Court
Nos. T-388-96 & T-793-96
BETWEEN:
GLAXO
WELLCOME INC.,
-
and -
THE WELLCOME
FOUNDATION LIMITED,
Applicants,
-
and -
THE
MINISTER OF NATIONAL
HEALTH
AND WELFARE,
-
and -
APOTEX
INC.,
Respondents.
REASONS
FOR ORDER
TEITELBAUM J:
INTRODUCTION
These two applications for judicial
review both concern the medicine acyclovir. The applicants seek orders
pursuant to the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133, March 12, 1993 (the "Regulations"). The
applicants wish the Court to prohibit the respondent, the Minister of
National Health and Welfare ("the Minister"), from issuing Notices of
Compliance ("NOCs") to the respondent Apotex ("Apotex").
These cases are not formally joined
but were heard at the same time. I have therefore prepared one comprehensive
set of reasons because of the intertwining of the facts and issues.
FACTS
In essence, these proceedings hinge
on the criteria for issuing a NOC. By way of background, I shall therefore
briefly explain the significance and meaning of NOCs before analyzing the
particular issues and law. A NOC, which formally authorizes a drug to be sold,
is issued by the Minister after a drug manufacturer has complied on two
fronts. The first element of compliance concerns the overall safety and
efficacy of the drug: (see regulation C.08.004 of the Food and Drug
Regulations, C.R.C., c.870). The second element of compliance figures on
the drug manufacturer's non-infringement of certain patents embodied in the
drug. This second, rather more unexpected, patent-related requirement came
into existence after changes to the compulsory licensing regime. Formerly, under a
compulsory license, a generic drug manufacturer could obtain a licensed supply
of a patented drug from the patent owner. The NOC process did not then concern
itself with questions of patent infringement. However, with the abolition of
compulsory licenses under the Patent Act Amendment Act, 1992, S.C. 1993,
c.2, (the "Patent Act") the regime for obtaining NOCs also
changed. Generic drug manufacturers now seeking NOCs must file what is called
a Notice of Allegation under Section 5 of the Regulations.
Section 5 of the Regulations
states:
5.(1) Where a person files or,
before the coming into force of these Regulations, has filed a submission for a
notice of compliance in respect of a drug and wishes to compare that drug with,
or make a reference to, a drug that has been marketed in Canada pursuant to a
notice of compliance issued to a first person in respect of which a patent list
has been submitted, the person shall, in the submission, with respect to each
patent on the patent list,
(a) state
that the person accepts that the notice of compliance will not issue until the
patent expires; or
(b)
allege that
(i)
the statement made by the first person pursuant to paragraph 4(2)(b)
is false,
(ii)
the patent has expired,
(iii)
the patent is not valid, or
(iv)
no claim for the medicine itself and no claim for the use of the medicine would
be infringed by the making, constructing, using or selling by that person of
the drug for which the submission for the notice of compliance is filed.
(2) Where, after a second person
files a submission for a notice of compliance, but before the notice of
compliance is issued, a patent list is submitted or amended in respect of a
patent pursuant to subsection 4(5), the second person shall amend the
submission to include, in respect of that patent, the statement or allegation
that is required by subsection (1).
(3) Where a person makes an
allegation pursuant to paragraph (1)(b) or subsection (2) the
person shall
(a)
provide a detailed statement of the legal and factual basis for the allegation;
and
(b) serve
a notice of the allegation on the first person and proof of such service on the
Minister.
In effect, under Subsection 5(3) of
the Regulations, in a "Notice of Allegation", the generic drug
manufacturer, "the second person", signals its compliance with the
patents embodied in a medicine. Under Section 4 of the Regulations, the
patent owner or licensee, usually a brand name drug manufacturer like the
applicants, submits a list of the patents that contain claims for the medicine
itself or the use of the medicine. Under Section 3 of the Regulations,
the Minister compiles the patent lists into a public document called the
"Patent Register".
The applicants are the owners or
licensees of four patents in respect of acyclovir, the medicine at issue in
the current proceedings. They are patent numbers 1,172,169 (the "'169
patent"), 1,062,257(the "'257 patent"), 1,096,863 (the
"'863 patent") and 1,096,864 (the "'864 patent). The '169
patent relates to the medicine acyclovir in the particular form of a topical
cream or ointment. The '257 patent concerns more general claims for the
medicine. Both the '863 and '864 patents contain claims for the methods and
processes for the manufacture of acyclovir itself (the '863 patent) and its
intermediates (the '864 patent).
In the current proceedings, Apotex, a
generic drug manufacturer, sent two Notices of Allegation to the applicants.
The first Notice of Allegation was dated January 4, 1996. Apotex alleged that
its manufacture and sale of acyclovir tablets would not infringe the '257, '863
and '864 patents because it intended to obtain its supply of acyclovir from
Medichem Inc., a company holding a compulsory license for acyclovir. On February 19, 1996, in
Court Action No. T-388-96 ("the 388 proceeding"), the applicants
responded to Apotex's Notice of Allegation by issuing an Originating Notice of
Motion for judicial review.
Apotex quickly responded to the
issuance of the applicants' Originating Notice of Motion and Amended Notice of
Motion in the '388 proceeding. Two days later, on February 21, 1996, Apotex
sent a second Notice of Allegation to the applicants. The new Notice of
Allegation also concerned the medicine acyclovir in tablet form, but in this
instance, Apotex specifically cited only the '863 and '864 patents. Apotex
asserted that it would not infringe those patents because the patents contained
no claim for the medicine acyclovir or no claim for the use of the medicine.
On April 4, 1996, in Court Action No. T-793-96 (the "793
proceeding"), the applicants issued a second Originating Notice of Motion
in response to Apotex's Notice of Allegation dated February 21, 1996.
ISSUES
The burden is on the applicants to
establish on the balance of probabilities that Apotex's allegations of
non-infringement in its Notices of Allegation dated January 4, 1996 and
February 21, 1996 were not justified: (see Eli Lilly and Co. v. Novopharm
Ltd. (1995), 60 C.P.R. (3d) 417 at 430).
There are two overriding issues
relating to the justification of the Notices of Allegations. The first issue
concerns the expiry and relevancy of certain of the applicants' patents. A
second issue centres on the question of whether a drug manufacturer must
mention in its Notice of Allegation all of the patents found on the Patent
Register for a particular drug.
DISCUSSION
I. The Expiry and Relevancy of the
Patents.
To streamline discussion of the
issues, I have decided to take the lead of counsel for Apotex and address in a
systematic fashion the patents cited in Apotex's two Notices of Allegation.
The first issue is whether the remedies sought by the applicants are now moot
either because of the expiry or irrelevancy of their patents.
(i) The Patents in the '388
Proceeding
In the '388
proceeding, the applicants have sought an order prohibiting the Minister from
issuing a NOC until after the expiry of the '257, '863 and '864 patents. Apotex
had cited those very patents in its Notice of Allegation dated January 4, 1996.
(a) The '257 Patent
I shall
state from the outset that I can see no need for an order of prohibition in the
'388 proceeding. The patents at issue have either expired or contain claims
that are not encompassed under the Regulations. For instance, the '257
Patent expired on September 11, 1996. Nonetheless, the applicants argue that
the Court should make a declaratory finding despite the expiry of the '257
patent. They also submit that the relevant date for assessing the validity of
the allegation of non-infringement is the date the Notice of Allegation was
issued or forty-five days after that date: (see Merck Frosst Canada Inc. v.
Canada (Minister of National Health and Welfare (1996), 65 C.P.R. (3d)
483(F.C.T.D.) (Merck Frosst, (T-1306-93)).
I also
share and support Justice Muldoon's conclusion in Yamanouchi, supra.
In other words, the Court cannot be blind to the fact that the '257 patent has
expired. The relevant time for assessing Apotex's allegations of
non-infringement is the date of the hearing. The '257 patent expired some
eight months before the matter was heard before this Court in April, 1997. As
counsel for the applicants himself acknowledged during the course of oral
argument, these cases proceeded at a relatively rapid clip compared to the
often painstakingly slow progress of claims for relief under the Regulations.
Indeed, the parties appeared to recognize or were made aware of the
doubtful viability of the '257 patent even prior to its expiry on September 11,
1996. In Apotex's Application Record dated August 29, 1996, Apotex accepted
that no Notice of Compliance should issue to it prior to September 12, 1996,
the day after the expiry of the '257 patent.
(b) The '863 and '864 Patents
As for the
'863 and '864 patents, the applicants themselves conceded that neither patent
contains claims that are encompassed by the Regulations. In paragraph 2
of their original Originating Notice of Motion dated February 19, 1996, and in
paragraph 2 of their final Re-Amended Notice of Motion dated July 3, 1996, the
applicants stated:
The Wellcome Foundation is also
the owner of Canadian Patent Nos. 1, 096, 863 and 1, 096, 864, both granted
March 3, 1981. The former contains claims for methods and processes of
manufacture of the medicine acyclovir while the latter contains claims for
intermediates used in the preparation of the medicine acyclovir. The
Applicants do not rely upon these two patents in the present proceedings.
(my
emphasis)
The status
of the highlighted phrase, "the applicants do not intend to rely
..." in paragraph 2 of the applicants' Notices of Motion was the subject
of controversy between the parties and a topic of judicial comment. The
applicants had argued that the phrase was included in the original Originating
Notice of Motion dated February 19, 1996 because of a non-binding
administrative oversight. In contrast, Apotex submitted that the applicants
had made an admission that should be read against them because it reflects the
law on the irrelevancy of such process patents and patents devoted to
intermediates.
For the
sake of clarity, I shall now address in an abbreviated fashion the dispute
surrounding the inclusion or deletion of the phrase beginning "the
applicants do not rely upon ...". On February 20, 1996, the day after the
issuance of the original Originating Notice of Motion, the applicants issued an
Amended Originating Notice of Motion which deleted the phrase, "the
applicants do not intend to rely ...". The applicants later sought leave
to file and serve a Re-amended Originating Notice of Motion. However, during
the course of the hearing before Justice Rouleau of the Federal Court, Trial
Division, Apotex's objections to the validity of the deletion of the phrase in
paragraph 2 became an issue. According to the applicants, they asked Justice
Rouleau to validate the deletion of the phrase. However, in his Order
dated June 11, 1996, Justice Rouleau characterized the motion in a different
manner. He stated: "the verbal motion to add to paragraph no. 2 a
clause which was included in the original Originating Notice of Motion and
which had been deleted from the first amended Originating Notice of Motion is
hereby denied" (my emphasis). In my opinion, the two characterizations -
validating a deletion or rejecting an addition - amount to the same result.
However,
the applicants asked Justice Rouleau to reconsider his June 11, 1996 Order and
issue an express validation of the deletion. In their Notice of Motion in
support of the reconsideration, the applicants argued that Justice Rouleau had
overlooked or accidentally omitted to deal with certain amendments on consent
and the express validation of the deletion. By an Order dated June 28, 1996,
Mr. Justice Rouleau varied the terms of his June 11 Order. He allowed the
additional amendments on consent. However, he concluded that the amendments made
in the Amended Originating Notice of Motion filed February 20, 1996 had not
been overlooked nor omitted. The applicants apparently interpreted this Order
to mean that Justice Rouleau had implicitly refused to validate the deletion of
the phrase in the February 20, 1996 Amended Notice of Motion. Arguably,
however, Justice Rouleau was simply stating in his June 28, 1996 Order that the
matters had not been overlooked because he had already addressed the issue under
a different guise or characterization by rejecting the addition of the
phrase. However, because they had no express authority to sanction the
deletion of the phrase from paragraph 2 of the original Originating Notice of
Motion, the applicants issued a final Originating Notice of Motion on July 3,
1996 with the phrase intact. Justice Rouleau's Order of June 28, 1996 is not
under appeal. The applicants and the Court are therefore bound by the contents
of the Originating Notice of Motion issued on July 3, 1996.
The
applicants have therefore expressly acknowledged in their Originating Notice of
Motion for the '388 proceeding that they will not be relying upon the '863 and
'864 patents. I can only conclude that the Court would accomplish little by
issuing an order of prohibition based on patents that the applicants themselves
do not invoke. Given this lack of reliance on the applicants' own part, the
Court will not act to prohibit the Minister from issuing a NOC to Apotex until
after the expiry of the '863 and '864 patents.
More
importantly, even without the express statement in the Originating Notice of
Motion, the applicants could not rely on the '863 and '864 Patents. The '863
and '864 patents describe methods and processes for the manufacture of
acyclovir and its intermediates. In Deprenyl Research Ltd. v. Apotex
Inc. (1994), 55 C.P.R. (3d) 171 (F.C.T.D.), affirmed (1995) 60 C.P.R. (3d)
501 (F.C.A.), the Court held that such method or process patents were not the
type of patents encompassed by the term "medicine or use of medicine"
in Subsection 4(2) of the Regulations. In Eli Lilly and Co. v. Apotex
Inc. (1995), 63 C.P.R. (3d) 245 (F.C.T.D.), affirmed (1996) 68 C.P.R. (3d)
126 (F.C.A), there was a similar conclusion in the case of intermediates, the
type of claims embodied in the '864 patent in the cases at bar. Thus,
according to Apotex, the applicants stated in their Originating Notice of
Motion that they did "not rely upon [the '863 and '864] patents in the
present proceedings" because they could not in law rely on these types of
patents. I agree. It is clear that such process and intermediate patents are
unquestionably irrelevant to the Regulations. Indeed, in Merck
Frosst (T‑304-96), supra, the issue before the Court was
whether the Minister could unilaterally prune such process patents from the
Patent Register. The Court held that the Minister could and should act in this
fashion.
Moreover,
in the Notice of Allegation at issue in the '793 proceeding, Apotex noted
expressly that the '863 and '864 patents "have no claim for the medicine
(acyclovir) itself or the use of the medicine" (page 165, Application
Record of the applicants in the '793 proceeding). However, the applicants now
argue that the Court must take the Notice of Allegation in the '388 proceeding
as it stands and not read into it what Apotex might have or should have stated
at the first opportunity. In contrast, Apotex argues that the scope of the
patents embraced by the Regulations is a question of jurisdiction.
Section 5 of the Regulations establishes allegations that may be made in
the context of a Notice of Allegation but does not expressly outline an
allegation of non-infringement based on the jurisdiction of the Court under the
Regulations. Thus, according to Apotex, such an allegation need not be
made in the allegation itself but can be raised at any point as a defence.
I accept
Apotex's submission that the Court should not issue an Order of prohibition in
relation to patents whose claims do not fall under the purview of the Regulations.
As Justice Nadon stated at pages 19 and 20 in Merck Frosst, (T-304-96),
supra, the issue of "whether pure process claims fall within the
ambit of the Regulations has already been decided ... a process
only patent confers no rights on the patent-holder in the context of these Regulations"
(my emphasis). While I am also reluctant to see the Notice of Allegation
process become an endless and seemingly interminable revised series of Notices,
Apotex insists that it issued the Second Notice of Allegation in respect of the
'863 and '864 patents only out of a "sense of precaution (paragraph 14,
page 20, respondents' Record in the ‘388 proceeding). However, there are
practical consequences to Apotex's second Notice of Allegation or its attempt
to issue a comprehensive allegation of non-infringement for the ‘863 and 864
patents. After all, the second Notice of Allegation is but one more piece of
paper to “gum up the works” and slow the approval process for the NOC,
Apotex's ultimate goal.
In these
particular circumstances, the Court has to go beyond the contents of the Notice
of Allegation and decide whether it should grant an order of prohibition based
on the ‘863 and ‘864 patents. It would be an absurdity if the Court had to
issue such an order until after the expiry of such patents when it is conceded
by the applicants themselves that the ‘863 and ‘864 patents are not encompassed
by the Regulations. I am satisfied that an Order of prohibition should
not be issued as it relates to the ‘863 and ‘864 patents because such method or
process patents have no bearing on the medicine or the use of the medicine
acyclovir under the Regulations. And as stated above, the ‘257 patent
cited by the applicants in their claim for relief has already expired. I
therefore conclude that the ‘388 proceeding should be dismissed.
However, in
the '388 proceeding, the applicants also raise the issue of the validity of
Apotex's arrangement with Medichem to obtain acyclovir. Apotex asserted in its
Notice of Allegation dated January 4, 1996 that it would not infringe the '257,
'863 and '864 patents because it could obtain the medicine used to make the
drug from Medichem, a company holding a compulsory license for acyclovir.
According to the applicants, the arrangement between Medichem and Apotex
concerning the supply of acyclovir actually constitutes a sub-license or
transfer by Medichem to Apotex of the compulsory license. The applicants argue
that Apotex would be acting as the directing mind in its supply agreement with
Medichem, a closely related company. In effect, the applicants submit that
Apotex cannot find shelter behind a compulsory license in its allegation of
non-infringement when the license has been implicitly converted into a
sub-license.
The
applicants argue that the cases at bar are analogous to the facts in several
linked Federal Court of Appeal decisions: (see Eli Lilly and Co. v. Apotex
Inc. (1996), 66 C.P.R. (3d) 329 (F.C.A), Eli Lilly and Co. v.
Novopharm Ltd. (1996), 67 C.P.R. (3d) 377 and Merck Frosst Canada Inc. v.
Canada(Minister of National Health & Welfare) (1996), 67 C.P.R. (3d)
455 ( "the Court of Appeal decisions")). In the Federal Court of
Appeal decisions, the issue was the status of a written agreement between
Apotex and Novopharm, another generic drug manufacturer. Apotex and Novopharm
agreed to provide each other with patented medicine under their respective
compulsory licenses. The Court of Appeal held that this written agreement was
in fact a sub-license of the compulsory license.
However, I
am satisfied that I need not address the applicants' arguments on the
compulsory license issue in depth. For the reasons stated above, namely the
expiry and irrelevancy of the patents in the '388 proceeding, an Order of
prohibition until after the expiry of the '257, '863 and '864 patents is not a
viable remedy.
In any
event, I am not convinced that the Court of Appeal decisions absolutely
determine the status of Apotex's arrangements with Medichem. As Counsel for
Apotex noted, Medichem's compulsory license was issued in December 1991 and
implicitly provides for non-arm's length transactions (page 161,
applicants' Record in the 388 proceeding). Sub-paragraph 1 (a) of the
compulsory license sets out the royalty rate for "arm's length
transactions". However, sub-paragraph 3(b) indicates a different rate for
calculating the royalty when the transaction does not fall under sub-paragraph
1(a) or the "arms's length setting". The compulsory license itself
does not foresee an incompatibility between non-arm's length transactions and
the prohibition against sub-licensing. Surely then Medichem can deal in
acyclovir with Apotex on a non-arm's length basis without necessarily violating
the prohibition against sub-licensing found at paragraph 12 of the same
compulsory license? While I am not prepared to make conclusions on the issue of
the analogies between the Federal Court of Appeal decisions and Medichem's
arrangements with Apotex, the contents of the compulsory license and the
significant points of difference are noteworthy.
(ii) The Patents in the '793
Proceeding
As stated
above, in the '793 proceeding, Apotex's Notice of Allegation dated February 21,
1996 cites both the '863 and '864 patents. Apotex stated that it would not
infringe those patents because the patents have no claim for the medicine
itself or the use of the medicine. However, the applicants in the '793
proceeding seek an order prohibiting the Minister from issuing a NOC not only
until the expiry of the '863 and '864 patents but also in relation to all four
of their patents on the Patent Register for acyclovir: namely, the '169,
'257, '863 and '864 patents.
The
applicants cite all four patents because they argue that the Regulations require
a specific allegation from Apotex for each patent found on the Patent Register
for a medicine. In the Notice of Allegation dated January 4, 1996, Apotex did
not refer to the '169 patent but cited only the '257, '863 and '864 patents.
The second Notice of Allegation dated February 21, 1996 equally did not refer to
the '169 Patent. I have therefore examined the '169 Patent, the only patent
that has yet to be discussed in these reasons, under the rubric of the second
issue of referring to each patent on the Patent Register.
II. The Reference to Each Patent
(i) The '169 Patent
To buttress
their claim that a generic drug manufacturer like Apotex must cite each and
every patent on the Patent Register for a medicine, the applicants invoke the
wording of Subsection 5(1) of the Regulations. Subsection 5(1) states
that the "second person", in other words, the individual making the
Notice of Allegation, "shall, in the submission, with respect to each
patent on the patent list...."(my emphasis) make a specific
allegation. As I noted in the introductory material describing the NOC process,
the "first person", or patent owner or licensee, usually a brand name
drug manufacturer like the applicants, submits a patent list to the Minister
under Section 4 of the Regulations. The Minister compiles the patent
lists into the Patent Register. The applicants argue that Apotex's Notice of
Allegation dated February 21, 1996 was procedurally deficient because it failed
to address the '169 patent even though this patent was on the Patent Register
for acyclovir. According to the applicants, if a patent is on the Patent
Register, but remains conspicuously absent from the Notice of Allegation, then
the Minister is left in the dark about the status of the patent. In essence,
the applicants submit that Apotex has defeated the economy of the regulatory
scheme by putting the onus on the Minister to examine the Notice of Allegation
and the Patent Register with the proverbial "fine tooth comb".
However, I
am satisfied that the applicants in this instance have misconstrued the
contents of the Patent Register for acyclovir. They also appear to have
underestimated the perspicacity of the Minister. While there is a reference to
"each" in Subsection 5(1) of the Regulations, the subsection
refers to "each patent on the patent list". Under the Regulations,
Apotex must only give an allegation with respect to every patent on a patent
list in respect of the particular form of the drug for which it seeks a
NOC. In effect, the patent list is the building block for the Patent Register,
the public document compiled by the Minister under Section 3 of the Regulations.
Turning now
to the patent lists for acyclovir, it is clear that the applicants had to
submit a separate list for each drug product or form of acyclovir embodied in
the medicine (pages 152-157, applicants' Record in the 793 proceeding). In the
pre-printed application form for submitting a patent list, the applicants had
to indicate the "medicine/active substance", the "route of
administration" (i.e. oral or topical), the "pharmaceutical dosage
form" and the "strength per unit". Thus for acyclovir, in an
oral, tablet dosage form of the 200 mg strength, the applicants cited the '257,
'863 and '864 patents. It is important to note that the applicants did not
refer to the '169 patent on this patent list. The applicants did not invoke the
'169 patent because it contains claims for the medicine acyclovir in the topical
route of administration. The applicants filed separate patent lists for
acyclovir in other oral capsule or tablet dosages, but for all the oral routes
of administration, the '169 patent was absent from the patent list. The
applicants only cited the '169 patent in the separate patent list for ayclovir
in the topical cream 50 mg strength.
More
importantly, these distinctions in the patent lists are reflected in the Patent
Register (pages 167-168, applicants' Record in the 793 proceeding). The Patent
Register organizes the information provided in the patent lists into columns
with such titles as "medicine", "strength" "per
unit" and "patent(s)". Under the heading "medicine"
for acyclovir, there are eight entries, each with a different strength (i.e.
500 mg, 200 mg, etc.) or unit (i.e. "TAB", "CAP"). For
seven of the entries, all associated with the oral route of administration,
there are only three patents listed or associated with the medicine acyclovir
(i.e. the '257, '863 and '864 patents) . In other words, the '169 patent is not
listed for those forms of the medicine. Only the last entry for acyclovir
in the topical route of administration cites the '169 patent. And this entry is
set apart from the preceding eight because it is called "acyclovir 1"
(my emphasis) and comes in the "GM" or topical, not oral unit.
From my
examination of the Patent Register, I am satisfied that Apotex did not have to
cite the '169 patent in the Notice of Allegation dated February 21, 1996. In
the cases at bar, in both Notices of Allegation, Apotex expressly stated that
it proposed to make "Acyclovir tablets: 200 mg, 400 mg and 800
mg" (my emphasis) (pages 163, 165, applicants' Record in the '793
proceeding). Apotex has made no application for a NOC for the topical solution
or cream ointment form of acyclovir, and absent such an application, it could
not manufacture those forms of acyclovir. It would therefore be odd and only
confuse the issue if the Court had to issue an Order of prohibition based on a
patent that was not encompassed by the proposed form of the medicine.
Apotex did
make an application for a NOC for the oral tablet form of acyclovir in varying
dosages. However, as stated above, the Patent Register clearly indicates that
the '169 patent is only implicated in the manufacturer of acyclovir in a topical
cream or ointment form. Since the Minister has the obligation under Section
3 of the Regulations to maintain the Patent Register, he is well-versed
in its intricacies and can use it in his evaluation, for the purposes of
issuing a NOC, of Apotex's Notice of Allegation concerning the tablet forms of
acyclovir medicine. Justice Nadon in Merck Frosst (T-304-96), supra,
held at 26 that the Minister is not a " mere pawn" in the process.
Furthermore,
the applicants were unable to point to any jurisprudence holding that a mention
of each patent on the Patent Register, no matter the proposed formulation, was
obligatory. The Regulations and the Patent Register itself must be read
and used in a purposive fashion. If every Patent had to be mentioned, no matter
the content or significance of the patent on the Patent Register, then the
Notice of Allegation would be an entirely formulaic document with little or no
connection to the actual proposed form of the drug. What would be the practical
utility of citing the '169 Patent implicated only in the topical formulation
when one only seeks to manufacture the oral form of the medicine?
It is also
interesting to note that the applicants, in their Notices of Motion, only
specifically pleaded Apotex's alleged failure to cite the '169 patent in the
later '793 proceeding, the judicial review application specifically triggered
by the second February 21, 1996 Notice of Allegation. However, during the
course of oral pleading, the applicants were at pains to argue that their
submissions on the '169 patent equally applied to both the '388 and '793
proceedings. Nonetheless, I am struck by the fact that the applicants had a
rather belated conversion to the principle that each and every patent had to be
mentioned in the Notice of Allegation. The applicants' tardy embrace of this
argument casts some doubt on its weight and significance. Certainly, the second
February 21, 1996 Notice of Allegation also did not specifically cite the '257
patent. As I stated above, the '257 patent is now a moot point since it expired
in September, 1996.
In conclusion, on the '793
proceeding, I find that the allegation of non-infringement in the Notice of
Allegation dated February 21, 1996 was justified. The jurisprudence is clear
that process or intermediate claims are not claims for the medicine itself or
the use of the medicine under the ambit of the Regulations. Apotex's
ostensible "failure" to cite the '169 patent is irrelevant to the
issue of justified allegations of non-infringement.
CONCLUSION
For these reasons, the applications
in the '388 and '793 proceedings are dismissed.
"Max
M. Teitelbaum"
J.F.C.C.
OTTAWA
August
19, 1997
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