Case: Apotex Inc. v. Eli Lilly Canada Inc.
2013 FCA 282
Nature of case: Appeal of Motion to Vary
Order brought under Rule 399
Date of decision: December 4, 2013
This case dealt with an appeal by Apotex Inc.
(Apotex) from a decision of Justice Gauthier in
T-156-05 and T-787-05 which dismissed Apotex's motion to set
aside an order granted to Eli Lilly Canada Inc. (Eli
Lilly) in an earlier proceeding that prohibited the
Minister of Health from issuing a Notice of Compliance to Apotex
with respect of its olanzaprine product until the expiry of Eli
Lilly's Canadian Patent No. 2,041,113 ('113
The appeal was dismissed. The Federal Court of Appeal confirmed
that a finding of patent invalidity at a later point in time does
not enable the Court to reach back and retroactively dismiss an
application for an order of prohibition granted in an proceeding
under the Patented Medicines (Notice of Compliance)
where the court had determined that the generic company's
allegation of non-infringement or invalidity was not justified. In
the result, a subsequent declaration of patent invalidity does not
allow a generic manufacturer to avail itself of the statutory cause
of action for damages under section 8 of the PMNOC
Regulations for having been delayed market entry.
In a PMNOC proceeding brought by Eli Lilly, concerning the
'113 Patent, the court granted an Order prohibiting the
Minister from issuing an NOC to Apotex. This prohibition Order was
later confirmed by the Court of Appeal. However, Justice
O'Reilly, in the context of a separate and subsequent
infringement action and cross-claim for a declaration of invalidity
of the '113 patent declared all the claims of '113 Patent
to be invalid.
The question at issue before the Federal Court, and the Federal
Court of Appeal, was whether a declaration that a patent is invalid
enables the Court to vary an earlier order and to dismiss an
application for prohibition which the Court had already granted; in
this case, an order prohibiting the Minister from issuing a NOC
until the expiry of the '113 Patent.
Based on well-established law in Canada, in the Federal Court
decisions in Apotex Inc. v. Syntex Pharmaceuticals
International Inc., 2010 FCA 155
(Syntex) and Pfizer Canada Inc. v.
Ratiopharm, 2011 FCA 215
(Ratiopharm), the Federal Court of Appeal
reiterated that courts have "unequivocally held on several
occasions" that a retroactive dismissal of a prohibition order
after a subsequent finding of patent invalidity is not
The Federal Court of Appeal further held that Apotex had not met
the stringent test established by Miller v. Canada (Attorney
General), to find that these decisions are "manifestly
wrong" and therefore should not be considered.
Interestingly, the Court addressed Apotex's claims that
"Syntex and Ratiopharm are bad law and inconsistent
with the overall scheme and purposes of the Regulations" by
stating that this should more appropriately be addressed by the
Supreme Court of Canada.
Link to decision:
The Federal Court of Appeal decision may be found at:
Norton Rose Fulbright is a global legal practice. We provide
the world's pre-eminent corporations and financial institutions
with a full business law service. We have more than 3800 lawyers
based in over 50 cities across Europe, the United States, Canada,
Latin America, Asia, Australia, Africa, the Middle East and Central
Recognized for our industry focus, we are strong across all
the key industry sectors: financial institutions; energy;
infrastructure, mining and commodities; transport; technology and
innovation; and life sciences and healthcare.
Wherever we are, we operate in accordance with our global
business principles of quality, unity and integrity. We aim to
provide the highest possible standard of legal service in each of
our offices and to maintain that level of quality at every point of
Norton Rose Fulbright LLP, Norton Rose Fulbright Australia,
Norton Rose Fulbright Canada LLP, Norton Rose Fulbright South
Africa (incorporated as Deneys Reitz Inc) and Fulbright &
Jaworski LLP, each of which is a separate legal entity, are members
('the Norton Rose Fulbright members') of Norton Rose
Fulbright Verein, a Swiss Verein. Norton Rose Fulbright Verein
helps coordinate the activities of the Norton Rose Fulbright
members but does not itself provide legal services to
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.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).