Nature of case: Prohibition application
regarding validity of a formulation patent
Successful party: Leo Pharma Inc.
Date of decision: November 18, 2015
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
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.
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 (ComponentA); ii) at least one corticosteroid
(ComponentB); and iii) a solvent
(SolventC). The addition of the
Solvent C resolves the instability issue that results when
Components A and B are mixed together on their own.
Teva argued that the 565 Patent is obvious because, inter
alia, the simultaneous topical use of Components A and B for
the treatment of psoriasis was part of the common general knowledge
at the relevant date. Justice Locke rejected this argument on the
following bases: use of the combination was known, but not common,
among skilled persons; and, it was neither known, nor obvious, that
a pharmaceutical combination of Components A and B would be stable
enough to be a practical pharmaceutical product with the addition
of a Solvent C.
Justice Locke also found that the patented combination was not
"obvious to try" since there were many possible
combinations of Components A, B and C, not all of which would
No lack of utility
Teva argued that the 565 Patent lacked utility on two grounds:
1) it contains no drug-release or skin-penetration data and
therefore, the skilled person could not soundly predict that all
formulations would be effective; and 2) it claims millions of
formulations, not all of which could be soundly predicted to be
stable and effective. Justice Locke rejected both arguments.
Justice Locke rejected Teva's first argument on the basis
that it was not raised in notice of allegation
(NOA). Justice Locke rejected Teva's second
argument on the basis that at least claim 17, the narrowest of the
claims, was soundly predicted. It is enough that one claim of the
565 Patent is valid and infringed for Leo to succeed in its
Teva argued that because the 565 Patent is silent as to which of
Components A or B has to be dissolved in Solvent C (if any) and
that therefore, the skilled person could not put the invention into
practice. Justice Locke rejected this argument on the basis that it
was not raised in Teva's NOA.
In any event, Justice Locke commented that Teva's allegation
was not justified. The Court reasoned that the process for making
ointments was well-known at the time and that the skilled person
would be able to make the claimed formulation using the teachings
in the 565 Patent and her/his own knowledge.
Norton Rose Fulbright is a global legal practice. We provide
the world's pre-eminent corporations and financial institutions
with a full business law service. We have more than 3800 lawyers
based in over 50 cities across Europe, the United States, Canada,
Latin America, Asia, Australia, Africa, the Middle East and Central
Recognized for our industry focus, we are strong across all
the key industry sectors: financial institutions; energy;
infrastructure, mining and commodities; transport; technology and
innovation; and life sciences and healthcare.
Wherever we are, we operate in accordance with our global
business principles of quality, unity and integrity. We aim to
provide the highest possible standard of legal service in each of
our offices and to maintain that level of quality at every point of
Norton Rose Fulbright LLP, Norton Rose Fulbright Australia,
Norton Rose Fulbright Canada LLP, Norton Rose Fulbright South
Africa (incorporated as Deneys Reitz Inc) and Fulbright &
Jaworski LLP, each of which is a separate legal entity, are members
('the Norton Rose Fulbright members') of Norton Rose
Fulbright Verein, a Swiss Verein. Norton Rose Fulbright Verein
helps coordinate the activities of the Norton Rose Fulbright
members but does not itself provide legal services to
The content of this article is intended to provide a
general guide to the subject matter. Specialist advice should be
sought about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).