Apotex Inc. v. Merck Frosst Canada & Co.

Drug: norfloxacin

This is an action decided under s 8 of the Patented Medicines (Notice of Compliance) Regulations between Apotex and Merck relating to norfloxacin. The proceeding was dismissed on consent against the foreign patentee, and proceeded only against the Canadian entity.

The underlying proceeding was appealed to the Supreme Court of Canada, which released its decision, overturning the previous prohibition orders, in July 1998. The NOC Regulations had been amended in March 1998. The Court held that it was the March 1998 version of the NOC Regulations that applied, and not the earlier 1993 version.

The Court held that the possible time frame for which Merck may be responsible under s. 8 was June 10, 1993 to July 9, 1998, although the Court did not indicate the basis for the June 1993 date. The Court reviewed when Apotex could have entered the market with its product, taking into consideration a compulsory licence held by Novopharm and a supply agreement between Apotex and Novopharm whereby the company with the compulsory licence agreed to supply the other company.

The Court noted that Novopharm was an unwilling partner, despite the supply agreement, and that the Canadian supplier had problems. As a result, the Court found that it would have taken Apotex up to a year to resolve these issues, and Apotex would have been able to come to market as of June 10, 1994. Thus, the Court held Apotex was entitled to damages between June 10, 1994 and July 9, 1998.

Merck argued, inter alia, that the start date would not have been so early as Apotex had not amended its ANDS to include the correct supplier or the DMF to include the correct process, but the Court dismissed these arguments, holding that these changes could have been made relatively easily.

The decision has not yet been posted on the Federal Court website. However, the Court File number is T-411-01.