BioPharma Inc. - 2019/010

• Administrative Decision Number: 2019/010
• Year: 2021
• Date: 12 March 2021
• Section: Patents 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

INTRODUCTION

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