In her February 14th decision of Alcon Canada Inc
v. Cobalt Pharmaceuticals Company (2014 FC 149), Justice
Gleason of the Federal Court denied Alcon's application for an
order of prohibition with respect to its PATADAY® product.
PATADAY®, used to treat allergic and inflammatory eye
reactions, contains a 0.2% solution of olopatadine. The validity of
Canadian Patent 2,447,924 was at issue in this proceeding.
The '924 Patent
The relevant claims of the '924 Patent claimed
pharmaceutical compositions for the treatment of allergic or
inflammatory disorders of the eye and nose comprising olopatadine
and the excipient PVP, where the composition does not contain any
of five named "excluded excipients". The two claims at
issue in this proceeding (claims 2 and 7) both claimed allowable
molecular weight ranges for PVP (5,000-1,600,000), and ranges of
allowable olopatadine concentrations in the composition.
The Court construed the promise of the patent before undertaking
its utility analysis. The Court framed the promise as that "of
the asserted claims", and considered the promise of each of
claims 2 and 7 separately (eventually finding separate promises for
these two claims).
However, after making noted reference to the claims in
determining certain elements of the promise, the Court went on to
find that there is a promise that the excluded compounds would not
enhance the physical stability of the claimed olopatadine solutions
despite an absence of an explicit statement to this effect in the
claims. Rather, the Court came to this aspect of the promise on the
basis that the disclosure mentions that two of the five excluded
excipients will not enhance the stability of the solution. By way
of inference, the Court found that this statement should apply to
all five "excluded excipients".
In construing the promise, the Court also considered the
inventive concept of the claims. In particular, the Court held that
the inventive concept included the fact that the excipient PVP
enhances the solution's stability and the excluded excipients
do not. The Court held that it was "incongruous" in the
context of this patent to argue that the inventive concept was
something different from the promise.
Promised Utility Not Met
The '924 Patent contained five examples relevant to the
utility of claims 2 and 7. No data apart from these examples was
considered for utility. From her review of these examples, the
Court found that 58K molecular weight PVP enhanced stability of the
solutions, and thus utility was demonstrated for this value. The
other molecular weight tested, 1300K, had some positive
information, but there also were experiments where utility was not
shown. This information was held to be "not conclusive",
and thus insufficient to demonstrate utility.
With respect to sound prediction, the Court held that there was
no basis for predicting that the entire range of molecular weights
of PVP claimed will have a physically stabilizing effect. Based on
a finding that the physical stability of solutions is random and
unpredictable, the Court held that the need for disclosure of a
sound line of reasoning was "heightened" in this case as
compared to other sound prediction cases. Unusually, the Court did
not mention the 58K data point in the sound prediction analysis,
even though utility was found to be demonstrated for this
Allegations of obviousness, ambiguity, and sufficiency were
dismissed. On the last point, the Court confirmed that trial and
error experimentation is permissible in putting the invention into
practice in order to satisfy the sufficiency requirement.
This decision once again highlights problems with the promise
and utility doctrines in Canada. Unfortunately, the findings in
this proceeding appear unlikely to see reconsideration via appeal,
as Cobalt (under the new name Actavis Pharma Company) has already
received its Notice of Compliance for its version of
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