LEXPERT MAGAZINE
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JANUARY/FEBRUARY 2018 29
with that of our international trading part-
ners and is in particular a significant win for
pharmaceutical innovation in Canada.
Background of dispute
e Supreme Court's decision was in the
context of a dispute regarding the validity
of a patent for esomeprazole, a proton-pump
inhibitor (PPI) used in the reduction of gas-
tric acid, reflux esophagitis, and related mal-
adies. AstraZeneca markets esomeprazole
in Canada as NEXIUM
®
; esomeprazole is
claimed in Canadian Patent No. 2,139,653
(the 653 Patent).
In the lower Federal Court judgments on
the validity of the 653 Patent, the entire pat-
ent was declared invalid for failure to demon-
strate or soundly predict utility alleged by the
generic company Apotex to be promised in
the disclosure portion of the patent.
e main issue before the courts was
whether statements of usefulness in the dis-
closure amounted to a promise of utility by
which standard the validity of the patent
should be measured.
Following the dismissal by the Federal
Court's Hughes J. (as he then was) of a pro-
hibition application by AstraZeneca under
the Patented Medicines (Notice of Compli-
ance) Regulations in 2010, Apotex launched a
competing esomeprazole product in Canada.
is launch led to an action in which Astra-
Zeneca sued Apotex for infringement of the
653 Patent.
Apotex defended the action in part by
counterclaiming for a declaration of invalid-
ity. In 2014, Rennie J. (as he then was) found
the 653 Patent invalid and dismissed Astra-
Zeneca's action for infringement. Although
Rennie J. agreed with AstraZeneca that the
subject matter of the claims of the 653 Pat-
ent in suit was novel and inventive (non-ob-
vious), he found the entire patent invalid for
failure to demonstrate or soundly predict the
utility promised in the patent.
AstraZeneca's appeal to the Federal
Court of appeal was dismissed by a unani-
mous panel in 2015. Dawson J.A. concluded
that Rennie J. had correctly applied the law
in his construction of the promised utility of
the patent.
On the appeal, the SCC heard oral ar-
gument from the AstraZeneca and Apotex
parties, as well as the following interven-
ers: Innovative Medicines Canada and
BIOTECanada (jointly); the Centre for
Intellectual Property Policy; and the Fé-
dération internationale des conseils en
propriété intellectuelle.
e court also received written submis-
sions from the Canadian Generic Pharma-
ceutical Association, the Intellectual Proper-
ty Owners Association, and the Intellectual
Property Institute of Canada.
Promise Doctrine is an error of law
In unanimous reasons, the Supreme Court
of Canada allowed AstraZeneca's appeal and
struck down the promise doctrine as an error
of law.
Writing for the court, Rowe J. emphasised
the connection between utility and the sub-
ject-matter of the invention as identified by
claims construction:
For the subject matter to function as an
inventive solution to a practical problem, the
invention must be capable of an actual rel-
evant use and not be devoid of utility.
With this in mind, Rowe J. held that util-
ity must instead be assessed using the follow-
ing two-step test:
First, courts must identify the subject-
matter of the invention as claimed in the
patent. Second, courts must ask whether that
subject-matter is useful — is it capable of a
practical purpose (i.e. an actual result)?
is test is driven by the claims of the pat-
ent, rather than the disclosure portion.
Rowe J. also confirmed that there is a
single, low bar for proof of utility, restor-
ing the "scintilla" standard as the focus of
the analysis.
e Act does not prescribe the degree
or quantum of usefulness required, or that
every potential use be realized — a scintilla
of utility will do. A single use related to the
nature of the subject-matter is sufficient, and
the utility must be established by either dem-
onstration or sound prediction as of the filing
date […].
In reaching this conclusion, the court rec-
ognised that the promise doctrine was ex-
cessively onerous and inconsistent with the
scheme of the Patent Act. By wrongly conflat-
ing the utility requirement in section 2 with
the disclosure requirement in subsection
27(3), the promise doctrine had the potential
to punish patentees for attempting to fulfill
their part of the patent bargain by fully de-
scribing the invention and its use.
Declaration of invalidity reversed
Applying the correct test for utility, the SCC
held that the 653 Patent was valid and re-
versed the courts below.
In the Federal Court, Rennie J. had held
that the subject matter of the main 653 Pat-
ent claims in issue was "optically pure salts of
the enantiomer of omeprazole". He had also
held that one of the uses he identified un-
der the promise doctrine — that these salts
would be useful as PPIs to reduce gastric acid
secretion — had been soundly predicted by
the relevant date.
ese holdings were sufficient to support
the utility of the 653 Patent claims in suit:
the other uses found by the lower courts to
have been promised were irrelevant to the
utility analysis.
Gunars Gaikis, Yoon Kang and Y. Lynn
Ing of Smart & Biggar acted for the appel-
lants, AstraZeneca Canada Inc., AstraZene-
ca Aktiebolag and AstraZeneca UK Limited.
Harry B. Radomski, Andrew R. Brod-
kin, Richard Naiberg and Sandon Shogilev
of Goodmans LLP were counsel for the
respondents, Apotex Inc. and Apotex Phar-
machem Inc.
Patrick E. Kierans, Kristin Wall and Jillian
Hyslop of Norton Rose Fulbright Canada
LLP represented the interveners Innovative
Medicines Canada and BIOTECanada.
Jeremy de Beer of the University of Ot-
tawa and E. Richard Gold of McGill Univer-
sity represented the intervener the Centre for
Intellectual Property Policy.
Jonathan Stainsby and Scott A. Beeser
of Aitken K lee LLP acted for the inter-
vener the Canadian Generic Pharmaceu-
tical Association.
Julie Desrosiers and Kang Lee of Fasken
Martineau DuMoulin LLP and Alain M.
Leclerc of Goudreau Gage Dubuc acted for
the intervener Fédération internationale des
conseils en propriété intellectuelle.
Andrew Bernstein and Yael Bienen-
stock of Tor ys LLP were counsel for the
intervener the Intellectual Property Own-
ers Association.
Jason Markwell of Belmore Neidrauer
LLP acted for the intervener the Intellectual
Property Institute of Canada.
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