On Nov. 18, 2015, Justice Locke granted Leo Pharma's
application to prohibit the minister of health from approving
Teva's version of Leo Pharma's patented DOVOBET®
product until after expiry of Canadian Patent 2,370,565 (the
"565 Patent"). DOVOBET® (50 mcg/g calcipotirol
and 0.5 mg/g betamethasone dipropionate ointment) is used in the
treatment of psoriasis.
While the two active ingredients were known in the art to treat
psoriasis, they could not be combined due to pH incompatibility.
This rendered any combined formulation unstable. The inventors of
the 565 Patent had developed a stable formulation which combined
the two active ingredients.
Teva had argued that the claimed formulation was obvious, based
in part on its experts' testimony that they had previously
prescribed the simultaneous application of the two active
ingredients. Justice Locke rejected this allegation for two
principal reasons. First, he noted that this simultaneous
application was not part of the common general knowledge.
Second, he found that the inventive concept of the claim in
question included the fact that the formulation was stable, which
was something that even Teva's experts supposed "prior
use" did not address.
Although his analysis did not turn on this point, Justice Locke
rejected the argument that any prior art
publication was relevant in considering whether a "New
Act" patent (filed post-October 1, 1989) was obvious. He held
that, as with "Old Act" patents, publications must be
locatable in a reasonable and diligent search to be considered for
In his utility analysis, Justice Locke followed the Federal
Court of Appeal's decision in Bell Helicopter Textron
Canada Limitée v Eurocopter (2013 FCA 219), holding
that the common general knowledge could be considered in
determining whether the utility was soundly predicted.
Teva had alleged a lack of sound prediction based on the fact
that only one, out of several, claimed formulations had been made
and tested. In rejecting this allegation, Justice Locke held
that Leo Pharma "need not establish anything close to
certainty that all combinations would be useful" (at paragraph
Teva argued at the hearing that the patent did not sufficiently
describe which, if either, of the active ingredients had to be
dissolved in the solvent in order to make the claimed
formulation. Justice Locke held that it would be unfair to
consider this argument as it was not raised in Teva's
NOA. In any event, the Court found this allegation to be
meritless as the skilled person could make the formulations through
non-inventive trial and error.
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