SPCs For Medicinal Products - The Opinion Of The Advocate General In The Neurim Case

On 3rd May 2012, Advocate General Verica Trstenjak issued her opinion in case C-130/11, also known as the Neurim case. Should the Court of Justice choose to accept the findings of the opinion, it will improve the possibility for the pharmaceutical industry in Europe to obtain SPCs for medicinal products.

Neurim Pharmaceuticals Ltd (Neurim) discovered in its research that certain formulations of melatonin can be used as a medicine for insomnia, and submitted an application for a European patent concerning certain formulations of melatonin in 1992.

Neurim applied for a marketing authorisation to place the melatonin formulation in question on the market as a medicinal product for human use. The authorization was however, not granted until June 2007. This medicinal product for human use is currently sold under the name Circadin.

After the grant of the authorisation, Neurim Pharmaceuticals accordingly applied for a SPC. The application was based on the June 2007 marketing authorisation and designated that marketing authorisation as the first authorisation to place the product on the market within the meaning of Article 3(d) of Regulation No 1768/92 (now Regulation 469/2009).

The UK Intellectual Property Office (IPO) refused the application. It said that Neurim's marketing authorisation was not the relevant first authorisation to place the product on the market, since there was an earlier authorisation for melatonin for use in sheep, granted between January and March 2001. The veterinary medicinal product was sold under the trade mark 'Regulin'.

Neurim brought an action against the refusal of its application before the national court, which confirmed the IPO's decision. Neurim then appealed against that judgment to the UK Court of Appeal. The Court of Appeal was...