Date: 20090116
Docket: A-484-07
Citation: 2009 FCA 8
CORAM: LÉTOURNEAU J.A.
NOËL J.A.
BLAIS J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
and
PFIZER CANADA INC. and
PFIZER IRELAND PHARMACEUTICALS
Respondents
(Applicants)
and
THE MINISTER OF HEALTH
Respondent
(Respondent)
REASONS FOR
JUDGMENT
NOËL J.A.
[1]
This
is an appeal from the decision of Justice Mosley (the Federal Court Judge) allowing
the application brought by Pfizer Canada Inc. and Pfizer Ireland
Pharmaceuticals (the respondents) to prohibit the Minister of Health (the Minister)
from issuing a Notice of Compliance (NOC) to Apotex (the appellant or Apotex)
in accordance with subsection 6(1) of the Patented Medicines (Notice of
Compliance) Regulations, S.O.R./93-133 (PM(NOC) Regulations) for its
sildenafil tablets until after the expiration of the respondents’ Canadian Patent
No. 2,163,446 (the ‘446 patent).
[2]
In
the Memorandum filed in support of its appeal, the appellant pursued the issues
of faulty disclaimer, claims broader than the invention made and disclosed, patent
ineligibility, obviousness and anticipation. Two days prior to the scheduled
hearing, the appellant wrote to advise that it would only pursue the appeal in
respect of the issue of obviousness, intending to rely upon the decision of the
Supreme Court of Canada in Apotex Inc. v. Sanofi-Synthelabo Canada Inc.,
2008 SCC 61 (Sanofi-Synthelabo) released November 6, 2008.
THE RELEVANT FACTS
[3]
The
respondents market a drug for the treatment of Erectile Dysfunction (ED), under
the brand name VIAGRA.
[4]
The
respondents obtained patent protection for the use of the compound sildenafil
for this purpose. They obtained the ‘446 patent on July 7,1998 from an
application filed in Canada on May 13, 1994 claiming priority from Great
Britain Patent Application No.
9311920.4 filed on June 9, 1993. The ‘446 patent will expire on May 13, 2014.
[5]
The
respondents submitted
a patent list to the Minister pursuant to subsection 4(1) of the PM(NOC)
Regulations in connection with NOCs for 25
mg, 50 mg and 100 mg oral tablets of the drug sildenafil citrate (sildenafil).
The ‘446 patent was added to the Patent Register in respect of the above NOCs.
[6]
The
appellant delivered
its Notice of Allegation (NOA) on June 16, 2005 to the respondents (i.e.,
specifically, Pfizer Canada Inc.) in relation to the ‘446 patent. In its NOA,
the appellant claims to have filed with the Minister a submission for
sildenafil citrate tablets for oral administration in strengths of 25, 50 and
100 mg tablets for the treatment of ED in men, arguing that the ‘446 patent is
invalid for several reasons, notably that the use of sildenafil for the
treatment of ED in men was obvious in light of the state of the art, and that
it should therefore, be allowed to market its own generic version.
[7]
The
respondents filed their Notice of Application on July 28, 2005 and it was
amended on February 5, 2007.
THE PATENT AT ISSUE
[8]
The ‘446 patent
relates to the use of a series of pyrazolo[4,3-d] pyrimidin-7-ones compounds and their
pharmaceutically acceptable salts for the treatment of ED. Sildenafil is one such
compound and has the formula
5-[2-ethoxy-5-(4-methyl-1-piperazinylsulphonyl)phenyl]-1-
methyl-3-n-propyl-1,6-dihydro-7Hpyrazolo[4,3-d]pyrimidin-7-one].
[9]
Each of
the claims in issue is specific to the treatment of ED with sildenafil, or its
salt, sildenafil citrate, which is the active ingredient in the appellant’s
proposed products. For ease of reference, the relevant claims are reproduced
below:
Claim
1
The
use of a compound of formula (I) [which is then defined] or a
pharmaceutically acceptable salt thereof, or a pharmaceutical composition
containing either entity, for the manufacture of a medicament for the curative
or prophylactic treatment of erectile dysfunction in man.
Claims
2-4 in essence claim “The use according to claim 1” and give more narrow
definitions for formula (I).
Claim
7
The
use according to claim 4 wherein the compound of formula (I) is
5-[2-ethoxy-5-(4-methyl-1-piperazinylsulphonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7Hpyrazolo[4,3-d]pyrimidin-7-one]
or a pharmaceutically acceptable salt thereof.
Claim
8
The
use according to any one of claims 1 to 7 for the manufacture of a medicament
for the curative or prophylactic treatment of erectile dysfunction in man.
Claim
18
The
use of a compound of formula (I) according to any one of claims 1 to 7, or a
pharmaceutically acceptable salt thereof, for the curative or prophylactic
treatment of erectile dysfunction in man.
Claim
22
The
use according to any one of claims 1 to 8 wherein the
medicament is adapted for oral treatment.
THE FEDERAL COURT DECISION
[10]
The
Federal Court Judge concluded that, based on the evidence, the respondents’
discovery was truly inventive and that none of the appellant’s attacks on the patent
should succeed. He held that the respondents met their legal burden to
establish the validity of the ‘446 patent on a balance of probabilities and
that the application to prohibit the Minister from issuing an NOC to the
appellant until after the expiry of the ‘446 patent should be granted.
[11]
More
specifically, with
respect to the issue of obviousness, which is the only one left to be
considered in the present appeal, the Federal Court Judge held that the core
question in the case was whether the person of ordinary skill in the art, in the light of the state of the art
and of common general knowledge as at the claimed date of invention, would have found the solution
taught by the patent. The “solution taught by the patent” that he used for this
inquiry was consistent with his claim construction, namely “the appreciation
that the oral administration of sildenafil, as a potent PDE5 inhibitor, would
be useful in the treatment of [ED] in men” (Reasons, para. 57).
[12]
On the
basis of the scientific literature and the experts’ opinions tendered in
evidence, the Federal Court Judge defined the notional skilled person for the ‘446
patent as a trained and experienced scientist working in drug development with
a knowledge of penile
physiology and erectile response.
[13]
In
considering the relevant prior art, the Federal Court Judge referred in
particular to the National Institute of Health Consensus Statement resulting
from the Consensus Conference on Impotence held in December 1992. While he noted that the
document did not purport to be an exhaustive review of the literature, it was
useful as a reference to what was commonly known and was not known at the time
by the highly trained physicians and scientists experienced in the field of ED
research and therapy. He held that what was clear from the document was that
important information was lacking and that more work needed to be done to fully
understand penile physiology. In his view, the content of the document could
not be reconciled with what the appellant’s experts claimed to be the state of
the art at the time.
[14]
The
Federal Court Judge also considered the specific literature references relied
on by the appellant in support of its claim of obviousness, in particular three
papers written by Drs. Rajfer, Murray and Bush (Reasons, para. 87). He
concluded that based on an analysis of the expert testimony, none of the
literature references would have led a skilled person directly and without difficulty
to the invention of the ‘446 patent.
[15]
In
concluding his obviousness analysis, the Federal Court Judge held that what emerged from
the prior art was a picture of a field of rapidly advancing science which led
to the discovery, but which did not point directly to it. He specifically noted
that, in 1993, none of the scientists who had speculated that PDE inhibition
might be a factor in erectile tissue physiology, arrived at the solution of
using oral administration of sildenafil as a PDE5 inhibitor in the treatment of
ED. He therefore concluded that the evidence did not establish that the
solution taught by the patent was obvious at the time. At best, the Federal
Court Judge noted that there was speculation, which in hindsight proved to be
correct, that PDE5 inhibitors might treat
impotence.
[16]
In
addition to his findings on the state of the art, the Federal Court Judge also
considered the other factors for analyzing obviousness as set out in Novopharm Ltd. v.
Janssen-Ortho Inc.
2007 FCA 217, aff’g 2006 FC 1234 (Novopharm). He found that there was a
strong motivation to come up with a convenient drug treatment for ED, and
genuine surprise when the respondents did so. He also noted the cumulative
effect of the secondary indicia such as the commercial success of VIAGRA®, its
wide use, and the surprise that accompanied its first publication, all of which
he found to further support his conclusion that the use of sildenafil to treat
ED was not obvious.
ORAL SUBMISSIONS OF THE APPELLANT AT THE HEARING
[17]
The
appeal was argued on the basis of the revised grounds first announced by the
appellant two days before the hearing. No advance submissions were provided, so
that the exact nature of the issues only became clear as the hearing progressed.
[18]
The
appellant argued that the Supreme Court in Sanofi-Synthelabo brought a
fundamental change to the jurisprudential approach to obviousness in Canada by incorporating the “worth
a try” test into Canadian law. The state of the law in Canada is now in line with
that applicable in the United Kingdom (U.K.) so that U.K. precedents become highly
relevant. The “worth a try” test must now be conducted in cases involving advances
won by experimentation (Sanofi-Synthelabo, supra, para. 68). This is
such a case and the Federal Court Judge erred in failing to apply this test.
[19]
The
appellant urges us to apply the “worth a try” test and suggests that the
decision of Mr. Justice Laddie of the Chancery Division in Lilly Icos Ltd.
v. Pfizer Ltd., [2001] F.S.R. 16 (Pfizer Ltd.), confirmed by the English
Court of Appeal in Lilly Icos Ltd. v. Pfizer Ltd., [2002] EWCA Civ 1 (Lilly
Icos Ltd.), provides the “blue print” for the application of this test. In
these decisions the U.K. Courts concluded that the relevant claims of the patent
in issue in the present appeal were invalid on the ground of obviousness.
[20]
The
appellant further argues that the previously published patent application
EP-0463756A1 (the ‘756 patent, also referred to as the Bell application) was a crucial
element in the obviousness analysis conducted by the U.K. Courts. It identifies
sildenafil
(the active ingredient in VIAGRA) as one of five compounds useful in the treatment
of cardiovascular disorders (Appeal Book, Vol. 4, pp. 1343 to 1349). This patent was referred to
by Apotex in its NOA in order to establish that the relevant claims were made
obvious by the state of the prior art. According to the appellant, the ‘756 patent
was an essential component of the prior art and the Federal Court Judge erred
in law in failing to consider this patent in his obviousness analysis.
[21]
Counsel
for the appellant confirmed in the course of his argument that his appeal rests
solely on these two grounds, and that if the Court should come to the
conclusion that the Federal Court Judge applied the proper test, and did not
ignore the ‘756 patent as alleged, the appeal should be dismissed. To be clear,
the construction of the patent and the findings of fact made by the Federal
Court Judge are no longer in issue.
ANALYSIS AND DECISION
[22]
The first
ground of appeal is based on the appellant’s understanding of the decision of
the Supreme Court in Sanofi-Synthelabo and in particular the test that
was adopted in that case. The appellant views this decision as establishing
that the “worth a try” test is now part of the law of Canada. As the Federal Court Judge
did not apply this test, the appellant invites us to do so.
[23]
Before considering
whether the Federal Court Judge failed to apply the appropriate test, as is
being alleged by Apotex, the test in question must first be identified. In Sanofi-Synthelabo,
Rothstein J. writing for the Court began his obviousness inquiry by noting that
the Federal Court Judge in that case (Shore J.) conducted his analysis on the
basis that the test set out by this Court in Beloit Canada Ltd. v.
Valmet Oy, [1986] F.C.J. No. 87, 8 C.P.R. (3d) 289 (Beloit) at page 294 would
not accommodate the “worth a try” test (para. 52). Rothstein J. identified the position
of Apotex in that case as follows (para. 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.
[24]
Rothstein J. first looked to the United States and U.K. case law. He concluded that a test described as the “obvious to try” test
has been accepted in both of these jurisdictions (paras 56 to 59). Given the
state of the law in these other jurisdictions, Rothstein J. says (para. 60):
… the restrictiveness with which the Beloit test has been interpreted
in Canada should be
re-examined.
[25]
Under the
heading “Approach to Obviousness in Canada”, Rothstein J. notes that until now
Canadian Courts have tended to treat the Beloit test as a statutory
prescription that limits the obviousness inquiry (para. 61). The “obvious to
try” test can have a useful role under Canadian law (para. 64).
[26]
Rothstein
J. then focuses on the scope of this test. After noting that the factors set
forth in the passage adopted by Lord Hoffmann in Generics (UK) Ltd. v. H. Lundbeck A/S, [2008]
R.P.C. 19, [2008] EWCA Civ 311, which he quotes at paragraph 59, provide useful
guidance, he
says (para. 64):
… 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.
[27]
Rothstein
J. then hones in on the precise test. At paragraph 66, he says:
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.
[My emphasis]
In the prior paragraph, he made it clear that the word “obvious” in
the phrase “obvious to try” is to be given its primary meaning of “very plain”.
[28]
I take it
from this that the test adopted by the Supreme Court is not the test loosely referred
to as “worth a try”. After having noted Apotex’ argument that the “worth a try”
test should be accepted (para. 55), Rothstein J. never again uses the
expression “worth a try” and the error which he identifies in the matter before
him is the failure to apply the “obvious to try” test (para. 82).
[29]
The test
recognized is “obvious to try” where the word “obvious” means “very plain”. According
to this test, an invention is not made obvious because the prior art would have
alerted the person skilled in the art to the possibility that something might be
worth trying. The invention must be more or less self-evident. The issue which
must be decided in this appeal is whether the Federal Court Judge failed to
apply this test.
[30]
In my
respectful view, he did not. While the Federal Court Judge does not use the
phrase “obvious to try”, his reasons show that he conducted his analysis along
the dividing line drawn in Sanofi-Synthelabo. Specifically, he rejected
the contention that the invention was obvious based on mere possibilities or
speculation and looked for evidence that the invention was more or less
self-evident.
[31]
A review
of the Federal Court Judge’s assessment of the experts’ opinions and the
literature references tendered in evidence supports this conclusion. More
specifically, it is apparent that he turned his mind to the question of whether
the patented invention was more or less self-
evident in examining this evidence. Indeed, the following excerpts
show that he found, based on the expert evidence, that the invention was not
self-evident:
[76] In
Dr. Brock’s view, the discovery of the ability of a selective PDE5 inhibitor,
such as sildenafil, to be an effective and safe oral agent to enhance erectile
function in man was fortuitous and insightful. The fact that hundreds of
active investigators had studied ED for decades without this realization, in
his opinion, strongly supports this conclusion.
[83] Dr.
Christ was actively researching erectile physiology and mechanisms of erectile
dysfunction in the late 1980s and early 1990s. He states that prior to the
publication of Pfizer’s positive results with sildenafil citrate, it was not
obvious to scientists working in the field that a PDE5 inhibitor could be used
to treat ED and it also was not obvious that oral administration of a PDE5
inhibitor would work. Indeed, he says, many remained skeptical even after
publication of the Pfizer results. The focus was on intracavernous drug
injections and other therapies. It was counterintuitive and surprising that
a PDE5 inhibitor administered orally could have a localized effect …
[84] … In
[Dr. Palmer’s] affidavit he recounts the history of the physiology of NO and
its role as a chemical messenger. Palmer says that while by the early 1990s
much was known about this, the surrounding complexity tended to blur what now
appears clear in hindsight. He states that it was not commonly and generally
accepted at the relevant time that the NANC pathway was the right pathway to
target for treatment of impotence, citing a compilation of abstracts from the
first meeting of the European Society for Impotence Research in September 1995.
In particular, Palmer refers to an abstract of research by a leading group at
the Hanover
Medical School (Taher,
Stief et al.,) which describes the continuing controversy regarding the
involvement of cyclic nucleotide monophosphates in the process of penile
erection in males. The research of the Hanover group into
the potential of inhibiting PDEs as a treatment for impotence led them away
from PDE5 to PDE3.
[85] Dr.
Heaton was conducting research on neural stimulation of the NANC pathway for ED
from about 1990 and attended an international impotence research conference at Singapore in 1994
where developments in the field were presented. He describes his first
reaction when he heard that Pfizer had an oral PDE inhibitor compound for ED as
"real surprise and skepticism". He and many other scientists at
the time doubted that the selectivity of sildenafil would be enough to avoid
significant systemic effects at clinically useful doses. They found it
surprising and "revolutionary" that sildenafil worked when an
erection was wanted and worked through oral administration as opposed to local
injection. He saw this development as a paradigm shift in the field of ED
treatment.
[My emphasis]
[32]
In the
same vein, it is also apparent that the Federal Court Judge was looking for
more than mere possibilities in examining the primary literature references
relied upon by the appellant. With respect to the Rajfer and Trigo-Rocha
papers, he found that they did not disclose, or even
suggest, that a cGMP
PDE5 inhibitor, like sildenafil, would treat ED:
[101] In the
view of the applicants’ experts, and as supported by cross-examination of the
respondent’s experts, what the 1992 Rajfer article did was essentially to
confirm further previous work that the NO/cGMP pathway in the corpus cavernosum
was involved in penile erection. It did not suggest the use of cGMP
inhibitors for the treatment of ED. This conclusion is not altered by the
subsequent Trigo-Rocha studies from the same group. They do not, as Apotex argues,
disclose that the solution to ED is to use a cGMP PDE inhibitor. Rather
they present an in vivo parallel of the Rajfer findings in healthy dogs,
not what might be expected in either impotent dogs or impotent men. They do
not point specifically to, or even suggest, the use of cGMP PDE inhibitors as a
therapeutic remedy but provide further evidence for the involvement of the
NO pathway in vivo.
[My
emphasis]
[33]
With
respect to the Murray paper, while it identified some cGMP PDE5 inhibitors,
their relationship to smooth muscle relaxation and their potential uses as a
drug therapy, the Federal Court Judge found that (Reasons, para. 105) “… at
best, [the paper could] be taken to suggest that there [was] a possibility that
cGMP PDE5 inhibitors could be developed for ED, subject to human testing,
but that, in any event, [it] point[ed] to the potential utility of zaprinast,
not sildenafil.”
[34]
Similarly,
the Federal Court Judge noted that a similar conclusion could be drawn from the
Bush paper, namely that it was not a given that a specific cGMP
PDE inhibitor would be clinically effective in treating ED and that it was a
possibility to be
considered and further researched:
[121] In Dr.
Brock's opinion, when a skilled person read [the summary and conclusion section
of the Bush paper] in context, he would not have understood that a specific
cyclic GMP PDE inhibitor would successfully treat erectile dysfunction. It was
a possibility to be considered and further researched, which is consistent with
the views of the other experts at the time such as Rajfer and Trigo-Rocha.
[122] For Dr.
Heaton, the Bush thesis showed just how much remained unknown that could be the
subject of future research projects. It was not a given that a cGMP PDE
inhibitor would be clinically effective as a treatment for ED and there is no
suggestion in the thesis that such a drug could be administered orally. On
cross examination, Dr. Corbin agreed with the suggestion that what Dr. Bush was
saying is that understanding the mechanism for relaxation will establish a
basis for future research into not only the mechanism of erection but also for
treatment of impotence. But that does not, in my view, point directly to
the invention claimed by the ‘446 patent.
[My
emphasis]
[35]
The
Federal Court Judge goes on to confirm that the most that he could gather from
the prior art at the priority date was that using orally administered sildenafil
to treat ED was “worth a try”:
[126] Even if the person of ordinary skill had arrived, based on the art,
at oral administration of sildenafil, and being mindful of the caution stated
in Novopharm above about the use of catchphrases, the most that could
have been said at the priority date is that it would be “worth a try”. Indeed
that is essentially how Dr. Ringrose characterized his view when he suggested
that sildenafil be tried out as a treatment for impotence by the Urogenitals
Group at Pfizer in January, 1992. …
[My emphasis]
In so saying, the Federal Court Judge equates the expression
“worth a try” with “a possibility worth exploring” as Dr. Ringrose had
characterized the matter when he suggested that sildenafil be tried as a
treatment for impotence (Reasons, para. 61).
[36]
It is
apparent from the above review that the Federal Court Judge throughout his
analysis looked for more than possibilities understanding that mere
possibilities were not enough, and that the prior art had to show more than
that. His appreciation of the matter is summed up and further demonstrated by
his concluding remarks (Reasons, para. 125):
Although
there was a significant amount of evidence indicating that cGMP PDE inhibitors
should be further explored with regards to the treatment of ED in the months
leading up to the Pfizer discovery, the evidence does not in my view establish
that the solution taught by the patent was obvious at the time. At best
there was speculation, which in hindsight proved to be correct, that PDE5
inhibitors might treat impotence. Experiments with zaprinast, a cGMP PDE
inhibitor, had been performed but in an effort to understand how the erectile
process works, not how to treat ED.
[My emphasis]
[37]
In so
holding, the Federal Court Judge drew the line precisely where the Supreme
Court drew it in Sanofi-Synthelabo when it held that (para. 66) “the
mere possibility that something might turn up is not enough”.
[38]
The other
alleged error is that the Federal Court Judge failed to consider the ‘756
patent in his obviousness analysis. The ‘756 patent was relied upon by Apotex
in the Federal Court to show that by 1993, it had been disclosed that sildenafil
was a potent and selective cGMP PDE inhibitor that could be orally-administered
for the treatment of ailments involving the need to relax smooth muscle
(Apotex’ Memorandum, para. 29). Had the Federal Court Judge considered this element
of the prior art, he would have been bound to conclude that the skilled person
had the means to obtain the invention.
[39]
In this
respect, Counsel for Apotex pointed to the decision of Mr. Justice Laddie in
the U.K. case who began his analysis by referring to the ‘756 patent (Pfizer
Ltd., supra, para. 23). This, according to Apotex, highlights the importance
of the ‘756 patent and the extent of the error committed by the Federal Court
Judge in failing to give it any consideration.
[40]
Although
the Federal Court Judge does not refer to the ‘756 patent by name in his
obviousness analysis (he does so in his anticipation analysis), it is clear
that he had this patent in mind. The issue before the Federal Court Judge,
based on the way in which he construed the patent, was whether the skilled
person would be led to use sildenafil orally to treat ED. The ‘756
patent identified sildenafil as an antihypertensive. The Federal Court Judge
did not give the ‘756 the significance which Apotex contends it should have
because he found as a fact that it would have been counterintuitive to use a
drug that lowers blood pressure to treat ED when ED is associated with low
blood pressure (Reasons, paras 68, 78, 83, 85, 95 and 98). While Apotex
disagrees with this factual assessment, it cannot be seriously argued that the
‘756 patent was not considered.
[41]
The
assessment made by the Federal Court Judge is different than that made by Mr. Justice
Laddie of the Chancery Division and confirmed by the English Court of Appeal in
the U.K. case. The Federal Court Judge
was aware of these decisions (Reasons, para. 119). However, he was entitled,
indeed obliged to draw his own conclusions.
[42]
Furthermore,
a review of Mr. Justice Laddie’s decision suggests that the issue of
obviousness was determined on the basis of a broader test than that adopted by
the Supreme Court in Sanofi-Synthelabo. In his decision, Mr. Justice
Laddie says (Pfizer Ltd., supra, paras. 106 and 107):
[106] … Where
something is obvious to try depends to a large extent on balancing the expected
rewards if there is success against the size of the risk of failure. Here it
was apparent that the rewards for finding an oral treatment would be
substantial. The risk was not, as indicated above, the risk of killing anyone,
but the risk that trying oral administration would not work so that the
research would be unproductive. In considering this, it is worth bearing in
mind the approach adopted by the EPO Technical Board of Appeal in case
T0379/96, a case concerned with attempts to replace ozone damaging aerosol
propellants with non-damaging ones. The Board said:
Moreover,
having regard to the degree of pressure put on industry by existing or imminent
legislation and by the public interest, to try to replace P12 [i.e. a damaging
propellant], in the Board’s view, it is a minor matter whether or not there
was a particularly high degree of expected success before starting experimental
work with HFC 134a.
[107] I have
come to the conclusion that the skilled team would not have been put off trying
oral administration of a PDE inhibitor. On the contrary, on balance there is
much in the evidence which suggests that trying oral administration was a
worthwhile, and perhaps the first, avenue to pursue. …
[My emphasis]
The English Court of Appeal in confirming the decision of Mr.
Justice Laddie expressed the view that he properly identified the test (Lilly
Icos Ltd., supra, paras 67 and 68).
[43]
The
reasoning advanced by Mr. Justice Laddie and approved by the English Court of
Appeal is that where the motivation to achieve a result is very high, the
degree of expected success becomes a minor matter. In such circumstances, the
skilled person may feel compelled to pursue experimentation even though the
chances of success are not particularly high.
[44]
This is no
doubt the case. However, the degree of motivation cannot transform a possible
solution into an obvious one. Motivation is relevant in determining whether the
skilled person has good reason to pursue “predictable” solutions or solutions
that provide “a fair expectation of success” (see respectively the passages in KSR
International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007) at page 1742 and
Angiotech Pharmaceuticals Inc. v. Conor Medsystems Inc., [2008] UKHL 49,
at paragraph 42, both of which are referred to with approval in Sanofi-Synthelabo,
supra, at paragraphs 58 and 59).
[45]
In
contrast, the test applied by Mr. Justice Laddie appears to be met if the prior
art indicates that something may work, and the motivation is such as to make this
avenue “worthwhile” to pursue (Pfizer Ltd., supra, para. 107, as quoted
at para. 42 above). As such, a solution may be “worthwhile” to pursue even
though it is not “obvious to try” or in the words of Rothstein J. even though
it is not “more or less self-evident” (Sanofi-Synthelabo, supra, para.
66). In my view, this approach which is based on the possibility that something
might work, was expressly rejected by the Supreme Court in Sanofi-Synthelabo,
at paragraph 66.
[46]
The
Federal Court Judge rendered his decision on the basis that more than possibilities
were required. He concluded based on the evidence before him that Apotex had
failed to establish more than that. In so doing, he applied the correct test.
[47]
The
appellant having failed to establish that either of the two alleged errors was
committed, I would dismiss the appeal with costs. The respondents sought
increased costs by reason of the late change in the appellant’s position on
appeal. I agree that if proper attention had been given to the matter, the change
in approach would have been communicated earlier, and the respondents would
have been in a position to reflect on their response. I would order that costs
be computed in accordance with the mid-range of column V of Tariff B.
“Marc Noël”
“I agree.
Gilles Létourneau J.A.”
“I agree.
Pierre Blais J.A.”
Email this Content