Actelion Pharmaceuticals Canada Inc. v. Canada (Attorney General), 2014 FC 1249

Drug: TRACLEER® bosentan

Actelion has persuaded the Court to quash the NOCs provided to two generic companies after they were awarded by the Minster of Health. However, the patent at issue had expired by the time this decision was reached, and so the relief was arguably moot. Actelion had the option to continue to seek to quash the NOCs, but the court docket indicates that Actelion decided not to pursue this course of action. Instead, Actelion was awarded declatory relief that the OPML failed to comply with the PM(NOC) Regulations by failing to require Cobalt and Sandoz to address the 193 Patent before issuing them NOCs for their bosentan products. 

This litigation arose when Pharmascience settled PM(NOC) litigation with Actelion, and then cross-licenced its NOC for bosentan with Cobalt and Sandoz. The Minister of Health issued the two additional NOCs to the licensees without requiring them to address the requirements of the PM(NOC) Regulations. The Minister had previously amended its Guidance Document to provide for such an allowance, but this Guidance Document was found to contravene thePM(NOC) Regulations

This reasoning was first applied in Pfizer Canada Inc. v The Attorney General of Canada and Teva Canada Limited, 2014 FC 1243, and was summarized here.