Newron Pharmaceuticals SPA (appellant) v The Comptroller-General of Patents, Trade Marks and Designs (respondent)

Wednesday 24 January 2024

This is an appeal against the decision of Recorder Douglas Campbell KC dated 23 June 2023, that dismissed the appeal and upheld the decision that the application for supplementary protection certificate number SPC/GB15/046 shall not be granted.

The Appellant’s appeal was from the decision of Dr L Cullen, Deputy Director acting for the Comptroller, dated 1 December 2022. In that decision Dr Cullen (“the Hearing Officer”) refused the Appellant’s application for a supplementary protection certificate on the grounds that such application did not meet the requirements of Article 3(b) of Regulation (EC) No. 469/2009.

The basic patent (EP 1 613 296 B) is entitled “Methods for the Treatment of Parkinson’s Disease”. It was granted on 1 July 2009 and expires on 7 April 2024. It was only necessary to consider claim 1, which is as follows:

“1. The use of a first agent selected from safinamide from 0.5 to 1, 2, 3, 4 or 5 mg/kg/day in combination with levodopa/PDI, for the preparation of a medicament as a combined product for simultaneous, separated or sequential use for the treatment of Parkinson’s Disease.”

PDI is the abbreviation for a Peripheral Decarboxylase Inhibitor. The role of the PDI is to inhibit the breakdown of levodopa while travelling through the bloodstream of the body to the brain. Once the levodopa crosses the blood-brain barrier, which the PDI cannot, the levodopa exerts its therapeutic effect.

It was accepted by the Appellant that the use of levodopa with a PDI was already a known treatment for Parkinson’s disease.

View hearing:

Part 1

Part 2