Docket: A-330-15
Citation:
2016 FCA 267
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CORAM:
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PELLETIER J.A.
BOIVIN J.A.
RENNIE 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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ELI LILLY
CANADA INC.
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Respondent
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and
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ICOS
CORPORATION
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Respondent
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and
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THE
MINISTER OF HEALTH
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Respondent
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REASONS
FOR JUDGMENT
PELLETIER J.A.
[1]
It is not often that a panel of this Court is
asked to rule that another panel’s decision, issued days before, was wrongly
decided. But that is what we were asked to do in this appeal. We were asked to
depart from the recent judgment of this Court in Mylan Pharmaceuticals ULC
v. Eli Lilly Canada Inc., 2016 FCA 119, [2016] F.C.J. No. 406 (QL) [Mylan
FCA], on the ground that it did not follow the Supreme Court’s decision in Whirlpool
Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067 [Whirlpool],
a case which the appellant Apotex Inc. (Apotex) says decided the major issue in
this appeal and in Mylan FCA. This is the fourth time the Federal Courts
have been called upon to rule on whether Canadian patent no. 2,226,784 (the
‘784 patent), which claims the use of tadalafil in the treatment of erectile
dysfunction, contains “patentably distinct”
claims relative to an earlier patent covering tadalafil itself, Canadian patent
no. 2,181,377 (the ‘377 patent). In the other three cases, the Federal Courts
have referred to Whirlpool but, for various reasons, found that it did
not assist them in answering the question which the parties had put before
them.
[2]
It is incontrovertible that every panel of this
Court speaks for the Court and that no panel of the Court sits in appeal of
other panels. That said, the jurisprudence recognizes the right of the Court to
overrule its prior jurisprudence in very narrow circumstances: Miller v.
Canada (Attorney General), 2002 FCA 370, [2002] F.C.J. No. 1375 (QL) [Miller].
Apotex argues that the Miller criteria are met in this case because Mylan
FCA did not follow Whirlpool. Given this argument, it is incumbent
on us to review Whirlpool to see if Apotex is right. Having done so, I
agree that Whirlpool does not settle the question of the time at which
to compare the claims of the two patents in issue in an obviousness-type double
patenting case.
[3]
Apotex makes a further argument in support of
its appeal. It argues that the Federal Court erred in finding that the
disclosure in the‘784 patent was sufficient to teach the person skilled in the
art how to make the invention claimed, in particular the hydrate of the claimed
compound. In my view, this argument is without merit.
[4]
I would therefore dismiss the appeal with costs.
I.
BACKGROUND
[5]
This appeal arises as a result of Apotex’s
application for a notice of compliance (NOC) pursuant to the terms of the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133, which would
enable it to market its generic version of tadalafil. In its notice of
allegation, Apotex contended that the ‘784 patent, which claims a monopoly on
the use of tadalafil to treat erectile dysfunction, was invalid on various
grounds. In particular, Apotex alleged that the relevant claims of the ‘784
patent claimed nothing new or inventive relative to the claims of the ‘377
patent, which claimed a number of compounds including tadalafil, for use as a
medicine in humans. In doing so, Apotex was relying on the judge-made doctrine
of double patenting. In response to Apotex’s notice of allegation, Eli Lilly
Canada Inc. (Eli Lilly), the holder of the rights under the ‘784 patent,
brought an application for an order of prohibition to prevent the Minister of
Health from issuing an NOC to Apotex.
[6]
While these proceedings were underway, Eli Lilly
faced an identical challenge from another generic, Mylan Pharmaceuticals ULC,
which also alleged that the ‘784 was invalid by reason of double patenting. Eli
Lilly’s application to the Federal Court for an order of prohibition in that
matter was heard in October 2014; judgement and reasons in favour of Eli Lilly,
reported as 2015 FC 17, [2015] F.C.J. No. 10 (QL) [Mylan FC], were
issued in January 2015.
[7]
Eli Lilly’s application for prohibition in the
Apotex matter was heard in May 2015 so that the Federal Court Judge hearing
that application had the benefit of the reasons in Mylan FC in deciding
the double patenting argument. The Federal Court’s reasons and judgement
allowing Eli Lilly’s application for an order of prohibition issued on July 20,
2015 and were reported as 2015 FC 875, 2015 F.C.J. No. 870 (QL) [Apotex FC].
[8]
Mylan FC was
appealed to this Court and, on April 20, 2016, Mylan FCA issued. This
Court rejected Mylan’s arguments as to double patenting. The argument turned on
the date at which the comparison between the claims of the ‘377 and ‘784
patents should be made. This Court decided that the contest was between the
priority dates of the two patents and, that on the facts, the choice of date
did not matter as the result was the same in both cases: see Mylan FCA
at paragraph 52. A few days later, on May 5, 2016, this appeal from Apotex
FC was heard. In the normal course, given that the double patenting issue
is identical in both cases, this Court would have simply followed Mylan FCA
and rejected Apotex’s double patenting argument on the basis that it had
already decided this issue. Undeterred by this prospect, Apotex argued that Mylan
FCA should not be followed for the reasons set out above.
[9]
As noted earlier, Apotex framed its argument in
terms of Miller where this Court identified the circumstances in which
it would overrule its prior decisions. At paragraph 10 of Miller, this
Court held that it would not overturn a prior decision unless it was “manifestly wrong, in the sense that the Court overlooked a
relevant statutory provision, or a case that ought to have been followed.”
If the case that ought to have been followed is a decision of the Supreme
Court, the doctrine of stare decisis would require us to follow the
Supreme Court quite apart from any dicta in Miller: see Canada v.
Craig, 2012 SCC 43, [2012] 2 S.C.R. 489 at paras. 18-22.
II.
THE EARLIER CASES
[10]
Before reviewing the decisions in Mylan FC
and Apotex FC (the Earlier Cases) which are the backdrop to this appeal,
a few words about the science underlying the ‘377 and ‘784 patents are in
order.
[11]
Tadalafil is a member of a class of compounds
known as PDE V inhibitors that interfere with an intercellular process that inhibits
smooth muscle relaxation. The effect is thus to prolong smooth muscle
relaxation. Smooth muscles are controlled by the autonomic nervous system,
which means that they are not susceptible to voluntary control. Smooth muscles
are found in various places including the heart, as well as other specialized
tissue such as bronchial and vascular tissue. Smooth muscle relaxation can be
useful in the treatment of conditions in which disordered smooth muscle
contraction interferes with the normal functioning of human physiological
systems. The ‘377 patent claims a number of compounds including tadalafil “for use in the treatment of stable, unstable and variant
angina, hypertension, pulmonary hypertension, chronic obstructive pulmonary
disease, congestive heart failure, renal failure, atherosclerosis, conditions
of reduced blood vessel patency, peripheral vascular disease, vascular
disorders, inflammatory diseases, stroke, bronchitis, chronic asthma, allergic
asthma, allergic rhinitis, glaucoma or diseases characterised by disorders of
gut motility”.
[12]
The tissue responsible for an erection in the
human male is smooth muscle tissue. While it has long been known that an
erection occurs when the penis becomes engorged with blood, it has taken some
time to understand that this engorgement is the result of the relaxation of
smooth muscles in structures in the penis known as corposa cavernosa.
This understanding came to light in the period between the priority date of the
‘377 patent and the publication date of the ‘784 patent, which are the bookends
for the discussion of the comparison date of the two patents.
[13]
Turning now to the relevant issue in the Earlier
Cases, it is undisputed that double patenting involves a comparison of the
claims of the patents in issue, and not of the disclosure: Whirlpool at para.
63. However, before the claims can be compared, they must be construed.
Construction is done from the point of view of the person skilled in the art,
using the general knowledge common to such skilled persons at the material
date. In the Earlier Cases, the critical issue was the date at which the claims
of the two patents were to be compared, an issue whose relevance was a function
of the evolution of the common general knowledge between the earliest and the
latest candidates for the comparison date.
[14]
There are three dates that recur in the
discussion that follows. The first is the priority date which is the date of an
international filing, or of another Canadian filing, as of which a Canadian
patent application claims priority. The second is the filing date, which is the
date of the filing of the patent application in the Canadian patent office. Not
every patent has a priority date but all have a filing date. The last date is
the publication date of the patent, which occurs at the end of a confidentiality
period of 18 months – which can be shorter at the applicant’s request – which
begins on the earlier of the priority date or the filing date of a patent.
[15]
In addition, section 28.1 of the Patent Act,
R.S.C. 1985 c. P-4 (the Act) provides that the date of a claim in a patent
application is the filing date or, if there is one, the priority date. Further,
section 28.3 of the Act provides that the date for assessing obviousness (not
necessarily obviousness double patenting) is the claim date.
[16]
In Mylan FC, the Federal Court rejected
the priority date of the ‘784 patent as the date for comparison of the claims
of the two patents under discussion:
…this priority date of the '784 Patent [the
later patent] cannot be the relevant date. One cannot read into the claims of
the first patent more than what would have been understood by the person
skilled in the art at the claim date when comparing the claims of the second
patent to those of the first patent.
Mylan FC at
para. 134.
[17]
The Court assessed Mylan’s double patenting
argument as of the priority date of the ‘377 patent. The Federal Court found
that, as of that date, it would not have been obvious to a person skilled in
the art that tadalafil could be used to treat erectile dysfunction,
particularly via oral administration. The Court then went on to consider if the
result would be different if patent comparison occurred as of the priority date
of the ‘784 patent, a date that it had previously discarded. The relevant
change in the state of the art was the publication of the Canadian patent
covering sildenafil (the ‘902 patent), the active ingredient in the drug marketed
as Viagra. The Court ultimately concluded that the publication of the ‘902
patent did not make it obvious to a person skilled in the art that tadalafil
could be used to treat erectile dysfunction.
[18]
In both cases, the choice between the priority
dates of the patents in question was not determinative of the double patenting
issue because the claims of the ‘784 patent were found to be patentably
distinct from those of the ‘377 patent as of either date.
[19]
The Federal Court did not address the possibility
that the comparison date might be the publication date of either of the
patents, probably because the parties framed their arguments in terms of the
priority date of the ‘784 patent: see Mylan FC at para. 134. As for Whirlpool,
the Federal Court found that it was of no assistance because it did not
consider the issue of the comparison date: see Mylan FC at para. 133.
[20]
In Apotex FC, which is the decision under
appeal, Apotex argued before the Federal Court that the comparison date was the
publication date of the ‘784 patent while Eli Lilly argued that it was the
priority date of the ‘377 patent: see Apotex FC at para. 71. The Court’s
work was made easier by the fact that the parties agreed on the outcome of the
analysis on each of these dates. Specifically, Apotex conceded in oral argument
that the claims of the ‘784 patent would not be obvious over the claims of the
‘377 patent as of the priority date of the ‘377 patent. On the other hand, Eli
Lilly did not contest that the relevant claims of the ‘784 patent would be void
for double patenting if the date for comparison of the claims of both patents
was the publication date of the ‘784 patent: Apotex FC at paras. 72-74.
[21]
Given that the Federal Court had assessed double
patenting as of the priority date of the ‘377 patent in Mylan FC, Eli
Lilly argued that the Court should follow that decision and assess double
patenting as of the same date. This led the Federal Court to consider whether
it should follow Mylan FC as a matter of judicial comity. A number of
arguments were made in that context but, for our purposes, there are two
relevant conclusions.
[22]
Apotex argued that the Federal Court should
depart from Mylan FC because in that case the Federal Court erred in not
selecting the publication date of the ‘784 patent as the comparison date, as
taught by the Supreme Court decision in Whirlpool.
[23]
The Federal Court rejected this argument. It
found that while the Supreme Court ruled that the date for construction of the
claims of a patent is its publication date, it did not decide as of which date
courts should decide obviousness double patenting. Furthermore, the Court held
that the decision in Whirlpool turned on a question of the sufficiency
of the evidence on the issue of obviousness: see Apotex FC at para. 124.
As a result, any comments in Whirlpool dealing with the publication date
in the context of the double patenting analysis were, in the Federal Court’s
view, simply obiter dicta and thus not binding on lower courts: see Apotex
FC at para. 125.
[24]
The second relevant conclusion is found at paragraph
135 of the Federal Court’s reasons where the following appears:
The issue of the correct date for
undertaking the double patenting analysis is therefore moot as the same result
obtains if the analysis is undertaken as of the priority date of either the 377
Patent or of the 784 Patent. Given the comity principle and the lack of
authority on the point, I prefer not to make a firm determination on the point
as under either of the two possible dates the same result obtains.
[25]
This conclusion anticipates and is based upon a
careful analysis of the evidence as to the common general knowledge of the
person skilled in the art as of these two dates: see Apotex FC at paras.
136-68.
[26]
In the end result, the Federal Court found that,
whether one chose one priority date or the other as the comparison date, the
claims of the ‘784 patent were patentably distinct from the claims of the ‘377
patent. Apotex’s allegations of double patenting were therefore dismissed.
[27]
Given the pleadings of the parties and the
findings of the Federal Court in Apotex FC, the sole double patenting
issue in this appeal is whether, as Apotex asserts, Whirlpool decided
that the date for comparison of the claims of the patents in a double patenting
case is the publication date of the later of the two patents. If Apotex is
correct, both Apotex FC and Mylan FCA (and, by extension, Mylan
FC) are wrongly decided.
III.
WHAT DID WHIRLPOOL DECIDE?
[28]
The issue in Whirlpool was whether the claims of
the later patent, the ‘734 patent, which claimed flexible vanes on a dual
action washing machine agitator were patentably distinct from the claims of the
earlier patent, the ‘803 patent, which simply claimed “vanes”
on a dual action agitator. A dual action agitator was a washing machine
agitator which had an upper agitator which forced water and the washing machine
load onto the lower agitator which rotated back and forth. In the ‘734 patent,
the upper agitator came in two varieties: continuous operation and intermittent
operation. Only the claims relating to intermittent dual action machines were
in issue in the double patenting analysis.
[29]
Binnie J., writing for the Court, began his analysis
with a careful examination of the date at which the claims of a patent should
be construed. He held that the correct date was the publication date of the
patent. All the patents in suit in Whirlpool were issued prior to
October 1, 1989 and were therefore subject to the terms of the “old” Patent
Act. Under that Act, the publication date of a patent was its issue date.
As noted earlier, the publication date of a patent under the current regime is
at the end of the confidentiality period.
[30]
Binnie J. then went on to address the issue of
the construction of the ‘803 patent. He noted that, contrary to the usual case,
the party challenging the patent was arguing for a broad interpretation of the
claims of the patent while the patent holder argued for a narrow interpretation
of those claims. This was so, he said, because of the appellant’s desire “to broaden the ‘803 patent to set up their argument for the
invalidity of the later ‘734 patent”: Whirlpool at para. 51.
Binnie J. reviewed the trial judge’s reasons and found that, in light of the
evidence, it was open to the trial judge to conclude that as of the date of
issuance of the patent (and thus, its publication) the claims of the ‘803
patent referred only to rigid vanes.
[31]
The next step in the analysis was the
construction of the ‘734 patent. This was done under the heading of “If the ‘803 Patent Claims Properly Construed do not include
Flex Vanes, is the ‘734 Patent Nevertheless Invalid Because of Double
Patenting.” Binnie J. began this analysis by setting out the law as to
double-patenting and, in particular, the distinction between “same invention” double patenting and “obviousness” double patenting. The latter, wrote
Binnie J., “prohibits the issuance of a second patent
with claims that are not patentably distinct from those of the earlier patent.”:
Whirlpool at para. 66.
[32]
Having set out the law, Binnie J. turned to the evidence.
Once again deferring to the trial judge’s conclusions, he wrote that:
What distinguished '734 technology from '803
technology in respect of the intermittent drive claims was the substitution of
flex vanes for rigid vanes, as the trial judge noted at pp. 189-90: "[t]he
essence of the invention is the unique wash system produced by the combination
of flex vanes with dual action agitation".
Whirlpool at
para. 69.
[33]
In light of this construction, were the claims
of the ‘734 patent “patentably distinct” from
the claims of the ‘803 patent? This question led to a discussion of the
evidence of the competing experts in the case. The trial judge had discounted
the evidence of the appellant’s expert on the basis that he had little
experience with dual action agitators, an assessment with which Binnie J.
agreed. On the other hand, Binnie J. found the respondent’s expert should not
have been relied upon because he was an engineer who had worked in the
respondent’s product development group. Binnie J. found that he was, therefore,
not a “satisfactory proxy for the ‘ordinary worker’”:
see Whirlpool at para. 70. The ‘ordinary worker’ is the person skilled
in the art, sometimes referred to as the person of ordinary skill in the art –
often identified by the acronym POSITA.
[34]
Binnie J.’s discussion of the state of the art
is the basis for Apotex’s argument that the comparison date is the publication
date of the later patent. After having confirmed that the trial judge was
entitled to reject the evidence of the respondent’s expert because he was a
member of the respondent’s product development group, Binnie J. turned to the
qualifications of the appellant’s expert who had no experience with dual action
washing machines. Binnie J. set out the factual context:
At the date the '734 patent issued (February
17, 1981), dual action machines no longer constituted esoteric technology
intelligible only to the initiated. Dual action machines had been public since
June 1975 – almost six years prior to issuance of the '734 patent. The '401 and
'803 "dual action" patents had issued in Canada on January 2, 1979,
and March 6, 1979, respectively, and in the United States considerably earlier
than that. They were not prior art opposable to the validity of the '734 patent
because they were co-pending in the Canadian Patent Office, but by 1981 dual
action machines and the earlier patents were nevertheless well known and
available to those with "a practical interest in the subject matter of
[the] invention" (Catnic, supra, at p. 242).
Whirlpool at para.
73.
[35]
In the next paragraph, Binnie J. continued his
analysis of the weakness of the appellant’s witness’ evidence:
The trial judge was concerned, as I read his
opinion, that Mr. Mellinger's testimony was not supported by the level of
practical understanding of dual action washing machines that by 1981 was common
knowledge among the skilled workers who were interested in this end of the
washing machine business. Dual action agitators were, after all, big news for
these people in the late 1970s.
[36]
Whirlpool at para.
74.Apotex has fastened on the repeated references to 1981, the publication date
of the ‘377 patent, to argue that Binnie J. would have assessed double
patenting as of that date. At this point in his analysis, Binnie J. has already
settled on the construction of the ‘734 patent: see Whirlpool at
para.69. These references to 1981 occur in the context of the ability of the
parties’ experts to comment on whether the change from rigid to flexible vanes
was obvious. Apotex argues that this demonstrates Binnie J.’s intention to
decide the question of double patenting as of the date of the publication date
of the later of the two patents.
[37]
While this line of argument has a certain
appeal, there are a number of factors which lead away from the conclusion urged
by Apotex. It is, in my view, improbable that Binnie J. would settle a
significant point in the law of double patenting by implication and without
addressing it directly. The care taken to justify the publication date of a
patent as the date at which it is to be construed suggests that if Binnie J.
intended to decide the issue of the comparison date of the claims of the
patents in an obviousness double patenting suit, he would do so explicitly.
[38]
Furthermore, the issue of the comparison date in
double patenting cases had not arisen previously in the Supreme Court
jurisprudence, nor in the works of the text book writers. It would be
surprising, to say the least, if Binnie J. purported to deal with a novel
question by implication. This is all the more so when one considers that the
issue was there to be addressed if the Court chose to do so. Binnie J. flagged
the fact that the state of the common general knowledge had evolved between the
date of the date of the invention, the date of the filing of the ‘734 patent,
and the latter’s publication date: see Whirlpool at para. 55. In those
circumstances, I can only conclude that Binnie J.’s reticence on the point was
deliberate and that he did not intend to settle that particular question.
[39]
For these reasons, I do not agree that Whirlpool
has decided that the date at which the claims of the two patents in issue in a
double patenting case are to be compared is the date of publication of the
later patent. This remains an open question.
[40]
I might add that the analysis in the Earlier
Cases, in Mylan FCA, and in this case was driven by the fact that the
parties chose to frame the issue in terms of the date for comparison of the
claims of the patents in issue. Having conducted the analysis on the basis
chosen by the parties, we should not be taken as having decided that this
framework for analysis is the correct one. The fact that this issue has not
arisen in this form in the past may be an indication that there may be other
ways to approach it. Perhaps, the Court, having construed the claims of each of
the patents with the assistance of the persons skilled in the art, simply
compares the claims and decides whether the later claims are patentably
distinct from the earlier claims on the basis of the insights which it has
gained in the course of the construction of the patents. This appears to be
what was done in Commissioner of Patents v. Farbwerke Hoechst
Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49,
1966 CanLII 66, and more recently in Apotex Inc. v. Sanofi-Synthelabo Canada
Inc., 2008 SCC 61, [2008] 3 S.C.R. 265. This is not to argue that this
approach is any more correct than the comparison date approach but rather that,
going forward, parties should not feel that they are locked into the framework
chosen by the parties in these cases.
[41]
That said, on the basis of my conclusion as to
what Whirlpool decided, I find that Apotex’s argument that Mylan FCA
was wrongly decided fails; there is no reason for us to depart from it.
IV.
INSUFFICIENCY
[42]
Apotex’s second ground of appeal is that the
Federal Court erred in its conclusion that the specification of the ‘784 patent
taught a person skilled in the art how to proceed from the manufacture of
tadalafil itself to a solvate of tadalafil, more specifically a hydrate. The
distinction between a solvate and a hydrate was set out by the Federal Court at
paragraph 23 of its reasons:
A solvate is a physical form of a chemical
compound that is a crystalline solid containing a solvent incorporated within
the crystal structure. A hydrate is a solvate in which the incorporated solvent
is water.
[43]
The specification itself does not teach how this
is to be done. Apotex’s evidence tended to show that a person skilled in the
art would have to engage in experimentation beyond what would be considered
routine and the results were not guaranteed. The Federal Court acknowledged
that further steps would have to be taken to get from tadalafil to a hydrate of
tadalafil but accepted the evidence of Eli Lilly’s expert that this was a
matter of routine experimentation.
[44]
Apotex relies upon a number of the Supreme Court
decisions including Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents),
[1989] 1 S.C.R. 1623 at 1638, 1989 CanLII 64:
The description must be such as to enable a
person skilled in the art or the field of the invention to produce it using only
the instructions contained in the disclosure ... and once the monopoly
period is over, to use the invention as successfully as the inventor could at
the time of his application.
[Emphasis added.]
[45]
This passage was repeated with approbation in Teva
Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 at
paras. 51, 71 [Sildenafil]. In Sildenafil, the patent was found
deficient because the person skilled in the art would have had to conduct a
minor research project to arrive at the invention: see Sildenafil at
para. 75.
[46]
The Federal Court found that the dispute as to
the sufficiency of the disclosure was an evidentiary problem. Apotex disagrees
and argues that the Federal Court erred in law in accepting that the disclosure
was adequate. In my view, applying the legal test for sufficiency of disclosure
to the facts of this case is a question of mixed law and fact, reviewable on
the standard of palpable and overriding error. The Federal Court relied on the
same authorities as Apotex did in setting the test for sufficiency. The
difference in their positions consists in applying that test to the facts of
the case. This, in turn, turned on the Federal Court’s preference for the
evidence of Eli Lilly’s expert as opposed to that of Apotex’s expert. We are
not in a position to second-guess the Federal Court’s assessment of the expert
evidence.
[47]
In my view, Apotex’s arguments on this portion
of the appeal also fail.
V.
CONCLUSION
[48]
I would therefore dismiss the appeal with costs.
"J.D. Denis Pelletier"
“I agree
Richard Boivin J.A.”
“I agree
Donald J. Rennie J.A.”
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