Humira: the English Court of Appeal approves the 'Arrow declaration' as a legitimate tool

Humira: the English Court of Appeal approves the 'Arrow declaration' as a legitimate tool

In a case involving the best-selling Humira anti-inflammatory product, the English Court of Appeal has confirmed, in principle, that the court has discretion to grant an ‘Arrow’ declaration in cases where a patentee is shielding the subject matter of its patents from scrutiny by the court. The question whether such a declaration is justified in this particular case goes forward to trial.

AbbVie’s Humira, which is used in the treatment of rheumatoid arthritis and other inflammatory diseases, is said to be the highest-selling prescription drug in the world. It is reported that worldwide sales in 2014 exceeded US$ 12.5 billion and that AbbVie UK, which markets the product in the United Kingdom, achieved a turnover of £438.6 million in 2014. 

Basic patent protection about to end
UK patent protection for the active ingredient, adalimumab, will end on 15 October 2018 when the SPC expires. As is the usual practice in such cases, AbbVie have filed applications for ‘follow-on’ patents protecting dosage regimens, formulations and uses of adalimumab. These patents are challenged by FKB, a joint venture between Fujifilm Corporation and Kyowa Hakko Kirin Co Ltd, which wishes to launch a biosimilar adalimumab product (known as FKB 327) on expiry of AbbVie’s SPC. As required by the English courts, FKB is now attempting to ‘clear the path’ for its biosimilar before launch by establishing that its product does not infringe AbbVie’s follow-on patents.  In order to succeed in this FKB must either establish that the follow-on patents are invalid or that their biosimilar falls outside the subject matter of the claims.

Delaying tactics
The practical problem alleged by FKB is that through it use of divisional applications, by withdrawing applications just before grant and even submitting to revocation of a patent AbbVie was deliberately avoiding judicial scrutiny of its patents and creating a period of uncertainty about what form any patent protection in the UK might eventually take. This, argued FKB, made it difficult for FKB to clear the way in time for its launch. FKB therefore asked the court for an ‘Arrow’ declaration – a declaration by the court that at the priority date of the relevant application FKB’s proposed biosimilar was obvious based on the prior art. This would amount to a defence against an action by AbbVie for infringement of any patent eventually granted based on the application, because if the product is obvious at the priority date it necessarily follows that either the granted patent is invalid or the product does not infringe. 

The court’s discretion to grant declarations
The English court has a wide discretion to grant declarations, but it will not do so unless “it is useful to do so”. The court pointed out that negative declarations, such as an Arrow declaration, were unusual remedies. Under the statutory scheme set up by the Patents Act 1977 and the European Patent Convention a challenger to a patent should normally wait and see what patent is granted and then apply to revoke it.  However, where, for example, it appears that the ability to do this is being frustrated by the shielding of the subject matter from scrutiny in the national court it should be open to the court to grant an Arrow declaration. This issue now goes forward to trial.

Importance of the decision
The Court of Appeal’s decision makes it clear in principle that the court does have discretion to grant an Arrow declaration and that it may do so in a situation where the patentee is using delaying tactics to create uncertainty. We now await the High Court’s decision on whether an Arrow declaration is, in fact, justified in this particular case.

If you have any questions on these or other issues relating to intellectual property, do please contact Tom Lingard, Partner and Head of Intellectual Property or Charlotte Tillett, Partner and Head of Life Sciences, who will be happy to discuss.

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