Georgetown University - 2017/035

• Administrative Decision Number: 2017/035
• Year: 2021
• Date: 12 April 2021
• Section: Patents and SPC's

Grounds of Decision in Respect of a Request by Georgetown University for

the Grant of a Supplementary Protection Certificate (SPC) No. 2017/035

INTRODUCTION

1. This decision concerns a request for the grant of SPC no. 2017/035 filed on 15 August

2017 on behalf of Georgetown University by Anne Ryan & Co. related to the medicinal product

“Imlygic - talimogene laherparepvec”.

2. The legislation governing the granting of SPC applications in Ireland is Regulation (EC)

No. 469/2009 "concerning the supplementary protection certificate for medicinal products" –

hereinafter, the “SPC Regulation”. The legislation governing the authorisation of medicinal

products is Directive 2001/83/EC relating to “medicinal products for human use” – hereinafter,

the “Medicinal Products Regulation”.

3. In the application, the product (‘the active ingredient or combination of active

ingredients of a medicinal product’ as defined in Article 1 (b) of the SPC Regulation) for which

a certificate was requested was talimogene laherparepvec.

4. Patent no. EP 1 776 957 (‘Use of herpes vectors for tumour therapy’) was cited as the

“basic patent” in support of the request, as required by Article 1(c) of the SPC Regulation.

5. Copies of marketing authorisations (MAs) EU/1/115/1064/001 & EU/1/115/1064/002

issued by the European Commission on 16 December 2015 were also submitted.

6. In her accompanying letter, the agent also mentioned the existence of other earlier

SPC requests for the same product: - “SPC application Nos 2016/027 and 2016/028 are also

for talimogene laherparepvec and are based on EP 1 252 322 B2 and EP 1 252 323 B1,

respectively. Both of these SPC applications are in the name of BioVex Limited, which was

acquired by Amgen Inc. in 2011. We would ask you to note that Amgen Inc. is the exclusive

licensee of Georgetown University in respect of the Basic Patent and any SPC granted thereon

in the present case.”

7. The examiner issued a communication on 4 October 2018 to explain that the

information provided under item 7(ii) of the SPC request was not sufficient for her to determine

if the product was protected by the basic patent as required by Article 3(a) of the SPC