Apotex applied for a Notice of Compliance (NOC) to market the patented drug Norfloxacin, alleging non-infringement because it would obtain the drug from Novopharm under a supply agreement.
Novopharm held a compulsory licence that prohibited sublicensing.
The patentee and its licensees sought an order prohibiting the Minister from issuing the NOC, arguing the supply agreement was an invalid sublicence and the application was premature.
The Supreme Court of Canada held that the supply agreement was not a sublicence.
Furthermore, the Court determined that the proper date for assessing the justification of a Notice of Allegation is the date of the hearing, not the date it was issued.
Since Novopharm was legally entitled to produce the drug for the Canadian market by the hearing date, the allegation was justified.
The appeal was allowed and the prohibition order was dismissed.