Ground-breaking declaratory relief from English High Court clears the route to market for Humira biosimilar

07 March 2017

This morning, a judgment was handed down in the hard-fought litigation between Fujifulm Kyowa Kirin Biologics (FKB), and 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 Partners Paul Inman and Luke Kempton, and Principal Associate Jenny Davies.

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.

Partner Paul Inman commented: "This is an exciting development for UK patent law, with implications far beyond the launch of biosimilar pharmaceuticals. Today's decision gives a new remedy to companies at risk of potential infringement proceedings under as yet ungranted patent applications. Importantly the Court clearly indicated 'unusual circumstances' will be required for such relief to be granted. In this case the Court found the patentee's behaviour to have created those circumstances and granted the remedy required to give FKB commercial certainty".

The Gowling WLG team of Partners Paul Inman and Luke Kempton, Principal Associate Jenny Davies and Senior Associates Chris Freeth and Tom Foster advised FKB, with Andrew Waugh QC, Justin Turner QC, Geoffrey Pritchard and Katherine Moggridge as counsel.

FKB was established in Japan in 2012, with a mission statement to ensure the "Earliest possible delivery of products to patients in need of them". FKB's biosimilar monoclonal antibody to Humira has received positive results in Phase 3 and is progressing towards launch.

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