Warner-Lambert Company LLC v Sandoz GmbH & Anor (Rev 1) [2016] EWHC 3317 (Pat)

“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.”

“ … I consider that Warner-Lambert is justified in saying that the present evidence suggests that the NHS Guidance is not yet fully effective in England so far as prescribing is concerned, and may not be so for some time to come.”

“So far as the validity of the Patent is concerned, Warner-Lambert has a real prospect of success in its appeal with respect to the validity of claims 1 and 3. Even if Warner-Lambert is not successful in that appeal, I have held claims 10, 11 and 12 to be valid, and Sandoz is supplying pregabalin with a marketing authorisation which embraces those kinds of pain. Turning to infringement, as stated in Warner-Lambert II at [37], it is arguable that “preparation” in a Swiss form claim includes packaging and labelling. On that basis, the relevant date for assessing Sandoz’s state of mind would be shortly before 1 October 2015. In my judgment, applying the construction of the word “for” laid down in Warner-Lambert CA in the manner described in Warner-Lambert V, Warner-Lambert has a well arguable case that, as at that date, it was foreseeable to Sandoz that there would be intentional administration of the Sandoz Full Label Product to treat neuropathic pain (and in particular the types of neuropathic pain covered by claims 10, 11 and 12) where doctors prescribed generic pregabalin for neuropathic pain and pharmacists dispensed the Sandoz Full Label Product. As counsel for Warner-Lambert submitted, this is supported by the numbers: if Lloyds expects to dispense over 100,000 packs of Sandoz Full Label Product in three months, it is known from Lloyds’ sales of Lyrica that this would represent some 66% of Lloyds’ total sales of pregabalin, far above the 30% represented by sales of pregabalin for the non-patented indications. Although the evidence on this application suggests that the kinds of pain covered by claims 10, 11 and 12 represent no more than 5% of the pregabalin market, even if Warner-Lambert were restricted to those claims once the appeals and the amendment application had been determined, it would have still have an arguable case of infringement.”

“First, I consider that there is a greater risk of Warner-Lambert suffering unquantifiable and irremediable loss if an injunction is refused than there is of Sandoz suffering unquantifiable and irremediable loss if an injunction is granted. Secondly, I consider that there is a strong case for preservation of the status quo pending trial (or the decision of the Court of Appeal, if that is available sooner). If no injunction is granted, the arrival of full label generic pregabalin on the market will make it significantly more difficult for the Court to ensure appropriate compensation of those parties which it is finally determined merit compensation.”

“Following the Court of Appeal’s judgment, and pending the outcome of its appeal to the Supreme Court, Pfizer will now seek to have the NHS England Pregabalin Guidance on prescribing and dispensing by brand name, Lyrica®, limited to prescribing and dispensing for the types of pain in those patent claims upheld as valid by the Court of Appeal.”

“1. When prescribing pregabalin for the treatment of inflammatory pain, post-operative pain, burn pain, gout pain, osteo-arthritic pain, trigeminal neuralgia pain, acute herpetic pain, post-herpetic pain or causalgia pain, you should only do so by reference to the brand name Lyrica® so far as reasonably possible (i.e. write ‘Lyrica’ on the prescription and not the generic name or any other generic brand) except where there are clinical contra-indications or other special clinical needs (e.g. patient allergic to an excipient or the Lyrica® product is unavailable). Please note that Lyrica® is licensed for the treatment of neuropathic pain and not other pain types. Therefore, where the pain type does not include a neuropathic element, treatment with Lyrica® is unlicensed. 2. When prescribing pregabalin for the treatment of anything other than inflammatory pain, post-operative pain, burn pain, gout pain, osteo-arthritic pain, trigeminal neuralgia pain, acute herpetic pain, post-herpetic pain or causalgia pain, you should continue to prescribe by reference to the generic name pregabalin. 3. When dispensing pregabalin, if you have been told that it is for the treatment of inflammatory pain, post-operative pain, burn pain, gout pain, osteo-arthritic pain, trigeminal neuralgia pain, acute herpetic pain, post-herpetic pain or causalgia pain, you should ensure, so far as reasonably possible, that only Lyrica®, the branded form of pregabalin, is dispensed. Please note that Lyrica® is licensed for the treatment of neuropathic pain and not other pain types. Therefore, where the pain type does not include a neuropathic element, treatment with Lyrica® is unlicensed. 4. When dispensing pregabalin for the treatment of anything other than inflammatory pain, post-operative pain, burn pain, gout pain, osteo-arthritic pain, trigeminal neuralgia pain, acute herpetic pain, post-herpetic pain or causalgia pain, you are not restricted to dispensing Lyrica®.”

“We note that your proposed revisions to the Guidance include references to unlicensed indications … We have not had a chance to consider this thoroughly but on an initial review, we queried whether the inclusion of such language might raise issues of direct or disguised promotion of unlicensed use, contrary to the ABPI Code. Please let us know whether you have considered this point. We would be grateful for an explanation as to how you have alleviated these concerns. …”

“NHS England’s solicitors have already amended the first draft of the revised Guidance to wording that they are comfortable with … as regards off label indications. Please reach out to NHS England’s solicitors if the proposed wording causes your clients any difficulties.”

“For the avoidance of doubt, and without prejudice to our client’s application to the Supreme Court for permission to appeal and a future claim for back damages for infringement, our client does not wish to prevent your clients’ access to the market for those indications which are only protected by the Patent claims which the Court of Appeal has held to be invalid.”

“1. The guidance refers to a number of specific unlicensed indications for pregabalin. Your client never asserted in its claim against our clients that they infringed the claims to these unlicensed indications … and the previous guidance sought by your client makes no reference to these. The likely impression given to a recipient who is aware of the existing guidance but unaware of the developments in the litigation is that the freedom to prescribe our clients’ product has been restricted to [a] greater extent than before. This is likely to have a chilling effect on the prescription of our clients’ product in a way that is contrary to the judgment of the Court of Appeal. 2. Further, our clients are seriously concerned that the directions given to clinicians to prescribe your client’s product by brand for unlicensed indications amount to a promotion of Lyrica for these purposes, contrary to Council Directive 2001/83/EC … as well as the ABPI Code of Practice … Our client considers it inappropriate for your clients to seek or NHS England to issue any statements that are in breach of the above and so any guidance should be limited to indications for which Lyrica is licensed. 3. Our clients are also concerned at the wider policy implications of requiring the NHS to issue guidance relating to second medical use claims to indications for which the relevant medicinal product is unlicensed. …”

“By way of update on our client’s review of the revised Guidance, in view of the serious policy issues raised in relation to the difference in scope of Lyrica’s® marketing authorisation and the extant patent claims, it is necessary that these issues are considered at a senior clinical level within NHS England. Due to limited availability of key individuals, we anticipate that we will be able to revert to you in the first part of next week.”

“As your letter notes, our client is seeking permission to appeal to the Supreme Court in relation to the validity of the Patent. The appeal is being sought because our client believes the decisions of the High Court and Court of Appeal were in error in three serious respects, as set out in our client’s grounds of appeal (which we have provided to you previously). In the meantime, the order for revocation from the High Court remains stayed (as we understand would be usual). In view of the above, our client naturally reserves all of its rights as to the position regarding infringement of the Patent, in particular, in the event that further claims are upheld as valid following appeal to the Supreme Court, or if claim 3 of the Patent is successfully amended. That said, our client does not envisage that it will take action under the Patent against prescribing doctors, NHS pharmacists or NHS bodies generally (including your client and CCGs). Notwithstanding the above, our client also recognises the possibility that claim 3 (and other claims that have thus far been held invalid) may not ultimately be upheld. Pending the outcome of the application to the Supreme Court, our client accordingly does not wish to adopt a position that prevents generic pharmaceutical companies from selling pregabalin products for indications that are only protected by the Patent claims that have thus far been held invalid, if those generic companies wish to do so (albeit it reserves its rights in respect of such sales). From a commercial perspective, it is also undesirable for our client to be exposed to unknown but potentially significant liabilities as a result of the various cross-undertakings given during proceedings, including in relation to the issuing of the original NHS guidance. In addition to the above, our client had anticipated that a narrowing of the guidance would be what prescribing doctors and pharmacists, and indeed NHS England, would expect of our client, given the Court of Appeal’s decision. Whilst our client believes that the Court of Appeal decision is wrong, our client does not wish to cause damage to its stakeholder and customer relationships through continued insistence on the previous guidance. Our client has made its views on this issue public. However, if your client believes that another approach is appropriate or preferable, our client is of course open to discussion.”

“[168] Remedies. What remedy or remedies should the court grant if it finds that the defendant is threating to do acts which will fall within the claim sufficiently often that they cannot be discounted as de minimis, but which nevertheless amount to infringement on a very small scale? Suppose, for example, it is concluded on the balance of probabilities that the defendant will sell 2000 infringing patches randomly distributed among 1,998,000 non-infringing patches, and it is also concluded that that quantity cannot be discounted as de minimis? [169] As counsel for Napp accepted, remedies for patent infringement, and in particular the remedy of an injunction, must be effective, proportionate and dissuasive and must be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse: see Article 3(2) of European Parliament and Council Directive 2004/48/EC of 29 April 2004 on the enforcement of intellectual property rights and HTC Corp v Nokia Corp [2013] EWHC 3778 (Pat), [2014] Bus LR 217 at [19]-[28]. [170] It seems to me that these principles provide the answer to the question posed in paragraph 168 above. Even if the level of infringement cannot be discounted as de minimis in such a case, I consider that an injunction would be both disproportionate and a barrier to legitimate trade. It would be disproportionate because the harm to the patentee from infringement on such a small scale would be indistinguishable from the harm caused by wholly non-infringing acts. It would be a barrier to legitimate trade because the practical effect of such an injunction would be to require the defendant to operate even further outside the boundaries of the claim, and thus would effectively extend the scope of the patentee’s monopoly. In such a case, the appropriate remedy would be a financial one.”

“[31] By its second question, the referring court asks, in essence, whether the third sentence of Article 11 of Directive 2004/48 must be interpreted as meaning that the conditions for an injunction within the meaning of that provision against an intermediary who provides a service relating to the letting of sales points in market halls are identical to those for injunctions which may be addressed to intermediaries in an online marketplace, set out by the Court in the judgment of 12 July 2011 in L’Oréal and Others (C-324/09, EU:C:2011:474).” [32] In paragraph 135 of that judgment, the Court first of all noted, referring to recital 23 of Directive 2004/48, that the rules for the operation of the injunctions for which the Member States must provide under the third sentence of Article 11 of the directive, such as those relating to the conditions to be met and to the procedure to be followed, are a matter for national law. [33] Next, it stated that those rules of national law must be constructed so as to achieve the objectives of Directive 2004/48. For that purpose, and in accordance with Article 3(2) of that directive, injunctions must be effective and dissuasive (judgment of 12 July 2011 in L’Oréal and Others, C‑324/09, EU:C:2011:474, paragraph 136). [34] Lastly, the Court held that injunctions must be equitable and proportionate. They must not therefore be excessively expensive and must not create barriers to legitimate trade. Nor can the intermediary be required to exercise general and permanent oversight over its customers. By contrast, the intermediary may be forced to take measures which contribute to avoiding new infringements of the same nature by the same market-trader from taking place (see, to that effect, judgment of 12 July 2011 in L’Oréal and Others, C-324/09, EU:C:2011:474, paragraphs 138 to 141). [35] The Court thus took the view that any injunction within the meaning of the third sentence of Article 11 of Directive 2004/48 may be pronounced only if it ensures a fair balance between the protection of intellectual property and the absence of obstacles to legitimate trade (see, to that effect, judgment of 12 July 2011 in L’Oréal and Others, C‑324/09, EU:C:2011:474, paragraph 143). [36] While, admittedly, in the case which gave rise to the judgment of 12 July 2011 in L’Oréal and Others (C-324/09, EU:C:2011:474), the Court had to interpret the third sentence of Article 11 of Directive 2004/48 in the context of injunctions which may be addressed to an intermediary in an online marketplace, it interpreted that article in the light of the general provisions formulated in Article 3 of that directive, without specific considerations relating to the nature of the marketplace at issue. Nor is it apparent from Article 3 of the directive that its scope is limited to situations which occur in online marketplaces. Moreover, it follows from the wording of Article 3 of the directive that it applies to any measure referred to by that directive, including those provided for in the third sentence of Article 11 of the directive. [37] Therefore, the answer to the second question is that the third sentence of Directive 2004/48 must be interpreted as meaning that the conditions for an injunction within the meaning of that provision against an intermediary who provides a service relating to the letting of sales points in market halls are identical to those for injunctions which may be addressed to intermediaries in an online marketplace, set out by the Court in the judgment of 12 July 2011 in L’Oréal and Others (C-324/09, EU:C:2011:474).”

“Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.”

“Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury. Efficacy has not been studied in other models of neuropathic pain. … In clinical trials up to 12 weeks for both peripheral and central neuropathic pain, a reduction in pain was seen by week 1 and was maintained throughout the treatment period. In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score. …”