Arrow Declarations - Part II

FUJIFILM KYOWA V ABBVIE [2016] EWHC 2204 (PAT)

In October 2016, we reported the decision Fujifilm Kyowa V Abbvie [2016] EWHC 2204 (Pat) where Arnold J refused to strike out Fujifilm’s claim for an Arrow declaration in the ongoing litigation between these two parties. Since then, this decision has been appealed to the Court of Appeal and AbbVie have taken further steps to try and avoid a full trial on the matter.

Background

Arrow Declarations are declarations regarding the validity of subject-matter (rather than specific patents) and provide accused infringers of legal certainty that their proposed activities will not fall within the scope of any valid patent that may be granted in the future.

In this case, Fujifilm sought an Arrow declaration that the subject matter of a pending divisional application owned by AbbVie, that covered the antibody adalimumab (marketed as Humira) was not patentable, as they wish to launch a biosimilar product.

In September 2016 Mr Justice Arnold had previously refused to strike out Fujifilm's request for an Arrow Declaration, at the request of AbbVie, based on "bad faith" acts carried out by AbbVie in previous proceedings before the UK Court. Since then, AbbVie have appealed this decision and taken further steps in an attempt to avoid the scheduled trial.

Fujifilm v AbbVie [2016] EWHC 3383 (Ch)

Following the refusal of their request to have the claim for an Arrow Declaration struck out of proceedings, AbbVie took the following steps in order to try and avoid the full trial scheduled to commence on 16 January 2017:

– AbbVie de-designated the UK from one of the European patents that was at issue

– AbbVie revoked the other European patent at issue that was under opposition proceedings at the EPO

– AbbVie offered Fujifilm an undertaking not to obtain patent protection in the UK that would be infringed by Fujifilm's product.

Mr Justice Carr had to decide whether, in light of AbbVie's actions, there was a still a real prospect that the Arrow declarations sought would still be of use to Fujifilm.

The judge noted that the undertaking offered by AbbVie was not equivalent to the declaration which was sought. AbbVie could have submitted to judgement or provided an acknowledgement in the same terms as the declaration if they really did wish to provide an undertaking that was equivalent to the Arrow declarations sought. However, they had not done so.

It was also noted that the undertaking offered by AbbVie only covered patent protection in the UK and not elsewhere in Europe. As some components of Fujifilm's product would be sourced from Europe, an undertaking from AbbVie that did not extend to Europe would not provide sufficient legal certainty to Fujifilm regarding their proposed commercial activities.

It was therefore held that, despite AbbVie's attempt to avoid the trial, the trial would still proceed as the declaration sought would still be of use to Fujifilm.

Fujifilm v AbbVie [2017] EWCA Civ 1

Following the decision of Mr Justice Arnold in Fujifilm v AbbVie [2016] EWHC 2204 (Pat), AbbVie appealed on the basis that the declaration sought would contravene Section 74 of the UK Patents Act.

Section 74 states that:

74.-

(1) Subject to the following provisions of this section, the validity of a patent may be put in issue -

(a) by way of defence, in proceedings for infringement of the patent under section 61 above or proceedings under section 69 above for infringement of rights conferred by the publication of an application;

(b) in proceedings under section 70 above;

(c) in proceedings in which a declaration in relation to the patent is sought under section 71 above;

(d) in proceedings before the court or the comptroller under section 72 above for the revocation of the patent;

(e) in proceedings under section 58 above.

(2) The validity of a patent may not be put in issue in any other proceedings and, in particular, no proceedings may be instituted (whether under this Act or otherwise) seeking only a declaration as to the validity or invalidity of a patent.

AbbVie argued that Arrow declarations put the validity of a patent (in this case potentially a patent that has not yet been granted, or even filed) at issue and, as such declarations were not listed in Section 74(1), according to Section 74(2) Arrow declarations were unlawful.

The Court of Appeal dismissed this argument as they believed that Section 74 was only concerned with the validity of granted patents and in the case of Arrow declarations, these do not themselves declare any patent invalid. The Court also found no basis in either the UK Patents Act or the EPC that precluded them from issuing such declarations.

The Court emphasised that Arrow declarations could not be used by third parties simply to determine whether it is likely that a pending application will lead to a valid, granted patent. It is a matter of the discretion of the court as to whether to award such a declaration. In this case, as a result of AbbVie's previous attempts to "hide" various applications from the courts a declaration should be issued if appropriate.

Next Steps

The case has now proceeded to full trial and we await the judgement regarding an whether the Arrow declaration will be awarded against AbbVie.