In a recent decision, Apotex Inc. v. Janssen-Ortho Inc,
the Federal Court of Appeal has limited the scope of the abuse of
process doctrine in applications under the Patented Medicines
(Notice of Compliance)Regulations. In particular,
the Court held that even when an innovator company has been
successful in a patent case against one generic manufacturer, it is
not an abuse for a second generic to re-litigate the same issues.
This is an important clarification in the law, and will affect the
way in which innovators conduct and argue cases under the
The facts of the case are slightly unusual. Several years ago,
Novopharm served a notice of allegation, alleging patent
invalidity, regarding the patent for Janssen's drug
levofloxacin. Janssen's consequent application for prohibition
was heard by Justice Mosley, who decided that Novopharm's
allegation of invalidity was justified. When Novopharm received a
Notice of Compliance, Janssen sued for patent infringement on the
same patent. Novopharm defended the lawsuit on the basis that the
patent was invalid. The trial was heard by Justice Hughes, who held
that the patent was valid, and enjoined Novopharm from selling
Notwithstanding Justice Hughes's decision, Apotex served its
own allegation, alleging patent invalidity. Justice Shore, in
hearing the case, looked to the Court of Appeal's decision in
Sanofi-Aventis Canada Inc. v. NovopharmLimited
and concluded that for a second person (i.e., generic) to succeed
after a patent has been upheld, it must show "better
evidence" or "more appropriate legal argument."
Finding that Apotex had not advanced better evidence or more
appropriate legal argument in its case, Justice Shore allowed the
application and granted prohibition on the basis that it was an
abuse of process for Apotex to re-litigate the same issue upon
which Justice Hughes had already decided.
The Federal Court of Appeal has now reversed that decision. All
three judges (Justices Nadon, Trudel and Layden-Stevenson) agreed
that the doctrine of abuse of process, while capable of barring a
first person (i.e., innovator) from re-litigating an issue, was
never intended to apply to a generic who is litigating a patent for
the first time. The Court held that, instead, each subsequent case
should be considered on its own merits.
Although this decision appears to take an arrow out of the brand
name company's quiver, other than requiring first persons to
re-litigate a case on the merits, it remains to be seen to what
degree this decision will affect the outcome of PM(NOC)
applications. It is true that brand name companies will no longer
be able to argue that a generic's arguments constitute an
"abuse of process" and will have to deal with each case
on its merits. However, it is equally true that once another
generic has been unsuccessful, first persons remain able to rely on
the principles of judicial comity and stare decisis (i.e.,
respect for precedent). These principles require the court to
follow its own decisions unless the party urging the court to
depart from that decision is able to either point to a factual
distinction between the previous decision and the case before the
court or to demonstrate that the original decision is
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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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