REASONS
FOR ORDER
CULLEN, J.:
This is an application by ICN
Pharmaceutical Inc. and ICN Canada Limited ("the applicants") for
judicial review of a decision made by the Patented Medicine Prices Review Board
("the Board"), dated November 30, 1995. The matter came on for
hearing before me on January 29, 30, and 31, 1996.
With consent of the parties, the
style of cause is amended such that the respondents are the Staff of the
Patented Medicines Prices Review Board, the Attorney General of Canada, and the
Minister of Consumer and Corporate Affairs, and the Patented Medicine Prices
Review Board is changed to be an intervenor. I also note that the respondent
Ministers took no part in these proceedings and hereafter the Staff of the
Patented Medicine Prices Review Board will be referred to as the respondent.
THE PATENTED MEDICINE PRICES REVIEW BOARD
Given that this is the first case
considering the Board's jurisdiction and, indeed, one of the first cases
concerning the Board before this Court, I have set out the legislative history
and framework within which the Board operates.
The Patented Medicine Prices Review
Board was established through the 1987 amendments to the Patent Act. Under the Act, the Board
is responsible, inter alia, for ensuring that prices being charged in
Canada for patented medicines are not, in the opinion of the Board, excessive.
The history of the Board is set out
in the decision of Re Manitoba Society of Seniors Inc. v. Canada (Attorney
General) (1991), 35 C.P.R. (3d) 66 at 69-71 (Man. Q.B.), aff'd (1992), 45
C.P.R. (3d) 194 (Man. C.A.), to which I was directed by counsel for the
applicants. Given that this Court has not been called upon to review many
decisions of the Board, I have decided to reproduce Mr. Justice Dureault's
summary in its entirety:
A brief historical review of the
patent legislation affecting medicines will be found relevant to the
circumstances under which the impugned provisions were enacted. The Patent
Act, S.C. 1923, c. 23, s. 17 allowed for compulsory licenses to be granted
for the manufacture, use, and sale of patented processes. Up until 1969, when
the 1923 Act was amended (S.C. 1968‑69, c. 49) to permit compulsory
licenses to import patented pharmaceutical products, few applications for
compulsory licenses were made. Subsequent to the 1969 amendment, however, 559
licenses to import and sell have been applied for; of these, 306 have been
granted, 15 have been refused or terminated, 96 have been abandoned or
withdrawn, and 142 were still pending as of January 31, 1985. (See H.C.
Eastman, Report of The Commission of Inquiry on the Pharmaceutical Industry
(1985) 1‑2.)
The 1969 amendment resulted in the
licensing of brand name patented products by generic firms which then produced
and marketed their own brand or copy of the patented medicine. Compulsory
licensing to import medicines resulted in increased competition by generic
firms against patent‑holding firms. This competition was further encouraged
by the provincial policy of generic substitution under their respective
pharmacare plans. The result has been the growth of large and profitable
Canadian‑owned generic pharmaceutical firms, which in turn led to lower
prices. Needless to say, this aspect of compulsory licensing permitting a
competitor (generic firm) to import and produce a copy of the patent holder's
product (brand name) has been the object of intense political lobbying by the
patent‑holding firms. There was no such thing as patent exclusivity for
an invention of medicine. Indeed an applicant could apply for a compulsory
license immediately upon the grant of the patent.
Restoration of patent exclusivity
and revocation of compulsory licensing for patented medicine had for some time
been the elusive goal of the patent‑holding firms. Reacting to the
pharmaceutical lobby, the government appointed Dr. H.C. Eastman as Commissioner
to inquire into and report upon the then current situation in the
pharmaceutical industry in Canada. The Commissioner's report was submitted on
February 28, 1985.
The government's response to the
Eastman report was the introduction in Parliament of Bill C‑22, entitled An
Act to amend the Patent Act and to provide for certain matters in relation
thereto, 33rd Parl., 2nd Sess. (1986). It was given first reading on
November 7, 1986. The Bill, following its usual legislative route including
several references to both the House of Commons Legislative Committee and the
Special Committee of the Senate, was eventually passed by Parliament and
received Royal Assent on November 19, 1987 (See S.C. 1987, c. 41, also R.S.C.
1985, c. 33 (3rd Supp.))
It is widely acknowledged that s.
14 of Bill C‑22 created a new regime of patent exclusivity applicable to
medicines. The amending provisions were designed to give back some measure of
patent exclusivity to the brand name firms. While compulsory licensing was
retained, it carried with it a prohibition from exercising any rights obtained
under the compulsory license for periods varying generally from seven to ten
years.
Patents in respect of medicine, as
for any other patent, are issued for 17 or 20‑year terms. What is
exceptional about these patents, however, is the provision for their immediate
compulsory licensing. The new regime does not change this unique provision.
It merely prohibits a licensee from exercising the rights given under the
license for a particular period of time. In other words, a monopoly is created
for the patent holder for the period during which the licensee is prohibited
from working the patent.
Under this limited monopoly, it
was recognized that the price of new medicines would be introduced and
maintained at higher levels than otherwise would be the case with competition
under compulsory licensing. The increased financial return to the brand name
firm was expected to encourage pharmaceutical research and development in
Canada. From the government's standpoint, growth of this industry with
enhanced employment opportunities was considered to be a desirable objective.
On the other hand, legitimate concerns arose that, from the consumer's
standpoint, prices might escalate to unacceptable levels during the exclusivity
period. To counteract this mischief, the impugned amending provisions were
also linked to a regulatory scheme to be administered by the Board referred to
earlier.
The Board's main regulatory
function is to monitor and review prices at which these new patented medicines
are being sold. It is charged with the responsibility of requiring new
patentees of medicines to provide information and documents with respect to a
patented medicine, the selling price of the medicine, and the cost of making
and marketing the medicine.
If the Board concludes that the
medicine is being sold at a price it determines to be excessive, it can order
remedial action. Moral suasion by threat of public disclosure is one of the
options open to the Board or it can take the form of lifting the prohibition
against a licensee in respect of the medicine in question and/or in respect of
one other patent for medicine held by that firm. The result is loss of the
monopoly for that or one additional patent. It may, as an alternative, direct
the patent‑holding firm to reduce the price of that medicine to such an
extent the Board would no longer find excessive. It is further noted that, for
the enforcement of its orders, the Board is clothed with the powers of a
superior court (see s. 39.23(4) of the amended 1985 Act). This last measure
has generated much argument, particularly the right to enforce its orders
through the contempt power. Without deciding if the Board can avail itself of
this last remedy, it is my view that, even if it did, it is not determinative
of the issue to be decided.
As
explained by Mr. Justice Dureault, the Board has considerable powers. Pursuant
to sections 80, 81, 82, and 88, a patentee is required to disclose information
to the Board about its patented medicines: the identity of the medicines,
prices, costs or marketing and making the medicine, and so forth. However, as
pointed out by counsel for the respondent, the Board does not have
investigative powers to determine, for example, if the patentee is actually
using a particular patent to produce a medicine.
Based
on the information obtained from the patentee, the Board has authority to
determine whether the prices charged for the medicine are excessive.
Subsection 83(1), which gives the Board power with respect to excessive
pricing, reads 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.
The
reference in subsection 83(1) to an "invention pertaining to a
medicine" is discussed in subsection 79(2) of the Patent Act.
Subsection 79(2) provides that an invention pertains to a medicine if "the
invention is intended or capable of being used for medicine or for the
preparation or production of medicine." The proper interpretation of this
phrase, in the context of subsection 83(1), is at issue in the case at bar.
THE DECISION OF THE PATENTED MEDICINE PRICES REVIEW BOARD
By
Amended Notice of Hearing dated September 28, 1995, the Board gave notice that
it would hold a hearing, the purpose of which was "to determine whether,
under sections 83 and 85 of the Patent Act ("the Act"), the
respondents [the applicants herein] are selling and/or have, while patentees,
sold the medicine known as Virazole in any market in Canada at a price that, in
the Board's opinion, is or was excessive and if so, what order, if any should
be made." In response to the amended notice of hearing, the applicants
(the respondents before the Board) brought an Amended Notice of Motion before
the Board,
seeking an order that the Board is without jurisdiction to investigate, hold
hearings or make any Order in relation to the medicine Virazole.
The
Board found that five Canadian patents pertain to Virazole; however, three have
expired and only two remain at issue in the case at bar. Canadian Patent No.
1,028,264 ("the '264 Patent") was granted to ICN Pharmaceuticals Inc.
on March 21, 1978 and expired on March 21, 1995. The '264 Patent describes an
enzymatic process for preparing ribavirin, the active ingredient in the
medicine which the applicants sell under the name "Virazole."
Canadian Patent No. 1,261,265 ("the '265 Patent") was granted to
Viratech Inc. (a predecessor of ICN Pharmaceuticals Inc.) on September 26, 1989
and will expire on September 26, 2006. The '265 Patent pertains to various methods
of medical treatment utilizing ribavirin.
The
applicants (the respondents before the Board) submitted that neither the '264
Patent nor the '265 Patent pertained to Virazole within the meaning of the Patent
Act and, accordingly, the Board was without jurisdiction to make any order
in relation to Virazole. By decision dated November 30, 1995, however, the
Board concluded that both patents pertained to Virazole and it had
jurisdiction.
I
note that in its decision, the Board also made reference to the applicants'
supply of ribavirin in capsule form pursuant to the Emergency Drug Release
Programme ("the EDRP"). Counsel for the applicants strongly objected
to this portion of the Board's judgment, noting that an NOC has not been issued
for ribavirin in the EDRP dosage and form. In my view, the reference to the
EDRP is a red herring. The Board considers the EDRP under the heading
"Virazole and its Recent Pricing History" and, in the end, the EDRP
was irrelevant to the question of whether the '264 and '265 Patents were
intended or capable of being used for medicine or for the preparation or
production of medicine.
ISSUE
The
question before this Court is whether the Board correctly decided that it had
authority to consider whether the prices that the applicants charged for
ribavirin, under the brand name Virazole, are excessive. The answer to that
question flows from a determination as to whether either or both of the
applicants' '264 and '265 Patents are "intended or capable of being used
for medicine or for the preparation or production of medicine" within the
meaning of subsection 79(2) of the Patent Act.
STANDARD OF REVIEW
As
a preliminary matter, counsel for the Board raised the question is the
appropriate standard of review, arguing that regardless of the standard, the
Board's decision was correct.
Counsel
directed me to U.E.S., Local 298 v. Bibeault, [1988] 2 S.C.R. 739, in
which the Supreme Court stated that a reviewing court should ask the question,
"Did the legislator intend the question to be within the jurisdiction
conferred on the tribunal?" If the answer to that question is
"Yes," the Board's decision is entitled to curial deference unless it
is patently unreasonable. The respondent submits that the Board is a specialized
tribunal and Parliament intended it to make the determinations which are in
issue in this proceeding.
The
applicants directed this Court to a more recent Supreme Court of Canada
decision concerning standard of review: Pezim v. British Columbia
(Superintendent of Brokers), [1994] 2 S.C.R. 557. In this case, Mr. Justice
Iacobucci advocated a "spectrum" analysis at 589-591:
From the outset, it is important
to set forth certain principles of judicial review. There exist various
standards of review with respect to the myriad of administrative agencies that
exist in our country. The central question in ascertaining the standard of
review is to determine the legislative intent in conferring jurisdiction on the
administrative tribunal. In answering this question, the courts have looked at
various factors. Included in the analysis is an examination of the tribunal's
role or function. Also crucial is whether or not the agency's decisions are
protected by a privative clause. Finally, of fundamental importance, is whether
or not the question goes to the jurisdiction of the tribunal involved.
Having regard to the large number
of factors relevant in determining the applicable standard of review, the
courts have developed a spectrum that ranges from the standard of reasonableness
to that of correctness. Courts have also enunciated a principle of deference
that applies not just to the facts as found by the tribunal, but also to the
legal questions before the tribunal in the light of its role and expertise. At
the reasonableness end of the spectrum, where deference is at its highest, are
those cases where a tribunal protected by a true privative clause, is deciding
a matter within its jurisdiction and where there is no statutory right of
appeal. See Canadian Union of Public Employees, Local 963 v. New Brunswick
Liquor Corp., [1979] 2 S.C.R. 227; U.E.S., Local 298 v. Bibeault,
[1988] 2 S.C.R. 1048, at p. 1089 (Bibeault), and Domtar Inc. v.
Quebec (Commission d'appel en matiere de lesions professionnelles), [1993]
2 S.C.R. 756.
At the correctness end of the
spectrum, where deference in terms of legal questions is at its lowest, are
those cases where the issues concern the interpretation of a provision limiting
the tribunal's jurisdiction (jurisdictional error) or where there is a
statutory right of appeal which allows the reviewing court to substitute its
opinion for that of the tribunal and where the tribunal has no greater
expertise than the court on the issue in question, as for example in the area
of human rights. See for example Zurich Insurance Co. v. Ontario (Human
Rights Commission), [1992] 2 S.C.R. 321; Canada (Attorney General) v.
Mossop, [1993] 1 S.C.R. 554, and University of British Columbia v. Berg,
[1993] 2 S.C.R. 353.
The
applicants urged this Court to find that the Board's decision fell into the
"correctness" end of the spectrum. While there is no statutory right
of appeal under the Patent Act, decisions of the Board are not protected
by a privative clause and the case at bar concerns the interpretation of a provision
limiting the Board's jurisdiction.
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. This expert nature indicates curial deference should
be in order. However, the issue to be determined on judicial review is clearly
a question of jurisdiction. While this Court can consider from a
"functional and pragmatic" perspective whether Parliament intended a
certain question to be within the Board's jurisdiction, in the end, the Board
must answer that key question correctly or risk being overturned by the reviewing
court. In my view, on the jurisdictional issue of whether the '264 and '254
Patents are "intended or capable of being used for medicine or for the
preparation or production of medicine" within the meaning of subsection
79(2) of the Patent Act, the standard of review is correctness.
THE '264 PATENT
In
the case of the '264 Patent, the applicants submit that the evidence is clear
that the method of the '264 Patent is neither intended nor capable of being
used for medicine or for the preparation or production of medicine because it
is a research and development process. Thus, there is, no exclusionary right
flowing from the '264 Patent which could conceivably give rise to excessive
prices flowing from the claims of the '264 Patent.
The
affidavit of Robert Orr,
submitted by the applicants, asserts that the applicants were the holders of
Canadian Letters Patent No. 997,756 ("the '756 Patent") which expired
on September 28, 1993. This patent described a process of making ribavirin
and, according to the affiant, was the process which was and is actually
utilized for making the Virazole sold in Canada. The affiant further stated
that the '264 Patent, which also describes a process for making ribavirin, is
irrelevant to the medicine Virazole being marketed in Canada by the
applicants. At paragraph 31 of his affidavit, the affiant summarizes why it
would be impossible, in the practical sense, to the process of the '264 Patent
to make virazole:
(a) The world-wide supply of
ribose-1-phosphate [one of chemical substances required to make ribavirin] is
insufficient to produce a single dose of the medicine Virazole;
(b) Ribose-1-phosphate is unstable
and must be stored at 0 to -18C. It would be very difficult to handle, and
very costly to store, if it were available in sufficient quantities for the
industrial scale reaction suitable for the preparation or production of actual
dosage forms of the medicine Virazole;
(c) If ribose-1-phosphate were
available in sufficient quantities, the cost of U.S. $4.9 million for one 20
kilogram batch [the amount of ribavirin necessary to produce sufficient
quantities of Virazole in Canada for one year], would be prohibitive (i.e.,
would exceed the market value of the final dosage forms of the medicine
Virazole);
(d) The cost of the nucleoside
phsphoylase enzyme raw material [the catalyst for reacting the two chemical
compounds used to produce ribavirin], at approximately U.S. $63 million, would
be prohibitive (i.e., it would vastly exceed the market value of the dosage forms);
(e) The reaction vessel required
for the industrial scale reaction of approximately 3,000,000 litres required to
produce 20 kilograms is beyond the scope of what is available.
The
evidence of Mr. Orr is supported by the affidavit of Dr. Howard Cottam, also submitted by the
applicants. At paragraphs 6 and 7 he states:
6. After having reviewed the
details of the process described in the '264 Patent, it is my opinion that this
process as described is suitable and practical for only small scale preparation
of the nucleoside; that is, in amounts that are typically considered as
research laboratory scale as opposed to industrial scale amounts. The '264
Patent, in my opinion, teaches only the process of preparation of nucleoside
using the purified enzyme, and base and sugar mentioned in the patent, only
on a milligram scale and does not teach a method for its large scale
preparation. A milligram scale is not suitable for the preparation of even a
single dose of medicine.
7. It is my further opinion
that if one were to attempt to use this process on a large scale, that is, in
amounts useful for pharmaceutical application (i.e., kilogram amounts), the
total cost would certainly be prohibitive due to the cost and limited
availability of the enzyme and sugar materials. Indeed, this process, in my
opinion, cannot be used for even the preparation of gram quantities of
nucleoside; that is, in amounts necessary to provide for a single
pharmaceutical dose of the substance which is about 6 grams.
The
evidence of Mr. Orr and Dr. Cottam is not disputed by the respondent. Rather,
counsel for the respondent argues that, on its face, the '264 Patent is an
invention for the preparation of medicine and, secondly, it is an invention
that is capable for being used for the preparation of medicine. Limiting the
meaning of the phrase "intended or capable of being used for medicine or
for the preparation or production of medicine" in the manner suggested by
the applicants would be contrary to the plain and ordinary meaning of
subsection 79(2). There is nothing in the subsection which would limit its
application to situations where the invention is in fact being used. Indeed,
the Board has no power to investigate and determine whether a patent is being
actually used; if the Court adopts the applicants' definition, the jurisdiction
of the Board could easily be circumvented by a patentee simply claiming that it
was not using a particular patent.
Furthermore,
the respondent submits that there is nothing in subsection 79(2) which would
suggest that "capable of being used for medicine or for the preparation or
production of medicine" should be interpreted to mean "capable of
being used for medicine or for the preparation or production of medicine in
quantities which the patentee deems to be commercially feasible." The
applicants are advocating that this Court "read in" words which
Parliament never included in the statute.
While
I accept that the applicants' evidence that the '264 Patent cannot be worked,
at this point in time, to create suitable quantities of ribavirin and was not
intended by the patentee to be used to create industrial quantities of the
ribavirin, I do not accept the applicants' submissions that the '264 Patent is
not capable of preparing the medicine. The word "capable," in the
context of the Patent Act, should not be given a meaning that is akin to
"commercially feasible" or "reasonably practicable."
Sections
79 to 103 of the Patent Act, creating the Patented Medicine Prices
Review Board, were enacted in response to the abolition of the compulsory
licensing regime. Parliament's intent was certainly to address the
"mischief" that the patentee's monopoly over pharmaceuticals during
the exclusivity period might cause prices to rise to unacceptable levels.
Accordingly, the words of these sections of the Patent Act should be
read purposively, acknowledging that the Board has jurisdiction over all
patents that are either intended or capable of preparing or producing a
medicine, and not only those that the patentee insists that it is using or
deems to be feasible. To adopt such a restrictive interpretation would not
mesh with the legislative scheme which does not provide the Board any powers to
investigate a patentee's conduct or actual use of a patent. Effectively, a
patentee could avoid the Board's jurisdiction simply by asserting that it is
not using a patented process because it is commercially infeasible or that the
raw materials are not available; the Board, without investigative powers, would
be bound by this assertion.
That
is not to say that the applicants in the case at bar are purposely seeking to
avoid the Board's jurisdiction. As already mentioned, I accept their evidence
that the process described by the '264 Patent was not and is not being used to
produce the ribavirin used in Virazole. Parliament may not have had their
particular situation in mind when drafting the subsection 79(2); however, this
Court, and the applicants, are bound by the clear meaning of the phrase
"intended or capable of being used for medicine or for the preparation or
production of medicine." The '264 Patent is capable of being used for the
preparation or production of ribavirin within the meaning of subsection 79(2)
and, accordingly, is within the jurisdiction of the Board. That being said, it
would be open to the Board to conclude that the applicants are not selling the
medicine in Canada within the meaning of subsection 83(1) of the Patent Act.
Such a finding, however, is best left to the Board adjudicating this matter on
its merits.
THE '265 PATENT
The
applicants submit that in order to find that the '265 Patent is intended for
the preparation or production of medicine, there must be some rational
connection between the claims of the '265 patent and the use or approved
indications for Virazole and the claims in the patent. However, in the case at
bar, the claims of the patent, properly construed, are not rationally related
to the medicine Virazole being sold in Canada.
The
applicants directed this Court to certain claims in the '265 Patent which refer
to the invention as a formulation for the treatment of respiratory syncytial
viruses in immunocompromised patients or in patients with severe combined
immune deficiency syndrome. According to the applicants, the words
"immunocompromised" and "severe combined immune deficiency
syndrome" are key elements to the patent claims. However, the Virazole
product monograph, which is included by the Health Protection Branch as a part
of the Notice of Compliance for a New Drug Submission, does not mention these
key words. Rather, the product monograph refers only to "immune
deficiency" and "severe combined immune deficiency disease."
According
to the evidence of Dr. Heinz-Joachim Biedermann,
submitted on behalf of the applicants, the information disclosed in the product
monograph for Virazole was available over two years before the '265 Patent was
issued. Dr. Biedermann makes particular reference to two articles by Hall and Gelfand; both articles refer to
ribavirin as a treatment for "immune deficiency" and "severe
combined immune deficiency disease." Based on this information, Dr.
Biedermann concludes that "immune deficiency" and "severe
combined immune deficiency disease" must mean something different than
"immunocompromised" and "severe combined immune deficiency
syndrome," otherwise the '265 Patent would be anticipated or rendered
obvious by the prior art and prima facie invalid. The applicants submit
that such an approach would run contrary to the purposive approach to claim
construction which is to construe the patent so as to allow the patentee
protection for that which he has invented.
In
summary, the applicants submit that the claims in the '265 Patent do not
pertain to Virazole as it is being sold in Canada. Virazole is authorized for
sale for use in patients with immune deficiency and for severe combined immune
deficiency disease, while the patent itself describes uses for
immunocompromised patients and for the treatment of severe combined immune
deficiency syndrome. There is no rational nexus between the '265 Patent and
the product monograph and NOC for Virazole and, accordingly, the '265 Patent is
not intended to be used for medicine or for the preparation or production of
medicine.
The
respondent, however, counters the applicants' submissions, primarily relying on
the affidavit evidence of Dr. Raymond Corrin.
Although the applicants sought to impeach Dr. Corrin's credentials, implying he
had no specialized training in immunology or virology, I note that Dr. Corrin
is a medical doctor, employed at the Ottawa General Hospital in the
Immunodeficiency Clinic where he treats patients with immunodeficiencies,
primarily AIDS. According to the affiant, the claims in the patent are
identical to the uses approved in the NOC for Virazole. It was his evidence
that while the words "immunocompromised" and "immune
deficiency," and "severe combined immune deficiency disease" and
"severe combined immune deficiency syndrome" are different, their
meanings are the same. This evidence was unshaken on cross-examination.
The
respondent also pointed out that the Gelfand and Hall articles, contrary to the
applicants' submissions, are dated less than two years prior to the patent
application. The application for the '265 Patent was filed on May 7, 1985 and,
under subsection 27(1) of the Patent Act as it then read, the invention
must not be published two years prior to application; May 7, 1983 would,
therefore, be the critical date. However, the New England Journal of
Medicine article by Hall is dated June 16, 1983 and the Lancet
article by Gelfand is dated September 24, 1983. I note that the applicants
asserted that the Gelfand article was presented at a conference and, hence,
published in March 1983, in addition to the subsequent publication in Lancet.
Given my conclusions concerning the Board's jurisdiction over the '265 Patent,
I find it unnecessary to resolve the dispute over publication dates.
The
respondent's most convincing argument, and one on which the Board relied, is
that the Board would exceed its jurisdiction if it was asked to construe the
claims of the patent. At page 17 of its decision, the Board stated:
... the Board notes that its
mandate under the [Patent] Act requires it to have experience and
expertise in the pricing of patented medicines. In carrying out that mandate,
the Board does not consider that it has either the further mandate or the
necessary experience and expertise to review a patent prosecution file, follow
the history of the patent claims as they are assessed, revised, and then
included in the issued patent, review the medical literature extant at the time
of the patent application and then apply the voluminous case law cited by the
respondents [the applicants before this Court] with a view to concluding that
some or all of the claims in the Patent should be limited in scope or otherwise
found to mean something different from what they say.
Counsel
for the respondent urged me to follow the Board's lead, noting that the Court,
in the context of this judicial review, should not be asked to construe the
claims of the '265 Patent.
This
Court is faced with a "battle of the experts," with both Dr.
Biedermann and Dr. Corrin asserting different propositions. On judicial review,
it is particularly difficult to choose one affiant's version of the evidence
over that of the other. In the end, I have decided that such a choice is not
necessary. Whether "immunocompromised" and "immune
deficiency," and "severe combined immune deficiency disease" and
"severe combined immune deficiency syndrome" have synonymous or
differing meanings is irrelevant if I conclude that the '265 Patent is intended
for the preparation or production of a medicine. Having carefully considered
the evidence, I have concluded that there is no argument that the '265 Patent
comprises uses for ribavirin and that ribavirin is, indeed, a medicine.
"Medicine,"
in the context of subsection 79(2) of the Patent Act, should not be
interpreted to mean only the drug as described in the product monograph and for
which an NOC has been issued, contrary to the applicants' submissions. The
applicants urged this Court to conclude that "medicine" should be
given the same definition as under the Patented Medicines (Notice of Compliance)
Regulations since both the NOC Regulations and the Board were created to
replace the compulsory licensing regime. Under the Patented Medicines
(Notice of Compliance) Regulations, "medicine" is defined as
"a substance intended or capable of being used for the diagnosis,
treatment, mitigation or prevention of a disease, disorder, or abnormal
physical state, or the symptoms thereof." However, I do not accept the
applicants' submissions. In my view, the term "medicine" in the context
of subsection 79(2) should be given the same interpretation as it was given
under the former compulsory licensing provisions of the Patent Act. The
language of subsection 79(2) is lifted from subsection 39(4) of the
"old" Patent Act dealing with compulsory licensing; both use
the phrase "intended or capable of being used for medicine or for the
preparation or production of medicine." This phrase has a far broader
meaning than the restrictive definition of "medicine" in the Patented
Medicines (Notice of Compliance) Regulations and includes all medicines,
not only those sold pursuant to an NOC.
It
is my conclusion that the Board was correct in finding that it should not go
beyond the face of the patent and construe the claims to determine if they
corresponded to the NOC for Virazole. On its face, the '265 Patent is intended
for the preparation or production of medicine and that finding, alone,
establishes the Board's jurisdiction. However, as I stated with respect to the
'264 Patent, it would be open to the Board, when considering the merits of this
case, to find that the applicants are not selling the medicine Virazole in
Canada, pursuant to subsection 83(1) of the Patent Act.
THE DISCLAIMER
Subsequent
to the hearing and decision by the Board, the applicants filed a disclaimer
with the Patent Office in connection with the '265 Patent; the Patent Office
confirmed this filing on December 6, 1995. The Patent Office confirmed that
the applicants disclaimed the following part of the '265 Patent:
1. A formulation for, and the use
of, the chemical compound 1-_-D-ribofuranosyl-1,2,4-triazole-3-carboxamide
(ribavirin) (supplied in 100 ml. glass vials of 6 grams of sterile lyophilized
powder of ribavirin) for the treatment of severe Respiratory Syncytial virus
infection in neonates and infants when associated with underlying
cardiovascular, pulmonary or immune deficiency.
2. Under independent Claims 1, 11,
17, 18, or 19 of the Patent and the dependent claims thereof, any formulation
containing the chemical compound 1-_-D-ribofuranosyl-1,2,4-triazole-3-carboxamide
(ribavirin) (supplied in 100 ml. glass vials of 6 grams of sterile lyophilized
powder of ribavirin) for the treatment of Respiratory Syncytial Virus in
neonates and infants with underlying cardiovascular, pulmonary or immune
deficiency.
3. Under independent Claim 20 and
the dependent claims thereof, the use of the chemical compound
1-_-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin) for the
manufacture of a pharmaceutical composition and compositions for the medical
treatment of viral diseases, characterized in the composition and compositions
are for use in neonates and infants for the treatment of viral disease caused
by Respiratory Syncytial viruses in neonates and infants with underlying
cardiovascular, pulmonary or immune deficiency.
The
applicants submit that the Board, subsequent to the December 6, 1995 filing
date, is without jurisdiction to deal with the '265 Patent since the disclaimer
specifically disclaims any claims to any invention in relation to the
indications for which Virazole is approved for sale in Canada.
The
respondent, however, submits that the disclaimer is without force and effect
for three reasons. First, even if the disclaimer is valid, the Board's
authority would not terminate because the invention disclosed by the '265
Patent continues to pertain to ribavirin with the meaning of subsection 79(2)
of the Patent Act. Given my conclusion on the meaning of
"medicine" in the context of that subsection, I am in agreement with
the respondent's submission. As discussed under the heading "The '265
Patent", supra, I am satisfied that this patent disclosed uses and
is intended to be used in the preparation or production of medicine, including
medicines which are not available for sale pursuant to an NOC.
Since
I have concluded that the Board's jurisdiction is not terminated by the
disclaimer, there is no need to address the respondent's second and third
submissions. However, in the interest of completeness, I will do so briefly.
The
respondent also submits that the disclaimer does not affect the Board's
authority because it does not comply with section 48 of the Patent Act
and was filed for the improper purpose of seeking to avoid the Board's
authority. Subsection 48(1) of the Act provides for the filing of a disclaimer
to narrow a patent claim when a patentee has made a specification too broad
"by mistake, accident or inadvertence, and without any wilful intent to
defraud or mislead the public." The respondent claims that the applicants'
sole motivation in filing the disclaimer is to avoid the jurisdiction of the
Board. That may indeed be the applicants' intention and I can see nothing
objectionable in such an action. A patentee, if he so chooses, can forsake his
monopoly and organize his affairs so as to avoid price regulation by the
Board. However, in the case at bar, the disclaimer does not change the fact
that the '265 Patent continues to be an invention intended for medicine and,
accordingly, it remains in the Board's jurisdiction.
Finally,
the respondent submits that the disclaimer has no effect on the Board's
authority because is was filed after the Board issued its Notice of Hearing and
after it had rejected the applicants' challenge to its jurisdiction.
Subsection 48(4) of the Patent Act provides:
No disclaimer affects any action
pending at the time when it is made, unless there is unreasonable neglect or
delay in making it.
I
am in agreement with the respondent's submissions on this point, however, if
this were the sole ground of argument, I would have addressed the question of
the validity of the disclaimer nonetheless, to provide some guidance and
direction to the Board. In any event, I am satisfied, for the reasons already
mentioned, that the disclaimer is invalid and does not otherwise affect the
jurisdiction of the Board.
CONCLUSIONS
After
having read the documents and evidence filed and considered the able
submissions of counsel, I have determined that:
(1) the word "capable" in subsection
79(2) of the Patent Act must be given its plain and ordinary meaning;
accordingly, the '264 Patent is capable of being used for the preparation or
production of the medicine, ribavirin, and is within the jurisdiction of the
Board;
(2) the word "medicine" in subsection
79(2) of the Patent Act includes all medicines and is not limited to
drugs for which an NOC has been issued; accordingly, the '265 Patent is
intended to be used for the preparation or production of the medicine,
ribavirin, and is within the jurisdiction of the Board; and
(3) the Board's authority is not terminated by
the disclaimer filed by the applicants on December 6, 1995 because the
invention disclosed by the '265 Patent continues to pertain to ribavirin with
the meaning of subsection 79(2) of the Patent Act.
The
application for judicial review, as well as the within motion concerning the
validity of the disclaimer, are dismissed.
Email this Content