AstraZeneca AB - 2014/038

Administrative Decision Number2014/038
Date24 May 2021
SectionPatents and SPC's
Decision in Respect of a Request by AstraZeneca AB for the Grant of a
Supplementary Protection Certificate (SPC) No. 2014/038
1. This decision concerns a request for the grant of an SPC No. 2014/038 filed on 7
July 2014 on behalf of AstraZeneca AB (the applicant) by FRKelly (the agent) for the
product: “A combination of dapagliflozin or a pharmaceutically acceptable salt thereof and
metformin or a pharmaceutically acceptable salt thereof.
2. The basic patent cited in support of the SPC request was European 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 marketing authorisation for a different

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