Two recent patent decisions in the United States and Canada
highlight the differences in the application of utility and
disclosure even though the relevant statutory sections are the
same. The patents at issue claim the use of atomoxetine
hydrochloride for use in the treatment of ADHD. The U.S. patent was
found to be valid even though the results of a clinical trial were
received after the U.S. application was filed. The positive results
were received before the Canadian patent application was filed, yet
the Canadian patent was invalidated on a utility attack.
ADHD is a chronic and inheritable neurobiological disorder
characterized by an inappropriate level of inattention,
hyperactivity and impulsiveness. The disorder impacts 3 to 5 per
cent of school-age children, most of whom carry symptoms into
adulthood. It can result in the significant impairment of school,
family, and social relationships. There is no cure for ADHD, but
symptoms may be ameliorated by medication. Stimulants are
controlled substances and are not effective for all patients.
Tricyclic antidepressants (TCAs) were also used but concerns were
raised when desipramine was implicated in the sudden death of some
Eli Lilly's Strattera atomoxetine hydrochloride was the
first non-stimulant ADHD drug approved by the FDA and Health
Canada. Atomoxetine was synthesized around 1980 and tested
extensively in the treatment of depression. The results of the
clinical trials lead to the abandonment of atomoxetine for use in
depression but did show that atomoxetine was well-tolerated by
Lilly scientists conceived that atomoxetine may be effective in
the treatment of ADHD and so they approached leading ADHD
researchers at the Massachusetts General Hospital (MGH), the
teaching hospital associated with Harvard University, to conduct a
clinical trial. Lilly funded an ADHD study, provided atomoxetine
and placebo and allowed MGH access to Lilly's confidential FDA
f lings for the purpose of running the study. The overall response
rate for atomoxetine was clinically and statistically higher than
placebo. The relative timing of the study is as follows: (1) FDA
approval for the study; (2) U.S. patent application filed; (3)
positive results received by Lilly and published at the world's
largest meeting of ADHD practitioners; and (4) Canadian patent
The disclosure and claims of the U.S. and Canadian patents are
virtually the same. The patents disclose that atomoxetine is
effective in all forms of ADHD in children, adolescents and adults.
The improved safety profile of atomoxetine is disclosed and
recommended dosing is provided. In both jurisdictions, the central
invalidity argument related to the fact that the results of the MGH
study were not provided in the patent disclosures.
The U.S. Court of Appeals for the Federal Circuit (Eli Lilly
and Co. v. Actavis Elizabeth LLC et al., Appeal No. 2010-1500
(Fed. Cir. July 29, 2011)) overturned the trial decision, which
found the patent invalid for "lack of
enablement/utility." The Court of Appeal reasoned the
invention had utility and the specification met the objective
disclosure test required by the statute. On the other hand, the
Canadian Federal Court and Federal Court of Appeal held the patent
invalid for want of disclosure of sound prediction (Novopharm
v. Eli Lilly and Co., 2010 FC 915, 87 C.P.R. (4th) 301, upheld
2011 FCA 220, 94 C.P.R. (4th) 95). Under current Canadian law, a
utility analysis is measured by reference to the "promise of a
patent." The trial judge said that the patent implicitly
promised long-term usefulness. Because long-term testing had not
been done at the time of filing, the patent was based upon sound
prediction, which requires enhanced disclosure of the factual basis
and a sound line of reasoning for the prediction. As such, the
results of the MGH study were required to be disclosed.
There is nothing in the Canadian Patent Act that
requires this "enhanced disclosure" for inventions based
upon sound prediction. If a patent discloses a new, non-obvious and
useful invention and provides sufficient information to allow a
person of skill to make and use an invention, there should be
sufficient consideration for the grant of a patent. Increasing
utility standards by reference to a promise of the patent
discourages applicants from discussing the attributes of their
inventions for fear of being held to a higher utility standard. It
is hoped that future cases will clarify this law.
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