CSL Limited v Novo Nordisk Pharmaceuticals Pty Ltd

AND: NOVO NORDISK PHARMACEUTICALS PTY LTD

REASONS FOR JUDGMENT 1 This proceeding, which was commenced by Application and Statement of Claim filed on 10 March 2009, concerns Australian Standard Patent No 716,747, in respect of an invention for a stabilised growth hormone and a method of preparation thereof. The proprietors are CSL Limited and Monash University. They are the applicants in the proceeding, in which they allege that certain claims in the patent were infringed by the respondents, Novo Nordisk Pharmaceuticals Pty Ltd and Novo Nordisk A/S. In their Defence and Cross-Claim filed on 21 May 2009, the respondents allege that the invention was not novel, and that it lacked an inventive step, by reference to various citations of prior art said to have been published as at the priority date. They seek a declaration of invalidity, and an order that the patent be revoked. 2 By Notice of Motion filed on 6 November 2009, the applicants applied for a direction that the patent be amended pursuant to s 105 of the Patents Act 1990 (Cth). It appears that this step was taken at least substantially to make the applicants the better to resist the respondents' case on validity. To the extent presently relevant, the amendments sought involved the introduction of new text into Claim 1 of the patent, and the deletion of existing text from Claim 7. Showing the amendments proposed, those claims would be as follows: Claim 1: A method for the preparation of a stable, liquid formulation of growth hormone, comprising growth hormone, a buffer and a stabilising effective amount of at least one stabilising agent selected from the group consisting of: (i) polyoxyethylene-polyoxypropylene block copolymer non‑ionic surfactants, (ii) taurocholic acid or salts or derivatives thereof, and (iii) methyl cellulose derivatives, wherein the pH of the formulation is from 5.0 to 6.8, and wherein the method comprises admixing the growth hormone with the buffer and the stabilising agent(s) under conditions such that the growth hormone is not exposed to concentrations of the buffer or stabilising agent(s) which are greater than 2x the final concentrations of the buffer or stabilising agent(s) in the formulation. Claim 7: A method according to any of claims 1 to 6, wherein the pH of the formulation is from 5.0 to 7.5, preferably 5.0 to 6.8, more preferably from 5.2 to 6.5, and most preferably from 5.4 to 5.8. 3 The applicants' s 105 application is to be heard in advance of the main proceeding for infringement of the patent. A question has arisen as to the sufficiency of the applicants' compliance with their discovery obligations for the purposes of that application. On 24 November 2009, I ordered, by consent, that the applicants give discovery relevant to the s 105 application. They did so, by filing a list of documents in the conventional way. 4 On 31 March 2010, the respondents filed a Notice of Motion which sought orders for what was described as "further and better discovery", and for the unqualified inspection of documents which had been discovered by the applicants with redactions. That Notice of Motion was resolved by the following consent order made on 19 April 2010: 1. The Applicants give further and better discovery relevant to their section 105 amendment application within four weeks of the date of this order and, in particular: (a) enumerate all relevant documents over which any claim of privilege from production is made and state the grounds of the privilege in accordance with Order 15 rule 6 of the Federal Court Rules. (b) enumerate all documents which have been destroyed in the ordinary course of the Applicants' businesses and state when each document was destroyed, in accordance with Order 15 rule 6 of the Federal Court Rules. (c) give discovery of the documents or categories of documents listed in Schedule 1 to these orders. Schedule 1, as referred to in this order, was an extensive list of documents, or categories of documents, said to be either "Documents Recording or Evidencing Matters Described in the Applicants' Evidence" or "Documents Relevant to the Applicants' s 105 Amendment Application". In purported compliance with this order, the applicants filed a further list of documents on 22 April 2010, and a supplementary list on 7 May 2010. 5 Regrettably, the sufficiency of the applicants' compliance with the order of 19 April 2010 was not uncontroversial. It lead to the filing of a Notice of Motion by the respondents on 9 June 2010, in which the following orders were sought: The Applicants give discovery of each of documents numbered 21 to 31 in the Applicants' Further List of Documents dated 22 April 2010 and document numbered 183 in the Applicants' Supplementary List of Documents dated 6 May 2010 in un-redacted form and produce for inspection by the Respondents each of those documents in un-redacted form. Pursuant to Order 15, rule 11(1)(a) and (d), the Applicants produce for inspection by the Respondents each of documents numbered 131 to 182 in the Applicant's Further List of Documents dated 22 April 2010. Pursuant to Order 15, rule 8, the Applicants file and serve an affidavit of an officer of the First Applicant stating whether any of the following documents is or has been in either Applicant's possession, custody or power and, if it has been but is not then in its possession, custody or power, when it parted with that document and what has become of it: (a) The document or documents comprising the "Information on 20th January from John Slattery"; and (b) The "draft provisional patent" and the resulting provisional patent as filed, referred to in Confidential Annexure A to the Affidavit of Christopher David Schlicht made 8 June 2010 It is this Notice of Motion which was heard on 21 and 22 June 2010, and which is the subject of these reasons. 6 The base line for a consideration of the respondents' motion is s 105 of the Patents Act. That gives the court a discretion to direct the amendment of a patent, but provides no indication of the criteria or circumstances that should be taken into account on such an application. It is, however, common ground that the relevant principles at least include those referred to by Aldous J in Smith Kline and French Laboratories Ltd v Evans Medical Ltd [1989] 1 FSR 561, 569: The discretion as to whether or not to allow amendment is a wide one and the cases illustrate some principles which are applicable to the present case. First, the onus to establish that amendment should be allowed is upon the patentee and full disclosure must be made of all relevant matters. If there is a failure to disclose all the relevant matters, amendment will be refused. Secondly, amendment will be allowed provided the amendments are permitted under the Act and no circumstances arise which would lead the court to refuse the amendment. Thirdly, it is in the public interest that amendment is sought promptly. Thus, in cases where a patentee delays for an unreasonable period before seeking amendment, it will not be allowed unless the patentee shows reasonable grounds for his delay. Such includes cases where a patentee believed that amendment was not necessary and had reasonable grounds for that belief. Fourthly, a patentee who seeks to obtain an unfair advantage from a patent, which he knows or should have known should be amended, will not be allowed to amend. Such a case is where a patentee threatens an infringer with his unamended patent after he knows or should have known of the need to amend. Fifthly, the court is concerned with the conduct of the patentee and not with the merit of the invention. Counsel for the respondents stressed the fourth principle, submitting that documents would be relevant, and ought to be discovered, if they identified the point in time at which the applicants knew, or should have known, that the patent in suit should be amended. 7 The patent claims priority from Australian Provisional Specification No PN 8012, filed on 12 February 1996. By reference to that provisional specification, an International Application was filed under the Patent Cooperation Treaty on 12 February 1997. The Australian patent (the patent in suit) was granted on 15 June 2000. 8 There is a European equivalent of the patent in suit. On 26 June 2007, the second respondent filed a Notice of Opposition to the European patent. On 11 April 2008, the applicants filed a Response to that opposition in which, in their "main request", they defended the claims in the European patent in their existing terms, and, by way of an "auxiliary request", they proposed that the patent should be amended in ways which specified, either for the first time or by way of variation, pH ranges for the formulation. In an opinion published on 25 May 2009, the Opposition Division of the European Patent Office stated that significant claims of the main request had been anticipated by certain items of the prior art, but that the claims as proposed to be amended in the auxiliary request satisfied the requirements of novelty. 9 As I understand the case which the applicants will advance under s 105 of the Patents Act, it was this opinion of the Opposition Division which set in train a period of deliberations which ultimately led to the filing of the amendment application on 6 November 2009. As I understand at least one aspect of the case foreshadowed by the respondents, it will be said that it was well before the publication of that opinion - and, I think, possibly even well before the filing of the auxiliary request in the European opposition proceedings - that the applicants knew enough to have required them to form the judgment that the patent in suit should be amended. The controversy as to the timing of the applicants' knowledge of facts which might be relevant in these ways lies at the centre of the present dispute on discovery. 10 Before turning to the respondents' Notice of Motion as such, I should observe that the notion of "relevance", in a discovery context, is no longer that given content by The Compagnie Financiere et Commerciale du Pacifique v The Peruvian Guano Company (1882) 11 QBD 55. Its content, rather, now derives from O 15 r 2(3) of the Federal Court Rules, which provides that, with presently immaterial exceptions, discovery must be given of documents on which the party relies, documents that adversely affect the party's own case or the case of another party, and documents that support another party's case. 11 Turning then to the respects in which the respondents challenge the sufficiency of the applicants' discovery, their first point is that the applicants ought to have discovered certain documents in their entirety, rather than by employing a method by which those parts of the documents which were considered to be irrelevant were redacted. This point related to documents numbered 21 to 31 in the applicants' further list of documents dated 22 April 2010 and document numbered 183 in their supplementary list dated 5 May 2010. 12 The respondents accepted that, in compliance with the obligation to give general discovery, a party may (eg by sealing up, masking or redacting) discover only those parts of a particular document which are considered to be relevant: GE Capital Corporate Finance Group Ltd v Bankers Trust Co [1995] 1 WLR 172, 174. As was made clear in that case, a party's oath on the matter of relevance is conclusive, and no less so in a case where the discoverability of parts of a document is contentious than in a case where the discoverability of a document as a whole is contentious. However, it was argued on behalf of the respondents that the order made by the court on 19 April 2010, at least to the extent that it required discovery of the categories of documents specified in the schedule thereto, did not merely establish the applicants' obligation to give general discovery. Rather, it was what has been described as an order for "specific discovery", made under O 15 r 8, and foreclosed any question of relevance. Relevance was assumed by the making of the order, the applicants' only further obligation being to discover the documents if they existed, and were within their possession, custody or power. In these respects, the respondents relied upon the judgment of Besanko J in Egglishaw v Australian Crime Commission (No 2) (2009) 253 ALR 354, 358‑361. 13 The difficulty with the respondents' submission is that neither their Notice of Motion of 31 March 2010 nor the order which the court made on 19 April 2010 in terms invoked O 15 r 8. Rather, as I have noted above, what the respondents sought, and what they obtained, was "further and better discovery". With respect to the documents and categories listed in the schedule to the order, the respondents sought, and obtained, the imposition of an obligation upon the applicants to "give discovery" of those documents and categories. Although not adverted to at the time, the most natural sense in which this order is to be understood is as one made under O 15 r 5, although subject to limitations. 14 In the circumstances, I am of the view that the applicants' obligations under the order made on 19 April 2010 were those arising under O 15 r 2(3), and that they included the obligation to make the conventional judgment as to the relevance of any document, or part of a document. That being so, the principle referred to in GE Capital operates in the circumstances, and the applicants were entitled, at the point of giving discovery, to redact those parts of the documents which, in their judgment, were not relevant. 15 The respondents' next objection to the applicants' redactions was that it was clear from those parts of the relevant documents which remained un-redacted, and from the circumstances existing generally when each such document was created, that the applicants had applied the wrong test of relevance to the task which they undertook. The correct test, according to counsel for the respondents, was whether the document, or part, related (in the sense conveyed by O 15 r 2(3)) to the applicants' knowledge, or to facts from which such knowledge ought reasonably to have arisen, of the need to amend the patent in suit. According to counsel, anything which cast doubt upon the validity of the patent - including, and most particularly, anything from which it ought reasonably to have been apparent that the invention had been anticipated - ought to have been discovered, whether or not it related to the particular respects in which the s 105 amendment was ultimately sought. The test which I should infer had been applied by the applicants, according to counsel for the respondents, was a much narrower one, namely, whether the document, or part, disclosed facts or circumstances from which the applicants knew, or should have known, that an amendment along the lines ultimately proposed should be made. In these respects, counsel drew a distinction between the broad issue as to the doubt by which the validity of the patent was presumptively attended and the particular remedy to which the applicants ultimately resorted. 16 Having looked at the contentious documents in their discovered form (ie as redacted), I could not form the conclusion to which counsel for the respondents sought to direct me. It is not self-evident from those documents, or from the circumstances of their creation to the extent that they are known, that the wrong test as to relevance was applied by the applicants' legal advisors. Counsel for the respondents sought to reinforce his argument on this point by referring to the terms of certain correspondence which passed between the parties' solicitors, but that correspondence does not betray the application of an inappropriate test. As pointed out by counsel for the applicants, the relevant lists of documents were verified on oath, and carried the certification of the applicants' solicitor as required by O 15 r 6(8). The very fact of the present Notice of Motion, and the correspondence with which it has been associated, has, I presume, given a sharper edge to the focus which the applicants and their advisors bring to their discovery obligations in relevant respects. There is nothing in the material put before the court by the respondents, or in the submissions made on their behalf, which warrants a departure from the conventional assumption that the oath of a party, and the certification of his or her practitioner, is conclusive. 17 The respondents' next point is that, in some respects, the documents have been so heavily redacted that it is impossible to understand the sense of the un-redacted portions. However, the most conspicuous example of this aspect of the applicants' discovery was in a document which, for other reasons, the applicants chose to release to the respondents in an un‑redacted form during the course of the hearing of the respondents' Notice of Motion. There are other examples of documents in which only very short passages of text remain un‑redacted, but there is nothing from which I could infer that further light would be thrown on the sense of those passages by viewing what lies beneath the redactions. I do not accept the argument advanced on behalf of the respondents that the applicants' redactions were inappropriate for this reason. 18 It was also submitted on behalf of the respondents that the applicants ought to have followed the reasonable course of allowing the respondents' legal advisors to view the un‑redacted parts of the contentious documents on a confidential basis, at least for the purpose of satisfying themselves that the redactions were appropriate. I agree that that would have been a reasonable course, and might even have made the present motion unnecessary, but the facts of the case are not such as would make it appropriate for the court to follow the unusual course of requiring the applicants to proceed in this way. It was a matter for the applicants, and I am not disposed to embark upon a review of the wisdom of the course which they adopted. 19 The second aspect of the respondents' Notice of Motion relates to the claims of privilege advanced by the applicant with respect to 52 of the documents which they discovered. The first such document is a file note dated 26 November 2008 apparently recording a conversation between the corporate counsel of the first applicant and two solicitors then (and now) representing the applicants. The other documents are dated between 2 June and 24 August 2009 and, by their descriptions, appear to be within the class of documents that would conventionally attract a claim of legal professional privilege. The respondents say that any privilege claim otherwise open to the applicants has been waived, either by way of "issue waiver" or by way of "disclosure waiver". 20 Dealing first with issue waiver, it was common ground that the timing and content of the applicants' knowledge (or of facts from which the applicants ought to have had knowledge) of the need to amend the patent in suit is an issue which arises in the s 105 application. Furthermore, it seems to be an issue which the applicants themselves have no choice but to bring to the table, as it were. It seems to be accepted that the application will be required to be determined by reference to the principles adumbrated by Aldous J in Smith Kline,one of which was that the application should be rejected if the applicants knew, or should have known, that the patent should be amended at a time when they seek to obtain unfair advantage from it, and another of which was that the onus lies upon the applicants, and that they must make full disclosure of all relevant matters. I accept that these principles, as Aldous J described them, are not principles in the sense of being "fixed rules to be applied inexorably to every case" (Apotex Pty Ltd v Les Laboratoire Servier (No 2) (2009) 83 IPR 42, 57 [86]), but on any view they are principles in the sense of being relevant considerations to which the court, if required by the respondents, must pay due regard. 21 As what his Lordship apparently regarded as the paradigm instance of a case to which the fourth principle would apply, Aldous J referred to a patentee who threatened an infringer with the unamended patent, after he knew or should have known of the need to amend. As noted above, this proceeding was commenced on 10 March 2009, and the Motion for amendment was filed only on 6 November 2009. The applicants' response in the European opposition proceedings, which included the auxiliary request to which I have referred, was filed on 11 April 2008. Depending on the timing and content of the knowledge of the applicants, it is not difficult to see that the respondents may have at least an arguable proposition under the fourth principle in Smith Kline. Particularly in a situation in which an application to amend is made in previously commenced proceedings for infringement, I read the principles of Aldous J as requiring it to be part of the applicants' case under s 105 to demonstrate that, at any relevant time, their state of knowledge was not such as would justify the conclusion that they were seeking to take unfair advantage of the unamended patent. 22 That brings me to the jurisprudence established in this court with respect to the principle of "issue waiver". That principle was stated by Branson and Lehane JJ in Telstra Corporation Ltd v BT Australasia Pty Ltd (1998) 85 FCR 152, 168 as follows: Where, however, a party relies on a cause of action, an element of which is the party's state of mind (including the quality of the party's assent to a transaction) the party is taken to have waived privilege in respect of legal advice which the party had, before or at the time of the relevant events, material to the formation of that state of mind. Telstra was approved by a later Full Court in Perpetual Trustees (WA) Ltd v Equuscorp Pty Ltd [1999] FCA 925, [16] and followed by Allsop J in DSE (Holdings) Pty Ltd v Intertan Inc (2003) 127 FCR 499, 529 [112]. In part because of some suggestion of a tension between Telstra and the later judgment of the High Court in Mann v Carnell (1999) 201 CLR 1, 13 [29], the principle was examined again in Commissioner of Taxation v Rio Tinto Ltd (2006) 151 FCR 341, the Full Court there affirming that "the governing principle required a fact-based inquiry as to whether, in effect, the privilege holder had directly or indirectly put the contents of an otherwise privileged communication in issue in litigation, either in making a claim or by way of defence": 151 FCR at 359 [61]. 23 In the present case, counsel for the applicants frankly acknowledged that there was what he described as a "tension" between a party's obligation to give full disclosure of its state of knowledge when prosecuting a s 105 application and the right to maintain confidentiality with respect to communications which would conventionally attract legal professional privilege. The gravamen of his submissions was that it could not be the case that a party might resort to s 105 only at the risk of having its entire suite of communications with its legal advisors exposed for inspection by its opponents. 24 It is, of course, not documents or letters that attract legal professional privilege, but communications. Generally in the conduct of existing or anticipated contested proceedings, there will be little controversy arising from the sworn statement of a party's legal representative that a letter written or received by, or a file note made by or addressed to, him or her, about matters in dispute, contained only communications which were privileged. However, as explained above, the cases recognise issue waiver as an exception to this general approach. As was made clear by the High Court in Mann v Carnell, it is an exception which is imputed to the party by law, rather than an exception which turns upon the conduct or intention of the party itself. That being so, I consider that, in giving effect to the exception, the court should do so with respect only to communications which deal with the matter put in issue by the party otherwise claiming privilege, and should be astute to ensure that the protection of privilege otherwise available is not lost. 25 In the present case, I accept that the existence, timing and content of the applicants' knowledge or appreciation of the necessity, or advisability, of amending the patent in suit are matters which the applicants necessarily placed in issue upon making their s 105 application. Accordingly, a waiver of privilege in relation to communications dealing with such matters is imputed to them. For reasons expressed in the previous paragraph, however, this is not the same thing as saying that the whole of all of the documents referred to in this part of my reasons must be produced for inspection by the respondents. Such part or parts of those documents only as deal with the matters referred to in this paragraph must be excepted from the applicants' claim for privilege, and made available for inspection by the respondents. 26 The other aspect of the respondents' submissions on waiver concerned what they described as "disclosure waiver". They submitted that, in some respects at least, the applicants had made limited, and seemingly selective, disclosures of the legal advice which they received for the purpose of establishing the reasonableness of the timing of their application to amend, and in some instances had disclosed some, but not all, of the details of communications in the context of which that advice was sought or given. The respondents submitted that for the applicants to have proceeded in this way was "inconsistent with the maintenance of the confidentiality which the privilege is intended to protect": Mann v Carnell 201 CLR at 13 [29]; Bennett v Chief Executive Officer of the Australian Customs Service (2004) 140 FCR 101, 104 [6]. 27 The respondents submit that the applicants have waived privilege with respect to communications which would disclose their reasons for seeking legal advice as to the advisability of applying to amend the patent, and for accepting that advice. They rely upon passages in affidavits sworn by Peter Turvey, Executive Vice President - Licensing in the R&D department of the first applicant. Prior to 1 January 2009, Mr Turvey had been the group general counsel and the company secretary of the first applicant. In his affidavit sworn on 12 February 2010, Mr Turvey adverted to the preliminary opinion of the Opposition Division of the European Patents Office, and said: In the light of the Preliminary Opinion, I sought advice from DCCL concerning the amendment of the Patent to avoid the prior art successfully cited by the Respondents in the European Opposition. DCCL recommended to me that the Applicants apply to amend the Patent as shown in paragraph 12 above and I accepted that recommendation and instructed DCCL to proceed with an application to amend the Patent in that manner on 13 August 2009. In a further affidavit sworn on 5 May 2010, Mr Turvey said: In paragraphs 12, 21 and 32 of my first affidavit, I state that I instructed Davies Collison Cave Law (DCCL) to apply to amend claims 1, 3 and 7 of the Patent in August 2009 in the manner that I set out in paragraph 12. My first affidavit correctly states that the application to amend the Patent was filed by DCCL on my instructions. However I wish to clarify that, in accordance with my common practice, once I had considered and decided to proceed with the recommendations from DCCL with respect to applying to amend the Patent, I asked John Cox (scientist and intellectual property consultant engaged by CSL Limited) and Amy Demediuk (CSL Corporate Counsel) to convey my instructions to DCCL on behalf of CSL. To the extent, if any, that it is unclear from paragraphs 15-21 of my first affidavit, I wish to clarify the reason I accepted the recommendation of DCCL and gave my instructions (through Mr Cox) for CSL and Monash to apply to amend claims 1 and 7 of the Patent. In the European Opposition, the Respondent had cited certain prior art which the European Patent Office had indicated in its Preliminary Opinion dated 25 May 2009 would anticipate the corresponding claims in the European Patent, unless those claims were amended to limit the pH range of the formulation from 5 to 6.8. As the same prior art had been cited by the Respondents in this proceeding, I considered it necessary to introduce a similar limitation to the pH range of the formulation claimed in the Patent to avoid such prior art being held to invalidate the Patent. 28 The substance of the passage in Mr Turvey's first affidavit set out above is that the applicants, faced with a potentially successful citation of prior art in the present proceeding, sought legal advice as to whether an application to amend should be made. They were advised that it should, and proceeded in accordance with that advice. As it appears to me, this paragraph goes no further than, for example, a statement by any intending plaintiff that he or she sought legal advice whether to institute proceedings to achieve a particular advantage, or to avoid a particular detriment, received advice in the affirmative, and acted in accordance with that advice. In my view, to say as much is not inconsistent with maintaining the confidentiality of the advice. Indeed, I regard this passage in Mr Turvey's first affidavit as quite uncontroversial, and as stating no more than would have been self-evident to the respondents, as a matter of inference, from the sequence of events which led to the application to amend, and from the application itself. I do not consider that the disclosures made in this paragraph amounted to a waiver of the applicants' claim for privilege. 29 The position is, however, different with respect to the disclosures made by Mr Turvey in his affidavit of 5 May 2010. The first of the two paragraphs in the extract set out above is not contentious, but, in the second of those paragraphs, Mr Turvey goes out of his way to be explicit as to the reasons why he accepted the recommendation of the applicants' solicitors. The point he seeks to make, implicitly if not directly, is that it was only the preliminary opinion of the Opposition Division which gave the applicants any cause to believe that the patent might need to be amended. That disclosure was, in my opinion, inconsistent with the applicants maintaining their claim for privilege over any communication from their legal advisors with respect to reasons why an amendment should be sought. In context, it was not as though Mr Turvey, in his affidavit of 5 May 2010, was purporting to go no further than to state his own reasons, or the applicants' reasons, for deciding to amend. That decision was not made independently: it was made as the result of, and seemingly in accordance with, a recommendation by the applicants' solicitors, the implication being that the gravamen of the advice was that, save for the preliminary opinion of the Opposition Division, there was no reason to consider an amendment. Informed by considerations of fairness of the kind adverted to in Mann v Carnell (201 CLR at 13 [29]), the conclusion I reach is that the disclosures made in Mr Turvey's affidavit of 5 May 2010 are inconsistent with the maintenance of a claim for privilege with respect to communications to or from the applicants' legal advisors which related to the reason, or reasons, why an amendment would be advisable. 30 The next group of disclosures upon the strength of which the respondents claim that privilege has been waived is to be found in the affidavit of Ian Stanley Pascarl, the partner in the firm of solicitors representing the applicants who has the conduct of this proceeding on their behalf, sworn on 11 February 2010. In that affidavit, Mr Pascarl undertook an apparently detailed survey of the events leading to the commencement of the present proceeding, and to the s 105 application. He said that, on 25 May 2009, arrangements were confirmed for the holding of a meeting on 2 June 2009, which was to be attended by representatives of the applicants and of their solicitors, including Mr Pascarl. He said that the purpose of the meeting was to review the respondents' Defence and Cross-claim (which had been filed on 21 May 2009) and to commence determining a strategy to meet the invalidity attack mounted by the respondents. It was not until about 8:45 am on the morning of 2 June 2009 itself, however, that Mr Pascarl received an electronic copy of the preliminary opinion of the Opposition Division of the European Patents Office. He briefly skim-read the opinion in the short time available before he was obliged to leave his office to travel to the office of the first applicant, for the purpose of the meeting which had been arranged. 31 In his affidavit of 11 February 2010, Mr Pascarl said: At about 10am on 2 June 2009, Penny Smith and I met with Peter Turvey, John Cox, Chela Niall and Amy Demediuk (with Ms Demediuk by telephone), at CSL's premises. We discussed the grounds of invalidity relied on by the Respondents in Australia and Europe and particularly the OD's Preliminary Opinion that the European Patent as granted was anticipated by the prior art cited by Novo Nordisk A/S but that the European Patent would be novel over those prior art citations if amended in accordance with the "First Auxiliary Request" filed with the Response to the Opposition. I then became aware that in the Response to the Opposition filed on 11 April 2008, the Applicants had submitted to the OD a "Main Request" which requested as a first preference that the European Patent be maintained as granted and, if that Main Request was rejected, a "First Auxiliary Request" that the European Patent be maintained on the basis of an amended claim set. The Preliminary Opinion (published on 25 May 2009) determined in substance that the European Patent was only valid over the relevant novelty citations (which are also relied upon against the Patent) if the claims were amended in accordance with the First Auxiliary Request. During the meeting at CSL, we also discussed the fact that the Particulars of Invalidity in this proceeding cited each of the prior art documents relied upon in the European Opposition. At the conclusion of meeting at CSL on 2 June 2009, Penny Smith and I were instructed to carefully read the Statement of Facts and Arguments, Response to the Opposition and Preliminary Opinion of the OD and consider the utility of amending one or more of the claims of the Patent with a view to strengthening it in light of the OD's Preliminary Opinion that the claims of the European Patent as granted, which were similar to the claims of the Patent as granted, were anticipated but would be novel as a consequence of the proposed amendments to the pH range contained in the First Auxiliary Request. 32 I consider that, in the passages set out above, Mr Pascarl has sufficiently disclosed the substance of the matters discussed at the meeting on 2 June 2009 to have waived his clients' claim for privilege with respect to that meeting generally. On this occasion, my view depends not upon the content of what was discussed at the meeting, but upon the fact that the discussion has been sufficiently made part of the open record in this proceeding as would be inconsistent with the maintenance of a claim to confidentiality over any record thereof. Put another way, for Mr Pascarl to have made the statements in his affidavit set out above is inconsistent with the assertion that the meeting should be regarded as protected by the cloak of legal professional privilege. I shall require the applicants to produce for inspection those documents over which privilege is presently claimed which contain a record of the things which were discussed and said at the meeting on 2 June 2009. 33 The next disclosure to which the respondents refer in this aspect of their case is that contained in para 65 of Mr Pascarl's affidavit of 11 February 2010: Throughout June, July and August 2009, Penny Smith and I held discussions at different times with Counsel (Garry Fitzgerald), the inventors, Mr Slattery and Andrew Sheard (the European Patent Attorney conducting the defence of the European Opposition) concerning proposed amendments. Penny Smith and I determined that the following two amendments should be sought: (a) an amendment to claims 1 and 7 of the Patent to introduce the integer "and wherein the pH of the formulation is from 5.0 to 6.8" in claim 1 and an amendment to claim 7 to delete the pH ranges of "from 5.0 to 7.5" and "preferably 5.0 to 6.8" (in line with the amendments requested in the First Auxiliary Request in the European Opposition); and (b) an amendment to remedy the error in claim 3 by replacing the figure "0.1" with the correct figure "0.01". In my view, there is nothing in this paragraph which is inconsistent with the maintenance by the applicants of a claim to confidentiality over the content of the discussions referred to. It is quite acceptable for a party (or, as here, for a party's solicitor) to say that the party had discussions, and took legal advice (if that should be what happened), after which the party (or the solicitor) decided to act in a particular way. This does not involve any waiver of privilege. 34 Finally in this part of its submissions, the respondents relied upon the following passage in Mr Pascarl's affidavit sworn on 5 May 2010: To the extent, if any, that it is unclear from paragraphs 57 to 67 of my 11 February 2010 affidavit, I wish to state explicitly that the reason I recommended, and the reason Mr Cox informed me and I believed that he instructed me on behalf of CSL to apply to amend claims 1 and 7 of the Patent was to overcome the novelty citations that the Opposition Division of the EPO, in its Preliminary Opinion dated 25 May 2009, suggested would anticipate the equivalent claims in the corresponding European Patent unless those claims were amended to limit the pH range of the formulation to from 5 to 6.8. The issues arriving in this context are, in my view, indistinguishable from those with which I have dealt at para 27 and 29 above. I would reach a like conclusion as I reached in para 29. 35 The final matter raised by the respondents' Notice of Motion arises from the discovery by the applicants, on a confidential basis, of notes of a meeting which took place on 18 January 1994 at the Victorian Pharmacy College, and which was attended by the two named inventors of the patent in suit, and by representatives of the first applicant. In those notes, under the heading "Patent issues", it was said that a draft provisional patent had been prepared, and the matters which that patent would cover were stated. Further, reference was made to "Information on 20th January from John Slattery" with apparent reference to one aspect of the invention. At the time, it appears that Mr Slattery was one of the first applicant's legal advisors. 36 The respondents seek specific discovery of the draft provisional patent, and of the information received from Mr Slattery (assuming, as they do, that the latter was in writing). In the course of the hearing of the respondents' motion, however, it became clear that this was not a matter which called for attention under O 15 r 8 at all. The applicants accepted that the documents in question were in their possession, custody or power, but submitted that, had they been relevant to the proceeding (in the sense conveyed by O 15 r 2(3)), they would have been discovered, additionally to the notes of the meeting on 18 January 1994. Counsel for the respondents drew my attention to correspondence passing between the parties' solicitors, and asked me to infer from the terms of one of the letters written on behalf of the applicants that the applicants took an inappropriately narrow view of what constituted relevance for the purpose of the application under s 105 of the Patents Act. 37 However much the respondents think it likely that such advice as may be presumed to exist in writing from Mr Slattery, or that the draft patent, dealt with matters relevant to the s 105 application, I consider that I am bound to accept the oath of the applicants' representative, and the certification of their solicitor. Although the terms of their solicitor's correspondence is, on one view, consistent with the applicants taking too narrow a view of relevance for the purposes of s 105, they are not such as requires an inference to that effect to be drawn. I must assume that the applicants' advisors were well able to assess the documents within their clients' possession, custody or power for relevance under s 105, and I am not prepared to second guess the conclusions which they reached in those respects. 38 In the result, I shall grant the relief which the respondents seek with respect to some of the documents, or classes of documents, over which a claim for privilege has, as explained above, been inappropriately made, but I shall otherwise refuse the respondents' motion. I certify that the preceding thirty-eight (38) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Jessup.