MIT wins Court's support over brain tumour drug

Published: 1-Feb-2006
Regulatory


The Massachusetts Institute of Technology (MIT) has won crucial support at the European Court of Justice (ECJ) in securing a supplementary protection certificate in Germany for brain tumour drug Gliadel. MIT is appealing against the blocking of this protection by the German Patent and Trade Mark Office because the drug's key active ingredient, carmustine, has been long established and Gliadel's technological advance is combining it with biodegradable polifeprosan that regulates the release of this therapeutic material, rather than attacking tumours directly.

The Americans argued that 'polifeprosan is an essential component of Gliadel, since it enables carmustine to be administered in a therapeutically relevant way'. This has been supported by ECJ Advocate General Philippe Leger, who has suggested that the full court rules EU Regulation EEC1768/92 allows supplementary protection in these circumstances.

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