Warner-Lambert Company, LLC v Actavis Group PTC EHF & Ors

On 21 January 2015 I dismissed an application by Warner-Lambert for an interim injunction in this matter, holding that, on the basis of the evidence and arguments then before the court, Warner-Lambert's infringement claim did not raise a serious issue to be tried and that, even if it did, the balance of the risk of the injustice favoured refusal of the relief sought. The background to the matter and the reasons for those conclusions are set out in full in my judgment of that date ([2015] EWHC 72 (Pat)), which I shall take as read.

I now have two applications before me. First, by application notice dated 23 January 2015 Actavis applied to strike out Warner-Lambert's claim for infringement of the Patent pursuant to CPR rule 3.4(2)(a) alternatively for summary judgment dismissing that claim. Secondly, by application notice dated 27 January 2015 Warner-Lambert applied for permission to amend its Particulars of Infringement to plead a case of subjective intention, as foreshadowed at the previous hearing (see the judgment at [112], although the form of the proposed amendment differs from that proposed at the previous hearing). It was sensibly agreed between counsel that in these circumstances I should consider Actavis' application on the basis of Warner-Lambert's claim as proposed to be amended.

It is convenient before proceeding further to note two points about Warner-Lambert's proposed Amended Particulars of Infringement. First, they delete the allegation of infringement pursuant to section 60(1)(a) of the Patents Act 1977. Secondly, the draft which accompanied the application notice also deleted the allegation of infringement pursuant to section 60(2). At the hearing, however, counsel for Warner-Lambert informed me that Warner-Lambert had changed its mind and wished to maintain this plea. Nevertheless, as at the previous hearing, Warner-Lambert's arguments were almost entirely devoted to its case under section 60(1)(c).

It is also convenient to note two further pieces of evidence which I was shown about what is happening on the ground. The first, which was relied on by Warner-Lambert, consists of a paragraph in the Minutes of Meeting of the North of Tyne Area Prescribing Committee ("APC") on 13 January 2015 which reads as follows:

"Generic Pregabalin

The patent for Lyrica® (pregabalin) with respect to generalized anxiety disorder (GAD) and epilepsy expired in July 2014 but there is a second medical use patent protecting pregabalin's use in neuropathic pain which extends to July 2017.

Pfizer have contacted CCGs and community pharmacies to highlight that they believe the supply of generic pregabalin for use in the treatment of pain, whilst the pain patent remains in force in the UK, would infringe Pfizer's patent rights. They are therefore requesting that clinicians prescribe pregabalin by brand (Lyrica®) for neuropathic pain.

The APC supports generic prescribing where clinically appropriate and have issued a document – APC Guideline on Medicines that are Not Suitable for Generic Prescribing … which outlines clinical circumstances were they believe prescribing by brand may be appropriate.

Whilst recognising pharmaceutical company rights with regards to patent protection, the APC does not believe there is any significant clinical difference between the branded and generic pregabalin products. Providing patients have sufficient information provided to them to take their medication safely and, providing prescribers prescribe in line with their GMC responsibilities around 'off-label' prescribing, the APC do not believe it is clinically necessary to prescribe pregabalin by brand name."

I would make two comments about this. First, in my view it emphasises the desirability of NHS England (and NHS Wales) issuing guidance on this subject. Secondly, and more importantly for present purposes, it is not suggested by Warner-Lambert, nor could it be, that the stance adopted by the APC is a result of anything Actavis have done. Moreover, it can be seen that the APC has adopted this stance despite Pfizer's letters to CCGs and community pharmacies.

The second, which was relied on by Actavis, consists of a paragraph from the Newsletter of the Pharmaceutical Services Negotiating Committee ("PSNC"), which represents NHS pharmacy contractors, dated 2 February 2015

"Important: dispensing of Lyrica/Pregabalin

At present the generic pregabalin is listed in Part VIIIA of the tariff as a Category C line with reimbursement currently based on Lyrica. Where a generic prescription for pregabalin is presented to the pharmacy, if the pharmacy is minded to dispense the generic, they should first satisfy themselves it is not being provided for the patented indications (peripheral and central neuropathic pain). If it is being provided for those indications, the pharmacy should dispense Lyrica and may wish to advise the prescriber."

Like the APC minutes, this emphasises that the situation which confronts the parties in this case depends on the past, current and future actions of third parties who are not under either party's control or direction.

The first question to be considered is whether, assuming that I was correct to hold in my previous judgment that the word "for" in the "for treating" part of a Swiss form claim imports a requirement of subjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition, Warner-Lambert's draft Amended Particulars of Infringement disclose reasonable grounds for alleging subjective intention on the part of Actavis. As counsel for Actavis accepted, it is both necessary and sufficient for this purpose that the manufacturer's acts are targeted or aimed at that consequence. As counsel for Actavis also accepted, in a proper case such an intention may be inferred from objective facts even if (as will usually be the case) there is no direct evidence of it.

It is not disputed, at least for present purposes, that Lecaent has been and will be manufactured by Balkanpharma-Dupnitsa AD ("Balkanpharma") in Bulgaria, that Balkanpharma changed its trading name to Actavis on 12 May 2014 and Balkanpharma is owned by Actavis' parent company. Furthermore, counsel for Actavis made it clear that Actavis was not taking any point on the fact that Lecaent is manufactured by Balkanpharma rather than Actavis. Accordingly, I shall mostly refer for convenience to Actavis rather than Balkanpharma.

The Amended Particulars of Infringement allege at sub-paragraph 4(a2) that the manufacture of Lecaent has been and will be undertaken in circumstances where Actavis both know and intend that a major proportion of Lecaent will be used for treating pain. Numerous particulars are pleaded in support of this allegation. Counsel for Actavis submitted that neither individually nor cumulatively did the particulars plead a sustainable case for drawing an inference that Actavis intended that Lecaent would be used for treating pain.

Before turning to consider the particulars, two points should be noted. First, it is common ground that for this purpose the facts pleaded in the particulars must be assumed to be true. Secondly, counsel submitted that the particulars must be read against the uncontentious background, and in particular (i) the steps which Pfizer have taken (see my previous judgment at [51]-[61]), (ii) the steps which Actavis have taken or promised that they will take (see my previous judgment at [62]-[66] and [79]-[82]) and (iii) the steps which third parties such as NICE, PAG and now the PSNC have taken (see my previous judgment at [53] and [57] and paragraph 7 above). I did not understand counsel for Warner-Lambert to dispute this point, but in any event I accept it.

Sub-paragraphs 4(b) to (e1) of the draft Amended Particulars of Infringement plead that over 54% of pregabalin is prescribed for pain; that the majority of prescriptions are written generically; that about 95% of prescriptions do not state the indication; that it is therefore inevitable that generic pregabalin will be dispensed by pharmacists for treatment of pain; and that use of a "skinny label" will not prevent pregabalin being dispensed for pain and that Actavis know this.

Actavis contends that these allegations simply ignore all the measures that have been taken and will be taken. More importantly, however, Actavis contends that they do not amount to an allegation that Actavis intends pregabalin to be dispensed for the treatment of pain, but only an allegation that this is a foreseeable consequence of Actavis marketing its product under a skinny label. I agree with this.

Sub-paragraphs 4(e2) and (e3) allege that these facts "would have" formed the basis for Actavis' decision to launch a skinny label generic pregabalin product; that they "would have" formed the basis for Actavis' forecasts of sales and revenues and its business plans; and that such forecasts etc "will have" included sales for the treatment of pain.

Actavis complains that these sub-paragraphs ignore the fact that Actavis does have a contingent intention to market a generic product with a full label for treating pain if, but only if, it is successful in revoking the Patent.

Actavis also contends that these allegations ignore the fact that the non-pain market is very substantial. It is common ground that other suppliers consider it worthwhile to enter this market (see my previous judgment at [67]-[72]). In particular, Warner-Lambert accepts that Consilient will not infringe the Patent. Accordingly, it cannot be alleged that Consilient must have taken the pain indication into account in its business plans when deciding to go for a skinny label. Actavis asks why, in those circumstances, must it be assumed that Actavis did?

Most importantly, Actavis contends that these sub-paragraphs, apart from being naked speculation, simply assume the intention they seek to establish and do not plead any objective facts that are supportive of an inference that Actavis has the intention at all. I agree with this.

Sub-paragraph 4(e4) alleges that it is likely that Actavis will have been in contact with Balkanpharma as to the measures requested by Pfizer as to packaging notices. Sub-paragraphs 4(e5) to (e7) recite steps belatedly taken by Warner-Lambert to put Balkanpharma on notice of its contentions and some of the evidence, all of which Actavis already had. Given Actavis' acceptance that no distinction need be drawn between Balkanpharma and itself for present purposes, these sub-paragraphs add nothing to Warner-Lambert's case on intention.

Sub-paragraph 4(e8) alleges that it is to be inferred from the foregoing that Actavis know that Lecaent will be used for treating pain, but it is not alleged in this sub-paragraph that this is intended.

Sub-paragraph 4(e9) alleges that Actavis' intention that Lecaent should be used for the treatment of pain can be inferred from its failure to take adequate steps to prevent such use. So far as the alleged failure to take adequate steps is concerned, the pleading sets out no less than 12 separate steps that it is said Actavis could have taken.

Remarkably, many of the steps are not ones that Warner-Lambert had ever previously suggested that Actavis should take, let alone ones which Warner-Lambert sought to compel Actavis to take by its interim injunction application (such as (v) implementing a communications campaign on their website and via social media etc and (xi) placing notices in journals such as Pulse, The Lancet etc). They also include steps that Warner-Lambert only requested at a very late stage of that application (such as (ii) use of a removable wrapper). They also include steps which Actavis has agreed to take (such as (x) writing to superintendent pharmacists). They also include steps that are wholly irrelevant (such as (ix) a complaint that Actavis did not agree to short service of the interim application in December 2014). They also include steps which do not lie within Actavis' power (such as (i) consulting with NHS England and NHS Wales to ensure that prompt, clear and effective guidance is issued to ensure that prescribers Lyrica for pain and (vii) procuring a change to prescription software).

In addition to these individual points, Actavis makes the overarching point that a failure on the part of Actavis to take positive steps to prevent independent third parties who are not under its control and direction from doing things which result in pregabalin being dispensed for the treatment of pain does not support the inference that Actavis intended that result. I agree with this. Indeed, it was a striking feature of counsel for Warner-Lambert's submissions that he went so far as to submit that it would be proper to infer that Actavis intended that result even if Actavis could not prevent it by taking such steps. In my view that proposition only has to be stated to be seen to be untenable.

Sub-paragraph 4(e10) pleads the failure of Actavis to take any steps prior to the correspondence between Warner-Lambert's solicitors and Actavis' solicitors in September 2014 (see my previous judgment at [39]-[40]) and the fact that Actavis' solicitors' letter dated 3 October 2014 only proposed use of a skinny label and sending a letter to superintendent pharmacists (see my previous judgment at [42]).

In so far as sub-paragraphs 4(e9) and 4(e10) complain about the timing of Actavis' steps and proposed steps, and in particular its failure to take certain steps before it receives its marketing authorisation, Actavis points out that, as was discussed at the previous hearing, Actavis is anxious not to fall foul of the regulatory rules against promoting a product prior to the grant of the marketing authorisation and that I accepted that concern as being reasonable (see my previous judgment at [80] and [82]). Warner-Lambert alleges that this concern is unfounded, but it does not allege that Actavis had no genuine belief in this matter. Absent such an allegation, I do not see how Actavis' failure to take such steps prior to receipt of its marketing authorisation can support an inference of intention.

In any event, I do not consider that sub-paragraph 4(e10) adds anything of substance to the previous sub-paragraph.

Sub-paragraphs 4(f) and (g) rely upon the correspondence in late November 2014 (see my previous judgment at [44]-[45]). This takes Warner-Lambert no further forward.

Subparagraph 4(g1) alleges that it is inferred from the foregoing that Actavis has at all times wished to avoid taking steps to limit the extent to which Lecaent would be used for treating pain in order to maximise its sales of Lecaent.

Actavis complains with justification that this simply ignores the steps that Actavis has taken or agreed to take and its knowledge of the steps that others have taken. More importantly, Actavis contends that the matters relied upon do not support this inference. I agree with this.

Subparagraph 4(h) complains about a statement in Actavis' PIL that pregabalin capsules may be prescribed to treat conditions not listed in the leaflet (those being epilepsy and GAD) and that, if the patient has any questions, they should ask their doctor or pharmacist. Actavis points out that this is a correct statement of fact, since doctors may prescribe pregabalin off-label for a variety of indications, including restless leg syndrome. Actavis also contends that the inclusion of this statement is good practice to avoid patient confusion and encouraged by regulatory authorities. Warner-Lambert pleads that Consilient has not included such a statement in its PIL and relies upon this as showing that the inclusion of this statement was not necessary. Even if it is not necessary, however, that does not show it is not good practice, still less that Actavis does not have a genuine belief that it is good practice. Accordingly, this allegation does not support an inference of intention on Actavis' part.

Sub-paragraph 4(h1) complains about some of the safety information included in Actavis' SmPC, which relates to central neuropathic pain. Again, Actavis contends that the inclusion of this information is good practice and encouraged by regulatory authorities. Warner-Lambert does not allege that Consilient's SmPC does not include this information, but nevertheless alleges that it is voluntary. Again, even if it is voluntary, that does not show it is not good practice, still less that Actavis does not have a genuine belief that it is good practice. Accordingly, this allegation does not support an inference of intention on Actavis' part.

It remains for me to stand back and consider all of the particulars together to see whether, cumulatively even if not individually, they support the inference that Actavis intends Lecaent to be dispensed for treating pain. In my judgment they do not. Accordingly, I conclude that the Amended Particulars of Infringement do not disclose reasonable grounds for alleging subjective intention on Actavis' part.

Counsel for Warner-Lambert contended that, even if the draft Amended Particulars of Infringement did not disclose reasonable grounds for alleging subjective intention on the part of Actavis, it would not be correct to strike out or summarily dismiss Warner-Lambert's claim for infringement of the Patent. He advanced three main submissions in support of this contention.

First, he submitted that it was arguable that my previous judgment was wrong in holding that subjective intention was required. So far as this point is concerned, it is right to acknowledge straightaway that, if my conclusion had been based solely on the question of serious issue to be tried, I would have granted Warner-Lambert permission to appeal; I only refused permission to appeal because I was also against Warner-Lambert on the balance of the risk of injustice. Perhaps more importantly, counsel for Warner-Lambert advanced a wide-ranging argument as to the requirement of intention in different branches of the law, most of which had not been advanced at the previous hearing.

Secondly, he submitted that this was a developing area of the law and he relied upon the well-established principle that in such circumstances a claim should not be struck out, but rather the facts should be found first and then the law determined: see Civil Procedure (2014) at note 3.4.2 and the cases cited. In this regard, counsel particularly relied upon the recent decision of the Court of Appeal of The Hague in Novartis AG v Sun Pharmaceutical Industies (Europe) BV given on 27 January 2015.

Thirdly, he submitted that there was an "other compelling reason why the case should be disposed of at a trial" within CPR rule 24.2(b).

I shall consider these submissions in turn.

There were two branches of counsel for Warner-Lambert's argument in relation to intention. The first, minor, branch attacked my conclusion that the relevant intention was that of the manufacturer (see my previous judgment at [99]). It is worth recording that it was common ground between counsel that it was at least arguable that, in this context, manufacture (or, more strictly, "preparation") should be broadly interpreted as extending to, for example, a person who packaged and labelled the product (if different to the manufacturer of the pharmaceutical composition). It is also worth pointing out that the fact that a generic supplier subcontracts manufacture will not necessarily cause any difficulty. Nevertheless, I remain unpersuaded that the relevant intention can be that of a person who disposes of the product subsequently in the chain of supply, such as a pharmacist. As noted above, Warner-Lambert has abandoned its claim under section 60(1)(a). It follows that Warner-Lambert accepts that the claims of the Patent are process claims. Given that the claims are process claims directed to the preparation of the pharmaceutical composition, I asked counsel for Warner-Lambert how, as a matter of logic, the relevant intention could be that of a person who disposes of the product subsequently in the chain of supply. He had no answer to that question.

I turn therefore to the second and major branch of the argument, which concerned the nature of the mental element imported by the words "for treating" in Swiss form claims. Counsel for Warner-Lambert accepted that these words had to import some form of mens rea, but he advanced two main submissions: first, it was arguable that something less than intention would suffice; and secondly, that even if intention was required, it was arguable that something less than subjective intention, and in particular intention in the sense of conduct targeted or aimed at the result, would suffice.

In support of these submissions, and in particular the second one, counsel for Warner-Lambert deployed an impressive body of legal learning which ranged over the subjects of intention in the criminal law, recklessness in the criminal law, equitable liability for dishonest assistance and knowing receipt and the law with regard to a series of different torts: not only procuring breach of contract (as to which, see my previous judgment at [104]-[106]), but also unlawful interference, conspiracy, malicious prosecution, deceit, defamation and, in particular, misfeasance in public office.

It is not necessary for the purposes of this judgment to set out all of the points which counsel for Warner-Lambert made or the authorities he relied on in support of them (although it is right to record that particular attention was paid by both counsel to the decision of the House of Lords in Three Rivers District Council v Governor and Company of the Bank of England (No 3) [2003] 2 AC 1). It is sufficient to concentrate on what I regard as counsel for Warner-Lambert's key propositions. The first is that intention has often given rise to difficulties in the law. The second is that intention can have different meanings in different areas of the law. The third is that, in some contexts, a person is taken to intend the natural and probable consequences of his or her actions. The fourth is that, in some contexts, reckless indifference to consequences is regarded as sufficient to satisfy the requirement for a mental element in the alternative to intention. The fifth is that, in determining the correct meaning in any particular legal context, it is necessary to pay close regard to the policies which inform that aspect of the law.

I have no difficulty in accepting each of these propositions. The problem with the argument, as I see it, is that none of these propositions really advances Warner-Lambert's case on the meaning of the words "for treating" in a Swiss form claim. In construing those words in my previous judgment, I concentrated on this specific legal context and I did pay close regard to the policies which inform it.

Nevertheless, I return to the point which I made in paragraph 33 above. I accept that it is possible that an appellate court may conclude that my construction of the words "for treating" is wrong. In deciding whether to strike out the claim, or grant summary judgment, I consider that this is an important factor to take into account, as I shall explain further below.

I accept that this is a developing area of law. Although the subject has been much discussed, my previous judgment was the first judgment in the UK which squarely addressed the issue of the mental element of Swiss form claims in the infringement context, and certainly the first to address the problems thrown up by generic pharmaceuticals marketed with skinny labels. None of the earlier cases from England, Germany, the Netherlands and Spain mentioned in my previous judgment (at [110]) is anywhere near being definitive.

An important development which has occurred since my previous judgment is the judgment in Novartis v Sun cited above, in which the Hague Court of Appeal provisionally held in kort geding (interim) proceedings that Sun had infringed claim 7 of Novartis' European Patent (NL) No. 1 296 689. This is a second medical use patent with claims in Swiss form. Claim 7 is to use of zoledronic acid or a pharmaceutically acceptable salt thereof or any hydrate thereof for the preparation of a medicament for the treatment of osteoporosis wherein said medicament is adapted for intravenous administration in a unit dosage form which comprises from about 2 up to about 10 mg and the period between administrations is about once a year.

Patent protection for zoledronic acid expired on 16 May 2013. Novartis marketed a 5 mg/100 ml solution of zoledronic acid for intraveneous administration under the trade mark Aclasta for the treatment of both osteoporosis (i.e. the patented second indication) and Paget's disease (for which there was no patent).

Whereas osteoporosis is a common disease which requires periodic treatment with zoledronic acid, Paget's disease is a very rare disease for which only a single administration is required. Novartis' evidence was that 97.3% of sales of Aclasta were for osteoporosis and only 2.7% (just 135 units per year) were for Paget's disease.

On 29 July 2013 Sun obtained a Dutch marketing authorisation for generic zoledronic acid using Aclasta as the reference product. The marketing authorisation covered both osteoporosis and Paget's disease. On 26 August 2013 Sun asked the regulator to remove osteoporis as an indication from its SmPC and PIL, and the regulator agreed to this the following day. Despite this, this carve out was (as a matter of policy) not shown in the digital versions of the SmPC and PIL published by the regulator on its website.

In October 2013 Sun won a tender to supply a zoledronic acid 5 mg/100 ml product to patients treated at home who were covered by a healthcare insurer called VGZ. This meant that Sun's generic product was the only zoledronic acid 5 mg/l00 ml product that was reimbursed by VGZ, except in cases of medical necessity. VGZ required that only one product was to be designated for any patient insured with VGZ who was treated at home with zoledronic acid in a dosage of 5 mg/100 ml, without distinguishing the indication for which it was prescribed. Remarkably, pharmacists were obliged to dispense the designated product even if the prescription specified Aclasta. Thus it was inevitable that the vast majority of Sun's generic zoledronic acid product supplied under this contract would be dispensed to patients with osteoporosis.

It did not appear that Sun had attempted to convince VGZ to frame the invitation to tender differently, so as to separate the supply of zoledronic acid for Paget's disease from the supply for osteoporosis, whether or not such an attempt would have succeeded. Moreover, it was only after it had won the tender that Sun sent VGZ an email stating that its generic product was only licensed for Paget's disease and that osteoporosis was covered by the Novartis patent. Sun also sent a similar email, stating that it pertained to formality, to wholesalers and pharmacists, but did not state that the generic product should not be prescribed or dispensed for osteoporosis.

The following points should be noted about the Dutch Court's reasoning. First, the Court (provisionally) held that Sun had committed indirect infringement of claim 7 of the patent, that is to say, infringement under the Dutch implementation of Article 26 of the Community Patent Convention, which is implemented in the United Kingdom by section 60(2) of the 1977 Act.

Secondly, it was common ground between the parties (see [4.31]) that Sun's generic zoledronic acid product was an essential element of the invention of claim 7 of the patent.

Thirdly, the Court held (see [4.33]) that Sun had the requisite knowledge of infringing use of its generic product for the purposes of indirect infringement. Its reasoning for so holding is entirely consistent with the approach to section 60(2) laid down by the Court of Appeal in this country in Grimme v Scott and KCI v Smith & Nephew (see my previous judgment at [102]).

Fourthly, the Court took into account (at [4.34]-[4.36]) the fact that Sun had not taken steps which it could have taken, but this does not appear to have been critical to its reasoning. What was critical was Sun's knowledge.

Fifthly, the Court did not find that Sun intended to supply zoledronic acid for treating osteoporosis, but the facts of the case might well have justified such an inference.

Sixthly, and most importantly, the Court's analysis assumes that claim 7 is a product claim. There is no mention of the fact that it is a process claim. Still less is there any discussion of the meaning of the words "for treating" or of the mental element which those words import. I can only assume that Sun failed to draw these matters to the Court's attention and to advance the arguments which were advanced by Actavis before me.

Seventhly, counsel for Warner-Lambert submitted that the reasoning could be justified on the basis that Swiss form claims were to be interpreted in the same way as EPC 2000 claims. I do not accept this. Leaving aside the fact that the Dutch Court said nothing of the kind, as I pointed out in my previous judgment at [13], the EPO Boards of Appeal have held that the two types of claim have different scope. I would also point out it is difficult to reconcile this submission with Warner-Lambert's abandonment of its case under section 60(1)(a) (corresponding to Article 25(a) CPC).

As counsel for Warner-Lambert candidly explained, it was because of this decision that Warner-Lambert changed its mind about dropping its section 60(2) case. He was unable to submit, however, that the decision provided an answer to the difficulties with that case identified in my previous judgment at [103]. No doubt it was for that reason that he focussed, as his predecessor had, on the section 60(1)(c) case (corresponding to Article 25(c) CPC).

Counsel for Warner-Lambert pointed out that, if the infringement claim was struck out or summary judgment was granted, Warner-Lambert would seek to appeal to the Court of Appeal. It followed from my previous indication that permission should be granted. He also submitted that, whatever the Court of Appeal decided, the issue was one which would be suitable for consideration by the Supreme Court. He further submitted that, given that I had directed that the infringement issue should be tried at the end of June 2015, even assuming that the Court of Appeal expedited its consideration of the matter, it would be very difficult to obtain a decision from the Supreme Court before the trial. I accept these points.

Counsel for Warner-Lambert also submitted that this reinforced his submission that, in cases concerning developing areas of the law, the correct approach was to find the facts first and then determine the law. Again, I accept this.

The conclusion I reach is that it would not be correct to strike out Warner-Lambert's claim for infringement. Although I am not persuaded that the Amended Particulars of Infringement disclose reasonable grounds for alleging subjective intention on the part of Actavis, and, if I am right that subjective intention is required, that means that the claim is bound to fail, I recognise that I may be wrong about the requisite mental element. In any event, I consider that this is a developing area of the law and therefore the proper course is to establish the facts at a trial before attempting definitively to determine the law. That is particularly so given that I consider that the issue is one which is likely to be suitable for consideration not merely by the Court of Appeal, but also by the Supreme Court. Similarly, I shall not grant summary judgment dismissing the claim. Even if the claim does not have a real prospect of success as matters stand, for the reasons explained above there is another compelling reason for trial.

I would add four points. The first is that I am reinforced in the conclusion I have just reached by the consciousness that, even now, there are arguments which might be advanced which have not yet been deployed. For example, suppose it turned out at trial that, despite the fact that Actavis had not intended Lecaent to be dispensed for treating pain and despite the fact that Actavis, Pfizer and others had taken reasonable steps to prevent this, in fact some Lecaent had been dispensed for pain. Suppose also that it could be established that Actavis had sold £8 million worth of Lecaent which had been used for treating non-patented indications and £2 million worth which had been used for treating pain. It might be said that, in those circumstances, Warner-Lambert ought to have a financial remedy even if it was not entitled to an injunction. It is not easy to see how such a result could be arrived at, particularly given the way Warner-Lambert's case is currently framed; but that does not mean that it is impossible.

The second is that I shall hear further argument as to whether the section 60(2) claim should be allowed to proceed to trial.

The third is that, although I shall give Warner-Lambert permission to amend the Particulars of Infringement largely as sought, I shall refuse permission to include the references to the position in France in sub-paragraphs 4(d) and (e7). In my judgment the position in France is wholly irrelevant.

The last is that Warner-Lambert's claim as presented in the Amended Particulars of Infringement and in counsel for Warner-Lambert's arguments at this hearing is one that will require firm case management. In particular, counsel made it clear that Warner-Lambert would be seeking wide-ranging disclosure from Actavis. Without prejudging any application which may be made, my provisional view is that much of this amounts to a fishing expedition. Disclosure must be limited to what is relevant and proportionate.