Calcipotriol & Betamethasone dipropionate – Canada

Calcipotriol & Betamethasone dipropionate – Canada

On March 14, 2017, The Federal Court of Appeal (FCA) dismissed Teva’s appeal on both counts (utility and insufficiency of disclosure) and upheld the prohibition order granted by Federal Court pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations.

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 Federal court 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 relates to a combination formulation of: at least one vitamin D or vitamin D analogue (Component A); at least one corticosteroid (Component B); and a solvent (Component C).
With respect to Utility, Teva argued that the Federal Court erred by dismissing its inutility allegation without evidence from Leo regarding the factual basis and logic or reasoning used by the inventors to support their sound prediction of the invention’s utility. The FCA rejected Teva’s argument that, as a matter of law, subjective proof of the inventors’ prediction must be made through evidence directly from the inventors, not an expert witness.

With respect to Insufficiency, Teva argued that the Federal Court erred in law because it did not find that the 565 Patent fails to correctly and fully disclose the invention as contemplated by the inventors. The FCA held that one must always consider the nature of the invention to determine what needs to be included in the disclosure. Furthermore, the FCA accepted that non-inventive trial-and-error experimentation is permissible when determining whether a skilled person would be able to work the invention.
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