This decision is the second by the Trial Judge in this matter.
The first decision of the Trial Judge, finding the
patent invalid, was appealed to the Federal Court of Appeal,
which overturned the Trial Judge on a number of issues and sent the
matter back for reconsideration on others. Our summary of the Court
of Appeal decision can be found here.
The Trial Judge considered the issues of lack of utility and
insufficient disclosure. In construing the patent, the Court held
that a selection patent must promise more than its genus patent.
The Court then held that the promise of the patent in this case was
set out in a summary statement in the disclosure. As the Court of
Appeal had held that a sufficient factual basis exists for a sound
prediction, the Trial Judge was left to consider whether there was
demonstrated utility at the time of filing or whether there was a
sound line of reasoning from the factual basis to the promise of
The Trial Judge held that the evidence available at the time of
patent filing did not demonstrate actual utility for the promise of
the patent. Thus, Lilly must rely on a sound prediction of utility.
In considering whether there was a prima facie reasonable
inference of the patent's promise, the Trial Judge held that
"one could not reasonably infer from the available evidence
that olanzapine would treat schizophrenia patients in the clinic in
a markedly superior way." The Court also held that the chronic
nature of the disease must be taken into account when considering
whether the promise of the patent had been met. The Court held that
at best, the "the evidence supported a working hypothesis that
olanzapine had some antipsychotic effect and a manageable safety
profile." Thus the patent was invalid for a lack of sound
In considering sufficiency, the Court held that the patent makes
clear what the invention is, and that there is no evidence that
skilled persons would be unable to put it into practice. Thus, the
requirements of s. 27(3) of the Patent Act were met.
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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