Unlike other actions, fulsome particulars of generic
pharmaceutical damages claims (under section 8 of the Patented
Medicines (Notice of Compliance) Regulations) have not always
been thought to be necessary. It had been suggested that
information in the possession of defendants might define the scope
of such claims.
However, in Mylan Pharmaceuticals v Takeda Canada et
al,1 the Court questioned the appropriateness
of such unparticularized pleadings and clarified that they remain
subject to basic pleading principles, including that they must
permit defendants to intelligently reply. Specifically, with
respect to claims for section 8 damages extending beyond the
product at issue in the underlying NOC litigation (ie. "other
products"), the Court required the generic plaintiff to
provide details of that claim including, at a minimum, identifying
the alleged "other products".
This action follows NOC litigation relating to pantoprazole
magnesium. In addition to claiming section 8 damages for its
alleged lost sales of generic pantoprazole magnesium, the generic
plaintiff claimed damages relating to, among other things,
non-pantoprazole magnesium products. The defendants sought
particulars of these allegations and then ultimately brought a
motion after the plaintiff provided only limited additional details
of its allegation.
Open-ended Claims Relating to "Other Products"
Prevent Intelligent Reply
There was no dispute as to the requirements for obtaining
particulars on a motion or the purpose of requiring a party to
provide particulars. With respect to the latter, particulars are
required, for example, to inform the other side of the nature of
the case they have to meet, permit parties to reply intelligently,
and limit and define the issues to be tried.
The Court noted at the outset that in the only prior
decision2 specifically addressing allegations relating
to "other products" the Court had required, without
providing reasons, that the plaintiff specify those "other
products". However, this decision was rendered early in the
development of section 8 damages jurisprudence. More recent
jurisprudence had suggested that a generic plaintiff need not
detail every possible claim it might assert.
The Court thus returned to first principles for motions for
particulars. The Court expressed discomfort with the
plaintiff's argument that a party may plead with limited
details hoping to learn further details in discovery. The Court
found this improper. In particular, while accepting that the
plaintiff might learn about the market for pantoprazole magnesium
from the defendants during discovery, there was no evidence that
the plaintiff needed this information to particularize its claim
for other products.
The Court also expanded on the requirement that pleadings be
sufficiently detailed so as to permit the other party to
"reply intelligently". Specifically, the Court did not
agree that being able to respond with vague denials and putting the
other party to the strict proof of its allegation constituted an
intelligent reply. The Court cited past jurisprudence expressing
concern about open-ended heads of damages which could only be
vaguely denied. Such pleadings would only invite motions for
particulars and would likely result in protracted and inefficient
discoveries because their scope and subject matter would be
The Court's concern about the potential scope of discoveries
was also apparent throughout. In particular, the Court agreed that
unless the plaintiff particularized its claim for other products,
discoveries could potentially extend to sales and financial
information of every non-pantoprazole magnesium product that was
sold or could have been sold by the plaintiff during the relevant
period. A list of the other products alleged would thus narrow the
scope of discovery.
Finally, the Court rejected the plaintiff's argument that
there was no evidence that it, and not the defendants, had the
requested information. The Court felt compelled to assume that the
plaintiff knew what it was referring to when it made its
allegations and, further, found it to be apparent that the
defendants did not know which other products the plaintiff had in
mind in those allegations.
The Court did not address, on this preliminary motion, the
merits of the plaintiff's claim for section 8 damages relating
to products other than the product at issue in the underlying NOC
litigation. That issue remains open for debate. However, for now,
it is clear that generic pharmaceutical manufacturers "having
introduced the idea of other products... should be prepared to
identify to which other products they are referring."
1 Mylan Pharmaceuticals v Takeda Canada et al,
2016 FC 491.
2 Apotex v Lundbeck, 2004 FC 728
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