Life Sciences: clearing the path for a Humira biosimilar

The English courts generally expect companies wishing to launch a generic or biosimilar product to ‘clear the path’ first to avoid infringement of the originator’s patents. Companies clearing the path can face delays, however, where the originator has filed multiple divisionals as there may be a period of uncertainty about exactly what patents will eventually be granted. A decision handed down on 8 September 2016 by the English High Court  demonstrates that in such a situation it may be possible for the company clearing the path to cut the Gordian knot by applying for an ‘Arrow’ declaration.  This is a declaration by the court that at the priority date of the relevant divisional application its proposed new product was obvious based on the prior art.  This will amount to a defence against an action by the originator for infringement of any patent granted based on that application, because if the product was obvious at the priority date it necessarily follows that either the granted patent is invalid or the product does not infringe.

AbbVie’s patent position for Humira
AbbVie’s Humira product, said to be the highest-selling prescription drug in the world, is used in the treatment of several human inflammatory diseases including rheumatoid arthritis. The active ingredient is adalimumab, a monoclonal antibody. Patent protection for adalimumab in the UK will end on 15 October 2018.  AbbVie had filed applications for a large number of secondary patents covering dosage regimens, formulations and uses of the drug and had made clear its intention to seek injunctive relief where necessary.

The dispute
Fujifilm Kyowa Biologics applied to the High Court for an Arrow declaration and an injunction to prevent AbbVie from threatening or commencing proceedings for patent infringement in respect of the acts covered by the declaration. AbbVie countered by applying for summary judgment rejecting these claims. The High Court found for Fujifilm, holding that it had a ‘real  prospect of success’ in obtaining the Arrow declaration and injunction sought. A key factor here was that the court felt that AbbVie may have deliberately tried to create a period of uncertainty by withdrawing a patent application just before grant in order to avoid the granted patent being held invalid by the court, whilst expressly reserving the right to bring forward divisionals which covered similar ground at a later date. This suggested that AbbVie’s purpose was to shield some or all of the subject matter of the patent from timely scrutiny by the court or at least to prolong uncertainty about whether the subject matter of the patent could form the basis of a valid patent.

Significance of the decision
The decision will be welcomed by generics and others seeking to ‘clear the way’ for their own products. It may also influence the filing tactics of originators who wish to avoid a situation in which the court will feel they are deliberately creating uncertainty in this way.

1. Fujifilm Kyowa Kirin Biologics Company Ltd and AbbVie Biotechnology Limited and Anr [2016] EWHC 2204(Pat)

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