Apotex Inc. v. Eli Lilly, 2013
ONSC 1135 (Div. Ct.)

Lilly sought leave to appeal from a
decision of Justice J. Macdonald of the Ontario Superior Court dismissing in
part a motion to strike parts of the Statement of Claim delivered by Apotex
pursuant to rule 21.01(1)(b) and rules 25.11(b) and (c) of the Rules of
Civil Procedure.

The action arose from PM(NOC)
proceedings related to Lilly’s patented drug atomoxetine hydrochloride
(STRATTERA). In the course of the PM(NOC) proceedings, Lilly applied for an
order prohibiting the Minister of Health from issuing a NOC to Apotex. Prior to
the hearing of this prohibition application, Lilly’s patent was declared
invalid and void ab initio in a separate proceeding involving another
generic drug company. As a result, Lilly's prohibition proceeding with respect
to Apotex was dismissed, and the Minister issued a NOC to Apotex for its
generic drug.

Apotex claims that it was delayed in
obtaining its NOC for approximately 23 months by reason of Lilly’s voided
patent having been listed in the patent register and by the applicable
provisions of the PM(NOC) Regulations. As a result, the within action
was commenced by Apotex seeking, inter alia, disgorgement of Lilly’s
profits under a claim for unjust enrichment with respect to STRATTERA and
damages under the Trade-marks Act.

Leave to appeal is granted with
respect to the refusal to strike Apotex’s claim for Lilly’s profits based on
unjust enrichment.

Leave to appeal is denied with
respect to the refusal to strike Apotex’s claim for damages under the Trade-mark
Act.

Unjust Enrichment

The Court cited with approval the
decision in Apotex v. Takeda and Abbott, 2013 ONSC 356 establishing that
in Ontario there is no equitable disgorgement of a pharmaceutical innovator’s
profits absent a cause of action independent of the operation of s. 8 of the PM(NOC)
Regulations.

Damages under the Trade-marks Act

Apotex also claims damages pursuant
to ss. 7(a) and 7(d) of the Trade-Marks Act. Apotex’s claim alleges an
improper assertion of patent rights by Lilly without the commencement of an
infringement action, namely by registering on the Patent Register a patent
which was ultimately declared invalid and commencing the prohibition
proceeding.

The Court refused to interfere with
the Motions Judge’s decision that it was an “unsettled legal question” whether
statements made within the statutory framework set out in the Patent
legislation could form the basis of a claim under the Trade-Marks Act,
or whether these statements were subject to absolute privilege.