Andrey_Popov /
8 March 2016Biotechnology

English High Court grants Fujifilm declaration in AbbVie patent row

The English High Court has allowed Japan-based drug maker Fujifilm Kyowa Kirin Biologics to amend some of its arguments in a patent dispute surrounding AbbVie’s arthritis drug Humira (adalimumab).

In an interim judgment at the English High Court, Mr Justice Carr said Fujifilm should be able to amend the claims and rejected an application by AbbVie to have some of the pleadings thrown out.

The dispute centres on Fujifilm’s attempt to market a biosimilar of Humira.

Humira is the highest selling prescription drug in the world by global sales, achieving net sales in excess of $12.5 billion in 2014, according to the judgment. It is used to treat rheumatoid arthritis, psoriatic arthritis and psoriasis.

AbbVie’s basic patent covering the drug is EP 0,929,578.

Fujifilm’s proposed biosimilar, called FKB327, is in phase III clinical trials and the company intends to market the biosimilar in the UK after the ‘578 patent expires in 2018.

The original claim, which also still stands, seeks to revoke two patents, EP 1,406,656 and EP 1,944,322, both of which relate to the dosage regime for adalimumab, on the grounds of obviousness.

However, Fujifilm was also concerned about several divisional applications applied for by AbbVie which are related “in some way” to adalimumab.

Fujifilm applied for a declaration that patents incorporating claims directed to “products containing a biosimilar monoclonal antibody to the antibody adalimumab” would have been obvious at the priority dates of the ‘656 and ‘322 patents.

AbbVie sought to strike out this declaration.

Carr, refusing AbbVie’s bid to strike out the declaration and allowing the amendments sought by Fujifilm, said the court had jurisdiction to grant the declaration.

He said there was a reasonable prospect that at trial the court will decide to “exercise its discretion” to grant this declaration.

“Therefore, I shall dismiss AbbVie’s application to strike out this part of the claim, and allow the amendments in the form currently pursued by Fujifilm,” he wrote.

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