Docket: A-284-14
Citation: 2015 FCA 191
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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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ALCON CANADA
INC. and ALCON PHARMACEUTICALS, LTD.
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Appellants
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And
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ACTAVIS PHARMA
COMPANY and THE MINISTER OF HEALTH
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Respondents
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REASONS FOR
JUDGMENT
BOIVIN J.A.
I.
Background
[1]
This appeal concerns a decision rendered on May
14, 2014 by a Federal Court judge (the Judge) who found that Canadian Patent
2,342,211 (the ‘211 Patent) was invalid for reasons of obviousness (2014 FC
462). On the basis of this finding, the Judge dismissed the application of
Alcon Canada Inc., Alcon Pharmaceuticals, Ltd., and Bayer Intellectual Property
GmbH (the appellants), who had applied 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
respondent) for its generic version of the appellants’ drug product Vigamox®.
[2]
As per the Notice of Appeal filed on June 13,
2014, Bayer Intellectual Property GmbH is no longer a party in this matter.
[3]
The Judge’s decision of May 14, 2014 also
addresses Canadian Patents 1,340,114 (the ‘114 Patent) and 2,192,418 (the ‘418
Patent). While the ‘418 Patent was not appealed before this Court, the appeal
of the ‘114 Patent is dealt with under a separate set of reasons (2015 FCA 192).
[4]
Vigamox® is an antibacterial eye drop commonly
used during cataract surgery. Its active ingredient is the antibacterial agent
moxifloxacin hydrochloride (moxifloxacin) which belongs to the fluoroquinolone
class of antibacterial agents. Moxifloxacin is claimed and disclosed as the
most preferred compound in the ‘211 Patent which covers the use of moxifloxacin
in a formulation for treatments of bacterial infections and medicaments to
prevent such infections, including ophthalmic infections.
[5]
The ‘211 Patent is entitled, “Antibiotic
Compositions for Treatments of the Eye, Ear and Nose” and claims a priority
date of September 30, 1998 from US Patent Applications 60/102,506 and
60/102,504. As the Canadian application was filed on September 19, 1999, the ‘211
Patent will expire September 29, 2019 (Notice of Allegation, Appeal Book,
Volume 2, Tab 8-A at page 537).
[6]
The only claims made by the ‘211 Patent which
are at issue in this appeal are the independent claims 1, 35, and 61 and their
dependents. The essential elements of these independent claims are as follows:
the use of moxifloxacin or its pharmaceutically useful salts or hydrates at a
concentration of 0.1 to 1.0 wt% for topically treating or preventing ophthalmic
infection (Claim 1); the use with a pharmaceutically acceptable vehicle in a
composition for the above purpose (Claim 35); and the pharmaceutical composition
itself (Claim 61) (Judge’s reasons at paragraphs 149-153).
[7]
In the decision under appeal, the Judge
determined that the ‘211 Patent was invalid for reasons of obviousness. More
specifically, he concluded that the ‘211 Patent relates to the known compound
moxifloxacin being used for a known use (treating and preventing ophthalmic infection)
at a concentration known to be effective (0.1 to 1.0 wt%). It would therefore have
been obvious or obvious to try to treat or prevent ophthalmic infections with moxifloxacin
in a pharmaceutical composition at the specified concentration. In so
concluding, the Judge found that there was no difference between the state of
the art at the relevant time and the inventive concept of the ‘211 Patent
(Judge’s reasons at paragraph 139).
II.
Issue
[8]
In this appeal, there is only one issue before
the Court: did the Judge err in concluding that the ‘211 Patent was obvious or
obvious to try?
[9]
For the reasons that follow, I conclude that the
Judge did not err in reaching his conclusion. I would accordingly dismiss the
appeal.
III.
Standard of Review
[10]
Following Sanofi-Aventis v. Apotex Inc.,
2013 FCA 186, [2015] 2 F.C.R. 644 at paragraph 33, the construction of the
promise of the patent is a question of law and must therefore be reviewed under
the standard of review of correctness (citing Whirlpool Corp. v. Camco Inc.,
2000 SCC 67, [2000] 2 S.C.R. 1067 at paragraph 76; also Free World Trust v.
Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 at paragraph 51; Mylan
Pharmaceuticals ULC v. AstraZeneca Canada Inc., 2012 FCA 109, 432 N.R. 292 at
paragraph 20). A judge must therefore interpret the patent as it would be
understood by a person skilled in the art to which it pertains, taking into
account the evidence as to how persons skilled in the art would understand
certain words and phrases used in the patent and determine what the patent discloses
and claims (Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1
S.C.R. 504 at page 523).
[11]
As per Pharmascience Inc. v. Canada (Health),
2014 FCA 133, 460 N.R. 343 at paragraph 31, the standard of review for factual
determinations of the Judge with respect to utility and obviousness in the
patent context is palpable and overriding error. Provided a judge does not
misidentify or misapply the legal test, that deferential standard applies. Moreover,
provided that a judge’s reasons are alive to the issues, the judge is assumed
to have considered all evidence before the court and does not make a palpable
and overriding error by failing to refer to a particular piece of evidence (Teva
Canada Limited v. Novartis Pharmaceuticals Canada inc., 2013 FCA 244, 451
N.R. 246 at paragraphs 10-12, citing Housen v. Nikolaisen, 2002 SCC 33,
[2002] 2 S.C.R. 235 at paragraph 46).
[12]
Significantly, a judge’s function necessarily
involves weighing the evidence and choosing which evidence to rely upon in the
face of conflicting expert opinions (Zero Spill Systems (Int’l) Inc. v.
Heide, 2015 FCA 115, [2015] F.C.J. No. 554 (QL) at paragraphs 47-49 [Zero
Spill]). Demonstrating a palpable and overriding error is a high threshold:
as our Court recently held in Zero Spill at paragraph 49, interfering in
a judge’s weighing of evidence in a patent case requires demonstrating a clear
(palpable) and fundamental (overriding) error going to “the
very core of the outcome of the case”.
IV.
Analysis
[13]
From the outset, I note that in challenging the
Judge’s conclusion to the effect that the ‘211 Patent is invalid, the appellants
do not question the Judge's construction of the inventive concept which was
identified as “a pharmological (sic) composition for
topically treating or preventing an ophthalmic infection, which comprises 0.1
to 1.0 wt% moxifloxacin” (Judge’s reasons at paragraph 172). However,
the appellants strongly disagree with the evidentiary basis relied upon by the
Judge in assessing obviousness from the perspective of a skilled person in the
art. Specifically, the appellants argue that the Judge failed to understand the
requirements and implications of what the inventive concept at issue means to a
skilled person in the art. This, the appellants maintain, led the Judge to
misapply the test for obviousness (Apotex Inc. v. Sanofi-Synthelabo Canada
Inc., 2008 SCC 61, [2008] 3 S.C.R. 265 [Sanofi]).
[14]
In support of their contention, the appellants
assert that the Judge erred in both preferring Dr. Lightman's evidence and
relying on it. In particular, the appellants contend that the Judge erred in
adopting Dr. Lightman's characterization of what can be understood as the "three
knowns": the known compound (moxifloxacin); the known use (treating and preventing
ophthalmic infections), and the known concentration (to be effective 0.1 to 1.0
wt%) (Judge's reasons at paragraph 139).
[15]
According to the appellants, this reliance on Dr.
Lightman’s affidavit evidence coupled with the failure to consider certain
admissions she made on cross-examination led the Judge to adopt an
inappropriate “hindsight approach” in assessing obviousness. At this juncture,
I find it useful to set out the Judge’s reasoning in this regard, at paragraphs
178 and 180-182 of his reasons:
[178] In reaching a conclusion on this
issue, the Court was particularly influenced by the evidence of Dr. Lightman.
It was clear, cogent, objective and consistent with the objective evidence of
the State of the Art.
…
[180] Dr. Lightman’s conclusion was that the
211 Patent was “in one sense” a mere collection of publicly available
information on moxifloxacin. There was no difference between the state of the
art as of September 30, 1998 and the inventive concept of the 211 Patent
claims.
[181] In light of the circumstances and
state of the art, it was obvious to try to treat ophthalmic infections with
moxifloxacin. The claims of the 211 Patent were directed to a known compound
being used for a known use in a concentration known to be effective.
[182] There was obviously contrary evidence
by accepted experts. In placing greater weight on Dr. Lightman’s evidence, the
Court is not suggesting that these other experts were not honest in their work
and opinions nor that they may have had long associations with their client
which disqualified their independence. However, Dr. Lightman’s evidence, where
it conflicted with Alcon’s experts, was more persuasive against the backdrop of
the state of the art.
[16]
The difficulty with the appellants’ challenge
with regard to the “three knowns” is that it imports concepts related to anticipation
into the obviousness analysis. Indeed, the question is not whether the
invention had been previously performed in the sense that the said features
(compound, use and concentration - the “three knowns”) were collectively known.
[17]
Rather, one must consider, as the Judge
logically did, each of the knowns separately in light of the state of the art
with a view to determining whether or not moxifloxacin was obvious or obvious
to try at the relevant date. In reaching his conclusion, the Judge carefully
set out the prior art evidencing what a skilled person would have knowledge of,
i.e. what
would make moxifloxacin obvious to try given its activity against bacteria, the
known concentration range for efficacy of ophthalmic formulations and the
efficacy of similar quinolones compounds like ciprofloxican (Judge's reasons at
paragraphs 164-166). In this regard, the Judge relied on the Dalhoff poster
(1996), the Fass article (1997) and Woodcock article (1997) as support for
identifying moxifloxacin as a candidate to replace the compounds of ciprofloxacin
and oflaxacin, pointing to its efficacy and potential in a wide range of
infections (References respectively: Meetings Highlights, Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Appeal Book,
Volume 8, Tab 13 at page 2877; Appeal Book, Volume 8, Tab 10 at pages 2805-2811;
Appeal Book, Volume 8, Tab 19 at pages 2980 and 2982). Moreover, the Judge
noted that an ophthalmic formulation containing the quinolone compound ciprofloxacin
(Ciloxan®) was already being sold commercially for ophthalmic treatments and
that another one containing the quinolone oflaxacin (Ocuflox®) was also used
against bacteria in the eye (Judge’s reasons at paragraph 166).
[18]
The evidence also demonstrates that the ‘211
Patent disclosed and enabled the essential elements of moxifloxacin claimed in
more than one patent addressing the treatment of eye infections (US Patent
4,990,517 (February 5, 1991), Appeal Book, Volume 8, Tab 2 at pages 2624-2682 (US
Patent 517); US Patent 5,607,942 (March 4, 1997), Appeal Book, Volume 8, Tab 3
at pages 2683-2734 (US Patent 942)). In addition, the Judge found that other
pieces of prior art, inter alia, a 1990 European patent, likewise pointed the way to moxifloxacin
(Judge’s reasons at paragraph 166, European patent WO 90/01933 (March 8, 1990),
Appeal Book, Volume 8, Tab 1 at pages 2613-2623).
[19]
Against this background, the Judge was entitled
to accept Dr. Lightman's expert opinion without necessarily adopting every
single aspect of it. Indeed, upon reading the Judge’s reasons, it is clear that
he did not merely accept Dr. Lightman's evidence unreservedly. Rather, the
Judge considered the entire body of conflicting expert evidence put before him and
concluded that Dr. Lightman's evidence was the most consistent with the prior
art from the perspective of the skilled reader in the art.
[20]
Thus, the contention that the Judge embarked on
an "unescorted romp" through the evidence must fail. Relying on carefully
considered expert testimony and having properly situated himself as the skilled
person in the art, the Judge, equipped with the “goggles” of the person skilled
in the art, drew his own factual conclusions from the evidence on the prior art
and the inventiveness steps. It follows that, regardless of any alleged deficiencies
in Dr. Lightman’s approach to obviousness, I am satisfied that the Judge drew
his own conclusions on the evidence adduced as to whether the inventive step of
trying moxifloxacin for the claimed application would have been obvious to the
skilled person in the art.
[21]
The appellants also allege that the Judge erred in
assessing obviousness by misapprehending or ignoring evidence that a new
compound for the treatment of eye infections could not have been developed unless
certain features were known, namely the compound’s toxicity, penetration, and
activity of moxifloxacin against P. aeruginosa. The appellant contends
that the existing prior art in this regard taught away from moxifloxacin:
- Moxifloxacin
showed limited in vitro
resistance to P. aeruginosa;
- Quinolones were considered to be
toxic;
- Drug ocular penetration must be known and until moxifloxacin
was formulated it remained unknown.
[22]
In making this contention, the appellants are essentially
asking the Court to accept that the skilled person in the art would have
understood at the relevant time that a compound claimed “for topically treating or preventing an ophthalmic
infection” to necessarily also be “safe and
effective” in clinical practice. Yet, the inventive concept of the ‘211
Patent does not require such features. Rather, it covers the treatment of
ophthalmic infections. I note that the Judge considered this contention and
rejected it (Judge's reasons at paragraphs 163, 173 and 175) finding that:
i. the ‘211 Patent is focused on the treatment of a range of
pathogens and does not emphasize P. aeruginosa (Judge's reasons at paragraphs
151, 162-163, and 175);
ii. on penetration, he found that three of the four factors
required to determine ocular penetration were disclosed in the Petersen poster
(Judge's reasons at paragraph 177, citing “Synthesis and In Vitro Activity of
BAY 12-8039, a New 8-Methoxyquinolone,” Appeal Book, Volume 1, Tab 6-B, p. 248);
iii. oflaxacin had worse activity than moxifloxacin but was developed
into a commercial product (Judge's reasons at paragraphs 168 and 169);
iv. on concentration in the formulation, moxifloxacin was similar
to other quinolones ophthalmic solution such as Ciloxan® and Ocuflox®; and
v. there was reason to believe that toxicity would not be a
concern for moxifloxacin (Vohr poster (1996) “Meeting Highlights –
Anti-infectives: 36th Interscience Conference on Antimicrobial Agents and
Chemotherapy”, Appeal Book, Volume 8, Tab 13, p. 2877; Staβ Schuhly
abstract (1997) “8th European Congress of Microbiology and
Infectious Diseases”, Appeal Book, Volume 8, Tab 4, p. 2739).
[23]
Finally, the appellants insist that the Judge
erred in failing to evaluate the Sanofi factors in his obvious to try
analysis. It is to be recalled that the Judge's reasons concerning the ‘211
Patent are part of a decision which also addressed two other patents that were
at issue in the underlying application: the ‘114 Patent and the ‘418 Patent. In
paragraph 112 of his reasons, regarding the ‘114 Patent, the Judge explicitly
set out the Sanofi factors of the obvious to try test. And
significantly, in the context of his analysis of the ‘211 Patent, the Judge
made reference to the obvious to try test on a number of occasions (Judge's
reasons at paragraphs 139, 144, 160-170, 174, 175, 181, and 183). I am thus
satisfied that the Judge was alive to the obvious to try factors in his ‘211
Patent reasons which he had in turn carefully considered in his reasons with
respect to the ‘114 Patent.
[24]
I am therefore unconvinced that the Judge made a
palpable and overriding error in his factual finding or reasoning. In light of
the foregoing, there is no need to address the submissions with respect to
anticipation.
[25]
Before concluding, I have the following
observation.
[26]
At the hearing before this Court, the appellants
referred to a flurry of evidence before the panel which allegedly pointed to
the opposite conclusions from those reached by the Judge. Throughout their
submissions, the appellants argued that several errors allegedly committed by
the Judge constituted errors of law. In reality, the grounds raised by the
appellants in this appeal, although dressed as errors of law, directly
challenged the Judge’s factual findings. In so doing, the appellants actually
attempted to re-argue their case on appeal, asking this Court to reweigh the
evidence. This is not the role of a Court of Appeal.
[27]
For these 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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