CANADA FEATURED CONTENT
used to seek early resolution of proceedings. In order to take advantage of this provision, the later-to-the-game generic must have made the same successful allegation in its NOA. Of note, NOAs cannot be amended at any point, and a generic is limited to the allegations in its NOA. In Canada, the trade-off for the automatic 24-month stay is the generic’s entitlement to “section 8” damages for the period between the date on which its regulatory submission would have been approved, butfor the ongoing PM(NOC) proceeding and the date of the court decision in favour of the generic. Accordingly, in recent practice, brands have tended to discontinue subsequent generic cases following success by the first generic, in part to avoid further “section 8” damages against a multiplicity of generics. While treble damages are not available under Canadian law, significant section 8 damages have been awarded to generics; for example, Apotex was awarded $215 million in damages in PM(NOC) proceedings involving ramipril. The first-moving generic’s incentive in the US is the 180-day exclusivity period that is granted to the first generic to file a Paragraph IV certification. Unlike in Canada, where generics may continue to jockey for position all the way until the matter is heard, the 180-day exclusivity holder can
rest a little easier. Accordingly, it is somewhat more common for generics in the US to combine forces in litigation to minimize litigation costs and improve efficiencies, because the ‘race to market’ effectively ends with the first regulatory filing. As a result of Canadian generics’ efforts to move quickly, the Canadian Federal Court system can become overrun with patent pharmaceutical cases leading to a multiplicity of proceedings arising over a single patent, sometimes with the unfortunate result of differing outcomes on the same grounds of invalidity. The ineffici V?7??bF??2?F?vF???66?V?R?2??Bv??RV???F?6VB??F?RfVFW&?6?W'B?2F?67W76VB'??W7F?6R?Vv?W3?F?W&R?2??F?V'BF?BF?R??2&VwV?F???26WB?WB???W&fV7B&?6VGW&Rf?"F?RVff?6?V?B&W6??WF????b????fF?"?vV?W&?2?&?6WWF?6?F?7WFW2?F?RV??FVB7FFW2?F6??v???7B???6?VF??r?G2f&??W2?V?F?V?G2???vV?W&?F?W2?V6?&WGFW"??"?bFV??rv?F?6WfW&??bF?R&?6VGW&??GFW'2F?BfW??W"6?W'B?&R??F?vF????2??R?bF?V??f???????6??G&7BF?F?RU2?v?V?6?W'BF?6?76W2'&?N( ?2?6F???f?"&???&?F????&FW"??B?V?F?6?F?26???WFVB?G2&Wf?Wr?bF?BvV?W&?27V&?76????&?f?v???&Rw&?FVB???7B???VF?FV?W???77V?6R?bF?R6?W'B?&FW"?2&W7V?B???V??bF?RFV6?6???'?F?P??'&?B?2???B???vWfW"?( ?&R??F?vF???( ???6?FF?W2??B7F?v?F??V?7V66W76gV??6F???f?"&???&?F????&FW"'?'&?B2'&?G26??BF?&V76W'BF?R6?RFV?B?2?'?'&??v??r7V'6WVV?B7F???f?"FV?B??g&??vV?V?BV?FW"6?F ( ?2FV?B7B?66?&F??v????F?RU2?vV?W&?72F?BV?FW"F?R?&?WBf????v??r7V66W72?????vR&?6VVF??w2F?6?g&VR?b&?6??v???R??6?FF?W?V?FW"F?R?&?WBB&?6??bgW'F?W"?F?vF??????GW7G'?6?F?26??v?&V6V?Bv????v?W72F?&Wf?6?BF?R???2?&VwV?F???2?????W"F?Bf?&?&??6W2F?R??FW&W7G2?b'&?G2?BvV?W&?72?F?RfVFW&?v?fW&??V?BV'2F?&V6?v?RF?BF?R7?7FV??2???W&V?B&?&?V?2F?B7&VFR?V??V6W76'??V?F??6?G??b?F?vF????vRW?V7BF?6VRF?R7?7FV???&?fVB??F?R?W?BfWr?V'2?6??6?W6????&?F?6?F?BF?RU2?F?R&VwV?F?'?66?V?W2f?"vV?W&?2&?f?&RV?FW'66?&VB'?6?????7?7FV??bFV?B???vR?v???RF?RF?ffW&V?6W2v???G&?fRF?ffW&??r7G&FVv?W2??V?F?W"6?FR?bF?R&?&FW"?FW7?FR&?6VGW&?V?&?2?B7V'F?RF?ffW&V?6W2??F?V?"&W7V7F?fRFW7G2??FV?Bf?F?G????F?Rf7B&V??b?&?6WWF?6?FV?B?r?6?F?BF?RU2&R?&vV???F?R6?RG&6??S@????r?dR44?T?4U2#0??