Case: Teva Canada Limited v. Novartis
Pharmaceuticals Canada Inc. and the Minister of Health, 2013 FCA
244 Drug: ACLASTA® (zoledronate) Nature of case: Appeal from a prohibition
proceeding under s. 6 of the PM(NOC) Regulations Successful party: Novartis Pharmaceuticals Canada
Inc. Date of decision: October 15, 2013
This is an appeal from a decision of Justice Hughes, allowing an
application for an order prohibiting the Minister of Health from
issuing a Notice of Compliance ("NOC") to Teva Canada
Limited ("Teva") for its drug containing zoledronate. On
appeal, Teva argued that the Hughes J. erred in his analysis of
obviousness by importing a higher standard and failing to properly
apply the test for obviousness as set out by the Supreme Court of
Canada in Apotex v. Sanofi1 (the "Sanofi
Test"). The Court of Appeal found that Hughes J. did not err
in his analysis of obviousness. As such, the appeal was
A summary of the decision of Hughes J. in 2013 FC 283 can be
Novartis Pharmaceuticals Canada Inc. ("Novartis")
brought an application pursuant to section 6 of the Patented
Medicines (Notice of Compliance) Regulations for an order
prohibiting the Minister of Health from issuing a NOC to Teva in
respect of its zoledronate tablets until the expiry of Canadian
Patent Nos. 1,338,937 (the "'937 Patent") and
1,338,895 (the '895 Patent"). Zoledronic acid (also
called zoledronate) is a bisphosphonate drug marketed by Novartis
under the brand name ACLASTA® for the treatment of
In the section 6 proceeding, Teva alleged that the '895
Patent was invalid for obviousness, lack of utility and
insufficiency. The '895 Patent relates to a class of
heteroarylalkane disphosphonic acids, which includes zoledronate.
In respect of the '937 Patent, Teva alleged that the patent was
invalid for obviousness, lack of utility, insufficiency, and
overbreadth. The '937 Patent is directed to zoledronate and
pharmaceutical compositions of zoledronate. The Court held that
Teva's allegation of lack of utility of the '895 Patent was
justified. However, the allegations in respect of the '937
Patent were not justified, and, as such issued a Prohibition
Teva appeals from the decision of the Federal Court.
On appeal, Teva argued that Hughes J. did not properly apply the
third prong the Sanofi Test for obviousness as he failed to
identify the differences between the state of the art at the
relevant date and the inventive concept. Particularly, Teva
asserted that important evidence in respect of the prior art was
ignored by the Court. The Court of Appeal did not find a
higher standard of obviousness was applied, and also acknowledged
that there is no single approach to the third prong of the Sanofi
Test as illustrated by the post-Sanofi jurisprudence. It was
held that there was no error in law with Justice Hughes'
application of the Sanofi Test. Although, the reasons for his
decision could have included more detail about the difference
between the state of the art and the inventive concept, the Court
did not doubt that Hughes J. was "alert and alive to the
issues raised" and properly conducted this analysis.
1 Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC
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