Novo Nordisk A/S - 2013/035

Administrative Decision Number2013/035
Date14 January 2019
SectionPatents and SPC's
Decision in Respect of a Request by Novo Nordisk A/S for the Grant of a
Supplementary Protection Certificate (SPC) No. 2013/035
1. This decision concerns a request for the grant of SPC No. 2013/035 filed on 15
July 2013 on behalf of Novo Nordisk A/S (applicant) by Tomkins & Co. (agent) for the
product RYZODEG, a Combination of insulin degludec and insulin aspart in all its forms
as they are protected by the basic patent.” The basic patent cited in support of the
request was European Patent EP2107069 with the title Novel insulin derivatives.” In
relation to this patent, the applicant stated that: Patent No. 2107069 protects the
product by at least claim 1 and specifically by at least claim 11 of the basic patent.
2. In support of the request, the agent submitted - a copy of the Commission
Implementing Decision of 21 January 2013 granting five marketing authorisations (MAs)
to Novo Nordisk A/S for Ryzodeg - insulin degludec and insulin aspart, namely
EU/1/12/806/001, 004, 005, 007 and 008. In addition, the agent requested that the
examination be deferred pending a judgment in the case C-443/12 Actavis Group PTC
EHF & Actavis UK Ltd. v Sanofi (Sanofi).
3. The legislation governing SPCs is Council Regulation (EEC) No. 1768/92
concerning “the supplementary protection certificate for medicinal products.” This was
amended by the Paediatric Regulation to provide for a further 6-month extension and
was codified as Regulation (EC) 469/2009 hereinafter the ‘SPC Regulation’.
4. On 25 February 2014 the agent wrote to the examiner to request that
examination of this application be further stayed pending a decision from the Court of
Justice of the European Union (CJEU) in the case C-577/13 Actavis Group PTC EHF
and Actavis UK Ltd v. Boehringer Ingelheim Pharma GmbH & Co. KG (Boehringer).
This request was duly granted.
5. The examiner wrote to the agent on 10 June 2016 to report that the CJEU had

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