Neurim Pharmaceuticals (1991) Ltd v Generics (UK) Ltd T/A Viatris
| Jurisdiction | England & Wales |
| Judge | Mr Justice Meade |
| Judgment Date | 24 January 2022 |
| Neutral Citation | [2022] EWHC 109 (Pat) |
| Docket Number | Case No. HP-2021-000021 |
| Court | Chancery Division (Patents Court) |
[2022] EWHC 109 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Rolls Building
Fetter Lane
London, EC4A 1NL
Mr Justice Meade
Case No. HP-2021-000021
Andrew Waugh QC, David Scannell QC and Katherine Moggridge (instructed by Gowling WLG (UK) LLP and Pinsent Masons LLP) for the Claimants
Piers Acland QC, Adam Gamsa and Daniel Piccinin (instructed by Taylor Wessing LLP) for the Defendants
Hearing dates: 15–17 December 2021, 19 January 2022
I direct that 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 | 3 |
| Conduct of the trial | 5 |
| The Agreed Facts | 5 |
| Teva | 8 |
| Areas of factual dispute/where more detail is necessary | 8 |
| The nature of the Patent and the Divisional | 8 |
| The attacks on the Patent and the Divisional | 9 |
| The lay-patient argument | 9 |
| Was the lay-patient argument run before Marcus Smith J? | 10 |
| Events at the TBA | 10 |
| Events in the proceedings before Marcus Smith J | 14 |
| Practical matters and the real justice of the situation | 16 |
| Issue estoppel | 18 |
| Main legal principles not in dispute | 18 |
| Disputed legal principles – appealability and “winner's appeals” | 19 |
| Lilly v. Genentech | 28 |
| Analysis | 31 |
| Special circumstances | 32 |
| Mylan's abuse argument | 33 |
| The competition issues | 36 |
| The procedural situation that occurred | 39 |
| Case management; submissions after my draft judgment | 40 |
| Conclusions | 42 |
INTRODUCTION
This is my judgment following a three-day trial on (15–17 December 2021) of certain preliminary issues in this patent action. This judgment also addresses a further hearing on 19 January 2022 which took place because Mylan raised an issue on my draft judgment that I thought merited further oral submissions. I deal with that in the last substantive section of this judgment, “Case management”. I have amended and supplemented my original draft judgment (by adding that section and by amending the section “Practical matters and the real justice of the situation”) in the light of that issue, as will appear below.
In the action, the Claimants allege that the Defendants infringe European Patent (UK) 3,103,443. I will refer to this as “ EP443” or (for reasons that appear below) “ the Divisional”. EP443 will expire in August 2022.
I will refer to the Claimants collectively as “ Neurim”, save occasionally where it is necessary to refer to them individually in connection with the status of the Second Claimant as alleged exclusive licensee, the First Claimant being the patentee.
I will refer to the Defendants collectively as “ Mylan” (I will stick to this, although it recently changed its name to “Viatris”).
A detailed account of the context and history appears below. By way of introduction I will outline the main points, so that I can explain what the preliminary issues that I have tried are.
In previous proceedings, started in 2020 (“ the 2020 Action”), Neurim sued Mylan for infringement of European Patent (UK) 1,441,702, the parent patent of the Divisional. I will refer to it as “ EP702” or “ the Patent”. Those proceedings concerned (as does this action) the market for melatonin for use in treating a certain kind of insomnia which I explain in further detail below. Neurim's product is called Circadin and Mylan wishes to sell a generic competitor.
In a detailed judgment in the 2020 Action, handed down on 4 December 2020 (“ the Main Judgment”), Marcus Smith J held that the Patent was valid and infringed, but that the Second Claimant (“ Flynn”) was not an exclusive licensee under the Patent.
On 16 December 2020 Marcus Smith J made various Orders at a hearing. They were not reduced to writing because the parties failed to agree wording. The Orders included an injunction and delivery up, and refusal of permission to appeal for Mylan on validity; the Claimants obtained permission to appeal on the exclusive licence issue.
The trial before Marcus Smith J took place at a time when the Opposition Division (“ OD”) of the European Patent Office (“ EPO”) had revoked the Patent. That revocation was suspended pending appeal by Neurim, but on 18 December 2020 the Technical Board of Appeal (“ TBA”) brought that suspension to an end when Neurim withdrew its appeal on the second day of a two day hearing. So the Patent was revoked ab initio for the UK (and all other designated member states) by operation of the European Patent Convention (“ EPC”), Article 68.
Marcus Smith J then made an Order on 30 December 2020 on the papers, revoking all the material parts of his 16 December 2020 Order (“ the 30 December Order”). The parties returned to Court in February 2021 for a full “consequentials” hearing and Marcus Smith J gave a judgment dated 12 March 2021 (“the Consequentials Judgment”), and made a written Order. Aspects of the Consequentials Judgment are under appeal.
However, Neurim had the Divisional in prosecution, and obtained its grant on 30 June 2021, whereupon it began these proceedings. In these proceedings, Neurim has applied to amend the claims of the Divisional into a form identical for practical purposes to the claims of the Patent as they stood at the time of the trial before Marcus Smith J.
Neurim alleges that issue estoppel arising from the Main Judgment prevents Mylan from challenging the validity of the Divisional in these proceedings. For its part, Mylan says that Neurim's conduct in amending the Divisional is an abuse of process, and it says that Neurim's conduct in seeking to shut out its challenge to the validity of the Divisional is an abuse of a dominant position under s. 18 of the Competition Act 1998.
On Neurim's application, Mellor J made an Order of 12 August 2021 for the expedited trial of certain preliminary issues, including in particular the issue estoppel allegations. At that stage, Mylan had not pleaded its defence. When it had done so, and raised the competition issues, Mellor J made a further Order of 27 August 2021 adding to the preliminary issues whether “in principle”, and on the assumption that Neurim had a dominant position in a relevant market, Neurim's conduct would be an abuse.
The reason for Mellor J considering the application for preliminary issues in the vacation, and for ordering expedition, is Neurim's desire to be able to obtain an injunction on the Divisional before it expires.
In this unusual and fast-moving situation, Mellor J left it to the parties to draw up the detailed list of preliminary issues. The list runs to 14 paragraphs with many sub-paragraphs and it was not much used at the trial before me. It is enough to say for now that the preliminary issues that I have to determine are in substance:
i) Whether Mylan is issue-estopped from challenging the validity of the Divisional in the light of the 2020 action.
ii) Whether Neurim's conduct in amending the Divisional is an abuse.
iii) Whether Neurim's conduct amounts to an abuse of a dominant position (on the assumption of dominance and market definition).
There were to have been preliminary issues about Flynn's status as exclusive licensee, but they were disposed of by agreement and I need say no more about them.
CONDUCT OF THE TRIAL
Initially, the trial was conducted in Court. There was only one witness to give live oral evidence, and that was Mr Inman of Neurim's solicitors. He gave his evidence right at the start of day 1. All the rest of the time was taken up in oral argument.
Unfortunately, one of the parties' solicitors tested positive for COVID overnight between the first and second days, and given the need for the Court to be deep-cleaned and the obvious risk of further spread, the rest of the trial was conducted remotely.
Mr Waugh QC, Mr Scannell QC and Ms Moggridge appeared for Neurim. Mr Scannell addressed me on competition issues with Mr Waugh undertaking the rest of the oral advocacy. Mr Acland QC, Mr Gamsa and Mr Piccinin appeared for Mylan; Mr Acland and Mr Piccinin shared the oral advocacy in a similar way to Neurim, with Mr Piccinin addressing competition law. After the oral hearing of the trial I directed further written submissions on some discrete points.
THE AGREED FACTS
As one would hope for a trial of preliminary issues, many facts were agreed. At the PTR I directed the preparation of an Agreed Statement of Facts, which, with only slight amendments, forms the basis of this section of my judgment. I then return to some aspects of the history where more detail is required and/or resolution of factual issues is necessary.
EP443, the Divisional, was granted on 30 June 2021. It will expire on 12 August 2022. The Application for EP443 was published on 14 December 2016.
The Patent, EP702, was granted on 10 May 2017. It was opposed at the EPO by, amongst others, the First Defendant.
EP443 and EP702 relate to the First Claimant's commercial product, Circadin, which is a 2mg prolonged release melatonin product indicated for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. Circadin is commercialised in the UK by the Second Claimant.
On 20 November 2019 the OD found EP702 lacked novelty over a piece of prior art referred to in this action and the action concerning EP702 as “Haimov”.
In early 2020, the Claimants...
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Neurim Pharmaceuticals (1991) Ltd v Generics (UK) Ltd
...(“the March Judgment”) and in even greater detail by Meade J in a judgment in the proceedings concerning EP443 dated 24 January 2022 [2022] EWHC 109 (Pat). The key events in the chronology for present purposes are as 31 EP702 was applied for on 12 August 2002 and granted on 10 May 2017. My......
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