Fujifulm Kyowa Kirin Biologics (FKB) v. AbbVie Biotechnology

For the first time, a UK court has granted declaratory relief to a company trying to launch a product in the face of a myriad of patent applications in order to protect it against later infringement claims.

FKB’s claim was led by Gowling WLG with Paul Inman (Picture), Luke Kempton, Jenny Davies, Chris Freeth and Tom Foster.

While the Patents Act 1977 provides no mechanism for challenging the validity of patent applications in the UK courts, the High Court has today found an answer.

FKB sought to clear the way for the launch of its monoclonal antibody therapy, which is a biosimilar to AbbVie’s blockbuster Humira – the world’s best-selling drug, with a global turnover of over $16 billion and daily UK sales of around £1.4 million.

The judge commented on the duplicative divisional applications, tactics to delay applications being granted, and abandonment of granted patents in favour of pending “divisional” applications. The strategy was described by the judge as being designed “to shield the claims of its patents from scrutiny in the EPO and in the UK Court”.

With no proven way for FKB to clear the way to launch its biosimilar to Humira, FKB sought declarations that dosing regimens using its own product to treat the relevant diseases would have been obvious (so FKB cannot in future be said to infringe any patent granted for those regimens). The grant of these declarations today gives FKB a cloak of invisibility from future AbbVie patents for those regimens.

Today’s High Court decision also removes the uncertainty that remained after Arrow’s 2007 battle with Merck, when the same court refused to strike-out Arrow’s claim for declaratory relief, but no final ruling emerged on the availability of declaratory relief. At an earlier stage in the present proceedings AbbVie similarly tried to strike-out FKB’s claim for a declaration and, having failed twice in the High Court and once in the Court of Appeal, is now seeking leave to appeal to the Supreme Court.

Involved fees earner: Paul Inman – Gowling WLG; Luke Kempton – Gowling WLG; Jenny Davies – Gowling WLG; Christopher Freeth – Gowling WLG; Tom Foster – Gowling WLG;

Law Firms: Gowling WLG;

Clients: Fujifulm Kyowa Kirin Biologics;

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