“1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain. 2. Use according to Claim 1 wherein the pain is inflammatory pain. 3. Use according to Claim 1 wherein the pain is neuropathic pain.”
“Meaning of infringement. (1) Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say— … (b) where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent; (c) where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise. (2) Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom. … (5) An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if— … (c) it consists of the extemporaneous preparation in a pharmacy of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner or consists of dealing with a medicine so prepared; …”
“Remedy for groundless threats of infringement proceedings. (1) Where a person (whether or not the proprietor of, or entitled to any right in, a patent) by circulars, advertisements or otherwise threatens another person with proceedings for any infringement of a patent, a person aggrieved by the threats (whether or not he is the person to whom the threats are made) may, subject to subsection (4) below, bring proceedings in the court against the person making the threats, claiming any relief mentioned in subsection (3) below. (2) In any such proceedings the claimant or pursuer shall, subject to subsection (2A) below, be entitled to the relief claimed if he proves that the threats were so made and satisfies the court that he is a person aggrieved by them. (2A) If the defendant or defender proves that the acts in respect of which proceedings were threatened constitute or, if done, would constitute an infringement of a patent— (a) the claimant or pursuer shall be entitled to the relief claimed only if he shows that the patent alleged to be infringed is invalid in a relevant respect; (b) even if the claimant or pursuer does show that the patent is invalid in a relevant respect, he shall not be entitled to the relief claimed if the defendant or defender proves that at the time of making the threats he did not know, and had no reason to suspect, that the patent was invalid in that respect. (3) The said relief is— (a) a declaration or declarator to the effect that the threats are unjustifiable; (b) an injunction or interdict against the continuance of the threats; and (c) damages in respect of any loss which the claimant or pursuer has sustained by the threats. …”
“First of all let me say that making allegations of infringement against pharmacists (who are in most cases also our customers) is not something that Pfizer would engage in lightly. I also take your point that, as a general matter, patentees have not tended to assert patent infringement against pharmacists for dispensing generic product, although it certainly has happened on occasion. … The key issue is whether there is any relevant patent in place — if there is, then subject to the fairly narrow exception insection 60(5)(c) of the Patents Act 1977 , it is indeed possible for retail pharmacists to be liable for infringement. The facts we are dealing with here are different from the usual generic launch scenario, but the bottom line is that Pfizer has in place a patent that it believes is valid and which it believes could be infringed. … … there are various ways in which a retail pharmacist could be said to be liable for infringement, for example if they started taking more than their non-pain demand for pregabalin supplies from generic companies with the inevitable result that neuropathic pain prescriptions were not being filled with Lyrica. In direct response to your query we do believe that retail pharmacists would be infringing if they receive prescriptions for ‘pregabalin’ and dispense the generic, knowing it to be for treating neuropathic pain. …”
“Whilst Pfizer’s pain patent remains in effect, we expect that generic manufacturers will generally only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder, i.e. the two indications for which Pfizer has no patent protection. It is likely that the generic companies will initiate discussions with you about their products and we therefore think it is important for you to understand that we believe the supply of generic pregabalin for use in the treatment of pain, whilst the pain patent remains in force in the UK, would be infringing Pfizer’s patent protection and would constitute an unlawful act.”
“If the Court later finds that this Order has caused loss to … the Dr Reddy’s group of companies, and decides that the … Dr Reddy’s group of companies should be compensated for that loss, [Warner-Lambert] will comply with any Order the Court may make.”
“1. Pregabalin should only be prescribed for the treatment of neuropathic pain under the brand name Lyrica® (unless there are clinical contra-indications or other special clinical needs e.g. patient allergic to an excipient, branded product unavailable etc which apply to Lyrica®, when you should not prescribe Lyrica® or pregabalin) 2. When prescribing pregabalin for the treatment of neuropathic pain to patients you should (so far as reasonably possible): a. prescribe by reference to the brand name Lyrica®; and b. write the prescription with only the brand name ‘Lyrica’, and not the generic name pregabalin or any other generic brand. 3. When prescribing pregabalin for the treatment of anything other than pain, you should continue to prescribe by reference to the generic name pregabalin. 4. When dispensing pregabalin, if you have been told that it is for the treatment of pain, you should ensure, so far as reasonably possible, that only Lyrica®, the branded form of pregabalin, is dispensed. However, when dispensing pregabalin for the treatment of anything other than pain, you are not restricted to dispensing Lyrica®.”
“… Whereas Warner-Lambert’s position at the time of the 17 November Order was that it relied upon claim 3 to prevent generic access to the pregabalin market prior to expiry of the Patent, it no longer does so. This matters when it comes to the assessment of the balance of the risk of injustice, because claim 3 confers a broader monopoly on Warner-Lambert than claims 10, 11 and 12, particularly if claim 3 covers both peripheral and central neuropathic pain as is Warner-Lambert’s primary contention. In particular, as noted in the preceding paragraph, it enables Sandoz to advance its argument on proportionality. That argument was not open to Sandoz in the same way at the hearing on21 October 2015 because at that stage Warner-Lambert was still relying upon claim 3. While it is true that I held in Sandoz I that Warner-Lambert had an arguable case of infringement of claims 10, 11 and 12 even if claim 3 was invalid, I went on to assess the balance of the risk of injustice on the basis that Warner-Lambert had a real prospect of success on claim 3 and I did not carry out a separate assessment on the assumption that Warner-Lambert only had a real prospect of success on claims 10, 11 and 12.”
“77. In its current Amended Particulars of Infringement Warner-Lambert alleges infringement by Sandoz of claims 1, 3, 11 and 12 of the Patent, but not claim 10. (This is a point which appears to have been overlooked at the hearing on21 October 2015 .) On7 December 2016 , however, Warner-Lambert served draft Re-Amended Particulars of Infringement on Sandoz which add an allegation of infringement of claim 10. Counsel for Sandoz did not have instructions formally to consent to that amendment, but he accepted that the Court should proceed on the assumption that that amendment would be made. … 78. Warner-Lambert’s draft Re-Amended Particulars of Infringement also introduce allegations of claims 2 and 8. Counsel for Sandoz indicated that Warner-Lambert’s application to introduce those allegations would be resisted. Given that, and given that there was no application by Warner-Lambert for permission to make those amendments before the Court, those allegations cannot be relied upon by Warner-Lambert for the purposes of resisting Sandoz’s application. I would add that, as I indicated to counsel for Warner-Lambert during the course of argument, my provisional view is that the allegations require further particularisation anyway. 79. What was not drawn to my attention during the course of the hearing, but I have subsequently noticed, is that Warner-Lambert’s existing Amended Particulars of Infringement allege infringement of claims 5, 7 and 9. It follows that, in principle, Warner-Lambert would be entitled to rely upon those allegations for the purposes of resisting Sandoz’s application. Counsel for Warner-Lambert did not rely upon those allegations as part of his argument, however. This is consistent with the stance adopted by Warner-Lambert at the hearing on21 October 2015 , when it did not rely upon those allegations for the purposes of its interim injunction application. I would add that my provisional view is that those allegations also require further particularisation. 80. This does not mean that claims 2, 5, 7, 8 and 9 are irrelevant for the purposes of the present application. On the contrary, those claims have been found to be valid and there is no extant challenge to that finding. It follows that, in principle, Warner-Lambert is entitled to the benefit of the monopoly conferred by those claims even if it is not in a position to allege infringement of those claims (as distinct from claims 10, 11 and 12).”
“… Even though the conditions covered by claims 10, 11 and 12 represent a small percentage of the pregabalin market, if the marketing of the Sandoz Full Label Product infringes those claims, Warner-Lambert is prima facie entitled to an injunction to prevent such marketing prior to expiry. If Sandoz were permitted to market the Sandoz Full Label Product now, it is clear that they would be quickly followed by other generic companies. Some might be able to launch very quickly after Sandoz, while others might have to wait 30-60 days. Within a couple of months, however, there would be a free-for-all in the full label market. The consequence would be further pressure on the market price of pregabalin. This would require Pfizer to spend even more money on Brand Equalisation deals if it was to try to maintain the ex-factory price of Lyrica. In practice, Pfizer might well have to cease supporting the ex-factory price in that way. Moreover, although expiry of the Patent is now less than seven months away, re-categorisation of pregabalin for the purposes of the Drug Tariff during that period remains a possibility. Pfizer would not be able put the price up again if Warner-Lambert is successful, not least because the Patent would have expired. The loss which Warner-Lambert would suffer as a result would be very difficult to quantify. The difficulty of the quantification exercise would be exacerbated by the substantial level of off-label prescribing of pregabalin for conditions covered by claims 2, 5, 7, 8 and 9, particularly given the likely uncertainty as to the extent to which that demand is met by full label as opposed to skinny label pregabalin. Moreover, it would be far from easy to quantify Warner-Lambert’s loss even in that part of the pregabalin market which is protected solely by claims 10, 11 and 12.”
“108. … counsel for Sandoz placed proportionality at the forefront of his argument. In short, he submitted that an injunction to prevent Sandoz from marketing the Sandoz Full Label Product would be disproportionate when (i) the effect of the NHS Guidance was that about 30% of prescriptions in England were written by reference to the brand name Lyrica and thus could not have any generic product dispensed against them and (ii) in practice Pfizer retained about 50% of the pregabalin market, but (iii) claims 10, 11 and 12 only covered 1.13% of the market. … 109. … I do not consider that proportionality is a trump card for Sandoz on the present application for the following reasons. First, the figure of 1.13% ignores the rather larger part of the market (over 13.8% on Warner-Lambert’s evidence) which is covered by claims 2, 5, 7, 8 and 9. As I have said, in principle, Warner-Lambert is entitled to the benefit of a monopoly of the latter part of the market even if it is not in a position to allege infringement of those claims (as distinct from claims 10, 11 and 12). It is immaterial for this purpose that Pfizer only reaches that part of the market through off-label prescribing because pregabalin is not authorised for the conditions covered by those claims. 110. Secondly, even if one disregards the part of the market covered by claims 2, 5, 7, 8 and 9, and leaving aside for the moment the effect of the NHS Guidance, the main cause of the problem which faces Sandoz is the preference which certain pharmacy chains have to stock full label product. Even though the conditions covered by claims 10, 11 and 12 represent a small percentage of the total market, Warner-Lambert is prima facie entitled, assuming that its claim for infringement of those claims succeeds, to use that monopoly to protect the full label market for pregabalin (as distinct from the skinny label and intermediate label markets). I do not consider it disproportionate to grant an injunction to enforce that entitlement on an interim basis. In this regard, it should not be forgotten that Sandoz have the benefit of Warner-Lambert’s cross-undertakings not only with respect to the injunction, but also, to the extent that it contributes to the damage Sandoz suffer by ensuring that too large a percentage of prescriptions is written for Lyrica, the NHS Guidance. When it comes to the stage of considering whether to grant a final injunction, the position may be different …; but that is a matter for another day.”
“63. It is common ground that Swiss-form claims are purpose-limited process claims. Claim 3 of the patent in suit is not a product claim, because the product is not novel. It is a process claim because it protects the process of ‘preparation’ (or manufacture) of a medicament containing pregabalin. It is purpose-limited because it only protects that process so far as it is undertaken ‘for’ treating neuropathic pain. The monopoly claimed is a monopoly of preparation or manufacture of the product for the designated purpose. It is not a monopoly of the subsequent use of the product for that purpose. This is the basis on which Claim 3 is consistent with the prohibition of patents for methods of treatment or diagnosis. It follows that Warner-Lambert's allegation of direct infringement is and must be based on section 60(1)(c). 64. Section 60(1)(c) is concerned with cases where a product is obtained directly by means of the patented process. Infringement occurs whenever a person disposes of that product, offers to dispose of it, uses or imports it, or keeps it, whether for disposal or otherwise. The infringer may be, but need not be, the same as the person who makes the product. The section also applies to anyone in the downstream generic market, including wholesalers and pharmacists. Liability is strict. Provided only that the product has been obtained directly by means of the process, it extends to subsequent dealings with all and every such product irrespective of knowledge. … 67. At the hearing before us, the parties were agreed that there was a mental element in infringement under section 60(1)(c) . This was not because of the terms of the section itself, which provides for strict liability. It was said to be because a mental element was intrinsic to the claim said to have been infringed. The preparation of the compound must be ‘for’ the treatment of the designated condition. This cannot mean ‘suitable for’ that purpose, for a claim thus framed would lack novelty: the product was just as suitable for the newly discovered purpose before the priority date, even if this was not generally known. Therefore, it was said, it must mean that the manufacturer must make the product with the intention that it be used for that purpose, if the product is to fall within the confines of section 60(1)(c). The difference between the parties concerned the test of intention. Actavis’s case was that the test of the manufacturer's intention was subjective. The manufacturer must make the product with intent to target the patent-protected market. Arnold J accepted that submission. Warner-Lambert’s primary case was that the test of the manufacturer’s intention was objective, and that a manufacturer must be taken to intend the foreseeable consequences of his actions. It was therefore enough to support a case of infringement of Claim 3 under section 60(1)(c) that it was foreseeable to the manufacturer that a more than de minimis amount of it would in due course be used for the treatment of neuropathic pain. … 70, … after the hearing the parties addressed [the ‘only packaging will do’ approach] in writing, at the invitation of the court. Actavis adopted it by way of alternative to their primary case that the test required proof of subjective targeting. … 71. It is clearly correct that this issue depends not on the meaning of section 60(1)(c) of the Patents Act but on the construction of the relevant claims in the patent. The question is what, as a matter of construction, does it mean to claim in a patent the use of pregabalin for the preparation of a medicament ‘for’ treating neuropathic pain. …”
“The short answer to this is that the invention protected by Claim 3 is the manufacture of pregabalin for the designated use, and not the subsequent use of the product for treating patients. This is what the Court of Appeal decided, correctly in my view, in Menashe Business Mercantile Ltd v William Hill Organisation Ltd[2003] 1 WLR 1462 , para 24, per Aldous LJ. It was the ground on which the judge struck out the indirect infringement claim on the interlocutory application of Actavis. It was re-instated by the Court of Appeal as arguable. At trial, Arnold J held that the argument was bad. In the Court of Appeal, Floyd LJ adhered to his earlier view. He accepted that Menashe was authority for the proposition that the ‘invention’ in section 60(2) was the process identified in the relevant claim. But he considered that the ‘preparation’ referred to in the claims might still not be put fully into effect until the pharmacist had dispensed the medicament and affixed a sticker with the patient’s name on it. He warned against the danger of translating section 60(2) into infringement limited to acts upstream of manufacture. In my view Arnold J was right about this. The whole purpose of the Swiss-form for purpose-limited medical use claims is to avoid the problem of lack of novelty associated with product claims and the statutory provision which makes a method of treatment unpatentable. It is well understood that the degree of protection available from a Swiss-form claim may be more limited than that available from standard product claims. These essential features of purpose-limited patents are fatal to any attempt to construe Claim 3 as extending to steps taken by the pharmacist.”
“Warner-Lambert contends that, to the extent any damage is said to have arisen from [the] sale and supply [of] pregabalin products which would have been used for or attributable to the treatment of any condition covered by the Inflammatory Pain Claims, such damage should be excluded from the final calculation of quantum. PARTICULARS It would be unjust and inequitable for NHS Scotland to recover any damages arising from the supply and sale of pregabalin products which would have been used to treat one or more of the conditions covered by the Inflammatory Pain Claims, held valid by the Court. This is so, regardless of whether such use in the counterfactual would have infringed the Inflammatory Pain Claims or not.”
“Warner-Lambert contends that, to the extent that the pregabalin products sold and supplied by Dr Reddy’s would have been used for or attributable to the treatment of any condition covered by the Inflammatory Pain Claims, any profits said to have arisen from such sale and supply should be excluded from the final calculation of loss of profit. PARTICULARS The dispensing of pregabalin products supplied in the UK by Dr Reddy’s for or attributable to the treatment of any condition covered by the Inflammatory Pain Claims would have infringed the Inflammatory Pain Claims. Therefore, Warner-Lambert contends that Dr Reddy’s may not recover any such loss of profits founded substantially upon an unlawful and/or illegal act, being in this case the infringement of a European Patent (UK). By this, Warner-Lambert does not presently bring any claim before the Court that Dr Reddy’s has infringed the Patent. Without prejudice to its ability to do so, this contention is advanced in relation to the counterfactual.”
“The assessment is made upon the same basis as that upon which damages for breach of contract would be assessed if the undertaking had been a contract between the plaintiff and the defendant that the plaintiff would not prevent the defendant from doing that which he was restrained from doing by the terms of the injunction …”
“In a proceeding of an equitable nature it is generally proper to adopt a view which is just and equitable, or fair and reasonable, in all the circumstances rather than to apply a rigid rule. However the view that the damages should be those which flow directly from the injunction and which could have been foreseen when the injunction was granted, is one which will be just and equitable in the circumstances of most cases and certainly in the present case. No doubt the view … does not constitute a rigid rule and circumstances may sometimes require a different approach. However it will in my opinion be seldom that it will be just or equitable that the unsuccessful plaintiff should bear the burden of damages which were not foreseeable from circumstances known to him at the time.”
“… I reach the conclusion that the law as to the recoverability of loss suffered by reason of a cross-undertaking is as stated by Lord Diplock in his dictum in Hoffmann-La Roche, but with this caveat. Logical and sensible adjustments may well be required, simply because the court is not awarding damages for breach of contract. It is compensating for loss for which the defendant ‘should be compensated’ (to apply the words of the undertaking). Labels such as ‘common law damages’ and ‘equitable compensation’ are not, to my mind, useful. The court is compensating for loss caused by the injunction which was wrongly granted. It will usually do so applying the useful rules as to remoteness derived from the law of contract, but because there is in truth no contract there has to be room for exceptions.”
“Warner-Lambert is entitled to the benefit of the monopoly conferred by those claims even if it is not in a position to allege infringement of those claims”
“… Henderson v Henderson abuse of process, as now understood, although separate and distinct from cause of action estoppel and issue estoppel, has much in common with them. The underlying public interest is the same: that there should be finality in litigation and that a party should not be twice vexed in the same matter. This public interest is reinforced by the current emphasis on efficiency and economy in the conduct of litigation, in the interests of the parties and the public as a whole. The bringing of a claim or the raising of a defence in later proceedings may, without more, amount to abuse if the court is satisfied (the onus being on the party alleging abuse) that the claim or defence should have been raised in the earlier proceedings if it was to be raised at all. I would not accept that it is necessary, before abuse may be found, to identify any additional element such as a collateral attack on a previous decision or some dishonesty, but where those elements are present the later proceedings will be much more obviously abusive, and there will rarely be a finding of abuse unless the later proceeding involves what the court regards as unjust harassment of a party. It is, however, wrong to hold that because a matter could have been raised in earlier proceedings it should have been, so as to render the raising of it in later proceedings necessarily abusive. That is to adopt too dogmatic an approach to what should in my opinion be a broad, merits-based judgment which takes account of the public and private interests involved and also takes account of all the facts of the case, focusing attention on the crucial question whether, in all the circumstances, a party is misusing or abusing the process of the court by seeking to raise before it the issue which could have been raised before. As one cannot comprehensively list all possible forms of abuse, so one cannot formulate any hard and fast rule to determine whether, on given facts, abuse is to be found or not. Thus while I would accept that lack of funds would not ordinarily excuse a failure to raise in earlier proceedings an issue which could and should have been raised then, I would not regard it as necessarily irrelevant, particularly if it appears that the lack of funds has been caused by the party against whom it is sought to claim. While the result may often be the same, it is in my view preferable to ask whether in all the circumstances a party’s conduct is an abuse than to ask whether the conduct is an abuse and then, if it is, to ask whether the abuse is excused or justified by special circumstances. Properly applied, and whatever the legitimacy of its descent, the rule has in my view a valuable part to play in protecting the interests of justice.”
“… it is one thing to say that A should bring all his claims against B in one action, whereas it is quite another thing to say that he should bring all his claims against B and C (let alone against B, C, D, E, F and G) in one action. There may be many entirely legitimate reasons for a claimant deciding to bring an action against B first and, only later (and if necessary) against others.”
“Warner-Lambert contends that, to the extent any damage is said to have arisen from sale and supply of pregabalin products which would have been used for or attributable to the treatment of any condition covered by the Inflammatory Pain Claims, such damage should be excluded from the final calculation of quantum. PARTICULARS It would be unjust and inequitable for [the inquiry claimant] to recover any damages arising from the supply and sale of pregabalin products which would have been used to treat one or more of the conditions covered by the Inflammatory Pain Claims, held valid by the Court. This is so, regardless of whether such use in the counterfactual would have infringed the Inflammatory Pain Claims or not.”
“80. This does not mean that claims 2, 5, 7, 8 and 9 [the Inflammatory Pain Claims] are irrelevant for the purpose of the present application. On the contrary those claims have been found to be valid and there is no extant challenge to that finding. It follows that, in principle, Warner-Lambert is entitled to the benefit of the monopoly conferred by those claims even if it is not in a position to allege infringement of those claims (as distinct from claims 10, 11 and 12.”
“Warner-Lambert contends that, to the extent that the pregabalin products sold and supplied by Dr Reddy’s would have been used for or attributable to the treatment of any condition covered by the Inflammatory Pain Claims, any profits said to have arisen from such sale and supply should be excluded from the final calculation of loss of profit. PARTICULARS The dispensing of pregabalin products supplied in the UK by Dr Reddy’s for or attributable to the treatment of any condition covered by the Inflammatory Pain Claims would have infringed the Inflammatory Pain Claims. Therefore, Warner-Lambert contends that Dr Reddy’s may not recover any such loss of profits founded substantially upon an unlawful and/or illegal act, being in this case the infringement of a European Patent (UK). By this, Warner-Lambert does not presently bring any claim before the Court that Dr Reddy’s has infringe the Patent. Without prejudice to its ability to do so, this contention is advanced in relation to the counterfactual.”