Neurim Pharmaceuticals (1991) Ltd v Generics (UK) Ltd
| Jurisdiction | England & Wales |
| Judge | Lord Justice Arnold,Lord Justice Newey,Lord Justice Birss |
| Judgment Date | 29 March 2022 |
| Neutral Citation | [2022] EWCA Civ 370 |
| Docket Number | Case No: CA-2022-000413 |
| Court | Court of Appeal (Civil Division) |
[2022] EWCA Civ 370
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE, BUSINESS AND PROPERTY
COURTS OF ENGLAND AND WALES, INTELLECTUAL PROPERTY LIST (ChD),
PATENTS COURT
Marcus Smith J
[2022] EWHC 512 (Pat)
Royal Courts of Justice
Strand, London, WC2A 2LL
Lord Justice Newey
Lord Justice Arnold
and
Lord Justice Birss
Case No: CA-2022-000413
Adam Gamsa and Mitchell Beebe (instructed by Taylor Wessing LLP) for the Appellants
Katherine Moggridge (instructed by Gowling WLG (UK) LLP) for the First Respondent and (instructed by Pinsent Masons LLP) for the Second Respondent
Hearing date: 16 March 2022
Approved Judgment
This judgment was handed down remotely at 10.30 on 29 March 2022 by circulation to the parties or their representatives by email and by release to BAILII and the National Archives.
Introduction
On 16 March 2022 this Court (i) granted the Defendants (“Mylan”) permission to appeal against an order made by Marcus Smith J on 7 March 2022, (ii) expedited the hearing of the appeal to be fixed in the weeks commencing 16 or 23 May 2022 and (iii) granted Mylan a stay of the injunction contained in Marcus Smith J's order pending the determination of the appeal, for reasons to be given in writing later. This judgment sets out my reasons for concurring in those orders.
Procedural background
Conceptually this claim is a sequel to a claim (“the First Claim”) by the Claimants against Mylan for alleged infringement of European Patent (UK) No. 1 441 702 (“EP702”), although chronologically the proceedings have overlapped with the First Claim.
The proceedings concerning EP702
EP 702 was a second medical use patent which (as unconditionally proposed to be amended) claimed the use of a prolonged release formulation of melatonin in 2 mg dose form for improving the restorative quality of sleep in a patient aged 55 years or older suffering from primary insomnia characterised by non-restorative sleep. The First Claimant (“Neurim”) was the proprietor of EP702. The Second Claimant (“Flynn”) markets a product falling within the claims of EP702 under the trade mark Circadin in the United Kingdom pursuant to an exclusive licence granted by Neurim. The market for Circadin is worth around £30 million a year.
The history of the First Claim and of parallel proceedings in the European Patent Office concerning EP702 is summarised in my judgment on an appeal in the First Claim heard immediately before the hearing in this claim [2022] EWCA Civ 359 at [30]–[38]. For present purposes the key events are as follows.
EP702 was applied for on 12 August 2002 and granted on 10 May 2017. On 20 November 2019 the Opposition Division of the EPO held that EP702 lacked novelty and therefore revoked it. On 14 January 2020 Neurim filed a notice of appeal. That had the effect of suspending the revocation of EP702.
The First Claim was commenced on 14 February 2020. On 2 March 2020 the Claimants applied for an interim injunction to restrain Mylan from launching a generic version of Circadin. On 3 June 2020 Marcus Smith J refused to grant an interim injunction. The Claimants' appeal against that decision was dismissed by this Court on 24 June 2020 on the ground that the Claimants would be adequately compensated by an award of damages for losses suffered by them as a result of any infringing acts committed during the period prior to judgment following the expedited trial. The Supreme Court refused permission to appeal on 29 June 2020. In late September 2020 Mylan launched a generic version of Circadin in the UK under the name Melatonin Mylan.
The trial was heard by Marcus Smith J from 29 October 2020 to 5 November 2020. By that time Mylan did not dispute that they were infringing EP702 if it was valid, but disputed its validity on a number of grounds. On 4 December 2020 the judge handed down a judgment concluding that (as proposed to be amended) EP702 was valid and had been infringed: [2020] EWHC 3270 (Pat) (“the December Judgment”).
On 17 and 18 December 2020 the Board of Appeal at the EPO heard Neurim's appeal. On 18 December 2020 the Board of Appeal orally announced their opinion that EP702 was invalid for insufficiency. In the light of this decision, Neurim withdrew its appeal and EP702 was revoked.
Mylan's argument that was successful before the Board of Appeal (“the lay-patient argument”) was helpfully summarised by Meade J in a judgment in these proceedings dated 24 January 2022 [2022] EWHC 109 (Pat) at [56] as follows:
“i) Because the invention is a second medical use, the clinical result must be made plausible by the specification.
ii) Since the claims are to specifically addressing non-restorative sleep they must render that plausible, not merely some more general improvement in sleep quality.
iii) There is no objective test or measurement of sleep quality and it is assessed by asking patients about their subjective experience.
iv) The relevant materials in the Patent (Examples 2 and 3) relate to asking patients about their sleep, but there is no description showing that what they were asked was about restorative sleep, or that that is what they reported on. They may just have interpreted the questions as being about improvement in sleep generally and if they reported an improvement it may just have been an improvement in, for example, getting to sleep.”
On 12 March 2021 Marcus Smith J made a final order dismissing the First Claim in the light of the revocation of EP702 and making consequential orders.
These proceedings
In this claim the Claimants allege infringement by Mylan of European Patent (UK) No. 3 103 443 (“EP443”). EP443 is a divisional of EP702, and therefore expires on the same date that EP702 would have expired had it not been revoked, namely 12 August 2022. The procedural history of these proceedings down to mid-December 2021 is recounted in some detail by Meade J in his judgment, but I must also outline what happened after his judgment. The key events in the chronology for present purposes are as follows.
EP443 was granted on 30 June 2021. Mylan filed a notice of opposition in the EPO on the same day. It is inevitable that the opposition proceedings will not be finally determined until after the expiry of EP443.
Also on 30 June 2021 the Claimants commenced these proceedings. On 1 July 2021 Neurim applied unconditionally to amend the claims of EP443 to make them patentably indistinct from the claims of EP702 as proposed to be amended in the First Claim. This course is open to Neurim because the existence of EP443 enables Neurim to have a second attempt to secure patent protection for the claimed invention even though its first attempt came to grief in the Board of Appeal. That is a consequence of the facts that (i) the European Patent Convention places relatively few limits on the ability of applicants to file divisional applications and (ii) the Opposition Division and Board of Appeal hearing the opposition to EP443 will not be bound by the outcome of the opposition to EP702. (Indeed, Meade J found that one of Neurim's reasons for withdrawing its appeal against the revocation of EP702 was in order to avoid the Board of Appeal giving written reasons which might prove an obstacle to this second attempt.)
On 7 July 2021 Mylan applied to stay this claim pending the final determination of the EPO proceedings concerning EP443. On 29 October 2021 Ian Karet sitting as a Deputy High Court Judge dismissed that application.
On 12 August 2021 Mellor J made an order for the trial of preliminary issues arising out of a contention by the Claimants that the December Judgment gave rise to issue estoppels preventing Mylan from challenging the validity of EP443 as proposed to be amended and contentions by Mylan that Neurim's conduct in amending EP443 was an abuse of process and that the Claimants were abusing a dominant position by attempting to prevent Mylan from challenging the validity of EP443.
Those preliminary issues were tried before Meade J on 15–17 December 2021. At the trial the Claimants made it clear that their concern was to prevent Mylan from re-litigating all of the issues decided adversely to Mylan in the December Judgment with the attendant delay that would cause. For their part, Mylan made it clear that they did not want to re-litigate all those issues at first instance. Rather, Mylan were content to confine their challenge to the validity of EP443 in this jurisdiction to plausibility insufficiency, and in particular the lay-patient argument. Moreover, Mylan were also content to rely solely upon the evidence which was before Marcus Smith J at the trial in the First Claim. Mylan's concern was that they should not be prevented from advancing the lay-patient argument on the basis of that evidence, and in particular that they should not be prevented from seeking permission to appeal to this Court on the lay-patient argument by the fact that they were successful in their challenge to the validity of EP702 in the EPO.
In his judgment Meade J held, in summary, that (i) the Claimants' issue estoppel arguments failed, (ii) Mylan's abuse of process argument failed, (iii) it was unnecessary and inappropriate to decide the competition law issues and (iv) the trial of these proceedings should be listed before Marcus Smith J and confined to the evidence which was before him at trial in the First Claim, it being a matter for Marcus Smith J whether to deal with the matter on paper or whether to direct an oral hearing.
In the event Marcus Smith J elected to deal with the matter on paper in the light of written submissions from the parties. On 10 February...
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