Date: 20111102
Dockets: A-390-09
A-386-09
A-389-09
A-387-09
Citation: 2011 FCA 300
Toronto, Ontario, November 2, 2011
CORAM: NOËL J.A.
PELLETIER
J.A.
LAYDEN-STEVENSON
J.A.
A-390-09
BETWEEN:
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Appellants
and
APOTEX INC.
Respondent
and
SCHERING CORPORATION
Respondent
A-386-09
AND
BETWEEN:
SCHERING CORPORATION
Appellant
and
APOTEX INC.
Respondent
and
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondents
A-389-09
AND
BETWEEN:
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Appellants
and
NOVOPHARM LIMITED
Respondent
and
SCHERING CORPORATION
Respondent
A-387-09
AND
BETWEEN:
SCHERING CORPORATION
Appellant
and
NOVOPHARM LIMITED
Respondent
and
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondents
Heard at Toronto, Ontario, on October
31, November 1 and 2, 2011.
Judgment delivered from the
Bench at Toronto, Ontario,
on November 2, 2011.
REASONS FOR JUDGMENT OF THE COURT BY: LAYDEN-STEVENSON
J.A.
Date: 20111102
Dockets: A-390-09
A-386-09
A-389-09
A-387-09
Citation: 2011 FCA 300
Toronto,
Ontario, November 2, 2011
CORAM: NOËL
J.A.
PELLETIER J.A.
LAYDEN-STEVENSON
J.A.
A-390-09
BETWEEN:
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Appellants
and
APOTEX INC.
Respondent
and
SCHERING CORPORATION
Respondent
A-386-09
AND
BETWEEN:
SCHERING CORPORATION
Appellant
and
APOTEX INC.
Respondent
and
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondents
A-389-09
AND
BETWEEN:
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Appellants
and
NOVOPHARM LIMITED
Respondent
and
SCHERING CORPORATION
Respondent
A-387-09
AND
BETWEEN:
SCHERING CORPORATION
Appellant
and
NOVOPHARM LIMITED
Respondent
and
SANOFI-AVENTIS CANADA INC., and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondents
REASONS FOR JUDGMENT
LAYDEN-STEVENSON J.A.
[1]
These reasons relate to Court File Numbers
A-390-09, A-386-09, A-389-09 and A-387-09. The original of the reasons will be
filed in A-390-09, the lead file, and copies will be placed in the other three
files.
[2]
The appeals are from the judgment of Justice Snider
of the Federal Court (the judge). The judge dismissed patent infringement
actions against Apotex Inc. (Apotex) and Novopharm Limited (Novopharm) and
declared Claims 1, 2, 3, 6 and 12 of Canadian Patent No. 1,341,206 (the '206
Patent) to be invalid, void, unenforceable and of no force or effect. The
judge’s reasons (2009 FC 676) contain a lengthy and detailed review of the
background, the evidence, the law and the judge’s findings.
[3]
The basis of the judge’s conclusion is her
finding, on a balance of probabilities, that the inventors of the '206 Patent
could not soundly predict, as of the filing date of the patent application,
that all eight compounds of Claim 12 of the '206 Patent would have the utility
promised by the patent. Claim 12 comprises eight compounds and describes
compounds with five stereocentres (or chiral centres) that can have either an S
or R configuration (stereochemistry). It prescribes the S configuration for two
chiral centres and allows for the other three to be either S or R. When all
five sterocentres are in the S configuration, the compound is ramipril. The
judge found, of the eight compounds, only ramipril could be soundly predicted
(judge’s reasons at paragraph 194). Consequently, the claim failed for want of utility.
[4]
Since Claims 1, 2, 3 and 6 include the same
compounds as Claim 12, it followed that Claims 1, 2, 3, and 6 of the '206
Patent are also invalid. The judge stated, at paragraph 230 of her reasons,
that the prediction of the appellant, Schering Corporation (Schering), at the
date of the patent application, was not sound because it “failed on all three
requirements making up the test for sound prediction – factual basis,
articulable line of reasoning and disclosure.”
[5]
Despite the detailed and capable arguments of
the appellants’ counsel, we are of the view that the appeals must be dismissed.
The soundness of a prediction is a question of fact: Apotex Inc. v. Wellcome
Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153 at paragraph 71 (AZT).
The appellants contend that the judge erred in law by elevating the legal test
for sound prediction to a level requiring near certainty. More particularly,
they submit that the judge required positive test results and ignored the
common general knowledge of the person skilled in the art. Although we agree
that, if the judge applied the wrong legal test, it would constitute an error
of law, we do not believe that is what the judge did.
[6]
Rather, the judge correctly identified the test
for sound prediction set out in AZT. Indeed, she applied the test to
arrive at her conclusion regarding ramipril. The appellants’ submissions ignore
the fundamental factual finding that underpins and informs the judge’s
analysis. That is, in the stereochemistry context, even a small change to a
molecule can yield profound effects on activity (judge’s reasons at paragraphs
160-162). The judge’s references to testing related to that specific factual
context of volatility.
[7]
The thrust of the appellants’ attack on the
trial judge’s findings is that she applied a purely subjective test to the
issue of sound prediction, basing her conclusion on the inventor’s state of
mind without reference to the common general knowledge attributable to the
person of ordinary skill in the art. This attack cannot be sustained in light
of the judge’s reasons. She did focus on the work done by the inventor
(judge’s reasons at paragraphs 164 to 188) and found that, taken by itself, it
did not provide a factual basis for a sound prediction. She then went on to
consider the common general knowledge. After reviewing the state of the art she
found that the common general knowledge, applied to Schering’s own
investigations, did not suffice to provide a factual basis for a sound
prediction (judge’s reasons paragraphs 199-200).
[8]
The appellants also find fault with the judge’s
treatment of Schering’s test results. In their view, she mischaracterized
inactive test results as evidence of inactivity as opposed to evidence of lack
of potency at the stipulated test levels. This line of attack is misconceived.
The appellants’ position was that the patent promised utility with the R
configuration at the various chiral centres, though at a reduced level. They
took this from the patent’s statement that S configurations were preferred ('206
Patent at pages 17, 18). When the trial judge’s reasons are read as a whole,
it is apparent that the conclusion she drew from Schering’s test results was
that an inactive test at a stipulated test level did not prove or allow one to
predict activity at a different test level. Thus, to the extent that the
appellants claimed a sound prediction of some activity in relation to molecules
with the R configuration, inactive test results did not support their
prediction. This is not an error.
[9]
Indeed, in summarizing her conclusions, the
judge reiterated the proposition that patent protection rests on the concept of
a bargain between the inventor and the public. She noted that Schering included
compounds in Claim 12 to cover off future possibilities. In this respect, she referenced
an excerpt from the cross-examination of Dr. Smith, one of the inventors of the
'206 Patent. Part of that excerpt is reproduced here; the entire excerpt may be
found at paragraph 357 of the judge’s reasons.
Q. And I take it the reason you wrote that was to cover off the
possibility that at some point down the road, a particular stereoisomer might
surprisingly turn out to have a very good activity, because you didn’t want to
miss one and then have the patent department come back to you and say, “Dr.
Smith, you missed a good one”?
A. Right.
Q. So you were just protecting yourself, and you wrote this down to
just make sure in case there was an unexpected one down the road, you had it
covered off?
A. Yes, that would have it covered, and it’s also what is done in
patents.
[10]
The remaining issues raised by the appellants
involve questions of fact or mixed fact and law, which can be reversed on
appeal only if palpable and overriding error is demonstrated. We are not
persuaded that the appellants have demonstrated such errors.
[11]
The judge rendered detailed and comprehensive
reasons for her conclusions with respect to sound prediction. Her findings are
grounded on her assessment of the evidence and are fulsomely explained. The
appellants have not identified any reviewable error in the judge’s assessment
of the evidence although they question the judge’s application of the legal
principles to the facts before her. Essentially, the appellants’ arguments
constitute an invitation to this Court to reweigh the evidence and to draw our
conclusions from it. That is not our function.
[12]
To reiterate, absent palpable and overriding
error, there is no basis upon which this Court can intervene. In our view, the
judge properly cited the legal principles applicable to the doctrine of sound
prediction, applied those principles to the evidence before her and arrived at
her conclusions. The appellants have not demonstrated any error warranting this
Court’s intervention.
[13]
Having concluded that Claims 1, 2, 3, 6 and 12
of the '206 Patent were invalid for want of utility, in the alternative, the
judge addressed the issue of validity on the basis of obviousness. The judge’s
obviousness analysis is obiter. The matter was determined on the basis
of sound prediction. These reasons should not be taken as an endorsement of the
judge’s conclusions regarding the issue of obviousness and do not constitute
such an endorsement.
[14]
The appeals will be dismissed with costs to the
respondents in each appeal.
"Carolyn
Layden-Stevenson"
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKETS: A-390-09, A-386-09, A-389-09, and
A-387-09
(APPEAL FROM THE JUDGMENT OF THE
HONOURABLE JUSTICE SNIDER, DATED JUNE 29, 2009, IN DOCKET NO. T-161-07)
STYLE OF CAUSE:
A-390-09 - SANOFI-AVENTIS CANADA INC., and SANOFI-AVENTIS DEUTSCHLAND GmbH v. APOTEX INC. and SCHERING
CORPORATION
A-386-09 - SCHERING CORPORATION v. APOTEX INC. AND SANOFI-AVENTIS
CANADA INC., and SANOFI-AVENTIS
DEUTSCHLAND GmbH
A-389-09 - SANOFI-AVENTIS CANADA INC., and SANOFI-AVENTIS DEUTSCHLAND GmbH v. NOVOPHARM LIMITED and SCHERING
CORPORATION
A-387-09 - SCHERING CORPORATION v. NOVOPHARM LIMITED
AND SANOFI-AVENTIS CANADA INC., and SANOFI-AVENTIS
DEUTSCHLAND GmbH
PLACE OF HEARING: Toronto, Ontario
DATES OF HEARING: October 31, November 1 & 2, 2011
REASONS FOR JUDGMENT OF THE COURT BY: (NOËL, PELLETIER & LAYDEN-STEVENSON JJ.A.)
DELIVERED FROM THE BENCH BY: LAYDEN-STEVENSON J.A.
APPEARANCES:
|
Gunars A. Gaikis
J. Sheldon Hamilton
Junyi Chen
|
FOR THE APPELLANTS
- SANOFI-AVENTIS CANADA INC.
- SANOFI-AVENTIS DEUTSCH LAND Gmbh
|
|
Anthony Creber
Marc Richard
|
FOR THE APPELLANT
- SCHERING CORPORATION
|
|
Harry
Radomski
Nando De Luca
Ben Hackett
|
FOR THE RESPONDENT
- APOTEX INC.
|
|
Jonathan Stainsby
Mark Davis
Lesley Caswell
|
FOR THE RESPONDENT
- NOVOPHARM LIMITED
|
SOLICITORS OF RECORD:
|
Smart & Biggar
Toronto, Ontario
|
FOR THE APPELLANTS
- SANOFI-AVENTIS CANADA INC.
- SANOFI-AVENTIS DEUTSCH LAND Gmbh
|
|
Gowling Lafleur Henderson LLP
Ottawa, Ontario
|
FOR THE APPELLANT
- SCHERING CORPORATION
|
|
Goodmans LLP
Toronto, Ontario
|
FOR THE RESPONDENT
- APOTEX INC.
|
|
Heenan Blaikie
Toronto, Ontario
|
FOR THE RESPONDENT
- NOVOPHARM LIMITED
|
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