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• Administrative Decision Number: 2015/043
• Date: 14 May 2024
• Year: 2024
• Section: Patents and SPC's

Decision in the maer of SPC applicaon 2015/043.

Applicant: Newron Pharmaceucals S.p.A.

Hearing Date 17 January 2024

Hearing Ocer: Dr Fergal Brady

DECISION

Introducon

1.This decision concerns the Request for a Supplementary Protecon Cercate numbered

2015/043 (the ‘Request’), led by Newron Pharmaceucals S.p.A (the ‘applicant’) under

Regulaon (EC) 469/2009 (the ‘SPC regulaon’).

2.The Request was led on 21 July 2015, relying on the basic patent EP 1613296 B1, a European

patent led on 08 April 2004, which upon grant on 01 July 2009 became a valid granted patent

in Ireland. This patent is tled ‘Methods for Treatment of Parkinson’s Disease’.

3.The Request further relied on a European Market Authorisaon no. EU/1/14/984/001-010, for

the product Xadago®-Safinamide made under Regulaon (EC) 726/2004 on 24 February 2015,

and noed on 26 February, and which is valid in Ireland.

4.The product, as idened in the Request, is ‘Sanamide for use in combinaon with

levodopa/PDI, and oponally with other PD products, for the treatment of Parkinson’s Disease.’

The applicant declared in the request that the product is protected under claims 1-8 of the

basic patent.

5.On 16 July 2017, the examiner issued an ocial leer indicang a deciency in the Request, in

that though the Request is directed towards sanamide in combinaon with other acve

substances, the Market Authorisaon only idenes sanamide as the acve substance in the

product. Thus, the examiner deemed that the Request was defecve, as it did not meet the

requirements of Art 3(b) of the SPC regulaon.This argument has formed the main substance

of the objecon made to the grant of the Request.

6.The examiner also drew the applicant’s aenon to their view that were the applicant to

amend the request such that the product constuted sanamide alone, it would not be

supported by the basic patent and would not instead meet the requirements of Art 3(a) of the

SPC regulaon. It is noted that, while the applicant has presented argument in this maer,

they have not at any point formally requested to change the product identy to sanamide

alone, so this argument is not directly relevant in the present circumstances. Indeed, it was

agreed by the applicant’s agent at the Hearing that the issue to be resolved rests solely on

whether the Request meets the requirements of Art 3(b).I note that the applicant did indicate