Patent decision

BL number
Concerning rights in
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)
Supplementary Protection Certificates
Related Decisions


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 PDF document53Kb