Warner-Lambert Company, LLC (Claimant) Actavis Group PTC EHF and Others (Defendants) National Health Service Commissioning Board (Respondent) Teva UK Ltd and Others (Interested Parties)
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 02 March 2015 |
| Neutral Citation | [2015] EWHC 485 (Pat) |
| Docket Number | Case No: HC-2014-001795 |
| Court | Chancery Division (Patents Court) |
| Date | 02 March 2015 |
[2015] EWHC 485 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
The Hon Mr Justice Arnold
Case No: HC-2014-001795
and
Charlotte May QC and Jaani Riordan (instructed by Allen & Overy LLP) for the Claimant
Jessie Bowhill (instructed by DAC Beachcroft LLP) for the Respondent
Adrian Speck QC (instructed by Powell Gilbert LLP) for the Defendants
Michael Tappin QC (instructed by Pinsent Masons LLP) for the First Interested Party
Kathryn Pickard (instructed by Taylor Wessing LLP) for the Second Interested Party
Hearing date: 26 February 2015
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
On 21 January 2015 I dismissed an application by Warner-Lambert for an interim injunction in this matter, holding that, on the basis of the evidence and arguments then before the court, Warner-Lambert's infringement claim did not raise a serious issue to be tried and that, even if it did, the balance of the risk of the injustice favoured refusal of the relief sought. The background to the matter and the reasons for those conclusions are set out in full in my judgment of that date ( [2015] EWHC 72 (Pat)), which I shall take as read.
Under the heading "The best solution to the problem", I stated:
"73. As I understand the evidence and arguments before me, it is more or less common ground between all concerned that the best solution to the problem which arises in this case is to try to ensure that prescribing doctors prescribe pregabalin for the treatment of pain by reference to the brand name Lyrica rather than by reference to the generic name pregabalin. That will ensure that pharmacists only dispense Lyrica when presented with prescriptions for pregabalin which are (at least so far as the prescriber is concerned) for pain without requiring the pharmacist to know the indication for which pregabalin has been prescribed.
74. As I hope I have made clear, it does not lie within the power of either Warner-Lambert or Actavis to ensure that this happens. It depends ultimately on the behaviour of the prescribers. The prescribers can be, and are already being, influenced in a number of ways, in particular by the NICE guidance and by communications via the CCGs (and Welsh Health Boards). Warner-Lambert is understandably concerned that this is not enough, and that what is required is for two further things to happen. Actavis agree that these steps are desirable.
75. First and most importantly, Warner-Lambert contends that prescribers should be given clear guidance that, in this situation (and other future situations like it), the proper course is to prescribe by reference to the brand name for the patented indication and by reference to the generic name for non-patented indications. Counsel for the Department of Health informed me that the Department is not a position to issue such guidance. Under the National Health Service Act 2006, the Secretary of State is under a duty to promote the autonomy of NHS England and may only intervene if NHS England is guilty of a significant failure properly to discharge its functions. The Department does not consider that a failure by NHS England to issue guidance with regard to the relevance of the Patent to the prescribing of pregabalin would constitute such a failure. The Department notes, however, that NHS England may consider it appropriate to issue such guidance. If NHS England were to do so, the Department would not consider that inappropriate. I presume that the position is much the same with regard to NHS Wales. Clearly, it is a matter for NHS England and NHS Wales to decide whether or not to issue such guidance, but for my part I would encourage them to consider doing so as a matter of urgency.
76. Secondly, Warner-Lambert contends that prescription software suppliers should alter their software to make it easier for doctors to prescribe pregabalin by brand name for treating pain. Again, I would encourage them to do so. This is less important, however, since the existing software does permit Lyrica to be prescribed.
77. Before proceeding further, it is necessary to emphasise two points. The first is that Warner-Lambert is not seeking any order against Actavis which will make either of the two things described above happen. The second is that, if those things do happen sufficiently quickly, the relief which Warner-Lambert seeks against Actavis on this application will become unnecessary. It follows that, in deciding whether to grant Warner-Lambert the relief it seeks, I need take into account the prospects of those steps being taken by those responsible. I consider that there is a reasonable prospect of NHS England and NHS Wales issuing guidance in the near future, but a lower prospect of software suppliers modifying their software quickly."
On 6 February 2015 I granted Warner-Lambert permission to amend its Particulars of Infringement to plead a case of subjective intention on the part of Actavis, dismissed an application by Actavis to strike out, alternatively for summary dismissal of, Warner-Lambert's claim for infringement of the Patent under section 60(1)(c) of the Patents Act 1977 and granted Actavis summary judgment dismissing Warner-Lambert's claim under section 60(2) of the 1977 Act. Again, I shall take my judgments of that date ( [2015] EWHC 223 (Pat) and [2015] EWHC 249 (Pat)) as read.
In the first of those judgments, I quoted a paragraph from the Minutes of a Meeting of the North of Tyne Area Prescribing Committee on 13 January 2015 and commented at [5] that "in my view [this] emphasises the desirability of NHS England (and NHS Wales) issuing guidance on this subject."
Since 6 February 2015 further evidence has emerged of concern and inconsistency amongst Clinical Commissioning Groups ("CCGs") as to what course they should be adopting in the present circumstances. It is not necessary for present purposes to set this evidence out.
On 22 January 2015 Pfizer wrote to the Respondent (which operates under the name NHS England, which is how I shall continue to refer to it) asking it promptly to issue guidance to CCGs. Following telephone conferences between representatives of Pfizer and representatives of NHS England on 23 January, 28 January, 4 February and 9 February 2015, on 10 February 2015 Sir Bruce Keogh, NHS England's National Medical Director, wrote to Pfizer stating:
"… at present I do not think that the correct formulation of prescriptions for pregabalin is an issue on which we should express a view on behalf of NHS England, at least on a timescale that is likely to be material to the litigation under way."
On 16 February 2015 Warner-Lambert's solicitors wrote to NHS England stating that Warner-Lambert intended to make an application to the Court for an order requiring NHS England to issue guidance to CCGs. On 18 February 2015 NHS England's solicitors wrote to Warner-Lambert's solicitors stating, in summary, that (i) NHS England was an innocent bystander in the present dispute, (ii) NHS England was unwilling for various reasons to issue guidance of its own motion, but (iii) NHS England would not oppose an application by Warner-Lambert for an order requiring it to issue guidance provided certain conditions were met. On 20 February 2015 Warner-Lambert duly issued an application for such an order.
Before proceeding further, it is relevant to note certain other developments that have occurred since 6 February 2015. First, on 10 February 2015, Floyd LJ granted a renewed application by Warner-Lambert for permission to appeal against the refusal of an interim injunction for the reasons given in his judgment of that date [2015] EWCA Civ 90. It appears from that judgment at [17]–[19] that NHS England's letter dated 10 February 2015 was a factor in the decision to grant permission to appeal. Secondly, on 9 February and 13 February 2015 respectively Warner-Lambert commenced proceedings for infringement of the Patent against Dr Reddy's and Teva and launched applications for interim injunctions against those parties. Thirdly, on 12 February and 16 February 2015 respectively Dr Reddy's and Actavis obtained marketing authorisations. Both launched their generic pregabalin products shortly after those dates. Consilient has also recently launched its generic pregabalin product. Teva has not yet obtained a marketing authorisation or launched a generic pregabalin product.
Warner-Lambert rightly served its application upon Actavis, Dr Reddy's, Teva, Consilient, Mylan, Sandoz and the Department of Health as interested parties. None of the interested parties opposed an order being made in principle, but Actavis, Dr Reddy's and Teva made comments via their respective solicitors on the terms both of the order and of the proposed guidance. With the exception of one point which I shall consider below, agreement was reached between all parties as to the terms of the order and of the guidance. (Despite this, counsel for Warner-Lambert in her submissions in reply requested an amendment to the terms of the guidance which was not agreed to by NHS England or the other parties. I declined to order this for the reasons advanced by counsel for NHS England.)
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