28 LEXPERT MAGAZINE
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JANUARY/FEBRUARY 2018
BIG SUITS
IDENIX PHARMACEUTICALS V. GILEAD
PHARMASSET, 2017 FCA 161
DECISION DATE: JULY 24, 2017
Norton Rose Fulbright Canada LLP and
Belmore Neidrauer LLP successfully rep-
resented Gilead Sciences Inc., Gilead Sci-
ences Canada Inc. and Gilead Pharmasset
LLC ("Gilead") in a Federal Court action
against Idenix to invalidate a patent owned
by Idenix for compounds that were claimed
to be useful for the treatment of Hepatitis C.
Idenix defended these allegations and filed a
counterclaim to impeach a patent owned by
Gilead and claim for infringement of Idenix
patent (bifurcated).
e trial judge found in favour of Gilead
and found Idenix's patent invalid, upholding
the validity of Gilead's patent. e appeal was
argued before the Federal Court of Appeal in
January 2017. In July 2017, the Federal Court
of Appeal likewise ruled in favour of Gilead.
is highly complex case was of importance
in Canada and globally.
Gilead initiated the underlying invalidity
action against Idenix based on a belief that
the manufacture, use or sale in Canada of
sofosbuvir (marketed in Canada as SOVAL-
DI®) for treatment of Hepatitis C (HCV)
would be impugned by Idenix as an infringe-
ment of the patent. Idenix counterclaimed,
and claimed that Gilead's sale of sofosbuvir
in Canada constituted infringement of its
patent. Idenix also sought to invalidate a Gil-
ead owned patent on the basis that it was not
novel in light of the Idenix patent at issue in
the action.
Decision of the Federal Court
e Federal Court allowed Gilead's claim,
finding that each claim of the Idenix patent
was invalid for: (i) for lack of sound predic-
tion of utility; and (ii) failing to sufficiently
disclose how to synthesize the compounds at
issue. e Federal Court also dismissed Ide-
nix's counterclaim, finding that the Idenix
patent did not enable (and therefore did not
anticipate) the Gilead patent.
With respect to the allegations of lack of
sufficiency, the Federal Court found that
Idenix's patent did not sufficiently disclose
how to synthesize the compounds at issue,
including sofosbuvir, a D-ribose-2'-methyl
(up), 2'-fluorine (down) nucleoside. In par-
ticular, the 191 Patent did not teach: (1)
how to make the intermediate compounds
needed to synthesize these compounds; or
(2) how to fluorinate the intermediate com-
pounds needed to arrive at these compounds.
e Federal Court compared Idenix's Patent
disclosure to Gilead's Patent disclosure and
noted that Gilead's Patent set out six schemes
for the synthesis for these compounds explic-
itly, while Idenix's Patent did not.
With respect to the allegations of lack of
utility, Idenix conceded that it had not test-
ed any of the compounds in its Patent until
March 2005 (aer the filing date) and as
such, utility had to be established based on
sound prediction. Idenix argued that util-
ity of the compounds could be predicted on
the basis of testing of similar compounds
(2'-methyl (up), 2'-hydroxy (down) nucleo-
sides), which Idenix argued had demonstrat-
ed antiviral activity.
e Federal Court rejected this argument,
noting that it would not have been possible
to soundly predict the therapeutic advantag-
es of substituting a fluorine for the hydroxyl
group at the 2' (down position).
In obiter, the Federal Court found that
the factual basis for sound prediction did not
have to be disclosed because Idenix's Patent
related to a new composition. However, to
the extent that a factual basis had to be dis-
closed, the Federal Court found that Idenix's
Patent did not disclose adequate testing on
which to form a sound prediction.
In particular, the court found that Idenix's
patent disclosed testing of 2'-methyl (up),
2'-hydroxy (down) nucleosides in viruses
other than the Hepatitis C virus, but did not
disclose a factual basis to support that those
tests would have been adequate surrogates
for antiviral activity against the Hepatitis C
virus specifically.
Findings of the Federal Court of Appeal
Idenix argued on appeal that the Federal
Court made multiple errors in reaching its
conclusions on insufficiency and lack of
sound prediction. e Federal Court of Ap-
peal dismissed Idenix's appeal finding no er-
ror warranting the Court's intervention.
In rejecting Idenix's argument that the
Federal Court applied an incorrect test for
insufficient disclosure, the Court of Appeal
held that, read in context, the Federal Court
correctly considered how the skilled person
would have understood the patent when it
concluded that the Idenix patent, together
with the common general knowledge, did
not sufficiently disclose how to synthesize
the compounds at issue. e Idenix patent
was invalid on this basis. Having reached this
conclusion there was no need to determine
other grounds on appeal.
Leave to appeal to the Supreme Court of
Canada has been sought by Idenix.
Jordana San, Amy Grenon and Jillian
Hyslop of Norton Rose Fulbright Canada
LLP were counsel for Gilead Sciences Inc.
Jason Markwell of Belmore Neidrauer
LLP also acted for Gilead Sciences Inc.
Patrick Smith, Christopher Van Barr, Alex
Gloor and Marc Crandall of Gowling WLG
represented Idenix Pharmaceuticals Inc.
ASTRAZENECA CANADA
V. APOTEX, 2017 SCC 36
DECISION DATE: JUNE 30, 2017
e Supreme Court of Canada judgment in
this case concerned AstraZeneca's appeal of
the invalidation of its patent for NEXIUM
(esomeprazole) for lack of patent utility based
on the "promise of the patent" doctrine. is
was the most significant patent case before
the SCC since the Sanofi decision in 2008
reconfigured the test for patent obviousness
(see "Top 10 Cases," p. 46). e "promise of
the patent" doctrine has been the most con-
troversial issue in Canadian pharmaceutical
patent law for the past several years.
As a result of the lower Federal Courts'
adoption of this doctrine, Canada's patent
utility law had been widely perceived to be
overly stringent and out of step with its inter-
national trade obligations in a manner that
has particularly negatively affected the valid-
ity of pharmaceutical patents.
On June 30, 2017, the so-called promise
doctrine was conclusively rejected by Cana-
da's highest court as a basis for invalidating a
Canadian patent. In a significant judgment
that reversed years of jurisprudence in the
lower courts, the Supreme Court held that
the level of utility required of a Canadian pat-
ent must not be measured by any "promise"
in the patent disclosure, but rather should be
based on a claims-based analysis of the sub-
ject-matter of the invention. is judgment,
which applies to patents for all subject mat-
ters, brings Canadian law more closely in line
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