In Apotex Inc. v. Merck & Co., Inc (2010 FC 287), the Federal Court of Canada (FC) held that Apotex is entitled to obtain compensation from Merck for having been kept out of the norfloxacin market for several years while the parties litigated Apotex's Notice of Compliance (NOC) application.

Apotex tried to market a generic version of norfloxacin in the early 1990s, a drug patented by Merck. Merck filed an order to prohibit Apotex from obtaining a NOC. The Supreme Court of Canada set aside the prohibition order on July 9, 1998 in Merck Frosst Canada v. Canada. Apotex sought relief under s.8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 ("the 93 Regulations"), as amended by SOR/98-166 ("the '98 Regulations"), for delayed market entry caused by Merck's prohibition order application. (more...)

In Canada (Minister of Health) v. Merck Frosst Canada Ltd. (2009 FCA 166), the Federal Court of Appeal ("FCA") reversed the Federal Court ("FC") and held the Minister of Health ("MOH") could disclose pharmaceutical regulatory approval records to a competitor access requestor under section 4(1) of the Access to Information Act ("the Act") without notice since none of the narrow exceptions listed in sections 20(1)(a)-(c) of the Act applied.

An access requestor requested records from the Minister of Health ("MOH") regarding Merck Frosst Canada's ("Merck Frosst") New Drug Submission ("NDS") for Singulair, a drug used in the treatment of asthma. After considering the section 20(1) exceptions, the MOH disclosed sections of the records to the requesting party without notice to Merck Frosst. The FC had held the MOH could not disclose information to an access requestor unless Merck Frosst was given notice to object since the records contained trade secrets, confidential technical information, or materials that could affect the financial or competitive position of a party. (more...)