ECJ Denies SPCs for Novel Formulation of Known Drug
According to a recent article by Dr. Stefan Danner at the Munich office of Maiwald Patentanwalts GmbH, the European Court of Justice (ECJ) has ruled (C-431/04) that the German courts were correct in rejecting an application for a Supplementary Protection Certificate (SPC) for Gliadel,™ having a novel formulation of a known therapeutic agent.
So-called "SPCs" extend the term of patents covering medicines for up to five years in order to compensate for the long time needed to obtain regulatory approval of these products. Applications for a supplementary protection certificate must be filed on a country-by-country basis. Certificates are granted for products which constitute the "active ingredient", or combination of active ingredients, of a "medicinal product."
According to Dr. Danner's article:
The product in question, Gliadel™, comprises the cytotoxic drug carmustine embedded in a matrix made of the polymer polifeprosan. The Federal Patent Court had rejected the SPC, arguing that Gliadel™ was no true combination of active
ingredients but rather a new formulation of the long known carmustine.
More than 8,000 SPCs for medicinal and plant protection products were reportedly filed in Europe between 1991 and 2003. For more informaton, check out "Supplementary Protection Certificates for Medicinal Products and Plant Protection Products - A Guide for Applicants" from the UK Patent Office.