Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents, Court of Appeal, London, UK, 8 March 2011, Case no.  EWCA Civ 228
This case concerns Neurim’s application for an SPC on “melatonin”. Further to the requirements of Council Regulation 1768/92/EEC Article 3(b) and (d) (the “SPC Regulations”), the application cited a first marketing authorisation. In this case it was for “Circadin-melatonin”, relating to the use of melatonin and excipients as a monotherapy for the short-term treatment of primary insomnia in over 55 year olds.
However, an earlier authorisation to place melatonin on the market exists. This is for the veterinary product Regulin that comprises melatonin and excipients. Regulin is used to improve the reproductive importance of pure bred and cross bred lowland sheep that are to be mated before the usual peak of reproductive activity. Both the Regulin product and the Circadin product were protected by patents. However, Circadin did not fall within the protection of the Regulin patent and vice versa.