Date: 20051117
Dockets: T-1576-99
T-1671-00
Citation: 2005
FC 1552
Ottawa, Ontario,
November 17, 2005
PRESENT: THE HONOURABLE MADAM JUSTICE HENEGHAN
BETWEEN:
HOECHST
MARION ROUSSEL CANADA INC.
Applicant
and
ATTORNEY
GENERAL OF CANADA
Respondent
and
PATENTED MEDICINE PRICES REVIEW BOARD
Intervener
REASONS FOR ORDER
INTRODUCTION
[1]
Hoechst Marion
Roussel Canada Inc. (“HMRC” or the “Applicant”) seeks judicial review of two
decisions of the Patented Medicine Prices Review Board (the “Board”). The first
decision, dated August 3, 1999 is the subject of cause number T-1576-99. The
second decision dated August 8, 2000, is the subject of cause number T-1671-00.
[2]
HRMC is the exclusive
distributor in Canada of Nicoderm. Nicoderm is an aid to cessation of smoking.
It is available in strengths of 7 mg, 14 mg and 21 mg, administered by the
continuous delivery of nicotine through the skin into the circulatory system,
by means of a patch. This product is manufactured in the United States by Alza Corporation. It is sold in Canada pursuant to a Notice of Compliance (“NOC”) issued by Health
and Welfare Canada on May 12, 1992.
[3]
The Board was
established pursuant to the Patent Act, R.S.C. 1985, c. P-4, as amended
(the “Act”), in 1987. Its mandate is to review the prices of patented
medicines. It obtained leave to intervene in these proceedings pursuant to the
Federal Court Rules,1998, SOR/98-106, as amended, (the “Rules”) in these
proceedings by Order of Prothonotary Aronovitch dated July 13, 2001. The decision of the
Prothonotary, reported as Hoechst Marion Roussel Canada v. Canada (Attorney General), [2002] 1 F.C. 76 was upheld
on appeal, aff’d. February 11, 2002 [unreported] (T.D.) aff’d. [2002] F.C.J.
No. 1785 (C.A.).
[4]
The Attorney General
of Canada (the “Respondent”) is named as the responding party, pursuant to Rule
303(2) of the Rules.
BACKGROUND
[5]
In or about 1986,
Alza Corporation commenced a joint venture with Merrell Dow Pharmaceuticals
Inc., the predecessor to HMRC, to develop and market a transdermal nicotine
patch. A number of agreements were made with Alza Corporation, including the
following:
1)
a Confidentiality
Agreement dated March 21, 1986;
2)
an Interim
Development Agreement dated January 1, 1987;
3)
a Development and
Licence Agreement (the “Licence Agreement”) dated November 27, 1989, amended
October 25, 2995 and November 29, 1995;
4)
a Nicotine Patch
Supply Agreement (the “Supply Agreement”) dated November 27, 1989; and
5)
an Interim
Development Agreement dated October 5, 1992.
[6]
Alza Corporation
holds several Canadian patents relating to nicotine patches, as well as a
minimum of two outstanding patent applications, as follows:
·
Canadian Patent No.
1,331,340 (the “ ’340 Patent”), a method of prolonging the shelf life of a
nicotine transdermal patch, was granted to Alza Corporation on August 9, 1994
and will expire on August 9, 2011;
·
Canadian Patent No.
1,333,689 (the “ ’689 Patent”), a nicotine transdermal patch with a method of
controlling the rate of release of nicotine, was granted to Alza Corporation on
December 27, 1994 and will expire on December 27, 2011;
·
Canadian Patent No.
1,338,700 (the “ ’700 Patent”), a transdermal patch for the delivery of
nicotine through the skin of a user, was granted to Alza Corporation on
November 12, 1996 and will expire on November 12, 2013;
·
Canadian Patent
Application No. 2,032,446 (the “ ’446 Application”), relating to packaging
material for a nicotine transdermal patch, was filed on December 17, 1990 and
was laid open on June 22, 1991;
·
Canadian Patent
Application No. 2,040,352 (the “ ’352 Application”), a transdermal patch for
the delivery of nicotine through the skin of a user, was filed on April 12,
1991 and was laid open on October 17, 1991.
[7]
In May 1998, HMRC
submitted to the Board a Form 1, dated April 9, 1998, pursuant to the
provisions of the Patented Medicine Regulations, 1994, SOR/94-688. This
was the first time that HMRC had reported Nicoderm to the Board as a patented
medicine. HMRC reported that the ’700 patent pertains to Nicoderm and that it
held a licence other than a licence referred to under section 41 of the Act, as
it stood prior to the 1993 amendments. HMRC provided the information that had
been required by the Regulations, including reports on prices and sales for the
period November 12, 1996 to December 31, 1997.
[8]
By letter dated June
12, 1998, Ms. Laura Y. Reinhard, Director of the Board’s Compliance and
Enforcement Branch, advised HMRC that the Board was investigating the pricing
of Nicoderm. HMRC was given the opportunity to present further information
before the matter would be referred to Dr. Robert G. Elgin, the Chairperson of
the Board. Ms. Reinhard, in her letter, referred to the Board’s Compendium
of Guidelines, Policies and Procedures (the “Compendium”) and advised that
for the purposes of that document, the price of Nicoderm should not exceed the
lower of the maximum non-excessive (“MNE”) prices of the comparable strengths
of Habitrol and the prices for Nicoderm in the other countries that are listed
in the Regulations. Habitrol is the comparable medicine for price review
purposes as it is the most similar to Nicoderm.
[9]
Ms. Reinhard indicated
that, based upon the information provided by HMRC, the price of Nicoderm
exceeded the Excessive Price Guidelines (the “Guidelines”) of the Compendium
during the period November 1996 to December 1997 by amounts varying between 4%
and 10.7% and consequently, HMRC had received excess revenues of more than
$1,000,000.00. Further, she advised that the price of Nicoderm exceeded the
Guidelines prior to November 12, 1996. The Board Staff also concluded that
both the ’689 Patent and the ’352 Application pertain to Nicoderm and that HMRC
is a patentee of the ’689 Patent for the purposes of the Act.
[10]
HMRC responded to
this letter on July 21, 1998 and provided additional documentation, including
copies of the Licensing Agreement with Alza Corporation and the Supply
Agreement. It submitted further material in August 1998, in response to a
request from the Board Staff about the patent status of Nicoderm. This information
was considered by the Board Staff, as well as the discussion at a meeting
between Board Staff and representatives of the Applicant on July 30, 1998.
[11]
On September 21,
1998, Ms. Reinhard wrote a letter advising HMRC of the results of the Board’s
Staff Investigation into the prices of Nicoderm transdermal nicotine patches.
The Board Staff had concluded that the price of Nicoderm exceeded the
Guidelines and informed it that a confidential report on the Board’s Staff
Investigation (the “Staff Report”) would be submitted to the Chairperson for
consideration. She also advised that HMRC could submit to a Voluntary
Compliance Understanding (“VCU”), that is a written proposal that it would
adjust the price of Nicoderm. The VCU, if submitted, would be considered by
the Chairperson, as well as the Staff Report. The Chairperson is authorized to
accept a VCU to resolve pricing issues if satisfied that it meets the statutory
objectives and conforms with the policies of the Board.
[12]
On March 9, 1999, the
Applicant submitted a VCU for consideration by the Chairperson. Nonetheless, the
Chairperson determined that a hearing should be held, in the public interest.
On April 20, 1999, the Board issued a Notice of Hearing to determine, pursuant
to sections 83 and 85 of the Act, whether HMRC, as a patentee, is selling or
has sold Nicoderm in Canada at a price that, in the Board’s opinion,
is or was excessive.
[13]
HMRC filed a
“Conditional Response” on May 5, 1999, objecting that the Notice of Hearing was
deficient because it did not provide sufficient detail to enable it to prepare
a response. On May 14, 1999, HMRC sent a letter to counsel for the Board,
requesting a summary description of the proposed Order to be made against it.
[14]
On May 17, 1999, the
Board replied and advised that it would treat the Conditional Response and the
May 14th letter as a motion for particulars of the Order to be sought by the
Board at the hearing. The Board further noted that HMRC’s Conditional Response
asserted that the Board lacked jurisdiction to issue the Notice of Hearing.
The Board indicated that if HMRC intended to challenge the Board’s
jurisdiction, it should do so by means of a motion before the Board at the
Pre-Hearing Conference scheduled for May 28, 1999.
[15]
On May 21, 1999, the
Board sent a letter to HMRC, providing full particulars about the Order sought
from the Board concerning the matter of excessive pricing.
[16]
On May 25,
1999, HMRC filed a notice of motion requesting that the Board rescind its
Notice of Hearing. A variety of jurisdictional issues were raised, as follows:
5) The Board is without jurisdiction to
inquire into the Respondent’s pricing of Nicoderm® as Nicoderm® is not a
medicine for the purposes of section 83 of the Patent Act;
6) The Board is without jurisdiction to inquire
into the Respondent’s pricing of Nicoderm® as an overlap of Board functions as
investigator, prosecutor and adjudicator creates a reasonable apprehension of
bias against the Respondent which is not excused at law and is contrary to the
principles of fundamental justice and the Canadian Bill of Rights;
7) The Board is without jurisdiction as the
Notice of Hearing was issued in this case in breach of the principles of
natural justice and procedural fairness. The manner in which the Board proceeded
by making determinations prior to the issuance of the Notice of Hearing denied
the Respondent a reasonable opportunity to be heard and gives rise to a
reasonable apprehension of bias;
8) In any event, the Board is without
jurisdiction to inquire into the Respondent’s pricing of Nicoderm® commencing
with the grant of Canadian Patent No. 1,331,340, as the Respondent is not a
person entitled to the benefit of that patent nor a person entitled to exercise
any rights in relation to that patent. Furthermore, the only patent which
pertains to Nicoderm® is Canadian Patent No. 1,338,700 granted on November 12,
1996. Any interpretation of the Patent Act that would extend the
Board’s jurisdiction to make orders based on the other patents, or patent
applications, identified in the Notice of Hearing would be contrary to sections
91 and 92 of the Constitution Act, 1867;
9) The Notice of Hearing issued by the Board,
including the summary of the proposed order subsequently provided, fails to
provide the allegations, grounds and material facts in sufficient detail to
enable the Respondent to know the case it has to meet. Proceeding on the
Notice of Hearing would constitute an abrogation of the Respondent’s right to
natural justice and procedural fairness and would prevent the Respondent from
making a full and proper response thereto;
[17]
The Board
Panel, consisting of the Board Chairperson and members Réal Sureau, Anthony
Boardman and Ingrid Sketis dealt with the motion in two parts. It first
addressed the allegations of institutional bias and procedural fairness raised
in paragraphs 6, 7 and 9. The Applicant argued that, in consequence of the
overlapping functions of the Board as investigator, prosecutor and adjudicator,
as well as its manner of proceeding in making decisions prior to the issuance
of a Notice of Hearing, a reasonable apprehension of bias was created. As
well, the Applicant alleged that the Notice of Hearing lacked sufficient detail
for this purpose, thereby breaching its right to procedural fairness.
[18]
The Board
addressed the second part of the Applicant’s motion, dealing with allegations
set out in paragraphs (5) and (8), in a separate hearing. The Board’s decision
on jurisdiction is the subject matter of cause number T-1671-00.
[19]
In its
first decision on jurisdiction rendered on August 3, 1999, the Board
unanimously dismissed the Applicant’s allegation of institutional bias, breach
of natural justice and lack of particulars in the Notice of Hearing. The Board
declined to end the proceedings and to rescind the Notice of Hearing. The
Applicant filed its application for judicial review relative to this decision
on September 3, 1999.
[20]
In its
reasons, the Board Panel considered the various allegations raised by the
Applicant. It concluded, with respect to the issue of institutional bias, that
the Board is an expert tribunal that develops and applies health care policy
within the pharmaceutical industry and is the kind of tribunal that Parliament
may create with overlapping functions without violating the right to a fair
hearing. As well, the Board Panel found that there was no violation of the
Applicant’s right to a fair hearing such that the Act must be expressly said to
apply “notwithstanding” the provisions of the Canadian Bill of Rights,
S.C. 1960, c. 44, reproduced in R.S.C. 1985, App. III (the “Bill of Rights”).
[21]
The Board
Panel also addressed the Applicant’s alternative argument, that the Board had
exceeded any overlap authorized by the Act in the manner in which it discharged
its statutory obligations. The Board Panel considered some specific
submissions raised by the Applicant in this regard.
[22]
First, the
Board Panel concluded that the Board Staff had conducted an investigation for
the purpose of determining if there was a prima facie case that there
has been excessive pricing. As such, the purpose of Ms. Reinhard’s
correspondence was to put the Applicant on notice of the findings of the
investigation. The Board Panel found nothing inappropriate in the presentation
of those findings in unambiguous terms since they were only the allegations of
Board Staff and not the conclusions of the Board Panel.
[23]
Second,
the Board Panel found that the decision of the Chairperson to issue a Notice of
Hearing, despite receipt of a VCU from the Applicant, does not represent any
conclusion as to the merits of the case to be presented at the hearing.
Rather, the issuance of the Notice of Hearing represents the Chairperson’s
conclusion, as Chief Executive Officer of the Board, that a public hearing
would be in the public interest.
[24]
Third, the
Board Panel concluded that, having regard to the limited purpose of the
Chairperson’s preliminary review of the confidential Staff Report and the VCU,
that is to determine if it is in the public interest to hold a public hearing,
no reasonable apprehension of bias will arise from the Chairperson’s
participation in the Panel conducting the public hearing.
[25]
Fourth,
the Board found there was no denial of procedural fairness flowing from the
Chairperson’s decision to initiate a public hearing without receiving the
submissions of the Applicant on that matter; that decision only required that
the matters in issue be presented and decided in public rather than internally,
by the Board alone.
[26]
As for the
Applicant’s allegation about the sufficiency of the Notice of Hearing, the
Board found that, for its intended purpose, the Notice of Hearing provided
sufficient details from its issuance. As well, the Board Staff agreed that the
allegations in Ms. Reinhard’s letter of September 21, 1998, except where superseded
in the Notice of Hearing by more recent information, should be deemed to be
particulars of the Notice of Hearing. That being so, with the further
information provided by the Board Staff, the Board Panel concluded that there
should be no reason for the Applicant to delay filing its response within
fifteen days of the date of its first decision on jurisdiction.
[27]
On
December 8, 2000, the Board Staff filed a Notice of Motion seeking to be added
as a party, either in its own name or in the name of the Board, pursuant to the
Rules. Alternatively, the Board Staff sought leave to intervene. On March 7,
2001, the Board filed a Notice of Motion, seeking to be added as an intervener
with limited scope or alternatively, in the event that the Board Staff was
denied standing, to intervene with broader rights of participation.
[28]
These
motions were heard by Prothonotary Aronovitch and by Order dated July 13, 2001,
the Board Staff’s Motion was dismissed. The Board was granted intervener
status for the limited purpose of making submissions upon the record before the
Court, to explain the roles of the Chairperson and Board Staff in discharging
the Board’s dual mandate pursuant to its governing legislation and the Board’s
rules and policy, but only to the extent that such matters are not addressed by
the Respondent Attorney General of Canada.
[29]
On June
25, 2003, the Applicant brought a motion, seeking an order for production of
documents in the possession of the Board, relevant to the application for judicial
review. By Order dated November 14, 2003, the motion was dismissed, on the
grounds that there was no basis to enlarge the Tribunal Record, to include the
confidential Staff Report that the Board Panel would not refer to in its
adjudication of the case on the merits. This decision was upheld on appeal, in
Hoechst Marion Roussel Canada v. Canada (Attorney General), [2004] F.C.J. No. 633
(T.D.).
[30]
In the
meantime, the Board Panel, consisting of the Board Chairperson and the same members
heard the second part of the
Applicant’s jurisdictional challenge in December 1999 and June 2000. That
hearing dealt with various issues relating to the statutory guidelines of the
Board.
[31]
On August
8, 2000, the Board Panel rendered its decision, denying most of the relief
sought by the Applicant. The Board declined to terminate the proceedings and
to rescind the Notice of Hearing. The Applicant then commenced a second
application for judicial review in cause T-1671-00.
[32]
In its
reasons, the Board Panel addressed the substance of the Board’s specialized
jurisdiction, beginning with the Applicant’s submissions that Nicoderm is not a
“medicine” for the purposes of the Act, but rather a delivery device for the
administration of nicotine.
[33]
The Board
Panel rejected this argument. Referring to subsections 83(1) and 79(2) of the
Act, the Board Panel noted that the word “medicine” remains undefined, although
the Federal Court of Appeal held, in ICN Pharmaceuticals, Inc. v. Canada
(Staff of the Patented Medicines Prices Review Board), [1997] 1 F.C.
(F.C.A.), that the word “medicine” is to be interpreted broadly and in its
ordinary sense, following the practice under section 39 of the former Patent
Act, S.C. 1923, c. 23 (the “Former Act”).
[34]
The Board
Panel considered the Applicant’s arguments that reference should have been made
to the decision of the Federal Court of Appeal Glaxo Group Ltd. v. Novopharm
Ltd. (1999), 244 N.R. 199 (“Glaxo”) where it was held that a
mechanical device known as an “inhaler”, used to administer medicine in aerosol
form, was not a medicine within the scope of the Patented Medicines (Notice
of Compliance) Regulations, SOR/93-133 (the “NOC Regulations”).
[35]
The Board
Panel concluded that Glaxo, supra did not assist, based upon the
reasoning in ICN, supra where the Federal Court of Appeal held
that the NOC Regulations are part of a separate regime with a distinct
purpose. As such, the jurisprudence in interpreting those regulations is not
helpful with respect to the Board’s jurisdiction. In any event, the Board
Panel concluded that in view of the integration of the elements in a
transdermal patch, it would not consider a transdermal patch to be analogous to
an inhaler. Further, inhalers are considered to be medicines for the purposes
of the Board’s mandate and in fact, the NOC issued for Nicoderm shows that
Health Canada considers Nicoderm to be a drug, not a medical device, and regulates
it accordingly.
[36]
The Board
Panel concluded that the components of the nicotine patch are integrated and
integral to the drug product Nicoderm. In this regard, the Board Panel relied
upon the expert evidence of Dr. Patrick du
Souich, a medical practitioner, professor of clinical pharmacology and a senior
medical researcher, who gave evidence on behalf of the Board Staff. He provided
the opinion that together, the nicotine and layers of material of which the
patch is composed, “generate the ‘pharmacodynamic and pharmacokinetic
characteristics’ that result in Nicoderm having a therapeutic effect”, likening
the product to an ointment.
[37]
The Board Panel also
found that there was evidence to show that the Applicant itself refers to
Nicoderm as a “medicine” on its labeling and packaging information. As well, it
found that the Applicant accepted that Nicoderm was a medicine over which the
Board had pricing jurisdiction when it filed its Form 1 respecting the ’700
Patent. The Board Panel also noted that patentees of other nicotine
transdermal patches, including Habitrol and ProStep, have filed Form 1’s and
have accepted the Board’s jurisdiction to regulate the price of those patches.
[38]
Following the
interpretative approach set out by the Federal Court of Appeal in ICN, supra,
the Board Panel observed that Ms. Joan Van Zant, a patent agent who gave
evidence on behalf of the Applicant, acknowledged in cross-examination that “if
she were a ‘regular person who was not involved in the intellectual property
area’, she would consider Nicoderm to be medicine”. Finally, Mr. Robert Gale,
inventor of the ’340 and ’700 Patents, agreed that when nicotine is imbedded in
the patch, the product Nicoderm, as a transdermal patch, is medicine.
[39]
In
reaching its conclusion, the Board Panel held that where a substance that has
no inherent therapeutic effect, such as nicotine, can become useful as a
medicine when it is integrated with other substances and the manner in which
those components are integrated is patented, the resulting product, here
Nicoderm, is in every pertinent sense a “patented medicine” for the purposes of
the Board’s jurisdiction. Accordingly, it found Nicoderm to be a medicine
within the meaning of the Act.
[40]
Second,
the Board Panel considered whether the ’700, ’689 and ’340 Patents pertain to
Nicoderm, that is whether there is a rational connection between the invention
described in the patent and the medicine itself. In this regard, the Board
Panel referred to ICN, supra, where the Court held there need
only be the “merest slender thread” of connection between the patent and the
medicine in order to find that it is a
patent pertaining to the medicine, thereby grounding the Board=s jurisdiction over pricing.
[41]
The Board Panel noted
that with respect to the ’700 Patent the Applicant agreed that it pertains to
Nicoderm and as such, the pricing of Nicoderm has been subject to the
jurisdiction of the Board since November 12, 1996, when the ’700 Patent was
granted.
[42]
The Board
Panel also addressed the ’689 Patent. The Board Panel concluded that while
this Patent describes a product differing from Nicoderm in respect of its rates
of release of nicotine following application of the patch, there is still a
sufficient nexus between it and Nicoderm to find that it pertains to the
medicine, within the meaning of the Act. It recognized that although proof of
market power is not determinative in determining the Board’s jurisdiction, in ICN,
supra, the Federal Court of Appeal found that the potential for a
deterrent effect, regardless of its actual effect on market power, provides the
basis of the Board’s jurisdiction. The Board Panel ultimately concluded that
the ’689 Patent pertains to Nicoderm because it pertains to a transdermal
nicotine patch, a generic type of medicine of which Nicoderm is a particular
example.
[43]
With
respect to the ’340 Patent, the Board Panel identified the real question as to
whether, looking at the face of the patent as instructed by the Federal Court
of Appeal in ICN, supra, there is sufficient reference to a nicotine
patch to say that the patch pertains to Nicoderm. The Board Panel considered
that the ’340 Patent does pertain to Nicoderm on its face and, in any event, it
can be inferred from the language of the patent that the inventors “intended”,
within the meaning of subsection 79(2) of the Act, that it would be useful for
a nicotine patch.
[44]
Third,
having concluded that the ’700, ’689 and ’340 Patents all pertain to Nicoderm,
the Board Panel proceeded to consider whether the Applicant is a “patentee” of
those patents within the meaning of the Act. The Board discussed the various agreements
entered into between Alza and the Applicant’s predecessor, Hoechst Marion
Roussel (“HMR”). It noted that, pursuant to the Licensing Agreement and the
Supply Agreement, Alza had the exclusive right to manufacture the product,
subject to an exception in section 8 of the Supply Agreement that where Alza is
unable to supply the product, HMR is entitled to manufacture it or to have it
manufactured by another supplier. As the Canadian affiliate of HMR, the
Applicant enjoys the right of HMR in Canada,
pursuant to the Licensing Agreement and the Supply Agreement.
[45]
For the
purposes of the Board’s jurisdiction, the Board Panel found that the definition
of “patentee” is deliberately expanded by subsection 79(1) of the Act to
include not only the person entitled to the benefit of the patent, but also any
person entitled to exercise rights relative to it. In respect of the ’700
Patent, the Board Panel found that the Applicant had acknowledged that it is a
licensee for the purposes of that patent. Accordingly, the Board Panel
concluded that the Applicant is a patentee of a medicine that pertains to
Nicoderm, for the purposes of the ’700 Patent.
[46]
The Board
Panel then considered whether the Applicant was a patentee with respect to the
’689 Patent. It concluded that the inclusion of the ’689 Patent in Appendix B
strongly favoured its status as a licensed patent and that its inclusion is
consistent with the structure of the joint venture and various agreements made
between the parties. In particular, the joint venture was an exclusive
agreement. As such, Alza did not have the right to develop or market a nicotine
patch using the ’689 Patent, other than with HMR. The Board Panel found that if
the Applicant were not a licensee of the ’689 Patent pursuant to the Licensing
Agreement, it would not be able to protect its market for Nicoderm in Canada. Accordingly, the Board
Panel concluded that the Applicant was a patentee with respect to the ’689
Patent.
[47]
Turning to
the ’340 Patent, the Board Panel noted that it was not developed for Nicoderm
or for any nicotine patch but rather to address a particular problem
encountered by Alza with crystallization occurring in the liquid scopolamine in
patches. The Board Panel ultimately concluded that the parties never intended
to licence the ’340 Patent or the technical information it contained, to HMR.
The Board Panel found that the exclusion of the ’340 Patent from Appendix B
further illustrated that point that the Applicant is not nor has been a
patentee of the ’340 Patent.
[48]
The
Chairperson wrote a dissenting opinion on this point. He found that, in view
of the broad terms of the Licensing Agreement, the Applicant had, and has the
benefit of the ’340 Patent and is a patentee for the purpose of the Act.
[49]
Fourth,
the Board Panel considered whether the Applicant has been a “patentee” of the
patents for which application has been made in the ’352 and ’446 Applications,
from the date on which those applications were laid open to public inspection.
[50]
The Board
Panel held that the ’352 Application is for a patent constituting the “inline”
adhesive used in Nicoderm patches. The ’446 Application is for a patent for
the pouch in which Nicoderm is packaged and sold. The Board Panel found that
the inventions described in these two applications pertain to Nicoderm.
[51]
In
considering whether the Applicant is a “patentee” of these two patent
applications, the Board Panel concluded that once the patents are granted, they
will be licenced to the Applicant for the marketing of Nicoderm. Both patent
applications are listed in Appendix B. Further to the commercial arrangements
between Alza and HMR, the Applicant has the rights in Canada that flow from the
patent applications including the right to sell nicotine patches that use the
inventions described in the two applications. As such, the Board Panel
concluded that the Applicant is a “patentee” for the purposes of the ’352 and ’446
Applications.
[52]
Fifth,
the Board Panel considered whether the Board has jurisdiction on the basis of
patent applications, prior to the issuance of any patent to the Board Panel.
First, it concluded that while not dispositive, the payment of royalties by HMR
at the higher rate under the licence agreement shows that Alza and HMR
considered HMR to have patent protection in Canada from the beginning of the
sale of Nicoderm in Canada in 1992. The Board
Panel found this to be strong evidence of the extent to which the laid-open
process provides de facto patent protection.
[53]
The
Board Panel went on to note that the laid-open patent application process creates
the potential for patent applicants to charge excessive prices for medicines
during the period between the laying-open of the patent application and the
granting of the patent. Pursuant to the laid-open application process, the
public is put on notice of a pending application and made aware that any person
who uses the invention described in the application will be liable in damages
if the patent is granted.
[54]
The
Board Panel observed that both Alza and the Applicant are content with the de
facto patent protection provided by the laid-open patent application
process. It also noted the evidence that the Applicant and Alza have considered
abandoning the patent applications. In the Board Panel’s view, the only
explanation for such abandonment would be to support an argument that the Board
lacks jurisdiction to require the Applicant to repay any excessive revenues
earned for 1992 until the date on which the first patent pertaining to Nicoderm
was granted.
[55]
The
Board Panel then considered whether the Act grants the Board jurisdiction, in
order to fulfill its mandate, with
respect to the ’352 and ’446 patent applications. It concluded that if the
Board does not have the jurisdiction to avoid excessive pricing of medicines where
patent applications can be presumed to have given the applicants pricing power,
the statutory purpose of the Act will not be achieved in those circumstances.
[56]
The Board
Panel referred to section 55 of the Act. This section provides for the
retroactivity of patent protection and accordingly, the ultimate rights and
interests of the parties are clear from the time the application is laid open.
The Board Panel found that there is no reason why the Board should decline to
investigate an allegation of excessive pricing in this type of situation, in
order to wait for the inevitable grant of the patent before taking remedial
steps that will be inadequate, after the fact of excessive pricing. The Board
Panel found that it had jurisdiction to consider the two patent applications.
[57]
In
conclusion, the Board Panel determined that the pricing of Nicoderm has been
subject to the jurisdiction of the Board since Nicoderm was introduced to the
Canadian market in July 1992.
DISCUSSION AND DISPOSITION
I Decision on Jurisdiction –
Part I
[58]
In the
matter of the Applicant’s challenge to the first decision on jurisdiction, the
following issues are addressed:
1)
Did the
procedure followed by the Board for conducting a hearing provide for a fair and
impartial tribunal in accordance with the principles of procedural fairness and
the Bill of Rights?
2)
Whether or
not the following factors constitute a reasonable apprehension of bias so as to
justify judicial intervention:
a)
Do the
operations of the Board create an impermissible overlap of investigative and
adjudicative functions by the Board and the Chairperson?
b)
Did the
Board and Chairperson predetermine certain matters that were in issue at the
hearing?
c)
Did the
participation of the Chairperson in the Board Panel, having previously reviewed
the Staff Report and VCU and issued the Notice of Hearing, constitute a
reasonable apprehension of bias?
[59]
This
application for judicial review involves the issues of procedural fairness and
bias. The first subject addressed by the Applicant, in respect of alleged breaches
of procedural fairness, is the applicable standard of review. Both the
Applicant and the Respondent Attorney General of Canada urged the view that the applicable
standard of review is correctness.
[60]
The Applicant
referred to the recent decision in Dr. Q v. College of Physicians and Surgeons
of British Columbia, [2003] 1 S.C.R. 226 (“Dr. Q”) where the Supreme
Court of Canada held that the pragmatic and functional analysis must be
undertaken in every case where legislation delegates power to an administrative
decision-maker. It submitted, however, that this approach does not necessarily
apply to the procedural framework in which the decision is made. Relying on
the decision of the Federal Court of Appeal in Ha v. Canada (Minister of Citizenship and
Immigration)
(2004), 236 D.L.R. (4th) 485, the Applicant argues that the
pragmatic and functional analysis need not be applied to questions of
procedural fairness.
[61]
I agree
with these arguments of the Applicant. While Dr. Q, supra
clearly states that the pragmatic and functional analysis must be applied to
all questions, it is my opinion that this means it is to be applied to all
substantive questions. No decision of the Supreme Court of Canada was cited to
require the application of the pragmatic and functional analysis approach to
procedural fairness questions. Even if that approach were applied it seems to
me that the result would be the correctness standard. The Court’s relative
expertise to that of a tribunal is greater when dealing with questions of
procedural fairness, as these are questions of law.
[62]
However,
the application of the standard of correctness to procedural fairness questions
does not mean that the content of that duty is absolute. The duty of fairness
varies, depending upon the circumstances; see Knight v. Indian Head School Division No. 19, [1990] 1 S.C.R. 653 at 682.
Nonetheless, once a breach of the duty is found, the decision below must be set
aside; see Congrégations des témoins de Jéhovah deSt-Jérome-Lafontaine v.
Lafontaine (Village), [2004] 2 S.C.R. 650 at paragraph 30. There is no
room for deference.
The Duty of Fairness
[63]
In Baker
v. Canada (Minister of Citizenship and
Immigration),
[1999] 2 S.C.R. 817, the Supreme Court of Canada again recognized that the duty
of procedural fairness is flexible and depends upon an appreciation of the
context of the particular statute and the rights affected. All parties here
have argued that a distinction must be drawn between those tribunals whose
function tends towards the judicial end of the spectrum and those that tend to
the legislative or policy-making end. In Baker, supra, the
Supreme Court provided a non-exhaustive list of factors to be considered in
determining the content of procedural fairness owed by an administrative
tribunal at common law, as follows:
1) the nature of the decision
being made and the process followed in making it;
2) the nature of the statutory
scheme and the terms of the statute pursuant to which the body acts;
3) the importance of the decision
to the individual(s) affected;
4) the legitimate expectations of
the person challenging the decision; and
5) the choices of procedure made
by the body itself.
[64]
First, in ICN,
supra, the Federal Court of Appeal commented at paragraph 12, that the
1993 amendments to the Act reinforced the Board’s remedial and punitive powers.
Orders of the Board carry the same force and effect as those of the Federal Court.
Section 83 of the Act grants the Board statutory authority to make various
remedial orders against the patentee or former patentee who is selling a
patented medicine at an excessive price.
[65]
As for the
Board’s procedural framework, subsection 96(2) of the Act allows the Board,
subject to the approval of the Governor-in-Council, to make rules to regulate
its practice and procedure. In my opinion, these factors tend towards more procedural
protection for the Applicant.
[66]
Second,
concerning the nature of the statutory scheme and the statutory provision under
which the Board operates, section 2.2 of the Introduction of the Board’s
Compendium provides that:
2.2 The Board is an independent and autonomous
quasi-judicial body. To ensure this independence and autonomy, the Act
provides no power, either expressly or implicitly, to the government to direct
the Board or to review its decisions and orders. However, decisions of the
Board are subject to judicial review by the Federal Court of Canada on
jurisdictional or procedural grounds in accordance with administrative law
principles.
[67]
However,
in Ciba-Geigy Canada Ltd. v. Canada (1994), 56 C.P.R. (3d) 377 (F.C.A.),
the Federal Court of Appeal found that the Board is an administrative tribunal
with economic regulatory functions and as such, law and policy require that
some leeway be provided in pursuing its mandate. Further, in this case, the
application for judicial review relates to a jurisdictional decision of the
Board, that is its decision to proceed with a public hearing to determine to
proceed with a public hearing to determine whether the Applicant has sold
Nicoderm at an excessive price.
[68]
In my
opinion, this decision on Jurisdiction, Part I, is clearly not determinative of
the issue of whether the price of Nicoderm exceeds the guidelines. Accordingly,
a lower degree of procedural fairness is required.
[69]
Third, as
noted by the Federal Court of Appeal in Ciba-Geigy, supra, there
are very serious economic consequences for an unsuccessful patentee in a
section 83 hearing, including a potential negative effect on a corporation’s
reputation in the marketplace. However, these consequences will not arise
until the formal public hearing has taken place. At that hearing, the
Applicant will have the opportunity to present its evidence and arguments, and
to cross-examine opposing evidence. In my opinion, the consequences of a
negative decision by the Board, after a public hearing, are inherent in any situation where a
corporation is alleged to be in breach of accepted standards and is called upon
to defend itself in a hearing.
[70]
Fourth, subsection
97(1) of the Act provides that hearings before the Board are expected to
proceed as informally and expeditiously as the circumstances and considerations
of fairness permit. As well, the Board is mandated to protect the public
interest. In my opinion, there appears to be a basis for finding that the
Applicant has a legitimate expectation that fairness will be accorded it in the
public hearing. However, that stage has not yet arrived.
[71]
As for the procedure
to be followed by the Board Staff in conducting investigations and the action
of the Chairperson in reviewing the confidential Staff Report and the VCU submitted
by the Applicant, these processes are set out, in general terms, in the Board’s
Policy. In my opinion, there is no indication that the investigation and the
issuance of the Notice of Hearing were not carried out in accordance with the
Board’s Policy and consequently, I cannot say that the duty or fairness was
absent or ignored.
[72]
Fifth, the procedure
chosen by the Board, and outlined in the Policy, was introduced to ensure a
separation of functions and necessary safeguards. When the Board Staff began its
investigation, the Applicant was informed of the allegations against it and
given the opportunity to respond. The Act has given the Board the right to
choose its own procedures. In my view, the Board is an expert tribunal with
the ability to decide what procedures are appropriate, in light of the duty of
fairness owed to a patentee or former patentee. While not determinative,
significant weight is to be given to the choice of procedure made by the
tribunal, subject to its institutional constraints; see IWA v. Consolidated
Bathurst Packaging Ltd., [1990] 1 S.C.R. 282, per Gonthier J.
[73]
As the
basis of the foregoing, I conclude that the basic requirements of procedural
fairness, as described by the Supreme Court of Canada in Lakeside Colony of Hutterian
Brethren v. Hofer, [1992] 3 S.C.R. 165, that is the right to an unbiased
tribunal, the right to notice and the opportunity to make representations,
apply to the Board’s actions. However, I would grant a considerable degree of
flexibility to the Board in respect of the procedural requirements in light of
the factors described in Baker, supra. Subsection 97(1) of the
Act clearly states that proceedings of the Board are to be dealt with as
informally and expeditiously as the circumstances and considerations of fairness
permit, providing ample room for flexibility on the part of the Board, as long
as natural justice and procedural fairness are respected.
The Context of the Duty of
Fairness
[74]
As noted
above, the basic requirements of the principles of natural justice include
notice, the opportunity to make representations and an unbiased tribunal. In
the present case, the Applicant’s allegations relate solely to the issue of
bias. It is clear that the requirements of notice and the opportunity to make
representations have been respected. The Applicant received several letters
from the Director of the Board’s Compliance and Enforcement Branch and was
given the opportunity to respond to the allegations of excessive pricing by
providing additional documentation, as well as a VCU for consideration by the
Chairperson. The remaining question is whether the Board is a biased tribunal.
Reasonable Apprehension of
Bias
[75]
In Baker,
supra, the Court reiterated that procedural fairness requires that
decisions be made by an impartial decision-maker and free from any reasonable
apprehension of bias. The classic test for reasonable apprehension of bias was
set out by De Grandpré, J.
writing in dissent, in Committee for Justice and Liberty et al. v. National
Energy Board et al., [1978] 1 S.C.R. 369 at page 394 as follows:
...
As already seen by the quotation above, the
apprehension of bias must be a reasonable one held by reasonable and right
minded persons, applying themselves to the question and obtaining thereon the
required information ... [t]hat test is “what would an informed person, viewing
the matter realistically and practically - and having thought the matter
through - conclude. Would he think that it is more likely than not that [the
decision maker], whether consciously or unconsciously, would not decide fairly.
[76]
In Baker,
supra, L’Heureux-Dubé, J. reaffirmed the well-established principle that
“the standards for reasonable apprehension of bias may vary, like other aspects
of procedural fairness, depending on the content and the type of function
performed by the administrative decision-maker involved.” The Applicant has
raised these allegations of bias arising from impermissible overlap of
functions, predetermination of issues and the participation by the Chairperson
in the Board Panel.
Impermissible Overlap
[77]
The fact
that an administrative tribunal may perform multiple functions does not, by
itself, create a reasonable apprehension of bias. In this regard, the Supreme
Court of Canada in Bell
Canada v. Canadian Telephone
Employees Association,
[2003] 1 S.C.R. 884, made the following comments at paragraph 40:
[O]verlapping of different functions in a single
administrative agency is not unusual, and does not on its own give rise to a
reasonable apprehension of bias [see 2747-3174 Québec Inc., supra
at paragraphs 46-48, per Gonthier J.; Newfoundland Telephone, supra,
at page 635, per Cory J.; Brosseau, supra.] As McLachlin C.J.
observed in Ocean
Port, supra,
at para. 41, “[t]he overlapping of investigative, prosecutorial and
adjudicative functions in a single agency is frequently necessary for [an
administrative agency] to effectively perform its intended role.”
[78]
As well,
in Ocean Port Hotel Ltd. v. British Columbia (General Manager, Liquor
Control and Licensing Branch), [2001] 2 S.C.R. 781, the Supreme Court of
Canada observes that the common law does not outweigh legislative
provisions that are reasonably clear, since this would have the effect of
reducing procedural fairness rights. In Ocean Port, supra at paragraph 41, Chief
Justice McLaughlin went on to say that “without deciding the issue, I would
note that such flexibility may be appropriate in licensing schemes involving
purely economic interests.”
[79]
In my
opinion, that description is applicable to the type of regime at issue in this
case. The Board is responsible for ensuring that patentees of patented
medicines are not selling their products at prices that exceed the guidelines.
The Board is carrying out a type of economic regulatory function, as noted by
the Federal Court of Appeal in Ciba-Geigy, supra. As such, it
must be accorded a degree of flexibility.
[80]
Again, I
refer to Ocean Port, supra, relied on by
the Intervener, where the Supreme Court made the following observation at
paragraph 42:
Further, absent constitutional
constraints, it is always open to the legislature to authorize an overlapping
of functions that would otherwise contravene the rule against bias. Gonthier
J. alluded to this possibility in Régie, at para. 47, quoting from the
opinion of L,Heureux-Dubé J. in Brosseau, supra, at pp. 309-10:
As with most principles,
there are exceptions. One exception to the “nemo judex” principle is
where the overlap of functions which occurs has been authorized by statute,
assuming the constitutionality of the statute is not in issue.
...
In some cases, the
legislator will determine that it is desirable, in achieving the ends of the
statute, to allow for an overlap of functions which in normal judicial
proceedings would be kept separate. ... If a certain degree of overlapping of
functions is authorized by statute, then, to the extent that it is authorized,
it will not generally be subject to the doctrine of “reasonable apprehension of
bias” per se.
[81]
The
Applicant has not raised a constitutional argument in this application for
judicial review.
[82]
The
legislative scheme here in issue specifically contemplates that the Board will
discharge multiple functions, including investigation, prosecution and
adjudication. Subsections 96(2) and (3) of the Act authorize the Board,
subject to the approval of the Governor in Council, to make rules regulating
its own practices and procedures, to make by-laws for conducting its work, for the
management of its internal affairs and for the duties of its staff. The existence
of this legislative scheme militates against finding the existence of inherent
institutional bias or lack of impartiality.
[83]
I am
not persuaded by the Applicant’s arguments that the Board lacks sufficient
institutional impartiality as a result of overlapping functions as performed by
individuals working as Board Staff or serving as members of the Board Panel.
The Applicant concedes that an overlap of functions may
be authorized by statute, if validly within the power of the legislation. The
Applicant also recognizes that the Board may establish its own policies and
procedures.
[84]
The Federal Court of
Appeal in ICN, supra found that while the Board is required to act as
both prosecutor and adjudicator in fulfillment of its statutory mandate, the
Board through its Policy has decided, in fact, to operate independently of
Board Staff. The Court, in ICN, supra noted that the relationship
between the Board and its staff was described by the majority of the Board in Genentech
Canada Inc. (Re) (1992), 44 C.P.R. (3d) 316 (P.M.P.R.B.) at p. 320 as
follows:
In conducting hearings
with respect to the price of a patented medicine, the Board’s staff is
segregated from the Board. The Board’s staff, through its own counsel, adduces
evidence, tests evidence of other parties, and makes submissions on procedural,
jurisdictional, legal, and substantive issues arising during the course of the
proceeding.
[85]
The
Board’s Policy serves to enforce the principles of procedural fairness and
natural justice, by attempting to ensure a separation of functions and
necessary safeguards beyond what is provided for by the Act itself.
Predetermination of
Issues
[86]
The
Applicant has argued that the Chairperson’s consideration of the Staff Report
and the VCU, and his decision to issue a Notice of Hearing, amount to
predetermination of the issues to be decided at the public hearing. In other
words, according to the Applicant, in deciding to issue the Notice of Hearing,
the Chairperson must have already concluded that Nicoderm was being sold at an
excessive price and that the VCU submitted by the Applicant did not accord with
the Board’s policies.
[87]
The
Board’s Policy provides that the Chairperson “may” issue a Notice of Hearing if
he holds the view that the investigation has shown that the price “may” be or
has been excessive. This language obviously confers discretion upon the
Chairperson to issue a Notice of Hearing if, after reviewing the Staff Report
and the VCU, he believes that there may have been excessive pricing. This does
not represent, in any way, a determination concluding that there was excessive
pricing by the patentee or former patentee.
[88]
In
this regard, I refer to the Board’s reasons in its Decision on Jurisdiction,
Part I. The Board noted that in deciding whether to issue a Notice of Hearing,
the Chairperson considers whether the results of the investigation, if
proven true, would show a prima facie case of excessive pricing
[emphasis added].
[89]
The
issue of actual excessive pricing is a matter to be resolved at the public
hearing, when all interested parties are given the opportunity to lead
evidence, cross-examine and make submissions. That being so, I agree with the
arguments of the Respondent Attorney General of Canada and the Intervener that
the issuance of the Notice of Hearing does not represent the Board’s conclusion
on the issue, but rather constitutes an allegation that is sufficiently
substantiated to justify a hearing on the merits. I conclude that no
objectionable bias has been proven in this regard.
Participation by the
Chairperson in the Board Panel
[90]
As
noted above, the test as to whether a reasonable apprehension of bias exists in
a particular set of circumstances was set out by the Supreme Court of Canada in
Committee for Justice and Liberty et al, supra : what would an informed
person, viewing the matter realistically and practically and having thought the
matter through conclude?
[91]
The
Applicant has argued that, on the basis of MacBain v. Canada (Human Rights
Commission), [1985] 1 F.C. 856 (F.C.A.) and 2747-3174 Québec Inc. v.
Québec (Régie des permis d’alcool), [1996] 3 S.C.R. 919, the fact that the
Chairperson, after reviewing the Staff Report and considering the VCU submitted
by the Applicant, then decided to hold a hearing and to participate in the
adjudication process, gives rise to a reasonable apprehension of bias.
[92]
In
my opinion, this issue is closely related to the question of predetermination
of key issues, discussed above. As noted above, the Chairperson, when reviewing
the Staff Report and VCU, was acting in his administrative capacity as chief
executive officer, for the limited purpose of deciding whether or not to issue
a Notice of Hearing. I agree with the submissions of the Respondent and the
Intervener that no independent analysis was conducted by the Chairperson as to
whether the results of the investigation are, or may be, established.
[93]
Finally,
the Act does not ban the Chairperson from sitting as a member of a Board Panel,
notwithstanding his role in the issuance of a Notice of Hearing. Having regard
to the fact that the Board is an expert tribunal, that the Chairperson is
presumably highly knowledgeable in this field, and that the Chairperson, to
date, has had no role in determining the well-foundedness of the allegation
contained in the Staff Report, I see no basis upon which an informed person,
viewing the matter realistically and practically, and having thought the matter
through, would conclude that there is a reasonable apprehension of bias arising
from the Chairperson’s participation in the panel. This view is reinforced by
my opinion as to the degree of flexibility to be afforded to the Board in
satisfying the duty of fairness.
[94]
For
these reasons, the application for judicial review in respect of the Board’s
Decision on Jurisdiction, Part I, is dismissed.
II Decision
on Jurisdiction - Part II
[95]
In seeking
to set aside the Board Panel’s decision to proceed to a hearing, the Applicant
raises the following issues:
1)
What is
the appropriate standard of review for decisions of the Board?
2)
Is
Nicoderm a “medicine” within the meaning of the Act?
3)
Do the
’700 and ’689 Patents pertain to a medicine?
4)
Is the
Applicant the “patentee”, of the ’700 and ’689 Patents.
5)
Does the
Act grant the Board jurisdiction on the basis of patent applications and prior
to the issuance of any patent?
6)
If the Act
does purport to confer such jurisdiction, is it ultra vires the
Parliament of Canada?
[96]
Again, the
analysis begins with consideration of the applicable standard of review. The
decision under review deals with a direct challenge to the Board’s statutory
jurisdiction relative to Nicoderm as a patented medicine. The pragmatic and
functional analysis described in Dr. Q, supra will apply here, in
determining the applicable standard of review.
[97]
Generally,
there are four factors to be taken into account for each question at issue in
this application for judicial review:
1.
the nature
of the review mechanism (privative clause);
2.
relative
expertise – the Court must categorize the expertise of the tribunal, compare
the expertise of the tribunal to that of the Court, and identify the nature of
the specific issue before the tribunal relative to that expertise;
3.
the
purpose of the statute; and
4.
the nature
of the question.
[98]
Traditionally,
the view was that if a question related to jurisdiction, the applicable
standard was that of correctness. That view was refined in Pushpanathan v.
Canada, [1998] 1 S.C.R. 982 and a jurisdictional question is now to be
treated as another kind of legal question. It is necessary, in light of the
decision in Dr. Q, supra, to consider each issue in light of the
pragmatic and functional analysis outlined in that decision, as follows:
The nature of the review mechanism
[99]
The
Board’s review mechanism is set out by subsection 97(1) of the Act, as follows:
|
97. (1) All proceedings before the Board shall
be dealt with as informally and expeditiously as the circumstances and
considerations of fairness permit.
|
97. (1) Dans la mesure
où les circonstances et l'équité le permettent, le Conseil agit sans
formalisme, en procédure expéditive.
|
[100]
As noted
by the trial judge in ICN Pharmaceuticals, Inc. v. Canada (Patented Medicine Prices
Review Board)
(1996), 66 C.P.R. (3d) 45 (F.C.T.D.), decisions of the Board are not subject to
a privative clause, although this factor is not determinative. There is no
statutory right of appeal under the Act and decisions of the Board are amenable
only to judicial review pursuant to section 18.1 of the Federal Courts Act,
R.S.C. 1985, c. F-7, as amended. In my opinion, this suggests that greater
deference should be afforded to the Board.
Relative Expertise of the
Board
[101]
In ICN,
supra, the trial judge discussed the Board’s expertise in paragraph 17:
I have no difficulty
finding that the Board is an expert tribunal. Parliament has created an
appointment mechanism to ensure that the Board is composed of members who are
knowledgeable about the pharmaceutical industry. Section 92 of the Patent
Act provides that the Minister establish an advisory panel, composed of
representatives of the provincial ministers of health, representatives of the
pharmaceutical industry, and consumer advocates. The Minister is further
obliged to consult this advisory panel before making an appointment to the
Board.
[102]
The Board
applies its expertise in accordance with subsection 83(1), as follows:
|
83. (1) Where the Board finds that a patentee
of an invention pertaining to a medicine is selling the medicine in any
market in Canada at a price that, in the Board's opinion, is excessive, the
Board may, by order, direct the patentee to cause the maximum price at which
the patentee sells the medicine in that market to be reduced to such level as
the Board considers not to be excessive and as is specified in the order.
|
83. (1) Lorsqu'il
estime que le breveté vend sur un marché canadien le médicament à un prix qu'il
juge être excessif, le Conseil peut, par ordonnance, lui enjoindre de baisser
le prix de vente maximal du médicament dans ce marché au niveau précisé dans
l'ordonnance et de façon qu'il ne puisse pas être excessif.
|
[103]
In my
opinion, the interpretation of specific provisions of the Act, particularly
section 79 and subsection 83(1), relies greatly upon technical meaning in order
to establish the Board’s jurisdiction over a specific patentee. In Barrie
Public Utilities v. Canadian Cable Television Association , [2003] 1 S.C.R.
476, Justice Bastarache in dissent, said that the interpretation of enabling
legislation by a specialized tribunal is more like the administration of the
statute, a core part of a tribunal’s mandate.
[104]
As well,
the Board administers the section of the Act pertaining to the price review of
patented medicines in furtherance of its policy objectives. The Board has more
expertise in respect of these matters than does a generalized Court.
[105]
However,
the issues to be determined relate directly to the jurisdiction of the Board to
inquire into the pricing of a particular patented medicine. The jurisdictional
“character” of the issues suggest less deference.
The purpose of the Act
[106]
I agree
with the submissions of the Respondent AGC that the Act is intended to resolve
and balance competing policy objectives. This means that the statutory purpose
may be described as polycentric. This suggests that more deference be afforded
to the Board.
The nature of the question
[107]
As
indicated above, the issues in this application for judicial review involve the
interpretation of “medicine” as it is used in subsection 83(1) of the Act,
whether certain patents “pertain to” a medicine as addressed in subsection
79(1) of the Act, whether the Applicant is a “patentee” for the purposes of
subsection 79(1) of the Act, and whether patent applications are subject to the
Board’s jurisdiction.
[108]
In my
opinion, all of these issues, except the last, raise questions of mixed fact
and law that are factually intensive. That suggests that more deference be
afforded to the Board’s findings in this regard. The last issue may be
characterized more as a straight question of jurisdiction that is legally
intensive, suggesting that less deference will be given to the Board on this issue.
[109]
In my
opinion, upon conducting a pragmatic and functional analysis of each question
at issue in this application for judicial review, the appropriate standard of
review applicable to the decision on jurisdiction, Part II, will vary,
depending upon the issue. I conclude that the standard of reasonableness simpliciter
applies to the following issues: is Nicoderm a “medicine” within the meaning
of the Act; do the ’700 and ’689 Patents pertain to a medicine; and is the
Applicant the “patentee” of the ’700 and ’689 Patents.
[110]
In my
opinion, the standard of correctness should apply to the question of whether
patent applications are subject to the Board’s jurisdiction.
Is Nicoderm a “medicine”
within the meaning of the Act?
[111]
For the
purposes of the Act, the word “medicine” remains undefined. In ICN, supra,
the Federal Court of Appeal held that the word, as used in subsection 83(1),
should be interpreted in the same manner as it had been under the old section
39 of the former Act, that is, broadly and in its ordinary sense.
[112]
The
Applicant has referred to the Board’s definition of “medicine” in its Compendium,
which was considered by the Federal Court of Appeal in ICN, supra.
Although that definition is not binding, the Court found that it clearly
includes products that would typically be considered as “medicine” as that term
is used in the vernacular.
[113]
On the
standard of review of reasonableness simpliciter, this Court must
consider the reasons given by the Board and determine whether there is some
line of analysis that could reasonably lead the Board from the evidence before
it to the conclusion that it reached; see Law Society of New Brunswick v.
Ryan, [2003] 1 S.C.R. 247.
[114]
In my
opinion, having reviewed the Board Panel’s reasons, there is a tenable basis
for its decision. Based upon the evidence that was submitted, I am satisfied
that a reasonable person could move from that evidence to the result reached by
the Board Panel, that is, a finding that Nicoderm is a “medicine” for the
purposes of the Board’s jurisdiction.
[115]
Alternatively,
if the appropriate standard of review is that of correctness, I am equally
satisfied that the Board Panel’s decision was correct, based upon the guidance
given by the Federal Court of Appeal for the interpretation of the word “medicine”
in ICN, supra. As well, I am not persuaded by the Applicant’s
argument that jurisprudence addressing the definition of “medicine” in the
context of the NOC Regulations, such as Glaxo, supra, would be of
use in the present application. The Federal Court of Appeal explicitly
rejected the utility of that jurisprudence in ICN, supra as
follows:
...The interpretation of
the word “medicine” and the phrase “intended or capable of being used for” as
used in section 2 of the NOC Regulations has no relevance to their
interpretation under subsections 79(2) and 83(1) of the Act. The NOC
Regulations are part of a separate regime with a distinct purpose.
Do the “700 and “689 Patents
pertain to a medicine?
[116]
As noted
by the Federal Court of Appeal in ICN, supra, there must be a
rational connection or nexus between a patent and the medicine in issue in
order for the Board to have jurisdiction. In view of the broad scope of the
words “pertaining to” and “pertains to” as used in subsections 83(1) and 79(2)
of the Act, the Court found that the nexus can be one of the merest slender
thread and it is unnecessary to go beyond the face of the patent to establish
the required nexus.
[117]
In its
decision on jurisdiction, Part II, the Board Panel concludes that the ’689, ’700
and ’340 Patents pertained to Nicoderm. It found that the Applicant was not a
“patentee” of the ’340 Patent and the Applicant is not challenging the finding
that the ’340 Patent pertains to Nicoderm. As well, the Applicant does not
challenge the Board Panel’s finding that the ‘760 Patent pertains to Nicoderm
if this Court concludes that Nicoderm is a “medicine” for the purposes of the
Board’s jurisdiction. This means that the sole inquiry, in respect of this
issue, is whether the ’689 Patent pertains to Nicoderm.
[118]
The
Applicant has argued that the structure of the delivery system protected by the
’689 Patent is not the system used in Nicoderm and accordingly, the ’689 Patent
is not a patent for the Nicoderm product itself or for a process for
manufacturing or preparation of Nicoderm. However, in ICN, supra,
both the Board and the trial judge concluded that whether a patentee is making
use of the patent in question is irrelevant to the legal question of whether
that patent “pertains” to a medicine within the meaning of the Act. In that
case, the Trial Judge held that the Board was correct in finding that it should
not go beyond the face of the patent to construe the use claims before
determining whether they correspond to the use stipulated in the notice of
compliance for the medicine.
[119]
On the
face of the ’689 Patent, it is clear that it is a patent for a transdermal
nicotine patch, that is the type of medicine of which Nicoderm is a particular
example. It is intended or capable of being used for medicine such as
Nicoderm. Dr. du Souich
said the following in his affidavit, “The [nicotine]
transdermal patch is the drug delivery system which controls the rate of
release of the active ingredient, nicotine, into the blood.”
[120]
The
Federal Court of Appeal in ICN, supra has confirmed that the
nexus between the patent in question and the medicine, in light of the broad
language of subsections 83(1) and 79(2) of the Act, need only be of the merest
slender thread. In my opinion, the fact that the ’689 Patent is for a nicotine
transdermal patch system, capable of being used in the drug product Nicoderm,
is a sufficient connection to support the conclusion that the ’689 Patent
pertains to Nicoderm. It is irrelevant whether the ’689 Patent is actually
being used in connection with the medicine Nicoderm.
[121]
Applying
the standard of reasonableness simpliciter I am satisfied that the Board
Panel’s conclusion that both the ’700 and ’689 Patents pertain to Nicoderm is
reasonable and withstands a somewhat probing analysis. There is no basis for
judicial intervention on this issue.
Is the Applicant the
“patentee” of the ’700 and ’689 Patents?
[122]
Subsection
79(1) of the Act defines “patentee” as follows:
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79(1)
In this section and in sections 80 to 103,
...
"patentee",
in respect of an invention pertaining to a medicine, means the person for the
time being entitled to the benefit of the patent for that invention and
includes, where any other person is entitled to exercise any rights in
relation to that patent other than under a licence continued by
subsection 11(1) of the Patent Act Amendment Act, 1992, that other person in
respect of those rights;
...
[emphasis mine]
|
79.
(1) Les définitions qui suivent s'appliquent au présent article et aux
articles 80 à 103.
« breveté »
ou « titulaire d'un brevet » La personne ayant pour le
moment droit à l'avantage d'un brevet pour une invention liée à un
médicament, ainsi que quiconque était titulaire d'un brevet pour une telle
invention ou exerce ou a exercé les droits d'un titulaire dans un cadre
autre qu'une licence prorogée en vertu du paragraphe 11(1) de la Loi de 1992
modifiant la Loi sur les brevets.
…
[je souligne]
|
[123]
The
Applicant has argued that the only licensed patent for which it obtained a
licence was that necessary or useful to make, use or sell Nicoderm, that is,
the ’700 Patent. In light of my conclusion above, that Nicoderm is a
“medicine” within the meaning of the Act and that the ’700 Patent pertains to
Nicoderm, there is no doubt that the Applicant is a “patentee” within the meaning
of section 79, with respect to the ’700 Patent. The remaining issue is whether
the Applicant is a “patentee” with respect to the ’689 Patent.
[124]
In
assessing the reasonableness of the Board Panel’s conclusion that the Applicant
is a patentee of the ’689 Patent, I must consider the language of section 79 of
the Act and the relevant facts relating to the ’689 Patent. It must be
determined whether it was reasonable for the Board Panel to conclude that the
Applicant was entitled to the benefit of the ’689 Patent or entitled to
exercise any rights in relation to that patent. In my opinion, the Board
Panel’s conclusions in that regard were reasonable.
[125]
I agree
with the submission of the Respondent, that the fact that the ’689 Patent was
never developed or marketed is irrelevant to the question of whether the
Applicant was entitled to the benefit of that patent or entitled to exercise
any rights in respect of that patent. The Board Panel concluded that the
Applicant had the power to prevent a competitor from entering the Canadian
market with the delayed release nicotine patch, described in the ’689 Patent,
that would compete with Nicoderm. That power may be considered as an exercise
of rights in relation to the ’689 Patent.
[126]
The
parties made submissions concerning the inclusion of the ’689 Patent in
Appendix B to the License Agreement. The Applicant has argued that despite the
inclusion of the ’689 Patent in Appendix B, not all the patents listed there
are licensed patents. Further, according to the revised Appendix B, neither
the ’689 Patent nor its U.S. counterpart appears on the
list.
[127]
The
Respondent argues that the inclusion of the ’689 Patent in Appendix B is
consistent with the notion of the joint venture formed between Alza and HMR.
He suggests that it would be
odd if HMR were not a licensee of the ’689,
as it would have no means with which to protect its market for Nicoderm in Canada.
[128]
While the
’689 Patent is actually held by Alza, under the Licence Agreement between HMC
and Alza, the Applicant is authorized to exercise in Canada the rights held by its parent, HMC,
under that agreement. In my opinion, a review of the Licence Agreement and
Appendix B shows that all licensed patents shall be listed on Appendix B and
Appendix B is clearly entitled “Licensed Patents (Section 1.6)”. Consequently,
I do not see any basis upon which to conclude that the ’689 Patent was
erroneously included in the Appendix.
[129]
Since the
Board Panel concluded that Nicoderm is a “medicine” within the meaning of the
Act and that the ’689 Patent pertains to Nicoderm, the fact that the ’689
Patent was a Licensed Patent for the purposes of the Licence Agreement is
enough, in my view, to support the conclusion that the Applicant was a patentee
within the meaning of section 79 of the Act. Although the ’689 Patent was not
developed for use in Canada, the applicant still had an
enforceable right to protect its Canadian market for that product. In light of
this analysis, I agree that the Board Panel’s conclusion in this regard was reasonable
and there is no basis for judicial intervention.
Are patent applications
subject to the Board’s Jurisdiction?
[130]
Having
regard to the pragmatic and functional analysis undertaken previously, the
appropriate standard of review to the Board Panel’s decision on this issue is
that of correctness.
[131]
In its
decision on Jurisdiction - Part II, the Board Panel addressed the implications
of evidence that Alza and the Applicant had considered abandoning the patent
applications here in issue. The Board Panel opined that the only possible
explanation for such abandonment would be to generate an argument that the
Board lacked jurisdiction to require the Applicant to repay any excessive
revenues earned from 1992 until the date on which the first patent pertaining to
Nicoderm was granted.
[132]
The
Applicant argued that section 2 of the Act defines “patent” as “letters patent
for an invention” and that the definition does not include a patent
application. It has been submitted that section 79 has expanded the definition
of a “patentee” approaching that contained in section 2; however, even the
definition in section 79 specifically relates to a patent, not a patent
application.
[133]
The
Respondent has argued that subsection 55(2) provides a benefit to a
patent-holder from the time that the application is laid open, creating
significant de facto protection, even without the patent having been
granted de jure. Both the Respondent and the Intervener have argued
that the Board Panel was correct in asserting jurisdiction over the patent
applications, in light of the
possibility that a person applying for a
patent may delay the actual grant of the patent to avoid regulation by the
Board.
[134]
However,
if this is the case, and the Board assumes jurisdiction when a patent is laid
open, the question arises as to why the Board did not attempt to assert
jurisdiction as of the date on which the ’700 and ’689 Patents were also laid
open. In my opinion, it is inconsistent for the Board to assert jurisdiction
over patent applications by reference to the dates upon which they are laid
open and to assume jurisdiction over granted patents as of the date upon which
they are granted.
[135]
This
approach ignores the critical fact that a patent is a creature of statute. The
effect of the grant of a patent is a statutory monopoly, in accordance with the
Act. Section 42 of the Act provides as follows:
|
42. Every patent granted under this Act shall
contain the title or name of the invention, with a reference to the
specification, and shall, subject to this Act, grant to the patentee and the
patentee's legal representatives for the term of the patent, from the
granting of the patent, the exclusive right, privilege and liberty of making,
constructing and using the invention and selling it to others to be used,
subject to adjudication in respect thereof before any court of competent
jurisdiction.
|
42. Tout brevet
accordé en vertu de la présente loi contient le titre ou le nom de
l'invention avec renvoi au mémoire descriptif et accorde, sous réserve des
autres dispositions de la présente loi, au breveté et à ses représentants
légaux, pour la durée du brevet à compter de la date où il a été accordé, le
droit, la faculté et le privilège exclusif de fabriquer, construire,
exploiter et vendre à d'autres, pour qu'ils l'exploitent, l'objet de
l'invention, sauf jugement en l'espèce par un tribunal compétent.
|
[136]
In my
opinion, a patent application gives rise only to the potential for the grant of
a patent. In no way does the existence of a laid-open patent application support
the inference that a patent will inevitably be granted. That being so, I
conclude that the Board Panel erred in finding that it was authorized to assert
jurisdiction over the two laid-open patent applications. Further, in my
opinion, the Board Panel’s reasons with respect to this issue demonstrate an
attempt to justify its conclusion in that regard.
[137]
In the
result, I conclude that the Board erred in law in purporting to exercise
jurisdiction over the two patent applications, that is the ’446 and the ’352
applications. Accordingly, that part of the Board’s decision will be quashed.
[138]
The
application for judicial review relative to the Board’s decision in relation to
jurisdiction, Part II, is allowed in part as addressed above, and is otherwise
dismissed.
[139]
If the
parties cannot agree on costs, brief submissions may be made no later than
December 1, 2005.
[140]
These
reasons shall be filed in T-1576-99 and placed on the file in T-1671-00.
“E. Heneghan”
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