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.

In her decision dated December 23, 2019 (2019 FC 1659), Case Management Judge Furlanetto allowed the U.S. to file a reply.  She reasoned that since the PMNOC Regulations require the patent owner to either initiate the proceedings or be made a party, it would be inconsistent to interpret the same regulations as only providing a role to the patent owner if it is a plaintiff. To prevent duplication of the role of the plaintiff, the Court put into place certain safeguards on the discovery process. Any similar safeguards to the trial process were left to be determined by the trial judge.

The Court also allowed the U.S. to plead that Apotex’s statement of defence disclosed insufficient facts to establish that the decision of the Commissioner of Patents to grant the patent at issue was improper and that Apotex must establish that the Commissioner of Patents acted unreasonably in granting the patent at issue.