AbbVie has obtained or applied for a number of patents and divisional patents relating to the antibody adalimumab, including patents relating to various dosage regimens.
The Claimants had applied to revoke two of AbbVie's dosage regimen granted patents (EP (UK) 1 406 656 and EP (UK) 1 944 322). They also sought an 'Arrow' declaration that "products containing a biosimilar monoclonal antibody to the antibody adalimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every other week by subcutaneous injection…" would have been obvious at the priority dates of the 656 and 322 Patents. The Claimants' intention was to clear the way of secondary patents so that they can launch their biosimilar products, on expiry of AbbVie's supplementary protection certificate for Humira in October 2018.
A significant factor in this case was that AbbVie had applied for five divisional patents relating to Humira. As the Court of Appeal explained, the prospect of 'submarine divisionals' (i.e., where the protection conferred by the parent application may have ended, but many divisionals and sub-divisionals based on the same subject matter may still be in the pipeline) can give rise to real, practical problems for third parties - in particular generic pharmaceutical companies - in determining the extent of patent protection.
Given the uncertainty of AbbVie's 'submarine divisionals', the Claimants sought an 'Arrow' declaration in respect of their proposed products. The aim was to obtain protection from any subsequent infringement action by AbbVie on the basis of one of its divisional applications, once they had proceeded to grant.
AbbVie's application to strike out the claim for the declaration was determined by the Court of Appeal in January (see our recent bulletin for more detail).
Having found that the dosage regimens of the Claimants' products were anticipated and/or obvious at the priority dates, the Judge concluded that the declarations sought would serve a useful purpose in the UK, for the following reasons:
- Commercial certainty: given Abbvie's conduct of publicly expressing its confidence in its portfolio, and its intention to enforce it against biosimilar competition, whilst also shielding its patents from court scrutiny (by disapproving of the text of the 656 and 322 patents, thereby leading to them being revoked centrally and de-designating a further divisional patent), the declarations would serve a useful purpose of dispelling commercial certainty in the UK and European market.
- Protection of the Claimants' supply chain for the UK market: Abbvie's threats of worldwide litigation were intended to have, and were likely to have had, a chilling effect on competition from biosimilars, including on third party suppliers. This was likely to impede the Claimants' ability to market their products successfully in the UK.
- Promotion of settlement: it was reasonably foreseeable that the grant of the declarations will promote a settlement on a European or even a worldwide basis in that it would change the parties' negotiating positions.
- Spin off value: the Judge accepted that the spin-off value of a judgment could be very valuable in other courts and tribunals, but he did not take this into account other than to the extent that it might impact on the UK market.
Accordingly, it would be just to the Claimants to grant the declarations sought and there would be no injustice to Abbvie in doing so.
However, the Judge commented that it was potentially misleading shorthand" to call the declarations 'Arrow' declarations as the circumstances relied on in this case were different to that in Arrow (and, indeed, were different from those that were originally pleaded by the Claimants).