Humira patent rights shot by "Fujifilm declaration"
By Dr. Manuel Kunst and Dr. Janet Strath
In a recent case before the UK Patents Court, Mr Justice Henry Carr granted the declaration sought by the claimants that the dosage regimes for the biosimilar adalimumab products they intended to launch in Europe were obvious and/or anticipated at the claimed priority dates of certain European (UK) patents owned by AbbVie relating to the antibody adalimumab, sold under the trade mark HUMIRA.
An array of legal issues arose, including entitlement to priority. In this particular case, the inventors of the patent subject-matter were US and German employees, the patents at issue had been abandoned by AbbVie prior to trial, and therefore complex issues of UK, US and German law were involved.
As Mr Justice Carr noted, it would be “potentially misleading shorthand” to describe the declaration granted to the claimants as an “Arrow declaration”, in light of the fact that AbbVie had taken steps to revoke all the patents at issue, thereby mitigating the need for a so-called “Gillette defence”. However, some concern remained over a number of divisional applications filed by AbbVie which related to adalimumab and, therefore, Carr J decided to grant the claimants what might become known as a “Fujifilm declaration” in order to dispel uncertainty in the UK and beyond, and allow the claimants to market their biosimilar products.
Read full article here (published in E.I.P.R. 2017, 39(8), 518-524).
For questions about this matter or related issues, please contact our Senior Associate Dr. Manuel Kunst (firstname.lastname@example.org).
Tuesday, August 15, 2017