English Patents Court Grants Declaratory Relief in Humira® Dosage Regime Dispute

On 3 March 2017, the English Patents Court—Henry Carr J—issued a decision (see here) in the joint claims filed by Fujifilm Kyowa Biologics (FKB) and Samsung Bioepis/Biogen (S/B) against AbbVie Biotechnology Limited. The dispute centred on so‑called Arrow declarations regarding the dosage regimes of adalimumab, marketed by AbbVie as Humira®, for rheumatoid arthritis and psoriasis/psoriatic arthritis.

Arrow Declarations Explained

An Arrow declaration establishes that a product or process was already known or obvious as of a specified priority date. Its purpose is to give an alleged infringer a so‑called Gillette defence—a shortcut that, if a product was disclosed in the prior art or is an obvious modification, it cannot infringe any valid claim dated before that priority. The term derives from Arrow Generics v Merk [2007] EWHC 1900 (Pat).

In March 2016, Henry Carr J confirmed that the court had jurisdiction to grant such declarations. The English Court of Appeal reaffirmed this in January 2017, clarifying that the courts possess the power to issue Arrow declarations where appropriate.

Strategic Context for FKB and S/B

FKB and S/B sought declaratory relief to clear the path for their biosimilar products ahead of the October 2018 expiry of adalimumab’s compound patent protection. Initially they pursued revocation of the patents, but AbbVie abandoned those claims and continued to maintain divisional applications at the European Patent Office covering the same subject matter. AbbVie therefore intended to enforce its portfolio once the basic patent expired.

Having established that the dosage regimes were old or obvious at the relevant priority dates, Henry Carr J had to decide whether to exercise the court’s discretion to grant the declarations. He weighed “justice to the claimant, justice to the defendant, the useful purpose of the declaration, and any special reasons for or against grant” (Neuberger J, Financial Services Authority v Rourke [2002] C.P. Rep. 14).

Reasons for Granting the Declarations

• AbbVie’s conduct—threatening infringement while abandoning proceedings—required judicial intervention.
• The substantial investment in clinical trials and potential damages for the claimants demanded certainty.
• AbbVie’s threats of global infringement enforcement underscored the need for commercial clarity.

Henry Carr J found that the declarations would serve a useful purpose in the UK: they would dispel the commercial uncertainty that AbbVie’s enforcement threats had created, provide clear guidance to third parties, and protect the claimants’ UK supply chain by reducing the likelihood of injunctive relief elsewhere.

The judge also noted that he did not consider the potential spin‑off value of the judgment beyond its impact on the UK market.

Clarifying the Purpose of the Declarations

Although the claimants referred to the declarations as “Arrow declarations,” Henry Carr J clarified that this was misleading shorthand. In this case the declarations served to grant a Gillette defence against a specific infringement claim, rather than the broader purpose associated with the original Arrow case.

Priority and Chain of Title Issues

The case also addressed whether Abbott Bermuda, the applicant for the PCT that led to a European patent, was entitled to claim priority from a U.S. application. FKB and S/B argued that Abbott Bermuda was not the successor in title to the U.S. inventors, a requirement under U.S. law at the time. Henry Carr J rejected this argument, holding that a right to claim priority may only be exercised by the original applicant or a true successor in title, not both.

He ruled that Abbott Bermuda was indeed a successor in title for the purposes of priority, based on the chain‑of‑title principles laid out in Edwards Lifesciences v Cook Biotech [2009] EWHC 1340 (Pat) and KCI v Smith & Nephew [2010] EWHC 1487 (Pat). A key point was that one of the inventors was an employee under German employment law, which entitles an employer to claim a service invention if written notice is given within four months of the invention’s discovery. The claimants’ argument that the U.S. priority filing constituted such notice was abandoned; the employee’s duty to notify had not yet begun, so the employer retained the right to claim the invention at the time of the PCT filing.

Ultimately, the court found that the challenge to the chain of title failed, confirming Abbott Bermuda’s succession and the validity of the priority claim.

Conclusion

The English Patents Court’s decision underscores the courts’ willingness to grant declaratory relief that clarifies patent rights in the biosimilars market, protects commercial interests, and ensures that enforcement actions are based on clear, enforceable claims.