FEDERAL COURT OF AUSTRALIA Merck Sharp & Dohme Corp. v Ono Pharmaceutical Co., Ltd [2016] FCA 1015 File number: NSD 954 of 2014 Judge: YATES J Date of judgment: 24 August 2016 Catchwords: PRACTICE AND PROCEDURE – patent proceedings – infringement and validity in issue – leave granted to rely on experimental proof – experiments conducted overseas in the absence of the opposing party – experiments extending beyond the facts sought to be proved – discovery of documents relating experiments – whether the documents sought will facilitate the just resolution of the proceeding PRACTICE AND PROCEDURE – whether, in light of admission made, experimental proof should be rejected in advance of the hearing Legislation: Federal Court Rules 2011 rr 20.11. 34.50 Date of hearing: 11 August 2016 Registry: New South Wales Division: General Division National Practice Area: Intellectual Property Sub-area: Patents and associated Statutes Category: Catchwords Number of paragraphs: 119 Counsel for the Applicants/ Cross-Respondents: Ms K Howard SC with Mr T Cordiner Solicitor for the Applicants/ Cross-Respondents : Corrs Chambers Westgarth Counsel for the Respondents/ Cross-Claimants: Mr BN Caine QC with Ms CL Cochrane Solicitor for the Respondents/ Cross-Claimants: MinterEllison ORDERS NSD 954 of 2014 BETWEEN: MERCK SHARP & DOHME CORP. (and another named in the Schedule) First Applicant AND: ONO PHARMACEUTICAL CO., LTD (and another named in the Schedule) First Respondent AND BETWEEN: ONO PHARAMACEUTICAL CO., LTD (and another named in the Schedule) First Cross-Claimant AND: MERCK SHARP & DOHME CORP. (and another named in the Schedule) First Cross-Respondent JUDGE: YATES J DATE OF ORDER: 24 AUGUST 2016 THE COURT ORDERS THAT: 1. The document titled "Amended Annexure A" annexed to the respondents' submissions dated 3 August 2016 (the Annexure) be placed on the Court file. 2. The Annexure be taken as the annexure referred to in paragraph 1 of the interlocutory application filed on 4 July 2016 (the first interlocutory application) and the first interlocutory application be taken to have been amended accordingly. 3. The respondents' application for discovery by categories in accordance with paragraphs 4 and 5 of the Annexure be stood over for hearing, if necessary, to a date and time to be appointed. 4. The respondents' application for discovery by categories in accordance with paragraphs 1(a), 1(b)(ii) and 7 of the Annexure be stood over for further hearing, if necessary, to a date and time to be appointed. 5. The respondents' claim for relief in prayer 4 of the first interlocutory application be dismissed. 6. Within 7 days, or within such further time as the parties might agree, the cross-claimants file and serve a statement of the facts, if determined at the experiments to be conducted pursuant to Order 3 made on 8 July 2016, that would be necessary to satisfy the requirement(s) of cross-competition referred to in Section B of the Particulars of Experiment contained in Ex 1 tendered on the hearing of the cross-respondents' interlocutory application dated 5 August 2016 (the second interlocutory application). 7. Order 2 made on 12 April 2016 be varied as follows: Subject to the applicants/cross-respondents' compliance with Order 3 of these orders, pPursuant to r 34.50(2) of the Federal Court Rules 2011 (the Rules), leave be granted to the applicants/cross-respondents (Merck) to tender, as evidence in this proceeding, Information relating to the US Experiments (as defined in Annexure A to these orders). 8. Order 4 made on 12 April 2016 be varied as follows: Subject to the Merck's compliance with Order 5 of these orders, pPursuant to r 34.50(2) of the Rules, leave be granted to Merck to tender, as evidence in this proceeding, Information relating to the UK Experiments (as defined in Annexure B to these orders). 9. The parties confer and advise the Court (through the Associate to Yates J) on how, subject to the orders made above, the first interlocutory application and the second interlocutory application be dealt with in light of the reasons published today as Merck Sharp & Dohme Corp. v Ono Pharmaceutical Co., Ltd [2016] FCA 1015. 10. Costs to date of the first interlocutory application and the second interlocutory application be reserved. THE COURT NOTES THAT: 11. For the purpose only of the cross-claim in this proceeding, the applicants/ cross-respondents admit that each of 17D8, 2D3, 4H1 and 7D3 would compete with Keytruda for binding to human PD-1, as determined by Biacore analysis as set out in the protocol in Annexure C to the respondents/cross-claimants' Particulars of Experiment dated 12 July 2016. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011. REASONS FOR JUDGMENT YATES J: Introduction 1 The respondents, Ono Pharmaceutical Co., Ltd (Ono Pharmaceutical) and E.R. Squibb & Sons, L.L.C. are registered pursuant to the Patents Act 1990 (Cth) (the Act) as patentees of Australian Patent No. 2011203119 (the patent), the complete specification of which is entitled "Human monoclonal antibodies to programmed death 1 (PD-1) and methods for treating cancer using anti-PD-I antibodies alone or in combination with other immunotherapeutics" (the specification). For ease of exposition, it is convenient to treat the respondents as one party, which I will call Ono. 2 The invention described in the specification relates to the use of anti-PD-1 antibodies and the use of combination immunotherapy to treat cancer. The invention provides a method of inhibiting the growth of tumour cells in vivo using these antibodies. 3 PD-1 is a protein. It is an inhibitory member of the CD28 family of receptors. It is expressed on activated B cells, T cells, and myeloid cells. B cells and T cells are involved in the production of antibodies. Two ligands for PD-1 (PD-L1 and PD-L2) have been shown to downregulate T cell activation upon binding to PD-1. Whilst both PD-L1 and PD-L2 bind to PD-1, they do not bind to other CD28 family members. PD-L1 is abundant in a variety of human cancers. The interaction between PD-1 and PD-L1 results in a decrease in tumour infiltrating lymphocytes, a decrease in T-cell receptor mediated proliferation, and immune evasion by cancerous cells. Immune suppression can be reversed by inhibiting the local interaction of PD-1 with PD-L1. The effect is additive when the interaction of PD-1 with PD-L2 is blocked as well. 4 In the principal proceeding, the applicants, Merck Sharp & Dohme Corp. and Merck Sharp & Dohme (Australia) Pty Ltd seek to revoke claim 3 of the patent on various grounds, including that the invention, as there claimed, lacks novelty. They also seek to revoke other claims that are dependent on claim 3. For the purposes of these reasons, it is only necessary for me to refer to claim 3. Once again, for ease of exposition, I will treat the applicants as one party, which I will call Merck. 5 Claim 3 of the patent is as follows: A monoclonal antibody, or an antigen-binding portion thereof, which cross-competes for binding to PD-1 with a reference antibody or reference antigen-binding portion thereof comprising: a) a heavy chain variable region comprising amino acids having the sequence set forth in SEQ ID NO: 1 and a light chain variable region comprising amino acids having the sequence set forth in SEQ ID No: 8; b) a heavy chain variable region comprising amino acids having the sequence set forth in SEQ ID NO: 2 and a light chain variable region comprising amino acids having the sequence set forth in SEQ ID NO: 9; c) a heavy chain variable region comprising amino acids having the sequence set forth in SEQ ID NO: 3 and a light chain variable region comprising amino acids having the sequence set forth in SEQ ID No: 10; or d) a heavy chain variable region comprising amino acids having the sequence set forth in SEQ ID NO: 6 and a light chain variable region comprising amino acids having the sequence set forth in SEQ ID NO: 13. 6 The reference antibodies in sub-paragraphs (a) to (d) of claim 3 are called, conveniently, 17D8, 2D3, 4H1 and 7D3, respectively (the reference antibodies). 7 Page 29, line 25 to page 30, line 9 states: Antibodies that Bind to the Same Epitope as Anti-PD-1 Antibodies of the Invention In another embodiment, the invention provides antibodies that bind to the same epitope on human PD-1 as any of the PD-1 monoclonal antibodies of the invention (i.e., antibodies that have the ability to cross-compete for binding to PD-1 with any of the monoclonal antibodies of the invention). In preferred embodiments, the reference antibody for cross-competition studies can be the monoclonal antibody 17D8 (having VH and VL sequences as shown in SEQ ID NOs: 1 and 8, respectively), or the monoclonal antibody 2D3 (having VH and VL sequences as shown in SEQ ID NOs: 2 and 9, respectively), or the monoclonal antibody 4H1 (having VH and VL sequences as shown in SEQ ID NOs: 3 and 10, respectively), or the monoclonal antibody 5C4 (having VH and VL sequences as shown in SEQ ID NOs: 4 and 11, respectively), or the monoclonal antibody 4A11 (having VH and VL sequences as shown in SEQ ID NOs: 5 and 12, or the monoclonal antibody 7D3 (having VH and VL sequences as shown in SEQ ID NOs: 6 and 13, or the monoclonal antibody 5F4 (having VH and VL sequences as shown in SEQ ID NOs: 7 and 14, respectively). Such cross-competing antibodies can be identified based on their ability to cross-compete with 17D8, 2D3, 4H1, 5C4, 4A11, 7D3 or 5F4 in standard PD-1 binding assays. For example, BIAcore analysis, ELISA assays or flow cytometry may be used to demonstrate cross-competition with the antibodies of the current invention. The ability of a test antibody to inhibit the binding of, for example, 17D8, 2D3, 4H1, 5C4, 4A11, 7D3 or 5F4, to human PD-1 demonstrates that the test antibody can compete with 17D8, 2D3, 4H1, 5C4, 4A11, 7D3 or 5F4 for binding to human PD-1 and thus binds to the same epitope on human PD-1 as 17D8, 2D3, 4H1, 5C4 or 4A11. In a preferred embodiment, the antibody that binds to the same epitope on human PD-1 as 17D8, 2D3, 4H1, 5C4, 4A11, 7D3 or 5F4 is a human monoclonal antibody. Such human monoclonal antibodies can be prepared and isolated as described in the Examples. 8 One issue in the proceeding—and one of the other grounds on which Merck seeks revocation of claim 3—is that the words "cross-competes for binding to PD-1", as used in claim 3, are not clear. In this connection, Merck contends, amongst other things, that it is not clear whether: the monoclonal antibody (or an antigen-binding portion thereof) of claim 3 must bind to the same epitope of PD-1 as one of the reference antibodies (as required by the description in the specification set out above); or the monoclonal antibody (or an antigen-binding portion thereof) of claim 3 need not bind to the same epitope of PD-1. 9 Ono has cross-claimed against Merck for infringement of various claims of the patent, including claim 3, because of Merck's importation, use and supply in Australia of a PD-1-blocking antibody product (pembrolizumab) called Keytruda. 10 There are two interlocutory applications before the Court. The first was filed by Ono on 4 July 2016. By this interlocutory application, Ono seeks discovery against Merck of various categories of documents concerning experiments carried out in the United States of America and the United Kingdom (the US experiments and the UK experiments, respectively). 11 The second interlocutory application is dated 5 August 2016. At the time of hearing, this interlocutory application had not been filed, but it was convenient and expedient to hear it at the same time as the first interlocutory application. By this interlocutory application, Merck seeks to vary certain orders that have been made. It also seeks an order preventing Ono from relying, at the final hearing, on evidence relating to certain experiments that Ono proposes to undertake in aid of its case on infringement. The evidence 12 In respect of the first interlocutory application, Ono read the following affidavits: Paul John Conroy made 4 July 2016 and 1 August 2016; and Rebecca Sarah Pereira made 4 July 2016. 13 Ono also tendered certain pages of an affidavit made by Odette Margaret Gourley on 21 October 2015 (namely, certain particulars of experiments): Ex A. 14 Merck read the following affidavits: Fitz Beckwith Collings made 18 July 2016 and 6 August 2016; and Odette Margaret Gourley made 19 July 2016 and 9 August 2016. 15 In respect of the second interlocutory application, Merck read the affidavit of Odette Margaret Gourley made 5 August 2016 and tendered a protocol and Particulars of Experiment: Ex 1. Technical background 16 In order to understand the present debate between the parties, it is necessary to have some understanding of two assays used in the US experiments and the UK experiments. This background is sourced from Dr Conroy's first affidavit (4 July 2016). Biacore analysis 17 Biacore is a technique that measures changes in mass on a surface in real time. The interaction between substances (for example, antibodies) can be investigated in a Biacore instrument by monitoring how the mass on the surface changes when one or more substances are introduced to another substance bound on the surface. 18 Biacore analysis is performed on a sensor chip in the Biacore instrument. The sensor chip is divided into four cells, called "flow cells", on which substances can be bound. Substances in solution flow across the bound substances on the sensor chip. The flow of the solution is controlled by a pump with a defined flow rate. Separate measurements are taken at each flow cell, which can enable four different measurements to be acquired simultaneously on the one sensor chip. The changes on the sensor chip (measured in "response units" (RU)) over time are collected by the instrument and saved as a Biacore Results File (a .BLR file). A .BLR file is a native file produced by the Biacore instrument. It contains the data produced as well as the conditions under which the experiment was run. The .BLR file is a record of what has occurred during a Biacore experiment. According to, Dr Conroy, .BLR files are critical to the conduct, review and analysis of Biacore studies. 19 In this connection, a .BLR file typically contains: sensorgrams, which are graphs of RU values verses time for each flow cell; and parameters and events recorded by the machine, such as flow rates, collection rates, temperature, flow cells in use, injection times, and injection positions from the reagent rack. 20 A .BLR file contains additional information inputted to the .BLR file by the user. Dr Conroy said that it is his practice to input the following information to the .BLR file: the identity of the reagents in each position in the reagent rack (and thus the identity of what is injected at a particular time); the concentration and molecular weight of the reagents; and annotated "report points" on the sensorgrams, which are used to describe and mark the time in which an event occurs in the Biacore instrument, such as the injection of a sample or reagent. 21 Dr Conroy said that, to assist his analysis of a Biacore experiment, he processes the information in the .BLR files using various computer programs which generate different types of files, including: BIAevaluation files (with a .BLE file extension), which are generated by the BIAevaluation software provided by GE Healthcare. .BLE files do not necessarily contain all of the information in the .BLR files. The purpose of the BIAevaluation software is to enable the user to manipulate the data in the .BLR files for analysis. For example, using the BIAevaluation software, curves can be omitted, areas of a curve can be cropped, and curves can be aligned and overlayed. Scrubber files (with a .SCB file extension), which are generated by the analysis program "Scrubber". .SCB files do not necessarily contain all of the information in the .BLR files. Scrubber is an alternative program that can be used to manipulate the data in the .BLR files for analysis. Prism files, or other graphing software files, that are used to create graphs in a publication quality format. Prism files are used to visually represent selected and modified sensorgrams as a high quality image for publication. 22 Dr Conroy also said that, when performing a Biacore experiment, it is his practice to keep a detailed laboratory notebook, which typically includes the following information: identification of the individual carrying out the experiments (including the signature or initials of that individual and the date); reagent preparation, such as dilutions and calculations to determine concentrations; a detailed list of all experiments he has performed, and the date of the experiments; print outs of the data that is generated by the Biacore instrument; and any observations, such as deviations and preliminary conclusions. 23 Dr Conroy said that if he needed to place himself in the position he would have been in had he conducted and analysed, or observed and analysed, a Biacore experiment himself, he would require access to: a detailed document setting out all the steps taken in the experiment (for example, a protocol and laboratory notebook); detailed .BLR files, or .BLR files together with corresponding detailed records of the experiment; and any processing files that were used (see [21] above). Flow cytometry 24 Flow cytometry is a technique that analyses particles in solution flowing past a laser beam. As the particles flow past the laser beam, the particles scatter the light from the laser. The light is scattered in different directions, which gives information about the number of particles in the solution, and the size and shape of those particles. 25 Fluorescent markers or tags can be used to label the particles in solution or different parts of those particles. As a particle labelled with a fluorescent tag flows past the laser beam, the laser causes the fluorescent tag to emit light. Scattering of this light gives information about the particles labelled with that particular fluorescence tag. 26 Flow cytometry can be used to investigate the interaction between substances (for example, antibodies). This can be done by labelling each substance with a different fluorescent tag or by labelling one of the substances with a fluorescent tag. Flow cytometry can also be used to investigate the interaction between proteins expressed on cells and one or more substances (for example, antibodies). 27 The native file generated by flow cytometry instruments is the Flow Cytometry Standard file (a .FCS file). 28 These files can be processed. One processing step for .FCS files is to apply a "gating strategy" for the information contained in them. A gating strategy tells the computer which particles (or cells, if cells have been used in the experiment) to include in the analysis of the experiment, and which particles or cells to exclude. Dr Conroy said that, without knowing the gating strategy applied to a .FCS file, one cannot accurately verify results generated from the files. 29 "FlowJo" is one program that is commonly used to: process .FCS files (such as by applying a gating strategy); analyse .FCS files (such as by obtaining statistics); and generate graphical results. 30 Dr Conroy said that, when undertaking a flow cytometry experiment, it is his practice to keep a detailed laboratory notebook recording the steps that he conducted and his analysis of the data received from the flow cytometry technician. This typically includes information about how he has cultured the cells, prepared the antibodies (including concentrations of reagents and fluorescent tagging of the antibodies), and incubated the cells with antibodies/proteins, and processed the data. 31 Dr Conroy said that if he needed to place himself in the position that he would have been in had he conducted and analysed, or observed and analysed, a flow cytometry experiment himself, he would require access to the following information: a detailed document setting out all steps taken in the experiment (for example, a protocol and laboratory notebook); detailed .FCS files, or .FCS files together with corresponding detailed records of the experiment; and any processing files (see [29] above) that were used, with the gating strategy saved. The first interlocutory application The US experiments Background 32 It seems that the US experiments were conducted on behalf of Merck from about June 2015 to October 2015. One purpose of the experiments was to obtain experimental proof that would support Merck's case that claim 3 of the patent lacks novelty. The experiments were conducted in Ono's absence. The first time that Ono became aware of the experiments was when Merck sought Ono's consent to leave being granted under r 34.50(2)(b) of the Federal Court Rules 2011 (FCR) to rely on certain parts of the results of the experiments as experimental proof in Merck's case on invalidity. 33 Rule 34.50 FCR provides: (1) If a party (the proponent) proposes to tender, as evidence in a proceeding, experimental proof of a fact, the proponent must apply for orders in relation to the experimental proof, including orders about any of the following: (a) the service on other parties of particulars of the experiment and of each fact that the proponent asserts is, will or may be proved by the experiment; (b) any persons who must be permitted to attend the conduct of the experiment; (c) the time when, and the place where, the experiment must be conducted; (d) the means by which the conduct and results of the experiment must be recorded; (e) the time by which any other party (the opponent) must notify the proponent of any grounds on which the opponent will contend that the experiment does not prove a fact that the proponent asserts is, will or may be proved by the experiment. (2) Evidence of the conduct and results of the experiment is admissible in the proceeding, only: (a) if the proponent has complied with subrule (1) and any orders given under that subrule; or (b) with the leave of the Court. (3) If an order mentioned in paragraph (1)(e) has been made, and the opponent has not complied with the order in relation to a ground, the opponent may rely on the ground only with the leave of the Court. 34 It had been Ono's belief and expectation that experiments, based on protocols provide to it on 29 May 2015 and 3 July 2015, would be carried out by Merck later in October 2015, which Ono would attend for the purpose of observation. 35 At the time that the US experiments were carried out, Merck's pleaded case was that claim 3 of the patent had been anticipated by seven prior art antibodies: PD1-17, PD1-28, PD1-33 and PD1-35 (the Wyeth antibodies); J105, hBAT and J43. 36 The particulars of experiments provided to Ono on 29 May 2015 stated that Biacore and flow cytometry studies would be conducted using nine antibodies, namely the seven prior art antibodies identified immediately above, and two further antibodies J116 and J110. The protocols provided to Ono on 3 July 2015 provided for studies to be carried out on 14 antibodies, namely the Wyeth antibodies; four variants of the Wyeth antibodies; J105; J110; and four additional antibodies. The identity of the four additional antibodies has not been revealed. 37 Merck says that the US experiments show that the Wyeth antibodies and J105 "compete" with 17D8, 2D3, 4H1 and 7D3 (that is, the reference antibodies referred to in claim 3 of the patent) for binding to human PD-1 using standard assays (that is, using the Biacore and flow cytometry assays). Importantly for present purposes, the US experiments included assays of prior art antibodies that Merck does not rely on in this proceeding (the non-asserted antibodies). 38 By way of explanation, on 22 January 2016 Merck amended the particulars of its pleading on lack of novelty to rely only on the public availability, before the priority date of 9 May 2005, of J105 and the "instructions" in International Patent Application No. PCT/IB2003/006304 (Wyeth, Cambridge Antibody Technology, "Antibodies against PD-1 and uses therefor") published on 8 July 2004 as WO2004/056875 (Wyeth) in relation to the production of the four Wyeth antibodies. Merck also relies on an earlier publication by Ono Pharmaceutical (International Patent Application No. PCT/JP2003/008420 (Ono Pharmaceutical Co Ltd, Honjo, "Immunopotentiating compositions"), published on 15 January 2004 as WO2004/004771) but not in any way that relies on experimental proof. 39 On 12 April 2016, I made the following orders by consent: … 2. Subject to the applicants/cross-respondents' compliance with Order 3 of these orders, pursuant to r 34.50(2) of the Federal Court Rules 2011 (the Rules), leave be granted to the applicants/cross-respondents (Merck) to tender, as evidence in this proceeding, Information relating to the US Experiments (as defined in Annexure A to these orders). 3. Merck serve on the respondents/cross-claimants (Ono), by 4.00 pm on 10 May 2016, a copy of all laboratory notebooks for the US Experiments (as defined in Annexure A to these orders), redacted to remove any confidential and irrelevant information. … (Emphasis in original.) 40 It is not necessary for me to refer to the detail of Annexure A to orders made on 12 April 2016, other than to note that Annexure A identifies documents and data that had already been provided to Ono by Merck prior to the orders being made. This appears to have been the result of much correspondence between the parties leading to their agreement that information relating to the US experiments could be relied upon by Merck as experimental proof in the proceeding. Importantly, the description of the data files listed in Annexure A shows that, in respect of some files, data had been redacted and replacement files had been provided. 41 It is also to be noted, for later reference, that the parties had agreed that the laboratory notebooks for the US experiments, referred to in Order 3, could be redacted to remove any confidential and irrelevant information. This can only refer to Merck redacting information which it considered to be confidential and irrelevant. 42 There is no dispute between the parties that the pre-condition of Order 3 has been satisfied for the leave granted in Order 2. 43 The context for Ono's application for discovery is that, for the reasons stated below, the just resolution of the proceeding will be facilitated by the discovery and production of documents providing additional information in relation to the US experiments. Documents that have been provided 44 Merck has produced, informally, a number of documents in respect of the US experiments. Some of these are referred to in Annexure A to the orders made on 12 April 2016. Since that date, further documents have been produced. Ono does not have all the documents it wishes to have or which it believes it is entitled to have. 45 Certain documents were given to Dr Conroy for review in relation to a Biacore study. These included a document titled "Antibody/hPD-1 Binding Characterisation and Competition Study" from Biosensor Tools, which carried out the Biacore study for Merck (the Biosensor Tools report) in accordance with a protocol titled "Antibody Characterization and Binding Competition Study" (the Biacore protocol). In his first affidavit, Dr Conroy referred to the Biacore protocol as "a high level summary of a proposed Biacore study". He also reviewed certain data files, some of which he noted had been marked as "redacted". Further, he was given a notebook used by Dr Myszka, the principal investigator at Biosensor Tools (the Myszka notebook). 46 Based on the material he was given, Dr Conroy observed that: certain data files were not provided to him in .BLR format; pages in the Myszka notebook were obscured by "black boxes"; the Myszka notebook does not contain information to the level of detail which, Dr Conroy said, is typically kept when conducting a Biacore experiment; and the Myszka notebook contains "additional information" that is not contained in the Biosensor Tools report or the data files that Dr Conroy was given. 47 The "additional information" referred to in the immediately preceding paragraph appears to relate to additional experiments conducted on variants of PD-1, the ligands of PD-1 and the ligands of variants of PD-1. 48 The "additional information" also appears to include experiments involving alternative capturing surfaces for the antibodies that are different to the capturing surfaces disclosed in the Biosensor Tools report, and experiments involving the addition of reagents not listed in the Biacore protocol. 49 Dr Conroy said that the data and results from the additional experiments are likely to provide relevant information. In this connection, he said that experiments conducted on the ligands of PD-1 are likely to function as experimental controls. The ability of PD-1 to bind to its natural ligands shows that the PD-1 protein is correctly folded and that the Biacore assays is operating properly. With respect to experiments involving the addition of reagents not listed in the Biacore protocol, Dr Conroy said that certain reagents (one was mentioned by name) tend to be included in sample solutions to bind contaminants in the sample which, if unbound, may bind non-specifically and affect the results of the assay. Thus, Dr Conroy said, the reasons for and results of any experiment using such reagents are likely to be relevant to an assessment of the veracity of the results presented. 50 In his first affidavit, Dr Conroy said that, because: the Biacore protocol contains a high level summary only; he does not have all necessary .BLR files that relate to the Biosensor Tools report; and the Myszka notebook contains additional experiments that are not included in the Biosensor Tools report or in the data files he had reviewed, he cannot properly "review and verify" the Biosensor Tools report. 51 I pause to note, for later reference, that Merck draws attention to the fact that, in his first affidavit, Dr Conroy did not state that he needed information on the testing of other antibodies—that is to say, antibodies other than the antibodies now relied upon by Merck as anticipating the invention claimed in claim 3 of the patent. 52 Certain documents were given to Dr Conroy for review in relation to a flow cytometry study. These included a document titled "CB-003436 - Investigations of Binding Properties of PD-1 Specific Antibodies to Cell Lines Expressing Human PD-1" from Cambridge Biomedical, which conducted the flow cytometry study for Merck (the Cambridge Biomedical report). Dr Conroy said that that the Cambridge Biomedical report includes "a high level summary of a proposed flow cytometry experiment" (the flow cytometry protocol) and the results that relate to this protocol. He also reviewed certain data files relating to the results in the Cambridge Biomedical report. Dr Conroy observed that some of the data files were marked as "redacted" or "redactions applied". Dr Conroy said that he has not reviewed any laboratory notebook or similar document which sets out all steps taken in the flow cytometry study reported in the Cambridge Biomedical report. He said that, for that reason, he cannot properly "review and verify" the Cambridge Biomedical report. Documents that Ono seeks 53 Ono seeks documents according to categories listed in an amended annexure which it seeks to substitute for the present annexure to the first interlocutory application. The amended annexure will be placed on the Court file and the first interlocutory application will be taken as having been amended by treating the amended annexure as the annexure referred to in paragraph 1 of the interlocutory application. 54 So far as relevant to the US experiments, Ono seeks the following categories of documents: 1. All documents which record the conduct and results of the Biacore experiments conducted as part of [the US experiments], including but not limited to: (a) all .BLR files generated by the Biacore instrument in the Biacore experiments conducted as part of [the US experiments]; (b) raw data and results of the following experiments: (i) preparation and analysis of variants of PD-1, including but not limited to Fc forms and other species; (ii) preparation and analysis of ligands of PD-1, including but not limited to the performance of Phase 1 of the Biacore Protocol; (iii) preparation and analysis of ligands of variants of PD-1, including but not limited to other species; (iv) experiments involving alternative capturing surfaces for the antibodies that are different from those disclosed in the document titled "Anti-hPD-1 Binding Characterization and Competition Study BST-1.pdf" provided by the Applicants on 11 December 2015, including but not limited to "Protein A" and "anti-human" surfaces; (v) experiments involving the addition of reagents not listed in the Biacore Protocol, such as "Globulins from bovine blood Sigma G5009". … 2. All documents which record the conduct and results of the flow cytometry experiments conducted as part of [the US experiments]. 55 It can be seen that, in substance, Ono seeks all documents that record the conduct and results of the Biacore and flow cytometry experiments conducted as part of the US experiments. It has, however, nominated particular, non-limiting subcategories of documents which it says should be discovered in relation to the Biacore experiments. Where necessary, I will refer to the documents sought in these subcategories as the subcategory (a) documents, the subcategory (b)(i) documents, the subcategory (b)(ii) documents, and so on to reflect the subparagraphs quoted above. The issues between the parties General observations 56 At the outset, it is important to appreciate that Merck does not dispute that it has redacted information in the documents it has provided informally to Ono, and has not produced other documents in relation to the US experiments. Specifically, Merck has not provided, or has redacted, information and documents concerning: the non-asserted antibodies (because, in this proceeding, the disclosure of those antibodies is not alleged to be anticipatory); the testing of antibodies for binding to non-human PD-1 (because, in this proceeding, Merck only relies on the binding of the Wyeth antibodies and J105 to human PD-1, not non-human PD-1, for its case on anticipation); whether antibodies compete for binding to PD-1 with PD-1 ligands (because, in this proceeding, Merck only relies on the binding of antibodies and not ligands for its case on anticipation, given the terms of claim 3 of the patent which, Merck says, relates to antibodies and not ligands); and PD-1 ligand binding experiments to confirm that PD-1 has correct folding (because, in the US experiments, PD-1 was obtained from a commercial supplier that performs its own quality controls). 57 Merck's approach to the provision of documents and information reflects the specific and relatively limited way in which it wishes to pursue its case on anticipation using experimental proof. It is, of course, under no obligation to advance its case in any broader way. 58 It is also important to appreciate that Merck and Ono are engaged in litigation in a number of other jurisdictions in relation to the validity of patents corresponding to the patent. The present proceeding is but one theatre of war between the parties in relation to what might be seen, at one level of generality, to be a dispute over the same subject matter. However, the claims under challenge in the various jurisdictions are not necessarily cast in the same terms as claim 3 of the patent. A convenient example is claim 3 of European Patent No. 2161336 (EP336) where, prior to amendment, the reference antibody was the single antibody 5C4. This antibody is not referred to in claim 3 of the patent in suit, although it is referred to in the passage of the specification quoted at [7] above. As a general observation, it does not seem to be doubted that the scope of experimental proof required in the various proceedings is not the same for each jurisdiction. 59 The evidence reveals a debate between the parties as to the potential significance of the information and documents that have not been produced to date or that have been redacted. This debate is advanced, on Ono's behalf, through Dr Conroy's affidavits and, on Merck's behalf, through Mr Collings' affidavits. Mr Collings is a United States attorney. The firm of which Mr Collings is an Associate, Sidley Austin LLP, has been engaged to act for Merck in relation to litigation with Ono Pharmaceutical and its related companies concerning the Keytruda product (or products corresponding to that product). Mr Collings has undergraduate and postgraduate degrees in biological sciences and biotechnology, respectively. His work for Merck has included engaging independent third party expert laboratories in the United States to undertake Biacore and flow cytometry experiments. These experiments include, but are not limited to, determining whether the Wyeth antibodies and J105 each compete with the reference antibodies for binding to human PD-1. 60 Much of Mr Collings' evidence was given on information and belief. Ono criticised the indirect nature of this evidence and argued that the direct evidence given by Dr Conroy is to be preferred. Whilst advancing different positions, I do not think that there is a direct conflict between Dr Conroy's evidence and Mr Collings' evidence. I have no reason to doubt the accuracy of Mr Collings' evidence given on information and belief. Biacore experiments generally 61 Starting from the position that information and documents have not been produced or have been redacted, for the reasons stated at [56] above, the debate between the parties, on the evidence, has progressed in the following way. 62 In relation to the Biacore studies, Dr Conroy said that, as a researcher who conducts or supervises others to conduct Biacore experiments, he would want full access to all experimental data produced during the US experiments. Dr Conroy said that this was due to "the complex nature of protein interactions" which, he said, requires a thorough understanding of any experimental data which relates to the nature of that interaction. Dr Conroy considered that information and documents relating to the experiments conducted with the non-asserted antibodies may provide information relevant to the interpretation of the results for the antibodies he reviewed, given that they were tested as part of a "single study". 63 It is convenient to note here that Merck disputes Dr Conroy's characterisation of the US experiments as "a single study". There is evidence before me, albeit based on information and belief (the source of which is Dr Myszka), that each antibody (including each non-asserted antibody) was tested relative to its own control. Dr Myszka's view, expressed through Mr Collings, is that a Biacore expert would understand protein interactions by looking at the data relating to a particular antibody and its controls, without the need to look at how other antibodies behave relative to their own controls. I do not understand this proposition to be in dispute. 64 Dr Conroy illustrated his position by reference to whether the non-asserted antibodies used in the US experiments were either included, or not included, as controls. 65 Dr Conroy said that if the non-asserted antibodies were included as controls then information about their behaviour would operate as important benchmarks in assessing results in relation to the Wyeth antibodies and J105. It is not necessary to explore this particular argument further because there is evidence before me (once again, on information and belief but sourced in Dr Myszka) that the non-asserted antibodies were not used as controls in the experiments conducted on the Wyeth antibodies and J105. Dr Myszka, through Mr Collings, has affirmed that the controls used in respect of the Wyeth antibodies and J105 are those identified in the Biosensor Tools report. 66 Dr Conroy said that if the non-asserted antibodies were not included as controls, information about their behaviour against the controls he has reviewed would inform him whether "the entire experimental system" was behaving as expected. Further, Dr Conroy said that the behaviour of the non-asserted antibodies, compared with the behaviour of the Wyeth antibodies and J105, may provide information on the behaviour of the Wyeth antibodies and J105. However, having said this, Dr Conroy did not explain what that information might be. 67 There is evidence before me (once again, on information and belief but sourced in Dr Myszka) that there is no need to resort to extraneous data in order to understand the fully controlled experiments carried out with respect to the Wyeth antibodies and J105. Once again, I do not understand this proposition to be in dispute. 68 Dr Conroy also considered that "all tests" conducted as part of a study are relevant to understanding the study due to, once again, the complex nature of protein interactions. In giving this evidence, Dr Conroy was apparently referring to the tests identified in the last three dot points in [56] above. I will return to this topic when discussing Ono's application for discovery by reference to the designated subcategories. 69 Having summarised these issues, I make the following observations. 70 First, it is important to remember that, on 12 April 2016, Ono consented to leave being granted to Merck to tender, as evidence in this proceeding, the information identified in Annexure A to the orders made on that day. I have no reason to doubt that this consent was informed by the documents and data that Merck had provided to Ono prior to the relevant orders being made. Ono's consent must also have been informed by the knowledge that data had been redacted from files and that replacement files had been provided. This consent was also conditioned on the Myszka notebook being provided (although not identified as such), subject to redactions being made. 71 The leave sought, and granted, on 12 April 2016 was not conditioned on other information being provided, including information that might be provided by other experiments that might have been conducted. The orders are clear as to the experiments and the experimental information on which reliance is to be placed. 72 Secondly, as flagged at [51] above, the first mention by Dr Conroy of his desire to see information and documents on the testing of the non-asserted antibodies, is to be found in his second affidavit. This desire was not mentioned in his first affidavit. In oral submissions, Ono sought to explain this discrepancy on the basis that it was only on the filing of Mr Collings' first affidavit that it became apparent that information and documents concerning the testing of the non-asserted antibodies had not been provided or had been redacted. Merck disputes this explanation. Dr Conroy did not himself give evidence on why his desire to see the results of the testing of the non-asserted antibodies was only raised in his second affidavit. Whatever Dr Conroy's personal position might be, I think it is unlikely that it was only on receipt of Mr Collings' first affidavit that Ono itself became aware that non-asserted antibodies had been tested in the course of the US experiments. It nevertheless gave its consent to leave being granted without any qualification that sounded in the need for the testing of other antibodies to be provided. 73 Thirdly, it is clear that Dr Conroy's evidence of his desire to have access to all experimental data provided during the Biacore studies is expressed from the vantage of a researcher with unrestricted access to information. I can well understand the desire of a researcher, exercising an inquiring mind, to see all experimental information that might be available. However, the context in which Dr Conroy expresses his desire is not the context of legal proceedings in which a disciplined approach must be exercised when considering the requirements for the giving of discovery: see in particular r 20.11 FCR which provides that a party must not apply for an order for discovery unless the making of the order sought will facilitate the just resolution of the proceeding as quickly, inexpensively and efficiently as possible. 74 Fourthly, and relatedly, Dr Conroy does not say that the experimental data produced during the Biacore studies on the non-asserted antibodies is necessary to understand the results obtained in relation to the studies undertaken on the Wyeth antibodies and J105. Still less does Dr Conroy say that, in order to produce valid results in relation to the experiments conducted with respect to the Wyeth antibodies and J105, it is necessary to test other antibodies. This perhaps explains the tentative language employed in this part of Dr Conroy's second affidavit ("may provide information relevant to the interpretation of the results for the antibodies I have reviewed"; "may provide information on the behaviour of [the Wyeth antibodies and J105]"). 75 Fifthly, insofar as it is said that the behaviour of the non-asserted antibodies would provide information as to whether "the entire experimental system was behaving as expected", Dr Conroy does not point to any material in relation to the testing of the Wyeth antibodies and J105 that would suggest that "the entire experimental system" was not behaving "as expected" or cast any doubt about that matter. I would expect that if there was any reason to doubt that "the entire experimental system" was not behaving "as expected" then some suggestion or appearance of this would be apparent from the documents already provided, including the Myszka notebook. 76 In light of the evidence given and the observations I have made above, I am not persuaded that discovery should be given of all the documents that record the conduct and results of the Biacore experiments conducted as part of the US experiments. Without in any way being critical of Dr Conroy, it seems to me that his evidence on this issue rises no higher than an understandable desire to see other information and documents in relation to the US experiments, simply because it is known that other information and documents exist. The utility of the other information and documents for the resolution of the issues to be determined in this proceeding seems to me to be, at best, speculative. I am not persuaded that the general order for discovery that is sought in relation to the Biacore experiments would facilitate the just resolution of the proceeding as quickly, inexpensively and efficiently as possible. 77 My conclusion on this aspect of Ono's application informs my consideration of the need for discovery in relation to the particular subcategories of documents to which I have referred. There are, however, other issues arising in relation to those subcategories which I should address. The documents sought in subcategories 78 With respect to the subcategory (a) documents, Dr Conroy said that the data files that relate to the "Solution competition mAb studies" and the "Sandwich competition mAb studies" in the Biosensor Tools report were not provided in .BLR format. He said that, for this reason, he has not been able to review a complete set of the .BLR files that relate to the Biosensor Tools report. 79 Mr Collings responded to Dr Conroy on the basis of information provided by Dr Myszka. Mr Collings said that all .BLR files and their corresponding .SCB files relating to the Wyeth antibodies and J105 have been provided to Ono except for those .BLR files containing not only data relating to the Wyeth antibodies and J105, but also data relating to the non-asserted antibodies. Mr Collings said that where a .BLR file contains such "intermingled" data, .BLE and .SCB files relating to the Wyeth antibodies and J105 were generated by Dr Myszka because it was not possible to edit the .BLR files. The .BLE and .SCB files have been provided to Ono. Mr Collings said that he has been informed by Dr Myszka that when he (Dr Myszka) generated the .BLE files from the .BLR files, the .BLE files contained the same data that were in the .BLR files, with the exception of data relating to the non-asserted antibodies. In addition, new .SCB files, corresponding to the .BLE file, were generated to allow the analysis of the Biacore binding responses in the .BLE files. Dr Myszka informed Mr Collings that these were standard file manipulations. 80 In response, Dr Conroy said that the .BLE and .SCB files he has reviewed in relation to the Biacore experiments do not contain all the information that is automatically captured in .BLR files, including flow rates, collection rates, temperature, precise injection times, injection positions from the reagent rack and annotated "report points" on the sensorgrams used to describe and mark the time in which an event occurs in the Biacore instrument (for example, an injection of a sample or reagent). Dr Conroy said that, additionally, manually inputted information that he would typically include in a .BLR file is also missing from the .BLE and .SCB files he has reviewed. 81 Mr Collings replied to Dr Conroy's response, affirming that the .BLE files that were provided contain the same data as in the .BLR files, with the exception of data relating to the non-asserted antibodies. However, Mr Collings also said: I have been informed by Dr Myszka that all of the data have been provided in all of the forms in which they were able to be provided without disclosing data relating to antibodies not relied on. (Emphasis added.) 82 This reply causes me some concern because, on one reading, it suggests that certain data in the .BLR files concerning the testing of the Wyeth antibodies and J105 may not have been provided to Ono in any form, including in the .BLE and .SCB files. In other words, Mr Collings' reply leaves open the possibility that the confidentiality of data relating to the non-asserted antibodies has taken precedence over the disclosure of data relating to the testing of the Wyeth antibodies and J105, even to the extent of not including that data in the .BLE or .SCB files. If that be so, then I do not regard that to be a satisfactory state of affairs. 83 With respect to the subcategory (b)(i) documents and the subcategory (b)(iii) documents, I have already referred to the fact that Merck does not rely on the binding of antibodies to non-human species of PD-1. Similarly, it does not rely on the binding of antibodies to variants of PD-1. Merck's case on anticipation will stand or fall on the experimental proof that it puts forward (namely, the binding of the Wyeth antibodies and J105 to human PD-1), not on experiments that deal with the binding of antibodies to non-human species of PD-1 or variants of PD-1, which are extraneous to its case. Dr Conroy does not explain any possible significance of the latter experiments beyond saying that they might provide "relevant information". That is not a sufficient reason to require discovery of the subcategory (b)(i) documents or the subcategory (b)(iii) documents. 84 With respect to the subcategory (b)(ii) documents concerning the preparation and analysis of ligands of PD-1, I have already noted that Merck only relies, in this proceeding, on the binding of antibodies and not ligands. In his first affidavit, Dr Conroy said that experiments conducted on the ligands of PD-1 are likely to function as experimental controls. He said that the ability of PD-1 to bind to its natural ligands shows that the PD-1 protein is correctly folded and that the Biacore assay is operating properly. 85 Dr Myszka has generated data relating to Phase 1 of the Biacore protocol (specifically referred to in this subcategory). Without accepting that these data are necessary controls for the data upon which Merck seeks to rely in this proceeding, Merck has provided the data to Ono informally. At the time of hearing the first interlocutory application, Dr Conroy had not been able to review this data. In the course of oral submissions, Ono indicated that the information recently provided by Merck still does not satisfy the reach of this subcategory. It is not clear to me what further information is sought. In all the circumstances, further consideration of this subcategory of documents should await Dr Conroy's review of the documents recently provided. 86 With respect to the subcategory (b)(iv) documents, Mr Collings gave evidence that the capturing surfaces provided by Merck on 11 December 2015 were successfully used in relation to the testing of the Wyeth antibodies and J105. In other words, it was not necessary to use alternative capturing services to those described in the Biosensor Tools report. With respect to the "Protein A" and "anti-human" surfaces referred to in this subcategory, Mr Collings said that these surfaces were used for the purpose of evaluating the non-asserted antibodies. Ono has not demonstrated a sufficient reason to require discovery of the subcategory (b)(iv) documents. 87 There is a related matter. The Myszka notebook refers to two antibodies (identified only as "42" and "44") having been captured on the Protein A and anti-human capturing surfaces. In his second affidavit, Mr Collings says that these alternative surfaces "were used to analyse the binding of an antibody not relied on" (that is, a non-asserted antibody). I infer that the entries in the Myszka notebook in respect of antibody or antibodies "42" and "44" have been disclosed inadvertently. However, nothing turns on that fact. It does not alter the conclusion to which I have come. 88 With respect to the subcategory (b)(v) documents, Dr Conroy stated that reagents such as "Globulins from bovine blood Sigma G5009" tend to be included in sample solutions to bind to contaminants in the sample which, if unbound, may bind non-specifically in a Biacore assay and affect the results. He said that the results of experiments performed using such a reagent are likely to be relevant to an assessment of the veracity of the results presented. 89 In response, and on the basis of information provided by Dr Myszka, Mr Collings said that globulins from bovine blood are used to block non-specific binding on a Protein A alternative capturing surface. In the US experiments, these globulins were used only for experiments involving the Protein Alternative capturing surface. These experiments only involved the non-asserted antibodies. Ono has not demonstrated a sufficient reason to require discovery of the category (b)(v) documents. The documents sought in subcategories: conclusion 90 The parties should confer on the particular concern I have raised at [82] above. It is possible that I have misunderstood the purport of the passage I have quoted at [81] above. If the parties are unable to resolve this aspect of the matter, then I will hear further argument in relation to the subcategory (a) documents. 91 Similarly, for the reasons I have given at [85] above, I will also hear further argument, if necessary, in relation to the subcategory (b)(ii) documents. Flow cytometry 92 As I have noted at [52] above, Dr Conroy said that he had not reviewed any laboratory notebook or similar document which sets out all steps taken in the flow cytometry study reported in the Cambridge Biomedical report. He said that, for that reason, he could not properly "review and verify" the Cambridge Biomedical report. I have also referred to the fact that Dr Conroy described the flow cytometry protocol (used for the Cambridge Biomedical report) as a high level summary of a proposed flow cytometry experiment. 93 In his first affidavit, Mr Collings responded to Dr Conroy's comments on the basis of information given to him by Dr Mangada, who was the principal investigator responsible for the flow cytometry experiments conducted by Cambridge Biomedical. Mr Collings said that Dr Mangada had informed him that the flow cytometry protocol is the type of protocol that Cambridge Biomedical would ordinarily provide to its clients and that personnel at Cambridge Biomedical followed the steps in that protocol when carrying out the flow cytometry experiments. Mr Collings also said that Dr Mangada informed him that personnel do not keep notes in handwritten laboratory notebooks but, rather, keep "electronic notes in the data sheets and plate maps". The relevant data sheets and plate maps have been provided to Ono. 94 In his second affidavit, Dr Conroy said that the data files he reviewed in relation to the flow cytometry experiments indicated that additional experiments had been conducted, which fell outside the flow cytometry protocol. Further, these experiments were not reported in the Cambridge Biomedical report. Dr Conroy gave as an example a file named "DATA-000062.pdf" that contains data relating to competitive binding experiments between labelled anti-PD-1 antibodies incubated either sequentially or simultaneously. 95 In his second affidavit, Mr Collings replied by stating, on information from Dr Mangada, that the particular file identified by Dr Conroy reflected an assay optimisation run used to evaluate concentration-dependent inhibition of one antibody against the other. The results of this assay yielded the assay method reported in the flow cytometry protocol, which was employed for all experiments in which two antibodies were used to stain cells. I do not understand this explanation to be incomplete in respect of the particular matter raised by Dr Conroy. 96 Ono has not demonstrated a sufficient reason to require discovery of all documents which record the conduct and results of the flow cytometry experiments conducted as part of the US experiments. The UK experiments Background 97 The UK experiments were carried out in 2014 and 2015 at Oxford University under the direction of Professor Simon Davis. The experiments carried out in 2015 repeated the experiments carried out in 2014. Both involved Biacore assays and flow cytometry experiments. 98 The UK experiments were carried out for the purpose of proceedings in the United Kingdom relating to the validity of certain claims of EP336. Ono Pharmaceutical is a defendant in those proceedings. As I have previously noted, claim 3 of EP336 corresponds to claim 3 of the patent, save that the sole reference antibody in claim 3 of EP336 is 5C4 and not the reference antibodies referred to in claim 3 of the patent. Documents that have been produced 99 Merck has produced, informally, a number of documents in respect of the UK experiments. Some of these are referred to in Annexure B to the orders made on 12 April 2016. Since that date, further documents have been produced. Once again, Ono does not have all the documents it wishes to have or which it believes it is entitled to have. 100 Following the making of the orders on 12 April 2016, Ono has been provided with the following documents in relation to the UK experiments: in relation to the 2014 UK experiments, experimental protocols, results and hard copies of raw data files (that is, printouts of sensorgrams and flow cytometry plots), copies of Professor Davis' laboratory notebooks, and electronic raw data files; in relation to the 2015 experiments, the raw data files; the laboratory notebook for the 2015 repeat Biacore assay experiments; a schedule of reagents and incubation times for the 2015 repeat flow cytometry experiments; Excel spreadsheets describing the Biacore assay data files generated during the 2014 experiments and the 2015 repeat experiments; and results of the 2015 repeat experiments. 101 Certain documents were given to Dr Conroy for review. These included a document titled "Annex 2 to Claimant's Notice of Experiments", pages 7 to 11 of which relate to flow cytometry experiments performed in 2014 (Annex 2-2014 Flow Cytometry Experiments). Dr Conroy was also provided with a document titled "Annex 2, pages 7-10" that relate to flow cytometry experiments performed in 2015 (Annex 2-2015 Flow Cytometry Experiments). 102 Dr Conroy said that it is not clear to him which data files were used to prepare the results presented in Annex 2-2014 Flow Cytometry Experiments and Annex 2-2015 Flow Cytometry Experiments. He said that he cannot, therefore, verify the accuracy of the results. He said that, in order to do this, he would need the FlowJo workspace files for each figure (graph) in these documents. 103 On 19 July 2016, Merck provided tables which would enable Dr Conroy to visually compare certain figures (graphs) in the results, which are presented as multiple figures on one page, with the data files listed in these tables. Dr Conroy said that this requires him to infer that wherever the figures match, the source of the relevant figure in the results is the relevant data file listed in the tables. Dr Conroy said that this process is more burdensome and inherently less precise than using the FlowJo workspace files which, by their nature, would accurately allow the figures in the results to be verified. Dr Conroy said that the tables do not provide him with the same level of certainty that he would have if he had access to the relevant FlowJo workspace files. 104 Merck's solicitor, Ms Gourley, has made inquiries with Professor Davis in relation to these observations by Dr Conroy, in particular his comment that the process of verification of the graphs is more burdensome and inherently less precise than it would be if Dr Conroy had access to the FlowJo files. Ms Gourley said that Professor Davis has informed her as follows. First, the graphs (figures) included in the results of the UK experiments are representations of the raw data that have already been provided. Secondly, it is a straightforward task for those working in the field to convert the raw data to graphs using software available to those working in the field. Thirdly, Professor Davis understands that the files sought by Dr Conroy are intermediate working files created during the conversion of the raw data into a format used by the graphics software. Such files are not required to verify the figures in the results of the UK experiments that have been provided. Fourthly, there are no data in the intermediate working files that are not include in the raw data files that have already been provided. 105 Notwithstanding these matters, Professor Davis has provided a number of intermediate working files relating to the preparation of the graphs of the results of the Biacore studies undertaken in the UK experiments. Ms Gourley said that these intermediate working files have now been provided to Ono's solicitors. 106 Ono has submitted that there is no evidence that the FlowJo files do not exist. It argues that Merck should provide them. Merck has suggested that further consideration of this category should be deferred on the basis that it will provide any further documents if they exist. Strictly speaking, this is not an answer to Ono's application, if that application be properly made. Nevertheless, Merck's suggestion provides a practical and sensible way forward. In these circumstances, Merck should make these further inquiries and provide the documents it has offered, if they exist. Once again, I will hear further argument on this aspect of the matter, if necessary. The Second Interlocutory application 107 The second interlocutory application raises two substantive issues. The first can be dealt with relatively shortly. It concerns the conditional nature of the orders made on 12 April 2016 granting leave to Merck to rely on information relating to the US experiments and information relating to the UK experiments. Merck says that the conditions on which leave was granted in each case have been satisfied and that the orders should now be varied to reflect that fact. If that be so, then strictly speaking no variation to the orders is required. Nevertheless, Ono does not oppose the variations that are proposed in this regard and there is some utility in formally acknowledging that there is no dispute between the parties concerning the satisfaction of the conditions on which leave was granted. For these reasons, I am prepared to make the variations which Merck seeks. 108 The second issue requires some explanation. Apart from the orders made on 12 April 2016 to which I have already referred, I also ordered that experiments on infringement, with an expected duration of two weeks, be conducted by Ono in the period August to September 2016. It would appear that, following the making of that order, Merck criticised Ono's proposed experiments as being "neither a standard assay, no[r] an assay described in the Patent". In response, Ono indicated that, in light of that criticism, it would conduct a Biacore assay. It said that the experimental protocol it proposed to follow would be a "refinement" of Merck's Biacore protocol provided on 3 July 2015. 109 On 8 July 2016, at the request of the parties, I vacated the order made on 12 April 2016 providing for the conduct of Ono's experiments. I ordered that, by 5.00 pm on 12 July 2016, Ono serve certain information, which included particulars of Ono's experiments under r 34.50 FCR and an experimental protocol. I then ordered that those experiments be conducted in the period August to September 2016. 110 Following receipt of the information that had been ordered, Merck reconsidered its position on infringement and indicated that it proposed to make an admission relating to infringement. The evident purpose of making this admission was to avoid the need for Ono to carry out its proposed experiments. The proposed admission was as follows: For the purposes only of the Cross-Claim in this proceeding, the Applicants/Cross-respondents admit that each of 17D8, 2D3, 4H1 and 7D3 would compete with Keytruda for binding to human PD-1, as determined by Biacore analysis as set out in the protocol in Annexure C to the Respondents/Cross-claimants' Particulars of Experiment dated 12 July 2016. 111 On 27 July 2016, Ono advised Merck that it was not prepared to accept this admission. Ono nevertheless said that if Merck would admit certain allegations in Ono's statement of cross-claim dated 20 March 2015, it would not proceed with the proposed experiments. In effect, this invitation required Merck to admit the infringement of claims 3, 5 and 8, 9 to 11 and 14 to 17 of the patent. I observe that claims 5, 8, 9 to 11 and 14 to 17 are each dependent, to some extent, on claim 3. 112 On 29 July 2016, Merck indicated that it was not prepared to make the admissions that Ono sought on the basis that, as made clear in the particulars of invalidity, Merck contends that the meaning of "cross-competes for binding to PD-1 with a reference antibody", as used in claim 3, is unclear. Merck urged Ono to accept the admission that Merck proposed because it would cover the facts that the proposed Biacore experiments seek to prove. In this connection, one of the goals of the Biacore experiments proposed by Ono, as stated in the protocol for the experiments (see Ex 1 in this application), is couched in the following terms: Perform binding competition study on the reference and test mAbs that bind PD-1 to determine whether they compete for binding to PD-1 with another, as determined by Biacore analysis. 113 The difference between the parties is this: Merck is prepared to provide an admission reflecting the goal quoted above, but is not prepared to admit infringement of the relevant claims that use or incorporate the expression "cross-competes" because Merck says that expression is unclear. 114 By the second interlocutory application, Merck seeks orders that provide for: setting aside the order made on 8 July 2016 for the conduct of Ono's proposed experiments; and preventing Ono from adducing evidence at the final hearing to prove the facts in Merck's voluntary admission. 115 For the reasons stated below, I am not prepared to make those orders. However, I am prepared to accept Merck's admission. 116 It appears to be the case that Ono wishes to determine facts that are additional to the facts contained in Merck's admission. However, those facts have not been stated. They should be stated so that Merck can consider its position in light of those additional facts and, perhaps, make a further admission. The point at issue appears to be the meaning of "cross-competes" as used in claim 3 of the patent and its dependent claims versus the meaning of "compete" as used in the experimental protocol. Ono undoubtedly knows the facts it considers it will need to prove in order to establish infringement of claim 3. That is why it intends to conduct the proposed experiments. The time has come for it to state those facts with greater clarity. I will order that, within 7 days or within such further time as the parties might agree, Ono file and serve on Merck a statement of the facts, if determined at the experiments to be conducted pursuant to Order 3 made on 8 July 2016, that would be necessary to satisfy the requirement(s) of cross-competition referred to in Section B of the Particulars of Experiment contained in Ex 1 in this application. 117 It is regrettable that they parties have reached the seemingly inflexible positions evident in the correspondence relating to this issue. Ono wishes to proceed with the experiments, which will take place over a six week period. The experiments are due to commence on 22 August 2016 and will take place at Stanford in California. There is no evidence on the matter, but I have assumed, from experience, that the arrangements for these experiments have been in place for some time and cannot be changed readily. On the other hand, Merck has made an admission which, in the absence of further debate, appears to meet, in terms, the third objective stated in Ono's experimental protocol. Although I have no considered view on the matter, Ono will no doubt appreciate that it is running a material risk that, regardless of the outcome of the proceeding, it will be responsible for the cost of those experiments. For its part, Merck has said that it will not attend the experiments. That is, of course, its choice. But, in making that choice, it no doubt appreciates that its capacity to challenge the results of the experiments may be diminished by its non-attendance. I say no more than that. 118 The parties are sophisticated corporations acting with the benefit of sophisticated advice. They are in a position to appreciate fully the possible consequences of the forensic decisions they choose to make. Disposition 119 I will make orders reflecting the various conclusions I have expressed in these reasons. I certify that the preceding one hundred and nineteen (119) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Yates. Associate: Dated: 24 August 2016 SCHEDULE OF PARTIES NSD 954 of 2014 Applicants Second Applicant: MERCK SHARP & DOHME (AUSTRALIA) PTY LTD Respondents Second Respondent: E.R. SQUIBB & SONS, L.L.C. Cross-Claimants Second Cross-Claimant: E.R. SQUIBB & SONS, L.L.C. Cross-Respondents Second Cross-Respondent MERCK SHARP & DOHME (AUSTRALIA) PTY LTD