Fujifilm Kyowa Kirin Biologics Company, Ltd v Abbvie Biotechnology Ltd (a company incorporated under the laws of Bermuda) (Defendant/Appellant in both appeals) Abbvie Ltd (Defendant/Appellant in A3 2016 3772)
| Jurisdiction | England & Wales |
| Judge | Lord Justice Floyd |
| Judgment Date | 12 January 2017 |
| Neutral Citation | [2017] EWCA Civ 1 |
| Docket Number | Case No: A3 2016 1199 |
| Court | Court of Appeal (Civil Division) |
| Date | 12 January 2017 |
and
[2017] EWCA Civ 1
Lord Justice Longmore
Lord Justice Kitchin
and
Lord Justice Floyd
Case No: A3 2016 1199
A3 2016 3772
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Mr Justice Henry Carr, Mr Justice Arnold
[2016] EWHC 425 (Pat); [2016] EWHC 2204 (Pat)
Royal Courts of Justice
Strand, London, WC2A 2LL
Geoffrey Hobbs QC, Mark Chacksfield and Jeremy Heald (instructed by Herbert Smith Freehills LLP) for the Appellants
Andrew Waugh QC, Thomas Raphael QC and Geoffrey Pritchard (instructed by Gowling WLG (UK) LLP) for the Respondent
Hearing dates: 28–29 November 2016
Judgment of the Court delivered by
There are two appeals before the court:
i) an appeal from the decision of Henry Carr J dated 1 March 2016 in an action between Fujifilm Kyowa Kirin Biologics Co., Ltd. ("FKB") and AbbVie Biotechnology Limited ("AbbVie Bermuda"), ("FKB 1") in which he declined to strike out a claim by FKB for a declaration that products which FKB proposed to market in the United Kingdom were old or obvious;
ii) an appeal from the decision of Arnold J dated 8 September 2016 in an action between FKB on the one hand and AbbVie Bermuda and AbbVie Limited ("AbbVie UK") on the other hand ("FKB 2"), in which he declined to strike out a claim by FKB for a similar declaration, as well as for an injunction against AbbVie Bermuda and AbbVie UK to restrain them from threatening or commencing proceedings for patent infringement in respect of acts covered by the declaration.
The appeals raise the question of whether, in proceedings such as the present, the court can properly grant declarations that a product was old or obvious in patent law terms at a particular date. An action for such a declaration was held to be arguable by Kitchin LJ (as Kitchin J) in Arrow Generics Limited v Merck & Co. Inc. [2007] EWHC 1900 (Pat), [2007] FSR 39 ("the Arrow case"). A declaration in these terms has been referred to in argument, for brevity, as an " Arrow declaration", and we will continue to do so. The appellants, whom we will refer to collectively as AbbVie (except where necessary to distinguish between them) contend that the Arrow case was wrongly decided, and that actions for Arrow declarations are, amongst other things, precluded by section 74 of the Patents Act 1977 ("the Act"), because they put the validity of a patent in issue. The question of whether Arrow declarations are a permissible remedy arises in both FKB 1 and FKB We will call it Issue 1.
There are two supplementary issues which arise in FKB 2. The first of these is whether the claim for an injunction to restrain AbbVie from threatening or commencing proceedings for patent infringement in respect of acts covered by the declaration is arguable or, alternatively, should be struck out at this stage. We will call this Issue 2. The second supplementary issue in FKB 2 is whether the claim against AbbVie UK should be struck out, independently of Issues 1 and 2, on the ground that it has no real prospect of success. This point arises principally because AbbVie UK is not the patentee or the exclusive licensee of any relevant patent or application. We will call this Issue 3.
To aid understanding of the procedural history of these cases, we first set out the basic framework of the European patent system, so far as relevant to this case, and identify the relevant provisions of national law.
The European patent system
The European Patent Convention ("EPC") is an international treaty creating, amongst other things, an international system for the grant of patents. It set up the European Patent Office ("EPO") as an international organisation based in Munich. Applicants apply to the EPO for protection for their inventions in such of the EPC member states as they choose ("designate") in their application.
The application is required (Article 78(1)(b) and (c) EPC) to include a description of the invention and one or more claims. The EPO examines the application in accordance with the EPC and the Implementing Regulations made pursuant thereto. The examination is carried out by the EPO's examining staff. It includes an examination for obviousness of the claims as drafted. The applicant can amend his claims in the course of prosecuting his application.
If the application survives examination by the EPO with the claims as originally filed (or as amended in the course of prosecution) the EPO will grant the "European Patent." However, as Jacob LJ pointed out in Unilin Beheer BV v Berry Floor NV and others [2007] EWCA Civ 364 at [9], that term is something of a misnomer, because what is granted (at least under current arrangements) is a bundle of national patents, one for each of the states designated by the applicant in his application.
Some aspects of the application procedure in the EPO require explanation. Firstly, we should mention divisional applications. Article 76 of the EPC makes provision for the filing of European divisional applications. Where an applicant has a pending application ("the earlier application"), he may file a new patent application (called a divisional) in respect of some of the subject matter of the earlier application. Such divisional applications will be entitled to the priority date of the earlier application if their subject matter does not extend beyond the content of the earlier application as filed.
Sometimes the EPO may require an applicant to make a divisional application, for example because the examiner considers that the application relates to more than one invention, referred to in the jargon as "lack of unity". In other circumstances the applicant may file a divisional application of his own initiative. Under Rule 36 of the Implementing Regulations of the EPC (EPCR) the applicant may make a divisional application at any time when the earlier application is pending. Because a divisional application is a patent application in its own right, it is possible for divisional applications to be based on applications which are themselves divisionals, and so on. So there may be a cascade of divisionals upon divisionals upon divisionals.
Because an applicant may wait until an earlier application has been in prosecution for many years before filing even a first divisional, it should be clear from the above description that the final form of any protection based on the subject matter of the parent application may take a very long time indeed to emerge. The protection conferred by the earliest application may have ended, but many divisionals and sub-divisionals based on the same subject matter may still be in the pipeline. At any given time a third party can examine the published applications which have been filed, but there may be others which have not been published, and more to come which have not even been filed. This is sometimes referred to as the problem of the "submarine divisional". The submarine divisional gives rise to practical problems for third parties in determining the extent of patent protection surrounding the patentee's product when they wish to launch competing products. It is plain that this uncertainty may have a chilling effect on competition.
The original version of the EPCR (Rule 25 in the 1973 version) allowed for the filing of divisional applications up to the date on which the text of the earlier application was approved by the applicant. Rule 25 was amended in 2002 to allow filing of a divisional at any time during the pendency of the earlier application. By a decision of the Administrative Council of the EPO dated 25 March 2009, the rule, which had by then become Rule 36, was amended to add a proviso that the divisional application had to be filed before the expiry of 24 months from the Examining Division's first communication in respect of the earliest application for which a communication had been issued (or 24 months from an objection by the Examiner that the earlier application did not meet the requirements of Article 82 EPC (unity of invention)). This rule change had the effect of curtailing to some degree the extent to which advantage could be taken by applicants of the procedure of filing divisionals. According to "Case Law of the Boards of Appeal of the European Patent Office", 6 th Edition 2010, the rationale for introducing the time limit was to prevent the filing of "abusive divisional applications" see page 389. One can understand why the authors of that publication should have taken that view.
However, by a further decision of the Administrative Council dated 16 October 2013, Rule 36 was amended again, this time to remove the 24 month time limit. We were not given any explanation as to why this amendment was made.
The grant of the patent (resulting in the bundle of national patents in the designated member states) does not always bring to an end the involvement of the EPO in the life of the patent. A further aspect of the procedure under the EPC is post-grant "opposition". Within nine months of grant, third parties may apply in the EPO for a determination that the patent be revoked. The procedure is a central one, and success by the opponent results in revocation for all the designated member states. The grounds of opposition are set out in Article 100 EPC.
The right to oppose in the EPO exists in parallel with the right to apply for revocation in each of the national courts of the states designated by the (now) patentee. Jacob LJ explained the evolution of this system in ( Unilin Beheer BV cited above) at [14] and [15]. In particular, as he pointed out, the new system under the...
To continue reading
Request your trial
-
Athena Capital Fund Sicav-Fis S.C.A. v Secretariat of State for the Holy See
...not only to the claimant, but also to the defendant: see Fujifilm Kyowa Kirin Biologics Co., Ltd. v Abb Vie Biotechnology Limited [2017] EWCA Civ 1; [2018] Bus LR 228 (‘ Fujifilm’) at [60]; iv) The Court must consider whether the grant of declaratory relief is the most effective way of re......
-
Teva UK Ltd and another v Novartis AG
... ... - Declaration - Generic pharmaceutical company seeking declaration as to obviousness of product ... to determine issues governed by its national laws; that, therefore, where the issue before the ... and another country in deciding issues under their own laws, the judge had been correct to ... 303 Inc [2011] EWHC 2959 (Pat) Fujifilm Kyowa Kirin Biologics Co Ltd v AbbVie ... Kirin Biologics Co Ltd v AbbVie Biotechnology Ltd [2017] EWHC 395 (Pat) ; [ 2018 ] RPC 1 ... September 2013, but deemed withdrawn in May 2016. (iv) A second divisional application, European ... applied to amend their statements of case in both actions. On 16 September 2022 Meade J declined to ... (Appeals lie from both courts (in the case of the ... ...
-
Technetix B.v v. Teleste Ltd
...or not infringed, see pp.480–1. However, Floyd LJ pointed out in Fujifilm Kyowa Kirin Biologics Co., Ltd v Abbvie Biotechnology Ltd [2017] EWCA Civ 1; [2017] RPC 9 that this idea has never been taken up and that the court must primarily consider whether the patent is valid: “[56] It is, we......
-
Athena Capital Fund Sicav-Fis S.C.A. v Secretariat of State for the Holy See
...not only to the claimant, but also to the defendant: see Fujifilm Kyowa Kirin Biologics Co., Ltd. v Abb Vie Biotechnology Limited [2017] EWCA Civ 1, [2018] Bus LR 228 (“ Fujifilm”) at [60]; iv) The Court must consider whether the grant of declaratory relief is the most effective way of re......
-
English Court Of Appeal 'Widens The Target' For Arrow Declarations (And Hands Control To Defendants)
...on to the Court of Appeal for another shot. This pattern has been observed from the Court of Appeal's judgments in Fujifilm v AbbVie [2017] EWCA Civ 1, Glaxo v Vectura [2018] EWCA Civ 1496, and, most recently Mexichem v Honeywell [2020] EWCA Civ 473. In each of the Fujifilm and Glaxo cases,......
-
Patents Court Grants Arrow-Style Declarations Aimed At Piercing Secondary Patent Shields
...the claims, including the Arrow declaration, which was dismissed by both the Patents Court and Court of Appeal ([2016] EWHC 425 (Pat); [2017] EWCA Civ 1; and [2016] EWHC 3383 On the technical case, the issues at trial was whether the administration of the proposed products at a dose of 40 m......
-
Ground-Breaking Declaratory Relief From English High Court Clears The Route To Market For Humira Biosimilar
...to strike out FKB's claim, but its application was refused in March 2016, [2016] EWHC 425 (Pat). On 12 January, the court of Appeal [2017] EWCA Civ 1 agreed with the High Court - the court had jurisdiction to grant declaratory relief, at its In an unexpected twist, two months before the tri......
-
Infringement - Annual Patents Review 2017
...https://www.supremecourt.uk/cases/uksc-2016-0197.html Fujifilm Kirin Biologics Co., Ltd v AbbVie Biotechnology Limited & Anr [2017] EWCA Civ 1 (12 January 2017) Longmore, Kitchin & Floyd LLJ Fujifilm Kirin Biologics Company Limited v AbbVie Biotechnology Limited [2017] EWHC 395 (Pat......