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 . 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 .