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Intellectual Property Law - Patents - Procedure - Judicial review - Grounds

Thursday, November 10, 2016 @ 7:00 PM  


Appeals by two generic drug manufacturers, the Attorney General and the Minister of Health from orders setting aside Notices of Compliance (NOC) issued by the Minister. The Minister issued a NOC to Teva Canada Limited (Teva) for its generic version of exemestane tablets. Pfizer Canada Inc. (Pfizer), who marketed exemestane tablets under the brand name AROMASIN, challenged the Minister’s decision to issue the NOC to Teva. A judge of the Federal Court found that the standard of review of the Minister’s decision was correctness. The Federal Court went on to find that the Minister’s interpretation of the Regulations was incorrect and, as a result, he set aside the NOC issued to Teva. Teva, the Attorney General and the Minister of Health appealed the decision of the Federal Court judge. The Minister also issued a NOC to Hospira for its generic version of 100mg/vial infliximab powder. Janssen, who marketed infliximab under the brand name REMICADE, challenged the Minister’s decision to issue the NOC to Hospira. With the consent of the parties, the Federal Court set aside the decision of the Minister to issue the NOC, without prejudice to any right to appeal. Both Hospira and the Attorney General and the Minister of Health appealed the judgment.

HELD: Appeals allowed. The Federal Court erred by reviewing the Minister’s decisions on the standard of correctness. A contextual analysis did not rebut the presumption of reasonableness. While the Regulations were not the Minister’s home statute, they were closely connected to the function of the Minister of Health. Thereedit was no intention in the Regulations that decisions of the Minister interpreting the Regulations be reviewed on a less deferential standard of review. The question of whether Teva or Hospira early worked the relevant patents was a relevant consideration. Any interpretation of the Regulations not limited to preventing infringement occurring as a result of the early working exception would exceed the scope of the regulation-making authority conferred by s. 55.2(4) of the Patent Act. In addition, the Federal Court erred in law by failing to apply the jurisprudence which interpreted “submission” as used in s. 4(1) of the Regulations when interpreting “submission” in s. 5(1) of the Regulations. Applying the standard of reasonableness, the Minister’s decisions were reasonable. In the case of Teva, it was licensed to sell the tablets from another company that possessed a NOC. That required Teva to obtain its own NOC, in which it certified that its drug product was identical to the licensing company’s drugs except for the name of the manufacturer and the product. No evidence supported the submission that Teva “early worked” Pfizer’s patented invention. In the circumstances, it was not unreasonable for the Minister to decline to confer on Pfizer the advantages conferred on an innovator by the Regulations. For the same reasons, the Minister’s decision to issue a NOC to Hospira was reasonable. Another company possessed a NOC and named Hospira as its distributor and Hospira filed its new drug submission (NDS) cross-referencing the other company’s NDS.