The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, including by making new and different allegations than those made by the plaintiff. 


This decision arose in the context of Allergan Inc.’s (Allergan) action against Apotex under s 6(1) of the PM(NOC) Regulations concerning ulipristal acetate. Allergan licenses two patents to market ulipristal acetate as FIBRISTAL. One of the patents, Canadian Patent No. 2,713,254 Patent (254 Patent), is jointly owned by the USA and another entity. Under s 6(2) of the PM(NOC) Regulations, the USA and the other entity were added to the action as “defendants”. These patentees were issued status as “defendants” rather than “plaintiffs” because they did not intend to pursue infringement allegations against Apotex Inc. (Apotex). 

In its Statement of Defence, Apotex alleged non-infringement and challenged the validity of the 254 Patent. The USA sought leave to respond to Apotex’s 254 Patent validity challenge.

Patent owner defendants are entitled to defend the validity of their patents 

Apotex argued that only plaintiffs, and not named defendants, are entitled to file a “Reply”. The Federal Court found that section 6(2) of the PM(NOC) Regulations ensures that patentees may participate in litigation by requiring patentees to be named parties. Although as a defendant, filing a reply would not strictly comply with the Federal Courts Rules, section 6(2) cannot be read to deprive a defendant patentee from its right to participate. The Federal Court found that the situation called for a flexible approach and determined that the USA’s pleadings should be identified as a “Reply to the Statement of Defence”. 

Patent owner defendants can raise new arguments in their pleadings

Apotex also argued that the USA should not be permitted to raise new arguments beyond what Allergan asserted in its pleadings. The Federal Court held that the USA was entitled to represent its independent interests in the proceedings, including by way of independent and distinct arguments. 

This case is: Allergan v Apotex, 2019 FC 1659.