Date: 20070628
Docket: A-580-06
Citation: 2007
FCA 251
CORAM: NADON
J.A.
SEXTON J.A.
RYER
J.A.
BETWEEN:
NOVOPHARM
LIMITED
Appellant
and
ABBOTT LABORATORIES LIMITED, TAP
PHARMACEUTICALS INC.,
THE MINISTER OF HEALTH and
TAKEDA PHARMEUTICAL COMPANY LIMITED
Respondents
REASONS FOR JUDGMENT OF THE
COURT
(Delivered
from the Bench at Toronto, Ontario, on June 28, 2007)
NADON J.A.
[1]
This
is an appeal by the appellant Novopharm Limited from a decision of von
Finkenstein J. of the Federal Court, 2006 FC 1411, dated November 21, 2006, who
allowed the application of the respondents Abbott Laboratories Limited and TAP
Pharmaceuticals Inc. (“Abbott”), under subsection 6(1) of the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (“NOC
Regulations”), for an order prohibiting the Minister of Health (the “Minister”)
from issuing a NOC to Novopharm for Lansoprazole (the “drug”) in 15mg or 30 mg
delayed release capsules for oral administration until after the expiry of
Canadian patent no. 2,009,741 (the “ ‘741 patent”).
[2]
At
issue in these proceedings is the drug Lansoprazole in respect of which the
respondent Takeda Pharmaceutical Company Limited (“Takeda”) obtained Canadian
patent no. 1,255,314 (the “ ‘314 patent”) which expired on June 6, 2006.
[3]
In
March 1999, Takeda was issued the ‘741 patent for a new use of Lansoprazole.
[4]
The
‘314 patent was issued in respect of Lansoprazole to treat excess gastric secretions
which were believed to cause gastric and duodenal ulcers. Such use of Lansoprazole
is referred to as the “old use”.
[5]
The
subsequent scientific discovery that most ulcers were in fact caused by a
bacterium called Helicobacter pylori (“H. pylori”) led to a new
treatment approach based on antibacterial drugs. As a result, the ‘741 patent
was issued in respect of a “new use” for Lansoprazole as an antibacterial agent
to treat and prevent infectious diseases, i.e. ulcers caused by H. pylori.
[6]
A
NOC for the new use of Lansoprazole under the name PREVACID was issued to
Abbott on April 7, 1998.
[7]
Because
it was seeking the issuance of a NOC for its generic formulation of delayed
release capsules in 15mg and 30mg strengths, in regard to which it claimed
bioequivalence to PREVACID, which would allow the sale thereof in Canada,
Novopharm was obliged, pursuant to subsection 5(1) of the Regulations, to serve
on the respondent Abbott a Notice of Allegation (a “NOA”) wherein it alleged
that its formulation of Lansoprazole, Novo-Lansoprazole,
would not infringe the ‘741 patent. Specifically, Novopharm asserted that its
drug would not be made, constructed, used or sold as an antibacterial
composition or for the treatment of H. pylori infections.
[8]
Following
the service of Novopharm’s NOA, Abbott commenced the application which resulted
in von Finkenstein J. concluding that Novopharm’s allegations of non
infringement were not justified and that, hence, an order of prohibition should
be issued in respect of Novopharm’s NOVO-LANSOPRAZOLE until the expiry of the
‘741 patent.
[9]
In
making his order, the judge construed the ‘741 patent, as he was bound to, and
made a number of findings regarding the issue of infringement.
[10]
First,
he construed the patent and, in particular, claim 16 thereof. After a brief
review of the Supreme Court of Canada’s decisions in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, and Free
World Trust v. Electrosanté Inc., [2000] 2 S.C.R. 1024, in which the
Supreme Court sets out the principles relevant to claim construction, the judge
turned to the expert evidence adduced by the parties which he assessed in the
light of their respective submissions.
[11]
This led
the judge to conclude that claim 16 was a claim for the antibacterial use of
Lansoprazole alone or in combination with other drugs to prevent infectious
diseases caused by H. pylori.
[12]
The judge
then turned to the question of infringement, i.e. whether Novopharm would
infringe claim 16 if it made, constructed, used or sold its NOVO-LANSOPRAZOLE.
[13]
After a
careful review of the evidence and, in particular of Novopharm’s proposed
product monograph for its NOVO-LANSOPRAZOLE and its proposed bottle label, the
judge concluded, inter alia, that:
·
Novopharm’s
product monograph will induce and encourage physicians to prescribe NOVO-LANSOPRAZOLE
to treat ulcers caused by H. pylori.
·
Novopharm’s
bottle label will induce or encourage physicians to prescribe NOVO-LANSOPRAZOLE
to treat ulcers caused by H. pylori.
[14]
By
reason of these findings, the judge concluded that claim 16 of the ‘741 patent
would be infringed if the Minister issued a NOC to Novopharm for its NOVO-LANSOPRAZOLE.
[15]
In
a postscript to his Reasons, the judge pointed out that following the hearing
of the prohibition application, Novopharm referred him to the Supreme Court of
Canada’s recent decision in Astrazeneca Canada Ltd. v. Canada (Minister of
Health), [2006] 2 S.C.R. 560, in support of the proposition that since the
new use of Lansoprazole, i.e. as an antibacterial agent, was not an approved
use of PREVACID, it did not incorporate the invention found in the ‘741 patent.
Consequently, in Novopharm’s view, it had not “early worked” the ‘741 patent in
submitting its Abbreviated New Drug Submission (“ANDS”) and, as a result, the
NOC Regulations did not require it to make reference to the ‘741 patent.
[16]
The
judge held that Novopharm’s submissions would not be considered because the
point had not been raised by Novopharm in its NOA nor, for that matter, in its
Memorandum of Fact and Law.
[17]
Novopharm
challenges the judge’s decision on a number of counts. First, it says that the
judge erred in law in failing to properly construe claim 16 in that:
1.
he
omitted an essential element of the claim, i.e. its antibacterial use and, as a
result, he construed to claim to cover the per se use of Lansoprazole to
prevent an ulcer caused by excess gastric secretions (the old use), and
2.
he
incorrectly construed the claims of the patent to include the use of
Lansoprazole when administered with other drugs.
[18]
In
our view, the judge made no such error. At paragraph 23 of his Reasons, he
adopted the point of view put forward by Dr. Armstrong, one of Abbott’s expert
witnesses, who said;
[23] Point a) is
conclusively dealt with by the testimony of Abbott’s witness, Dr. Armstrong,
who observed:
27. In 1990 there were
no data, and there are none today, to support any suggestion that taking
Lansoprazole can prevent a patient from acquiring an H. pylori infection. This
is an important medical fact which given background to the meaning of “treating
and preventing”. No person of ordinary skill in the art, reading the patent in
1990, would have concluded that Lansoprazole was being described for use in
preventing an H. pylori infection. For this reason, among others, such a
person would also understand, necessarily, that claim 16 cannot be directed at
preventing or treating H. pylori infections (as Dr. Graham has it) but is
clearly directed at preventing the diseases that such infections cause –
ulcers.
28. A person with
ordinary skill in the art reading the patent as a whole would understand that
the invention relates to the antibacterial ability of Lansoprazole to prevent
the diseases caused by H. pylori and that it is not limited to eradication of
H. pylori or directed to the prevention of H. pylori infections from occurring.
(Reply
Affidavit of Dr. David Armstrong, AR, Vol III at 527.)
[19]
This
makes it clear that the judge’s construction of the claim is that it pertains
to the use of Lansoprazole as an antibacterial agent to prevent the diseases
caused by H. pylori and that he did not confuse the old use of Lansoprazole found
in the ‘314 patent with its new use found in the ‘741 patent.
[20]
In
our view, the judge also made no error in holding that the claim did not
exclude the use of Lansoprazole with other drugs. In so holding, he relied, inter
alia, on the evidence of Drs. Sekar and Saibil, two of Novopharm’s expert
witnesses, and on that of Dr. Fass, an Abbott expert witness.
[21]
The
judge clearly understood the principles of claim construction and he applied
them, correctly in our view, in the light of the expert evidence available to
him. As a result, we fail to see how it can be said that the judge’s
construction is in error.
[22]
Consequently,
we conclude that the judge properly construed the patent. Novopharm’s
submissions on this point are therefore dismissed.
[23]
With
respect to the judge’s findings that its product monograph and its bottle label
will cause or induce infringement to occur, Novopharm makes the following
points. It says that the judge made an unreasonable or incorrect application of
this Court’s decisions in A.B. Hassle, Pharmascience Inc. v. Sanofi-Aventis
Canada Inc., 2006 FCA 229, and Sanofi-Aventis Canada Inc. v. Apotex Inc.,
2006 FCA 357, which required him to examine the intentions and activities of
the generic manufacturer so as to determine whether there was inducement to
infringe. In our view, the judge clearly understood the principles set by these
cases and made no error in applying them.
[24]
Novopharm
also says that there was no evidence before the judge which could lead him to
conclude that its product monograph and bottle label would induce or encourage
physicians to prescribe NOVO-LANSOPRAZOLE to patients for the new use. First,
Novopharm says that its product monograph does not include, contrary to that of
PREVACID, any reference to H. pylori or triple therapy, i.e. the new use.
[25]
Second,
it says that there is nothing in its product monograph that could influence
physicians to prescribe its NOVO-LANSOPRAZOLE as an antibacterial agent for the
prevention of H. pylori. To the contrary, it submits that its product monograph
makes it clear that the conditions to be treated with its drug product are
limited to conditions pertaining to the reduction of gastric acid secretions.
[26]
The
judge did not accept Novopharm’s contentions. At paragraphs 40 to 42 of his
Reasons, after a careful review of the evidence, including the expert evidence,
he sets out his rationale for concluding that Novopharm’s product monograph
would induce infringement:
[40]
Admittedly, Dr. Graham also points out that: a) physicians rarely look at a PM
when making a prescription; and b) that a pharmacist might, when filling out
the prescription, note that Novo-Lansoprazole has no indication for triple
therapy use. This however, does not detract from the fact that the Novopharm PM
is set up in such a way that, by his own admission, it can be seen to be a prescription
of Novo-Lansoprazole for triple therapy which would be an encouragement to
infringe claim 16 of the 741 patent.
[41] Given the
expert testimony that ulcers caused by something other than H. pylori, NSAID’s
or Zollinger-Ellison Syndrome are extremely rare, it is hard to understand why
the reference to duodenal and gastric cancer is on the Novopharm PM and why it
occupies the first two bullets.
[42]
Accordingly, I find, based on the testimony of Novopharm’s most renowned witness,
that on a balance of probabilities the Novopharm PM would induce a physician to
prescribe Novo-Lansoprazole for a triple therapy to fight H. pylori-caused
infections.
[27]
In
our view, this conclusion was open to the judge on the evidence before him and
Novopharm has not persuaded us that in so finding, the judge made an overriding
and palpable error.
[28]
Novopharm
makes a similar argument regarding the judge’s finding with respect to the
bottle label. It says that there was no evidence to support a finding that by
reason of the information appearing on its bottle label, it would induce
infringement by physicians or anyone else.
[29]
The
judge carefully examined the label and the evidence of the experts and, in
particular, the evidence of Drs. Sekar and Armstrong. This led him to the
following conclusion at paragraph 47 of his Reasons:
[47] The Court
is driven to the conclusion that the inclusion of the amount, the frequency and
the duration of the dosage for triple therapy on the label for Novo-Lansoprazole
under the rubric ‘Adult dosage’ and the absence of any other clinically
indicated use for that dosage, on the balance of probabilities, will have the
effect of inducing or encouraging physicians to prescribe Novo-Lansoprazole for
triple therapy.
[30]
Novopharm
says that that conclusion is untenable and that it constitutes an overriding
and palpable error. We cannot agree. We are satisfied that, on the evidence
before him, it was open to the judge to conclude as he did.
[31]
In
the end, what Novopharm is really asking us, in effect, is to reassess the
evidence in a light more favourable to it. That we cannot do, absent an
overriding and palpable error on the part of the judge.
[32]
Two
further matters remain for consideration.
[33]
The
first one is an issue of unfairness. Novopharm says that the issue of
inducement by reason of its product monograph and bottle label was not pleaded
nor put in play by Abbott in its Notice of Application. It says that the issue
only appeared when Abbott, following the cross-examinations of the experts,
raised it for the first time in its written submissions to the judge.
[34]
Although
Novopharm protested against this in its written submissions, it never argued or
took the position that allowing Abbott to raise the issue at a late stage was
prejudicial and that it required, if the issue was allowed to proceed, leave to
adduce additional expert evidence in response.
[35]
We
are all agreed that it is now too late for Novopharm to take the position that
the judge erred in allowing Abbott to raise the issue and, accordingly, in
deciding the matter on Abbott’s behalf on the ground of inducement.
[36]
The
last issue arises by reason of the Supreme Court of Canada’s decision in Astrazeneca,
supra. It will be recalled that Novopharm submitted that decision to the
judge prior to the rendering of his decision and that the judge refused to
consider Novopharm’s arguments.
[37]
Novopharm
says that the judge erred in so deciding, since Astrazeneca was
determinative of the matter. We do not agree.
[38]
First,
whether Novopharm was obliged by the NOC Regulations to compare its drug to
PREVACID and to address the patents listed in regard to the relevant NOC was a
matter for the Minister. Consequently, Novopharm ought to have raised the issue
with the Minister and, if met with an unfavourable decision, it was open to it
to challenge the Minister’s decision by way of judicial review.
[39]
Second,
if it was open to Novopharm to raise the issue in the proceedings commenced by
Abbott, we, like the judge, are of the view that Novopharm was obliged to raise
the matter in its NOA, which it did not. We are therefore satisfied that the
judge made no reviewable error on this point.
[40]
Consequently,
notwithstanding Mr. Godfrey’s most forceful arguments, Novopharm’s appeal will
be dismissed with costs.
“M.
Nadon”
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