Epicept has filed for a judicial review of the Minister’s decision that its histamine dihydrochloride product is not an innovative drug and is thus not eligible for listing on the register of innovative drugs. Epicept sought confidentiality for its identity, the identity of any employee of it, the brand name, the medicinal ingredient or its variations, other drug products containing the medicinal ingredient, or its variations, the disease at issue and the entire contents of the new drug submission (NDS). The motion was denied with the exception of protection for the NDS filed with the Minister.

The Court found that while the fact of the filing of the NDS would normally be confidential, Epicept issued a Press Release announcing its filing in Canada. The information in the Press Release was published after Epicet had been informed of the decision that its product was not eligible for data protection. Thus, by issuing this Press Release, Epicet put its competitors on notice regarding its histamine product. Thus, the Court could not see the concerns and risks Epicet identified with respect to any potential headstart by its competitors as a reasonable basis to order the breadth of confidentiality sought.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2010/2010fc120/2010fc120.html