Federal Court of Canada Grants Leo Pharma’s Calcipotriol Application Against Teva

On November 18, 2015, Locke J of the Federal Court of Canada issued his Public Judgment and Reasons in Leo Pharma Inc v Teva Canada Limited, 2015 FC 1237, granting the application of Leo Pharma Inc (Leo Pharma) for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Teva Canada Ltd (Teva) for its generic calcipotriol and betamethasone dipropionate ointment (Leo Pharma’s DOVOBET®) until expiry of  Canadian Patent No. 2,370,565 (the 565 Patent).

The 565 Patent claims a formulation combining two psoriasis drugs: i) one vitamin D or vitamin D analogue (Component A) and ii) corticosteroid (Component B) with the addition of a solvent (Solvent C).  According to the 565 Patent, the addition of Solvent C solves the instability problem resulting from mixing the two drugs together due to their pH incompatibility.  Betamethasone is a corticosteroid and calcipotriol is a vitamin D analogue.  Locke J held that Teva’s invalidity allegations on the grounds of obviousness, lack of utility and insufficiency were not justified.

Regarding obviousness, Locke J accepted Teva’s argument that the skilled person could take risks; nevertheless, he found that the claims of 565 Patent were inventive principally because the claimed combination was not obvious to try in light of many possible combinations.

Teva has appealed to the Federal Court of Appeal.