Date: 20060714
Docket: T-836-04
Citation: 2006 FC 861
BETWEEN:
AVENTIS PHARMA INC. and
SANOFI-AVENTIS DEUTSCHLAND
GmbH
Applicants
and
PHARMASCIENCE INC. and
THE MINISTER OF HEALTH
Respondents
AMENDED REASONS
FOR ORDER AND ORDER
GAUTHIER J.
[1]
Aventis
Pharma Inc. and Sanofi-Aventis Deutschland GmbH (collectively “Aventis”) seek a
declaration that the Pharmascience’s letter dated March 11, 2004 (the NOA) is
not a notice of allegation and detailed statement as contemplated by the Patented
Medicines (Notice of Compliance Regulations), S.O.R. /93-133 (the
“Regulations”) and, in the alternative, an order prohibiting the Minister of
Health from issuing a Notice of Compliance (“NOC”) to Pharmascience in respect
of ramipril oral capsules of 2.5mg, 5mg and 10mg until after the expiration of Canadian
Patent 2,023,089 (the “’089 Patent”).
[2]
Aventis’
brand name product, which is the reference product for Pharmascience’s
abbreviated new drug submission, is ALTACE.
[3]
The
drug ramipril is an angiotensin-converting enzyme (ACE) inhibitor that has long
been used for the treatment of hypertension (high blood pressure). The patent
on the compound itself, Canadian Patent 1,187,087 (the “’087 Patent”), expired
on May 14, 2002.
[4]
The
claims of the ’089 Patent are limited to the use of ramipril for the treatment
of cardiac and vascular hypertrophy (a general increase in bulk of part of an organ
not due to tumor formation) and hyperplasia (an increase in the number of cells
in a tissue or organ, for example an increase in the number of cells that line
blood vessels). The ’089 Patent was added by Aventis to the patent register
for ramipril after the expiry of the ’087 Patent.
Related patents and proceedings
[5]
Although
the ’089 Patent is the only one in play in the present proceeding, it is worth
noting that there are at least three other patents on the patent register for ramipril,
they are:
a) Canadian Patent
1,341,206 (the “’206 Patent”), which claims a broad class of compounds that covers
ramipril, although this compound is not itself mentioned.
b) Canadian Patent 1,246,457
(the “’457 Patent”), which claims the use of ramipril for the treatment of
cardiac insufficiency (heart failure).
c) Canadian Patent 2,055,948
(the “’948 Patent”) which claims a further new use for ramipril in combination
with a calcium antagonist for the treatment of proteinuria.
[6]
Pharmascience
has also served a notice of allegation alleging non infringement of the ’948
Patent and this resulted in an application in file T-1602-04, which was heard
together with this application but will be dealt with in a separate order as
different evidence was filed by the parties.
[7]
The
three patents described in paragraph 5, above, have been the subject of other
applications under the Regulations. In Aventis Pharma Inc. v.
Pharmascience Inc., 2005 FC 340, [2005] F.C.J. No. 511, Justice Judith Snider
held that Pharmascience’s allegation that the ’206 Patent was invalid for
obviousness and double patenting was not justified and that Pharmascience’s
notice of allegation in respect of the ’457 Patent was deficient. However,
Justice Snider did not comment on the merits of the non-infringement
allegations of Pharmascience with respect to the ’457 Patent. At the time of
the hearing, this order was still under appeal.
[8]
In
Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1381, [2005] F.C.J. No. 1691,
Justice Sandra Simpson ruled that Apotex’s notice of allegation alleging that
it would not infringe the ’457 Patent was not justified because it had not been
established how it would prevent its product from being used by patients for
the treatment of cardiac insufficiency. This order is under appeal.
[9]
Justice
Anne Mactavish held in Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1283,
[2005] F.C.J. No. 1559, that
Apotex’s notice of allegation, alleging that the ’206 Patent was invalid, was
justified. This decision was confirmed by the Federal Court of Appeal in Aventis
Pharma Inc. v. Apotex Inc., 2006 FCA 64, [2006] F.C.J. No. 208.
[10]
Finally,
in Aventis Pharma Inc. v. Apotex Inc, 2005 FC 1461, [2005] F.C.J. No. 1793,
Justice Konrad von Finckenstein held that Apotex’s notice of allegation was
sufficient and justified with respect to its allegation that it would not
infringe the ’089 Patent since it would be selling ramipril specifically for
the treatment of hypertension rather than for treating hypertrophy or
hyperplasia. This order is under appeal.
[11]
Some
of these decisions are relevant because Aventis argued that the Court should,
on the basis of judicial comity, follow the decision of Justice Judith Snider
with respect to the inadequacy of Pharmascience’s notice of allegation, whereas
Pharmascience said that the Court should be guided by the decision of Justice
Konrad von Finckenstein with respect to the effect of a certain reference in Pharmascience’s
product monograph (the Benetos reference) upon the latter’s allegation of
non-infringement.
[12]
Also,
it is worth noting that the twenty four (24) months stay in the present file
and in T-1602-04 will expire on September 1, 2006 (it was extended by consent).
[13]
Although,
in its NOA, Pharmascience initially alleged that the ’089 Patent was invalid
for various reasons including anticipation and double patenting, the parties
are agreed that this proceeding now only involves the allegation of
non-infringement and, more particularly, the non-infringement of the use claims
such as Claim 11, which reads as follows:
11. A use of a
compound of the formula I as claimed in any one of claims 1 to 8 or of an agent
as claimed in claim 10 for the treatment of cardiac and of vascular hypertrophy
and hyperplasia.
[14]
Considering
the issues to be decided in this case, the most relevant portions of
Pharmascience’s NOA are the following:
089
Patent Claim 11
(…)
This claim would not be infringed by the
making, constructing, using or selling by Pharmascience of the drug for which
the submission for the Notice of Compliance has been filed. In particular, the
Pharmascience products containing ramipril for which a Notice of Compliance is
sought will only be made, constructed, used, promoted for use and sold by
Pharmascience for the treatment of hypertension …
(…)
The Pharmascience Product
and Its Use
15.
The Pharmascience
products for which a Notice of Compliance is sought are capsules containing Ramipril
for the treatment of hypertension. These products will not be made or
sold for the treatment of cardiac and of vascular hypertrophy and hyperplasia.
16.
In particular, the
product monograph will not list such uses, the Notice of Compliance is not
being sought for such uses, and the marketing of the product by Pharmascience
will not include any references to such use
(…)
Non-Infringement of New Use Claim
(…)
39.
The grant of an NOC
for an old product cannot be restrained unless it is proved that infringement
will occur and that the second person has implicated itself in the
infringements by, for example, inducing or encouraging them. AB Hassle v. Canada (Minister of National Health and
Welfare) (2002) 22 C.P.R.
(4th) 1 (F.C.A.); Lundbeck v. Gerpharm [sic], (supra); Lundbeck
v. Apotex (supra).
[15]
Aventis
filed three affidavits. Their affiants are:
i)
Franca
Macino, the Director of Regulatory Affairs at Aventis Pharma Inc. Her affidavit
essentially serves to put into evidence the text of the ’089 Patent and
Pharmascience’s NOA.
ii)
John
David Parker, a doctor qualified to practice in Ontario and Massachusetts who
teaches medicine and pharmacology at the University of Toronto and practices
cardiology at the University Health Network and at Mt. Sinai Hospital. Among other things, he
describes the practice of physicians that prescribe ramipril and explains how
he and others would use the generic version of ramipril in the same way Altace
is used.
iii)
Barbara
Marie Berry, who worked as a licensed pharmacist in Manitoba from 1974 to 2004 and
was called to the Bar in that province in 1993. She also worked as a health
care consultant and is the author of a textbook entitled Canadian Pharmacy
Law. Ms. Berry was asked to provide an opinion as to whether Pharmascience’s
ramipril product, once available on the market, will be used by patients for
the treatment of cardiac and of vascular hypertrophy and hyperplasia, even though
Pharmascience has not sought federal regulatory approval for such uses.
[16]
Pharmascience
relied on the affidavits of:
i)
Leonard
Neirinck, Pharmascience’s Vice-President of Scientific Affairs, who states that
Pharmascience is seeking an NOC only to sell ramipril for the treatment of
hypertension. He also says that the application for the listing on provincial
formularies by Pharmascience “will be based on approval for use in the
treatment of hypertension”. He appends a draft product monograph and a draft
label. He also explains that, if anyone were to inquire with Pharmascience
whether their version of ramipril is “approved for cardiac and vascular
hypertrophy and hyperplasia, Pharmascience will respond, ‘not at this time’”.
ii)
Michael
Kutryk, who holds a Ph.D. in cardiovascular physiology and is currently an
Assistant Professor at the University of Toronto Medical School as well as an
interventional cardiologist at St. Michael’s Hospital. Dr. Kutryk comments on
the prevalence of cardiac and vascular hyperthophy and gives his opinion on the
incidence of these conditions as caused by hypertension and as caused by any
other factor.
iii)
Ronald
Henry Kluger, a professor of chemistry at the University of Toronto whose opinion on the meaning of
the claims is not particularly relevant to the specific issues to be determined
by the Court for reasons that will be explained later.
iv)
Ronald
Nefsky, a licensed pharmacist in Ontario whose mandate was to describe how a drug
product is selected for dispensing when the pharmacist has the choice of more
than one brand of the same medication. Mr. Nefsky based his explanation on the
premise that Pharmascience would have obtained an NOC for the use of ramipril
to treat hypertension only and would have sought and obtained a listing
under the Ontario Drug Benefit Formulary where its product’s interchangeability
would be limited to use in the treatment of hypertension.
[17]
All
these affiants were cross-examined.
Issues
[18]
First,
Aventis argues as a threshold issue that, as found by Justice Snider in Aventis
Pharma Inc., above, the NOA is deficient because it fails to explain how
infringement by patients would not occur. In that respect, the NOA contains
only a bald assertion of non-infringement.
[19]
Second,
Aventis says that Pharmascience’s allegation of non-infringement is simply not
justified because Aventis’ expert evidence clearly establishes that
infringement by patients will inevitably occur. According to Aventis, this is
true regardless of whether one considers the infringement by patients who
suffer from hypertension as well as one of the uses covered by the ’089 Patent
or whether one only looks at the more limited use of patients who suffer from cardiac
or vascular hypertrophy or hyperplasia without suffering from hypertension (Proctor
and Gamble Pharmaceutical Canada v. Canada (Minister of Health), 2002 FCA
290, commonly known as Genpharm).
[20]
Moreover,
Aventis claims that, even if the Court adopts Pharmascience’s interpretation of
the law (see AB Hassle v. Canada (Minister of National Health and Welfare), 2002 FCA 421), its
allegation of non-infringement would still not be justified. In that respect,
it submits, among other things, that Pharmascience’s product monograph contains
a reference which clearly teaches that ramipril reverses cardiac hypertrophy
(the Benetos reference). Contrary to what is asserted in the NOA, this
reference would suggest to an informed person that Pharmascience’s ramipril product
could be employed for a patented use.
[21]
Pharmascience
admitted at the hearing that its NOA does not address the issue of infringement
by patients. It submits that it did not have to do so. It says that such infringement
is only relevant if the use by patients was induced or procured by
Pharmascience.
[22]
Although
Pharmascience does not agree that Aventis has established that infringement by
patients would be inevitable, most of its submissions at the hearing focused on
the legal test applicable pursuant to sub-paragraph 5.1(b)iv) of the Regulations
and on whether the Court should follow Justice von Finckenstein’s finding that
the inclusion of the Benetos reference in the product monograph is not
sufficient to justify a finding of infringement by inducement or procurement (Valmet
OY v. Beloit Canada Ltd. (1988), 20 C.P.R. (3d) 1 at 14 (F.C.A.)).
[23]
At
the hearing, considerable time was spent by the parties discussing the meaning
of the decisions of the Court of Appeal in Genpharm and AB Hassle,
above, as well as twelve other decisions of this Court. Similarly, the Court
spent quite some time reviewing these cases. But before these reasons were
completed, the Court of Appeal issued its decision in Pharmascience Inc. v. Sanofi-Aventis
Canada Inc., 2006 FCA 229. This decision essentially settles, in my view,
the first two issues raised by Aventis. Thus, it will not be necessary to
review in any detail the arguments put forward by the parties, for these were
essentially the same ones as those they presented to the Court of Appeal in Pharmascience,
above.
Analysis
[24]
The
nature of the proceedings as well as the history and the scheme of the Regulations
have been described and commented upon in several cases (Fournier Pharma
Inc. v. Canada (Minister of Health), 2004 FC 1718 at para. 6, 8-9), including
the recent decision of the Supreme Court of Canada in Bristol-Myers Squibb
Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533, commonly known as Biolyse.
[25]
The
principles with regard to the burden of proof in such proceedings were
summarized by Justice Arthur Stone of the Federal Court of Appeal in Hoffman
Laroche Limited v. Canada (Minister of National Health and Welfare), [1996]
F.C.J. No. 1333 at paragraphs 7 and 8.
a) Is the NOA deficient?
[26]
The
Court agrees with Aventis that there are no relevant factual or evidentiary
distinctions between the situation that was before the Justice Snider in Aventis
Pharma Inc., above, and the present one. The Court would have been bound on
the basis of judicial comity to adopt the same conclusion. Given that the Court
of Appeal has now found that the NOA in that case was perfectly adequate,
because Pharmascience only had to deal with the factual and legal basis
supporting its allegation that it did not itself infringe the ’089 Patent, the
Court is bound to adopt the same conclusion.
[27]
In
that respect, it is worth noting that the Court of Appeal found at paragraph 25
that the NOA in Pharmascience, above, was not a bald assertion of
non-infringement because there was a clear reference to the fact that its
marketing would not be directed toward the treatment of cardiac insufficiency.
The passage of the NOA quoted at paragraph 23 of the Court of Appeal’s decision
contains no more information than what is included in the passages quoted at
paragraph 13, above.
[28]
I
conclude that the NOA is adequate.
b) Is Pharmascience’s
allegation of non-infringement justified?
[29]
Before
analyzing the evidence, it is essential to determine the test to be applied,
for this was the main point of contention between the parties at the hearing.
This essentially depends on the interpretation to be ascribed to sub-paragraph
5.1(b)iv) of the Regulations.
[30]
As
mentioned, the arguments made by the parties before the Court were essentially
the same as those they presented to the Court of Appeal in Pharmascience,
above. In its decision, the Court of Appeal addresses the apparent
contradictions between the Genpharm and AB Hassle decisions,
above, and clarifies their meaning. It reconsiders the ambit of
sub-paragraph 5.1(b)iv) in light of the recent decision of the Supreme Court of
Canada in Biolyse,
above. In particular Justice Karen Sharlow said:
55.
I turn now to the relevant words of subparagraph 5(1)(b)(iv) of the NOC
Regulations, which sets out the required contents of a non-infringement
allegation. It states that in a non-infringement allegation, the generic drug
producer must allege that:
|
|
... no claim for the
medicine itself and no claim for the use of the medicine would be infringed
by the making, constructing, using or selling by that person of the drug for
which the submission for the notice of compliance is filed.
|
|
|
|
...
aucune revendication pour le médicament en soi ni aucune revendication pour
l'utilisation du médicament ne seraient contrefaites advenant l'utilisation,
la fabrication, la construction ou la vente par elle de la drogue faisant
l'objet de la demande d'avis de conformité.
|
|
56.
Pharmascience argues that the words "by that person" means that this
provision refers only to acts of Pharmascience that would constitute
infringement of the 457 patent (which I understand would include acts of
Pharmascience that induce or procure infringement by others). Aventis argues
that subparagraph 5(1)(b)(iv) is capable of being read more broadly, and should
be read more broadly, so that it includes any infringement by anyone of the 457
patent that results in any way from the issuance of a notice of compliance to
Pharmascience.
57.
In my view, the interpretation proposed by Pharmascience is more consistent with
the ordinary grammatical meaning of subparagraph 5(1)(b)(iv) of the NOC
Regulations, and is also more consistent with the legislative scheme and
purpose. Subsection 55.2(4) of the Patent Act and by extension the NOC
Regulations are intended to prevent patent infringement by Pharmascience,
not by patients.
58.
The narrower interpretation proposed by Pharmascience is also more consistent
with the general scheme of the Patent Act. The bargain represented by
the 087 patent permits anyone to use the patented invention (that is, to make
ramipril using one of the claimed processes) once the term of that patent
expired in November of 2002. If Pharmascience is now prevented from obtaining a
notice of compliance for its ramipril capsules for use in the treatment of
hypertension only because the inevitable result is infringement of the 457
patent by patients who use the Pharmascience product for the treatment of
cardiac insufficiency, the practical result will be an artificial extension of
the monopoly represented by the now expired 087 patent. I do not believe that
Parliament intended the NOC Regulations to permit such a result. (This
point is also made in AB Hassle, at paragraph 57.)
59.
I acknowledge that there are statements in Genpharm that could be taken
to support the broader interpretation of subparagraph 5(1)(b)(iv) proposed by
Aventis (see, for example, paragraphs 45 to 50). I make three observations
about those statements. First, they are obiter dicta, made in the
context of evidence that Genpharm would in fact market its product for a use
that came within the claims of one of the listed patents, which was not true in
AB Hassle and is not true in this case. Second, Genpharm was
decided before this Court had the benefit of the decision of the Supreme Court
of Canada in Biolyse. In my view, the statements in
paragraphs 45 to 50 of Genpharm interpret subparagraph 5(1)(b)(iv) in a
manner that is not consistent with Biolyse. Third, although I remain of
the view that Genpharm was correct in result, paragraphs 45 to 50 of Genpharm,
read in isolation, do not reflect the correct interpretation of subparagraph
5(1)(b)(iv) of the NOC Regulations, and to that limited extent should be
taken to have been reversed by AB Hassle.
60.
For these reasons, I conclude that the narrower interpretation of subparagraph
5(1)(b)(iv) of the NOC Regulations, as proposed by Pharmascience, is
correct. As there is no evidence that Pharmascience will infringe the 457
patent, or that it will induce or procure the infringement by others of the 457
patent, the allegation of non-infringement of the 457 patent is justified. It
follows that, even before the 457 patent expired on December 13, 2005, there
was no basis upon which the Federal Court could have granted the application of
Aventis for an order prohibiting the Minister from issuing a notice of
compliance to Pharmascience for its ramipril capsules.
[31]
This
means that even if Aventis does prove that infringement by patients of the use
claims of the ’089 Patent is highly probable, if not inevitable, it would not
be sufficient to establish that Pharmascience’s allegation of non-infringement
is not justified.
[32]
In
that context, it would normally only be necessary to make a finding in respect
of use by patients if I found that Aventis had established that Pharmascience’s
product monograph or its other proposed actions can support a finding of
infringement by inducement or procurement.
[33]
However,
given that the delay to seek permission to appeal in Pharmascience,
above, has not expired, the Court will assess the evidence in respect of
potential infringement by patients.
[34]
For
that purpose, it will not be necessary to determine whether the claims at issue
should be construed restrictively or not. I am satisfied that my conclusion on
this issue would be the same whether or not the use claims are construed, as
suggested by Pharmascience, to cover only the use by patients suffering from
cardiac or vascular hypertrophy not caused by hypertension.
[35]
As
is the case here, Pharmascience had submitted evidence to Justice Snider with
respect to limited interchangeability (in particular the affidavit of Mr.
Nefsky). The learned judge had considered that this was an impermissible
attempt by Pharmascience to expand the factual basis of its non-infringement
allegation. The Court of Appeal in Pharmascience, above, did not make
any finding in that respect (see para. 28) but it noted that the remedy in such
a case would be to disregard the evidence, not to find the NOA to be
inadequate.
[36]
Having
carefully considered the NOA before me, I am satisfied that Pharmascience
cannot support its allegation of non-infringement on the basis of the fact that
it would only seek a limited interchangeability listing on the Ontario
formulary and that it would send a separate warning to health professionals
with respect to the limited use for which its NOC was granted. This simply goes
beyond the factual basis asserted in the NOA.
[37]
However,
the Court has considered this evidence in assessing the weight to be given to
the evidence of Ms. Berry for she asserts at
paragraph 14 of her affidavit that it is highly probable that Pharmascience’s
product would be listed as a generic bio-equivalent of ALTACE in the Manitoba drug benefits and
interchangeability formulary, regardless of its federally approved use.
Pharmascience is entitled to present evidence to rebut that statement.
[38]
I
have also reviewed very carefully the transcripts of the various
cross-examinations and considered the arguments raised by Pharmascience with
respect to the little weight that should be given to Ms. Berry’s affidavit as well as
some of the contradictions or admissions made by Dr. Parker.
[39]
Based
on my review of all the evidence, I find that it is highly probable that
Pharmascience’s ramipril product will be listed without restriction, at least
in Manitoba and in Ontario (Astrazeneca
Canada Inc. v. Apotex Inc., 2006 MBCA 21). Although it is conceivable
that the situation would be the same in the other provinces, there is no
evidence to that effect before me, for I agree that Ms. Berry and Mr. Nefsky
are not qualified to give an opinion in respect of the situation in those provinces.
I also note that these two affiants are not qualified to opine on the knowledge
and practices of doctors, even in their respective provinces.
[40]
I
accept the evidence of Dr. Parker and Dr. Kutryk, who are both well qualified as
experts on the matters referred to in their affidavits. I accept Dr. Kutryk’s
opinion that the rate at which ramipril would be prescribed for the treatment
of hypertrophy or hyperplasia, in cases where the cause is something other than
hypertension, is very low. Nevertheless, considering the popularity of this
drug and the prescribing practices of doctors in Ontario, including the fact
that hospitals use mostly, if not only, the generic version of drugs (even for
Zoloft, which was the only product listed for a limited use in Ontario), I have
concluded that it is probable, if not inevitable, that at one point patients
suffering from hypertrophy and hyperplasia that do not also suffer from
hypertension (albeit few in number) will use Pharmascience’s product for the
patented uses.
[41]
That
said, is there any evidence that Pharmascience’s proposed product monograph or the
actions it intends to take will induce the infringement by such patients?
Aventis alleges that the uses covered by the ’089 Patent are discussed in an
article of Athanase Benetos et al., “Effects of Ramipril on Arterial Hemodynamics”
(1991) 18:2 Journal de Cardiovascular Pharmacology 153 (the Benetos reference).
As I mentioned earlier, Aventis made this same argument before Justice von
Finckenstein in Aventis Pharma Inc., above. In that case, the Court found
that the Benetos reference could not be considered to link ramipril with the
treatment of cardiac and vascular hypertrophy and hyperplasia. In that respect,
Justice von Finckenstein said:
[35]
As for the Benetos Article, on which
Aventis "hangs its hat" to quote its counsel, I do not find that it
amounts to the requisite "something more" for the following reasons:
a)
it does not appear in the body of the
product monograph nor is it footnoted anywhere. The Benetos Article is merely
cited as the first reference among 18;
b)
it does not deal with Hypertrophy
but as the introduction states:
the aim of this study was to determine the
arterial effects of the ACE inhibitor ramipril in relation to its acute and
chronic antihypersentensive action.
c)
the word hypertrophy is only
mentioned once; the word hyperplasia is not mentioned at all;
d)
the sentence containing the word
"hypertrophy" is in the introductory background portion of the
article and it refers to another article. The sentence reads:
Angiotensin-coverting enzyme (ACE) inhibitors
have been reported to lower BP, reverse cardiac hypertrophy (3), and improve
large arteries compliance (4) .
If one then looks up footnote (3) of the Benetos
Article, one finds the following reference:
Asmar R, Journot H, Lacolley P, Santoni JP,
Billaud E, Safar M. Treatment for one year with perindopril: effect on
cardiac mass and arterial compliance in essential hypertension. J Hypertens
1988; 6 (suppl 3): S33-40. (Underlining added)
There is no dispute that perindopril is an ACE
inhibitor but there is also no dispute that it is not ramipril;
e)
there is no evidence that the
reference to the Benetos Article will guide the behaviour of physicians or
pharmacists. Aventis' star expert witness, Dr. Dagenais, whose qualifications
are not questioned by Apotex merely states in his affidavit:
20. The list of
references at page 45 of the draft product monograph includes a paper dealing
with the use of ACE inhibitors in the treatment of cardiac hypertrophy. In
reference 1, entitled "Effects of Ramipril on Arterial Hemodynamics",
published in 1991 the authors note on page S153:
Angiotensin - converting enzyme (ACE) inhibitors
have been reported to lower BP [Blood Pressure], reverse cardiac hypertrophy,
and improve large arteries compliance.
A copy of the reference is attached as Exhibit
"B".
Neither Dr. Dagenais nor any other expert
witness provide any evidence that purports to show how the Benetos article is
linked to infringement by doctors, pharmacists or patients.
[36]
In short, Aventis would like to
establish a nexus between Apotex and indirect infringers not on the basis of
anything contained in the body of the Original PM but on the basis of a mere
footnote contained in a reference appended to the Original PM. However, as the
foregoing analysis shows, except for the one word " hypertrophy" in
the background introductory paragraph of the appended reference (directing one
to a study on perindropril), there is no link whatsoever between the Benetos
Article and Hypertrophy. I fail to see how the mere use of the word in a
referenced article not dealing with Hypertrophy can in any way be interpreted
to establish a nexus (i.e. meet the "something more" requirement as
that term was used by Sexton J.A. in AB Hassle v. Minister of Health &
Welfare, supra).
(My emphasis)
[42]
Aventis
argues that the Court should not follow this decision because it is clearly wrong.
It says that Justice von Finckenstein did not properly consider the fact that
the sentence underlined in the passage quoted above refers to inhibitors
and not simply to the inhibitor referred to in the reference at footnote 3 of
the article (perindopril).
[43]
Even
if this were true (and I do not need to decide this), the Court does not find
that it could justify the conclusion sought by Aventis.
[44]
Although,
there is some evidence that Pharmascience would provide copies of this article
on request (Q:136 of the cross-examination of Mr. Neirinck), there is no
indication that it is customary for health professionals to make such requests.
It is also far from evident that pharmacists and doctors customarily review
generic products monographs when they are familiar with the brand name product.
In fact, Dr. Kutryk indicated that he infrequently reads the product monograph
when a drug is genericized (Q:179 of his cross-examination). Mr. Nefsky also
indicated that, in the normal course of things, he would not read a generic
product monograph when he receives it because he would have already read the
innovator product monograph and there would be no real need to do so. (Q: 76 of
his cross-examination).
[45]
There
is no evidence as to how the Benetos reference would affect other health professionals
if they happened to read the product monograph, requested a copy of this
reference from Pharmascience and actually reviewed it.
[46]
I
have no good reason not to adopt the conclusion reached by Justice von
Finckenstein in Aventis Pharma Inc., above. In fact, I am convinced that
I would have reached the same conclusion, even in the absence of this
precedent.
[47]
Finally,
I have considered the other argument put forth by Aventis on the basis of
Pharmascience’s statement that it would not send letters to health
professionals advising them of the possible infringement of the ’089 Patent.
[48]
The
evidence and the arguments presented to the Court cannot support the conclusion
that Pharmascience’s allegation of non-infringement is not justified. Aventis
has not met its burden of proof.
[49]
This
application is dismissed with costs which should be assessed on the basis of Column
III of Tariff B.
ORDER
THE COURT ORDERS that:
1. The application is
dismissed with costs to be assessed on the basis of Column III of Tariff B.
“Johanne
Gauthier”
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