Patent decision

BL number

O/711/22

Concerning rights in

SPC/GB17/055

Hearing Officer

Dr L Cullen

Decision date

23 August 2022

Person(s) or Company(s) involved

Roche Glycart AG

Provisions discussed

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

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

This SPC application concerns a combination of two active ingredients, obinutuzumab and bendamustine, in what was referred to by the applicant as a -�loose combination-�. A decision from the European Commission, dated 13 June 2016, approved the use of the medicinal product -�Gazyvaro-obinutuzumab-�, when used with bendamustine, for the treatment of non-Hodgkin lymphoma, as a Type-II variation to the centrally granted EU marketing authorisation (EU/1/14/937). The examiner-�s view was that the application for an SPC for the combination based on this type II variation fails to meet the requirements of Article 3(b). The examiner considered that the MA was for obinutuzumab only and, as an earlier SPC for this active ingredient already exists, this application also fails Article 3(d) of the SPC Regulation.

The applicant argues that, in accordance with the purpose of the SPC Regulation and, applying the principle of the judgment of the Court of Justice of the European Union (CJEU) in Medeva (C-322/10) and Georgetown (C-422/10), in the loose combination situation where the MA authorises fewer products than are stated as the subject of the authorisation, the MA should nonetheless be treated as one for the combination not the single product. Thus, this Type II variation should provide the basis to grant an SPC for a loose combination of this type.

Taking note of the relevant law and case law, including Yeda Research and Development Co Ltd v Comptroller General of Patents [2010] (EWHC) 1733 (Pat) and the related CJEU decision Yeda C-518/10, the Hearing Officer (HO) found that there was no basis on which to distinguish the present application from the approach laid down in the case law. The SPC can be granted for a subset of active ingredients referred to in the medicinal product but in this case there is only one active ingredient in the medicinal product. The HO also found that, as the applicant had already gained an SPC for the product -�Gazyvaro-obinutuzumab-� then this SPC application also did not meet the requirement of Article 3(d) of the SPC Regulation.

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

Full decisionO/711/22  465Kb