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30 June 2017

Arrow declarations

Fujifim Kyowa Kirin Biologics Company Limited v Samsung Bioepsis UK Limited v AbbVie Biotechnology Limited.

An “Arrow Declaration” has been granted for the first time by the High Court of England and Wales in London, allowing a product to go on the market despite facing patent applications which the product manufacturer cannot challenge. An Arrow Declaration is so named following the case of Arrow Generics Limited v Merck & Co. Inc. [2007] EWHC 1900 (Pat) (which had settled before trial). This is a novel remedy applied by the Court, giving the Claimants commercial certainty to launch having been confronted with the threat of infringement proceedings.

Background

The Defendant (AbbVie) is the proprietor of a large family of patents and patent applications covering dosing requirements for its Humira drug. Humira inhibits the inflammatory effects of certain diseases, including rheumatoid arthritis, psoriatic arthritis and psoriasis.

The product patent for Humira (EP 0,929,578 and SPC GB/04/002) is expiring in October 2018 and AbbVie has filed a number of divisional patent applications for the use of certain dosing regimens of Humira.

The Claimants (FKB and SB) sought declarations, (in separately issued actions), that AbbVie’s products, biosimilar drugs with certain dosing regimens, were obvious and/or anticipated at the relevant priority dates (8 June 2001 and 18 July 2003).

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