Glaxo Group Ltd v Vectura Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 13 December 2018 |
| Neutral Citation | [2018] EWHC 3414 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2017-000053 |
| Date | 13 December 2018 |
[2018] EWHC 3414 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS
INTELLECTUAL PROPERTY LIST (CHANCERY DIVISION)
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
Mr Justice Arnold
Case No: HP-2017-000053
Justin Turner QC and Geoffrey Pritchard (instructed by Gowling WLG (UK) LLP) for the Claimants
Andrew Lykiardopoulos QC and Anna Edwards-Stuart (instructed by Bristows LLP) for the Defendant
Hearing dates: 21–22, 26–27, 30 November 2018
Judgment Approved
Contents
| Topic | Paragraphs |
| Introduction | 1–7 |
| The witnesses | 8–21 |
| GSK's factual witnesses | 8–10 |
| Vectura's expert witnesses | 11–16 |
| GSK's expert witnesses | 17–21 |
| Technical background | 22–47 |
| Pre-formulation | 23 |
| Milling and micronisation | 24 |
| Excipients | 25–26 |
| Homogeneity | 27–30 |
| Ordered mix | 31 |
| Anatomy and physiology of the respiratory tract | 32–37 |
| Inhalation devices | 38 |
| DPIs | 39–40 |
| DPI formulation | 41 |
| Dosing terminology | 42–43 |
| In vitro testing of inhalable products | 44 |
| Dissolution and sustained release | 45–47 |
| The Patents | 48–84 |
| 240 | 48–77 |
| 241 | 78–84 |
| The claims | 85–100 |
| 240 | 86–89 |
| 817 | 90–92 |
| 818 | 93 |
| 241 | 94–97 |
| 763 | 98–100 |
| The skilled person | 101 |
| Common general knowledge | 102–123 |
| MgSt | 103–104 |
| High-shear blenders | 105–123 |
| Construction | 124–137 |
| Composite active particles | 125 |
| Fused to the surface/smeared over or fused on the surface | 126 |
| Form a coating | 127 |
| Milling | 128 |
| Milling in the absence of carrier? | 130–134 |
| What is milling? | 135–137 |
| GSK's products and processes | 138–139 |
| Infringement | 140–175 |
| Milling | 141–142 |
| Composite active particles, fused to/smeared over, | 143–144 |
| to form a coating | |
| SEM | 145–147 |
| EDX | 148–150 |
| Vectura's experiments | 151–158 |
| The experimental techniques | 159–164 |
| Limitations of EDX | 163–172 |
| Absence of validation | 173 |
| Conclusion | 174–175 |
| Insufficiency | 176–181 |
| The prior art | 182–224 |
| Staniforth | 182–199 |
| Keller | 200–212 |
| Musa | 213–224 |
| Obviousness of the Patents | 225–233 |
| Musa | 226–231 |
| Keller | 232 |
| Staniforth | 233 |
| Obviousness of GSK's process and products | 234–240 |
| GSK's claim for an Arrow declaration | 241–258 |
| The law | 241–244 |
| Assessment | 245–246 |
| The declarations sought by GSK | 245–246 |
| Vectura's undertaking | 247 |
| GSK's submissions | 248–250 |
| Vectura's submissions | 251 |
| Discussion and conclusion | 252–258 |
| Summary of principal conclusions | 259 |
Introduction
The Defendant (“Vectura”) is the proprietor of European Patents (UK) Nos. 1 337 240 (“240”), 2 283 817 (“817”), 2 283 818 (“818”), 1 337 241 (“241”) and 1 920 763 (“763”) (“the Patents”). 240, 817 and 818 are all entitled “Method of making particles for use in a pharmaceutical composition”, 241 is entitled “Method of preparing microparticles for use in pharmaceutical compositions for inhalation” and 763 is entitled “Pharmaceutical compositions for inhalation”. The Patents all have the same earliest claimed priority date of 30 November 2000, which is not challenged. Vectura alleges that the Claimants (“GSK”) have infringed the Patents by the manufacture and sale of dry powder inhalers (“DPIs”) containing the active ingredients vilanterol trifenatate (“vilanterol”) and/or umeclidinium bromide (“umeclidinium”) which are used to treat asthma and chronic obstructive pulmonary disease (“COPD”) and which GSK market under the trade mark Ellipta.
GSK deny infringement and claim revocation of the Patents on the grounds of obviousness over three items of prior art and insufficiency. The prior art relied upon by GSK is (i) International Patent Application No. WO 96/23485 “Carrier particles for use in dry powder inhalers” published on 8 August 1996 (“Staniforth”), (ii) International Patent Application No. WO 00/28979 “Dry powder for inhalation” published on 25 May 2000 (“Keller”) and (iii) International Patent Application No. WO/53157 “Improved powdery pharmaceutical compositions for inhalation” published on 14 September 2000 (“Musa”). In addition, GSK seek an Arrow declaration.
The Patents divide into two groups. The first group, consisting of 240, 817 and 818, claim methods of making “composite active particles” and composite active particles obtainable by those methods (“the WO701 Patents”). The specifications are very similar, and it is common ground that it is sufficient to refer to the specification of 240. The second group, consisting of 241 and 763, claim methods of making composite active particles (referred to as “microparticles”) exhibiting delayed dissolution and microparticles suitable for delayed dissolution (“the WO702 Patents”). Again, the specifications are very similar, and it is common ground that it is sufficient to refer to the specification of 241. What all the Patents have in common is the use of magnesium stearate (“MgSt”) to form the composite active particles.
The background to the dispute is as follows. On 5 August 2010 Vectura granted GSK a licence in respect of Staniforth and any patents deriving from it (“the Staniforth Patents”). GSK exploited the Staniforth Patents and paid Vectura substantial royalties pursuant to this agreement. The agreement identified an additional class of patent applications (referred to as “the Non-Assert Patents”) in respect of which GSK had the option to take a licence. The Staniforth Patents expired on 31 January 2016. On 8 February 2016 GSK informed Vectura that it did not require a licence under of the Non-Assert Patents. GSK's position was and remains that it uses an obvious development of the process disclosed in Staniforth and not the processes claimed in the Patents. In July 2016 Vectura commenced proceedings against GSK in the USA for infringement of US Non-Assert Patents. In June 2017 GSK commenced these proceedings in respect of four of the Patents, with the fifth being added by agreement later.
In the European Patent Office, 240 was upheld by the Opposition Division following opposition by a third party; 817 and 818 have been opposed by GSK, but the proceedings are ongoing; 763 was upheld with amended claims following opposition by a third party, but the decision is under appeal; and 241 has not been opposed. Vectura has made an unconditional application to amend claim 1 of 763 to correspond with its main request in the appeal proceedings and has made a conditional application to amend claim 1 in accordance with one of its auxiliary requests. GSK opposes these applications, but only on the ground that they do not cure the invalidity of 763.
A complicating factor in the present case is that GSK contend that they have a Gillette defence because their process is objectively obvious in the light of the prior art (although GSK have not disclosed how the process was in fact developed). In a nutshell, GSK say that, although their process uses MgSt, this is disclosed by each of the three items of prior art. Although in theory this might make it unnecessary to decide whether the Patents were invalid or not infringed, in practice it is desirable to reach definite conclusions on both sets of issues for the reasons given by the Court of Appeal in Fujifilm Kyowa Kirin Biologics Co Ltd v AbbVie Biotechnology Ltd [2017] EWCA Civ 1, [2018] Bus LR 228 at [56]. The Gillette defence has led to experiments, expert evidence and argument as to the extent to which GSK's process produces different results to the prior art.
In most respects there was no dispute between the parties as to the applicable legal principles, which are well established, and so there is no need for me to set them out.
The witnesses
GSK's factual witnesses
GSK adduced evidence from three factual witnesses. Trevor Roche is a Scientific Leader for GSK who has worked for companies in what is now the GSK group since 1985 in various capacities. In his current role he has responsibilities relating to DPIs. He collated the information for and verified GSK's original and amended Product and Process Description (“PPD”) and provided further details in a witness statement. Counsel for Vectura made no criticism of Mr Roche as a witness, but complained that his evidence showed that GSK had not disclosed all the relevant particle size data in their possession. As counsel for GSK pointed out, however, Vectura made no application for disclosure of such data.
Nigel Bowen is a manager at GSK who has worked for companies in what is now the GSK group since 1989 in various capacities including Senior Formulation Scientist. He was asked to prepare blends in accordance with Staniforth and Musa for GSK's experiments. He was not required to attend for cross-examination.
John Harrington is the Facility Manager and Senior Experimental Officer at the Leeds Electron Microscopy and Spectroscopy Unit at the University of Leeds. He undertook GSK's experiments and repeats, and attended the repeats of Vectura's experiments. Counsel for Vectura made no criticism of his evidence.
Vectura's expert witnesses
Both parties called experts in formulation science and experts in scanning electronic microscopy (“SEM”) and electron dispersive X-ray spectroscopy (“EDX”).
Vectura's formulation expert was Professor James Birchall. He obtained a Bachelor of Pharmacy degree from Bath University in 1993. He became a registered pharmacist (MRPharmS) in 1994 following a year as a pre-registration pharmacist at Abbott Laboratories UK and St George's Hospital in London. In 1998 he was awarded a PhD in pulmonary gene delivery by Cardiff University. He then became successively a...
To continue reading
Request your trial
-
Takeda UK Ltd v F. Hoffmann-La Roche AG
...contribution case. Ambiguity type insufficiency 233 There was no dispute as to the law. The recent cases are Glaxo v Vectura [2018] EWHC 3414 (Pat), Unwired Planet v Huawei [2016] EWHC 576 (Pat) and Sanvik v Kennametal [2011] EWHC 3311 (Pat). The principles set out there are not too hard......
-
Teva UK Ltd v Novartis AG
...threats to sue for infringement throughout the world (§416). 27 An Arrow declaration was granted by Arnold J in Glaxo v Vectura [2018] EWHC 3414 (Pat), but on facts that are quite different to those of the present 28 More recently, however, in Pfizer v Hoffman-La Roche [2019] EWHC 1520 (P......
-
Actavis v Eli Lilly: The Impact On Patent Infringement Law In The UK Two Years On
...priority date of a relevant patent or application. Arrow relief was awarded in FKB v AbbVie [2017] EWHC 395 (Pat) and GSK v Vectura [2018] EWHC 3414 (Pat). If there is now a validity gap, such that a patent need only not be obvious to the extent that its claims are construed according to th......
-
Brexit And Patents: 10 Key Things To Know
...covering the UK. Arrow relief was awarded by the Patents Court in Fujifilm v AbbVie [2017] EWHC 2748 (Pat) and GSK v Vectrura [2018] EWHC 3414 (Pat). As a signatory to the Hague Convention on Choice of Court Agreements, the UK courts will continue to recognise and give effect to exclusive j......
-
GSK Breathes Easy After Arrow Declaration Success
...in a patent infringement action brought by Vectura in respect of inhalable medicaments - Glaxo Group Ltd & Ors v Vectura Ltd [2018] EWHC 3414 (Pat) (13 December Vectura alleged that GSK infringed its patents EP 1 337 240, EP 2 283 817, EP 2 283 818, EP 1 337 241 and EP 1 920 763 (the Pa......
-
Briefing Note For Patent Practitioners: An Analysis Of Arrow Declarations Following Glaxo v Vectura
...Fujifilm v AbbVie decision, which was handed down on 12th January 2017 in the Court of Appeal. The latest case of Glaxo v Vectura ([2018] EWHC 3414 (Pat)) looks at the approach being taken by the English Patents Court and seeks to learn lessons from this. To this extent, it is hoped that pa......