Docket: A-299-14
Citation:
2015 FCA 137
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CORAM:
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DAWSON J.A.
WEBB J.A.
BOIVIN J.A.
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BETWEEN:
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APOTEX INC.
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Appellant
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and
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ALLERGAN INC.
AND ALLERGAN, INC.
and
THE MINISTER OF
HEALTH
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Respondents
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REASONS
FOR JUDGMENT
DAWSON J.A.
[1]
For reasons cited as 2014 FC 567, a judge of the
Federal Court issued a judgment prohibiting the Minister of Health from issuing
a notice of compliance to Apotex Inc. in respect of its generic version of the
drug LUMIGAN RC until the expiration of Canadian patent 2,585,691 (691 patent).
The prohibition order was issued to Allergan Inc. and Allergan, Inc. (Allergan)
pursuant to subsection 6(1) of the Patented Medicine (Notice of Compliance)
Regulations, SOR/93-133. In the Judge’s view, Apotex’ allegations of
obviousness, lack of utility and anticipation were not justified (reasons of
the Federal Court, at paragraphs 2, 36, 45 and 51).
[2]
On this appeal from the judgment of the Federal
Court, Apotex largely re-argues the issues it raised in the Federal Court. It
also argues that the reasons of the Federal Court as to why the 691 patent was
not obvious were inadequate.
[3]
I am of the view that the appeal cannot succeed
for the following reasons.
[4]
With respect to the adequacy of the reasons of
the Federal Court, Apotex submits that the reasons ignored substantial portions
of its evidence, arguments and the authorities it relied upon and did not explain
why the Judge preferred the evidence of Allergan’s witnesses over those of
Apotex.
[5]
In oral argument, Apotex acknowledged that it
did not assert that any finding made by the Judge was unsupported by evidence.
Instead, it argued that there was conflicting evidence and that the Judge did
not explain why he preferred one version over another. However, a reviewing
court is entitled to presume that a judge reviewed all of the evidence;
reliance on the evidence of some witnesses over others cannot by itself
demonstrate that the Judge forgot, ignored or misconceived the evidence in a
manner that affected his conclusion (Housen v. Nikolaisen, 2002 SCC 33,
[2002] 2 S.C.R. 235, at paragraph 46). Read fairly, in light of the extensive
record before the Federal Court, and in light of the fact that the Judge was
alive to all of the issues and that all of his findings were supported by
evidence, the reasons are adequate.
[6]
Apotex next submits that, while the Federal
Court accurately recited the four-step test for the obviousness inquiry
articulated in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC
61, [2008] 3 S.C.R. 265, it erred in law and in fact when applying each stage
of the analysis.
[7]
Dealing with each asserted error, I am satisfied
that:
- The Federal
Court did not err in its construction of the inventive concept of the 691 patent.
The nub of Apotex’ argument is that the Federal Court inferred the
inventive concept from data found in the 691 patent. In Sanofi, at
paragraph 77, the Supreme Court found that the inventive concept of the
claims there in issue was not readily discernible from the claims
themselves. It was therefore acceptable to read the specification in the
patent to construe the inventive concept. In the present case, the
relevant claims related to a chemical composition and the use of the
composition for treating glaucoma or intraocular hypertension in a mammal.
The Federal Court found the composition claimed did not determine the
claims’ inventive concept and so it construed the inventive concept by
reading the patent as a whole. In doing so, the Federal Court considered
the inventive concept in light of the disclosure of the patent from the
viewpoint of the skilled reader. This was not an error of law and no
palpable and overriding error has been shown in the Federal Court’s
conclusion as to the inventive concept.
- The Federal
Court did not err when determining the state of the art as of the claim
date. As noted above, Apotex argues that the Court ignored or
misapprehended evidence, drew unreasonable inferences and reached a
conclusion that was unsupported by the evidence. The Federal Court’s
analysis of the state of the art is reviewable on the deferential standard
of palpable and overriding error, and Apotex acknowledged that the
findings of the Federal Court were all supported by the evidence.
- The Federal
Court did not err in finding there were differences between the state of
the art and the inventive concept. This finding is again one entitled to
deference. Based on the Federal Court’s conclusions about the state of the
art and the inventive concept, Apotex has not demonstrated any palpable or
overriding error in the finding that there were differences between the
two.
- The Federal
Court did not err in finding that the differences between the state of the
art and the inventive concept were not obvious to try. It found: the
significant differences between the claims in issue and the state of the art
would not have been obvious to the skilled person; the formulation of
LUMIGAN RC required experimentation and inventive steps; extensive,
expensive testing was required before arriving at the claimed invention;
and the result was a commercially successful product. These factual
findings were based on admissible evidence and they support the conclusion
that the composition at issue was not obvious to try. These findings have
not been shown to be palpably and overridingly wrong.
[8]
Apotex next argues that the utility of the
invention was not soundly predicted because the line of reasoning from which
the desired result can be inferred was not explicitly disclosed in the patent.
As the Federal Court correctly noted, citing Apotex Inc. v. Wellcome
Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153, at paragraph 70, a
patent will be valid based on a sound prediction of utility if the inventor has
an articulable and sound line of reasoning available at the date of the patent
application from which the predicted utility can be inferred from the factual
basis and there is proper disclosure to the public.
[9]
The Federal Court identified the factual basis
for the prediction (the minimum inhibitory concentration values of several
compounds tested against a number of bacteria species together with comparative
data) and the line of reasoning that would, to the skilled reader, flow from
that data. As this Court observed in Eurocopter v. Bell Helicopter Textron
Canada Ltée, 2013 FCA 219, 449 N.R. 111, at paragraphs 152 and 153, the
factual basis, line of reasoning and level of disclosure required by the
doctrine of sound prediction are to be assessed as a function of both the
knowledge that the skilled person would have to base that prediction on and
what the skilled person would understand as a logical line of reasoning leading
to the utility of the invention. Those elements of the doctrine of sound
prediction that would be self-evident to the skilled person need not be
explicitly disclosed in the patent.
[10]
Finally, in the Federal Court, Apotex argued
that the claims in issue were anticipated by Canadian patent 2,144,967 (967
patent). The Federal Court, assuming without deciding that the 691 patent was a
selection patent, held that, if the 967 patent, as the asserted genus patent,
did not describe the special advantages of the invention of the 691patent, the
genus patent did not anticipate the 691 patent. This was a correct statement of
the law articulated by the Supreme Court in Sanofi at paragraph 32. The
Federal Court then made two findings: first, the prior patent did not disclose
the special advantage of the 691 patent and, second, the prior patent would not
have enabled the skilled patent to perform the invention of the 691 patent
because an inventive step was required. These are findings of fact.
[11]
On this appeal, Apotex has not shown these
findings to be palpably and overridingly wrong. This is fatal to its argument
that the 691 patent was anticipated by the 967 patent.
[12]
Central to the reasons of the Federal Court were
its construction of the inventive concept and its conclusion with respect to a
sound prediction of utility found in the 691 patent. These conclusions were
based upon the Court’s finding that the opinion of Dr. Stella was persuasive
(Federal Court reasons, at paragraph 42) and its rejection of Apotex’ concerns
(Federal Court reasons, at paragraphs 43 and 44). These findings have not been
shown to be wrong in a manner that justifies intervention by this Court.
[13]
It follows that I would dismiss the appeal with
costs.
“Eleanor R. Dawson”
“I agree.
Wyman
W. Webb J.A.”
“I agree.
Richard
Boivin J.A.”
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