Latest

Inside Life Sciences

Patents Court grants ground-breaking declarations in Humira dosage regimen case
Inside Life Sciences

Inside Life SciencesIssue 1 | April 2017

Date
27 April 2017

David Rose Partner

Nina O'Sullivan Legal Director, Professional Support Lawyer

Cassandra Hill Managing Associate

In the latest instalment in the battle concerning AbbVie's 'Humira' product (the highest-selling prescription drug in the world by global sales), Mr Justice Henry Carr has ordered declarations in favour of Fujifilm and Samsung Bioepsis/Biogen.


Patents Court grants ground-breaking declarations in Humira dosage regimen case

In the latest instalment in the battle concerning AbbVie's 'Humira' product (the highest-selling prescription drug in the world by global sales), Mr Justice Henry Carr has ordered declarations in favour of Fujifilm and Samsung Bioepsis/Biogen, that administration of their intended biosimilar adalimumab products in particular dosage regimens were obvious and/or anticipated at the claimed priority dates of certain of Abbvie's patents. The decision follows the Court of Appeal's judgment in January 2017 that so-called 'Arrow' declarations were permissible under the scheme of the Patents Act.   

An Arrow declaration (named after the first case in which such a declaration was considered, Arrow v Merck) is to the effect that a product would have been obvious and/or anticipated at the priority date of a particular patent application. As a result, if that application proceeds to grant, the party with the benefit of the Arrow declaration can rely on it as a defence (i.e., as a squeeze through a 'Gillette' defence) to a claim for infringement.   

The Court has concluded that, on the unusual facts of the case, the declarations would serve a useful purpose.  In particular, the Judge took into account:

  • Abbvie's conduct of threatening infringement whilst abandoning proceedings at the last minute (so as to shield its portfolio from scrutiny by the Court);
  • The need for commercial certainty, given Abbvie had made threats to sue for infringement throughout the world;
  • Protection of the Claimants' supply chain for the UK market;
  • The amount of money at stake for the Claimants in terms of their investment in clinical trials (and potential damages if they launched at risk);  and
  • Promotion of settlement.

For patent challengers, the ability to seek such declarations to clear the way to market is significant.  Whilst the decision focuses on pharmaceutical products, there is no reason why such a declaration could not be sought in relation to other forms of technology.

Background

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).

The decision to grant the declaration

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).