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UK – Fujifilm Kyowa Biologics v. AbbVie

17 Mar 2016

Fujifilm Kyowa Biologics Co., Ltd. v AbbVie Biotechnology Ltd., High Court of England and Wales (Carr J), London, UK, 1 March 2016, Neutral Citation Number: [2016] EWHC 425 (Pat)

The English High Court has confirmed that it has jurisdiction to grant a declaration that a dosage regime for a biosimilar product would have been anticipated or obvious at the priority date of a granted patent. This decision by Mr Justice Carr came out of Fujifilm Kyowa Biologics’ (FKB) application to amend its pleadings in a patent revocation action against AbbVie.

On 29 October 2015, FKB issued invalidity proceedings in the High Court seeking to revoke two AbbVie patents, namely EP (UK) 1 406 656 and EP (UK) 1 944 322, relating to dosage regimes for use of the antibody adalimumab (branded Humira) in the treatment of rheumatoid arthritis and psoriasis. FKB is seeking to clear the path for the launch of its biosimilar adalimumab after AbbVie’s basic patent and its associated UK SPC expires on 15 October 2018.

On 4 November, AbbVie wrote to the EPO saying that it no longer approved the text of EP ’656. The EPO subsequently revoked the patent. On the same date, the EPO published one of four divisional applications based on EP ’656. The divisional covered essentially the same subject matter as EP ’656. AbbVie also has other pending divisional applications claiming the same adalimumab dosage regime for treating different indications.

In its application, FKB sought to amend its pleadings to ask for a declaration that its adalimumab biosimilar products for the treatment of RA and psoriasis using the same dosage regimes covered by EP ‘656 and EP ‘322 would have been obvious and/or anticipated at the priority dates of those patents. If granted, the declaration would create a squeeze between infringement and validity such that an action for infringement of AbbVie’s granted patents, and any pending divisionals (once granted) with the same subject-matter, could not succeed.

The arguments from both sides centred on whether the decision in the English High Court case, Merck v Arrow, was correctly decided.  In Arrow, Kitchin J (as he then was) held that the High Court had jurisdiction to grant a declaration that a generic pharmaceutical product was obvious at the priority date of certain divisional patent applications.  Arrow addressed a number of issues, including the scope of section 74 of the UK Patents Act (concerning the circumstances in which the validity of granted patents may be put into issue) and whether granting a declaration of the type requested would impermissibly introduce pre-grant opposition proceedings or otherwise usurp the function of the EPO in its examination of European patent applications.

Carr J reviewed the Arrow decision and concluded that it was correctly decided.  He noted that without Arrow declarations “it would be impossible for parties who wished to clear the way for the launch of a product to do so, without facing years of commercial uncertainty posed by cascading divisionals pending before the EPO”.

Having decided that the court has jurisdiction to grant declarations of the sort requested by FKB, Carr J went on to consider the circumstances in which the court would exercise its discretion to grant this type of declaratory relief. He advocated caution, holding that declarations would not be granted simply because pending applications existed. Instead, “a full analysis of the facts will be required, to ensure that any such declaration is justified”.  In particular, the party seeking the declaration must show that the declaration would serve a useful purpose.  On the facts in this case, he considered that, whether intentionally or not, AbbVie’s abandonment of EP ‘656 and the existence of the divisional application at the EPO has created prolonged commercial uncertainty for FKB.

In addition, Carr J considered that the amount of money at stake for FKB, both in terms of clinical trials investment and potential damages if it launches at risk, is unusually high.  He also noted that AbbVie has already indicated that it will seek to enforce its patent rights in respect of Humira biosimilars. The declaration, if granted, would therefore dispel real commercial uncertainty and remove the risk of a large damages claim in the UK.  Carr J stressed that FKB is seeking a declaration only in respect of particular characteristics of its own product, which are clearly defined, and the declaration itself is limited to the UK – FKB is not seeking a declaration that no valid patent can be granted based on the divisional applications.

Taking these factors into account, and considering the limited scope of the declaration, Carr J decided that FKB had a real prospect of being granted the declarations at the full trial of the action.

A copy of the judgment can be found here.

Headnote: Beth Williams, Marks & Clerk Solicitors