Patent decision

BL number

O/384/09

Concerning rights in

SPC/GB/07/051

Hearing Officer

Mrs C L Davies

Decision date

15 December 2009

Person(s) or Company(s) involved

Neurim Pharmaceuticals (1991) Ltd

Provisions discussed

Regulation (EC) No. 469/2009; Article 3(d)

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

Neurim Pharmaceuticals (1991) Ltd filed an application for an SPC for the product melatonin, identifying authorisation EU/1/07/392/001 for the medicinal product Circadin - melatonin as the first authorisation to place the product on the market.

However, the Hearing Officer found that an earlier veterinary authorisation for Regulin having the active ingredient melatonin precluded the grant of an SPC based on the later authorisation for Circadin.

Since the conditions of Article 3(d) of the Regulation have therefore not been met, the Hearing Officer rejected the application for an SPC under Article 10(2).

Full decision O/384/09 53Kb