High Court gives ground-breaking declaratory relief judgment in favour of Fujifulm Kyowa Kirin Biologics (FKB) and Gowling WLG

04 March 2017

The March 2017 High Court judgment granted declaratory relief to FKB, which was attempting to launch a product and protect it against later, as yet ungranted, patent applications by AbbVie Technology.

The case deals with FKB's launch of its monoclonal antibody therapy, which is a biosimilar to AbbVie's Humira, being the world's bestselling drug. EU regulatory legislation obliged biosimilar drugs to employ the same dosing regimen as the originator drug.

AbbVie's strategy was to delay granting secondary patent applications, including for dosing regimens, for as long as possible, an action that had not, up until this High Court judgment, been successfully challenged in a UK court.

Gowling WLG's Life Sciences team, led by partners Paul Inman and Dr Luke Kempton, argued in the High Court for a declaration that FKB's biosimilar (specifically its dosing regimen) was obvious at the relevant date. This meant that if granted, FKB was safe against future claims: if the dosing regimen was obvious, it could not infringe any future-granted patent.

The novel remedy argued by Gowling WLG and handed down by the High Court means FKB can address multiple patents/applications simultaneously, reducing costs and avoiding the need for repeated litigation. 


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