SUPREME
COURT OF CANADA
Citation: AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36
|
Appeal Heard:
November 8, 2016
Judgment
Rendered: June 30, 2017
Docket:
36654
|
Between:
AstraZeneca
Canada Inc., AstraZeneca Aktiebolag and AstraZeneca UK Limited
Appellants
and
Apotex
Inc. and Apotex Pharmachem Inc.
Respondents
-
and -
Innovative
Medicines Canada, BIOTECanada, Centre for Intellectual Property Policy,
Canadian Generic Pharmaceutical Association, Fédération internationale des
conseils en propriété intellectuelle, Intellectual Property Owners Association
and Intellectual Property Institute of Canada
Interveners
Coram: McLachlin C.J. and Abella, Moldaver, Karakatsanis, Wagner,
Gascon, Côté, Brown and Rowe JJ.
Reasons for
Judgment:
(paras. 1 to 64)
|
Rowe J. (McLachlin C.J. and Abella, Moldaver,
Karakatsanis, Wagner, Gascon, Côté and Brown JJ. concurring)
|
Note: This document is subject to editorial revision before its
reproduction in final form in the Canada Supreme Court Reports.
astrazeneca canada inc. v. apotex inc.
AstraZeneca Canada Inc.,
AstraZeneca Aktiebolag and
AstraZeneca UK Limited Appellants
v.
Apotex Inc. and
Apotex Pharmachem Inc. Respondents
and
Innovative Medicines Canada,
BIOTECanada,
Centre for Intellectual Property Policy,
Canadian Generic Pharmaceutical
Association,
Fédération internationale des conseils
en propriété intellectuelle,
Intellectual Property Owners Association
and
Intellectual Property
Institute of Canada Interveners
Indexed as: AstraZeneca Canada
Inc. v. Apotex Inc.
2017 SCC 36
File No.: 36654.
2016: November 8; 2017: June 30.
Present: McLachlin C.J. and Abella, Moldaver, Karakatsanis,
Wagner, Gascon, Côté, Brown and Rowe JJ.
on appeal from the federal court of appeal
Intellectual property — Patents — Medicines —
Validity — Pharmaceutical patent invalidated for want of utility on basis of
promise of patent doctrine — Whether doctrine is correct approach to determine
whether invention has sufficient utility under s. 2 of Patent Act —
Whether drug for which pharmaceutical patent was granted is “useful” within
meaning of s. 2 of Patent Act at filing date — Patent Act, R.S.C. 1985, c. P‑4,
s. 2 “invention”.
AstraZeneca
applied for the 2,139,653 patent (“the ‘653 patent”) which claimed the optically pure salts of esomeprazole, a proton
pump inhibitor used in the reduction of gastric acid, reflux esophagitis and related
maladies. Apotex applied to the federal Minister of Health for a Notice of
Compliance, allowing it to sell its generic version of the drug. AstraZeneca’s
application to prohibit the Minister from issuing a Notice of Compliance to
Apotex was dismissed, allowing Apotex to bring its generic drug to the market.
AstraZeneca brought an action against Apotex for patent infringement, and
Apotex counter‑claimed to have the ‘653 patent impeached. The Federal
Court held that the ‘653 patent was invalid for lack of utility because,
applying the promise of the patent doctrine (“Promise Doctrine”), it promised
more than it could provide. The Federal Court of Appeal upheld this decision. AstraZeneca
appeals, arguing its patent was improperly invalidated on the basis of the
Promise Doctrine.
Held: The appeal should be allowed.
The Promise Doctrine is not the correct method of determining whether
the utility requirement under s. 2 of the Patent Act is met. This doctrine holds that if a patentee’s patent application promises
a specific utility, only if that promise is fulfilled, can the invention have
the requisite utility, but where no specific utility is promised, a mere
scintilla of utility will suffice. Generally, an analysis regarding issues of
validity will focus on the claims alone, and only considers the disclosure
where there is ambiguity in the claims. This is in accordance with the
Court’s direction that claims construction precedes all considerations of
validity. The Promise Doctrine, by contrast, directs courts to make
determinations regarding utility by reading both the claims and the disclosure
to identify potential promises, even in an absence of ambiguity in the claims.
The Promise Doctrine then provides that if any one of the promises is not
fulfilled, the utility requirement in s. 2 is not met and the patent, in
its entirety, is invalid.
The
Promise Doctrine is incongruent with both the words and the scheme of the Patent
Act . First, it conflates ss. 2 and 27(3) , by requiring that to satisfy
the utility requirement in s. 2 , any use disclosed in accordance with s. 27(3)
must be demonstrated or soundly predicted at the time of filing. If that is not
done successfully, the entire patent is invalid, as the pre‑condition for
patentability — an invention under the s. 2 of the Act — has not been
fulfilled. Second, to require all multiple uses be met for the patent’s
validity to be upheld, runs counter to the words of the Act and has the potential
for unfair consequences. The Promise Doctrine risks, as was the case here, for
an otherwise useful invention to be deprived of patent protection because not
every promised use was sufficiently demonstrated or soundly predicted by the
filing date. Such a consequence is antagonistic to the bargain on which patent
law is based wherein we ask inventors to give fulsome disclosure in exchange
for a limited monopoly.
The
words in s. 2 of the Act ground the type of utility that is pertinent by
requiring that it is the subject‑matter of an invention or improvement
thereof that must be useful. To determine whether a patent discloses an
invention with sufficient utility under s. 2 , courts must first identify
the subject‑matter of the invention. Second, courts must then ask whether
that subject‑matter is useful, that is, whether it is capable of a
practical purpose. The Act does not prescribe the degree of
usefulness required, or that every potential use be realized. Therefore, a
single use related to the nature of the subject‑matter is sufficient, and
that utility must be established by either demonstration or sound prediction as
of the filing date. Even though utility of the subject‑matter is a
requirement of patent validity, a patentee is not required to disclose the
utility of the invention to fulfill the requirements of s. 2 .
In
the present case, the subject matter of the ‘653 patent that must be useful for
the purposes of s. 2 is the optically pure salts of the enantiomer of
omeprazole. It was soundly predicted by the relevant date that the drug for
which the ‘653 patent was granted would be useful as a proton pump inhibitor to
reduce production of gastric acid. Such use is appropriately related to the
subject‑matter of the ‘653 patent and makes it useful within the meaning
of s. 2 . The ‘653 patent is therefore not invalid for want of utility.
Cases Cited
Applied:
Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504;
referred to: Apotex Inc. v. Sanofi‑Synthelabo Canada Inc.,
2008 SCC 61, [2008] 3 S.C.R. 265; Eli Lilly and Co. v. Canada,
I.C.S.I.D. Case No. UNCT/14/2, March 16, 2017; Apotex Inc. v. Wellcome
Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153; Teva Canada Ltd. v.
Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625; Pfizer Canada Inc.
v. Mylan Pharmaceuticals ULC, 2011 FC 547, 304 F.T.R. 1; Eli Lilly
Canada Inc. v. Novopharm Ltd., 2010 FCA 197, [2012] 1 F.C.R. 349; Free
World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024; Whirlpool
Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067; Bristol‑Myers
Squibb Co. v. Apotex Inc., 2005 FC 1348, 45 C.P.R. (4th) 423; Laboratoires
Servier v. Apotex Inc., 2009 FCA 222, 392 N.R. 96; Sanofi‑Aventis
Canada Inc. v. Apotex Inc., 2009 FC 676, 350 F.T.R. 165; AstraZeneca
Canada Inc. v. Mylan Pharmaceuticals ULC, 2012 FCA 109, 432 N.R. 292; Hatmaker
v. Joseph Nathan & Co. (1919), 36 R.P.C. 231; Alsop’s Patent (Re)
(1907), 24 R.P.C. 733; Bloxam v. Elsee (1827), 6 B. & C. 169, 108
E.R. 415; Pioneer Hi‑Bred Ltd. v. Canada (Commissioner of Patents),
[1989] 1 S.C.R. 1623; British United Shoe Machinery Co. v. A. Fussell &
Sons Ltd. (1908), 25 R.P.C. 631; Re Application of Abitibi Co.
(1982), 62 C.P.R. (2d) 81.
Statutes and Regulations Cited
Patent Act, R.S.C. 1985, c. P‑4,
s. 2 “invention”, 27(1), (2), (3), (4), (5), 53, 58.
Patented Medicines (Notice of Compliance) Regulations, SOR/93‑133.
Authors Cited
Fox, Harold G. The Canadian Law and Practice Relating to
Letters Patent for Inventions, 4th ed. Toronto: Carswell, 1969.
Siebrasse, Norman. “The False Doctrine of False Promise” (2013), 29 C.I.P.R.
3.
Vaver, David. Intellectual Property Law: Copyright, Patents,
Trade‑marks, 2nd ed. Toronto: Irwin Law, 2011.
APPEAL
from a judgment of the Federal Court of Appeal (Dawson, Ryer and
Webb JJ.A.), 2015 FCA 158, 474 N.R. 296, 138 C.P.R. (4th) 1, [2015] F.C.J.
No. 802 (QL), 2015 CarswellNat 2431 (WL Can.), affirming a decision of
Rennie J., 2014 FC 638, 457 F.T.R. 227, 129 C.P.R. (4th) 1, [2014] F.C.J. No. 671
(QL), 2014 CarswellNat 2268 (WL Can.). Appeal allowed.
Gunars A. Gaikis, Yoon Kang and Y. Lynn Ing, for the appellants.
Harry B. Radomski, Andrew R. Brodkin, Richard Naiberg and Sandon Shogilev, for the respondents.
Patrick E. Kierans and Kristin Wall, for the interveners Innovative
Medicines Canada and BIOTECanada.
Jeremy de Beer and E. Richard
Gold, for
the intervener the Centre for Intellectual Property Policy.
Jonathan Stainsby and Scott A.
Beeser, for
the intervener the Canadian Generic Pharmaceutical Association.
Julie Desrosiers, Kang Lee and Alain M. Leclerc, for the intervener Fédération
internationale des conseils en propriété intellectuelle.
Andrew Bernstein and Yael S.
Bienenstock,
for the intervener the Intellectual Property Owners Association.
Jason Markwell, for the intervener the Intellectual Property Institute of Canada.
The judgment of the Court was delivered by
Rowe J. —
I.
Introduction
[1]
In the context of infringement/impeachment
proceedings in the lower courts, this appeal involves a challenge to the
validity of the appellants’ (“AstraZeneca”) 2,139,653 patent (the ‘653 patent)
for want of utility.
[2]
The main issue in this appeal is whether
AstraZeneca’s patent is invalid for want of utility under s. 2 of the Patent
Act, R.S.C. 1985, c. P-4 , on the basis of the “promise of the patent”
doctrine (“Promise Doctrine”). Unquestionably, a patent is invalid if it lacks
utility. However, for the reasons that follow, I conclude the application of
the Promise Doctrine is not the correct approach to determine whether a patent
has sufficient utility. Had the trial judge not applied this doctrine, he would
have been compelled to find that the ‘653 patent had sufficient utility, and
upheld its validity. Accordingly, I would set aside the decisions of the
Federal Court and the Federal Court of Appeal which held that the ‘653 patent
was invalid for want of utility.
II.
Facts
[3]
In 1994, AstraZeneca applied for the ‘653 patent
which claimed the optically pure salts of the (-) enantiomer of omeprazole,
esomeprazole (the “drug”). Esomeprazole is a proton pump inhibitor (“PPI”) used
in the reduction of gastric acid, reflux esophagitis and related maladies. This
means that it is a compound that acts by blocking acid producing pumps within
cells to reduce the amount of acid in the stomach. Commercialized under the
name NEXIUM, it has been a very successful drug for AstraZeneca.
[4]
The respondents (“Apotex”), seeking to sell a
generic version of the drug, applied to the Minister of Health for a Notice of
Compliance allowing it do so. AstraZeneca, in response, brought an application
for prohibition under the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133, to prohibit the Minister from issuing a Notice of
Compliance to Apotex. On June 30, 2010, Justice Hughes dismissed the
application for prohibition (2010 FC 714, 88 C.P.R. (4th) 28).
[5]
Apotex subsequently began to sell its generic
version of the drug. AstraZeneca brought an action against Apotex for patent
infringement, and Apotex counter-claimed to have the ‘653 patent impeached
(i.e. declared invalid).
[6]
The Federal Court judge found that although the
‘653 patent was novel and non-obvious, it was invalid because it lacked
utility. In so doing, he accepted that it was useful for certain purposes, but
declared the patent invalid because, applying the Promise Doctrine, it
“promised more than it could provide”. On appeal, AstraZeneca argued the
Federal Court erred by relying on the Promise Doctrine to invalidate the
patent. The Federal Court of Appeal dismissed the appeal. AstraZeneca then
appealed to this Court arguing that the Promise Doctrine is unsound.
III.
Judicial History
A.
Federal Court, 2014 FC 638, 129 C.P.R. (4th) 1
(Rennie J.)
[7]
Justice Rennie dismissed AstraZeneca’s action for infringement
and granted Apotex’s counter-claim for a declaration of invalidity. He held
that: “The ‘653 patent, though it was novel and non-obvious, is invalid because
it lacks utility.” (para. 367).
[8]
Justice Rennie’s utility analysis was premised
on two propositions. First, “an alleged patent satisfies the requirement of
utility if, from the perspective of the skilled person as of the filing date
(May 27, 1994), its utility is demonstrated, or in the alternative, if
its utility is soundly predicted” (para. 83 (emphasis in original)).
Second, central to his utility analysis was the doctrine of the “promise of the
patent”, which Rennie J. termed “the yardstick against which utility is
measured” (para. 86).
[9]
Applying this doctrine, Justice Rennie
ultimately identified two promises of utility in the ‘653 patent: (1) use as a
PPI; and (2) improved pharmacokinetic and metabolic properties which would give
an improved therapeutic profile such as a lower degree of interindividual
variation. In other words, the drug would (1) reduce the amount of acid in the
stomach; and (2) work more effectively for a wider range of persons, having
less variation in patient response. The fulfilment of the first promise was not
in dispute; it was soundly predicted that the drug did act as a PPI to reduce
acid in the stomach. However, he found that the second promise was neither
demonstrated nor soundly predicted at the filing date.
[10]
Applying the Promise Doctrine, he declared the
entire patent to be invalid on the basis that the utility requirement for an
“invention” under s. 2 of the Patent Act was not met, notwithstanding
that on his findings the patent fulfilled one of the two promises of utility
that he had identified.
[11]
Justice Rennie’s reasons also dealt with other
requirements of validity. He applied the tests for anticipation and obviousness
as set out by this Court in Apotex Inc. v. Sanofi-Synthelabo Canada Inc.,
2008 SCC 61, [2008] 3 S.C.R. 265, and found that the ‘653 patent was both
novel and not obvious. Neither novelty nor non-obviousness, however, is in
issue before this Court. Rather, the only issue in this appeal relates to the
utility requirement in the definition of an invention under s. 2 of the Act.
B.
Federal Court of Appeal, 2015 FCA 158, 138 C.
P.R. (4th) 1 (Dawson, Ryer and Webb JJ.A.)
[12]
Dawson J.A., writing for the Federal Court of
Appeal, dismissed AstraZeneca’s appeal. Essentially, she adopted Justice
Rennie’s analysis, which affirmed both the status and application of the
Promise Doctrine.
[13]
Dawson J.A. found that the Federal Court did not
err in the following ways.
[14]
First, the Federal Court did not err in applying
the Promise Doctrine by construing the promises across the patent. She wrote:
“It is also now settled law that some promises can be construed to impose
utility requirements across each of a patent’s claims, while other promises may
touch only a subset of the claims” (para. 5).
[15]
Second, the Federal Court did not err in
construing the utility of the claims. Dawson J.A. wrote: “The Court’s reasons
show that the Federal Court directed itself to the correct legal tests
applicable to claims construction, inventive concept and utility” (para. 11).
[16]
Third, the Federal Court did not err in its
approach to construing a promise in the patent: “The Federal Court’s
construction of the promise was reached reading the patent as a whole through
the eyes of the skilled reader. . . . [T]he Federal Court did not err in law by
applying too low a threshold in order to establish a promise” (para. 13).
[17]
Dawson J.A., thus, upheld the Federal Court’s
decision based on the Promise Doctrine. She further stated “it is unnecessary
to consider the assertions advanced by Apotex that the Federal Court erred in
failing to find the patent to be both obvious and anticipated” (para. 15).
IV.
Positions of the Parties
[18]
AstraZeneca appeals to this Court arguing its
patent was improperly invalidated on the basis of the Promise Doctrine. It
argues the “law of patents is wholly statutory” (A.F., at para. 2), and that
the Promise Doctrine is an extra-statutory requirement of utility with no basis
in law. It maintains that the Promise Doctrine has no foundation in either the Patent
Act or the patent jurisprudence of this Court.
[19]
Apotex bases its argument on the correctness of
the Promise Doctrine and its application in this case. Apotex says that the law
of utility under the Patent Act requires a patentee’s invention do what
the patent says it will do. The Promise Doctrine merely requires a patentee to
be held to what is disclosed in the patent. Applying the Promise Doctrine,
AstraZeneca’s patent specification contained one promise that was neither
demonstrated nor soundly predicted at the time it was filed and, therefore, the
‘653 patent, in its entirety, was properly declared to be invalid.
[20]
This Court also heard from several interveners
regarding the Promise Doctrine.
[21]
Five interveners argued against the Promise
Doctrine. Fédération internationale des conseils en propriété intellectuelle
highlighted that the Promise Doctrine puts Canada’s patent law out of step with
international standards; the utility standard should reflect a low threshold
that would be in accordance with Canada’s international obligations under NAFTA
(North American Free Trade Agreement) and TRIPS (Trade-Related Aspects of
Intellectual Property Rights) agreement.[1] Innovative Medicines Canada and BIOTECanada likewise stressed that
the Promise Doctrine was a departure from Canada’s international obligations.
The Intellectual Property Owners Association argued that the Promise Doctrine
encourages inventors to disclose less, which is inconsistent with the
objectives of the Patent Act . The Intellectual Property Institute of
Canada emphasised that the Promise Doctrine does not appear in the Act and its
application leads to inconsistent results that could be avoided if utility were
assessed having regard to the subject-matter of a claim.
[22]
Two interveners argued in support of the
Promise Doctrine. The Canadian Generic Pharmaceutical Association argued that
the Promise Doctrine is not a new trend, but simply requires a patent to do
what it says it will do. As well, changes to patent law to harmonize Canadian
law with that of other major jurisdictions should be left to Parliament. The
Centre for Intellectual Property Policy said that it is the specification as a
whole and not just the claims that are important to determine the utility of an
invention as the uses disclosed to fulfill the requirements under s. 27(3) of
the Patent Act are related to the utility requirement under s. 2
(further discussed below).
V.
Issues
[23]
There are two issues. First,
is the Promise Doctrine the correct approach for the
requirement in s. 2 of the Act that an “invention” be “useful”? Second,
was the drug for which the ‘653 patent was granted
“useful” within the meaning of s. 2 of the Act at the filing date?
[24]
I conclude that the Promise Doctrine is not the
correct method of determining whether the utility requirement under s. 2 of the
Patent Act is met. Given the correct approach, as set out below, the
drug for which the ‘653 patent was granted is useful as a PPI; thus, it is an
“invention” under s. 2 of the Act. The ‘653 patent is therefore not invalid for
want of utility.
VI.
Relevant Legislation Provisions
[25]
The following statutory provisions of the Patent
Act are relevant in this appeal:
2 In this Act, except as otherwise provided
. . .
invention means
any new and useful art, process, machine, manufacture or composition of matter,
or any new and useful improvement in any art, process, machine, manufacture or
composition of matter;
Commissioner may grant patents
27 (1) The Commissioner shall
grant a patent for an invention to the inventor or the inventor’s legal
representative if an application for the patent in Canada is filed in
accordance with this Act and all other requirements for the issuance of a patent
under this Act are met.
Application requirements
(2) The prescribed application fee must be paid and the application
must be filed in accordance with the regulations by the inventor or the
inventor’s legal representative and the application must contain a petition and
a specification of the invention.
Specification
(3) The specification of an invention must
(a) correctly
and fully describe the invention and its operation or use as contemplated by
the inventor;
(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;
(c) in the case
of a machine, explain the principle of the machine and the best mode in which
the inventor has contemplated the application of that principle; and
(d) in the case
of a process, explain the necessary sequence, if any, of the various steps, so
as to distinguish the invention from other inventions.
Claims
(4) The specification must end with a claim or claims defining
distinctly and in explicit terms the subject-matter of the invention for which
an exclusive privilege or property is claimed.
Alternative definition of
subject-matter
(5) For greater certainty, where a claim defines the subject-matter
of an invention in the alternative, each alternative is a separate claim for
the purposes of sections 2 , 28.1 to 28.3 and 78.3 .
Void in certain cases, or
valid only for parts
53 (1) A patent is void if any
material allegation in the petition of the applicant in respect of the patent
is untrue, or if the specification and drawings contain more or less than is
necessary for obtaining the end for which they purport to be made, and the
omission or addition is wilfully made for the purpose of misleading.
Invalid claims not to affect
valid claims
58 When,
in any action or proceeding respecting a patent that contains two or more
claims, one or more of those claims is or are held to be valid but another or
others is or are held to be invalid or void, effect shall be given to the
patent as if it contained only the valid claim or claims.
VII.
Analysis
A.
Issue #1: Is the Promise Doctrine the Correct
Standard of Utility Under the Patent Act ?
[26]
Section 2 of the Patent Act is the source
of the utility requirement; it defines an invention as a “new and useful art,
process, machine, manufacture or composition of matter” or a new and useful
improvement thereof. The utility requirement is a necessary pre-condition to
patentability (Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981]
1 S.C.R. 504, at p. 527) “If it is not useful, it is not an invention
within the meaning of the Act” (Apotex Inc. v. Wellcome Foundation Ltd.,
2002 SCC 77, [2002] 4 S.C.R. 153 (“AZT”), at para. 51). In order for a
patent to be valid, the invention it purports to protect must be useful (Teva
Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625, at
para. 37).
[27]
It is the utility requirement that is at the
core of this appeal.
(1)
The Promise Doctrine
[28]
Requiring that a patent have utility begs the
question “useful for what?” (trial judgment, at para. 86). The Federal Courts
have answered that question with the “promise of the patent” (Pfizer Canada
Inc. v. Mylan Pharmaceuticals ULC, 2011 FC 547, 394 F.T.R. 1). The Promise
Doctrine, as developed by the Federal Courts’ jurisprudence, holds that if a
patentee’s patent application promises a specific utility, only if that
promise is fulfilled, can the invention have the requisite utility — “the
promise of the patent is the yardstick against which utility is measured”
(trial judgement, at para. 86).
[29]
The Promise Doctrine has been articulated by the
Federal Court of Appeal as follows:
Where the specification
does not promise a specific result, no particular level of utility is
required; a “mere scintilla” of utility will suffice. However, where the
specification sets out an explicit “promise”, utility will be measured against
that promise: Consolboard; Pfizer Canada Inc. v. Canada (Minister
of Health), 2008
FCA 108, [2009] 1 F.C.R. 253 (Ranbaxy). The question is
whether the invention does what the patent promises it will do. [Emphasis
added.]
(Eli Lilly Canada Inc. v.
Novopharm Ltd., 2010 FCA 197, [2012] 1 F.C.R. 349, at para. 76)
[30]
Applying the promise of the patent doctrine, as
the name suggests, involves identifying “promises” by considering the “patent
as a whole” (Eli Lilly, at para. 80):
The promise of the patent must be
ascertained. Like claims construction, the promise of the patent is a question
of law. Generally, it is an exercise that requires the assistance of expert
evidence: Bristol-Meyers Squibb Co. v. Apotex Inc., 2007 FCA 379,
at paragraph 27. This is because the promise should be properly defined, within
the context of the patent as a whole, through the eyes of the POSITA [person of
ordinary skill in the art], in relation to the science and information
available at the time of filing.
[31]
That is, the promise doctrine requires the
identification of promises based on a review of the entire specification, i.e.
both the claims and the disclosure. Generally, an analysis regarding issues
of validity, such as novelty or non-obviousness, focuses on the claims alone,
and only considers the disclosure where there is ambiguity in the claims (Sanofi-Synthelabo).
This is in accordance with this Court’s direction that claims construction
precedes all considerations of validity: Free World Trust v. Électro Santé
Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024, at paras. 33-50; Whirlpool
Corp. v. Camco Inc., 2000 SCC 67, [2000] 2 S.C.R. 1067, at paras. 42-43.
The Promise Doctrine, by contrast, directs courts to read both the claims and
the disclosure to identify potential promises, rather than the claims alone,
even in an absence of ambiguity in the claims. After a process of identifying
promises, the doctrine equates the fulfillment of these promises (by demonstration
or sound prediction) with the requirement in s. 2 that an invention be useful.
The doctrine then goes on to provide that if any one of the promises is not
fulfilled, then the utility requirement in s. 2 is not met and the patent, in
its entirety, is invalid.
[32]
In recent years, the Federal Courts have applied
this doctrine to determine whether a patent has sufficient utility in several
cases: see Bristol-Myers Squibb Co. v. Apotex Inc., 2005 FC 1348,
45 C.P.R. (4th) 423; Laboratoires Servier v. Apotex Inc., 2009 FCA 222,
392 N.R. 96; Sanofi-Aventis Canada Inc. v. Apotex Inc., 2009 FC 676, 350
F.T.R. 165; Eli
Lilly; AstraZeneca Canada Inc. v. Mylan
Pharmaceuticals, 2012 FCA 109, 432 N.R. 292.
[33]
While the Promise Doctrine, in its current
formulation, has been said to be “uniquely Canadian”, it has its roots in
English law (N. Siebrasse, “The False Doctrine of False Promise” (2013),
29 C.I.P.R. 3).
[34]
The Doctrine can be traced back to the early
20th century in the United Kingdom, specifically in Hatmaker v. Joseph
Nathan & Co. (1919), 36 R.P.C. 231 (H.L.), and Alsop’s Patent Re
(1907), 24 R.P.C. 733 (Ch.). The doctrine in England was referred to as the
“False Promise Doctrine”. It was premised on the nature of patents at that time
— a grant from the Crown as an exercise of the Royal prerogative. It was argued
that where the Crown had been deceived in the grant, an objection could be
made. As explained by Norman Siebrasse:
. . . the false promise doctrine
is based on the view that the grant of a patent is a discretionary decision and
the consideration for the grant is the entirety of the representations made by
the applicant in its petition to the Crown. Consequently, it is not for the
courts to second-guess the Crown and presume to decide that the Crown would have
granted the patent on the basis of some lesser consideration, simply because
the court would have upheld the same patent on that lesser basis. [p. 17]
[35]
Thus, the origin and justification of the
promise doctrine in English law was the “unwillingness of the courts to
second-guess the Crown in the exercise of its discretion” (Siebrasse, at p. 17;
Bloxam v. Elsee (1827), 6 B. & C. 169, 108 E.R. 415 (K.B.)). While
the False Promise Doctrine is now extinct in the English law, it has found a
new home in the Federal Courts’ jurisprudence as the “promise of the patent”
doctrine.
[36]
This doctrine, however, is unsound. It is an
interpretation of the utility requirement that is incongruent with both the
words and the scheme of the Patent Act .
[37]
The Promise Doctrine is excessively onerous in
two ways: (1) it determines the standard of utility that is required of a
patent by reference to the promises expressed in the patent; and (2) where
there are multiple expressed promises of utility, it requires that all be
fulfilled for a patent to be valid.
(a)
Expressed Promises
[38]
First, the Promise Doctrine runs counter to the
scheme of the Act by conflating ss. 2 and 27(3) — the very confusion
this Court sought to clarify in Consolboard, as
described below.
[39]
The Act sets out a scheme to ensure that
an “inventor is granted exclusive rights in a new and useful invention for a
limited period in exchange for disclosure of the invention so that society can
benefit from this knowledge” (Teva, at para. 32). Thus, the patent
regime has a dual purpose — to incentivise the creation of inventions and to
encourage inventors to publicly disclose the knowledge regarding these
inventions for society’s benefit.
[40]
The Act defines what may receive
the protection of a patent. For a creation to be an invention under the
Act, s. 2 mandates that the art, process, machine, manufacture or composition
of matter (i.e. the subject-matter) be useful. The subject-matter of an
invention is defined by the claims, in accordance with s. 27(4). The claims set
out the scope of the monopoly granted under the patent and allows others “to
ascertain with some measure of exactness the boundaries of the exclusive
privilege upon which they may not trespass during the exercise of the grant” (Pioneer
Hi-Bred Ltd. v. Canada (Commissioner of Patents), [1989] 1 S.C.R.
1623, at p. 1636, quoting H. J. Fox, Canadian Patent Law and Practice
(4th ed. 1969), at p.163).
[41]
Once an inventor seeks
to patent something that qualifies as an invention under s. 2, this invention
must be properly disclosed in accordance with the Act.
[42]
Section 27(3) of the Act provides
that in the specification, a “patentee must describe the invention ‘with
sufficiently complete and accurate details as will enable a workman, skilled in
the art to which the invention relates, to construct or use that invention when
the period of the monopoly has expired’” (Whirlpool, at para.
42, quoting Consolboard, at p. 517).
[43]
There is a difference between the requirement in
s. 2 that an invention be “useful” and the requirement to disclose an
invention’s “operation or use” as per s. 27(3) . As explained by Dickson J. (as
he then was) in Consolboard, the former is a “condition precedent to an
invention” and the latter a “disclosure requirement, independent of the first”:
. . . the Federal Court
of Appeal erred also in holding that s. 36(1) [now s. 27(3) and (4) ] requires
distinct indication of the real utility of the invention in question. There is
a helpful discussion in Halsbury’s Laws of England (3rd ed.), vol. 29,
at p. 59, on the meaning of “not useful” in patent law. It means “that the
invention will not work, either in the sense that it will not operate at all
or, more broadly, that it will not do what the specification promises that it
will do”. There is no suggestion here that the invention will not give the
result promised. . . .
. . .
. . . the Federal Court
of Appeal has confused the requirement of s. 2 of the Patent Act
defining an invention as new and “useful”, with the requirement of s. 36(1)
[now s. 27(3) ] of the Patent Act that the specification disclose the
“use” to which the inventor conceived the invention could be put. The first is
a condition precedent to an invention, and the second is a disclosure
requirement, independent of the first. [Emphasis added.]
(Consolboard, at pp. 525
and 527)
While the above passage
uses the word “promise” it does not refer to, nor does it embody, the Promise
Doctrine.
[44]
The Promise Doctrine effectively imports s.
27(3) into s. 2 inappropriately, by requiring that to satisfy the utility
requirement in s. 2 , any disclosed use (by virtue of s. 27(3) ) be demonstrated
or soundly predicted at the time of filing. If that is not done successfully,
the entire patent is invalid, as the pre-condition for patentability — an
invention under s. 2 of the Act — has not been fulfilled.
[45]
Supporters of the doctrine assert that the
consequences of the Promise Doctrine play a key role in ensuring patentees do
not “overpromise” in their patent applications. That is, a patentee will be
dissuaded from stating the invention can be used for things that are not
sufficiently established at the time of filing if doing so would risk
invalidating the entire patent. The utility requirement should not be
interpreted, however, as the Federal Courts have done, to address such
concerns. Nonetheless, overpromising is a mischief.
[46]
The scheme of the Act treats the mischief
of overpromising in multiple ways. There are consequences for failing to
properly disclose an invention by claiming, for instance, that you have
invented more than you have. A disclosure which is not correct and full, or
states an unsubstantiated use or operation of the invention, may be found to
fail to fulfill the requirements of s. 27(3) . An overly broad claim may be
declared invalid; however, under the operation of s. 58 of the Patent Act ,
remaining valid claims can be given effect. As well, this mischief may result in
a patent being void under s. 53 of the Act, where overpromising in a
specification amounts to an omission or addition that is “willfully made for
the purpose of misleading”.
(b)
Multiple Uses
[47]
Second, the Promise Doctrine runs counter to the
words of the Act by requiring that where multiple promised uses are
expressed, they all must be satisfied for the patent to meet the utility
requirement in s. 2 .
[48]
Section 2 of the Act requires a “useful”
subject-matter; a single use makes a subject-matter useful.
[49]
The subject-matter of an invention can be
multi-faceted, such that a single subject-matter can be described in many ways.
As explained by David Vaver:
For simplicity’s sake,
the rule is “one invention, one application, one patent.” But inventions are
like a many-faceted prism: multiple claims (sometimes running into the
hundreds) covering all facets are allowed in the same patent if a “single
general inventive concept” links them.
(D. Vaver, Intellectual
Property Law, (2nd ed. 2011), at p. 275)
Yet, ultimately, every
invention pertains to a single subject-matter, and any single use of that
subject-matter that is demonstrated or soundly predicted by the filing date is
sufficient to make an invention useful for the purposes of s. 2 .
[50]
To require all multiple uses be met for the
patent’s validity to be upheld, has the potential for unfair consequences. The
Promise Doctrine risks, as was the case here, for an otherwise useful invention
to be deprived of patent protection because not every promised use was
sufficiently demonstrated or soundly predicted by the filing date.
[51]
The effect of the Promise Doctrine to deprive
such an invention of patent protection if even one “promised” use is not
soundly predicted or demonstrated is punitive and has no basis in the Act. Furthermore,
such a consequence is antagonistic to the bargain on which patent law is based
wherein we ask inventors to give fulsome disclosure in exchange for a limited
monopoly (British United Shoe Machinery Co. v. A. Fussell & Sons
Ltd. (1908), 25 R.P.C. 631(C.A.), at p. 650). To invalidate a patent solely
on the basis of an unintentional overstatement of even a single use will
discourage a patentee from disclosing fully, whereas such disclosure is to the
advantage of the public. The Promise Doctrine in its operation is inconsistent
with the purpose of s. 27(3) of the Act which calls on an inventor to
“fully describe the invention and its operation or use”. Thus, the Promise
Doctrine undermines a key part of the scheme of the Act; it is not good law.
(2)
The Correct Approach to Utility
[52]
The words in s. 2 of the Act ground the type of utility
that is pertinent by requiring that it is the subject-matter of an
invention or improvement thereof that must be useful. For the subject-matter to
function as an inventive solution to a practical problem, the invention must be
capable of an actual relevant use and not be devoid of utility. As
stated by Justice Binnie in AZT, a patent “is a
method by which inventive solutions to practical problems are coaxed
into the public domain by the promise of a limited monopoly for a limited time”
(para. 37, (emphasis added)).
[53]
Utility will differ based on the subject-matter of the invention as
identified by claims construction. Thus, the scope of potentially acceptable
uses to meet the s. 2 requirement is limited – not any use will do. By
requiring the usefulness of the proposed invention to be related to the nature
of the subject-matter, a proposed invention cannot be saved by an entirely
unrelated use. It is not sufficient for a patentee seeking a patent for a
machine to assert it is useful as a paperweight.
[54]
To determine whether a patent discloses an invention
with sufficient utility under s. 2 , courts should undertake the following
analysis. First, courts must identify the subject-matter of the invention as
claimed in the patent. Second, courts must ask whether that subject-matter is
useful — is it capable of a practical purpose (i.e. an actual result)?
[55]
The Act does not prescribe the degree or quantum of usefulness
required, or that every potential use be realized — a scintilla of utility will
do. A single use related to the nature of the subject-matter is sufficient, and
the utility must be established by either demonstration or sound prediction as
of the filing date (AZT, at para. 56).
[56]
The utility requirement serves a clear purpose. To avoid granting
patents prematurely, and thereby limiting potentially useful research and
development by others, the case law has imposed a requirement that an
invention’s usefulness be demonstrated or soundly predicted at the time of
application, rather than at some later point. This ensures patents are not
granted where the use of the invention is speculative. What matters is that an invention “be useful, in the sense that it
carries out some useful known objective” and is not merely a “laboratory curiosity whose only possible claim to
utility is as a starting material for further research” (Re
Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81, (Patent Appeal Board and Commissioner of Patents), at
p. 91).
[57]
The application of the utility requirement in s. 2 , therefore, is to be
interpreted in line with its purpose — to prevent the patenting of fanciful,
speculative or inoperable inventions.
[58]
Even though utility of the subject-matter is a requirement of
patent validity, a patentee is not required to disclose the utility of the
invention to fulfill the requirements of s. 2 . As was stated by Dickson J. in Consolboard:
. . . I do not read the concluding
words of s. 36(1) [now s. 27(4)] as obligating the inventor in his disclosure
or claims to describe in what respect the invention is new or in what way it is
useful. He must say what it is he claims to have invented. [p. 526]
See also Teva, at
para. 40.
B.
Issue #2: Was the Drug for Which
Patent ‘653 Was Granted “Useful” Within the Meaning of Section 2 of the Act?
[59]
The second issue in this appeal is whether
AstraZeneca’s ‘653 patent is valid, or whether it is invalid for want of
utility as found by Justice Rennie, applying the Promise Doctrine. As the Promise
Doctrine is unsound, Justice Rennie’s analysis must be re-visited.
[60]
Justice Rennie identified the subject-matter of
the ‘653 patent:
. . . the subject matter of the
‘653 patent was optically pure salts of the enantiomers of omeprazole,
described as novel compounds, having improved pharmacokinetic and metabolic
properties and high stability to racemization in neutral and basic pH, a method
to make them, and therapeutic uses. [Emphasis in original; para. 93.]
[61]
The subject-matter of the patent that must be
useful for the purposes of s. 2 is the “optically pure salts of the enantiomer
of omeprazole”.
[62]
Justice Rennie accepted that it was soundly
predicted by the relevant date that the optically pure salts of the enantiomer
of omeprazole would be useful as a PPI to reduce production of gastric acid.
Use as a PPI is appropriately related to the subject-matter of the ‘653 patent
and makes it useful within the meaning of s. 2 .
[63]
Justice Rennie found that the ‘653 patent failed
for lack of utility because it promised more than it could provide. Yet,
promises are not the yardstick against which utility is to be measured. Justice
Rennie found that the subject-matter described by AstraZeneca’s patent was
soundly predicted to be useful as a PPI. This is sufficient utility to satisfy
the requirements of s. 2 .
VIII. Relief
[64]
The appeal is allowed. The ‘653 patent is not
invalid for want of utility. AstraZeneca will have its costs in this Court and
the courts below.
Appeal
allowed with costs throughout.
Solicitors
for the appellants: Smart & Biggar, Toronto.
Solicitors
for the respondents: Goodmans, Toronto.
Solicitors
for the interveners Innovative Medicines Canada and BIOTECanada: Norton
Rose Fulbright Canada, Toronto.
Solicitor
for the intervener the Centre for Intellectual Property Policy: McGill
University, Montréal.
Solicitors
for the intervener the Canadian Generic Pharmaceutical Association: Aitken
Klee, Toronto.
Solicitors for the intervener Fédération internationale des conseils
en propriété intellectuelle: Fasken Martineau, Montréal; Goudreau Gage
Dubuc, Montréal.
Solicitors for the intervener the Intellectual Property Owners
Association: Torys, Toronto.
Solicitors for the
intervener the Intellectual Property Institute of Canada: Belmore
Neidrauer, Toronto.