Actavis UK Ltd and Others v Eli Lilly & Company

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeThe Hon Mr Justice Arnold,Mr Justice Arnold
Judgment Date15 May 2014
Neutral Citation[2014] EWHC 1511 (Pat)
Docket NumberCase Nos: HC12E02962, HP13A01487, HP13B04212, HP13E04604, HP13B05505, HP14D00753, HP14A01611, HP14F01792

[2014] EWHC 1511 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Rolls Building

Fetter Lane, London, EC4A 1NL

Before:

The Hon Mr Justice Arnold

Case Nos: HC12E02962, HP13A01487, HP13B04212, HP13E04604, HP13B05505, HP14D00753, HP14A01611, HP14F01792

Between:
(1) Actavis UK Limited
(2) Actavis Group EHF (Formerly Actavis Group HF)
(3) Actavis Group PTC EHF
(4) Medis EHF
(5) Actavis Deutschland GmbH & Co. KG
(6) Medis Pharma GmbH
(7) Medis Pharma France SAS
(8) Actavis France SAS
(9) Actavis Spain S.A.
(10) Actavis Italy SPA A Socio Unico
Claimants
and
Eli Lilly & Company
Defendant

Richard Meade QC, Thomas Raphael and Isabel Jamal (instructed by Bird & Bird LLP) for the Claimants

Simon Thorley QC, Thomas Mitcheson QC and Stuart Baran (instructed by Hogan Lovells International LLP) for the Defendant

Hearing dates: 9–10, 15–16 April 2014

Approved Redacted 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.

The Hon Mr Justice Arnold Mr Justice Arnold

Contents

Topic

Paragraphs

Introduction

1–9

The witnesses

10–23

Fact witness

10

Technical experts

11–15

French law experts

16–17

Italian law experts

18–19

Spanish law experts

20–22

General comments on the evidence of foreign law

23

Burden of proof

24

The Patent

25–34

The claims

35

The prosecution history of the Patent

36–45

The skilled person or team

46–64

UK law: general

47–49

UK law: Swiss form claims

50–55

Analysis

56–64

Common general knowledge

65–86

UK law

66–67

Assessment: common general knowledge of the oncologist in 2000/2001

68–73

Antifolates

69

Pemetrexed

70–71

Vitamin B12 and folic acid

72

Salt forms and counter-ions

73

Common general knowledge of the oncologist in 2007

74

Common general knowledge of the chemist in 2000/2001

75–86

and in

2007

Salts and counter-ions

76–79

The impact of the salt form on a drug and the difficulties in making salts

80

Salt screening

81

Predictability of the viability of salts

82

Sodium salts

83

Potassium salts

84

Tromethamine salts

85

Free acids

86

Article 69 and the Protocol

87–88

Construction of the UK Patent

89–149

UK law: general

89–107

UK law: prosecution history as an aid to construction

108–112

Assessment

113–149

Improver question 1

118–119

Improver question 2

120–128

Improver question 3

129–149

The judgment of the Düsseldorf Regional Court

150–158

Construction of the French designation of the Patent

159–165

French law

159–162

Assessment

163–165

Construction of the Italian designation of the Patent

166–179

Italian law

166–175

Assessment

176–179

Construction of the Spanish designation of the Patent

180–187

Spanish law

180–185

Assessment

186–187

Actavis' proposed products

188

Direct infringement

189

Indirect infringement

190–203

Infringement of the UK designation

190–201

The law

190–193

The facts

194–198

Assessment

199–201

Infringement of the French, Italian and Spanish designations

202–203

Law applicable to the DNI claims

204–236

The relevant provisions of the Rome II Regulation

206–209

Brief summary of the rival contentions

210

Characterisation of the rules

211–220

Interpretation of the Regulation

221–236

Procedural timetable

237–292

Actavis' preparations for launch of a pemetrexed product

293–303

DNI respect of the UK designation applying English law

304–306

DNI respect of the French, Italian and Spanish designations applying English law

307

DNI respect of the French designation applying French law

308–326

French law

308–318

Assessment

319–326

Route 1

320–323

Route 2

324–325

Route 3

326

DNI in respect of the Italian designation applying Italian law

327–334

Italian law

327–332

Assessment

333–334

DNI in respect of the Spanish designation applying Spanish law

335–360

Spanish law

335–352

Assessment

353–360

Route 1

354–356

Route 2

357–358

Route 3

359

Route 5

360

Lilly's abuse of process argument in relation to the French and

361–375

Spanish designations

Summary of conclusions

376

Introduction

1

Pemetrexed disodium is a cancer treatment which has been marketed by the Defendant ("Lilly") or its subsidiaries under the brand name Alimta since 2004. Pemetrexed and its pharmaceutically acceptable salts were protected by European Patent No. 0 432 677 ("677"), which expired on 10 December 2010. The protection conferred by that patent has been extended by Supplementary Protection Certificates ("the SPCs") which will expire on 10 December 2015. Lilly also owns European Patent No. 1 313 508 ("the Patent"), which will not expire until June 2021, for the use of pemetrexed disodium in combination with vitamin B12 or a pharmaceutical derivative thereof and optionally a folic protein binding agent. The Claimants (whom I will refer to as "Actavis" save when it is necessary to distinguish between them) intend to launch a generic pemetrexed product the active ingredient in which will be either pemetrexed diacid, pemetrexed dipotassium or pemetrexed ditromethamine. Actavis intend to obtain regulatory approval for their product by reference to Alimta. Actavis contend that dealings in their product will not infringe the Patent. Lilly disputes this. Actavis would like a resolution of this issue in good time for them to enter the market on expiry of the SPCs. Furthermore, Actavis wanted the issue to be determined with respect to the French, German, Italian, Spanish and United Kingdom designations of the Patent, which cover the major pharmaceutical markets in Europe, in a single trial. Accordingly, Actavis commenced these proceedings seeking declarations of non-infringement ("DNIs") in respect of each of those designations of the Patent. Lilly has counterclaimed for threatened infringement only of the UK designation.

2

At an early stage of these proceedings, I heard a jurisdictional challenge by Lilly in relation to the French, German, Italian and Spanish designations which I rejected for the reasons given in my judgment dated 27 November 2012, [2012] EWHC 3316 (Pat) (affirmed [2013] EWCA Civ 517, [2013] RPC 37). Since then, there have been a number of developments, of which the following are the most significant for present purposes. A detailed procedural timetable is set out in paragraphs 237–292 below.

3

First, as indicated in paragraph 1 above, Actavis now seek DNIs in relation to pemetrexed diacid and ditromethamine as well as dipotassium. Indeed, the diacid is currently Actavis' lead candidate.

4

Secondly, a number of additional Actavis subsidiaries have been joined as claimants. Recently, however, Actavis Deutschland GmbH & Co KG, Actavis France SAS and Actavis Spain SA have ceased to be claimants consequential upon the sale of those companies to the Aurobindo Group.

5

Thirdly, as explained in more detail below, Lilly brought proceedings against Actavis for threatened infringement of the German designation of the Patent before the Düsseldorf Landgericht (Regional Court). Despite the fact that this court was first seized, Actavis' jurisdictional challenge was rejected and on 3 April 2014 the Düsseldorf Regional Court gave judgment on the merits of Lilly's claim. In those circumstances, Actavis decided to discontinue the present proceedings so far as they relate to the German designation.

6

Fourthly, whereas it was common ground at the time of the hearing before me in November 2012, as I recorded in my judgment at [30], that the law applicable to the question of whether this Court has power to grant DNIs with regard to the non-UK designations of the Patent was English law as the lex fori, since this was a question of procedure or remedy, Lilly subsequently changed its position and now contends that the applicable law is the law of the country in question. Furthermore, Lilly contends that Actavis have not satisfied certain requirements, which Lilly characterises as requirements of locus standi and Actavis characterise as procedural requirements, under French, Italian and Spanish law.

7

Fifthly, in an attempt to circumvent Lilly's objections under the foreign laws, Actavis have brought a series of further claims. In essence, Actavis say that, even if Lilly's procedural objections were well founded as at the date of the first and second actions, the relevant procedural requirements had been satisfied by the date of one or more of the later actions. Lilly contend that the bringing of the later actions amounts to an abuse of the process of the court. In a judgment given on 27 November 2013 ( [2013] EWHC 3749 (Pat)) I dismissed an application by Lilly to strike out the fourth and fifth actions as an abuse of process, primarily on the ground that, for the reasons given in that judgment, the application was premature.

8

Sixthly, at a pre-trial review on 20 March 2014, I ruled, for the reasons given in my first judgment of that date ( [2014] EWHC 838 (Pat)), that there should be no cross-examination of the foreign law experts upon their reports. I also ruled, for the reasons given in my second judgment of that date ( [2014] EWHC 839 (Pat)), that there should no cross-examination of Dr Maria Rotaru of Sindan Pharma SRL ("Sindan"), who had verified a Product and Process Description ("PPD") served by Actavis in lieu of giving disclosure with regard to relevant properties of pemetrexed diacid, dipotassium and ditromethamine. As a result, and...

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