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THE HIGH COURT

DUBLIN

Case No. 2002/12824p

SMITHKLINE BEECHAM PLC;

SMITHKLINE BEECHAM; PHARMACEUTICALS LTD. AND GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LTD.

PLAINTIFF

AND

GENTHON B.V. AND (BY ORDER) SYNTHON B.V.

DEFENDENTS

JUDGMENT OF MR. JUSTICE KELLY ON FRIDAY, 28 FEBRUARY 2003

MR. JUSTICE KELLY:

I have spent the last three days presiding over the first skirmish in this jurisdiction of a litigation battle which will be fought out at trial later on between these parties. That battle is, however, just one in a war which has been and is being conducted on a worldwide basis between the plaintiffs and the second defendants, Synthon.

This litigation relates to a compound called paroxetine which has pharmaceutical applications most notably in the treatment of depression. Paroxetine occurs in different forms. In Ireland the plaintiffs market a drug comprising paroxetine hydrochloride hemihydrate under the trademark Seroxat. The plaintiffs are the proprietors of Irish Patent No. 59901 which relates to the hydrochloride hemihydrate salt of paroxetine. That patent is not in issue in the present proceedings.

The patents which are in issue are numbered 81^,169 which has been referred to as the parent patent, and 82478 which has been referred to as the divisional patent. It is in respect of these patents that the present interlocutory injunction is sought so as to bring to an end their alleged infringement by the defendant pending trial.

Both of these patents are in respect of the methanesulfonate salt of the compound paroxetine, otherwise known as paroxetine methanesulfonate or paroxetine mesylate. The product produced and sold by the defendants under the trademark Meloxat is based on the crystalline form polymorph of the paroxetine mesylate claimed by patent 81469.

The second defendant, Synthon, has licensed a company called Clonmel Healthcare Ltd. which is not before the Court to market Meloxat. The first defendant, Genthon, has nothing to do with the manufacture, importation or distribution of the compound. The thrust of the plaintiff's case is therefore directed against the second defendant, Synthon.

The litigation between the parties arises because the plaintiffs claim patent protection in respect of paroxetine mesylate by reference to the two patents which I have just mentioned. The defendant accepts that it is infringing the plaintiff's patents with its Meloxat product but it asserts that the patents in question are invalid.

By a petition dated 1 July 2002 which antedated by three months the present action Synthon sought the revocation of patent No. 81469. It has not commenced separate revocation proceedings in respect of patent No. 82478 because the patent was granted after the petition of 1 July 2002 and notice of the grant was published just before the commencement of the present proceedings. However, Synthon will contend that patent No. 82478 is also invalid and will counterclaim for its revocation in the instant proceedings. Synthon contends that one its employees, a Dr. Bennker, in November 1996 discovered paroxetine mesylate.

Product authorisations for the defendant's product have been obtained in a wide number of countries and at present it is on the market in six European countries.

Litigation is extant in 15 different countries between the parties to this suit. There are both patent revocation proceedings and patent infringementactions together with proceedings concerning regulatory approval for the defendant's product.

Two of the such proceedings were referred in some detail in the hearing before me. The plaintiffs have a European patent in respect of the same invention as that claimed in the parent patent. This European patent was the subject of opposition against its maintenance by Synthon. That opposition was rejected by the opposition division of the European Patent Office on 28 June 2002. An appeal has been filed to the Technical Board of Appeal but no decision has yet been given on that appeal. The plaintiffs obviously attach some significance to this victory.

The defendants, however, pointed to their own victoryon 3 December 2002 where Jacob J. in the Patents Court in England revoked the UK patent equivalent off Irish patent No. 81469, that is to say the parent patent to the present proceedings. That decision has been appealed to the Court of Appeal. The defendant attaches significance to this.

The spoils are therefore divided as between the litigants at this stage insofar as these two decisions are concerned. However, neither are remotely decisive of the issues that fall to be determined by me on this application.

This application for an interlocutory injunction falls to be determined in accordance with principles set forth in the decision of the Supreme Court in Campus Oil -v- Minister for Energy (No. 2)' [1983] IR88 which in turn accepted the speech of Lord Diplock in American Cyanamid -v- Ethicon [1975] AC 396 as a correct statement of the law.

The first matter that I must therefore address my mind to is whether or not the plaintiffs have demonstrated a serious issue for trial. I do not have to give this much thought because it is accepted by Synthon that it is in fact infringing the patents in suit by its product Meloxat. It contends ofcourse that the patents are invalid.

The plaintiffs for their part accept that insofar as the defendant's petition seeking the revocation of the parent patent and its intention to counterclaim for the revocation of the divisional patent is concerned a serious issue for trial arises in respect of the defendant's such claims. So both sides agree that serious issues have been raised which will fall to be tried at the hearing of this action which no doubt will be heard in conjunction with the petition seeking the revocation of the parent patent.

Mercifully therefore I am spared the necessity of an excursion into the pharmacological details of the respective products. The existence of serious issues for trial having been accepted, I must now turn to the next step prescribed in the speech of Lord Diplock. In order to grant an injunction in favour of the plaintiffs I must be satisfied that damages would not be an adequate remedy in respect of the matters of which they now complain. Lord Diplock puts it thus, and I quote:

"If damages in the measure recoverable at common law would be adequate remedy and the defendant would be in a financial position to pay them, no interlocutory injunction should normally be granted however strong the plaintiff's claim appeared to be at that stage."

This approach of treating adequacy of damages as quite separate and apart from the question of balance of convenience has been approved by the Supreme Court in Westman Holdings Ltd -v- McCormack [1992] 1 IR 151. In that case Finlay C.J. said, and I quote:

"I am satisfied that once a conclusion is reached that the plaintiff seeking an interlocutory injunction has raised a fair question to be tried at the hearing of the action in which, if he succeeded, he would be entitled to a permanent injunction that the Court should not express any view on the strength of the contending submissions leading to the raising of such a fair and bona fide question, but should proceed to consider the other matters which then arise in regard to the granting of an interlocutory injunction.

They are, firstly, as to whether the plaintiff could, in the event of being refused an injunction and succeeding in the action, be adequately compensated by damages. That question raises two separate issues, potentially, in every case. The first is this question as to whether damages would be an adequate remedy, and the second is as to whether there is a defendant liable to pay such damages who is able to do so, and thus the appropriate compensation could actually be realised."

That second consideration does not arise in the instant case.

Reference has, however, been made to a number of decisions of the High Court where there appears to have been a conflation of the two issues of adequacy of damages and balance of convenience. In my view that approach is not justified by reference to either Campus Oil, Westman Holdings or American Cyanamid.

I must therefore in the next part of the exercise which I have to undertake ask myself whether or not damages would be an adequate remedy for the plaintiffs. If I am satisfied that damages would be such an adequate remedy then that is the end of the matter, and I should not proceed further to even consider balance of convenience.

A further decision of the Supreme Court seems to me to be relevant on this issue. It is the case of Curust Financial Service Ltd -v- Loewe [1994] 1 IR 450. Whilst the statements of law are of general application some are particularly apposite having regard to the factual background to the instant proceedings. I of course accept that that case did not involve patent infringement.

In the course of his judgment in that case Finlay C.J. set forth general principles which apply on this topic. He said, and I quote:

"The loss to be incurred by Curust if it succeeds in the action and no interlocutory injunction is granted them is clearly and exclusively a commercial loss, in what had been, apparently, a stable and well established market. In those circumstances, prima facie, it is a loss which should be capable of being assessed in damages both under the heading of loss actually suffered up to the date when such damages would fall to be assessed, and also under the heading of probable future loss. Difficulty, as distinct from complete impossibility, in the assessment of such damages should not, in my view, be a ground for characterising the award of damages as an inadequate remedy."

Later in the judgment he touched upon the standard of proof which must be satisfied on the question of adequacy of damages. He said, and I quote again:

"Since this issue on affidavit and the inferences to be drawn from it was not decided in the High Court, by reason of the learned trial judge's view that damages were for other reasons not an adequate remedy, and since I find myself in disagreement with that view, it is necessary that I should reach a conclusion on the affidavit evidence as to whether it has, as a matter of probability, been established at this stage for the purposes of the interlocutory injunction that damages would not be an adequate remedy by reason of the real risk of the financial collapse of the Curust companies."

That passage suggests that the plaintiff must, as a matter of probability, demonstrate the risk that damages would prove to be an inadequate remedy.

There is no doubt but that as a matter of law monetary damages are available to a plaintiff which demonstrates an infringement of its patent. The principle is that it should be restored by monetary compensation to the position which it would have occupied but for the wrongful acts of the defendant, provided of course that such loss is the natural and direct consequence of the defendant's act and is not excluded from recovery by public or social policy.

That much is clear from a long line of authorities going back over many years and reasserted in the speech of Lord Wilberforce in General Tire [1976] RPC197. But in the present case the plaintiffs contend that such damages would not be adequate for them. I must therefore look as succinctly as I can at the facts and issues identified as being indicative of irreparable damage being sustained.

Before doing so I should however deal with a contention made by the defendants to the effect that a claim for patent infringement is almost always remediable by an award of damages. The suggestion was that therefore the remedy of the injunction should not normally be available to a patentee.

The authority cited in support this assertion was adictum of Laddie J. in the case of Unilever PLC -v- Frisa NV [2000] F.S.R 708. At page 717 and Laddie J. said, and I quote:

"I am aware that interlocutory proceedings in the Patents Court arenot common. That is at least in part due to the fact that it is possible to get a full trial on in about a year and sometimes much less time than that."

Having cited that passage I did, however, draw counsel's attention to the next sentence where the judge went on, and I quote:

"But practitioners should not believe that there is an inherent hostility to interlocutory relief in suitable cases."

I wish to state that there is no hostility, inherent or otherwise, to the grant of interlocutory injunctions in patent infringement proceedings. The tests for the grant of such an injunction are the same as in any other case. No better exemplar of this is the decision of the House of Lords in American Cyanamid which set forth those guidelines of wide and general application in what was itself a patent infringement suit. The plaintiff's product, Seroxat, is used for the treatment of depressive illness, obsessive compulsive disorders and panic disorders. Rather alarmingly for the state of health of this nation I am told on oath that the antidepressant market is the second largest therapeutic market in Ireland. Seroxat is described as the No. 1 antidepressant drug in Ireland. It accounts for roughly 12% of the pharmaceutical sales of the plaintiffs and represents the second largest product in its portfolio accounting for almost €9 million in annual sales.

The total antidepressant market in Ireland for the year 2002 was worth approximately €50 million with an anticipated growth of an end of that year of 15 to 16%. The sales figures for Seroxat over the last five years in Ireland are as follows: 1998, €5,460,310; 1999, €6,546,975; 2000, €7,982,207; 2001, €8,768,522; 2002, €8,790,482.

These figures demonstrate the strength of the Seroxat product and the fact that in the last two years there has been apparent stability as to its sales. It also demonstrates very considerable knowledge on the part of the plaintiff as to its market share and market projections. Given its brand position this is hardly surprising.

It is also to be noted that since 1 August 2001 the plaintiffs have supplied their product to a company Rowex Ltd. with which they have a commercia relationship for the promotion, distribution and sale in Ireland of the product under the brand name Parox. Apart from telling me that there had been significant sales of Parox since this relationship was entered into, and that it is anticipated that they will increase significantly, I have been given no other information about this relationship and Rowex Ltd. is not before the Court.

Its entrance into the market would, however, suggest that the plateau in sales between 2001 and 2002 as demonstrated by reference to the figures which I have just quoted is more apparent than real and that some growth at least took place by reference to the sale of Parox. Seroxat is available only on prescription. Meloxat, the defendant's product, is used for precisely the same complaints as Seroxat.

This product is marketed by an entity called Clonmel Healthcare Ltd. on foot of a licence agreement of 1 October 2001 issued to it by the second defendant, Synthon. Typically Clonmel Healthcare produces generic drugs and is a subsidiary of a German company which is the third largest generic drugs manufacturer in that country.

It began marketing Meloxat in Ireland in September 2002. The launch of its product was antedated by the presentation of the petition for revocation of the parent patent on 1 July and was postdated by the institution of the present proceedings on 3 October 2002.

The defendant s began marketing their product in Ireland in September 2002. In October 2000 the defendants were granted marketing authorisation in Denmark in respect of 20 mg paroxetine mesylate film-coated tablets. It appears that in May 2001 the defendants completed the mutual recognition process in which Ireland was designated as a concerned member State for this product.

The plaintiffs became aware of this and were concerned that the completion of this process indicated an intention to put the product on the market in Ireland. I should say that the completion of this process led ultimately to an abridged form ofapplication being made to the Irish regulatory authority, the Irish Medicines Board in respect of the defendant's product.

Being so concerned, on 5 July 2001 the plaintiff's solicitors wrote to the defendants pointing out that if it was the intention of the defendants to market the product in Ireland this would directly infringe claim No. 1 of the patent 81469. They asked the defendants to confirm that it was not their intention at that stage to engage in the making or importing for disposal in Ireland of the product in question. If it was the intention of the defendants so to do they were asked to put the plaintiff's solicitors on notice so as to give them a reasonable opportunity to apply to Court for injunctive relief. The letter concluded by saying, and I quote:

"If such confirmation is not forthcoming our clients will have no alternative but to commence proceedings to protect their position."

A response to that letter was received on 25 July 2001 which did not confirm the defendant's intention as apprehended by the plaintiff's solicitors, but rather asked a series of questions concerning the criteria for the grant of the injunctive relief which had been mentioned in the earlier letter. This was responded to on 27 July 2001 and thereafter nothing more was heard from the defendants despite reminders on 17 September 2001 and 5 March 2002. For what it is worth I should point out that prior to the writing of the reminder of 5 March a Dutch Court refused an interlocutory injunction in respect of patent infringement for both parent and divisional patents.

In May 2002 the defendant's solicitors wrote and having referred to the earlier correspondence concluded, and I quote:

"You pointed out that there was litigation pending in many European jurisdictions and as you will be aware since the date of your letter the number of jurisdictions in which litigation is ongoing has increased. As you can appreciate our clients have in these other jurisdictions vigorously opposed the proceedings that have been brought by our clients. We doubt if your clients would expect our clients to have a different attitude in this jurisdiction. our clients take the view that Irish patent No. 81469 is invalid. Consequently they are not prepared to give the undertaking as sought. We trust that this clarifies the position."

Further correspondence ensued and eventually the defendant's product was put on the market.

I mention this correspondence because it was the subject of vigorous and robust debate between counsel on both sides. The plaintiffs contend that the correspondence amounts to a smokescreen to keep the plaintiffs in the dark as to the defendant's real intentions. They further contend that the actual launch of the product in September 2002 was most unusual and was not accompanied by the normal form of advertising and public relations exercise which accompanies the launch of a new product.

For their part the defendants equally robustly reject each and every one of these allegations. They say that the correspondence makes it clear that as they did not give the confirmation which was sought concerning the putting of the plaintiff's solicitors on notice in the letter of 5 July 2001 the plaintiffs could have been in no doubt as to what was going to happen.

Insofar as there was an assertion of some form of sleight of hand concerning the launch of the product they point to advertisements which appeared at the time and a prior application by Clonmel Healthcare for the registration of the trademark Meloxat. They assert that this line of argument by the plaintiffs is a mere attempt to blacken them in the Court.

I am reaching no conclusion on any of these allegations and counter allegations since it is not necessary for me to do so. I mention them because they occupied a considerable portion of the Court's time and created more heat than light.

The assertions on the part of the plaintiffs who relied on by them to inter alia say that the defendants cannot now complain about the alleged devastating effects an injunction might have on them and the plaintiffs call attention to the observations of Jacob J. in a case of SmithKline Beecham PLC -v- Apotex Europe Ltd. Which is an unreported judgment of 28 November 2002.

In the Apotex case Jacob J. cited with approval what he had said in an earlier case called Generics. He said, and I quote:

"I turn to another fact which to my mind indicates that the injunction should be granted. It is this. The defendants have known for a long time about this patent. He would have to be very naive in the pharmaceutical industry to think that the patentee with a product as important as this would not, if it had anything other than a frivolous chance of success, take action so the defendants knew when they set out upon this project in 1997 that the patentees would cause trouble. The defendant could, as soon as they settled on the product they were intending to sell, have caused the litigation to start. They could have done a number of things. First', they could have launched a petition for the revocation of a patent and started a claim for a declaration of non-infringement or since there are certain difficulties with the latter, (for example onus of proof goes the other way round, they could simply have said to the patentees we intend, we are not saying when, but it is a settled intention to launch our product within the next five years. If you intend to sue us, sue us now.

If they had taken such a course having settled upon the product they intended to sell the whole of this dispute would have been got out of the way before their date of intended launch. Mr. Arnold says that this is quite unfair. It puts the burden upon the defendant. Why should there be any such burden to start litigation when they are firmly of the opinion that they do not infringe. The answer to my mind is self-evident. They knew perfectly well the issue of infringement was likely to arise. If they wanted to be sure of their position they could and would have made sure that all their experimental data was properly in place and vouched by an independent scientist and they would have presented the evidence to the patentees.

This is not a case where they could say on the material they had it was certain not to fall within the claims. They had materials they could point to from their supplier and from the experiments conducted by their sister company in Australia which suggested that was so. They did not in fact give details of the experiments themselves, no notebooks, no examples of the samples that were tested or anything of the kind. The commercial position was that they did not take the steps necessary to show exactly what the product they were intending to sell was.

As for the validity of the patent their case is that if you conduct what is described in 407 you will fall within the claims of this patent. Nothing could be simpler than do just that and show that that was^, so. At the moment the case is constructed by way of inference and it is no more than a possible case. I see no question of principle involved here of any sort. It is purely commercial common sense. If there may be an obstacle in your way clear it out. To my mind this is a case where the retention of the status quo is a rational thing to do. It was something that could have been avoided by the defendants. They chose not to do it."

That is the quotation from what he had to say in the earlier case of Generics which he then adopted and applied to the Apotex case going on to say, and I

quote:

"I think that it is wholly uncommercial in the circumstances of this case. There was bound to be litigation unless the case was hopeless. Both sides knew that, and in any event if there had been open disclosure of what Apotex were planning to sell and how it is made and SKB accepted that it did not infringe the matter would have been settled ages ago. I remain of the opinion that I was in the Generics case were litigation is bound to ensue if the defendant introduces his product he can avoid all the problems of an interlocutory injunction if he clears the way first. That is what the procedures for revocation and declaration for non-infringement are for."

Jacob J.'s decision was tested in the Court of Appeal. In a passage from the judgment of Aldous LJ, he touched upon the matters which I have just quote from Jacob J.'s judgment, and he said as follows, and I quote:

"I find no error of principle in the way that the judge exercised his discretion. The judge was in my view entitled to take into account when deciding to maintain the status quo that Apotex walked into the situation that they find themselves in with their eyes open to the risks that they were taking. They knew the risk and decided that it was best not to remove it."

Whilst what both Jacob J. and Aldous LJ have said have much to recommend their views it seems to me that those views impact on the issue of balance of convenience and possibly the defendant's assertions of irreparable loss which will not be compensated on foot of the plaintiff's undertaking as to damages if an injunction is granted rather than on the issue of irreparable loss being sustained by the plaintiff.

I am fortified in that view by a passage from Terrell on Patents which reads as follows:

"Where a defendant commences the commission of acts in the full knowledge of the complaint against him, limited consideration would be given to the effect of the injunction in relation to those acts in considering where the balance of convenience lies."

Whilst therefor I am of the view that there is much to be said in favour of these expressions of opinion both at first instance and on appeal in England it seems to me that they are relevant to the question of balance of convenience rather than irreparable loss being sustained by the plaintiff.

In any event the present position is that the defendants have been on the market with their product since 2002. I am given little or no information as to the extent of their market penetration. I do not accept that they entered the market without doing their homework. I think it likely that there were projections as to likely market penetration and indeed there must be available even at this stage some results.

I am of course conscious of the peculiar circumstances of a market such as this, a matter touched upon in the speech of Lord Diplock in American Cyanamid where he said, and I quote:

"It is notorious that new pharmaceutical products used exclusively by doctors or available only on prescription take a long time to become established in the market."

Even allowing for that I am quite satisfied that the defendants must have as I say done their homework and that there would even at this stage be available some figures demonstrating market penetration.

Whilst I have not been given any such information I have however been furnished with an undertaking on oath that between now and the trial of the action both the defendants named and indeed Clonmel Healthcare Ltd. which is not before the Court will keep records of all of the sales of Meloxat. I have made it clear to the parties that the Court will be in a position to have a trial of both the patent revocation petition and these proceedings not later than July of this year.

In these circumstances it appears to be that unless the plaintiffs are able to point to some particular feature giving rise to an irreparable loss, damages would be an adequate compensation for any wrongdoing on the part of the defendants.

The plaintiffs are the brand leader in the area. There is a well settled and indeed growing market. The plaintiffs know precisely what their market shar is and was. They are able to do and have done projections as to any increase in the market share which they anticipate.

The defendant is a relative newcomer to the market. If it wrongfully makes inroads into the plaintiff's market that will be easily discernable both by reference in the fall of the plaintiff's market share and the records which the defendants will, pursuant to their undertaking, be obliged to keep as indeed will Clonmel Healthcare.

In these circumstances it seems to me that the position is similar to what obtained in the Curust case in that a commercial loss will be suffered by the plaintiffs which is compensatable in damages.

Insofar as the plaintiff's allege that the defendants have engaged in a wilful and deliberate wrongdoing by reference in particular to its tactics in entering the market, alleged lack of candor in correspondence A and the failure to "clear the obstacle out of the way" before entering the market, pace Jacob J., I am of the view that damages will be recoverable for loss incurred as a result of such wrongdoing.

In this regard I bear in mind that there is included in the plenary summons instituting these proceedings a claim for damages for conspiracy and for intentional interference with the plaintiff's economic interests, over and above the claim for damages for patent infringement.

However, the plaintiff's say that they are able to point to a number of features which suggest that damages would not be an adequate remedy. I will consider each of these in turn.

First, they refer to what can be loosely called public health concerns. I wish to make it clear that in this regard this is a strictly confined claim and there is no suggestion whatsoever of the defendant's product being toxic or dangerous. The gist of the complaint is as follows. Seroxat had to undergo a rigorous examination by the Irish regulatory authority, the Irish Medicines Board, before it could be put on the market. Meloxat was able to avail itself of an expedited or abridged procedure because of the fact that it had obtained approval from the Dutch authorities. Consequently the Irish Medicines Board was not required to embark upon the same sort of exercise as was required in respect of Seroxat. It seems to me that I must proceed on the basis that the statutory regulator in this jurisdiction knows its business and conducts it competently. Both products have received the necessary authorization from the Irish Medicines Board. The fact that a different procedure was followed in one rather than the other does not appear to me to give rise to any legitimate complaint on the part of the plaintiffs still less one which would demonstrate a probability of irreparable loss and damage being sustained if the defendant's product remains on the market. Accordingly I reject this contention.

I do not propose to deal in any detail with the other health issue, if I may so describe it, arising from the BBC programme on Seroxat which was broadcast last year. I think that that is a peripheral issue to the matters that fall for determination here.

The next complaint is to the effect that because the plaintiffs are marketing some of their product through the Rowex company under the name Parox, losses may be sustained by that entity which is also a comparative newcomer to the market. I do not accept that this gives rise to a probability of irreparable damage. Rowex is not before the Court. I have been given very little information as to the relationship between the plaintiffs and Rowex. I knew nothing of Parox's market penetration.

I have little doubt but that in entering into whatever commercial arrangement it did with Rowex the plaintiffs were fully aware of how the market was likely to be affected and will have such figures available in the event of the defendant's product having an adverse consequence on that market. In my view none of this gives rise to a likelihood of irreparable loss. The next area which is pointed to is of course the fact that the defendant's product is some 18% cheaper than the plaintiff's. It is said that this may result in the plaintiffs having to reduce its price.

If that is so and the plaintiffs are wrongly deprived of an additional profit that is clearly recoverable as an item of monetary damage against the defendants. I cannot see how this gives rise to an irreparable loss. Neither do I see anything to support the notion that the whole price structure in the market may collapse. Even if that were to occur, which I think is unlikely, it is hardly likely to occur in the next four months.

The next point made by the plaintiffs is by reference to an article which was published in a Dutch medical journal. The article relates to two patients who changed from Seroxat to the equivalent of Meloxat. It is suggested that there were adverse consequences as a result of them so doing. It is accepted by the plaintiffs that what occurred in respect of those two patients is statistically insignificant.

I also have to bear in mind that in this jurisdiction both the plaintiff's and the defendant's product is obtainable only on prescription. If Seroxat is prescribed it must be dispensed; if Meloxat is prescribed it must be dispensed. The possibility of confusion only arises if the generic is prescribed, but the plaintiff's own evidence is that over 90% of prescriptions in Ireland are for branded rather than generic drugs. Should a doctor decide to change a patient's medication and any adverse consequences were to occur the matter is remediable. I do not think that the concerns voiced by the plaintiffs under this heading demonstrate a risk of irreparable loss.

In my view the plaintiffs have not by reference to these various complaints demonstrated that damages would not be an adequate remedy for them. I am satisfied on the evidence that in the event of the plaintiffs being correct and succeeding at trial they can be completely compensated by an award of damages in respect of any losses which they may suffer between now and trial by reason of the defendants alleged wrongful marketing of their product.

There is not the slightest suggestion that the defendants would not be in a position to meet any such award of damages. Such being so that is an end to the inquiry which I am obliged to carry out.

I do not have to go on to consider the defendant's position vis-a-vis the cross undertaking as to damages nor balance of convenience. If however I did have to consider them in detail my decision on the grant of the injunction would I believe be the same. In my view damages are a wholly adequate remedy for the plaintiff between now and trial and consequently the application for an interlocutory injunction will be refused. With a view to ensuring an early trial I am now going to proceed to give comprehensive directions in preparation for the trial of both the patent revocation suit and the instant proceedings and I will hear counsel in that regard.

THE JUDGMENT CONCLUDED.