New NICE budget impact test

Further to a number of changes to the NICE evaluation procedure, to be introduced in April, drugs that will cost more than £20million in any one of their first three years of use will be subject to a budget impact test. NHS England will be able to delay the introduction of drugs reaching this threshold unless agreement can be reached on price between NHS England and the drug company concerned.

Other changes include a new fast-track option for appraising treatments which offer exceptional value for money.

English Patents Court awards first Arrow declaration

We reported last month in Synapse that Mr Justice Carr has been deciding the trial of Fujifilm Kyowa Kirin Biologics Co. Ltd & Anor (FKB) v AbbVie Biotechnology Ltd.

On 3 march 2017, the judge decided to award the first 'Arrow declaration' in the English Patents court, concerning FKB's biosimilar of adalimumab:

"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); the amount of money at stake for the Claimants in terms of investment in clinical trials and potential damages if they launch at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world."

We will provide more detailed analysis of this decision in the April edition of Synapse.

UPC Committee agrees a 'state of readiness' for provisional application

At the most recent meeting of the UPC Preparatory Committee on 15 March 2017, the Committee agreed a 'state of readiness' for provisional application. The provisional application period allows the Court to make necessary preparations before its planned entry into force on 1 December 2017. However, a few more Signatory States are needed to accede to the Protocol on Provisional Application before the provision period can begin. The Committee is confident that this will happen in order to enable the provisional application to start at the end of May 2017, in keeping with the timetable it published in January.