Docket: T-944-15
Citation:
2017 FC 437
Ottawa, Ontario, May 2, 2017
PRESENT: Madam Prothonotary Mireille Tabib
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BETWEEN:
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TEVA CANADA
LIMITED
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Plaintiff
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and
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JANSSEN INC.
AND MILLENNIUM PHARMACEUTICALS, INC.
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Defendants
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AND BETWEEN:
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MILLENNIUM
PHARMACEUTICALS INC., JANSSEN INC., CILAG GMBH INTERNATIONAL, CILAG AG AND
JANSSEN PHARMACEUTICA NV
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Plaintiffs By Counterclaim
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and
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THE UNITED
STATES OF AMERICA REPRESENTED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Patentee
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and
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TEVA CANADA LIMITED
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Defendant by Counterclaim
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ORDER AND REASONS
I.
Overview
[1]
Teva, after both parties had improperly filed
materials under seal, brought a belated motion for a confidentiality order in
respect of its information. The relief requested overreached, and greatly
exceeded the scope of the evidence filed to support it. Given an opportunity to
adjust its ask or provide appropriate support, Teva filed what can only be
characterized as inaccurate and misleading evidence, bringing into question and
irrevocably tainting the credibility and reliability of all the evidence
adduced in support of its motion. As a result, the Court cannot be satisfied
that the materials at issue should be treated as confidential notwithstanding
the public interest in open and accessible court proceedings.
[2]
For these reasons, more fully explained below,
Teva’s motion is dismissed, and the material filed by the parties under seal
will be placed on the open court record. The parties’ request to remove certain
parts of the record is however granted, and these portions will be removed
before the remaining parts of the records are unsealed.
II.
General Principles
[3]
The open court principle is of crucial
importance in a democratic society, as recognized in CBC v Québec (Procureur
général), 2011 SCC 2. It ensures that citizens have access to the courts
and can comment on how courts operate and on proceedings that take place in
them. Courts are publicly funded. Citizens, whose tax dollars pay for the
courts’ operations, are entitled to expect that judicial resources are
allocated fairly and judiciously amongst many competing demands; they have the
right to know how these resources are being used.
[4]
Confidentiality orders inherently compromise
these fundamental principles and important rights. Private parties to
high-stakes pharmaceutical litigation may prefer that the details of their
disputes remain shielded from the public view; however their counsel, as
officers of the court, have a duty to uphold the independence and authority of
the Court. They must assist the Court in upholding the fundamental principles
of justice, including the public interest in public and accessible court
proceedings. It is not open to counsel, acting as advocates for their clients’
private interests, to put aside their duty to the Court and choose to put
before the Court incomplete or misleading information, to wilfully blind
themselves to the availability of important and relevant information and to
fail to fairly put all relevant facts before the Court, whether or not they
support their position.
[5]
The requirements for the Court to make a
confidentiality order, as set out in Rule 151 of the Federal Courts Rules
SOR/98-106 and as further explained and refined by the Supreme Court of Canada
in Sierra Club of Canada v Canada (Minister of Finance), 2002 SCC 41, is
not merely that a party assert or believe that information is confidential or
should be treated confidentially, but that the Court be satisfied that it is
so. The onus is a heavy one. It is not satisfied by consent or by bald assertions
(Bah v Canada (Ministre de la citoyenneté et de l’immigration), 2014 FC
693; Canada (AG) v Amalki, 2010 FC 733).
[6]
One of the conditions to be satisfied is that
the confidentiality order be necessary to prevent a serious risk of harm to an
important interest. It may be a trite observation, but for this condition to be
met, the moving party must necessarily establish that the information is
actually confidential. A party cannot hope to satisfy the Court that a
prejudice might be suffered should the information become public, or that a
confidentiality order is necessary to prevent that prejudice, if the
information is already publicly available and beyond the reach of the Court’s
protection.
III.
The Circumstances of the Case
[7]
This is an action brought by Teva Canada Limited
to recover from Janssen Inc. and others damages it claims to have suffered as a
result of being delayed entry into the Canadian market for bortezomib, pursuant
to section 8 of the Patented Medicine (Notice of Compliance) Regulations SOR/93-133,
as amended.
[8]
The parties sought and obtained from the Court
on consent a protective order setting out the terms under which information
exchanged between them was to be treated. The order provided that:
“(…) this Protective Order applies only to
govern the manner in which the Parties deal with information exchanged in the
course of this litigation and does not entitle any party to file confidentially
in this Court information designated as Confidential Information pursuant to
this Protective Order in the absence of a separate, specific Confidentiality
Order (…)”
[9]
A confidentiality order was also issued,
allowing the parties to file supporting materials under seal, but only for the
purpose of motions to compel.
[10]
Notwithstanding these terms, both parties purported
to file, pursuant to these orders, sealed materials in the context of a motion
brought by Janssen for leave to amend its statement of defence and
counterclaim. Such misuse of the terms of protective and confidentiality orders
is, alas, all too common in pharmaceutical patent litigation. It is symptomatic
of a careless attitude towards the principle of open and accessible court
proceedings and of a disregard of counsel’s duties as officers of the court to
uphold the authority of the Court and respect its orders.
[11]
On noticing the parties’ improper filing, the
Court issued a direction requiring them to show cause why the sealed material
should not be opened and placed on the record or removed from the record. The
parties agreed that some of Janssen’s information and of Teva’s information
could be removed from the record. Teva agreed that other parts of its
information could be placed on the open record. However, Teva also made a
motion to allow substantial portions of its information to remain under seal.
[12]
Two types of information were at issue in Teva’s
motion for a confidentiality order: the supply contract between Teva and the
supplier of its bortezomib product, including all of the information contained
therein and all documents that refer to that information, and excerpts of
Teva’s ANDS for its bortezomib product, including the portions of the discovery
transcript and written representations that refer to it.
[13]
Janssen had included and referred to the supply
contract in its motion record because some of the amendments it sought to make
alleged that Teva is not the “Second Person” entitled to claim section 8
damages because under the terms and conditions of the supply contract, the
supplier had complete control over Teva’s activities and should therefore be considered
to be the Second Person. Teva filed the ANDS information to show that it was
the person who applied for and was named as applicant in the ANDS and
therefore, properly the Second Person.
[14]
The identity of the supplier and the terms of
the supply agreement are accordingly key to the proposed amendments and to the
determination of whether they disclose a reasonable defence and should be
allowed. Indeed, the particulars of the proposed amendments recite the terms of
the supply agreement. The ANDS, for its part, is only relevant insofar as it
identifies Teva, and not the supplier, as the applicant.
[15]
Teva filed the affidavit of Glenn Ikeda in
support of its motion for a confidentiality order. The parts of that affidavit
relating to the confidentiality of the supply contract read as follows:
“3. Teva Production
0074 is a License, Supply and Distribution Agreement between Teva and its
related supplier. This document refers to the royalty rate, pricing
structure and payment terms as between Teva and its supplier, and for
that reason, has been designated as “Confidential – Financial
Information.” This document contains a
confidentiality clause in paragraph 12 which requires Teva and its supplier to
maintain any information disclosed pursuant to this agreement as confidential,
except to consultants, affiliates and employees who need or are entitled to
know the confidential information for the purposes of carrying out the
objectives of the agreement. The agreement contains sensitive commercial
information (Teva’s costs and information regarding Teva’s supply chain)
that could be used by competitors to Teva’s disadvantage in a competitive
bidding process.
4. Teva considers this document to be
confidential and treats it as such, as this agreement sets out the pricing
arrangement for bortezomib as between Teva and its supplier, and this
information is not publicly disclosed or shared with parties external to Teva.”
[Emphasis
added.]
[16]
Even though that paragraph refers to “information regarding Teva’s supply chain”, the emphasis
is on the financial aspects of the agreement, and not on the identity of the
supplier. Paragraph 3 even acknowledges that the supplier is related to Teva.
[17]
Given the importance of the supply terms to the
issues on the motion to amend and the lack of evidentiary support for their
confidential nature or for the prejudice Teva might suffer from public
disclosure of these terms, the Court was not satisfied that a confidentiality
order was justified in respect of any element other than the financial aspects of
the agreement. With respect to the ANDS, the affidavit only spoke to the
confidentiality of the scientific information it contained.
[18]
The confidentiality designations sought by Teva
greatly exceeded these parameters. They sought to seal the entirety of the
supply agreement and of the ANDS and any reference to their content. The
designations even included the particulars of the proposed pleadings. The Court
accordingly called the parties to a hearing, to give Teva an opportunity to
explain the extent of the proposed confidentiality order or suggest a more
tailored approach.
[19]
Teva acknowledged at the hearing that some of
the transcripts it had sought to protect did not actually contain any
confidential information and that confidentiality may not be justified in
respect of portions of the ANDS and of the supply agreement. However, and
surprisingly in view of the focus of the affidavit and of the fact that the
supplier is a company related to Teva, as already acknowledged in Mr. Ikeda’s
affidavit, Teva’s counsel took the position that the identity of the supplier
should remain confidential.
[20]
Given the inadequacy of the evidence and
counsel’s insistence, the Court allowed Teva until the end of the day to verify
whether the supplier’s identity was truly confidential, and if so, to file
further evidence demonstrating the need for confidentiality. The Court at the
hearing specifically questioned how disclosure of the identity of the supplier
could be prejudicial given that it was a related company and sought assurances
that the identity of the product’s manufacturer was not already publicly
disclosed anywhere else in the world, including in product monographs.
[21]
Teva thus filed a second affidavit from Mr.
Ikeda. In that affidavit, he makes the following statements:
“5. Teva Canada and the Teva global group
of companies maintain the details of their products supply chains in
confidence for commercial competitive reasons. Information relating to the
location or identity of the entities that supply Teva’s bortezomib products,
including the active pharmaceutical ingredient (API) and the finished
formulation, is not available to the public. For example, this
information is not included on product labels or in product monographs. The
supply chain information, including the location, manufacturer information,
and details of the processes and materials used are filed with regulatory
authorities, including Health Canada. Teva understands and expects that
the contents of those filings, including that of bortezomib, are maintained as
confidential by the regulatory authorities, including Health Canada, and
Teva does not disclose such information to third parties in the absence of an
agreement or Court order to maintain confidentiality. The identity and
location of Teva’s suppliers in relation to its bortezomib products are
confidential and not known to the public.
6. Public dissemination of the details of
information contained within Teva’s regulatory submissions, particularly
scientific product information as well as Teva’s confidential arrangements with
suppliers, including the identity and location of those suppliers (whether
external to or within the Teva group of companies), has the potential to harm
Teva’s commercial interests for a number of reasons.”
[Emphasis
added.]
[22]
These statements seemed at odds with the Court’s
experience, from previous litigation, in respect of the regulatory regime in
Europe. The Court accordingly sought the following clarifications from the
parties:
“From experience in pharmaceutical
litigation, it is the Court’s understanding that for medicines marketed in
European countries, the identity and location of the drug product’s
manufacturer is required to be disclosed and made available to the public as
part of the product’s Patient Information Leaflet, or Package Leaflet.
In the interest of ensuring that the Court’s
decisions are not based on incomplete or misleading information, both parties
are asked to provide the Court with evidence setting out their information
knowledge or belief as to whether Teva bortezomib is marketed in any European
Union countries, and if so, whether the identity of its manufacturer is
disclosed in the Package Leaflet(s).”
[23]
In response to this direction, Janssen filed a
package of six documents it understood were publicly available. One of these
documents is a Patient Information Leaflet (“PIL”) for Bortezomib Teva from
Ireland, which identifies the Marketing Authorization Holder as Teva BV of The
Netherlands and lists as “Manufacturer” TEVA Gyogyszergyar Zrt (TEVA
Pharmaceutical Works Private Limited Company) of Hungary, PLIVA Hrvatska d.o.o.
(PLIVA Croatia Ltd.) of Croatia and Teva Operations Poland Sp z.o.o. of Poland.
The PIL also states that “this medicinal product is
authorized in the Member states of the EEA under the following names”.
There follows a list of names under which the product is authorized to be sold
in 29 countries. The names are variations of Bortezomib Teva, Bortezomib
ratiopharm and Bortezomib Pliva.
[24]
Also included in the package delivered by
Janssen were Summary of Product Characteristics documents for Bortezomib Teva
and Bortezomib Actavis, as well as Bortezomib Actavis PILs for the Czech
Republic, Hungary and Bulgaria. All these documents appear to disclose the
“Manufacturer” of the product; in Actavis’ case, it is S. C. Sindan-Pharma
S.R.L. of Romania.
[25]
Teva filed, as part of the third affidavit from
Glenn Ikeda, a PIL for Teva Bortezomib for the UK, showing Teva UK as
“Marketing Authorization Holder” and the same three Teva/Pliva entities as
“Manufacturer”. The affidavit acknowledges that PILs do sometime become
publicly available before a product is launched, and that Teva has amalgamated
with Actavis so that Actavis branded bortezomib products are currently being
sold by Teva in some European countries.
[26]
This information contradicts the statements made
in Mr. Ikeda’s earlier affidavit, where, speaking of the Teva global group of
companies, he asserted that “Information relating to
the location or identity of the entities that supply Teva’s bortezomib products
(…) is not available to the public”, and “is not
included on product labels or on product monographs”. It also
contradicts the statement that “the location,
manufacturer information (…) are filed with regulatory authorities” but
that “Teva understands and expects that the contents of
these filings (…) are maintained as confidential by the regulatory authorities”.
It shows that the final, unequivocal statement of paragraph 5 of Mr. Ikeda’s
affidavit, that “The identity and location of Teva’s
suppliers in relation to its bortezomib products are confidential and not known
to the public” is untrue.
[27]
Yet remarkably, and undermining any vestige of
credibility his earlier affidavits might still have in light of this new
information, Mr. Ikeda doubles down and asserts that these statements are
nevertheless accurate. The convoluted argument by which Mr. Ikeda tries to
justify himself is that these PILs disclose “the sites
that are approved as release sites” for these products, but not the “identity or location of the manufacturer that is used for
any specific manufacturing step”, because the site or sites “approved to finally release the product” “may be limited in its involvement to quality control work”.
However, it defies any logic to suggest that the entity that is referred to in
regulated patient information as “manufacturer”,
and is the entity who finally approves and releases to product to be sold, is
not “an entity that supplies” the product or “a supplier” of the product.
[28]
What Mr. Ikeda swore to in his April 20, 2017
affidavit is not merely that the precise identity of the manufacturer of the
API that goes into its Canadian bortezomib product is not publicly known, but,
sweepingly, that the Teva global group of companies keeps information “relating to” the location or identities of entities
that “supply” their products confidential. That,
it turns out, is patently untrue: Teva does identify, in PILs that it knows are
publicly available, the location and identities of the entities that are
authorized to supply bortezomib products to members of its global group of
companies.
[29]
Teva’s dive into granularity in an attempt to
explain the inexplicable also misses the point of what the original affidavit
was meant to establish. The issue here is whether Teva would suffer serious
harm if the identity of its supplier, as set out in the supply agreement, were
to be disclosed publicly.
[30]
The harm described in Mr. Ikeda’s April 20, 2017
affidavit is that Teva’s competitors or other suppliers could obtain an unfair
competitive advantage by combining the “otherwise
confidential identity or location” of Teva’s suppliers with public
information about the supplier and/or issues relating to the location or
jurisdiction in which it operates. For example, if this supplier were to
experience manufacturing difficulties, other suppliers of Teva could use that
knowledge to pressure Teva for higher prices.
[31]
This supposed harm was already speculative.
Combined with the facts as they now appear, it lacks any air or reality: The
supplier under the supply agreement at issue is the same related entity as is
publicly identified in European PILs for Teva bortezomib; accordingly, if the
hypothetical scenario described were to occur, other suppliers of Teva could
use that knowledge to pressure Teva for higher prices, whether or not the
specific identity of the Canadian supplier is made public. In any event, like
the European PILS, the supply agreement provides no details as to where or by
what entities any specific manufacturing steps are to be performed, including
the manufacture of the API. Any prejudice that might befall Teva Canada by the
publication of this information would equally befall the Teva entities who
publish the same information in Europe; yet publication of supplier information
appears to be routinely done in Europe.
[32]
In conclusion, I find that that first affidavit
of Glenn Ikeda was incomplete and insufficient, and that his second affidavit
was, in material respects, untrue and misleading. Combined with his stubborn
insistence, in his third affidavit, that the statements of his second affidavit
were accurate, despite clear evidence to the contrary, I find that none of the
evidence offered by Mr. Ikeda is reliable or worthy of being believed. This
means that there is no reliable evidence on record to support a finding that
any of the information of Teva should be treated as confidential. Teva’s motion
for a confidentiality order must accordingly fail.
[33]
This finding equally applies to the portions of
Teva’s ANDS. Mr. Ikeda’s affidavit asserts that the portions of the ANDS
contain information regarding the materials and processes employed to make
Teva’s bortezomib product, which could be used by competitors to produce
competing products. It adds that it treats this document as confidential and
that Health Canada also treats it as confidential.
[34]
The Court is aware and recognizes that ANDS
filings are treated confidentially by Health Canada and that there are
important public policy reasons to maintain the confidentiality of these
filings. However, the fact that information is included in an ANDS is not
determinative of the confidential nature of the information itself, or of the
continued confidentiality of information over time.
[35]
For example, the mere fact that a generic has
filed an ANDS for a product is treated confidentiality up until the moment an
NOC is issued. However, confidentiality is lost if the generic serves a notice
of allegation in respect of that ANDS. Confidentiality is also lost when an NOC
issues. Likewise, the draft product monograph included in an ANDS in Canada is
treated as confidential, as is the information it contains. Yet, once the
product is approved and put on the market, the product monograph becomes public
and no claim can reasonably made that the information it contains remains confidential.
[36]
Similarly, while a pharmaceutical company may
assert that the information contained in its ANDS as to the composition and
method of manufacture of its product is treated as confidential, this
information may lose its confidentiality once the product is publicly sold. The
composition of pharmaceutical products can often be determined by analysing a
sample of the product; its mode of manufacture can also often be deduced by
analysis or may simply be reasonably deduced from publicly available scientific
knowledge.
[37]
The circumstances of this case also highlight
the fact that the regulatory regime in Europe is different from the Canadian
regime. Pharmaceutical companies are not required in Canada to disclose
information as to a product’s supplier, while some of that information is
publicly disclosed in Europe. Information as to a product’s composition and
mode of manufacture might equally be treated differently in Europe.
[38]
Mr. Ikeda’s evidence as to the confidentiality
of the scientific information found in the ANDS relies solely of his assertion
that Teva and Health Canada treat the ANDS and the information it contains as
confidential. It addresses none of the ways in which that information might
otherwise be publicly available. Given the lack of credibility of Mr. Ikeda’s
evidence, I am not prepared to accept that the scientific information contained
in the portions of the ANDS that was filed as part of Teva’s record is not
otherwise publicly available, or cannot reasonably be inferred from public
information.
[39]
Given the general lack of credibility of Mr.
Ikeda’s evidence, I also do not have reliable or credible evidence that serious
harm may be suffered by Teva if the royalty rate, pricing structure or payment
terms found in the supply agreement are made public. There is no reliable
evidence before me to explain why financial terms agreed to between related
companies “might be used by competitors to Teva’s
disadvantage in a competitive bidding process” as asserted by Mr. Ikeda
in his first affidavit.
[40]
Finally, I note that among the information
sought to be kept confidential are the particulars of certain amendments to
Janssen’s Statement of Defence to which the parties consented. These
allegations are to the effect that Teva would not have been in a position to
enter the bortezomib market before March 2015 because its supplier realized, in
November 2014, that it was not making the product in accordance with the
specifications set out in the ANDS and DMF on file with Health Canada.
Although the confidentiality order sought by Teva includes these particulars
within the scope of the order sought, none of the evidence filed mentions this
information or explains why Teva might suffer harm if it became public. While
the particulars touch upon the reaction used in the preparation of the drug
product, there is, as mentioned above, no reliable evidence before me to the
effect that the use of this reaction is not already a matter of public
knowledge, and that Teva might suffer any kind of harm if the allegations were
not protected by a confidentiality order.
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