Patent decision

BL number

O/0023/26

Concerning rights in

EP (UK) 1210428

Hearing Officer

Dr R Dinham

Decision date

15 January 2026

Person(s) or Company(s) involved

DANA-FARBER CANCER INSTITUTE, INC. & GENETICS INSTITUTE LLC

Provisions discussed

Regulation (EC) 469/2009 (Medicinal Products), Article 8; Human Medicines Regulations 2012

Keywords

Extension for Paediatric Testing, Supplementary Protection Certificates

Related Decisions

None

Summary

An application for a paediatric extension to granted certificate SPC/GB17/071 for the product avelumab was filed, but the examiner considered that the requirements of Regulation 58A(2)(a) of the Human Medicines Regulations 2012 (“HMR”) because a statement in the MA, indicating compliance with an agreed completed Paediatric Investigation Plan (“PIP”), had not been provided. Without such a compliance statement, the requirements of Article 8(1)(d)(i) of the SPC Regulation could not be met. The Examiner refused to allow an extension of time for the Applicant to correct this irregularity beyond 22 August 2025, i.e. the expiry date of the SPC.

The Applicant argued that there was no basis to not allow the provision of a compliance statement following the expiry of the SPC, and relied upon the decision of the hearing officer in BL O/019/22 (Chiesi Farmaceutici S.P.A.), where compliance statements were provided after the expiry of the SPC in order to correct the irregularity therein.

Taking into account the Office decision in Chiesi and also the Court of Appeal in EI DuPont Nemours & Co v United Kingdom Intellectual Property Office [2009] EWCA Civ 966, the hearing officer agreed that an applicant should be allowed some time to allow for rectification of irregularities of an application, which included provision of a statement of compliance. However, in the present case, there was no indication that the PIP had been completed (and indeed during the course of writing the decision the final date for completion of the PIP was pushed back further to 30 September 2026). Therefore, whilst the hearing officer agreed with Jacob LJ in DuPont that unless the applicant has behaved unreasonably, then time should be extended so that it gets its reward, in the present case, as the work needed to meet the requirements of the PIP had not been completed, there was no reward to be had. It therefore followed that the requirements of Article 8(1)(d)(i) of the SPC Regulation cannot be met.

The application was refused under Article 10(4) of the SPC Regulation.

Full decision O/0023/26 317Kb