Roche Glycart AG - 2017/044

Administrative Decision Number2017/044
Date19 January 2021
SectionPatents 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
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

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