ONSC Refuses to Strike Apotex’s Claim that It Has Lost Some of its S. 8 Claims Against the Brands Because the Minister of Health Improperly Delayed Issuing its NOCs

ONSC Refuses to Strike Apotex’s Claim that It Has Lost Some of its S. 8 Claims Against the Brands Because the Minister of Health Improperly Delayed Issuing its NOCs

Apotex Inc. v. Canada, 2013
ONSC 986

This motion was brought pursuant to rule
21.01(1)(b) and (3)(d) and rules 25.06(1) and 25.11 of the Rules of Civil
Procedure
for an order striking portions of the statement of claim. In
addition, the defendant seeks an order for particulars pursuant to Rule 25.10.

The statement of claim alleges that the
plaintiff incurred damages as a result of the defendants’ conduct in dealing
with new drug submissions filed by the plaintiff and seeks recovery of those
damages from the defendants.

The motion to strike is partly allowed and
partly dismissed. The motion for particulars is dismissed.

Striking Claims for Unlawful Discrimination

Plaintiff’s claim of discrimination should be
struck as it is plain and obvious that it cannot succeed.

The plaintiff alleges discrimination based on
the defendant dealing differently with it than with other corporations in
applying the regulatory scheme for drug approval. The true nature of this claim
is the pleaded claim of misfeasance. The claim insofar as it is based on
discrimination is struck.

Striking Claims on the Basis of Res Judicata

The defendant is not entitled to have the claim
with respect to Apo-ASA struck.

The plaintiff alleges, with respect to Apo-ASA,
that the refusal to grant a NOC was not a position that could have been taken
in good faith. The plaintiff claims that it has suffered damages as a result of
the improper position that was taken by the Minister.

Supporting the conclusion that the claim with
respect to Apo-ASA should not be struck is the distinction between judicial
review and claims for damages. The plaintiff’s claim with respect to Apo-ASA is
framed in tort. The plaintiff’s application with respect to that product in the
Federal Court of Appeal was with respect to the validity of the administrative
decision regarding its approval. Though both proceedings involve the issue of
bioequivalence, the two present distinct and separate justiciable issues.

Moreover, the defendant is not entitled to have
struck the claims with respect to Apo-Lansoprazole, Apo-Pantoprazole and
Apo-Omeprazole.

The claim with respect to Apo-Lansoprazole and
Apo-Pantoprazole are based on the Minister having subsequently revoked his
approval and then “re-approved” the submission though the plaintiff had not
provided any additional bioequivalence data.  The claim with respect to
Apo-Omeproazole is based on the Minister revoking the approval.

The defendant submits that the claims with
respect to these products are, in the case of Apo-Omeproazole, res judicata,
and in the case of the other products, frivolous or vexatious or an abuse of
process as a result of the Federal Court of Appeal decision in Apotex v.
Minister of Health et. al.
, 2012 FCA 322.

However, the fact that the plaintiff has been
found by the FCA not to have a vested right to the issuance of an NOC does not
prevent the failure to issue an NOC from being a consideration in determining
the plaintiff’s entitlement to damages in tort, breach of contract and punitive
damages.

Furthermore, there is insufficient connection
between the claim with respect to these drugs and the decision on which the
defendant relies to make it plain and obvious that the claims must fail because
they are frivolous or vexatious or otherwise an abuse of process

Striking Claims Based on Section 8 of the PM(NOC)
Regulations

The defendant has not established a basis for
striking the claims based on s. 8 of the Regulations.

The plaintiff claims that it has lost some or
all of its s. 8 claims against the innovator companies because of the actions
of the defendant in improperly delaying the issuance of NOC’s. It seeks to
recover from the defendant the difference between the losses it recovered, if any,
from the innovators and what it would have recovered from them but for the
impugned acts of the defendant.

Regarding particulars, the plaintiff has
specified the products with respect to which it claims damages resulting from
its inability to have full benefit of s. 8, and has pleaded with respect to
which products s. 8 claims have been made. The defendant does not require
additional particulars in order to plead in response.

Striking Pleading on the Basis of Rules
25.06(1) and 25.11

Paragraphs 32 through 39 offend the rules of
pleading and should therefore be struck, as these paragraphs contain evidence
in support of the plaintiff’s pleading. 

In addition, the defendant is not entitled to the
particulars sought. The defendant limited the particulars it seeks to the
identification of which facts support which causes of action. However, the
defendant’s ability to plead to the statement of claim is not affected by how
the allegations to which it must respond are characterized.