SUPREME
COURT OF CANADA
Between:
Apotex Inc.
Appellant
and
Sanofi‑Synthelabo
Canada Inc., Sanofi‑Synthelabo
and
Minister of Health
Respondents
‑ and ‑
Canadian
Generic Pharmaceutical Association,
BIOTECanada
and Canada’s Research‑Based Pharmaceutical Companies
Interveners
Coram: Binnie, LeBel, Deschamps, Fish, Abella, Charron
and Rothstein JJ.
Reasons for
Judgment:
(paras. 1 to 117)
|
Rothstein J. (Binnie, LeBel,
Deschamps, Fish, Abella and Charron JJ. concurring)
|
______________________________
Apotex Inc. v. Sanofi‑Synthelabo Canada Inc., [2008] 3
S.C.R. 265, 2008 SCC 61
Apotex Inc. Appellant
v.
Sanofi‑Synthelabo Canada Inc., Sanofi‑Synthelabo
and Minister of Health Respondents
and
Canadian Generic Pharmaceutical Association,
BIOTECanada and Canada’s Research‑Based Pharmaceutical
Companies Interveners
Indexed as: Apotex Inc. v. Sanofi‑Synthelabo
Canada Inc.
Neutral citation: 2008 SCC 61.
File No.: 31881.
2008: April 16; 2008: November 6.
Present: Binnie, LeBel, Deschamps, Fish,
Abella, Charron and Rothstein JJ.
on appeal from the federal court of appeal
Intellectual property — Patents — Medicines —
Selection patents — Validity — Whether selection patent invalid on grounds of
anticipation, obviousness or double patenting.
Intellectual property — Patents — Anticipation — Two‑step
approach to anticipation — Requirements of “prior disclosure” and “enablement”.
Intellectual property — Patents — Obviousness — Four‑step
approach to obviousness — When “obvious to try” test appropriate.
Intellectual property — Patents — Double patenting —
Whether doctrine of selection patents invalid on ground of double patenting.
S is the holder of the ‘875 patent which discloses a
large genus or class of over 250,000 possible compounds useful in inhibiting
platelet aggregation activity in the blood. One of these compounds is the
racemate relevant in this case. A racemate is a substance containing equal
amounts of two structurally different compounds, called the dextro‑rotatory
isomer and the levo‑rotatory isomer. S also holds the subsequent ‘777
patent which discloses and claims clopidogrel bisulfate, marketed by S under
the trade name of Plavix as an anti‑coagulant that exhibits platelet
aggregation inhibiting activity. Clopidogrel is the dextro‑rotatory
isomer of the racemate that was selected from and is encompassed by the
compounds claimed in the ‘875 patent, and is less toxic and better tolerated
than the levo‑rotatory isomer and the racemate. In 2003, A, a
generic manufacturer served a notice of allegation on S to obtain a notice of
compliance from the Minister of Health in order to market its generic version
of Plavix, claiming that it would not infringe S’s patent for Plavix because
the ‘777 patent was invalid on the grounds of anticipation, obviousness and
double patenting. S successfully sought an order in the Federal Court
prohibiting the Minister from issuing the notice of compliance to A on the
ground that the generic version of Plavix did infringe the ‘777 patent. The
Federal Court of Appeal upheld the decision. The issue is whether selection
patents are invalid in principle or on the facts of this case, on the grounds
of anticipation, obviousness and double patenting.
Held: The appeal should
be dismissed.
In the field of chemical patents, originating or genus
patents are based on the discovery of a new invention, namely, a reaction or
compound, while selection patents are for compounds chosen from the compounds
described in the originating patent. Selection patents do not differ in nature
from any other patent, but in order to be valid, the selected compound must be
novel and possess a substantial advantage to be secured or disadvantage to be
avoided. [9-10]
A system of genus and selection patents is acceptable in
principle and does not necessarily involve anticipation and therefore
invalidity. The real question is whether, on the facts of this case, the
particular selection patent has been anticipated. This means that, having
regard to s. 27(1) of the Patent Act , the claimed invention has
already been made or publicly disclosed. Here, the applications judge set the
bar for proving anticipation too high and overstated the stringency of the test
by requiring that the “exact invention” must have already been made and
publicly disclosed. Rather, for a successful anticipation claim, a two‑step
approach should be adopted whereby the requirements of “prior disclosure” and
“enablement” should be considered separately and proven. For prior disclosure,
the genus patent must disclose subject matter which, if performed, would
necessarily result in infringement of that patent. At this stage, the person
skilled in the art is reading the prior patent to understand whether it
discloses the special advantages of the second invention. No trial and error
is permitted. If in reading the genus patent, there is no discovery of the
special advantages of the selection patent, the genus patent does not
anticipate the selection patent and the disclosure requirement to prove
anticipation, as in this case, fails. For “enablement”, the person skilled in
the art must have been able to perform the invention without undue burden. The
question at this stage of the test is how much trial and error or experimentation
is permitted. If an inventive step were required to get to the invention of
the second patent, the specification of the first patent would not have
provided enabling disclosure. The entire prior genus patent must provide
enough information to allow a person skilled in the art to perform or make the
selected subsequently claimed invention without “undue burden”. The skilled
person may use his or her common general knowledge of the relevant art at the
relevant time to supplement information contained in the prior genus patent and
may conduct routine trials without being considered an undue burden, but
prolonged or arduous trial and error experiments would not be considered
routine. In this case, the allegation that the ‘777 patent is invalid on the
basis of anticipation must fail. Twenty‑one examples from the ‘875
patent were made and tested, one of which was the relevant racemate. There was
no evidence that a person skilled in the art would know, from reading the ‘875
patent, the specific beneficial properties associated with the more active
dextro‑rotatory isomer and that it would be less toxic than the racemate
or levo‑rotatory isomer or any of the other compounds made and tested.
Since the ‘875 patent did not teach these special advantages, the invention of
the ‘777 patent was not disclosed and was therefore not anticipated.
Regarding enablement, the evidence with respect to trial and error and the
methods of separating the racemate into its isomers, indicates that the
identification of clopidogrel, its bisulfate salt and their advantageous
properties required extensive investigation over a period of months. However,
it was not necessary to determine the question of enablement in view of the
finding that there was no disclosure of the ‘777 invention in the ‘875 patent.
[18-20] [23-25] [31-33] [37-38] [40-42] [46-50] [116]
The allegation that the ‘777 patent is invalid on the
basis of obviousness must also fail. Obviousness is largely concerned with how
a skilled worker would have acted in the light of the prior art. An
obviousness inquiry should follow a four‑step approach. First, the
notional “person skilled in the art” and that person’s relevant common general
knowledge must be identified. Here, that person is a trained pharmachemist.
Second, the inventive concept of the claim in question must be determined or
construed. The inventive concept of the claims in the ‘777 patent is that it
is a compound useful in inhibiting platelet aggregation which has greater
therapeutic effect and less toxicity than the other compounds of the ‘875
patent. Third, the differences, if any, that exist between the matters cited
as forming part of the “state of the art” and the inventive concept of the
claim or the claim as construed must be identified. There is no disclosure in
the ‘875 patent of the specific beneficial properties associated with the
dextro‑rotatory isomer of this racemate or its bisulfate salt, in
contrast to the ‘777 patent, which claims the invention of the dextro‑rotatory
isomer of the racemate, clopidogrel, and its bisulfate salt, discloses their
beneficial properties over the levo‑rotatory isomer and the racemate, and
expressly describes how to separate the racemate into its isomers. Fourth, a
court must consider whether, viewed without any knowledge of the alleged
invention as claimed, those differences constitute steps which would have been
obvious to the person skilled in the art or whether they require any degree of
inventiveness. It is at this final step that the issue of “obvious to try”
will arise and the nature of the invention in this case is such as to warrant
this test. For a finding that an invention was “obvious to try”, there must
be evidence to convince a judge on a balance of probabilities that it was more
or less self‑evident to try to obtain the invention. Mere possibility
that something might turn up is not enough. Here, when the relevant factors
are considered, the invention was not self‑evident from the prior art
and common general knowledge in order to satisfy the test. While there were
five well‑known methods to separate this racemate into its isomers, there
was no evidence that a person skilled in the art would have known which of the
five known separation techniques would work with this racemate. Further, S
spent millions of dollars and several years developing the racemate up to the
point of preliminary human clinic trials before it was discovered that the
dextro‑rotatory isomer was active and non‑toxic. As the ‘875 patent
did not differentiate on the basis of efficacy and toxicity, what to select or
omit was not then self‑evident to a person skilled in the art. It
was also not self‑evident from the ‘875 patent or common general
knowledge what the beneficial properties of the dextro‑rotatory isomer of
this racemate or its bisulfate salt would be and therefore what was being tried
ought to work. The course of conduct and the time involved throughout
demonstrate that the advantage of the dextro‑rotatory isomer was not
quickly or easily predictable. [66-68] [70] [74] [78-81] [85-86] [90-93]
Finally, the challenge to selection patents based on the
ground of double patenting is not well founded. Strategies that attempt to
extend the time limit of exclusivity of a patent may be contrary to the
objectives of the Patent Act , depending on the circumstances, but a
generalized concern about evergreening is not a justification for an attack on
the doctrine of selection patents. A selection patent may be sought by a party
other than the inventor or owner of the original genus patent so that evergreening
does not arise. In addition, selection patents encourage improvements over the
subject matter of the original genus patent because that selection does
something better than or different from what was claimed in the genus patent.
There is no “same invention” double patenting because the claims of the ‘875
and ‘777 patents were not identical or coterminous and the former is broader
than the latter. Further, as the claims in the ‘777 patent reflect a
patentably distinct compound from the compounds in the ‘875 patent, it is not
invalid for “obviousness” double patenting. [97-98] [100-101] [110-111] [113]
[115] [117]
Cases Cited
Applied: In
re I. G. Farbenindustrie A. G.’s Patents (1930), 47 R.P.C. 289; Synthon
B.V. v. SmithKline Beecham plc, [2006] 1 All E.R. 685, [2005] UKHL 59; Windsurfing
International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59; Pozzoli
SPA v. BDMO SA, [2007] F.S.R. 37 (p. 872), [2007] EWCA Civ 588; Whirlpool
Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67; Monsanto
Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; referred to: Commissioner
of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius &
Bruning, [1964] S.C.R. 49; Free World Trust v. _lectro
Sant_ Inc., [2000] 2 S.C.R. 1024, 2000 SCC
66; Beloit Canada Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289; General
Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C.
457; Hills v. Evans (1862), 31 L.J. Ch. (N.S.) 457; E. I. Du Pont de
Nemours & Co. (Witsiepe’s) Application, [1982] F.S.R. 303; Halliburton
Energy Services Inc. v. Smith International (North Sea) Ltd., [2006] EWCA
Civ 1715 (BAILII); Wobben v. Vestas‑Celtic Wind Technology Ltd.,
[2007] EWHC 2636 (BAILII); Application of Tomlinson, 363 F.2d 928
(1966); In re O’Farrell, 853 F.2d 894 (1988); KSR International Co.
v. Teleflex Inc., 127 S. Ct. 1727 (2007); Johns‑Manville
Corporation’s Patent, [1967] R.P.C. 479; H. Lundbeck A/S v. Generics
(UK) Ltd., [2008] R.P.C. 19 (p. 437), [2008] EWCA Civ 311; Angiotech
Pharmaceuticals Inc. v. Conor Medsystems Inc., [2007] R.P.C. 20 (p. 487),
[2007] EWCA Civ 5, rev’d [2008] R.P.C. 28 (p. 716), [2008] UKHL 49; Saint‑Gobain
PAM SA v. Fusion Provida Ltd., [2005] EWCA Civ 177 (BAILII); Apotex Inc.
v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, 2002 SCC 77; Ciba‑Geigy
AG v. Commissioner of Patents (1982), 65 C.P.R. (2d) 73; May & Baker
Ltd. v. Boots Pure Drug Co. (1950), 67 R.P.C. 23.
Statutes and Regulations Cited
Food and Drug Regulations, C.R.C. 1978, c. 870, s. C.08.004.
Patent Act, R.S.C.
1985, c. P‑4, ss. 2 , 27 , 34(1) (b) [rep. 1993, c. 15, s. 36],
55.2(4), 59.
Patented Medicines (Notice of Compliance)
Regulations, SOR/93‑133, ss. 5, 6(1).
Patents Act 1977 (U.K.), 1977, c. 37.
Treaties and Other International Instruments
Convention
on the Grant of European Patents, 1065 U.N.T.S.
199.
Authors Cited
Vaver, David. Intellectual
Property Law: Copyright, Patents, Trade‑marks. Concord, Ont.:
Irwin Law, 1997.
APPEAL from a judgment of the Federal Court of Appeal
(Richard C.J. and Noël and Evans JJ.A.) (2006), 282 D.L.R. (4th) 179, 358 N.R.
135, 59 C.P.R. (4th) 46, [2006] F.C.J. No. 1945 (QL), 2006 CarswellNat
4587, 2006 FCA 421, affirming a decision of Shore J. (2005), 271 F.T.R.
159, 39 C.P.R. (4th) 202, [2005] R.P.C. 34 (p. 855), [2005] F.C.J. No. 482
(QL), 2005 CarswellNat 726, 2005 FC 390. Appeal dismissed.
Harry B. Radomski,
Richard Naiberg, Andrew R. Brodkin and Miles Hastie,
for the appellant.
Anthony G. Creber
and Cristin A. Wagner, for the respondents Sanofi‑Synthelabo
Canada Inc. and Sanofi‑Synthelabo.
No one appeared for the respondent the Minister of
Health.
Edward Hore, for
the intervener the Canadian Generic Pharmaceutical Association.
Peter Wilcox and Jana
Stettner, for the intervener BIOTECanada.
Patrick E. Kierans,
Jason Markwell and Cynthia L. Tape, for the intervener Canada’s
Research‑Based Pharmaceutical Companies.
The judgment of the Court was delivered by
Rothstein J. —
I. Introduction
[1]
This appeal raises questions relating to the validity of what are
known as selection patents. In the context of chemical compounds, in general
terms, a selection patent is one whose subject matter (compounds) is a fraction
of a larger known class of compounds which was the subject matter of a prior
patent.
[2]
The appellant (“Apotex”) challenges the validity of the selection
patent in this case on the grounds of anticipation, obviousness and double
patenting. I would dismiss the appeal.
II. Facts
[3]
The parties have accepted that the Sanofi respondents (“Sanofi”)
are the relevant holders of patent 1,194,875 (‘875 patent). This patent
disclosed a genus or class of compounds useful in inhibiting platelet
aggregation activity in the blood which is important in treating coronary
artery, peripheral vascular and cerebral vascular diseases. This genus patent
discloses over 250,000 possible different compounds useful for this purpose.
One of the compounds is a racemate described as methyl alpha-5
(4,5,6,7-tetrahydro (3, 2-c)-thieno pyridyl) (2-chlorophenyl)-acetate (the
“racemate”).
[4]
A racemate is a substance containing equal amounts of two
structurally different compounds, called enantiomers or optical isomers. The
two isomers, the dextro-rotatory isomer and the levo-rotatory isomer, are
mirror images of each other and rotate plane-polarized light in opposite
directions.
[5]
The parties have accepted that Sanofi is also the relevant
holder of subsequent Canadian patent 1,336,777 (‘777 patent), the patent in
suit. It discloses and claims clopidogrel bisulfate, which is marketed by
Sanofi under the trade name of Plavix as an anti-coagulant that inhibits
platelet aggregation activity in the blood.
[6]
Clopidogrel bisulfate is encompassed within the scope of the
claims in the ‘875 patent. Clopidogrel is the dextro-rotatory isomer of the
racemate, having beneficial properties over both the racemate and the
levo-rotatory isomer. The dextro-rotatory isomer exhibits a platelet
aggregation inhibiting activity and is less toxic and better tolerated than the
levo-rotatory isomer and racemate. The salts of the dextro-rotatory isomer,
such as clopidogrel bisulfate, have a better therapeutic index than the salts
of the racemic mixture and in fact, the levo-rotatory isomer exhibits almost no
platelet aggregation inhibiting activity, and its toxicity is markedly higher
than that of the dextro-rotatory isomer.
[7]
On March 10, 2003, Apotex served a notice of allegation under the
Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (“NOC
Regulations”), on Sanofi for the purpose of obtaining a notice of
compliance pursuant to s. C.08.004 of the Food and Drug Regulations,
C.R.C. 1978, c. 870, from the Minister of Health for a generic version of Plavix.
The basis of Apotex’s notice of allegation was that it would not infringe
Sanofi’s ‘777 patent for Plavix because the ‘777 patent was invalid on account
of anticipation, obviousness and double patenting. On April 28, 2003, Sanofi
initiated proceedings under s. 6(1) of the NOC Regulations in the
Federal Court seeking an order prohibiting the Minister of Health from issuing
a notice of compliance to Apotex on the grounds that its generic version of
Plavix would infringe the ‘777 patent. The Federal Court granted the order of
prohibition ((2005), 271 F.T.R. 159, 2005 FC 390). The Federal Court of Appeal
dismissed Apotex’s appeal ((2006), 282 D.L.R. (4th) 179, 2006 FCA 421).
III. Selection Patents
[8]
This appeal requires the Court to determine whether selection
patents are invalid in principle or on the facts of this case on the grounds of
anticipation, obviousness and double patenting.
[9]
The locus classicus describing selection patents is the
decision of Maugham J. in In re I. G. Farbenindustrie A. G.’s Patents
(1930), 47 R.P.C. 289 (Ch. D.). At p. 321, he explained that in the field of
chemical patents (which would of course include pharmaceutical compounds),
there are often two “sharply divided classes”. The first class of patents,
which he called originating patents, are based on an originating invention,
namely, the discovery of a new reaction or a new compound. The second class
comprises patents based on a selection of compounds from those described in
general terms and claimed in the originating patent. Maugham J. cautioned that
the selected compounds cannot have been made before, or the selection patent
“would fail for want of novelty”. But if the selected compound is “novel” and
“possess[es] a special property of an unexpected character”, the required
“inventive” step would be satisfied (p. 321). At p. 322, Maugham J. stated
that a selection patent “does not in its nature differ from any other patent”.
[10]
While not exhaustively defining a selection patent, he set out
(at pp. 322-23) three conditions that must be satisfied for a selection patent
to be valid.
1. There must be a substantial
advantage to be secured or disadvantage to be avoided by the use of the
selected members.
2. The whole of the selected members
(subject to “a few exceptions here and there”) possess the advantage in
question.
3. The selection must be in respect of
a quality of a special character peculiar to the selected group. If further
research revealed a small number of unselected compounds possessing the same
advantage, that would not invalidate the selection patent. However, if
research showed that a larger number of unselected compounds possessed the same
advantage, the quality of the compound claimed in the selection patent would not
be of a special character.
[11]
Although much has been written about selection patents since I.
G. Farbenindustrie, Maugham J.’s analysis is consistently referred to and
is well accepted. I find it is a useful starting point for the analysis to be
conducted in this case.
IV. The Regulatory Scheme Under Which the
Matter Proceeded
[12]
At the outset, it is appropriate to refer to the words of Judson
J. for this Court in Commissioner of Patents v. Farbwerke Hoechst
Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49,
at p. 57:
There is no
inherent common law right to a patent. An inventor gets his patent according
to the terms of the Patent Act , no more and no less.
The most recent
reference to the law of patents being wholly statutory are the words of
Lord Walker in Synthon
B.V. v. SmithKline Beecham plc, [2006] 1 All E.R. 685, [2005] UKHL 59, at
paras. 57-58:
The law of patents is wholly statutory, and has a surprisingly long
history. . . . In the interpretation and application of patent statutes
judge-made doctrine has over the years done much to clarify the abstract
generalities of the statutes and to secure uniformity in their application.
Nevertheless it is salutary to be reminded, from time
to time, that the general concepts which are the common currency of patent
lawyers are founded on a statutory text, and cannot have any other firm
foundation.
I therefore turn
to the regulatory scheme applicable in this case.
[13]
The procedure under the NOC Regulations pursuant to which
a manufacturer of drugs may apply to the Minister of Health for a notice of
compliance is well known. A manufacturer, usually a generic manufacturer,
wishes to compare its drug with that of a patent holder for which a patent list
has been submitted to the Minister by the patent holder. The generic
manufacturer’s purpose is to establish the safety and efficacy of its drug for
the purposes of securing marketing approval from the Minister. The process of
comparison saves the generic competitor time and resources. However, the
Minister will not issue a notice of compliance unless the patent on the
comparator drug has expired, is invalid, or the generic’s product will not
otherwise infringe the patent. Thus the NOC Regulations create a
connection between government approval to market a generic drug and the issue
of patent validity and infringement.
[14]
Section 5(1)(b) of the NOC Regulations states that
the generic manufacturer, in its submission for a notice of compliance, may
allege that the patent has expired, is not valid or will not be infringed. The
patent holder may then apply to the Federal Court for an order prohibiting the
Minister from issuing a notice of compliance to the generic manufacturer until
after expiration of the patent that is the subject of the notice of
allegation. The court will grant the prohibition order if it finds that the
allegation of invalidity, expiry or non-infringement is not justified. If it
finds the allegation justified, it will dismiss the application for prohibition
and the Minister may then issue a notice of compliance to the generic
manufacturer if all other requirements are met.
[15]
The NOC Regulations do not provide guidance about how an
allegation of “not valid” as stated in s. 5(1)(b)(iii) is to be
considered and determined by the court. For this purpose, reference must be
made to the relevant version of the Patent Act , which is R.S.C. 1985, c.
P-4 , applicable to patent applications filed prior to October 1, 1989.
[16]
The application for the ‘875 patent was filed in 1983. The
patent was issued in 1985 and expired in 2002. The application for the ‘777
patent was filed in 1988. The patent was issued in 1995 and unless found to be
invalid, will expire in 2012.
[17]
The use of the term “not valid” in s. 5 of the NOC Regulations
parallels what would otherwise be a defence to an infringement action referred
to in s. 59 of the Act:
The defendant, in any action for infringement of a
patent may plead as matter of defence any fact or default which by this Act or
by law renders the patent void, and the court shall take cognizance of that
pleading and of the relevant facts and decide accordingly.
The NOC
Regulations are promulgated under s. 55.2(4) of the Act, and it seems
apparent that the determination of the invalidity of a patent must be based on
“any fact or default which by this Act or by law renders the patent void”. In
this case, Apotex relies on anticipation, obviousness and double patenting to
allege that the ‘777 patent is invalid. These allegations implicate both the
Act and the judge-made doctrine based on the Act.
V. Anticipation
(a) Relevant Legislation
[18]
For purposes of anticipation, it is necessary to have regard to
s. 27 of the Act which sets forth the basic conditions necessary for obtaining
a patent. The invention must not have been previously known or used nor
described in any patent or other publication printed in any country more than
two years before the filing of the patent application and must not have been in
public use or sale in Canada more than two years prior to the filing of the
patent application. Section 27(1) provided:
27. (1) Subject to this section, any inventor or legal
representative of an inventor of an invention that was
(a) not
known or used by any other person before he invented it,
(b) not
described in any patent or in any publication printed in Canada or in any other
country more than two years before presentation of the petition hereunder
mentioned, and
(c) not
in public use or on sale in Canada for more than two years prior to his
application in Canada,
may, on presentation to the Commissioner of a petition setting out the
facts, in this Act termed the filing in the application, and on compliance with
all other requirements of this Act, obtain a patent granting to him an
exclusive property in the invention.
[19]
It is with s. 27 in mind that the law of anticipation must be
considered. Apotex’s arguments based on anticipation are not that the
applications judge erred in his analysis of the law of anticipation or its
application to the facts of this case. Rather, Apotex implies that the current
understanding of the law sets the bar for proving anticipation too high and
that the acceptance of a system of genus and selection patents necessarily, or
at least on the facts of this case, involves anticipation and therefore
invalidity. I would reject the broader objection. A system of genus and
selection patents is acceptable in principle, on the line of authority stemming
from I. G. Farbenindustrie. The real question is whether, on the facts
of this case, the particular selection patent has been anticipated.
(b) Reasons of the Applications Judge
[20]
In his reasons after referring to s. 27(1) of the Act, the
applications judge defined anticipation as meaning “that the exact invention
had already been made and publicly disclosed” (para. 55). Shore J. cited this
Court’s decision in Free World Trust v. _lectro Sant_
Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66, at para. 26, which approved of the
test for anticipation described in Beloit Canada Ltd. v. Valmet OY (1986),
8 C.P.R. (3d) 289 (F.C.A.), at p. 297:
One must, in effect, be able to look at a prior, single publication and
find in it all the information which, for practical purposes, is needed to produce
the claimed invention without the exercise of any inventive skill. The
prior publication must contain so clear a direction that a skilled person
reading and following it would in every case and without possibility of error
be led to the claimed invention. [Emphasis added by the applications
judge.]
[21]
The applications judge noted that the English Court of Appeal
stated in General Tire & Rubber Co. v. Firestone Tyre & Rubber Co.,
[1972] R.P.C. 457, at p. 486:
If, on the other hand, the prior publication
contains a direction which is capable of being carried out in a manner which
would infringe the patentee’s claim, but would be at least as likely to be
carried out in a way which would not do so, the patentee’s claim will not have
been anticipated, although it may fail on the ground of obviousness. To
anticipate the patentee’s claim the prior publication must contain clear and
unmistakable directions to do what the patentee claims to have invented . . . .
[Emphasis added by the applications judge.]
He then noted
that in Free World, at para. 26, this Court approved the following
statement from General Tire:
A signpost, however clear, upon the road to the patentee’s invention will
not suffice. The prior inventor must be clearly shown to have planted his flag
at the precise destination before the patentee. [p. 486]
[22]
The law of anticipation as explained in Beloit and General
Tire has been accepted in Canada without reservation: see Free World,
at para. 26. In his application of the law to the facts, there is no doubt
that Shore J. was using the test as set out in Beloit when he stated, at
para. 57:
Based on the law, the question before the Court is
whether a person skilled in the art was given such a clear direction that, by
reading and following the ’875 patent (or its U.S. or French equivalents) would
in every case and without possibility of error make a compound or
pharmaceutical composition within the claims of the ’777 patent (e.g. the
bisulfate salt of clopidogrel).
(c) Recent United Kingdom Jurisprudence
[23]
For the reasons that follow, and in light of recent
jurisprudence, I am of the respectful opinion that the applications judge
overstated the stringency of the test for anticipation that the “exact
invention” has already been made and publicly disclosed.
[24]
In the 2005 decision of the House of Lords in Synthon,
Lord Hoffmann has brought some further clarity to the law of anticipation as
understood since General Tire. His reference at para. 20 to the
“unquestionable authority” of Lord Westbury in Hills v. Evans (1862), 31
L.J. Ch. (N.S.) 457, at p. 463, makes it plain that his analysis does not
depend on any change on English law flowing from the enactment of the Patents
Act 1977 (U.K.), 1977, c. 37, or the U.K.’s adoption of the Convention
on the Grant of European Patents, 1065 U.N.T.S. 199 (entered into force
October 7, 1977). He distinguishes between two requirements for anticipation
that were not theretofore expressly considered separately, prior disclosure and
enablement.
[25]
He explains that the requirement of prior disclosure means that
the prior patent must disclose subject matter which, if performed, would
necessarily result in infringement of that patent, and states, at para. 22:
If I may summarise the effect of these two well-known
statements [from General Tire and Hills v. Evans], the matter
relied upon as prior art must disclose subject matter which, if performed,
would necessarily result in an infringement of the patent. . . . It follows
that, whether or not it would be apparent to anyone at the time, whenever
subject matter described in the prior disclosure is capable of being performed
and is such that, if performed, it must result in the patent being infringed,
the disclosure condition is satisfied.
When considering
the role of the person skilled in the art in respect of disclosure, the skilled
person is “taken to be trying to understand what the author of the description
[in the prior patent] meant” (para. 32). At this stage, there is no room for
trial and error or experimentation by the skilled person. He is simply reading
the prior patent for the purposes of understanding it.
[26]
If the disclosure requirement is satisfied, the second
requirement to prove anticipation is “enablement” which means that the person
skilled in the art would have been able to perform the invention (para. 26).
Lord Hoffmann held that the test for enablement for purposes of anticipation
was the same as the test for sufficiency under the relevant United Kingdom
legislation. (Enablement for the purposes of sufficiency of the patent
specification under the Canadian Patent Act, s. 34(1)(b) of the
pre-October 1, 1989 Act, now s. 27(3)(b), is not an issue to be decided
in this case and my analysis of enablement is solely related to the test for
anticipation. The question of whether enablement for purposes of sufficiency
is identical in Canada is better left to another day.)
[27]
Once the subject matter of the invention is disclosed by the prior
patent, the person skilled in the art is assumed to be willing to make trial
and error experiments to get it to work. While trial and error experimentation
is permitted at the enablement stage, it is not at the disclosure stage. For
purposes of enablement, the question is no longer what the skilled person would
think the disclosure of the prior patent meant, but whether he or she would be
able to work the invention.
[28]
The Beloit decision by which the applications judge
rightly felt bound dealt with only one aspect of anticipation, that is, whether
or not the invention in a patent had been disclosed in a single prior
publication or patent. In that decision, Hugessen J.A. held that it had not.
He had no need to consider the further point whether or not, had there been
such a clear disclosure, the working of the invention was also enabled by that
disclosure. That point was not in issue in Beloit. Explicitly
separating disclosure and enablement is a refinement of the approach set out in
Beloit. It explains the process a person skilled in the art would
follow if the original patent anticipated the invention of the subsequent
patent. I would adopt this approach.
[29]
Subject to any limitations expressed in the Patent Act , I
see no reason why the discussion of anticipation should not apply to other
prior art than merely genus patents. Again, subject to limitations in the Patent
Act , the discussion of anticipation and obviousness would seem applicable
to patents generally.
[30]
Two questions now must be answered: (1) what constitutes
disclosure at the first stage of the test for anticipation, and (2) how much
trial and error or experimentation is permitted at the enablement stage?
i. Disclosure
[31]
Section 27(1) of the Act requires as a condition for obtaining a
patent that the invention was not “known or used” and was not “described” in
any patent or any publication more than two years before the patent application
was filed. In the context of genus and selection patents, in E. I. Du Pont
de Nemours & Co. (Witsiepe’s) Application, [1982] F.S.R. 303 (H.L.),
Lord Wilberforce stated, at p. 311:
It is the absence of the discovery of the special
advantages, as well as the fact of non-making, that makes it possible for such
persons to make an invention related to a member of the class.
The compound
made for the selection patent was only soundly predicted at the time of the
genus patent. It was not made and its special advantages were not known. It
is for those reasons that a patent should not be denied to the inventor who
made and discovered the special advantages of the selection compound for the
first time.
[32]
In the context of disclosure as explained in Synthon, “the
absence of the discovery of the special advantages” to which Lord Wilberforce
was referring in Witsiepe’s means that the genus patent does not
disclose the special advantages of the invention covered by the selection
patent. Where there is no such disclosure, there is no discovery of the
special advantages of the selection patent as compared to the genus patent, and
the disclosure requirement to prove anticipation fails. At this stage, the
person skilled in the art is reading the prior patent to understand whether it
discloses the special advantages of the second invention. No trial and error
is permitted. If in reading the genus patent the special advantages of the
invention of the selection patent are not disclosed, the genus patent does not
anticipate the selection patent.
ii. Enablement
[33]
What amount of trial and error or experimentation is permitted before
a prior disclosure will not constitute enabling disclosure? Certainly, if the
applications judge finds that an inventive step was required to get to the
invention of the second patent, the specification of the first patent will not
have provided enabling disclosure. But even if no inventive step is required,
the skilled person must still be able to perform or make the invention of the
second patent without undue burden.
[34]
Two recent United Kingdom decisions are of assistance. In Halliburton
Energy Services Inc. v. Smith International (North Sea) Ltd., [2006] EWCA
Civ 1715 (BAILII), Jacob L.J., a highly experienced patent judge, states at
para. 18:
Patents are meant to teach people how to do things. If what is “taught”
involves just too much [work] to be reasonable allowing for all the
circumstances including the nature of the art, then the patent cannot be
regarded as an “enabling disclosure.” . . . The setting of a gigantic project,
even if merely routine, will not do.
[35]
Jacob L.J. characterizes the problem at para. 20 as: “[H]ow is
one to say when the work involved to perform the invention is too much?” The
determination of how much work is too much is inevitably a line-drawing
exercise. His answer to the problem is at para. 21:
The answer is that the line is one to be drawn by an
exercise of judgment, taking into account all of the relevant factors, one of
which is of course the nature of the invention itself and its field of
technology. But there are other factors too — for instance, the width of the
patent claim or whether it has functional limitations which require too much
work to explore.
[36]
A more extensive review of the law of enablement as defined in Synthon
is contained in a decision of Kitchin J. in Wobben v. Vestas-Celtic Wind
Technology Ltd., [2007] EWHC 2636 (Pat.) (BAILII), at paras. 196-97.
Although Wobben was a case in which the alleged infringer raised as one
of its defences insufficiency under the United Kingdom legislation, I think
guidance is provided as to what will or will not constitute enablement for
purposes of anticipation.
[37]
Drawing from this jurisprudence, I am of the opinion that the
following factors should normally be considered. The list is not exhaustive.
The factors will apply in accordance with the evidence in each case.
1. Enablement is to be assessed having
regard to the prior patent as a whole including the specification and the
claims. There is no reason to limit what the skilled person may consider in
the prior patent in order to discover how to perform or make the invention of
the subsequent patent. The entire prior patent constitutes prior art.
2. The skilled person may use his or
her common general knowledge to supplement information contained in the prior
patent. Common general knowledge means knowledge generally known by persons
skilled in the relevant art at the relevant time.
3. The prior patent must provide
enough information to allow the subsequently claimed invention to be performed
without undue burden. When considering whether there is undue burden, the
nature of the invention must be taken into account. For example, if the
invention takes place in a field of technology in which trials and experiments
are generally carried out, the threshold for undue burden will tend to be
higher than in circumstances in which less effort is normal. If inventive
steps are required, the prior art will not be considered as enabling. However,
routine trials are acceptable and would not be considered undue burden. But
experiments or trials and errors are not to be prolonged even in fields of
technology in which trials and experiments are generally carried out. No time
limits on exercises of energy can be laid down; however, prolonged or arduous
trial and error would not be considered routine.
4. Obvious errors or omissions in the
prior patent will not prevent enablement if reasonable skill and knowledge in
the art could readily correct the error or find what was omitted.
(d) Application to the Facts of This Case
i. Disclosure for the Purposes of
Anticipation
[38]
The ‘875 genus patent covered over 250,000 possible different
compounds. Obviously, every compound was not made or tested. The patent
covering those compounds was based on sound prediction. From the
specification, it is apparent that 21 examples were made and tested, one of
which was the racemate relevant in this case. According to the applications
judge, there was no disclosure in the ‘875 patent of the specific beneficial
properties associated with the dextro-rotatory isomer of this racemate, nor was
there disclosure of any advantages which flow from using the bisulfate salt in
combination with the dextro-rotatory isomer (para. 71).
[39]
It was open to Shore J. on the record before him to conclude that
a person skilled in the art and reading the ‘875 patent would not be able to
come up with the invention of the ‘777 patent. Nothing in the ‘875 patent
distinguished this dextro-rotatory isomer as having beneficial properties
different from the racemate or the levo-rotatory isomer or from any of the
other compounds made and tested and referred to in the ‘875 patent, let alone
the compounds based only on sound prediction. At para. 72 of his reasons, he
found:
The Court also notes that, although Dr. Klibanov agreed with Apotex’
experts that a skilled person could have ascertained the activity and
characteristics of two isomers and of different salts using well-known methods
at the time, they did not say that the beneficial properties of these isomers
and of their salts — let alone of the dextro-rotatory isomer and of its bisulfate
salt — would be known with certitude before conducting the tests designed to
identify the respective properties of the isomers and of the salt.
[40]
There was no evidence that the person skilled in the art would
know from reading the ‘875 patent that the more active dextro-rotatory isomer
would be less toxic than the racemate or levo-rotatory isomer or any of the
other compounds made and tested. Indeed, Dr. McClelland’s evidence was that
while you “often” get more activity by separating isomers, the answer to the
question whether this increased activity was to be found in the levo‑rotatory
isomer or the dextro‑rotatory isomer was unknown. (Affidavit, at para.
42, and cross-examination, at pp. 928-30 and question 322).
[41]
Since the ‘875 patent did not disclose the special advantages of
the dextro-rotatory isomer and of its bisulfate salt, as compared to the
levo-rotatory isomer or the racemate and their salts, or the other compounds
made and tested or otherwise referred to in the ‘875 patent, the invention of
the ‘777 patent cannot be said to have been disclosed and therefore it cannot
be said to have been anticipated.
ii. Enablement for the Purposes of
Anticipation
[42]
It is not strictly necessary to discuss enablement since
anticipation requires proof of both disclosure and enablement, and disclosure
has not been proven. However, for future guidance, I would make the following
few observations about enablement on the facts of this case.
[43]
The applications judge was of the opinion that “the skilled
reader following the prior art must be able to arrive at the invention claimed
in the impugned patent the first time he or she tries and every time
thereafter” (para. 65 (emphasis in original)). However, under the test for
enablement as described in these reasons, some trial and error is permitted.
[44]
For anticipation, the genus patent must provide enough
information so as to allow the selected invention to be performed without undue
burden. In this case, the applications judge concluded that the ‘875 patent
did not specifically lead to the claimed invention. He noted, on the record
before him, that if one were to follow the teachings of the prior art, one
would obtain racemates, never their isomers.
[45]
However, Apotex argues that the methods for separating the
isomers were well known to persons skilled in the art at the time of the
invention. According to Apotex, such a person could eventually obtain the
isomer through what amounts to routine tests.
[46]
In determining whether the enablement step for proving
anticipation has been met, it is important to note that routine trials are
acceptable but inventive steps are not permitted. Also, reasonable skill and
knowledge of the art is expected in order to correct omissions in the original
patent if a means of determining what is missing can readily be found. The
skilled person may use his or her common general knowledge to supplement
information contained in the patent.
[47]
Even though Shore J. referred to the excessively stringent anticipation
test “in every case”, his findings are relevant to trial and error. He found
that the evidence with respect to the methods of separation, including the
evidence of the inventor, shows that the identification of clopidogrel, its
bisulfate salt and their advantageous properties required extensive
investigation over a period of months (paras. 68-70).
[48]
One might infer that, had the applications judge been asked to
decide if these investigations constituted an undue burden for the skilled
person, he would have held that they did. However, in view of my earlier
conclusion on disclosure, it is unnecessary for me to pursue this point
further.
(e) Conclusion on Anticipation
[49]
As indicated above, in the context of anticipation, the two-step
approach, disclosure and enablement, is a refinement of the approach set out in
Beloit and should be adopted.
[50]
In the case at bar, the invention of the ‘777 patent was not
disclosed by the ‘875 patent and was therefore not anticipated. The allegation
of anticipation has not been justified.
VI. Obviousness
(a) Relevant Legislation
[51]
The definition of invention in s. 2 of the Act is relevant
because at the time the pre-October 1, 1989 version of the Act was in force,
there was no statutory provision expressly providing that obvious inventions
were unpatentable. As explained by Professor D. Vaver in Intellectual
Property Law: Copyright, Patents, Trade-marks (1997), at p. 136:
Until very recently, the Patent Act did not expressly say that
obvious inventions were unpatentable. Courts implied this criterion from the
notion of “invention”. Inventions implied inventive ingenuity, without which
an advance was obvious; and patents are not granted for the obvious.
The definition
of invention in s. 2 of the Act provided:
“invention” means any new and useful . . .
composition of matter, or any new and useful improvement in any . . .
composition of matter;
(b) Reasons of the Applications Judge
[52]
Shore J. first correctly observed that at the relevant time
obviousness was not mentioned expressly in the Act. He then cited the
well-known test for obviousness in Beloit (at p. 294):
The test for obviousness is not to ask what competent
inventors did or would have done to solve the problem. Inventors are by
definition inventive. The classical touchstone for obviousness is the
technician skilled in the art but having no scintilla of inventiveness or
imagination; a paragon of deduction and dexterity, wholly devoid of intuition;
a triumph of the left hemisphere over the right. The question to be asked is whether
this mythical creature (the man in the Clapham omnibus of patent law) would, in
the light of the state of the art and of common general knowledge as at the
claimed date of invention, have come directly and without difficulty to the
solution taught by the patent. It is a very difficult test to satisfy.
[Emphasis added by the applications judge; para. 75.]
In the view of
Shore J., the Beloit test would not accommodate a “worth a try” test by
the skilled person.
[53]
The applications judge accepted that there were five well-known
separation techniques in order to obtain the dextro-rotatory isomer of the
racemate. At para. 80, he stated:
. . . what the experts are really saying from a legal perspective is that
separating the racemate was worth a try. Having to try different methods,
though they be well-known, in order to discover which one will yield the
desired result cannot mean that the desired result, in this case, the compounds
in claims 1 and 3 and their pharmaceutical compositions, was obvious.
[54]
He further held that the dextro-rotatory isomer and its salts had
to be tested for their beneficial properties to be discovered and that the
isomer and its beneficial properties were therefore not known before the
racemate was separated into its isomers. He stated, at para. 81:
Here again, having to try different separation techniques with
uncertainty as to whether each or some specific techniques would actually
result in a successful separation and then having to perform tests to discover
what the properties of the dextro-rotatory isomer of the racemate were, cannot
mean that this compound and its beneficial properties were obvious.
(c) United Kingdom and United States Approach
to Obviousness
[55]
Apotex says that the Beloit approach is excessively rigid
and is out of step with the tests for obviousness in the United Kingdom and the
United States, where “worth a try” has been accepted.
[56]
Generally, in the United States, it appears that at the Court of
Appeals level, the “obvious to try” test had not been accepted. In Application
of Tomlinson, 363 F.2d 928 (C.C.P.A. 1966), Rich J. wrote, at p. 931:
Slight reflection suggests, we think, that there is usually an element of
“obviousness to try” in any research endeavor, that is not undertaken with
complete blindness but rather with some semblance of a chance of success, and
that patentability determinations based on that as the test would not only be
contrary to statute but result in a marked deterioration of the entire patent
system as an incentive to invest in those efforts and attempts which go by the
name of “research”.
See also In
re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988), at p. 903.
[57]
However, in KSR International Co. v. Teleflex Inc., 127 S.
Ct. 1727 (2007), Kennedy J., for a unanimous court, rejected the restrictive
approach that the Court of Appeals had taken in that case. He stated, at p.
1739:
Throughout this Court’s engagement with the question of obviousness, our
cases have set forth an expansive and flexible approach inconsistent with the
way the Court of Appeals applied its TSM [Teaching-Suggestion-Motivation] test
here. To be sure, Graham recognized the need for “uniformity and
definiteness.” Yet the principles laid down in Graham reaffirmed the
“functional approach” of Hotchkiss. To this end, Graham set
forth a broad inquiry and invited courts, where appropriate, to look at any
secondary considerations that would prove instructive.
[58]
At p. 1742, he was clear that “obvious to try” could be a
relevant test in an obviousness inquiry:
The same constricted analysis led the Court of
Appeals to conclude, in error, that a patent claim cannot be proved obvious
merely by showing that the combination of elements was “obvious to try.” . . .
When there is a design need or market pressure to solve a problem and there are
a finite number of identified, predictable solutions, a person of ordinary
skill has good reason to pursue the known options within his or her technical
grasp. If this leads to the anticipated success, it is likely the product not
of innovation but of ordinary skill and common sense. In that instance the
fact that a combination was obvious to try might show that it was obvious under
§103.
[59]
In the United Kingdom the “obvious to try” test has been accepted
since at least 1967: see Johns‑Manville Corporation’s Patent,
[1967] R.P.C. 479 (C.A.). The current state of the law in the United Kingdom
was summarized in H. Lundbeck A/S v. Generics (UK) Ltd., [2008]
R.P.C. 19 (p. 437), [2008] EWCA Civ 311. Lord Hoffmann stated the following,
at paras. 24-25, in response to the argument that the trial judge in that case,
Kitchin J., had refused to consider the “obvious to try” test:
[The trial
judge] cited from Angiotech Pharmaceuticals Inc. v. Conor Medsystems Inc.
[2007] R.P.C. 20, which represents this [Court of Appeal’s] last word on the
extent to which the notion of some step being obvious to try is helpful in
deciding whether an invention is obvious. The judge then summed up (at para.
72) the current state of the law:
“The question
of obviousness must be considered on the facts of each case. The court must
consider the weight to be attached to any particular factor in the light of all
the relevant circumstances. These may include such matters as the motive to
find a solution to the problem the patent addresses, the number and extent of
the possible avenues of research, the effort involved in pursuing them and the
expectation of success.”
No criticism has been made of this statement of principle . . . .
See also Angiotech
Pharmaceuticals Inc. v. Conor Medsystems Inc., [2007] R.P.C. 20 (p. 487),
[2007] EWCA Civ 5, at para. 45 (rev’d [2008] R.P.C. 28 (p. 716), [2008] UKHL
49). The passage at para. 45 in the decision of the Court of Appeal remains
relevant and uncontested.
[60]
There is a similarity between the current state of the law in the
United Kingdom and the United States in respect of “obvious to try”. It is now
clear that both jurisdictions accept that an “obvious to try” test can be
relevant in an obviousness inquiry. The United States Supreme Court has now
stated so explicitly in KSR. The convergence of the United Kingdom and
the United States law on this issue suggests that the restrictiveness with
which the Beloit test has been interpreted in Canada should be
re-examined.
(d) Approach to Obviousness in Canada
[61]
I take as a starting point the words of Diplock L.J. in Johns-Manville,
at pp. 493-94:
Patent law can too easily be bedevilled by linguistics, and the citation
of a plethora of cases about other inventions of different kinds. The
correctness of a decision upon an issue of obviousness does not depend upon
whether or not the decider has paraphrased the words of the Act in some
particular verbal formula. I doubt whether there is any verbal formula which
is appropriate to all classes of claims.
Although we are
not here dealing with obviousness provided by an express statutory test, but
rather by necessary implication based on the requirement for invention in the Patent
Act , the words of Diplock L.J. are nonetheless apt because the courts have
often tended to treat the word formulation of Beloit as if it were a
statutory prescription that limits the obviousness inquiry.
[62]
I do not think that Hugessen J.A. in Beloit intended that
the rather colourful description of obviousness that he coined be applied in an
acontextual manner applicable to all classes of claims. I note particularly
that “obvious to try” is not a mandatory test in the United Kingdom or in the
United States. It is one factor of a number that should be considered, having
regard to the context and the nature of the invention.
[63]
In KSR, Kennedy J. warns against an overly rigid rule that
limits the obviousness inquiry. Rather, an expansive and flexible approach
that would include “any secondary considerations that [will] prove instructive”
will be useful (p. 1739). I read KSR as teaching that as in most
matters in which a judge or a jury is called upon to make a factual determination,
rigid rules are inappropriate unless mandated by statute.
[64]
While I do not think the list is exhaustive, the factors set
forth by Kitchin J. and adopted by Lord Hoffmann in Lundbeck, referred
to at para. 59 of these reasons, are useful guides in deciding whether a
particular step was “obvious to try”. However, the “obvious to try” test must
be approached cautiously. It is only one factor to assist in the obviousness
inquiry. It is not a panacea for alleged infringers. The patent system is
intended to provide an economic encouragement for research and development. It
is well known that this is particularly important in the field of
pharmaceuticals and biotechnology.
[65]
In Saint-Gobain PAM SA v. Fusion Provida Ltd., [2005] EWCA
Civ 177 (BAILII), Jacob L.J. stated, at para. 35:
Mere possible inclusion of something within a research programme on the
basis you will find out more and something might turn up is not enough. If it
were otherwise there would be few inventions that were patentable. The only research
which would be worthwhile (because of the prospect of protection) would be into
areas totally devoid of prospect. The “obvious to try” test really only works
where it is more-or-less self-evident that what is being tested ought to work.
In General
Tire, Sachs L.J. said, at p. 497:
“Obvious” is, after all, a much-used word and it does not seem to us that
there is any need to go beyond the primary dictionary meaning of “very plain”.
In Intellectual
Property Law, at p. 136, Professor Vaver also equates “obvious” to “very
plain”. I am of the opinion that the “obvious to try” test will work only
where it is very plain or, to use the words of Jacob L.J., more or less
self-evident that what is being tested ought to work.
[66]
For a finding that an invention was “obvious to try”, there must
be evidence to convince a judge on a balance of probabilities that it was more
or less self-evident to try to obtain the invention. Mere possibility that
something might turn up is not enough.
[67]
It will be useful in an obviousness inquiry to follow the
four-step approach first outlined by Oliver L.J. in Windsurfing
International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59
(C.A.). This approach should bring better structure to the obviousness inquiry
and more objectivity and clarity to the analysis. The Windsurfing
approach was recently updated by Jacob L.J. in Pozzoli SPA v. BDMO SA,
[2007] F.S.R. 37 (p. 872), [2007] EWCA Civ 588, at para. 23:
In the result
I would restate the Windsurfing questions thus:
(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, differences 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? [Emphasis added.]
It will be at
the fourth step of the Windsurfing/Pozzoli approach to obviousness that
the issue of “obvious to try” will arise.
i. When Is the “Obvious to Try” Test
Appropriate?
[68]
In areas of endeavour where advances are often won by
experimentation, an “obvious to try” test might be appropriate. In such areas,
there may be numerous interrelated variables with which to experiment. For
example, some inventions in the pharmaceutical industry might warrant an
“obvious to try” test since there may be many chemically similar structures
that can elicit different biological responses and offer the potential for
significant therapeutic advances.
ii. “Obvious to Try” Considerations
[69]
If an “obvious to try” test is warranted, the following factors
should be taken into consideration at the fourth step of the obviousness
inquiry. As with anticipation, this list is not exhaustive. The factors will
apply in accordance with the evidence in each case.
1. Is it more or less self-evident
that what is being tried ought to work? Are there a finite number of
identified predictable solutions known to persons skilled in the art?
2. What is the extent, nature and
amount of effort required to achieve the invention? Are routine trials carried
out or is the experimentation prolonged and arduous, such that the trials would
not be considered routine?
3. Is there a motive provided in the
prior art to find the solution the patent addresses?
[70]
Another important factor may arise from considering the actual
course of conduct which culminated in the making of the invention. It is true
that obviousness is largely concerned with how a skilled worker would have
acted in the light of the prior art. But this is no reason to exclude evidence
of the history of the invention, particularly where the knowledge of those
involved in finding the invention is no lower than what would be expected of
the skilled person.
[71]
For example, if the inventor and his or her team reached the
invention quickly, easily, directly and relatively inexpensively, in light of
the prior art and common general knowledge, that may be evidence supporting a
finding of obviousness, unless the level at which they worked and their
knowledge base was above what should be attributed to the skilled person.
Their course of conduct would suggest that a skilled person, using his/her
common general knowledge and the prior art, would have acted similarly and come
up with the same result. On the other hand, if time, money and effort was
expended in research looking for the result the invention ultimately provided
before the inventor turned or was instructed to turn to search for the
invention, including what turned out to be fruitless “wild goose chases”, that
evidence may support a finding of non-obviousness. It would suggest that the
skilled person, using his/her common general knowledge and the prior art, would
have done no better. Indeed, where those involved including the inventor and
his or her team were highly skilled in the particular technology involved, the
evidence may suggest that the skilled person would have done a lot worse and
would not likely have managed to find the invention. It would not have been
obvious to him/her to try the course that led to the invention.
(e) Application
to the Facts of This Case
[72]
Applying the four steps of Windsurfing/Pozzoli, I accept
the applications judge’s findings of fact where they are unaffected by his
rejection of the “obvious to try” test. Where application of the obvious to
try test requires further consideration of the evidence, it will be necessary
for this Court to make some findings of fact. In this case, I think it is
preferable to remitting the matter to the trial judge for redetermination and
subjecting his decision to further possible appeals.
[73]
Apotex filed its notice of allegation in 2002. It is now some
six years later. If the ‘777 patent is invalid, and provided all other
requirements are met, Apotex should be entitled to a notice of compliance from
the Minister without any further delay. Indeed, the NOC Regulations are
intended to be a summary procedure. I think it is time that this matter
finally be resolved. I would conduct the following analysis:
i. Identify the Notional Person Skilled in
the Art
[74]
Both parties agreed that a trained pharmachemist is that person.
ii. Identify the Relevant Common General
Knowledge of That Person
[75]
Apotex reiterates its submissions made with respect to
anticipation, insisting that, since the methods of separation were well known,
the claimed invention and its advantages would have been obvious to the person
skilled in the art. Shore J. found on the evidence before him that there were
five well-known methods to separate this racemate into its isomers. However,
he did not find that the relative advantage of the dextro-rotatory isomer would
have been known by the skilled person.
iii. Identify the Inventive Concept of the Claim in Question
or, if That Cannot Readily Be Done, Construe It
[76]
The construction of the claims in the ‘777 patent is not an
issue. It is agreed that they constitute the dextro-rotatory isomer of the
racemate and its pharmaceutically acceptable salts and processes for obtaining
them.
[77]
The inventive concept of the claims is not readily discernable
from the claims themselves. A bare chemical formula in a patent claim may not
be sufficient to determine its inventiveness. In such cases, I think it must
be acceptable to read the specification in the patent to determine the
inventive concept of the claims. Of course, it is not permissible to read the
specification in order to construe the claims more narrowly or widely than the
text will allow.
[78]
In the present case, it is apparent that the inventive concept of
the claims in the ‘777 patent is a compound useful in inhibiting platelet
aggregation which has greater therapeutic effect and less toxicity than the
other compounds of the ‘875 patent and the methods for obtaining that compound.
iv. Identify What if Any Differences Exist Between the ‘875
Patent and the ‘777 Patent
[79]
The ‘875 patent disclosed over 250,000 possible different
compounds predicted to inhibit platelet aggregation. Twenty-one compounds were
made and tested. Nothing distinguishes the racemate in this case from other
compounds disclosed or tested in terms of therapeutic effect or toxicity. As
stated above, there is no disclosure in the ‘875 patent of the specific
beneficial properties associated with the dextro‑rotatory isomer of this
racemate in isolation; nor was there disclosure of any advantages which flow
from using the bisulfate salt of the dextro‑rotatory isomer. The ‘875
patent did not differentiate between the properties of the racemate, its
dextro-rotatory isomer and levo-rotatory isomer or indeed the other compounds
made and tested or predicted to work.
[80]
On the other hand, the ‘777 patent claims that the invention of
the dextro‑rotatory isomer of the racemate, clopidogrel, and its
bisulfate salt discloses their beneficial properties over the levo‑rotatory
isomer and the racemate and expressly describes how to separate the racemate
into its isomers.
v. Viewed Without Any Knowledge of the ‘777
Patent, Do Those Differences Constitute Steps Which Would Have Been Obvious to
the Person Skilled in the Art or Do They Require a Degree of Inventiveness?
[81]
At this stage, it must be determined whether the nature of the
invention in this case is such as to warrant an “obvious to try” test. The
discovery of the dextro-rotary isomer and its bisulfate salt came after
experimentation. There were interrelated variables with which Mr. Badorc had
to experiment. An “obvious to try” test in this case would recognize the
evidence of the expert witnesses as to the discovery of the beneficial
properties of the dextro-rotary isomer and its bisulfate salt and the methods
for finding them.
[82]
The applications judge cannot be faulted for the analysis he
conducted as far as it went. However, he erred in not allowing for the
application of the “obvious to try” test, which is warranted in this case.
[83]
The following factors are therefore relevant at this fourth step
of the obviousness inquiry:
(1) Is It More or Less Self-Evident That What
Is Being Tried Ought to Work?
[84]
As I have observed earlier, Shore J. found that the skilled
person would not know, before separating this particular racemate into its
isomers and then testing the separated isomers, that the properties of the
dextro‑rotatory isomer would be different from the properties of the
racemate or the levo‑rotatory isomer (para. 81). Similarly, he found
that the person skilled in the art would not know before trying the different
salts in combination with the dextro‑rotatory isomer what the bisulfate
salt’s beneficial properties would be (para. 82).
[85]
Just because there are known methods of separating a racemate
into its isomers does not mean that a person skilled in the art would
necessarily apply them. The fact that there are such known methods of
separation will be of no account if the evidence does not prove that it was
more or less self-evident to try them. It is true that at the relevant time
there was evidence that a skilled person would know that the properties of a
racemate and its isomers might be different. However, a possibility of finding
the invention is not enough. The invention must be self-evident from the prior
art and common general knowledge in order to satisfy the “obvious to try”
test. That is not the evidence in this case.
(2) What Is the Extent, Nature and Amount of
Effort Required to Achieve the Invention?
[86]
As indicated, the applications judge found that there were five
well-known techniques for separating this racemate into its isomers. He also
found that there was no evidence that at the relevant time, a person skilled in
the art would know which one would work with the racemate at issue in this
case. The evidence was that a skilled person would eventually find the right
technique.
[87]
As earlier indicated, Shore J. also found that there was no
evidence that at the relevant time a person skilled in the art would know
before separating the racemate and testing the isomers what their properties
would be, although the specific properties of the isomers could be discovered.
There was evidence that, using known techniques, the properties of different
pharmaceutically acceptable salts to be used with the dextro-rotatory isomer
could be discovered.
[88]
However, in considering whether it was “obvious to try” to find
the invention, once it was decided to isolate the dextro-rotatory isomer, the
methods for doing so were known, the methods for testing the properties of the
isomers were known and the method for determining the beneficial properties of
the salts to be used with the isomer would also have been known.
[89]
According to Mr. Badorc’s affidavit, it took from November 1985
to April 1986 to find the ‘777 invention, and he was already familiar with the
‘875 invention. Potentially five different methods to separate the racemate
would have had to have been tried and tested before determining the properties
of the dextro-rotatory isomer. As in the case of anticipation, one might infer
that the applications judge, if asked to decide this question, would have held
that the investigation here was not routine, but rather was prolonged and
arduous. In any event, on the facts of this case, this factor would assume
small significance in view of the finding I make with respect to the whole course
of conduct discussed at para. 91 below.
(3) Is There a Motive From the Prior Art to
Find the Solution That the ‘777 Patent Addresses?
[90]
It is well known that the pharmaceutical industry is intensely
competitive. Market participants are continuously in search of new and
improved medications and want to reach the market with them as soon as
possible. So demand for an effective and non-toxic product to inhibit platelet
aggregation might be assumed to exist. However, nothing in the ‘875 patent or
common general knowledge provided a specific motivation for the skilled person
to pursue the ‘777 invention. The prior patent was a genus patent, and
selection might be expected. However, the prior patent did not differentiate
between the efficacy and the toxicity of any of the compounds it covered. This
suggests that what to select or omit was not then self-evident to the person
skilled in the art.
(4) What Is the Course of Conduct Which Was
Followed Which Culminated in the Making of the Invention?
[91]
Mr. Badorc’s affidavit reveals that for several years prior to
November 1985, Sanofi was in the process of developing the racemate in its
salified form. In November 1985, the racemate was being tested in preliminary
human clinical trials. It was at that time that Mr. Badorc was asked to
separate the racemate into its isomers. After he discovered that the
dextro-rotatory isomer was active and non-toxic and that the levo-rotatory
isomer was non-active and toxic, Sanofi decided to develop the dextro-rotatory
isomer and abandon its work on the racemate. However, this was after it had
“spent millions of dollars and several years developing [the racemate] up to
the point of preliminary human clinical trials” without at least trying to see
if the dextro‑rotatory isomer had advantageous properties to those of the
racemate (Affidavit of Mr. Badorc, at para. 25). This evidence was
uncontradicted.
(5) Was the Invention of the ‘777 Patent
“Obvious to Try”?
[92]
The methods to obtain the invention of the ‘777 patent were
common general knowledge. It can be assumed that there was a motive to find a
non-toxic efficacious product to inhibit platelet aggregation in the blood.
However, it was not self-evident from the ‘875 patent or common general
knowledge what the properties of the dextro-rotatory isomer of this racemate
would be or what the bisulfate salt’s beneficial properties would be and
therefore that what was being tried ought to work. The course of conduct and
the time involved throughout demonstrate that the advantage of the
dextro-rotatory isomer was not quickly or easily predictable. Had the
dextro-rotatory isomer been “obvious to try”, it is difficult to believe that
Sanofi would not have opted for it before unnecessary time and investment were
spent on the racemate. I conclude that the prior art and common general
knowledge of persons skilled in the art at the relevant time were not
sufficient for it to be more or less self-evident to try to find the dextro-rotatory
isomer.
(f) Conclusion on Obviousness
[93]
As I have earlier explained, there was a significant difference
between the ‘875 genus patent and the ‘777 selection patent. The difference
was not obvious. Having regard to the foregoing analysis, I conclude that the
allegation of obviousness is not justified.
VII. Double Patenting
[94]
Apotex also bases its challenge to the validity of the ‘777
patent on double patenting. Apotex also challenges the validity of the
doctrine of selection patents itself on this basis.
[95]
There may only be one patent covering an invention (Whirlpool
Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67, at para. 63).
Apotex says that a selection patent claims the same invention as the original
class or genus patent and as a result, the selection patent cannot be valid.
[96]
The concern expressed by Apotex is that the doctrine of selection
patents allows a patent holder to “evergreen” an invention. The original genus
patent is granted for a finite period of years. If a selection patent is later
obtained by the owner of the genus patent covering the same invention as the
genus patent, the number of years the owner is entitled to exclude others from
making or using the invention is extended, contrary to the limited period of
exclusivity provided by the original patent.
[97]
Evergreening is a legitimate concern and, depending on the
circumstances, strategies that attempt to extend the time limit of exclusivity
of a patent may be contrary to the objectives of the Patent Act . The
Act aims to promote inventiveness by conferring exclusivity for a limited
period of time while providing for public disclosure of the invention to enable
others to make or use it after expiry of the period of exclusivity.
[98]
However, a generalized concern about evergreening is not a
justification for an attack on the doctrine of selection patents for two
reasons. First, a selection patent may be sought by a party other than the
inventor or owner of the original genus patent. In such a case, anticipation
or obviousness may be an issue, but evergreening does not arise.
[99]
At the hearing, counsel for Apotex submitted that, in the
pharmaceutical industry, the only party that would ever attempt to obtain a
selection patent would be the genus patent holder. This is a highly
competitive industry and a market participant who is able to develop a more
effective product might be expected to be anxious to do so and seek patent
protection through a selection patent even if it requires the making of an
agreement with the holder of the genus patent to allow for the marketing of the
selected product. However, even if counsel is correct, the doctrine of genus
and selection patents is not restricted to the pharmaceutical industry. It is
of general applicability.
[100]
Second and more importantly, selection patents encourage improvements
by selection. The inventor selects only a bit of the subject matter of the
original genus patent because that bit does something better than and different
from what was claimed in the genus patent.
[101]
The applications judge found that the claims of the ‘777 and ‘875
patents were not identical or coterminous. I agree with him. Apotex’s factum
compares claims 1, 8, 14 and 15 of the ‘875 patent with claims 1 and 3 of the
‘777 patent.
‘875 Patent
Claim 1 “A
process for the preparation of derivatives of general formula (I): . . . as
well as the 2 enantiomers or their mixture [racemate] of these compounds
of formula (I); wherein: . . . if desired, its enantiomers are separated
and/or it is salified by mineral or organic acid action; . . .” (page 14)
Claim 8 “Process
according to claim 1 for the preparation of methyl %-[4,5,6,7‑tetrahydro‑thieno[3,2‑c]‑5‑pyridyl]‑o.chlorophenylacetate,
wherein the 4,5,6,7‑tetrahydro thieno[3,2‑c]pyridine is condensed
over the methyl 2‑chloro‑o.chlorophenylacetate, and the derivative
sought, which is isolated, is obtained.” (page 15)
Claim 14
“Derivatives of general formula (I): . . . as well as the 2 enantiomers
or their mixture of these compounds of formula (I). . .
Claim 15 “Methyl %‑[4,5,6,7‑tetrahydro‑thieno[3,2‑c]‑5‑pyridyl]‑o.
chlorophenylacetate, each time it is obtained by the process of claim 8
or its manifest chemical equivalents.” (page 16)
(Underlining in trial reasons; italics added by Apotex.)
‘777 Patent
1. Dextro‑rotatory
isomer of methyl alpha‑5(4, 5, 6, 7‑tetrahydro (3, 2‑c)
thieno pyridyl) (2‑chlorophenyl)‑acetate and its
pharmaceutically acceptable salts.
3. Hydrogen sulfate of the dextro‑rotatory isomer of
methyl alpha‑5 (4, 5, 6, 7‑tetrahydro (3, 2‑c) thieno
pyridyl) (2‑chlorophenyl)‑acetate.
(Underlining and italics added by Apotex.)
[102]
Although Apotex does not expressly state which of the ‘875 and
‘777 claims it is comparing, it is apparent, for double patenting purposes,
that there is no identity between the product claims 1 and 3 of the ‘777 patent
and claims 1, 8 and 15 of the ‘875 patent because claims 1 and 8 are process
claims and claim 15 is a product by process claim. The only comparison that
need be considered is between claim 14 of the ‘875 patent and claim 1 of the
‘777 patent. Claim 3 of the ‘777 patent reflects the hydrogen sulfate of claim
1 of the ‘777 patent, so that if claim 1 is not invalid, claim 3 will not be
invalid either.
[103]
Claim 14 of the ‘875 patent claims all derivatives of general
formula (I) as well as the two isomers and the racemic mixture. It is a broad
claim for a class or genus. Claim 1 of the ‘777 patent is specific. It claims
only the dextro‑rotatory isomer of the racemate. This is a typical
selection patent.
[104]
Sound prediction was the basis for granting the original genus
patent. That had to be the case when the genus involved over 250,000 possible
compounds. Not every compound would itself have been tested. But there was,
to the satisfaction of the Commissioner of Patents, sound prediction that what
was included in the original genus patent was new, useful and not obvious. It
was later determined that some of the subject matter of the original genus
patent did not work or did not work as well as the subject matter of the
selection patent. That information is valuable.
[105]
The doctrine of “sound prediction”, explicitly adopted by this
Court in Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108,
balances the public interest in early disclosure of new and useful inventions
even before their utility has been fully verified by tests, and the public
interest in avoiding cluttering the public domain with useless patents and
granting monopoly rights in exchange for misinformation: see Apotex Inc. v.
Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, 2002 SCC 77, at para. 66.
In Monsanto, Pigeon J., writing for the majority, drew the following
conclusion, at p. 1117:
I have quoted again the passage quoted by the [Patent Appeal] Board
because I consider the last sentence of the paragraph of some importance as it
does clearly indicate what is meant by a “sound prediction”. It cannot mean
a certainty since it does not exclude all risk that some of the area
covered may prove devoid of utility. It thus appears to me that the test
formulated by Graham J. [in Olin Mathieson Chemical Corp. v. Biorex
Laboratories Ltd., [1970] R.P.C. 157 (Ch. D.)] involves just two possible
reasons for rejecting claims such as those in issue.
1. There is evidence of lack of utility in respect of some of the
area covered; [or]
2. It is not a sound prediction. [Emphasis added.]
This approach
has been consistently accepted by courts in Canada (see for example Ciba‑Geigy
AG v. Commissioner of Patents (1982), 65 C.P.R. (2d) 73 (F.C.A.)).
[106]
In the present case, it was found that the levo-rotatory isomer
did not work at all and was toxic. The racemate did not work as well as the
dextro-rotatory isomer. Isolating the dextro-rotatory isomer as being more
effective and less toxic than other compounds of the genus patent is a valuable
advance to be encouraged as a matter of patent policy.
[107]
It is true that the sound prediction of the ‘875 patent that the
racemate and the levo-rotatory isomer produced the same results as the
dextro-rotatory isomer was not borne out. That may leave parts of the original
genus patent open to challenge. But it does not affect the validity of the
selection patent.
[108]
Apotex argues that the focus in a double patenting challenge is
on the claims of the two patents rather than on the disclosure. I agree. In Whirlpool,
Binnie J. stated, at para. 63:
It is clear that the prohibition against double patenting involves a
comparison of the claims rather than the disclosure, because it is the claims
that define the monopoly.
Whirlpool
was not a selection patent case. However, because selection patents are to be
subject to the same considerations as other patents, the clear statement of
Binnie J. in Whirlpool must apply to selection patents.
[109]
I agree with Apotex that a challenge to patent validity based on
double patenting does not require the existence of identical language in the
two patent claims. Even so, the wording of the claims, however different, must
claim the same invention.
[110]
The invention defined by claim 14 of the ‘875 patent is not the
same as the invention claimed by claim 1 of the ‘777 patent because the former
is broader than the latter. Although not a selection patent case, there is a
striking passage in the judgment of Lord Simonds in May & Baker Ltd. v.
Boots Pure Drug Co. (1950), 67 R.P.C. 23 (H.L.), at p. 32. It describes a
scenario very much the same as in the case at bar:
Is there then a difference in the inventions claimed
in the original and amended specifications? On the one hand a vast range of
possible compounds, a fragment no doubt in the whole sphere of organic
chemistry yet so numerous that the number becomes meaningless, within which no
one can say what hidden things might be brought to light, what benefits
discovered for the relief of humanity. On the other hand two specific drugs.
Are these inventions the same or different inventions? My Lords, I hesitate to
appeal to common sense, lest others should take a different view of the case.
Yet in the consensus of opinion of all the learned judges who have dealt with
this matter I find justification for the view which I most emphatically hold
that it is plain common sense to say that the inventions are not the same but
different: and I think that, if they are different, the substantial difference
could not be denied.
I think Lord
Simonds’ comments cover this case precisely.
[111]
To this point, the issue has been what is sometimes called “same
invention” double patenting. This is the main thrust of Apotex’s double
patenting argument. The applications judge found that the claims in the ‘777
and ‘875 patents were not identical or coterminous, requirements to prove same
invention double patenting: see Whirlpool, at paras. 64-65.
[112]
Apotex also relies on “obviousness” double patenting. Binnie J.
explains in Whirlpool, at para. 66, that “obviousness” double patenting
is a more flexible and less literal test that prohibits the issuance of a
second patent with claims that are not “patentably distinct” from those of the
earlier patent.
In Commissioner
of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius &
Bruning, it was held that even though the claims were not identical nor
coterminous, the dilution of a new substance once its medical uses were
established in the first patent did not result in a further invention
justifying a second patent. Even though the claims were not identical or
coterminous, the subsequent patent was found to be invalid.
[113]
A selection patent that claims a compound that is patentably
distinct from the genus patent will not be invalid for obviousness double
patenting. Here, out of the many compounds predicted to be effective as
exhibiting platelet aggregation inhibiting activity in the ‘875 patent, it was
found that the dextro-rotatory isomer of the racemate relevant in this case had
beneficial properties over both the racemate and the levo-rotatory isomer. As
I have explained above, the claims in the ‘777 patent reflect a patentably
distinct compound from the compounds in the ‘875 patent. As a result, there is
no basis for a challenge based on “obviousness” double patenting.
[114]
While double patenting requires a comparison of the claims of a
genus and selection patent, it is necessary that the specification of the
selection patent define in clear terms the nature of the characteristic which
the patentee alleges to be possessed by the selection for which he claims a
monopoly. See I. G. Farbenindustrie, at p. 323. Here the ‘777
specification satisfies this requirement by providing, at p. 1:
In an unexpected manner only the dextro-rotatory
enantiomer Id exhibits a platelet aggregation inhibiting activity,
the levo-rotatory enantiomer I1 being inactive. Moreover, the
inactive levo-rotatory enantiomer I1 is the less well tolerated of
the two enantiomers. [A.R., at p. 156]
[115]
For these reasons, I do not find Apotex’s challenge to selection
patents on the grounds of double patenting, and in particular that Sanofi has
engaged in double patenting in the case of the ‘777 and ‘875 patents, to be
well founded.
VIII. Disposition
[116]
It follows from the findings above that claims 1 and 3 of the
‘777 patent are neither anticipated nor obvious. The composition claims 10 and
11 of the ‘777 patent are therefore also neither anticipated nor obvious.
Finally, I find that Apotex’s arguments in respect of double patenting are not
well founded. In the result, the allegations that the ‘777 patent is invalid for
anticipation, obviousness and double patenting are not justified.
[117]
I would dismiss the appeal with costs.
Appeal dismissed with costs.
Solicitors for the appellant: Goodmans, Toronto.
Solicitors for the respondents Sanofi‑Synthelabo Canada Inc. and
Sanofi‑Synthelabo: Gowling Lafleur Henderson, Ottawa.
Solicitors for the intervener the Canadian Generic Pharmaceutical
Association: Hazzard & Hore, Toronto.
Solicitors for the intervener BIOTECanada: Torys, Toronto.
Solicitors for the intervener Canada’s Research‑Based
Pharmaceutical Companies: Ogilvy Renault, Toronto.