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England and Wales High Court (Patents Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Warner-Lambert Company LLC v Sandoz GmbH & Ors  EWHC 3153 (Pat) (04 November 2015)
Cite as:  EWHC 3153 (Pat)
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Fetter Lane, London, EC4A 1NL
B e f o r e :
| WARNER-LAMBERT COMPANY LLC
|- and -
LLOYDS PHARMACY LIMITED
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
Crown Copyright ©
MR JUSTICE ARNOLD :
|The Mylan and Actavis proceedings||2-11|
|Warner-Lambert's licensing of the Patent||12-14|
|Sandoz and Lloyds||15-16|
|The skinny label market for generic pregabalin||17-18|
|The genesis of the present application||19-51|
|Lloyds' position with respect to skinny label generic pregablin products||52-64|
|Manufacture, packaging and labelling of the Sandoz Full Label Product||65|
|The Pfizer-Lloyds Brand Equalisation deal||66|
|Pfizer's market share||67|
|The NHS Guidance||68-70|
|Effectiveness of the NHS Guidance||71-78|
|Warner-Lambert's claim against Sandoz||81-108|
|Principles to be applied||82-83|
|Serious question to be tried?||84-86|
|Harm to Warner-Lambert if no relief is granted||87-95|
|Harm to Sandoz if relief is granted||96-98|
|Clearing the path and preservation of the status quo||99-102|
|Balance of the risk of injustice||103|
|The packs already supplied to AAH and Lloyds||104-105|
|Ambit of the cross-undertakings||106-108|
|Warner-Lambert's claim against Lloyds||109-118|
|Jurisdictional basis for the application||110-117|
|Balance of the risk of injustice||118|
The Mylan and Actavis proceedings
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.
"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.
Warner-Lambert's licensing of the Patent
"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."
Sandoz and Lloyds
The skinny label market for generic pregabalin
The genesis of the present application
"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."
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.
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.
"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]"
"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."
Lloyds' position with respect to skinny label generic pregabalin products
"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."
"… 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."
"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)."
"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.
Manufacture, packaging and labelling of the Sandoz Full Label Product
The Pfizer-Lloyds Brand Equalisation deal
Pfizer's market share
The NHS Guidance
"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®."
Effectiveness of the NHS Guidance
"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's claim against Sandoz
Principles to be applied
Serious issue 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
The jurisdictional basis for the application
"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 …"
Balance of the risk of injustice