Bristol-Myers Squibb Company v Apotex Pty Ltd

REASONS FOR JUDGMENT 1 This proceeding concerns the infringement and validity of Australian Patent No. 2002334413 entitled "Low hygroscopic aripiprazole drug substance and processes for the preparation thereof" (the patent or the patent in suit). 2 Aripiprazole is an atypical antipsychotic agent that is useful in the treatment of schizophrenia and other conditions. The patent claims, amongst other things, a particular form of aripiprazole described as Anhydrous Aripiprazole Crystals B (Crystals B), which is said to be an improved form of aripiprazole which has reduced hygroscopicity and is more amenable to pharmaceutical processing and formulation. 3 The hearing of certain claims for final relief and also the respondent's challenge to validity of certain claims of the patent is to commence on 10 December 2012. In the course of preparing the parties' respective cases for hearing, various experiments have been conducted. 4 The respondent has filed an interlocutory application in which it seeks the production of notes made by Professor Easton (an expert retained by the applicants) during the course of an experiment conducted by Associate Professor McGeary (an expert retained by the respondent). The experiment was conducted pursuant to orders made on 1 August 2011 in purported compliance with a protocol developed and prepared by Associate Professor McGeary to carry out Example 1 in European Patent No. EP 367,141 entitled "Carbostyril Derivatives". 5 Example 1 in the European Patent contains the following disclosure: A suspension of 47 g of 7-(4-bromobutoxy)-3,4-dihydrocarbostyril, 35 g of sodium iodide with 600 ml of acetonitrile was refluxed for 30 minutes. To this suspension was added 40 g of 1-(2,3-dichlorophenyl)-piperazine and 33 ml of triethylamine and the whole mixture was further refluxed for 3 hours. After the solvent was removed by evaporation, the residue thus obtained was dissolved in chloroform, washed with water then dried with anhydrous magnesium sulfate. The solvent was removed by evaporation, and the residue thus obtained was recrystallized from ethanol twice, to yield 57.1 g of 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. Colorless flake crystals Melting point: 139.0 -139.5°C. 6 The respondent contends that the resultant product referred to above is Crystals B as claimed in certain claims of the patent in suit. Thus the respondent will argue at the hearing that this disclosure is novelty-destroying of those claims, such that they are invalid for not claiming a patentable invention and should be revoked. 7 The applicants resist production of Professor Easton's notes on the ground of legal professional privilege. 8 Professor Easton has made an affidavit in the principal proceeding in which, amongst other things, he says that he was asked by the applicants' solicitors to attend the experiment to be conducted by Associate Professor McGeary and to comment on: (a) whether the procedures specified in Associate Professor McGeary's protocol were followed and, if not, what the deviations from the protocol were; (b) if there were deviations, would a skilled organic chemist have performed those steps in September 2001 in accordance with usual experimental practice; and (c) any other areas which he considered were not consistent with how he, and how he believes other organic chemists, would carry out a reproduction of the steps in Example 1 quoted above. 9 This affidavit has been filed and served by the applicants on the respondent. The applicants propose to call Professor Easton as a witness in their case at the hearing to commence on 10 December 2012 and to rely on his affidavit as constituting, at least in part, his evidence in chief. The respondent has indicated that it proposes to cross-examine Professor Easton. 10 In an affidavit made for the purposes of the present interlocutory application Professor Easton has confirmed that he made notes at the time that he observed Associate Professor McGeary conducting the experiment. It would seem that these notes were made in an A5 notebook. He said that he cannot recall whether he was expressly asked to make notes, but he knew that he would need to communicate his views on the matters noted in [8] above orally and in writing to the applicants' solicitors. He said that he made the notes so that he would have an aid-to-memory of all the matters that he wanted to communicate to them. He said that he has not shown his notes, or disclosed the contents of them, to anyone other than the applicants' solicitors. 11 The solicitor on the record for the applicants, Mr Kerr, has also made an affidavit that was relied on for the purposes of the interlocutory application. It was Mr Kerr who asked Professor Easton to attend the experiment to be conducted by Associate Professor McGeary and to report on the matters that I have noted in paragraph [8] above. He said that he considered that he would need Professor Easton's observations in order to advise the applicants about matters in dispute in the principal proceeding as well as to assist him and others at his firm in the conduct, generally, of the principal proceeding. 12 A redacted version of Professor Easton's notes has been provided by the applicants' solicitors to the respondent's solicitors. In this form, certain parts of the notes have been masked and remain undisclosed. The present area of controversy is those parts of the notes that remain undisclosed. The respondent contends that it is entitled to have all of Professor Easton's notes that were made by him in the course of observing Associate Professor McGeary's experiment. The applicants contend that the respondent is entitled to no more than they have given it in this regard.

Consideration 24 I am satisfied that Professor Easton's notes attracted legal professional privilege (specifically, litigation privilege) upon their creation. Although there is no evidence that the applicants' solicitors asked Professor Easton to make notes of his observations of the performance by Associate Professor McGeary of the experiment, there is no doubt at all that Professor Easton's presence at the experiment was for the purposes of providing information, advice and opinions that were responsive to the applicants' solicitors' requests of him. There is also no doubt at all that his notes were made to enable him to communicate those matters to them. I do not accept the respondent's submission that the applicants' evidence on this score lacks focus or is not specific, or that it rests in nothing more than bare statements of conclusion. 25 Similarly, I do not accept that Professor Easton's notes fall into the category of "working notes" or "field notes" of the kind to which Lindgren J referred in Southcorp at [21]. In that connection his Honour further characterised the documents he had in mind as those that "are not in the nature of, and would not expose, communications". Although legal professional privilege protects the confidentiality of communications and not documents as such (Esso Australia Resources Limited v Commissioner of Taxation of the Commonwealth of Australia (1999) 201 CLR 49 at 64), it does not seem to be in doubt that documents created for the dominant purpose of making the protected communication, the terms of which have remained confidential, also attract the privilege, certainly where litigation privilege is the issue: Pratt Holdings Pty Ltd v Commissioner of Taxation (2004) 136 FCR 357 at [19]; Trade Practices Commission v Sterling (1979) 36 FLR 244 at 246; Interchase at 162; Optiver Australia Pty Ltd v Tibra Trading Pty Ltd (No 5) [2012] FCA 1226 at [13]. Professor Easton's notes are of that character. 26 However, I am unable to see how the applicants can maintain a claim for privilege in respect of any part of the notes in light of what was undoubtedly their deployment by Professor Easton in making his affidavit to be read in the principal proceeding. 27 In this connection it does not matter that Professor Easton has chosen to refer in his affidavit to only certain observations recorded by him at the time of the experiment, and not to others. The undisclosed parts of Professor Easton's notes do not represent mere musings by him unrelated to the very tasks that had been assigned to him by the applicants' solicitors. I can only conclude on the evidence before me that Professor Easton made the notes to assist him in fulfilling the tasks that had been assigned to him and that, thereafter, he used the notes as the direct source for the observations and consequent opinions he expresses in his affidavit concerning the manner in which the experiment was conducted by Associate Professor McGeary. 28 The applicants' reliance on the observations made by Young J in AWB at [164] is misplaced. His Honour's general observation must be seen in the context of his later detailed discussion of the relevant authorities. Importantly, his Honour's observation in [164] was addressed to the waiver of privilege in associated material. In my view it would be an error of both principle and fact to treat Professor Easton's notes as if the undisclosed parts of them were "associated" material in the sense in which Young J used that expression and in the sense in which it is generally used in this area of discourse. 29 Here the notes represent a single subject matter: Professor Easton's observations of the experiment conducted by Associate Professor McGeary. Once that fact is appreciated, and it is recognised that Professor Easton's notes have been deployed in making his affidavit on that very subject matter, the applicants cannot selectively disclose parts of the notes through the filing and service of Professor Easton's affidavit and consistently maintain legal professional privilege over the balance of them. The true principle in operation in the present case is that privilege relating to a document which deals with one subject matter cannot be waived as to part and asserted as to the remainder: Great Atlantic Insurance Co v Home Insurance Co [1981] 1 WLR 529 at 538-539; Attorney-General for the Northern Territory v Maurice (1986) 161 CLR 475 at 481-482, 488, 493, 497.

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