Neurim Pharmaceuticals (1991) Ltd (a company incorporated under the laws of Israel) v Generics UK Ltd (trading as Mylan)
| Jurisdiction | England & Wales |
| Judge | Mr Justice Marcus Smith |
| Judgment Date | 12 March 2021 |
| Neutral Citation | [2021] EWHC 530 (Pat) |
| Date | 12 March 2021 |
| Docket Number | Claim No: HP-2020-000005 |
| Court | Chancery Division (Patents Court) |
[2021] EWHC 530 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (Pat)
PATENTS COURT
Royal Courts of Justice
Rolls Building
7 Rolls Buildings
Fetter Lane
London EC4A 1NL
THE HONOURABLE Mr Justice Marcus Smith
Claim No: HP-2020-000005
Mr Andrew Waugh, QC and Ms Katherine Moggridge (instructed by Gowling WLG (UK) LLP) for the First Claimant
Mr Andrew Waugh, QC and Ms Katherine Moggridge (instructed by Pinsent Masons LLP) for the Second Claimant
Mr Mark Vanhegan, QC and Mr Mitchell Beebe (instructed by Taylor Wessing LLP) for the Defendants
Hearing date: 22 February 2021
Judgment on Consequential Matters
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.
A. INTRODUCTION
. Over the course of four days in October and November 2020, I heard the trial of a patent claim brought by Neurim Pharmaceuticals (1991) Limited ( Neurim) and Flynn Pharma Limited ( Flynn) against Generics UK Limited and Mylan UK Healthcare Limited (collectively, unless the context otherwise requires, Mylan). The issues before me concerned the validity of a patent, EP (UK) 1,441,702 B1 (the Patent). Infringement was not a separate issue before me: Mylan accepted and admitted infringement if the Patent was valid.
. For the reasons given in my judgment (the Judgment), handed down on 4 December 2020 under Neutral Citation Number [2020] EWHC 3270 (Pat), I concluded that the Patent was valid, and so infringed by Mylan. I do not propose, in this Consequentials Judgment, to repeat the Judgment, which I take as read for the purposes of this Consequentials Judgment. I also propose to adopt the terms and abbreviations used in the Judgment, as set out in Annex 1 to the Judgment.
. For reasons that it will be necessary to explore in this Consequentials Judgment, the orders consequential on my Judgment are by no means straightforward and I have heard detailed submissions from both the Claimants and Mylan as to the orders I should make. At first sight, to a reader of the Judgment only, that might seem surprising. Apart from one point – the question whether Flynn was an exclusive licensee within the meaning of sections 67 and 130 of the Patents Act 1977, which I shall term the Exclusive Licence Point – I found in favour of the Claimants and concluded that Mylan's challenges to the validity of the Patent all failed, and that Mylan was either threatening to, or was, infringing the Patent. 1 On the face of the Judgment, therefore, one might expect an injunction enjoining Mylan from infringing the Patent to follow; and for the Claimants to obtain an order for all – or substantially all – their costs.
. No order in these terms presently exists, although orders along these lines were made in the immediate aftermath of the Judgment on 16 December 2020 (the 16 December 2020 Orders).
. It is necessary, before describing the matters at issue before me, to set out the facts in some detail. I do so in the next section, Section B.
B. THE FACTS
(1) The history of these proceedings
. The claim was commenced by the Claimants under a Part 7 Claim Form on 14 February 2020. Pleadings and amendments to pleadings followed, in the usual course, and it is unnecessary to consider these in any great detail. Paragraph 1 of the Amended Particulars of Infringement provided that:
“The Defendants [i.e., Mylan] threaten and intend to infringe the Patent by threatening and intending to do the following acts in the United Kingdom without the consent of the Claimants, namely: keep, use, dispose of and/or offer to dispose of a prolonged release melatonin product obtained directly by means of a process as claimed in at least claim 1 and being a product within the scope of claim 4 of the Patent.”
. There was, from the Claimants' perspective, considerable urgency in ensuring that Mylan did not infringe the Patent. The threat to the Claimants' United Kingdom monopoly, arising out of the Patent, and the threat to the market that the Claimants' had established in reliance upon the Patent, were – to the Claimants – both obvious and urgent. The urgency was exacerbated, in the Claimants' eyes, by two factors:
(1) First, a failure, on the part of Mylan, to offer any unequivocal undertaking not to infringe the Patent whilst these proceedings were on-going.
(2) Second, and relatedly, a failure on the part of Mylan to “clear the way” to bringing its (allegedly infringing) product to market by commencing revocation proceedings in these courts well before Mylan was at the stage of actually threatening to infringe. In short, as part of its preparations to bring a rival product to market, Mylan should – according to the Claimants – have “cleared the way” by having the issue of the Patent's validity and any separate questions of infringement resolved well-before there could be any question of actual or imminently threatened infringement.
. As I have noted, the Claim Form was issued on 14 February 2020. It was served on Generics UK Limited (as the sole defendant, and now the First Defendant) on 17 February 2020. Thereafter:
(1) On 2 March 2020, the Claimants issued an application for an interim injunction against Generics UK Limited, which was fixed on 9 March 2020 to be heard between 18 and 20 May 2020 (the Interim Relief Application).
(2) On 13 March 2020 the Claimants issued an application for “interim interim” relief, seeking interim relief pending the hearing of the Interim Relief Application (the Holding Application).
(3) On 16 March 2020, the Claimants were informed that Mylan Healthcare UK Limited was performing the relevant acts about which complaint was made in the UK and thus should be a defendant to the proceedings.
. The matter came before Nugee J on 19 March 2020. At this hearing:
(1) The Claimants sought permission to add Mylan Healthcare UK Limited as the Second Defendant. Mylan Healthcare UK Limited formally consented to be added as the Second Defendant and Nugee J gave permission to the Claimants to amend the Claim Form to add Mylan Healthcare UK Limited to the proceedings. The Claimants' Amended Claim Form, adding the Second Defendant, was sealed on 30 March 2020.
(2) Mylan (as I can now safely refer to both Defendants) gave undertakings not to launch or deal in Mylan Melatonin product, the (allegedly) Infringing Products, 2 until 18 May 2020, thereby addressing the Holding Application. Nugee J accepted these undertakings.
(3) At the same hearing, Mylan (with the consent and agreement of the Claimants) formally sought expedition of the UK trial. Nugee J directed that the trial be expedited for hearing on the first available date after 21 October 2020. 3 As I have described, the trial was heard, as envisaged by Nugee J, in late October/early November 2020, and the Judgment was handed down – after having been circulated in draft – on 4 December 2020.
. The Interim Relief Application came before me on 20 May 2020. The application was refused for the reasons given in my judgment of 3 June 2020 ( [2020] EWHC 1362 (Pat)). Mylan continued to give the undertakings it had given to Nugee J so as to enable the Claimants to appeal my decision to the Court of Appeal. The appeal was heard by the Court of Appeal (Floyd, Males and Arnold LJJ) on 18 June 2020, and the outcome, affirming my order, was notified to the parties on 19 June 2020. The judgment of the Court of Appeal, explaining its decision, was handed down on 24 June 2020 ( [2020] EWCA Civ 793). Permission to appeal to the Supreme Court was not given, although it was sought by the Claimants.
. The consequence is that Mylan was not enjoined from (allegedly) infringing the Patent and was free to import into the United Kingdom, and sell, Infringing Products. In fact, although there was a clear suggestion by Mylan that the sale of Infringing Products was imminent – and certainly that was the Claimants' concern and understanding – the importation and/or sale of Infringing Products did not occur until rather later in the year, towards the end of 2020, in about September. 4 Thus, importation and/or sale of Infringing Products had only just begun and/or was truly imminent at about the time I handed down the Judgment.
(2) Proceedings in the European Patent Office
. The Patent was granted to Neurim on 10 May 2017. Mylan filed a notice of opposition to the Patent on 9 February 2018. This procedure – which operates post-grant – enables any third party to challenge the validity of a patent at the European Patent Office (the EPO). Mylan was not the only opponent of the Patent: notices of opposition were also filed by Aspire Pharma Limited and Teva Pharmaceutical Industries Limited.
. The Opposition Division of the EPO published a preliminary opinion on the Patent on 8 March 2019, expressing the view that the Patent was invalid for lack of novelty. The precise reasons for this preliminary opinion do not matter.
. There was an oral hearing before the Opposition Division on 20 November 2019. Mylan (as well as Neurim) attended: the other opponents did not. The Opposition Division confirmed the preliminary opinion that it had expressed, giving that decision orally at the conclusion of the hearing on 20 November 2019. In his evidence before me, Dr Royle (a partner at Taylor Wessing LLP, solicitors for Mylan) described the position as at 20 November 2019 as follows: 5
“…The [Opposition Division] found that the Patent was invalid for lack of...
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