Date: 20090715
Docket: T-2100-07
Citation: 2009 FC 721
Ottawa, Ontario, July 15, 2009
PRESENT: The Honourable Mr. Justice Beaudry
BETWEEN:
APOTEX
INC.
Applicant
and
THE MINISTER OF HEALTH and
ASTRAZENECA CANADA INC.
Respondents
REASONS FOR JUDGMENT AND
JUDGMENT
[1]
This
is an application for judicial review, pursuant to section 18.1 of the Federal
Courts Act, R.S.C., 1985, c. F-7, by Apotex Inc. in respect of the refusal
of the Respondent, the Minister of Health, to process Apotex’s Supplementary
New Drug Submission (SANDS) seeking to change the Product Monograph for its
Apo-Omeprazole 20 mg capsules to add an indication for the use of the capsules
in combination with antibiotics for the eradication of H. pylori, in
accordance with Part C of the Food and Drug Regulations, C.R.C., c. 870.
Specifically, the Applicant seeks orders in the nature of declaration and mandamus.
Factual Background
[2]
The
Applicant, Apotex Inc., is an Ontario drug company who
produces and distributes a variety of pharmaceutical products. Most of Apotex’s
drug products are termed “generic” in the sense that they are formulations of
active medicinal ingredients which have already been brought to market by other
manufacturers companies in Canada. Apotex’s products are approved for sale
by the Minister as therapeutically equivalent to the original brand formulation
of the same active medicinal ingredient.
[3]
The
Respondent AstraZeneca Canada Inc. received the original Notice of Compliance
(NOC) for its 20 mg Omeprazole capsules, known under the brand name LOSEC, on
June 13, 1989. Eight patents were listed on the patent register under the Patented
Medicines (Notice of Compliance) Regulations (SOR/93-133, as amended
SOR/98-166, SOR/99-379, SOR/2006-242 and SOR/2008-211) (PM (NOC) Regulations)
in respect of the Canadian reference product LOSEC 20 mg capsules: Canadian
Patents Nos. 1,292,693 (the ‘693 patent), 1,302,891 (the ‘891 patent),
2,025,668 (the ‘668 patent), 2,133, 762 (the ‘762 patent), 1,338,377 (the ‘377
patent), 2,180,535 (the ‘535 patent), 2,186,037 (the ‘037 patent) and 2,284,470
(the ‘470 patent).
[4]
On
January 27, 2004, the Minister issued a NOC to Apotex in respect of submission
054341 for 20 mg Apo-Omeprazole capsules based, in part, upon a bioequivalence
comparison to Respondent AstraZeneca’s brand name LOSEC 20 mg capsules. On January 4, 2006, the
Minister issued a revised NOC, to reflect that AstraZeneca’s drug LOSEC 20 mg
served as the Canadian reference product against which Apotex made the
comparisons to demonstrate bioequivalence.
[5]
In
obtaining this NOC, Apotex was required to address the patents listed by
serving a Notice of Allegation (NOA) in respect of each patent, pursuant to the
PM (NOC) Regulations. Apotex was exempted by the Court from addressing the ‘037
patent and the ‘470 patent because the PM (NOC) Regulations were not
applicable, as confirmed by the Supreme Court of Canada in AstraZeneca
Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] 2 S.C.R.
560.
[6]
In
respect of the remaining NOAs, Apotex was successful in prohibition proceedings
commenced by AstraZeneca in five cases (regarding the ‘668 patent, the ‘762
patent, the ‘693 patent, the ‘891 patent and the ‘377 patent). In respect of
the sixth, the ‘535 patent, AstraZeneca did not commence a proceeding in
response to the NOA. In respect of the ‘668 and the ‘762 patents, Apotex
alleged non-infringement and asserted that it would not use, make or sell its
product for the uses claimed by the two patents.
[7]
On
April 21, 2005, Apotex filed a supplemental submission (SANDS), supplement
098243, with the Minister, seeking approval for a proposed change to its
Product Monograph for Apo-Omeprazole 20 mg capsules to add an indication for
the use of the capsules in combination with antibiotics for the eradication of H.
pylori.
[8]
There
were eight patents listed on the register in respect of LOSEC 20 mg capsules at
the time Apotex filed its SANDS. These were the same patents which were on the
register at the time that Apotex obtained its NOC for Apo-Omeprazole 20 mg
capsules.
[9]
Regarding
its SANDS, Apotex did no further bioequivalence studies, acquired no further
LOSEC 20 mg capsules and made no changes to its original submission which had
led to obtaining its NOC in 2004, except that the SANDS now sought the
additional indication previously omitted by which the ‘668 and ‘762 patents
were attracted.
[10]
Because
Apotex sought approval for the additional indication, thereby attracting the
‘668 and ‘762 patents, Apotex served a NOA in respect of these two patents,
alleging invalidity of the patents in order to be able to make, use and sell
its Apo-Omeprazole 20 mg capsules for the patented use. A prohibition
application was commenced in court file no. T-985-05 before this Court, which was
dismissed by Justice Barnes on June 28, 2007 (AstraZeneca AB v. Apotex Inc.,
2007 FC 688, 314 F.T.R. 177).
[11]
By
letter dated April 28, 2005, the Minister’s officials notified Apotex that its
SANDS had been transmitted for review. On July 6, 2005, Apotex was
informed by letter that the examination of the supplement was complete and that
the NOC would not be issued until the requirements of the PM (NOC) Regulations
were met. The supplement was accordingly placed on “patent hold” on that date.
[12]
In
correspondence with the Office of Patented Medicines and Liaison (OPML)
starting in June 2007, Apotex requested immediate issuance of the NOC on the
basis of the decision in Court file no. T-985-05. Apotex argued that the
remaining patents are not relevant to its SANDS, that they did not use the
subject matter of any of the patents in relation to the supplemental
submission, and that the patents had been addressed in relation to the NOC
issued previously.
[13]
The
Declaration Re: Patent List (Form V) which Apotex had filed with the supplement
indicated its acceptance that the NOC would not issue until the declared
expiration date of each patent, so the OPML requested updated Form Vs and
corresponding NOAs and proofs of service for each of the eight listed patents. Apotex
then filed updated Form V’s with respect to all of the patents, alleging
invalidity and/or non-infringement.
[14]
By
letter in response dated August 15, 2007, the OPML agreed that the ‘668 and
‘762 patents (and the ‘535 patent, not in issue in this application) no longer
barred issuance of a NOC. However, Apotex was required to address all of
the remaining patents listed on the register in respect of LOSEC 20 mg capsules
pursuant to section 5 of the PM (NOC) Regulations (the ‘693, ‘891, ‘377, ‘037
and ‘470 patents). The OPML applied its approach in light of the Supreme Court
of Canada’s decision in AstraZeneca, above, followed in Ferring Inc.
v. Canada (Minister of Health), 2007 FC 300, [2008] 1 F.C.R. 19 (F.C.),
aff’d 2007 FCA 276, 370 N.R. 263. The Minister indicated that the OPML was “not
in a position to determine whether an allegation in respect of a particular
patent is justified for the purpose of section 5. Rather, such determinations
are to be made by the Federal Court.”
[15]
By
letter dated August 27, 2007, Apotex disputed the OPML’s reasoning, arguing
that it was contrary to the decisions of the Supreme Court of Canada in Bristol-Myers
Squibb Co. v. Canada (Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533 (Biolyse)
and AstraZeneca, above. Apotex argued that the OPML should compare the
subject matter of the patents to that of the generic submission, determine
whether they are relevant to one another and, if they are not, exempt the
submission from compliance with the PM (NOC) Regulations. Apotex repeated that
the patents had bee addressed in its original submission, therefore they did
not have to be addressed again in relation to its SANDS.
[16]
By
letter dated November 26, 2007, the OPML distinguished the decisions in Biolyse
and AstraZeneca, maintained the view that the OPML is not in a position
to determine whether there has been early-working or infringement of a given
patent and repeated that the Regulations Amending the Patented Medicines
(Notice of Compliance) Regulations, SOR/2006-242 (the October 5, 2006
Amended Regulations) applied. In summary, the OPML considered that Apotex was
required to fulfill the requirements of section 5 of the PM (NOC) Regulations
in respect of the ‘693, ‘891, ‘377, ‘037 and ‘470 patents.
[17]
This
application for judicial review was commenced on December 3, 2007. AstraZeneca
Canada Inc., as the innovator in respect of the patents at issue, sought to be
added as a Respondent and was added, on consent, by order dated April 24, 2008.
[18]
According
to its Notice of Application, Apotex is not seeking judicial review of the
Minister’s refusal to process its SANDS. Rather, Apotex states that it is
seeking orders in the nature of declaration and mandamus.
Legislative Framework
[19]
The
relevant legislative provisions are contained in Appendix A at the end of this
document.
[20]
In
Canada, the sale of
pharmaceutical products is subject to both federal and provincial regulatory
control. In order to sell and to advertise for the sale of a new drug in Canada, every drug
manufacturer must obtain a Notice of Compliance (NOC) for that drug from the
Minister pursuant to the provisions of the Food and Drugs Act, R.S.,
1985, c. F-27 and the Food and Drug Regulations.
[21]
Section
C.08.004 of the Food and Drug Regulations directs that a drug
manufacturer may obtain a NOC in respect of a new drug only after submitting a
New Drug Submission (NDS), filed by an innovative drug manufacturer for a new
drug product, or an Abbreviated New Drug Submission (ANDS), filed by a generic
company that claims its product is bioequivalent to a drug that has been
previously approved (a Canadian reference product). A Canadian reference
product is a drug in respect of which a NOC has been granted and is marketed in
Canada (section
C.08.001.1 of the Food and Drug Regulations).
[22]
An
ANDS usually contains voluminous clinical trial data and detailed studies and
pursuant to section C.08.002 of the Food and Drug Regulations, it must
include descriptions of the benefits claimed, the adverse reactions
experienced, the chemical composition of the ingredients and the methods of
manufacture and purification, all in sufficient detail to enable the Minister
to assess the safety and effectiveness of the new drug. The examination process
then conducted by the Minister can take several years (Biolyse, above at
paras. 13-15).
[23]
With
an ANDS, a generic company must satisfy the Minister that its generic
copy of a Canadian reference product is safe and effective by comparing the two
products to show that they are bioequivalent (section C.08.002.1 of the Food
and Drug Regulations). The generic drug must be the pharmaceutical
equivalent of the Canadian reference product (section C.08.001.01 of the Food
and Drug Regulations), meaning that in comparison with the Canadian
reference product, the generic drug contains identical amounts of the identical
medicinal ingredients, in comparable dosage forms, but does not necessarily
contain the same non-medicinal ingredients.
[24]
The
properties, claims, indications, conditions of use, and any other information
that may be required for the optimal, safe, and effective use of a drug are
described in a document called a Product Monograph. For a generic drug, the
conditions of use must fall within the conditions of use of the Canadian
reference product (paragraph C.08.002.1 (1)(d), Food and Drug
Regulations). Thus, a generic company is required to rely on the
information contained in the Product Monograph for the Canadian reference
product.
[25]
After
a NOC has issued, any significant changes to the drug (or to the information
regarding the drug contained in the previous submission) are made by filing a
supplement to the NDS or ANDS (SNDS or SANDS). The supplement must also receive
a NOC before the modified drug may be marketed (section C.08.003 of the Food
and Drug Regulations).
[26]
The
addition of a new use for a generic drug requires such a supplemental
submission (subparagraph C.08.003 (2)(h)(iii) of the Food and Drug
Regulations). However, when a generic drug company files a supplemental
submission seeking approval for a new use, it is not required to include
material to re-establish bioequivalence with the Canadian reference product.
Rather, the establishment of bioequivalence that was originally required for
the approval of the generic’s underlying submission is considered to remain
effective.
[27]
The
PM (NOC) Regulations were enacted by the Governor in Council pursuant to
subsection 55.2(4) of the Patent Act, R.S., 1985, c. P-4. For the
determination of whether a drug is safe and effective, a submission enters into
the drug review process conducted by the Therapeutic Products Directorate (TPD)
at Health Canada. In the case
of an NDS, if the Minister is satisfied that the submission demonstrates the
safety and effectiveness of the drug, a NOC is issued. In the case of an ANDS,
a final patent check is performed by the OPML. If the NOC would be issuable but
for the operation of the PM (NOC) Regulations, the drug’s sponsor is so
notified. The submission is then placed on “patent hold”, with no NOC issued
until all the requirements under the PM (NOC) Regulations have been met. On the
other hand, if the PM (NOC) Regulations present no bar, the NOC is issued
forthwith. In other words, even where a generic drug has been found to be safe
and effective, the Minister may not issue a NOC where prohibited by the
patent-related concerns set out in the PM (NOC) Regulations.
[28]
A
generic company seeking a NOC on the basis of a comparison with or
reference to another drug for the purpose of demonstrating bioequivalence
triggers the application of subsection 5(1) of the PM (NOC) Regulations as
enacted in 2006, such that the generic company is required, in its
submission, to address patents listed on the patent register in respect of the
other drug.
[29]
According
to subsection 5(2) as enacted in 2006, the same requirements apply where a
generic company files a SANDS where that supplement seeks a NOC for a
change in formulation, a change in dosage form or a change in use of the
medicinal ingredient. Under the 2006 Amending Regulations, subsection 5(2)
applies explicitly to a generic company who has filed its SANDS prior to
October 5, 2006.
[30]
If
patents listed in respect of the innovator’s drug are to be addressed under
section 5, the generic company proceeds as follows: It either states its
acceptance that a NOC will not issue until each patent expires or makes an
allegation, of which the most common are that the patent is invalid and that
the patent will not be infringed. In practice, the generic company provides
this information by filing out a “Form V: Declaration Re: Patent List” (Form V)
with the submission. If it makes an allegation, the generic company also
provides a notice of allegation (NOA) to the innovator, describing its
allegation. A submission requiring a Form V is considered incomplete without
one, as section 5 specifies that the generic company must address all relevant
patents in the submission. An incomplete submission cannot enter into the drug
review process until the generic company completes it by filing the requisite
Form V. If the submission is complete, it enters into the drug review process
without delay.
[31]
A
generic company who makes an allegation must then serve a notice of allegation
on the innovator under subsection 5(3) of the PM (NOC) Regulations. Within 45
days after service, an innovator may, under section 6, apply to the Federal
Court for an order prohibiting the Minister from issuing a NOC until after the
expiration of the patent that is the subject of the allegation.
Issue
[32]
The
issue to be determined in the case at bar is the following: should this
application be allowed? If the answer is in the affirmative, what is the
appropriate relief?
Analysis
Standard of Review
[33]
Questions
concerning the interpretation of the PM (NOC) Regulations are questions of law,
reviewable upon a standard of correctness (AstraZeneca, above at para.
25; Bayer Healthcare AG v. Sandoz Canada Inc., 2008 FCA 25, 375 N.R. 357
at para. 12).
Applicant’s Submissions
[34]
In
seeking approval of its SANDS, Apotex took steps to re-address two patents on
the patent register which related to the use of Omeprazole 20 mg capsules in
combination with antibiotics. The Minister agrees that Apotex has done so
satisfactorily pursuant to the PM (NOC) Regulations. There is no dispute that
Apotex has satisfactorily addressed the ‘668, ‘762 and ‘535 patents. The only
issue at bar is whether the PM (NOC) Regulations require Apotex to re-address
the remaining five patents on the patent register.
[35]
The
Applicant submits that the other patents on the register have no relevance to
the change proposed in the SANDS and, as such, are not required to be
re-addressed because they have already been addressed in the initial
submission. Apotex filed no new bioequivalence studies in its SANDS but
instead, it relies upon the old comparisons it had made in obtaining its NOC.
Furthermore, Apotex does not seek to make any changes to its Omeprazole 20 mg
capsules which could possibly change its product in a manner which would
attract these patents.
[36]
In
obtaining its original NOC, Apotex had addressed the remaining five patents and
their SANDS is based upon this NOC. The Apotex SANDS at bar is not a new
submission as it is a supplement to a submission which has already been
approved and the underlying NOC met the requirements of the PM (NOC)
Regulations in addressing all of the remaining patents.
[37]
Apotex
submits that the PM (NOC) Regulations do not require it to re-address that
which it has already addressed provided that there is no change in its SANDS
requiring the patents to be re-addressed. There is no proposed change in
Apotex’s SANDS which could possibly attract the remaining patents.
[38]
The
Minister’s position is that he is neither required nor able to turn his mind to
that issue but the jurisprudence shows that the Minister’s position is
incorrect. Had the Minister completed his obligations under the PM (NOC)
Regulations, he would have granted Apotex its NOC. The Minister erred in
interpreting Apotex’s position as asking the Minister to determine whether or
not any particular allegation is justified because Apotex never asked the
Minister to do that. Instead, the Applicant asked the Minister to confirm that,
pursuant to the PM (NOC) Regulations, Apotex was not required to re-address the
five remaining patents as they had already been addressed in obtaining the
initial NOC, which is the role of the Minister under the PM (NOC) Regulations.
[39]
This
Court and the Federal Court of Appeal have held that a generic company who has
already served a NOA in respect of a ANDS is not required to re-address those
patents previously addressed when filing a SANDS. In a situation involving
strikingly similar circumstances, a generic company who had already served a
NOA in respect of a ANDS was not required to re-address those patents when
filing a SANDS where the Minister determined that no new patent issues could
prevent the issuance of an NOC. The Courts further held that the Minister has
the authority and the responsibility to make that determination (see Patented
Medicines (Notice of Compliance) Regulations (Re) (1998), 152 F.T.R. 262,
81 A.C.W.S. (3d) 874 (F.C.T.D.), aff’d. (1999), 249 N.R. 110, 92 A.C.W.S. (3d)
1064 (F.C.A.) at paras. 13-16 and 28-29 (Re Patented Medicines)). In
recent jurisprudence, this Court and the Federal Court of Appeal have confirmed
the Minister’s authority to determine whether particular patents do not need to
be addressed by generic companies (Ferring, above at paras. 63-65).
Respondent Minister’s
Submissions
[40]
The
Respondent Minister of Health submits that Apotex has overlooked subsection
5(2) of the PM (NOC) Regulations, as enacted in October 2006, which explicitly
invokes the application of the PM (NOC) Regulations in relation to a SANDS. In
addition, Apotex’s claim that it did not use the subject matter of the patents
in relation to the supplement amounts to an allegation of infringement. Under
the PM (NOC) Regulations, the innovator of the drug copied by Apotex is
entitled either to make that determination itself or have it determined by the
Court and not by the Minister.
[41]
Apotex
first argues that it has previously addressed the patents in its original
submission which contained the bioequivalence studies; therefore, they should
not have to do so again. However, this entirely disregards the provisions of
subsection 5(2) of the PM (NOC) Regulations, enacted October 5, 2006, which
provides that a SANDS like Apotex’s triggers the application of the PM (NOC)
Regulations in the same way as the ANDS itself does.
[42]
Apotex’s
supplement is one of the types explicitly referred to in the provision, as it
is a submission seeking a NOC for a change in use. Moreover, the 2006 Amending
Regulations at section 7(2) make subsection 5(2) of the PM (NOC Regulations
even more plainly applicable to Apotex’s SANDS.
[43]
The
Minister argues that the decision in Re Patented Medicines, above, is of
no assistance to Apotex because it was based on earlier versions of the PM
(NOC) Regulations which did not include the current subsection 5(2).
Accordingly, Apotex’s argument does not apply here and pursuant to subsection
5(2) of the PM (NOC) Regulations, the fact that Apotex has previously addressed
the patents at issue, in the context of its original submission, does not
exempt it from doing so in respect of its supplement.
[44]
In
its second argument, Apotex states that the Minister must determine that the
new use is not the subject of the patents at issue, and accordingly, he must
process the submission without regard to the PM (NOC) Regulations. Apotex says
that the Minister must compare the subject matter of the patents at issue to
the subject matter of its SANDS in order to determine that one is not relevant
to the other and to exempt the submission from compliance with the PM (NOC)
Regulations. To support this argument, Apotex cites the decisions in AstraZeneca,
Ferring and Re Patented Medicines. However, the Respondent
Minister submits that those cases involved different facts and different
reasoning which do not apply to the facts in the case at bar or to the current
legislative context. Furthermore, the responsibility for the determination that
Apotex ascribes to the Minister is actually within the mandate given not to the
Minister by the Governor in Council but to the Court.
[45]
In
deciding AstraZeneca and Ferring, the Courts developed and
applied the notion of a “patent-specific analysis” to conclude that a generic company
is not always required to address every patent listed against a drug it
seeks to copy. However, these cases required the analysis of issues of timing
and not of issues of subject matter. In AstraZeneca, different versions
of the innovator’s drug were available on the market at different times and the
Supreme Court held that the generic company was not required to address patents
that had been listed in respect of the version of the innovator drug that was
available only after the generic company had conducted its comparative tests.
In Ferring, the Minister applied the timing test described in AstraZeneca
and in three of the four instances comprised in the Ferring case, did
not require the generic companies to address such patents and issued
NOCs to them.
[46]
In
Novopharm v. Sanofi-Aventis, Court file no. T-2220-06, one of the cases
contained in the Ferring decision (see Ferring, above at paras.
111 and 117), the generic company had argued, as Apotex does here, that the
Minister should have applied not only a timing test, but also a test involving
a comparison of the subject matter of the patents to the subject matter of the
submission. The Minister refused to do so and this Court upheld that decision.
Even in AstraZeneca, the Supreme Court recognized that if the timing
test had not exempted the generic company, the patents would at least have to
be addressed. However, in AstraZeneca and in Ferring, the Court
did not, as stated by Apotex, extend the Minister’s responsibilities to include
any test involving a subject matter comparison between the innovator’s patent
and the generic’s submission.
[47]
AstraZeneca’s timing
test has been superseded by the 2006 Amending Regulations. Prior to the
decision, under the legislative provisions at issue in AstraZeneca, a
generic company was required to address all patents listed by an
innovator against the Canadian reference product, including any listed between
the time the generic filed its ANDS and the issuance of the NOC. The
application of AstraZeneca’s timing test in cases to which the 2006
Amending Regulations apply is thus neither necessary nor appropriate.
[48]
The
Respondent Minister specifies that the comparison of the subject matter of the
patent to that of Apotex’s submission is to be made by the Court and not by the
Minister. The comparison may first be made by the innovator who may decide that
its patent will not be infringed and choose not to initiate an application
under section 6 of the PM (NOC) Regulations upon receipt of Apotex’s allegations.
If it does choose to do so, the Court will determine whether Apotex’s
allegation that the innovator’s patent will not be infringed is justified. In
other words, the question that Apotex says should be determined in its favour
by the Minister is the kind of question that the Governor in Council has
directed to be determined in the Court proceeding resulting from the right
granted to an innovator in section 6 of the PM (NOC) Regulations.
[49]
The
Respondent Minister notes that in Apotex Inc. v.
Canada (Attorney General), [1994] 1 F.C. 742, (C.A.) aff’d [1994] 3 S.C.R. 1100, the Applicant sought an Order
requiring the Minister of Health to issue a NOC for one of its drugs. The Court
reviewed some 50 years of jurisprudence and ruled that, as affirmed by the Supreme
Court, that “several principal requirements must be satisfied before mandamus
will issue”, and articulated those requirements. The law has been clearly
established for many years that the Court will not issue an order of mandamus
unless the Applicant first shows that it satisfies certain specific
requirements as conditions precedent. The most fundamental of these
requirements may be summarized as such: the Applicant must show that it has a
clear right to the performance of a public legal duty owed to the Applicant at
the time of the hearing.
[50]
Here, Apotex seeks orders requiring the Minister
to process its submission immediately, and an order requiring the Minister to
“prioritize” the review of its supplement “on the basis of a filing date of April 21, 2005”. However, Apotex has presented
neither evidence nor argument to show that it has satisfied the conditions
precedent established by the jurisprudence.
Respondent’s
AstraZeneca’s Submissions
[51]
It
is trite law that the words of an Act and Regulations are to be read in their
entire context and in their grammatical and ordinary sense harmoniously with
the scheme of the Act, the object of the Act and the intention of Parliament (AstraZeneca,
above at para. 26). The duty of the courts is to give effect to the intention
of the legislature as expressed in the words of the statute. This follows from
the constitutional doctrine of the supremacy of the legislature when acting
within its legislative powers. The fact that the words would give an
unreasonable result when interpreted, however, is certainly ground for the
courts to scrutinize a statute carefully to make abundantly certain that those
words are not susceptible of another interpretation (Barton No-till Disk
Inc. v. Dutch Industries Ltd., 2003 FCA 121, [2003] 4 F.C. 67 at para. 41).
[52]
Apotex
submits that the Minister has misconstrued the PM (NOC) Regulations but fails
to put forth any arguments relating to the applicable provisions. The
Respondent AstraZeneca respectfully submits that the Minister was correct to
apply subsection 5(2) of the currently enacted PM (NOC) Regulations,
specifically by virtue of subsection 7(2) of the 2006 Amending Regulations.
[53]
Because
Apotex’s SANDS was filed on April 21, 2005, subsection 5(2) of the PM (NOC)
Regulations, as currently enacted, is applicable because this subsection is
triggered when the supplement seeks approval for a “change in use” of the
medicinal ingredient pursuant to section C.08.003(2)(h)(iii) of the Food
and Drug Regulations, as in the case of Apotex’s supplement, which seeks
approval for a new use of Apo-Omeprazole for the eradication of H. pylori.
[54]
According
to the plain and ordinary terms of subsection 5(2), which states that Apotex shall
make the requisite statement or allegation with respect to each patent on the
register as of October 5, 2006 in respect of AstraZeneca’s LOSEC 20 mg capsules
in its SANDS, the Minister’s decision was correct.
[55]
The
Supreme Court of Canada has accepted that the general purpose of the PM (NOC)
Regulations is to protect the rights of patentees by preventing generic companies
from marketing their products until the expiry of all relevant patents. The
Supreme Court has stated that: “It seems clear that the NOC Regulations were
introduced to help generic drug companies and at the same time curb potential
patent abuse by them.” (Biolyse, above at paras. 45-47).
[56]
If
a generic company is not required to address a patent, the innovator will not
have the opportunity to determine in Court whether the generic company will
infringe their patent when they market their product. The requirement to make
an allegation under section 5 is therefore critical to the protection of the
innovator’s patent rights. When a generic company relying on an
innovator’s drug files a SANDS related to a change in formulation, a change in
dosage form or a change in use, because these are substantive submissions that
have the potential to bear on patent infringement, this triggers a reasonable
presumption that the generic company has early-worked the invention and therefore
must address the patents on the patent register.
[57]
The
Respondent AstraZeneca submits that the PM (NOC) Regulations cannot bear the
interpretation urged by Apotex because by reading the text of subsection 5(2)
in its context, mindful of the scheme and object of the PM (NOC) Regulations
and the intention of Parliament, the grammatical and ordinary sense of the
words does not lead to the absurd result suggested by Apotex. The
interpretation of subsection 5(2) urged by Apotex would require a fundamental
re-writing of the provision. Parliament wanted section 5 of the PM (NOC)
Regulations to mirror the structure of section 4; therefore, it had compared
the language of the two provisions. Yet, Parliament specifically chose not to
include the language of subsection 4(3) in subsection 5(2) of the PM (NOC)
Regulations.
[58]
Requiring
a generic company to address, in its SANDS, patents that may have been
addressed in its initial submissions was contemplated by Parliament in drafting
the 2006 Amending Regulations. These amendments include a provision (section
4.1) which allows innovators to carry forward patent lists submitted in
relation to a NDS by resubmitting them in relation to a supplement to that NDS.
In contrast to the language of section 5 of the PM (NOC) Regulations prior to
October 5, 2006, subsections 5(1) and 5(2) now expressly provide that the
comparison to the innovator drug may occur “directly or indirectly”. In
addition, the previous language that the comparison or reference be “for the
purpose of establishing bioequivalence” was removed. Following this amendment,
a change in use of the medicinal ingredient is now included as a triggering
circumstance in subsection 5(2), notwithstanding that further bioequivalence
studies are not required for such supplements.
[59]
Apotex’s
arguments that the supplement is based upon the original NOC and is not a new
submission, that without the underlying submission the SANDS could not be
applied for or approved, and that no bioequivalence studies were filed in the
supplement, improperly disregard the entire scheme of the PM (NOC) Regulations.
The PM (NOC) Regulations expressly treat a supplement for a new use as a separate
and distinct trigger of a generic company’s obligations.
[60]
The
filing of a SANDS for a change in formulation, a change in dosage form or a
change in use of the medicinal ingredient creates a reasonable presumption that
the submission may bear on patent infringement. Therefore, it would not be
absurd to require a patent to be addressed in relation to such a supplement
even if the patent was addressed in relation to the original submission.
Furthermore, paragraph 6(5)(b) provides for a summary dismissal of a
proceeding “on the ground that it is redundant, scandalous, frivolous or
vexatious or is otherwise an abuse of process in respect of one or more
patents”. Thus, the generic company has recourse if it believes that an
application has no merit. An innovator would not have the opportunity to make
submissions if such a determination would be made by the Minister alone
pursuant to subsection 5(2).
[61]
The
Respondent AstraZeneca submits that the only authority relied upon by Apotex, Re
Patented Medicines, does not apply to the present circumstances because
that decision was based on the PM (NOC) Regulations as originally enacted in
1993, which did not include subsection 5(2).
[62]
Furthermore,
AstraZeneca agrees with the Minister that a consideration of whether Apotex has
early-worked or infringed the patents at issue falls outside the scope of what
is required of the Minister under the PM (NOC) Regulations and is a
consideration for the innovator, who can then refer the matter to the Court
pursuant to section 6 of the PM (NOC) Regulations. If the Minister was required
to review every SANDS filed by a generic company to consider whether it
is relevant to the subject matter of each patent, this would have been
mentioned in the legislative scheme.
[63]
Apotex’s
interpretation of the PM (NOC) Regulations reads in a relevance requirement
into subsection 5(2), linking the subject matter of the listed patents and the
generic company’s drug submission. However, this Court has affirmed, following
the patent-specific analysis articulated by the Supreme Court in AstraZeneca
under the pre-amended PM (NOC) Regulations, that a generic company would
always be required to address patents listed in respect of the innovator drug
before the filing of the ANDS. This analysis considers the previously listed
patents purely from a timing perspective (see Ferring, above; Abbott
Laboratories Limited v. Canada (Attorney General), 2008 FCA 186, 380 N.R.
40; Pharmascience Inc. v. Canada (Minister of Health), 2008 FC
922, [2008] F.C.J. No. 1135 (QL)). Similar early
working arguments (including that the claims are irrelevant to Apotex’s ANDS)
have been rejected by the Court on a subsequent occasion (Solvay Pharma Inc.
v. Apotex Inc., 2008 FC 308, (2007), 323 F.T.R. 1 at para. 61).
[64]
Under the current PM (NOC) Regulations, the
requirement to address patents is now explicitly premised on timing and
subsection 5(4) now limits the patents that are required to be addressed by a generic
company to those listed as of the date it filed its regulatory submission or
supplement, as the case may be. The further timing requirement that the generic
company must have filed its submission before making an allegation will
decrease the risk of a generic company avoiding a patent that would be
infringed.
[65]
The fact that a generic company was not
required to address a patent in relation to its original submission in view of
timing issues does not mean that its original product would not infringe such a
patent. Indeed, regarding the ‘470 and ‘037 patents, the Supreme Court stated
that there was no evidence before it either way as to infringement by Apotex (AstraZeneca,
above at para. 42). Since it is premised on timing
alone, section 5 of the PM (NOC) Regulations is both over and under inclusive.
It is therefore not absurd that certain patents that may not ultimately be
infringed are required to be addressed as this is inherent in the scheme. In
the case at bar, despite Apotex’s assertions, it is not plain that there will
be no infringement.
[66]
Apotex’s argument that the Minister has the
authority to determine whether particular patents do not need to be addressed
is misguided. The issue raised by this application is not the Minister’s
authority but rather the scope of the Minister’s duty in making this
determination. Apotex would impose a duty upon the Minister to consider the
subject matter of the listed patents and to make a comparison to Apotex’s drug
submission. However, it is well established that in determining whether patents
must be addressed, the Minister is acting in a purely administrative capacity.
The evaluation urged by Apotex would go beyond a purely administrative role (Ferring,
above at paras. 77-78).
[67]
AstraZeneca submits that there is no absurdity
in interpreting subsection 5(2) according to its ordinary meaning and requiring
Apotex to address all of the remaining patents at issue. If, despite this, the Court is of the view that the Minister was
required to determine whether the submission at issue relates to the subject
matter of the patents, AstraZeneca submits that insofar as the Minister did not
consider this factor and insofar as the necessary evidence is not before this
Court to make such determination, the matter should be remitted back to the
Minister to make such determination.
Analysis
[68]
Pursuant
to the PM (NOC) Regulations as they read prior to October 5, 2006, a generic
drug company seeking a NOC on the basis of a comparison with or reference to an
innovator’s drug for the purpose of demonstrating bioequivalence triggers the
application of subsection 5(1) such that the generic company must, in the
submission, address each patent on the patent register in respect of the
innovator’s drug. Under the 2006 Amending Regulations, subsection 5(2) applies
to a generic company who has filed a supplemental submission prior to
October 5, 2006.
[69]
According
to subsection 5(2) of the current PM (NOC) Regulations, a generic company who
files a SANDS seeking a NOC for a change in formulation, a change in dosage
form or a change in use of the medicinal ingredient and the supplemental
submission directly or indirectly compares the drug with, or makes reference
to, another drug in respect of which patents are listed on the patent register
must, in the SANDS, address each patent listed on the patent register in
respect of the other drug. In all cases, when addressing the patents listed in
respect of the innovator’s drug under section 5, the second person (the generic
company) must either state its acceptance that a NOC will not issue until each
patent expires or make an allegation. As noted by AstraZeneca in their
submissions, the requirement that the comparison or reference with the innovator’s
drug be for the purpose of establishing bioequivalence as been removed in the
current PM (NOC) Regulations.
[70]
Subsection
5(1) applies to generic company who file “a submission for a notice of
compliance”. Subsection 5(2) applies to a “supplement to a submission referred
to in subsection 5(1)”, whenever a generic company files a SANDS to a
submission for a change in formulation, a change in dosage form or a change in
use of the medicinal ingredient.
[71]
Under
the 2006 Amending Regulations, the PM (NOC) Regulations apply to a generic company
who has filed either a submission or a supplement, as described in
subsections 5(1) and 5(2), respectively, prior to October 5, 2006. The date of
filing for each submission or supplement filed prior to that date is deemed to
be October 5, 2006.
[72]
The
Supreme Court decision in AstraZeneca clarified the law as to which
patents must be addressed by a generic company under section 5 of the PM
(NOC) Regulations as they read prior to the amendments in force on October 5,
2006. Justice Binnie held at paragraph 39 that a “patent-specific analysis” is
necessary and went on to determine that a generic company “is only required to
address the cluster of patents listed against submissions relevant to the NOC
that gave rise to the comparator drug”. All patents added to the patent
register in respect of the comparator drug must be addressed under subsections
5(1) and 5(2) of the PM (NOC) Regulations.
[73]
Following
AstraZeneca, the Minister developed a policy for determining whether
there were patents listed in respect of an innovator drug that a generic
company would not be required to address under section 5 of the PM (NOC)
Regulations. The framework was summarized by Justice Hughes in Ferring,
above at para. 63. Firstly, the Minister would determine the date upon which
the generic company purchased the version of the innovator drug it used for the
purpose of testing for the required bioequivalence comparison. The generic
company would necessarily be required to address any patents listed prior
to that purchase. As explained by Justice Simpson in Pharmascience,
above at para. 32: “AstraZeneca stands for the proposition that a
generic company need only address patents listed against NOC’s filed at the
time it purchases the comparator drug it selects for the purpose of its ANDS.”
[74]
Secondly,
the Minister would consider each NOC issued for the innovator drug after the
date of purchase, in order to determine whether the generic company had
made use of any changes made to the innovator drug since the date of purchase.
If so, the generic company would be required to address patents listed after
the date of purchase in relation to those changes.
[75]
As a
result of certain comments made by Justice Hughes in Ferring, the first
step in the analytical framework adopted by the Minister after AstraZeneca
was changed slightly. Instead of using, as a starting point, the date of
acquisition of the innovator drug for testing purposes, the Minister would use
the date of the filing of the generic company’s ANDS. Thus, the generic company
would always be required to address patents listed in respect of the innovator
drug before the filing date of the ANDS. If an examination of NOCs issued for
the innovator drug after the date indicated that the generic company had made use
of changes made to the innovator drug after that date, the generic company
would be required to address patents listed after that date in relation to
those changes.
[76]
The
current PM (NOC) Regulations constitute relatively new legislation, thus far
only applied on a case-by-case basis. In Ferring at para. 6, the Federal
Court of Appeal confirmed the use of this individual approach: “We have concluded that
the analytical approach adopted by the Minister in these four appeals was
adequate for the factual circumstances of these cases. Whether it is adequate
for all possible circumstances […] is a question upon which we express no opinion.”
[77]
In
the case at bar, the Applicant wants a declaration from the Court that the
requirements of the regulations have been satisfied and alleges that it is
entitled to an order of mandamus because Apotex has already addressed
the remaining five patents on the register that have been listed by the
Minister to be re-addressed.
[78]
Apotex
also argues that the Minister ought to grant the notice of compliance without
requiring him to address the patents because the Minister ought to be able to
decide, and should decide, that the subject matter of the patents is not the
same as the subject matter of its SANDS.
[79]
The
Federal Court of Appeal in Pharmascience Inc. v. Canada (Minister of Health),
2009 FCA 183 recently upheld by Justice Simpson in Pharmascience Inc. v.
Canada (Minister of Health), 2008 FC 922 and concluded that the Minister
erred in law by failing to perform the patent- specific analysis mandated by
the Supreme Court's decision in AstraZeneca v. Canada (Minister of Health),
2006 SCC 49, [2006] 2 S.C.R. 560. In her case, Justice Simpson wrote the
following at paragraphs 34 and 35:
[34] The Minister wants to avoid the
requirement to conduct the patent specific analysis mandated by the Supreme Court
in AstraZeneca. He suggested that, if they were issues about which
patents should be addressed, a prohibition proceeding should be undertaken and
any such issues could then be resolved by the Court on a motion for summary
judgment under subsection 6(5) of the NOC Regulations.
[35] I have rejected this approach
for three reasons: …
[80]
The
Minister states that a consideration of whether Apotex has early-worked or
infringed the ‘693, ‘891, ‘377, ‘307 and ‘470 patents falls outside the scope
of what is required of the Minister under the PM (NOC) Regulations.
In
light of Pharmascience Inc. v. Canada (Minister of
Health)
by the Court of Appeal, I have to disagree. At paragraph 27, the Court stated:
“As the respondent points out, a SANDS is not a stand-alone submission. The
Minister must take into account the relationship between a particular SANDS and
an earlier filed ANDS when conducting the patent specific analysis”.
[81]
In
the present case, the Minister did not perform the patent- specific analysis as
mandated by the Supreme Court's decision in AstraZeneca above before
determining that Apotex had to address all five remaining patents.
[82]
About
the relief requested by the Applicant, the proper test which must be applied to
determine whether a writ of mandamus should issue is explained in Dragan
v. Canada (Minister of
Citizenship and Immigration), 2003 FCT 211 at para. 39, [2003] 4 F.C.
189 (see also Khalil v. Canada (Secretary of State), [1999] 4
F.C. 661 (C.A.)):
[39] In Apotex Inc. v. Canada
(A.G.), [1994] 1 F.C. 742 (C.A.), aff’d [1994] 3 S.C.R. 1100, the Federal
Court of Appeal conducted an extensive review of the jurisprudence relating to mandamus
and outlined the following conditions that need to be satisfied for the Court
to issue a writ of mandamus:
(1)
There must be a public legal duty to act.
(2)
The duty must be owed to the applicant.
(3)
There is a clear right to the performance of that duty, in
particular:
(a) the
applicant has satisfied all conditions precedent
giving
rise to the duty;
(b) there
was (i) a prior demand for performance of the
duty;
(ii) a reasonable time to comply with the demand unless refused outright; and
(iii) a subsequent refusal which can be either expressed or implied, e.g.
unreasonable delay.
(4)
No other adequate remedy is available to the applicant.
(5)
The order sought will be of some practical value or effect.
(6)
The Court in the exercise of discretion finds no equitable bar to
the relief sought.
(7)
On a “balance of convenience” an order in the nature of mandamus
should issue.
[83]
The Court is of the opinion that the Minister
should perform a patent -specific analysis before taking a decision as to
whether or not the applicant should address one or more of the following patents:
‘693, ‘891, ‘377, ‘307 and ‘470 or in the alternative issue a NOC to Apotex.
[84]
Thus,
the Court finds that the applicant’s request for a writ of mandamus is
premature because the Minister has no legal duty at this time to issue a NOC
following Apotex’s SANDS.
[85]
There
is no evidence before this Court to undertake the patent specific analysis as
did Justice Simpson in her case. Therefore, the appropriate relief is that the
matter should be remitted back to the Minister to make such determination.
JUDGMENT
THIS COURT
ORDERS that the Applicant’s
application be allowed. The matter is remitted back to the Minister to perform
a patent specific analysis as mandated by the Supreme Court’s decision in AstraZeneca
v. Canada (Minister of
Health),
2006 SCC 49, [2006] 2 S.C.R. 560. The Applicant is entitled to costs by way
of a lump sum of $7,500 plus disbursements and GST as agreed by the parties. Both
respondents shall pay half of the costs granted.
“Michel
Beaudry”
APPENDIX A
Relevant Legislation
APPENDIX A
Relevant Legislation
Food
and Drug Regulations,
C.R.C., c. 870, Part C:
|
C.08.002.
(1)
No person shall sell or advertise a new drug unless
(a) the
manufacturer of the new drug has filed with the Minister a new drug
submission or an abbreviated new drug submission relating to the new drug
that is satisfactory to the Minister;
(b) the
Minister has issued, pursuant to section C.08.004, a notice of compliance to
the manufacturer of the new drug in respect of the new drug submission or
abbreviated new drug submission;
(c) the notice
of compliance in respect of the submission has not been suspended pursuant to
section C.08.006; and
(d) the
manufacturer of the new drug has submitted to the Minister specimens of the
final version of any labels, including package inserts, product brochures and
file cards, intended for use in connection with that new drug, and a
statement setting out the proposed date on which those labels will first be
used.
(2) A new drug
submission shall contain sufficient information and material to enable the
Minister to assess the safety and effectiveness of the new drug, including
the following:
(a) a
description of the new drug and a statement of its proper name or its common
name if there is no proper name;
(b) a
statement of the brand name of the new drug or the identifying name or code
proposed for the new drug;
(c) a list of
the ingredients of the new drug, stated quantitatively, and the
specifications for each of those ingredients;
(d) a
description of the plant and equipment to be used in the manufacture,
preparation and packaging of the new drug;
(e) details of
the method of manufacture and the controls to be used in the manufacture,
preparation and packaging of the new drug;
(f) details of
the tests to be applied to control the potency, purity, stability and safety
of the new drug;
(g) detailed
reports of the tests made to establish the safety of the new drug for the
purpose and under the conditions of use recommended;
(h)
substantial evidence of the clinical effectiveness of the new drug for the
purpose and under the conditions of use recommended;
(i) a
statement of the names and qualifications of all the investigators to whom
the new drug has been sold;
(j) a draft of
every label to be used in conjunction with the new drug;
(k) a
statement of all the representations to be made for the promotion of the new
drug respecting
(i) the
recommended route of administration of the new drug,
(ii) the
proposed dosage of the new drug,
(iii) the
claims to be made for the new drug, and
(iv) the
contra-indications and side effects of the new drug;
(l) a
description of the dosage form in which it is proposed that the new drug be
sold;
(m) evidence
that all test batches of the new drug used in any studies conducted in
connection with the submission were manufactured and controlled in a manner
that is representative of market production; and
(n) for a drug
intended for administration to food-producing animals, the withdrawal period
of the new drug.
(3) The
manufacturer of a new drug shall, at the request of the Minister, provide the
Minister, where for the purposes of a new drug submission the Minister
considers it necessary to assess the safety and effectiveness of the new
drug, with the following information and material:
(a) the names
and addresses of the manufacturers of each of the ingredients of the new drug
and the names and addresses of the manufacturers of the new drug in the
dosage form in which it is proposed that the new drug be sold;
(b) samples of
the ingredients of the new drug;
(c) samples of
the new drug in the dosage form in which it is proposed that the new drug be
sold; and
(d) any
additional information or material respecting the safety and effectiveness of
the new drug.
|
C.08.002. (1) Il est interdit de
vendre ou d'annoncer une drogue nouvelle, à moins que les conditions
suivantes ne soient réunies :
a)
le fabricant de la drogue nouvelle a, relativement à celle-ci, déposé auprès
du ministre une présentation de drogue nouvelle ou une présentation abrégée
de drogue nouvelle que celui-ci juge acceptable;
b)
le ministre a, aux termes de l'article C.08.004, délivré au fabricant de la
drogue nouvelle un avis de conformité relativement à la présentation de drogue
nouvelle ou à la présentation abrégée de drogue nouvelle;
c)
l'avis de conformité relatif à la présentation n'a pas été suspendu aux
termes de l'article C.08.006;
d)
le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme
définitive, des échantillons des étiquettes—y compris toute notice jointe à
l'emballage, tout dépliant et toute fiche sur le produit—destinées à être
utilisées pour la drogue nouvelle, ainsi qu'une déclaration indiquant la date
à laquelle il est prévu de commencer à utiliser ces étiquettes.
(2)
La présentation de drogue nouvelle doit contenir suffisamment de
renseignements et de matériel pour permettre au ministre d'évaluer
l'innocuité et l'efficacité de la drogue nouvelle, notamment :
a)
une description de la drogue nouvelle et une mention de son nom propre ou, à
défaut, de son nom usuel;
b)
une mention de la marque nominative de la drogue nouvelle ou du nom ou code
d'identification projeté pour celle-ci;
c)
la liste quantitative des ingrédients de la drogue nouvelle et les
spécifications relatives à chaque ingrédient;
d)
la description des installations et de l'équipement à utiliser pour la
fabrication, la préparation et l'emballage de la drogue nouvelle;
e)
des précisions sur la méthode de fabrication et les mécanismes de contrôle à
appliquer pour la fabrication, la préparation et l'emballage de la drogue
nouvelle;
f)
le détail des épreuves qui doivent être effectuées pour contrôler l'activité,
la pureté, la stabilité et l'innocuité de la drogue nouvelle;
g)
les rapports détaillés des épreuves effectuées en vue d'établir l'innocuité
de la drogue nouvelle, aux fins et selon le mode d'emploi recommandés;
h)
des preuves substantielles de l'efficacité clinique de la drogue nouvelle aux
fins et selon le mode d'emploi recommandés;
i)
la déclaration des noms et titres professionnels de tous les chercheurs à qui
la drogue nouvelle a été vendue;
j)
une esquisse de chacune des étiquettes qui doivent être employées
relativement à la drogue nouvelle;
k)
la déclaration de toutes les recommandations qui doivent être faites dans la
réclame pour la drogue nouvelle, au sujet
(i)
de la voie d'administration recommandée pour la drogue nouvelle,
(ii)
de la posologie proposée pour la drogue nouvelle,
(iii)
des propriétés attribuées à la drogue nouvelle,
(iv)
des contre-indications et les effets secondaires de la drogue nouvelle;
l)
la description de la forme posologique proposée pour la vente de la drogue
nouvelle;
m)
les éléments de preuve établissant que les lots d'essai de la drogue nouvelle
ayant servi aux études menées dans le cadre de la présentation ont été
fabriqués et contrôlés d'une manière représentative de la production destinée
au commerce;
n)
dans le cas d'une drogue nouvelle destinée à être administrée à des animaux
producteurs de denrées alimentaires, le délai d'attente applicable.
(3)
Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui
fournir, selon ce que celui-ci estime nécessaire pour évaluer l'innocuité et
l'efficacité de la drogue dans le cadre de la présentation de drogue
nouvelle, les renseignements et le matériel suivants :
a)
les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle
et les nom et adresse des fabricants de la drogue nouvelle sous sa forme
posologique proposée pour la vente;
b)
des échantillons des ingrédients de la drogue nouvelle;
c)
des échantillons de la drogue nouvelle sous sa forme posologique proposée
pour la vente;
d)
tout renseignement ou matériel supplémentaire se rapportant à l'innocuité et
à l'efficacité de la drogue nouvelle.
|
|
C.08.002.1.
(1) A manufacturer of a new drug may file an abbreviated
new drug submission for the new drug where, in comparison with a Canadian
reference product,
(a) the new
drug is the pharmaceutical equivalent of the Canadian reference product;
(b) the new
drug is bioequivalent with the Canadian reference product, based on the
pharmaceutical and, where the Minister considers it necessary,
bioavailability characteristics;
(c) the route
of administration of the new drug is the same as that of the Canadian
reference product; and
(d) the
conditions of use for the new drug fall within the conditions of use for the
Canadian reference product.
(2) An abbreviated new drug submission
shall contain sufficient information and material to enable the Minister to
assess the safety and effectiveness of the new drug, including the following:
(a) the
information and material described in paragraphs C.08.002(2)(a) to (f) and
(j) to (l);
(b)
information identifying the Canadian reference product used in any
comparative studies conducted in connection with the submission;
(c) evidence
from the comparative studies conducted in connection with the submission that
the new drug is
(i) the
pharmaceutical equivalent of the Canadian reference product, and
(ii) where the
Minister considers it necessary on the basis of the pharmaceutical and, where
applicable, bioavailability characteristics of the new drug, bioequivalent
with the Canadian reference product as demonstrated using bioavailability
studies, pharmacodynamic studies or clinical studies;
(d) evidence
that all test batches of the new drug used in any studies conducted in
connection with the submission were manufactured and controlled in a manner
that is representative of market production; and
(e) for a drug
intended for administration to food-producing animals, sufficient information
to confirm that the withdrawal period is identical to that of the Canadian
reference product.
(3) The
manufacturer of a new drug shall, at the request of the Minister, provide the
Minister, where for the purposes of an abbreviated new drug submission the
Minister considers it necessary to assess the safety and effectiveness of the
new drug, with the following information and material:
(a) the names
and addresses of the manufacturers of each of the ingredients of the new drug
and the names and addresses of the manufacturers of the new drug in the
dosage form in which it is proposed that the new drug be sold;
(b) samples of
the ingredients of the new drug;
(c) samples of
the new drug in the dosage form in which it is proposed that the new drug be
sold; and
(d) any
additional information or material respecting the safety and effectiveness of
the new drug.
|
C.08.002.1. (1) Le fabricant d'une
drogue nouvelle peut déposer à l'égard de celle-ci une présentation abrégée
de drogue nouvelle si, par comparaison à un produit de référence canadien :
a)
la drogue nouvelle est un équivalent pharmaceutique du produit de référence
canadien;
b)
elle est bioéquivalente au produit de référence canadien d'après les
caractéristiques pharmaceutiques et, si le ministre l'estime nécessaire,
d'après les caractéristiques en matière de biodisponibilité;
c)
la voie d'administration de la drogue nouvelle est identique à celle du
produit de référence canadien;
d)
les conditions thérapeutiques relatives à la drogue nouvelle figurent parmi
celles qui s'appliquent au produit de référence canadien.
(2)
La présentation abrégée de drogue nouvelle doit contenir suffisamment de
renseignements et de matériel pour permettre au ministre d'évaluer
l'innocuité et l'efficacité de la drogue nouvelle, notamment :
a)
les renseignements et le matériel visés aux alinéas C.08.002(2)a) à f) et j)
à l);
b)
les renseignements permettant d'identifier le produit de référence canadien
utilisé pour les études comparatives menées dans le cadre de la présentation;
c)
les éléments de preuve, provenant des études comparatives menées dans le
cadre de la présentation, établissant que la drogue nouvelle :
(i)
d'une part, est un équivalent pharmaceutique du produit de référence
canadien,
(ii)
d'autre part, si le ministre l'estime nécessaire d'après les caractéristiques
pharmaceutiques et, le cas échéant, d'après les caractéristiques en matière
de biodisponibilité de celle-ci, est bioéquivalente au produit de référence
canadien selon les résultats des études en matière de biodisponibilité, des
études pharmacodynamiques ou des études cliniques;
d)
les éléments de preuve établissant que les lots d'essai de la drogue nouvelle
ayant servi aux études menées dans le cadre de la présentation ont été
fabriqués et contrôlés d'une manière représentative de la production destinée
au commerce;
e)
dans le cas d'une drogue destinée à être administrée à des animaux
producteurs de denrées alimentaires, les renseignements permettant de
confirmer que le délai d'attente est identique à celui du produit de
référence canadien.
(3)
Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui
fournir, selon ce que celui-ci estime nécessaire pour évaluer l'innocuité et
l'efficacité de la drogue dans le cadre de la présentation abrégée de drogue
nouvelle, les renseignements et le matériel suivants :
a)
les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle
et les nom et adresse des fabricants de la drogue nouvelle sous sa forme
posologique proposée pour la vente;
b)
des échantillons des ingrédients de la drogue nouvelle;
c)
des échantillons de la drogue nouvelle sous sa forme posologique proposée
pour la vente;
d)
tout renseignement ou matériel supplémentaire se rapportant à l'innocuité et
à l'efficacité de la drogue nouvelle.
|
|
C.08.003.
(1)
Notwithstanding section C.08.002, no person shall sell a new drug in respect
of which a notice of compliance has been issued to the manufacturer of that
new drug and has not been suspended pursuant to section C.08.006, if any of
the matters specified in subsection (2) are significantly different from the
information or material contained in the new drug submission or abbreviated
new drug submission, unless
(a) the
manufacturer of the new drug has filed with the Minister
(i) a
supplement to that new drug submission, or
(ii) a
supplement to that abbreviated new drug submission;
(b) the
Minister has issued a notice of compliance to the manufacturer of the new
drug in respect of the supplement;
(c) the notice
of compliance in respect of the supplement has not been suspended pursuant to
section C.08.006; and
(d) the
manufacturer of the new drug has submitted to the Minister specimens of the
final version of any label, including any package insert, product brochure
and file card, intended for use in connection with the new drug, where a
change with respect to any of the matters specified in subsection (2) is made
that would require a change to the label.
(2) The
matters specified for the purposes of subsection (1), in relation to the new
drug, are the following:
(a) the
description of the new drug;
(b) the brand
name of the new drug or the identifying name or code proposed for the new
drug;
(c) the
specifications of the ingredients of the new drug;
(d) the plant
and equipment used in manufacturing, preparation and packaging the new drug;
(e) the method
of manufacture and the controls used in manufacturing, preparation and
packaging the new drug;
(f) the tests
applied to control the potency, purity, stability and safety of the new drug;
(g) the labels
used in connection with the new drug;
(h) the
representations made with regard to the new drug respecting
(i) the
recommended route of administration of the new drug,
(ii) the
dosage of the new drug,
(iii) the
claims made for the new drug,
(iv) the contra-indications
and side effects of the new drug, and
(v) the
withdrawal period of the new drug; and
(i) the dosage
form in which it is proposed that the new drug be sold.
(3) A supplement to a new drug
submission or to an abbreviated new drug submission, with respect to the
matters that are significantly different from those contained in the
submission, shall contain sufficient information and material to enable the
Minister to assess the safety and effectiveness of the new drug in relation
to those matters.
|
C.08.003. (1) Malgré l'article
C.08.002, il est interdit de vendre une drogue nouvelle à l'égard de laquelle
un avis de conformité a été délivré à son fabricant et n'a pas été suspendu
aux termes de l'article C.08.006, lorsqu'un des éléments visés au paragraphe
(2) diffère sensiblement des renseignements ou du matériel contenus dans la
présentation de drogue nouvelle ou la présentation abrégée de drogue
nouvelle, à moins que les conditions suivantes ne soient réunies :
a)
le fabricant de la drogue nouvelle a déposé auprès du ministre :
(i)
soit un supplément à la présentation de drogue nouvelle,
(ii)
soit un supplément à la présentation abrégée de drogue nouvelle;
b)
le ministre a délivré au fabricant un avis de conformité relativement au
supplément;
c)
l'avis de conformité relatif au supplément n'a pas été suspendu aux termes de
l'article C.08.006;
d)
le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme
définitive, des échantillons de toute étiquette—y compris une notice jointe à
l'emballage, un dépliant et une fiche sur le produit—destinée à être utilisée
pour la drogue nouvelle, dans le cas où la modification d'un des éléments
visés au paragraphe (2) nécessite un changement dans l'étiquette.
(2)
Pour l'application du paragraphe (1), les éléments ayant trait à la drogue
nouvelle sont les suivants :
a)
sa description;
b)
sa marque nominative ou le nom ou code sous lequel il est proposé de
l'identifier;
c)
les spécifications de ses ingrédients;
d)
les installations et l'équipement à utiliser pour sa fabrication, sa
préparation et son emballage;
e)
la méthode de fabrication et les mécanismes de contrôle à appliquer pour sa
fabrication, sa préparation et son emballage;
f)
les analyses effectuées pour contrôler son activité, sa pureté, sa stabilité
et son innocuité;
g)
les étiquettes à utiliser pour la drogue nouvelle;
h)
les observations faites relativement :
(i)
à la voie d'administration recommandée pour la drogue nouvelle,
(ii)
à sa posologie,
(iii)
aux propriétés qui lui sont attribuées,
(iv)
à ses contre-indications et à ses effets secondaires,
(v)
au délai d'attente applicable à celle-ci;
i)
sa forme posologique proposée pour la vente.
(3)
Le supplément à la présentation de drogue nouvelle ou à la présentation
abrégée de drogue nouvelle doit contenir, à l'égard des éléments qui
diffèrent sensiblement de ce qui figure dans la présentation, les
renseignements et le matériel nécessaires pour permettre au ministre
d'évaluer l'innocuité et l'efficacité de la drogue nouvelle relativement à
ces éléments.
|
|
C.08.004.
(1)
Subject to section C.08.004.1, the Minister shall, after completing an
examination of a new drug submission or abbreviated new drug submission or a
supplement to either submission,
(a) if that
submission or supplement complies with section C.08.002, C.08.002.1 or
C.08.003, as the case may be, and section C.08.005.1, issue a notice of
compliance; or
(b) if that
submission or supplement does not comply with section C.08.002, C.08.002.1 or
C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer
that the submission or supplement does not so comply.
(2) Where a new drug submission or
abbreviated new drug submission or a supplement to either submission does not
comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or
section C.08.005.1, the manufacturer who filed the submission or supplement
may amend the submission or supplement by filing additional information or
material.
(3) Subject to section C.08.004.1, the
Minister shall, after completing an examination of any additional information
or material filed in respect of a new drug submission or an abbreviated new
drug submission or a supplement to either submission,
(a) if that
submission or supplement complies with section C.08.002, C.08.002.1 or
C.08.003, as the case may be, and section C.08.005.1, issue a notice of
compliance; or
(b) if that
submission or supplement does not comply with the requirements of section
C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1,
notify the manufacturer that the submission or supplement does not so comply.
(4) A notice of compliance issued in
respect of a new drug on the basis of information and material contained in a
submission filed pursuant to section C.08.002.1 shall state the name of the
Canadian reference product referred to in the submission and shall constitute
a declaration of equivalence for that new drug.
|
C.08.004. (1) Sous réserve de
l'article C.08.004.1, après avoir terminé l'examen d'une présentation de
drogue nouvelle, d'une présentation abrégée de drogue nouvelle ou d'un
supplément à l'une de ces présentations, le ministre :
a)
si la présentation ou le supplément est conforme aux articles C.08.002,
C.08.002.1 ou C.08.003, selon le cas, et à l'article C.08.005.1, délivre un
avis de conformité;
b)
si la présentation ou le supplément n'est pas conforme aux articles C.08.002,
C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, en informe
le fabricant.
(2)
Lorsqu'une présentation de drogue nouvelle, une présentation abrégée de
drogue nouvelle ou un supplément à l'une de ces présentations n'est pas
conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à
l'article C.08.005.1, le fabricant qui l'a déposé peut le modifier en
déposant des renseignements ou du matériel supplémentaires.
(3)
Sous réserve de l'article C.08.004.1, après avoir terminé l'examen des
renseignements et du matériel supplémentaires déposés relativement à une
présentation de drogue nouvelle, à une présentation abrégée de drogue
nouvelle ou à un supplément à l'une de ces présentations, le ministre :
a)
si la présentation ou le supplément est conforme aux articles C.08.002,
C.08.002.1 ou C.08.003, selon le cas, et à l'article C.08.005.1, délivre un
avis de conformité;
b)
si la présentation ou le supplément n'est pas conforme aux articles C.08.002,
C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, en informe
le fabricant.
(4)
L'avis de conformité délivré à l'égard d'une drogue nouvelle d'après les
renseignements et le matériel contenus dans la présentation déposée
conformément à l'article C.08.002.1 indique le nom du produit de référence
canadien mentionné dans la présentation et constitue la déclaration
d'équivalence de cette drogue.
|
Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133:
|
4. (1) A first person who files or who
has filed a new drug submission or a supplement to a new drug submission may
submit to the Minister a patent list in relation to the submission or
supplement for addition to the register.
(2) A patent
on a patent list in relation to a new drug submission is eligible to be added
to the register if the patent contains
(a) a claim
for the medicinal ingredient and the medicinal ingredient has been approved
through the issuance of a notice of compliance in respect of the submission;
(b) a claim
for the formulation that contains the medicinal ingredient and the
formulation has been approved through the issuance of a notice of compliance
in respect of the submission;
(c) a claim
for the dosage form and the dosage form has been approved through the
issuance of a notice of compliance in respect of the submission; or
(d) a claim
for the use of the medicinal ingredient, and the use has been approved
through the issuance of a notice of compliance in respect of the submission.
(3) A patent
on a patent list in relation to a supplement to a new drug submission is
eligible to be added to the register if the supplement is for a change in
formulation, a change in dosage form or a change in use of the medicinal
ingredient, and
(a) in the
case of a change in formulation, the patent contains a claim for the changed
formulation that has been approved through the issuance of a notice of
compliance in respect of the supplement;
(b) in the
case of a change in dosage form, the patent contains a claim for the changed
dosage form that has been approved through the issuance of a notice of
compliance in respect of the supplement; or
(c) in the
case of a change in use of the medicinal ingredient, the patent contains a
claim for the changed use of the medicinal ingredient that has been approved
through the issuance of a notice of compliance in respect of the supplement.
(4) A patent
list shall contain the following:
(a) an
identification of the new drug submission or the supplement to a new drug
submission to which the list relates;
(b) the
medicinal ingredient, brand name, dosage form, strength, route of administration
and use set out in the new drug submission or the supplement to a new drug
submission to which the list relates;
(c) for each
patent on the list, the patent number, the filing date of the patent
application in Canada, the date of grant of the patent and the date on which
the term limited for the duration of the patent will expire under section 44
or 45 of the Patent Act;
(d) for each
patent on the list, a statement that the first person who filed the new drug
submission or the supplement to a new drug submission to which the list
relates is the owner of the patent or has an exclusive licence to the patent,
or has obtained the consent of the owner of the patent to its inclusion on
the list;
(e) the
address in Canada for service, on the first person, of a notice of allegation
referred to in paragraph 5(3)(a) or the name and address in Canada of another
person on whom service may be made with the same effect as if service were
made on the first person; and
(f) a
certification by the first person that the information submitted under this
subsection is accurate and that each patent on the list meets the eligibility
requirements of subsection (2) or (3).
(5) Subject to
subsection (6), a first person who submits a patent list must do so at the
time the person files the new drug submission or the supplement to a new drug
submission to which the patent list relates.
(6) A first
person may, after the date of filing of a new drug submission or a supplement
to a new drug submission, and within 30 days after the issuance of a patent
that was issued on the basis of an application that has a filing date in
Canada that precedes the date of filing of the submission or supplement,
submit a patent list, including the information referred to in subsection
(4), in relation to the submission or supplement.
(7) A first
person who has submitted a patent list must keep the information on the list
up to date but, in so doing, may not add a patent to the list.
(8) The
Minister shall insert on the patent list the date of filing and submission
number of the new drug submission or the supplement to a new drug submission
in relation to which the list was submitted.
|
4. (1) La première personne
qui dépose ou a déposé la présentation de drogue nouvelle ou le supplément à
une présentation de drogue nouvelle peut présenter au ministre, pour
adjonction au registre, une liste de brevets qui se rattache à la
présentation ou au supplément.
(2)
Est admissible à l’adjonction au registre tout brevet, inscrit sur une liste
de brevets, qui se rattache à la présentation de drogue nouvelle, s’il
contient, selon le cas :
a)
une revendication de l’ingrédient médicinal, l’ingrédient ayant été approuvé
par la délivrance d’un avis de conformité à l’égard de la présentation;
b)
une revendication de la formulation contenant l’ingrédient médicinal, la
formulation ayant été approuvée par la délivrance d’un avis de conformité à
l’égard de la présentation;
c)
une revendication de la forme posologique, la forme posologique ayant été
approuvée par la délivrance d’un avis de conformité à l’égard de la
présentation;
d)
une revendication de l’utilisation de l’ingrédient médicinal, l’utilisation
ayant été approuvée par la délivrance d’un avis de conformité à l’égard de la
présentation.
(3)
Est admissible à l’adjonction au registre tout brevet, inscrit sur une liste
de brevets, qui se rattache au supplément à une présentation de drogue
nouvelle visant une modification de la formulation, une modification de la
forme posologique ou une modification de l’utilisation de l’ingrédient
médicinal, s’il contient, selon le cas :
a)
dans le cas d’une modification de formulation, une revendication de la
formulation modifiée, la formulation ayant été approuvée par la délivrance
d’un avis de conformité à l’égard du supplément;
b)
dans le cas d’une modification de la forme posologique, une revendication de
la forme posologique modifiée, la forme posologique ayant été approuvée par
la délivrance d’un avis de conformité à l’égard du supplément;
c)
dans le cas d’une modification d’utilisation de l’ingrédient médicinal, une
revendication de l’utilisation modifiée de l’ingrédient médicinal,
l’utilisation ayant été approuvée par la délivrance d’un avis de conformité à
l’égard du supplément.
(4)
La liste de brevets comprend :
a)
l’identification de la présentation de drogue nouvelle ou du supplément à la
présentation de drogue nouvelle qui s’y rattachent;
b)
l’ingrédient médicinal, la marque nominative, la forme posologique, la
concentration, la voie d’administration et l’utilisation prévus à la
présentation ou au supplément qui s’y rattachent;
c)
à l’égard de chaque brevet qui y est inscrit, le numéro de brevet, la date de
dépôt de la demande de brevet au Canada, la date de délivrance de celui-ci et
la date d’expiration du brevet aux termes des articles 44 ou 45 de la Loi sur
les brevets;
d)
à l’égard de chaque brevet qui y est inscrit, une déclaration portant que la
première personne qui a déposé la présentation de drogue nouvelle ou le
supplément à une présentation de drogue nouvelle qui s’y rattachent en est le
propriétaire, en détient la licence exclusive ou a obtenu le consentement du
propriétaire pour l’inclure dans la liste;
e)
l’adresse au Canada de la première personne aux fins de signification de
l’avis d’allégation visé à l’alinéa 5(3)a) ou les nom et adresse au Canada
d’une autre personne qui peut en recevoir signification comme s’il s’agissait
de la première personne elle-même;
f)
une attestation de la première personne portant que les renseignements
fournis aux termes du présent paragraphe sont exacts et que chaque brevet qui
y est inscrit est conforme aux conditions d’admissibilité prévues aux
paragraphes (2) ou (3).
(5)
Sous réserve du paragraphe (6), la première personne qui présente une liste
de brevets doit le faire au moment du dépôt de la présentation de drogue
nouvelle ou du supplément à une présentation de drogue nouvelle qui s’y
rattachent.
(6)
La première personne peut, après la date de dépôt de la présentation de
drogue nouvelle ou du supplément à une présentation de drogue nouvelle et
dans les trente jours suivant la délivrance d’un brevet faite au titre d’une
demande de brevet dont la date de dépôt au Canada est antérieure à celle de
la présentation ou du supplément, présenter une liste de brevets, à l’égard
de cette présentation ou de ce supplément, qui contient les renseignements
visés au paragraphe (4).
(7)
La première personne qui a présenté une liste de brevets doit tenir à jour
les renseignements y figurant, mais ne peut toutefois y ajouter de brevets.
(8)
Le ministre inscrit sur la liste de brevets la date de dépôt et le numéro de
la présentation de drogue nouvelle ou du supplément à une présentation de
drogue nouvelle qui se rattache à la liste présentée.
|
|
5. (1) If a second person files a
submission for a notice of compliance in respect of a drug and the submission
directly or indirectly compares the drug with, or makes reference to, another
drug marketed in Canada under a notice of compliance issued to a first person
and in respect of which a patent list has been submitted, the second person
shall, in the submission, with respect to each patent on the register in
respect of the other drug,
(a) state that
the second 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 under paragraph 4(4)(d) is false,
(ii) the
patent has expired,
(iii) the
patent is not valid, or
(iv) 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 by the second person making, constructing, using or selling the
drug for which the submission is filed.
(2) If a
second person files a supplement to a submission referred to in subsection
(1) seeking a notice of compliance for a change in formulation, a change in
dosage form or a change in use of the medicinal ingredient and the supplement
directly or indirectly compares the drug with, or makes reference to, another
drug that has been marketed in Canada under a notice of compliance issued to
a first person and in respect of which a patent list has been submitted, the
second person shall, in the supplement, with respect to each patent on the
register in respect of the other drug,
(a) state that
the second 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 under paragraph 4(4)(d) is false,
(ii) the
patent has expired,
(iii) the
patent is not valid, or
(iv) 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 by the second person making, constructing, using or selling the
drug for which the supplement is filed.
(3) A second
person who makes an allegation under paragraph (1)(b) or (2)(b) shall
(a) serve on
the first person a notice of allegation relating to the submission or
supplement filed under subsection (1) or (2) on or after its date of filing;
(b) include in
the notice of allegation
(i) a
description of the medicinal ingredient, dosage form, strength, route of
administration and use of the drug in respect of which the submission or supplement
has been filed, and
(ii) a
detailed statement of the legal and factual basis for the allegation;
(c) include in
the material served a certification by the Minister of the date of filing of
the submission or supplement; and
(d) serve
proof of service of the documents and information referred to in paragraphs
(a) to (c) on the Minister.
(4) A second
person is not required to comply with
(a) subsection
(1) in respect of a patent added to the register in respect of the other drug
on or after the date of filing of the submission referred to in that
subsection, including a patent added under subsection 3(5); and
(b) subsection
(2) in respect of a patent added to the register in respect of the other drug
on or after the date of filing of the supplement referred to in that
subsection, including a patent added under subsection 3(5).
(5) For the
purposes of subsections (3) and (4), if subsection (1) or (2) applies to a
submission or supplement referred to in paragraph C.07.003(b) of the Food and
Drug Regulations, if the drug to which the comparison or reference is made is
an innovative drug within the meaning of subsection C.08.004.1(1) of those
Regulations and if the date of filing of the submission or supplement is less
than six years from the day on which the first notice of compliance was
issued in respect of the innovative drug, the deemed date of filing of the
submission or supplement is six years after the date of issuance of the
notice of compliance.
(6) A second
person who has served a notice of allegation on a first person under
paragraph (3)(a) shall retract the notice of allegation and serve notice of
the retraction on the first person within 90 days after either of the
following dates:
(a) the date
on which the Minister notifies the second person under paragraph
C.08.004(3)(b) of the Food and Drug Regulations of their non-compliance with
the requirements of section C.08.002, C.08.002.1 or C.08.003, as the case may
be, or section C.08.005.1 of those Regulations; or
(b) the date
of the cancellation by the second person of the submission or supplement to
which the allegation relates.
(7) A first
person who has applied for a prohibition order under subsection 6(1) in
response to a notice of allegation shall, if the notice is retracted in
accordance with subsection (6), apply without delay for a discontinuance of
the proceedings.
|
5. (1) Dans le cas où la
seconde personne dépose une présentation pour un avis de conformité à l’égard
d’une drogue, laquelle présentation, directement ou indirectement, compare
celle-ci à une autre drogue commercialisée sur le marché canadien aux termes
d’un avis de conformité délivré à la première personne et à l’égard de
laquelle une liste de brevets a été présentée — ou y fait renvoi —, cette
seconde personne doit, à l’égard de chaque brevet ajouté au registre pour
cette autre drogue, inclure dans sa présentation :
a)
soit une déclaration portant qu’elle accepte que l’avis de conformité ne sera
pas délivré avant l’expiration du brevet;
b)
soit une allégation portant que, selon le cas :
(i)
la déclaration présentée par la première personne aux termes de l’alinéa
4(4)d) est fausse,
(ii)
le brevet est expiré,
(iii)
le brevet n’est pas valide,
(iv)
elle ne contreferait aucune revendication de l’ingrédient médicinal, revendication
de la formulation, revendication de la forme posologique ni revendication de
l’utilisation de l’ingrédient médicinal en fabriquant, construisant,
utilisant ou vendant la drogue pour laquelle la présentation est déposée.
(2)
Dans le cas où la seconde personne dépose un supplément à la présentation
visée au paragraphe (1), en vue d’obtenir un avis de conformité à l’égard
d’une modification de la formulation, d’une modification de la forme
posologique ou d’une modification de l’utilisation de l’ingrédient médicinal,
lequel supplément, directement ou indirectement, compare celle-ci à une autre
drogue commercialisée sur le marché canadien aux termes de l’avis de
conformité délivré à la première personne et à l’égard duquel une liste de
brevets a été présentée — ou y fait renvoi — , cette seconde personne doit, à
l’égard de chaque brevet ajouté au registre pour cette autre drogue, inclure
dans son supplément :
a)
soit une déclaration portant qu’elle accepte que l’avis de conformité ne sera
pas délivré avant l’expiration du brevet;
b)
soit une allégation portant que, selon le cas :
(i)
la déclaration présentée par la première personne aux termes de l’alinéa
4(4)d) est fausse,
(ii)
le brevet est expiré,
(iii)
le brevet n’est pas valide,
(iv)
elle ne contreferait aucune revendication de l’ingrédient médicinal,
revendication de la formulation, revendication de la forme posologique ni
revendication de l’utilisation de l’ingrédient médicinal en fabriquant,
construisant, utilisant ou vendant la drogue pour laquelle le supplément est
déposé.
(3)
La seconde personne qui inclut l’allégation visée à l’alinéa (1)b) ou (2)b)
doit prendre les mesures suivantes :
a)
signifier à la première personne un avis de l’allégation à l’égard de la
présentation ou du supplément déposé en vertu des paragraphes (1) ou (2), à
la date de son dépôt ou à toute date postérieure;
b)
insérer dans l’avis de l’allégation :
(i)
une description de l’ingrédient médicinal, de la forme posologique, de la
concentration, de la voie d’administration et de l’utilisation de la drogue
visée par la présentation ou le supplément,
(ii)
un énoncé détaillé du fondement juridique et factuel de l’allégation;
c)
joindre à la signification une attestation par le ministre de la date du
dépôt de la présentation ou du supplément;
d)
signifier au ministre la preuve de toute signification des documents et
renseignements visés aux alinéas a) à c).
(4)
La seconde personne n’est pas tenue de se conformer :
a)
au paragraphe (1) en ce qui concerne tout brevet ajouté au registre à l’égard
de l’autre drogue — y compris celui ajouté aux termes du paragraphe 3(5) — à
la date de dépôt de la présentation visée au paragraphe (1) ou à toute date
postérieure;
b)
au paragraphe (2) en ce qui concerne tout brevet ajouté au registre à l’égard
de l’autre drogue — y compris celui ajouté aux termes du paragraphe 3(5) — à
la date de dépôt du supplément visé au paragraphe (2) ou à toute date
postérieure.
(5)
Pour l’application des paragraphes (3) et (4), si les paragraphes (1) ou (2)
s’appliquent à l’égard d’une présentation ou d’un supplément à une telle
présentation visés à l’alinéa C.07.003b) du Règlement sur les aliments et
drogues et que la drogue faisant l’objet de la comparaison ou du renvoi est
une drogue innovante, au sens du paragraphe C.08.004.1(1) du même règlement,
et si la date de dépôt de la présentation ou du supplément est de moins de
six ans après la date de délivrance du premier avis de conformité à l’égard
de cette drogue innovante, la date de dépôt est réputée être la date qui suit
de six ans celle de la délivrance.
(6)
La seconde personne qui a signifié l’avis d’allégation à la première personne
en vertu de l’alinéa (3)a) doit retirer celui-ci et signifier un avis du
retrait à la première personne dans les quatre-vingt-dix jours qui
suivent :
a)
soit la date à laquelle le ministre a informé la seconde personne, aux termes
de l’alinéa C.08.004(3)b) du Règlement sur les aliments et drogues, de sa
non-conformité aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas,
ou à l’article C.08.005.1 du même règlement;
b)
soit la date de l’annulation par la seconde personne de sa présentation ou de
son supplément faisant l’objet de l’allégation.
(7)
La première personne qui demande une ordonnance d’interdiction en vertu du
paragraphe 6(1) en réponse à l’avis d’allégation doit, dans le cas où l’avis
est retiré aux termes du paragraphe (6), demander dans les plus brefs délais
un désistement des procédures.
|
|
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.
(4) Where the
first person is not the owner of each patent that is the subject of an
application referred to in subsection (1), the owner of each such patent shall
be made a party to the application.
(5) Subject to
subsection (5.1), in a proceeding in respect of an application under
subsection (1), the court may, on the motion of a second person, dismiss the
application in whole or in part
(a) in respect
of those patents that are not eligible for inclusion on the register; or
(b) on the
ground that it is redundant, scandalous, frivolous or vexatious or is
otherwise an abuse of process in respect of one or more patents.
(5.1) In a
proceeding in respect of an application under subsection (1), the court shall
not dismiss an application in whole or in part solely on the basis that a
patent on a patent list that was submitted before June 17, 2006 is not
eligible for inclusion on the register.
(6) For the
purposes of an application referred to in subsection (1), if a second person
has made an allegation under subparagraph 5(1)(b)(iv) or (2)(b)(iv) in
respect of a patent and the patent was granted for the medicinal ingredient
when prepared or produced by the methods or processes of manufacture
particularly described and claimed in the patent, or by their obvious
chemical equivalents, it shall be considered that the drug proposed to be
produced by the second person is, in the absence of proof to the contrary,
prepared or produced by those methods or processes.
(7) On the
motion of a first person, the court may, at any time during a proceeding,
(a) order a
second person to produce any portion of the submission or supplement filed by
the second person for a notice of compliance that is relevant to the
disposition of the issues in the proceeding and may order that any change
made to the portion during the proceeding be produced by the second person as
it is made; and
(b) order the
Minister to verify that any portion produced corresponds fully to the
information in the submission or supplement.
(8) A document
produced under subsection (7) shall be treated confidentially.
(9) In a
proceeding in respect of an application under subsection (1), a court may
make any order in respect of costs, including on a solicitor-and-client
basis, in accordance with the rules of the court.
(10) In
addition to any other matter that the court may take into account in making
an order as to costs, it may consider the following factors:
(a) the
diligence with which the parties have pursued the application;
(b) the
inclusion on the certified patent list of a patent that should not have been
included under section 4; and
(c) the
failure of the first person to keep the patent list up to date in accordance
with subsection 4(7).
|
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.
(4)
Lorsque la première personne n’est pas le propriétaire de chaque brevet visé
dans la demande mentionnée au paragraphe (1), le propriétaire de chaque
brevet est une partie à la demande.
(5)
Sous réserve du paragraphe (5.1), lors de l’instance relative à la demande
visée au paragraphe (1), le tribunal peut, sur requête de la seconde
personne, rejeter tout ou partie de la demande si, selon le cas :
a)
les brevets en cause ne sont pas admissibles à l’inscription au registre;
b)
il conclut qu’elle est inutile, scandaleuse, frivole ou vexatoire ou
constitue autrement, à l’égard d’un ou plusieurs brevets, un abus de
procédure.
(5.1)
Lors de l’instance relative à la demande visée au paragraphe (1), le tribunal
ne peut rejeter tout ou partie de la demande pour la seule raison qu’un
brevet inscrit sur une liste de brevets présentée avant le 17 juin 2006 n’est
pas admissible à l’inscription au registre.
(6)
Aux fins de la demande visée au paragraphe (1), dans le cas où la seconde
personne a fait une allégation aux termes des sous-alinéas 5(1)b)(iv) ou
5(2)b)(iv) à l’égard d’un brevet et que ce brevet a été accordé pour
l’ingrédient médicinal préparé ou produit selon les modes ou procédés de
fabrication décrits en détail et revendiqués dans le brevet ou selon leurs
équivalents chimiques manifestes, la drogue qu’elle projette de produire est,
en l’absence d’une preuve contraire, réputée préparée ou produite selon ces
modes ou procédés.
(7)
Sur requête de la première personne, le tribunal peut, au cours de
l’instance :
a)
ordonner à la seconde personne de produire les extraits pertinents de la
présentation ou du supplément qu’elle a déposé pour obtenir un avis de
conformité et lui enjoindre de produire sans délai tout changement apporté à
ces extraits au cours de l’instance;
b)
enjoindre au ministre de vérifier si les extraits produits correspondent
fidèlement aux renseignements figurant dans la présentation ou le supplément
déposé.
(8)
Tout document produit aux termes du paragraphe (7) est considéré comme
confidentiel.
(9)
Le tribunal peut, au cours de l’instance relative à la demande visée au
paragraphe (1), rendre toute ordonnance relative aux dépens, notamment sur
une base avocat-client,
conformément
à ses règles.
(10)
Lorsque le tribunal rend une ordonnance relative aux dépens, il peut tenir
compte notamment des facteurs suivants :
a)
la diligence des parties à poursuivre la demande;
b)
l’inscription, sur la liste de brevets qui fait l’objet d’une attestation, de
tout brevet qui n’aurait pas dû y être inclus aux termes de l’article 4;
c)
le fait que la première personne n’a pas tenu à jour la liste de brevets
conformément au paragraphe 4(7).
|
Regulations
Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/2006-242:
|
TRANSITIONAL
PROVISIONS
7. (1)
Subsection 5(1) of the Patented Medicines (Notice of Compliance)
Regulations, as enacted by section 2 of these Regulations, applies to a
second person who has filed a submission referred to in subsection 5(1) prior
to the coming into force of these Regulations and the date of filing of the
submission is deemed to be the date of the coming into force of these
Regulations.
(2) Subsection
5(2) of the Patented Medicines (Notice of Compliance) Regulations, as
enacted by section 2 of these Regulations, applies to a second person who has
filed a supplement to a submission referred to in subsection 5(2) prior to
the coming into force of these Regulations and the date of filing of the
supplement is deemed to be the date of the coming into force of these
Regulations.
|
DISPOSITIONS
TRANSITOIRES
7.
(1) Le paragraphe 5(1) du Règlement sur les médicaments brevets (avis de
conformité), édicté par l’article 2 du présent règlement, s’applique à
toute seconde personne qui a déposé la présentation visée à ce paragraphe
avant l’entrée en vigueur du présent règlement, et la date de dépôt de cette
présentation est réputée être la date d’entrée en vigueur du présent
règlement.
(2)
Le paragraphe 5(2) du Règlement sur les médicaments brevetés (avis de
conformité), édicté par l’article 2 du présent règlement, s’applique à
toute seconde personne qui a déposé le supplément à une présentation visée à
ce paragraphe avant l’entrée en vigueur du présent règlement, et la date de
dépôt de ce supplément est réputée être la date d’entrée en vigueur du
présent règlement.
|
Patent Act, R.S., 1985, c. P-4:
|
55.2 (1)
It is not an infringement of a patent for any person to make, construct, use
or sell the patented invention solely for uses reasonably related to the
development and submission of information required under any law of Canada, a
province or a country other than Canada that regulates the manufacture,
construction, use or sale of any product.
(2) and (3)
[Repealed, 2001, c. 10, s. 2]
(4) The Governor in Council may make
such regulations as the Governor in Council considers necessary for
preventing the infringement of a patent by any person who makes, constructs,
uses or sells a patented invention in accordance with subsection (1),
including, without limiting the generality of the foregoing, regulations
(a) respecting
the conditions that must be fulfilled before a notice, certificate, permit or
other document concerning any product to which a patent may relate may be
issued to a patentee or other person under any Act of Parliament that
regulates the manufacture, construction, use or sale of that product, in addition
to any conditions provided for by or under that Act;
(b) respecting
the earliest date on which a notice, certificate, permit or other document
referred to in paragraph (a) that is issued or to be issued to a person other
than the patentee may take effect and respecting the manner in which that
date is to be determined;
(c) governing
the resolution of disputes between a patentee or former patentee and any
person who applies for a notice, certificate, permit or other document
referred to in paragraph (a) as to the date on which that notice,
certificate, permit or other document may be issued or take effect;
(d) conferring
rights of action in any court of competent jurisdiction with respect to any
disputes referred to in paragraph (c) and respecting the remedies that may be
sought in the court, the procedure of the court in the matter and the
decisions and orders it may make; and
(e) generally
governing the issue of a notice, certificate, permit or other document
referred to in paragraph (a) in circumstances where the issue of that notice,
certificate, permit or other document might result directly or indirectly in
the infringement of a patent.
|
55.2 (1) Il n’y a pas
contrefaçon de brevet lorsque l’utilisation, la fabrication, la construction
ou la vente d’une invention brevetée se justifie dans la seule mesure
nécessaire à la préparation et à la production du dossier d’information
qu’oblige à fournir une loi fédérale, provinciale ou étrangère réglementant
la fabrication, la construction, l’utilisation ou la vente d’un produit.
(2)
et (3) [Abrogés, 2001, ch. 10, art. 2]
(4)
Afin d’empêcher la contrefaçon d’un brevet d’invention par l’utilisateur, le
fabricant, le constructeur ou le vendeur d’une invention brevetée au sens du
paragraphe (1), le gouverneur en conseil peut prendre des règlements,
notamment :
a)
fixant des conditions complémentaires nécessaires à la délivrance, en vertu
de lois fédérales régissant l’exploitation, la fabrication, la construction
ou la vente de produits sur lesquels porte un brevet, d’avis, de certificats,
de permis ou de tout autre titre à quiconque n’est pas le breveté;
b)
concernant la première date, et la manière de la fixer, à laquelle un titre
visé à l’alinéa a) peut être délivré à quelqu’un qui n’est pas le breveté et
à laquelle elle peut prendre effet;
c)
concernant le règlement des litiges entre le breveté, ou l’ancien titulaire
du brevet, et le demandeur d’un titre visé à l’alinéa a), quant à la date à
laquelle le titre en question peut être délivré ou prendre effet;
d)
conférant des droits d’action devant tout tribunal compétent concernant les
litiges visés à l’alinéa c), les conclusions qui peuvent être recherchées, la
procédure devant ce tribunal et les décisions qui peuvent être rendues;
e)
sur toute autre mesure concernant la délivrance d’un titre visé à l’alinéa a)
lorsque celle-ci peut avoir pour effet la contrefaçon de brevet.
|
Email this Content