Patent applicant CONSTANTIN EFTHYMIOPOULOS loses at CAFC, but Judge Newman dissents
to methods of treating or
preventing influenza by administering the drug
zanamivir1 by oral inhalation.
Judge Newman's dissent in In re EFTHYMIOPOULOS concludes:
It was undisputed that, at the time of this invention,
it was believed that the influenza virus infected primarily
the upper respiratory tract, that is, the nasal passages. It
was undisputed that there was not a reasonable expectation
that administration to the lower respiratory tract by
oral inhalation would be effective. The Von Itzstein
references do not show or suggest oral inhalation, either
for zanamivir or for any related compounds. The Board’s
statement that inhalation is “reasonably understood” to
include oral inhalation, PTAB Op. 12, is without authority.
There was no record showing or supporting such an
understanding. There was no suggestion or hint in any
reference that treatment by oral inhalation would have a
reasonable expectation of success.
This mode of therapy is taught only by this inventor.
There was not substantial evidence to support the Board’s
ruling of obviousness. From the court’s flawed analysis
and unsupported conclusion, I respectfully dissent.
Of expert opinion:
Hayden, who discussed a large international study in which
he participated, and concluded that the “effectiveness of
orally inhaled zanamivir as compared with nasal administration
. . . could be considered an unexpected result”:
In part because uncertainties existed regarding
the transmission and pathogenesis of influenza as
of the effective filing date of the present application,
it was unclear whether oral inhalation of
zanamivir with the dry powder inhaler device utilized
in the studies would be clinically effective
alone for prevention or treatment of naturally occurring
uncomplicated influenza. In view of this
uncertainty, the clinical effectiveness of orally inhaled
zanamivir as compared to nasal administration
for prevention of naturally occurring
uncomplicated influenza above could be considered
an unexpected result. Similarly, the effectiveness
of orally inhaled zanamivir without
intranasal zanamivir for treatment of naturally
occurring uncomplicated influenza alone could be
considered an unexpected result.