Docket: A-404-15
Citation:
2016 FCA 230
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CORAM:
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DAWSON J.A.
GAUTHIER J.A.
NEAR 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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NOVARTIS
PHARMACEUTICALS
CANADA INC.,
NOVARTIS AG and
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THE MINISTER OF
HEALTH
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Respondents
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REASONS
FOR JUDGMENT
DAWSON J.A.
[1]
For reasons cited as 2015 FC 770 the Federal
Court issued a judgment prohibiting the Minister of Health from issuing a
Notice of Compliance to Teva Canada Limited in respect of a generic version of
Novartis Pharmaceuticals Canada Inc.’s patented product EXJADE. The Federal
Court concluded that Teva’s allegations of inutility, obviousness and
insufficiency were not justified. On this appeal from the judgment of the
Federal Court, Teva only places in issue the conclusion of the Federal Court
that Teva’s allegation of inutility was not justified.
[2]
In my view, and Teva agrees, this appeal turns
on a single issue: did the Federal Court err in law in its construction of the
promise of the relevant patent?
[3]
At paragraph 34 of its reasons, the Federal
Court set out the principles of law relevant to the utility requirement:
I believe this approach to construction is
supported by well-accepted principles of patent law. Generally speaking, the
utility requirement represents a fairly low threshold. The exception is where
the inventors explicitly promise a specific result, particularly if the stated
utility is set out in the claims as opposed to the disclosure. An explicit
promise set out in the disclosure can apply to all claims but, at the same
time, it may be appropriate to distinguish between the promise of the compound
claims, on the one hand, and the promise of the use claims, on the other (Apotex
Inc v Pfizer Canada Inc, 2014 FCA 250 at paras 64, 65, 71, 77, 87, 88).
[4]
Teva acknowledges that the Federal Court made no
error in this statement of relevant principles. Rather, Teva argues that the
Federal Court erred in its application of these principles to the evidence
before it.
[5]
The key passage in the patent disclosure is
that:
It has now been found that certain
substituted 3,5-diphenyl-1,2,4-triazoles have valuable pharmacological properties
when used in the treatment of disorders which cause an excess of metal in the
human or animal body or are caused by it, primarily a marked binding of
trivalent metal ions, in particular those of iron.
[6]
Teva contends that:
i.
this passage makes an explicit promise that the
patented compounds had been tested in humans and had been found to be both
non-toxic and valuable in the therapeutic treatment of iron-excess disorders in
humans by virtue of the compounds’ capacity to bind markedly to iron; and,
ii.
this promise applies to all of the patent’s
claims, including the claims made for novel compounds, particularly including claims
5 and 32 which claim the compound that is the active ingredient in EXJADE.
[7]
The Federal Court rejected these contentions. It
found that the patent “would be read by the skilled
person as describing the desirable properties possessed by the compounds of the
invention, namely, their distinct ability to bind to iron, their solubility,
and their capacity to induce excretion” (reasons, at paragraph 22). This
was the promise of the patent as construed by the Federal Court.
[8]
At paragraph 24 of its reasons, the Federal
Court explained the key passage as follows:
The reference to “valuable pharmaceutical
properties” at the beginning of the sentence is completed by the identification
at the end of the sentence of what those properties are: primarily a marked
binding to trivalent metals, particularly iron. So, the compounds have valuable
properties, most importantly, a striking affinity to iron. The middle of the
sentence explains why those properties are valuable: “they are valuable when
used in the treatment of iron excess disorders”. It is those properties that
are said to be valuable when used in the treatment of iron excess disorders;
the patent does not say that the compounds have been used for that purpose.
[9]
On this appeal Teva argues that the Federal
Court erred in its construction of the promise of the patent by:
i.
relying on the patent’s abstract to construe the
promise;
ii.
distinguishing between the promise made in
respect of the patented formula I and formula II compounds; and,
iii.
applying the doctrine of claim differentiation.
[10]
I agree that the Federal Court ought not to have
considered the abstract when construing the promise of the patent (Apotex
Inc. v. ADIR, 2009 FCA 222, 392 N.R. 96, at paragraphs 104-105). However,
in my view this error was not material to the decision of the Federal Court. Prior
to this reference to the patent’s abstract the Court had, at paragraph 24 of
its reasons, construed the key passage textually and contextually. The Federal
Court also supported its construction by reference to a later portion of the
paragraph containing the key passage that dealt with tests on rats and monkeys,
not humans (reasons, at paragraph 28). Also of relevance is that this paragraph
contains a reference to prior art which described iron binding observed in
vitro (a study which did not consider toxicity).
[11]
I also reject the argument that the Federal
Court erred by drawing a distinction between the compounds of formula I and the
compounds of formula II when determining the promise of the patent.
[12]
The patent expressly differentiates between the
two classes of compounds in both the claims and the disclosure. Thus, the
formula I compounds are described from the bottom of page 2 of the patent to the
middle of page 10 of the patent. The formula II compounds are described on page
10 and following of the patent. The formula II compounds are a subset of the
formula I compounds.
[13]
Contrary to Teva’s assertion, the Federal Court
was well aware that the formula II compounds were a subset of the formula I
compounds (reasons, at paragraphs 13 and 14).
[14]
The compounds of formula II are said to be novel.
The patent states that one of the inventions of the patent relates to these
novel compounds, which are described in the examples set out on pages 18-31 of
the patent.
[15]
Conversely, the formula I compounds contain some
compounds that had previously been made. The novelty of these compounds is their
use, not the compounds themselves. At pages 3 and 6 the patent states in
reference to these compounds that the invention relates to the use of the
compounds of formula I:
… in the treatment of diseases which cause
an excess of metal in the human or animal body or are caused by it; preferably
in the form of pharmaceutically acceptable preparations, in particular in a
method for the therapeutic treatment of the human body, and to a treatment
method of this type.
[16]
The patent contains 43 claims. All of these
claims relate to the substituted 3,5-diphenyl-1,2,4-triazoles described in formulas
I or II. Some of the claims relate to the use of these compounds (or their
salts or pharmaceutical preparations containing them) in the treatment of a
disease which causes (or is caused by) an excess of metal in a human or animal
body (see, for example, claim 1). Other claims relate to the use of these
compounds (or their salts) for the treatment of an excess of iron in a human or
animal body (see, for example, claim 41). Claim 43 relates to a process to make
compounds of formula II.
[17]
Claims such as claims 5 and 32 are compound
claims (as opposed to use claims). Claim 5 claims all of the compounds of
formula II and their salts. Claim 32 claims the compound at issue in the
prohibition proceeding.
[18]
It can be seen from a reading of the patent that
all of the statements of use found in the disclosure from the bottom of page 2
through to page 10 relate only to the formula I compounds. The disclosure
contains no statements of use of the formula II compounds, other than the key
passage quoted above at paragraph 5.
[19]
Dr. Baillie’s evidence was that the patent
differentiates between the two formulas “for reasons of
convenience in that the formula II compounds were all novel structures”
whereas some of the formula I compounds were previously known
(cross-examination of Dr. Baillie, Appeal Book volume 12, tab 104, page 2304).
Dr. Baillie is a medicinal chemist called on behalf of Novartis.
[20]
The Federal Court was also alert and attentive
to the fact that the expressions formula I and formula II were used as a
convenient means to point to support in the disclosure for particular claims.
When the patentee wanted to refer to all the compounds covered by both
expressions, he described them as certain substituted 3,5-diphenyl-1,2,4-triazoles
(as in the key passage at page 2 of the disclosure). Thus, the Federal Court
was correct to find that the other passages relied upon by Teva (found at pages
6-9 of the disclosure) were not particularly useful when construing the promise
in respect of the compounds of formula II claimed in claims 5 and 32.
[21]
A further example of the differentiation between
the two classes of compounds is that claims 1 to 4 of the patent claim the use
of the formula I compounds for the treatment of a disease, while claims 40 to
42 claim the formula II compounds, or a pharmaceutically accepted salt thereof,
for use in treatment of an excess of iron in an animal or human body.
[22]
Notwithstanding the manner in which the patent
differentiates between the formula I and formula II compounds, Teva argues that
because every formula II compound is a subset of the formula I compounds, there
is no basis to exempt the formula II compounds from the utility in humans
promised for the formula I compounds.
[23]
In my view, this argument ignores the fact that
at law different claims can have different utilities for the same compound (see,
for example, Apotex Inc. v. Pfizer Canada Inc., 2014 FCA 250, 465 N.R.
306 (Celebrex); Teva Canada Limited v. Novartis AG, 2013 FC 141, 109
C.P.R. (4th) 1 (Imatinib)).
[24]
Given the manner in which the patent
differentiates between the formula I and II compounds (particularly in the
disclosure and in claims 1 and 5) the statements of use at the bottom of page 2
through to page 10 of the disclosure can only relate to claims 1 to 4. They
cannot relate to the novel compounds (claims 5 to 37).
[25]
The Federal Court’s construction of the promise
of the patent was consistent with differentiation contained in the disclosure
and the claims. It is also consistent with the useful advance over the prior
art described in the patent. The Federal Court’s construction was correct.
[26]
Before leaving this issue it is relevant to note
that the promise of the patent doctrine will hold an invention to an elevated
standard of utility “only where a clear and unambiguous
promise has been made.” Where a patent’s validity is “challenged on the basis of an alleged unfulfilled promise,
the patent will be construed in favour of the patentee where it can reasonably
be read by the skilled person as excluding this promise” (Celebrex, at
paragraph 66).
[27]
As the Federal Court found, this patent can be
read by a person skilled in the art as excluding Teva’s asserted elevated
promise of utility.
[28]
I also reject the argument that the Federal
Court erred by applying “claim differentiation”
to construe the promise of the novel formula II compounds claims to be
different from the promise of the formula I use claims. For the above reasons,
the Federal Court was correct to differentiate between the compounds and use
claims.
[29]
Finally, in oral argument Teva argued that the
Federal Court erred in determining that the skilled person could, but need not
be, a physician (reasons, at paragraph 21). This was not an issue raised in
Teva’s memorandum of fact and law. In any event, I am satisfied the Federal
Court’s determination of the attributes of the skilled person was supported in
the evidence.
[30]
Having construed the stated utility of the
patent to be the capacity of the compounds to bind markedly to iron and to be
sufficiently soluble to induce iron excretion, the Federal Court went on to
conclude that the stated utility had been clearly demonstrated or soundly
predicted as of the filing date of the patent (reasons, at paragraph 40). It
followed that Teva’s allegation of inutility was not justified.
[31]
For these reasons, I would dismiss the appeal
with costs.
“Eleanor R. Dawson”
“I agree.
Johanne Gauthier J.A.”
“I agree.
D. G. Near J.A.”
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