The Amended Particulars of Invalidity filed by Arrow
3 On 7 February 2003, Arrow filed so-called Amended Particulars of Invalidity. This document was brought into existence in the context of preceding requests for particulars made by Merck's solicitors commencing from 2 January 2003. The document was the centre of much of the debate in the present interlocutory proceedings. In summary, those Amended Particulars of Invalidity assert that the invention propounded in each of the Patent claims is not a patentable invention within the meaning of s 18(1) of the Act, because it does not satisfy the threshold requirement of an invention, and is not properly the subject of letters patent. I will now describe and partly reproduce in full in the following six paragraphs of these reasons the substance of that controversial document, since much of the debate in the interlocutory proceedings the subject of these reasons for judgment was directed to its contents.
4 Under the sub-heading 'Manner of Manufacture', Arrow contends by pars 3 and 4 of the Amended Particulars of Invalidity that the alleged invention the subject of the claims of the Patent is not a patentable invention within the meaning of s 18(1) of the Act, and does not satisfy the threshold requirement of an invention, and further is not properly the subject of letters patent. Thereafter follows the assertion of Arrow that the alleged invention, as propounded in each of the claims of the Patent, is not a patentable invention within the meaning of s 18(1)(a) of the Act, because it is not a manner of manufacture within the meaning of s 6 of the Statute of Monopolies. The particulars supplied by Arrow in relation to that assertion, are as follows:
'(a) As at the Priority Date the alleged invention consisted of merely the use of known substances the known properties of which made them suitable for use.
(b) The Patent discloses no invention having regard to:
(i) admissions contained in the specification; and/or
(ii) the common general knowledge at or before the Priority Date of each claim of the Patent.
(c) As at the Priority Date the alleged invention as claimed in each of the claims was:
(i) no more than a mere collocation of known integers with no working interrelationship between those integers which could lead to a patentable invention;
(ii) no more than a method or system for using known integers to provide a known method of treatment;
(iii) no more than a method of optimising a known method of treatment;
(iv) not a technical advance over the common general knowledge but a marketing plan;
(v) not a technical advance over the prior art but mere working instructions; or
(vi) not otherwise an invention within the meaning of section 6 of the Statute of Monopolies, 1624.'
5 Arrow further contends by par 5 of the Amended Particulars of Invalidity that the Patent is not a patentable invention within the meaning of s 18(1)(b)(i) of the Act, because it was not novel as at the Priority Date, by reason of the prior art information made available by the publication of the documents, or of the doing of the acts set out in the particulars comprising Annexure 'A' to the Amended Particulars of Invalidity. The contents of Annexure 'A' are reproduced below:
'1. The publication in or around April 1996 of an article entitled 'Update: Bisphosphonate on page 31 of the April 1996 issue of 'Lunar News' ('Lunar News 1').
2. The publication in or around July 1996 of an article entitled 'Update: Bisphosphonate' on pages 23-24 of the July 1996 issue of 'Lunar News' ('Lunar News 2').
3. The giving of a prescription to a patient for the treatment and/or prevention of osteoporosis by Dr Phillip Sambrook of the Royal North Shore Hospital, Sydney on or around 17 September 1997 of 10mg of alendronate sodium to be taken every third day.
4. The giving of a prescription to a patient for the treatment and/or prevention of osteoporosis by Dr Phillip Sambrook of the Royal North Shore Hospital, Sydney on or around 17 September 1997 of 5mg of alendronate sodium to be taken every third day.
5. The release of Australia by the respondent of a 70mg once-a-week formulation of alendronate sodium to be prescribed for the treatment and/or prevention of osteoporosis on or around 9 February 2001.
6. The marketing by the respondent:
(a) from in or around 1996 in Australia of 10mg and 40mg unit dose formulations of alendronate sodium, where the 10mg dose was approved and marketed for the treatment of osteoporosis and the 40mg dose for the treatment of Paget's disease of bone;
(b) from in or around 1995 in the United States of America of 10mg and 40mg unit dose formulations of alendronate sodium, where the 10mg dose was approved and marketed for the treatment of osteoporosis and the 40mg dose for the treatment of Paget's disease of bone;
(c) from in or around 1996 in the United Kingdom of a 10mg unit dose formulation of alendronate sodium approved for the treatment of osteoporosis.'
6 Arrow contends by par 6 of the Amended Particulars of Invalidity styled 'Lack of inventive step' that the Patent is not a patentable invention within the meaning of s 18(1)(b)(ii) of the Act, because the same does not disclose an inventive step when compared with the prior art base as it existed before the Priority Date. By way of particulars of this head of invalidity, Arrow relies on the common general knowledge in Australia, at or before the Priority Date of each claim, taken either alone or in combination with one or more of the pieces of the prior art information referred to in the said particulars headed Annexure 'A' (reproduced in [5] above). Arrow further relies on publications and text books identified below under the heading Annexure 'B' to the Amended Particulars of Invalidity, being material to the effect that a person skilled in the relevant art could, before the Priority Date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant in Australia:
'1. The publication in or around 1991 in volume 15 of Bone and Mineral of an article entitled 'Intermittent Treatment with Intravenous 4-amino-1-hydroxybutylidene-1, 1-Bisphosphonate in the Therapy of Postmenopausal Osteoporosis' by M Passeri et al;
2. The publication in or around 1991 in Volume 6 of the Journal of Bone and Mineral Research of an article entitled 'The Bisphosphonate alendronate (MK 217) inhibits Bone Loss Due to Ovariectomy in Rats' by J Gregory Seedor et al;
3. The publication in or around December 1993 in volume 92 of 'J Clin. Invest' of an article entitled 'The Effects of 2-year Treatment with the Aminobisphosphonate Alendronate on Bone Metabolism, Bone Histomorphomety and Bone Strength in Ovariectomized Nonhuman Primates' by R. Balena et al;
4. The publication in or around 1993 in Osteoporosis International of an article entitled 'Clinical Pharmacology of Alendronate Sodium' by B Gertz et al;
5. The publication in or about 30 November 1995 in Volume 333 of the New England Journal of Medicine of an article entitled 'Effect of Oral Alendonate on bone Mineral Density and Incidents of Fractures in Post Menopausal Bone Loss' by Liberman et al;
6. The publication in or around February 1996 in Volume 18 of 'Bone' of an article entitled 'Oral Alendronate Induces Progressive Increases in bone Mass of the Spine, Hip and Total Body over 3 years in Postmenopausal women with osteoporosis' by Devogelaer et al;
7. The publication on or around 3 October 1996 in the New England Journal of Medicine, Volume 335 of an article entitled 'Esophagitis & Alendonate' written by Libreman V et al;
8. The publication in or around 1996 in volume 335 of the New England Journal of Medicine of an article entitled 'Pill Esophagitis - the case of alendronate' by D.O. Castell;
9. The publication in or around 1997 in volume 29 of 'Horm, Metab. Res' of an article entitled 'Bishopsphonates: Mechanisms of Action and Clinical Use in Osteoporosis - An Update' by H. Fleisch;
10. The 3rd edition of the text book 'Bisphosphonates in Bone Disease From the Laboratory to the Patient' edited by Herbert Fleisch MD published by The Parthenon Publishing Group in or around 1997;
11. The 2nd edition of the text book 'Bisphosphonates in Bone Disease From the Laboratory to the Patient' edited by Herbert Fleisch MD published by The Parthenon Publishing Group in or around 1995.'
7 Arrow next contends by par 7 of the Amended Particulars of Invalidity, under the heading 'Not fairly based', that Claims 1 to 346 of the Patent are not fairly based on the matter described in the specification, contrary to s 40(3) of the Act. The following particulars to par 7 were provided:
'(a) Claims 1-346 in so far as they claim:
(i) bisphosphonates and/or uses of bisphosphonates other than alendronate monosodium trihydrate (claims 1-5, 9-11, 14, 18, 20, 22-49, 54, 56, 57, 60, 62, 64, 66, 91, 96, 98, 99, 102, 104, 106, 108-133, 144-169, 175-180, 184, 190-215, 221-225, 236-256, 263, 266-286, 296-312, 319-327, 334-346);
(ii) dosages and/or uses of dosages which include amounts of alendronate monosodium trihydrate other than 35mg, 70mg or 140mg (claims 1-15, 18-20, 22, 24-26, 31, 32, 37-58, 60, 62, 64, 66-68, 73, 74, 79, 80, 8-100, 102, 103, 104, 106, 108-110, 115, 116, 121-141, 144-146, 151, 152, 157, 158, 159-169, 175-187, 190-192, 197, 198, 203-215, 221-233, 236-164, 266-294, 296-312, 319-327, 334-346);
(iii) the treatment of bone disorders other than osteoporosis with alendronate monosodium trihydrate (claims 1-44, 45-49, 60, 62, 64, 66-91, 99, 102, 104, 106, 108-220); or
(iv) formulations, uses of formulations or methods of treatment which make use of either combinations of a bisphosphonate with an H2 receptor blocker or a proton pump inhibitor, or a combination of more than one bisphosphonate (claims 1-128, 132-169, 178-215, 224-252, 256-282, 286-312)…
are not fairly based on the matter described in the specification because the specification only describes:
(i) alleged use of alendronate monosodium trihydrate in the treatment or prevention of osteoporosis;
(ii) 35mg tablet or 70mg liquid formulations of alendronate monosodium trihydrate.
(b) Claims 1-346, in so far as they claim administration of any bisphosphonate according to a continuous schedule having a periodicity of one weekly, twice weekly, biweekly or twice monthly, over an undetermined treatment period are not fairly based on the matter described in the specification because examples 2 to 5 of the specification stipulate that the administration must be carried out for 'at least one year'.'
8 Arrow contends by par 8 of the Amended Particulars of Invalidity headed 'No best method' that if (which is denied in any event by Arrow) the Patent involves any inventive step, the specification does not describe the invention fully, and in particular does not describe the best method known to Merck of performing the invention, contrary to s 40(2)(a) of the Act. Arrow furnishes in support of that contention the following particulars to par 8:
'There is no description provided of the best method of performing the alleged invention as claimed in claims 1-346 of the Patent, in so far as it relates to all or any of:
(i) formulations or uses of bisphosphonates other than alendronate monosodium trihydrate at a stipulated frequency of administration (claims 1-5, 9-11, 14, 18, 20, 22-49, 54, 56, 57, 60, 62, 64, 66, 91, 96, 98, 99, 102, 104, 106, 108-133, 144-169, 175-180, 184, 190-215, 221-225, 236-256, 263, 266-286, 296,-312, 319-327, 334-336);
(ii) use of bisphosphonates for the treatment of any disorder which is not osteoporosis (claims 1-44, 45-49, 60, 62, 64, 66-91, 99, 102, 104, 106, 108-220);
(iii) methods for preparing or using tablet and liquid preparation of bisphosphonates other than alendronate monosodium trihydrate in 35mg, 70mg or 140mg (claims 1-15, 18-20, 22, 24-26, 31, 32, 37-58, 60, 62, 64, 66-68, 73, 74, 79, 80, 81-100, 102, 103, 104, 106, 108-110, 115, 116, 121-141, 144-146, 151, 152, 157, 158, 159-169, 175-187, 190-192, 197, 198, 203-215, 221-233);
(iv) methods for co-administration of a bisphosphonate and a histamine H2 receptor blocker or a proton pump inhibitor or a combination of bisphosphonates in the treatment of any bone disorder (claims 1-128, 132-169, 178-215, 224-252, 256-282, 286-312);
(v) methods of use, pharmaceutical compositions or kits which are adopted for oral administration according to a continuous schedule having a periodicity from about once every 3 days to once every 16 days as distinct from being a method of use, pharmaceutical composition or kit which is not so adopted but is merely suitable for oral administration according to a continuous daily schedule or for what the Patent refers to as a cyclical or intermittent regimen.'
9 Lastly, Arrow contends by par 9 of the Amended Particulars of Invalidity, under the heading 'No Sufficient Description', that if (which is denied) the patent involves any inventive step, the alleged invention is in any event not sufficiently described in order to enable a person skilled in the art 'to perform it'; the particulars furnished pursuant to par 9 are as follows:
'There is no sufficient description provided to enable a person skilled in the art to perform the alleged invention as claimed in claims 1-346 of the Patent, in so far as it relates to all or any of:
(i) formulations and/or uses of bisphosphonates other than alendrnate monosodium trihydrate at stipulated frequency of administration (claims 1-5, 9-11, 14, 18, 20, 22-49, 54, 56, 57, 60, 62, 64, 66, 91, 96, 98, 99, 102, 104, 106, 108-133, 144-169, 175-180, 184, 190-215, 221-225, 236-256, 263, 266-286, 296-312, 319-327, 334-346);
(ii) uses of bisphosphonates for the treatment of any disorder which is not osteoporosis (claims 1-44, 45-49, 60, 62, 64, 66-91, 99, 102, 104, 106, 108-220);
(iii) methods for preparing or using tablet and liquid preparation of bisphosphonates other than alendronate monosodium trihydrate in 35mg, 70mg or 140mg doses (claims 1-15, 18-20, 22, 24-26, 31, 32, 37-58, 60, 62, 64, 66-68, 73, 74, 79, 80, 81-100, 102, 103, 104, 106, 108-110, 115, 116, 121-141, 144-146, 151, 152, 157, 158, 159-169, 175-187, 190-192, 197, 198, 203-215, 221-233, 236-164, 266-294, 296-312, 319-327, 334-346);
(iv) methods for co-administration of a bisphosphonate and a histamine H2 receptor or a proton pump inhibitor or a combination of bisphosphonates in the treatment of any bone disorder (claims 1-128, 132-169, 178-215, 224-252, 256-282, 286-312);
(v) the following
(A) methods of treatment by the administration of;
(B) dosages of;
(C) uses of;
(D) its consisting of or including:
bisphosphonates adapted for oral administration dosages according to a continuous schedule having a periodicity from about once every 3 days to once every 16 days or a dosing interval of once-weekly, twice-weekly, biweekly or twice-monthly as opposed to merely being suitable for oral administration in either (on the one hand) a continuous daily schedule or (on the other hand) what the Patent refers to as a cyclical or intermittent regimen.'
Arrow's notice of motion for interlocutory orders
10 Arrow by notice of motion sought the following orders against Merck:
'1. That within 14 days the respondent file and serve a Statement in Answer to the applicant's Amended Particulars of Invalidity filed on 7 February 2003.
2. That within 14 days the respondent file and serve Particulars of the Inventive Step said to give rise to a Patentable invention within the meaning of section 18 of the Patents Act 1900.
3. That within 14 days the respondent file and serve particulars identifying the person or persons skilled in the relevant art in relation to Australian Patent No 741818.
4. That the respondent give discovery in the categories set out in Annexure A to this Notice of Motion on or before a date nominated by the Court.
5. That alternatively to 4, the respondent give general discovery on or before a date nominated by the Court.'
Order 5 is no longer pressed.
11 Annexure A to Arrow's notice of motion, containing Arrow's proposed categories for discovery by Merck for the purposes of Order 4 sought by the notice of motion, reads as follows:
'Unless otherwise stated, the term 'document' is as defined in Parts 1 and 2 of the Dictionary to the Evidence Act 1995, and the term 'Alleged Invention' means the oral administration of bisphosphonates at dosing intervals which are less frequent than once a day for the inhibition of bone resorption, treatment or prevention of osteoporosis.
The categories of documents which the applicant proposes be discovered by the respondent are all documents being, confirming, referring or relating to:
1. research, development, experimental work, animal and clinical trials carried out in the course of making the invention claimed in the subject patent;
2. communications (whether internal to the respondent or to or from third parties) concerning the idea, concept or suggestion underlying or behind the Alleged Invention or the impetus for the discovery, invention, trailing, testing, researching or developing of the Alleged Invention;
3. applications to, correspondence with and communications to or from the following or any of their respective employees or agents to obtain:
(i) US Food and Drugs Administration approval;
(ii) Australian Therapeutic Goods Administration approval;
(iii) Listing on the Australian Pharmaceutical Benefits Scheme; or
(iv) European Medicines Evaluation Agency approval,
for pharmaceutical compositions or medicaments embodying or relating to the Alleged Invention;
4. presentations, seminars, speeches, lectures or demonstrations (whether internal to the Respondent or otherwise) disclosing, explaining, promoting, recommending or proposing the Alleged Invention or its commercialisation, exploitation or adoption, brought into existence up until two (2) years after the date of first marketing of non-daily dosage forms of alendronate in Australia;
5. marketing or advertising of pharmaceutical compositions or medicaments embodying, consisting of or relating to the Alleged Invention or any instructions for administration. (The applicant proposes that one sample document of each document falling within this category should be discovered);
6. the April 1996 and July 1996 publications of Lunar News;
7. (i) depositions, statements or affidavits of or from Richard Mazess, Robert Beckman and David Weissburg or any other officers or personnel of Lunar Corporation;
(ii) depositions, statements or affidavits of or from witnesses responding to, or in answer or in reply to, any such depositions, statements or affidavits; and
(iii) transcripts of testimony from or cross-examination of or in relation to any of (i) or (ii) above.
8. applications to register, including any submissions made and correspondence with the relevant patent authorities regarding the prosecution of the following patents and applications:
(i) US Provisional Application 60/053,535;
(ii) US Provisional Application 60/053,351;
(iii) GB 9717590.5;
(iv) GB 9717850.3;
(v) PCT/US98/14796;
(vi) PCT/US00/23595;
(vii) US 09/388,659 (CIP);
(viii) US 5994329;
(ix) US 6225924;
(x) CAN 2294595;
(xi) EP 0998 292;
(xii) US 6015801 (CIP); and
(xiii) Any other patents or applications in any other jurisdiction, claiming priority from any of (i) to (xii) (inclusive) above or from Australian patent no. 741818 (or any other patent or application from which that patent claims priority).'
I will later address the issues of discovery in relation to the documents set out immediately above and being the subject of order 4 of Arrow's notice of motion for interlocutory relief.
Pleading to Amended Particulars of Invalidity sought by Arrow - order 1 of Arrow's notice of motion
12 Arrow submitted that the relief sought by orders 1 to 3 effectively invokes the need for appropriate case management of the proceedings. Although no rule could be cited to the specific effect that Merck was required to plead to the Amended Particulars of Invalidity, Arrow submitted that Order 10 rules 1(1) and 1(2)(a)(v) and Order 12 rules 1(1) and 5(1) of the Federal Court Rules authorised the making of orders by way of case management in circumstances such as the present, the same respectively reading as follows, so far as is presently material:
Order 10
'1(1) On a directions hearing the Court shall give such directions with respect to the conduct of the proceedings as it thinks proper.
…
(2) Without prejudice to the generality of subrule (1)… the court may -
(a) make orders with respect to -
…
(v) the defining of the issues by pleadings or otherwise.
…'
Order 12
'1(1) A Party pleading shall state in the pleading or in a document filed and served with it the necessary particulars of any claim, defence or other matter pleaded by him.
5(1) The Court may order a party to file and serve on any other party -
` (a) particulars of any claim, defence or other matter stated in his pleading, or in any affidavit ordered to stand as his pleading.'
By responding to the Amended Particulars of Invalidity as though it was part of the initiating process, so Arrow submitted, Merck would thereby assist to define critical issues arising from the pleadings, as well as provide particulars of its bare denial of invalidity.
13 Arrow asserted that it has sought the first order of the notice of motion in order to ensure that there would be no false issues which might 'derail' the preparation of the evidence or the progress of the hearing, it being clearly desirable that the parties be aware of all issues arising. I was referred in particular to the dictum in White v Overland [2001] FCA 1333, where Allsop J observed at [4] as follows:
'… However, by way of general principle I would simply like to make perfectly plain my view that in the efficient and proper conduct of civil litigation, even civil litigation hard fought between parties, it should always be recognised that in the propounding of issues for trial the parties should take steps to ensure that all relevant parties to the dispute are cognisant of what the issues are. Any practice of quietly leaving footprints in correspondence or directions hearings to be uncovered some time later in an attempt to reveal that a matter was always in issue should be discouraged firmly. Even if something has been said, where it is evident, or indeed suspected, that the other side is proceeding on the basis of a misconception or has not appreciated something, as a general rule, efficiency, common sense and an appreciation of the costs and resources (both public and private) likely to be wasted by confusion in litigation will mandate that a party through his or her representative ensure that the other is not proceeding on a misconception or that the other does appreciate something that has been said. Litigation is not a game. It is a costly and stressful, though necessary, evil.'
14 Those observations were cited with approval by Heydon JA (as he then was) in Nowlan v Marson Transport Pty Ltd (2001) 53 NSWLR 116 (at 128) (Mason P and Young CJ in Eq agreed with his Honour's reasons for judgment). Whether however Arrow can wholly justify the interlocutory initiatives it has taken upon the footing of that dictum, by its present notice of motion, is of course another matter. The lengthy oral and written submissions of the parties have not persuaded me that Merck, by its resistance to the interlocutory relief sought by Arrow, has engaged in the pursuit of litigious practices which the warnings of his Honour are designed to obviate. Conversely, it may be observed that the so-called particulars the subject of Arrow's Amended Particulars of Invalidity are in a number of instances cast in general terms (see for example [4] above), and the references to publications are merely to titles and authors, and not to page or paragraph numbers (see part of [5] above and the whole of [6] above).
15 Arrow acknowledged from the outset that the onus was cast upon it to establish invalidity pursuant to s 138 of the Act, and that the course it has adopted of seeking the first order the subject of its notice of motion, namely that Merck should formally plead to the Amended Particulars of Invalidity, has no specific authorisation as such in the Federal Court Rules. In purported reliance upon the Federal Court Rules which I have cited in [12] above, Arrow contended that since Merck's filed defence to the statement of claim '… provides no genuine indication of Merck's position in relation to the very specific issues raised [but constitutes] simply a formal denial of the plea of invalidity', Arrow was entitled to compliance with the first order sought from the outset of the interlocutory process. Arrow further contended that it was clearly desirable for Arrow to know with sufficient particularity the case that the patentee was raising in opposition, and cited the dictum of French J in Charlie Carter Pty Ltd v SDAEA (Western Australia) (1987) 13 FCR 413 (at 417) that '[t]here are certain levels of generality of pleading which, while they may bring in all facts necessary to establish a cause of action, are insufficient for the purpose of properly informing the defendant of the case it has to meet'. Nevertheless of course, Arrow is the applicant and not the respondent in these proceedings for revocation of the Patent, and has initiated the course of challenging the validity of the Patent by a statement of claim which pleads in essence an allegation of invalidity, yet accompanied initially by Particulars of Invalidity (and later by the Amended Particulars of Invalidity), each of those particulars demonstrating an apparently comprehensive knowledge of the purport and implications of the Patent.
16 Arrow has asserted that Merck, by a formal pleading in response to the Amended Particulars of Invalidity, should state for instance '…what it asserts is the priority date or dates, and 'whether it concedes the publication of any of the prior art that has been particularised', and further 'whether a best method has been disclosed in the specification and, if so, where etc'. The issues thus arising in relation to the first order sought by Arrow's notice of motion nevertheless largely overlap with those involved in relation to the second order sought. I observe that whilst the Federal Court Rules provide by the above extracted Order 12 rule 1(1) for 'necessary particulars of any claim, defence or other matter pleaded' to be stated, there is no obligation imposed by the Federal Court Rules upon a respondent to plead to particulars purportedly accompanying a statement of claim, or any other pleading for that matter. Moreover for a respondent to merely join issue upon an allegation of invalidity of a patent would normally provoke the need for particularity.
17 Arrow anticipated one basis for Merck's resistance to its first order sought, namely that Merck plead to the Amended Particulars of Invalidity, that basis being the absence therefrom of particulars of 'common general knowledge' (references to that term appear in what has been extracted from the Amended Particulars of Invalidity in [4] and [6] above). Authority was cited by Arrow in support of that proposition: Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd (1961) 180 CLR 98 (at 111-112) (Windeyer J) followed by Werner & Company v Bailey Aluminium Products Pty Ltd (1989) 13 IPR 513 (at 539-540) (Gummow J) (both decided in the context of the 1952 Act). Merck submitted that as a matter of principle and practice, it is not appropriate that particulars of common general knowledge be provided by an applicant for revocation, in contrast for instance to particulars of the inventive step and of the identity of the skilled worker in the art, since what would be common general knowledge of the skilled addressee at the priority date would be 'classically evidence, not particulars'. Moreover it was said by Merck that the notion of common general knowledge involved the use of that which is known by those in the relevant trade, and formed the background knowledge and experience that is available to all in the relevant class of persons. Arrow referred in any event to a concession made on behalf of Merck that particulars of general knowledge was not commonly required, though provision of the same 'would be of assistance'. Moreover Arrow submitted that it would be impractical to limit Arrow to particulars of that kind of information, at least until after Arrow's evidence in chief has been completed. I think that Arrow's submission concerning any need for particularisation of common general knowledge in the context of its application for revocation is correct subject perhaps to the qualification that Arrow should make clear that it is not relying upon common general knowledge otherwise than in Australia (Wellcome Foundation Ltd v V R Laboratories (Aust) Pty Ltd (1981)148 CLR 262 at 284-285). The implications however of that outcome tend to further demonstrate the absence of any justification for requiring Merck to plead to the Amended Particulars of Invalidity, by way of a further defence.
Particulars of inventive step sought by Arrow - order 2 of Arrow's notice of motion
18 Arrow sought to justify its application for particulars of the inventive step involved in Merck's patentable invention (the subject of order 2 sought by Arrow's notice of motion) upon the initial footing of s 18(1)(b)(ii) of the Act, which provides, so far as is material, as follows:
'18 Patentable inventions
(1) … an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
…
(b) when compared with the prior art base as it existed before the priority date of that claim:
…
(ii) involves an inventive step…'
Arrow contended that for Merck to maintain its monopoly right as owner of the Patent, and since the Patent does not identify an inventive step, Merck should be required to particularise what allegedly comprises that step, and Arrow should not be left to make assumptions as to what it may comprise. Arrow pointed to the existence of 342 claims allegedly comprising the Patent, and its need to know what allegedly unified all of those claims.
19 Reliance was placed by Arrow upon the reasons for decision of Heerey J at first instance in Grace Australia Pty Ltd v MBT Holding AG [2002] FCA 1512, where in the context of an application for revocation of a patent and so-called 'bare denials', his Honour ordered that the respondent file and serve particulars of the inventive step the subject of its Patent under attack. In so doing, Heerey J followed what he considered to be an analogous approach, taken by the High Court in Bailey v Commissioner of Taxation (1977) 136 CLR 214, of making an order that the respondent Commissioner of Taxation give particulars in relation to a tax avoidance arrangement previously alleged by the Commissioner to fall foul of s 260 of the Income Tax Assessment Act 1936 (Cth)('Tax Act'), in the context of income tax litigation brought by a taxpayer against the Commissioner by way of challenge to an income tax assessment. I will later examine more closely the reasons for decision of Heerey J in Grace Australia. In Bailey, Aickin J(with whose reasons Barwick CJ, Gibbs, Mason and Jacobs JJ agreed, whilst adding observations respectively of their own), said (at 227-228) on the subject of particulars as set out below:
'The purpose of particulars is to assist in the defining of issues and there is in my opinion no reason why in appropriate cases the Commission should not give particulars where they are necessary in order that both the appellant and the court may understand the basis upon which the assessment has been made… No doubt there are many cases in which the return, the notice of assessment, the alteration sheet and the notice of objection will reveal the issues with sufficient certainty so that no particulars are necessary. This however is seldom the case where an assessment has been issued upon the basis of s 260. To tell a taxpayer and the Court that an assessment is based upon s 260 reveals nothing beyond the fact that the Commissioner contends that there is some contract, agreement or arrangement which falls within the ambit of that section and that either the whole or some part of it, or some step taken pursuant to it, or in the course of carrying it out, is void as against the Commissioner and that the taxable situation stands revealed by such avoidance. If no more is said the taxpayer and the Court are left entirely in the dark as to critical matters and the issues remain undefined except as to the ultimate conclusion contended for by each party.
There is nothing in the policy of the Act nor in general considerations of policy to require that the Commissioner should not inform the appellant prior to the commencement of the hearing of those details so that the case may proceed in an orderly and comprehensible manner. It is not in the interests of the proper administration of justice that, when the matter comes before the court, the appellant should have to speculate about, and adduce evidence to negate, every possible kind of agreement or arrangement and avoidance which the imagination of his advisers can conjure up. Such a process is not merely time-wasting but is likely to obscure the real issues…'
20 No compelling analogy of the process involved in a taxpayer's challenge to an income tax assessment based upon a tax avoidance arrangement or scheme, to the process involved in a challenge to the validity of a patent, readily springs to mind. When a taxpayer challenged an assessment, based upon a tax avoidance arrangement, and issued by the Commissioner of Taxation pursuant to s 260 of the Tax Act, the taxpayer may well have had no, or at least insufficient, understanding of what was the nature of the tax avoidance arrangement, or its terms, which the Commissioner had propounded by an adverse notice of assessment of income tax. In relation to patent litigation, the applicant for revocation of a patent has ready access at least to the patent specifications, the same being open to public inspection (see Chapter 4 of the Act). A closer analogy to the circumstances in Bailey with a patent dispute would be the challenge by a putative inventor to a refusal by the Commissioner of Patents of the inventor's patent application, in circumstances where no ground for refusal is communicated by the Commissioner to that inventor applicant under the purported authority of the Act.
21 Arrow supported further its claim to the relief sought by par 2 of its notice of motion by contending that whilst the onus lay upon it to establish invalidity of the patent pursuant to s 138 of the Act, Merck holds a monopoly right in relation to the patent, the validity whereof necessarily requires an inventive step, something which is not identified by the terms of the Patent, and that Arrow should not be left to make assumptions as to what the inventive step might purportedly comprise. To illustrate what Arrow asserted to be its present dilemma, Arrow pointed out that Merck's patent application originally contained 29 claims, and was thereafter amended to embody 342 claims. Arrow hence asserted the need and the entitlement to know what inventive step supposedly 'unified all of these claims'.
22 Arrow additionally maintained its claim to the second order sought by its notice of motion upon the basis particularly of the need for the Court to provide case management. I was referred by Arrow to certain passages in the Full Court's reasons for judgment in Minnesota Mining and Manufacturing Co v Tyco Electronics Pty Ltd [2002] FCAFC 315 at [43-45] (Heerey, Emmett and Dowsett JJ), which are reproduced below. Those passages were said to highlight the need for only relevant evidence being placed before the Court, and to reflect Arrow's concern to ensure an early definition of the issues of relevance by a process of case management taking the form of Merck being required to plead to the Amended Particulars of Invalidity. Those passages from Tyco cited by Arrow are as follows:
'43. Before dealing with the issues that arise on the question of obviousness, it is convenient to deal with several preliminary evidentiary questions. His Honour was somewhat critical of the nature of some of the evidence adduced by the parties in relation to the question of obviousness. Tyco's amended particulars of invalidity relied on a large number of patents published at the Patents Office and a large number of other documents published in Australia before the Priority Date. Tyco did not ultimately pursue that aspect of its case and substantial portions of Tyco's affidavits were either rejected or not read.
44. Consequently, as his Honour observed, it is not easy to determine whether a particular opinion was based partly or wholly on material that had not been admitted into evidence. A further difficulty is that, on some occasions, Tyco's experts were asked to address questions that were framed in general terms and were not specifically directed to the criteria that must be used to determine whether a claimed invention is obvious.
45. The manner in which the evidence of some of the experts in the present case was brought into existence suggests that relatively little weight should be given to certain of that evidence. For example, witnesses were provided with a copy of the Patent. They were either provided with a large number of other documents or found them in response to the task that was set them. That is hardly calculated to result in objective evidence as to what the hypothetical uninventive but skilled worker would have done. To give the Patent to a prospective witness is tantamount to leading the witness. Further, unless the other documents were part of the common general knowledge in Australia before the Priority Date, they are not relevant to any question of obviousness.'
23 That dicta does not in my opinion assist Arrow. Any process of pleading to an overstated or misstated cause of action for revocation of a patent will not obviate the kind of confusion that occurred in Tyco, which was seemingly occasioned by excessive particularity concerning an inventive and faulty briefing of experts. Particulars may illustrate to a respondent patentee the nature of the allegations which will be made, and which will be the subject of testimony, including the testimony of experts, but will not necessarily be definitive of the issues.
24 Arrow further contended that what an inventor might actually think to be an inventive step is not conclusive, and for Arrow to be given information as to the alleged inventive step was said to be 'certainly a starting point', being the descriptive phrase used by Heerey J in Grace Australia in the following context at [10]:
'Counsel for the respondent argued that at worst there should only be an order for particulars of [an] inventive step after the applicant had given general particulars of common general knowledge. There may be some force in that as a matter of general principle. However, in the present case, as I have already indicated, very substantial particulars of common general knowledge were given by the applicant as far back as February of this year. There has been no complaint about the adequacies of these particulars or a request for any further particulars. Realistically the respondent has been for a substantial period of time in possession of what might be called at least the main thrust and substance of the applicant's case as to common general knowledge. It is true that what the inventor actually thought was the inventive step is not conclusive, although it is certainly a starting point and the respondent proposes to lead evidence of those matters in the present case.'
Conversely in the present case, Merck has been critical of the Amended Particulars of Invalidity, which have purportedly provided particulars of common general knowledge and prior art base information in Australia at or before the priority date, as set out in Annexures A and B to the Amended Particulars of Invalidity (see [5-6] above).
Particulars of identity of a person skilled in the art as sought by Arrow - order 3 of Arrow's notice of motion
25 Arrow's next segment of contentions related to order 3 of its notice of motion set out in [10] above. Arrow contended that '[t]he same logic that the Court accepted in Grace Australia' should apply to the provision by a patentee of particulars of the person who it claims to be the skilled addressee, being the 'hypothetical or notional person of ordinary skill in the relevant art' described by the Full Federal Court in Freeman & Anor v T J & F I Pohlner Pty & Anor (1994) 30 IPR 377 (at 381) (Black CJ, Gummow and O'Loughlin JJ). I was referred to Fina Research SA v Halliburton Energy Services [2003] FCA 55, where Moore J rejected the applicant's primary witness upon issues as to novelty, obviousness, and construction of the patent, because he was not a relevantly skilled addressee for the purpose of maintaining an objection to the grant of a patent relating to the composition of drilling mud. I do not think that Fina Research provides sufficient assistance to Arrow to obtain order 3. I do not understand why Arrow should not for its part assume the task of identifying the person skilled in the art (see generally Sunbeam at 12). Whilst of course the issue of the identity of the hypothetical skilled addressee is ultimately one for the Court to resolve, the Court is entitled to know in the first place who the applicant for revocation defines to be the relevant skilled addressee. Arrow's rejoinder was that in order to bring the proceedings to the Court in an orderly manner, it would be appropriate for Merck to be ordered to file a responsive statement as to whom it considers to be the person skilled in the art to which the invention related. The notion of a person skilled in the art may be identified from the provisions of the Act relating to obviousness, s 7(2) whereof reading as follows:
'Inventive step
For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).'
In pressing its contention that there was no reason why Merck should take the initiative of describing for present purposes the 'person skilled in the relevant art', Merck pointed out that the notion comprised a legal construct used to test inventiveness, somewhat analogous to the 'reasonable person' test used to determine negligent conduct.
Merck's submissions in reply to Arrow's motion for further pleading by Merck in response to Arrow's Amended Particulars of Invalidity, and in response to Arrow's motion for particulars of the inventive step and of the identity of persons skilled in the relevant art
26 Merck commenced its submissions in reply to Arrow's application for the first three orders of Arrow's notice of motion to the effect that Arrow's Amended Particulars of Invalidity are not in form or in content such as to render it appropriate, convenient, or indeed possible, for Merck, to treat the same as a de facto pleading, whether by way of a supplementary statement of claim or otherwise, to which Merck as a respondent should respond, and moreover, the Federal Court Rules make no provision for any such procedure, nor is there any judicial precedent for the process. It was therefore submitted by Merck that there should be no departure from the traditional rules of pleading already implemented by the parties by way of the statement of claim (accompanied by appropriate particulars) and the defence which had earlier been filed. Merck submitted in any event that it would not be appropriate, but instead unfair and inappropriate, that Merck should be compelled to respond to the Amended Particulars of Invalidity as though it was a formal pleading akin to a supplementary statement of claim, with all the implications thereby involved in terms of satisfactory definition of the issues correctly arising.
27 By way of amplification of those contentions, Merck contended that the Amended Particulars of Invalidity did not satisfy the ordinary rules of pleading applicable to statements of claim, and were not so framed as to justify or require any pleading from Merck in response thereto, for the reason that the same did not plead in appropriate summary form a statement of the material facts on which Arrow purportedly relied for revocation of the Patent. Addressing individual paragraphs of the Amended Particulars of Invalidity, Merck thereafter submitted as follows:
(i) Pars 3 and 4 thereof do not constitute statements of material facts, but are in the nature of argumentative conclusions; in particular par 4 thereof does not identify the factual basis for the assertions there made, and does not identify for instance the admissions or the common general knowledge referred to, or the factual basis for the assertion that each of the inventive claims is for 'a mere collocation of known integers with no working relationship between those integers which could lead to a patentable invention', nor is any basis identified by Arrow for the other assertions set out in sub paras (c)(ii)-(vi);
(ii) Par 5 thereof is merely an argumentative conclusion, in that the information alleged to be derived from the prior art is not stated by Arrow, nor is there stated in par 5 the facts underlying the allegations in the preceding pars 3 and 4 of Annexure A to the Amended Particulars of Invalidity, or the relationship of those allegations to the other items in Annexure A;
(iii) Par 6 thereof is merely argumentative, in that the common general knowledge relied upon with any precision, and the various combinations of prior art therein referred to, are not identified, nor is there provided any factual basis for the reasonable expectation alleged;
(iv) Par 7 thereof comprises merely an argumentative conclusion, in that the particulars do not on their face reveal the material facts said to support the allegation of absence or want of any fair basis, yet presumably Arrow would be relying in any event on further propositions of fact which are nowhere stated in that document;
(v) Par 8 thereof is merely an argumentative conclusion, and the particulars do not appear to relate to the statutory test purportedly set out therein; and
(vi) Par 9 thereof is also merely an argumentative conclusion, in that there is no identification of the material facts said to support the assertion that a person skilled in the art is not enabled to perform the invention; moreover the particulars do not appear to support that conclusion.
28 Senior Counsel for Merck informed the Court that an application for revocation of a patent was required by the former High Court Rules to provide particulars of alleged invalidity, and was similarly required to do so pursuant to the Supreme Court Rules. Order 58 rule 15 of the Federal Court Rules presently governs the requirement for particulars to be provided by an applicant for a revocation of a patent in the following terms:
'15 (1) A party who disputes the validity of a patent must deliver with the pleading or other document in which the party disputes the validity of registration, particulars of the grounds of invalidity on which the party relies.
(2) If one of the grounds referred to in subrule (1) is that the invention is not a patentable invention because of information about the invention in a document or through the doing of an act, the particulars must specify:
(a) in the case of a document - the time when, and the place where, the document is alleged to have become publicly available; and
(b) in the case of an act:
(i) the name of the person alleged to have done the act; and
(ii) the period in which, and the place where, the act is alleged to have been done publicly; and
(iii) a description that is sufficient to identify the act; and
(iv) if the act relates to apparatus or machinery - whether the apparatus or machinery exists and, if so, where it can be inspected.
(3) If one of the grounds referred to in subrule (1) is:
(a) that the invention, so far as claimed in any claim of the complete specification of the patent, is not useful; and
(b) it is intended, in connection with that ground, to rely on the fact that an example of the invention which is the subject of any such claim cannot be made to work, either at all or as described in the specification;
the particulars must identify each such claim and state that fact and must include the particulars of each such example, specifying the respect in which it is alleged that it does not work as described.
(4) Except by leave of the Court, evidence is not admissible in proof of a ground of invalidity of which particulars have not been given.'
29 There has never been, so far as Senior Counsel for Merck was aware, any requirement imposed on a patentee to provide any response to particulars of the kind stipulated by Order 58 rule 15 of the Federal Court Rules. No such requirement is at least explicitly imposed by the Rules. Consequently, he submitted, 'the ordinary principles apply', namely that the onus remains upon Arrow to plead and prove obviousness or lack of an inventive step, by undertaking a comparison between what has been claimed by Merck by way of a patent and what was the relevant prior art base. I was referred in detail to the recent restatement by the High Court of the basic principles of patent law, and in particular the principle that obviousness and inventiveness are antitheses, since '[w]hat is obvious cannot be inventive, and what is inventive cannot be obvious' (Aktiebolaget Hassle and Another v Alphapharm Pty Ltd (2003) 194 ALR 485 at 490-491 [20]) (Gleeson CJ, Gaudron, Gummow and Hayne JJ). Merck's submission therefore was to the effect that the statement of claim and the defence had already defined the issues in the traditional way, and Arrow's invocation of the Federal Court Rules, to the extent set out in [12] above, as a supposed basis for requiring Merck to in effect plead to Arrow's Amended Particulars of Invalidity, was misconceived.
30 Senior Counsel for Merck described the predication of Arrow's controversial Amended Particulars of Invalidity as being implicitly to the effect that the issues arising in the proceedings were not necessarily confined to the statement of claim and defence, and further that patent disputes are supposedly to be pleaded differently to what is required of other causes of action. He contended that Arrow's Amended Particulars of Invalidity were implicitly predicated on the notion that there must be an inventive step established by the grantee of a patent, when the patent is assessed on its own in comparison with the relevant prior art base, whereas the reality may be that a step is not inventive when taken on its own, but becomes inventive when taken in combination with another integer or other integers.
31 Merck placed reliance on the dictum of Aickin J in Wellcome Foundation, discussed in Alphapharm (at 494-5), where his Honour pointed out (at 272, 279 and 287)that inventions may be the outcome, not only of long experiments, profound research and skill, but also of chance, or of some sudden lucky thought, or merely an accidental discovery, and moreover must depend on the nature of the result ultimately claimed, whether product or process, viewed against the background of common general knowledge. Those restatements of principle tended to demonstrate, so Merck continued, the lack of utility, as well as of qualification as a pleading, of Arrow's Amended Particulars of Invalidity, and in any event the inappropriateness of Merck being required to plead thereto in ordersupposedly to define the issues arising in the proceedings, being a definition already established by the traditionally framed statement of claim and defence presently on file.
32 Senior Counsel for Merck then addressed the implications flowing from the High Court's reasons for decision in Bailey, and the reliance placed upon the same by Heerey J in Grace Australia, and pointed out that his Honour's judgment in Grace Australia was delivered shortly before the High Court's landmark decision in Alphapharm, and as a consequence, his Honour did not have the benefit of two critical points emerging from the joint judgment of Gleeson CJ, Gaudron, Gummow and Hayne JJ. The first was that it is not necessary that any of the events or steps taken in isolation in relation to the realisation of an invention should have involved an inventive capacity. The second was that the exercise of attempting to dissect an invention into steps or stages is one which is unlikely to reproduce what actually happened in the process of invention. There being no requirement for any so-called 'subjective inventiveness', and moreover a scintilla of invention being capable of supporting the grant of a patent, it was submitted on behalf of Merck that the point emphasised by Arrow, namely that Merck presumably knew what the invention comprises, because Merck must have known what the inventors actually did, misconceived the implications of the correct test as to the existence or otherwise of obviousness in patent law.
33 My attention was next drawn to the observation of Heerey J in [7] of his reasons for judgment in Grace Australia that 'it may be wasteful if the applicant has to gather evidence to counter every possible ground on which it might be shown that the invention was not obvious', and the further submission was made by Senior Counsel for Merck that his Honour thereby wrongly reversed the onus of proof and the order of inquiry in proceedings for revocation of a patent. The current order of inquiry was said to be whether the applicant for revocation has shown the alleged invention to be obvious, rather than whether the applicant for revocation has covered 'every possible ground of non-obviousness'. Moreover it was submitted by Merck that the dictum of Heerey J in Grace Australia extracted at [24] above, in so far as his Honour observed that what the inventor actually thought was an inventive step was 'certainly a starting point', could not survive part of the High Court's reasoning in Alphapharm which I have already summarised.
34 In relation to the reasoning and rulings of the High Court in Bailey, upon which reliance was placed by Heerey J in Grace Australia, Senior Counsel for Merck next drew attention to the following further matters:
(i) At the commencement of the reasons for judgment of Jacobs J in Bailey (at 221), his Honour observed that '[i]t is far more usual to order particulars of an allegation or claim which the party advancing it bears the burden of proving than particulars of a matter which may be alleged without undertaking the burden of its proof…'. In that context it was contended that ordinarily, a party simply denying the proposition of an opponent, which the opponent is required to prove, will not be subjected to an order to provide particulars.
(ii) In one of the authorities cited by Aickin J in Bailey (at 228), namely Pinson v Lloyds [1941] 2 KB 72, the allegation was that the defendant had dealt with certain property without the plaintiff's authority, and was merely denied by the defendant; understandably in that context, the defendant was ordered to indicate that if the denial was intended to be addressed to the allegation of dealing with the property, particulars of what was alleged to be the plaintiff's authority should be provided; in other words, the mere denial pleaded by the defendant was ambiguously inadequate as a joinder of issue.
(iii) The other authority cited by Aickin J (at 228), namely George v Federal Commissioner of Taxation (1952) 86 CLR 183, involved the refusal of the Commissioner to particularise the source of a taxpayer's taxable income the subject of a default assessment of tax. In refusing to order the Commissioner to particularise the sources of additional taxable income the subject of the default assessment, Kitto J (sitting as a single justice of the High Court) explained in George (at 190) as follows:
'I was not referred to any authority on the point, and so far as I know there is none. But an analogy may be found in the cases in which the courts in England have considered applications by plaintiffs upon whom lies the onus of proving a negative, for particulars from defendants who have put in issue the plaintiff's negative allegation. The principle laid down is that if it is clear to the court, either from the nature of the case or from the admission of counsel or otherwise, that the defendant intends under his denial of the negative, to set up an affirmative case, particulars of the defendant's case may be ordered; but not otherwise…'
His Honour's reasons for judgment in George were subsequently upheld by a Full High Court (whose unanimous judgment is simultaneously reported with that of Kitto J at first instance). There could be no viable contention on the part of Arrow that Merck's denial of invalidity of the subject Patent involved the setting up of an 'affirmative case', in the sense explained above in George.
35 By way of a concluding observation made in relation to the first order sought by Arrow in its notice of motion, Merck submitted that what Arrow was seeking thereby to impose indirectly upon it, by way of purported particulars constituted by the Amended Particulars of Invalidity document, was a case which Merck has not advanced by reason of its denial of Arrow's claim of invalidity.
36 As to the second order sought by Arrow in its notice of motion set out in [10] above, to the effect that Merck provide particulars of the inventive step said to give rise to its patented invention within s 18 of the Act, Merck repeated what it had contended in derogation of the first order sought by Arrow, namely that what Arrow was seeking to require was again in substance that Merck plead to a case which Merck has not pleaded.
37 As to the third order sought by Arrow in its notice of motion set out in [10] above, namely that Merck provide particulars identifying the person or persons skilled in the relevant art in relation to the Patent, Merck contended that the same suffers from a not dissimilar defect, in that Arrow does not thereby seek particulars of anything pleaded, Merck having nowhere made reference in its defence to any person or persons skilled in the relevant art in Australia in relation to the Patent.
Conclusions regarding orders sought by Arrow that Merck plead to the Amended Particulars of Invalidity, and serve particulars of the inventive step and of identification of the person or persons skilled in the relevant art
38 I am of the opinion that Arrow is not entitled to the first three orders of its notice of motion. The submissions of Merck, in opposition to the making of those orders, are in my opinion essentially correct. In the absence of support from the Federal Court Rules, I think that I should take the conservative approach of denying to Arrow in principleentitlement to an order of a pleading character having the tendency to cast an evidentiary onus upon Merck to establish the viability of its Patent. The time has arrived, or will shortly arise, for Arrow to establish its prima facie case by affidavit evidence in chief upon which it will rely for initiating its attack upon the viability of the patent. That process seems to me to be more likely to expose whatever case is intended to be pursued by the parties, in consonance with the principles recently enunciated by the High Court in Alphapharm.
39 As I have foreshadowed, I do not think that any decisive assistance is obtainable by Arrow, at least at the present stage of this litigation, from Grace Australia. Apart from the circumstance that Heerey J did not have the benefit of the authoritative restatement of applicable principles of patent law which has since been provided by the majority judgments of the High Court in Alphapharm, the progress of the litigation in Grace Australia, at the time of the procedural order made by Heerey J, was not sufficiently comparable with that of the subject proceedings. Moreover as I have already outlined, I do not think that the earlier High Court's approach to the income tax interlocutory litigation in Bailey can provide judicial precedent for the interlocutory circumstances of patent litigation, at least of the kind here involved. Moreover I do not think that it is accurate for Arrow to describe the Amended Particulars of Invalidity as containing 'very substantial particulars of common knowledge', such as to authorise the procedural obligations upon Merck presently propounded by Arrow. Though the amendments made since the filing of the initial Particulars of Invalidity have added a certain degree of specificity not previously present, it seems to me that apart from any preliminary or initial discovery issues which either party now or hereafter seeks or might hereafter seek to pursue, the next major interlocutory course to be pursued in the proceedings should be the filing of affidavit evidence, in the first instance in chief by Arrow. I will leave it to the parties to raise an appropriate affidavit regime in due course.
40 I would add the observation that Merck has of course already undergone the statutory procedure conducted by the Commissioner of Patents, including any opposition process within Chapter 5 of the Act that might have taken place, in order to obtain the grant of the Patent. Whether Merck encountered any objections from Arrow or otherwise in the course of that process, I do not know, though I appreciate that such a process would doubtless have involved a less formidable scope of challenge than may be anticipated in relation to the present revocation proceedings (F Hoffman-La Roche AG v New England Biolabs Inc (2001) IPR 305 at 315-319).
41 I am hence of the view that Arrow is not entitled, at least at this stage of the proceedings, to any of the first three orders sought by Arrow's notice of motion.
Merck's submissions in reply to Arrow's notice of motion for categories of documents required to be immediately discovered by Merck
42 As to the fourth order sought by Arrow in its notice of motion set out in [10] above relating to discovery of the documents enumerated in [11] above, Merck's responses to the extent of outstanding controversial categories remaining for my resolution were as follows:
(i) as to categories 1 and 2, without conceding the viability of Arrow's entitlement to discovery thereof, at least at this stage, Merck will give discovery thereof up to 17 July 1998;
(ii) as to category 3, Merck accepted that it was possible that the category of documents described in sub-pars (ii) and (iv) thereof could contain discoverable material under ordinary principles, but as the category is presently framed, by reason of the words 'which are or which confirm, refer to or relate to', this request of Arrow is 'still oppressive, far too wide and remote'; moreover the basis for the order in its entirety was 'fishing' and entirely speculative;
(iii) as to category 4, Merck has agreed to discover the same, conditional upon the replacement of the words 'whether internal to the Respondent or otherwise' by the words 'internal to the Respondent', and the replacement of the words 'up until two (2) years after the date of first marketing of non-daily dosage forms of alendronate in Australia' by the words 'before 17 July 1998 in Australia';
(iv) as to category 5, Arrow has, in the first instance, sensibly confined the request for discovery to 'one sample document of each marketing document or advertisement of a pharmaceutical composition or medicament which embodies, consists of or relates to the Alleged Invention or any instructions for administration of such a composition'; given that the justification for the request was to establish the period of time of prior use, Merck agreed to offer one document which would show the date on which its marketing began; subject thereto, Merck asserted that the more widely framed category sought by Arrow was unnecessary and burdensome.
(v) as to category 8, Merck maintained its opposition to production thereof, even as subsequently redefined by Arrow, as 'too remote', and pointed out in any event that the specifications referred to were already in the possession of Arrow.
43 My resolution of the residual five areas of dispute, assisted by certain compromises sensibly made by both parties in the course of submissions, is as follows:
(i) As to categories 1 and 2 (see again [11] above), Arrow contended that discovery should be made by Merck up to the latest priority date for which Arrow bona fide contends, which is apparently the time when Merck made substantial amendments to the Patent on 10 October 2001. That outcome would be consistent, so Arrow contended, with the approach adopted by Branson J in Lubrizol Corporation Inc & Ors v Imperial Chemical Industries PLC (2001) 50 IPR 526 (at 532-533), as follows:
'I am satisfied that there is a genuine dispute between the parties as to the priority date of the claims of the complete specification of each patent application and that the identification in each proceeding of the priority date of the claims may prove to be of crucial importance to the outcome of the proceedings. In these circumstances, I conclude that the interests of justice require that the respondent give discovery of documents relating to its research, development or experimental work concerning each of the alleged inventions up until the latest (ie the nearest in time to the present) priority date for which the applicant in the relevant proceeding contends in respect of the relevant claims.'
Incidentally, I have encountered one indication in the papers that the relevant day in October 2001 was the twentieth and not the tenth day of that month, something which should be verified. Without prejudice to any later application which Arrow may make on the issue, Arrow has tentatively agreed at any rate to a cut-off day for discovery of this category to 17 July 1998, being the compromise date proposed by Merck, and I will so order, though with liberty to either party to subsequently apply.
(ii) As to category 3, Senior Counsel for Merck conceded that it was possible that the same could contain documents which are discoverable under the ordinary principles, but that circumstance would not make the whole class discoverable. Arrow proposed that category 3 be amended to read as follows:
'All documents falling within the class of documents identified in FCR Or 15 r 2(2) and which are or which confirm, refer to or relate to applications to, correspondence with and communications to or from the following or any of their respective employees or agents to obtain:
(i) US Food and Drug Administration approval;
(ii) Australian Therapeutic Goods Administration approval;
(iii) Listing on the Australian Pharmaceutical Benefits Scheme; or
(iv) European Medicines Evaluation approval,
For pharmaceutical compositions or medicaments or relating to the Alleged Invention.'
Merck maintained nevertheless outstanding concerns in relation to sub-categories (i) and (iv) above and, to the expression 'which are or which confirm, refer to or relate to', and maintained that the categories remained oppressive, far too wide and remote, and further that the basis for the order sought was 'fishing and entirely speculative'. No submission was made by Merck as to confidentiality or privilege. I would allow categories (ii) and (iii) in the first instance, on the basis that the words 'or which confirm, refer to or relate to' are omitted, and grant liberty to Arrow to apply, after completion of the initial discovery process, in relation to categories (i) and (iv). I have adopted that tentative course, largely because of the apparently different patent regimes of those countries to that of Australia.
(iii) As to category 4, I would accept Merck's contention that the words 'whether internal to the Respondent or otherwise' should be replaced by the words 'internal to the Respondent'; otherwise I record Arrow's agreement that the words 'up until two (2) years after the date of first marketing of non-daily dosage forms of alendronate in Australia' should be replaced by the words 'before 17 July 1998 in Australia'.
(iv) As to category 5, Arrow has offered to accept, as sufficient for discovery purposes, that Merck produce 'one sample of each marketing document or advertisement of a pharmaceutical composition or medicament which embodies, consists of or relates to the Alleged Invention or any instructions for administration of such a composition'. Merck's response was that all that was relevantly required was one document showing the date on which Merck's marketing began, and that any wider category would be 'unnecessary and burdensome'. I would incline to the view that category 5 as proposed by Arrow is reasonable, so long as the same is confined to advertising in Australia, at least in the first instance undertaken up to 17 July 1998, and that Merck is not required to account for such advertising in Australia which can no longer be located. In the event of dispute arising in relation to the manner and extent of implementation of discovery of this category, or otherwise as to any expansion of the present scope of this ruling, there should again be liberty to apply.
(iv) As to category 8, Arrow seeks discovery of applications to register, including submissions made and correspondence with the relevant Patent authorities regarding the prosecution of a number of listed cognate patents; Arrow has agreed for the time being to confine this category to the following patent applications/patents:
(i) US Provisional Application 60/053.535;
(ii) US Provisional Application 60/053.351;
(iii) PCT/US98/14796;
(iv) US 09/388.659 (CIP).
Each of the above four patent applications/patents was said by Arrow to be directly relevant to the patent in suit, and to be specifically referred to in par 1 thereof. The contents of each was further said to be 'incorporated by reference in their entirety into the subject Patent in suit'. It was therefore submitted by Arrow that the documents sought are clearly relevant and ought to be discovered. Merck's response was that even the limited category proposed by Arrow remains remote to the issue of absence of inventiveness, and that the specifications referred to are already in Arrow's possession. Merck emphasised the uncertainty and difficulty in any purported reliance upon foreign laws, as emphasised in Alphapharm. Consistently with the approach to discovery which I have taken in relation to category 3, in so far as the same relates to overseas patent matters, I will not order discovery of this category at all. However there should be liberty to apply upon the same basis as that indicated above for category 3.
Merck's notice of motion for interlocutory orders
44 Merck by notice of motion seeks the following orders against Arrow:
'1. that on or before a date to be fixed by the Court the applicant provide further and better particulars of its Amended Particulars of Invalidity filed on 7 February 2003;
2. that on or before a date to be fixed by the Court the applicant give discovery with verification of documents in the categories set out in Schedule A to this Notice of Motion by service on the respondent of a list of documents in conformity with Order 15 Rule 6 of the Federal Court Rules;
3. that on or before a date to be fixed by the Court the applicant make available for inspection the documents contained in the list of documents served pursuant to Order 2 above.'
45 The categories of documents the subject of the above extracted order 2 of and Schedule A to Merck's notice of motion for discovery are as follows:
'1. All documents recording or relating to research conducted by or on behalf of the applicant concerning bisphosphonates generally and alendronate in particular administered as therapeutic agents in the treatment of prevention of diseases caused by or associated with abnormal bone resorption including, without limitation, the inhibition of bone resorption, treatment of osteoporosis and/or the prevention of osteoporosis.
2. All documents recording or relating to research conducted by or on behalf of the applicant concerning a non-daily dosage regimen of bisphosphonates generally and alendronate in particular administered as therapeutic agents in the treatment or prevention of diseases caused by or associated with abnormal bone resorption including, without limitation, the inhibition of bone resorption, treatment of osteoporosis and/or the prevention of osteoporosis or the development of any such regimen, including but not limited to tests, experiments and trials.
3. All documents referring to or concerning Australian Patent no 741818 or the subject matter thereof which relate to the validity or otherwise of the Patent on the grounds set out in the Amended Particulars of Invalidity.
4. All documents recording or relating to any test, experiment or trial performed by or on behalf of the applicant to evaluate or determine the validity or otherwise of Australian patent no 741818 on the ground set out in the Particulars of Invalidity.
5. All documents constituting, referring to or concerning the documents referred to in Annexures A and B to the Particulars of Invalidity.
6. All documents constituting, recording or relating to the prescriptions given by Dr Phillip Sambrook as referred to in paragraphs 3 and 4 of Annexure A to the Particulars of Invalidity, including any correspondence between Dr Sambrook and the applicant or any other person on behalf of either of them.
7. All documents upon which the applicant proposes to rely at the trial of this action.'
46 The focus of Merck's notice of motion is essentially upon Arrow's Amended Particulars of Invalidity, which I have summarised and largely extracted in [4-9] above, and Annexure A thereto reproduced at [11] above. Annexure B thereto comprises eleven publications made between 1991 and 1997. I will address below in sequence each of the three orders the subject of Merck's notice of motion.
Further and Better Particulars sought by Merck in relation to pars 3 to 6 of Annexure A to the Amended Particulars of Invalidity
47 The first order sought by Merck's notice of motion was said by Merck to concern the 'acts' the subject of pars 3, 4, 5 and 6 of Annexure A to the Amended Particulars of Invalidity, which were described by the letter of Arrow's Solicitors of 7 February 2003 in response as 'related', and thus to be read as a single source of information, and to be in any event 'a matter for evidence'. Annexure A is the Arrow document already reproduced in [5] above, which is said by par 5 of the Amended Particulars of Invalidity, under the heading 'Lack of Novelty', to contain a description of the prior art information publicly available by the publication of the documents or the doing of the acts referred to in the said Annexure 'A'.
48 Merck submitted that pars 3 to 6 of the Annexure A to the Amended Particulars of Invalidity refer to a variety of different matters spread over the period of time from 1995 to 2001. Merck then pointed to par 6 of the Amended Particulars of Invalidity document itself, which has been summarised in [6] above, and which inferred already, so Merck submitted, that the relationship between the pieces of information the subject of Annexure A is such that a person skilled in the relevant art in the patent area would have combined them, in order to produce an inventive step, in effect antecedently to that the subject of the Patent (see again the s 7(2) definition of 'Inventive Step' extracted in [25] above). Merck further submitted that no relationship had been identified between the matters set out in the said Annexure A, and thus there could be no factual basis for the conclusion that a person skilled in the relevant art in the patent area would have combined them in order to produce an inventive step.
49 Arrow's response was that a person skilled in the relevant art would in fact treat the events described in pars 3 to 6 of Annexure A as a single source of information within s 7(1)(b) of the Act, and moreover that there was no requirement that the matters be performed publicly. Set out below for convenience of reference is s 7(1)(b) of the Act:
'7(1) For the purposes of this Act, an invention is taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
…
(b) prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information.'
50 Arrow further submitted that the question thus arising pursuant to s 7(1)(b) is one of fact which is properly the subject of evidence, and that the particulars supplied in the Amended Particulars of Invalidity have already made Merck aware of the allegation it was required to meet. In that regard, Arrow said that '…it is obvious from the particulars already supplied that the location was Royal North Shore Hospital'. Moreover in so far as Merck had pressed for particulars of documents relied upon in support of par 6, Arrow would respond to that request. I do not think moreover that the assertion of obviousness is as readily apparent as Arrow has claimed.
51 Merck rejoined as follows:
(i) by pars 5 and 6 of the Amended Particulars of Invalidity, referred to and extracted in [5-6] above, Arrow contended that there was a lack of novelty and of an inventive step, contrary to ss 18(1)(b)(i) and 18(1(b)(ii) of the Act;
(ii) by the definition set out in Schedule 1 to the Act, the 'prior art base', so far as presently relevant, is limited to 'information in a document that is publicly available', or made publicly available 'through doing an act, whether in or out of the patent area';
(iii) both the statutory notions of novelty and inventive step are required by s 7 to be tested against the prior art base;
(iv) the only acts that Arrow can rely upon in the present context are acts that made information publicly available, and not merely some other or anterior acts; and
(v) Order 58 rule 15(2) of the Federal Court Rules (extracted in [28] above) requires in effect that a person disputing the validity of a patent must establish, in the case of 'an act', the matters set out in par (b) of subs 15(2), including 'the period in which, and the place where, the act is alleged to have been done publicly'.
Consequently, so Merck further submitted, '… these parts of r 15 are intended to prevent exactly the sort of evasiveness shown by [Arrow] in the present case'.
52 In my opinion, the submissions of Merck are to be preferred, for the reasons which Merck has advanced, and which I need not rehearse. Merck is entitled to the further and better particulars in relation to the matters the subject of the first order sought by Merck's notice of motion, at the time the same were duly requested.
Discovery sought by Merck
53 As to the second order sought by Merck's notice of motion, that is to say, for discovery of the categories of documents set out in Schedule A to the notion of motion extracted in [45] above, Arrow responded, in my opinion constructively. Categories 4 and 6 were accepted by Arrow without reservation or qualification.
54 As to category 1, Arrow submitted as follows:
'21. The respondent's category is not limited as to time and is too broad.
22. As to breadth, the category seeks production by the applicant of all documents relating to research conducted by the applicant concerning 'bisphosphonates generally and alendronate in particular administered as therapeutic agents in the treatment or prevention of diseases caused by or associated with abnormal bone resorption including, without limitation, the inhibition of bone resorption, treatment of osteoporosis and/or the prevention of osteoporosis…'. The patent does not directly claim bisphosphonates generally or alendronate per se. It is for the dosing and administration regimens for those substances. There is no limitation in this category by reference to the invention claimed in the Patent in dispute. Unless the respondent contends (and does so as an admission) that the claims of the Patent include as part of the invention all matter that falls within this category, it is submitted that the documents sought are clearly broader than the claims of the Patent. A copy of the claims in the Patent is attached to these submissions.
23. As to timing, the priority date of the Patent asserted by the respondent is 27 July 1997 (transcript page 60). It is said by the respondent that the category goes to the issues of obviousness and sufficiency. In the case upon which the respondent relies - F Hoffman-La Roche v Chiron Corporation (2000) 47 IPR 516 - Burchett J accepted (at paragraph 14) that the revoker could be obliged to give discovery of documents relevant to obviousness, but noted such documents could only be relevant up to the priority date of the Patent. Where sufficiency was in issue, his Honour accepted that discovery should be limited, in accordance with the practice in the United Kingdom, to a period of two years after the priority date.
24. If the court adopts the view that the notional Priority Date proposed in paragraph 6 above is an appropriate cut off for the provision of discovery of the respondent's documents, then it is submitted that this priority date also be accepted by the provision of discovery by the applicant. Accordingly, it is proposed that, to the extent that the applicant is required to give discovery in this category at all, the applicant give discovery up until two years after 17 July 1998 - ie until 17 July 2000.'
55 As to limitation on the period of time for discovery of category 1, consistently with what appears in [43(i)] above, the proposal of Arrow is reasonable. As to the breadth of Merck's category 1, I am of the opinion that at least in the first instance, the same should be limited to the extent proposed, but Merck should have liberty to apply.
56 As to category 2, Arrow submitted as follows:
'25. The same criticisms concerning timing apply to category 2. It is submitted that the Notional Priority Date (plus two years as a result of the sufficiency argument) be applied to this category also.
26. The same criticism concerning breadth does not apply to category 2 as it does for category 1 because category 2 limits the discovery to documents which refer to 'a non-daily dosage regimen of bisphosphonates' which appear to fall within the matter which is claimed to be the subject of the Patent.'
I make the same observation, concerning timing and breadth as I have in relation to category 1.
57 As to category 3, I agree with the substance of Arrow's complaint set out below; Merck shall have liberty to apply in respect of a more confined category, in conformity with Arrow's complaint:
'27. This category seeks discovery of all documents referring to or concerning the Patent in suit. The respondent makes no attempt to limit the discovery to documents relevant to any of the issues in the proceedings. Nor is there any limitation as to the date of creation of the documents sought. It is submitted that this category is far broader than any general discovery would require. There can be no justification for putting the applicant to the burden of producing such documents.'
58 As to category 5, the grounds of Arrow's complaint are as follows:
'29. It is submitted that this category is too broad. It seeks production of documents 'referring to or concerning' documents, particulars of which have been provided and copies of which have been supplied to the respondent. The request is a request for documents that make secondary references to the documents supplied.
30. The construction of documents for the purposes of novelty and obviousness is a matter for the court. The role of expert evidence as to the interpretation of those documents is limited (see Minnesota Mining and Manufacturing v Tyco Electronics (2000) FCAFC 315 at [40] - copy previously supplied). In this context, the likely utility of documents commenting on the contents of primary documents by any one of an unspecified range of persons with or without qualifications as an expert within this category would, at best, be nominal. Further, most, if not all of the documents in this category would be privileged.
31. To require the applicant to review all documents created before and after the priority date of the Patent, to locate, list and then claim privilege of documents of such nominal (if any) relevance is, it is submitted, simply a waste of time and cost and falls outside of the balance between requiring the discovery of documents and the benefit to be achieved from such documents.'
Again there is substance in the thrust of Arrow's complaints. I have not of course perused any documents of the kind or scope which Merck has so broadly described; at least as presently framed, this category must be disallowed. Merck must demonstrate greater specificity, and in any event, more persuasive potential utility.
59 As to category 7, Arrow submitted as follows:
'33. This category seeks 'all documents upon which the applicant proposes to rely at trial'. This category is impractical and unduly burdensome.
34. The decision as to what will be relied upon will not be made until shortly before the hearing. Legal advisors may now have an idea of what they think may be relied upon, but that will no doubt change as the preparation for trial matures. In any event, many of the central documents have been identified in the Particulars of Invalidity. The parties will have the further benefit of affidavit evidence in chief, in answer and in reply. They will not be taken by surprise. It is not the purpose of discovery to require a party to identify documents upon which it may rely long before the final hearing of the case. Other pre-trial procedures (including bundles of documents and pre-hearing submissions) are available for that and will more appropriately apply at a time when the case is far closer to hearing.'
This category is not so broad as to be described as a request for general discovery. I would imagine in any event that many of the documents within this category will be annexed or exhibited to Arrow's affidavit evidence. It may well be that after all affidavit evidence has been filed by the parties, there would conceivably be an application for general discovery. In the meantime I would disallow category 7 as oppressive and burdensome.
Conclusion
60 It follows that Merck has succeeded in obtaining the relief it has sought in relation to the further and better particulars whereas Merck has not been successful or entirely successful in relation to the discovery issues the subject of debate.
61 The notices of motion of the respective parties should be stood over to a date to be fixed by arrangement between the parties and the Court, in order that short minutes reflecting the reasons of the Court may be brought in, and for the hearing of submissions as to costs.
I certify that the preceding sixty-one (61) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Conti.