Drug: histamine dihydrochloride

This is a Judicial Review of a decision of the Minister of Health under the Data Protection provisions holding that CEPLENETM is not an innovative drug pursuant to the Food and Drug Regulations. The Court dismissed the application.

The Court summarized the drug approval process in Canada and the relevant statutes and treaties that lead to the Data Protection Regulations. The Court then came to a number of conclusions regarding the intent of the Data Protection Regulations.

The Court held that the medicinal ingredient in CEPLENETM is histamine dihydrochloride which has been previously approved in several drugs. The Court then dismissed the Applicant’s argument that the Data Protection Regulations are to protect the extensive clinical data required to gain approval for a new drug. The Court held that the Data Protection Regulations provide protection for new chemical entities, not all new drugs, as set out in the NAFTA and TRIIPS division.

The Court held that histamine dihydrochloride is an old ingredient and that CEPLENETM falls under the definition of a “new drug” for the purposes of the Food and Drug Regulations as a new use but not as a new substance or chemical entity. Thus, the product was not eligible for data protection.