Adalimumab - UK

On Mar 03, 2017, The High Court has granted declarations to FKB and SB to the effect that their products lacked novelty or an inventive step at a particular date - Fujifilm Kyowa Kirin Biologics Company Limited and Samsung Bioepsis UK Limited v AbbVie Biotechnology Limited [2017] EWHC 395 (Pat). 

The dispute concerns the antibody adalimumab, marketed by AbbVie under the trade mark Humira.  Humira is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and psoriasis.  The dosage regimes for those indications include the administration of 40mg of adalimumab every other week as a single dose via subcutaneous injection.  AbbVie has obtained or applied for a number of patents and divisionals for adalimumab which claim the use of this dosage regime, and applied for a fifth divisional patent.   Fujifilm Kyowa Kirin Biologics (FKB) and Samsung Bioepsis and Biogen Idec (SB) issued separate proceedings in 2015 and 2016 to revoke two of AbbVie's dosage regime patents (EP UK 2,940,044 and EP UK 1,944, 322) in an attempt to clear the way for their proposed biosimilar product launches after the SPC on Humira expires in Oct 2018.  Those patents were subsequently withdrawn by AbbVie.

FKB and SB allege that AbbVie is implementing a well-established strategy of dragging out proceedings for as long as possible, causing maximum expense and inconvenience to its opponents, and then throwing in the towel by withdrawing its patents, just before they are scrutinised by the court, whilst covering the same subject matter with further divisionals. The Claimants sought declarations that their products were obvious and/or anticipated at the claimed priority dates of certain of AbbVie’s patents, namely 8 June 2001 and 18 July 2003.  The reason behind these declarations to is to prevent their biosimilar products being threatened by any future divisional patents.

Summary of conclusions:

i)  AbbVie has proved that, at the date of filing of the PCT Application on 5 June 2002, Abbott Bermuda was “successor in title" to the invention the subject of US 961. Therefore, the 656 patent was entitled to its claimed priority date of 8 June 2001.

ii) The administration of the Claimants’ proposed products in the treatment of RA by a dosage regimen of 40 mg once every two weeks by subcutaneous injection was obvious as of 8 June 2001 in the light of Kempeni 1999.

iii)  Further or alternatively, the administration of the Claimants’ proposed products in the treatment of RA by a dosage regimen of 40 mg once every two weeks by subcutaneous injection was obvious as of 8 June 2001 in the light of Kempeni 2000.

iv) The administration of the Claimants' proposed products at a dose 40mg sc every other week for the treatment of psoriasis and psoriatic arthritis was anticipated or obvious as of 18 July 2003.