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ARTICLE · 31 JANUARY 2020

Patent Owner Files Its Own Pleading In A PM(NOC) Action

In its Statement of Defence, Apotex alleged non-infringement and challenged the validity of the 254 Patent.

CanadaIntellectual Property

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.

Background

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"

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