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

Hearing dates: 29 and 30 October, 2 and 5 November 2020

I direct that no official note or transcription shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

A. INTRODUCTION

(1) Background

. The First Claimant – Neurim Pharmaceuticals (1991) Limited ( Neurim1) – 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 United Kingdom. Although it will be necessary, from time-to-time, to differentiate between Neurim and Flynn, where such differentiation is unnecessary, I shall refer to Neurim and Flynn collectively as the Claimants.

. The Patent 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 Claimants have applied to amend the Patent unconditionally, which is not opposed by the Defendants and to which no other objection has been made.2 Where appropriate, I shall identify the amendments proposed to the Patent.

. The pharmaceutical formulation claimed by the Patent is sold under the brand name Circadin. Circadin is a medicine authorised for use in the European Union, including (for present purposes) the United Kingdom. A company within the Neurim group holds a marketing-authorisation for melatonin 2mg prolonged release tablets (the description of Circadin). That company is RAD Neurim Pharmaceuticals EEC SARL ( RAD Neurim).

. The Patent was filed on 12 August 2002 and claims priority from 14 August 2001 (the Priority Date). The Patent is a “second medical use” patent. If not revoked sooner, the Patent will expire on 12 August 2022, i.e. in abot a year and eight months' time.

. Assuming the Patent to be valid, the Defendants – Generics UK Limited and Mylan UK Healthcare Limited (collectively, Mylan) – threaten to infringe the Patent in the following way: 3

“The Defendants threaten and intend to infringe the Patent by threatening and intending to do the following act 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.”

In fact, it may well be the case that Mylan has gone beyond threatening to infringe the Patent and has, by now, actually infringed. Neurim sought, but failed to obtain, an interim injunction restraining Mylan from infringing the Patent.4 For the purposes of this judgment, nothing turns on this question.

. The First Defendant is, itself, the holder of a marketing authorisation in the United Kingdom (as well as the European Union) for melatonin 2mg prolonged release products. Those products will be, or are already, commercialised in the United Kingdom by the Second Defendant.

(2) Issues arising

. This dispute came on for trial in late October / early November 2020. The issues before me all concerned the validity of the Patent. Infringement was not a separate issue before me: in other words, if the Patent is valid, Mylan accepts and admits infringement.5

. Mylan contends that the Patent is invalid on the following grounds:

(1) First, because the Patent lacks novelty. In order to be patentable, an invention must (amongst other things) be “new”.6Section 2(1) of the Patents Act 1977 provides that “[a]n invention shall be taken to be new if it does not form part of the state of the art”. Section 2(2) of the Act then provides:

“The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way.”

Mylan contends that the Patent lacks novelty in reliance upon an article published in (1995) 18(7) Sleep 598–603 by Haimov et al entitled Melatonin Replacement Therapy of Elderly Insomniacs ( Haimov 1995).7

(2) Secondly, because the Patent is obvious. In order to be patentable, an invention must (amongst other things) involve an “inventive step”.8Section 3 of the Patents Act 1977 provides:

“An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above…”

Mylan contends that the subject matter of the Patent is obvious and did not involve an inventive step by reason of the following prior art: 9

(a) Haimov 1995.

(b) The product Melatonex, which was available as a supplement in the United States of America before the Priority Date of the Patent. Melatonex is a formulation of melatonin that contains 3mg of melatonin in a prolonged release tablet. Details of Melatonex were contained in a webpage dated 1 August 2001 (i.e., before the Patent's priority date) (the Melatonex Webpage).10

(c) An article published in Biological Signals & Receptors 1999 (8:84–89) by Zisapel entitled The Use of Melatonin for the Treatment of Insomnia ( Zisapel 1999).

(3) Thirdly, because the Patent is insufficient. A patent may be revoked on the ground that “the specification of the patent does not disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art”.11 Insufficiency is something of a broad church. A Patent may be insufficient because:

(a) The skilled person is unable to carry out the claimed invention given the description of it in the specification and the skilled person's common general knowledge. This form of insufficiency is often referred to as classical insufficiency, a term that I will adopt. In Zipher Ltd v. Markem Systems Ltd, Floyd J described classical insufficiency in the following terms: 12

“The first, or so-called classical insufficiency, is where following the express teaching of the patent does not enable the skilled addressee to perform the invention. This type of insufficiency requires an assessment by the court of the steps which it would be necessary for the skilled reader or team to take...