English High Court grants Arrow declaration in Fujifilm v AbbVie
The English High Court has ruled in favour of Fujifilm Kyowa Kirin Biologics in a case against AbbVie, granting Fujifilm an Arrow declaration allowing it to market a biosimilar of AbbVie’s Humira ( adalimumab), a medication used to treat arthritis.
An Arrow declaration states that the subject matter of an invention is not patentable.
Fujifilm intends to market the biosimilar in Europe, including in the UK, after expiry of the basic adalimumab patent and its associated supplementary protection certificates.
The case, which was handed down on Friday, March 3, was described by Mr Justice Carr as “unusual”.
Carr said in his decision: “I consider that, on the most unusual facts of this case, there are special reasons which support the grant of the declarations. These include AbbVie’s conduct of threatening infringement whilst abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny).”
In an interim judgment in March 2016, the court allowed Fujifilm to amend some of its arguments in the patent dispute, while rejecting an application by AbbVie to have some of the pleadings thrown out.
The judgment was issued by Carr. Appeals by AbbVie were heard in November last year, and judgment was reserved.
In October 2015, Fujifilm commenced patent revocation proceedings against AbbVie seeking a declaration that AbbVie’s dosing regimen patents were invalid.
Following the patent revocation proceedings, AbbVie abandoned and withdrew the patents in the UK, which resulted in the court giving Fujifilm permission to continue proceedings to obtain an Arrow declaration.
Paul England, senior associate of Taylor Wessing, said: “The criticism is sometimes made that the number of follow-up patents protecting some drugs prevent competing products entering the market for too long after expiry of the original compound patent.”
England explained that patents that are still at the application stage cannot be challenged in courts in order to clear the way for competitor launch, until they have been granted.
He added: “This is an incentive, in some cases, to keep patents in prosecution for as long as possible, and to use the filing of divisional applications covering the same subject matter to prolong commercial uncertainty for rival products.
“In a move to circumvent the uncertainty caused by divisional patents, the English High Court has awarded a so-called Arrow declaration.
“The declaration's effect is to render invalid any of the patents asserted against the [biosimilar] product in infringement proceedings.”
