In Sanofi-Aventis Canada Inc. v. Ratiopharm Inc. (2010 FC 230), the Federal Court (“FC”) denied Sanofi-Aventis Canada’s (Sanofi) application to prohibit the Minister of Health from issuing a Notice of Compliance (“NOC”) to Ratiopharm Inc. pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations“). The FC held Sanofi’s Canadian Patent No. 2,177,772 was invalid for overbreadth, lack of utility and in any case was not infringed by the use of Ratiopharm’s proposed composition.

Ratiopharm’s NOC application was for irbesartan, a drug for treatment of cardiovascular ailments such as hypertension and heart failure. Canadian Patents 2,177,772 (“’772 patent”) and 2,057,913 had been listed by Sanofi on the patent register in respect of irbesartan pursuant to section 4 of the PMNOC Regulations. Ratiopharm accepted that no NOC would issue prior to expiry of the ’913 patent, so only the ’772 patent remained for consideration. The ’772 patent claims pharmaceutical compositions containing irbesartan, preferably in the form of tablets with a high relative amount of the active ingredient that allowed for a rapid dissolution and release. Continue Reading