Apotex Inc. v. Her Majesty the Queen,
2014 FC 1087 In 1988, Apotex Inc. ("Apotex") filed a submission for
approval of its trazodone product with Health Canada. The Apotex
product was ultimately approved in 1995, at which time two other
generic companies already had approval in respect of their
trazodone products. Apotex commenced the within action for damages,
including punitive damages, on the basis of claims such as
negligence, breach of a contract in the form of a settlement
agreement, misfeasance in public office and misrepresentation. The issue in dispute related to Apotex' use of a United
States Reference Product for the purposes of its submission, and
not a Canadian Reference Product. The Court noted that Health
Canada wanted a Canadian Reference Product unless the United States
Reference Product could be "conclusively proven to be
identical", which the Court noted was almost impossible to
establish. The parties reached a settlement in 1990 after Apotex
commenced a judicial review proceeding, leading to a Settlement
Agreement. The Court found that Apotex proved misfeasance in public office,
and negligence. The Court found that the allegations relating to
misrepresentation are part of the misfeasance and negligence
claims. The Court found breach of the Settlement Agreement but also
found that the claim for breach of contract was barred by a
limitation period. The Court determined the date upon which Apotex' damages
began to accrue. The Court used the date of the Settlement
Agreement as the date that Health Canada should have reviewed
Apotex' submission and added one year to obtain the date that
Apotex should have received its NOC. The Court noted that Apotex
had demonstrated that it may have suffered damages in the nature of
lost sales and loss of the ability to be the first or second
generic in the marketplace, but held that Apotex was required to
mitigate its damages. In particular, the Court found that the
termination date for damages should be one year later, namely 1992,
the date an NOC would have been received if Apotex had taken steps
to mitigate its damages. The Court declined to award punitive
damages. The value of the damages was bifurcated and will thus be
determined in a separate proceeding. The Court indicated that a
trial would be more expedient in this regard. The BLG Life Sciences Group has published
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Drug: trazodoneIndustry News
ARTICLE
1 December 2014
Damages In Tort Awarded Against Her Majesty In Respect Of The Issuance Of An NOC (Intellectual Property Weekly Abstracts Bulletin – Week Of November 24 2014)
In 1988, Apotex Inc. ("Apotex") filed a submission for
approval of its trazodone product with Health Canada. The Apotex
product was ultimately approved in 1995, at which time two other
generic companies already had approval in respect of their
trazodone products.