Patent decision

BL number

O/1016/24

Concerning rights in

SPC/GB19/057, SPC/GB19/059, SPC/GB19/060, SPC/GB20/035, SPC/GB21/070 and SPC/GB21/071

Hearing Officer

Dr R Dinham

Decision date

24 October 2024

Person(s) or Company(s) involved

Genmab A/S

Provisions discussed

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

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

Applications SPC/GB19/057, SPC/GB19/059, SPC/GB19/060, SPC/GB20/035, SPC/GB21/070 and SPC/GB21/071 each concern a combination of the anti-CD38 antibody daratumumab with a corticosteroid and at least one non-corticosteroid chemotherapeutic, in what is referred to as a “loose combination”. The marketing authorisation (MA) for the medicinal product “DARZALEX-daratumumab” was granted following Commission Implementing Decision EU/1/16/1101 on 20 May 2016, and this was varied, as a type II variation, to include the various combinations for daratumumab in the treatment of specific myeloma patients (SPC/GB19/057, SPC/GB19/059, SPC/GB19/060 and SPC/GB20/035) and for the treatment of newly diagnosed light chain amyloidosis (SPC/GB21/070 and SPC/GB21/071). The Examiner’s view was that the application for an SPC for the various combinations, based on the type II varied MAs fails to meet the requirements of Article 3(b).

The Applicant, applying the principles of the Court of Justice of the European Union (CJEU) in Farmitalia (C-392/97), Medeva (C-322/10) and Georgetown (C-422/10), Forsgren (C-631/13), argues that an SPC for a loose combination is in accordance with the purpose of the SPC Regulation, and so each MA for each combination should be treated as one for that combination, and not the single product. Thus, these Type II variations should provide the basis to grant an SPC for loose combinations of this type.

Taking into account the relevant case law, including Newron Pharmaceuticals S.p.A v Comptroller General of Patents, Trademarks and Designs [2024] EWCA Civ 128, and Yeda Research and Development Co Ltd v Comptroller General of Patents [2010] (EWHC) 1733 (Pat), the Hearing Officer found that there was no basis to conclude that the Type II variations to the MA related to the combination of active ingredients sought, but rather to the single active ingredient, daratumumab. As such these SPC applications did not meet the requirement of Article 3(b) of the SPC Regulation.

The applications were refused under Article 10(2).

Full decision O/1016/24 423Kb