Futile Attacks on Section 8 of the NOC Regulations

Apotex Inc v AstraZeneca Canada Inc / omeprazole (NOC) 2012 FC 559 Hughes J

In Apotex v AstraZeneca / omeprazole AstraZeneca attacked the validity of s 8 of the NOC Regulations on various grounds, which were all rejected by Hughes J. While the objections were framed phrased a number of ways, AstraZeneca had two basic complaints.

First, AstraZeneca in effect complained that it is being punished simply for invoking section 6 of the NOC regulations: [115]. The essential answer to this is that section 6 and section 8 are a package, and if AstraZeneca does not want to expose itself to section 8 liability, it should not seek to a stay: “In making a choice to list a patent and a choice to institute prohibition proceedings, that party must be mindful that, just as if it had given an undertaking in order to secure an  interlocutory injunction, it must make good the losses suffered by the other party should it fail to secure the prohibition Order” [58]. There is nothing unfair about this, since the automatic stay, like an interlocutory injunction, being decided on the basis of limited information, may wrongly interfere with the rights of the other party. The quid pro quo for the stay is that the patentee will be liable for that harm in the case the stay is “wrongly” triggered. It is worth remembering that the greater availability of interlocutory injunctions formalized in American Cyanamid emerged as a result of the practice of requiring an undertaking from the applicant to compensate the defendant if the defendant’s position was ultimately vindicated. When the applicant was not liable to compensate the defendant, the courts would require a much stronger showing on the merits before granting an interlocutory injunction.

The second basic complaint was that liability under s 8 strikes the wrong “balance” [94], [97]. But as Hughes J pointed out, “[i]t is for Parliament to provide for the appropriate weighing or balancing of interests in enacting the Patent Act, and for the Governor-in-Council to do likewise in promulgating the NOC Regulations. There is no independent ground for arguing that section 8 of the NOC Regulations is invalid, simply because it was not “balanced” in the view of one of the interested parties” [99].