Date: 20070516
Docket: A-59-07
Citation: 2007 FCA 187
CORAM: DESJARDINS
J.A.
NOËL
J.A.
NADON
J.A.
BETWEEN:
ABBOTT LABORATORIES and ABBOTT
LABORATORIES LIMITED
Appellants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR JUDGMENT
NOËL J.A. (concurring reasons
(except on the issue of jurisdiction)):
[1]
This
is an appeal from the Order of Heneghan J. of the Federal Court (2006 FC 1558),
dismissing an application to prohibit the Minister of Health (“the Minister”) from
issuing a Notice of Compliance (“NOC”) to Apotex Inc. (“Apotex” or “the respondent”),
pursuant to the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133 (“NOC Regulations”), with respect to Canadian Letters Patent No.
2,387,361 (“the ‘361 Patent”) on the basis that the relevant claim of the said
patent was not an eligible claim.
[2]
Abbott
Laboratories and Abbott Laboratories Ltd. (“Abbott” or “the appellants”)
request that this decision be set aside and that an order be issued prohibiting
the Minister from issuing the NOC sought by the respondent until after the
expiry of the ‘361 Patent.
[3]
The
reason why this NOC has not yet issued is another prohibition proceeding
involving the same patent which was to be heard by the Federal Court in the
days following the hearing of the present appeal.
[4]
The
appellants sell clarithromycin, an antibiotic and the active medicinal
ingredient in the commercially-available product Biaxin. The respondent intends
to market a generic version of clarithromycin.
[5]
Clarithromycin
is polymorphic: it exists in different number of crystalline forms, some of
which were invented by Abbott. Several of Abbott’s patents, including the ‘361
Patent which is at issue, cover clarithromycin compounds and three of its
crystalline forms, namely Form 0, Form I and Form II.
[6]
The
‘361 Patent was filed on December 19, 1997 with a claim date of January 17,
1997. The monopoly which it confers pertains to the use of Form 0 to make Form
II by way of heating at high temperatures. The proposed generic version of
clarithromycin seeks to replicate this process of converting Form 0 to Form II.
[7]
The
respondent filed a Notice of Allegation pursuant to the NOC Regulations that
alleged, inter alia, that the ‘361 Patent was ineligible for listing on
the patent register, was not infringed, and was invalid based on obviousness
and anticipation. An application for an order prohibiting the Minister from
issuing to Apotex the requested NOC was filed by Abbott on October 7, 2003 and
the decision under appeal ensued.
[8]
The
statutory stay period provided for under paragraph 7(1)(e) of the NOC
Regulations which normally would have ended on October 7, 2005 (i.e., 24 months
after the application was filed), was extended pursuant to paragraph 7(5)(b) of
the NOC Regulations to December 30, 2006.
[9]
Heneghan
J. dismissed Abbott’s application. The reasons which are dated January 11,
2007 indicate that a confidential version was issued on December 29, 2006.
However, the record shows that the confidential version was actually signed on
December 30, 2006 (Appeal Book, Vol. I, Tab 1, at p. 44).
[10]
Heneghan
J. held that claim 31 of the ‘361 Patent is not a claim for the use of the
medicine, and is therefore not an eligible claim under the NOC Regulations. In
reaching this conclusion, Heneghan J. relied on this Court’s decision in Eli
Lilly and Co. et al. v. Apotex Inc. et al. (1996), 68 C.P.R. (2d) 126, at
p. 128, which ruled that in order to come within the definition of “medicine” as
defined in section 2 of the NOC Regulations, “a substance must be intended for
or capable of one or more of the precise listed medical uses. Chemical
conversion or synthesis into another substance which may itself be used as a
medicine is not one of them” (Reasons, at para. 129).
[11]
The
applications judge held that Form 0, as it is used in the ‘361 Patent, acts as
an intermediate, not as a medicine. As such, claim 31 is not a claim for the
use of a medicine (Reasons, at paras. 132-134). Having come to the conclusion
that claim 31 was not an eligible claim under the NOC Regulations, Heneghan J.
did not address the respondent’s alternative allegations based on invalidity.
[12]
On
appeal, the appellants take issue with Heneghan J.’s construction of claim 31.
They argue that claim 31, properly construed, is a claim for the use of a
medicine and that Heneghan J. erred in law in holding that claim 31 was not an
eligible claim.
[13]
Should
they be successful on the issue of eligibility, the appellants ask this Court
to address and dispose of the issue of validity, and issue an order prohibiting
the Minister from issuing the NOC sought by Apotex. They argue that even
though Heneghan J. did not address the issue of validity, it would be
inappropriate to send the matter back to the Federal Court on this point since
the statutory stay period as it was extended has now expired and the Federal
Court would no longer be in a position to issue the order which they seek.
JURISDICTION
[14]
Apotex
has brought a preliminary objection to the hearing of the appeal. It contends
that this Court no more than the Federal Court has the jurisdiction to issue a
prohibition order once the statutory stay period has expired. In this case,
this period has expired both as a result of Heneghan J.’s dismissal of Abbott’s
application (see ss 7(4)) and by reason of the fact that the 24-month period,
as extended pursuant to paragraph 7(5)(b), has run its course.
[15]
Counsel
for Abbott objected to this argument being raised on the ground that it has
already been addressed and was rejected by this Court in Abbott Laboratories
v. Canada (Minister of Health), [2004] F.C.J. No. 708; 2004 FCA 154, where Richard
C.J. said on behalf of the Court
(at paras. 30 and 31):
[30] Before
concluding, I will briefly treat the argument made by the respondent,
Pharmascience, on the question of jurisdiction. Pharmascience suggested that
this Court had no jurisdiction to entertain the present appeal, as the PM(NOC)
Regulations do not provide for an appeal from an Order dismissing an
application pursuant to section 6(5)(a) of the PM(NOC) Regulations.
[31] I am
unable to endorse the respondent's position. Section 27.1 of the Federal
Courts Act expressly provides for an appeal to this Court from a final or
interlocutory judgment of the Federal Court. Emphatic statutory language would
be required to preclude the right of appeal set out in this Act.
[16]
According
to Counsel for Apotex, it is difficult to know the precise argument which the
Court was addressing in this brief passage so that it cannot be said with
certainty that the argument which it proposes to make was addressed. I agree.
[17]
The
crux of Apotex’ argument is set out in its Memorandum of Fact and Law at paras.
19 and 20:
19. The
events described under section 7 of the Regulations – which, so long as
they are pending, prohibit Ministerial action – are absolute. For example,
once the 24 month time period specified in paragraph 7(1)(e) expires, the court
loses jurisdiction to extend the period of prohibition any further. The
lifting of the prohibition is not conditional upon on a determination by the
Court of any of the issues raised in the application.
20.
Likewise, if a prohibition application under subsection 6(1) of the Regulations
is withdrawn or discontinued or is “dismissed by the court hearing the
application,” then the 24 month stay of Ministerial action is automatically
lifted by operation of subsection 7(4). The effect of subsection 7(4) is that,
upon the dismissal of a prohibition application, neither the Federal Court nor
the Federal Court of Appeal will any longer have jurisdiction under the [NOC] Regulations
to grant a prohibition order in respect of the patents from which the right to
commence the application was derived. There is no provision in the Regulations
to resurrect the 24 month stay of Ministerial action once it is lifted by
subsection 7(4) or to continue it pending an appeal. The words “dismissed by
the court hearing the application” in subsection 7(4) of the Regulations
specifically preclude any extension of the statutory stay, pending an appeal
from a dismissal of an application.
[18]
Section
7 of the NOC Regulations provides:
|
7. (1) The
Minister shall not issue a notice of compliance to a second person before the
latest of
(a)
[Repealed, SOR/98-166, s. 6]
(b) the
day on which the second person complies with section 5,
(c)
subject to subsection (3), the expiration of any patent on the register that
is not the subject of an allegation,
(d)
subject to subsection (3), the expiration of 45 days after the receipt of
proof of service of a notice of any allegation pursuant to paragraph 5(3)(b)
or (c) in respect of any patent on the register,
(e)
subject to subsections (2), (3) and (4), the expiration of 24 months after
the receipt of proof of the making of any application under subsection 6(1),
and
(f) the
expiration of any patent that is the subject of an order pursuant to
subsection 6(1).
(2) Paragraph
(1)(e) does not apply if at any time, in respect of each patent that
is the subject of an application pursuant to subsection 6(1),
(a) the
patent has expired; or
(b) the
court has declared that the patent is not valid or that no claim for the
medicine itself and no claim for the use of the medicine would be infringed.
(3) Paragraphs
(1)(c), (d) and (e) do not apply in respect of a patent
if the owner of the patent has consented to the making, constructing, using
or selling of the drug in Canada by the second person.
(4) Paragraph
(1)(e) ceases to apply in respect of an application under subsection
6(1) if the application is withdrawn or discontinued by the first person or
is dismissed by the court hearing the application.
(5) If the
court has not yet made an order under subsection 6(1) in respect of an
application, the court may
(a)
shorten the time limit referred to in paragraph (1)(e) on consent of
the first and second persons or if the court finds that the first person has
failed, at any time during the proceeding, to reasonably cooperate in
expediting the application; or
(b)
extend the time limit referred to in paragraph (1)(e) on consent of
the first and second persons or, if the court finds that the second person
has failed, at any time during the proceeding, to reasonably cooperate in
expediting the application. SOR/98-166, ss. 6, 9.
|
7. (1) Le ministre ne peut
délivrer un avis de conformité à la seconde personne avant la plus tardive
des dates suivantes :
a) [Abrogé, DORS/98-166, art.
6]
b) la date à laquelle la
seconde personne se conforme à l'article 5;
c) sous réserve du paragraphe
(3), la date d'expiration de tout brevet inscrit au registre qui ne fait pas
l'objet d'une allégation;
d) sous réserve du paragraphe
(3), la date qui suit de 45 jours la date de réception de la preuve de
signification de l'avis d'allégation visé aux alinéas 5(3)b) ou c)
à l'égard de tout brevet inscrit au registre;
e) sous réserve des
paragraphes (2), (3) et (4), la date qui suit de 24 mois la date de réception
de la preuve de présentation de la demande visée au paragraphe 6(1);
f) la date d'expiration de
tout brevet faisant l'objet d'une ordonnance rendue aux termes du paragraphe
6(1).
(2)
L'alinéa (1)e) ne s'applique pas si, à l'égard de chaque brevet visé
par une demande au tribunal aux termes du paragraphe 6(1) :
a) soit le brevet est expiré;
b) soit le tribunal a déclaré
que le brevet n'est pas valide ou qu'aucune revendication pour le médicament
en soi ni aucune revendication pour l'utilisation du médicament ne seraient
contrefaites.
(3)
Les alinéas (1)c), d) et e) ne s'appliquent pas à
l'égard d'un brevet si le propriétaire de celui-ci a consenti à ce que la
seconde personne utilise, fabrique, construise ou vende la drogue au Canada.
(4)
L'alinéa (1)e) cesse de s'appliquer à l'égard de la demande visée au
paragraphe 6(1) si celle-ci est retirée ou fait l'objet d'un désistement par
la première personne ou est rejetée par le tribunal qui en est saisi.
(5)
Lorsque le tribunal n'a pas encore rendu d'ordonnance aux termes du
paragraphe 6(1) à l'égard d'une demande, il peut :
a) abréger le délai visé à
l'alinéa (1)e) avec le consentement de la première personne et de la
seconde personne, ou s'il conclut que la première personne n'a pas, au cours
de l'instance relative à la demande, collaboré de façon raisonnable au
règlement expéditif de celle-ci;
b) proroger le délai visé à
l'alinéa (1)e) avec le consentement de la première personne et de la
seconde personne, ou s'il conclut que la seconde personne n'a pas, au cours
de l'instance relative à la demande, collaboré de façon raisonnable au
règlement expéditif de celle-ci. DORS/98-166, art. 6 et 9.
|
[19]
In
Pfizer Canada Inc. v. Apotex Inc., [2001] F.C.J. No. 17 (“Pfizer”),
this Court examined the impact of subsection 7(4) on a subsequent appeal. In
that case, the patentee was appealing the dismissal of its prohibition
application and asking the Court of Appeal to quash the NOCs which had been
granted by the Minister in the interim. Isaac C.J. writing for the Court said:
[17] Prohibition proceedings under the Regulations are not similar to
patent infringement proceedings. The scheme established by the Regulations has
been described at length in previous decisions of this Court (see e.g. Bayer
AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R.
(3d) 329, per Mahoney J.A.; Merck Frosst Canada Inc. v. Canada
(Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302, per
Hugessen J.A.; Hoffman-La Roche Ltd v. Canada (Minister of National Health
and Welfare) (1996), 70 C.P.R. (3d) 206, per Stone J.A.; Merck
Frosst Canada Inc. v. Apotex Inc. (1997), 72 C.P.R. (3d) 170, per
Strayer J.A.).
…
[19] This unique benefit conferred upon
patentees has as its corollary that Parliament intended s. 6 proceedings be
dealt with expeditiously by way of summary application for judicial review.
This much is evident from the remarks of Strayer J.A. in Merck Frosst, supra,
at 177:
In summary, the legislative
stay is an extraordinary sanction detracting from the normal rights of a
defendant under ordinary patent law. It must be applied strictly according to
its terms. The 30-month period was no doubt intended in part to focus the minds
of the parties and the Court as to the need for an expeditious prosecution of
the application for prohibition.
[20] I should
like to deal now with some of the arguments advanced by the appellants. They
contend that this Court (the Court of Appeal) has the power under section 52 of
the Federal Court Act to do what the Trial Judge should have done, namely issue
the prohibition. This position assumes that subsection 7(4) of the Regulations
lifts the 30 month stay period in subparagraph 7(1)(e) only when the Court of
Appeal has given final judgment on the issue of prohibition. This assumption is
false in light of the view expressed by this Court in Hoffman Laroche, supra at
paragraph 196, that the phrase "dismissed by the court" in subsection
7(4) of the Regulations is to be interpreted as meaning "dismissed by the
Federal Court Trial Division". I see no reason to depart from the
interpretation placed on that phrase in that case.
[21] It follows that once the prohibition
proceedings brought by the appellants were dismissed by the Trial Division, the
Minister was entitled to and did issue the NOCs to Apotex and to Nu Pharm with
respect to fluconazole. The issue of these NOCs foreclosed any attempts
to continue prohibition proceedings under the Regulations, as the summary
procedure therein was spent. As Décary J.A. put it in Merck Frosst Canada, supra at paragraph 4, "the appeal
is obviously moot, the Minister having done what he is empowered to do under
subsection 7(1) of the Regulations, i.e. he issued a Notice of
Compliance".
[22] It is my respectful view that no injustice flows from such an
interpretation of the Regulations. The appellants have had the benefit of a
near-automatic interlocutory injunction for a period of 30 months. If they
wished to benefit from an appeal to this Court on the issue of prohibition,
they could have brought their application and appeal expeditiously within the
period of 30 months provided in subparagraph 7(1)(e) of the Regulations, but
they did not. Arguably, the appellants' ability to bring an appeal within that
period would have depended upon the Minister not having exercised his
discretion to issue the NOCs. But that is a fact that the regulation-making
authority provided for by formulating the Regulations in the way it did. I am
of the opinion that it would be wrong for us to disturb that arrangement by
avoiding a decision on the issue of mootness.
[20]
Counsel
for Abbott correctly points out that in Pfizer (supra), the NOC had been
issued. According to Counsel, it is the issuance of the NOC rather than the
expiration of the 30-month statutory stay (now 24-month) which led the Court to
conclude that it could not provide the relief sought.
[21]
Obviously,
where an application for a prohibition order is dismissed and the Minister
proceeds to issue the NOC before the appeal is heard, the jurisdiction of this
Court to prohibit the issuance of the NOC can no longer be invoked. This is
what has led the Court, in the case referred to by Isaac C.J. in the above
quoted passage, and in a number of cases which have since been decided, to
decline to hear appeals from decisions of the Federal Court dismissing
prohibition applications.
[22]
However,
I do not read the reasons of Isaac C.J. as being based on the fact that the NOC
had issued. He does state that the issuance of the NOCs “foreclosed any
attempts to continue prohibition proceedings” and that "arguably, the
appellants’ ability to bring an appeal within that period would have depended
upon the Minister not having exercised his discretion to issue the NOCs".
However, the focus of his analysis rests on the clearly expressed intent that
prohibition proceedings be brought to an end within the statutory stay period.
[23]
Counsel
for Apotex also brought to our attention an earlier decision of the Federal
Court, Trial Division, in Merck Frosst Canada Inc. v. Canada (Minister of
National Health and Welfare) (1997), 72 C.P.R. (3rd) 453
where Rothstein J. (as he then was) held that the Trial Division (now the
Federal Court) can no longer issue a prohibition order once the statutory stay
has expired. In that case, the statutory stay had expired before the
application could be heard. This situation arose by reason of a decision of
the Court of Appeal quashing an extension of time which had been granted by the
Trial Division "until such time as a judgment is rendered on the
merits". When Merck re-applied to extend the time under subsection
7(5) of the NOC Regulations (as they then read), Muldoon J. formulated a
preliminary question as to the status of a prohibition application after the
expiry of a statutory stay. The matter came before Rothstein J. who identified
the issue which he had to decide as follows at p. 455:
What is the status of a
prohibition application brought by a patentee under subsection 6(1) of the
Regulations after expiry of the statutory stay provided under paragraph 7(1)(e)
of the Regulations?
[24]
The
essence of the reasoning adopted by Rothstein J. in holding that he was without
jurisdiction to provide the relief sought by Merck is as follows:
Nothing in the Regulations
expressly provides that the Court loses jurisdiction to extend the statutory
stay or to decide the prohibition application upon the expiry of the statutory
stay. The only express time constraint is in subsection 7(5) with respect to
the issuance of an extension order. The extension order may be made “where the
Court has not yet made an order pursuant to subsection 6(1)”.
While the Court may not
read words into a statute or regulation, a statute or regulation cannot be
considered in the abstract. Regard must be had to the context and scheme of
the provisions at issue.
(at pp. 458-459)
…
Except for the
Regulations, the fact that a generic competitor may be infringing a patent
would not confer on the patentee the right to prevent the Minister from issuing
a NOC, because a NOC is simply a ministerial approval for the purposes of the Food
and Drugs Act, R.S.C. 1985, c. F-27. In the absence of the Regulations,
the question of whether a competitor is entitled to a NOC is one solely between
the competitor and the Minister. Thus, it its only the Regulations that create
a patentee’s right to a prohibition order against the Minister from issuing a
NOC to a competitor.
(at p. 459)
…
It is noteworthy that
while the Regulations provide for automatic and then Court ordered prohibition
on the Minister from issuing a NOC, there is nothing in Regulations that
confers on the Court jurisdiction to order certiorari to quash a NOC
that may have been issued after expiry of the statutory stay but which the
Court ultimately finds is based on an allegation of non-infringement that is
found not to be justified. The implication of the silence of the Regulations
as to a remedy for a patentee if a NOC issues after expiry of the statutory
stay based on a non-justified allegation is that once the statutory stay
expires, the Court is without jurisdiction to grant any remedy under the
Regulations.
This view is supported
by the purpose of the Regulations, which is to provide a summary mechanism for
determining whether a generic competitor may compete with a patentee. The
30-month period specified in paragraph 7(1)(e) was prescribed for a purpose.
This was the time frame
within which the Governor-in-Council considered it would be possible to
complete the prohibition proceedings in the absence of failure to reasonably
cooperate in expediting the prohibition application by a party. In Merck v.
Apotex, supra, Strayer J.A. at 9 [p. 178] found that the Regulations
contemplate that matters “proceed at a pace likely to allow a hearing of the
application before the expiration of a (not unreasonable) period of 30 months”.
(at pp. 459-460)
…
It would be inconsistent
with the expeditious way in which proceedings under Regulations are to be
carried out to construe the Regulations as continuing the right to prohibition
indefinitely irrespective of the expiry of the statutory stay.
As I have indicated, if
the right to prohibition remains after the expiration of the statutory stay,
one would have expected that the Regulations would also have provided for a
remedy if the Minister issued a NOC before the Court ordered prohibition, i.e. certiorari
to quash the NOC. No such rights or remedies exist in the Regulation. In view
of the prescribed statutory stay, it is difficult to think that the Regulations
envisage a race between the Minister and the Court after expiry of the
statutory stay with no remedy to the patentee in the event that the Minister
issued a NOC for an infringing process before the Court issues a prohibition
order. (at pp. 459-460)
…
Lest the impression be
left that this is a draconian reading of the Regulations, two things should be
noted. One is that a patent infringement action is still open to Merck.
In such action the Court has jurisdiction to order an interlocutory injunction,
a permanent injunction and/or damages. Thus Merck is not left without a
remedy. Second, the circumstances in this case are unusual. They arise
because of the decision by he Federal Court of Appeal which overturned the
decision by Dubé J. of the Trial Division that extended time. While I cannot
rule out other situations arising, I have no doubt in view of the Federal Court
of Appeal’s decision, that applicants litigating under the Regulations will
ensure, if necessary by seeking an expedited hearing under Rule 327.1 of the Federal
Court Rules, that cases are decided before expiry of the statutory stay and
that when extensions are necessary under subsection 7(5) of the Regulations,
they will be applied for well before expiry of the statutory stay.
(at p. 461)
…
In the circumstances, I
am satisfied that upon expiry of the statutory stay the Court no longer has
jurisdiction to issue a prohibition order under subsection 6(2) and an
extension order under subsection 7(5).
(at p. 461)
…
[25]
I
agree with this conclusion and with the reasoning advanced for reaching it.
[26]
Counsel
for Abbott points out that Rothstein J. was dealing with the jurisdiction of
the Federal Court (Trial Division). According to Counsel, this Court’s
jurisdiction to hear appeals from final decisions of the Federal Court pursuant
to section 27 of the Federal Courts Act, R.S.C. 1985, c. F-7 (“the
Federal Courts Act”) is unaffected by the reasoning advanced by Rothstein J. Counsel
submits that, absent a clear indication to the contrary, effect must be given
to the right of appeal provided under the Federal Courts Act.
[27]
In
my respectful view, the reasoning of Rothstein J. does reveal a clear legislative
intent that prohibition proceedings be brought to a final end within the 24-month
statutory stay period provided in paragraph 7(1)(e) of the NOC Regulations or
any extension thereof granted within that period pursuant to subsection 7(5).
Allowing proceedings to continue after the statutory stay has expired, regardless
of the forum where the proceedings happen to lie, is inconsistent with that
intent and undermines the arrangement prescribed by the Governor-in-Council
under the NOC Regulations.
[28]
As
was stated by Strayer J.A. in the passage quoted by Isaac C.J. (see para. 19
above), this 24-month period was no doubt intended to focus the minds of the
parties and the Court on the summary nature of the proceedings and the need for
their expeditious prosecution. It is the absence of focus on this time frame
which has given these summary proceedings over time the ponderous character of
patent infringement actions commonly known to last numerous days and sometimes
weeks. The end result is that judicial resources are increasingly being consumed
by these so called summary proceedings at the expense of other jurisdictions which
advance more obvious public policy concerns. In my respectful view, an
application for prohibition comes to a final end after the 24-month period has
expired.
[29]
Since
more than 24 months have passed since the filing of Abbott’s application for
the issuance of a prohibition order and since the order extending this period
expired on December 30, 2006, I conclude that this Court, like the Federal
Court, no longer has the jurisdiction to issue the order sought by Abbott.
[30]
Given
this conclusion I need not address Apotex’ contention that the same result
arises where an application for a prohibition is dismissed by the Federal Court
before the expiration of the 24-month period (or any extension thereof).
[31]
Since
this is the first decision which deals squarely with the impact of the
expiration of the statutory stay period on the jurisdiction of this Court, it
is prudent to nevertheless address the merits of the appeal on the assumption
that the Court does have the jurisdiction to provide the relief sought by
Abbott.
MERITS
[32]
Turning
to the first issue raised on appeal, claim 31 reads:
The use of
[clarithromycin] Form 0-ethanolate in the preparation of [clarithromycin] Form
II for use as an antibiotic.
[33]
Abbott
does not dispute Henegan J’s conclusion that claim 31 is not a claim for the
“medicine itself”. The sole issue is whether Henegan J. correctly held that
claim 31 is not an eligible claim under the NOC Regulations because it is not
(section 2) “… a claim for the use of the medicine for the diagnosis,
treatment, mitigation or prevention of a disease, disorder or abnormal physical
state, or the symptoms thereof”.
[34]
Abbott
submits that Heneghan J. erred in holding that claim 31 is not a claim for the
use of the medicine. The applications judge concluded that claim 31 “claims
the use of Form 0 to make something else, that is Form II” (Reasons, at para.
120). In so doing, according to Abbott, she erred by giving no meaning to the
words “for use as an antibiotic” in claim 31.
[35]
When
given a purposive construction, Abbott submits that claim 31 is a claim for the
use of a medicine, thereby rendering it eligible for inclusion on the Patent List.
In other words, had the phrase “for use as an antibiotic” not been disregarded,
an eligible use would have been found.
[36]
In
this respect, Abbott submits that claim 31 should be read with claim 30 which
is identical to claim 31, but for the fact that the concluding words “for use
as a medicine” are omitted. According to Abbott, these additional words in
claim 31 must be given meaning, and Heneghan J. erred in law, in choosing to
ignore them.
[37]
I
do not believe that Heneghan J. ignored the words “for use as an antibiotic” in
construing claim 31. She refers to that phrase throughout her reasons. On a
fair reading of her reasons, she held that the person skilled in the art would
have read claim 31 as claiming the use of Form 0 to make Form II and considered
that the closing words were not essential to the invention claimed (Reasons, at
para. 104, 120-134). The issue in this appeal is whether this conclusion was
open to her. In my respectful view, it was.
[38]
On
a plain reading of claim 31, it makes a claim to a use of a substance (Form 0 clarithromycin)
in the preparation of another substance (Form II clarithromycin). This is
achieved by heating Form 0 at extreme temperatures (between 70° C and 110°C).
[39]
The
68 claims of the ‘361 Patent vary in scope, but all relate to Form 0 being used
to make Form II. None purports to claim Form 0 clarithromycin as a medicine. Claims
for Form 0 clarithromycin per se and for the use of Form 0 as an antibiotic are
made in Patent 2,277,274 which was filed at the same time as the ‘361 Patent
(Appeal Book, Vol. VI, p. 2270).
[40]
On
the other hand, the use of Form II as an antibiotic is disclosed in Patent
2,258,606 which was filed before the ‘361 Patent and has a claim date which
precedes that of the ‘361 Patent (ibid).
[41]
It
is significant that Abbott’s own expert (Dr. Byrn) omitted the phrase “for use
as an antibiotic” entirely in describing what is claimed by the ‘361 Patent
(Appeal Book, Vol. VI, pp. 2171-2172). In the same vein, Dr. Atwood (who also
provided expert evidence on behalf of Abbott) does not qualify the words “for
use as an antibiotic” as being essential to the claim (Appeal Book, Vol. VII,
p. 2645).
[42]
Moreover,
Form II was known to have but one use, that being use as an antibiotic. Dr.
Byrn indicates so much at para. 296 of his affidavit (Appeal Book, Vol. VI, p.
2333). It is true, as Counsel for Abbott point out, that the statement made by
Dr. Byrn relates to clarithromycin tablets, but Dr. Byrn’s evidence does not
suggest that Form II from which the tablets are made, had any other use.
[43]
Although,
the Court should strive to construe claims which do not bear the same words
differently, Heneghan J. was on solid ground in this case, when she held that
the words “for use as an antibiotic” at the end of claim 31, do not add
anything to the invention claimed. At best, these words describe the utility
of Form II once made in accordance with the claimed invention. The fact that
clarithromycin in Form II is used as an antibiotic was well known. Saying, in
effect, that an antibiotic is used as an antibiotic adds nothing to the
invention.
[44]
Finally,
I note that Henegan J. spoke on occasion of the ‘361 Patent (or parts thereof)
not meeting “the eligibility requirements for inclusion in the Patent List”
(see for instance, Reasons at para. 134). The eligibility of a Patent for
inclusion on the Register is usually raised by way of a separate motion made
pursuant to paragraph 6(5)(a) of the NOC Regulations (see Apotex Inc. v.
Canada (Minister of Health and Welfare), (2000), 3 C.P.R. (4th)
1 (F.C.A.), as applied in Apotex Inc. v. Canada (Minister of Health),
2004 FC 650 at paras. 59 to 64). It does not appear as though such a motion
was made in this instance.
[45]
However,
nothing turns on this as Heneghan J.’s conclusion is properly stated at
paragraph 133 of her reasons where she holds that claim 31 “is ineligible under
the NOC Regulations”.
[46]
Having
decided that Heneghan J. committed no error in reaching this conclusion, we
need not consider Apotex’ alternative contention that the ‘361 Patent is
invalid based on obviousness and anticipation. Had it been necessary to
consider this issue, a continuation of the one-day hearing which had been set
for this appeal on an urgent basis would have been required. I note in this
respect that the hearing before the Federal Court lasted six days, most of
which were spent canvassing prior art and evidence as to anticipation and
obviousness. Since this Court does not have the benefit of prior reasons on
this point, it would have to consider the issue of validity as a matter of
first instance.
[47]
Counsel
for Apotex insisted during the hearing that if it became necessary to deal with
this issue, the matter should be returned before Heneghan J. for adjudication
in order to preserve the parties’ right of appeal. He conveyed to the Court his
client’s undertaking not to raise the issue of jurisdiction before the Federal
Court in order to permit the matter to be referred back. However, this would
not be a proper course of action given that jurisdiction cannot be conferred by
consent.
[48]
It
follows that if this Court does have the jurisdiction to issue the relief sought
by Abbott and if I am wrong on the issue of eligibility, the matter will have
to be remitted back to this Court so that it may hear and dispose of the
allegation that the ‘361 Patent is invalid.
[49]
I
would dismiss the appeal with costs.
“Marc Noël”
NADON J.A.:
[50]
Although I
agree with my colleague Noël J.A., for the reasons that he gives, that Heneghan
J. made no error in concluding that claim 31 of the ‘361 patent was not a claim
for the use of the medicine, I cannot concur in his view that this Court, like
the Federal Court, no longer has jurisdiction to issue the order sought by the
appellants because the statutory stay period of 24 months has expired.
[51]
In
concluding as he does, Noël J.A. relies in great part on the reasoning of
Rothstein J. (as he then was) in Merck Frosst Canada Inc. v. Canada
(Minister of National Health and Welfare) (1997, 72 C.P.R. (3d) 453
(F.C.T.D.). My colleague also relies on this Court’s decision in Pfizer
Canada Inc. v. Apotex Inc., [2001] F.C.J. No. 17.
[52]
In my
view, this Court’s decision in Pfizer, supra, does not support the
conclusion reached by my colleague. In Pfizer, supra, as my colleague
points out at paragraph 17 of his Reasons, by the time the appeal was heard by
this Court, the Minister had already issued a NOC to Apotex. This led Isaac
C.J., who wrote for the Court, to conclude that the appeal had become moot as
the Court could no longer issue the order sought by Pfizer, i.e. an order
prohibiting the Minister from issuing a NOC to Apotex. It is important to note that
Isaac C.J. did not conclude that the Court was without jurisdiction to make the
order sought because the statutory stay had expired, but rather that the Court
would not exercise its jurisdiction because the matter had become moot.
[53]
I
therefore cannot read Isaac C.J.’s Reasons as signifying that proceedings
commenced by a first person under subsection 6(1) of the NOC Regulations cannot
continue beyond the statutory stay of 24 months.
[54]
I now turn
to Rothstein J.’s decision in Merck, supra, wherein he concluded that
upon the expiry of the statutory stay of 30 months (now 24 months), the Court
could no longer issue an order of prohibition under subsection 6(2) of the
Regulations. Rothstein J. came to that conclusion for the following reasons.
[55]
First, the
fact that the NOC Regulations did not allow the Court to order certiorari
to quash a NOC issued by the Minister after the expiry of the statutory stay
led, in his view, to the inevitable conclusion that once the statutory stay had
expired, the Court lost jurisdiction to grant any remedy under the NOC
Regulations. In other words, whether the Minister had issued a NOC or not, the
Court was without jurisdiction once the statutory stay had expired.
[56]
Second,
the purpose the NOC Regulations supported the view that the Court lost its
jurisdiction after the expiry of the statutory stay because the Regulations
provided for a summary mechanism to determine whether a second person could
launch its product on the market.
[57]
Hence,
Rothstein J. found that the purpose of the statutory stay period was to make it
clear to the parties that prohibition proceedings, subject to any extension
that might be given by the Court, were to be completed within the prescribed
timeframe. At page 460, Rothstein J. expressed his view in the following terms:
It would be inconsistent
with the expeditious way in which proceedings under the Regulations are to be
carried out to construe the Regulations as continuing the right to prohibition
indefinitely irrespective of the expiry of the statutory stay.
As I
have already indicated, if the right to prohibition remains after the
expiration of the statutory stay, one would have expected that the Regulations
would also have provided for a remedy if the Minister issued a NOC before the
Court ordered prohibition, i.e. certiorari to quash the NOC. No such
rights or remedies exist in the Regulations. In view of the prescribed
statutory stay, it is difficult to think that the Regulations envisage a race
between the Minister and the Court after expiry of the statutory stay with no
remedy to the patentee in the event that the Minister issued a NOC for an
infringing process before the Court issues a prohibition order.
[58]
I cannot,
with respect, agree with Rothstein J.’s reasoning. In my view, neither the
Federal Court nor this Court loses jurisdiction upon the expiry of the
statutory stay.
[59]
I begin by
setting out subsections 6(1), (2), (3) and section 7 of the NOC Regulations
which are, obviously, of considerable relevance to the determination of the
issue:
|
6. (1) A first person may, within 45 days after
being served with a notice of allegation under paragraph 5(3)(a), apply to a
court for an order prohibiting the Minister from issuing a notice of
compliance until after the expiration of a patent that is the subject of the
notice of allegation.
(2) The court shall make an order pursuant to subsection (1) in respect of
a patent that is the subject of one or more allegations if it finds that none
of those allegations is justified.
(3) The first person shall, within the 45 days referred to in subsection
(1), serve the Minister with proof that an application referred to in that
subsection has been made.
…
7. (1) The Minister shall not issue a notice
of compliance to a second person before the latest of
(a)
[Repealed, SOR/98-166, s. 6]
(b)
the day on which the second person complies with section 5,
(c)
subject to subsection (3), the expiration of any patent on the register that
is not the subject of an allegation,
(d)
subject to subsection (3), the expiration of 45 days after the receipt of
proof of service of a notice of allegation under paragraph 5(3)(a) in respect
of any patent on the register,
(e)
subject to subsections (2), (3) and (4), the expiration of 24 months after
the receipt of proof of the making of any application under subsection 6(1),
and
(f)
the expiration of any patent that is the subject of an order pursuant to
subsection 6(1).
(2) Paragraph (1)(e) does not apply if at any time, in respect of each
patent that is the subject of an application pursuant to subsection 6(1),
(a)
the patent has expired; or
(b)
the court has declared that the patent is not valid or that no claim for the
medicinal ingredient, no claim for the formulation, no claim for the dosage
form and no claim for the use of the medicinal ingredient would be infringed.
(3) Paragraphs (1)(c), (d) and (e) do not apply in respect of a patent if
the owner of the patent has consented to the making, constructing, using or
selling of the drug in Canada by the second person.
(4) Paragraph (1)(e) ceases to apply in respect of an application under
subsection 6(1) if the application is withdrawn or discontinued by the first
person or is dismissed by the court hearing the application.
(5) If the court has not yet made an order under subsection 6(1) in respect
of an application, the court may
(a)
shorten the time limit referred to in paragraph (1)(e) on consent of the
first and second persons or if the court finds that the first person has
failed, at any time during the proceeding, to reasonably cooperate in
expediting the application; or
(b)
extend the time limit referred to in paragraph (1)(e) on consent of the first
and second persons or, if the court finds that the second person has failed,
at any time during the proceeding, to reasonably cooperate in expediting the
application.
|
6. (1) La première personne peut, au plus tard
quarante-cinq jours après avoir reçu signification d’un avis d’allégation aux
termes de l’alinéa 5(3)a), demander au tribunal de rendre une ordonnance
interdisant au ministre de délivrer l’avis de conformité avant l’expiration
du brevet en cause.
(2) Le tribunal rend une ordonnance en vertu du paragraphe (1) à l’égard du
brevet visé par une ou plusieurs allégations si elle conclut qu’aucune des
allégations n’est fondée.
(3) La première personne signifie au ministre, dans la période de 45 jours
visée au paragraphe (1), la preuve que la demande visée à ce paragraphe a été
faite.
…
7. (1) Le ministre ne peut délivrer un avis de
conformité à la seconde personne avant la plus tardive des dates suivantes :
a)
[Abrogé, DORS/98-166, art. 6]
b)
la date à laquelle la seconde personne se conforme à l’article 5;
c)
sous réserve du paragraphe (3), la date d’expiration de tout brevet inscrit
au registre qui ne fait pas l’objet d’une allégation;
d)
sous réserve du paragraphe (3), la date qui suit de quarante-cinq jours la
date de réception de la preuve de signification de l’avis d’allégation visé à
l’alinéa 5(3)a) à l’égard de tout brevet ajouté au registre;
e)
sous réserve des paragraphes (2), (3) et (4), la date qui suit de 24 mois la
date de réception de la preuve de présentation de la demande visée au
paragraphe 6(1);
f)
la date d’expiration de tout brevet faisant l’objet d’une ordonnance rendue
aux termes du paragraphe 6(1).
(2) L’alinéa (1)e) ne s’applique pas si, à l’égard de chaque brevet visé
par une demande au tribunal aux termes du paragraphe 6(1) :
a)
soit le brevet est expiré;
b)
soit le tribunal a déclaré que le brevet n’est pas valide ou qu’aucune
revendication de l’ingrédient médicinal, revendication de la formulation,
revendication de la forme posologique ni revendication de l’utilisation de
l’ingrédient médicinal ne seraient contrefaites.
(3) Les alinéas (1)c), d) et e) ne s’appliquent pas à l’égard d’un brevet
si le propriétaire de celui-ci a consenti à ce que la seconde personne
utilise, fabrique, construise ou vende la drogue au Canada.
(4) L’alinéa (1)e) cesse de s’appliquer à l’égard de la demande visée au
paragraphe 6(1) si celle-ci est retirée ou fait l’objet d’un désistement par
la première personne ou est rejetée par le tribunal qui en est saisi.
(5) Lorsque le tribunal n’a pas encore rendu d’ordonnance aux termes du
paragraphe 6(1) à l’égard d’une demande, il peut :
a)
abréger le délai visé à l’alinéa (1)e) avec le consentement de la première
personne et de la seconde personne, ou s’il conclut que la première personne
n’a pas, au cours de l’instance relative à la demande, collaboré de façon raisonnable
au règlement expéditif de celle-ci;
b)
proroger le délai visé à l’alinéa (1)e) avec le consentement de la première
personne et de la seconde personne, ou s’il conclut que la seconde personne
n’a pas, au cours de l’instance relative à la demande, collaboré de façon
raisonnable au règlement expéditif de celle-ci.
|
[60]
First, let
me set out my view of the Regulations and, in particular, my view of the
significance of the statutory stay period of 24 months. The clear purpose of
that timeframe is to prevent the Minister from issuing a NOC to a second person
prior to the expiry of the statutory stay period. By reason of section 7 of the
Regulations, however, the first person is clearly put on notice that it must
complete its proceedings within the statutory timeframe, failing which the
Minister will be at liberty to issue a NOC to a second person. No extensions of
the statutory stay period will be given by the Court, unless both the first and
second persons consent thereto or where the Court finds that the second person
has failed to “reasonably cooperate in expediting the application” (subsection
7(5)(b) of the Regulations).
[61]
Thus, once
the 24 months expire, the Minister may issue a NOC to a second person unless
there is an order of prohibition preventing him from doing so. However, it does
not necessarily follow, in my view, that upon the expiry of the statutory stay
period, the Court can no longer make an order of prohibition under subsection
6(1). As I indicated earlier in discussing the Reasons of Isaac C.J. in Pfizer,
supra, the Court did not refuse to make the order sought in that case by
reason of a lack of jurisdiction, but because the appeal had become moot by
reason of the issuance of a NOC by the Minister.
[62]
Second,
there is nothing in the Regulations which expressly or implicitly provides that
the Court is without jurisdiction to make an order of prohibition once the
statutory stay period has expired.
[63]
Third,
there cannot be any dispute that section 7, other than subsection (5) thereof,
is solely directed at the Minister and provides in express terms when the
Minister may issue a NOC to the second person. Subsection 7(5) sets out those
instances where the Court may either shorten or extend the statutory time
period. However, there is nothing in section 7 which could, in my view, lead to
the conclusion that the proceedings commenced by the first person under
subsection 6(1) must necessarily be completed within the statutory stay period
and, hence, that the Federal Court and this Court lose jurisdiction upon the
expiry of that period.
[64]
Subsections
6(1) and (2), on the other hand, clearly address the order which the Federal
Court is asked to make by a first person and there is nothing in those
provisions which suggests that the proceedings must be completed within the
statutory stay period set out at section 7.
[65]
Thus,
there is no timeframe in which the Federal Court and this Court must make the
order sought by a first person other than the real possibility that the matter
may become moot if no order is made prior to the issuance of a NOC by the
Minister. Consequently, if at the end of the statutory stay period there is no
order of prohibition, the Minister, as directed by section 7 of the
Regulations, may issue a NOC to a second person. If he does, the matter before
the Court will become moot. However, if after the expiry of the 24 months the
Minister has not yet issued a NOC to a second person, the Federal Court and
this Court may still make an order of prohibition. In such circumstances, it is
my view that the Minister will be prevented from issuing a NOC to a second
person.
[66]
I again repeat that
there is nothing in section 7 which says or suggests that the order made
pursuant to subsection 6(1) must be made before the expiry of the statutory
stay. Hence, in my view, the order referred to in paragraphs 7(1)(f) can
be made after the expiry of the statutory stay. Consequently, where after the
expiry of the 24 months the Minister has not issued a NOC to a second person,
he may be prohibited from so doing if the Court makes the appropriate order.
[67]
The essence of my
colleague’s conclusion on the issue of jurisdiction appears clearly from
paragraphs 27 and 28 of his Reasons, which I reproduce for ease of reference:
[27] In my respectful view, the
reasoning of Rothstein J. does reveal a clear legislative intent that
prohibition proceedings be brought to a final end within the 24-month statutory
stay period provided in paragraph 7(1)(e) of the NOC Regulations or any
extension thereof granted within that period pursuant to paragraph 7(5).
Allowing proceedings to continue after the statutory stay has expired,
regardless of the forum where the proceedings happen to lie, is inconsistent
with that intent and undermines the arrangement prescribed by the Governor in
Council under the NOC Regulations.
[28] As was stated by Strayer J.A. in
the passage quoted by Isaac C.J. (see para. 19 above), this 24-month period was
no doubt intended to focus the minds of the parties and the Court on the
summary nature of the proceedings and the need for their expeditious
prosecution. It is the absence of focus on this time frame which has given
these summary proceedings over time the ponderous character of patent
infringement actions commonly known to last numerous days and sometimes weeks.
The end result is that judicial resources are increasingly being consumed by
these so called summary proceedings at the expense of other jurisdictions which
advance more obvious public policy concerns. In my respectful view, an
application for prohibition comes to a final end after the 24-month period has
expired.
[68]
I have two comments
to make. The first one is that even if it were true that judicial resources are
being utilized in great numbers by first and second persons “at the expense of
other jurisdictions which advance more obvious public policy concerns”, that
does not constitute a valid reason for concluding that the expiry of the
statutory stay terminates the Federal Court’s and this Court’s jurisdiction in
regard to an application brought under subsection 6(1). Second, as I hope to
have shown, there is no basis whatsoever for concluding that the Regulations
reveal a clear legislative intent that prohibition proceedings be absolutely
terminated after 24 months.
[69]
One last comment. If
Noël J.A. is right, unless the parties mutually agree to an extension of time
pursuant to paragraph 7(5)(b), it will be difficult to have appeals
heard by this Court and impossible to have appeals heard by the Supreme Court
of Canada.
[70]
I am therefore unable
to conclude that the order sought by the appellants cannot be made after the
expiry of the 24 months. In other words, I am of the opinion that had we taken
a different view of the appeal on its merits, it would have been open to us to
prohibit the Minister from issuing a NOC to Apotex.
[71]
However, since the
appellants have failed to persuade us that Heneghan J. made any error in
holding that claim 31 of the patent is not an eligible claim under the
Regulations, I would dismiss the appeal with costs.
“M. Nadon”
“I concur
Alice Desjardins J.A.”
Email this Content