Date: 20070731
Docket: T-513-07
Citation: 2007 FC 797
Ottawa, Ontario, July 31, 2007
PRESENT: The Honourable Madam Justice Simpson
BETWEEN:
ABBOTT LABORATORIES LIMITED
TAP PHARMACEUTICALS INC. and
TAP PHARMACEUTICAL PRODUCTS INC.
Applicants
and
ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND
JUDGMENT
[1]
In
a decision dated February 22, 2007, the Minister of Health (the Minister)
concluded (i) that the amendments to the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the New Regulations)
changed the eligibility requirements for patents listed on the Patent Register
and (ii) that the Applicants’ patent did not meet those requirements.
Accordingly, further to his obligation to maintain the Patent Register, the
Minister de-listed the Applicants’ patent (the Decision) even though it had
been validly listed before the New Regulations came into force on
October 5, 2006.
[2]
In
this application for judicial review, the Applicants seek an order quashing
the Decision and restoring their patent to the Patent Register.
PREVACID
[3]
PREVACID®
is a drug used to reduce gastric acid secretions in the stomach and prevent
infectious diseases caused by Helicobacter Pylori. The active medicinal
ingredient in PREVACID® is lansoprazole. It is a compound used to treat gastric
ulcers.
THE PATENT
[4]
Canadian Patent No.
2,269,053 (the 053 Patent) was filed in the Canadian Patent Office (the
Patent Office) on November 13, 1997. On May 12, 2006, a Notice of
Allowance was issued which meant that all the requirements for the issuance of
the 053 Patent had been met. As well, by that date, the required fee had been
paid. However, the 053 Patent did not actually issue until July 18, 2006.
[5]
The
053 Patent claims various methods for producing solvent-free lansoprazole
crystals and the crystals themselves. There are also three claims related to
the crystals’ use in the treatment of ulcers. These use claims are the ones
which are relevant in this case and are as follows: claim 10 claims a medicine
comprising the solvent-free crystal for use as an anti-ulcer agent, claim 12 is
for use of the solvent-free crystal for manufacturing a medicine for use as a
anti-ulcer agent and claim 13 is for the use of the solvent-free crystal for
treating or preventing ulcers.
[6]
On
July 20, 2006, the Applicants submitted a patent list (the Patent List) for the
purpose of listing the 053 Patent on the Patent Register in relation to a Supplementary
New Drug Submission for PREVACID®. The 053 Patent was added to the Patent Register
on July 25, 2006. All parties agree that the 053 Patent was properly listed
under the Patented Medicines (Notice
of Compliance) Regulations which then applied (the Old Regulations).
THE SUPPLEMENTARY NEW
DRUG SUBMISSION
[7]
The
Patent List was submitted in relation to Supplementary New Drug Submission (SNDS)
number 066102 dated March 31, 2000. It was for a new use of lansoprazole in the treatment of
ulcers caused by non-steroidal anti-inflammatory drugs (NSAID). For this
reason, SNDS 066102 will hereafter be described as the NSAID SNDS. The NSAID
SNDS was entitled “New Indications: Healing of NSAID-Associated Gastric Ulcer
and Reduction of Risk of NSAID-Associated Gastric Ulcer.”
THE APPLICANTS
[8]
TAP
Pharmaceuticals Inc. (TAP) is
the party which files submissions and receives Notices of Compliance for
PREVACID® products in Canada. However, TAP does not have a regulatory
affairs department in Canada. For this reason, Abbott Laboratories
Limited (Abbott Canada) acts as TAP’s agent in Canada for all
matters relating to TAP’s submissions. In the case of PREVACID®, Abbott Canada acted as
TAP’s agent for the filing of the NSAID SNDS and the submission of the Patent
List.
[9]
TAP
Pharmaceutical Products Inc. (TAP Products) is a holding company for TAP. TAP
Products is a joint venture between Takeda Pharmaceutical Company Limited and
Abbott Laboratories. The latter is the American parent of the Applicant, Abbott
Canada.
THE DECISION
[10]
By
letter dated February 22, 2007, the Minister informed the Applicants that
notwithstanding their representations to the contrary, the 053 Patent would be
removed from the Patent Register pursuant to the Minister’s authority to maintain
the Patent Register under subsection 3(2) of the New Regulations. Several
reasons were given for the Decision but only two were argued on this
application.
[11]
First,
the Minister said that the 053 Patent does not contain a claim to a changed use
as required by paragraph 4(3)(c) of the New Regulations. The Minister’s view is
that, to be listed on the Patent Register against the NSAID SNDS, the 053
Patent must specifically mention the treatment of NSAID ulcers. Since the 053
Patent only refers to the treatment of ulcers generally it fails to meet the
Minister’s criterion.
[12]
Second,
the 053 Patent was de-listed because it claims a polymorphic form of
lansoprazole and, according to the Regulatory Impact Analysis Statement
for the New Regulations SOR/DORS/2006-242 (the RIAS), patents claiming
polymorphic forms are not eligible for listing on the Patent Register in
relation to an SNDS. For this reason, the Minister says that patents which also
claim uses of such forms are ineligible.
THE OLD AND NEW
REGULATIONS
[13]
Attached
as Schedule “A” to these reasons, is a chart which was used during the hearing
to compare the Old and New Regulations. The following points of comparison are
noteworthy:
(i)
Subsection
3(1) in the Old Regulations and subsection 3(2) in the New Regulations deal
with the Minister’s obligation to maintain the Patent Register. The parties
agreed that, for the purposes of this case, there are no material differences
between the provisions.
(ii)
The
language used to describe the listing of the patents on the Patent Register has
changed. The Old Regulations in subsection 3(3), and paragraphs 4(2)(b) and
4(7)(b) generally spoke of “including” patents on the Patent Register. In
contrast, the New Regulations in subsections 3(5), (7), and 4(1), (2), (3) and
4.1(2) generally speak of “adding” patents to the Patent Register.
However, this usage is
not entirely consistent because the sections dealing with maintaining the
Patent Register in both the Old and New Regulations 3(1) and 3(2) both refer to
“adding” and “deleting” patents.
(iii)
Subsection
4(3) in the New Regulations is entirely new. It provides only three situations
in which a patent is eligible to be added to the Patent Register in relation to
an SNDS. These provisions are referred to in paragraph 4(4)(f) of the New
Regulations as the “eligibility requirements”. It is paragraph 4(3)(c) that is
relevant in this case.
STANDARD OF REVIEW
The parties agree that questions of
interpretation of the Old and New Regulations are questions of law and that the
Standard of Review is correctness. In this regard, see AstraZeneca Canada
Inc. v. Canada (Minister of Health), [2006] 2 S.C.R. 560 at
paragraph 25.
THE ISSUES
[14]
Against
this background, there are two broad issues. The first is whether the Minister had
authority under the New Regulations to delete the 053 Patent in the course of
maintaining the Patent Register. The second issue is whether the 053 Patent
meets the eligibility requirements in paragraph 4(3)(c) of the New Regulations.
Issue 1 – Maintaining
the Patent Register
[15]
This issue involves the proper
interpretation of the New Regulations. In AstraZeneca, the Supreme Court
reiterated the modern approach to statutory interpretation in the context of
the Notice of Compliance Regulations. At paragraph 26 the court wrote:
It
is now 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. Further, the scope of a regulation such as the provisions of
the NOC Regulations is constrained by its enabling legislation, in this
case s. 55.2(4) of Patent Act (Biolyse, at para. 38).
[16]
The
provisions at issue are subsection 3(2) and paragraph 4(3)(c) of the New
Regulations and section 6 of the Regulations
Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/2006-242
(the Amending Regulations).
[17]
Subsection
3(2) obliges the Minister to maintain the Patent Register. It states:
|
3.(2)
The Minister shall
maintain a register of patents and other information submitted under section
4. To maintain the register, the Minister may refuse to add or may delete any
patent or other information that does not meet the requirements of that
section.
|
3.(2) Le ministre tient un registre des brevets et des autres
renseignements fournis aux termes de l’article 4. À cette fin, il peut
refuser d’y ajouter, ou en supprimer, tout brevet ou tout autre renseignement
qui n’est pas conforme aux exigences de cet article.
|
[18]
Paragraph
4(3)(c) provides the eligibility requirements for adding a patent to the Patent
Register in relation to an SNDS for a changed use. It says:
|
4.(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
…
(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.
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4.(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 :
[…]
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.
|
[19]
Section 6 of the Amending
Regulations
is a transitional provision. It sets a cutoff date of June 17, 2006.
Patent Lists submitted on or after that date are subject to the New
Regulations. The section reads:
|
6. Section 4
of the Patented Medicines (Notice of Compliance) Regulations, as
enacted by section 2 of these Regulations, does not apply to patents on a
patent list submitted prior to June 17, 2006.
|
6.
L’article 4 du Règlement sur les médicaments brevetés (avis de conformité),
édicté par l’article 2 du présent règlement, ne s’applique pas aux brevets
inscrits sur la liste de brevets présentée avant le 17 juin 2006.
|
[20]
The
Applicants’ submissions on this issue were made under five headings. I will
deal with each in turn.
The “Plain Meaning” Submission
[21]
The
Applicants take the position that since section 4 of the New Regulations deals
only with the eligibility requirements for adding patents to the Patent Register,
it cannot be that the requirements in paragraph 4(3)(c) can be used in
conjunction with the requirement to maintain the Patent Register in subsection
3(2) of the New Regulations when the Minister is considering deleting
patents.
[22]
However,
in my view, if this approach is taken, subsection 3(2) has no meaning when
applied to the deletion of patents because there would be no requirements in
section 4 that relate to deletions. In other words, the Applicants’
interpretation does not fit within the scheme of the New Regulations which
apparently intends subsection 3(2) and section 4 to interrelate on two subjects
– both the addition and the deletion of patents.
[23]
At
the hearing the Applicants emphasized that their interpretation did not eviscerate
the Minister’s power to maintain the Patent Register because the Minister could,
for example, remove patents from the Register if a Drug Identification Number
were cancelled, or if a patent expired or had been added in error, or if
delisting had been ordered by a Court. However, the problem with this submission
is that these situations are not referred to in section 4.
[24]
As AstraZeneca
states at paragraph 26, provisions should, if possible, be construed to fit with
the scheme of the Regulations. With that in mind, it is my view that the words
of subsection 3(2), when read in their context and in their ordinary sense,
have the effect of cross-referencing the requirements for adding patents in
section 4 so that they also become the requirements for the deletion of patents
under subsection 3(2).
The “Retroactivity”
Submission
[25]
The
Applicants say that the eligibility requirements for listing a patent on the
Patent Register in relation to an SNDS in paragraph 4(3)(c) of the New
Regulations cannot justify de-listing the 053 Patent because this involves a
retroactive application of the New Regulations which is not authorized by
section 55.2 of the Patent Act, R.S.C. 1985, c. P-4. For this proposition,
see Apotex Inc. v. Canada (Attorney General) (C.A.), [1994] 1 F.C. 742, at paragraph 126.
[26]
I acknowledge
that the New Regulations cannot have retroactive effect but I have also
concluded that they have no such effect. In my view, the Federal Court of
Appeal’s decision in Eli Lilly Canada Inc. v. Canada (Minister of Health) (2003), 23 C.P.R. (4th)
289 (F.C.A.) is directly on point. There Justice Sharlow, for the majority said
this:
[15] The 1998 amendments also made some changes
to section 4 which narrowed the scope of information that is eligible for
inclusion on the patent register. Counsel for Eli Lilly argued that the
eligibility of any patent lists it submitted prior to the 1998 amendments
should not be assessed under the narrower rules. I do not agree. In my view,
the 1998 amendments entitle the Minister to delete from the patent register any
information that does not meet the requirements of the PMNOC Regulations, as
they are established from time to time by the Governor in Council. Thus, a
patent that qualified for inclusion on a patent list in 1993, but does not
qualify under the 1998 amendments, may be removed at any time after March 11,
1998.
[16] I see no merit in the submission of
counsel for Eli Lilly that this offends any right or presumptive right on the
part of Eli Lilly not to be subject to retroactive legislation. The 1998
amendments are not retroactive. The 1998 amendments speak only from March 11,
1998. The fact that they properly may apply to cause the removal from the
patent list of a patent that was accepted for listing in 1993 does not make the
1998 amendments retroactive...
[27]
The
Applicants say that I should not accept Lilly as a binding precedent
because under paragraph 4(7)(b) of the Old Regulations, the Minister was
considering whether patents qualified for “inclusion”, i.e. both whether they
could be added to and deleted from the Patent Register, while under subsection
4(3) of the New Regulations the Minister considers only whether patents can be
“added” to the Register.
[28]
In
my view, this submission is not persuasive. I am not satisfied that the words
“include” and “add” are materially different. In the sections relied on by the
Applicants both words involve the idea that a patent will be placed on the
Patent Register. Paragraph 4(7)(b) of the Old Regulations deals with the
contents of a patent list which is being prepared for submission and subsection
4(3) of the New Regulations deals with adding patents to the Register. Given these
contexts, there is no basis for concluding that “include” has anything to do
with removing patents from the Patent Register.
The “Vested Rights”
Submission
[29]
The
Applicants say that the Minister erred when he interpreted section 6 of the
Amending Regulations to mean that paragraph 4(3)(c) of the New Regulations
applied to all patents lists submitted after June 17, 2006 whether or not
the patents had been listed on the Patent Register before the New Regulations
came into force on October 5, 2006. The Applicants base this submission on
the presumption against interference with vested rights. They say that they
have a vested right to have the 053 Patent remain on the Patent Register so
that it must be addressed by generic companies. As well, they submit they have a
vested right to continue the prohibition action they commenced on
November 23, 2006 in response to Apotex’s filing a Notice of Allegation on
September 27, 2006 with respect to the 053 Patent.
[30]
However,
these submissions depend on the Applicants’ alleged right to have the 053
Patent remain on the Patent Register and I have concluded that they have no such
right in view of the Minister’s obligation to maintain the Register under
subsection 3(2) of the New Regulations.
The “Addressability”
Submission
[31]
The
Applicants suggest that the Minister’s interpretation of subsection 3(2) of the
New Regulations which allows him to delete patents which do not meet the
eligibility requirements in section 4 is incorrect because it is inconsistent
with the provisions of section 7 of the Amending Regulations. It is another
transitional provision and it reads as follows:
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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.
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7.
(1) Le paragraphe 5(1) 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 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 visé 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.
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[32]
Essentially
this provision means that, if before October 5, 2006 a generic company filed
an abbreviated new drug submission, it would be deemed to be filed on
October 5, 2006, thus requiring the generic to address all the patents on
the Patent Register at that date. The Applicants say that this provision is
meaningless if the 053 Patent is deleted.
[33]
I am
not persuaded by this submission. In my view, section 7 is only sensibly read
if it requires a generic to address all patents properly on the Register
at October 5, 2006. The fact that the Minister may delete some patents listed
before that date does not render the provision meaningless.
The “Delay” Submission
[34]
The
Applicants are frustrated because, although they received a Notice of Allowance
from the Patent Office dated May 12, 2006, the 053 Patent did not issue
until July 18, 2006. This meant that they did not have the 053
Patent on June 17, 2006 which was the cut off date for submitting patent
lists under the Old Regulations. In spite of this, they say that, based on the
Notice of Allowance they had an accrued right to the 053 Patent before
June 17, 2006 and the Patent List should therefore be treated as if it had
been submitted on or before June 17, 2006.
[35]
I
was not referred to any case law indicating that a Notice of Allowance creates
any rights. Further, the Applicants’ frustration is based on the conduct of the
Patent Office. It has nothing to do with the Minister who is the respondent in
this case. In these circumstances, I am not prepared to conclude that the
Minister should deem the 053 Patent List to have been submitted before June 17,
2006 when the 053 Patent was not issued until July 18, 2006.
Issue 2 - Does the 053
Patent meet the requirements of paragraph 4(3)(c) of the New Regulations?
[36]
The
Minister concedes that the NSAID SNDS was for a new use and that a Notice of Compliance
had issued for that new use. However, the Minister says that the 053 Patent
which includes three claims for the use of lansoprazole in the treatment
of ulcers is not eligible for listing under paragraph 4(3)(c) of the New
Regulations because it does not expressly claim the treatment of NSAID ulcers.
[37]
However,
paragraph 4(3)(c) says that the 053 Patent is eligible to be listed on the
Patent Register if it “contains” a claim for the new use, i.e. the treatment of
NSAID ulcers. To address the question of whether the 053 Patent claims uses to
treat NSAID ulcers, the Applicants adduced the evidence of two experts who they
describe as informed and skilled readers of the 053 Patent. The Minister took
no issue with their qualifications.
[38]
Dr.
David Armstrong is a specialist in gastroenterology. He is a professor at McMaster University and Chief of Clinical
Service in the Division of Gastroenterology for the Hamilton Health Sciences group
of academic hospitals. He is familiar with the use of PREVACID® in the
treatment of NSAID-associated gastric ulcers.
[39]
Dr.
Armstrong reviewed the 053 Patent and at paragraphs 20 and 21 of his affidavit
sworn on April 20, 2007, said the following:
20.
In my opinion, a skilled physician, on May 22, 1998, would have clearly
understood the word “ulcer”, in claims 10, 12 and 13 to include and refer to
NSAID ulcers and would certainly have known that the claims cover the use of
the solvent-free crystal for healing NSAID-associated ulcers and reduction of
the risk of NSAID associated ulcers. NSAID ulcers are a well-known type of
ulcer. As of the relevant date, a skilled physician would readily know that an
NSAID ulcer is a type of “ulcer” included within the scope of claims 10, 12 and
13. There is no scientific reason nor is there anything the ‘053 patent to
suggest to the skilled physician any meaning for the claims that would exclude
NSAID ulcers, and no such meaning would be given.
21.
Indeed, the disclosure of the ‘053 Patent discusses the use of the solvent-free
crystal as a medicine, as an anti-ulcer agent for treating or preventing ulcers
(see page 14 lines 3-11). From this and the claims, a skilled physician would
clearly understand that this patent is claiming a medicine and a new use for
that medicine; namely, the use of that medicine as an anti-ulcer agent. A
skilled physician would have no hesitation in concluding that this description
includes NSAID ulcers. Similarly, from reading the claims in light of this
disclosure, a skilled physician would understand that claims 10, 12 and 13
claim the use of the medicine (the solvent-free crystal of lansoprazole) for
the treatment or prevention of NSAID ulcers.
[40]
Dr.
Jerry Atwood is the Curators’ Professor of Chemistry and Chair of the
Department of Chemistry at the University of Missouri-Columbia. At paragraphs
23 and 24 of his affidavit sworn on April 23, 2007, he said:
23.
A skilled chemist would understand from reading the ‘053 patent that the term
“ulcer” as it is used in claims 10, 12, and 13 is not limited to any particular
type of gastric ulcer. Instead, the term “ulcer” would be read and understood
by a skilled chemist as referring to all stomach ulcers.
24.
Thus, it is my opinion that a skilled chemist would interpret claim 13 as
covering the healing and reducing the risk of stomach ulcers however caused.
Similarly, it is my opinion that a skilled chemist would interpret claim 13 as
covering any stomach ulcer, however caused.
[41]
In
my view, it is consistent with the expert evidence to conclude that the 053
Patent is eligible to be on the Patent Register pursuant to paragraph 4(3)(c)
of the New Regulations because it includes a claim to the new use of
lansoprazole to treat NSAID ulcers.
[42]
However,
the Minister had a second problem with the 053 Patent. He also considered it to
be ineligible to be listed on the Patent Register in relation to the NSAID SNDS
because the RIAS says that polymorphic forms cannot be listed against SNDSs.
[43]
The
relevant passage at page 1518 of the RIAS reads as follows:
The
amendments to section 4 also formally confirm the right to list new patents on
the basis of SNDS filings and introduce listing requirements governing that
right. Under these requirements, a patent which had been applied for prior to
the filing of an SNDS may be submitted in relation to that SNDS provided the
purpose of the latter is to obtain approval for a change in use of the
medicinal ingredient (i.e. new method of use or new indication), a change in
formulation or a change in dosage form and the patent contains a claim to the
formulation, dosage form or use so changed. This will protect and encourage
legitimate and substantive incremental innovation of direct therapeutic
application. New patents claiming novel physical forms of the approved
medicinal ingredient will not be eligible for listing in this manner.
[my emphasis]
[44]
While
it is true that the 053 Patent includes claims for the polymorphic form of
lansoprazole, it is my view that this fact does not disqualify it for listing
under paragraph 4(3)(c) of the Regulations. All that provision requires is that
the 053 Patent “contain” a claim for the changed use. As described in paragraph
5 above and as confirmed by the Applicants’ experts there are three such claims
in the 053 Patent. In my view, it is therefore eligible in spite of the fact
that it also contains claims to polymorphic forms.
[45]
For
these reasons, I have concluded that the 053 Patent meets the eligibility
requirements in paragraph 4(3)(c) of the New Regulations and should not have
been removed from the Patent Register.
JUDGMENT
THIS COURT ORDERS AND
ADJUDGES that
-
This
application is allowed with costs.
-
The
053 Patent is to be listed on the Patent Register under the New Regulations in relation
to the NSAID SNDS. The listing is to be as of March 1, 2007 which was the
effective date of its de-listing.
“Sandra J. Simpson”
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