In a decision dated May 27, 2016 in respect of Bristol-Myers
Squibb's ("BMS") REYATAZ® (atazanavir
bisulfate),1 Justice Mactavish of the Federal Court
prohibited the minister of health from issuing a NOC to Teva in
respect of its generic atazanavir bisulfate product until after the
expiry of Canadian Patent No. 2,250,840 ("840 Patent").
In particular, the Court disagreed with Teva's allegations that
the 840 Patent (which relates, inter alia, to the compound
atazanavir) was invalid on the grounds of anticipation and
However, Justice Mactavish dismissed BMS's application in
respect of Canadian Patent 2,317,736 ("736 Patent"),
which relates to the bisulfate salt of atazanavir, as the Court
found that BMS had failed to prove that Teva's allegation of
obviousness was unjustified.
The 840 Patent
In respect of Teva's allegation of obviousness of the 840
Patent, the Court first noted that Teva had failed to discharge its
evidential burden of proving that certain pieces of prior art were
publically available at the relevant date. The Court noted that the
generic must adduce "some evidence which, if accepted, is
capable of establishing the invalidity of the patent" (at
paragraph 56). The Court also reaffirmed that the generic cannot
rely on prior art that is not listed in the NOA.
When considering the issue of obviousness in light of the
admissible prior art, the Court first sought to identify the
inventive concept of the relevant claims. The issue was whether the
inventive concept included the advantageous properties of
atazanavir (including, for example, its advantageous resistance
profile and high selectivity against HIV protease).
Teva, having not made an allegation relating to the
"promise of the patent", argued that the statements of
advantageous properties in the disclosure were merely
"aspirational" and not part of the inventive concept.
However, the Court agreed with BMS that the advantageous properties
of atazanavir should be considered to be part of the inventive
When viewing the inventive concept in light of the admissible
prior art and without the benefit of hindsight, the Court held that
the relevant claims were not obvious. In doing so, the Court
rejected Teva's argument that only a "fair expectation of
success" is required to demonstrate obviousness, noting the
Federal Court of Appeal's recent decision to the contrary in
Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC, 2015 FCA
286. In coming to its decision, the Court also appeared to put
significant emphasis on the inventors' prolonged and arduous
research in developing atazanavir.
The Court also rejected Teva's allegation of anticipation in
respect of the 840 Patent. Teva had argued that atazanavir fell
within a genus of compounds disclosed in an earlier patent. The
Court first noted that it was not clear that the earlier patent
encompassed atazanavir. Second, Justice Mactavish held that, even
if it was encompassed, this does not mean that the genus
anticipates the species, which is consistent with the Supreme
Court's decision in Apotex Inc v Sanofi-Synthelabo Canada
Inc, 2008 SCC 61. In particular, Justice Mactavish held
A claim to a specific chemical compound such as atazanavir is
not anticipated by a prior art reference that only teaches a broad
genus of compounds into which the specific compound in question
arguably falls, where the genus patent does not provide directions
that would inevitably result in the specific compound in issue. (at
Finally, the Court noted that the genus patent did not
anticipate the claims in question as there was no enablement;
inventive steps would be required to discover atazanavir and its
The 736 Patent
In respect of the 736 Patent, the Court found Teva's
obviousness allegation to be justified. The Court again rejected
Teva's approach to determining the inventive concept (which was
to disregard the disclosure), and found the inventive concept to
include the advantages set out in the disclosure (e.g.,
crystallinity, stability, improved bioavailability).
However, the Court found the claimed invention to be obvious, as
it would be "obvious to try" to make atazanavir
bisulfate, and the techniques used to identify these properties
were routine. The Court again appeared to place significant weight
on the inventors' actual course of conduct, finding that the
evidence showed that the bisulfate salt was made easily and
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