tax incentive in relation to each of the products it develops”. It follows that such records would be relevant to demonstrating the extent of Randlab’s independent work in developing the formulations. As counsel for Troy submitted, at one extreme:

… if there is none, that would, we submit, strongly point to an absence of an independent research process, because it would be a strange situation that a commercial enterprise would expend money and not relevantly claim it in respect of that development. So that category is quite important because it’s either – the absence of those documents, we say, will be telling.

97 By solicitor correspondence, Randlab asserted that it has no such documents, but it has not given sworn evidence to that effect (which Randlab’s solicitors conceded would require more extensive searches to be undertaken). I am thus not satisfied that Troy does not have a reasonable belief as to the likely existence of such documents.

98 I accept that any such documents would be helpful, in that any narrations of work done by employees on the relevant products could reveal how much work was done, and on what parts of the development process (including, for example, whether significant efforts were expended on adjusting excipient concentrations in the months leading to Randlab’s relevant APVMA submissions). It follows that I would allow category 11.

Category 12

99 Category 12 seeks all documents comprising, evidencing or recording communications between Randlab and Dr Jhanker before 20 November 2023 (being the date on which Dr Jhanker commenced employment at Randlab).

100 This category would obviously be relevant to the question of the potential transmission or use by Dr Jhanker of Troy’s confidential information in the context of her proposed employment by Randlab. These communications would be capable of shedding light on any representations made by Dr Jhanker for the purpose of obtaining employment, or the basis upon which she was employed. It follows that I do not consider that it would be appropriate to limit this category to documents relating to the Frusemide Injection, the Xylazine Injection, or the Meloxicam 40 Injection. The relevance of this category is broader, in that it relates to the basis upon which employment was sought, or offered, rather than the use of information relating to specific products.

101 I would thus allow category 12.

Category 13

102 Category 13 seeks all communications between Randlab and Dr Jhanker from 20 November 2023 onwards of two kinds.

103 The first is communications that comprise, reproduce or otherwise relate to the documents that will be produced pursuant to category 9. It is unclear to me why any such document would not be caught by category 9 in any event. On that understanding, I would not allow this aspect of category 13 (that is, solely on the basis that it is unnecessary in light of category 9).

104 The second is communications that relate to various specified Troy products. I would allow this aspect of category 13, in relation to the Frusemide Injection, the Xylazine Injection and the Meloxicam 40 Injection only. Such documents would plainly be relevant to Troy’s decision to commence proceedings in relation to those products.

CONCLUSION

105 For the foregoing reasons, Troy is entitled to preliminary discovery over the categories of documents that I have accepted are appropriate. I will direct the parties to confer and provide draft orders, agreed if possible, to give effect to my conclusions, as well as in relation to costs and any confidentiality regime in respect of the discovered documents, within 14 days. I will also direct the parties to confer, identify and provide to my chambers any proposed redactions to this judgment prior to its publication, also within 14 days, in order to ensure consistency with the suppression orders I have previously made.

Associate:

Dated:    20 July 2026