Fujifilm Kyowa Biologics Co Ltd v Abbvie Biotechnology Ltd (Rev 1)

A Patents Court may grant an Arrow-type declaration that a claimant’s own product was obvious or anticipated at the priority date of pending divisional applications. Such relief is not a pre-grant opposition or an impermissible determination of the validity of a future patent. Section 74 of the Patents Act 1977 does not prohibit a declaration concerning a published application. The jurisdiction is discretionary and must be exercised cautiously, having regard to justiciability, commercial utility and the cumulative circumstances.

Fujifilm Kyowa Biologics sought to amend its claim against AbbVie to include a declaration that its proposed biosimilar adalimumab product would have been obvious or anticipated at the relevant priority dates. AbbVie applied to strike out the declaration, arguing that section 74 of the Patents Act 1977 barred it and that the relief would usurp the European Patent Office’s examination function.

The court considered whether Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat) was wrongly decided and whether the pleaded circumstances gave the proposed declaration a realistic prospect of being granted.

1. AbbVie’s strike-out application was dismissed and the amendments were allowed. The court had jurisdiction to grant a declaration directed to the claimant’s own product.

2. Section 74 of the Patents Act 1977 concerns proceedings in which the validity of granted patents may be put in issue. Sections 130 and 69 do not extend its prohibition to a declaration concerning a published patent application. The court agreed with the reasoning in Arrow Generics Ltd v Merck & Co Inc [2007] EWHC 1900 (Pat).

3. The relief did not constitute a pre-grant opposition or directly determine whether a valid patent could be granted. The court could not properly declare that no valid patent could be granted on an application being prosecuted before the EPO. A declaration that the claimant’s defined product was obvious or anticipated at the priority date served a different purpose, including clearing the way where infringement proceedings could create substantial commercial uncertainty.

4. Exceptional circumstances were not a separate mandatory requirement, but caution was required. The court should consider whether the issue was clearly defined and justiciable, whether the declaration served a useful purpose, whether the cumulative circumstances justified relief, and justice to both parties.

5. The pleaded facts gave a realistic prospect that the trial judge would grant relief. They included the abandonment of the granted patent shortly after revocation proceedings began, continuation of similar subject matter in a divisional application, substantial investment and potential loss, a clearly defined product and acts, the United Kingdom limitation of the declaration, and a real prospect that the product was obvious or anticipated.

First-instance interlocutory decision on an application to amend the claim and a cross-application to strike out part of the pleading. No prior appellate decision is stated in the judgment.