Abbott U.S. and Abbott Canada succeed in preventing launch of Generic BIAXIN XL in Canada

Date Closed

June 19, 2009

Lead Office


Abbott U.S. and Abbott Canada successfully prevented Sandoz Canada Inc. from obtaining regulatory approval to launch its generic copycat version of Abbott’s antibiotic drug product called BIAXIN XL, an oral extended-release clarithromycin tablet used in the treatment of certain bacterial infections marketed and sold in Canada since 2001.

Sandoz sought approval to market and sell its own generic version of BIAXIN XL by seeking a regulator approval from the Minister of Health in the form of a Notice of Compliance ("NOC"). As a part of its attempt, the federal Patented Medicines (Notice of Compliance) Regulations required Sandoz to address Abbott’s Canadian patents listed against BIAXIN XL before a NOC could be issued.

Sandoz served its Notice of Allegation addressing such patents, which set forth extensive allegations including non-infringement, invalidity and fraud on the Canadian patent office. Abbott commenced an application in response seeking an Order prohibiting the Minister from issuing a NOC until 2018 , the expiry date of the relevant Canadian Patents.

Madam Justice Elizabeth Heneghan of the Federal Court presided over the hearing . Justice Heneghan rejected Sandoz's allegations and granted Abbott an Order of Prohibition preventing Sandoz from obtaining its NOC and securing its Canadian market for BIAXIN XL. Sandoz did not appeal Justice Heneghan's decision.

Abbott was represented at the hearing by McCarthy Tétrault.