FKB and Samsung Bioepsis sought declarations from the Patents Court that at the priority date of various pending patent applications it would have been obvious or anticipated to use their biosimilar adalimumab products at a dose of 40mg every other week by subcutaneous injection for the treatment of rheumatoid arthritis, psoriatic arthritis, and/or psoriasis. The Claimants had originally sought the declarations as part of revocation proceedings brought against AbbVie in relation to two granted patents, but due to AbbVie’s abandonment of the granted patents in respect of the UK, only the declaration was in issue by the time of trial. The declarations establish a so called “Gillette” defence for the products subject to the declarations such that any subsequently granted patents with a priority date after that in the declaration would be non-infringed and/or invalid. The availability of such declarations has recently been confirmed by the Court of Appeal who held that whether such a declaration is justified depends on whether a sufficient case can be made for the court to exercise its discretion to do so. Ahead of trial AbbVie gave undertakings which it said would have the effect that AbbVie and its affiliates would not obtain UK patent claims that contained as an integer the use by subcutaneous injection of 40mg adalimumab weekly or every other week, which it argued made the declarations unnecessary. FKB and Samsung Bioepsis disagreed.
Carr J. held that the Claimants had established that it would have been obvious or anticipated to use their products as they had stated in their declarations and so went on to consider whether the declarations sought should be granted. FKB and Samsung argued that the declarations were necessary as they had “spin-off” value in other jurisdictions. Whilst accepting that this can be valuable and it would be legitimate for FKB and Samsung to rely on the declarations in other jurisdictions, Carr J. concluded that a declaration which is sought solely for the benefit of foreign proceedings will rarely be justified, and the court must consider whether the declaration would have useful purpose for the UK. In this regard, Carr J held that the declarations would have a useful purpose as:
1. AbbVie’s conduct had been to threaten infringement whilst abandoning proceedings at the last moment in order to shield the claims of its patents from scrutiny in the EPO and in the UK courts. This conduct was designed to prolong commercial uncertainty, and the declarations will have a useful purpose in dispelling this uncertainty;
2. the declarations would be beneficial to third parties due to their clarity and would have a useful purpose in protecting the Claimants’ supply chains for the UK market which had manufacturing steps in other European jurisdictions, and for which the declaration will make injunctive relief less likely;
3. the declarations would have a useful purpose in promoting settlement as AbbVie would need to take into account that the Court has declared that it cannot prevent the marketing of the Claimants’ products; and
4. the amount of money at stake for the Claimants in terms of both investment in clinical trials and the potential damages should they have been found to infringe a valid patent.
This is the first time that the Patents Court has exercised its discretion to grant negative declarations (or so called “Arrow” declarations) of the type sought by the claimants. The result will be welcomed by those parties looking to launch biosimilar products in the UK as it will negate the risk of pending patent applications proceeding to grant shortly before or after a product has been launched and the resultant injunction/damages risk. However, it is far from clear that the Patents Court will grant such negative declarations regularly, particularly since it can be difficult to frame negative declarations so to encompass all the technical features which may ultimately be included in a patent claim on grant. Further in this case AbbVie did not adduce any evidence to suggest why the negative declarations provided no useful purpose nor did it challenge in cross-examination the evidence adduced by the Claimants.