Patent Owner Named As Defendant May File Reply In Actions Under The PMNOC Regulations

In an action commenced by Allergan against Apotex in respect of ulipristal (Allergan's FIBRISTAL) under the Patent Medicines (Notice of Compliance) Regulations (PMNOC Regulations), an issue arose as to the appropriate pleading, if any, that a defendant patent owner could file.

The United States of America (the "U.S.") is one of the co-owners of the patent at issue. Under subsection 6(2) of the PMNOC Regulations, the owner of the patent "shall be or shall be made a party to the action". In this action, Allergan named the U.S. as a defendant. Initially, Apotex disputed that the U.S. could file any pleading separate from Allergan. Ultimately, Apotex disputed that the pleading could be a reply to Apotex's statement of defence, in part because the U.S. was a defendant.