The Federal Court of Appeal recently released its decision in
Eli Lilly and Company v Teva Canada
Ltd, confirming the trial court's finding
that Canadian Patent No. 2,209,735 (the 735 patent), which claims a
new use for an old medicine that has long been in the public domain
(the use of atomoxetine for treating attention deficit
hyperactivity disorder (ADHD) in three of its manifestations among
all age groups), is invalid. We reported the lower Court's
ruling in a previous blog.
This appeal raised three principle legal issues. Namely, did the
Judge err by: (i) misconstruing the patent's promise by finding
an implicit promise that atomoxetine "will work in the longer
term"; (ii) requiring too high a standard of proof for
utility; and (iii) deciding that Lilly could not rely on the sound
prediction of the utility of the invention because Lilly had not
disclosed the factual foundation for that prediction in the 735
The Court rejected all of Lilly's arguments. As to the
patent's promise, the Court found that the trial judge did not
construe the patent as promising more than its explicit promise
that it will treat ADHD in some people. The trial judge had
simply interpreted what "treatment" meant in the 735
patent in the context of ADHD, a chronic disorder requiring
sustained treatment. He was therefore not adding any
promise above and beyond that already expressed in the words of the
735 patent itself. Moreover, this argument could not assist
Lilly in any event. The trial judge found that the evidence
was insufficient to demonstrate that atomoxetine was an effective
clinical treatment, regardless of the length of time for which
it was taken.
As to the standard of proof for utility, Lilly argued that only
a low level or scintilla of utility is required for the purpose of
patentability. As such, Lilly argued that the trial judge
erred by requiring evidence that was "sufficiently compelling
to independently support the [patent's] inventive
promise." The Court found that this argument could not
succeed however, because the 735 patent specifically promised that
atomoxetine is a clinically effective treatment of
ADHD. Utility was therefore not to be measured against a
hypothetical or theoretical standard lower than that promised in
the patent. Although data from a pilot study was promising and
"indicated a clinically and statistically significant response
rate for atomoxetine over placebo", it was proper for the
trial judge not to infer from the limited experimental data that
there was sufficient evidence that atomoxetine was a clinically
effective treatment of ADHD.
Lastly, as to the issue of proper disclosure for sound
prediction, Lilly argued that neither the Patent Act nor
the Supreme Court's jurisprudence requires disclosure of study
results in a patent as a condition precedent to successfully
invoking sound prediction as the basis of the utility of the
claimed invention. The Court noted in response, however, that
the Federal Court of Appeal has previously affirmed that a patentee
must disclose in a patent a study that provides the factual basis
for the sound prediction. In addition, the Court stated:
[I]f disclosure in the patent of the factual basis of the
prediction of utility was not required for sound prediction, it
would be difficult to see what Lilly could be said to have given to
the public, in exchange for the grant of the monopoly, that it did
not already have. When utility is based on sound prediction,
disclosure of its factual foundation goes to the essence of the
bargain with the public underlying patentability.
We look forward to the Supreme Court's decision in the
sildenafil citrate (Viagra) case, where we will be provided with
further guidance on the issue of sound prediction.
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A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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