Warner-Lambert Company LLC v Sandoz GMBH and Another
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 21 December 2016 |
| Neutral Citation | [2016] EWHC 3317 (Pat) |
| Docket Number | Case No: HP-2015-000049 |
| Court | Chancery Division (Patents Court) |
| Date | 21 December 2016 |
[2016] EWHC 3317 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
THE ADMINISTRATIVE COURT
PATENTS COURT
Rolls Building
Fetter Lane, London EC4A 1NL
Mr Justice Arnold
Case No: HP-2015-000049
Richard Miller QC and Tim Austen (instructed by Allen & Overy LLP) for the Claimant
Geoffrey Hobbs QC and Andrew Lomas (instructed by Olswang LLP) for the Defendants
Hearing date: 13 December 2016
Judgment Approved
Introduction
This is an application by the Defendants ("Sandoz") to vary an interim injunction which I granted against Sandoz by an order dated 17 November 2015 which was sealed on 19 November 2015 ("the 17 November Order") for the reasons given in my judgment dated 4 November 2015 [2015] EWHC 3153 (Pat) (" Sandoz I"). The injunction was granted on the application of the Claimant ("Warner-Lambert") to restrain Sandoz from infringing European Patent (UK) No. 0 934 061 ("the Patent") by dealings in a full label generic pregabalin product ("the Sandoz Full Label Product").
Sandoz contend that there has been a material change of circumstances since 17 November 2015, and that as a result paragraph 1 of the 17 November Order should be amended as shown below:
"The First and Second Defendants will not, while EP 0 934 061 B3 (the "Patent") is in force, pending an order made post-judgment in this action or further order in the meantime (whether acting by their directors, officers, servants, agents or otherwise howsoever) do or cause or procure others to do any of the following acts within the UK, namely: offer for sale, sell or supply pregabalin for use in the treatment of acute herpetic and postherpetic pain or causalgia pain: (i) under Sandoz GmbH's European Medicines Agency marketing authorisation EMEA/H/C/004010 (identified on the SmPC as MA no EU/1/15/1011); or (ii) bearing a patient information leaflet which indicates use for the treatment of pain or neuropathic painunderSandoz GmbH's European Medicines Agencymarketing authorisation EMEA/H/C/004010 (identified on the SmPC as MA no EU/1/15/1011)(hereinafter pregabalin supplied pursuant to that marketing authorisation or carrying such a patient information leaflet is referred to as Sandoz Full Label Pregabalin Product) PROVIDED THAT the First and Second Defendants may supply any Sandoz Full Label Pregabalin Product returned to it by the Third Defendant or AAH Limited to any other company within the Sandoz Group for the purposes of repackaging that product to then supplying it under Sandoz GmbH's European Medicines Agency marketing authorisation EMEA/H/C/004010 (identified on the SmPC as MA no EU/1/15/1011) in territories where the Patent and corresponding patents are not in force, or otherwise under Sandoz GmbH's European Medicines Agency marketing authorisation EMEA/H/C/004070 (identified on the SmPC as MA no EU/1/15/1012/069–083) AND FURTHER PROVIDED THAT nothing in this paragraph of this Order shall prevent any Sandoz Full Label Pregabalin Product from being offered for sale, sold or supplied as pregabalin to be prescribed, administered and dispensed in the UK subject to and in accordance with the requirements of the NHS Guidance in the form of Schedule 1 of this Order in force at the date of this Order or as revised from time to time."
For reasons that I will explain, counsel for Sandoz accepted during the course of argument that the first variation should be revised so as to read " for use in the treatment of trigeminal neuralgia pain or acute herpetic and postherpetic pain or causalgia pain". Furthermore, Warner-Lambert raised certain issues about the wording of these variations. Regardless of the precise wording, however, the purpose of Sandoz's application is to enable Sandoz to market the Sandoz Full Label Product pending trial (or, more realistically for the reasons explained below, until expiry of the Patent).
The Patent
Claims 1, 2 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.
2. Use according to Claim 1 wherein the pain is inflammatory pain.
3. Use according to Claim 1 wherein the pain is neuropathic pain."
Claims 4–14 are limited to various specific types of pain. Claims 5 ("post-operative pain"), 7 ("burn pain"), 8 ("gout pain") and 9 ("osteoarthritic pain") cover specific types of inflammatory pain. Claims 10 ("trigeminal neuralgia"), 11 ("acute herpetic and postherpectic pain", also known as "PHN pain") and 12 ("causalgia pain") cover specific types of neuropathic pain, and in particular specific types of peripheral neuropathic pain.
The Mylan and Actavis proceedings down to 21 October 2015
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 order to shorten this judgment, I shall assume that the reader is familiar with the history of those proceedings. I shall nevertheless provide a brief summary.
Pfizer markets pregabalin for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder ("GAD") under licence from Warner-Lambert under the trade mark Lyrica. The marketing authorisation is held by Pfizer. Pfizer's data exclusivity in respect of the data used to obtain the marketing authorisation expired on 8 July 2014. Mylan and Actavis launched separate claims challenging the validity of the Patent on 24 June 2014 and 12 September 2014 respectively. Actavis applied for a full label marketing authorisation for pregabalin on 9 July 2014, but subsequently they decided to launch initially under a so-called "skinny label" marketing authorisation (i.e. one which excluded the indications covered by the Patent and only covered epilepsy and GAD). They notified Warner-Lambert of this intention on 30 September 2014. On 8 December 2014 Warner-Lambert commenced quia timet proceedings against Actavis for infringement of claims 1 and 3 of the Patent in respect of Actavis' skinny label pregabalin product. Actavis subsequently counterclaimed in respect of allegedly groundless threats made by Pfizer. On 16 February 2015 Actavis received a skinny label marketing authorisation, and on 17 February 2015 Actavis launched their skinny label pregabalin product.
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 [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 [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 [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 ("the BSA") for transmission to NHS pharmacy contractors for the reasons given in my judgment dated 2 March 2015 [2015] EWHC 485 (Pat), [2015] RPC 24 (" 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 [2015] EWCA Civ 556, [2015] RPC 25 (" 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 [2015] EWHC 2548 (Pat), [2016] RPC 3 (" 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.
So far as the issue of insufficiency was concerned, 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, 11 and 12 were valid because these were specific types of peripheral neuropathic pain.
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) because I was satisfied that those appeals had a real prospect of success.
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