Roche Glycart AG - 2017/044

• Administrative Decision Number: 2017/044
• Year: 2021
• Date: 19 January 2021
• Section: Patents and SPC's

Decision in Respect of a Request by Roche Glycart AG for the Grant of a

Supplementary Protection Certificate (SPC) No. 2017/044

INTRODUCTION

1. This decision concerns a request for the grant of SPC application no. 2017/044 filed

on 26 October 2017 on behalf of Roche Glycart AG by FRKelly in respect of “Gazyvaro -

obinutuzumab in combination with bendamustine”.

2. The original legislation governing SPCs is Council Reg ulation (EEC) No.

1768/92 relating to "the creation of a supplementary protection certificate for medicinal

products". This was subsequently amended and codified in Regulation (EC) 469/2009 –

hereinafter, the “SPC Regulation”. The legislation governing the authorisation of

medicinal products is Directive 2001/83/EC relating to “medicinal products for human use”

– hereinafter, the “Medicinal Products Regulation”.

3. In the application, the product (‘the active ingredient or combination of active

ingredients of a medicinal product’ as defined in Article 1 (b) of the SPC Regulation) for which

a certificate was requested was “obinutuzumab in combination with bendamustine”.

4. Patent no. EP 2 464 382 (‘Combination therapy of an afucosylated CD20 antibody with

bendamustine’) was cited as the “basic patent” in support of the request, as required by Article

1(c) of the SPC Regulation.

5. A copy of the Commission Decision of 13 June 2016 issued by the EC amending the

original marketing authorisation (MA) of 23 July 2014 for "Gazyvaro – obinutuzumab" was

also submitted. Attached to this document was a copy of the amended annexes, in particular

the amended Summary of Product Characteristics (SmPC) to account for the changes arising

from what is known as a “Type II variation” to the original MA.

6. In the letter accompanying the application, the agent explained that, rather than a new

authorisation being issued for this new combination, the original MA for obinutuzumab had

been amended by way of such a Type II variation. The agent explained that for this to happen,

additional major clinical studies using the new combination treatment had had to be carried

out in accordance with the Medicinal Products Regulation. He argued that such a variation to

the original MA should therefore be deemed to have met the requirement of Article 3(b) of the