Abelcet - a recent French SPC decision

Michèle Lavé of Cabinet Alice de Pastors in Paris has informed us of the following recently published decision by the French Patent Office:

"On 27 February 2009, the French Patent Office published the refusal of French SPC application FR97C0131.

SPC application FR97C0131, was lodged by The Liposome Company, Inc. on 8 December 1997 for a product comprising of a lipid complex of amphotericin B, a phosphatidyl choline and a phosphatidyl glycerol. The application is based on European patent EP0282405, on the British marketing authorisation 14188/0001 of 9 February 1995 and on the French marketing authorisation NL 21338 of 10 June 1997 for Abelcet®. The SPC application was transferred to Cephalon Limited.

On 26 September 2008, the French Patent Office rejected this SPC application on the following grounds:

• the French marketing authorisation NL 21338 relates to a drug containing amphotericin B as the sole active ingredient
• The 2 phospholipids which complex amphotericin B are mere excipients, which enable the reduction of the toxicity of amphotericin, but do not modify amphotericin therapeutic properties
• The therapeutic activity of Abelcet® is determined by amphotericin B
• The product subject of the SPC application can only be amphotericin B
• Amphotericin B was already covered by a previous French marketing authorisation, NL 5653 of 26 November 1973
• Therefore, as this SPC application does not refer to the first marketing authorisation for amphotericin B, it does not comply with conditions for obtaining an SPC set out in Regulation No. 1768/92.

This decision seems to be in line with the ECJ decision C-431/04 relating to carmustine/polifeprosan.

It is interesting to note that 12 SPC applications were filed in Europe by The Liposome Company, Inc. based on either EP0282405 or national corresponding patents. Ten applications were granted (AT, CH, DK, GB, IE, IT, LU, NO (2 SPCs), SE) and two were rejected (FR, NL). There is no published German SPC application referring to EP0282405 patent."