Dockets: T-598-17
T-599-17
T-600-17
T-601-17
T-602-17
T-603-17
T-604-17
T-605-17
Citation:
2017 FC 676
Ottawa, Ontario, July 25, 2017
PRESENT: The Honourable Mr. Justice Manson
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BETWEEN:
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ABBVIE
CORPORATION AND
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ABBVIE
BIOTECHNOLOGY LTD.
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Applicants
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and
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SAMSUNG BIOEPIS
CO., LTD. AND
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THE MINISTER OF
HEALTH
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Respondents
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AMENDED
ORDER AND REASONS
I.
Introduction
[1]
There are three applications by the Applicants,
AbbVie Corporation and AbbVie Biotechnology Ltd (together, “AbbVie”), for an
Order pursuant to Rules 3, 55, 306, 307, and 385(1)(a) of the Federal Court
Rules requiring the Respondents, Samsung Bioepis, Ltd. (“Bioepis”), to
reverse the order of the Parties’ evidence and serve its evidence on the issues
of (1) claim relevancy, (2) priority date entitlement, and (3) material
misrepresentation before AbbVie is required to deliver its evidence on those
issues. The Applicants’ also seek their costs of the motion.
II.
Background
[2]
On March 2,, 2017, Bioepis filed new drug
submissions (“NDS”) no. 203250 (“NDS 2032050'”) and no. 203292 (“NDS 263292”)
for its adalimumab product named HADLIMA. The NDSs contain different but
overlapping indications for HADLIMA. The indications for which NDS 203250 was
filed include the treatment of Crohn’s disease, ulcerative colitis, and
hidradenitis suppurativa, whereas NDS 203292 does not include these
indications.
[3]
On March 13,20l7, Bioepis served eight Notices
of Allegation (“NOAs”) in relation to the HADLIMA product (the “Bioepis
Letters”). For each NDS, Bioepis served a NOA for each of the following
patents, which AbbVie had listed on the Patent Register: i) Canadian Patent No.
2,385,745 (the “‘745 Patent”); ii) Canadian Patent No. 2,494,756 (the “‘756
Patent”); iii) Canadian Patent No. 2,847,142 (the “‘142 Patent”); and iv)
Canadian Patent No. 2,504,868 (the “‘868 Patent”).
[4]
The Bioepis Letters each contain the following
allegations of invalidity: anticipation, obviousness, double patenting, lack of
utility, overbreadth, insufficiency, ambiguity, and unpatentable subject-matter
(method of medical treatment). Bioepis also alleges that:
a)
Bioepis is not required to address the claims of
the ‘868 and ‘142 Patents;
b)
AbbVie is not entitled to rely on any of the
priority dates of the ‘868 and ‘142 Patents (April 9, 2004, April 12, 2004, or May
7, 2004) on the basis that the requirements of section 28.1(1) of the Patent
Act were not met; and
c)
the petitions for the ‘868 and ‘142 Patents
contained a material allegation that was untrue and wilfully made for the
purpose of misleading, pursuant to section 53 of the Patent Act.
[5]
AbbVie denies each and every allegation made by
Bioepis.
[6]
On April 25, 2017, the AbbVie initiated eight
applications, under the Patented Medicines (Notice of Compliance)
Regulations (the “Regulations”) in response to the NOAs, for orders
prohibiting the Minister of Health from issuing notices of compliance to Bioepis
for the Bioepis Products:
a)
Court File No. T-598- l7 addressing the NOA for
NDS 203250 and the ‘868 Patent;
b)
Court File No. T-599-17 addressing the NOA for
NDS 203250 and the ‘745 Patent;
c)
Court File No. T-600-17 addressing the NOA for
NDS 203292 and the ‘868 Patent;
d)
Court File No. T-601-17 addressing the NOA for
NDS 203292 and the ‘142 Patent;
e)
Court File No. T-602-17 addressing the NOA for
NDS 203292 and the ‘745 Patent;
f)
Court File No. T-603-17 addressing the NOA for
NDS 203292 and the ‘756 Patent;
g)
Court File No. T-604-17 addressing the NOA for
NDS 203250 and the ‘142 Patent; and
h)
Court File No. T-605-17 addressing the NOA for
NDS 203250 and the ‘756 Patent.
[7]
In its motions for reversal of evidence, AbbVie
asserts that Bioepis’ allegations concerning claim relevancy, priority date
entitlement, and material misrepresentation are insufficient, unclear, and do
not constitute a detailed statement pursuant to the Regulations. For
this reason, AbbVie seeks a reversal of the ordinary order of evidence on these
issues.
III.
Analysis
[8]
Rules 306 and 307 of the Federal Court Rules
set out the order for evidence to be filed in an application, and generally
provide that the applicant’s evidence is to be filed before the respondent’s
evidence.
[9]
However, the Court has the discretion to reverse
the order of evidence where it would provide a just, most expeditious and least
expensive determination of the proceeding on its merits (Federal Court Rules
3, 55, and 385(1)(a); Eli Lilly Canada Inc v Novopharm Limited, 2008
FC 875 at para 10; Tekeda v Canada (Minister of Health), 2013 Carswell
Nat 11553 at para 3).
[10]
Moreover, reversal of evidence should only be
granted where there are special circumstances and not where such a reversal
will delay the proceedings and result in additional costs (Pfizer Canada Inc
v Apotex Inc, 2013 FC 1036 at paras 1, 3; Abbott Laboratories Limited et
al v Novopharm et al, 2007 FC 1291 at para 17).
[11]
By Direction of this Court dated June 7, 2017, a
timetable governing the proceedings was issued stating that, inter alia:
5.
The Applicants’ evidence on all issues shall be
served by October 17, 2017.
6.
The Respondent’s evidence on all issues shall be
served by February 9, 2018.
[12]
Notwithstanding AbbVie’s motion for a partial
reversal of the filing of evidence relating to claim relevancy, priority date
entitlement and material misrepresentation, AbbVie has otherwise agreed to
serve its evidence first on issue of claim construction, non-infringement,
anticipation, obviousness, lack of utility, insufficiency, and method of
medical treatment.
[13]
The three motions concerning these allegations
are divided as follows:
- T-598-17, T-600-17, T-601-17 and
T-604-17, relating to the ‘868 Patent and ‘142 Patent;
- T-599-17 and T-602-17, relating to the
‘745 Patent; and
- T-603-17 and T-605-17, relating to the
‘756 Patent.
[14]
I will deal with the motions by way of dealing
with each of the three issues for all the patents.
A.
Claim Relevancy Allegations
[15]
At the hearing, counsel for Bioepis admitted
that claim relevancy is no longer an issue with respect to the ‘898 Patent in
T-598-17, T-600-17, T-601-17 and T-604-17. Counsel for AbbVie drew to the
Court’s attention the grounds for a Notice of Allegation under section 5(1) and
5(2) of the Patented Medicines (Notice of Compliance) Regulations:
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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,
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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 :
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(a) state that the second person accepts
that the notice of compliance will not issue until the patent expires; or
(b) allege that
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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 :
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(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.
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(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.
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(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,
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(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 :
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(a) state that the second person accepts
that the notice of compliance will not issue until the patent expires; or
(b) allege that
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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 :
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(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.
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(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.
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[16]
AbbVie argued that, for each of the patents in
the three applications, the allegations relating to claim relevancy have no
basis under either section 5(1) or 5(2), unless that allegation relates to
subparagraph 5(1)(b)(iv), namely that :
(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.
[17]
Therefore, the allegations should have been
clear and limited to the question of infringement in each of the applications.
[18]
Counsel for Bioepis agreed that, pursuant to the
decision of Justice Johanne Gauthier of the Federal Court (as she then was), in
Solvay Pharma Inc v Apotex Inc, 2008 FC 308 at paragraphs 55 to 66, the
allegation of claim relevancy is to be so limited, and the Parties agreed that as
a result this issue as it relates to infringement is no longer part of the
motions to be decided with respect to reversal of evidence.
B.
Priority Date Entitlement
(1)
T-598-17, T-600-17, T-601-17 and T-604-17: the
‘898 and ‘142 Patents
[19]
AbbVie argues that the priority date allegations,
in respect of the ‘898 Patent (section 5.1, page 40 of the NOA) and in respect
of the ‘142 Patent (section 7.1, page 43 of the NOA), are deficient in not
providing any basis for the priority date entitlement allegations.
Specifically, Bioepis alleges that “AbbVie is not entitled to any of its
priority dates of April 9, 2004, April 12, 2004, or May 7, 2004, because the
requirements of section 28.1(1) of the Patent Act are not met”.
Therefore, certain prior art to be relied on will be relevant to the issues of novelty
and obviousness.
[20]
Section 28.1(1) states:
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Claim date
28.1 (1) The date of a claim in an
application for a patent in Canada (the “pending application”) is the filing
date of the application, unless
(a) the pending application is filed by
(i) a person who has, or whose agent,
legal representative or predecessor in title has, previously regularly filed
in or for Canada an application for a patent disclosing the subject-matter
defined by the claim, or
(ii) a person who is entitled to
protection under the terms of any treaty or convention relating to patents to
which Canada is a party and who has, or whose agent, legal representative or
predecessor in title has, previously regularly filed in or for any other
country that by treaty, convention or law affords similar protection to
citizens of Canada an application for a patent disclosing the subject-matter
defined by the claim;
(b) the filing date of the pending
application is within twelve months after the filing date of the previously
regularly filed application; and
(c) the applicant has made a request for
priority on the basis of the previously regularly filed application.
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Date de la revendication
28.1 (1) La date de la revendication
d’une demande de brevet est la date de dépôt de celle-ci, sauf si :
a) la demande est déposée, selon le cas :
(i) par une personne qui a antérieurement
déposé de façon régulière, au Canada ou pour le Canada, ou dont l’agent, le
représentant légal ou le prédécesseur en droit l’a fait, une demande de
brevet divulguant l’objet que définit la revendication,
(ii) par une personne qui a
antérieurement déposé de façon régulière, dans un autre pays ou pour un autre
pays, ou dont l’agent, le représentant légal ou le prédécesseur en droit l’a
fait, une demande de brevet divulguant l’objet que définit la revendication,
dans le cas où ce pays protège les droits de cette personne par traité ou
convention, relatif aux brevets, auquel le Canada est partie, et accorde par
traité, convention ou loi une protection similaire aux citoyens du Canada;
b) elle est déposée dans les douze mois
de la date de dépôt de la demande déposée antérieurement;
c) le demandeur a présenté, à l’égard de
sa demande, une demande de priorité fondée sur la demande déposée
antérieurement.
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[21]
Bioepis’ replies that it is readily apparent
that only subparagraph 28.1(1)(a)(ii) applies, and therefore AbbVie is aware
that the allegation is challenging whether Bioepis is entitled to claim
priority on the basis that Bioepis did not acquire title through an agent,
legal representative or predecessor in title, who previously regularly filed an
application for a patent disclosing the subject-matter claimed in either the
‘898 or ‘142 Patent.
[22]
AbbVie responds by arguing that the assignment
and title issue is very complex, and will require substantial time, money, and
expert testimony if a reversal of order for evidence on this issue is not
granted by the Court.
(2)
T-599-17 and T-602-17: the ‘745 Patent
[23]
AbbVie argues that the priority allegation with
respect to the ‘745 Patent (section 6.1, page 45 of the NOA), while it has some
detail, nevertheless is insufficient, unjustified, and not a proper allegation
under section 5 of the Regulations.
[24]
Bioepis responds with the fact that the allegation
at 6.1 specifies that:
AbbVie is not entitled to the priority date
of June 8, 2001 because the requirements of section 28.1(1) of the Patent
Act have not been met. At the time Canadian Patent Application 2,385,745
(the “745 Application”) was filed, on May 10, 2002, this Application and the
priority application (US60/296,961) were owned by two different entities. On
May 10, 2002, the application of the 745 Application was Abbott Laboratories
(Bermuda) Ltd., but the priority application was owned by another entity.
Abbott Laboratories (Bermuda) Ltd. was not the agent, the legal representative
or the predecessor in title of the entity which owned the priority application,
and Abbott Laboratories (Bermuda) Ltd. was therefore not entitled to take
advantage of the priority date of US60/296,961. Therefore, the novelty and
inventiveness of the 745 Patent must be analyzed as of the Canadian filing date
of May 10, 2002.
(Emphasis in original)
[25]
Therefore, sufficient detail of the allegation
is provided. Furthermore, Bioepis argues that AbbVie in its Notice of
Application provides no detail as to how the priority application complies with
the Patent Act.
(3)
T-603-17 and T-605-17: the ‘756 Patent
[26]
AbbVie concedes that the allegation concerning
this priority claim is sufficient.
[27]
Further, AbbVie agrees that there is no section
53 allegation in respect of this patent.
[28]
I have considered the allegations concerning
priority entitlement in detail. I am not convinced, on a balance of
probabilities, that a reversal of evidence would be more just, and save time or
expenses in these proceedings, nor is there a basis to find that special
circumstances exist that would benefit from such a reversal in dealing with the
issue of priority entitlement.
[29]
A partial reversal of evidence, particularly on
one issue, in only some of the matters involved in these multiple proceedings,
which are to be heard together, would probably result in more complex
proceedings and necessitate reply evidence by Bioepis, if ordered.
[30]
Moreover, I find that sufficient facts are
provided on this issue for AbbVie to serve its evidence in the normal course (AstraZeneca
Canada Inc et al v Apotex Inc et al, 2008 FC 537 at paras 8 to 10).
C.
Material Misrepresentation Allegation
(1)
T-598-17, T-600-17, T-601-17 and T-604-17: the
‘898 and ‘142 Patents
[31]
AbbVie’s position is that the Bioepis allegation
of material misrepresentation under section 53 of the Patent Act “baldy
alleges that the failure to name the proper inventors was wilfully made for the
purpose of misleading” (section 5.9, pp 85, 86 of the NOA). Given that the
Court has held that section 53 allegations are essentially allegations of
fraud, a consideration of the wrong doer’s state of mind is necessary, and no
facts are provided in this regard.
[32]
Bioepis replies by stating that the basis of the
section 53 allegation is the failure to name the proper inventors, as fully set
out in section 5.9:
Claims 1-16 of the 142 Patent are invalid
because a material allegation in the petition of the applicant in respect of
the 142 Patent is untrue and wilfully made for the purpose of misleading,
contrary to section 53 of the Patent Act. The petition fails to
name the proper inventors of the 142 Patent. The failure to list the inventors
was wilfully made for the purpose of misleading.
The petition is the application for
the 142 Patent stated that Rebecca Hoffman, Elliott Keith Chartash, Lori
Taylor, George Richard Granneman and Philip Yan are the inventors of the 142
Patent. The 142 Patent purportedly relates to
the use of D2E7 to treat IBD and HS. Examples 1 and 2 in the 142 Patent related
to the treatment of Crohn’s disease and are the only examples in the 142 Patent
related to IBD or HS.
Example 1 of the 142 Patent was
disclosed in Hanaeur, “Human Anti-Tumor Necrosis Factor Monoclonal Antibody
(Adalimumab) in Crohn’s Disease: the CLASSIC-I Trial”, Gastroenterology,
2006, 130:323-333 (“Hanauer 2006”). None of the authors of Hanauer 2006 are
listed as inventors of the 142 Patent. Hanauer
2006 states that “[t]his study was designed by Abbott Laboratories staff
members and 2 of the investigators who are authors of this report (S.B.H. and
W.J.S.)”. S.B.H. is Stephen B. Hanauer and W.J.S. is William J. Sandborn.
Example 2 was disclosed is Sandborn
2004. None of the authors of Sandborn 2004 are listed as inventors of the 142
Patent.
None of the proper inventors of the
142 Patent were named in the petition. The proper inventors included Stephen B.
Hanauer, William J. Sandborn and possibly others who were not named as
inventors in the petition of the 142 Patent. This failure to name the proper
inventors was wilfully made for the purpose of misleading.
(Emphasis in original)
(2)
T-599-17 and T-602-17: the ‘745 Patent
[33]
AbbVie argues that, like in the motion related
to the ‘898 and ‘142 Patents, the allegation of material misrepresentation in
respect of the ‘745 Patent (section 6.7, page 74 of the NOA) is vague and
insufficient, focussing on the lack of facts supporting any wilful intent in
making the alleged misrepresentation concerning named inventors – i.e., there
is a lack of particularity (Apotex Inc v Shire LLC, 2016 FC 1267 at para
7; Ratiopharm Inc v Pfizer Limited, 2009 FC 711 at para 196).
[34]
Once again, Bioepis responds by stating that the
allegation of material misrepresentation is clear, in that the inclusion of
Abbott Bermuda being listed as the applicant in the petition is a material
misrepresentation, because Abbott Bermuda was not in fact the applicant when
the petition was signed.
(3)
T-603-17 and T-605-17: the ‘756 Patent
[35]
As stated above, there is no section 53
allegation in respect of this application and therefore no issue with respect
to the ‘756 Patent.
[36]
For reasons similar to those given above, in
respect of the issue of priority entitlement, I find that on the record before
me there are sufficient facts in support of the alleged material
misrepresentation for AbbVie to proceed in serving its evidence in the normal
course, without a reversal order.
[37]
If there is a deficiency in the allegation in
that the wilfulness of the misrepresentation has not been set out, Bioepis will
run the risk that it has failed to plead sufficient facts to support its
allegation and, as admitted by Bioepis at the hearing, no reversal of evidence
will remedy the defect – that is an issue for the applications judge.
[38]
Further, I agree with Bioepis that a reversal
order in this proposed piecemeal fashion will likely add to the complexity of
the proceedings, and will not ensure the most expeditious and least expensive
determination of this issue.
[39]
One further note is worth making. Both Parties’
counsel referred to extensive litigation in the United Kingdom involving the
question of title and assignments involving the Parties under German and UK
law, where a determination of ownership and title on related patents to those
in issue here was reached. I encouraged counsel for the Parties to explore
resolving this issue and questions of fact and law prior to the hearing on the
merits, which could substantially reduce time and expense in the proceedings.
[40]
The motion is dismissed with costs to Bioepis.
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