In the Courts below, Apotex brought a motion to dismiss the application. This motion was granted by Prothonotary Aalto and upheld by Justice Hughes. Janssen has appealed the Hughes Order to the Federal Court of Appeal. The within motion was to stay the Aalto Order pending the appeal. The Court dismissed the stay motion.
In the underlying proceeding, upon receipt of Apotex' NOA, Janssen filed a disclaimer. Janssen then commenced an application in Court. The main ground of that application was that the NOA was invalid as it did not address the disclaimed claims. In response to Apotex' motion, Prothonotary Aalto stated that Apotex was only obliged to address the claims of the patent as they read when the NOA was served. Thus, Janssen's prohibition application was an abuse of process.
The Court of Appeal found that generally the function of a stay is to stop a party from taking a step that an Order requires to be taken. An Order that does nothing but dismiss an unmeritorious claim does not require anybody to do anything. The Minister is compelled to act because of the Food and Drug Regulations, not because of the Aalto Order. Thus, the motion must fail because there is nothing to stay.
Furthermore, Janssen was seeking a remedy that is not contemplated by the statutory scheme of the NOC Regulations. Finally, the Court of Appeal found that there was no irreparable harm. The Court of Appeal found that the negative effects on marketing and promotional programs, hindrances to the company's plan to become a leader in the field of pain management and any other remedies for infringement could all be quantified in monetary terms. The Court of Appeal also found that the loss of the statutory stay under the NOC Regulations cannot constitute irreparable harm. Finally, a clear undertaking was not provided. Thus, Janssen's motion was dismissed on all grounds.
The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2009/2009fca250/2009fca250.html