In Canada, innovator drug companies can protect their market
exclusivity from generic copycats by asserting patents against the
generic manufacturer in litigation under the PM(NOC)
Regulations. Until now, the consequences of losing PM(NOC)
litigation was the potential payment of damages to the generic
whose market access was delayed by the litigation. These so-called
"section 8 damages" are limited to the actual loss
suffered by the generic during that specific period of delay.
Public policy is such that the profits earned by the innovator
during that period cannot, however, be disgorged pursuant to
section 8 of the PM(NOC) Regulations.
In this potential class action, however, the representative
plaintiff seeks disgorgement of the profits Pfizer earned during
the period it prevented generic competition from Teva for VIAGRA by
asserting a patent that was ultimately found invalid in PM(NOC)
litigation. The plaintiff's claim is based on the theory that
people overpaid Pfizer for VIAGRA relative to what they could have
paid had Pfizer not wrongfully delayed generic competition through
the assertion of an invalid patent.
The plaintiff asserts three causes of action: (1) unlawful
interference with economic relations; (2) waiver of torts; and (3)
unjust enrichment. The proposed class includes all British Columbia
residents who purchased VIAGRA between January 1, 2006 and November
30, 2012, representing the period from Teva's application for
generic approval to the decisions invalidating and voiding its
While a class has yet to be certified, the recent motion
decision in Low v. Pfizer signals a potential significant
paradigm shift, whereby profits earned by innovators during PM(NOC)
litigation, are at risk. Justice Smith refused to strike some
significant aspects of the plaintiff's claim on a preliminary
motion, holding that it was not "plain and obvious" that
all of the plaintiff's causes of action were futile. For the
full decision see: Low v. Pfizer.
This watershed ruling raises the spectre of significant economic
liability in future class actions against innovators who frequently
engage the special patent enforcement provisions of the PM(NOC)
The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
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