Idenix Pharmaceuticals, Inc. v Gilead Sciences, Inc. and Others

JurisdictionEngland & Wales
CourtChancery Division (Patents Court)
JudgeThe Hon Mr Justice Arnold,Mr Justice Arnold
Judgment Date01 December 2014
Neutral Citation[2014] EWHC 3916 (Pat)
Date01 December 2014
Docket NumberCase No: HP14D01069

[2014] EWHC 3916 (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 No: HP14D01069

Between:
Idenix Pharmaceuticals, Inc.
Claimant
and
(1) Gilead Sciences, Inc.
(2) Gilead Sciences Ltd
(3) Centre National De La Recherche Scientifique
(4) Università Degli Studi Di Cagliari
(5) L'Université Montpellier II
Defendants
And Between:
(1) Gilead Sciences, Inc.
(2) Gilead Sciences Ltd
Part 20 Claimants
and
(1) Idenix Pharmaceuticals, Inc.
(2) Centre National De La Recherche Scientifique
(3) Università Degli Studi Di Cagliari
(4) L'Université De Montpellier II
Parts 20 Defendants

Andrew Waugh QC, Piers AclandQC and Stuart Baran (instructed by Jones Day) for Idenix

Justin Turner QC, Andrew LykiardopolousQC, Thomas Moody-Stuart and William Duncan (instructed by Herbert Smith Freehills) for Gilead

Hearing dates: 3, 7–10, 14–16, 21–23 October 2014

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.

The Hon Mr Justice Arnold Mr Justice Arnold

Contents

Topic

Paragraphs

Introduction

1–4

The parties and their respective patent applications

5–7

The witnesses

8–37

Technical experts

8–21

The virologists

9–13

The medicinal chemists

14–21

Experts in US law

22–27

Federal patent law

23–24

Georgia State law

25–27

Factual witnesses

28–37

Idenix's witnesses

28–33

Gilead's witnesses

34–37

Technical background

38–177

Stereochemistry

39–45

Nucleic acids, nucleotides and nucleosides

46–47

Pentoses

48–51

Nucleobases

52–57

Nucleotide formation

58–60

Nucleic aicd formation

61

Viruses

62–64

Flaviviridae

65–66

Hepatitis C

67–70

HCV genotypes

71–73

The HCV genome

74–76

HCV replication

77–79

Structures of enzymes

80–81

RNA-dependent RNA polymerase, NS5B

82–85

HCV treatment

86–90

Direct acting antivirals

91–92

Nucleoside analogues

93–109

Nucleoside analogues in chemotherapy

94–96

Nucleoside analogues to trat viral infections

97–100

Direct acting nucleoside analogues for viral infections

101–106

Virus specificity and selectivity of nucleoside analogues

107–108

Nucleoside analogues for HCV

109

Structure-activity relationships and the rational design of nucleoside analogues

110–111

Assays to test anti-HCV activity in 2003

112–125

Phosphorylation assay

113

Polymerase assay

114–115

BVDV surrogate model

116–119

The replicon assay

120–125

Measures of antiviral activity and toxicity

126–129

Bioavailability

130

Prodrugs

131

Retrosynthetic analysis

132

Nucleoside analogue synthesis in 2003

133–137

Primary, secondary and tertiary carbons

138–141

Nucleophilic substitution reactions

142–147

Mechanisms of nucleophilic substitution reactions

148–157

Elimination reactions

158–161

Electrophilic addition to carbon-carbon double bonds

162–163

Fluorination

164–171

Analysis of chemical compounds in 2003

172–177

Thin layer chromatography (TLC)

173

Chromatography

174

Mass spectrometry (MS)

175

Nuclear magnetic resonance (NMR) spectroscopy

176

X-ray crystallography

177

The Application

178–221

Field of the invention

179

Background

180–183

Summary of the invention

184–190

Brief description of the figures

191–192

Detailed description of the invention

193–218

Claims

219–221

Prosecution history

222–225

The Patent

226–239

The claims

240–242

Idenix's amendment application

243

The skilled team

244–249

Common general knowledge

250–302

Knowledge that 2'-methyl up-2'-hydroxy down nucleoside analogues had the potential to be efficacious in treating HCV

255

General evidence

256–279

The Carroll paper

280–286

The presentations at the Savannah conference

287–292

Knowledge of NM107

293–296

Overall conclusion

297

The effect of substituting F for OH

298–300

Predicting activity across the Flaviviridae family

301–302

Construction

303–322

The compound claims

304–306

Phosphate

307–320

Are the claims restricted to compounds which are for administration to a patient?

321–322

Priority of the Pharmasset PCT

323–424

The right to priority: the legislative framework and earlier case law

324–330

Outline of the dispute

331–332

The facts concerning the R&D Agreement

333–353

Agreed principles of US law

354–385

Application of Federal law and State law

355–357

Georgia State law – contractual requirements

358–366

Georgia State law — contractual construction

367–373

Designee

374

Federal law — patent assignment requirements

375–382

Equitable interest

383–385

A disputed principle of Georgia law

386

Disputed principles of Federal patent law

387–391

Route 1

392–408

Construction of the R&D Agreement applying Georgia law

397–404

Is the R&D Agreement an immediate assignment in accordance with Federal patent law?

405–408

Conclusion on Route 1

409

Route 2

410–420

Did Pharmasset Barbados have equitable title?

411–418

Is equitable title enough?

419

Conclusion on Route 2

420

Route 3

421–424

Novelty

425

Inventive step

426–462

The law

427–443

Assessment

444-

Claim 1 as granted

447–449

Claim 1 as proposed to be amended

450–461

Subsidiary claims

462

Insufficiency

463–599

The law

463–468

Classical insufficiency

465

Excessive claim breadth

466–468

Plausibility

469

Undue burden to perform the invention at all?

470–594

Dr Griffon's work

471–523

Dr Stewart's and Ms Wang's work

524–531

The Idenix Experiments

532–549

Mr Clark's work

550–569

To what extent does the teaching of the Patent on its own enable the skilled person to make the claimed compounds?

570–574

Would the skilled person be able to make the claimed compounds applying his common general knowledge?

575–593

Conclusion

594

Undue burden across the breadth of the claims

595–598

Subsidiary claims

599

Added matter

600–610

Claim 1 as granted

601–605

Claims 4 and 5 as granted

606–608

The claims as proposed to be amended

609–610

Can the granted claims be allowed to stand if they are partially invalid?

611

Infringement

612–620

Direct infringement

612–614

Indirect infringement

615–619

Subsidiary claims

6120

Summary of main conclusions

621

Introduction

1

Idenix Pharmaceuticals, Inc. ("IPI"), Centre National de la Recherche Scientifique, Università degli Studi di Cagliari and L'Université Montpellier II (collectively, "Idenix") are the joint registered proprietors of European Patent (UK) No. 1 523 489 entitled "Modified 2' and 3' – Nucleoside Produgs [ sic] for Treating Flaviridae [ sic] Infections" ("the Patent"). The application for the Patent, International Patent Application No. WO 2004/002999 ("the Application"), was filed on 27 June 2003. The Patent was granted on 12 March 2014. Although the Patent on its face claims priority from four United States priority documents dating from 28 June 2002 to 14 May 2003, no claim to priority is made by Idenix in these proceedings.

2

Idenix claim that Gilead Sciences, Inc and Gilead Sciences Ltd (collectively, "Gilead") have infringed the Patent by the keeping and disposal of sofosbuvir, which Gilead market under the trade mark Sovaldi. Sovaldi represents a significant breakthrough in the treatment of Hepatitis C virus ("HCV"). A standard course of treatment of Sovaldi takes from only 12 weeks (a significant reduction compared to previously available HCV treatments), has a high efficacy rate and few, if any, side effects when compared with other treatments. Sovaldi received a marketing authorisation from the European Medicines Agency in January 2014. In the UK it is in the process of approval by the National Institute for Clinical Excellence ("NICE"). On 15 August 2014 NICE published draft guidance on Sovaldi which contained positive recommendations based inter alia on the cost-effectiveness of the treatment. By contrast, Idenix has no product either on the market or near to receiving a marketing authorisation which is covered by the Patent.

3

Gilead deny infringement and counterclaim for revocation of the Patent on the grounds of lack of novelty over Gilead's own International Patent Application PCT/US2004/012472 ("the Pharmasset PCT"), lack of inventive step, insufficiency and added matter. Somewhat unusually, there is an issue as to the entitlement to priority, not of the Patent, but of the Pharmasset PCT. As explained below, this involves issues both of fact and US law. In support of their allegation of insufficiency, Gilead rely upon work done by a number of Idenix scientists. As part of their answer to Gilead's case on this point, Idenix rely upon certain experiments conducted for the purposes of these proceedings. Idenix contend that claims 1, 5–7, 21 and 24 are independently valid and infringed. Idenix have also made a conditional application to amend the Patent. As a result, there are a considerable number of issues to be determined, on which the parties adduced a large body of evidence.

4

Idenix's claim was issued within hours of the Patent being granted. On 17 March 2014, Gilead filed its Defence and Counterclaim. Gilead applied to expedite the trial, and on 16 April 2014 Birss J gave directions for an expedited trial. As a result, the case came on...

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