Docket: T-1161-13
Citation: 2014 FC 1076
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BETWEEN:
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TAKEDA CANADA INC. AND TAKEDA GMBH
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Applicants
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and
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THE MINISTER OF HEALTH AND MYLAN PHARMACEUTICALS ULC
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Respondents
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REASONS
FOR ORDER
TABIB P.
[1]
In the context of this proceeding under the Patented
Medicines (NOC) Regulations (SOR/93-133), Mylan seeks a confidentiality
order that would designate as confidential – and therefore shield from public
disclosure – portions of its Notice of Allegations (“NOA”), as well as detailed
evidence in support of the NOA.
[2]
This is not the first time a generic drug
manufacturer has sought to have its NOA declared confidential. In Pfizer
Canada Inc. v Novopharm Limited, 2010 FC 668, Novopharm had sought a
confidentiality order in respect of its NOA, on the argument that such an order
was necessary to protect its first-to-market position. The Court examined all
aspects of the test applicable to a confidentiality order pursuant to Rule 151
of the Federal Court Rules, as further explained by the Supreme Court of
Canada in Sierra Club of Canada v Canada (Minister of Finance), 2002 SCC
41, and found that Novopharm had failed to establish every branch of that test.
Yet, Mylan comes to this Court, on the very same argument and on no better evidence
than was tendered by Novopharm in Pfizer, seeking to protect the factual
basis of its NOA from disclosure to its competitors.
I.
Background
[3]
By letter dated May 15, 2013, Mylan served upon the
Applicants Takeda Canada Inc. and Takeda GMBH (“Takeda”) a Notice of
Allegations, as contemplated by section 5 of the PM(NOC) Regulations, in
relation to the drug pantoprazole magnesium. Mylan’s NOA alleges that the
patents owned by Takeda and listed against Takeda’s own TECTA-brand
pantoprazole magnesium tablets would not be infringed by Mylan’s product, and
that one of the patents is invalid for, inter alia, anticipation and
obviousness.
[4]
The NOA sets out Mylan’s construction of the
patents, claim by claim, stating the essential element of each claim and
alleging that the Mylan compound will not contain one of those elements or will
not be made in that particular way. Very occasionally, the NOA goes on to state
what the Mylan compound would in fact contain or how it would in fact be
made, but only in the very broadest of terms. The passages of the NOA which
Mylan seeks to keep confidential include both the claim construction and the
information as to what its compound would or would not contain and how it would
or would not to be made.
[5]
As to invalidity, the NOA alleges that the
patent is anticipated and made obvious by, inter alia, a specific piece of
prior art. The NOA asserts that Mylan has commissioned an independent expert to
reproduce this prior art process to support that allegation, and the results of
this testing are included in Annex to the NOA. Mylan seeks to keep the specific
prior art process it has reproduced and the results of the testing
confidential.
[6]
The notation “CONFIDENTIAL” appears on every
page of the NOA. However, there is no evidence on the record that Mylan had,
prior to serving it, sought or obtained from Takeda any assurance that Takeda
would treat the NOA or the information contained therein in a confidential
fashion.
[7]
Takeda commenced this application for a
prohibition order pursuant to section 6 of the PM(NOC) Regulations on
June 28, 2013. Takeda’s Notice of Application does not repeat or set out
Mylan’s non-infringement allegations, but in respect of the testing, it states,
at paragraph 34:
Mylan alleges that Example 10 of WO 114
necessarily produces pantoprazole magnesium dihydrate. However, this example
says nothing about producing a dihydrate of pantoprazole magnesium. Mylan
alleges that it performed testing which confirms said allegation. […].
[8]
Thus, the specific allegation to the effect that
it is Example 10 of WO114 that necessarily produces pantoprazole magnesium
dihydrate, and the allegation that Mylan performed tests to confirm that
allegation were publicly disclosed by the filing of Takeda’s Notice of
Application.
[9]
Paragraph 66 of the Notice of Application also
states:
Takeda denies Mylan’s allegation that the Mylan
letter [NOA] is confidential and that it should be subject to any Protective
Order granted by this Honorable Court.
[10]
Takeda requested from Mylan further documents
and information as to the composition and method of manufacture of Mylan’s
product, and as to the testing it had performed. The parties agreed to the
wording of a protective order to govern, as between them, the manner in which
information designated as confidential was to be treated. The Protective Order
was issued on consent on August 28, 2013, following which Mylan communicated to
Takeda the requested documents and information. The Protective Order defines
the information that each party may unilaterally designate as confidential in a
non-limitative fashion, but does not permit the parties to file under seal any
information so designated unless the parties formally apply for and obtain a
confidentiality order. The Protective Order further provides, at paragraph 14 (c),
that it does not apply to information which “was in the
possession of a Party prior to the commencement of this proceeding other than
by virtue of a Court order containing terms respecting the preservation of
confidentiality of information […]”.
[11]
The parties served on each other their affidavit
evidence. All affidavits were designated as confidential, in their entirety. In
September 2014, Mylan announced its intention to make a motion for leave to
file further evidence in reply to the affidavits served by Takeda. As that
motion would have to be supported by the affidavits exchanged by the parties,
Mylan brought the present motion for a confidentiality order.
II.
The test to be applied:
[12]
Rule 151 of the Federal Courts Rules
reads as follows:
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151. (1) On motion,
the Court may order that material to be filed shall be treated as
confidential.
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151. (1) La Cour peut, sur requête, ordonner que des documents ou
éléments matériels qui seront déposés soient considérés comme confidentiels.
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(2) Before making
an order under subsection (1), the Court must be satisfied that the material
should be treated as confidential, notwithstanding the public interest in
open and accessible court proceedings.
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(2) Avant de rendre une ordonnance en application du paragraphe
(1), la Cour doit être convaincue de la nécessité de considérer les documents
ou éléments matériels comme confidentiels, étant donné l’intérêt du public à
la publicité des débats judiciaires.
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[13]
The Supreme Court of Canada, in Sierra Club
above, has elaborated further on the criteria to be considered in applying Rule
151, as follows:
53 […] A confidentiality order under Rule 151
should only be granted when:
(a) such an order is necessary in order to
prevent a serious risk to an important interest, including a commercial interest,
in the context of litigation because reasonably alternative measures will not
prevent the risk; and
(b) the salutary effects of the confidentiality
order, including the effects on the right of civil litigants to a fair trial,
outweigh its deleterious effects, including the effects on the right to free
expression, which in this context includes the public interest in open and
accessible court proceedings.
[14]
The Supreme Court added that “three important elements are subsumed under the first branch
of this test” , which elements have been summarized as follows in Pfizer,
above:
9 […]
(i) the risk in question must be real and
substantial, in that the risk is well grounded in the evidence, and poses a
serious threat to the commercial interest in question;
(ii) in order to qualify as an "important
commercial interest", the interest in question cannot merely be specific
to the party requesting the confidentiality order, the interest must be one
which can be expressed in terms of a public interest in maintaining confidentiality;
and
(iii) the Court must consider not only whether
reasonable alternatives to a confidentiality order are available, but must also
restrict the order as much as is reasonably possible while preserving the
commercial interest in question.
[15]
The Supreme Court further specified, under the
heading of “necessity” in the first branch of the test, that it was a strict
requirement that the applicant for a confidentiality order demonstrate that the
information in question is, in fact, confidential:
60 Pelletier J. noted that the order
sought in this case was similar in nature to an application for a protective
order which arises in the context of patent litigation. Such an order
requires the applicant to demonstrate that the information in question has been
treated at all relevant times as confidential and that on a balance of
probabilities its proprietary, commercial and scientific interests could
reasonably be harmed by the disclosure of the information: AB Hassle v. Canada
(Minister of National Health and Welfare) (1998), 83 C.P.R. (3d) 428
(F.C.T.D.), at p. 434. To this I would add the requirement proposed by
Robertson J.A. that the information in question must be of a "confidential
nature" in that it has been "accumulated with a reasonable expectation
of it being kept confidential" as opposed to "facts which a litigant
would like to keep confidential by having the courtroom doors closed"
(para 14).
[Emphasis
added]
III.
Application of the Test to this Case:
[16]
The kind of information at issue on this motion can
be divided in three categories. There is, first, the basic information relating
to the composition and method of manufacture of Mylan’s product and to Mylan’s
testing of anticipatory art, as that information is set out in the NOA. There
is also the additional information as to the details of the testing performed
by Mylan’s expert on the allegedly anticipatory prior art, contained in the
August 28, 2013 affidavit of Dr. Jerry Atwood (the “Atwood fact affidavit”).
Finally, there is the more detailed information relating to the composition and
method of manufacture of Mylan’s product, drawn from Mylan’s Abbreviated New
Drug Submission and Drug Master File (the “ANDS Information”), that was
requested and provided after the issuance of the Protective Order.
[17]
The latter category can be analyzed and dealt
with summarily. The first and second categories will discussed together at
greater length below.
A.
The ANDS Information:
[18]
I am compelled by precedent to recognize, in
respect of the ANDS Information, an interest in confidentiality which qualifies
as an important interest under the Sierra Club test. It is the public
interest in ensuring that generics provide full and complete information to the
Minister when applying for a NOC, to allow the Minister to properly assess the
safety and efficacy of drugs, without fear that this information would become
public as a result of a request for disclosure under sub-section 6(7) of the PM(NOC)
Regulations. Both the case law and sub-section 6(8) of the PM(NOC)
Regulations recognize that this general public interest, which is entirely
separate and independent from a generic’s market position, is seriously at risk
where disclosure of the details of an ANDS beyond what is set out in a NOC must
be made in the context of prohibition proceedings, and that the benefits of the
protection of a limited confidentiality order outweigh the public interest in
open and accessible court proceedings. The Federal Court of Appeal in AB
Hassle v Canada (Minister of National Health and Welfare), [2000] F.C.J.
No. 283, in a concise analysis at paragraphs 4 to 6, reiterated that the
perceived confidentiality of information was a cornerstone of the regulatory
scheme, which should be honoured and maintained to the extent possible. It also
cited precedents recognizing that while a generic must provide in its NOA a
detailed statement of the factual basis for non-infringement to allow the
innovator to identify the grounds raised, decide whether to begin prohibition
proceedings and define the issues, full disclosure was not expected to be made
until proceedings were commenced and confidentiality could be assured by a
protective order. The Federal Court of Appeal finally noted that the 1998
amendments to the PM(NOC) Regulations now expressly state, in subsection
6(8), that “a document produced under subsection (7)”
-- i.e. any portion of the submission for a notice of compliance filed by the
second person relevant to the disposition of the issues in the proceedings -- “shall be treated confidentially”. As a result, the
Court of Appeal endorsed the principle that confidentiality orders can issue to
protect ANDS information in NOC proceedings, but cautioned that the Courts must
restrict their application to what is strictly necessary to strike a balance
between this recognized confidentiality interest and the need for public
scrutiny of the Court process.
[19]
The ANDS Information was voluntarily provided by
Mylan to Takeda, rather than under compulsion of a motion under subsection
6(7), and subsection 6(8) therefore does not directly apply. However, the
reasoning of the Court of Appeal in AB Hassle stands for the proposition
that where it appears that information from an ANDS would have been compellable
pursuant to sub-section 6(7) and is voluntarily produced under an agreement or
an order providing for confidentiality of that information between the parties,
there is a presumption that the information meets the criteria for a limited
confidentiality order of the kind discussed in AB Hassle. I note in any
event that Mylan has, on this motion, submitted an affidavit which establishes
that that Mylan voluntarily complied with Takeda’s request for documents from
its ANDS and DMF in order to avoid a motion under section 6(7) of the
Regulations, that the ANDS Information is of a confidential nature, was at all
time treated by Mylan as confidential and that Mylan had a reasonable
expectation that it would be kept confidential.
[20]
I am satisfied that the proposed Confidentiality
Order presents appropriate limits and safeguards, and that it should be issued
in respect of the ANDS Information.
[21]
I now turn to the other two categories of
information, being the NOA and the Atwood fact affidavit.
B.
The NOA and the Atwood Fact Affidavit
(1)
The condition precedent: Is the information in
fact confidential?
[22]
Mylan, whose burden it was on this motion to
demonstrate that it had treated the information as confidential at all relevant
times and had a reasonable expectation of confidentiality, failed to adduce any
such evidence in respect of the NOA. That alone is fatal to Mylan’s motion as
it concerns the NOA.
[23]
In any event, in view of the decision in Pfizer,
above, I do not see how a generic could reasonably expect the Court to
recognize the confidentiality of a NOA. The Court in Pfizer noted that
the absence of a prior request for an agreement by the innovator to treat the
NOA as confidential raised a serious question as to the generic’s reasonable
expectation that its NOA would be kept confidential, even if unilaterally
marked as confidential. The Court also inferred that the absence of a provision
in the PM(NOC) Regulations relating to the confidentiality of NOAs,
contrasted with the express provision of confidentiality of additional
information drawn from ANDSs, suggested that NOAs should not be treated as
confidential.
[24]
I am satisfied that in the circumstances of this
case, Mylan did not treat the information contained in the NOA as confidential
at all relevant times, because it voluntarily included it in a letter sent to
Takeda, with no reasonable expectation of it being kept confidential. Indeed,
Takeda, in its Notice of Application, could and did publicly set out some of
the details of the NOA which Mylan asserts should benefit from a
confidentiality order, and expressly denied Mylan’s right to claim confidentiality
over the NOA. Mylan’s own conduct in consenting to the drafting of both the
Protective Order and the present proposed Confidentiality Order, pursuant to
which confidentiality does not apply to information that came into the
possession of a party prior to the commencement of the application, tends to
confirm that it never expected its NOA to remain confidential.
[25]
Mylan has provided some evidence in respect of
its expectations of confidentiality in respect of the Atwood fact affidavit.
Specifically, the affidavit of Brad Jenkins, one of Mylan’s lawyers, states
that the Atwood fact affidavit was designated as confidential prior to being
delivered to Takeda, pursuant to the Protective Order issued by the Court on
August 28, 2013, which order “provided that […] the
Atwood Fact Affidavit […] could be treated as confidential”. That
statement is true, but only insofar as the definition of what may be designated
as confidential in that order is expressly said not to be limited to the
specific information identified therein, and therefore allows a party to
designate as confidential anything at all, subject only to the exclusions found
in paragraph 14. The Protective Order does not make any mention of the Atwood
fact affidavit, or even more generally of a party’s independent testing of
publicly available prior art. Mr. Jenkins stops short of stating that he, or
anyone at his firm or at Mylan, expected the Atwood fact affidavit to be kept
confidential. I also note that the affidavit of David E. Blais, general counsel
for Mylan Pharmaceuticals ULC, is entirely silent as to the confidential nature
of the Atwood fact affidavit or as to Mylan’s expectations that it would be
kept confidential.
[26]
I am not satisfied that Mylan had any real
expectation that the Atwood fact affidavit would be kept confidential, and find
that even if Mylan had such expectations, they were not reasonable for two
reasons. First, the Federal Court in Pfizer recognized that the very
strong public interest in openness as regards allegations of invalidity of a
patent weighed significantly against a finding of confidentiality:
30 Where an
NOA raises legitimate questions regarding the validity of one or more patents,
another significant factor that weighs against the view that the entire NOA
should be treated as a confidential document is that a patent effectively
confers a statutory monopoly on the patent holder, in the sense that the patent
holder is shielded from competition for the life of the patent. This provides
the basis for a strong public interest in transparency and openness with
respect to (i) the allegations contained in an NOA, (ii) the basis for those
allegations, and (iii) the proceedings involving those allegations.
[27]
Given those comments, Mylan could not reasonably
expect that the Court would recognize the confidentiality of the Atwood fact
affidavit. Secondly, Mylan’s motion record itself recognizes the significance
of the Atwood fact affidavit to the determination of the issues before the
Court and the public interest in its disclosure. What Mylan seeks to achieve by
this motion is not recognition of the information’s inherent confidentiality,
but that its inevitable publication be delayed until the hearing of the
application on its merits. This speaks to a hope or a wish for secrecy, but not
of a reasonable expectation of confidentiality.
[28]
In any event, the Atwood fact affidavit contains
no information of a confidential nature. As mentioned above, Takeda has already
publicly disclosed, in its Notice of Application, Mylan’s allegation that
Example 10 of WO 114 was reproduced to prove that it produces pantoprazole
magnesium dehydrate and therefore anticipates Takeda’s Patent. Once that is
made public, there can be nothing original or worthy of protection in the
details of such testing, since the testing must, by necessity, strive to
reproduce the example as any person skilled in the art would, armed with
nothing more than the common general knowledge.
[29]
Given my conclusion that Mylan has failed to
satisfy the condition precedent for a confidentiality order in respect of the
NOA and the Atwood fact affidavit, there is no need for me to consider or
determine the other criteria of the Sierra Club test. However, given
Mylan’s insistence that the decision in Pfizer supports its argument
that a generic’s market position is a matter of substantial public interest,
and that this interest outweighs the public interest in open and accessible
Court proceedings, I feel compelled to address some of its arguments.
(2)
Is Mylan’s “first-to-market” position an important
interest as contemplated in Sierra Club?
[30]
Mylan cites its expectation of being the first
to market a generic version of pantoprazole magnesium as the important
commercial interest justifying its request for a confidentiality order.
[31]
The Court extensively discussed this issue at
paragraphs 38 to 46 of the reasons in Pfizer. The Court concedes, at
para 40, that: “[f]irms’ concerns with their market
positions […] lie at the very root of our market-oriented economy and, arguably,
are a matter of substantial public interest”. However it addresses that
argument in detail, and ultimately concludes that Novopharm’s competitive
position was personal to Novopharm and did not therefore qualify as an
important interest under the Sierra Club test:
46 That said, it is not clear that the
Supreme Court intended the aforementioned language at page 546 of Sierra Club,
above, to stand for the proposition that a firm's market position can be
characterized as an important commercial interest, as contemplated by the
second element in the first part of the test established in that decision.
Therefore, I am unable to conclude that Prothonotary Milczynski's conclusion on
this point was clearly wrong.
[32]
Mylan’s situation appears, on the record before
me, to be no different than the situation of Novopharm or of any other generic.
Mylan failed to bring evidence of circumstances or considerations that would
bring a generic’s interest in being first-to-market to a level that transcends
its own personal interest. Where Mr. Blais’ affidavit speaks of the incentive
created by the anticipation of being first-to-market, the incentive he
describes is to engage in activities “which are necessary
to challenge patents listed on the Patent Register”. Since challenging
the patents is essential to Mylan’s wish to be the first to enter the market, Mylan’s
argument is circular, and goes back to its own personal commercial interest. I
do not accept Mylan’s argument that there is a general public interest in
challenging patents which must be fostered. Indeed, in enacting section 60 of
the Patent Act, R.S.C., 1985, c. P-4, pursuant to which only interested
persons can sue to impeach a patent, Parliament has indicated that the personal
interest of those who are affected by the monopoly created by a patent is not
only a sufficient incentive to mount such challenges, but a necessary
requirement. In any event, as proceedings under the PM(NOC) Regulations
are summary and do not result in the invalidation of patents, any alleged
public interest in encouraging generics to challenge patents would not be
served by allowing generics to keep the grounds for their challenge secret.
[33]
Mylan’s argument also appears to suggest, but
provides no cogent basis to establish, that there is a public interest in
encouraging generics to avail themselves of the mechanism provided in the PM(NOC)
Regulations to gain entry into the market prior to the expiration of
registered patents, and that the prospect of being first to market, or a close
second, is an important incentive without which generics would not go to the
expense of preparing and serving NOAs. While it is understandable that a
generic’s primary goal would be to be first-to-market, there is no evidence
that the prospect of being a distant second, third or fourth on the market provides
insufficient rewards for generics to invest in drafting and serving NOAs.
Indeed, the sheer volume of NOC litigation before this Court involving NOAs
served by multiple generics in respect of the same patent is testament to the
contrary.
[34]
Finally, Mylan argues that there is a public
interest “in ensuring that all information, including
Mylan’s ANDS/DMF and the Atwood affidavit, that is relevant and important to
the central issues in this application is placed before the Court” and
in “protecting the right to a fair hearing”. The
public interest in fair hearings and complete records is not in doubt. However,
it is not in play in this matter. There is no evidence or suggestion that the
unavailability of a confidentiality order to protect the NOA or the detailed
evidence in support of invalidity allegations would lead Mylan, or has ever led
any generic, to forego serving a NOA or fully presenting its evidence or its
case.
(3)
Is the risk real and substantial, well grounded
in evidence and does it pose a serious threat?
[35]
Even had I accepted Mylan’s argument that a
generic’s first-to-market status has a public interest dimension, Mylan, like
Novopharm before it in Pfizer, has failed to a establish that there is a
“real and substantial” risk that disclosure of its NOA or of the Atwood fact
affidavit would pose a “serious threat” to its alleged first-to-market
position.
[36]
The only specific evidence on record on this
issue is found in paragraph 11 of Mr. Blais’ affidavit, and is to the effect
that: “There are currently no other proceedings pending
in this Court relating to pantoprazole magnesium, the drug at issue in this
proceeding. To my knowledge, no other generic drug company has yet taken steps
to develop a generic version of pantoprazole magnesium tablets.” Mr. Blais’
affidavit otherwise appears to proceed on the assumption - not otherwise
grounded in evidence – that Mylan’s competitors are in fact interested in
marketing and developing their own pantoprazole magnesium product and that the
only thing preventing them from doing so is their inability to come up with the
ideas that underlie Mylan’s NOA, that is, the construction of the relevant
patents, the basic composition and method of manufacture of a compound that
would fall outside the claims as construed, and the idea that example 10 of
WO114 is anticipatory because it produces pantoprazole magnesium dehydrate.
[37]
The problem here is the same as was noted in Pfizer,
above: the quality and emulation-worthiness of Mylan’s work product cannot
simply be assumed; it must be grounded in evidence:
35 In reaching her conclusion on this
point, Prothonotary Milczynski found that there were a number of significant
problems with Novopharm's argument that a failure to designate its NOA as
confidential would pose a serious threat to an important commercial interest,
as contemplated by the first element of the first part of the test set forth in
Sierra Club, above. Specifically, she noted the following:
First, there is no evidence of a serious risk to Novopharm's
commercial advantage with respect to its market position and what it hopes to
be the timing of its market entry. Novopharm assumes it will succeed on all
five patents in issue in this case and makes assumptions about how its and
ratiopharm's hearings will be scheduled by the Court. Novopharm may or may
not be first or a close second on the market. There is also no evidence other
than its own confidence in the quality of its work product to suggest that
other generics will be lining up to copy any part of the Novopharm NOA, particularly
when there is no evidence that ratiopharm's NOA has attracted such keen
attention (or evidence that ratiopharm's NOA should not warrant it).
[Emphasis added]
[38]
Mylan’s assumption that it will be
first-to-market and will maintain that position for a significant length of
time, if only it can shield its NOA from its generic competitors’ eyes, also
ignores the possibility that other generics might already (unbeknownst to Mylan
because of the inherent confidentiality of ANDS filings) have submitted ANDSs to
the Minister and received approval, and the possibility that Takeda might meet
Mylan’s entry in the market with the launch of an authorized generic, a
scenario well documented in section 8 cases (see, for example, Apotex v
Sanofi-Aventis, 2014 FCA 68, at para 58, Teva Canada Ltd v Pfizer Canada
Inc, 2014 FC 248 at para 94). A confidentiality order would do nothing to
protect Mylan from either of these scenarios.
(4)
Is there a significant public interest in the
information at issue?
[39]
Mylan relies on the following well-known passage
of AB Hassle, above, to minimize or dismiss any real or significant
public interest in the information it seeks to protect:
7 Let us not be naive. There is
little, if any, public interest in knowing the specific content of drug processes
and no one can seriously argue that the issuance of protective orders of the
type at issue in NOC proceedings imperils the principle of open justice. The
parties themselves may challenge the true confidentiality of specific documents
by the very terms of the orders and the Court will always be prepared to hear
challenge by a third party, whether or not the terms of the order so provide.
[40]
Mylan’s reliance on this passage is not
justified in the circumstances of this case.
[41]
First, the Federal Court of Appeal’s comments
are expressly directed to the “specific content of drug
processes”, i.e., the details found in the ANDS and not the basic
allegations of the NOA or the parties’ case on invalidity. Neither the NOA nor
the evidence on invalidity was protected by a confidentiality order in AB
Hassle. As also mentioned above, this Court in Pfizer expressly
noted the strong public interest in questions regarding the validity of
patents.
[42]
Further, given the significant increase in NOC
litigation this Court has seen since these words were written in 2000, and the
consequent developments of the law applicable to these cases, especially in the
areas of issue estoppel and abuse of process, the public interest in openness
can be seen as going beyond mere curiosity as to the details of drug processes.
This Court noted, in Pfizer Canada Inc v Canada (Minister of Health),
2008 FC 11 (the “Quinapril decision”:
38 NOC proceedings are flooding the
Court system at a rate which, roughly calculated, at the current pace, means that
three proceedings are instituted for each one disposed of by the Court. The
NOC Regulations require that the proceedings be disposed of by the Court within
24 months from institution barring consent of the parties to an extension.
Rarely is such consent, except for perhaps a few weeks, forthcoming. The Court
accepts the challenge. However, where essentially the same matters as were
previously disposed of are raised again, the Court must come to grips with the
question as to whether there is an unnecessary waste of the Court's resources.
[…]
43
Thus, in the context of NOC proceedings, in
particular this one, it is entirely appropriate to consider whether the
resources of the Court and the Minister are being unduly taxed by a generic
that raises essentially the same questions as were raised by another generic in
previous proceedings, and failed. The Court must be
mindful that the generic always has the remedy of a proceeding to challenge the
validity of a patent in the usual way. The Court is also mindful that, if a
different question is raised as to validity in subsequent proceedings, that
question should be considered as it was, for instance, in Eli Lilly Canada
Inc. v. Novopharm Ltd., [2007] F.C.J. No. 800, 2007 FC 596, previously
discussed.
[Emphasis
added]
[43]
The Federal Courts in Sanofi-Aventis Canada
Inc v Novopharm Ltd, 2007 FCA 163, Eli Lilly Canada Inc v Novopharm Ltd,
2007 FC 596, the Quinapril decision, above, and Allergan Inc v Canada
(Minister of Health), 2012 FC 767, amongst others, have applied sub-section
6(5)(b) of the PM(NOC) Regulations and the doctrines of issue estoppel,
abuse of process and judicial comity to curb re-litigation of invalidity issues
by both innovators and generics. Essentially, this jurisprudence is to the
effect that where a determination has previously been made in respect of an
allegation of invalidity found in a generic’s NOA, the Court, when seized of
the same allegation made by a different generic, should be cautious about
making a different determination unless there is “better evidence or more
appropriate argument”. Those same principles have also been held applicable to
non-infringement allegations (Nycomed Canada Inc v Novopharm Ltd, 2008
FC 454).
[44]
These principles were developed and must be
applied to safeguard the public’s right to equitable access to the Courts, and weigh
very heavily in favour of public disclosure of the details of the allegations, of
the evidence and of the Court’s assessment of that evidence. Given the
disproportionate share of the Court’s resources used by NOC proceedings, and
the growing realization that judicial resources are not endless and must be
shared equitably among all litigants, there is a clear public interest in
ensuring that unnecessary duplications are not concealed or allowed to proliferate
under a shroud of secrecy.
[45]
Finally, while Mylan has been unable to
establish that its NOA would attract particular attention among generics, the
strong desire displayed by Mylan and other generics to keep their NOAs
confidential does speak to the keen interest generics do have in litigation
resulting from others’ NOAs. Mylan’s broad assertion that “the public” has no
interest in the information at issue in NOC litigation fails to take into
account that the generic pharmaceutical industry forms part of “the public”.
That industry’s interest cannot be discounted as illegitimate, or driven solely
by a competitor’s desire to peer into a litigant’s proprietary information to
gain a commercial or competitive advantage. Other generics’ interest in the
details of the allegations and evidence in NOC proceedings is legitimate, as
the Court’s decisions on NOC proceedings are susceptible of having precedential
value, or of giving rise to arguments of issue estoppel, abuse of process or
judicial comity, and therefore, of affecting the outcome of these other
generics’ NOAs. For better or for worse, the PM(NOC) Regulations have
established a process whereby the allegations of non-infringement or invalidity
made by generic drug manufacturers must be assessed by the Courts, and not by
administrative tribunals. Other generics therefore do have a legitimate
interest in the Court’s practices, proceedings and decisions that cannot be
discounted or ignored when considering the public
interest in open and accessible Court proceedings involving the PM(NOC)
Regulations.
IV.
Conclusion
[46]
Mylan has failed to establish, in respect of its
NOA, of the information set out in the NOA and of the evidence in support of
its allegations of invalidity, that the information was treated as confidential
or benefited from a reasonable expectation of confidentiality, and that alone
is fatal to its motion. Mylan also failed to establish that a confidentiality
order would be necessary to prevent a real and substantial risk of serious harm
to its hope or desire to be first to market, that such a hope is an important
interest which qualifies for consideration under the Sierra Club test or
that such an interest would counterbalance the very strong legitimate public
interest in openness as regards all aspects of proceedings under the PM(NOC)
Regulations. A confidentiality order will therefore issue, but only in
respect of the ANDS Information not otherwise disclosed in the NOA.
“Mireille Tabib”
Ottawa, Ontario
2014-11-13
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