Patent decision

BL number
Concerning rights in
SPC/GB15/046, EP(UK) 1613296 B1
Hearing Officer
Dr L Cullen
Decision date
1 December 2022
Person(s) or Company(s) involved
Newron Pharmaceuticals S.p.A
Provisions discussed
Regulation (EC) 469/2009 (Medicinal Products), Article 3(b)
Supplementary Protection Certificates
Related Decisions


The applicant is seeking an SPC for a combination product comprising safinamide and “levodopa/PDI”. The term “levodopa/DPI” relates to levodopa and a peripheral decarboxylase inhibitor (PDI). Such a PDI is carbidopa

The marketing authorisation (MA) provided in support of this application is for the medicinal product XADAGO which comprises the single active ingredient safinamide. The MA discloses that safinamide is approved as an “add-on” or adjunct to treatment with levodopa or levodopa and a PDI of patients with Parkinson disease. The applicant considers that this provides the necessary basis for the grant of an SPC for the combination product.

Following the approach set down in Yeda Research and Development Co Ltd v Comptroller General of Patents [2010] (EWHC) 1733 (Pat), the Hearing Officer (HO) found that the MA does not relate to the combination of active ingredients sought but rather to the single active ingredient, safinamide.

The HO also found support for their conclusion in the present case from IPO decision BL O/711/22 (Roche Glycart AG) concerning SPC/GB17/055.

The application was refused under Article 10(2) of the SPC Regulation.

Full decision O/1053/22 PDF document473Kb