Apotex was unsuccessful in three Health Canada court challenges. First, the decision to refuse approval of Apo-Progesterone for containing unusually high levels of sodium lauryl sulfate (SLS) was found reasonable. Second, the requirement for Apotex to provide additional information for products manufactured or tested at Apotex's facilities in India was not improper or unreasonable with regard to the varenicline and sitagliptin submissions for which data integrity issues remained outstanding. Third, Apotex's challenge of the Minister's decision to cancel reconsideration of the Notice of Non-Compliance issued for Apotex's submission for omeprazole magnesium tablets (Apo-Omeprazole) was rejected. Apotex has appealed all three decisions.
On April 6, the FCA overturned the Federal Court's conclusion that Apotex failed to mitigate the loss it incurred as a result of Health Canada's tortious conduct in considering Apotex's Apo-Trazodone drug submission. The FCA otherwise dismissed the parties' appeals relating to Apotex's claims in negligence, misfeasance in a public office, and contract. The SCC denied Apotex leave.
Finally, on May 10, the Court allowed Apotex Inc. and two of its Indian affiliates' claims to proceed against the former federal Minister of Health (Rona Ambrose), the former federal Deputy Minister of Health, and other individuals, as well as the Crown, in connection with Health Canada's import ban placed on products from the Indian affiliates.
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