Patent decision

BL number

O/0484/23

Concerning rights in

SPC/GB18/007

Hearing Officer

Mrs M Taylor

Decision date

26 May 2023

Person(s) or Company(s) involved

Merck Serono S.A.

Provisions discussed

Regulation (EC) 469/2009 (Medicinal Products), Article 3(d)

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

This SPC application concerns cladribine, the active ingredient in the medicinal product, MAVENCLAD (RTM), used in the treatment of highly active relapsing multiple sclerosis.

The examiner-™s view was that the application for an SPC failed to meet the requirements of Article 3(d) of the SPC Regulation due to the existence of two earlier marketing authorisations (MAs) for cladribine for a different therapeutic indication (hairy cell leukaemia).

The applicant argued that the operative Court of Justice of the European Union (CJEU) case law for Article 3(d) for this application was Neurim (C-130/11), rather than the more recent Santen (C-673/18), as Neurim was the current case law in this area at the time of the SPC application being filed.

Having considered the relevant law and caselaw, in particular the principles of temporal effect established in Case 61/79 Denkavit Italiana, the HO concluded that the Santen judgment must apply ex tunc. The HO set out that only the CJEU itself could provide a temporal restriction of its judgment and had not done so in Santen. In line with Santen, the HO found that the MAVENCLAD MA could not be considered to be the first marketing authorisation to place cladribine on the market, and therefore the application did not meet the requirement of Article 3(d).

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

Full decisionO/0484/23  345Kb