16 As to the particulars provided by Arrow concerning the lack of an inventive step, Arrow contended that the July 2003 Particulars demonstrated, first, that the work involved in the conception of the invention as claimed, that is, the idea of prescribing an intermittent dosage form for alendronate, was routine, and that other qualified persons had intermittently succeeded in arriving at the same so-called invention, and further that the use of intermittent dosage forms the subject of controversy was already known to those skilled in the art. I was referred by Arrow to ICI Chemicals and Polymers Ltd v Lubrizol Corporation (1999) 45 IPR 577, where the following appears in the reasons for judgment of Emmett J (sitting as a single judge) at [94]:
'In determining whether the invention would have been obvious, the following circumstances may also be of relevance:
· whether the work involved in the invention was a matter of routine;
· whether the invention satisfied a long felt need;
· the commercial success of the invention;
· whether others sought but failed to find the invention;
· whether the invention has been copied.'
I was further referred in that context by Arrow to Chiron Corporation v Organon Teknika Limited (No 3) [1994] FSR 202 at 229-238, where Aldous J relied on the failure of others to find the invention as an indicator of its inventiveness.
17 Upon that footing, it was submitted by Arrow that the lack of an inventive step is not a so-called ground based on the Order 58 rule 15 subrule (2) expression information about the invention in a document or through the doing of an act, since the lack of an inventive step is not, as such, based on information. So much was asserted to be a fortiori. Moreover the rule was said to not even require that common general knowledge be the subject of particulars, the latter being a principle established under the previous patents legislation, as confirmed by a Full Federal Court (Lockhart, Jenkinson and Gummow JJ) in RD Werner & Co Inc v Bailey Aluminium Products Pty Ltd (1989) 13 IPR 513 at 540. It was additionally emphasised by Arrow that the dates, in relation to which the prior uses have been pleaded by Arrow, and which have been made the subject already of affidavit evidence, each arose in relation to the deferred priority date, and further that post priority date actions of the doctors (who have provided affidavit evidence) concerning the prescription of intermittent dosages was relevant to demonstrate the likelihood that before the first priority date, had they been presented with the same problem, they would have done the same by way of prescriptions. It was said to be 'a commonplace of the law of evidence that later events may cast light upon the true position at an earlier date' (Conde Nast Publications Pty Ltd v Taylor (1998) 41 IPR 505 at 509) (Burchett J sitting as a single judge).
18 As to the attack upon the six affidavits of medical practitioners set out in Schedule 1 to Merck's notice of motion, Arrow pointed out that each of those deponents had been working professionally in the field of bone disease in Australia since before the first claimed priority date; Arrow submitted that the paragraphs of their respective affidavits sought to be impugned by Merck were admissible as relevant to the pleaded grounds of invalidity.
19 As to the attack upon the remaining two affidavits set out in Schedule 1 to Merck's notice of motion, namely those of Professor Mazess and Mr Weissberg, whilst they were residents in the United States, and were not able to give evidence directly as to common general knowledge in Australia before any of the priority dates, Arrow contended that their evidence was relevant at least in relation to the following grounds of invalidity:
(i) the alleged disentitlement of Merck to the subject Patent within s 15 of the Act, because Professor Mazess conceived the invention and communicated it to Merck before the first priority date (see July 2003 Particulars par 10);
(ii) the subject Patent was obtained by Merck by fraud, false suggestion or misrepresentation (see July 2003 Particulars pars 11 to 13), in so far as it was obtained on the basis that persons other than Professor Mazess were inventors; and
(iii) the subject Patent lacked an inventive step on the part of Merck, in so far as the evidence demonstrated that another practitioner in the art had independently conceived to be inventive the idea claimed by Merck in the Patent.
20 Moreover pars 8, 19, 24 and 27 of Professor Mazess' affidavit were said by Arrow to provide relevant background to his testimony, in that his affidavit concerning 'his thoughts on the subject and his reasoning for recommending, well prior to the priority date, the use of an intermittent dosage regime, and to further indicate moreover his recollection that he did not keep his thoughts to himself on the subject, but communicated the same to others. In addition, pars 5 and 6 of the affidavit of Mr Weissman was said to have provided corroboration of Professor Mazess' evidence concerning the fact that he communicated his thoughts on the subject to others before the first priority date.
21 Arrow therefore submitted that the requirements of Order 58 rule 15 had been satisfied, such that evidence tendered by Arrow under attack, relating as it did to the grounds particularised, was open to be read, and moreover that there was no absence of relevant or probative value that would entitle Merck to the orders sought, at least at the present stage of the proceedings, pursuant to s135 of the Evidence Act 1995 (Cth).
22 As to Merck's application for an order for leave to serve subpoenas on each of the medical practitioner deponents of the affidavits identified in Schedule 1 to the notice of motion, I was referred to the circumstance that Dr Diamond had already testified as to the oppressive nature of a requirement that he produce documents within the broad compass sought, namely that it would require three to four months to read the approximate number of 20,000 documents in archives, and it was submitted that it should be inferred that similar oppression would be occasioned to the other doctors. I was referred to the circumstance that Arrow had offered, in the course of the directions hearing (transcript page 20 line 7) to, co-operate in formulating an admission that would meet, to the extent possible, 'the point at which the proposed subpoenas would be addressed', such as for instance, that the patients' records attached to the medical practitioners' affidavits represented either the full extent of the relevant prescriptions, 'or an example of a minor kind, whatever the fact be'. The matter was said to have been further raised by Arrow's letter of 1 September 2003, but not subsequently explored by Merck. Upon the foregoing footing, it was submitted by Arrow that there was no realistic utility in Merck pursuing the matter of issue of subpoenas when admissions would be sensibly volunteered, thus avoid extraordinary inconvenience to medical practitioners, and further that the utility to Merck's case, if any, of any such course, would be outweighed by the inconvenience and oppression that would be caused to independent witnesses.
23 Finally as to the orders sought respectively in relation to the affidavits of Dr Rowe and Ms Sarah-Jane Armstrong, no viable basis had been asserted in favour of the fifth and six orders sought as described in [1] above. In that regard, it was submitted as follows:
(i) the first Dr Rowe report provided background information to which the skilled addresses, being prescribing doctors, would have access by virtue of their roles as prescribers;
(ii) the second Dr Rowe report concerned the absence of allegation of the manner of manufacture, the concept of an invention within s 6 of the Statute of Monopolies being one that develops in line with the development of science; moreover the determination of the answer to the question 'is this a proper subject of letters patent according to the principles of s 6 of the Statute of Monopolies?' needed to be approached flexibly; in that regard, I was referred to the following dicta of Dixon CJ, Kitto and Windeyer JJ in National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 at 271 as follows:
'… The truth is that any attempt to state the ambit of s 6 of the Statute of Monopolies by precisely defining "manufacture" is bound to fail. The purpose of s 6, it must be remembered, was to allow the use of the prerogative to encourage national development in a field which already, in 1623, was seen to be excitingly unpredictable. To attempt to place upon the idea the fetters of an exact verbal formula could never have been sound. It would be unsound to the point of folly to attempt to do so now, when science has made such advances that the concrete applications of the notion which were familiar in 1623 can be seen to provide only the more obvious, not to say the more primitive, illustrations of the road sweep of the concept.'
(iii) it was contended in that context by Arrow that merely to produce a dosage form as a patenting strategy to prolong the patent protection given to a pharmaceutical compound is not a manner of manufacture, being a point said to be addressed in the Rowe affidavit; and
(iv) as to the affidavit of Ms Armstrong, which concerned the size of solid oral dosage forms, the patent specification indicated that some adverse gastrointestinal effects suffered by patients taking bisphosponates are caused by the 'irritant potential' of the bisphosponate in the oesophagus (for example page 3 line 31); the Armstrong affidavit was further said to have anticipated any argument that it would be counter intuitive to use a larger dosage less frequently because of the necessity for a commensurately larger pill to achieve that result.
24 By the time of the further hearing on 17 December 2003 of Merck's notice of motion filed on 10 November 2003, Arrow had filed the following additional affidavit material, by way of verification of the December 2003 Particulars, in relation to or touching upon at least those four segments of the Particulars of Invalidity presently in controversy:
(i) a second affidavit of Dr Diamond sworn 13 November 1993, relating further to his prescribing of Fosamax for patients in relation to both Paget's disease and osteoporosis since mid-1996, and also to the existence of records in relation to his treatment of patients on the St George Hospital campus, and in both private rooms and out-patients' clinics at the St George Hospital Department of Endocrinology, and the logistical difficulties involved in visiting and identifying those records;
(ii) a second affidavit of Dr Eden sworn 15 December 2003, relating to his practice generally as to prescribing Fosamax in 1998, and as to alteration to his recommended Fosamax regimen, including his practice as to what he would normally say and not say to patients in that regard; he also spoke of his presentation of a detailed case study in relation to one of his patients, given on 19 November 2003 and attended mainly by medical specialists, which included the treatment he prescribed and the outcome thereof (the presentation slides were exhibited); he further spoke of earlier presentations of that kind which he gave in 1997 and 1998;
(iii) a second affidavit of Dr Hooper sworn 16 December 2003, relating to his prescription of Fosamax for both Paget's disease patients and osteoporosis patients before and since July 1997, and his practice as to what he would tell his patients at the time of prescription concerning his recommended administration regimen and the manner of compliance therewith; he also spoke of what he considered to be his ethical duty to inform his 'bone' professional colleagues of drugs and dosing regimens which he prescribed for his patients, without infringing his ethical duties as to maintaining the anonymity of his patients; and
(iv) a second affidavit of Dr Sambrook sworn 16 December 2003, which related to his practices as to prescribing Fosamax to his patients, including explanations given to his patients in that context, being explanations embracing matters of compliance with the recommended administration regimen; the practices whereof he spoke were said to have been implemented by him since the years 1996 and 1997; Dr Sambrook additionally described the customary contents of his prescription of Fosamax, and his ethical duty to inform his professional colleagues of the types of drugs and dosing regimens of his prescriptions for patients suffering from osteoporosis; he also exhibited the April 1997 edition of Lunar News, apparently a medical publication issued three times a year by Lunar Corporation (ie Mr Weissburg's pharmaceutical employer), containing an article headed 'Update: Bisphosphonates'.
25 The present proceedings for interlocutory relief, the subject of the notice of motion filed on 10 November 2003, were re-listed for further hearing on 17 December 2003, at least partly in order for the Court to be informed as to whether the December 2003 Particulars resolved the issues propounded by that notice of motion. Written submissions of Merck provided to the Court on the preceding day raised the bar of interlocutory controversy, as follows:
(i) the December 2003 Particulars had failed to provide information as to the 'publicly available' notion or concept inherent in s 7(2) of the Act, and as to the statutory definition of 'prior art base'; in particular, no particularity had been furnished of information which could reasonably be expected to have been ascertained, understood and regarded as relevant by a person skilled in the relevant art, pursuant to s 7(3) of the Act;
(ii) it was clearly wrong to postulate it is sufficient that such information is available in circumstances where a person is free in law and equity to do whatever he or she may like with that information, without there being a threshold requirement that the information is made publicly available; emphasis was again placed on the dictum in Stanway Oyster Cylinders (supra), in so far as the same firstly referred to the information 'being accessible to the public';
(iii) Arrow's reliance on Fomento Industrial was misplaced, because itwas predicated upon s 32(1)(e) of the United Kingdom Patents Act 1949, which stipulated, as a ground of revocation:
'That the invention, so far as claimed in any claim of the complete specification, is not new having regard to what was known or used, before the priority date of the claim, in the United Kingdom.'
The nearest corresponding Australian statutory ground was then s 100(1)(g) namely:
'That the invention, so far as claimed in any claim, was not novel in Australia on the priority date of that claim.'
I was referred in that context to the discussion undertaken by Aickin J in Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Limited (1980) 144 CLR 253 at 290-292, which was said to reflect the existence of 'different meanings under the United Kingdom and Australian Acts', in what was described as 'important respects'; it was submitted that the communication to a patient does not, of itself, make the information 'publicly available', as required by the Australian legislation; in that regard, as I have earlier recorded, an intervening written submission of senior counsel for Arrow had earlier stated that the statutory notion of 'publicly available' did not connote that the act must be done in public, and that Order 58 rule 15(2)(ii) postulated a crucial difference in language by its use of the expression 'done publicly';
(iii) the amendments made to Annexure A to Arrow's December Particulars (pages 18 to 36) did not enable the reader to discern the basis on which it was said that the alleged acts made information publicly available, and in any event, the particulars of the circumstances said to have made information relied upon publicly available relate to confidentiality rather than public availability; and
(iv) the further affidavits from medical practitioners provided by Arrow, which I have earlier summarised, were no substitute for proper particulars; it was stressed that '… the crucial point at which [Arrow's] case can be tested is the point at which specific acts of specific people are said to have made specific information publicly available', and that 'it would be unfair to [Merck] if these matters were left to be inferred from affidavits delivered piecemeal while [Merck] is preparing its evidence'.
26 At the hearing on 17 December 2003, which occurred of course in the context of the December 2003 Particulars additionally to the July 2003 Particulars, Arrow submitted first that the issue as to whether the act of prescribing, for example by Dr Sambrook to a patient at Royal North Shore Hospital on or about 17 September 1997 of 10mg of alendronate sodium to be taken every third day for the treatment and/or prevention of osteoporosis, occurred in circumstances which made such 'information… publicly available' within the statutory definition of 'prior art base', was an issue to be determined at the trial. It was explained by senior counsel for Arrow that it did not have in its possession Dr Sambrook's prescription forms, and that Arrow did not 'rely on the prescription forms as a separate document which would amount to a novelty destroying publication'. All that Dr Sambrook had retained, Arrow's submission continued, was his prescriptive note which would be tendered in evidence. I was referred in that context to Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd (1961) 180 CLR 98 at 111-112, where Windeyer J said as follows:
'Since the question was, "is it now or has it been earlier disclosed?", it was immaterial whether or not it had become known to many people or to few people. A description in an obscure publication would suffice to destroy novelty, provided that it was a publication, that is to say that the document whether or not it was read generally by the public, had been available to the public: and similar considerations applied to publication by user.'
27 I was also referred by Arrow to Terrell on the Law of Patents (15th ed) (Thorley, Miller, Burkill and Birss) (Sweet & Maxwell 2000), upon the footing that United Kingdom law presently 'conforms quite closely' to the law of Australia, where (at 157-158) the following appears under the heading 'To whom must the matter be made available':
'The first point to note is that section 2(2) introduces the concept of absolute novelty. It makes no difference to the question of validity where the material forming the state of the art has been made available. Equally, it makes no difference, if the material is available, whether the skilled man would have had a reason to look for it.
The words "made available to the public" are not new to UK patent law in that they formed part of the definition of 'published" in the 1949 Act and the definition of "published" in the 1977 Act equates it with being made available to the public. Although the Act does not use the word "published" in respect of the novelty provisions, Aldous J in PLG Research Ltd v Ardon International Ltd stated that "made available to the public" should be given the same meaning as those words used in the definition of "published" in section 101 of the 1949 Act:
"Thus to form part of the state of the art, the information given (by the user) must have been made available to at least one member of the public who was free in law and equity to use it."
It follow from the above that there is no need for any person actually to have received the information. It is sufficient if it is available to be received, as, for example, being placed on the shelves of a library open to the public, no matter how obscure or remote the library is. Conversely, where the information is only known in confidence or where the information is embodied in a prior use which has remained secret, the information will not be made available to the public. In the latter case, section 64 of the 1977 Act provides a limited defence to a secret user to continue that use. This is to be contrasted with a previous law where prior secret use could serve to invalidate a claim to an invention on the ground of lack of novelty.
Accordingly, it is necessary to distinguish clearly between a recipient who is free to make use of information as he sees fit and one who receives information under an obligation of confidence, whether express or implied.'
Subsequently at 161, the authors continued as follows:
'Publication by oral description is now explicitly included in section 2(2) of the 1977 Act, but it had long been accepted that an invention can become "known" by the prior oral disclosure equally as by a prior published document or by a prior user. As Bowen LJ said in Humpherson v Syer (1887) 4 RPC 407 at 413:
"I put aside questions of public use and treat this as a question of whether there has been a prior publication: that is, in other words, had this information been communicated to any member of the public who was free in law and equity to use it as he pleased… If so, the information had been given to a member of the public and there was nothing further to serve as consideration for any patent."
Plainly, evidential difficulties will rise in proving what was said.'
28 It was acknowledged on behalf of Arrow that what was stated in Terrell above had changed, in so far as the secret use of subsequently patented information was concerned, but Arrow further submitted that it was enough that information had been made available at least to one member of the public who was free in law and equity to use it, and Arrow foreshadowed that the evidence would be that the information was duly made available to the public generally, indeed to a significant extent.
29 Beyond the issues arising in relation to orders numbered 1, 2 and 3 of the notice of motion, the outcome of the proceedings on 17 December 2003 was that any issues arising in relation to order numbered 4 would, if possible, be resolved between the parties, that Arrow would not press for the admission into evidence of the second of Dr Rowe's two reports (which related to so-called patent strategies), and that Arrow would consent to order numbered 6.
Written submissions of the parties made subsequent to the 17 December 2003 hearing
30 Subsequent to the hearing on 17 December 2003, Merck submitted to the Court on 22 December 2003 further written submissions for consideration, or reconsideration, which may be summarised as follows:
(i) Arrow had not narrowed its case to definite issues, nor has it given fair notice of the case to be met by Merck; there were still outstanding particulars which have not been forthcoming;
(ii) Merck had been confronted with a case based on information said to be publicly available, but because of defective particulars, Merck had 'no way' of determining, independently of the assertions of Arrow's witnesses, what the information happened to be;
(iii) this is a case for printed publications which are available for members of the public on shelves of libraries, but nothing of that sort has been identified in the present case; if the information is publicly available, it should be possible to gain access to it by publicly available means, and those means should be properly particularised;
(iv) at the hearing on 17 December 2003, Arrow 'appeared to mix indiscriminately principles of law applicable to information made publicly available in a document and those applicable to information made publicly available through the doing of an act'; however there existed relevant and important differences between the two concepts. Where an act is relied upon as making information publicly available, it must be possible to ascertain that public information by some other means; and
(v) accordingly Arrow should be ordered to provide proper particulars to enable Merck to ascertain, by reference to publicly available sources of information, what is the information made publicly available by the doing of the acts relied upon.
Those broadly stated assertions however constituted a measure of overstatement, which afforded insufficient recognition to the substantial additional affidavits which had been provided by Arrow prior, or just prior, to the final day's hearing of these interlocutory matters. I do not think that the case for further and better particulars was made out by the foregoing submissions.
31 Merck cautioned against the use of Terrell on the Law of Patents (15th ed 2000) at 7.04 et seq, which addresses the implications of the United Kingdom legislation of 1977. Merck asserted that Arrow had not however specified with precision in what respect or respects, relevantly to the issues between the parties which had thus far emerged, the extent precisely that the passages in Terrell cited by Arrow could be disregarded or distinguished in the light of Merck's contentions. In any event, reference was made by Merck in that context to par 7.08, where the following appears:
'Whether or not the document is ordinarily accessible to the public still appears to be the crucial test.'
Merck contended that passage to represent the critical test, conceding that it does not matter whether a document is available only in an obscure library, provided always that it is ordinarily accessible to the public at that library, and provided also that proper particulars of that library are furnished in accordance with Order 58 rule 15(2)(a). Once again however the submission did not take account of the shift in emphasis of Arrow's case from information made publicly available in documents to information provided by the single act of prescribing information in writing for the benefit of a third party (ie a pharmaceutical dispensary) which would be discarded in the ordinary course or put beyond practical recovery as a record.
32 Merck observed that irrespective of the discussion which occurred at the hearing as to 'prescription forms', Arrow was not relying on any prescriptive form as being a publicly available document, and thus information in individual prescriptions does not constitute information made publicly available in a single document within s 7(1)(a) of the Act. It was said to follow that Arrow cannot rely on the prescription forms as being a mechanism whereby information translates from a doctor's head onto a piece of paper, nor is what a doctor told a patient itself a document which is publicly available. The significance of that process running its standard course at the instance of a consumer was not realistically addressed by Merck. Merck submitted in any event that Arrow's reliance on Sunbeam Corporation was misplaced, and that the dictum of Windeyer J there cited, based as it was on earlier legislation which used a different form of words, did not assist Arrow in the present case. Merck did not however specify precisely where the dictum of his Honour could not be relied on for that purpose.
33 It was nevertheless said to follow, so Merck's further submissions continued, that Arrow could not rely on information made publicly available through doing a single act, and that it was not sufficient that an act per se should be performed, it being also necessary that the performing of the act should make information publicly available, thereby referring again to s 7(1)(a) of the Act and the definition of 'prior art base' in Schedule 1 thereto. What however could be more publicly available than the widespread dissemination by patients to pharmacists of medical practitioner's prescriptions? Merck referred in any event to para 7.09 of Terrell,which dealt with making information available by prior use, and where the authors referred to Merell Dow Pharmaceutical Inc v H.N. Norton & Co Ltd (1996) PRC 76, and cited Lord Hoffman as saying:
'The use of a product makes the invention part of state of the art only so far as that use makes available the necessary information.'
I am unable to perceive how that dictum is of ultimate material assistance to Merck or destructive of Arrow's case.
34 Merck further referred to Order 58 rule 15(2)(b), which requires that particulars of an allegation that information has been made publicly available through the doing of an act must specify:
'…
(ii) the period in which, and the place where, the act is alleged to have been done publicly;
(iii) a description that is sufficient to identify the act.'
Contrary to Arrow's submission, that was said by Merck not to involve 'a… new, interesting, legal question to be determined at trial', but an express requirement for proper particulars which, in fairness to Merck, should be observed. I think that with respect, Merck has not here addressed adequately the significance or implications realistically of medical prescriptions for dispensation by pharmacists, at least to the extent of the evidence as to practice more recently produced by Arrow.
35 Merck further submitted that it had been prejudiced by having to deal with a succession of particulars, none of which was said to meet what Merck described as the basic problem, and none of which have complied with the requirements of Order 58 rule 15(2)(b). Merck joined issue upon Arrow's contention that all that is at stake is a point of law capable of being resolved at any time, and emphasised that Arrow's submissions fell short of conceding that it cannot succeed unless as a matter of law, the prior art base includes facts which are ordinarily accessible to the public. Alternatively, Merck submitted that if Arrow is to continue to assert that it is possible for members of the public to gain access to all the information relied upon by Arrow as being art of the prior art base, then proper particulars should be provided.
36 Finally I should record that Merck indicated, with the commendable assistance and frankness which has characterised its conduct of the proceedings to date, that it did not contend that a doctor's prescription is necessarily the subject of legal professional privilege, but rather that a member of the public wishing to know the state of the art in prescribing alendronate would not ordinarily know of, or be able to obtain access to any of the prescriptions written by doctors, the same being simply not 'ordinarily accessible to the public', Merck thereby citing the passage in Terrell lastly extracted above. Merck concluded that if Arrow was to dispute the foregoing propositions, it should provide proper particulars at once so that Merck is given notice of the case it has to meet. However I am inclined to the view that despite its earlier inadequacy in pleading and in the provision of evidence, Arrow has since provided Merck with sufficient material to enable Merck to address the implications of the case which Arrow has now assembled. That is not to imply of course that the case is ready for trial. It is apparent to me that both parties may well be undertaking the assembly of a significant body of further material before the final hearing of the proceedings commences.
37 Arrow responded to the further written submissions of Merck to the effect, first, that the December 2003 Particulars were 'full and proper', and that the issue as to whether the conduct particularised constituting the making of information publicly available, and the nature and identity of the prior art information, involved separate issues to be resolved at the trial. In other words, Arrow contended that it had sufficiently defined with particularity the case which Merck was required to meet at the hearing, and that Merck's complaint went to issues of evidence rather than to non-compliance with statutory and regulatory requirements. Arrow rejoined secondly to the effect that it was a misconception for Merck to postulate that for information to be 'publicly available' within s 7(1) of the Act, it must be possible to ascertain whether that information emanated from a public source or public sources. I was referred by Arrow in that regard to Windsurfing International Inc v Petit (1983-1985) 2 IPR 449 at 484-490, where Waddell J exemplified the extent, which Arrow duly acknowledged, of the evidentiary task of establishing the existence of prior user; at 489, his Honour said as follows:
'It is essential that an allegation of prior public use should be strictly proved. Evidence which is uncorroborated is undoubtedly suspect and should be scrutinised with particular care. The Court must be satisfied that the proof is sufficient in the circumstances, having regard to the gravity of the allegation.'
Arrow agreed nevertheless with Merck's contention that any analogy with printed publications available to members of the public on library shelves was not appropriate, at least in all circumstances.
38 Arrow further contended that there is no authority to suggest that particulars of prior art must be mandated, nor is such particularity mandated by Order 58 rule 15. That may be strictly correct, but of course it may well be in the interests of justice that further and better particulars should be provided by Arrow. Arrow submitted on the other hand, I should record, that full details had already been provided in the affidavits, for instance, of Dr Sambrook (21.8.2003) at pars 41-58 and Dr Diamond (18.8.2003) at pars 81-99. Arrow acknowledged to the Court, in the course of the hearing on 17 December 2003, that no reliance would be placed on the prescription forms of the doctors who had provided affidavits in the proceedings, and which as a practical matter would not be capable of production as exhibits in the proceedings.
39 Arrow therefore contended, apart from the issue as to the adequacy of particulars provided in the affidavit evidence already filed in relation to the making available of certain prior art information purportedly within s 7(1) of the Act, that whether the acts, which it had identified by its affidavit evidence, made prior art information thereby publicly available was one for determination at the trial of the proceedings upon the basis of all the evidence there made legitimately and realistically available.
The Court's conclusions
40 I have reproduced at some length the respective submissions of the parties for two reasons, first in order that an appreciation of the evolution of their respective contentions in the context of disputes upon issues as to particularity are fully recorded for the purposes of procedural and evidentiary issues which may further arise; and secondly so that appropriate orders as to the costs of those disputes may be framed with the particularity required. It will be readily apparent from my tracing in chronological sequence of the events and areas of interlocutory disputation that Arrow has substantially enlarged upon the extent of its initial affidavit evidence, and of the particularity dictated by Order 58 rule 15, largely so it would seem as a consequence of the interlocutory steps initiated by Merck.
41 Merck has also taken in my opinion the appropriate stance of drawing the Court's attention to circumstances where issues as to the privilege of individual patients of medical practitioners may conceivably arise. It is apparent, from the material to which my attention has been drawn, that patient privilege akin to legal professional privilege may be open to be drawn in particular circumstances involving the relationship between medical practitioners and their patients concerning or involving matters of advice and treatment. However, I am of the view that the existence of any such privilege would not apply in principle to circumstances involving a medical practitioner's treatment of at least unidentified sick or injured persons generally, being unidentified in the sense of non-disclosure of identity of any individual persons. In that kind of context, a medical practitioner would be testifying as to matters of professional practice, without intruding into the medical condition and affairs of any identified or identifiable private individual.
42 The December 2003 Particulars evince in my opinion an apparent adequacy of compliance with Order 58 rule 15(2) in relation to the professional conduct and practices of each of Doctors Diamond, Sambrook, Martin, Hooper, Eden and Epstein, as well as in relation to identification of allegedly relevant medical professional journals. That is not to say that there may be room for further and better discovery on Arrow's part, and perhaps also for that matter on Merck's part. I would identify 'the act', for the purposes of the application of the rule, as an occasion or the occasion, when each medical practitioner undertook or performed the conduct of a professional nature constituting a procedure or practice as to treatment of osteoporosis, either by himself in person or by way of recommendation to a fellow practitioner. In circumstances such as have been here indicated by the evidence of the medical practitioners, I do not think that it is necessary or essential to specify with precision, for instance, the times, places and indeed some other related circumstances, of issue of each prescription of alendronate sodium. Otherwise relief of the kind here sought could be conceivably but unjustly rendered unattainable in any practical sense. In short, I do not think that the operation of Order 58 rule 15 is as inflexibly specific as the content or thrust of certain of Merck's contentions might be inferentially construed to have put forward.
43 I therefore decline to grant the declaratory relief and to make the orders respectively the subject of pars 1, 2 and 3 of Merck's notice of motion filed on 10 November 2003, on the footing that the references to 'the Further Amended Particulars of Invalidity filed on 25 July 2003' are to be additionally read and construed, in the events which have happened, as encompassing 'the Second Further Amended Particulars of Invalidity' filed on 5 December 2003.
44 As to the fourth order sought, the same would tend to operate oppressively to the medical practitioners there identified, though I do not thereby intend any criticism of Merck or its legal representatives, particular since that order was sought prior to the extensive affidavits as to medical practice, or the extent of implementation of medical practice, as has since been presented by Arrow's affidavits. I would however stand over the present application for relief for further consideration by the Court, if so sought by Merck, in the light of the developments that have occurred since the filing of the original notice of motion on 10 November 2003. The relief sought the subject of the fifth and sixth orders has apparently been resolved between the parties, and no longer requires the intervention of the Court.
45 There is inherently involved complex issues as to the costs of the interlocutory proceedings originally instituted by the notice of motion filed by Merck on 10 November 2003. My tentative view is that there should be no order made as to the costs of the interlocutory proceedings which have occurred from and including the commencement of the present interlocutory proceedings on 10 November 2003. On the one hand, I would incline to the conclusion, without finally so determining, that the commencement by Merck of the motion on 10 November 2003 was at least partly justified in the light of the limited content of the July 2003 Particulars, and on the other hand, I have found, against the contentions of Merck, that the December 2003 Particulars are reasonably appropriate and defensible, for the reasons I have already given. That is not to shut the door on further applications which might be said by Merck in relation to the December 2003 Particulars, which is of course a lengthy and complex document. I would not wish to foreclose my conclusion on any outstanding issues as to costs incurred from and after 10 November 2003 by either party, and I will not deal with any such issues as to costs arising from the disputes the subject of the present interlocutory proceedings for fourteen days, and in the meantime I invite submissions to be lodged by the parties with my associate within that time, in the absence of which I will assume that my foreshadowed neutral proposal as to costs is not opposed.
I certify that the preceding forty-five (45) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Conti.