Novo Nordisk A/S - 2013/035

• Administrative Decision Number: 2013/035
• Year: 2019
• Date: 14 January 2019
• Section: Patents 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

INTRODUCTION

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