ACTIONS
Motion to Amend Pleadings Granted; Motion for
Bifurcation Denied
Apotex Inc. v. H. Lundbeck A/S
Drug: escitalopram
The Court recently translated a decision from April regarding a
motion to amend a statement of claim and a motion to bifurcate in
an impeachment proceeding. The Court granted the motion to amend
and denied the motion for bifurcation.
The proposed amendments sought to add a new party (the proposed
supplier of Apotex' active pharmaceutical ingredient) to the
claim. The Court held that it is in the interest of justice in
ensuring efficient use of judicial resources and avoiding a
multiplicity of pleadings and the risk of contradictory judgments
that this amendment be permitted. The Court also held that there
had been no delay in filing the motion to amend the pleadings;
however, even if there had been, there was not any prejudice that
could not be compensated in costs. The Court considered some of the
procedural choices made by Apotex and held that a party, as
sophisticated as Apotex, "must be taken to accept the possible
consequences of the procedural choices it makes, and cannot be
heard to complain that these consequences are prejudicial to
it."
Regarding the bifurcation motion, Lundbeck undertook to forego its
entitlement to damages and claim only Apotex and Pharmachem's
profits, in the event that infringement is found; taking the risk
that its entitlement to those profits could be successfully
opposed. The Court held that had this concession not been made,
there would have been justification for a bifurcation order.
SECTION 8
Pleadings for Disgorgement of Profits and for an
Accounting of Profits in s. 8 Damages Not Struck in Ontario
Court
Apotex Inc. v. Eli Lilly and Company
Drug: atomoxetine
In this case, Apotex has claimed damages in Ontario Court pursuant
to, inter alia, section 8 of the NOC Regulations. Lilly brought a
motion to strike out parts of Apotex' statement of claim. The
motion was mainly dismissed.
In the underlying proceeding, Lilly's application for
prohibition was dismissed for mootness and not because Apotex'
allegations of invalidity were found to be justified. Thus, Lilly
argued in its motion to strike that section 8 does not apply in the
circumstances. The Court held that it was not plain and obvious
that the dismissal for mootness could not come within the ambit of
section 8 of the NOC Regulations. Thus, it did not strike the
claim.
Lilly also asserted in its motion that the claim should be struck
as the material facts relating to the damages claim were not pled.
However, the Court held that a basic pleading of damages was
present and it was implicit in the pleadings that Apotex was ready
to come to market. To require more than the basic pleading would
require Apotex to plead evidence, which is contrary to the Rules.
Lilly also tried to strike the pleadings regarding unjust
enrichment and disgorgement of profits. However, the Court held
that this claim had a reasonable chance of success and that it was
not scandalous, frivolous or vexatious or an abuse of process.
Thus, the claims were not struck.
Lilly moved to strike Apotex' claims pursuant to the
Trade-marks Act. Apotex is asserting, inter alia, that in alleging
in the NOC proceeding that the patent was properly listed on the
Patent Register and that the patent would be infringed, Lilly made
statements that were materially false and misleading and intended
to discredit the business wares and services of a competitor.
Furthermore, as a result of these alleged violations of the
Trade-marks Act, Apotex alleges that Lilly made profits it would
not otherwise have made and is claiming those profits. The Court
held that whatever Lilly may have thought when listing the patent
on the Patent Register, the subsequent determination that the
patent was void ab initio means Lilly did not hold a patent and had
no right to register it. Thus, there is a reasonable prospect that
Lilly can be held to have made assertions which, by reason of the
retroactive voiding of the patent, were false. Thus, the Court held
that the claim has a reasonable prospect of success.
The Court also held that absolute privilege applies for statements
made in court proceedings; however, it is unclear whether that
applies for listing a patent on the Patent Register. Thus, the
relevant pleadings were not scandalous, frivolous or vexatious or
an abuse of process and they were not struck. The Court also held
that the question of whether starting the proceeding falls within
absolute privilege or an exception to that absolute privilege is
also something that should not be resolved by means of motion at
this early stage of the litigation. Thus, the pleading was not
struck.
The claim to damages or an accounting of profits as may be
otherwise available at law was struck as it had no supporting
allegations of fact.
Other Cases of Interest
Second Judicial Review of Maintenance Fee Payments for
Wrong Patent
Repligen Corporation v. The Attorney General of
Canada
This is a second judicial review commenced by Repligen for a
second refusal by the Commissioner of Patents
("Commissioner") to correct errors made in maintenance
fee payment documents. In the first judicial review application,
the Court determined that the Commissioner did not
consider relevant factors in determining whether to make the
corrections pursuant to section 8 of the Patent Act.
The Commissioner made a redetermination of the issue and again
refused to make the correction. In arranging for a service to pay
required maintenance fees, the patent number was incorrectly
provided. Maintenance fee payments were then made against the wrong
patent, owned by Rolls-Royce PLC, and the Repligen patent lapsed.
The Commissioner refused to correct the error, citing concerns that
making the correction could negatively affect the rights of others.
The first judicial review was commenced in respect of this
refusal.
The Court in this second judicial review noted that the
appropriate standard of review is correctness for the
interpretation of section 8 of the Patent Act, and the application
of the law of the facts involves a review based on reasonableness.
The Court determined that the Commissioner should have taken into
consideration that Repligen had paid the prescribed maintenance
fees, although to the wrong patent. The Court considered that
Repligen's interests were completely discounted by the
Commissioner on the basis of a lack of due diligence. The Court
indicated that the approach taken by the Commissioner requires a
standard of perfection in terms of fee payments, which would render
section 8 of the Patent Act unnecessary.
Accordingly, the Court submitted the matter to a different
decision maker within the Patent Office, indicating that the
Commissioner should take into account the interests of Repligen and
Rolls-Royce, as both parties attempted to comply with maintenance
fee provisions.
Other Industry News
Health Canada has published a Draft Guidance Document –
Acetylsalicylic Acid Labelling Standard. Comments are due
September 25, 2012.
About BLG
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.