The Trial Judge found that the 1993 version of the NOC Regulations applied. The Court of Appeal granted the appeal from this decision and found that the 1998 version of the NOC Regulations applied and remitted the matter to the Trial Judge to determine the issues on this basis. The Trial Judge, in a separate action, found that the patent was valid and that some of the lovastatin tablets sold by Apotex infringed the patent, affirmed by the Court of Appeal.
The Trial Judge found that the appropriate date, in the absence of a certified date by the Minister of Health, was the date of the letter from Health Canada indicating that Apotex’ submission was on patent hold. In light of the Trial Judge’s finding that there was infringement of the patent, the Trial Judge exercised her discretion pursuant to section 8(5) of the NOC Regulations to find that the Relevant Period should be reduced to the period beginning when Apotex received approval to use its non-infringing process.