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 anyprior 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 obviousness.
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 178).
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.
A copy of the decision can be found here.