Ground-Breaking Declaratory Relief From English High Court Clears The Route To Market For Humira Biosimilar

In a landmark judgment, the High Court has granted a novel type of declaratory relief to clear the route to market for a product facing a raft of pending patent applications incapable of challenge in the UK court: If the declaration serves a useful purpose, and upon considering the justice to the parties and any special reasons, the court can grant declarations that effectively offer an invisibility cloak against infringement actions based on patent applications which are later granted.

The High Court's 3 March 2017 decision in Fujifilm Kyowa Kirin Biologics v AbbVie Biotechnology [2017] EWHC 395 (Pat) marks the first declaration of its kind to be granted in the UK, and a turning point in patent litigation - allowing companies at risk of patent infringement to potentially "clear the way" even before patents are granted.

The judgment also resolves the uncertainty that remained after Arrow's battle with Merck in 2007, when the court refused to strike-out Arrow's claim for declaratory relief, but no final ruling emerged.

The highest turnover drug in the world

The case concerned AbbVie's network of patents and patent applications protecting dosing regimens for the use of its blockbuster anti-TNFα monoclonal antibody drug, Humira. Humira is used to inhibit the inflammatory effects of cell signalling protein "TNFα" in inflammatory diseases, including rheumatoid arthritis ("RA"), psoriatic arthritis ("PsA") and psoriasis.

With a global turnover of over $16 billion and daily UK sales of around £1.2 million, Humira is the world's highest selling drug.

Confronted with the imminent expiry of its basic product patent in October 2018 (EP 0,929,578 and SPC GB/04/002), AbbVie applied for "secondary" patents claiming the use of Humira in certain dosing regimens to treat various inflammatory diseases.

Clearing the way

In preparation for the launch of its monoclonal antibody biosimilar to Humira, in October 2015 FKB commenced litigation ("FKB1" proceedings) to clear the way of certain of AbbVie's secondary patents, seeking revocation of two of AbbVie's dosing regimen patents relating to RA and Psoriasis/PsA. As the Patents Act 1977 provides no mechanism to challenge the validity of pending patent applications in the UK courts, FKB also sought a new type of remedy - a declaration that using its own product in the relevant dosing regimens would have been obvious or lacking in novelty at the relevant date.

Such a declaration would give FKB an invisibility cloak from future patents for those dosing regimens - if using FKB's biosimilar in those dosing regimens was obvious or lacking in novelty, it could not infringe any future patent granted in respect of those regimens.

AbbVie applied to the High Court 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 discretion.

In an unexpected twist, two months before the trial, AbbVie abandoned or de-designated the UK from its relevant dosing regimen patent and offered the court undertakings not to obtain future patent protection in the UK for those dosing regimens. With no relevant patents subsisting, AbbVie again attempted to strike-out FKB's claim. However, Henry Carr J. [2016] EWHC 3383 (Ch) found FKB had a...