Warner-lambert Company Llc v Sandoz Gmbh and Others
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 04 November 2015 |
| Neutral Citation | [2015] EWHC 3153 (Pat) |
| Docket Number | Case No: HP-2015-00049 |
| Court | Chancery Division (Patents Court) |
| Date | 04 November 2015 |
[2015] EWHC 3153 (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: HP-2015-00049
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
Contents
Topic Paragraphs
| Introduction | 1 |
| 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 |
| Trial date | 79–80 |
| 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 |
| Conclusion | 119 |
Introduction
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 [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 ("BSA") for transmission to NHS pharmacy contractors for the reasons given in my judgment dated 2 March 2015 [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 [2015] 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 [2015] 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 [0006] 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 [2005] EWCA Civ 906, [2006] FSR 4 and Nokia GmbH v IPCom GmbH [2011] EWCA Civ 6, [2011] 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...
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