AstraZeneca AB - 2014/038

• Administrative Decision Number: 2014/038
• Year: 2021
• Date: 24 May 2021
• Section: Patents and SPC's

Decision in Respect of a Request by AstraZeneca AB for the Grant of a

Supplementary Protection Certificate (SPC) No. 2014/038

INTRODUCTION

1.This decision concerns a request for the grant of an SPC No. 2014/038 filed on 7

July 2014 onbehalf of AstraZenecaAB (theapplicant) by FRKelly (the agent) for the

product: “A combination of dapagliflozin or a pharmaceutically acceptable salt thereof and

metformin ora pharmaceutically acceptable salt thereof”.

2.The basic patent cited in support ofthe SPC request wasEuropean Patent

EP1506211 with the title “C-aryl glucoside SGLT2 inhibitors and method”.

3. The agent also submitted a copy of the Commission Decision granting the

European marketing authorisation (MA) and the corresponding annexes including the

summary of product characteristics (SmPC).

4. The legislation governing SPCs is Council Regulation (EEC) No. 1768/92 -“the

supplementary protection certificate for medicinal products” - and as it was subsequently

amended by the Paediatric Regulation and codified as Regulation (EC) 469/2009 –

hereinafter the ‘SPC Regulation’.

5. The examiner wrote to the agent on 24 June 2016 to state that the request did not

comply with the requirements of Article 3(a) and (c) of the SPC Regulation. She pointed

out that an SPC (No. 2013/013) based on the same patent had already been granted to

the applicant for the product “Dapagliflozin and pharmaceutically acceptable salts thereof”.

She queried whether it was possible to obtain more than one SPC on the basis of the

same patent, albeit with different MAs, and she cited two CJEU rulings on this issue.

Firstly, in the case C-443/12 (Sanofi) the Court ruled: - “…on the basis of a patent

protecting an innovative active ingredient and a marketing authorisation for a medicinal

product containing that ingredient as the single active ingredient, the holder of that patent

has already obtained a supplementary protection certificate for that active ingredient …,

Article 3(c) …must be interpreted as precluding that patent holder from obtaining – on the

basis of that same patent but a subsequent marketingauthorisation for a different