Neurim - EU Advocate Genera argues that supplementary protection certificates should be allowed for usage patents
Matthew Royle and Helen Cline consider the latest opinion from the EU on the interpretation of the SPC legislation to be good news for companies investing in research to investigate new formulations and uses of known active ingredients but wonder how the proposed test will work in practice.
Neurim Pharmaceuticals is the latest in a number of cases that have been referred to the Court of Justice of European Union on the interpretation of Article 3 of the supplementary protection certificate (SPC) legislation.
In Neurim, the UK court has asked the CJEU to clarify the meaning of Article 3(d) of Regulation EEC No 1768/92, which states tat the marketing authorisation relied on must be "the first authorisation to place the product on the market as a medicinal product".
The product in question is melatonin, a natural hormone, which is not patented.
Neurim carried out important research into the use of and certain formulations of melatonin to treat insomnia in humans for which it obtained patent protection. However, because only five years remained on the patent term when the product received a marketing authorisation, Neurim applied for an SPC. The application for the SPC was refused by the UK Intellectual Property Office and then by the High Court on the basis that melatonin had previously been authorised for use in sheep and, therefore, Neruim's marketing authorisation was not the relevant first authorisation to place the product on the market, whithin the meaning of Article 3(d) of the UK Court of Appeal, which asked the CJEU for clarification of the correct interpretation of Article 3(d).
Lawyers Matthew Royle
This article was first published in the June edition of Scrip Regulatory Affairs and is reproduced with the kind permission of the editors.
