The Boots Company (Australia) Pty Ltd v Smithkline Beecham Healthcare Pty Ltd (Formerly Sterling Winthrop Pty Ltd)

[1995] FCA 1039

CATCHWORDS

Trade Practices - interlocutory application - marketing and advertising of analgesics - market positioning strategies - promotional material - whether false representations made in relation to goods - whether statements amount to conduct which is misleading and deceptive or likely to mislead or deceive - tests applicable to interlocutory applications.

Trade Practices Act 1974 s 52, s 53, s 80, s 82, s 87.
Therapeutic Goods Act 1989.

Sterling Winthrop Pty Ltd v The Boots Company (Australia) Pty Ltd, Tamberlin J, 23 August 1995, unreported, referred.
Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618 at 622, applied.
Shercliff v Engadine Acceptance Corporation Pty Ltd [1978] 1 NSWLR 729 at 736, applied.
Castlemaine Tooheys Ltd v South Australia (1986) 161 CLR 148 at 153, 154, applied.
Janssen Pharmaceutical Pty Ltd v Pfizer Pty Ltd (1986) 8 ATPR 40-654, considered.
Colgate Palmolive Pty Ltd v Rexona Pty Ltd (1981) 58 FLR 391, considered.
R & C Products Pty Ltd (t/a Samuel Taylor) v S C Johnson & Sons Pty Ltd (1993) 42 FCR 188 at 189, referred.

THE BOOTS COMPANY (AUSTRALIA) PTY LIMITED v SMITHKLINE BEECHAM HEALTHCARE PTY LIMITED (FORMERLY STERLING WINTHROP PTY LIMITED)
No. NG 856 of 1995

CORAM:Lehane J

PLACE:Sydney

DATE:        29 November 1995

IN THE FEDERAL COURT OF AUSTRALIA                 )
NEW SOUTH WALES DISTRICT REGISTRY                )
GENERAL DIVISION  )     No. NG 856 of 1995

BETWEEN:THE BOOTS COMPANY (AUSTRALIA) PTY LIMITED

Applicant

AND:SMITHKLINE BEECHAM HEALTHCARE PTY LIMITED (FORMERLY STERLING WINTHROP PTY LIMITED)

Respondent

CORAM:Lehane J

PLACE:Sydney

DATE:29 November 1995

MINUTE OF ORDERS

THE COURT ORDERS THAT:

1.      Upon the applicant by its counsel giving the usual undertaking as to damages, until further order of the Court the respondent by itself, its servants or agents or otherwise, be restrained from, in trade or commerce, using, publishing or distributing matter in the form or substantially in the form of the trade detailer that is exhibit "DMMS1" to the affidavit of David Montagu Martindale Stephens sworn 14 November 1995.

2.      On the same undertaking the respondent forthwith take such steps as are
         practicable to recover from the market place all such trade detailers.

3.      Otherwise, the applicant's motion be dismissed.

4.      Costs be reserved.

NOTE:        Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA                 )
NEW SOUTH WALES DISTRICT REGISTRY                )
GENERAL DIVISION  )     No. NG 856 of 1995

BETWEEN:THE BOOTS COMPANY (AUSTRALIA) PTY LIMITED

Applicant

AND:SMITHKLINE BEECHAM HEALTHCARE PTY LIMITED (FORMERLY STERLING WINTHROP PTY LIMITED)

Respondent

CORAM:Lehane J

PLACE:Sydney

DATE:29 November 1995

REASONS FOR JUDGMENT

LEHANE J: 
Background

The applicant and the respondent are both members of substantial corporate groups involved in the manufacture and sale of therapeutic products.  The products with which this case is concerned are analgesics, particularly what are known as over‑the‑counter, or OTC, analgesics.  The applicant has such a product, known as Nurofen, the active ingredient of which is ibuprofen.  The respondent has two well‑known products, Panadol (the active ingredient of which is paracetamol) and Panadeine (the active ingredients of which are paracetamol and codeine); it also has a product known as Actiprofen, which like the applicant's Nurofen has, as its active ingredient, ibuprofen.

OTC drugs, including analgesics, are classified according to the Standard for the Uniform Schedule of Drugs and Poisons.  The classifications relevant to this case are Schedule 2 and Schedule 3.  A drug which is classified as Schedule 3 may be sold only by a pharmacist or a medical, dental, or veterinary practitioner, must be kept in a restricted part of the premises to which the public does not have access and may not be promoted or advertised direct to consumers.  A drug which is classified as Schedule 2 is, in general terms, available to the public only from pharmacies but need not be kept in a restricted part of the premises and may be advertised directly to the general public.  Some analgesics are "unscheduled", which means that their sale is not restricted to pharmacies: they may, for instance, be sold in supermarkets.

Of the analgesics with which this case is principally concerned, Panadol is unscheduled in packs of 25 tablets or fewer and in larger packs is classified as Schedule 2.  Panadeine is classified as Schedule 2.  Ibuprofen (and hence both Nurofen and Actiprofen) is classified as Schedule 3 but, following an application made by the applicant in February 1995, is likely towards the end of December 1995 to be reclassified as Schedule 2.  That will mean that both Nurofen and Actiprofen may, from the time when the rescheduling happens, be advertised directly to the general public.

In those circumstances, both the applicant and the respondent have plans to "launch" their ibuprofen products by way of advertising campaigns directed at consumers as well as doctors and pharmacists.  The applicant, apparently, does not itself have in the market OTC analgesics with which its product Nurofen might compete.  Its proposed message is, therefore, a simple one: Nurofen does what other OTC analgesics, particularly those (like Panadol) whose active ingredient is paracetamol, will do but does it faster and more effectively.  Included in the applicant's aim is the acquisition of some of the market share at present held by Panadol, which is the clear market leader.  The respondent, of course, is in a slightly more difficult position.  As its counsel elegantly put it, the respondent has no wish to "cannibalise" its own highly successful product Panadol or, presumably, to gain sales merely at the expense of its other product Panadeine.  Its intended approach, therefore, is to "position" its ibuprofen analgesic, Actiprofen, as an appropriate analgesic for use against pain (particularly "strong" pain) with inflammation and against "strong", "severe" or "extra strong" pain more generally.

The respondent has already sent to doctors and pharmacists, and published in journals circulating among pharmacists, promotional material which vigorously foreshadows the message intended, on rescheduling, to be published abroad to consumers.

Applicant's claim

The applicant claims that the respondent's promotional material includes false representations in relation to goods, of a kind forbidden by s 53 of the Trade Practices Act 1974 and that the making of a number of the statements contained in the material amounts to conduct that is misleading or deceptive or is likely to mislead or deceive - i.e., conduct of a kind forbidden by s 52 of the Act. The applicant seeks orders under ss 80, 82 and 87 of the Act and, by the amended notice of motion with which I am now concerned, seeks certain interlocutory injunctions pending the final hearing of its application.

The interlocutory orders sought by the applicant are as follows:

1.      An injunction restraining the respondent by itself, its servants or agents or otherwise from using, publishing or distributing any promotional material, advertisements or other material in the form or substantially in the form of any of [a number of specified exhibits (to the detail of which I shall have to return later in these reasons)].

2.      An order requiring the respondent forthwith to take such steps as are practicable to recover from the marketplace [a number of those exhibits and to prevent the further publication of substantially similar materials].

3.      An injunction restraining the respondent by itself, its servants or agents or otherwise from using, publishing or distributing any promotional material, advertisements or other material which includes any of the following representations or substantially similar representations:

(a)     Actiprofen is suitable for use for any of:

(i)     persistent pain;
                  (ii)     strong pain;
                  (iii)    strong pain with inflammation;
                  (iv)    severe pain;
                  (v)     very strong pain; and

(vi)    extra strong pain.

(b)     Actiprofen is suitable to recommend for use for any of:

(i)     persistent pain;
                  (ii)     strong pain;
                  (iii)    strong pain with inflammation;
                  (iv)    severe pain;

(v)     very strong pain; and

(vi)    extra strong pain.

(c)     Actiprofen is approved for use for each of:

(i)     persistent pain;
                  (ii)     strong pain;
                  (iii)    strong pain with inflammation;
                  (iv)    severe pain;
                  (v)     very strong pain; and
                  (vi)    extra strong pain.

(d)     Actiprofen provides pain relief faster than any other over the counter analgesic available in tablet form.

(e)     Actiprofen provides pain relief faster than other ibuprofen products.

(f)     The introduction of Actiprofen is the most significant development in over the counter pain relief in Australia for many years.

(g)     Actiprofen is a significant improvement over other over‑the‑counter analgesics that have been available in Australia for the last few years.

(h)     Actiprofen is superior to other analgesics containing ibuprofen.

4.      An injunction restraining the respondent by itself, its servants or agents or otherwise from advertising Actiprofen for an indication other than headache, the temporary relief of minor aches and pains associated with the common cold, dental pain, period pain, the minor pain of arthritis, the relief of acute and/or chronic pain states in which there is an inflammatory component.

The respondent's promotional material

An understanding of the applicant's claims requires a somewhat more detailed description of some of the material of which it complains.

1.      The respondent has distributed among pharmacists a document, or at least an object, described as a trade detailer.  It is made of cardboard, coloured red.  Perhaps appropriately to the advent season, it comprises a series of panels which, when opened, display a succession of messages about Actiprofen.  The message on the front is "the biggest thing to happen in OTC pain relief".  On the next panel there was displayed, in the original version, the message "is also the fastest"; the next panel proclaims "introducing Actiprofen fast effective relief from strong pain" and the fourth tells one that the new product comes "from the Makers of Panadol".  Once all four panels are opened, a series of further messages is displayed.  The applicant complains about some of these, including the following:

(a)     "Actiprofen, no other tablet works faster";

(b)     "with 200mg of ibuprofen as the active ingredient, Actiprofen works faster than other pain relievers with the onset of pain relief usually occurring within 15 minutes" (a statement purportedly supported by an article, a reference to which is given);

(c)     "strong pain and inflammation", a phrase appearing in a number of panels in the centre of the detailer; and

(d)     "Australian research has shown that many consumers choose to keep normal strength and extra‑strength products on hand at all times" (the suggestion being that Actiprofen is in the latter category).

Following initial complaints by the applicant, through its solicitors, the respondent withdrew the detailer and amended copies distributed later by sticking a new message over each of two of the messages of which the applicant complained: thus "is also one of the most exciting" replaced "is also the fastest" and "Actiprofen contains 200mg of ibuprofen as the active ingredient, for fast, effective pain relief" replaced "with 200mg of ibuprofen as the active ingredient, Actiprofen works faster than other pain relievers, with the onset of pain relief usually occurring within 15 minutes".  The reference to the journal article was retained.  There is evidence of the recovery from pharmacies of some copies of the detailer on which the first amendment had been made but not the second; the respondent, however, asserts that it has no intention of distributing any copies of the detailer except copies incorporating both amendments.

2.      A leaflet headed "which product for what pain?", distributed to pharmacists; there is also a suggestion, I think, that it may be designed for distribution, when that is lawful, to consumers.  On the inside of the leaflet there is a heading, printed prominently in white on a red background "Actiprofen - no other tablet relieves strong pain faster".  The leaflet suggests that "there are days when acute or persistent, severe pain just gets you down; the kind of pain which, when it strikes, makes it hard to think about anything else"; then it is suggested that Actiprofen is "the advanced pain reliever that acts directly on the pain site to provide fast, effective, temporary relief of acute, severe pain and discomfort associated with headache, period pain, the common cold, toothache or other
acute pain where inflammation is present".  It is also said to be a "powerful product for day‑to‑day control of strong pain."  There is then a heading "fast relief from strong pain" under which are listed a series of conditions which may give rise to pain.  Among that material are references to "strong, throbbing headaches", "severe headaches which call for a strong pain reliever", "unbearable" period pain, the "strong pain arising from inflammation and swelling of toothache or dental surgery" and "severe back pain with inflammation".  Then, on the back of the leaflet, there appears what counsel for the applicant graphically described as the "pain ladder" or "hierarchy of pain".  The crucial statement is:

Actiprofen joins a family of products brought to you by the makers of Panadol, the proven and trusted name for pain relief.  Now you can choose the product that's right for your pain:

.Panadol for mild to moderate "everyday" pain;

.Panadeine for strong pain;

.Actiprofen for extra strong pain and strong pain with inflammation.

There are then given a series of "good reasons to choose Actiprofen for extra strong pain and strong pain with inflammation", the first of which is that "no other tablet relieves strong pain faster".  Then on the next, and last, panel of the leaflet there appears a table headed "choosing the right pain reliever".  The table has two columns one headed "pain state" and the other headed "product". The three pain states are "mild to moderate "everyday" pain", "strong pain" (or "stronger‑than‑normal pain") and "extra strong pain and strong pain with inflammation".  The product for the first is Panadol, that for the second is Panadeine and Actiprofen is said to be the analgesic of choice for the third.  The material relating to mild pain and Panadol is coloured green, that dealing with strong pain and Panadeine blue and the material about Actiprofen, and the pain state for which it is recommended, red.

3.      A "ready reckoner", also headed "which product for what pain" and, like the leaflet, describing the particular sorts of pain with which it is concerned as "headache, arthritis, period pain, dental pain, back pain and muscle pain".  It then invites the user to choose the right pain reliever by asking first "is it you or a child under age 12 who needs treatment?", by then discovering whether the pain is "normal/milder" or "strong/severe" (one side of the ready reckoner deals with the former, the other with latter) and finally, by asking whether there is inflammation.  One then turns to the appropriate side of the ready reckoner and pulls where indicated at the bottom of it to display, in a panel, the sort of pain for which a recommendation is sought against which there appears the recommendation itself.  On the "normal/milder side" Panadol only is recommended for each type of pain (i.e., headache, dental pain, period pain, arthritis, back or muscle pain) where there is no inflammation and Actiprofen, alone, is recommended in each case (other than period pain) where there is inflammation.  If one turns to the other side of the ready reckoner (the "strong/severe" side) one finds Panadeine recommended for each category of pain, other than period pain, where there is no inflammation, and that Actiprofen is recommended for arthritis and dental pain where there is inflammation and for the other categories of pain whether there is inflammation or not.

4.      A poster which was a loose insert in the November 1995 issue of the magazine Pharmacy Trade.  It is another and larger version of "which product for what pain?"  Though apparently intended for display, it is also evidently intended for use by pharmacists, not directly by consumers: for example, it suggests that before recommending a pain reliever the pharmacist should fully understand "your customer/patients symptoms" and suggests a series of questions which the customer should be asked.  Other than that, it is sufficient to say that the poster describes in tabular form "3 levels of pain" and describes various degrees of pain in terms which, by now, are familiar. 

5.      Finally, a series of promotional articles and advertisements which had been published in magazines and journals circulating among pharmacists, all of which incorporate the message that "no other tablet relieves strong pain faster" and that Actiprofen is indicated for strong pain and strong pain with inflammation.

Levels of Pain

At the forefront of the applicant's case was the proposition that it is false, misleading and deceptive to assert that there is a recognised "pain ladder" ranging from the "mild" or "everyday" to the "extra strong" and to assert that Actiprofen (or by implication any similar drug, e.g. Nurofen, whose active ingredient is ibuprofen) is suitable for strong, or extra strong, pain but is not (by contrast with Panadol) to be recommended for milder pain states.

In order to evaluate that argument it may be helpful first to list some matters as to which there seems to be common ground and then to consider some contentious matters.  Particularly, it seems to be common ground that:

(a)     there is no body of medical or scientific literature, or of medical or scientific opinion, which, at least in terms, supports a theory that there is a hierarchy of pain states appropriately treatable by OTC analgesics, ranging from the mild to the "extra strong", or as to the appropriateness, generally, of particular OTC analgesics in the treatment of particular levels or degrees of pain;

(b)     the "indications" approved for Actiprofen under the Therapeutic Goods Act 1989, are those listed in the affidavit of Ms Steans and, in substance, on the back of the Actiprofen packet, that is "headache, the temporary relief of minor aches and pains associated with the common cold, dental pain, period pain, and for the minor pain of arthritis. Relief of acute and/or chronic pain states where inflammation is present". "Strong pain", "extra strong pain", or any similar expression, is not an approved indication for Actiprofen. The approved indications for Actiprofen (and, for that matter Nurofen) are similar to those for Panadol;

(c)     Actiprofen and similar analgesics (e.g. Nurofen), whose active ingredient is ibuprofen, do have some apparent advantages over other analgesics.  First, ibuprofen has anti‑inflammatory properties; paracetamol, probably, does not; secondly, there is evidence that the onset of pain relief, after taking ibuprofen, is more rapid that the onset of relief induced by paracetamol, at least for some types of pain; thirdly, and perhaps most significantly, there is support in medical literature for the proposition that for a number of the common indications ibuprofen is more effective, in the sense of providing a greater degree of pain relief, than paracetamol.  On that third point, particularly, I was directed to a substantial quantity of the applicant's own promotional material, which cites support in the literature for, among others, the following propositions:

-"Nurofen (ibuprofen) has been shown to be more effective than paracetamol in headache, muscular pain, sore throat and dental pain";

-"ibuprofen was also significantly superior to paracetamol (at 180 to 360 minutes, p<0.01) in reducing the sensory quality of "'swollen throat'";

-"Nurofen is more effective than:

.aspirin and paracetamol in soft tissue injuries;

.paracetamol in sore throat;

.paracetamol and paracetamol/codeine combinations in dental pain".

-"Nurofen provides fast and effective relief of headache.  Ibuprofen 400mg provided greater pain relief than paracetamol 1000mg, and aspirin 650mg."  (It should be noted that those phrases appear in an advertisement for Nurofen, the opening words of which appear to be: "Difficult headaches.  Patients have often tried an ordinary treatment before they turn to you".  It might also be added that the same promotional material seems to end with a picture of a smiling face indicating, no doubt, the completeness of the relief produced by Nurofen, under the heading "for fast and effective relief of a difficult headache").

Given the commercial circumstances described above, it is understandable that whereas the applicant is happy to say that its ibuprofen product is more effective than paracetamol in treating the indicated types of pain, the respondent prefers to say that its similar ibuprofen product is to be recommended for "strong" or "extra strong" pain of the indicated types.  What is it, then, in the recommendation of an ibuprofen product as suitable for strong pain that distinguishes it from the statement that a similar product is more effective in the treatment of pain which produces the result that, while the latter is acceptable, the former is false, misleading or deceptive?

First, the applicant says, the answer is that whereas the latter has support in medical literature, the former (and in particular the "pain ladder" concept) has none.  The respondent's promotional statements, the applicant contends, are made in the realm of science and would be understood by recipients as serious medical statements with
an adequate foundation in scientific knowledge:  Janssen Pharmaceutical Pty Ltd v Pfizer Pty Ltd (1986) 8 ATPR 40‑654.

Secondly, the applicant says, neither (by contrast with certain other OTC analgesics, such as Mersyndol and Panadeine) the approved indications for Actiprofen nor the "consumer product information" required to be distributed with it refers to "strong pain" as an indication or as something for which Actiprofen is peculiarly appropriate: the consumer product information substantially simply repeats the approved indications by stating that "Actiprofen provides temporary relief from the pain and discomfort associated with headache, toothache, period pain, the common cold and arthritis, and acute and/or chronic pain states in which there is an inflammatory component".  The promotion of the drug as appropriate for "strong pain" carries a representation that it has been approved by the authorities as appropriate in the treatment of "strong" pain - whereas in fact the approved indications, and other material in relation to Actiprofen which requires approval - e.g. the packet and the "consumer product information" - contain no reference to "strong" pain or, for that matter, to any other degree of pain.

Thirdly, there is what might be described as a public health issue. That is, the statement that Actiprofen is appropriate for the treatment of strong, or extra strong, pain will mislead consumers into thinking that it is appropriate to "self medicate" for potentially dangerous conditions rather than take the more appropriate course of consulting a doctor.  The Applicant relied on evidence of Associate Professor Harry Owen, who gave expert evidence on behalf of the applicant.  Professor Owen's opinion as to this aspect of the case is sumed up in the following two paragraphs of his affidavit:

16.If [the] leaflet were seen by consumers, I would be concerned that it would encourage inappropriate analgesic self‑medication practices.  I feel it would encourage too quick a decision by the patient to self‑medicate rather than seeking professional advice.  Also, I feel it would encourage extended use of over the counter analgesics.  It is a fundamental medical principle that we use as little medicine as is necessary for therapeutic effect.  Over‑use of over the counter analgesics may have unforeseen adverse medical and social consequences.

17.The appropriate use of over the counter analgesics is for short lived pains where the patient knows what is causing them and does not expect them to go on for more than a day or two.  It is an inappropriate use of over the counter analgesics to use them for strong, severe, or extra strong pain where there may be an underlying condition that needs treatment.

Professor Owen expressed the view also that a representation that an over the counter analgesic was a satisfactory means of treating strong pain might encourage the use of such analgesics in circumstances where their effect might mask a more serious underlying condition which ought to be treated promptly; he referred to examples, some quite alarming, of such conditions.  Evidence to a similar effect was given by Professor Shalom Issac Benrimoj, Professor of Pharmacy Practice in the Department of Pharmacy, University of Sydney.

Respondent's contentions as to "strong" pain

What then does the respondent say in relation to its claims that Actiprofen is appropriate for strong, or extra strong, pain?  First, it relies on the literature, on which the applicant equally relies, which indicates that ibuprofen provides relatively fast pain relief (at least in certain cases) and is more effective than paracetamol (and, in some cases, than paracetamol combined with codeine) in relation to most of the pain states, if not all, for which it is indicated.  If it is more effective - that is, if it brings about a greater reduction in pain levels - then it is more appropriate to be recommended in cases of (in lay terminology) strong pain.  Secondly, the respondent says that its representation does not suggest that Actiprofen (or other ibuprofen analgesics) is not effective in the treatment of milder pain without inflammation; all it is saying is that in those circumstances it recommends its paracetamol product rather than its ibuprofen product.

That leads to the respondent's third point, involving a matter of substantial controversy between the parties which is being litigated elsewhere: see Sterling Winthrop Pty Ltd v The Boots Company (Australia) Pty Ltd, Tamberlin J, 23 August 1995, unreported.  It is that the respondent asserts, though the applicant denies, that paracetamol is better tolerated and produces fewer side effects than ibuprofen.  Whether that is so or not obviously is not a matter for determination, or even further consideration, here beyond saying that it is obviously a view which the respondent holds and is stoutly maintaining elsewhere, and is evidently not untenable.  It leads, however, to the respondent's assertion that for milder pain states it is appropriate to recommend Panadol which, though less effective (i.e weaker), nevertheless adequately controls mild pain and is somewhat safer than Actiprofen.  In saying this, the respondent relies on the evidence of Associate Professor Deborah Claire Saltman, Associate Professor of General Practice, University of Sydney, who says that "ibuprofen products are not used as a first line drug because they have more side effects of the type that stop consumers wanting to use them.  They are therefore reserved for use for conditions of a more serious nature; they are used as a second line product".

Fourthly, the respondent says that the area of discourse with which we are concerned is not the technically medical or scientific.  "Strong" pain, "extra strong pain" and "severe pain" are not intended as, and would not be understood as, medical or scientific terminology but as describing degrees of pain in a way that consumers will understand and which will lead them to make informed and appropriate choices.  Thus, the respondent relied and, it says, appropriately relied, in "positioning" its ibuprofen product, on a marketing consultant's report, a copy of which was in evidence: if, as counsel for the applicant said, the respondent is thus entering a "world of subjective psychology in which the arbiter is the market researcher" the respondent says, I think, that that may well be so and there is nothing wrong with it given the "happy coincidence" between what the market researcher says and what is medically appropriate.  In addition, however, the respondent relied on the evidence of Professor Saltman who, from the perspective of one who teaches general practitioners and has herself substantial experience as a general practitioner, saw nothing inappropriate in the positioning of Actiprofen as a product suitable for severe or "strong" pain.

On the public health issue, counsel for the respondent made a number of points, in which he had support in the evidence of Professor Saltman and, as I think it emerged in cross examination, little serious opposition from Professors Owen and Benrimoj.  Thus, the respondent said that there is no linear correlation between the strength of pain and the gravity of an underlying condition: severe pain may result from a temporary and self‑limiting condition, whereas a serious condition may result in slight pain only.  Some degree of risk is inherent in a system which allows the sale of analgesics over the counter.  Again, there is nothing novel about the sale, over the counter, of analgesics promoted, and accepted by consumers as, appropriate to be used for more severe or stronger pain: these include Mersyndol (a Schedule 3 drug) whose approved indications include the "symptomatic relief of moderate to severe pain including headache, toothache, back ache, or pain associated with trauma or surgery", Veganin (a Schedule 2 drug) whose indications are strikingly similar to those approved for Actiprofen but which is stated on its packaging to be for "stronger pain relief", "stronger" being in bold and large type; and there is, of course, also the respondent's own product, Panadeine (than which, according to literature relied on by both parties, ibuprofen is claimed in some cases to be more effective).  Finally, the respondent points to familiar warnings on the Actiprofen packet, on the leaflet of which the applicant complains and in the Actiprofen consumer product information.

Reasoning and conclusion on "strong pain" issue

On this issue there is obviously strong contention between the parties and it is impossible for me to say, at this interlocutory stage of the proceedings and on the material before me, that there is not an issue to be tried.  It is, of course, inappropriate that I "undertake a preliminary trial, and give or withhold interlocutory relief upon a forecast as to the ultimate result of the case":  Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618 at 622. I think, however, that I must form at least a preliminary view of the strength of the applicant's case, not, of course, in order to attempt to work out whether the applicant has a better than 50% chance of success (Shercliff v Engadine Acceptance Corporation Pty Ltd [1978] 1 NSWLR 729 at 736) but to assist me at least in making a proper assessment of where the balance of convenience lies: see, though in a rather different context, Castlemaine Tooheys Ltd v South Australia (1986) 161 CLR 148 at 153, 154. It is evident on the material before me that commercially the applicant's launch (or, more accurately, re‑launch) of its product Nurofen will be much assisted and, conversely, that the respondent's launch of its product Actiprofen will be seriously impeded, if interlocutory injunctions of the breadth of the those sort are granted. Conversely, it may be expected that if each party proceeds with the "positioning" of its product as proposed (the respondent not being restrained by injunction) the respondent will obtain a substantial benefit to which, if the applicant ultimately is successful, it will not have been entitled and the applicant will suffer a detriment against which, as it will then appear, it was entitled to be protected. It may be that the detriment, either way and in either event, is capable of being compensated in money, but the ascertainment of appropriate compensation is likely, I should think, to be not at all easy.

My conclusion on the evidence before me, tentative as it must be, is that despite the initial attraction of the applicant's argument and, if I may say so, the great persuasiveness with which it was put, the respondent has the better of the argument on this aspect of the case.  In particular, I do not think that the use of words such as "strong", "severe" or even "extra strong" are likely to be found to be false, or misleading or deceptive, in the context of the respondent's material (including, of course, its packaging and and its consumer product information).  It is evident that words such as "strong" and "severe" are by no means unprecedented in this context, and have long acceptance in their application to over the counter analgesics whose strength of action is, on the evidence, at least no greater than that of Actiprofen.  There is evidence, accepted by both sides, that ibuprofen is more effective than paracetamol, and combinations of paracetamol and codeine, in dealing with a number - probably most if not all - of the common indicated pain states.  The case is thus, in my view, a considerable distance from two authorities to which the applicant particularly referred me, Janssen Pharmaceutical Pty Ltd v Pfizer Pty Ltd (1986) 8 ATPR 40-654 and Colgate Palmolive Pty Ltd v Rexona Pty Ltd (1981) 58 FLR 391. Nor do I think that the argument is, in the end, greatly advanced by referring to a pain ladder or hierarchy, or by pointing out that the respondent does not recommend its ibuprofen product for pain states for which, at least if the applicant is right as to side effects, it might appropriately be used. If it is true, as is accepted, that the ibuprofen product is more effective in relieving against the relevant categories of pain, it is difficult to see that, in circumstances where the respondent has a well known though somewhat less effective product which it reasonably believes to be less likely than ibuprofen to produce undesirable side effects, it is false, deceptive or misleading to recommend that less effective product, and not the more effective one, for situations where the less effective product has been proved adequate.

There are also the "indications" point and the "public health" point.  As to the former, there may well be an inconsistency in retaining as part of the approved indications of Panadeine the phrase "moderate to severe pain" where the approved indications for Actiprofen, which is promoted as an even "stronger" drug than Panadeine, contain no reference to the degrees of pain for which the drug is appropriate.  It may well be that it would be appropriate to take steps to resolve that inconsistency.  Nevertheless, I cannot see why it is contrary to the Trade Practices Act, where there are two analgesics each of which is indicated for the same categories of pain but one of which is more "effective" (in the sense discussed) than the other, to recommend that one for "strong" pain of the relevant kind and the other for "mild" pain of that kind.  I think the "public health" argument is answered, so far as it can be at this stage and for present purposes, by the evidence of Professor Saltman, coupled with answers given in cross examination by Professors Owen and Benrimoj, to which I have already referred.

As to the balance of convenience, the opposing contentions of the parties concerned the likely commercial effects on each of either granting or withholding the injunctions claimed and also the public health consequences claimed by the applicant to arise from the respondent's promotion of its product.  For reasons already given, I do not think that I should give this factor any substantial weight in considering where the balance lies.  As to the commercial effects, Mr Stephens, the Managing Director of the applicant, has given evidence, which I accept, that the success of their promotion and "positioning" of Nurofen will be significantly adversely affected if the promotion of Actiprofen proceeds as foreshadowed.  Mr Stephens says that "the potential harm is so serious that Boots Australia might never be able completely to overcome that harm or it would take years to do so.  It would be impossible for Boots Australia to quantify exactly the extent of the damage to sales of S2 Nurofen in Australia".  On the other hand, Mr Addison, Category Director, Analgesics/Respiratory Tract of the respondent gave evidence of a "serious and wide‑ranging impact on the promotion of Actiprofen" which would result from the granting of interlocutory injunctions.  He made the obvious point that money spent on the current "positioning" would be substantially wasted, that it would be necessary to devise an entirely new "launch strategy" and that the principal problem would be what he described as loss of opportunity.  I think that the only conclusion I can draw is that there will, depending on whether injunctions are granted or refused, be significant commercial consequences for the parties.  It is not easy to conclude that, looking at those consequences alone, the balance tilts appreciably in either direction.

The respondent urged upon me a further consideration in relation to the balance of convenience, that is delay on the part of the applicant in commencing these proceedings given the imminence of the rescheduling of ibuprofen.  Certainly, it is true that correspondence commenced with a letter of demand written on behalf of the applicant on 6 September, that correspondence then proceeded largely inconclusively until mid September, following which there was a lull until 23 October when, for the first time, complaint was made about the "pain ladder" or hierarchy, no specific demands however being made and proceedings being commenced only on 10 November 1995.  Mr Stephens explained the apparent delay as resulting simply from the need to consult experts, to confer with executives of the applicant's holding company in the United Kingdom and the necessity to allow a period between demand and the commencement of proceedings.  Given the apparent gravity with which the applicant has come to view the matter, and given the rather strange course of the correspondence, I confess that I do not find the explanation entirely satisfying.  However, if I thought that on this part of the case the applicant was very likely ultimately to succeed I would attribute very little weight to the delay.  As matters stand, I think it is a factor which operates slightly in favour of the respondent.  As will be evident, however, in my view - and I think it is consistent with the way in which counsel on both sides argued the case - the principal factor, other matters being rather finely poised, is my assessment, on an interlocutory basis, of the relative strength of the parties' cases.

I should note, finally, the existence on the trade detailer, but also on some of the other material, of the claim to the effect that no tablet works faster than Actiprofen.  For reasons which I shall give when considering other matters relating to the detailer, I do not think that that representation is sufficiently arguably false, misleading or deceptive to justify interlocutory relief.

It follows that I shall refuse the injunctions sought in paragraphs 1(d) to (o), paragraph 3 (a), (b) and (c) and 4 of the applicant's amended notice of motion.

Other representations

That, however, is not quite the end of the matter: there were other complaints which the applicant made, relating principally, if not exclusively, to the trade detailer.

One of the applicant's complaints relates to the claims made in the detailer (and elsewhere) as to the speed with which Actiprofen works.  On the inside of the front panel of the detailer, both in its original and in its amended form, the heading, set out in an arresting way, is "Actiprofen no other tablet works faster".  Then in the original version of the detailer there was a statement that "Actiprofen works faster than other pain relievers" a claim replaced in the revised version by "fast, effective pain relief".  In each case, as I have mentioned, there is given as support for the statement a reference to an article entitled "Onset of Action of Ibuprofen in the Treatment of Muscle‑contraction Headache".  The respondent does not suggest that Actiprofen "works" any "faster" than Nurofen and it follows, I think, that the original version was, in that respect, false and, if there were a threat to circulate the original version, I think circulation would be restrained.  Counsel for the respondent has, however, said that there is no such threat and there is no evidence that, at present, any such threat exists.  Indeed, Mr Addison conceded in evidence that the earlier version was wrong.

The applicant, however, presses two matters in relation to the amended detailer's claims about speed of action.  They are, first, that the amended version still may be taken as implying a claim that Actiprofen works more quickly than other ibuprofen analgesics (such as Nurofen) and is therefore still misleading or deceptive.  The applicant also says that the reference given in support of the claim does not support its generality, and is therefore misleading.  As to the former of those matters, I do not think the applicant questions the literal truth of the claim that no other tablet (meaning, I suppose, no other over‑the‑counter analgesic in tablet form) works faster: both parties accept that there is evidence that ibuprofen in fact works faster than the active ingredients of other over‑the‑counter analgesics.  The question, therefore, is whether the expression of the claim is likely to mislead those to whom it is made into thinking that Actiprofen is not merely as fast as other ibuprofen analgesics, but faster at least than some of them.

On that question, I accept what the respondent says, that is that (at least if one disregards other aspects of the detailer, to which I shall return) the claims about speed in the amended detailer are merely "top parity" claims of a by no means unprecedented kind and are not misleading or deceptive.  It is not, I think, a point which in the present context is susceptible of profitable further analysis: I think a statement that nothing works faster than a particular product fairly clearly leaves open the possibility (indeed the likelihood if the claims go no further) that other products work equally fast.  It is perhaps worth noting that a very similar claim was at least countenanced in the decision of Davies J in R & C Products Pty Ltd (t/a Samuel Taylor) v S C Johnson & Sons Pty Ltd (1993) 42 FCR 188 at 189.

The complaint about the reference raises what is perhaps a somewhat unusual and curious issue.  In fact, the applicant does not complain that Actiprofen will not provide "fast, effective pain relief": that, in effect, is exactly what it claims about its own product, Nurofen.  Indeed, as I have said, both parties agree that there is support in the literature for a claim of that sort in relation to most, if not all, of the indications for an over‑the‑counter analgesic.  The complaint must, therefore, be that though the claim made is one which might be supported, the particular reference given does not support it in its generality.  Literally, no doubt, that is true.  As counsel for the respondent pointed out, however, the title of the article indicates the limited area with which it deals and, though one might reasonably question the appropriateness of using that reference to support that proposition in this document, it seems to me hardly a matter calling for restraint by injunction, at least at the interlocutory stage.

That brings me to the applicant's remaining complaint, which relates to the words, again printed in an arresting manner, on the front of the detailer, taken together with the opening "bullet" point on the top panel of the inside of the detailer.  The words on the front read "THE BIGGEST THING TO HAPPEN IN OTC PAIN RELIEF".  The paragraph on the inside panel (immediately underneath the heading "Actiprofen no other tablet works faster") reads "the introduction of Actiprofen from SmithKline Beecham is the most significant development in the Australian OTC pain‑relief market for many years".

This was in fact, together with the claims about speed of action, the principal object of the applicant's initial complaint.  The complaint may, I think, be expressed as follows.  Ibuprofen, as a drug for use in inflammatory conditions and for analgesia, was invented and developed by related corporations of the applicant.  The applicant's corporate group has had an ibuprofen drug on the market since at least 1966.  Research conducted by the applicant's group over the intervening period, particularly into side effects of the drug, has led to increasing acceptance of it and the gradual lifting of restrictions on its availability.  The applicant's product, Nurofen, has been on the market in over‑the‑counter form for some time.  The respondent itself earlier marketed a similar product.  In those circumstances the claims made in the detailer as to the great significance of the appearance of Actiprofen goes beyond justifiable hyperbole and a permissible appeal to the commercial instincts of pharmacists.  Combined with the references to speed and effectiveness, the claims are capable of
suggesting that Actiprofen represents an important scientific or medical advance.  There is support for that view in the evidence of Professor Benrimoj. 

The respondent's retort was, I think, twofold.  One branch of it may, I think not unfairly, be described as an attempt to brush this matter aside as de minimis in the context of the more serious issues under consideration; the other was to say that the statements were justifiable as a fair reflection of the importance of the introduction of a significant new weapon in the SKB pain relief armoury, for which there would be available to pharmacists all the commercial support from SKB to which they had become accustomed.

I am afraid that I find that justification rather unconvincing.  I think (as Professor Benrimoj was at first inclined to believe) that the words suggest a genuine advance in over‑the‑counter pain relief rather than merely the introduction, by a corporate group with whom pharmacists find it commercially satisfactory to deal, of a product which is not significantly different from other products which have been on the market for some time, particularly, of course, the applicant's Nurofen.

There being, I think, no consideration relevant to the balance of convenience indicating otherwise, it follows that the applicant is entitled to an injunction restraining the further distribution of the detailer and an order as to the recovery of detailers already distributed.  For what it is worth, I should perhaps make it clear that what I am talking about is the detailer itself, not the "mouse pad" which apparently has been
inserted in detailers recently distributed: the mouse pad was conceded to be, and obviously is, innocuous.

Proposed orders

Accordingly, upon the applicant by its counsel giving the usual undertaking as to damages, I shall order that the respondent by itself, its servants or agents or otherwise, be restrained from using, publishing or distributing matter in the form or substantially in the form of the trade detailer that is exhibit "DMMS1" to the affidavit of David Montagu Martindale Stephens sworn 14 November 1995.

On the same undertaking I shall order also that the respondent forthwith take such steps as are practicable to recover from the market place all such trade detailers.

Otherwise, the applicant's motion will be dismissed.  I think it is probably appropriate to order that costs be reserved; I invite counsel, however, to address me if they wish on the question of costs.

I certify that this and the preceding 29 pages are a true copy of the Reasons for Judgment of the Honourable Justice Lehane.

Associate:

Dated:  29 November 1995

Heard:  23 November 1995

Place:  Sydney

Decision:  29 November 1995

Appearances:  Mr J T Gleeson of counsel instructed by Minter Ellison

appeared for the applicant.

Mr D J Catterns QC and Ms K J Howard of counsel instructed by Freehill Hollingdale & Page appeared for the respondent.