Minister Cannot Issue NOC to Generic Licensee on Basis of Administrative Submission

Actelion Pharmaceuticals Canada Inc v Canada (Attorney General) 2014 FC 1249 Gleason J
            2,071,193 / bosentan / TRACLEER

This decision is a companion to Gleason J’s Exemestane 2014 FC 1243 decision, in which she held that when a first generic has received an NOC, a second generic which licenses from that first generic remains subject to s 5. Consequently, as discussed here, the second generic must serve an NOA on the patentee, and the Minister cannot issue an NOC to the second generic based on an administrative drug submission that cross-references the first generic’s submission.

The Bosentan case raised exactly the same question and Gleason J simply applied Exemestane and held that the patentee was entitled to a declaration that Health Canada had failed to comply with the PMNOC Regulations by failing to require the second generics to address the 193 Patent before issuing them NOCs for their bosentan products [9]. However, in this case the patent had expired by the time of judgment and Gleason J noted that an order quashing the NOC would potentially be moot. Since the mootness question had not been fully argued, she required the patentee to file additional submissions if it wished to pursue an order quashing the NOCs [10].