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  EWHC 395 (Pat). Although there are many inviting issues addressed in Carr J's 100 page decision handed down this morning - namely priority (chain of title), anticipation and obviousness of the dosage regimes - this post focuses on the issue of the Court's jurisdiction and appetite for granting such declarations. The long running-procedural history and detailed factual background to the litigation is set out in Annsley's post of last night (here), and is summarised below for those who could do with a brief re-cap.
|The IP Kitten on the edge of her seat|
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.
FKB and SB/Biogen’s position was that AbbVie is not prepared to offer the relief sought, or even an acknowledgement in terms of the declarations, because it would be an unambiguous indication that the biosimilar products have been cleared in the United Kingdom. The Claimants argued that AbbVie had threatened to pursue proceedings for infringement throughout the world. They suggested that AbbVie refuses to submit to the declarations precisely because they will serve a useful purpose, by removing any confusion in the marketplace, promoting settlement, preventing interference with the Claimants’ supply chains between Europe and the United Kingdom and by influencing other courts throughout Europe.
Furthermore, the Claimants submitted that AbbVie has engaged in a course of conduct whereby it has dragged out proceedings for as long as possible whilst threatening to sue for infringement, and then has abandoned its patent rights at the last moment, whilst filing further divisionals with very similar claims. According to the Claimants, this strategy is designed to encourage market uncertainty, whilst shielding AbbVie’s patents from the risk of a finding of invalidity.
The details of AbbVie's conduct are set out in earlier IPKat posts. One further illustrative example
|Carr J. in a less sceptical mood|