Idenix Pharmaceuticals, Inc. v Gilead Sciences, Inc. and Others
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 01 December 2014 |
| Neutral Citation | [2014] EWHC 3916 (Pat) |
| Docket Number | Case No: HP14D01069 |
| Court | Chancery Division (Patents Court) |
| Date | 01 December 2014 |
[2014] EWHC 3916 (Pat)
The Hon Mr Justice Arnold
Case No: HP14D01069
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
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.
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
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.
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.
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.
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...
To continue reading
Request your trial
-
Merck Sharp & Dohme Ltd v Ono Pharmaceutical Company Ltd and Another
...It is also argued to play a part in the novelty case (below). The term is not to be found in the legislation and as Arnold J said in Idenix v Gilead [2014] EWHC 3916 (Pat) as an aspect of patent law, it is a fairly new 134 The question of plausibility was considered by the Supreme Court in......
-
Idenix Pharmaceuticals Inc. v Gilead Sciences Inc. and Others
...COURT OF APPEAL (CIVIL DIVISION) ON APPEAL FROM THE HIGH COURT OF JUSTICE CHANCERY DIVISION (PATENTS COURT) THE HON MR JUSTICE ARNOLD [2014] EWHC 3916 (Pat) Royal Courts of Justice Strand, London, WC2A 2LL (Transcript of the Handed Down Judgment of WordWave International Limited Trading as ......
-
Accord Healthcare Ltd v Research Corporation Technologies, Inc.
...of occasions including at least the following: Arnold J in KCI Licensing v Smith & Nephew [2010] EWHC 1487 (Pat) and Idenix v Gilead [2014] EWHC 3916 (Pat), Henry Carr J in Fujifilm v Abbvie [2017] EWHC 395 (Pat); and me in HTC v Gemalto [2013] EWHC 1876 (Pat). In KCI Licensing v Smith & Ne......
-
Akebia Therapeutics Inc. v Fibrogen, Inc.
...1 should be assessed on the basis that it was to be construed as a claim to compounds which had anti-Flaviviridae activity (see [2014] EWHC 3916 (Pat) at [306]). I concluded that claim 1 was invalid for lack of inventive step on AgrEvo grounds because it covered compounds which the skilled......