Fujifilm Kyowa Kirin Biologics Company Ltd v Abbvie Biotechnology Ltd and Another
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 08 September 2016 |
| Neutral Citation | [2016] EWHC 2204 (Pat) |
| Docket Number | Case No: HP-2016-000025 |
| Court | Chancery Division (Patents Court) |
| Date | 08 September 2016 |
[2016] EWHC 2204 (Pat)
Mr Justice Arnold
Case No: HP-2016-000025
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London EC4A 1NL
Thomas Raphael QC, Richard Miller QC, Miles Copeland and Oliver Caplin (instructed by Gowling WLG (UK) LLP) for the Claimants
Alexander Layton QC and Mark Chacksfield (instructed by Herbert Smith Freehills LLP) for the Defendants
Hearing dates: 21–22 July 2016
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 | 1–13 |
| Arrow declarations | 14–17 |
| AbbVie's application for summary judgment | 18–68 |
| Principles applicable to summary judgment applications | 19 |
| The general merits of FKB's claim for an Arrow declaration | 20–33 |
| The merits of FKB's claim for an Arrow declaration against AbbVie UK | 34–40 |
| The merits of FKB's claim for an injunction | 41–44 |
| Jurisdiction to grant a domestic anti-suit injunction | 45–62 |
| Enforcement of the declaration | 63–67 |
| Independently of the declaration | 68 |
| Jurisdiction under Article 24(4) of the Recast Brussels I Regulation | 69–80 |
| Permission to serve the claim on AbbVie Bermuda outside the jurisdiction | 81–123 |
| The tests which FKB must satisfy | 81–92 |
| Gateway (11): Property within the jurisdiction | 93–99 |
| Gateway (9): Tort | 100–108 |
| Gateway (3): Necessary or proper party | 109–113 |
| Gateway (4A): Same or closely connected facts | 114–115 |
| Gateway (2): Injunction | 116–121 |
| Is England clearly or distinctly the appropriate forum? | 122 |
| Discretion | 123 |
| Result | 124 |
Introduction
The First Defendant ("AbbVie Bermuda"), which is a company incorporated in Bermuda, is the proprietor of European Patent (UK) No 0 929 579 ("the Basic Adalimumab Patent"), which protects the monoclonal antibody adalimumab, and of SPC/GB/04/002 ("the SPC"), which extends the protection conferred by the Basic Adalimumab Patent in respect of adalimumab. Adalimumab is a monoclonal antibody specific for human tumour necrosis factor a, which is a cell signalling protein the misregulation of which is implicated in several human inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, psoriasis, Crohn's disease and ulcerative colitis. The SPC will expire on 15 October 2018.
Adalimumab is marketed by companies in the group of companies headed by AbbVie Inc. under the trade mark Humira. Humira is the highest selling prescription drug in the word, achieving net sales in 2014 in excess of US$12.5 billion. In the United Kingdom Humira is marketed by the Second Defendant ("AbbVie UK"), a company incorporated in England. AbbVie UK achieved a turnover of £438.6 million in Humira in 2014 i.e. some £1.2 million a day.
AbbVie Bermuda has filed applications for numerous secondary patents protecting dosing regimens, formulations and uses of adalimumab ("the Secondary Applications"). As at 19 April 2016, the Claimant ("FKB"), a company incorporated in Japan, was aware of over 50 European patent applications in 17 families filed by AbbVie Bermuda. More have been discovered subsequently.
AbbVie Inc. has indicated its intention vigorously to enforce its adalimumab patent portfolio and to seek injunctive relief. During AbbVie Inc.'s Q3 2015 Earnings Report Conference Call for investors on 30 October 2015, AbbVie Inc.'s Chairman and Chief Executive Officer Rick Gonzalez said in relation to its US patent portfolio:
"Any company seeking to market a biosimilar version of Humira will have to contend with this extensive patent estate which AbbVie intends to enforce vigorously.
…
… in the event a biosimilar attempts to launch at-risk, AbbVie will seek injunctive relief."
FKB contends that it is to be inferred from other statements made by Mr Gonzalez that the AbbVie group has the same intention in relation to its European patent portfolio.
FKB intends to launch a product code-named FKB327 which is biosimilar to adalimumab in the UK when the SPC expires. Accordingly, FKB is desirous of clearing the way of any patents granted pursuant to the Secondary Applications which it might infringe prior to then in order to avoid the risks of (i) an interim injunction being granted to prevent its launch and (ii) being ordered to pay damages or account for its profits (including pursuant to section 69 of the Patents Act 1977, which confers rights on a patentee dating back to the date of publication of the application for the patent). FKB faces the difficulty, however, that it cannot apply to revoke a patent under section 72 of the 1977 Act until the patent has been granted. Furthermore, section 74(1) and (2) of the 1977 Act provide that the validity of a patent may only be "put in issue" in certain specified types of proceedings, such as a claim for revocation under section 72, and prohibit the institution of proceedings seeking only a declaration as to the validity or invalidity of a patent.
On 29 October 2015 FKB commenced proceedings in this Court ("the First Action") against AbbVie Bermuda seeking inter alia revocation of European Patents (UK) Nos. 1 406 656 ("EP656") and 1 944 322 ("EP322"), which are due to expire in June 2022 and July 2023 respectively. In addition, FKB sought a so-called Arrow declaration, following the precedent set by the decision of Kitchin J (as he then was) in Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat), [2007] FSR 39 (" Arrow"). The claim for an Arrow declaration is designed to provide FKB with protection against subsequent claims for infringement of any patents within families 2, 3, 6, 8 and 12 of the Secondary Applications. As subsequently refined, the declaration sought is that:
"importing into the United Kingdom and offering to sell and dispose of, and to sell and dispose, and to keep for such sale or disposal in the United Kingdom, the Claimant's products containing their biosimilar monoclonal antibody to the antibody adalimumab (Humira) for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40 mg every other week by subcutaneous injection for
(a) rheumatoid arthritis would have been obvious and/or anticipated at the date from which [EP656] is entitled to claim priority, whether or not co-administered with methotrexate (as would administration every week in the case of monotherapy in rheumatoid arthritis); and
(b) psoriasis and/or psoriatic arthritis would have been obvious at the date from which [EP322] is entitled to claim priority (whether as an initial or continuing dosing regimen)."
On 4 November 2015 AbbVie Bermuda's representatives wrote to the European Patent Office disapproving the text of EP656, which FKB and 14 other opponents had been opposing and which AbbVie Bermuda had filed no less than 19 witness statements and experts' reports in support of, but stating that AbbVie Bermuda would instead pursue the same subject matter by means of its existing divisional applications and in particular European Patent Application No. 2 490 044 (" EPA044"). FKB alleges in the First Action that AbbVie Bermuda abandoned EP656 in order to prevent its validity being scrutinised by this Court in good time before expiry of the SPC, and thus in order to prolong the uncertainty as to whether the subject matter of EP656 is capable of founding a valid patent.
FKB subsequently applied to amend its Claim Form and Particulars of Claim in the First Action and AbbVie Bermuda applied to strike out the claim for an Arrow declaration. On 1 March 2016 Henry Carr J dismissed AbbVie Bermuda's application and granted FKB permission to make amendments for the reasons given in his judgment of that date ( [2016] EWHC 425 (Pat), " FKB1"). In particular, Henry Carr J rejected the submission advanced by AbbVie Bermuda that Arrow was wrongly decided and that the court had no jurisdiction (in the sense of power) to make such a declaration. The First Action was subsequently listed for trial in January 2017.
On 21 June 2016 Kitchin LJ granted AbbVie Bermuda permission to appeal against the decision of Henry Carr J in FKB1 on the ground that it was arguable that the declaration sought by FKB was inconsistent with section 74 of the 1977 Act. The appeal has been fixed for 29–30 November 2016. AbbVie Bermuda and AbbVie UK (collectively "AbbVie") accept, however, that, unless and until the Court of Appeal decides otherwise, this Court should proceed on the basis that Arrow and FKB1 were correctly decided.
On 9 May 2016 FKB commenced these proceedings ("the Second Action") against AbbVie Bermuda and AbbVie UK seeking an Arrow declaration that:
"importing into the United Kingdom and offering to sell and dispose of, and to sell and dispose, and to keep for such sale or disposal in the United Kingdom, the Claimant's products containing their biosimilar antibody to … adalimumab (Humira) would insofar as the Higher Initial Dosing Regimens are concerned have been obvious and/or anticipated at the date from which EP (UK) 1,737,491 is entitled to claim priority. Such Higher Initial Dosing Regimens are dosing regiments for each of psoriasis, Crohn's disease and ulcerative colitis in the Humira SmPC comprising higher initial doses (as multiple initial doses of 40 mg via subcutaneous injection) as follows:
a. 80 mg for psoriasis;
b. 80 mg, or 160 mg then 80 mg, for Crohn's disease; and
c. 160 mg then 80 mg for ulcerative colitis
each of which is followed by one or more doses of 40 mg."
In the Second Action FKB also seeks an injunction against...
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