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

JurisdictionEngland & Wales
JudgeMr Justice Marcus Smith
Judgment Date04 December 2020
Neutral Citation[2020] EWHC 3270 (Pat)
CourtChancery Division (Patents Court)
Docket NumberClaim No: HP-2020-000005
Date04 December 2020

[2020] EWHC 3270 (Pat)

IN THE HIGH COURT OF JUSTICE

BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES

INTELLECTUAL PROPERTY LIST (Chd)

PATENTS COURT

Royal Courts of Justice

Rolls Building

7 Rolls Buildings

Fetter Lane

London EC4A 1NL

Before:

The Honourable Mr Justice Marcus Smith

Claim No: HP-2020-000005

Between:
(1) Neurim Pharmaceuticals (1991) Limited (a company incorporated under the laws of Israel)
(2) Flynn Pharma Limited (a company incorporated under the laws of the Republic of Ireland)
Claimants
and
(1) Generics UK Limited (trading as Mylan)
(2) Mylan UK Healthcare Limited
Defendants

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, Mr Adam Gamsa and Mr Mitchell Beebe (instructed by Taylor Wessing LLP) for the Defendants

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.

CONTENTS

A.

INTRODUCTION

§1

(1)

Background

§1

(2)

Issues arising

§7

(3)

Structure of the judgment

§10

B.

THE HEARING

§12

(1)

The evidence

§13

(2)

The form of the hearing

§14

C.

SKILLED PERSON AND COMMON GENERAL KNOWLEDGE

§19

(1)

Summary of the law

§19

(a)

The “person skilled in the art”

§19

(b)

Common general knowledge

§22

(c)

Territoriality and its significance

§23

(d)

Knowledge of the law

§27

(2)

Approach

§30

(3)

The present case

§32

(a)

Indications from the Patent

§32

(b)

The Skilled Person

§45

(c)

Common general knowledge

§50

(i)

Introduction

§50

(ii)

The nature of Primary Insomnia and the position of non-restorative sleep within Primary Insomnia

§52

(iii)

The co-existence (or otherwise) of non-restorative sleep with other indications

§54

(iv)

Primary Insomnia and Circadian Rhythm Sleep Disorder

§56

(v)

Diagnosing non-restorative sleep

§60

(vi)

Methods of treatment for Primary insomnia in general and non-restorative sleep in particular

§65

D.

THE TRUE CONSTRUCTION OF THE PATENT

§68

E.

LACK OF NOVELTY OR ANTICIPATION

§73

(1)

Introduction

§73

(2)

The law

§74

(3)

Haimov 1995

§77

(4)

Conclusion on novelty

§81

F.

LACK OF INVENTIVE STEP OR OBVIOUSNESS

§82

(1)

Introduction

§82

(2)

Haimov 1995

§86

(3)

Melatonex and the Melatonex Webpage

§89

(4)

Zisapel 1999

§94

G.

INSUFFICIENCY

§100

(1)

Introduction

§100

(2)

Insufficiency on a stand-alone basis

§101

(a)

Type of insufficiency alleged

§101

(b)

Uncertainty insufficiency

§102

(c)

Lack of plausibility insufficiency

§104

(i)

Approach

§104

(ii)

Example 2

§110

(iii)

Example 3

§114

(d)

Conclusion

§117

(3)

The “squeeze”

§118

H.

EXCLUSIVE LICENCE

§120

(1)

Introduction

§120

(2)

The contractual provisions

§126

(3)

Exclusivity

§137

(a)

Points taken by Mylan

§137

(b)

“Salami slicing”

§139

(c)

An inability in Flynn to vindicate its own rights

§142

I.

CONCLUSIONS AND DISPOSITION

§148

Mr Justice Marcus Smith

A. INTRODUCTION

(1) Background

1

. 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 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.

2

. 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.

3

. 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).

4

. 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.

5

. 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.

6

. 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

7

. 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

8

. 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”. 6 Section 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”. 8 Section 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...

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6 cases
  • Neurim Pharmaceuticals (1991) Ltd (a company incorporated under the laws of Israel) v Generics UK Ltd (trading as Mylan)
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    • Court of Appeal (Civil Division)
    • 29 March 2022
    ...COURT OF JUSTICE, BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES, INTELLECTUAL PROPERTY LIST (ChD), PATENTS COURT Marcus Smith J [2020] EWHC 3270 (Pat), [2021] EWHC 530 (Pat) Royal Courts of Justice Strand, London, WC2A 2LL Lord Justice Newey Lord Justice Arnold and Lord Justice Birss Ca......
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    • Chancery Division (Patents Court)
    • 2 August 2021
    ...– 5 November 2020: the EP702 trial was heard by Marcus Smith J, who in a judgment of 4 December 2020 found EP702 valid and infringed [2020] EWHC 3270 (Pat). Mylan admitted infringement if EP702 was valid. 16 December 2020: form of order hearing where Marcus Smith J made a number of oral or......
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    • 29 March 2022
    ...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 8 On 17 and 18 December 2020 the Board of Appeal at the EPO heard Neurim's appeal. On 18 December 2020 the Board of App......
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4 firm's commentaries
  • Expert Evidence in patent cases: recent guidance from the Bench
    • United Kingdom
    • JD Supra United Kingdom
    • 20 May 2021
    ...and Mr Justice Marcus Smith in Neurim v Mylan4.01_[2020] EWHC 866 (Pat)02_[2020] EWHC 2636 (Pat)03_[2020] EWHC 3282 (Pat)04_[2020] EWHC 3270 (Pat)allenovery.comA common theme expressed throughout these judgments is the level of care required in preparing expert evidence. The task of prepari......
  • Neurim v Mylan: Take Two
    • United Kingdom
    • Mondaq UK
    • 20 August 2021
    ...a difference 2 days makes") it was Mylan with the upper hand ([2021] EWHC 530 (Pat)). Neurim had been successful in the UK trial ([2020] EWHC 3270 (Pat)) but then lost that patent at the EPO by withdrawing their appeal (following negative indications at the oral proceedings). Fast-forward t......
  • Neurim v Mylan: Take Two
    • United Kingdom
    • Mondaq UK
    • 20 August 2021
    ...a difference 2 days makes") it was Mylan with the upper hand ([2021] EWHC 530 (Pat)). Neurim had been successful in the UK trial ([2020] EWHC 3270 (Pat)) but then lost that patent at the EPO by withdrawing their appeal (following negative indications at the oral proceedings). Fast-forward t......
  • Court Of Appeal Dismisses 'Lay Patient' Argument Agreeing Divisional Valid (Neurim v Mylan)
    • United Kingdom
    • Mondaq UK
    • 5 July 2022
    ...J decided that patent EP (UK) 1 441 702 was valid and infringed by Mylan's launch of a generic melatonin product (Neurim v Mylan [2020] EWHC 3270 (Pat)). However, shortly thereafter the EPO decided the same patent was invalid on the basis of the 'Lay Patient' argument and the patent was rev......

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