public availability and consent
118 In the event that I am incorrect and the document does anticipate all the integers of Claims 7 and 18, the issue is whether the novelty destroying disclosure was made "publicly available" before the priority date: s 7(1) of the Act. NSI bears the onus of establishing that the document was made publicly available: see Jupiters Ltd v Neurizon Pty Ltd (2005) 65 IPR 86 at 118. If this is established, then, in order to uphold the validity of the patent, the University must establish that it did not consent to the disclosure of the document: s 24(1)(b) of the Act. In this case, I am satisfied that the document was not made publicly available and also that the University did not consent to it being publicly disclosed.
119 I am satisfied that the document was made available to a limited body of persons in circumstances where it appeared, on the face of the document, that it had the quality of confidence about it. It appeared that the document was communicated for limited purposes and imported an obligation not to disclose it and suggested to the reader that its disclosure would amount to a breach of confidence: see Moorgate Tobacco Co Ltd v Philip Morris Ltd (No 2) (1984) 156 CLR 414 at 437-438.
120 Section 24 of the Act provides that for the purpose of deciding whether an invention is novel, the Court must disregard information made publicly available without the consent of the patentee through any publication by another person who derived the information from the patentee.
121 NSI contends that the Information Package was made publicly available and that the evidence demonstrates that the Information Package was sent from Professor Reynolds' office to a number of prospective third party licensees in about May 1996, including Dr Barnett of SmithKline Beecham, Ms Finidori of Synthelabo in France, Dr Nelson of Consumer Health Care in the United States, Mr Markowitz of the Block Drug Company in the United States, Mr Faller of Procter & Gamble in the United States, Mr Ziemkiewicz of Chesebrough Ponds in the United States and Mr Garland of NZP in New Zealand.
122 The questions as to disclosure in this case are twofold. The first question is whether the Information Package was made publicly available. The University claims that the Information Package was received in circumstances where an obligation of confidence was imposed on the recipients in respect of its contents, and therefore the disclosure of the Information Package was not a disclosure to people "free in law and equity to use it". The second question is whether the University consented to the Information Package being made publicly available.
123 In relation to the first question, NSI submits that there was no obligation of confidence owed by the recipients. NSI says that Professor Reynolds had been making complexes since at least mid-1994 and that, since this time, he regarded the details disclosed in the Information Package as protected by the existing patents. NSI also says that Professor Reynolds had known, as at May 1996, that the information was insufficient to enable commercial manufacture of the complex. Reliance is placed on what is said to be Professor Reynolds' evidence that he did not recognise the special closed structure that is said to have prompted the application for the Complex Patent until the end of 1996.
124 The onus to show that the information was made publicly available is on the person seeking to revoke a patent. To amount to a "public disclosure", the information must have been made available to persons who are free in law and equity to use that information. Therefore, a disclosure to a specified number of persons does not automatically constitute a "public disclosure".
125 If the disclosure in the Information Package is sufficient to constitute anticipation and NSI proves that the information was made publicly available, the University must then show that this disclosure was made without its consent and that a patent application for the invention was made within the prescribed period of one year. The University contends that the reference to a "patent application" in s 24(1) of the Act includes a "provisional application". I agree that s 24 should be so construed. The language of that section makes no distinction between provisional and complete applications. Section 29(2) makes it clear that a "patent application" may be a provisional application.
126 Mr Nunn was called for NSI. Mr Nunn is qualified and experienced in food science and technology, as set out at [16]-[18] above.
127 Between mid-1994 and September 1997, Mr Nunn's firm was retained by NZP, a wholly owned subsidiary of ICI, to assist with sales and marketing of the Calpep products. At this time, Calpep was being manufactured on behalf of Bonlac Bio Science International Pty Ltd, a subsidiary of Bonlac. Bonlac appointed ICI and NZP to market the complex. Mr Nunn's responsibility was to assist in marketing Calpep to companies in the food and dental industry. It was to be marketed specifically for inclusion in dental products and food products. In the course of this work, Mr Nunn liaised with Professor Reynolds and Bonlac. He also reported to Dr Garland, who was then the Managing Director of NZP.
128 In 1995, Mr Nunn prepared a petition for the affirmation of Calpep as a safe product. This is known as the "GRAS document". It was contemplated that this document might be filed with the United States Food and Drug Administration (FDA). Mr Nunn was responsible for those parts of the GRAS document directed to complying with the FDA Regulations. Professor Reynolds was involved in drafting some technical aspects of the GRAS document, such as the inclusion of the required manufacturing information.
129 Mr Nunn used the document in presentations from mid to late 1995 to a number of potential customers interested in using Calpep in their products, such as Uncle Toby's, Heinz and Johnson & Johnson. Copies of the GRAS document were left with prospective customers. He thought it was a useful marketing tool for prospective customers interested in using the complex in dental products and foodstuffs, because it set out some of the information necessary if one of the customers wished to subsequently seek approval from the FDA, the National Food Authority in Australia or other regulatory bodies for a product including the complex. Between late February 1996 and mid-March 1996, he visited a number of large oral care and confectionary companies in the United States and Europe. These included SmithKline Beechem (the manufacturer of "Macleans" Toothpaste) and Cadbury Confectionary (a leading confectionary manufacturer). He provided the companies with a sample of Calpep provided by Professor Reynolds and, on 8 May 1996, he asked Professor Reynolds' secretary to send the Information Package to the individuals named in a facsimile. These individuals included the persons named in [121] above.
130 Mr Nunn says that most of the section in the Information Package headed "An Introduction to Anticariogenic Casein Phosphopeptide" was largely reproduced from the GRAS document. He refers in his affidavit to a draft Evaluation and Confidential Disclosure Agreement referred to in correspondence with SmithKline Beecham, but says the agreement was never executed. Mr Nunn was not aware of any other confidentiality agreement entered into or any other obligation of confidence imposed on SmithKline Beecham in relation to the Information Package. He refers to letters from two large corporations, Chesebrough Pond's USA Co. and Pzfizer Inc, acknowledging receipt of the Information Package. Mr Nunn says that he was not informed by Professor Reynolds or any representative of Bonlac that the complex he was responsible for marketing to potential customers was different to the complex manufactured and supplied before 13 March 1997.
131 The evidence is that the Information Package was sent to the persons referred to at [121] above on 8 May 1996 at the direction of Mr Nunn. The material was sent by Professor Reynolds' secretary. However, this does not mean that Professor Reynolds sent the material or gave his consent to it being sent. Mr Nunn says he was not expressly told whether the particular manufacturing information in the Information Package was confidential. However, he agreed that he was not in a position to make a determination one way or the other about the confidentiality of the information. In cross-examination, he expressed his view as being that only a complete manufacturing description could be confidential.
132 Dr Garland refers to a meeting of 13 December 1995 and to subsequent discussions with Mr Nunn about the production of the Information Package. He says that at the meeting on 13 December 1995, it was agreed that Mr Nunn, Mr Quigley and Professor Reynolds would prepare an Information Package for the complex. He said that there was no discussion to the effect that the Information Package was to be treated by himself or Mr Nunn as a confidential document. Dr Garland provided to Mr Botsman, who was retained by Bonlac as a consultant, parts of the Information Package which referred to NZP prior to its finalisation. He refers to commercial meetings and states that he has no recollection of any indication being given at these meetings as to the importance of treating the Calpep manufacturing process described in the Information Package as confidential. He says that he was not informed that any material contained in the Information Package could not be disseminated to potential customers due to its confidential nature.
133 Professor Reynolds for the University gave evidence that the University, Bonlac and ICI/NZP held meetings on a regular basis from early 1994 onwards to review progress in relation to aspects of the phosphopeptide project. Regular attendees included Mr Hammermeister, Mr Quigley, Mr Botsman and Mr Nunn. Mr Garland also attended from time to time. The meetings discussed the negotiations between Bonlac and ICI/NZP in relation to their long-term involvement in the project, interest in the technology being shown by third parties such as Colgate and Warner Lambert, and the development of a commercial process for the manufacture of the product. Professor Reynolds says that, for a time, confidentiality was a regular issue for discussion at the meetings. He exhibits an Agenda dated April 1994 that lists an item entitled "Confidentiality Agreements/compliance". He also refers to another meeting of 28 October 1994 during which the issue of confidentiality was raised. Professor Reynolds says the issue was also brought up from time to time outside those meetings. He says that his understanding, from the meetings he attended and the various discussions he held with people involved in the project, was that those involved were informed of and aware of the need to protect the confidential information pertaining to the technology, and, in particular, the information concerning the manufacturing process.
134 Professor Reynolds also gave evidence that in 1994, the University was approached by the company NuLite, which expressed an interest to evaluate the technology for its potential inclusion in one or more dental products. He then refers to a confidentiality agreement between the University and NuLite dated May 1994. He says that confidentiality in relation to the project was an issue regularly raised by representatives of Bonlac particularly in relation to the provision of information concerning the technology to third parties. He annexes a document entitled "Notes for ACPP Meeting" dated 20 June 1996, which relates to the signing of confidentiality agreements. The signature of Mr Nunn appears at the bottom of this document.
135 Professor Reynolds also refers to receiving a copy of the requirements for GRAS affirmation from Mr Nunn and preparing the technical content of a draft document based on these requirements. The GRAS affirmation required that information concerning the manufacturing process be provided. Professor Reynolds says, and I accept, that he was unaware that Mr Nunn had used the GRAS document for presentations to potential customers in mid to late 1995. He says that he was unaware of the GRAS documents being used as a marketing tool or discussed at meetings by Mr Nunn or anyone else.
136 Professor Reynolds states that he wrote several reiterations of a document with and including the title "Anticariogenic Casein Phosphopeptides," and these did not include confidential information or manufacturing processes. He believed that a GRAS application had not been submitted to the FDA until after the completion of the Licence Agreement in 1998. Professor Reynolds also says that he does not recall having seen the Information Package exhibited to Mr Nunn's affidavit prior to being provided with a copy of his affidavit.
137 In relation to the Information Package, Professor Reynolds states that it contained errors where information important for understanding the efficacy of the product had been omitted or incorrectly transcribed. He added that it also contained inconsistent information in relation to the pH at which complexes were formed. Regarding the NFA application, Professor Reynolds states that he understood that both applications to the NFA/ANZFA had been treated as confidential by NFA/ANZFA, at least until 28 April 1997.
138 Mr Quigley gave evidence for the University. He was employed by Bonlac Foods from 1994 to 2002 as Senior Project Manager and Research & Development Manager. He reported to Mr Hammermeister, the Group Manager (Technology & Development) up to 1998. At Bonlac, Mr Quigley was involved in the project relating to anticariogenic casein phosphopeptide technology (also known as Calpep). From 1994, the CSIRO assisted Bonlac to carry out its pilot scheme. ICI was originally part of the project team and had responsibility for trying to develop a market for the technology.
139 Mr Quigley recalls that Professor Reynolds developed the Calpep technology. He states that Bonlac had rights in relation to the manufacturing and marketing of Calpep and, together with the University and other partners in the project, was trying to develop a product suitable for commercialisation. He refers to regular meetings of those involved in the Calpep project held as regularly as every week during the intensive periods of the process of development. These meetings were of a particularly technical nature.
140 Mr Quigley notes that separate meetings of a commercial nature relating to the development of the market for the technology were also held. Of this second type of meeting, he recalls general meetings involving Professor Reynolds, Mr Nunn and himself. He also remembers attending meetings with Professor Reynolds, Mr Nunn, Mr Hammermeister and Mr Botsman, a consultant of Bonlac. Mr Garland attended on occasions. Mr Quigley says he treated the details of Bonlac's developing manufacturing processes as confidential and does not recall disclosing any detailed information about the developing manufacturing process to ICI, NZP, Mr Garland or Mr Nunn. He does not recall Bonlac being approached for its consent to the external use of the Information Package concerning the manufacturing process or consent by Bonlac to the external use of the document. Mr Quigley says that the material entitled "An Introduction to Anticariogenic Casein Phosphate Peptides" is similar to an internal reference document used as a primer for the technology that was circulating when he first joined the Calpep project. However, he recalls that at that time, the material had a different title.
141 On 14 March 1990, the University entered into a Confidentiality Agreement with Bonlac and the Victorian Dairy Industry Authority ("VDIA") regarding the evaluation of a process for the production of anticariogenic phosphopeptides from caseins. This agreement provided for an obligation of "absolute secrecy" during the evaluation period. The University subsequently entered into a Manufacturing Agreement and Option for Licence with Bonlac on 14 March 1991. This agreement imported the confidentiality regime of the earlier document. Following this, another agreement was entered into by the University on 22 February 1993 involving the University, the VDIA, Bonlac and ICI. This agreement also identified and imposed obligations of confidentiality on the parties.
142 In a facsimile dated 2 May 1995 from Mr Michael Glass of Warner Lambert, there is evidence which refers to a confidentiality agreement made in June 1994 between that company and ICI. An amendment was proposed by Warner Lambert in November 1994 after ICI made certain adjustments to its business, but this was never signed due to the inclusion of certain exclusivity provisions. There is a reference, however, to the terms of confidentiality being clarified in an agreement to be drafted by NZP. Further confidentiality requests are also referred to in a Technology Licence Agreement finalised in December 1995 involving the University, Bonlac and the VDIA. This agreement imposed duties of non-disclosure and states that confidential information must only be used for specific purposes.
143 In my view, the existence of these agreements and undertakings supports the conclusion that the University was not prepared to consent to disclosure or publication of any novelty-defeating information concerning the development of the process. There is no agreement specifically on point, however, the history of the University's concerns regarding confidentiality and the periodic references to this issue at meetings make it more likely than not that there was a regime of non-disclosure in effect. I am satisfied that Mr Nunn appreciated that the information contained in the Calpep document was confidential in nature, notwithstanding his assertion that he only considered that a complete description of the manufacturing process would be confidential in nature. The recipients of the Information Package were obviously important clients and contacts of ICI with whom Nunn had had previous discussions. One might reasonably expect that they would treat material that was confidential on its face as imposing an obligation not to further disclose it. Dr Garland, to whom he reported, adopted the over-simplistic position that unless it was expressly spelt out to him that material disclosed was confidential, he would not infer that it would be confidential. Dr Garland said that, even in the case of a patent application disclosed for the purpose of entering into an agreement, he would not consider the information confidential unless it was expressly stipulated. I do not accept this as a reasonably tenable view. It is also important to bear in mind that although it was Professor Reynolds' secretary who sent out the Information Package, this was done at the direction of Mr Nunn. I accept that the distribution of this information was not known to Professor Reynolds. Having regard to the foregoing, I am not satisfied that the material in the Information Package was made publicly available. In any event, I am satisfied that the University did not consent to it being made publicly available.