Patent decision

BL number
O/321/20
Concerning rights in
SPC/GB12/034
Hearing Officer
Dr L Cullen
Decision date
11 June 2020
Person(s) or Company(s) involved
Chugai Seiyaku Kabushiki Kaisha & Tadamitsu Kishimoto
Provisions discussed
Regulation (EC) No. 469/2009, Article 16; Regulation (EC) No. 1901/2006, Article 36.
Keywords
Extension for Paediatric Testing, Revocation, Supplementary Protection Certificates
Related Decisions
None

Summary

A request for revocation of the granted 6-month paediatric extension to the duration of SPC/GB12/034 was initiated by the agent acting on behalf of the holder of this SPC.

The hearing officer (HO) considered the submission from the agent and the supporting material provided. Having reviewed the relevant law, the HO was satisfied that, because a one-year extension of the period of marketing protection for the medicinal product RoActemra, which comprises the active substance tocilizumab, the subject of SPC/GB12/034, had been obtained already, a further reward under the Paediatric Regulation, (EC) No. 1901/2006, in the form of the paediatric extension to duration of this SPC was not allowed. The paediatric extension to this SPC was granted contrary to Article 36(5) of the Paediatric Regulation. As a result, the extension to the duration of SPC/GB12/034 is revoked under Article 16(1) of the SPC Regulation.

Full decision O/321/20 PDF document308Kb