Date: 20070419
Docket: A-510-05
Citation: 2007 FCA 153
CORAM: SHARLOW
J.A.
MALONE
J.A.
RYER
J.A.
BETWEEN:
ABBOTT LABORATORIES and
ABBOTT LABORATORIES LIMITED
Appellants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR JUDGMENT
SHARLOW J.A.
[1]
This is an
appeal of a judgment of the Federal Court (2005 FC 1332) dismissing the application
of Abbott Laboratories and Abbott Laboratories Limited (collectively, “Abbott”)
under the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133 (the NOC Regulations), for an order prohibiting the Minister
of Health from issuing a notice of compliance to Apotex Inc. for
Apo-Clarithromycin 250 and 500 mg tablets until the expiry of Canadian Patent
2,261,732 (the 732 patent) in 2017.
[2]
Apotex is seeking
a notice of compliance for Apo-Clarithromycin on the basis of an abbreviated
new drug submission naming as the comparator drug a product called Biaxin,
produced and sold by Abbott since 1993. The medicine in both products is called
“clarithromycin Form II”. The patent list maintained by the Minister in
relation to Biaxin includes the 732 patent.
[3]
Apotex
argued as a preliminary point that this appeal is moot because of another
Federal Court decision, Abbott Laboratories v. Canada (Minister of Health), 2006 FC 1558. In that case,
a judge dismissed an application by Abbott for an order prohibiting the Minister
from issuing a notice of compliance to Apotex for Apo-Clarithromycin 250 and
500 mg tablets until after the expiry of a number of patents, one of which is
the 732 patent. Abbott has appealed that decision (Court File A-59-07) but without
challenging the correctness of that decision in relation to the 732 patent. On
that basis, Abbott has conceded that its appeal in this case is now moot.
[4]
However, Abbott
argued that this appeal should be heard despite being moot because of the part
of the decision under appeal that was based on Hoffmann-La Roche & Co.
Ltd. v. Commissioner of Patents, [1955] S.C.R. 414. Abbott argued that the
principle in Hoffmann was incorrectly applied by the Federal Court in
this case, and is being relied upon in a number of other matters soon to be
heard in the Federal Court. Given the striking similarities between this case
and the other cases to which we were referred, the Court permitted the appeal to
continue on that one point only.
[5]
The notice of appeal in this case also challenges
the correctness of the judgment under appeal in relation to utility and sound
prediction. Those issues were not heard. As Abbott would have had to succeed on
those issues as well as the Hoffman issue to achieve a reversal of the
judgment under appeal, the judgment under appeal will be affirmed.
Facts
[6]
There are 21 claims in the 732 patent. The first
fifteen (claims 1 through 15) claim methods for preparing clarithromycin Form
II. Previously, the
process for making clarithromycin Form II involved heating clarithromycin Form
I to a certain temperature. The process disclosed in the 732 patent is an
entirely different process in which clarithromycin Form I is treated with one
of a number of solvents and clarithromycin Form II is isolated from the
resulting substance.
[7]
Claims 16 through 21 of the 732 patent claim
clarithromycin Form II when made by one of the processes in claims 1 through 15.
It is undisputed that those claims are within the scope of the NOC
Regulations, while claims 1 through 15 are not. Patent claims that
are not within the scope of the NOC Regulations need not be addressed in
proceedings under the NOC Regulations.
[8]
When Apotex filed its abbreviated new drug
submission using Biaxin as its comparator, it was obliged by section 5 of the NOC
Regulations to address claims 16 through 21 of the 732 in a notice of
allegation, failing which it would not be entitled to a notice of compliance
for its product until after the expiry of the 732 patent. Apotex served a
notice of allegation asserting on a number of grounds that claims 16 through 21
are invalid. Abbott considered the allegations of invalidity not to be justified,
and responded with an application for an order prohibiting the Minister from
issuing a notice of compliance to Apotex. That application failed, resulting in
this appeal.
The presumption
of validity
[9]
It is now beyond debate that an applicant for a
prohibition order under the NOC Regulations bears the burden of
establishing its entitlement to the order. Abbott argues that the Judge in this
case failed to recognize and apply that principle correctly, in light of the
presumption of validity in subsection 43(2) of the Patent Act, R.S.C.
1985, c. P-4, which reads as follows:
|
43. (2) After the
patent is issued, it shall, in the absence of any evidence to the contrary,
be valid and avail the patentee and the legal representatives of the patentee
for the term mentioned in section 44 or 45, whichever is applicable.
|
43. (2) Une fois
délivré, le brevet est, sauf preuve contraire, valide et acquis au breveté ou
à ses représentants légaux pour la période mentionnée aux articles 44 ou 45.
|
[10]
In my view, the Judge made no such error. The presumption
in subsection 43(2) is weakly worded (Apotex Inc. v. Wellcome Foundation
Limited, [2002] 4 S.C.R. 153, per Justice Binnie at paragraph 43). It cannot
determine the outcome of prohibition proceedings under the NOC Regulations
if, as in this case, the record contains any evidence that, if accepted,
is capable of rebutting the presumption (see Rubbermaid (Canada) Ltd.
v. Tucker Plastic Products Ltd. (1972), 8 C.P.R. (2d) 6
(F.C.T.D.) at page 14, and Bayer Inc. v. Canada (Minister of National Health
and Welfare) (2000), 6 C.P.R. (4th) 285, at paragraph 9).
Invalidity allegation based
on Hoffmann
[11]
The only ground of invalidity to be considered
in this appeal is the allegation that claims 16 through 21 are invalid because
they are claims for a known substance. That allegation is based on the Hoffmann
case, cited above.
[12]
Hoffmann involved
an application for a patent that claimed a new process for making a known
substance called aldehyde, as well as aldehyde when made by that process. The
Commissioner of Patents granted the claim for the new process for making
aldehyde, but not the claim for aldehyde made by that process. The inventor
appealed to the Exchequer Court,
without success: Hoffmann-La Roche Ltd. v. Canada (Commissioner of Patents), [1954] Ex.
C.R. 52, and then to the Supreme Court of Canada, again without success.
[13]
Then, as now, a patent could be issued only for
an “invention”, defined as follows:
|
. . . “invention” means any new and useful art, process,
machine, manufacture or composition of matter, or any new and useful
improvement in any art, process, machine, manufacture or composition of
matter.
|
. . . « invention » Toute réalisation, tout procédé,
toute machine, fabrication ou composition de matières, ainsi que tout
perfectionnement de l’un d’eux, présentant le caractère de la nouveauté et de
l’utilité.
|
[14]
The inventor’s appeal was rejected
because there was nothing new about aldehyde, regardless of how it was made,
and the degree of novelty required for a patent cannot be achieved by
associating a known substance with a new process for making it. The inventor
was entitled to patent protection for what had actually been invented, which
was the new process, but no more. That protection was assured because anyone
making aldehyde in Canada by the new process, or importing into Canada any
aldehyde made by the new process, would necessarily be infringing the claim for
the process.
[15]
There is no jurisprudence that casts any doubt on the correctness
of the principle stated in Hoffmann. I did not understand Abbott to
argue that Hoffmann is no longer good law.
[16]
Rather, Abbott argues that the Hoffmann principle should
not have been applied in this case because the facts are not analogous. Abbott
argues that clarithromycin Form II, unlike aldehyde, was not “known” at the
relevant date. The parties
seem to have accepted without debate that the relevant date was July 29, 1996.
[17]
It is not clear from Hoffmann or the later jurisprudence
how one is to discern whether, for the purposes of applying the Hoffmann
principle, a substance is “known” at a particular point in time. In this case,
it was assumed in argument that a substance is “known” if a hypothetical claim
for its invention would fail on the ground of anticipation of lack of novelty.
I have proceeded on the basis of that same assumption, although I would leave
open the possibility that a substance might be “known” if a hypothetical claim
for its invention would fail for other reasons.
[18]
In this
case, the Judge found that clarithromycin Form II was known at the relevant
time. That conclusion is supported by a body of evidence to the effect that the
creation of a crystal form of clarithromycin by the use of solvents was known
prior to July 29, 1996. I need not list all the prior art references. It is
sufficient to say that the Judge understood the evidence of Dr. Myerson, a
witness for Abbott, to confirm that an article by Yoshiaki Watanabe and others,
published in 1993 in The Journal of Antibiotics, describes substantially
the same process as described in example 10 of the disclosure in the 732
patent, which is said to result in clarithromycin Form II.
[19]
Abbott
points out that that the Watanabe article does not state that the result of the
process in the article is clarithromycin Form II. Nor is there evidence that
any of the witnesses for Apotex attempted to follow the Watanabe article to see
if it produced clarithromycin Form II. Because of that, it would have been open
to the Judge to draw an inference adverse to Apotex on that point.
[20]
However,
the Judge also had before him the patent disclosure representing that the
method described in example 10 results in clarithromycin Form II. There was no
evidence that the representation in example 10 is false. Therefore, it was open
to the Judge to infer that following substantially the same process as described
in the Watanabe article would also have produced clarithromycin Form II. Given
the body of evidence presented to the Judge, I cannot conclude that he made a
palpable and overriding error in accepting the truth of the representation in example
10 of the patent disclosure and following its logic.
[21]
The conclusion
of the Judge is also supported by evidence relating to the creation of
clarithromycin Form II by a heating technique that was known before 1996. Clarithromycin
Form II can be obtained by heating clarithromycin Form I by that known technique
until its temperature exceeds 135˚C. It is undisputed that clarithromycin
Form I, when so heated, is transformed into clarithromycin Form II at some
point after the heated substance reaches 135˚C, although it ceases to be
clarithromycin Form II by the time the substance reaches the melting point at
225˚C.
[22]
Abbott argues
that a person skilled in the art who heated clarithromycin Form I by the known
technique would not and could not know that clarithromycin Form II had been
created, unless they also knew that the heating process had to be stopped before
the substance reached its melting point at 225˚C. In my view, the absence
of that knowledge is legally irrelevant. The undisputed evidence is that clarithromycin
Form II would have been present if the heating technique had been followed.
There were well established analytical techniques that would have disclosed its
presence if anyone had cared to look at the appropriate moment.
[23]
It was
argued by Abbott that the sale of clarithromycin Form II in Canada prior to 1993 in the form of
Biaxin could not establish that clarithromycin Form II was a known substance on
July 29, 1996. As the Judge did not rely on prior sales as a factor in
concluding that clarithromycin Form II was a known substance, it is not
necessary to deal with that point.
Conclusion
[24]
As
explained above, this appeal must be dismissed. As Abbott did not succeed on
the only point that was permitted to be argued, the costs of this appeal should
be borne by Abbott.
“K.
Sharlow”
“I
agree
B.
Malone J.A.”
“I
agree
C. Michael Ryer J.A.”
Email this Content