PATENTS |
Practice |
Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General)
A-721-00
Sharlow J.A.
9/1/01
10 pp.
Appeals from Motions Judge's decision staying Minister's decision to remove appellant's "436 patent" from patented medicines register--In 1994, when Bristol-Myers obtained notice of compliance (NOC) for product called Serzone containing medicine nefazodone hydrochloride, did not file patent list for 436 patent, but could have--Patent register cannot now be amended to include 436 patent in relation to Serzone--After NOC issued for Serzone, Apotex filed new drug submission (NDS) for Apo-Nefazodone alleged to be bioequivalent to Serzone--NOC did not refer to 436 patent as patent not then on register--In December 1999, Bristol-Myers submitted supplemental NDS relating to change in name of product for Serzone to Serzone-5HT2, adding patent list for 436 patent--In February 2000, Minister issued NOC for Serzone-5HT2 and advised Bristol-Myers patent list for 436 patent eligible for listing on patent register--436 patent added on patent register shortly thereafter--Apotex argued 436 patent should not be on register and should be removed therefrom--Minister reconsidered eligibility of 436 patent and concluded should not have been included on patent register--Bristol-Myers commenced application for judicial review and Minister deferred actual removal of 436 patent to allow Bristol-Myers time to seek interim relief until November 2000, absent court order precluding him from doing so--Stay granted to Bristol-Myers--Present appeal from stay--Appeal allowed--Tests in RJR-Macdonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311 applied: serious question, irreparable harm, balance of convenience--Serious question as Minister, within space of few months, adopted two contradictory interpretations of applicable Regulations--However, Motions Judge erred as to question of irreparable harm--Here, reasonable to assume that, but for stay, Minister would have removed 436 patent and would have issued NOC to Apotex in respect of Apo-Nefadozone--Regardless of ultimate fate of NOC for Apo-Nefazodone if Bristol-Myers application for judicial review succeeds, Bristol-Myers may suffer some harm from competition on part of Apotex that might have been stopped, at least during 24-month automatic stay, if 436 patent had remained on patent register until disposition of Bristol-Myers' application for judicial review--No evidence on record to suggest award of damages to Bristol-Myers in action for patent infringement would not be adequate remedy herein--Therefore, assuming infringement proved, harm caused to Bristol-Myers because of inability to take advantage of automatic stay in Regulations not irreparable--Regulations not enacted to protect loss not resulting from infringement of patent rights--Stay should not have been granted.