Date: 20080408
Docket: T-1836-06
Citation: 2008 FC 454
Vancouver, British
Columbia, April 8, 2008
PRESENT: Roger R. Lafrenière, Esquire
Prothonotary
BETWEEN:
NYCOMED CANADA INC. and
NYCOMED
GMBH
Applicants
and
NOVOPHARM LIMITED and
THE
MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
Introduction
[1]
This is a motion by the Respondent, Novopharm Limited
(Novopharm), pursuant to section 6(5)(b) of the Patented Medicines Notice of
Compliance Regulations (Regulations), seeking dismissal of the
application instituted by the Applicants, Nycomed Canada Inc. and Nycomed GmbH
(collectively referred to as Nycomed), on the grounds that the proceeding is
redundant, frivolous or vexatious and otherwise an abuse of process.
[2]
Nycomed’s application was brought under section
6(1) of the Regulations to obtain an order prohibiting the Respondent,
Minister of Health (Minister), from issuing a Notice of Compliance (NOC) under
the Food and Drug Regulations to Novopharm for the production and
marketing of enteric coated tablets of pantoprazole sodium in 20 mg and 40 mg
strengths (Novopharm’s Tablets) until after the expiration of Canadian Letters
Patent 2,092,694 ('694 Patent) and 2,089,748 ('748 Patent). An earlier patent
covering pantoprazole has expired and the use of pantoprazole to treat excess
gastric acid secretion is known. The ‘694 and ‘748 Patents generally relate to
the new use of pantoprazole for the treatment of H. pylori bacterial
infections.
[3]
Novopharm submits that Nycomed’s prohibition
application constitutes an abuse of process because Nycomed is attempting to
relitigate issues that have been decided in Solvay Pharma Inc. et al
v. Apotex Inc. et al., 2008 FC 308,
a recent decision by Madam Justice Johanne Gauthier that also involved Nycomed, a generic company, Apotex Inc.
(Apotex), the same two patents, and the same allegations of non-infringement
(Apotex Decision).
[4]
Nycomed opposes the motion on the grounds that that the current proceeding is the first
and only proceeding in which this Court is called upon to determine questions
of infringement and inducing infringement of the ‘748 and ‘694 Patents by
Novopharm’s Tablets and product monograph.
Issue to be
Determined
[5]
Novopharm does not dispute the validity the ‘748
and ‘694 Patents and their eligibility for listing for the purpose of this
motion. The only issue to be determined is whether, in light of the Apotex
Decision, this application should be dismissed pursuant to section 6(5)(b) of
the Regulations on the basis that it is clearly futile on its
merits.
Background Facts
[6]
By letter dated September 5, 2006, Novopharm
served Nycomed with a Notice of Allegation and Detailed Statement (Novopharm
NOA) pursuant to section 5 of the Regulations. The NOA alleges that the
‘748 and ‘694 Patents, which are owned by Nycomed GmbH, and are listed against
the Nycomed’s 20 and 40 mg strength pantoprazole sodium enteric coated tablets
(Nycomed’s Tablets), would not be infringed by the making, constructing, using or
selling of Novopharm’s Tablets.
[7]
The Novopharm NOA alleges, in particular, that
no claim for the medicine itself and no claim for the use of the medicine in
either of the ‘748 and ‘694 Patents would be infringed on the basis that:
(a)
Novopharm is not seeking approval for the use of
the Novopharm Tablets for the suppression or eradication of Helicobacter
pylori (“H. pylori”);
(b)
Novopharm is not seeking approval for the use of
the Novopharm Tablets in combination with an antibacterial drug (or drugs) for
any purpose;
(c)
The Novopharm Product Monograph will not include
the use of the Novopharm Tablets for the suppression or eradication of H.
pylori;
(d)
Upon approval of Novopharm’s Abbreviated New
Drug Submission (“ANDS”), Novopharm will only be permitted to market and sell
the Novopharm Tablets for the approved indications in their Product Monograph,
which does not include the suppression or eradication of H. pylori;
(e)
Novopharm will not induce or procure the
infringement of the ‘748 and/or ‘694 Patents, nor will it represent to third
parties that the Novopharm Tablets can be used for the treatment of H.
pylori; and
(f)
Novopharm cannot directly infringe the ‘748
and/or ‘694 Patents.
[8]
The indications in the Novopharm Product
Monograph are the use of enteric coated pantoprazole sodium tablets for the
treatment of conditions where a reduction of gastric acid secretion is
required, listed as follows:
§
Duodenal ulcer
§
Gastric ulcer
§
Reflux esophagitis
§
Symptomatic gastro-esophageal reflux disease (such as, acid
regurgitation and heartburn).
§
Prevention of gastrointestinal lesions induced by non-steroidal
anti-inflammatory drugs (NSAIDs) in patients with a need for continuous NSAID
treatment, who have increased risk to develop NSAID-associated upper
gastrointestinal lesions.
§
Maintenance treatment of patients with reflux espohagitis
[9]
In response to the Novopharm NOA, Nycomed
commenced this application on October 19, 2006, seeking an order prohibiting
the Minister from issuing an NOC to Novopharm for the Novopharm Tablets until
after the expiry of the ‘748 and ‘694 Patents.
[10]
Both parties filed their affidavit evidence in
the application and cross-examinations have begun. Eight of the sixteen
deponents have been cross-examined to date. Cross-examinations of four of
Novopharm’s deponents (Dr. Fred Saibil, Dr.
David Y. Graham, Dr. Charles Signorino, and Anthony Axon) have yet to be
conducted or completed. Four of Nycomed’s witnesses have not been
cross-examined to date: Mr. Jean-Yves Julien and Dr. Barry Marshall, Dr. Ruth
Corbin, and Dr. Peter Malfertheiner.
Apotex Decision
[11]
By Reasons for Judgment and Judgment dated March 3, 2008, Justice Gauthier dismissed the
Nycomed’s prohibition application against Apotex.
[12]
Justice Gauthier first decided the legal issue
of claim construction of the relevant claims. In respect of the ‘748 Patent,
she construed claims 1 – 14 to all include pantoprazole or a pharmaceutically
acceptable salt thereof and a Helicobacter-inhibiting antimicrobial agent
(“HIAMA”) as essential elements.
[13]
With respect to claim 15 of the ‘748 Patent,
Justice Gauthier found that the only other essential element was that the
composition be used for the “regulation of a gastrointestinal disorder”.
“Gastrointestinal disorder” was found to refer to those disorders caused or
exacerbated by H. pylori and the secretion of gastric acid and
“regulation” was found to mean the treatment of gastrointestinal disorder
through the combined action of pantoprazole, acting as an anti-secretory
proton-pump inhibitor and a HIAMA defined by its ability to eradicate H.
pylori. She also found that the definition of “eradication” was generally
understood to mean elimination of H. pylori at some period of time after
therapy in some percentage of patients.
[14]
Claim 16 of the ‘748 Patent was found to
include, as an essential element, the use of pantoprazole and a HIAMA for the
treatment of gastric or duodenal ulcer relapse. “Treatment” was held to
necessarily involve the eradication of H. pylori and the prevention of
relapse.
[15]
In construing the relevant claims of the ‘694
Patent, Justice Gauthier found that claim 3 has three essential elements: (1) a
formulation containing pantoprazole; (2) the formulation being designated to be
partially not resistant to gastric juice; and (3) the formulation also being
partially resistant to gastric juice. She found that there was no limitation as
to a specific use of those compositions. She also found that the essential
elements of claims 6 and 13 are: (1) a formulation of pantoprazole; (2) for use
as an antimicrobial; and (3) to treat H. pylori infections and diseases
arising therefrom.
[16]
Justice Gauthier then evaluated the allegations
of non-infringement in the following context:
(a)
An application under the Regulations is
not an action for infringement so the Court only needs to determine whether the
facts, assumed or proved, and the legal assertions made by the second person in
its NOA justify its specific allegation of non-infringement.
(b)
The Regulations are intended to prevent only
infringement by (or infringement induced or procured by) generic drug producers
who make abbreviated new drug submissions containing one of the stipulated
comparisons to an existing drug product.
(c)
To establish infringement of a use claim, the
inducer must have done something that leads the direct infringer to infringe. Normally,
the following elements must be established:
(i)
An act of infringement was completed by the
direct infringer;
(ii)
The act of infringement was influenced by the
inducing party to the point that, without said influence, infringement would
not take place;
(iii)
The inducing party must know that its influence
would result in the completion of the act of infringement.
(d)
To establish inducement or procurement under the
Regulations, mere sale by a second person is not sufficient: something
more is required. Something active must be done; mere passivity or even
knowledge that one’s product will likely be used in direct infringement of a
patent is not sufficient.
[17]
Justice Gauthier concluded that Apotex’s
allegation of non-infringement was justified,
namely, that the ‘748 and ‘694 Patents were not infringed because the Apotex
Tablets would not be marketed or promoted to doctors, pharmacists or others to
be used in combination with another antibiotic as part of a regimen for
combating, treating or eradicating Heliobacter or H. pyroli
bacteria.
[18]
Apotex began marketing its generic version of
pantoprazole sodium enteric coated tablets after received a NOC on March 5,
2006,
Evidence Adduced
on this Motion
[19]
On March 10, 2008, Novopharm brought the present
motion, supported by the affidavit of a law clerk, Alisha Meredith.
Attached to Ms. Meredith’s affidavit are copies of Novopharm’s NOA, the ‘748 and ‘694 Patents, Nycomed’s Notice of Application, the
parties’ affidavits in the main proceeding (without exhibits), and the Court
Index and Docket for Court File No. T-427-06. In cross-examination, Ms. Meredith confirmed that she had no personal
knowledge about the documents attached to her affidavit.
[20]
Nycomed filed responding affidavits of Dr. James McGinity, Dr.
Chuck Chakprani, Mr. Julien, Dr. Krishna Menon and Ms. Carole Morris. Due to
time constraints and the fact he was abroad in Thailand, the evidence of Dr. Stephen Wolman was adduced
through an affidavit of a solicitor, Daniel McKay. Novopharm did not object to
the manner in which Dr. Wolman’s evidence was presented.
[21]
Dr. McGinity, a pharmaceutical
scientist, deposes that the Novopharm productions provide insufficient
information to conclude that Novopharm’s assertion is justified. He opines,
based on Novopharm’s data concerning its proposed tablets, that many of the
Novopharm Tablets “likely” contain pantoprazole simultaneously in one form that
is resistant to gastric juice and in another form that is not resistant to
gastric juice. According to Nycomed, this would fall within the scope of claim
3 of the ‘694 patent.
[22]
Mr. Chakrapani, a survey
expert, confirms the materiality of Ruth Corbin surveys in the main
Application, and states that it is “reasonable to infer” that that Novopharm’s
Product Monograph will induce doctors and pharmacists to prescribe and dispense
Novopharm’s proposed pantoprazole tablets to treat H. pylori related
ulcers.
[23]
Drs. Wolman and Menon, both gastroenterologists, maintain that
the Novopharm Tablets will inevitably be prescribed and used by physicians to treat
duodenal and gastric ulcers, including those associated with H.pylori,
if Novopharm receives a NOC. Irrespective of the recommended dose and dosage
adjustment in Novopharm’s Product Monograph, the Novopharm product will benefit
from established physician use of and experience with PANTOLOC since the
generic is considered to be therapeutically equivalent with the branded
version. Absent a specific direction or warning, there would be no reason for a
physician to deviate from standard practice and not prescribe the generic
product.
[24]
Mr. Julien, a pharmacist, states that, absent a
warning to health care professionals not to use pantoprazole for the treatment
of H.pylori, Novopharm’s Product Monograph “directs pharmacists
to fill doctor’s script for ‘pantoprozale’ and two antibiotics with [Novopharm’s
Tablets] for use in triple therapy to treat H.pylori.
[25]
Ms. Morris, a legal assistant, provides a chronology of events,
and attaches as exhibits to her affidavit additional copies of Nycomed’s
affidavits served in the main proceeding, with selected exhibits, and
transcripts of certain cross-examinations that have taken place to date.
[26]
Nycomed’s evidence on this motion is uncontradicted as Novopharm
elected not to cross-examine any of Nycomed’s deponents.
Analysis
[27]
Novopharm submits that Nycomed’s application
constitutes an abuse of process because the pivotal matters at issue in this
application have already been decided by Justice Gauthier, both in relation to
use patents generally and in relation to the two patents generally.
[28]
Nycomed counters that it should not be precluded
from pursuing its allegations that Novopharm’s pantoprazole tablets and
Novopharm’s own conduct may directly infringe or induce infringement of
Nycomed’s patent claims merely because Apotex’s tablets and conduct were found
by Justice Gauthier to not infringe its patents. It points out that the Apotex
Decision was only concerned with Apotex’s tablets and Apotex’s conduct.
[29]
Nycomed relies on the recent decision of
Prothonotary Milczynski in Nycomed Gmbh v. Canada (Health) 2008 FC 330
(Milczynski Decision), rendered after issuance of the Apotex Decision, in which
she denied a motion to dismiss brought by the generic Genpharm Inc. (Genpharm)
against a Nycomed Notice of Application involving the same patents and
substantially the same issues that are the subject of this motion. Prothonotary
Milczynski concluded that Genpharm’s motion to dismiss based on s. 6(5)(b) of
the Regulations could not succeed for the following reasons:
[76]
On a motion brought pursuant to s.6(5)(b) of the
Regulations, the moving party has a very high onus. It must show that
the application for prohibition is clearly futile or that it is plain and
obvious that it will not succeed (Sanofi-Aventis Canada Inc. v. Novopharm
Limited, 2007 FCA 163 at para. 36).
[77]
This standard is extremely high, and is consistent with the
notion that motions brought under s.6(5)(b) of the Regulations are
intended to be summary in nature. Motions brought under s.6(5)(b) are not
intended to provide second persons with the first of two opportunities to argue
the merits of their case. Substantive arguments regarding the validity
and non-infringement of the patents at issue are properly addressed at a
prohibition proceeding; such substantive arguments are not properly raised on a
s.6(5)(b) motion, except in the clearest of cases.
[78]
The present case is not such a case. Over the course
of three days of submissions, counsel for both sides raised and argued many
factual and legal points, most of which were highly contentious. Claim
construction was heavily disputed. As claim construction must precede any
findings with respect to validity and infringement, on this basis alone I would
find that Nycomed’s position is not clearly futile. I note that many
other highly contentious issues were in dispute including the applicability of
inherent anticipation to claims for the use of a medicine and the apparently
contradictory jurisprudence on inducing infringement. Further, Nycomed’s
submissions on sound prediction include reference to affidavits filed by
experts on the main action that were not experts in the present
proceeding. Overall, given the standard of proof that must be met, I am
not persuaded that Nycomed’s position on validity and infringement is so
clearly futile that the inevitable conclusion is that it has no chance of
success.
[30]
The motion by Genpharm could not have been premised
on the Apotex Decision, since it was only issued after
the hearing of the motion. In any event, Prothonotary Milczynski did not have
the benefit of oral submissions from counsel for the parties on the question
whether the Genpharm NOA was in all material respects the same as the Apotex
NOA. In the circumstances, she was in no position to determine whether the same
issues would be re-litigated should Nycomed’s application be allowed to proceed
against Genpharm. The Milczynski Decision is therefore of little assistance in
the present case.
[31]
I agree with my colleague that substantive
arguments regarding non-infringement should, as a general rule, be addressed at
the hearing of the application. It remains that the Regulations specifically
allow for motions to dismiss.
[32]
The Court is generally loath to drive an
applicant from the judgment seat where the litigation of an issue has not
previously been decided between the same parties or their privies. However, if
a case is clearly not going to succeed based on findings made in an earlier
decision involving the same patents, the same issues, and substantially similar
facts, the Court is empowered by the Regulations to render judgment in
accordance with the inevitable outcome of the litigation.
[33]
This interpretation was recently supported by the Federal Court
of Appeal in Sanofi-Aventis Canada Inc. v. Novopharm Ltd. (2007), 59
C.P.R. (4th) 416 (Sanofi-Aventis
Appeal). Mr. Justice Sexton, writing for the majority, commented on the purpose of section 6(5)(b), and held that a
patentee who unsuccessfully challenges an allegation made by a generic drug
manufacturer under the Regulations cannot re-litigate the same
allegation made by any subsequent generic drug manufacturer. At paras.
36-37, he wrote as follows:
Proceedings in which the case for the patent
holder is clearly futile or plainly has no chance of success because of an
earlier, binding authority continue to be impermissible as abuses of process
because such proceedings will waste judicial resources and impose hardship on
generic drug manufacturers without any corresponding benefit such as a more
accurate result. However, applying the principles outlined by Arbour J., it is
evident that the types of proceedings that constitute abuses of process go
beyond those that are clearly futile to include cases such as the one at
present. Many of the concerns raised by Arbour J. are applicable to this
appeal. Allowing Sanofi-Aventis to proceed with its application will give rise
to the possibility of inconsistent judicial decisions, with one judge holding
that the inventors of the '206 patent lacked a sound basis for predicting the
utility of their invention and another holding that there was sound prediction.
Thus one generic would receive an NOC because of invalidity based on lack of
sound prediction while another would be refused an NOC even though its NOA
raised the same allegation. As Arbour J. identified, permitting that type of
inconsistency would threaten the credibility of the adjudicative process.
Likewise, as Arbour J. noted, there is no reason to think that a second
proceeding under section 6 of the NOC Regulations will lead to a more
accurate result than the first. This scenario is in contrast to an action for a
declaration of patent invalidity, where because the parties have the benefit of
a full trial and all the attendant procedural safeguards, a more accurate
result may arise. That is why the courts have on numerous occasions stated the
principle that decisions rendered under the NOC Regulations are not
binding on actions for patent infringement or to declare a patent invalid
[citations omitted].
[34]
Nycomed submits that the decision in Sanofi-Aventis
Appeal should be distinguished on the basis the case involved a patent
holder that lost in a prohibition proceeding on an issue relating to invalidity,
and that there is no basis to extend the
reasoning of the Federal Court of Appeal to support an abuse of process
argument in relation to questions of infringement. Justice Gauthier also
expressly cautioned against future courts relying on her infringement findings
in relation to Apotex when dealing with questions of infringement involving the
same patents but a different generic company, stating that “variations in the specific
evidence led from one case to another may lead the Court to different
conclusions (on infringement) even where the patents are the same.”
[35]
Although allegations of infringement are generally
fact-specific, it remains that the concerns expressed
by Justice Sexton regarding “the integrity of the adjudicative process, the
principle of finality, and the efficiency of the judicial system” resonate just
as strongly in prohibition proceedings raising such issues. Judicial
resources are already taxed considerably by the voluminous proceedings brought
under the Regulations. The Court has a legitimate interest in
encouraging the efficient use of scarce judicial resources, while at same time
discouraging repetitious litigation brought without any compelling
justification. The principles expressed in Sanofi-Aventis
Appeal are therefore apposite, and offer direction as to the appropriate
test to be applied in the present case.
[36]
Nycomed submits that Novopharm’s motion was brought prematurely, before its cross-examination
of Novopharm’s experts is complete. It also complains that the same experts
have been shielded from cross-examination on this motion.
[37]
Nycomed’s complaints are without merit. Novopharm
does not bear the evidential burden to support the allegations in its NOA and
detailed statement in the main proceeding. The legal burden was on Nycomed and
it cannot expect to make its case through Novopharm’s witnesses. Moreover, Nycomed
has not established any serious prejudice since the evidence must be viewed in
the light most favourable to Nycomed and all reasonable inferences must be drawn
in its favour: Abbott Laboratories Limited v. Canada (Health) 2007 FC 622. For the purposes of this motion, no weight can be
given to the evidence of Novopharm’s experts who have yet to be cross-examined.
[38]
A motion to dismiss under the Regulations
consists of a brief and summary review of the evidentiary record, as it stood
at the time the motion was brought, to determine whether there is a clear case
which would warrant an immediate judgment. In the absence of such a clear case
being demonstrated, the application should be allowed to continue.
[39]
In order to determine whether the proceeding
should be dismissed summarily, the Court must necessarily assess the merits of
the parties’ evidence in the main proceeding, bearing in mind the following
questions:
(a)
whether the case is clearly futile or plainly
has no chance of success;
(b)
whether allowing the application to proceed will
give rise to the possibility of inconsistent judicial decisions; and
(c)
whether there is a compelling reason to further
strain the resources of the parties and of the courts through repetitive
litigation.
[40]
Nycomed denies that the specific evidence in
this case is the same as, or substantially the same as, the record in the
Apotex proceeding. It claims that there are many highly contentious factual and
legal points between the parties, any of which is reason alone to deny this
motion. Reference is made, in particular, to the affidavit of Dr. Wolman sworn
February 22, 2007, the affidavit of Mr. Julien sworn November 27, 2006, and the
affidavit of Dr. McGinity sworn February 27, 2007.
[41]
The Apotex record
has not been put forward on this motion for comparative purposes (presumably
because the expert evidence filed in that proceeding is subject to a
confidentiality order). However, upon reading the
comprehensive reasons given by Justice Gauthier in the Apotex Decision, striking
similarities emerge between the Apotex Application and the present proceeding,
both in terms of facts and issues.
[42]
First, the indications in the Novopharm Product
Monograph are identical to those in the Apotex Product Monograph. Justice
Gauthier found that none of them related to triple therapy or were sufficient
to meet the test for inducing infringement of either the ‘748 or ‘694 Patents.
[43]
Second, Apotex alleged in its NOA that it would
not be making, using or selling its tablets as part of the triple therapy
combination which is claimed in the ‘748 Patent and also alleged that the ‘748
Patent would not be infringed since the Apo-pantoprazole tablets will not be
marketed or promoted to doctors, pharmacists or others for use in combination
with a HIAMA or as part of a medicament package comprising said agent. Novopharm
has made this same allegation that it will not be seeking approval for the use
of Novopharm Tablets: (1) for the eradication of H. pylori, or (2) in
combination with an antibacterial drug or drugs for any purpose.
[44]
Third, Apotex alleged that because the
indications, clinical uses and dosage regimens set out in Apotex’s draft
product monograph are distinct from those indicated with respect to
pantoprazole triple therapy, its 20mg and 40mg tablets will not infringe any
claims of the ‘748 Patent. Novopharm has alleged that the Novopharm
labelling, Product Monograph and any other marketing materials will not suggest
the use of the Novopharm Tablets in the regulation of a gastrointestinal disorder
or as a gastrointestinal disorder regulant. Nycomed has not pointed to any
difference between the Apotex and Novopharm materials that could enable the
Court to come to a different conclusion on this issue.
[45]
Fourth, the dosage indicated in the Apotex Product
Monograph with respect to gastric and duodenal ulcers is 40 mg daily for two
weeks. The Court found that this dosage could not in any way be construed as
referring to the standard triple therapy regimen of 40 mg twice daily for one
week. Novopharm’s Product Monograph also only refers to dosing in respect of
gastric and duodenal ulcers of 40 mg daily for two weeks.
[46]
Fifth, Justice Gauthier found the only question
was whether the Court can infer inducement on the sole basis that
Apo-pantoprazole is indicated for the treatment of conditions corresponding to
an old use, but for which the preferred treatment is now the patented
combination therapy. That issue was decided in Apotex’s favour. Based on the
evidence in the present proceeding, and in order to avoid inconsistent
decisions, the issue would also have to be resolved in Novopharm’s favour.
[47]
Sixth, Nycomed argued that Apotex would induce
physicians and pharmacists to use Apo-pantoprazole to treat H. pylori. The
Court rejected that evidence. In doing so, the Court noted the difficulty of
determining a question of patent law on the basis of the statements in a
product monograph, which is a document primarily, if not solely, intended to
address health and safety issues. The Court also found that there was no clear
indication from Nycomed’s experts that their prescribing or dispensing
practices are actually influenced in any way by the information found in
generic product monographs.
[48]
Justice Gauthier was not able to conclude from
the evidence before her that Apotex intended to market its tablets for use as
part of the triple therapy regimen or otherwise established any causal link
between Apotex’s actions (and its proposed monograph) and the direct
infringement the Court was asked to assume. As a result, the Court concluded
that Nycomed had not met its burden of establishing that the allegations of
non-infringement in respect of the ‘748 Patent were unjustified. In
particular, she distinguished a decision by Mr. Justice Von Finckenstein in Abbott
Laboratories Limited v. Minister of Health (2006), 55 C.P.R. (4th) 48;
aff’d [2007] F.C.J. No. 935.
[49]
Nycomed was required to put its best foot
forward in the Apotex proceeding. Since Nycomed failed to lead that evidence in
the case against Apotex, it would constitute an abuse of process for Nycomed to
try and argue for a different result in this application against Novopharm.
[50]
Seventh, in considering Apotex’s allegation of
non-infringement of claim 3 of the ‘694 Patent, Justice Gauthier found that
there was no dispute about whether the Apotex tablets would contain
pantoprazole sodium in a form that is at least partially resistant to gastric
juice. The dispute was found to center on whether the Apotex tablets were also
in a form which is partial not resistant to gastric juice. In contesting
Apotex’s allegation of non-infringement, Nycomed relied on the evidence of Dr.
McGinity. Dr. McGinity also gives evidence on this same subject in the present
proceeding. Dr. McGinity explains in his affidavit why Novopharm cannot have
established that its tablets fall outside formulation claim 3 of Nycomed’s ‘694
Patent and opines that the most reasonable conclusion from Novopharm’s own
productions is that Novopharm’s tablets directly infringe this claim. Justice
Gauthier concluded, on essentially the same facts, that all Nycomed had done is
raised a “vague theoretical doubt”. Even absent cross-examination of Dr.
McGinity, his theories on infringement were found to be “no more than
speculation”. I conclude that Nycomed’s case against Novopharm hangs on the
same insufficient speculation.
[51]
Eight, with respect to the allegations of
non-infringement of claims 6 and 13 of the ‘694 Patent, Justice Gauthier was
not satisfied that Nycomed had established that the Apo-pantorprazole tablets would
have any antimicrobial effect and therefore could not infringe the ‘694
Patent. Similarly, the Court found that there is nothing in the Apotex Product
Monograph that refers to or deals with the treatment of asymptomatic H.
pylori infections and that Apotex was not seeking an NOC for pantoprazole
as an antimicrobial. Apotex’s dosage regime was found to be particularly
relevant to this inquiry. There is similarly no evidence that Novopharm, which
has the same dosage regime, is seeking approval for use of the Novopharm
Tablets to treat H. pylori.
Conclusion
[52]
By commencing a proceeding under the Regulations,
a patent holder obtains an automatic stay, shutting out a generic company’s
product from the market for up to 24 months, without first having to satisfy any
of the criteria required before enjoining issuance of a NOC.
[53]
The Regulations were enacted for the dual purpose of
protecting legitimate patent rights and accelerating the market entry of
affordable generic drugs. To ensure that generic competition is not pre-empted
by baseless or tactical litigation, section
6(5)(b) of the Regulations allows the Court, at an early stage, to
“separate the wheat from the chaff”, and to dismiss an application that is
redundant, scandalous, frivolous, vexatious, or an abuse of process. A patent
holder (first person) who fails to obtain an order of prohibition under the Regulations
may nonetheless seek to protect its legal rights by bringing a patent
infringement action.
[54]
It is not necessary to show that the prior
decision would dictate the outcome of the present application or that the first
person has no chance of success in order for a 6(5)(b) motion for abuse of
process to be granted. The primary concern is to promote fairness and
effectiveness, to reduce unnecessary litigation, and to minimize the risk of
inconsistent results in respect of the same issues.
[55]
On the evidence before me, I am satisfied that
Novopharm has made the same allegations of non-infringement in respect of the
‘694 and ‘748 Patents based on the same factual nexus that was considered in
the Apotex Decision.
[56]
In light of the facts that Nycomed's position
with respect to infringement was found to be untenable in the Apotex Decision,
and that Nycomed has not adduced any materially different evidence in this
proceeding, I conclude that the application should be dismissed as an abuse of
process.
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