The Supreme Court of Canada denied leave to appeal today from
the Federal Court of Appeal ("FCA") decision in
Allergan Inc. et al ats. Apotex Inc., 2012 FCA 308. This Patented Medicines
Notice of Compliance ("PM(NOC)") proceeding
concerned the construction of the “inventive concept”
underlying patent claims for a combination of two known drugs into
a single formulation for the topical treatment of glaucoma.
In the Federal Court (2012 FC 767), Justice Hughes had found that
the “inventive concept” of Allergan’s patent
claims was that the claimed combination of ingredients in
particular quantities achieved the promises of the patent, as set
out explicitly in paragraph 1 of the patent, including improved
patient compliance, increased stability and increased efficacy.
Based on his construction of the “inventive concept”
Justice Hughes found the claims to be obvious. He nevertheless went
on to issue the requested prohibition order so that the NOC would
not issue and the FCA would have an opportunity to consider the
issue of judicial comity as it relates to the construction of
patents. The comity issue arose because in an earlier
PM(NOC) proceeding brought by Allergan against Sandoz with
respect to the same patent, Justice Crampton had found that the
“inventive concept” of the patent included an improved
safety profile that was observed during the clinical trials
discussed in the patent, and had concluded that the patent was not
obvious. Justice Crampton came to his decision based in part on
Allergan’s expert evidence that the skilled person would have
considered the improved safety profile to be part of the
The FCA held that it was an error for Justice Hughes to have
granted the prohibition order for the purpose of allowing the FCA
to clarify the comity issue. The FCA did nevertheless note that
whereas comity has no application with respect to findings of fact,
such as a finding that an invention is obvious because the solution
was plain to see; it does apply to construing the whole of a patent
in order to identify the inventive concept, which is a question of
law. Therefore, unless Justice Hughes could demonstrate that
Justice Crampton's determination of the patent's inventive
concept was wrong, or had evidence before him to justify a
different result, it would have been better to follow Justice
The FCA ultimately concluded that: Justice Hughes had
misconstrued the patent; the improved safety profile was part of
the inventive concept, and the allegation of invalidity was not
justified. In the result, the Court upheld the prohibition
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The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
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