Docket: T-1440-14
Citation:
2015 FC 388
Vancouver, British Columbia, March 26, 2015
PRESENT: Prothonotary Roger R. Lafrenière
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BETWEEN:
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BAYER INC. AND
BAYER INTELLECTUAL PROPERTY GMBH
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Applicants
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And
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PHARMACEUTICAL PARTNERS
OF CANADA INC. AND
THE MINISTER OF HEALTH
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Respondents
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PUBLIC REASONS FOR ORDER AND ORDER
[1]
This is a motion to strike portions of the
application pursuant to paragraph 6(5)(b) of the Patented
Medicines (Notice of Compliance) Regulations [PMNOC Regulations].
INTRODUCTION
[2]
The underlying proceeding is an application by
the Applicants, Bayer Inc. and Bayer Intellectual
Property GmbH [herein referred to collectively in the singular as “Bayer”] under section 55.2(4) of the Patent Act
and section 6 of the PMNOC Regulations. Bayer seeks a declaration that a
letter from the Respondent, Pharmaceutical Partners of
Canada Inc. [PPC] to Bayer dated April 8, 2014 is not a notice of allegation
and detailed statement for the purpose of the PMNOC
Regulations and has no legal effect. In the
alternative, Bayer seeks an order prohibiting the Minister of Health from
issuing a notice of compliance to PPC for its proposed moxifloxacin
hydrochloride product for injection until the expiration of three of Bayer’s
patents, including Canadian Patent No. 2,378,424 [the 424 Patent].
[3]
PPC has moved for an order pursuant to paragraph 6(5)(b) of the PMNOC Regulations
striking portions of Bayer’s application on the grounds that the application, insofar as it relates to the 424 Patent,
is scandalous, frivolous and vexatious or is otherwise an abuse of process. PPC
maintains that Bayer’s evidence simply cannot support a conclusion of direct
infringement or inducing infringement by PPC.
[4]
PPC did not file any evidence in support of its
motion. It relies solely on the affidavit evidence served by Bayer in the
main proceeding relating to the infringement or induced
infringement of the 424 Patent and, more particularly,
the affidavits of two experts, Dr. Linda Dresser and Dr. Roland Grossman.
Since Bayer did not file any additional evidence in response to the motion and
no cross-examination was conducted of Bayer’s two deponents, the facts on this
motion are not in dispute.
FACTS
[5]
PPC filed an Abbreviated New Drug Submission
[ANDS] to obtain a Notice of Compliance [NOC] for a moxifloxacin hydrochloride
intravenous solution for injection to be marketed in Canada under the name
PPC-Moxifloxacin. PPC compares PPC-Moxifloxacin with AVELOX® I.V., Bayer’s
version of moxifloxacin hydrochloride intravenous solution for injection.
[6]
Three patents are listed on the Patent Register
in respect of AVELOX® I.V., namely, Canadian Letters Patent No. 1,340,114,
Canadian Letters Patent No. 2,192,418 and the 424 Patent. As noted above, this
motion pertains only to the 424 Patent. The 424 Patent is entitled “Moxifloxacin Formulation Containing Common Salt”. It
discloses and claims a moxifloxacin formulation for parenteral administration,
including a formulation for intravenous administration. All 49 claims of the
424 Patent require the inclusion of moxifloxacin and sodium chloride within
specified concentrations.
[7]
Independent Claim 1 of the 424 Patent claims in
particular:
An aqueous formulation comprising:
from
0.04% to 0.4% (w/v) of moxifloxacin hydrochloride, based on the amount of
moxifloxacin, and
from 0.4% to 0.9% (w/v) of sodium chloride.
[8]
PPC-Moxifloxacin XXXXXXXXXXXXXXXXXXX. The non-medicinal
ingredients in PPC-Moxifloxacin are XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
[9]
One of Bayer’s experts, Dr. Dresser, is a
hospital pharmacist with over 25 years of experience. She is familiar with, and
has advised physicians on, the administration of AVELOX® I.V. and its
co-administration with sodium chloride solutions. Bayer’s other expert, Dr.
Grossman, is a staff physician at Credit Valley Hospital and a Professor of
Medicine at the University of Toronto. He is a world-renowned expert on the use
of antibiotics, including moxifloxacin, in the treatment of respiratory
infections such as community-acquired pneumonia.
[10]
Dr. Dresser provides evidence relating to the
construction of the 424 Patent and its claims. She has reviewed PPC’s Product
Monograph and provides evidence on how that document would be understood and
applied in practice. She notes that the Product
Monograph indicates that PPC-Moxifloxacin is compatible for co-administration
with the same six intravenous solutions as AVELOX® I.V. The relevant extract read as follows:
Moxifloxacin
injection is compatible with the following intravenous solutions at ratios from
1:10 to 10:1:
•→ 0.9% Sodium Chloride Injection, USP
•→ IM Sodium Chloride Injection
•→ 5% Dextrose Injection, USP
•→ Sterile Water for Injection, USP
•→ 10% Dextrose for Injection, USP
•→ Lactated Ringer’s for Injection
[11]
Both Dr. Dresser and Dr. Grossman explain how
PPC-Moxifloxacin will or will likely be used and sold if PPC receives a NOC for
PPC-Moxifloxacin. Dr. Dresser asserts that, in order to sell PPC-Moxifloxacin,
PPC will have to submit bids to supply hospitals, seeking to have those hospitals
stock and dispense PPC-Moxifloxacin instead of AVELOX® I.V. She asserts that if
PPC obtains a NOC for PPC-Moxifloxacin:
(a)
PPC-Moxifloxacin will be co-administered with a
0.9% sodium chloride saline solution in certain ratios using a “Y” connection.
(b)
The formulation that will be administered to
patients will infringe certain claims of the 424 Patent.
(c)
The resulting formulation that is administered
to the patient will contain moxifloxacin and sodium chloride and will infringe
claims 1, 2, 5, 8, 9, 11, 37, 38 and 49 of the 424 Patent.
[12]
Bayer concedes that there is no evidence of any
direct infringement of the 424 Patent by PPC. It maintains, however, that health practitioners will
infringe the 424 Patent as a direct result of PPC’s representations in its Product
Monograph and its attempts to have PPC-Moxifloxacin substituted for AVELOX®
I.V.
[13]
Counsel for Bayer agreed during the hearing of
the motion that the evidence of induced infringement by PPC boils down to
paragraph 42 of the affidavit of Dr. Dresser, which reads as follows:
Based on the
content of the PPC Product Monograph, if the PPC Product was to be marketed in Canada, as a pharmacist I would advise physicians that the PPC Product can be prescribed,
used and administered in the same way as AVELOX® I.V. It is therefore my
opinion that, as instructed by the PPC Product Monographs, physicians would
prescribe and use the PPC Product in the same was as AVELOX® I.V., including
co-administering the PPC Product with a normal saline solution in circumstances
where the treating physician determines it to be advisable.
[14]
PPC submits that Bayer’s evidence, taken at its
best, cannot possibly establish direct infringement or induced infringement of
the 424 Patent by PPC and that the application, as it relates to the 424
Patent, should be dismissed.
ANALYSIS
[15]
The present motion is brought by PPC, a second
person within the meaning of the PMNOC Regulations, pursuant to
subsection 6(5)(b), which reads as follows:
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6. (5) Subject
to subsection (5.1), in a proceeding in respect of an application under
subsection (1), the court may, on the motion of a second person, dismiss the
application in whole or in part …
(b) on the
ground that it is redundant, scandalous, frivolous or vexatious or is
otherwise an abuse of process in respect of one or more patents.
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6. (5) Sous
réserve du paragraphe (5.1), lors de l’instance relative à la demande visée
au paragraphe (1), le tribunal peut, sur requête de la seconde personne,
rejeter tout ou partie de la demande si, selon le cas …
b) il conclut
qu’elle est inutile, scandaleuse, frivole ou vexatoire ou constitue
autrement, à l’égard d’un ou plusieurs brevets, un abus de procédure.
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[16]
The purpose of s. 6(5) is to enable the Court to
expeditiously dispose of unmeritorious applications by first persons which have
no chance of succeeding at hearing. The parties agree that dismissal of an
application pursuant to subsection 6(5)(b) is an extraordinary
remedy. Such relief will only be granted when the application is “clearly futile” or it is “plain
and obvious” that the application has no chance of success: Sanofi-Aventis
Canada Inc v Novopharm Ltd, 2007 FCA 163 [Sanofi-Aventis] at para 28
and 36. The moving party bears
the entire burden of proof in a s. 6(5)(b) motion: Pfizer Canada Inc v
Apotex Inc, 2009 FC 671 at para 33.
[17]
A second person may move under s. 6(5)(b) to
dismiss a first person’s application on the basis that the first person’s
affidavit evidence is insufficient to prove the second person’s allegations of
infringement are not justified: Novopharm Limited v Sanofi-Aventis Canada
Inc, 2007 FCA 167 [Novopharm], at para 13.
In order to make such a determination, the motions judge must be able to make
the necessary findings of fact, viewed in the light most favourable to the
first person, and apply the law to the facts.
[18]
A motion to dismiss will only be granted where
it is apparent that there is no arguable case on the merits of the application.
The court is not justified in embarking on anything resembling a trial of the
action on conflicting affidavits in order to evaluate the strength of either
party’s case.
Inducement
[19]
Bayer has not adduced any evidence establishing
or even suggesting that PPC would directly infringe the 424 Patent. The said
patent claims a formulation which contains moxifloxacin and sodium chloride
within certain specified concentrations. Dr. Dresser acknowledges in her
affidavit that XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXX therefore, there is no direct infringement by PPC. Rather, Bayer
says that PPC will induce or procure others to infringe the 424 Patent.
[20]
Bayer submits that the evidence is clear that
PPC’s Product Monograph directs infringement of the 424 Patent and that the
sale of PPC-Moxifloxacin will result in the infringement of the 424 Patent.
[21]
In Dr. Dresser’s opinion, the PPC Product will
be co-administered with a 0.9% sodium chloride saline
solution within the ratios of the 424 Patent if a Notice of Compliance is
issued in respect of the PPC Product and PPC sells the PPC Product for use in
accordance with the PPC Product Monograph.
[22]
According to Bayer, its evidence demonstrates
that:
(a)
the use of PPC-Moxifloxacin
will infringe the 424 Patent;
(b)
such infringement will be a direct result of
representations made by PPC in its Product Monograph and as a result of PPC
seeking to have PPC-Moxifloxacin dispensed in place of Bayer AVELOX® I.V.; and
(c)
PPC made those representations knowing that
infringement of the 454 Patent is an inevitable consequence.
[23]
It is well established that there is no
infringement of a patent in selling an article which does not in itself
infringe the patent even when the vendor knows that the purchaser buys
the article for the purpose of using it in the infringement of the patent:
Slater Steel Industries Ltd v R Payer Co (1968), 38 Fox Pat C 139, 1968
CarswellNat 29, 55 CPR 61 (Can Ex Ct); citing Hatton v Copeland-Chatterson
Co (1906), 1906 CarswellNat 10, 10 Ex CR 224 (Can Ex Ct); affirmed (1906), 1906
CarswellNat 37, 37 SCR 651 (SCC).
[24]
It is not sufficient to say that pharmacists or
physicians would prescribe PPC-Moxifloxacin in an
infringing manner and therefore inducement is made out.
It is the second person’s actions which are at issue,
and not the infringing conduct of others, as was found by Madam Justice
Mactavish in Lundbeck Canada Inc v Ratiopharm Inc, 2009 FC 1102 at paras 367 to 369:
367 Based upon all of the above considerations, the applicants argue
that because of the nature of the Canadian market for memantine, infringement
of the '492 patent will inevitably occur as physicians will prescribe, pharmacists
will dispense, and patients will use ratiopharm's memantine product in
combination therapy.
368 This may well be the case. Indeed, the circumstantial evidence
suggests that ratiopharm's ratio-MEMANTINE product may indeed end up being used
in combination with acetylcholinesterase inhibitors for the treatment of
Alzheimer's disease, thereby infringing the '492 patent. ratiopharm may expect
this to happen. However, it is ratiopharm's actions and not its expectations
that are the issue before me.
369 The parties agree that the fact that there may be downstream
infringement is not enough, on its own, to show infringement by inducement.
Indeed, as Justice Gauthier observed in Aventis Pharma Inc. v. Pharmascience
Inc. (2006 FC 861, 51 C.P.R. (4th)) 161, even if it can be shown that
infringement by others "is highly probable, if not inevitable", that
will not be enough to establish that an allegation of non-infringement is not
justified: see para. 31.
[25]
A second person may be implicated in the
infringement by others of a patent if the second person induces that
infringement. The test for inducement was articulated
by the Federal Court of Appeal in Weatherford Canada Ltd v Corlac Inc,
2011 FCA 228 [Weatherford] at para 162. First, the act of
infringement must have been completed by the direct infringer. Second, the
completion of the acts of infringement must be influenced by the acts of the
alleged inducer to the point that, without the influence, direct infringement
would not take place. Third, the influence must knowingly be exercised by the
inducer, that is, the inducer knows that this influence will result in the
completion of the act of infringement.
[26]
The test for inducement is conjunctive, which
means that Bayer must establish all three elements of the test in order to
succeed in the application. Counsel for PPC submits that Bayer’s deponents do
not provide any evidence of influence exercised by PPC that would result in the
completion of an act of infringement of the 424 Patent, knowingly or otherwise,
and that it is therefore plain and obvious that the application cannot succeed
in respect of the 424 Patent.
[27]
PPC states in its Product Monograph that PPC-Moxifloxacin is safe to use with sodium choloride and can
be administered in sequence with a solution containing sodium chloride. The Product Monograph also states that dilution
of PPC-Moxifloxacin with another solution (including, presumably, sodium
chloride solutions) is not required. Based on these statements, Dr. Dresser is
of the opinion that physicians would prescribe, use and
administer PPC-Moxifloxacin in
the same way as AVELOX® I.V. “as instructed by the PPC
Product Monograph”.
[28]
In my view, Bayer has no reasonable chance of
success on the second prong of the inducement test set out in Weatherford
based on the evidence before the Court. Integral to the issue of inducement is
the requirement that the alleged inducer influence the direct infringer. There is nothing in PPC’s Product Monograph that is capable of
establishing that PPC will infringe the 424 patent by inducing infringement by
others.
[29]
Infringement by inducement may be established by
inferences reasonably drawn from the contents of the product monograph for the
generic drug product, or evidence relating to the dosage form of the generic
product, or its labelling or marketing: Lundbeck
Canada Inc v Ratiopharm Inc, 2009 FC 1102 at paras
356 and 399. The problem with Bayer’s evidence is that
there are no facts, other than Dr. Dresser’s opinion, to support a conclusion
that PPC is “instructing” others to infringe the
424 Patent. Whether such instructions are actually provided in PPC’s Product
Monograph is a question of fact, and not a matter of opinion. It is one matter
for an expert to provide assistance to the Court in interpreting technical
terms and quite another for the expert to proffer an opinion on the very issue
to be decided by the Court.
[30]
It should be recalled that PPC is seeking a
Notice of Compliance to permit it to market and sell its own non-infringing
product. PPC has not yet marketed its product. There is no evidence, other than
speculation, that PPC will be seeking to sell its product in combination with sodium chloride.
Moreover, there is no evidence of any overt attempt by PPC to influence or
encourage others to infringe the 424 Patent.
[31]
There are certainly no explicit instructions or
directions to complete an act of infringement such as found in Windsurfing
International Inc v Trilantic Corp (1986), 8 CPR (3d) 241 (FCA), [Windsurfing]
which involved the sale of components that might be assembled in order to
produce a device which infringed the plaintiff’s patent.
[32]
As Madam Justice Layden-Stevenson observed in AB
Hassle v Genpharm Inc, 2003 FC 1443 at para 155, “subtle references” in a product monograph may be
enough to leave a reader with the impression that a drug can be used in a
manner that would infringe a patent. However, the general and generic
references to sodium chloride in PPC’s Product Monograph do not amount to
inducement. There is no suggestion that the PPC-Moxifloxacin should be substituted
for, or used in same way as, AVELOX® I.V. PPC’s Product
Monograph also specifies in bold caps that PPC-Moxifloxacin
does not require dilution. Merely stating that PPC-Moxifloxacin is safe for
dilution with one of six intravaneous solutions, including sodium chloride, or
that it can be used in sequence with solutions containing sodium chloride,
without more, is not sufficient to conclude that PPC is knowingly inducing
healthcare practitioners to co-administer PPC-Moxifloxacin with sodium
chloride.
[33]
Bayer submits that PPC clearly intends for
PPC-Moxifloxacin to be substituted for AVELOX® I.V. and administered to
patients in the same manner as AVELOX® I.V, as evidenced by the manner in which
PPC will sell its product. Dr. Dresser asserts that once the PPC Product enters
the market in Canada, PPC will have to approach hospitals or wholesalers to
convince them to dispense PPC-Moxifloxacin instead of AVELOX® I.V. This is
nothing more than conjecture and speculation on the part of Dr. Dresser. If PPC
does in fact induce or procure another person to infringe the 424 Patent,
Bayer will have recourse in an action for infringement.
[34]
The onus is on Bayer in the main application to
establish on a balance of probabilities that the allegation that PPC will
not induce others to infringe the 424 Patent is unjustified. PPC has
established that, on the record before me, it is plain and obvious that Bayer
has no reasonable chance of success in showing that PPC is or will be inducing
infringement of the 424 Patent. As the test for inducement is conjunctive, and
Bayer has not adduced any evidence that can arguably satisfy all three prongs
of the test for inducement, I conclude that the prohibition application as it
relates to the 424 Patent will inevitably fail. As such it is “vexatious” within the meaning of s. 6(5) of the PMNOC
Regulations.
CONCLUSION
[35]
For the reasons above, I conclude that the
motion pursuant to subsection 6(5)(b) of the PMNOC Regulations striking
portions of the application relating to the 424 Patent should be granted.
[36]
Counsel agreed that costs fixed in the amount of
$5,000.00 should be awarded to any party that was entirely successful on the
motion. In the circumstances, costs shall be granted to PPC in the agreed
amount.
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