On March 21, 2016, Barnes J of the Canadian Federal Court upheld a Prothonotary’s decision allowing Gilead’s quia timet infringement action against Teva regarding its tenofovir disoproxil (TDF) products (Gilead’s TRUVADA®, ATRIPLA® and VIREAD®) in Gilead Sciences, Inc v Teva Canada Limited, 2016 FC 336, affirming 2016 FC 31.
By way of background, prior to Gilead’s action, Teva had commenced an impeachment action to challenge the validity of Gilead’s patent, asserting that Teva “will” market its TDF products immediately upon receipt of a Notice of Compliance. The Prothonotary found that there was a reasonable inference that Teva’s regulatory submission is on patent hold. In view of this finding and Teva’s expressed intention to market, the Prothonotary determined that there was “a strong possibility” of infringement by Teva in July 2017 (upon expiry of another Gilead patent), which was sufficiently imminent to justify a quia timet action.
Barnes J agreed. He noted that in a case where the likelihood of future harm is high, the temporal requirement of imminence for a quia timet claim may be a subordinate consideration.