Dockets: A-376-13
A-385-13
Citation:
2015 FCA 116
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CORAM:
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PELLETIER J.A.
STRATAS J.A.
WEBB J.A.
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Docket: A-376-13
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BETWEEN:
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COBALT
PHARMACEUTICALS COMPANY
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Appellant
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and
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BAYER INC. and
BAYER PHARMA AKTIENGESELLSCHAFT and
THE MINISTER OF
HEALTH
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Respondents
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Docket: A-385-13
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AND
BETWEEN:
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BAYER INC. and BAYER PHARMA AKTIENGESELLSCHAFT
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Appellants
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and
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COBALT PHARMACEUTICALS COMPANY and THE MINISTER OF HEALTH
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Respondents
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REASONS
FOR JUDGMENT
STRATAS J.A.
[1]
Bayer Inc. and Bayer Pharma Aktiengesellschaft (“Bayer”)
and Cobalt Pharmaceuticals Company (“Cobalt”) both appeal from the judgment dated
October 22, 2013 of the Federal Court (per Justice Hughes): 2013 FC
1061. These are my reasons in both appeals.
[2]
Bayer applied
under the Patented Medicines (Notice of Compliance) Regulations,
S.O.R./93-133 (“NOC Regulations”), to the Federal Court to prohibit the
Minister of Health from issuing a notice of compliance to Cobalt concerning its
proposed drospirenone and ethinylestradiol combination product until the expiry
of each of Canadian Letters Patent Nos. 2,382,426 (’426 Patent) and 2,179,728
(’728 Patent).
[3]
In its judgment, the Federal Court granted
Bayer’s application concerning the ’426 Patent. Cobalt appeals from that
(appeal A-376-13). The Federal Court dismissed Bayer’s application concerning
the ’728 Patent. Bayer also appeals (appeal A-385-13).
[4]
For the reasons below, I would dismiss both
appeals with costs.
[5]
These reasons are divided in two parts: Cobalt’s
appeal concerning the ’426 patent and Bayer’s appeal concerning the ’728
Patent. First, however, I shall offer a few background facts relevant to both
appeals.
[6]
Bayer distributes in Canada birth control
tablets under the brand name YAZ. The tablets include as active ingredients 3
mg drospirenone + 20 mg ethinylestradiol in tablet form for oral
administration.
[7]
Cobalt intends to distribute in Canada a generic
version of YAZ. It has applied to the Minister of Health for a notice of
compliance.
[8]
Acting under the NOC Regulations, Cobalt issued
a notice of allegation. In it, it alleged that it would not infringe the claims
of the ’426 Patent and the ’728
Patent and that any relevant claims of the two Patents were invalid. In the
notice of allegation concerning the ’426
Patent, it alleged invalidity on the basis of obviousness, lack of utility,
overbreadth, insufficiency and ambiguity. In the notice of allegation
concerning the ’728 Patent, it alleged that the claims were invalid on the basis of obviousness, double
patenting, lack of utility and lack of sound prediction, and non-patentable
subject-matter on the ground that it covers a method of medical treatment.
[9]
In response to the notice of allegation, Bayer
applied under the NOC Regulations for an order prohibiting the Minister of
Health from issuing Cobalt a notice of compliance for its proposed drospirenone
+ ethinylestradiol combination product until after the expiry of the ’426 Patent and the ’728 Patent.
[10]
As mentioned above, the Federal Court granted
Bayer’s application concerning the ’426 Patent. It accepted Bayer’s
construction of that Patent. As a result of that construction, it found that
none of Cobalt’s allegations were justified.
[11]
As also mentioned above, the Federal Court
dismissed Bayer’s application concerning the ’728 Patent. It construed the
Patent finding alternatively that it was invalid for ambiguity or that it
claimed only, as a maximum or only dosage, 2 mg of drospirenone or an
indeterminate amount of drospirenone: see the Federal Court’s reasons at
paragraphs 134-35. Cobalt’s product contained 3 mg of drospirenone and so it
did not infringe.
A.
Cobalt’s
appeal concerning the ’426 Patent (A-376-13)
(1)
The
construction of the patent
[12]
The Federal Court’s construction of the patent
is to be reviewed on the basis of correctness: Mylan Pharmaceuticals ULC v.
AstraZeneca Canada Inc., 2012 FCA 109, 432 N.R. 292 at paragraph 20. As the
Supreme Court has said, “claims construction is a
matter of law for the judge”: Whirlpool Corp. v. Camco Inc., 2000
SCC 67, [2000] 2 S.C.R. 1067 at paragraph 61.
[13]
This view has been said to stem from the fact
that issued letters patent are a “regulation”
under subsection 2(1) of the Interpretation Act, R.S.C. 1985, c. I-21,
and, thus, are laws whose interpretation should be reviewed on the basis of
correctness: Whirlpool, above at paragraphs 49(e) and 61.
[14]
However, in the process of interpretation,
patents are to be read through the eyes of the skilled reader: Whirlpool,
above at paragraph 45. The skilled reader approaches the patent with an
appreciation of the common general knowledge in the art to which the patent
relates. This is not within the purview of a judge, so almost always the
parties adduce expert evidence to explain how the skilled reader would read and
understand the patent: Whirlpool, above at paragraphs 57-62; Free
World Trust v. Electro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 at
paragraph 51.
[15]
The Federal Court’s assessment of the expert
evidence – for example, evidence concerning the state of scientific knowledge
at the relevant time or how a reasonable person skilled in the art would
understand the patent – is reviewable for palpable and overriding error: Mylan
Pharmaceuticals, above at paragraph 20; Wenzel
Downhole Tools Ltd. v. National-Oilwell Canada Ltd., 2012 FCA 333, [2014] 2
F.C. 459 at paragraph 44; Bell Helicopter Textron Canada Limitée v.
Eurocopter, 2013 FCA 219, 449 N.R. 111 at paragraphs 73-74; Corlac Inc.
v. Weatherford Canada Inc., 2011 FCA 228, 95 C.P.R. (4th) 101 at paragraph
24.
[16]
That is the law I must apply in these appeals
and I will do so. But, in the interests of the sound development of the law, I
would like to offer certain observations for the Supreme Court of Canada to
consider in a future case.
[17]
Overall, a court nearly always reads a patent
through goggles supplied by the experts whom the judge considers to be credible
and accurate. Because of that, in practice, the standard of review of palpable
and overriding error will often apply. This Court has acknowledged this
practical reality for a while now:
While the construction of a patent is for
the court, it is not initially to be undertaken simply in the manner a court
would construe an ordinary contract or a statute, for example, but with the
knowledge of the skilled artisan to the extent that such knowledge is revealed
by expert evidence accepted at trial. In short, construction turns heavily on
the evidence of a person skilled in the art. [emphasis added]
(Unilever PLC
v. Procter & Gamble Inc. (1995), 61 C.P.R. (3d)
499 at pages 506-07, 184 N.R. 378 (Fed. C.A.).)
[18]
Often the experts’ testimony
stretches beyond opinion evidence and goes into factual matters within their
knowledge that are relevant to the construction exercise:
The problem with treating questions of
construction as pure questions of law is that they frequently are not. Although
direct evidence as to the meaning of non-technical terms is inadmissible, the
court does not reach its conclusion as to the meaning of the claim in a factual
vacuum. Evidence as to the common general knowledge can frequently have an
important bearing, as part of the factual matrix against which construction is
decided, as can factual evidence about the consequences of the teaching of
passages in the specification.
(Novartis
AG v. Dexcel-Pharma Limited,
[2008] EWHC 1266 (Pat), [2008] All E.R. (D) 97 at paragraph 21.) And, as is well-known, appellate review of first
instance judges’ findings on factual matters is conducted on the basis of
palpable and overriding error.
[19]
Of course, I accept that in a formal sense a
patent is a “law” under the Interpretation
Act. And courts to date have simply assumed that the formal designation of
letters patent as laws determines the standard of review issue. But I do not
agree. That is to allow the form – a “law” in
the formal sense – to dictate substance. The common law relating to the
standard of review, a matter of substance, needs to be separately considered.
[20]
The rationales supporting an appeal court
adopting a deferential approach to the construction of patents where expert
evidence has played a significant role seem overwhelming to me: Housen v.
Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235, at paragraphs 8-37. How are
appellate judges supposed to cleave off those aspects of claim construction
that flow from the trial judge’s appreciation of expert evidence from the words
of the claim per se? Can appellate judges really second-guess the trial
judge, who, often over many days, has been educated in the relevant art and has
seen and evaluated the experts? Who are the appellate judges to review on the
basis of correctness, stepping into the shoes of the trial judge and imposing
their own views of the matter?
[21]
I do not accept that correctness review is
required for consistency and certainty in the interpretation of patents. The
doctrine of comity among judges will ensure there is sufficient consistency and
certainty in the meaning of patents, just as it ensures consistency and
certainty under the current approach to the standard of review: Apotex Inc.
v. Allergan Inc., 2012 FCA 308, 105 C.P.R. (4th) 371.
[22]
I also note that a recent decision of the
Supreme Court of the United States signals a growing acceptance that, as a
practical matter, deference should be accorded to the interpretations of
patents reached by those who have seen the experts and have evaluated them: Teva
Pharmaceuticals USA, Inc. v. Sandoz, Inc., No. 13-854, 574 U.S. __ (2015).
[23]
In considering the standard of review, it seems
to me there is much to be said for drawing a distinction between “letters patent” and patent specifications: William L.
Hayhurst, “The Distinction Between ‘Letters Patent’ and
Patent Specifications: How Did We Get Where We Are?” (2006), 57 C.P.R.
(4th) 161. Under this approach, “letters patent”
under the Interpretation Act include only the certificate bearing the
seal of the Canadian Intellectual Property Office issued to an inventor upon
approval of her application. The patent application – as it existed immediately
prior to approval – instead becomes the patent specification and is not to be
considered “letters patent” under the Interpretation
Act.
[24]
This distinction has the practical effect that
only the certificate – the “letters patent” –
will necessarily be reviewed for correctness. Interpretations of the
specification may be then be reviewed on the basis of palpable and overriding
error when they are heavily dependent on expert testimony, as they usually are.
The specification remains a legal document, but even legal documents may be
subject to review on a deferential standard: Sattva Capital Corp. v. Creston
Moly Corp., 2014 SCC 53, [2014] 2 S.C.R. 633.
[25]
As I have said, however, I shall apply the
standard of review as it exists on the books at the present time. And under
that law, I see no grounds to set aside the judgment of the Federal Court based
on its construction of the ’426 Patent.
[26]
Before the Federal Court, Cobalt argued that
Claim 31 is limited to micronized drospirenone particles. The Federal Court
disagreed holding that Claim 31 was not so limited.
[27]
Claim 31 of the ’426 Patent reads as follows:
31. A pharmaceutical composition
comprising:
from about 2 mg to about 4 mg of
drospirenone particles, wherein the drospirenone is in a form, which when
provided in a tablet containing 3 mg of drospirenone, has a dissolution such
that at least 70% of said drospirenone is dissolved in 900 ml of water at 37°
C. (~0.5° C) within 30 minutes, as determined by USP XXIII Paddle Method using
a USP dissolution test apparatus 2 at a stirring rate of 50 rpm, including 6
covered glass vessels and 6 paddles;
about 0.01 mg to about 0.05 mg of
17.alpha.-ethinylestradiol; and
one or more pharmaceutically acceptable
carriers; the composition being in an oral dose form, and the composition being
effective for oral contraception in a human female.
[28]
In this Court, Cobalt argues that the Federal
Court misinterpreted Claim 31. Cobalt says that, properly construed, Claim 31
claims only drospirenone particles in “micronized”
form. Cobalt would read into Claim 31, as an essential element, the word “micronized” as follows: “from
about 2 mg to about 4 mg of micronized drospirenone particles”.
[29]
Cobalt develops its submission by pointing to
stray phrases in the patent description to argue that the “purpose and intent of the invention was to achieve rapid
dissolution through micronizing drospirenone”:
To ensure good bioavailability of the
compound, it is therefore advantageously provided in a form that promotes rapid
dissolution thereof. It has surprisingly been found that when drospirenone is
provided in micronized form (so that particles of the active substance
have a surface area of more than 10,000 cm2/g and the following
particle size distribution…) in a pharmaceutical composition, rapid dissolution
of the active compound occurs in vitro (“rapid dissolution is defined as
dissolution of at least 70% over about 30 minutes, in particular at least 80%
over about 20 minutes…) [emphasis in original]
(Cobalt’s
Memorandum of Fact and Law at paragraph 51, citing the ’426 Patent at page 4.)
[30]
Cobalt additionally points to Claims 3 and 38,
both of which specifically claim spraying onto inert carrier particles, to
argue that had the inventors intended Claim 31 to capture sprayed drospirenone
particles they would have so specified.
[31]
I reject Cobalt’s submission. In my view, Cobalt
is cherry-picking particular portions of the patent to support the result it
wishes to reach. Patents are not to be construed in a tendentious way. Rather,
we must examine the patent as a whole construing the language of the claims
with due regard to the inventor’s purpose through the eyes of the skilled
reader: Whirlpool, above.
[32]
Claim 31 embraces all drospirenone particles
that rapidly dissolve in the manner described in the claim, whether micronized
or not. The word “micronized” is absent from
Claim 31. Claim 31 embraces all drospirenone particles that meet the
remaining limitations of the claim: “when [the
drospirenone particles are] provided in a tablet containing 3 mg of
drospirenone, [the drospirenone] has a dissolution such that at least 70% of
said drospirenone is dissolved in 900 ml of water at 37° C. (~0.5° C) within 30
minutes, as determined by USP XXIII Paddle Method using a USP dissolution test
apparatus 2 at a stirring rate of 50 rpm, including 6 covered glass vessels and
6 paddles.”
[33]
Examining the ’426 Patent as a whole, one must
conclude, as the Federal Court did, that Claim 31 embraces all rapidly
dissolving drospirenone particles.
[34]
The purpose of the invention was to provide good
bioavailability of drospirenone through rapid dissolution. The inventors are
clear throughout the patent that the particular means by which rapid
dissolution is achieved is not important. The inventors provide two examples of
ways to achieve rapid dissolution, and throughout the claims they
intermittently claim one, both, or any drospirenone particle that achieves
rapid dissolution. A considered reading of the whole patent confirms that Claim
31 is not limited to micronized drospirenone particles.
[35]
For example, around the excerpt at page 4 of the
’426 Patent that Cobalt cites (above), we see other passages that confirm the
Federal Court’s reading of the patent. At page 4, the patent states that “[t]o ensure good bioavailability of the compound, it is
therefore advantageously provided in a form that promotes rapid dissolution
thereof,” and that:
Instead of providing the drospirenone in
micronized form, it is possible to dissolve it in a suitable solvent, e.g.
methanol or ethyl acetate, and spray it onto the surface of inert carrier
particles followed by incorporation of the
particles containing drospirenone on their surface in the composition.
Without wishing to be limited to any
particular theory, it appears that the in vitro
dissolution rate of drospirenone is connected to the dissolution rate in vivo
resulting in rapid absorption of drospirenone in vivo on oral administration of
the compound. This is an advantage because isomerization of the compound in the
gastric environment and/or hydrolysis in the intestive is substantially
reduced, leading to a high bioavailability of the compound. [emphasis added]
[36]
Later, at page 9, the ’426 Patent states:
The composition of the invention may be
formulated in any manner known in the pharmaceutical art. In particular, as
indicated above, the composition may be formulated by a method
comprising providing drospirenone and, if desired, ethinylestradiol in
micronized form in said unit dosage form, or sprayed from a solution onto
particles of an inert carrier in admixture with one or more
pharmaceutically acceptable excipients that promote dissolution of the
drospirenone and ethinylestradiol so as to promote rapid dissolution of
drospirenone and preferably enthinylestradiol on oral administration. [emphasis
added]
[37]
Claim 1 (and dependent claims) of the ’426
Patent claim compositions wherein the drospirenone particles are provided in
“micronized” form. Claims 3 and 38 both claim spraying each onto an inert
carrier particle. Claim 31, in contrast, specifies neither that drospirenone
should be micronized, nor that it should be sprayed. Had the inventors intended
to limit Claim 31 to one form of drospirenone or another, they would have
specified the form, as they did in Claims 1, 3 and 38. The context of the claims
evidences the contrary intention.
[38]
Therefore, for the foregoing reasons, I agree
with the Federal Court’s conclusion that Claim 31 is not limited to micronized
drospirenone particles.
(2)
The allegation
of non-infringement
[39]
Any of the defendant’s activities that interfere
with the patentee’s exclusive rights under section 42 of the Patent Act
infringe the patent: Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34,
[2004] 1 S.C.R. 902 at paragraph 34, citing H. G. Fox, The Canadian Law and
Practice Relating to Letters Patent for Inventions, 4th ed. (Toronto:
Carswell, 1969) at page 349.
[40]
Following claim construction, the question that
must be asked is whether the defendant’s proposed product embodies each of the
essential elements of a patent claim. If so, the patent is infringed: Monsanto,
above at paragraph 30; Free World Trust, above at
paragraphs 68 and 75. According to the Supreme Court of Canada, the standard of
review for infringement – a question of mixed fact and law – is palpable and
overriding error: Whirlpool, above at
paragraph 76.
[41]
On appeal, Cobalt argued that it would not
infringe the’426 Patent because, properly construed, Claim 31 of the ’426
Patent was restricted to pharmaceutical compositions containing micronized
hormone. Since Cobalt alleged that its product does not contain any micronized
hormone, Cobalt argued it could not infringe.
[42]
However, as the Federal Court held – a holding I
have confirmed to be correct – Claim 31 is not restricted to compositions
containing micronized hormone. Properly construed, Claim 31 claims all
pharmaceutical compositions which embody the listed essential elements of Claim
31, irrespective of whether the hormone particles are micronized.
[43]
Given that Cobalt’s allegation of
non-infringement depended on a construction of Claim 31 that captured only
micronized hormone particles, and given that Cobalt’s only allegation of
non-infringement was that its product did not contain those particles, Cobalt’s
allegation of non-infringement is not justified. The Federal Court reached that
conclusion, and there is no basis upon which it can be set aside.
(3)
The allegation
of invalidity of the ’426 Patent based on obviousness
[44]
On appeal, Cobalt argued that its allegation
that the ’426 Patent was invalid for obviousness was justified.
[45]
In particular, Cobalt alleged that the Federal
Court failed to compare the inventive concept of Claim 31 to what the skilled
reader would have thought and known as of August 31, 1999. According to Cobalt,
instead of the skilled reader, the Federal Court considered what two Bayer
employees who were not named inventors did in 1983-1984 and failed to consider
relevant prior art: Appellant’s Memorandum, at paragraphs 69-74.
[46]
Under s. 28.3 of the Patent Act, R.S.C.
1985, c. P-4, a patent may not issue for an obvious invention. In considering
obviousness, Courts typically apply a four-step test:
(1)
(a) Identify the notional “person skilled in the
art”;
(b) Identify the relevant common general knowledge of that person;
(2)
Identify the inventive concept of the claim in
question or if that cannot readily be done, construe it;
(3)
Identify what, if any, difference exist between
the matter cited as forming part of the “state of the
art” and the inventive concept of the claim or the claim as construed;
(4)
Viewed without any knowledge of the alleged
invention as claimed, do those differences constitute steps which would have
been obvious to the person skilled in the art or do they require any degree of
invention?
(Apotex Inc. v. Sanofi-Synthelabo Canada Inc.,
2008 SCC 61, [2008] 3 S.C.R. 265 at paragraph 67.)
[47]
Sanofi-Synthelabo
did not mandate the above test in every case, but held that it would be “useful in an obviousness inquiry”. Strict rules are
inappropriate, since obviousness is a factual determination: Sanofi-Synthelabo
at paragraphs 63 and 67.
[48]
Obviousness is a question of mixed fact and law.
Unless the application judge committed an extricable
legal error, his obviousness analysis is subject to review for palpable
and overriding errors: Wenzel Downhole Tools,
above at paragraph 44.
[49]
The Federal Court’s reasons for rejecting the
obviousness claim are suffused by factual appreciation, including the
assessment of expert witnesses and their testimony. It found that the prior art
“taught away” from the solution of the ’426
Patent.
[50]
The Federal Court found that drospirenone is an
acid-labile compound. In the stomach, it is subject to rapid degradation to an
inactive form. The prior art method of overcoming acid-degradation was to
provide the particles with an enteric coating, so that they would only release
drospirenone in less acidic areas of the gastrointestinal tract. It was
surprising that rapidly dissolving drospirenone particles solved this problem,
and it was contrary to what had been observed in vitro. Therefore, Claim
31 of the ’426 Patent was not obvious.
[51]
In concluding as it did, the Federal Court
considered the expert evidence as at the relevant date (August 31, 1999) and,
for many reasons, preferred the evidence of Dr. Davies to that of Dr. Pramar:
[78] In cross-examination, Dr. Pramar
admitted that she was unaware of any literature that addressed the
isomerization of spironolactone at a pH of 1 (Q 46). She could not tell whether
spironolactone was an oral contraceptive because that was not her area of
expertise (Q 196). She could not say whether she was aware of the Krause
references before she was given them by Bayer’s Counsel (Q 198).
[79] On the other hand, Dr. Davies
appeared to be quite comfortable in discussing the references. He states in
answer to question 667 of his cross-examination that the information brought
forward through Dr. Pramar would not help come to the invention.
[80] I prefer the evidence of Dr.
Davies in this respect. As of August 1999, it was known that a
combination of drospirenone and ethinylestradiol in amounts falling within the
range stipulated in the claims of the '426 patent could be used as an oral
contraceptive. However, what was not known is that the dissolution of the
drospirenone in the stomach could be enhanced by providing it, without enteric
coating, in a form such as micronized, so that it would dissolve rapidly. Contrary
to what in vitro testing might demonstrate, the in vivo administration of such
a drug would not result in undue isomerization in the stomach.
[81] The inventive concept is, as I
have stated, that, in an oral contraceptive comprised of a combination of
drospirenone and ethinylestradiol, the drospirenone may be provided in
micronized or other rapidly dissolving form without an enteric coat.
[82] The difference between the prior
art and the inventive concept is the provision of the drospirenone comprised in
micronized or other rapidly dissolving form to provide a successful oral
contraceptive.
[83] I find that the difference was
not more or less self-evident. The prior art pointed away from providing an
acid-labile drug such as drospirenone, in a rapidly dissolving form. Previous
attempts were tested in vitro; the breakthrough was to ignore the in vitro
results and test in vivo with the unexpected result.
[emphasis added]
[52]
In this Court, Cobalt basically invites this
Court to re-weigh the evidence already considered by the Federal Court. In its
submissions, it parsed the Federal Court’s reasons, attacking them by taking us
to the minutae of the evidence.
[53]
On appeal, that is not our job. The standard of
review is palpable and overriding error. That is indeed a high standard:
[46] Palpable and overriding error is a
highly deferential standard of review: H.L.
v. Canada (Attorney General), 2005 SCC 25, [2005] 1 S.C.R. 401; Peart v. Peel Regional Police
Services (2006), 217
O.A.C. 269 (C.A.) at paragraphs 158-59;
Waxman [v. Waxman (2004), 186 O.A.C. 201]. “Palpable” means an error that is
obvious. “Overriding” means an error that goes to the very core of the outcome
of the case. When arguing palpable and overriding error, it is not enough to
pull at leaves and branches and leave the tree standing. The entire tree must
fall.
[47] In applying the concept of palpable
and overriding error, it is useful to keep front of mind the reasons why it is
an appropriate standard in a complex case such as this.
…
[49] Immersed from day-to-day and
week-to-week in a long and complex trial such as this, trial judges occupy a
privileged and unique position. Armed with the tools of logic and reason, they
study and observe all of the witnesses and the exhibits. Over time, factual
assessments develop, evolve, and ultimately solidify into a factual narrative,
full of complex interconnections, nuances and flavour.
(Canada v.
South Yukon Forest Corporation, 2012 FCA 165, 431 N.R.
286.)
[54]
The Federal Court’s finding that Cobalt’s
obviousness allegation was not justified discloses no extricable legal error,
nor any palpable and overriding errors of mixed fact and law. It cannot be
disturbed on appeal.
(4)
The allegation
of invalidity of the ’426 Patent based on lack of sound prediction of utility
[55]
On appeal, unless
there is an extricable legal error, 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; Sanofi-Aventis Canada Inc. v. Apotex Inc.,
2011 FCA 300, 97 C.P.R. (4th)
415 at paragraph 5.
[56]
A patented invention must be useful at the time
of the patent’s Canadian filing date. To establish utility, the inventor may
rely on a demonstration or a sound prediction. “Sound
prediction is not a free-standing statutory requirement [but rather] is a way of showing that
an invention is useful when the invention has not been directly demonstrated to
work”: Teva Canada Limited v. Novartis AG,
2013 FC 141, 109 C.P.R. (4th) 1 at paragraph 164.
[57]
Sound prediction requires that the patentee
provide “a solid teaching”; it does not protect “a lucky guess” or “mere
speculation.” An inventor need not explain exactly why or how the
invention works, but must provide in the patent the underlying knowledge
supporting that it does work. See generally Apotex Inc. v. Wellcome
Foundation Ltd., above at paragraphs 69, 70 and 83.
[58]
A sound
prediction requires three things:
•
a factual basis for the prediction;
•
an articulable and sound line of reasoning
connecting the desired result and the factual basis; and
•
proper disclosure of the factual basis and line
of reasoning in the patent.
(Apotex Inc. v. Wellcome Foundation Ltd., above at paragraph 70.)
[59]
On appeal, Cobalt submits in its memorandum (at
paragraphs 93-95 and 99) that the utility of Claim 31 across its scope was not
demonstrated because only micronized drospirenone was tested. Consequently,
Cobalt says that Claim 31 is invalid because it depends on an unsound
prediction that pharmaceutical compositions containing rapidly dissolving
drospirenone particles, however created, would work.
[60]
However, in making this submission, Cobalt has
strayed from its notice of allegation. In it, Cobalt only alleged that Claim 31
lacked utility because micronized drospirenone had not been demonstrated
or soundly predicted to work:
346. As of August 31, 2000, the patentee
had not demonstrated the utility of the subject matter claimed in the 426
Patent and could not have soundly predicted the utility of this subject matter…
350. …the studies conducted by the
patentee and reported in the patent are not predictive of the utility of, nor
do they support a sound prediction on the part of the patentee that tablets
made according to Example 1 having the in vitro dissolution profile evidenced
in Example 2, in fact, result in the rapid absorption of drospirenone in vivo
on oral administration of the compound.
351. The study conducted by the patentee
with respect to bioavailability in vivo, as reported in Example 4, did not use
a pharmaceutical composition containing micronized drospirenone particles.
Instead, this study investigated the relative bioavailability of a tablet
formulation containing 3 mg of non-micronized drospirenone…
[61]
It is not open to Cobalt in prohibition
proceedings under the NOC Regulations or appeals therefrom to stray from its
notice of allegation: Procter & Gamble Pharmaceuticals Canada, Inc. v.
Canada (Minister of Health), 2002 FCA 290, [2003] 1 F.C. 402 at paragraph
22. Therefore, Cobalt’s submission must be rejected.
(5)
The allegation
of invalidity of the ’426 Patent based on insufficiency of disclosure
[62]
The Federal Court held that it need not consider
Cobalt’s sufficiency allegation, because it depended on a construction that
limited Claim 31 to micronized drospirenone (at paragraphs 101-102).
[63]
In my view, this was in error. When one examines
Cobalt’s allegations as to insufficiency in its notice of allegation, one sees
that they concern constructions of Claim 31 which are broader than micronized
drospirenone particles:
344. The specification of the ’426
Patent is insufficient to support a claim to drospirenone other than micronized
drospirenone with the specific features set out in the specification. To the
extent that independent claims 30 to 35 and 44 to 46, dependent claims 36
to 42 and 47 to 51, are interpreted to include drospirenone particles that
are not micronized (for example, drospirenone that has a surface area of
more than 10,000 cm2/g, but no particular particle size distribution), then
the specification is insufficient to support these claims. [my emphasis]
Cobalt’s allegation was that if Claim 31
claimed more than micronized drospirenone particles, then the ’426 Patent
disclosure was insufficient. Since the Federal Court correctly construed Claim
31 to be broader than just micronized drospirenone, it was necessary for the
Federal Court to consider Cobalt’s insufficiency allegation. Accordingly, this
Court must consider Cobalt’s allegation of insufficiency.
[64]
Disclosure lies at the heart of the
patent system. The enabling description of an invention in the specification of
a patent is the quid pro quo for the monopoly under the Patent Act:
Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd, [1981] 1 S.C.R. 504
at page 517, 122 D.L.R. (3d) 203. Paragraphs 27(3)(a)
and (b) set out the requirements that an inventor describe and enable
the invention:
|
27. (3) The specification of an
invention must
|
27. (3) Le mémoire descriptif doit :
|
|
(a) correctly and fully describe the invention and
its operation or use as contemplated by the inventor;
|
a) décrire d’une façon exacte et
complète l’invention et son application ou exploitation, telles que les a
conçues son inventeur;
|
|
(b) set out clearly the various steps in a process, or the
method of constructing, making, compounding or using a machine, manufacture
or composition of matter, in such full, clear, concise and exact terms as to enable
any person skilled in the art or science to which it pertains, or with which
it is most closely connected, to make, construct, compound or use it;…
|
b) exposer clairement les diverses phases
d’un procédé, ou le mode de construction, de confection, de composition ou
d’utilisation d’une machine, d’un objet manufacturé ou d’un composé de
matières, dans des termes complets, clairs, concis et exacts qui permettent
à toute personne versée dans l’art ou la science dont relève l’invention, ou
dans l’art ou la science qui s’en rapproche le plus, de confectionner,
construire, composer ou utiliser l’invention;
|
|
[emphasis added]
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[j’ai souligné]
|
[65]
Basically, paragraphs
27(3)(a) and (b) require the inventor to answer two questions:
What is your invention? How does it work, in the sense of how to put it into
operation? See Consolboard, above at page 520. The purpose of
these paragraphs is to ensure that when the monopoly ends, the skilled reader,
armed only with the specification, can put the invention into practice: Consolboard
at pages 520-21, citing Minerals Separation North American Corporation v.
Noranda Mines, Limited, [1947] Ex. C.R. 306 at page 316, 12 C.P.R. 99.
[66]
In Pioneer Hi-Bred, the Supreme Court put
the test as follows:
The applicant must define the nature of the
invention [What is your
invention?] and describe how it is put into
operation [How does it work?]. A failure to meet the first condition would invalidate the
application for ambiguity, while a failure to meet the second invalidates for
insufficiency. The description must be such as to enable a person skilled in
the art of 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.
[comments added]
(Pioneer
Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R. 1623 at
page 1638, 25 C.P.R. (3d) 257.)
[67]
The question whether the patent specification
sets out in sufficiently clear and exact terms how the invention may be
deployed is one of fact: Apotex Inc. v. Lundbeck Canada Inc., 2010 FCA
320, 88 C.P.R. (4th) 325 at paragraph 116. The
disclosure must be sufficient as of the date of filing: Teva Canada Ltd. v.
Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 at paragraph 90.
[68]
An inventor need not disclose all modes of the
invention. Paragraphs 27(3)(a) and (b)
are satisfied if the inventor sufficiently discloses one mode: Abbvie
Corporation v. Janssen Inc., 2014 FC 55, 116 C.P.R. (4th) 399 at paragraph
166, rev’d on other grounds 2014 FCA 242; Patent Rules, S.O.R./96-423,
paragraph 80(1)(f). Were it otherwise, the requirement that an inventor
of a mechanical invention must disclose only the “best
mode” contemplated, as specified by paragraph 27(3)(c) of the Patent
Act, would be purposeless.
[69]
Applying these principles to the ’426 Patent, I
find that the disclosure is sufficient. The invention is that “an oral contraceptive comprised of a combination of
drospirenone and ethinylestradiol, the drospirenone may be provided in… rapidly
dissolving form without an enteric coat”: Federal Court’s reasons at
paragraph 81. The inventor teaches the skilled reader that the invention can be
practiced by preparing a pharmaceutical composition using micronized
drospirenone particles: ’426 Patent at page 4. The inventor has both described
the invention and taught the skilled reader how to practice it.
[70]
Therefore, I conclude that while the Federal
Court erred in failing to adjudicate Cobalt’s insufficiency allegation, it
would not have affected Bayer’s entitlement to a prohibition order. Cobalt’s
allegation is not justified.
(6)
The allegation
of invalidity of the ’426 Patent based on overbreadth
[71]
The Federal Court also held that it need not
consider Cobalt’s overbreadth allegation, because that allegation depended on a
construction of Claim 31 that was limited to micronized drospirenone (at
paragraphs 101-102).
[72]
This was the same error the Federal Court made
when it considered Cobalt’s insufficiency allegation. The relevant portion of
Cobalt’s notice of allegation is as follows:
341. The specification teaches only the
use of drospirenone in micronized form and defines this as having both a
surface area of more than 10,000 cm2/g and a particular particle size of
distribution.
342. Thus, the patentee provides that
the subject matter of the 426 Patent is limited to micronized drospirenone with
certain characteristics. However, independent claims 30 to 35 and 44 to 46,
dependent claims 36 to 42 and 47 to 51, are not so limited and, if they are
interpreted to include drospirenone particles that are not micronized (which
would be incorrect in our view), then these claims are overbroad.
[73]
The essence of Cobalt’s overbreadth allegation
was that if Claim 31 claimed more than micronized drospirenone particles, then
it was overbroad. As with Cobalt’s insufficiency allegation, following its
construction of Claim 31, the Federal Court should have considered Cobalt’s
overbreadth allegation. Accordingly, I must also decide whether this allegation
is justified.
[74]
One example of overbreadth is where a patent
claims more than it sufficiently discloses. If it does, then the overbroad
claims are invalid: Leithiser v. Pengo Hydra-Pull of Canada Ltd., [1974]
2 F.C. 954, 6 N.R. 301 (C.A.); Farbwerke Hoechst Akiengesellschaft Vormals
Meister Lucius & Bruning v. Commissioner of Patents, [1966] Ex. C.R. 91,
50 C.P.R. 220, aff’d [1966] S.C.R. 604.
[75]
In my view, Claim 31 is not overbroad.
[76]
As described above, Claim 31 embraces all
drospirenone particles which, when formulated into a tablet, have the required
dissolution properties. And as also described above, the disclosure of the ’426
Patent extends to drospirenone in forms other than micronized particles.
Therefore Claim 31 is not broader than the invention disclosed. Rather, Claim
31 claims exactly what was invented – the particular solution to a particular
problem.
[77]
While the Federal Court erred in failing to
adjudicate Cobalt’s allegation of overbreadth, it would not have affected
Bayer’s entitlement to a prohibition order. Cobalt’s allegation is not
justified.
(7)
Conclusion on Cobalt’s appeal concerning the ’426 Patent (A-376-13)
[78]
Cobalt has not established any reviewable errors
in the Federal Court’s decision relating to claim construction, obviousness, or
lack of utility for lack of sound prediction. While the Federal Court ought to
have considered insufficiency and overbreadth, it would not have prevented it
from issuing a prohibition order pending the expiry of the ’426 Patent.
[79]
Therefore I would dismiss Cobalt’s appeal.
B. Bayer’s
appeal concerning the ’728 Patent (A-385-13)
[80]
In the Federal Court, Bayer applied for a prohibition
order against the ’728 Patent on the ground that Cobalt’s allegation of
non-infringement of Claim 8 was justified. The Federal Court dismissed the
application.
[81]
On appeal, Bayer begins by challenging the
Federal Court’s construction of the ’728 Patent.
(1)
Patent
construction
[82]
The claim at issue on appeal reads as follows:
8. Use according to claim 1, whereby
the estrogen is present in a dose of 20 µg of ethinylestradiol or an equivalent
dose of 17β-estradiol and the gestagen is present in a dose of 75 µg of
gestodene or an equivalent dose of levonorgestrel, cyproterone acetate or drospirenone.
[emphasis added]
[83]
The Federal Court rightly focused its analysis
(at paragraph 109) on “where the shoe pinches,”
a drospirenone dose equivalent of 75 µg of gestodene (at paragraph 134):
[134] I find that there is no certainty
as to what precise dosage would be found to be the drospirenone equivalent of
75µg of gestodene. The most likely answer is that it is 2 mg, an amount that
would suppress ovulation. To find otherwise would require the reader to
scour the literature as of the relevant time, the date of publication, and
either pick the highest number then available, or to attempt to make a reasoned
choice among the numbers available. In neither case does any claim at issue
define “distinctly and in explicit terms the subject matter of the invention”
as required by subsection 27(4) of the Patent Act. [emphasis added]
[84]
This paragraph of the Federal Court’s reasons
leaves the reader in some doubt about what was decided. On the one hand, that
court appears to conclude that claim 8 is ambiguous. On the other, it appears
to find that the drospirenone dose equivalent of 75 µg of gestodene is 2 mg.
These conclusions are difficult to reconcile.
[85]
On appeal, Bayer submits that the Federal Court
did not find that the drospirenone dose equivalent of 75µg of gestodene is 2 mg
because the claim was found to be ambiguous, and that the Federal Court’s
finding of ambiguity was a clear legal error. Additionally, Bayer says that if
the Federal Court did find that the dose equivalent was 2 mg, then that finding
was also a reversible error.
[86]
To deal with this submission, it is necessary to
look closely at the Federal Court’s reasons. I disagree with Bayer’s view that
the Federal Court did not find 2 mg to be the drospirenone equivalent of 75µg
of gestodene. On a fair reading of paragraph 134 of the Federal Court’s
reasons, the reference to 2 mg of drospirenone is a finding. Only two
possibilities were put to the Federal Court, 2 mg and 3 mg and the Federal
Court clearly did not accept 3 mg: Federal Court’s reasons, settling upon 2 mg
as the “likely” dosage: at paragraphs 129-35.
[87]
We should not attach too much significance to
the Federal Court’s use of the word “likely” and
leap to a finding of ambiguity. Where a claim can be construed in a meaningful
way, that construction is to be preferred over finding ambiguity: Mobil Oil
Corp. v. Hercules Canada Inc. (1995), 63 C.P.R. (3d) 473 at pages 483-84,
118 N.R. 382 (Fed. C.A.); Lubrizol Corp. v. Imperial Oil Ltd. (1990), 33
C.P.R. (3d) 1 at page 26, 39 F.T.R. 161 (T.D.), var’d (1992), 45 C.P.R. (3d)
449, 150 N.R. 207 (C.A.); Apotex Inc. v. Wellcome Foundation Ltd.
(1998), 79 C.P.R. (3d) 193 at page 287 (Fed. T.D.), aff’d on this point 10
C.P.R. (4th) 65, 262 N.R. 137 (C.A.), aff’d (S.C.C.), above. The Federal Court
was able to construe the claim in a meaningful way and it arrived at 2 mg as
the dosage, not the other alternative, 3 mg. Its further observations
concerning ambiguity should be regarded as unnecessary.
[88]
I would add that when the Federal Court set out
the issues it had to decide, ambiguity was listed as an issue in relation to
the ’426 Patent only (at paragraph 29). Ambiguity was not raised for the ’728
Patent. This adds force to my view that the Federal Court’s comments about
ambiguity were obiter.
[89]
In short, the Federal Court found that Claim 8
posed a challenging question of construction. The Federal Court came close to
being unable to construe the “drospirenone dose
equivalent of 75µg of gestodene,” but plainly it was able to, and did.
The Federal Court found that the dosage equivalent was 2 mg.
[90]
Adopting the appellate standard of review for
decisions concerning the construction of patents, discussed above, I find no
basis for setting aside the Federal Court’s construction as argued by Bayer.
[91]
Incorporating the “[u]se
according to claim 1” and the Federal Court’s finding on dosage
equivalent of drospirenone, Claim 8 reads:
Use of an oral dosage form comprising an
estrogen… and a gestagen… for contraception for a female of reproductive age
who has not yet reached premenopause, by administration of the form of dosage
for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5
or 4 pill-free or placebo pill days, for a total of 28 days in the
administration cycle, whereby the estrogen is present in a dose of 20 µg of ethinylestradiol
or an equivalent dose of 17β-estradiol and the gestagen is present in a
dose of 2 mg of drospirenone. [emphasis added]
[92]
I begin by examining the ’728 Patent as a whole.
The ’728 Patent describes, on pages 2-6, that reducing hormone dosages is
desirable to minimize undesired side effects:
The development of new oral contraceptives
for females of reproductive age before premenopause was characterized during
the last twenty years above all by the reduction of the estrogen and gestagen
dosages.
The reduction of the daily hormone dose was
connected with the expectation to minimize the frequency of undesired side
effects…
It is assumed that a correlation exists
above all between the level of the estrogen dose and the incidence of
cardiovascular diseases. But the maintenance of the
contraceptive effectiveness stands in the way of an extreme reduction of the
daily estrogen dose. Although the ovulation-inhibiting effect of the
low-dosed oral contraceptives is caused mainly by the gestagenic component,
the estrogenic component also makes a significant contribution to the central
inhibition action and to the ovarian suppression (ovulation inhibition).
Moreover, the daily estrogen dose must not fall below the minimum dose ranges,
so that a satisfactory cycle control can be assured…
The object of this invention is an improved single-phase combination preparation for a female of
reproductive age, who is not yet in premenopause, containing an estrogen and
gestagen in each individual dosage unit, with the lowest possible estrogen
content in each individual dosage unit, but also with a low total hormone
content per administration cycle…
The daily hormone dose is kept to a very
low level here, while the usual 21-day intake is extended by two or three
days… [emphasis added]
[93]
The ’728 Patent does not disclose the dose
equivalent of drospirenone: Federal Court’s reasons at paragraph 127. However,
the purpose of the invention is to minimize the overall hormone dosage, while
maintaining contraceptive efficacy by extending the dosege regimen by a few
days. The particular advantage hoped to be achieved is the reduction in side
effects. While not determinative, the patent also acknowledges the particular
role of the gestagenic component in ovulation suppression.
[94]
Cobalt’s expert pointed out, and the Federal
Court accepted, that the dose equivalent depends on how the activity of the
compound is measured and the intended pharmacological effect/endpoint: Federal
Court’s reasons at paragraph 129.
[95]
For contraception, there are several potential
endpoints, including endometrial transformation (egg implantation inhibition),
ovulation inhibition and clinical usage including a safety margin. The Federal
Court accepted that the skilled reader would understand the relevant endpoint
to be either ovulation inhibition or endometrial transformation: Federal
Court’s reasons at paragraphs 130 and 134. In accordance with the patent’s
direction to minimize hormone dosages, the Federal Court found that 2 mg
drospirenone was the minimum dose to achieve contraception: Federal Court’s
reasons at paragraph 134. I find no ground to interfere with this finding.
[96]
On appeal, Bayer
argued that the Federal Court considered the wrong endpoint, arguing that
clinical use was the correct paradigm. Bayer urged the court to essentially
re-weigh the expert testimony to find that 3 mg was the dosage equivalent.
Absent palpable and overriding error, we cannot interfere with the Federal
Court’s assessment of the expert evidence and its preference for one expert
over another.
[97]
Bayer also urged
this Court to consider a paper by Oelkers, published in 1995, the same year as
the publication of the ’728 Patent (June 29, 1995). Exactly when it was
published in 1995 is unclear. A patent is read by the skilled reader as of its
publication date: Free World Trust, above at paragraph 54. For the Federal
Court to consider the Oelkers paper, Bayer had to establish that it was
published prior to June 29, 1995. Bayer failed to do so and the Federal Court
was correct not to consider it.
[98]
Based on the
foregoing, I am unable to accept any of Bayer’s grounds of appeal regarding the
construction of Claim 8 of the ’728 Patent. The Federal Court was able to
construct the necessary element “drospirenone dose
equivalent of 75µg of gestodene” finding that it
was 2 mg. That finding was not tainted by any reversible error.
(2) Allegation of non-infringement
[99]
In a case such as this, infringement is a
question of mixed fact and law that follows directly from claim construction.
Claim 8 does not claim 3 mg of drospirenone – the amount contained in Cobalt’s
combination oral contraceptive product. The Federal Court made no reviewable
error in concluding that Cobalt’s allegation of non-infringement was justified.
(3) Allegation
of invalidity of the ’728 Patent based on improper subject-matter: method of
medical treatment
[100] Cobalt submitted that Claim 8 of the ’728 Patent was invalid because
it impermissibly claimed a method of medical treatment. In light of my
conclusion that Cobalt’s allegation of non-infringement is justified, I need
not deal with this submission. However, I wish to offer an observation for
future consideration.
[101] The current law in this Court is that methods of medical treatment
are not patentable: Novartis Pharmaceuticals Canada Inc v. Cobalt Pharmaceuticals
Company, 2013 FC 985, 440 F.T.R. 1 at paragraphs 70-101, endorsed by this
Court at 2014 FCA 17, 459 N.R. 17, in very brief reasons based on the
particular arguments made. The provenance of this is Tennessee Eastman Co.
et al. v. Commissioner of Patents, [1974] S.C.R. 111, 33 D.L.R. (3d) 459, a
decision based on former subsection 41(1) of the Patent Act, now
repealed. In his blog, “Sufficient Description,” Professor Norman Siebrasse has
forcefully advanced arguments of policy and logic against the current position.
In my view, this calls for full consideration by this Court or the Supreme
Court in a case where the issue is squarely raised on the facts.
(4) Conclusion on Bayer’s appeal concerning the ’728 Patent (A-385-13)
[102]
As Cobalt’s allegation of non-infringement is
justified, the Federal Court’s dismissal of Bayer’s application for prohibition
must stand.
[103] Therefore, for the foregoing reasons, I would dismiss Bayer’s appeal
with costs.
C. Proposed disposition
[104]
I would dismiss both appeals with costs.
"David Stratas"
“I agree
Wyman W. Webb J.A.”
PELLETIER J.A. (concurring reasons)
[105] I agree with the reasons and conclusions of my colleague, save for
paragraphs 16-24 which are not necessary for the disposition of this appeal.
“J.D. Denis Pelletier”
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