UK court grants declarations allowing biosimilar companies to “clear the way” of secondary patents
In the latest of a series of related judgements between the parties, the UK High Court has granted so-called “Arrow” declarations to Fujifilm Kyowa Kirin Biologics Company Limited (“FKB”), Samsung Bioepsis UK Limited, and Biogen Idec Limited (SB/Biogen) in respect of their biosimilar adalimumab product, thereby clearing the way of Abbvie’s secondary patents.
Could this decision pave the way for other biosimilar companies to obtain similar declarations in the UK?
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 and was the highest selling prescription drug in the world by global sales, achieving net sales of over US$12.5 billion in 2014. The dosage regimes for these 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 divisional patents for adalimumab which claim the use of this dosage regime. Having applied for revocation of two of Abbvie’s patents back in 2015 and 2016, which were subsequently withdrawn by Abbvie, FKB and SB/Biogen were seeking to “clear the way” in relation to a number of AbbVie’s divisional patents, so that they could launch their biosimilar adalimumab products in the UK.
FKB and SB sought “Arrow” declarations. An “Arrow Declaration” is essentially a declaration that the subject-matter of an invention (rather than the claims of a specific patent) is not patentable. The term stems from the case Arrow v Merck  EWHC 1900 (Pat) where such a declaration was first issued. The purpose of such declarations is to provide accused infringers of legal certainty that their proposed activities will not fall within the scope of any valid patent that may be granted in the future.
FKB and SB invoked a so-called “Gillette defence”, arguing that their own adalimumab product was anticipated and/or non-obvious at the priority dates of the defendant’s patents, and therefore if it was found that they infringed the defendant’s patents, then those patents must be invalid for lack of novelty and/or obviousness. They sought Arrow declarations from the court to confirm that their products were obvious and/or anticipated at the priority dates. Their aim was to prevent AbbVie from being able to threaten them with any future divisional patents as this would jeopardise the launch of their biosimilar adalimumab product.
FKB and SB alleged that AbbVie was 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 divisional patents.
The Claimants had to demonstrate that the declarations sought would serve a useful purpose, and that they should be granted taking into consideration justice to the Claimants, justice to the Defendants, and any special reasons as to why the Court should grant the declaration.
Mr Justice Carr granted the declarations, but stressed that this was due to the unusual nature of the case, citingAbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world.”
Despite Mr Justice Carr’s emphasis that the circumstances in this case are unusual, the grant of the declaration is of interest as it provides an effective tool for biosimilar companies seeking to clear the path for a product launch where the patentee has created multiple layers of secondary patent protection. The focus on the “infringing” product being obvious or anticipated provides powerful protection and commercial certainty, without conflicting with a patentee’s ability to obtain patent protection.
However, the facts of this case were extreme so the decision should not be taken as a green light for the availability of such declarations for all product launches – it remains a discretionary remedy of the Court, and one which is only likely to be granted in unusual situations where there is a legitimate commercial rationale for doing so.