Generics (UK) Ltd Trading as Mylan v Warner-Lambert Company LLC
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 25 November 2015 |
| Neutral Citation | [2015] EWHC 3370 (Pat) |
| Docket Number | Case Nos: HP-2014-000035, HP-2014-000021, HC-2014-001795 |
| Court | Chancery Division (Patents Court) |
| Date | 25 November 2015 |
and
[2015] EWHC 3370 (Pat)
The Hon Mr Justice Arnold
Case Nos: HP-2014-000035, HP-2014-000021, HC-2014-001795
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NLL
Michael Bloch QC and Kathryn Pickard (instructed by Taylor Wessing LLP) for Mylan
Adrian Speck QC and Isabel Jamal (instructed by Powell Gilbert LLP) for Actavis
Richard Miller QC, Tom MitchesonQC and Miles Copeland (instructed by Allen & Overy LLP) for Warner-Lambert
Hearing date: 11 November 2015
Contents
| Topic | Paragraphs |
| Introduction | 1–6 |
| The law | 7–25 |
| General principles as to abusive re-litigation | 7–8 |
| Application to patent court | 9–14 |
| Article 138(3) EPC 2000 | 15–16 |
| Central limitation | 17–21 |
| Foreign cases | 22–25 |
| Procedural history | 26–108 |
| The IASP definition of neuropathic pain | 27–30 |
| The Patent | 31–32 |
| The Lyrica marketing authorisation | 33 |
| Mylan and Actavis' claims for revocation | 34–35 |
| Warner-Lambert's application for central limitation | 36–37 |
| Warner-Lambert's infringement claim | 38–39 |
| The pleas of insufficiency | 40–41 |
| The pleas of independent validity | 42 |
| Pleas as to common general knowledge | 43–48 |
| Evidence in chief | 49–56 |
| Evidence in reply | 57–64 |
| Further evidence | 65 |
| Skeleton arguments | 66–74 |
| Opening speech | 75–81 |
| Cross-examination | 82–92 |
| Written closing submissions | 93–99 |
| Oral closing submissions | 100–111 |
| Assessment | 112–148 |
| Would a second trial be required? | 114 |
| Validity | 115–133 |
| Infringement | 134–136 |
| Is Warner-Lambert the victim of procedural unfairness on the part of Mylan and Actavis? | 137–143 |
| Would the amendment application delay the overall resolution of the dispute? | 144–145 |
| The wider public interest | 146–147 |
| Conclusion | 148 |
| Result | 146 |
Introduction
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) of the Patents Act 1977; and
iv) Pfizer was liable for making groundless threats of patent infringement proceedings, albeit not in all the cases alleged by Actavis.
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. In view of certain submissions by counsel for Warner-Lambert during the hearing on 11 November 2015, I should make it clear that the permission to appeal which I granted to Warner-Lambert with respect to infringement was limited to claims 1 and 3 of the Patent, those being the only claims which were relied upon by Warner-Lambert at trial.
In the meantime, in case both appeals on validity are unsuccessful, on 1 October 2015 Warner-Lambert had made 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. For convenience I will continue to refer to it as claim 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. It is Mylan and Actavis' contention that the application to make that amendment amounts to an abuse of the process of the court. 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 lacks clarity, adds subject matter and does not cure the invalidity of claim 3 (using the old numbering).
It is worth noting that Warner-Lambert evidently anticipated this objection, because the application was supported by a witness statement of Nicola Dagg of Warner-Lambert's solicitors running to 40 paragraphs which canvassed the procedural history of the proceedings at some length and concluded with the assertion that "there can be no prejudice to the Claimants by the making of the application at this stage".
On 16 October 2015 I directed a preliminary hearing of the issue as to whether the application amounts to an abuse of process.
The law
General principles as to abusive re-litigation
Abuse of the process of the court can take a number of forms. The form of abuse of process which is relevant here is that associated with the case of Henderson v Henderson (1843) 3 Hare 100. Although Henderson v Henderson itself was a case of cause of action estoppel, Sir James Wigram V-C's dicta in that case subsequently gave rise to a wider rule preventing re-litigation in circumstances not amounting to strict res judicata. This wider rule has come to be regarded as a manifestation of the court's power to prevent an abuse of its own process. The authorities on this wider rule were reviewed by Lord Bingham of Cornhill in Johnson v Gore Wood & Co [2002] 2 AC 1. Lord Bingham concluded in a frequently cited passage at 3l:
"But Henderson v Henderson abuse of process, as now understood, although separate and distinct from cause of action estoppel and issue estoppel, has much in common with them. The underlying public interest is the same: that there should be finality in litigation and that a party should not be twice vexed in the same matter. This public interest is reinforced by the current emphasis on efficiency and economy in the conduct of litigation, in the interests of the parties and the public as a whole. The bringing of a claim or the raising of a defence in later proceedings may, without more, amount to abuse if the court is satisfied (the onus being on the party alleging abuse) that the claim or defence should have been raised in the earlier proceedings if it was to be raised at all. I would not accept that it is necessary, before abuse may be found, to identify any additional element such as a collateral attack on a previous decision or some dishonesty, but where those elements are present the later proceedings will be much more obviously abusive, and there will rarely be a finding of abuse unless the later proceeding involves what the court regards as unjust harassment of a party. It is, however, wrong to hold that because a matter could have been raised in earlier proceedings it should have been, so as to render the raising of it in later proceedings necessarily abusive. That is to adopt too dogmatic an approach to what should in my opinion be a broad, merits-based judgment which takes account of the public and private interests involved and also takes account of all the facts of the case, focusing attention on the crucial question whether, in all the circumstances, a party is misusing or abusing the process of the court by seeking to raise before it the issue which could have been raised before. As one cannot comprehensively list all possible forms of abuse, so one cannot formulate any hard and fast rule to determine whether, on given facts, abuse is to be found or not. Thus while I would accept that lack of funds would not ordinarily excuse a failure to raise in earlier proceedings an issue which could and should have been raised then, I would not regard it as necessarily irrelevant, particularly if it appears that the lack of funds has been caused by the party against whom it is sought to claim. While the result may often be the same, it is in my view preferable to ask whether in all the circumstances a party's conduct is an abuse than to ask whether the conduct is an abuse and then, if it is, to ask whether the abuse is excused or justified by special circumstances. Properly applied, and whatever the legitimacy of its descent, the rule has in my view a valuable part to play in protecting the interests of justice."
Lord Millett added at 59–60:
"It is one thing to refuse to allow a party to relitigate a question which has already been decided; it is quite another to deny him the opportunity of litigating for the...
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