Michael Tappin QC, Andrew Lykiardopoulos QC and Mark Chacksfield appeared for the Defendant (“AbbVie”) in this action concerning certain of AbbVie’s patents and applications for the anti-inflammatory drug adalimumab (marketed by AbbVie as “Humira”).
The Claimants (“FKB” and “SB/Biogen”) sought declarations (the “Declarations”) to the effect that use of their biosimilar adalimumab products in certain approved treatment regimens was obvious and/or anticipated at the priority dates of the patents concerned.
AbbVie had disapproved the text of two of these patents (the “656 patent” and the “322 patent”) and de-designated a third (the “044 patent) in respect of the UK. Abbvie had also offered undertakings to the Court, the effect of which it claimed would offer the Claimants equivalent protection as that sought through the Declarations.
At issue were:
- whether AbbVie was entitled to claim priority for the 656 patent from an earlier US application (“US 961”);
- whether treatment of Rheumatoid Arthritis (RA) with the Claimant’s products at the dose specified in the Declarations lacked inventive step at the claimed priority date of the 656 patent;
- whether, in light of AbbVie’s undertakings, the Declarations should be refused on the basis they would no longer serve a useful purpose.
The Judge accepted AbbVie’s evidence concerning its chain of title and therefore that AbbVie were entitled to claim priority for the 656 patent from US 961. However, he found that in light of two prior art publications (“Kempeni 1999” and “Kempeni 2000”), the use of the Claimants’ products to treat RA at the dosing regime specified in the Declarations was obvious at the claimed priority date.
The judge held that the Declarations ought to be granted. The Court had to consider whether the Declarations would serve a useful purpose in the UK; a declaration sought solely for the benefit of foreign courts would rarely be justified. However, despite AbbVie’s undertakings and the revocation/de-designation of its patents and applications, the Declarations would still serve a useful purpose in the UK: this included providing commercial certainty for the Claimants and for third parties, protecting the Claimants’ supply chains and promoting settlement. It would not be unjust to grant the Declarations, and further there were special reasons supporting the grant of the Declarations in this case, namely: AbbVie’s prior conduct; the amount of money at stake; the need for commercial certainty in light of AbbVie’s previous threats to sue for infringement.