Docket: A-286-14
Citation: 2015 FCA 192
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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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ACTAVIS PHARMA
COMPANY
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Appellant
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and
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ALCON CANADA
INC., ALCON PHARMACEUTICALS, LTD. and BAYER INTELLECTUAL PROPERTY GmbH
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Respondents
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REASONS FOR
JUDGMENT
BOIVIN J.A.
I.
Background
[1]
This appeal concerns a decision of a Federal
Court judge (the Judge) rendered on May 14, 2014 (2014 FC 462). The Judge
granted the application of Alcon Canada Inc., Alcon Pharmaceuticals, Ltd., and
Bayer Intellectual Property GmbH (the respondents) under subsection 6(1) of the
Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 for an
order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC)
to Actavis Pharma Company – formally known as Cobalt Pharmaceuticals Company – (the
appellant) for its generic version of the product Vigamox®, covered by the
Canadian Patent 1,340,114 (the ‘114 Patent).
[2]
As per the Notice of Appeal filed on June 13,
2014, the Minister of Health is no longer a party in this matter. Actavis
Pharma Company asks our Court to set aside the Judge’s prohibition Order.
[3]
The Judge’s decision of May 14, 2014 also
addresses Canadian Patent 2,342,211 (the ‘211 Patent), and 2,192,418 (the ‘418
Patent). While the ‘418 Patent was not appealed before this Court, the appeal
of the ‘211 Patent is dealt with under a separate set of reasons (2015 FCA 191).
[4]
Vigamox® is an antibacterial eye drop commonly
used during cataract surgery. It is covered by the ‘114 Patent which was filed
on July 13, 1989, issued on November 3, 1998, and will expire on November 3,
2015. The ‘114 Patent claims a class of quinolone compounds, including moxifloxacin
hydrochloride (moxifloxacin), the active ingredient in Vigamox®. The compounds
of this class are characterized by a fused pyrrolidine bicycle structure at the
C-7 position on the core ring of the quinolone compound. At issue in this
proceeding are Claims 8 and 13, which claim moxifloxacin and its stereoisomers
and mixtures thereof (Judge’s reasons at paragraph 21).
[5]
Before the Judge, the appellant argued that the
‘114 Patent is invalid, essentially on the basis of lack of sound prediction
and utility. All of the appellant’s contentions regarding the alleged
invalidity of the ‘114 Patent were rejected by the Judge. Specifically, the
Judge construed the promise of the ‘114 Patent and found that utility was
soundly predicted. As for the appellant’s allegation of obviousness which was largely
abandoned in oral argument, the Judge nonetheless held, based on the parties’
written representations, that the invention claimed by the portions of the ‘114
Patent at issue, was neither obvious nor obvious to try.
[6]
On appeal, the appellant challenges each of the
Judge’s holdings regarding the ‘114 Patent. For the reasons outlined below, I
propose to dismiss the appeal. I am unconvinced that the Judge made any
reversible error in rejecting the appellant’s allegations of invalidity of the
‘114 Patent.
II.
Issues
[7]
In this appeal, the issues are as follows:
1. Did the Judge
err in construing the promise of the ‘114 Patent?
2. Did the Judge err in finding that the ‘114 Patent’s utility was
soundly predicted?
3. Did the Judge err in determining that the ‘114 Patent was
neither obvious nor obvious to try?
III.
Standard of review
[8]
Appeals from prohibition applications such as
the one at issue are subject to the appellate standards set forth in Housen
v. Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235 [Housen], Pharmascience
Inc. v. Canada (Health), 2014 FCA 133, 460 N.R. 343 [Pharmascience] at
paragraph 31. The construction of the patent itself is a matter of law that
must be reviewed under the correctness standard (Whirlpool Corp. v. Camco
Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067 at paragraph 76 [Whirlpool];
Mylan Pharmaceuticals ULC v. AstraZeneca Canada Inc., 2012 FCA 109, 432
N.R. 292 at paragraph 20 [Mylan]).
[9]
Matters of mixed fact and law require the
governing legal principles to be correctly articulated and applied (Housen
at paragraphs 26 and 27). As a judge’s function necessarily involves weighing
the evidence put forward by the parties and particularly in the face of conflicting
expert opinions, the facts and evidentiary foundation on the basis of which the
judge reaches his decision will stand absent a palpable and overriding error (Cobalt
Pharmaceuticals Company v. Bayer Inc., 2015 FCA 116, [2015] F.C.J. No. 555
(QL) at paragraph 15 [Cobalt]; Pharmascience at paragraph 31; Mylan
at paragraph 20). Demonstrating a palpable and overriding error in connection
with this evidentiary exercise is subject to a high threshold (Zero Spill
Systems (Int’l) Inc. v. Heide, 2015 FCA 115, [2015] F.C.J. No. 554 (QL) at
paragraph 49).
[10]
Sound prediction and obviousness are matters of
mixed fact and law (Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77,
[2002] 4 S.C.R. 153 at paragraph 42 [AZT]; Cobalt at paragraph
48; Apotex Inc. v. Allergan Inc., 2015 FCA 137, [2015] F.C.J. No. 953
(QL) at paragraph 7). It follows that absent a palpable and overriding error, a
judge’s finding in this regard will not be disturbed.
IV.
Analysis
The Promise of the
‘114 Patent
[11]
In challenging the Judge’s decision regarding
the ‘114 Patent, the appellant frames its main argument around the question of
the promise of the ‘114 Patent and argues that the Judge erred in making
multiple, inconsistent, and ultimately incorrect holdings, which amounted to errors
of law on the construction of the promise of the ‘114 Patent.
[12]
Specifically, the appellant alleges that the
Judge erred in law by choosing Dr. Domagala’s evidence on the basis of his
patent experience and conferring upon him the status of legal expert on patents.
In support of this allegation, the appellant points to instances where the
Judge prefers Dr. Domagala’s evidence over the evidence of the appellant’s
expert witness, Dr. Hoban, on the basis of the latter’s relative
inexperience (Judge’s reasons at paragraphs 61 and 66).
[13]
This allegation is without merit. Indeed, a
judge is entitled to prefer one expert’s evidence over another on a number of
grounds. Here, a full reading of the Judge’s reasons demonstrates that his
stated preference for Dr. Domagala’s evidence was also based on Dr. Domagala’s
experience with quinolones (Judge’s reasons at paragraphs 48 and 66). Moreover,
the Judge explained that he preferred the respondents’ expert evidence regarding
the ‘114 Patent as being “both individually and read as
whole, […] more consistent internally and externally” (Judge’s reasons
at paragraph 31). In the circumstance, the Judge’s preference for one expert
over another accordingly does not amount to a reviewable error.
[14]
The appellant also alleges that paragraph 71 of
the Judge’s reasons demonstrates that he not only erred in construing the
promise of the patent but that he also misunderstood the law by stating as follows:
[71] Much of Cobalt’s submissions on the
issue of utility are premised on an erroneous construction of the promise. As
discussed above, I reject Cobalt’s construction of the promise. To the
extent the patent promises anything, it is limited to a promise that the class
as a whole will have in vitro activity against a broad spectrum of bacteria. Accordingly, based
on Plavix [Apotex v. Sanofi-Aventis, 2013 FCA 186, 230 ACWS (3d)
851] the question becomes whether there is a scintilla of utility. [Emphasis added].
[15]
Again, the appellant’s allegation fails. A fair
reading of the Judge’s reasons as a whole demonstrates that his above-reproduced
statement regarding the requirement of a mere scintilla of utility, is not
reflective of what he found as the promised utility or what he looked for in
terms of being soundly predicted.
[16]
Before the Judge, both parties argued that the
claims at issue had promised a certain utility, but disputed the content of
that promise. The Judge ultimately accepted the respondents’ expert evidence
regarding the promised utility of Claims 8 and 13 as tendered by Dr. Domagala
to the effect that the skilled person would interpret the ‘114 Patent to
promise only that “the new quinolone compounds have
potent antibacterial activity in vitro against a broad spectrum of
bacterial organisms, and in particular against Gram-positive bacteria” (Judge’s reasons at paragraph 66). The Judge then construed the
promise through the lens of this expert evidence, which he was entitled to
prefer, and specifically rejected the appellant’s analysis of the promised
utility (Judge’s reasons at paragraphs 69 and 71). This illustrates that the
Judge properly applied the law regarding utility.
[17]
Along the same lines, the appellant points to
various statements made by the Judge regarding the promise of the ‘114 Patent
in an attempt to argue that he erred by making multiple conflicting
constructions of the utility of the claims at issue. Specifically, the
appellant directed the Court’s attention to varying phrasing adopted by the
Judge in this regard (Judge’s reasons at paragraphs 66, 71 and 87). Read as a
whole, these slight differences in wording can be understood in a coherent
manner and are therefore inconsequential.
Utility and Sound Prediction
[18]
The Judge found that Claims 8 and 13 of the ‘114
Patent contained a limited promise of utility. This finding then underpinned
the Judge’s analysis of whether that utility had been soundly predicted. Given
that it was conceded that utility had not been demonstrated, the Judge
correctly turned to the soundness of the prediction to pursue his analysis
(Judge’s reasons at paragraphs 73 and 74).
[19]
There is no allegation that the Judge misstated
the law. Indeed, he based his analysis on the AZT requirements that
there be a factual basis for a sound line of reasoning as to the utility of the
invention, supported by proper disclosure (Judge’s reasons at paragraph 74).
The Judge summarized the result of his analysis as follows:
[102] Given the three components governing
the principle of sound prediction, I conclude that the requirements of factual
basis, line of reasoning and level of disclosure seen through the eyes of a
Skilled Person have been met.
[103] The factual basis consisted of:
. MIC data for nine
representative samples and ciprofloxacin data as a comparator;
. the method
of using MIC data was well accepted method for determining antibacterial
activity;
. Example 15
was the most potent compound (better than ciprofloxacin against certain
Gram-positive bacteria). The fact that it was ultimately proven toxic does not
undermine its usefulness in the line of reasoning;
. the use of
comparative data gives reliability and predictability of activity without
requiring that utility be measured as being superior to ciprofloxacin;
. based on
Example 15 (the closest example to Claims 8 and 13), there was a valid basis to
predict that the compounds in Claims 8 and 13, including moxifloxacin, would
have high antibacterial activity against a broad spectrum of bacteria;
. the
excellent activity exhibited by Example 15 would lead a Skilled Person to
predict that this activity would be retained when the methoxy group was
substituted in the 8 position and that single enantiomer including moxifloxacin
and its hydrochloride salt would have high antibacterial activity especially
against Gram-positive bacteria; and
. the common
general knowledge on the methoxy group at the 8 position provided a sound basis
to predict substituting methoxy for the fluorine found in Example 15 at the 8
position would lead to this high antibacterial activity.
[104] As the expert opinion established,
generally good activity in vitro more likely than not leads to good activity in
vivo. There was extensive history of the antibacterial effectiveness of
quinolones (so much so that Cobalt relies on it to say the patent was obvious).
There was a basis for a reasonable inference of utility.
[105] The fact that there was good in vitro
activity is sufficient. There was no claim to in vivo activity but that does
not mean there is inutility. In vivo activity at a minimum points to topical
use or use as a preservative.
[106] In summary, I conclude that;
. there was a
factual basis for the prediction;
. as of the
date of the patent application there was an articulate and sound line of
reasoning from which the desired result could be inferred from the factual
basis. The fact that further testing was required confirms that there is an air
of uncertainty. If that were not the case, it would not be prediction but
certainty and possibly obvious; and
. there was
proper disclosure in the detailed description of the fused pyrrolidine bicycle,
its synthesis and how to attach it to the quinolone molecule.
[20]
Given the above, rather than questioning the
Judge’s legal analysis, the appellant attacked the evidentiary basis for sound
prediction. The appellant points to its expert evidence, which included a table
that claimed to show what testing data was not reported in the patent and
submitted that all omitted data was where the compounds performed poorly (Hoban
Affidavit, Appeal Book, Volume 2, Tab 6 at page 441; Appellant’s compendium,
Tab 15). Essentially, the appellant contends that the exclusion of this testing
data from the patent meant that soundly predicting the utility of Example 15 –
and hence moxifloxacin – was impossible, and that the Judge made a palpable and
overriding error in holding otherwise.
[21]
The reality, however, is that the “omitted data”
issue was also argued before the Judge and dealt with by the Judge (Judge’s
reasons at paragraphs 88, 90, 92-99). More particularly, in distinguishing
this case from Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60,
[2012] 3 S.C.R. 625, the Judge concluded that there was no evidence that
any testing data had been excluded for an improper purpose (Judge’s reasons at
paragraph 92). The Judge therefore declined to draw an inference that any
discrepancies in data were made in bad faith, and further held that the inclusion
of this data would not have had any impact on how the skilled person would have
read the ‘114 Patent (Judge’s reasons at paragraph 100). These holdings are
supported by evidence (Zhanel cross-examination, Appeal Book, Volume 13, Tab 15
at page 3213, Qs 232-235; Zhanel Validity Affidavit at paragraphs 150-152,
Appeal Book Volume 11, Tab 14; Respondents’ compendium, Tab 129). I also note
that the Judge’s analysis conforms to our Court’s recent decision in Bell
Helicopter Textron Canada Ltée v. Eurocopter, 2013 FCA 219, 449 N.R. 111 at
paragraphs 149-155, with regard to the adequacy of disclosure.
[22]
Hence, the Judge’s conclusion that the utility of
the ‘114 Patent had been soundly predicted was based on expert evidence that he
was entitled to accept. Importantly, he found that the necessary factual basis
for sound prediction of the utility of the compounds claimed in Claims 8 and 13
could be based on Example 15 identified in the ‘114 Patent, which, while not identical
to the compounds of those claims, is “structurally very
similar” (Judge’s reasons at paragraph 78). This was supported by the
Domagala Affidavit (Respondents’ compendium, Tab 133 at paragraphs 45-47). The
Judge further held that moxifloxacin fulfills its utility as promised in Claims
8 and 13 as long as its activity can be described as “high”
(Judge’s reasons at paragraph 87; Zhanel Validity Affidavit at paragraphs
150-152, Respondents’ compendium, Tab 129). As the respondent noted, and I
agree, the definition of “high activity” was on
the record (Zhanel Validity Affidavit at paragraphs 145, 148-149, Respondents’
compendium, Tab 129).
[23]
In sum, I find that the appellant has essentially
attempted to re-argue its case by pleading evidence that it would have liked
the Judge to prefer, in the hopes of having our Court overturn the factual
determinations made by the Judge. This amounts to asking our Court to re-weigh
evidence. This is not our role and the appellant’s challenge in this regard must
also fail.
Obvious or obvious to try
[24]
Although the Judge observed that the appellant
had “largely abandoned” the allegations of
obviousness in oral argument (Judge’s reasons at paragraph 108), the Judge nonetheless
proceeded to address these allegations based on the parties’ written
submissions. The governing law in respect of obviousness is found in Apotex
Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, [2008] 3 S.C.R. 265 [Sanofi].
The Judge sets this out at paragraphs 110-113 of his reasons.
[25]
As noted at the outset, obviousness is a
conclusion of mixed fact and law. In cursory submissions before our Court, the
appellant neither contests the Judge’s statement of the law, nor disputes that
the choice of a fused pyrrolidine bicycle at the C-7 position of the quinolone
ring was inventive. Instead, the appellant now affirms that the Judge made
inconsistent holdings on the inventive concept of the claims, and points to
paragraphs 108 and 124 to advance that “high”
antibacterial activity must have been part of that inventive concept.
[26]
As with the evidentiary elements of the sound
prediction analysis, this Court’s intervention on obviousness would require a
palpable and overriding error, which the appellant has again failed to
demonstrate.
[27]
Significantly, the appellant failed to lead
evidence in this regard before the Judge. The Judge ultimately preferred the respondents’
expert evidence overall (Judge’s reasons at paragraph 31) and, on this
particular point, the implication of this holding is that he accepted the
evidence of Dr. Domagala that the inventive concept was neither obvious nor
obvious to try in light of any of the prior art (Confidential Domagala Validity
Affidavit, Volume 1, Appeal Book, Volume 7, Tab 11 at paragraphs 59 and 1497). It
was open to the Judge to make this holding and I find no palpable and
overriding error that would otherwise warrant the intervention of this Court.
V.
Conclusion
[28]
For the above reasons, I would dismiss the
appeal with costs.
“Richard
Boivin”
“I agree
Eleanor
R. Dawson J.A.”
“I agree
Wyman W. Webb J.A.”
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