Fujifilm declarations – High Court rules in favour of FKB in Humira challenge

Mr Justice Henry Carr has delivered his much-anticipated judgment on the trial of the joined claims of Fujifilm Kyowa Kirin Biologics Company Limited (FKB), Samsung Bioepis UK Limited and Biogen IDEC Limited (S/B) against AbbVie Biotechnology Limited (AbbVie) in the FKB1 action, finding in favour of the claimant companies and granting the declarations sought.

Background

The action relates to dosing regimens for second medical uses of Humira® (INN: adalimumab), a fully-human monoclonal antibody marketed by AbbVie as a therapy for various conditions including rheumatoid arthritis and psoriasis. At the time of trial, Humira was the largest selling prescription drug in the world by global sales, achieving net sales in 2014 in excess of US$12.5 billion.

We have covered the developments in this action previously, including AbbVie's summary judgment/strike out application and subsequent appeal. In January 2017, the Court of Appeal held that if the circumstances justify it, the English Court has the jurisdiction to grant so-called Arrow declarations. Henry Carr J's decision provides the first guidance from the High Court about when the circumstances might justify grant of an Arrow declaration.

FKB and S/B sought declarations that the use of their respective adalimumab biosimilar candidate products, FKB327 and SB5, by a 40mg subcutaneous every other week (40mg s/c eow) dosing regimen for the treatment of rheumatoid arthritis and psoriasis was obvious and/or anticipated at the claimed priority dates of AbbVie's patent applications.

The unusual facts of this case are well-summarised in the judgment. By the time of trial AbbVie had abandoned all relevant patent protection and applications in the UK and had provided undertakings to the Court that neither it nor its affiliates would obtain UK patent protection covering the dosing regimens in suit.

It was unwilling, however, to consent to the declarations in the form sought. This notwithstanding, in December 2016, Henry Carr J held that there was real prospect that at trial a judge would grant the declarations sought.

The technical case

Mr Justice Henry Carr decided that:

• patents and applications within the divisional family relating to rheumatoid arthritis were entitled to their claimed priority date
• the 40mg s/c eow dosing regimen for rheumatoid arthritis was obvious at the claimed priority date, and
• the 40mg s/c eow dosing regimen for psoriasis was anticipated by a public prior use at the claimed priority date.

The declarations

Having decided overall in the claimants' favour on technical issues, Henry Carr J considered whether the circumstances justified the exercise of the Court's discretion to grant the declarations sought.

Henry Carr J considered that on the facts it would be just to the claimants and not unjust to the defendant to grant the declarations.

Whatever the factual background, to be justified the declarations must serve a useful purpose in the UK. The judge confirmed that declarations solely for persuasive value in other jurisdictions would not satisfy this requirement.

In this case, the judge thought that the declarations would serve useful purposes by providing more commercial certainty than the undertakings given by AbbVie, helping to protect the claimants' European supply chains for the UK by reducing the risk of injunctive relief in other jurisdictions, and serving to promote wider settlement by changing the parties' relative positions in any negotiations.

Throughout his judgment, Henry Carr J made clear that the facts of this case are highly unusual. He considered therefore that there were special reasons in favour of granting the declarations including AbbVie's conduct of threatening infringement whilst shielding its patent portfolio from scrutiny, the amount of money at stake for the claimants and the need for commercial certainty.

Analysis

The judgment provides helpful guidance to manufacturers considering their strategy for 'clearing the way' prior to launch of biosimilar and generic products. As the Court of Appeal made clear in January, the default approach should be to wait for patent applications to proceed to grant and then seek revocation, but if the applicant-patentee's approach serves to frustrate this option the English Courts have provided a further mechanism for obtaining commercial certainty.

The guidance offered by this judgment is helpful, but the facts of this case are highly unusual and may represent a 'high-water mark' for when declarations should be granted. Future cases will be important in clarifying other situations that may justify the grant of Arrow declarations, and the decision will encourage others to try.

Next steps?

This is unlikely to be the last word on Arrow declarations. AbbVie has indicated that it will seek permission to appeal the Court of Appeal's decision from January to the Supreme Court, and it is likely the parties will seek to appeal Henry Carr J's decision to the Court of Appeal.

In the meantime, the second adalimumab action, FKB2, which relates to different dosing regimens for psoriasis, Crohn's disease and ulcerative colitis, is expected to proceed to trial in late-June 2017.