Neurim Pharmaceuticals (1991) Ltd (a company incorporated under the laws of Israel) v Generics UK Ltd (trading as Mylan)

Hearing dates: 20 May and 3 June 2020

Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 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. THE CLAIMANTS AND THE PATENT

. The First Claimant – Neurim Pharmaceuticals (1991) Limited ( Neurim 1) – is the registered proprietor of a patent, EP(UK) 1,441,702 B1 (the Patent). The Second Claimant – Flynn Pharma Limited ( Flynn) – is the registered exclusive licensee under the Patent in the UK.

. The Patent 2 claims prolonged release pharmaceutical formulations concerning the active ingredient melatonin to improve the restorative quality of sleep in a patient suffering from primary insomnia characterised by non-restorative sleep.

. The pharmaceutical formulation claimed by the Patent is sold under the brand name Circadin. More recently, Neurim has developed a paediatric version of prolonged release melatonin, Slenyto.

. The Patent was filed on 12 August 2002 and claims priority from 14 August 2001. The Patent is a “second medical use” patent. If not revoked sooner, the Patent will expire on 12 August 2022, i.e. in some two years and three months' time.

. Pharmaceuticals like Circadin receive protection from competition in the shape of a monopoly derived from the patent under which they are produced. This serves as a form of negative protection against competitors. However, in order actually to sell such a pharmaceutical (at least in the UK), regulatory approval is also required. In very general terms:

(1) Regulatory approval to sell a pharmaceutical will typically require considerable (and expensive) testing in order to be assured that the pharmaceutical provides clinical benefits with an acceptable level of side effects.

(2) If approval is granted, the pharmaceutical's label will indicate its intended use. Normally, this use is closely tied to the claims in the patent. However, at least in this jurisdiction, it is possible for there to be an off-label use for which the pharmaceutical may be sold and used. As the term implies, off-label refers to a use that is not described in the label.

. There are often, therefore, two markets for pharmaceuticals: the on-label market, which is generally closely tied to the claims in the patent (if there is a patent in relation to the pharmaceutical); and an off-label market, which involves prescribing or selling for uses that are not specified in the label. It will be necessary to consider the on-label and off-label uses of Circadin in the course of this judgment. For the present, it is simply worth noting that Circadin's label indicates a use for the short-term treatment of primary insomnia in patients aged 55 or over, which is a narrower use than the claims in the Patent (which have no age limitations as to use). There is, therefore, unsurprisingly an off-label

. Slenyto received regulatory approval in October 2018. Slenyto is for insomnia in children. There is obviously going to be competition between Circadin and Slenyto, with the latter taking sales away from the former, as well as bringing in new sales in those cases where Circadin would not previously have been prescribed.

. The Patent was granted by the European Patent Office (the EPO) on 10 May 2017. It was subject to opposition by – amongst others – the First Defendant, Generics UK Limited. I shall refer to the First Defendant and to the Second Defendant, Mylan UK Healthcare Limited, collectively as Mylan. At an oral hearing on 20 November 2019, the Patent was revoked by the EPO Opposition Division. It was held to be invalid as having been anticipated by certain prior art that I need not describe. The EPO Opposition Division published its written decision on 2 January 2020. That decision has been appealed, but it is unlikely that a final decision on the appeal will be made before 2022 at the earliest. It is perfectly possible that there will be no decision until the Patent has expired which, as I have said, will be on 12 August 2022.

B. MYLAN

. Mylan propose to release a “generic” rival to Circadin. Mylan's precise launch plans are confidential, and I am going to proceed on the basis that that launch is “fairly imminent”, without being any more specific than that. I have confidential evidence before me providing some greater specificity on this point: but I do not consider this to be material to this judgment. I shall refer to this rival pharmaceutical as the Generic Product.

. Mylan obtained a marketing authorisation for their Generic Product in about December 2019. This marketing authorisation “piggy backs” on Neurim's own marketing authorisation for Circadin. Unless restrained by this court, Mylan proposes to sell the Generic Product in the UK as soon as it can.

C. THESE PROCEEDINGS

. In these proceedings – commenced by Neurim and Flynn – Neurim and Flynn contend that Mylan intends to infringe the Patent. They seek a declaration of infringement and injunctive and other relief. Mylan counterclaims for revocation of the Patent on grounds of anticipation, obviousness and insufficiency.

. “Interim” interim protection has been obtained by Neurim and Flynn in the form of an undertaking from Mylan that “holds the ring” until 20 May 2020, the date of the hearing before me. This was the date of Neurim and Flynn's application for an interim injunction until trial. Because the hearing before me overran, and argument continued until the early evening, 3 that undertaking was, helpfully, extended by Mylan to 3 June 2020, when this judgment is formally to be handed down.

. For the purpose of this judgment, the question before me is, therefore, whether interim injunctive relief should be provided until after final judgment in these proceedings or further order.

. An expedited trial had been ordered, which is due to take place in a 5-day window floating from 26 October 2020.

D. THE LAW AS STATED IN AMERICAN CYANAMID

. The relevant law – or at least the starting point for considering the relevant law – remains the speech of Lord Diplock in American Cyanamid Co v. Ethicon Ltd. 4 Given the arguments that were put before me, it is appropriate – despite the well-known nature of the test propounded by Lord Diplock – to set out the reasoning in some detail.

. In general terms, the object of interlocutory relief is as follows: 5

“The object of the interlocutory injunction is to protect the plaintiff against injury by violation of his right for which he could not be adequately compensated in damages recoverable in the action if the uncertainty were resolved in his favour at the trial; but the plaintiff's need for protection must be weighed against the corresponding need of the defendant to be protected against injury resulting from his having been prevented from exercising his own legal rights for which he could not be adequately compensated under the plaintiff's undertaking in damages if the uncertainty were resolved in the defendant's favour at the trial. The court must weigh one need against another and determine where “the balance of convenience” lies.”

. Ascertaining the balance of convenience involves a number of steps:

(1) Stage 1: A serious issue to be tried? The applicant for interim relief, the claimant, must show that there is a “serious issue to be tried”: 6

“The court no doubt must be satisfied that the claim is not frivolous or vexatious; in other words, that there is a serious issue to be tried…So unless the material available to the court at the hearing of the application for an interlocutory injunction fails to disclose that the plaintiff has any real prospect of succeeding in his claim for a permanent injunction at the trial, the court should go on to consider whether the balance of convenience lies in favour of granting or refusing the interlocutory relief that is sought…”.

The whole point of this test is to avoid conducting a “trial within a trial”. If it were possible to correctly anticipate the outcome of a trial at an interlocutory stage, trials would become redundant and matters would be resolved finally (subject to any appeal) at what would no doubt no longer be known as an “interlocutory” hearing. Lord Diplock's point – which has as much force today as it had in 1975 – was that trials served an essential purpose, and that because there was inevitably a time-lag between the joining of issue on a legal dispute and the resolution of that issue at trial, interim protection between joinder of issue and trial needed to be based on criteria very different to those operating at the trial itself: 7

“It is no part of the court's function at this stage of the litigation to try to resolve conflicts of evidence on affidavit as to facts on which the claims of either party may ultimately depend nor to decide...