Supplementary Protection Certificates - Newron Pharmaceuticals SpA v Comptroller

Jane Lambert Patents Court (Douglas Campbell KC) Newron Pharmaceuticals SpA v Comptroller-General of Patents, Trade Marks and Designs [2023] EWHC 1471 (Ch) (16 June 2023) This was an appeal by Newron Pharmaceutical SpA ("Newron") against the decision of Dr L Cullen in Re SPC/GB15/046, Newron Pharmaceuticals S.p.A v Comptroller BLO/1053/22 1 Dec 2022. Newron is the proprietor of European patent (UK) 1613296 B1 for Methods for treatment of Parkinson's disease ("the Patent") which will expire on 24 April 2024. The appellant sought a supplementary protection certificate ("SPC") for a combination product comprising safinamide and “levodopa/PDI”, that is to say, a levodopa and a peripheral decarboxylase inhibitor (PDI) such as carbidopa . The hearing officer refused the application on the grounds that it did not meet the requirements of art 3 (b) of Regulation (EC) No. 469/2009 (“the SPC Regulation”). The appeal came on before Mr Dougla...