Docket: A-508-15
Citation: 2017 FCA 50
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CORAM:
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GAUTHIER J.A.
DE MONTIGNY J.A.
GLEASON J.A.
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BETWEEN:
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TEVA CANADA
LIMITED
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Appellant
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And
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LEO PHARMA INC. and LEO PHARMA A/S
Respondents
and
THE MINISTER OF
HEALTH
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Respondent
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REASONS FOR
JUDGMENT
GAUTHIER J.A.
[1]
Teva Canada Limited (Teva) appeals a decision of
Locke J. of the Federal Court (2015 FC 1237) allowing Leo Pharma Inc. and Leo
Pharma A/S’s (Leo) application under the Patented Medicines (Notice
of Compliance) Regulations, S.O.R./93-133 (Regulations) for an order
prohibiting the Minister of Health from issuing a notice of compliance (NOC) to
Teva in respect of 50 mcg/g calcipotriol and 0.5 mg/g betamethasone dipropionate
ointment until the expiry of Canadian Patent No. 2,370,565 (the 565 Patent).
[2]
This patented non-aqueous ointment is for use in
the treatment of psoriasis. It is prepared using three components referred to in
the claims in the 565 Patent as Component A (vitamin D or a vitamin D
analogue), Component B (a corticosteroid) and Component C (a solvent of the
type described in the claims). Components A and B are described as two pharmacologically
active compounds in the composition. In Claim 17, Component C is limited to polyoxypropylene-15-stearylether,
a solvent referred to as POP-15.
[3]
The findings of the Federal Court in respect of the
common general knowledge and the characteristics of the person skilled in the
art are not disputed (Federal Court’s Reasons (Reasons) at paras. 104, 107-112).
Among other things, at the relevant time, the person skilled in the art to whom
the 565 Patent is addressed knew that Components A and B were active
pharmaceutical compounds useful in the treatment of psoriasis. It was also
known that treatment by sequential application of both calcipotriol (a vitamin
D analogue) and a corticosteroid provided better results than either compound
alone in treating this condition. That said, it was also known that
calcipotriol (Component A) could not be combined with a corticosteroid
(Component B), given their pH incompatibility; calcipotriol requires a pH above
8 for maximum stability, whereas corticosteroids require pH values in the range
of 4-6 for maximum stability (Reasons at paras. 108-109).
[4]
In its notice of allegation (NOA) and before the
Federal Court, Teva contested the validity of the 565 Patent on the basis of
obviousness, lack of utility and insufficiency. In this appeal, the debate is more
limited. First, Teva contests the Federal Court’s finding that the utility of
the compositions covered in Claim 17 of the 565 Patent could be soundly
predicted, mainly because Leo could not explain exactly why these combinations
worked and because the line of reasoning relied upon by the Federal Court was
not set out in the disclosure. Second, Teva submits that the Federal Court did not
properly address two of the issues raised in respect of insufficiency. Hence, for
the purpose of this appeal, it is undisputed that the invention claimed was new
and not obvious.
[5]
For the reasons below, I am of the view that
this appeal should be dismissed.
I.
The Federal Court’s Decision
[6]
I will limit my brief review to the most
relevant findings of the Federal Court in respect of the issues properly raised
before us (see paragraphs 39-40 below). Thus findings made in respect of
arguments not raised in the appeal, even in relation to utility and
insufficiency, are not discussed below (for example see para. 167(1) of the
Reasons).
[7]
At paragraphs 187 to 192 of its Reasons, the
Federal Court dealt with Teva’s only argument to support the allegation of
insufficiency; Teva claimed it had set out this argument in its NOA. More
particularly, Teva argued that the 565 Patent is silent as to which, if either,
of the Components A and B has to be dissolved in the solvent (Component C). It
also submitted that the fact that the 565 Patent does not mention that
calcipotriol (Component A) must be dissolved in the solvent (Component C) leaves
the skilled person with insufficient information to put the invention into
practice (Reasons at para. 188). This argument arose from a portion of the
cross-examination of Dr. Hansen discussed at paragraph 187 of the Reasons.
However, the Federal Court made no finding based on this evidence that one should
conclude, as argued before us, that if calcipotriol is not first, or the first component,
dissolved in the solvent, the composition will not be effective.
[8]
Instead, the Federal Court rejected Teva’s argument
on two bases. First, it found that the allegations in the NOA in respect of
insufficiency could not be understood as encompassing this argument (Reasons at
paras. 189-190). Second, and in any event, on the evidentiary record before it,
the Federal Court found that the argument had no merit (Reasons at para. 191).
[9]
The Federal Court noted that even Teva’s own
expert, Dr. Cooper, testified that dissolving or dispersing an active
ingredient in a solvent is a common and helpful practice particularly when the
active ingredient is a powder (Reasons at para. 191). In the Federal Court’s view,
there was no need to explicitly tell the person skilled in the art that the
calcipotriol (Component A) had to be dissolved in the solvent (Component C)
since a skilled person would be able to make the claimed formulation based on
his or her own knowledge. It added that even if some non-inventive trial and
error testing could “possibly” be required, this would permit and would not
prevent the description from meeting the requirements of subsection 27(3) of
the Patent Act, R.S.C., 1985, c. P-4 (Act).
[10]
With respect to Teva’s allegations of lack of
utility, the relevant findings of the Federal Court are limited to Claim 17 as
the Federal Court found that its analysis could be simplified by focusing on
this claim which was in play in this proceeding (Reasons at para. 176). In the Reasons,
the Federal Court first summarized at paragraphs 156 to 164 the general
principles applicable to determine whether the subject matter claimed is
useful.
[11]
Considering that Leo did not test all the
combinations claimed, the Federal Court found that the issue to be determined
was whether the utility of the subject matter of Claim 17 had been soundly predicted
at the date of the Canadian filing. The Federal Court relied on the test as enunciated
at paragraph 70 in Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77,
[2002] 4 S.C.R. 153 [AZT] (Reasons at para. 159). It is not disputed
that the Federal Court correctly described the three components of the test to
be applied. Briefly stated, these are whether the inventor had (i) a factual
basis, ii) a sound line of reasoning from which the desired result could be
inferred from the factual basis, and iii) proper disclosure.
[12]
The Federal Court also noted that although the
focus is on the inventor’s point of view under the second component of the test
(sound line of reasoning), this does not exclude taking into consideration the
perspective of the skilled person. For the Federal Court, this was especially
so considering the teachings of this Court stated at paragraph 154 of Bell
Helicopter Textron Canada Limitée v. Eurocopter, société par actions simplifiée,
2013 FCA 219, 449 N.R. 219 [Bell Helicopter]. In that decision, our
Court found that the elements of the sound prediction doctrine need not be
explicitly disclosed in the specification if they would be self-evident to the
person skilled in the art to whom the patent is addressed in view of the common
general knowledge possessed by such person.
[13]
Teva’s sound prediction argument is dealt with at
paragraphs 177 to 183 of the Reasons. As is usually the case in NOC proceedings
where time is often of the essence, the Federal Court’s 65 page decision
analyzes each of Teva’s arguments briefly. Despite this, it is clear that the
Federal Court was alert and alive to all the points raised in Teva’s memorandum
on appeal (for example, that EB 1089 could have been tested). It acknowledged
that nobody at Leo understood exactly why the combinations covered in Claim 17 worked
while a combination using another common solvent did not (see example 2 table 2
in the 565 Patent).
[14]
Still, on the evidentiary record before it, the
Federal Court found as a fact that as of January 27, 2000 (the date of the
Canadian filing of the application for the 565 Patent), Leo had a factual basis
and a sound line of reasoning to predict the utility of the subject matter
covered by Claim 17. The Federal Court also found that a person skilled in the
art would have understood from a review of the specification read as a whole,
that the inventors’ line of reasoning was that the alternatives for Components
A and B share a chemical scaffold, that they would therefore behave similarly
and that there was no need for an express mention of this fact in the
disclosure of the 565 Patent. The Federal Court held that this line of
reasoning was sound.
II.
Issues
[15]
Teva characterized the issues that it relies
upon in this appeal as errors of law. It describes the issues in its memorandum
as follows:
1. Did the [Federal Court] err in law by reformulating the
test of sound prediction to permit reliance on a line of reasoning advanced by
Leo’s expert, rather than by the inventors or Leo, to establish the factual
basis and line of reasoning to support Leo’s sound prediction of utility, even
if that line of reasoning was not held by the inventors or Leo at the time the
565 Patent was filed? If so, are Teva’s allegations of inutility justified?
2. Did the [Federal Court] err in law by failing to allow
Teva to advance its allegations of insufficiency and by failing to find that
the 565 Patent fails to correctly and fully disclose the invention as
contemplated by the inventors? If so, are Teva’s allegations of insufficiency
justified?
Teva’s memorandum at paragraph 25
[16]
The standards of review are those set out in Housen
v. Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235. Questions of fact
(including factual inferences) are reviewed only for palpable and overriding
errors. The same standard applies to questions of mixed fact and law unless
there is an extricable question of law. When such a question of law is
identified, it is reviewed on the correctness standard like any other question
of law.
[17]
In Sattva Capital Corp. v. Creston Moly Corp.,
2014 SCC 53, [2014] 2 S.C.R. 633, at paragraph 54, Rothstein J.
expressly warned that courts should be cautious in identifying an extricable
question of law so as to not unduly limit the level of deference that should
normally apply to findings of mixed fact and law. This will be discussed
further when reviewing the merits of Teva’s arguments for I do not agree with
Teva’s characterization of the two questions before us.
[18]
This is particularly important here considering
that Teva acknowledged at the hearing before us that if the applicable standard
was palpable and overriding error, it was unlikely that it could meet its
burden in respect of the Federal Court’s findings of utility and sufficiency.
III.
Sound Prediction
[19]
In my view, the somewhat convoluted question
framed by Teva in its memorandum rests on the following two premises:
a)
The Federal Court had no evidence of the factual
basis on which the inventors relied to claim the compositions covered by Claim
17; and
b)
The Federal Court had no evidence to determine
the actual logic or reasoning of the inventors.
Thus, Teva says that
this Court should infer that the Federal Court necessarily failed to apply the test
it set out in the Reasons (which it claims would be an extricable error of
law).
[20]
On the record before us, Teva has not persuaded
me that the Federal Court erred in law. Considering that applying the AZT
test is normally a question of fact, Teva has not established that the Federal
Court made a palpable and overriding error (see Zero Spill Systems (Int’l) Inc.
v. Heide, 2015 FCA 115 at para. 49, 472 N.R. 127) [Zero Spill].
Thus, there is no basis for this Court to substitute its assessment of the
evidence to determine whether the allegations made by Teva in its NOA were
justified.
[21]
Teva argues that one cannot make a sound
prediction when one does not know exactly why a particular combination
works. This may well apply in many cases, or even to other claims in the 565
Patent, but the Federal Court rejected the argument in this case in respect of
Claim 17 because it found that in the particular circumstances in the matter
and on this evidentiary record, it simply was not so (Reasons at para. 179).
[22]
It is important to recall that the invention
covered in Claim 17 may be quite important in practical terms for patients
suffering from psoriasis. But, it remains that, as found by the Federal Court,
the invention covered in Claim 17 is quite simple (Reasons at para. 127). As
mentioned by Teva in first instance, there were ointments on the market using
only Component A or only Component B to treat psoriasis. The active pharmaceutical
components involved have been well-known for years, and the use of the
invention did not involve any new process. Simply put, the application of the
doctrine of sound prediction turns on the nature of the invention, the
particularities of each discipline to which it relates and on the particular
facts of each case.
[23]
There was expert evidence supporting the finding
of the Federal Court that on the factual basis available to the inventors (and
disclosed in the patent), the inventors could make a prediction that was
reasonable and sound. Based on what was known about Component A and B at the
time of filing, and the test data disclosed in the 565 Patent, Dr. Goldberg
testified that there was a high probability that if the particular solvent (POP
15) worked for the combination of the Component A and Component B tested, it
would work for the other combinations claimed in Claim 17 (see
Cross-Examination of Dr. Goldberg, Appeal Book, Vol. 14, Tab 310 at pp. 3807-3808).
Dr. Walters’ evidence, expressly referred to by the Federal Court, also
supports the finding of the Federal Court.
[24]
During the hearing, Teva took us through various
extracts of evidence on the basis of which it argued that one should conclude
to the contrary (see Teva’s Compendium). This exercise was insufficient to make
the tree fall down, to evoke the imagery of my colleague Justice Stratas in Zero
Spill above. Teva therefore did not establish a palpable and overriding
error.
[25]
Turning to the evidence on which the Federal
Court relied to make its finding in respect of the inventors’ factual basis and
line of reasoning, it is important to note that the inventors could not
participate in the proceedings.
[26]
Indeed, on the basis of Leo’s explanations, the
Federal Court was satisfied that Leo could not present the two inventors as
witnesses. It accepted as necessary and reliable the testimony of Dr. Hansen, a
supervisor of the inventors at Leo as of 1998, a significant period when the
invention was being developed. The Federal Court also found that most of Dr.
Hansen’s evidence was based on reports, notebooks and records that constituted
business records, a recognized exception to the rule against hearsay.
[27]
Although Teva originally objected to this evidence,
it did not contest the aforementioned Federal Court findings in this appeal. In
fact, Teva relied heavily on such evidence to support its arguments on both
insufficiency and lack of utility.
[28]
In my view, it was open to the Federal Court to
infer that the inventors’ logic and line of reasoning was, as a matter of fact,
the one conveyed to the person skilled in the art in the 565 Patent. There was
a legitimate basis to make that inference. Teva tries to elevate this issue of
fact to a legal principle. It argues that the Federal Court failed to follow a “subjective
approach” and submits that one must produce evidence emanating directly from
the inventors either as witnesses or through express words in the disclosure of
the patent. In Teva’s view, expert evidence cannot be used to determine facts
such as the line of reasoning of the inventors.
[29]
Nowhere in AZT does the Supreme Court of
Canada limit how the facts necessary to apply the doctrine of sound prediction
can be established. How one proves a fact depends on the particular
circumstances of each case.
[30]
It is only when asked why this Court should deny
a patentee the right to rely on the doctrine of sound prediction when an
inventor dies before the validity of the patent is challenged, that Teva
acknowledged that the Court could probably infer the inventor’s line of
reasoning from an express sentence in the disclosure of the patent. It further acknowledged
that in this case, it might have been open to the Federal Court to make the
factual finding that it made if the 565 Patent had included a sentence to the
effect that the logic followed to claim the subject matter covered by Claim 17
was that the chemical scaffold of all Components A and B were the same as those
tested in Example 1 of the Patent (second requirement of the test). Obviously
in such a case, this would mean that the third requirement of the AZT
test (disclosure) would also have been met. But this should not detract from
the fact that in a particular case the same evidence can be used to establish two
distinct elements of the test.
[31]
From the perspective of a person skilled in the
art, I see no difference in this case between an express sentence to this
effect and conveying the same logic through technical information disclosed in
the specification read as a whole. In both instances, the inventor conveys his
or her logic to the person to whom the patent is addressed, thereby fulfilling
its part of the patent bargain if this line of reasoning is held to be
reasonable and sound at the relevant times. In short, in both instances, the
person to whom the patent is addressed, namely, the person skilled in the art,
understands the sound line of reasoning of the inventors premised on what is
said in the patent.
[32]
Similarly, this Court held in Bell Helicopter
that there is no need to spell out in a patent that which is self-evident and
would be generally known to the person skilled in the art.
[33]
It bears repetition that in all cases,
the application of the doctrine of sound prediction is a matter of fact.
Technical facts, such as whether all vitamin D analogues covered in Claim 17
have the same chemical scaffold, can be established
by way of expert evidence.
[34]
What logic or reasoning, if any, is conveyed in
a patent, even when the logic is expressly set out, will also usually require consideration
of expert evidence to explain its significance unless the field to which the
invention relates can easily be understood by a court without the assistance of
an expert. Finally, expert evidence will be required to determine the soundness
of this logic.
[35]
On a fair reading of the Reasons, the Federal
Court did apply the proper test — the one it expressly set out in the Reasons.
It had evidence of the factual basis actually available to the inventors before
the Canadian filing date. It essentially consisted of the tests and other data
referred to in the disclosure of the 565 Patent, including matters that were
part of the common general knowledge at the time, as well as confirmation that
calcipotriol was one of the most unstable Vitamin D analogues (half-life
testing of vitamin D analogues done in 2000 prior to the filing date).
[36]
There was also evidence before the Federal Court
from Dr. Walters that as a matter of fact, all claimed alternatives of
Vitamin D analogues have the same chemical scaffold as calcipotriol, and that
all corticosteroids claimed have a sterone structure (see Affidavit of Dr.
Walters, Appeal Book, Vol. 6, Tab 104, at para. 210). These were not disputed
facts.
[37]
There was also expert evidence before the
Federal Court that the person skilled in the art would understand the logic of
the inventor from reading the 565 Patent as a whole, namely, that as all
claimed alternatives for Components A and B have the same chemical scaffold as
the ones tested in combination with POP-15, they would all be expected to be
useful.
[38]
The Federal Court was entitled to use this
expert evidence together with the evidence of the actual factual basis
available to the inventors to reach the conclusion that it did. As mentioned,
the evidentiary record also supports the finding that the line of reasoning was
sound. Thus, Teva’s first argument on appeal fails.
IV.
Insufficiency of the Disclosure
[39]
I will now turn to the sufficiency of the
description of the invention in the disclosure and start with two preliminary
comments. First, Teva raises an argument (that particular combinations would
not work according to prior art) that it acknowledged was not raised before the
Federal Court (see paragraphs 74 to 81 of Teva’s memorandum). Hence, the
Federal Court could not and did not make any finding in this respect. After
this was clarified at the hearing, Teva advised that it would not pursue this
argument. I will therefore not consider it.
[40]
Second, as indicated in the question put forth
by Teva in respect of its allegation of insufficiency, this Court should
normally deal with the Federal Court’s finding that the NOA did not include the
argument that the inventors failed to disclose an essential element of the
invention to the effect that the active pharmaceutical ingredients (especially Component
A and more particularly calcipotriol) had to first be dissolved in the solvent
(Component C) for the non-aqueous ointment to be effective. Teva argues that
there is no need to deal with this alleged error regarding the contents of its
NOA if this Court agrees that, in any event, its argument has no merit. Thus, I
will simply say that in my view, the Federal Court did not err in finding that
this argument was not properly raised in the NOA. There is no need to say
anything further on this issue for I agree that, in any event, the argument has
no merit.
[41]
Teva argued that based on a brief portion of the
cross-examination of Dr. Hansen it had established that the order in which the components
of the patented compositions must be added to the other ingredients that make a
non-aqueous ointment (such as a petrolatum-based ointment) is an essential
element of the invention that should have been disclosed in the 565 Patent. Teva
added that the Federal Court erred in law by referring to the possibility of
having to do some trial and error experiments to determine that in fact
calcipotriol must be dissolved or dispersed in the solvent before completing
the ointment using a petrolatum-base.
[42]
Again, the question to be determined is
presented as a pure question of law. However, I believe that Teva’s theory
rests on a fact or facts in respect of which the Federal Court did not make an
actual finding other than stating that some trial and error may perhaps be a
possibility.
[43]
The Federal Court properly instructed itself
that the description mandated by subsection 27(3) of the Act must enable the
person skilled in the art to produce the invention using only the instructions
contained in the disclosure. Obviously, this also means that the person skilled
in the art comes equipped with his or her common general knowledge.
[44]
Whether or not a particular disclosure is
sufficient to meet the requirements of subsection 27(3) of the Act
depends on what the skilled person would consider sufficient to enable it to
work the invention (Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60
at para. 79, [2012] 3 S.C.R. 625 [Sildenafil] . This is a
question of fact (Pfizer Canada Inc v Apotex Inc., 2014 FCA 250 at
para.60, 465 N.R. 306, leave to appeal to SCC denied, 36227 (December 23, 2014).
[45]
Thus, a key issue is whether or not the Federal
Court was required to conclude that the order in which the three components
listed in the claims were mixed was an essential element of the invention that
had to be disclosed.
[46]
As discussed at the hearing, the passage of the
cross-examination Teva relies on is far from conclusive.
[47]
The Federal Court described the relevant excerpt
at paragraph 187 of the confidential version of the Reasons. Simply put, in an
experiment done without a solvent “to see if oil and
petrolatum were needed”, Leo could not obtain an equally-distributed
amount of the Component A it used (see cross-examination of Dr. Hansen, Appeal
Book, Vol. 18, Tab 351, at p. 4984).
[48]
Teva acknowledged that there was no other evidence,
expert or otherwise, that would help this Court conclude that, as Teva’s
counsel suggested, this passage necessarily meant that the Component A that was
tested had to be dissolved in solvent C in order for the claimed composition to
be effective. Particularly, Teva did not test its theory during the
cross-examination of any of the affiants, including Dr. Hansen. This is
important because the composition that was referred to in the cross-examination
excerpt that Teva relies on did not include one of the essential elements of the
patented invention — Component C.
[49]
The issue here is not whether the Federal Court
could have made the inference suggested by Teva. Rather, it is whether the
Federal Court made a palpable and overriding error in not doing so. This Court
cannot simply assume that if Component C had been added to the tested composition,
the result would have been the same. Nor can it assume that the problem with
respect to the dispersion did not simply make the formulation less effective
rather than not effective. Leo also alluded to the fact that there may have
been an issue with the dry milling process used in making the composition
referred to in the cross-examination excerpt Teva relies on.
[50]
Moreover, it appears that the issue raised in
this portion of Dr. Hansen’s evidence relates to the dispersion of the active
ingredient in a non-aqueous base. This has little to do with the nature of the
invention, which is directed to a combination of three components that will
allow the active ingredients to “co-exist without
degradation, despite their different pH/stability profiles” (the 565
Patent at page 12 lines 1 to 5).
[51]
One must always consider the nature of the
invention to determine what needs to be included in the description. As
mentioned earlier, the invention is not about the process of making a
non-aqueous ointment. This was well-known. It is instead directed to the
combination of three particular sets of components to be included in a
non-aqueous ointment recipe. At page 13 of the 565 Patent, the inventors
specify that the invention “may be prepared in
accordance with methods well known to the person skilled in the field of
pharmacy… As an example, preparation of a composition according to the
invention is typically performed by melting white soft paraffin, adding a
solution (typically at a concentration in the range of 0.0005-2.5% w/w) of the
vitamin D analog in the required amount of solvent component C … followed by
addition of a dispersion of the corticosteroid component B in paraffin oil…”
(lines 1-12).
[52]
In example 1 of the specification, the
calcipotriol (Component A) is dissolved in the solvent (Component C). This
appears to be the best embodiment for the inventor. Although I agree with Teva
that this does not limit how the claimed compositions could be prepared, this is
not, in and of itself, evidence that dissolving Component B in Component C
before adding Component A to the solvent mixture would not work. As a solvent,
Component C would normally be used to dissolve the active ingredients.
[53]
As a matter of fact, Teva’s own expert evidence supports
the conclusion that no information about how to mix or process Components A, B
and C to complete the patented aqueous ointment was required. Indeed, Dr.
Cooper’s evidence indicates that it was commonly known that dissolving or
dispersing active ingredients in a small amount of solvent prior to adding them
to a petrolatum base helped to ensure that the active ingredients are evenly
dispersed in the ointment. The same expert added that it was especially useful when
an ointment is made on a commercial scale to add the active ingredient to the
petrolatum as a liquid as opposed to adding them in powder form (Affidavit of
Dr. Cooper, Appeal Book, Vol. 13, Tab 293 at paras. 93-94).
[54]
In the circumstances, the Federal Court did not
make a palpable and overriding error in weighing the evidence and in refusing
to conclude that the order in which the components are mixed together before
being incorporated into whatever base was used to make the ointment was an
essential element of the invention that had to be disclosed.
[55]
This brings me to the comment of the Federal
Court to which Teva also objects. At paragraph 191 of the Reasons, the Federal
Court stated that “a skilled person would be able to
make the claimed formulation based on his or her own knowledge, possibly
through some non-inventive trial and error (which is permitted per Valence
Technology Inc v Phostech Lithium Inc, 2011 FC 174 at para 224), without
having to be explicitly told that the calcipotriol must be dissolved in the
solvent C”.
[56]
In adding the last portion of this sentence, the
Federal Court appears to be dealing with Teva’s theory that calcipotriol is
somewhat special. First, this is only viewed as a possibility, not a
probability, and second, the Federal Court simply followed in this respect a
decision (Valence) which has been confirmed by our Court in Phostech Lithium
Inc. v. Valence Technology Inc., 2011 FCA 237, 422 N.R. 162 [Valence, FCA]. I moreover
note that this comment is in line with the law in the U.K. and in Europe (see Synthon
BV v. Smithkline Beecham plc, [2005] UKHL 59 at paras. 27, 30). It is also
how the Supreme Court of Canada defined an enabling description or disclosure
in Apotex Inc. v. Sanofi‑Synthelabo Canada Inc., 2008 SCC 61 at para. 43, [2008] 3 S.C.R. 265
[Sanofi-Synthelabo], albeit in a different context (anticipation). The wording
of subsection 27(3) of the Act is essentially the same as the provisions
applicable in England and in Europe. There is no reason to exclude the limited type
of testing that is usually referred to when one uses the expression used by the
Federal Court. As Justice Rothstein noted in Sanofi‑Synthelabo, in
a field such as the one involved before us where trial and error experiments
are generally carried out, such limited testing is permitted, and does not
involve an undue burden.
[57]
Teva argues that the Supreme Court of Canada
changed the law since Valence FCA in Sildenafil, where
Justice LeBel wrote at paragraph 74:
[74] The
disclosure in the specification would not have enabled the public “to make the
same successful use of the invention as the inventor could at the time of his
application”, because even if a skilled reader could have narrowed the
effective compound down to the ones in Claim 6 and Claim 7, further testing
would have been required to determine which of those two compounds was actually
effective in treating ED. As the trial judge stated, at para. 146, “[a] skilled
reader would then conduct tests on those two compounds and determine which of
those compounds worked”. And as he also stated, at para. 135, “the
skilled reader must undertake a minor research project to determine which claim
is the true invention”. [Emphasis added]
[58]
The case before us is very different from the
one that was before the Supreme Court of Canada in Sildenafil, where the
patentee had deliberately omitted essential information, thereby obscuring the
fact that only one of the compounds claimed actually worked (Sildenafil
at paras 72, 73 and 76) . Thus, the invention itself was not even properly disclosed.
[59]
Furthermore, the Supreme Court refers to the
factual findings of the Federal Court in Sildenafil which found that in
that case, one would require a minor research project to determine the true
invention. This statement of Justice Lebel is, as mentioned, perfectly in line
with the law as I understand it, not only in Canada but elsewhere, such as the
U.K. and Europe, which recognizes that some non-inventive trial and error may
be required to put a properly disclosed invention into practice. Had the
Supreme Court wished to change the law on this point in Sildenafil, one
would have expected a much more fulsome analysis of the issue and discussion of
the relevant authorities. In the absence of such a discussion, I do not believe
that the Supreme Court changed the law in Sildenafil in the manner Teva
argues.
[60]
In any event, what the Federal Court was
referring to in the present case was in no way a minor research project within
the meaning of Sildenafil. Rather, I would compare it to the trial and
error required to determine the most effective way to make a good pancake mix
with no lumps, i.e., whether one should put the eggs before or after the flour
and sugar are dissolved in milk. The possible need for this sort of trial and
error to enable the skilled person to use the invention does not render the
disclosure in a patent insufficient.
V.
Conclusion
[61]
In view of the foregoing, I conclude that this
appeal should be dismissed with costs.
"Johanne Gauthier"
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“I agree
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Yves de Montigny J.A.”
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“I agree
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Mary J.L. Gleason J.A.”
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