BioPharma Inc. - 2019/010

Administrative Decision Number2019/010
Date12 March 2021
SectionPatents and SPC's
Grounds of Decision in Respect of a Request by Array BioPharma Inc. for the
Grant of a Supplementary Protection Certificate (SPC) No. 2019/010
1. This decision concerns a request for the grant of SPC application no. 2019/010 filed
on 20 February 2019 on behalf of Array BioPharma Inc. by Hanna Moore + Curley in respect
of the following product identity Combination binimetinib and encorafenib, each in all forms
protected by the basic patent”.
2. The legislation governing SPCs is Regulation (EC) No. 469/2009 "concerning
the supplementary protection certificate for medicinal products" hereinafter, the SPC
Regulation”. The legisla tion governing the authorisation of medicinal products is
Directive 2001/83/EC relating to medicinal products for human use hereinafter, the
Medicinal Products Regulation”.
3. Patent no. EP 2 727 918 (‘Compounds and compositions as protein kinase inhibitors)
was cited as the “basic patent” in support of the request, as required by Article 1(c) of the
SPC Regulation.
4. Copies of the marketing authorisations (MAs) issued by the European Commission on
24 September 2018 respectively for "MEKTOVI binimetinib" (EU/1/18/1315) and for
"BRAFTOVI encorafenib" (EU/1/18/1314) were also submitted.
5. In her accompanying letter, the agent highlighted the fact that the respective MAs for
binimetinib and encorafenib were granted on the same date - 20 September 2018 - and that
no separate single MA had been granted for a fixed-dose combination of the two active
ingredients. However, she drew attention to the Summary of Product Characteristics” (SmPC)
document for both products, in which each respective single active ingredient was clearly
indicated for therapeutic use with in combination with language relating to the other active.
The agent remarked that there was nothing in the SPC regulation to expressly prohibit the
granting of an SPC for a so-called "loose" combination in such circumstances.
6. The examiner responded on 1 April 2020 to state her opinion that a copy of a valid
MA to place the combination medicinal product on the market had not been submitted.
Specifically, she noted that protection was being sought for a “combination of binimetinib and

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