Warner-Lambert Company, LLC v Actavis Group PTC EHF and Others (Defendants Proposed Defendant)
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 21 January 2015 |
| Neutral Citation | [2015] EWHC 72 (Pat) |
| Docket Number | Case No: HC-2014-001795 |
| Court | Chancery Division (Patents Court) |
| Date | 21 January 2015 |
[2015] EWHC 72 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case No: HC-2014-001795
Justin Turner QC, Daniel BeardQC, Miles Copeland and Tim Austen (instructed by Allen & Overy LLP) for the Claimant
Adrian Speck QC, Paul HarrisQC and Ronit Kreisberger (instructed by Powell Gilbert LLP) for the First to Third Defendants
Douglas Campbell (instructed by RPC) for the Proposed Fourth Defendant
Richard Davis (instructed by the Treasury Solicitor) for the Department of Health
Hearing dates: 13–15 January 2015
Further written submissions 16, 19, 20 January 2015
Contents
| Topic | Paragraphs |
| Introduction | 1–8 |
| Second medical use patents with claims in Swiss form | 9–13 |
| The Patent | 14–16 |
| The abridged procedure for marketing authorisations and skinny labels | 17–18 |
| The market for pregabalin | 19–24 |
| Treatment of neuropathic pain | 25–27 |
| Prescriptions | 28–29 |
| Prescription software | 30 |
| The NHS Drugs Tariff | 31–33 |
| Pharmacists and patients | 34–38 |
| Genesis of the proceedings | 39–50 |
| Steps taken by Pfizer to date | 51–61 |
| Steps taken or proposed to be taken by Actavis | 62–66 |
| Other generic suppliers | 67–72 |
| The best solution to the problem | 73–77 |
| The relief sought by Warner-Lambert on this application | 78–89 |
| Principles to be applied | 90–91 |
| Serious issue to be tried? | 92–115 |
| Harm to Warner-Lambert if no relief is granted | 116–124 |
| Harm to Actavis if relief is granted | 125–129 |
| Clearing the path, status quo and delay | 130–136 |
| Balance of the risk of injustice | 137 |
| Competition law | 138 |
| Summary of conclusions | 139 |
Introduction
This case arises out of a collision between the policy of incentivising important medical research by granting second medical use patents on the one hand and other policies and practices which form part of the United Kingdom's healthcare systems (and in particular the English and Welsh systems) on the other hand.
The essence of the problem is fairly simply stated, although the details are more complicated. The patentee markets a prescription-only drug for three different indications under a single registered trade mark. Patent protection for the drug itself has now expired, but the patentee still has a second medical use patent for one of the three indications. A supplier of generic pharmaceuticals wishes to enter the market for the drug for the two non-patented indications, as it is lawfully entitled to do. To that end, the generic supplier obtains a marketing authorisation for a generic version of the drug limited to those two indications (a so-called "skinny label"), and it only identifies those indications in its summary of product characteristics ("SmPC") and patient information leaflet ("PIL").
The main immediate causes for the problem that arises are two-fold. First, not only are about 83% of prescriptions written generically, but also about 95% of prescriptions do not state the indication for which the drug has been prescribed. As a result, the pharmacist who dispenses the prescription will generally not know the indication the drug has been prescribed for. Secondly, because the generic version of the drug will be cheaper than the patentee's product, pharmacists will have a strong commercial incentive to dispense the generic version of the drug against all generic scripts. Thus it is foreseeable that pharmacists will dispense the generic version of the drug for patients who have in fact been prescribed the drug for treating the patented indication, unless positive steps are taken to prevent this.
As a result, I have to resolve two main questions. The first question is whether, in such circumstances, the generic supplier will infringe the second medical use patent unless the supplier takes positive steps to prevent its generic version of the drug being dispensed for patients who have been prescribed the drug for the patented indication. The answer to this question depends on the correct interpretation of the claims of the second medical use patent, which are in the so-called "Swiss" form. If it is seriously arguable that the generic supplier will infringe, the second question concerns the steps, if any, which the generic supplier should be obliged to take pending the trial of that issue. This question is complicated by the involvement of third parties who are not under either party's control: not just prescribing doctors and pharmacists, but also healthcare organisations such as Clinical Commissioning Groups ("CCGs") (in England) and Health Boards (in Wales), regulators such as the Medicines and Healthcare Products Regulatory Agency ("MHRA") and the National Institute for Heath and Care Excellence ("NICE"), NHS England and NHS Wales, and the Department of Health itself. It is further complicated by the fact that the patentee has itself taken, and is continuing to take, steps to prevent the generic version being dispensed for patients who have been prescribed the drug for the patented indication. It is still further complicated by the behaviour of patients, many of whom do not take their own prescriptions to the pharmacy, some of whom may not remember what they have been prescribed pregabalin for and a few of whom may mislead their doctors for ulterior reasons.
The Claimant ("Warner-Lambert") is the patentee. Warner-Lambert is part of the Pfizer group, which also includes Pfizer Ltd ("Pfizer"), which holds the relevant marketing authorisation. There is no need to distinguish between the First to Third Defendants (collectively "Actavis"), who are the generic supplier. The drug is pregabalin, which is marketed by Warner-Lambert under the trade mark Lyrica for epilepsy, generalised anxiety disorder ("GAD") and neuropathic pain. Patent protection for pregabalin itself expired on 17 May 2013. Remarkably, Warner-Lambert obtained a supplementary protection certificate which extended protection for pregabalin to 17 May 2018, but allowed it to lapse for non-payment of fees, as was first noted on the Register of Patents on 14 October 2013. Warner-Lambert's data exclusivity expired in July 2014. The second medical use patent is European Patent (UK) No. 0 934 061 ("the Patent"), which has claims in Swiss form directed to pregabalin for treating pain, and in particular neuropathic pain. Actavis have applied for, and are on the verge of obtaining, a marketing authorisation for generic pregabalin limited to epilepsy and GAD. Once Actavis have obtained their marketing authorisation, they will launch their product under the trade mark Lecaent. A number of other generic suppliers have shown signs of interest in pregabalin, and one (Consilient) has already obtained a marketing authorisation.
Warner-Lambert alleges that Actavis will infringe the Patent. Actavis and another generic supplier (Mylan) have brought proceedings to revoke the Patent, and if successful they intend to obtain marketing authorisations and to sell pregabalin for all three indications; but that is not relevant for present purposes. I have directed that Warner-Lambert's infringement claim against Actavis be tried at the same time as the revocation claims, that is to say, in a five day window starting on 29 June 2015. Pending trial, Warner-Lambert has applied for an interim injunction requiring Actavis to take a number of steps to prevent Lecaent from being dispensed for treating pain. Actavis contend that Warner-Lambert's infringement claim has no real prospect of success, and in the alternative that the balance of the risk of injustice favours refusal of the relief sought. Actavis also argue that the relief sought is contrary to competition law.
The Proposed Fourth Defendant ("NHS Highland") is the Health Board for the Scottish Highlands. Warner-Lambert alleges that NHS Highland has infringed, or threatened to infringe, or procured infringement by others of, the Patent by publishing an article in its publication The Pink One dated October-November 2014 which is said to encourage doctors to prescribe and pharmacists to dispense generic pregabalin for all indications regardless of the patent position. Warner-Lambert has applied to join NHS Highland to this claim and to obtain interim relief against it. NHS Highland disputes that this Court has jurisdiction over the claim made against it. I have given directions for the hearing of these issues at the end of this month if that proves necessary given that Warner-Lambert and NHS Highland have been negotiating a settlement and agreement appears close.
On 10 December 2014 Warner-Lambert's solicitors, acting in accordance with the guidance given by Jacob LJ in SmithKline Beecham plc v Apotex Europe Ltd [2005] EWCA Civ 658, [2007] FSR 6 at [77], notified the Department of Health of Warner-Lambert's application, and served copies of Warner-Lambert's (and subsequently Actavis') evidence. The Department initially declined the opportunity to be represented before me, although it did provide helpful comments on behalf of itself and the MHRA through the medium of two letters from the Treasury Solicitor to Warner-Lambert's solicitors. After I had repeatedly made it clear through the parties that I would be assisted by its appearance, however, the Department relented and, on the afternoon of the third day of the hearing, instructed counsel to appear. I am grateful to the Department for its assistance, and in particular to counsel who appeared at very short notice. The value of the exercise is illustrated by the fact that, contrary to what had been indicated in an email sent by the...
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