Fujifilm Kyowa Kirin Biologics Company, Ltd (a company incorporated under the laws of Japan) Samsung Bioepis UK Ltd and Another v Abbvie Biotechnology Ltd (a company incorporated under the laws of Bermuda) and Another
| Jurisdiction | England & Wales |
| Judge | Mr Justice Henry Carr |
| Judgment Date | 29 December 2016 |
| Neutral Citation | [2016] EWHC 3383 (Ch) |
| Court | Chancery Division |
| Date | 29 December 2016 |
| Docket Number | Case No: HP-2015-000053 and HP-2016-000016 |
[2016] EWHC 3383 (Ch)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
The Rolls Building,
7 Rolls Buildings,
London EC4A 1NL
Mr. Justice Henry Carr
Case No: HP-2015-000053 and HP-2016-000016
Claim No. HP-2016-000025
Mr. Andrew Waugh QC and Mr. Geoffrey Pritchard (instructed by Gowling WLG (UK) LLP) for FKB.
Dr. Justin Turner QC and Ms. Katherine Moggridge (instructed by Powell Gilbert LLP and Simmons & Simmons LLP) for S/B.
Mr. Michael Tappin QC and Mr. Mark Chacksfield (instructed by Herbert Smith Freehills LLP) for AbbVie in the FKB1 and S/B claims and (instructed by Marks & Clerk Solicitors LLP) in the FKB2 claim.
The Defendant ("AbbVie") is the proprietor of a number of patents relating to the antibody adalimumab, sold under the trade mark Humira. Humira is the highest selling prescription drug in the world by global sales, achieving net sales in 2014 in excess of US$12.5 billion. Adalimumab is a fully human antibody that binds and neutralises the activity of TNFa. The basic patent for adalimumab (EP 0,929,578) and its associated UK SPC (GB/04/002) will expire on 15 October 2018.
Humira has been approved for the treatment in adults of rheumatoid arthritis, psoriatic arthritis and psoriasis. The basic dosage regimes for those indications, as set out in the Summary of Product Characteristics, specify or include the administration of 40 mg adalimumab every other week as a single dose via subcutaneous injection ("40 mg sc eow"). AbbVie has obtained or applied for a number of patents and divisionals for adalimumab which claim the use of this dosage regime in the treatment of various indications.
The Claimants in these various proceedings (respectively "FKB" and "SB/Biogen") each intend to market a biosimilar adalimumab product in Europe, including the United Kingdom, after expiry of the basic adalimumab patent and its associated SPCs, if they can clear the way of secondary patents before then. They seek declarations that their products were obvious and/or anticipated at the priority date. If such declarations are granted, then the Claimants will have a so-called "Gillette defence" to complaints of acts committed in the United Kingdom, on the basis that if there is infringement of any of the patents in suit, then these patents must be invalid.
This judgment concerns an application by AbbVie for summary judgment, or alternatively to strike out these proceedings as an abuse of process, and applications by FKB and SB/Biogen to amend their Particulars of Claim in the light of recent events.
This is the latest in a series of applications by AbbVie, the effect of which, if successful, would be to avoid a trial in the United Kingdom. In particular, Claim No HP-2015-000053 ("FKB1") (which concerns EP UK 2,940,044 ("the 044 patent") and EP UK 1,944,322 ("the 322 patent") was issued on 29 October 2015. AbbVie applied to strike out parts of that claim. I dismissed that application by a judgment dated 1 March 2016 ("the FKB1 judgment"). On 24 March 2016 SB/Biogen issued Claim No HP-2016-000016 ("S/B") in respect of the same patents as are in issue in FKB1. On 9 May 2016 FKB issued Claim No HP-2016–000025 ("FKB2") (which concerns EP UK 1,737, 491 ("the 491 patent")). AbbVie applied to set aside service of, or alternatively to strike out, FKB2. Arnold J dismissed that application by a judgment dated 8 September 2016 ("the FKB2 judgment"). Appeals by AbbVie from the FKB1 and FKB2 judgments were heard on 28 and 29 November, and judgment was reserved.
The trial of the FKB1 and S/B claims is due to commence imminently, on 16 January. Evidence of fact was served by the Claimants on 17 October 2016; technical expert evidence was exchanged on 8 November 2016; legal expert evidence relating to priority issues was exchanged on 25 November 2016 and reply evidence should have been exchanged by the date of this judgment. FKB2 is due to be tried in June 2017.
On 15 November 2016, AbbVie informed FKB and SB/Biogen, in solicitors' correspondence, that it had de-designated the UK from the 044 patent. It also informed the EPO that it no longer approved the text of the 322 patent. Both of these patents are in issue in FKB1 and S/B. Further, the letter indicated that AbbVie was prepared to submit to revocation in the United Kingdom of the 491 patent. AbbVie also offered undertakings, the effect of which, it claimed, was that it would not obtain any patent protection in the United Kingdom that would be infringed by the Claimants' biosimilar products as a result of their use of the dosage regimens for the indications specified in the declarations sought. It agreed to pay the costs of the proceedings and provided draft consent orders.
This offer was not acceptable to the Claimants, who invited AbbVie to submit to judgment, which would obviously end the proceedings. AbbVie refused to do this and continues to resist the grant of any declarations by the Court. Application notices, giving the juridical basis of the application (strike out or summary judgment) were served by AbbVie on 30 November 2016. Since the hearing in the Court of Appeal, when AbbVie gave certain undertakings to the Court, the scope of those undertakings has been expanded to take account of objections by the Claimants. The undertakings are now in their fourth draft.
In short, AbbVie's position on this application is that there is now no real prospect of a court finding that the declarations sought serve a useful purpose, and that the continuation of these proceedings would be an abuse of process, and a disproportionate waste of court resources.
FKB and SB/Biogen's position is that AbbVie is not prepared to offer the relief sought, or even an acknowledgement in terms of the declarations, because it would be a clear indication throughout Europe that the biosimilar products have been cleared in the United Kingdom. AbbVie resists such clarity because it has threatened to pursue proceedings for infringement throughout the world. The Claimants argue that AbbVie refuses the declarations precisely because they will serve a useful purpose, by influencing courts throughout Europe, removing any confusion in the marketplace, promoting settlement and preventing interference with the Claimants' supply chains between Europe and the United Kingdom. The Claimants say that if AbbVie continues to resist the declarations, then FKB1 should go to trial in January, as there remains a substantive issue between the parties as to the Claimants' entitlement to the relief sought.
Furthermore, the Claimants submit that the latest move by AbbVie cannot be viewed in isolation. It is part of a long course of conduct, whereby AbbVie has dragged out proceedings for as long as possible whilst threatening to sue for infringement, and then has abandoned its patent rights at the last moment, whilst filing further divisionals with very similar claims. This strategy is designed to encourage market uncertainty, whilst shielding AbbVie's patents from the risk of a finding of invalidity. In support of this submission they rely on conduct by AbbVie in the EPO, which is summarised below.
AbbVie's conduct in the EPO
In the FKB1 judgment, I summarised the facts relied on by FKB at the time. The Particulars of Claim in its original form sought to revoke two granted patents, namely EP (UK) 1 406 656 ("the 656 patent") and the 322 patent.
The 656 patent claimed the use of adalimumab in the treatment of rheumatoid arthritis by the 40 mg sc eow dosage regime. The application for the 656 patent was filed on 5 June 2002. It was not granted by the EPO until eleven years later, on 9 June 2013. During the nine month opposition period following grant, fifteen oppositions were submitted. AbbVie eventually filed its observations in response to the oppositions, together with no less than nineteen statements of fact and expert reports, on 22 December 2014. On 24 April 2015 AbbVie requested the grant of a divisional from the 656 patent ("the Fourth Divisional Application"), having previously requested the grant of three other divisionals. Between August and October 2015 various opponents submitted replies to the observations filed on behalf of AbbVie. However, on 4 November 2015, six days after the Claim Form was issued in FKB1, AbbVie wrote to the EPO stating that it no longer approved the text of the granted 656 patent. Accordingly, the EPO revoked the 656 patent on 16 November 2015. The Fourth Divisional Application, which claimed essentially the same subject matter as the 656 patent, was published on 4 November 2015.
FKB applied to plead these facts by amendment to its Particulars of Claim. It alleged that AbbVie intended to delay the entry of competing Humira biosimilar products by prolonging commercial uncertainty. FKB claimed that the purpose of abandoning the 656 patent was to avoid adjudication on its patentability by the UK court and the Opposition Division, whilst seeking to ensure that the subject matter of the alleged invention of the 656 patent was maintained by the Fourth Divisional Application. The object, according to FKB, was to prevent FKB from clearing the way in respect of its FKB327 biosimilar after expiration of the SPC for the basic adalimumab patent.
AbbVie disputed that there was any connection between its...
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