Pharma In Brief - Federal Court Of Appeal Upholds Prohibition Order Against Generic DOVOBET®, Dismisses Inutility And Insufficiency Challenges

Case: Teva Canada Limited v Leo Pharma Inc, 2017 FCA 50 (A-508-15), aff'g 2015 FC 1237 (T-1791-13)

Drug: DOVOBET® (calcipotriol/betamethasone dipropionate ointment)

Nature of case: Appeal from application for prohibition order granted pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133

Successful party: Leo Pharma Inc. and Leo Pharma A/S (collectively Leo)

Date of decision: March 14, 2017

Summary

Teva asked the Court of Appeal (FCA) to overturn the Federal Court's findings (reported here) on utility and insufficiency of disclosure. The FCA, dismissing Teva's appeal on both counts and upholding the prohibition order, addressed the role of inventors' evidence in proving sound prediction and the use of trial-and-error testing to support sufficiency of disclosure.

Background

Leo Pharma Inc. markets DOVOBET® (calcipotriol/betamethasone dipropionate ointment) in Canada for the treatment of psoriasis. Teva Canada Limited sought approval for a generic version of DOVOBET® and was opposed by Leo. Leo's application was successful, and Locke J issued an order prohibiting the Minister of Health from approving Teva's proposed generic until the expiry of Canadian Patent No. 2,370,565 (the 565 Patent).

The 565 Patent is listed on the patent register against DOVOBET®. It...