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IN THE HIGH COURT OF JUSTICE
Fetter Lane, London, EC4A 1NL
||4 November 2015
B e f o r e :
THE HON MR JUSTICE ARNOLD
|| WARNER-LAMBERT COMPANY LLC
||- and -
LLOYDS PHARMACY LIMITED
Andrew Waugh QC and Katherine Moggridge (instructed by Allen & Overy LLP) for the Claimant
Daniel Alexander QC and Maxwell Keay (instructed by Olswang LLP) for the First and Second Defendants
Hugo Cuddigan QC (instructed by Bird & Bird LLP) for the Third Defendant
Hearing date: 21 October 2015
HTML VERSION OF JUDGMENT
Crown Copyright ©
MR JUSTICE ARNOLD :
|The Mylan and Actavis proceedings
|Warner-Lambert's licensing of the Patent
|Sandoz and Lloyds
|The skinny label market for generic pregabalin
|The genesis of the present application
|Lloyds' position with respect to skinny label generic pregablin products
|Manufacture, packaging and labelling of the Sandoz Full Label Product
|The Pfizer-Lloyds Brand Equalisation deal
|Pfizer's market share
|The NHS Guidance
|Effectiveness of the NHS Guidance
|Warner-Lambert's claim against Sandoz
| Principles to be applied
| Serious question to be tried?
| Harm to Warner-Lambert if no relief is granted
| Harm to Sandoz if relief is granted
| Clearing the path and preservation of the status quo
| Balance of the risk of injustice
| The packs already supplied to AAH and Lloyds
| Ambit of the cross-undertakings
|Warner-Lambert's claim against Lloyds
| Jurisdictional basis for the application
| Balance of the risk of injustice
- This is an application by the Claimant ("Warner-Lambert") for (1) an interim injunction to restrain the First and Second Defendants ("Sandoz") from infringing European Patent (UK) No. 0 934 061 ("the Patent") by dealings in a full label generic pregabalin product and (2) an interim injunction in effect requiring the Third Defendant ("Lloyds") to refrain from dispensing quantities of that product which Lloyds has in its possession.
The Mylan and Actavis proceedings
- The background to the present application is of considerable complexity. To a large extent, it arises out of proceedings concerning the Patent between Warner-Lambert and Pfizer Ltd ("Pfizer") on the one hand and Generics (UK) Ltd trading as Mylan ("Mylan") and Actavis Group PTC ehf and related companies ("Actavis") on the other hand.
- In those proceedings I dismissed an application by Warner-Lambert for an interim injunction against Actavis for the reasons given in my judgment dated 21 January 2015  EWHC 72 (Pat) ("Warner-Lambert I"). Subsequently I dismissed an application by Actavis to strike out, alternatively for summary judgment dismissing, Warner-Lambert's claim for infringement under section 60(1)(c) of the Patents Act 1977 for the reasons given in my first judgment dated 6 February 2015  EWHC 223 (Pat) ("Warner-Lambert II"), but acceded to Actavis' application to strike out the claim for infringement under section 60(2) for the reasons given in my second judgment dated 6 February 2015  EWHC 249 (Pat) ("Warner-Lambert III"). On 26 February 2015 I made an order, largely by consent, requiring the National Health Service Commissioning Board ("NHS England") to issue guidance ("the NHS Guidance") to Clinical Commissioning Groups ("CCGs") in England and to the NHS Business Services Authority ("BSA") for transmission to NHS pharmacy contractors for the reasons given in my judgment dated 2 March 2015  EWHC 485 (Pat) ("Warner-Lambert IV"). On 28 May 2015 the Court of Appeal dismissed an appeal by Warner-Lambert against Warner-Lambert I and allowed an appeal by Warner-Lambert against Warner-Lambert III for the reasons given in the judgment of Floyd LJ delivered on that date  EWCA Civ 556 ("Warner-Lambert CA").
- On 10 September 2015 I handed down judgment following the trial of Mylan and Actavis' claims for revocation of the Patent, of Warner-Lambert's claim against Actavis for infringement of claims 1 and 3 of the Patent and of Actavis' claim against Pfizer for groundless threats  EWHC 2548 (Pat) ("Warner-Lambert V"). In that judgment I held that:
i) none of the claims of the Patent was obvious over any of the prior art relied upon by Mylan and Actavis;
ii) claims 1, 3, 4, 6, 13 and 14 of the Patent were invalid on the ground of insufficiency;
iii) even if claims 1 and 3 were valid, Actavis had not infringed those claims pursuant to section 60(1)(c) or section 60(2); and
iv) Pfizer was liable for making groundless threats of patent infringement proceedings, albeit not in all the cases alleged by Actavis.
- In order to shorten this judgment, I shall assume that the reader has read all of the judgments referred to in the preceding two paragraphs. It may nevertheless be helpful if I summarise the core of my reasoning in Warner-Lambert V with respect to insufficiency. Claims 1 and 3 of the Patent (as centrally limited on 21 January 2015) are as follows:
"1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.
3. Use according to Claim 1 wherein the pain is neuropathic pain."
I concluded that claim 3 was invalid, because although the specification made it plausible that pregabalin would be effective to treat peripheral neuropathic pain, it did not make it plausible that pregabalin would be effective to treat central neuropathic pain. I held that claim 1 was invalid both for this reason and because it was not plausible that pregabalin was effective to treat all types of pain. I held that claims 10 (trigeminal neuralgia pain), 11 (post-herpetic neuraglia pain) and 12 (causalgia pain) were valid because these were specific types of peripheral neuropathic pain.
- Since 10 September 2015 there have been two developments in the Mylan and Actavis proceedings which it is important to note. The first is that on 16 October 2015 I gave both Mylan and Actavis on the one hand and Warner-Lambert on the other hand permission to appeal against my decisions with respect to insufficiency and I gave Warner-Lambert permission to appeal against my decision with respect to infringement under section 60(1)(c) (but not section 60(2)), subject to the qualification that I refused permission to appeal against my findings of fact. I gave the parties permission to appeal because I was satisfied that those appeals had a real prospect of success. Mylan has stated that it intends to seek expedition of its appeal. Actavis does not support expedition of the appeals, but Warner-Lambert does. It remains to be seen whether the Court of Appeal will order expedition, and when the hearing of the appeals will be fixed for.
- Although I have made declarations with respect to the validity of the various claims, those declarations have been stayed pending the determination of the appeals. Until then, therefore, the Patent continues to have effect in the form in which it was centrally limited on 21 January 2015.
- The second development is that, in case both appeals on validity are unsuccessful, Warner-Lambert has launched a conditional application to amend the Patent. The proposed amendments fall into two categories. The first category consists of simple deletion of claims which were held to be invalid. Those proposed amendments are, as I understand it, uncontroversial. The second category consists of an amendment which does not amount to a simple deletion, but on the contrary, amounts to a re-writing of one of the existing claims. The proposed amendment is to what was claim 3 of the Patent and, following deletion of old claim 1, will become new claim 2. The amendment consists of adding to the end of the claim the words "caused by injury or infection of peripheral sensory nerves". The basis for that amendment is said to be the statement in  of the Patent that "Neuropathic pain is caused by injury or infection of peripheral sensory nerves".
- Mylan and Actavis both oppose the proposed re-writing amendment. Unsurprisingly, given that it is a re-writing amendment, it is Mylan and Actavis' contention that the application to make that amendment amounts to an abuse of the process of the court, applying the principles established in such cases as Nikken Kosakusho Works v Pioneer Trading Co  EWCA Civ 906,  FSR 4 and Nokia GmbH v IPCom GmbH  EWCA Civ 6, [201l] FSR 15. In addition, it will be Mylan and Actavis' contention, if the application is allowed to proceed, that the amendment is not allowable on the grounds that it adds subject matter and/or because it does not cure the invalidity of claim 3 (using the old numbering).
- On 16 October 2015 I directed that there be a preliminary determination of the issue as to whether Warner-Lambert's application to make the re-writing amendment is an abuse of process at a hearing between 11 and 25 November 2015. If it is held not to be an abuse of process, there will be a subsequent hearing on the merits of the application, which may involve opponents to the application in addition to Mylan and Actavis.
- There are a number of other consequential issues arising out of Warner-Lambert V, such as costs, relief for threats and relief pursuant to Warner-Lambert's cross-undertaking imposed in Warner-Lambert IV, which will be determined at a hearing between 1 and 15 December 2015.
Warner-Lambert's licensing of the Patent
- I stated in Warner-Lambert I at  that "pregabalin … is marketed by Warner-Lambert under the trade mark Lyrica". That statement was inaccurate. I stated in Warner-Lambert V at  that "Warner-Lambert markets pregabalin under the trade mark Lyrica …. through Pfizer". That statement was more accurate. The correct position is as follows.
- The proprietor of the Patent is Warner-Lambert. The marketing authorisation is held by Pfizer. As Paula Tully explained in her first witness statement dated 8 December 2014 in support of Warner-Lambert's application for an interim injunction against Actavis, various companies in the Pfizer Group are involved in the manufacture and distribution of Lyrica around the globe. Pfizer is responsible for distribution and sale of Lyrica in the UK. As Ms Tully put it:
"Ultimately, Warner-Lambert sits at the head of the Licence chain and receives a proportion of the Net Sales from sales of Lyrica in the UK. It follows that a reduction in the sale from Lyrica in the UK will lead to a reduction in the payments received by [Warner-Lambert ] for Lyrica."
- During the hearing of the present application, counsel for Warner-Lambert explained this a little further on instructions. He told me that Warner-Lambert received a specified percentage (which is confidential) of Net Sales of Lyrica in the UK through a series of agreements (which are confidential and have not, so far as I am aware, been disclosed).
Sandoz and Lloyds
- Sandoz are part of a large multinational group of companies which supply generic pharmaceuticals.
- Lloyds operates the second largest chain of retail pharmacies in the UK. Lloyds has more than 1,600 branches and approximately 12% of the UK pharmacy market. Its biggest competitors are Boots (which has about 17-18% of the market) and Well (formerly the Co-Op, which has about 8-9% of the market).
The skinny label market for generic pregabalin
- It is important to appreciate that, as described in Warner-Lambert V at  and -, since 13 February 2015 a number of generic suppliers have launched generic pregabalin products with skinny label marketing authorisations. As explained in more detail below, since 26 June 2015, these suppliers have included Sandoz.
- To date, the availability of generic pregabalin products with skinny label marketing authorisations has not led to any reclassification of pregabalin from Category C to Category A or M in the NHS Drug Tariff (as to which, see Warner-Lambert V at -).
The genesis of the present application
- As noted in Warner-Lambert V at , regulatory data exclusivity in respect of pregabalin expired on 8 July 2014. On 9 July 2014 Sandoz filed applications for marketing authorisation for both full label and skinny label generic pregabalin products through the centralised European procedure.
- Sandoz's evidence is that they learned of the Mylan and Actavis challenges to the validity of the Patent shortly after those actions were launched (on 24 June 2014 and 12 September 2014 respectively). Sandoz decided to watch the progress of those proceedings and not to bring any revocation claim of their own in the UK.
- On 3 December 2014 Warner-Lambert's solicitors wrote to Sandoz stating that Warner-Lambert did not consider that a skinny label would be sufficient to prevent infringement of the Patent and requesting Sandoz to notify Warner-Lambert of any plans they had to launch generic pregabalin. Following further letters from Warner-Lambert's solicitors on 11, 12 and 18 December 2014, Sandoz replied on 22 December 2014 stating that they did not have, and did not know when they were likely to receive, a marketing authorisation for pregabalin and that they would give Warner-Lambert notice of any marketing authorisation within seven days of receipt.
- Following further letters from Warner-Lambert's solicitors on 24 December 2014 and 8 January 2015, Sandoz replied on 9 January 2015 agreeing to give Warner-Lambert seven days' notice of the launch of generic pregabalin in the UK.
- Following further letters from Warner-Lambert's solicitors on 9 and 18 January 2015, Sandoz replied on 20 January 2015 confirming that they would not launch generic pregabalin in the UK before Warner-Lambert I was handed down.
- Following further letters from Warner-Lambert's solicitors on 22 and 27 January 2015, Sandoz replied on 28 January 2015 undertaking to inform Warner-Lambert as soon as they received a marketing authorisation for generic pregabalin in the UK and to inform Warner-Lambert at that time of the intended launch date for the product in the UK, providing that Warner-Lambert undertook not to commence infringement proceedings or request a preliminary injunction unless and until Sandoz gave notice.
- Following further letters from Warner-Lambert's solicitors on 30 January and 6 February 2015, Sandoz replied on 11 February 2015 stating inter alia that Sandoz did not intend their pregabalin to be used for the patent-protected indication (i.e. pain) and promising to supply copies of their SmPC and PIL.
- On 20 February 2015 Warner-Lambert's solicitors notified Sandoz of its application against NHS England and invited Sandoz to state their position with respect to that application. On 25 February 2015 Sandoz replied that they did not oppose the application, but otherwise reserved all rights.
- Following further letters from Warner-Lambert's solicitors on 20 and 26 February 2015, Sandoz replied on 27 February 2015 confirming inter alia that they would give Warner-Lambert seven days' notice of any launch of a generic pregabalin product in the UK. Sandoz also provided copies of the SmPC and PIL for their skinny label product. Sandoz did not inform Warner-Lambert that they had also applied for a full label marketing authorisation (i.e. including neuropathic pain). Sandoz say that their undertakings were intended only to apply to their skinny label product, although that was not made clear at the time.
- On 3 March 2015 Warner-Lambert's solicitors sent Sandoz a copy of the sealed court order against NHS England concerning the NHS Guidance.
- On 30 April 2015 Kristin Cooklin (Patent Litigation Counsel) and Julia Pike (Head of Global IP Litigation) of Sandoz International GmbH (another company in the Sandoz Group) wrote to Chase Romick (Assistant General Counsel, Intellectual Property Enforcement) of Pfizer Inc in New York. According to Ms Cooklin, she wrote to Ms Romick because she had found the correspondence from Warner-Lambert's solicitors to be "extremely and unnecessarily aggressive", and therefore she considered that it would be more appropriate to communicate directly between in-house counsel.
- The letter stated that on 23 April 2015 Sandoz had received positive Committee for Medicinal Products for Human Use ("CHMP") opinions regarding marketing authorisations for both full label and skinny label generic pregabalin products called Pregabalin Sandoz and Pregabalin Sandoz GmbH respectively. The letter went on to confirm that Sandoz would not "market any pregabalin product for the treatment of neuropathic pain, and thus will not launch Pregabalin Sandoz [the full label product] …, prior to the revocation or expiry of the patent".
- On 20 May 2015 Ms Romick replied asking for confirmation of Sandoz's launch plans with respect to their skinny label pregabalin product.
- On 12 June 2015 Ms Cooklin and Ms Pike replied stating that Sandoz anticipated receiving centralised approval of their marketing authorisation for skinny label pregabalin on 20 June 2015, intended to launch that product in the UK on the same date and expected to sell approximately 10,000 packs of that product within the first seven days of launch. This letter also reiterated that:
"prior to the expiration or revocation of [the Patent], Sandoz will market its pregabalin product for only the non-infringing indications. As Pfizer has acknowledged, there is a non-infringing market for pregabalin for which generic pregabalin can be sold. In order to compete in the patent-free market and to avoid infringement of the [Patent], Sandoz has carved the neuropathic pain indication from its SmPC and PIL, removed all additional information related to the indication and will only market for GAD and epilepsy indications."
- On 19 June 2015 Sandoz received marketing authorisations for their full label and skinny label pregabalin products.
- On 26 June 2015 Sandoz launched their skinny label pregabalin product, Pregabalin Sandoz GmbH. On the same date Sandoz sent a letter to CCGs and superintendent pharmacists referring to the patent position and the NHS Guidance. In this letter Sandoz stated that it was their intention to launch a generic pregabalin product indicated for the treatment of neuropathic pain as well as epilepsy and general anxiety disorder ("GAD") if they "received confirmation from the High Court that the second patent is invalid". This was preceded and followed by some email correspondence between Ms Cooklin and Ms Romick concerning the pharmacists to whom the letter was to be sent.
- At about 11:30 am (UK time) on Friday 2 October 2015 Ms Cooklin and Robert Gorman Jr (Global Head of Intellectual Property) sent a letter by email to Ms Romick, copied to Darren Noseworthy (recently appointed as Pfizer's Head of Legal Affairs in the UK). Warner-Lambert says that Mr Noseworthy did not receive this email, although there is no evidence from Mr Noseworthy himself on the point, while Ms Cooklin says that she did not receive any form of "bounce-back", out of office message or other form of message suggesting that the email had not been delivered or that Mr Noseworthy was not able to receive it.
- This letter stated, having referred to Warner-Lambert V and the NHS Guidance, that Sandoz had decided to supply, and had started to supply, its full label generic pregabalin product ("the Sandoz Full Label Product").
- Warner-Lambert complains that this letter was not sent to its solicitors. In my view that complaint is justified. While Sandoz are correct to say that the recent correspondence between the parties had been between in-house counsel, this was something that Warner-Lambert's solicitors plainly needed to know. On the other hand, it is evident that Ms Romick was able to instruct Warner-Lambert's solicitors within a few hours of the receipt of the email. Thus this omission made little difference.
- What is more significant is Sandoz's failure to give Warner-Lambert prior notice of its launch of the Sandoz Full Label Product. This is despite the fact that the launch had plainly been some time in the planning. It has subsequently emerged that, following confidential negotiations starting on an unspecified date, on 1 October 2015 Sandoz agreed to supply approximately 102,519 packs of the Sandoz Full Label Product to AAH Pharmaceuticals Ltd ("AAH"), representing approximately three months' supply for Lloyds. The Defendants' evidence is that title to those packs passed to AAH on 2 October 2015. On the same day, AAH sold those packs to Lloyds. Lloyds is a sister company of AAH, both AAH and Lloyds being part of the Celesio Group. By Sunday 4 October 2015, only a relatively small quantity (11,932 packs out of 102,519) was still in the hands of AAH.
- Sandoz seek to explain their non-compliance with their previous undertakings by construing "revocation or expiry" as being "a general reference to a substantive finding of invalidity and not to refer specifically to any jurisdiction–specific patent or legal issues or terms or art". But as Warner-Lambert rightly points out, any competent English patent lawyer would know that:
i) Warner-Lambert V would be likely to be the subject of an appeal, provided permission to appeal was granted by either the Patents Court or the Court of Appeal;
ii) an order for revocation is ordinarily stayed pending appeal, or at least pending an application to the Court of Appeal for permission to appeal if the Patents Court has refused permission to appeal; and
iii) in any event, the Patent was found partially valid with respect to a number of pain indications.
- At about 5:00 pm (UK time) on 2 October 2015 Ms Romick sent Ms Cooklin an email asking the latter to telephone her. At about 5:30 pm Ms Romick telephoned Ms Cooklin and asked about the letter dated 2 October 2015. Ms Cooklin said, in effect, that she had nothing to add to the letter, save that she identified the solicitors instructed on behalf of Sandoz.
- At about 5:50 pm Warner-Lambert's solicitors sent Sandoz a letter before action demanding undertakings as a matter of urgency. The letter was copied to Sandoz's solicitors. Shortly afterwards there was a telephone conversation between the solicitors, followed by exchanges of emails. At about 9.23 am on Saturday 3 October 2015 Warner-Lambert's solicitors notified Sandoz's solicitors that Warner-Lambert would be making an urgent application for an interim injunction. In the course of further email exchanges during the course of the day, Sandoz's solicitors informed Warner-Lambert's solicitors that Sandoz had made a single supply of about 100,000 packs of the Sandoz Full Label Product to a single wholesaler which had probably been distributed to retail pharmacies. They also offered an undertaking by Sandoz not to make further supplies of the Sandoz Full Label Product before close of business on Monday 5 October 2015, which was not accepted by Warner-Lambert.
- At about 5:00 pm on 3 October 2015 Warner-Lambert made its urgent application for an interim injunction against Sandoz by telephone to Birss J. The application was technically without notice, but, having been given informal notice, Sandoz's solicitors were able to participate. At the conclusion of the telephone hearing Birss J made an order restraining Sandoz from supplying or offering to supply the Sandoz Full Label Product and requiring Sandoz to provide certain information, including whether "there is an entitlement to recall product and if so the circumstances".
- After the order was made on 3 October 2015, Sandoz's solicitors disclosed that Sandoz had supplied the Full Label Sandoz Product to AAH. During the afternoon of 4 October 2015 they disclosed that the retail pharmacy to whom AAH had supplied the Product was Lloyds.
- On 5 October 2015 there was a hearing before Birss J at which Sandoz gave undertakings until the full hearing of Warner-Lambert's application and directions were made for the service of evidence.
- On 6 October 2015 Sandoz served a first witness statement of Mridula Pore (Sandoz's Head of Retail). This stated that:
i) Sandoz had supplied 102,519 packs of Sandoz Full Label Product to AAH;
ii) title had passed on confirmation of the order and issuance of an invoice to AAH;
iii) recall was provided for only if necessary to comply with a mandatory regulatory requirement;
iv) Sandoz were not aware of the terms of onward supply or recall under which AAH had supplied to third parties;
v) Sandoz believed that of the total supply to AAH, 11,932 packs remained in the possession of AAH;
vi) Sandoz believed that the Sandoz Full Label Product had been distributed to about 1,500 Lloyds pharmacies in the UK.
- Later on 6 October 2015 Warner-Lambert made an urgent application to Birss J for an interim injunction against Lloyds requiring Lloyds to notify all of its pharmacies that, until further notice, the Sandoz Full Label Product should not be dispensed. Although the application was technically without notice, informal notice was given to Sandoz and to Ms Wendy Hall (Head of Legal for both AAH and Lloyds). As a result, both Sandoz and Lloyds were able to instruct leading counsel to attend. At the conclusion of the hearing Birss J made the order sought by Warner-Lambert.
- In his judgment  EWHC 2919 (Pat) Birss J stated:
"24. … What is manifest in my judgment is that this is a matter which should have been dealt with by Lloyds and Sandoz and AAH giving proper notice to Warner-Lambert and the whole matter could have been resolved in an orderly fashion. To have taken the course they have taken by attempting to shift such a large volume of material in such a short space of time, Sandoz, AAH and Lloyds only have themselves to blame.
25. The court's task in a situation like this is to hold the ring as best one can in order that the dispute can be resolved in an orderly and proper fashion. By taking the course they have taken, Sandoz, AAH and Lloyds have made it as difficult as they could to allow that to take place. It would be entirely right that I should make the order sought and I will do so, subject to [joinder of Lloyds as a party to the proceedings]"
- I would entirely endorse those observations. The Patents Court expects litigants in patent disputes before it to behave responsibly to enable disputes to be resolved in an orderly manner. That generally entails the giving of prior notice in circumstances such as these. As the history related above demonstrates, the Patents Court will not hesitate to use its powers, and in particular its powers to grant urgent interim relief, to attempt to ensure that parties who try to steal a march on other parties and thereby present the Court with a fait accompli do not benefit from such conduct.
- While I have thought it right to endorse Birss J's observations with respect to the failure of Sandoz, AAH and Lloyds to give Warner-Lambert prior notice of their intended launch of the Sandoz Full Label Product, I should make it clear that in my judgment that failure has relatively little bearing on Warner-Lambert's present application. Fortunately, the prompt action taken by Warner-Lambert has been effective to ensure that all (or almost all) of the 102,519 packs of the Sandoz Full Label Product supplied by Sandoz to AAH and Lloyds remain in the possession of either AAH or Lloyds and have not been dispensed to patients and to ensure that there have been no further supplies by Sandoz. Thus the application can be considered as if Sandoz were not yet on the market, as should have been the case.
- In a letter dated 9 October 2015, responding to questions posed by Warner-Lambert's solicitors, Sandoz's solicitors disclosed that:
"Sandoz is not entitled under the agreement to supply [AAH] to recall the Sandoz pregabalin product other than when required to comply with mandatory regulatory requirements. …
Separate to the terms for the supply of Sandoz pregabalin to AAH, Sandoz and AAH have also agreed arrangements in the event that patent infringement proceedings are brought against AAH by Pfizer. As part of these arrangements, AAH can elect to make a claim for reimbursement from Sandoz if an injunction is granted in favour of Pfizer against AAH/Lloyds. In circumstances where this reimbursement is triggered the arrangements provide that, where the injunction does not prevent it, Sandoz can ask for and have returned to it, any Sandoz pregabalin product that remains in the control of AAH/Lloyds."
- Warner-Lambert complains that this ought to have been disclosed by Sandoz previously, and in particular in Ms Pore's statement. Again I agree with this, but again I consider that this has little bearing on the present application.
Lloyds' position with respect to skinny label generic pregabalin products
- Sandoz has explained that the reason why it has launched the Sandoz Full Label Product, rather than simply continue to sell its skinny label generic pregabalin product, is that some pharmacies are not willing to stock and dispense skinny label generic pregabalin products, but are willing to stock and dispense a full label generic pregabalin product. Although the only specific evidence on this point comes from Lloyds, it appears that Boots, Well and some other pharmacies take the same view.
- The reasons why Lloyds has declined to stock and dispense skinny label generic pregabalin products have been explained by Stephen Howard, who is Lloyds' Quality and Regulatory Director and superintendent pharmacist, a Fellow of the Royal Pharmaceutical Society and Visiting Professor of Pharmacy at the University of Huddersfield. In his first witness statement Mr Howard said this:
"8. It is a core component of the UK's medicines regulations that pharmacists should supply a licensed medicine where one exists as these medicines have supporting evidence of their efficacy and safety. If a medicine is dispensed outside its licensed indications and the patient suffers an adverse event, there can be negative consequences for the prescribing doctor and pharmacist.
9. There are many occasions, especially in hospitals and mental health practises [sic], where a medicine may be used 'off-label'. However, in such circumstances there are normally very good clinical justifications for this. This type of practise [sic], whilst common, should only be done with patient consent and where all parties in charge of the care of the patient are aware of the 'off-label' prescription.
10. In relation to Skinny Label pregabalin, I would not allow this to be used in Lloyds Pharmacy stores. The reason for this is that the pharmacist who receives a prescription for generic pregabalin cannot be certain that it has been prescribed for one of the uses within the skinny label. Therefore, there is a possibility that a pregabalin Skinny Label product could potentially be dispensed to a patient for an unlicensed use (pain). There is also a risk where the prescription was for pregabalin with no mention of the relevant indication and that the pharmacist might either incorrectly determine the indication based on information:
a. contained in the patient's file; or
b. supplied by the patient.
11. In such circumstances, if the patient was dispensed a Skinny Label pregabalin product for pain and suffered an adverse advent, the Lloyds pharmacist could be put in a negative position as he or she would have dispensed an unlicensed medical product where a licensed product existed (and therefore may be in breach of the guidance in Exhibit SH-1). In addition, in these circumstances, the patient that has been dispensed the Skinny Label pregabalin will not be able to review the PIL or SPC for further information or assistance in relation to the relevant indication. This can be distressing for the patient and can reflect poorly on Lloyds. Having a Full Label generic pregabalin product protects both the patient and the Lloyds pharmacist in such circumstances. For these reasons, I considered the above approach to represent the best practice for Lloyds to adopt."
- It can be seen that Mr Howard's reasons do not relate to infringement of the Patent. Indeed, Lloyds is, if anything, more likely to infringe as a result of dealing in full label generic pregabalin than it is to infringe as a result of dealing in skinny label generic pregabalin. Rather, as I understand it, Mr Howard's reasons involve concerns as to (i) the regulatory position and (ii) the potential reputational consequences for Lloyds.
- So far as the regulatory position is concerned, Mr Howard exhibits and refers to MHRA Guidance Note 14 entitled The supply of unlicensed medicinal products ("specials") published in 2014. The Guidance Note explains at paragraph 1.3 that it provides advice on
"… the manufacture, importation, distribution and supply of unlicensed medicinal products for human use (commonly described as 'specials') which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients."
- It can be seen from this that the Guidance Note is not concerned with off-label use. Confirmation of this is provided by paragraph 2.4:
"Although MHRA does not recommend 'off-label' (outside the licensed indications) use of products, if a UK licensed product can meet the clinical need, even off-label, it should be used instead of an unlicensed product (see Appendix 2)."
- As this makes plain, skinny label generic pregabalin is not an unlicensed product for the purposes of this Guidance Note. On the contrary, it is a UK licensed product. If a skinny label generic pregabalin product is dispensed to a patient who happens (unbeknownst to the pharmacist) to have been prescribed it for neuropathic pain, then it is an off-label supply so far as that particular product is concerned. It is not an unlicensed product or special. Furthermore, the supply is only "off-label" in the limited sense that the particular product is not licensed for that indication; but pregabalin is authorised for that indication, and thus has been demonstrated to the satisfaction of the regulators to be efficacious and safe.
- Turning to pregabalin which has been prescribed for pain other than neuropathic pain, this is true off-label use whether Lyrica or generic pregabalin is dispensed. The professional responsibility for ensuring that it is appropriate to prescribe pregabalin for the indication in question lies upon the prescribing doctor. The pharmacist will necessarily have to rely upon the prescriber's professional judgment. But even in this scenario neither Lyrica nor skinny label generic pregablin is properly described as an unlicensed medicine. Furthermore, it would not make any difference to the off-label nature of the use if the generic pregabalin product dispensed was a full label product (authorised for neuropathic pain) or a skinny label product (not authorised for neuropathic pain).
- Following the hearing, counsel for Lloyds provided the court with copies of two additional documents which he relied upon as supporting Lloyds' interpretation of the regulatory position. The first is entitled Mid Essex CCG Statement of Good Practice for Prescribing Unlicensed and Off Label Medicines dated May 2015. As a document issued by a single CCG, this is plainly much less authoritative than guidance issued by a national regulator such as the MHRA. Furthermore, in my view it is a somewhat confusing document. It is mainly concerned with what it calls "unlicensed medicines", but it defines "unlicensed medicines" as including the situation where "the license [sic] of a particular brand doesn't cover the indication it is prescribed for". Despite this, the document also contains a definition of "off-label prescribing" and contains some guidance about that. The section of the document directed to pharmacists states that, "When supplying a product without marketing authorisation or outside the product licence the supplying pharmacist may assume some liability with the doctor if an adverse reaction is experience as a result of the treatment", but most, if not all, of the remainder of this section is concerned with specials.
- The second document is entitled NHS Ayrshire & Arran Code of Practice for Medicines Governance Section 9(b) – "Off label" Use of Medicines dated 24 April 2012 and expressed to be due for review on 20 April 2014. Apart from being out of date, this is a document issued by a single Health Board and again is plainly much less authoritative than guidance issued by a national regulator such as the MHRA. Again, it is a slightly confusing document, in that it refers to "medicines that do not have a licence" as "unlicensed" and "medicines … used in ways different from those specified in the Marketing Authorisation" as "off-label", yet it goes on to say that "'Off-label' use is an unlicensed use". Page 3 of the document states that:
"A pharmacist will share clinical responsibility for the 'off-label' use of a medicine if his/her actions or omissions have contributed to the harm. …
However the pharmacist is often unaware of the actual indication being treated and as such may not be in a position to intervene."
The latter statement is in general an accurate statement of the practical reality.
- Given Mr Howard's qualifications, I am surprised that no reference was made by him or by counsel for Lloyds to the Guidance for Registered Pharmacies Preparing Unlicensed Medicines issued by the General Pharmaceutical Council in May 2014 (reproduced as Appendix 12 to Medicine, Ethics and Practice: The Professional Guide for Pharmacists (39th edition) issued by the Royal Pharmaceutical Society in July 2015). This Guidance is, as one would expect, entirely consistent with the MHRA Guidance Note, and clearly relates to the preparation of unlicensed medicines, and not to off-label prescribing and dispensing, let alone the dispensing of a skinny label product for an indication for which the medicine, but not the specific product, is licensed.
- In my judgment there is no risk of a pharmacy such as Lloyds being in contravention of any regulatory law, rule, principle or guidance if it dispenses a skinny label generic pregabalin product against a prescription for generic pregabalin which does not specify the indication, and it turns out that the patient has been prescribed pregabalin for neuropathic pain (or even other kinds of pain, if the doctor prescribes pregabalin truly off-label).
- As for the reputational consequences which Mr Howard expresses concern about, clearly it is a matter for Lloyds to decide what it considers is in its own best interests so far its reputation is concerned. Nevertheless, I would make the following observations. First, many other pharmacies are stocking and dispensing skinny label generic pregabalin products. Secondly, it is not clear to me that Lloyds has taken into account the fact that the SmPC and PIL for skinny label generic pregabalin products can and do include warnings as to adverse events when pregabalin is taken for the treatment of neuropathic pain (see Warner-Lambert V at ). Furthermore, at least in the case of Actavis' skinny label product, the PIL also includes the so-called "blue box" wording about prescription of the product for the treatment of conditions not listed in the PIL (see Warner-Lambert V at -). Thirdly, I find it difficult to see why Lloyds should be blamed if the pharmacist on duty does not know what indication pregabalin has been prescribed for. As one would expect, Mr Howard makes it clear in his evidence that Lloyds strives to ensure that, if the pharmacist does know, then the appropriate product is dispensed.
- At the end of the passage quoted above, Mr Howard expresses the question as being one of "best practice". Lloyds' desire to adopt the best practice is commendable, but for the reasons expressed above I am concerned that its decision may not be soundly based. On the other hand, if it is soundly based, it is a matter for concern that other pharmacies take a different view. This may be something for the General Pharmaceutical Council or the Royal Pharmaceutical Society to consider, in order to provide guidance to the profession.
Manufacture, packaging and labelling of the Sandoz Full Label Product
- Sandoz's evidence on the present application is that the packs of the Sandoz Full Label Product which Sandoz supplied to AAH, and thence Lloyds, were manufactured by a Sandoz Group company outside the UK on dates between November 2014 and August 2015. The Sandoz Full Label Product contains pregabalin capsules which are identical to those in Sandoz's skinny label generic pregabalin product. The only difference between the two products is the product information included on the foil of the blister packs, the PIL and the outer packaging. Sandoz's evidence is that the destination and packaging of the product was not known at the date of manufacture. In the case of the packs supplied to AAH for Lloyds, the product was packaged shortly before the supply with the knowledge that it would be supplied to AAH for dispensing by Lloyds in the UK.
The Pfizer-Lloyds Brand Equalisation deal
- As recorded in Warner-Lambert V at , Pfizer has entered into Brand Equalisation deals with a number of customers, including Lloyds, under which it offers discounts in respect of Lyrica based on the assumption that 78% of pregabalin is prescribed for pain.
Pfizer's market share
- Warner-Lambert's evidence on this application is that, although Pfizer's share of the pregabalin market has declined slightly in recent months, Pfizer retains just over 75% of the market for all indications.
The NHS Guidance
- Since it is central to Sandoz's case on this application, I shall set out the NHS Guidance again:
"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®."
- As recounted in Warner-Lambert V at -, this was issued by NHS England (under the title Important Information in Relation to Prescribing and Dispensing Pregabalin) on 27 February 2015. CCGs were required to distribute it to GPs by 6 March 2015 and the BSA to distribute it to pharmacists by the same date. Equivalent guidance was issued in Wales on 6 March 2015 and in Northern Ireland by 16 March 2015. It remains the case that no equivalent guidance has been issued in Scotland.
- Counsel for Sandoz and counsel for Lloyds pointed out that there is a mismatch between the wording of paragraphs 1 and 2 of the NHS Guidance on the one hand and paragraph 3 on the other hand. Paragraphs 1 and 2 refer to prescribing pregabalin for neuropathic pain, whereas paragraph 3 refers to prescribing pregabalin for pain. While this is understandable, in that pregabalin is only authorised for neuropathic pain (leaving aside epilepsy and GAD), but it is prescribed off-label for other types of pain, with the benefit of hindsight it is unfortunate that paragraphs 1 and 2 were restricted to neuropathic pain.
Effectiveness of the NHS Guidance
- I considered the effectiveness of the NHS Guidance in Warner-Lambert V at -. I concluded as follows:
"557. Accordingly, I conclude that it is reasonable to expect that, if it has not already happened by now, in the fairly near future most prescriptions for pregabalin for pain will be written by reference to the brand name Lyrica. …
558. Turning to the position of pharmacists, it is common ground that most pharmacists who were aware of the NHS England guidance would be likely to follow it so far as possible. … In my judgment it is unlikely that many pharmacists will be unaware of it. Of course, this still leaves the situation where the pharmacist is presented with a prescription for generic pregabalin, does not know what indication it has been prescribed for and cannot readily find out (e.g. because the prescription has been presented by someone other than the patient). The more that prescribers prescribe Lyrica for pain, however, the more pharmacists will be justified in assuming that prescriptions written generically are for the non-patented indications."
- Warner-Lambert has filed evidence on the present application which it contends shows that the NHS Guidance has been less effective than I anticipated on the basis of the evidence available at the trial of the Mylan and Actavis proceedings. This evidence derives from three sources. The first two sources relate to prescriptions by doctors and the third source relates to the behaviour of pharmacists.
- The first source consists of Prescription Cost Analysis ("PCA") data published by the BSA. This data shows that the rate of increase in the percentage of pregabalin prescriptions referring to Lyrica in England slowed from May 2015 to June 2015 to July 2015 and reached around 28% in July 2015. In addition, the data from July 2015 shows that the vast majority of CCGs have generic pregabalin prescribing levels of 70% or over and that over 3,500 GP practices have generic prescribing levels of 95% or more.
- The second source is one of Pfizer's pharmacy customers. This is a top 20 nationwide chain that is able to obtain data for levels of branded prescribing of Lyrica from the Patient Medical Records maintained in its branches. This data is reported to show that the percentage of pregabalin prescriptions referring to Lyrica increased from 21% on 21 April 2015 to 34% on 7 October 2015.
- So far as this evidence is concerned, I would make five points. The first is that I concluded in Warner-Lambert V at  that the percentage of pregabalin prescribed for pain in 2013 was about 70% and that the figure for subsequent years was no higher and may have been lower. It follows that one would not expect more than 70%, and possibly a lower percentage, of prescriptions to be for Lyrica if the NHS Guidance was fully effective. Secondly, the clinical software provided by some suppliers may only have been changed as recently as 10 June 2015: see Warner-Lambert V at -. This may have adversely affected the implementation of the NHS Guidance prior to that date. Thirdly, it is clear that, as discussed in Warner-Lambert V at -, the phenomenon of repeat prescriptions means that it is likely to take some time in order for the NHS Guidance to become fully effective. It may be the case that this is taking more time than I anticipated. Fourthly, as discussed in Warner-Lambert V at -, a further factor is the administrative time and cost required to switch patients from generic pregabalin prescriptions to Lyrica prescriptions. Warner-Lambert's evidence on this application shows that, since the trial, Pfizer has continued to engage with the Department of Health and NHS England on this point: in particular, by a letter dated 18 August 2015 Pfizer confirmed that it was willing to make an upfront payment for the reasonable and proportionate costs associated with GP practices amending patients' prescriptions and/or records. It is not clear whether this offer has been taken up, however. Fifthly, another factor may be the fact that, as discussed above, paragraphs 1 and 2 of the NHS Guidance are restricted to neuropathic pain.
- Nevertheless, 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.
- The third source of evidence relied on by Warner-Lambert is a telephone survey undertaken by Warner-Lambert's solicitors of 12 locum pharmacists. This appears to show that a number of these locums were either not aware of, or not adhering to, the NHS Guidance. In my judgment this evidence has to be treated with some caution, but nevertheless I accept that it does suggest that the NHS Guidance is not yet fully effective so far as dispensing by locum pharmacists is concerned. On the other hand, Lloyds' evidence is that it is careful to ensure that the locum pharmacists it engages do follow the NHS Guidance.
- I would add two comments. First, if it is indeed the case that the NHS Guidance is proving less effective than was anticipated, that would be very disappointing. It is not clear why this should be so, although it may have something to do with the novelty of the situation. The second is that doctors and pharmacists should not treat my decision in Warner-Lambert V as meaning that the NHS Guidance may be ignored. While it may need to be revised if my decision stands, the existing Guidance should be followed unless and until further guidance is provided once the decision of the Court of Appeal is known.
- As has frequently been made clear, an important factor when considering whether or not the court should grant an interim injunction is the time which will elapse until trial. Frequently, whether or not the court grants an interim injunction, it will be appropriate to consider expedition of the trial date. For these reasons, parties to an interim injunction application should always make inquiries about potential trial dates and come to court ready to address that question at an early point in the hearing. To my disappointment, the parties did not come to court properly prepared in this respect. In the case of Warner-Lambert's representatives, this was the second time in this set of proceedings that they had failed to do so.
- Fortunately, upon enquiry, it emerged that there was nothing between the parties. Counsel for Sandoz indicated that, at present, Sandoz were not minded to launch their own independent attack on the validity of the Patent. On that basis, all parties were agreed that the trial of Warner-Lambert's claim for infringement against Sandoz should be expedited and were content with a trial in March 2016. I am satisfied that the matter is fit for expedition and that a trial in March 2016 is appropriate. For the reasons explained above, it is not presently clear whether this will be before or after the judgment of the Court of Appeal is available.
Warner-Lambert's claim against Sandoz
- Warner-Lambert seeks a continuation until trial or further order in the meantime of the injunction granted by Birss J preventing Sandoz from supplying or offering to supply the Sandoz Full Label Product. Sandoz resist the continuation of the injunction. In the alternative, they contend that, even if an injunction is granted against Sandoz to restrain future supplies or offers, no relief should be granted in respect of the 102,519 packs already supplied to AAH and Lloyds.
Principles to be applied
- It is common ground that, as between Warner-Lambert and Sandoz, the principles to be applied on this application are those stated by Lord Hoffman when giving the advice of the Privy Council in National Commercial Bank Jamaica Ltd v Olint Corp Ltd  UKPC 16.  Bus LR 1110 at -. I set out the relevant passage in Warner-Lambert I at , and it is not necessary to do so again. The key point is that the court should adopt whichever course seems likely to cause the least irremediable prejudice to one party or the other.
- In the present case, the assessment is complicated by the fact that the court must take into account three different contingencies: first, the outcome of Warner-Lambert's claim for infringement against Sandoz in respect of the Sandoz Full Label Product; secondly, the outcome of the appeals by both Mylan and Actavis and Warner-Lambert against my conclusions as to validity and by Warner-Lambert against my conclusions to infringement in Warner-Lambert V; and thirdly, the outcome of Warner-Lambert's application to amend claim 3 of the Patent. So far as the second contingency is concerned, it should be emphasised that it remains possible that the Court of Appeal will conclude either that all the claims of the Patent (as centrally limited on 21 January 2015) are valid or that they are all invalid.
Serious issue to be tried?
- The first question I have to decide is whether Warner-Lambert's claim for infringement of the Patent raises a serious issue to be tried. Although Warner-Lambert's claim for infringement embraces Sandoz's skinny label generic pregabalin product, for present purposes it is only necessary to consider the claim in respect of the Sandoz Full Label Product.
- Counsel for Sandoz did not dispute that there was a serious issue to be tried. Rather, he submitted that the court could and should conclude that Sandoz's case was stronger than that of Warner-Lambert, and should take that into account when determining the balance of the risk of injustice. I do not accept this submission. 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 , 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.
- Counsel for Sandoz pointed out that, for the reasons explored in Warner-Lambert V at ff, even if Warner-Lambert was successful at trial, it did not necessarily follow that a permanent injunction would be granted. I accept this, but equally I did not think it is safe to assume that no permanent injunction would be granted. Indeed, it seems to me at present that granting a permanent injunction in respect of a full label generic pregabalin product would present less of a difficulty than doing so in respect of a skinny label product.
Harm to Warner-Lambert if no relief is granted
- Warner-Lambert contends that, if no relief is granted, but it is successful at trial, it will suffer unquantifiable and irreparable harm between now and judgment. Sandoz dispute this.
- Counsel for Warner-Lambert relied on a line of cases (including SmithKline Beecham plc v Apotex Europe Ltd  EWCA Civ 137,  FSR 31 and Novartis AG v Hospira UK Ltd  EWCA Civ 583,  1 WLR 1264) in which it has been held that a patentee who markets a patented drug will suffer unquantifiable and irreparable harm if a generic supplier enters the market pending trial, but is then excluded from the market by a final injunction at trial, particularly where the evidence shows that other generic suppliers are likely to follow suit. The patentee will suffer unquantifiable harm because calculating the profits it has lost will be very difficult and irreparable harm because generic competition will lead to price depression which will be difficult to reverse. In the present case, if Pfizer suffers unquantifiable or irreparable damage to its sales, that will translate into unquantifiable or irreparable loss of licence income to Warner-Lambert.
- Counsel for Sandoz disputed that the principles established by this case law were applicable in the circumstances of this case for two main reasons. First, he submitted that the effect of the NHS Guidance was that the marketing of the Sandoz Full Label Product was no more harmful to Pfizer, and hence Warner-Lambert, than the skinny label generic pregabalin products, including the Sandoz product, which had been on the market for time and in respect of which no injunction was sought at this stage. Secondly, he submitted that there was no real likelihood of price depression in the six months or so between now and trial anyway. I will consider these points in turn.
- So far as the first point is concerned, if the NHS Guidance was effective throughout the UK, if it was fully effective at prescriber level, and if the guidance to prescribers was understood to extend to all types of pain, then all prescriptions for pregabalin for pain would be written by reference to the brand name Lyrica. In those circumstances, then I would agree with Sandoz that the availability of the Sandoz Full Label Product would not cause Warner-Lambert any recoverable loss, and certainly no greater recoverable loss than would be caused by the availability of skinny label generic pregabalin products. (I refer to recoverable loss because Warner-Lambert cannot complain about loss of sales for the non-patented indications.) These conditions are not satisfied at present, however. First, no equivalent of the NHS Guidance has been issued in Scotland. Secondly, the evidence on this application indicates that the NHS Guidance is not yet fully effective in England, and there is no evidence that it has been more effective in Wales or Northern Ireland. Thirdly, I cannot be confident that the guidance to prescribers is understood to extend to all types of pain.
- Counsel for Sandoz submitted that the correct conclusion to be drawn from the evidence was that the NHS Guidance was fully effective with respect to prescriptions for neuropathic pain, and that that was what mattered. I agree that it is possible that the NHS Guidance has been substantially effective with respect to prescriptions for neuropathic pain, but has had little effect with respect to prescriptions for other sorts of pain. I do not consider that the court is in a position to make a firm finding one way or the other, however. Furthermore, even if further evidence and analysis confirmed that that was the factual position, this would not be a decisive point in Sandoz's favour, because it remains possible that Warner-Lambert will establish that it is entitled to a monopoly in Swiss form in respect of the use of pregabalin for all types of pain.
- I would add that it is implicit in Lloyds' stance that Lloyds does not believe that the NHS Guidance is fully effective at prescriber level yet, because if it was fully effective at prescriber level, then there would no prospect of a patient being dispensed a generic pregabalin product for pain whether it was skinny label or full label.
- Turning to the second point, it is common ground that the only other generic supplier which is presently known to have a full label marketing authorisation for pregabalin is Mylan, which has not yet launched any generic pregabalin product. Mylan's solicitors stated in a letter dated 5 October 2015 that Mylan "currently" has no intention to launch a full label product, but it is manifest that Mylan and other generic suppliers are awaiting the outcome of the present application, and will decide their strategy in the light of the Court's decision. If an interim injunction were to be refused, Mylan would be in position to launch a full label product very quickly. As for the other generic companies who have launched skinny label generic pregabalin products, it only takes 30-60 days to convert a skinny label marketing authorisation into a full label one, and they may have already embarked upon this process. Furthermore, it is implicit in Sandoz's reliance upon the "first mover" advantage discussed below that Sandoz consider it likely that other generic suppliers will follow its lead. Accordingly, I consider that there is a real likelihood that, if an interim injunction against Sandoz is refused, then other generic suppliers will launch full label products in the near future.
- It is fair to say that the availability of skinny label generic pregabalin products has not yet led to recategorisation of pregabalin for the purposes of the Drug Tariff and that Pfizer has succeeded in maintaining a very large share of the market with the assistance of its Brand Equalisation deals. In my judgment, however, the availability of the Sandoz Full Label Product would increase the likelihood of recategorisation (particularly since it appears likely that the Sandoz Full Label Product will be regarded as a true generic for this purpose), and the availability of other full label generic products would further increase the likelihood of this happening between now and March 2016. In those circumstances, there would be a significant downward price spiral regardless of Pfizer's Brand Equalisation deals. If that happened, it would be difficult for Pfizer to put its price back up even if it was successful at trial.
- Accordingly, I conclude that, if no injunction is granted now, but Warner-Lambert is successful in its infringement claim in respect of the Sandoz Full Label Product at trial, then there is a significant risk of Pfizer, and hence Warner-Lambert, suffering damage during the interim which is very difficult to quantify and irremediable loss in the long term.
Harm to Sandoz if relief is granted
- Sandoz contend that, if the relief sought by Warner-Lambert is granted but Warner-Lambert is unsuccessful at trial, they will suffer unquantifiable and irreparable harm which will not compensated by an award of damages pursuant to Warner-Lambert's cross-undertaking. Warner-Lambert disputes this.
- The principal factors relied upon by Sandoz are the absence of any track record of sales of the Sandoz Full Label Product and loss of the "first mover" advantage, that is to say, the advantage of being the first generic entrant into a particular market. I accept that, if an injunction is granted now, but Warner-Lambert is not successful at trial, then the loss sustained by Sandoz will be difficult to quantify for both these reasons. On the other hand, Sandoz will be able to continue to market its skinny label product.
- In addition, Sandoz relies upon supposed accounting difficulties and upon disruption of its relationship with AAH/Lloyds and with its customers more generally. I am unimpressed by these points. I see no reason to believe that a group of Sandoz's size and sophistication will have any real difficulties with its accounting. As for the relationship with AAH/Lloyds, it is plain that both sides entered into the contract for the sale of the 102,519 packs with their eyes open to the potential consequences. As for other customers, I do not accept this factor adds anything of substance to loss of the first mover advantage.
Clearing the path and preservation of the status quo
- Warner-Lambert contends that Sandoz have failed to "clear the path" for the launch of the Sandoz Full Label Product and that preservation of the status quo favours the grant of relief.
- It is well established that, where a generic supplier intends to market a product covered by a patent which the generic supplier contends is invalid, then the proper course for the generic supplier is to commence revocation proceedings to "clear the path" for the launch of its product sufficiently far in advance of launch to enable the validity of the patent to be determined prior to the launch date: see SmithKline Beecham v Apotex at - (Aldous LJ). This principle has also been applied in cases where the generic supplier has a non-infringement argument available to it.
- In the present case, of course, the validity of the Patent had already been challenged by Mylan and Actavis. Accordingly, there was no need for Sandoz to bring its own action for revocation. The marketing by Sandoz of the Sandoz Full Label Product raises a distinct issue on infringement which did not arise in the Mylan and Actavis proceedings, however. It would have been open to Sandoz to seek a declaration of non-infringement in respect of the Sandoz Full Label Product prior to launch, but it did not do so. To that extent, Sandoz failed to clear the path for its launch of that product.
- More generally, the status quo prior to launch of the Sandoz Full Label Product was that a number of generic suppliers, including Sandoz, had launched skinny label generic pregabalin products, but no one was marketing a full label generic pregabalin product.
Balance of the risk of injustice
- In my judgment, granting the relief sought by Warner-Lambert would create a lesser risk of irremediable harm than refusing it. This is for two main reasons. 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.
The packs already supplied to AAH and Lloyds
- The injunction which Warner-Lambert seeks against Sandoz will not itself bite on the 102,519 packs which Sandoz have already supplied to AAH and Lloyds. Nevertheless, Sandoz have an interest in those packs because of the possibility that they may be returned to Sandoz. It is convenient to consider that interest here. So far as Sandoz's interest is concerned, I see no justification for differentiating between the 102,519 packs which Sandoz have already supplied to AAH and Lloyds, and future supplies. First, to make such a differentiation would be to reward Sandoz for their failure to give prior notice of the launch to Warner-Lambert. Secondly, those packs represent Lloyds' supply for three months, that is to say, about half the period to trial. As such, this quantity is capable of inflicting significant and irremediable harm on Warner-Lambert.
- Counsel for Sandoz relied upon the absence of any claim for patent infringement by Warner-Lambert against Lloyds as a reason for not granting an injunction in respect of these packs. I will consider this point in the context of Warner-Lambert's claim against Lloyds.
Ambit of the cross-undertakings
- There is no dispute that Warner-Lambert must give the usual cross-undertaking in damages. Furthermore, counsel for Warner-Lambert confirmed that Warner-Lambert would give a cross-undertaking in favour of the Department of Health and the NHS as well as in favour of Sandoz. Nevertheless, counsel for Sandoz raised two points about the scope of Warner-Lambert's cross-undertakings.
- The first concerns the NHS Guidance. Sandoz do not currently benefit from the cross-undertaking required of Warner-Lambert when it obtained the order against NHS England, because Sandoz did not request that the benefit of that cross-undertaking be extended to them. Warner-Lambert is prepared to extend the benefit of that cross-undertaking to Sandoz prospectively, but Sandoz requests that Warner-Lambert be ordered to extend the benefit of that cross-undertaking retrospectively. I see no justification for this. Sandoz could have applied to the court for an order that the benefit of the cross-undertaking be extended to them, as some of the other generic companies did, but they chose not to do so. Sandoz could even have made such application after I handed my judgment in Warner-Lambert IV explaining my reasons for requiring Warner-Lambert to give a cross-undertaking to the generic companies, but again they chose not to do so. In my judgment, Warner-Lambert should only be required to give this undertaking prospectively. I will hear further argument as to the exact date from which this cross-undertaking should benefit Sandoz if that cannot be agreed.
- Secondly, counsel for Sandoz suggested that it was possible that, if an interim injunction was granted against Sandoz, Pfizer, and hence Warner-Lambert, would profit more than Sandoz lost, and he submitted that Warner-Lambert should be required to undertake to disgorge any excess profits. I do not accept this submission. In so far as Sandoz are prevented by the injunction from making sales of the Sandoz Full Label Product which they would otherwise have made, Warner-Lambert will be required to compensate them. I have accepted that there will be difficulties in quantification, and this may lead the court to resolve any uncertainties in Sandoz's favour (see Les Laboratoires Servier v Apotex Inc  EWHC 2347 (Ch),  FSR 3 at  (Norris J)). In my view it is unlikely that Warner-Lambert (or even Pfizer) will generate a greater sum in profits as a result of the injunction than the damages it has to pay Sandoz and the Department of Health/NHS. Even if it does, I am not persuaded that that would amount to unjust enrichment requiring Warner-Lambert to make restitution. That scenario would only arise if Warner-Lambert would make substantial profits in the absence of the Sandoz Full Label Product, so why should the grant of the injunction make a difference to Warner-Lambert's liability to disgorge such profits? Furthermore, if Warner-Lambert was required to disgorge such profits to Sandoz, it would result in Sandoz being better off as a result of being injuncted than if it had never launched the Sandoz Full Label Product.
Warner-Lambert's claim against Lloyds
- Warner-Lambert seeks a continuation until trial or further order in the meantime of the injunction granted by Birss J in effect preventing Lloyds from dispensing the packs of the Sandoz Full Label Product which it currently has in its possession.
The jurisdictional basis for the application
- Rather strangely, although Warner-Lambert has joined Lloyds as a defendant to the proceedings (as it was required to do by Birss J), and although Warner-Lambert seeks an interim injunction restraining Lloyds from dispensing the Sandoz Full Label Product in its possession, Warner-Lambert does not wish to bring a claim against Lloyds for infringement of the Patent. I can only think that this is something to do with either Pfizer's defence of the threats claim brought by Actavis or a concern about possible future claims for threats by other parties. Whatever the reason, Warner-Lambert's primary case is that the court should make an interim order pursuant to section 37(1) of the Senior Courts Act 1981. In the alternative, Warner-Lambert contends that the court should make the order by way of a conventional interim injunction for alleged patent infringement. Given that the alternative case is more straightforward than the primary case, it is tempting to short-cut the analysis by concentrating solely on the latter. Counsel for Warner-Lambert made it clear, however, that Warner-Lambert only relied on its alternative case if the primary case failed. Accordingly, I shall first consider the primary case. For this purpose, it must be assumed that Lloyds is not itself infringing the Patent by keeping the goods in question, nor would it infringe by dispensing the goods.
- Although counsel for Warner-Lambert relied both before Birss J and in his skeleton argument for this hearing upon my judgments in Cartier International AG v British Sky Broadcasting Ltd  EWHC 3354 (Ch),  Bus LR 298 and Warner-Lambert IV, in his oral submissions he relied more particularly upon the equitable protective jurisdiction described by Buckley LJ in Norwich Pharmacal Co v Customs & Excise Commissioners  AC 133 at 145-146:
"If a man has in his possession or control goods the dissemination of which, whether in the way of trade or, possibly, merely by way of gifts … will infringe another's patent or trade mark, he becomes, as soon as he is aware of this fact, subject to a duty, an equitable duty, not to allow those goods to pass out of his possession or control at any rate in circumstances in which the proprietor of the patent or mark might be injured by infringement ensuing. The man having the goods in his possession or control must not aid the infringement by letting the goods get into the hands of those who may use them or deal with them in a way which will invade the proprietor's rights. Even though by doing so he might not himself infringe the patent or trade mark, he would be in dereliction of his duty to the proprietor. This duty is one which, if necessary, will be enforced in equity by way of injunction …"
- In my judgment this principle does not apply to the present situation. There is no threat by Lloyds to part with possession of the Sandoz Full Label Product save by dispensing it to patients. If Lloyds dispenses the Sandoz Full Label Product to patients, the patients will not in any event infringe the Patent since their acts will be private and non-commercial: see section 60(5)(a) of the 1977 Act. Thus there is no prospect of Lloyds aiding infringement by a third party, or even of Lloyds being mixed up in infringement by any third party downstream from itself. (Lloyds could well be said to be mixed up in infringement by the upstream parties, Sandoz and AAH, but that is immaterial for these purposes, since any infringement by those parties has already occurred so far as the packs in question are concerned.)
- In those circumstances, while I adhere to the view as to ambit of the court's jurisdiction under section 37(1) of the 1981 Act which I expressed in Cartier v Sky, I do not consider that there is a principled basis for the grant of the injunction against Lloyds sought by Warner-Lambert if it is assumed that Lloyds will not itself infringe the Patent by dispensing the Sandoz Full Label Product, because the grant of the injunction would not prevent or reduce wrongdoing by any third party.
- In those circumstances it is unnecessary for me to express a concluded view with respect to the arguments advanced by counsel for Lloyds based on Article 9(1)(a) of European Parliament and Council Directive 2004/48/EC of 29 April 2004 on the enforcement of intellectual property rights ("the Enforcement Directive"). In brief, he submitted as follows: (1) an interim injunction could only be granted pursuant to Article 9(1)(a) of the Enforcement Directive against an intermediary where the intermediary's services were being used by a third party to infringe an intellectual property right, and not where it was merely arguable that the third party was infringing; (2) no third party was even arguably using Lloyds' services to infringe the Patent; and (3) it would be contrary to the Enforcement Directive for the English courts to have any greater power to grant an interim injunction than was provided for by Article 9(1)(a). Counsel for Warner-Lambert did not dispute point (1), but he did dispute points (2) and (3). All I will say is that my provisional view is that point (3) is not so clearly correct that I would have refused to grant an interim injunction for that reason.
- For completeness, I would add that counsel for Warner-Lambert accepted, rightly in my view, that the general requirements under Article 3 of the Enforcement Directive, and in particular the requirement of proportionality, had to be satisfied with respect to the order sought by Warner-Lambert against Lloyds.
- I turn, therefore, to consider Warner-Lambert's alternative case. For this purpose, I shall proceed on the basis that Warner-Lambert will amend its Particulars of Claim and Particulars of Infringement to plead a claim for patent infringement against Lloyds. The claim is a straightforward one. If the relevant Sandoz company has carried out the claimed process by manufacturing, packaging and labelling the packs of Sandoz Full Label Product in question, then it necessarily follows that Lloyds would infringe the Patent by dispensing those packs to patients regardless of its own state of mind (see Warner-Lambert V at ). Given that there is a serious question to be tried with respect to Warner-Lambert's claim against Sandoz, it follows that there is also a serious question to be tried with respect to Warner-Lambert's claim against Lloyds.
- Counsel for Lloyds submitted that it would be procedurally unfair for the court to grant an interim injunction against Lloyds on the basis of a claim for patent infringement and an assessment of the balance of the risk of injustice because that was not the case that Lloyds had come to court to meet. I do not accept this submission. In my judgment Warner-Lambert made it clear that, if necessary, it would claim for patent infringement and would rely upon the balance of the risk of injustice, and Lloyds had an adequate opportunity to address that case. I am not persuaded that Lloyds' evidence would have been materially different if that had been Warner-Lambert's primary case.
Balance of the risk of injustice
- In my judgment the balance of the risk of injustice comes down in favour of the grant of an injunction against Lloyds for the reasons explained above. In particular, the grant of such an injunction reduces the likelihood of irremediable prejudice to one party or another and preserves the status quo. Indeed, Lloyds will be able to claim reimbursement from Sandoz and will be able to return the goods. At worst, therefore, Lloyds will suffer a loss of its profit margin on these sales, which would appear to be purely quantifiable. The making of such an order is also proportionate and satisfies the other requirements under Article 3 of the Enforcement. In particular, it would not be a barrier to legitimate trade because it would not prevent Lloyds from purchasing and dispensing skinny label generic pregabalin products. Like Sandoz, Lloyds seeks a retrospective extension of the benefit of Warner-Lambert's cross-undertaking in respect of the NHS Guidance, but again I am not persuaded that this is justified.
- For the reasons given above I shall grant interim injunctions against both Sandoz and Lloyds. If the precise terms of the order cannot be agreed, I will hear further argument.
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