Neurim Pharmaceuticals (1991) Limited v. Comptroller-General of Patents, High Court of Justice, Chancery Division, Patents Court, London, UK, 6 May 2010, Case No.  EWHC 976 (Pat)
On 6 May 2010, the English High Court handed down its judgment in Neurim Pharmaceuticals (1991) Limited v. Comptroller-General of Patents upholding a decision of the UK Intellectual Property Office not to grant a supplementary protection certificate for a product containing the active ingredient melatonin, on the basis that the condition set out in Article 3(d) of regulation 1768/92/EEC was not satisfied.
Article 3(d) provides that an SPC will only be granted if the authorisation granted to market the product as a medicinal product under article 3(b) is the first authorisation to that effect.
In this case, Neurim had filed an application for an SPC in September 2007, based on an authorisation to market melatonin for human use given in June 2007. The examiner had objected to Neurim's SPC application because of a March 2001 authorisation for a veterinary medicinal product which contained melatonin as the active ingredient.
The judge followed the Court of Justice's interpretation of Article 3(d) in Pharmacia, MIT and Yissum, holding that the authorization required under 3(b) is the first authorisation to place the product on the market as "any" medicinal product. A different indication of the product or the fact it is used for a different species, here the use for treatment of primary insomnia in humans as opposed to increasing the reproductive performance of sheep, were held to be irrelevant.
Read the decison (in English) here.