Docket: A-420-14
Citation:
2015 FCA 158
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CORAM:
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DAWSON J.A.
RYER J.A.
WEBB J.A.
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BETWEEN:
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ASTRAZENECA
CANADA INC.
ASTRAZENECA
AKTIEBOLAG and
ASTRAZENECA UK
LIMITED
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Appellants
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and
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APOTEX INC. and
APOTEX
PHARMACHEM INC.
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Respondents
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REASONS FOR JUDGMENT
DAWSON J.A.
[1]
For reasons cited as 2014 FC 638, a judge of the
Federal Court declared Canadian patent 2,139,635 to be invalid because of
inutility. The Federal Court found that, while the patent promised that its compounds
provide improved pharmacokinetic and metabolic properties which will give an
improved therapeutic profile, such as a lower degree of interindividual
variation, this promise was neither demonstrated nor soundly predicted at the
time the patent was filed. For completeness, the Federal Court also dismissed Apotex’
assertions that the patent was both obvious and anticipated.
[2]
On this appeal from the judgment of the Federal
Court, AstraZeneca asserts that the Federal Court erred in law by misconstruing
the promise of the relevant claims. More specifically, it argues that the
Federal Court erred by failing to consider utility, and any promise of utility,
on a claim by claim basis, erred by construing the utility of the claims in
issue in a manner that was inconsistent with their inventive concept and
further erred by failing to apply a purposive construction to the promise of
utility.
[3]
I disagree that the Federal Court erred for the
following reasons.
[4]
I begin by observing that, as AstraZeneca
argues, it is well settled law that inutility must be assessed on a claim by
claim basis (Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012]
3 S.C.R. 625 (Sildenafil), at paragraphs 42 and 80; and, Apotex Inc. v. Wellcome
Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153 (AZT), at paragraphs 53
to 59).
[5]
It is also now settled law that some promises can
be construed to impose utility requirements across each of a patent’s claims,
while other promises may touch only a subset of the claims. In every case it is
a question of proper construction of the relevant claims (Pfizer Canada Inc.
v. Apotex Inc.; Pfizer Canada Inc. v. Mylan Pharmaceuticals ULC,
2014 FCA 250, 465 N.R. 306 (Celecoxib), at paragraphs 86 to 89).
[6]
I further agree that, when construing any
promise made in the patent, the Federal Court did not explicitly consider any
single claim or subset of claims. However, in light of the evidence and
submissions before the Court, this failure was neither an error of law nor a
palpable and overriding error of fact or mixed fact and law. I reach this
conclusion on the following basis.
[7]
It is important to understand that at trial
AstraZeneca did not ask the Federal Court to construe the promise of the patent
on a claim by claim basis. The patent contains 29 claims, of which only claims
1, 2, 4, 5, 7, 8, and 25 to 27 were in issue. Claims 1 to 8 are compound
claims; claims 25 to 27 are use claims. AstraZeneca’s expert on the issue of
utility, Dr. Tracy, asserted that the claimed compounds promised that optically
pure salts of (-)-omeprazole were useful as proton pump inhibitors, would
resist racemization and had improved pharmacokinetic and metabolic properties
over the racemate.
[8]
The Federal Court received expert evidence from
Apotex’ expert, Dr. Meyer, as to why a skilled reader would understand the
patent to promise not just what was asserted by AstraZeneca, but to additionally
promise that the claimed compounds promised an improved therapeutic profile and
lower degree of interindividual variation over the racemate. In this
circumstance, the analysis of the Federal Court cannot be faulted. The Federal
Court was entitled to rely upon the lis as framed by the parties. The
Court explained why it found Dr. Meyer’s evidence to be preferable to that of
Dr. Tracy. AstraZeneca has not shown any error that warrants our intervention.
[9]
Before leaving this issue I wish to address
AstraZeneca’s submission that in paragraph 125 of its reasons the Federal
Court demonstrated that it rejected the notion that utility should be construed
on a claim by claim basis. I disagree. On a fair reading, paragraph 125 was
directed to the weight to be given to Dr. Tracy’s evidence; the Federal Court
was not rejecting a claim by claim construction.
[10]
I now turn to AstraZeneca’s argument that the
Federal Court erred by construing the utility of the claims in issue in a
manner inconsistent with their inventive concept. AstraZeneca argues that
because it is a fundamental rule of claim construction that a claim receives
one interpretation for all purposes, there must be a unitary, harmonious
understanding of the essential elements of the claim, inventive concept and utility.
At trial, AstraZeneca argued that the inventive concept of the compound claims
(and inherent in the inventive concept of the use claims) was an optically pure
salt of (-)-omeprazole, together with improved pharmacokinetic and metabolic
properties over omeprazole and high stability to racemization. As this
inventive concept did not include an improved therapeutic profile, the Federal
Court is said to have erred by construing the claims to promise an improved
therapeutic profile.
[11]
Again, I disagree that the Federal Court erred.
The Court’s reasons show that the Federal Court directed itself to the correct
legal tests applicable to claims construction, inventive concept and utility.
In oral argument, AstraZeneca was unable to show that its submission was supported
by the jurisprudence. While it pointed to an admittedly obiter passage in Canada (Attorney
General) v. Amazon.com, Inc., 2011 FCA 328 , [2012] 2 F.C. 49, at
paragraphs 37 to 41, the obiter comments found there do not support AstraZeneca’s submission that a
promise of utility must be construed to be virtually coterminous with the
inventive concept of the relevant claim or claims.
[12]
AstraZeneca also argues that the Federal Court
gave the disclosure elevated emphasis when construing the promise. As noted by
Apotex, at trial AstraZeneca conceded that resort to the disclosure was
warranted in order to construe its truncated promise of utility that the
compound claims promised improved pharmacokinetic and metabolic properties. In
my view, the Federal Court did not err by construing the promise within the
context of the patent as a whole (Eli Lilly Canada Inc. v. Novopharm Limited,
2010 FCA 197, 405 N.R. 1 (Olanzapine), at paragraph 93). Similarly, on the
evidence it accepted, the Federal Court did not err by giving effect to all,
not just a portion, of the sentence in the disclosure relied upon by
AstraZeneca to establish the promise of pharmacokinetic and metabolic
properties.
[13]
I now turn to AstraZeneca’s argument that the
Federal Court failed to apply a purposive construction to the promise of
utility and instead applied a non-contextual construction of the promise by
embracing an overly narrow definition of the word
“will”. The Federal Court acknowledged the difference between goals and
promises, and at paragraphs 118 to 120 of its reasons explained why it rejected
the submission that the use of the word “will”
was indicative of a goal or expectation. The Federal Court’s construction of
the promise was reached reading the patent as a whole through the eyes of the
skilled reader. In light of the statement in the disclosure, relied upon by the
Federal Court, that described as “desirable”
compounds “with improved pharmacokinetic and metabolic
properties which will give an improved therapeutic profile” and the
further statement that “[t]he present invention
provides such compounds”, the Federal Court did not err in law by
applying too low a threshold in order to establish a promise.
[14]
To conclude, AstraZeneca has not demonstrated
any legal error in the Federal Court’s construction of the promise of the
relevant claims of the patent. Nor has it demonstrated any palpable and
overriding error in the Federal Court’s appreciation of the evidence.
[15]
For these reasons, I would dismiss the appeal
with costs. It follows that it is unnecessary to consider the assertions
advanced by Apotex that the Federal Court erred in failing to find the patent
to be both obvious and anticipated.
“Eleanor R. Dawson”
“I agree.
C.
Michael Ryer J.A.”
“I agree.
Wyman W. Webb J.A.”
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