Pharma In Brief - Federal Court Grants Prohibition Order In Relation To An Ointment Used For The Treatment Of Psoriasis

Case: Leo Pharma Inc v Teva Canada Limited et al, 2015 FC 1237

Drug: DOVOBET® (calcipotriol monohydrate / betamethasone dispropionate)

Nature of case: Prohibition application regarding validity of a formulation patent

Successful party: Leo Pharma Inc.

Date of decision: November 18, 2015

Summary

Leo Pharma Inc. (Leo) markets and sells 50 mcg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate) ointment in Canada under the name DOVOBET® for use in the treatment of psoriasis. Teva Canada Limited (Teva) sought approval of its generic ointment product for the same treatment indication.

The Federal Court granted Leo's application for an order prohibiting the Minister of Health from issuing a Notice of Compliance. Justice Locke held that Teva's allegations that the relevant patent is invalid for obviousness, lack of utility and insufficiency were not justified.

Background

Canadian Patent No. 2,370,565 (565 Patent) is listed on the patent register in respect of DOVOBET®. The 565 Patent describes and claims a combined formulation of: i) at least one vitamin D or vitamin D analogue (Component A); ii) at least one corticosteroid...