Glaxo Group Ltd v Vectura Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Birss,Lord Justice Floyd |
| Judgment Date | 28 June 2018 |
| Neutral Citation | [2018] EWCA Civ 1496 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3 2018 0499 |
| Date | 28 June 2018 |
[2018] EWCA Civ 1496
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH OURT OF JUSTICE
BUSINESS & PROPERTY COURTS OF ENGLAND AND WALES
PATENTS COURT
HHJ Hacon (sitting as a High Court Judge)
[2018] EWHC 375 (Pat)
Royal Courts of Justice
Strand, London, WC2A 2LL
Lord Justice Floyd
and
Mr Justice Birss
Case No: A3 2018 0499
Justin Turner QC and Geoffrey Pritchard (instructed by Gowling WLG UK LLP) for the Appellants
Andrew Lykiardopoulos QC and Anna Edwards-Stuart (instructed by Bristows LLP) for the Respondent
Hearing date: 12 June 2018
Judgment Approved
Following the initiation of revocation proceedings by the appellants (GSK), the respondent (Vectura) counterclaimed for infringement of five patents relating to the delivery of drugs by inhalation. GSK, who market such products for the treatment of chronic obstructive pulmonary disease and asthma under the brand name Ellipta, say that their products do not infringe and/or that the patents are invalid. The action is proceeding to a trial on all these issues in November of this year. In the meantime a dispute has arisen as to whether GSK can claim in addition a declaration that their Ellipta products were old or obvious at a particular date. Such a declaration, which has become known as an Arrow declaration after Arrow Generics Limited v Merck & Co Limited [2007] EWHC 1900 (Pat), would, it is said, provide protection against allegations of infringement by Vectura of as yet ungranted patents. The judge (HHJ Hacon sitting as a High Court judge) struck out the claim for the Arrow declaration on the grounds that there was no prospect of the court granting it on the facts of this case as they presently appeared, or as they might emerge at the trial. GSK appeals, arguing that the judge should have let the claim go to trial, to be decided alongside the other issues.
The assumed facts
As this is an application to strike out, or for summary judgment, I can take the assumed facts largely from GSK's pleading. Since the hearing before the judge, GSK have put forward draft re-amended particulars of claim which they contend fully reflect the facts and arguments as they were put before the judge. Mr Lykiardopoulos QC, who appeared for Vectura with Ms Anna Edwards-Stuart, took no objection to GSK's reliance on the draft re-amended particulars of claim for the purposes of the appeal. I will refer to this document as “the PC”.
Pursuant to an agreement made on about 5 August 2010 (“the 2010 Agreement”), and until some time in 2016, GSK were licensed by Vectura under a patent application referred to as “Staniforth” (and patents arising therefrom). The 2010 Agreement also identified an additional class of patents (the “Non-Assert Patents”) under which GSK were granted a further licence to take effect from 31 July 2016, but from which further licence they had the right to exclude any of the Non-Assert Patents.
GSK launched their Ellipta products in the UK in January 2014. Paragraph 2 of the PC alleges that the “Claimants' Products” are dry powder inhalation products containing the active ingredient vilanterol trifenatate blended with lactose and magnesium stearate and/or the active ingredient umeclidinium bromide blended with lactose and magnesium stearate. Paragraph 3 of the PC alleges that the Claimants' Products are manufactured by processes (“the Claimants' Processes”) in which (i) lactose monohydrate and magnesium stearate are first blended together to produce a lactose/magnesium stearate “Pre Blend”, (ii) micronized active ingredient combined with a portion of Pre-Blend is then sieved to de-lump the active ingredient, and (iii) the remaining Pre-Blend is added and the whole batch further blended to produce a homogenous blend.
Paragraph 4 of the PC explains why GSK say that the making of the Claimants' Products according to the Claimants' Processes does not infringe any of the five patents in suit (“the Patents”). The last of the Patents was added to the proceedings upon its grant, at the suggestion of Vectura. The Patents are a sub-set of the Non-Assert Patents identified in the 2010 Agreement. Paragraph 5 states that, if and so far as the Claimants' Processes or the Claimants' Products fall within a claim of any of the Patents, then the Patent in question is invalid on the grounds set out in the accompanying Grounds of Invalidity.
Paragraph 8 of the PC says that GSK are entitled to a declaration that (i) the Claimants' Processes and (ii) the Claimants' Products insofar as they are the direct product of the Claimants' Processes (and save for the active ingredients therein) were obvious for the reasons set of in the Grounds of Invalidity. In addition to identifying the prior art relied on (at paragraph 1), the Grounds of Invalidity assert (at paragraph 2) that:
“The Claimants' Processes … and the Claimants' Products … were obvious at and after 30 November 2000 to a person having regard to the state of art which comprised the matter set out under paragraph 1 …”
The PC set out the history of the subsequent exchanges between the parties in paragraph 14:
“14. Following launch of the Ellipta products:
(a) in an email dated 21 January 2014, [Vectura] indicated its belief that “ a number of [the Non-Assert Patents] cover the [GSK] products, or have the potential to do so”.
(b) In an email dated 23 July 2014, [GSK] informed [Vectura] that they had “ reviewed the Non-Assert Patents and at the present time we do not foresee the need to take the option of a licence post 2016. However, we will continually monitor the situation and will make our final decision at the appropriate time point.”
(c) In an email dated 08 February 2016, [GSK] informed [Vectura] that “ we've continued to monitor the Non-Assert Patents and can now confirm that we do not wish to take a licence under any of the patent families.”
(d) In an email dated 09 February 2016, [Vectura] informed [GSK] that, on the basis of Single Particle Aerosol Mass Spectrometry (SPAMS) analyses of the Claimants' products, “ these products are at least within the scope of US 8303991, EP 1337240 [i.e. '240 one of the patents in suit] and equivalent Vectura claims.”
(e) On 08 April 2016 [Vectura] provided copies of the SPAMS analytical reports to [GSK].
(f) In an e-mail dated 09 May 2016 [GSK] confirmed it had reviewed the reports, and that it did not use the processes of the '240 patent. [GSK] reiterated that “ we do not wish to take a licence under any of the Non-Assert Patents”.
(g) In an e-mail dated 02 July 2016, [Vectura] reiterated its belief that US patent US 8,303,991 (in family VL0108 which family includes the Patents) “ continue to be relevant to the products in question”.
(h) In the same e-mail [Vectura] said, “ In addition, there are a number of continuation and divisional applications pending in various territories from the Non-Assert patent families, including continuations from the '991 patent family that Vectura expect to grant shortly.”
(i) On 27 July 2016 [Vectura] filed a “Complaint for Patent Infringement” in the United States District Court for the District of Delaware (C.A. No. 16–638-RGA) against [GSK] (the “US Action”), in which [Vectura] alleged [GSK's] Products infringed US patent US 8,303,991.
(j) On 12 August 2016 [Vectura] filed a “First Amended Complaint for Patent Infringement” in which an additional US Non-Assert Patent, US 8,435,567, was added to the US Action, which [Vectura] alleged [GSK's] Products also infringe.
(k) On 7 June 2017 [Vectura] notified [GSK's] US counsel that it intended to amend its pleadings in the US Action to include further allegations that [GSK's] Products infringe an additional US Non-Assert Patent US 8,956,661.
(l) On 23 June 2017 [GSK] filed their Claim Form, Grounds of Invaldiity and this Particulars of Claim with the UK High Court. The Claim Form was deemed served on 27 June 2017.
(m) On 17 July 2017 [Vectura] wrote to [GSK] stating that '818 would be granted and come in to force in the UK on 2 August 2017 (having received approval for grant on 9 February 2017), that it considered '818 to be relevant to [GSK's] Processes and [GSK's] Products, and that it intended to amend '763 to bring the claims into line with the Main Request that was pending before the EPO. Consequently [Vectura] invited [GSK] to amend their claim.”
By January 2016 the patents licensed under the 2010 Agreement had expired. On 26 July 2016 GSK formally notified Vectura that all of the Non-Assert Patents were excluded from the licence. Paragraphs 16 to 20 of the PC (with some slight amendment to account for an obvious error in numbering) continue:
“16. By [GSK's] aforesaid letter dated 30 May 2017, [GSK] also applied to [Vectura] for an acknowledgement in writing that neither carrying out [GSK's] Processes nor [GSK's] Products would infringe the European Non-Assert Patents (in addition to the Patents) and to the extent that this was not acknowledged, requested details of which of the European Non-Assert patents were said to be infringed by [Vectura] and upon what basis.
17. [Vectura] did not provide the acknowledgment requested in the 30 May letter. Therefore by a letter dated 20 December 2017, [GSK] requested acknowledgment that [GSK's] Processes and [GSK's] Products di not, and would not in the future, infringe [Vectura's] patents. In particular [GSK] requested:
“Please would you now let us know if your client is willing to provide its assurance (in a form to be agreed, but we anticipate it will need to be by way of an undertaking to the Court), that it will not in the future assert against our clients, in respect of the Products and Processes in issue in these proceedings, any patent claims...
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