Astrazeneca Canada Inc. v. Mylan Pharmaceuticals
Drug: ARIMIDEX® anastrozole
Mylan alleged that the patent is invalid for lack of
utility and obviousness. The Court first considered a number of
preliminary issues. With respect to the admissibility of an
affidavit of an expert, the Court held that the witness's
credentials as an expert impact the weight and not the
admissibility of the affidavit. Further, the Court declined to hear
a motion by AstraZeneca at the outset of the hearing seeking to
strike portions of Mylan's Memorandum of Fact and Law that
allegedly made an argument that was not contained in the Notice of
Allegation (NOA). The Court held that the memorandum is not a
pleading that can be struck and that interlocutory motions in
applications are exceptional. The Court dismissed the motion but
directed that arguments with respect to the adequacy of the NOA be
made during the course of the hearing. The Court ultimately found
that the NOA was adequate to provide notice to
The Court construed the promise of the patent, considering the
language of the patent itself as well as the evidence of the
experts. The Court found that the patent does not promise
therapeutic utility, and that a statement as to the
"object" of the invention did not amount to a promise.
The Court considered the testing referred to in the patent and
found that utility had been demonstrated. In the event the Court
was incorrect with respect to the promise of the patent and that
the promise was broader than the Court's finding, the Court
found that the patent would be invalid for lack of demonstrated or
soundly predicted utility.
With respect to obviousness, the Court noted that there was no
obvious starting point for the development of the claimed compound
and therefore the inventive promise would not have been obvious to
a skilled person.
Materials from a recent "refresher training" for examiners at the Canadian Intellectual Property Office (CIPO) highlight inconsistencies between CIPO's examination practices and Supreme Court precedent.
In this recently reported decision, the Court granted Apotex leave to deliver Fresh as Amended Responding Statement of Issues for the reference into AstraZeneca's damages or Apotex's profits, following the Court's decision that the ‘693 Patent is valid and infringed by Apotex.
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