Fujifilm Kyowa Kirin Biologics Co, Ltd v Abbvie Biotechnology Ltd & Anor

An Arrow declaration, determining whether a specified product, process or use was old or obvious at a stated date, is available in principle. Patents Act 1977 section 74 bars such relief only where it is, in substance, a declaration that a granted patent is invalid without a revocation claim. A declaration may therefore be impermissible if it maps onto all features of a granted claim, but not merely because pending divisional applications may later include the specified features.

The EPC scheme does not prevent a national court from granting an inter partes declaration which leaves the EPO free to determine pending applications. The normal remedy remains revocation after grant. Declaratory relief requires a real and useful justification, which may arise where subject matter is being shielded from timely scrutiny and commercial uncertainty would otherwise persist.

FKB intended to market a biosimilar adalimumab product after expiry of AbbVie’s supplementary protection certificate. It sought declarations that specified dosage regimens were old or obvious at relevant priority dates, so as to establish a prospective Gillette defence against patents that might emerge from AbbVie’s pending divisional applications. These were described as Arrow declarations.

In FKB 1, Henry Carr J declined to strike out the claim for a declaration: [2016] EWHC 425 (Pat). In FKB 2, Arnold J likewise refused to strike out a similar claim, a proposed injunction against infringement proceedings, and the claim against AbbVie UK: [2016] EWHC 2204 (Pat).

The appeals raised whether Arrow declarations are available in principle, whether the proposed injunction was arguable, and whether AbbVie UK should remain a defendant.

1. The appeals were dismissed. An Arrow declaration is available in principle. The Court approved the reasoning in Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat).

2. Section 74 of the Patents Act 1977 concerns the validity of granted patents. It does not require statutory authorisation where no granted patent’s validity is put in issue. A declaration that a product was old or obvious can nevertheless be a disguised invalidity declaration where it corresponds to all the features of a granted patent claim. In that event, it is impermissible unless pursued with revocation proceedings. Revocation of a patent operates ab initio, so section 74 does not continue to protect a revoked patent.

3. The declarations sought did not map onto claims of a granted patent. They did not ask the court to declare a patent invalid. Nor did they review EPO action or bind the EPO. The EPC system necessarily permits national courts, when deciding domestic patent issues, to determine whether combinations of features are old or obvious while related applications remain pending before the EPO.

4. The existence of a future statutory remedy of revocation does not bar declaratory relief where no patent has been granted. It remains a significant discretionary consideration and the normal means of obtaining invalidity findings. Pending applications alone are insufficient. The pleaded conduct was, however, capable of showing that subject matter had been shielded from timely EPO and national-court scrutiny, creating a real need for commercial certainty.

5. The proposed injunction was not bound to fail. Although the Court doubted whether an injunction would ultimately be justified in the wide form sought, an appropriately framed injunction could be an alternative to, or support for, declaratory relief. The Article 6 issue did not require determination on a strike-out application.

6. There was an arguable basis for relief against AbbVie UK. The judge could infer from the commercial position that it might become an exclusive licensee or otherwise have a substantial interest in maintaining the United Kingdom monopoly. The claim against it was therefore not struck out.

• Court of Appeal (Civil Division): Dismissed AbbVie’s appeals and upheld the refusal to strike out the claims for Arrow declarations, the proposed injunction, and the claim against AbbVie UK.

• High Court, Patents Court: Henry Carr J refused to strike out the FKB 1 declaration claim: [2016] EWHC 425 (Pat).

• High Court, Patents Court: Arnold J refused to strike out the FKB 2 declaration and injunction claims and the claim against AbbVie UK: [2016] EWHC 2204 (Pat).