Federal Court of Appeal Finds That an Order Dismissing a Prohibition Application Cannot be Stayed
The Canadian Federal Court of Appeal, in Janssen-Ortho Inc v Apotex Inc (2009 FCA 250), effectively affirmed the dismissal of an application by Janssen-Ortho Inc (Janssen-Ortho) for a prohibition order under the Patented Medicines (Notice of Compliance) Regulations (Regulations) for abuse of process by dismissing Janssen-Ortho’s motion for a stay.
Apotex Inc (Apotex) had served Janssen-Ortho with a Notice of Allegation (NOA) in respect of the drug Tramacet, which is an analgesic, and Janssen-Ortho’s patent on the active ingredients of Tramacet. The NOA included allegations that the patent was invalid on various grounds, including that the claims were broader than the invention. Before initiating an application, Janssen-Ortho filed a disclaimer under section 48 of the Patent Act, narrowing the scope of the independent claim to the active ingredients. Three days after filing the disclaimer, it commenced an application under the Regulations seeking an order prohibiting the Minister from issuing a Notice of Compliance (NOC) to Apotex for a generic version of Tramacet, thereby staying the Minister from issuing an NOC for up to 24 months while the application proceeded. The application did not address the allegations in the NOA, but asserted it was invalid for failing to address the revised claims. Prothonotary Aalto found that this constituted an abuse of process and dismissed the prohibition application, and, on appeal, the dismissal was upheld by Justice Hughes of the Federal Court.
In order to prevent the issuance of an NOC before a further appeal could be heard, Janssen-Ortho brought this motion before the Court of Appeal to stay Prothonotary Aalto’s order. Sitting as a single judge, Justice Sharlow for the Court of Appeal dismissed the motion on the grounds that there was nothing to stay because the order did not require anything to be done, noting that it is the Food and Drug Regulations that would require the Minister to issue an NOC, not the Prothonotary’s order.
While the issue of abuse resulting from the disclaimer was not considered, Justice Sharlow went on to find that the motion for a stay was an improper attempt to extend the statutory stay. If Apotex were obliged to address the narrowed claims in a new NOA, which Justice Sharlow noted would be to the prejudice of Apotex, the result would be to similarly extend the statutory stay. It is therefore reasonable to assume the Court of Appeal would have upheld the finding of abuse had that been under consideration.
For the Federal Court of Appeal’s reasons for judgment, see:
http://decisions.fca-caf.gc.ca/en/2009/2009fca250/2009fca250.html
Summary by: Tom Feather
