Date: 20080611
Docket: T-2011-06
Citation: 2008 FC 730
Ottawa, Ontario,
June 11, 2008
PRESENT: The
Honourable Mr. Justice Blanchard
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]
The Applicants seek judicial review of the October 17, 2006,
decision of the Minister of Health (the Minister) not to list Canadian Letters
Patent No. 2,338,792 (the ‘792 Patent) on the Patent Register pursuant to the Patented
Medicines (Notice of Compliance Regulations) SOR/93-133, as amended
SOR/98-166 and SOR /99-379 (the Regulations), in respect of PREVACID 15 and 30
mg delayed-release capsules.
[2]
Only patents listed on the Register will be afforded the
protection of the Regulations. If a person has both a Notice of Compliance for
a drug and a patent with claims to the medicine contained in that drug, that
person may apply to the Minister to have the patent included on the Register
against the medicine and in respect of the drug.
[3]
In respect to listing, the Regulations, in force prior to October
5, 2006, required that the patent list identify the drug submission to which it
relates and provide, amongst other information, the dosage form, strength and
route of administration of the drug. Subsections 4(1) and 4(7) of the
Regulations provide:
|
4.(1) A person who files or has filed a submission for, or
has been issued, a notice of compliance in respect of a drug that contains a
medicine may submit to the Minister a patent list certified in accordance
with subsection (7) in respect of the drug.
4.(7) A person who submits a patent list or an amendment
to an existing patent list under subsection (1) or (4) must certify that
(a) the information submitted is accurate; and
(b) the patents set out on the patent list or in
the amendment are eligible for inclusion on the register and are relevant to
the dosage form, strength and route of administration of the drug in respect
of which the submission for a notice of compliance has been filed.
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4(1) La personne qui dépose ou a déposé
une demande d’avis de conformité pour une drogue contenant un médicament ou
qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à
l’égard de la drogue, accompagnée de l’attestation visée au paragraphe (7).
4.(7) La personne qui soumet une liste de
brevets ou une modification apportée à une liste de brevets aux termes des
paragraphes (1) ou (4) doit remettre une attestation portant que :
a) les renseignement fournis
sont exacts;
b) les brevets mentionnés dans
la liste ou dans la modification sont admissibles à l’inscription au registre
et sont pertinents quant à la forme posologique, la concentration et la voie
d’administration de la drogue visée par la demande d’avis de conformité.
|
[4]
Since the filing of the Applicants’ patent list in respect to
lansoprazole on January 25, 2006, the requirements for the contents of a patent
list have changed by amendments to section 4 of the Regulations. Those
amendments apply only to listing applications filed after October 5, 2006, and
are consequently not relevant to the within application.
[5]
In this instance, the Minister concluded that the ‘792 Patent, in
respect of PREVACID 15 and 30 mg delayed-release capsules, was ineligible for
listing. The Minister decided that the ‘792 Patent is not relevant to the
dosage form of the PREVACID products in question as required by paragraph 4(7)(b)
of the Regulations. I summarize below the Minister’s findings.
(i)
The ‘792 Patent contains claims to an orally rapidly disintegrating
solid preparation. However, the PREVACID products at issue are delayed-release
capsules and granules for delayed-release oral suspension. For the PREVACID
products at issue to be eligible for listing, they must not only be solid
preparations, but must also be rapidly disintegrable in the oral cavity;
(ii)
The Office of Patented Medicines & Liaison (OPML) agrees with the
Applicant’s position that the term “solid preparation” is broad enough to
encompass many dosage forms such as capsules and granules. However, the
limitation “orally rapidly disintegrable” renders the ‘792 Patent not relevant
to the delayed-release capsules and granules for delayed-release oral
suspension. Specifically, the OPML does not agree with the Applicants’ claim
that that the capsules and granules are rapidly disintegrable in the oral cavity;
and
(iii)
The OPML notes that ‘792 Patent has been found eligible for listing
against PREVACID FasTab which is a rapidly disintegrating tablet product.
[6]
The Applicants contend that PREVACID capsules are an orally rapidly
disintegrable solid preparation, the claims of the ‘792 Patent are relevant to
PREVACID capsules at issue and the Minister’s decision not to add the ‘792
Patent to the Patent Register was manifestly incorrect. The Respondents say the
Minister did not err in deciding as he did.
I. The Issue
[7]
Did the Minister commit a reviewable error in not listing the ‘792
Patent, in respect of PREVACID 15 and 30 mg delayed-release capsules, because
the patent was not relevant to the dosage form?
[8]
In addressing the above issue, the following matters must be considered:
1. What is the applicable standard of review of the Minister’s
decision?
2. Having regard to the applicable standard of review:
- What is the proper interpretation of the dosage forms
approved in the NOC particularly in respect to the PREVACID 15 and 30 mg delayed-release
capsule?
- What is the proper construction of the applicable
claims of the ‘792 Patent?
- Is the ‘792 Patent relevant to the PREVACID 15 and 30 mg
delayed-release capsules?
II. Standard of Review
[9]
The Supreme Court of Canada in Dunsmuir v. New Brunswick, 2008 SCC 9, recently decided that there are now only two standards of
review; reasonableness and correctness. The Court indicated that correctness
must be maintained in respect of jurisdictional and some other questions of law
(see Dunsmuir at paragraph 50). When applying the correctness standard,
a reviewing court will not show deference to the decision maker’s reasoning
process and must ask whether the tribunal’s decision was correct.
[10]
The Supreme Court also teaches that reasonableness
in judicial review is concerned mostly with the existence of justification,
transparency and intelligibility within the decision-making process. But it is
also concerned with whether the decision falls within a range of possible,
acceptable outcomes which are defensible in respect of the facts and law (see Dunsmuir
at paragraph 47; Lake v. Canada (Minister of Justice), 2008 SCC 23, [2008]
S.C.J. No. 23 (Lexis), at paragraph 41).
[11]
Guidance with regard to the application of the
reasonableness standard may be found in existing case law (Dunsmuir at
paragraph 54). The appropriate degree of deference to be afforded a tribunal
will be decided upon consideration of the following factors: the existence of a
privative clause; whether the decision maker has special expertise in a
discrete and special administrative regime; and the nature of the question to
be answered. (Dunsmuir at paragraph 55).
[12]
In the present case, the Minister was called upon
to answer those questions as posed previously:
i.
What is the proper interpretation of the dosage forms approved in
the NOC particularly in respect of the PREVACID 15 and 30 mg delayed-release
capsule?
ii.
What is the proper construction of the applicable claims of the
‘792 Patent?
iii.
Is the ‘792 Patent relevant to the PREVACID 15 and 30 mg
delayed-release capsules?
[13]
The first question concerns the interpretation of
the NOC, in particular whether the dosage form at issue is “orally …
disintegrable”. The question here, involves consideration of scientific
evidence which is essentially factual in nature. The question also requires
special expertise by the decision maker in order to understand and assess the
evidence. Given the administrative regime at issue, which is specifically set
up to consider the listing of patents on the Patent Register, the Minister has
expertise to address such questions. The applicable standard of review for the
first question is reasonableness. Given the nature of the question, the
expertise of the Minister and the absence of a privative clause, the Minister
is entitled to significant deference in making such decisions. (Ferring Inc.
v. Canada (Minister of
Health), 2007 FC 300, [2007] F.C.J. No. 420 (Lexis),
at para. 69.)
[14]
The second question involves patent claims
construction. It is settled law that construing patent claims is a matter of
legal interpretation, which is a question of law reviewable on the correctness
standard. See: AstraZeneca Canada Inc. v. Canada (Minister of Health),
2006 SCC 49, [2006] 2 S.C.R. 560 at paragraph 25;GD Searle & Co. v.
Canada (Minister of Health), 2008 FC 437, [2008] F.C.J. No. 520 (Lexis), at
paragraphs 17-18; and Abbott Laboratories Ltd. v. Canada (Attorney General),
2007 FC 797, [2007] F.C.J. No. 1046 (Lexis), at paragraph 13. On such
questions, no deference is owed to the Minister. The applicable standard of
review is correctness.
[15]
The third question asks whether the ‘792 Patent is
relevant to the PREVACID 15 and 30 mg delayed-release capsules, as
required by paragraph 4(7)(b) of the NOC Regulations. The
question requires that the pertinent claims of the ‘792 Patent be construed,
and the NOC which approved the impugned capsules, be interpreted. The claims,
as construed must be assessed against the NOC as interpreted. Clearly, this is
a mixed question of fact and law. The Federal Court of Appeal in Ferring
Inc. v. Canada
(Minister of Health), 2007 FCA 276, [2007] F.C.J. No. 1138
(Lexis), at para. 8, held that “where there is a
mixed question of law and fact then the standard of review is patent
unreasonableness unless the question of law is extricable from the question of
fact in which case the question of law is determined on the basis of
correctness.” I am satisfied that the question as to whether the
‘792 Patent is relevant to the PREVACID 15 and 30 mg delayed-release capsules is
a mixed question of fact and law and reviewable on the reasonableness standard.
Given the prior jurisprudence, the special expertise of the Minister in a
discrete administrative regime and absence of a privative clause, I am
satisfied that a high degree of deference is owed to the Minister on the question.
III. Preliminary matter
[16]
In the normal course of events, on judicial review, the Court only
considers the record that was before the decision maker in arriving at the
decision under review. At the hearing of the application, I raised with the
parties whether the Court should consider the affidavit of Dr. Stephen
Byrn, sworn December 15, 2006, in this proceeding. Dr. Byrn’s is the Applicants’
expert and his affidavit was not before the Minister at the time of the
decision. However, the Minister did have before him the submissions of the
Applicants contained in a letter dated September 27, 2006, sent to the
Therapeutic Products Directorate. These submissions comprehensively summarized
Dr. Byrn’s expert evidence. The Respondents are of the view that the
information at issue was before the Minister and consequently, did not object
to the Court receiving the affidavit nor did they take issue with Dr. Byrn’s
expertise. The Affidavit was received and considered.
IV. What
is the proper interpretation of the dosage forms approved in the NOC particularly
in respect to the PREVACID 15 and 30 mg delayed-release capsules?
[17]
The Drug PREVACID is marketed in Canada by the Applicant Abbott
Laboratories Limited in four separate dosage forms: delayed-release capsules,
granules for delayed-release oral suspension, FasTab delayed-release tablets and
PREVACID® I.V. lyophilized powder for reconstitution. The decision under review
concerns only PREVACID delayed-release capsules.
[18]
PREVACID delayed-release capsules are opaque, hard gelatin capsules
containing the active ingredient lansoprazole, in enteric-coated granules
(paragraph 17. Dr. Byrn affidavit). The purpose of the enteric-coated granule
formulation is to ensure that absorption of lansoprazole begins only after the
granules leave the stomach and enter the small intestine. This is significant,
because otherwise the acid content of the stomach would destroy the
effectiveness of the active ingredient, lansoprazole (paragraph 20, Dr. Byrn
affidavit).
[19]
While the Product Monograph outlines administration options for the
capsule, it is clear that the capsules are intended to be swallowed whole. This
is obvious from a review of the Product Monograph concerning alternative
Administration Options beginning at page 27 of the Monograph, which provides in
part:
Alternative Administration Options
For adults and children who have
difficulty swallowing capsules, there are three options. [My emphasis.]
Option 1. PREVACID® (lansoprazole
delayed-release capsules)
Lansoprazole delayed-release
capsules can be opened, and the intact granules contained within can be
sprinkled on one tablespoon of applesauce and swallowed immediately. The
granules should not be chewed or crushed.
[20]
Option 2 of the Product Monograph deals with PREVACID FasTab
(lansoprazole delayed-release tablets), which are not designed to be swallowed:
Option 2. PREVACID® Fas Tab (Lansoprazole delayed-release
tablets)
Lansoprazole delayed-release
tablets are available in 15 mg and 30 mg strengths. Lansoprazole
delayed-release tablets are not designed to be swallowed intact or chewed. The
tablet typically disintegrates in less than 1 minute.
Place the tablet on the tongue
and allow it to disintegrate with or without water until the particles can be
swallowed.
Do not chew the granules.
[21]
The Product Monograph indicates that the capsules could be opened and their
contents sprinkled on apple sauce, in cases where a patient had difficulty
swallowing the capsule. This suggests that the capsules were intended to be
swallowed whole. The FasTab dosage form, on the other hand, is specifically
designed not to be swallowed intact, but to be placed on the tongue and kept
there until the tablet disintegrates and the enteric-coated granules then
swallowed. This dosage form was found to be relevant to the ‘792 Patent and consequently
listed by the Minister.
[22]
The Applicants contend that the apple sauce preparation, noted as an
alternative option of administration, would be rapidly disintegrable in the
mouth and as such is a solid preparation relevant to the ‘792 Patent. In
support of their contention, the Applicants rely on paragraphs 56 and 57 of Dr.
Byrn’s affidavit, which I reproduce below:
56.
The applesauce sprinkled with granules would itself constitute a solid
preparation. That solid preparation would be rapidly disintegrable in the
mouth. As saliva acts on the solid preparation in the mouth it disintegrates
beginning the process by which the solid preparation is fully digested and the
contents of the enteric-coated granules are absorbed in the bloodstream.
57.
The disintegrants contained in the capsule should assist this process,
and assist with patient compliance by ensuring that the granules are readily
dispersed, thereby avoiding clumping which would make the preparation
unpalatable.
[23]
I disagree with Dr. Byrn’s characterization of the apple sauce
preparation. In my view, it does not constitute an approved dosage form. It
constitutes a method of administration of the contents of one of the approved
dosage forms, namely the PREVACID delayed-release capsules. The Product Monograph
speaks of an orally disintegrable dosage form. I agree with the Respondents,
the act of opening and sprinkling the contents of the capsules on apple sauce
is an act which in effect assists in the disintegration of the capsules. The
capsules cannot then be said to be orally disintegrable. While the non-active incipient,
included in the capsule, may assist in preventing clumping once sprinkled on
the apple sauce, it cannot be said that the apple sauce so prepared is a solid
preparation approved for marketing by the NOC. It is simply one method of
administering the contents of the capsules.
[24]
Upon consideration of the Product Monograph, on the whole, I do not read
the PREVACID 15 or 30 mg delayed-release capsule to constitute a dosage form intended
to be orally disintegrable. It is a dosage form intended to be swallowed
whole.
[25]
The Minister did not err in finding that “…the [delayed-release]
capsules are to be swallowed whole.” Nor did he err in concluding that “…the
ideal preparation embodying the invention of the ‘792 Patent is a lansoprazole
tablet designed to disintegrate rapidly in the mouth in order to facilitate
delivery of the medicine to patients who have trouble swallowing tablets
whole.” These findings were reasonably open to the Minister on the record.
[26]
I therefore conclude that the Minister’s interpretation of the NOC in
relation to the PREVACID 15 and 30 mg delayed-release capsules was reasonable.
He committed no reviewable error in interpreting the NOC as he did.
V. What is
the proper construction of the applicable claims of the ‘792 Patent?
[27]
The ‘792 Patent is entitled “Rapidly disintegrable solid preparation”
and contains 21 claims. Claims 1 through 12 are directed toward an orally
disintegrable solid preparation comprising lansoprazole, a sugar, and a
low-substituted hydroxypropylcellulose. Of particular interest to the issue in
this application are claims 1 through 9 which I reproduce below:
1. An orally rapidly
disintegrable solid preparation which comprises:
(i)
lansoprazole;
(ii) a sugar in an amount of
5 to 97 parts by weight per 100 parts by weight of the solid preparation; and
(iii) a low-substituted
hydroxypropylcellulose having 5% by weight or more to less than 7% by weight of
a hydroxypropyl group, in an amount of 3 to 50 parts by weight per 100 parts by
weight of the solid preparation.
2. The preparation of claim 1, which is
a tablet.
3. The preparation of claim 1 or 2,
wherein the sugar is a sugar alcohol.
4. The
preparation of claim 3, wherein the sugar alcohol is mannitol or erythritol.
5. The
preparation of claim 2, which disintegrates in buccal saliva of a healthy adult
within 5 to 50 seconds and in water within 5 to 40 seconds; and has a hardness
of 2 to 20 kg as measured with a tablet hardness tester.
6.
The preparation of claim 5, wherein the sugar is a sugar alcohol.
7.
The preparation of any one of claims 1 to 6, which further comprises a
basic inorganic salt of sodium, potassium, magnesium or calcium, for
stabilizing lansoprazole.
8. The preparation of
any one of the claims 1 to 7, which comprises fine granules.
9. The
preparation of claim 8, where lansoprazole is contained in the fine granules of
the solid preparation. [My emphasis.]
[28]
Claim 13 is directed toward the use of a low-substituted hydroxypropylcellulose
for producing an orally rapidly disintegrable solid preparation comprising
lansoprazole and sugar. Claims 14 and 21 are process claims. Claims 15 through
20 are directed toward an orally rapidly disintegrable pharmaceutical tablet
consisting of lansoprazole, at least one sugar alcohol, a low-substituted
hydroxypropylcellusole and at least one other ingredient selected from a number
of excipients. Claim 21 provides for a process for producing tablets defined in
any one of claims 15 to 20.
[29]
The solid preparations claimed by the ‘792 Patent must be “orally
rapidly disintegrable”. The Respondents agree that “solid preparation” is broad
enough to include dosage forms such as capsules and granules. The meaning of
“rapidly” is not in issue in this application. The capsules are capable of
disintegration in the mouth within less than a minute, well within the time set
out in the disclosure for rapid disintegration. The dispute between the parties
turns on the correct construction of the terms “orally … disintegrable” in
Claim 1 of the ‘792 Patent.
[30]
Dr. Byrn’s opinion in respect to this aspect of the claim is found at
paragraph 45 of his affidavit. He attests that “[u]se of the term
“disintegrable” makes clear to a person skilled in the art that the preparation
must be capable of such disintegration, not that it actually does so on each
administration.”
[31]
At paragraph 46 of his opinion, Dr. Byrn attests that the term
“orally…disintegrable” read alone in the words of the claim might be considered
ambiguous as to whether it actually requires rapid disintegrability in the
mouth or merely after being taken orally. He opines that the specification of
the ‘792 Patent supports the latter view. At paragraph 47 of his affidavit he
states:
Consideration of the
specification of the ‘792 Patent supports the view that “orally disintegrable”
as used in the Patent is a broad term that means the preparation is capable of
breaking apart after being taken orally. At page 2, line 1-3 of the Disclosure,
the Patent states “there has been desired the development of a rapidly
disintegrable solid preparation having fast disintegrability in the existence
of saliva in the oral cavity, in a little water or in the stomach”.
I do not agree that the terms
“orally…disintegrable” in claim 1 to be ambiguous. In my view a solid
preparation that is orally disintegrable, is clearly intended to disintegrate
in the oral cavity. Turning to the disclosure statement, another passage supports
a narrower construction of the terms “orally… disintegrable” than that proposed
by the Applicants. Page 2, lines 5 to 11 of the disclosure, speaks to the
nature of the dosage form intended to be protected by the invention:
The present invention relates to:
(1) a rapidly disintegrable
solid preparation which comprises (i) a pharmacologically active ingredient,
(ii) a sugar and (iii) a low-substituted hydroxypropylcellulose having 5 % by
weight or more or less than 7 % by weight of hydroxypropoxyl group;
(2) the preparation of the above
(1), which is an orally rapidly disintegrable solid preparation;
[My emphasis.]
[32]
This last cited passage from the disclosure reflects the language of Claim
1, namely, “An orally rapidly disintegrable solid preparation…” In my view, “Orally
disintegrable” can only mean, in the circumstances, that which disintegrates in
the mouth, not, as argued by the Applicants, taken by mouth and subsequently disintegrable
in the stomach.
[33]
Further, page 12 of the disclosure also notes the preferred dosage form
of the invention to be an orally disintegrable tablet:
4) Dosage
Forms
As the dosage form of
the rapidly disintegrable solid preparation of the present invention, for
example, tablet, granule, fine granule and the like, preferably tablet is
exemplified. Among rapidly disintegrable tablets such as an orally
disintegrable tablet and a tablet disintegrable in water, the orally
disintegrable tablet is preferable. [My emphasis.]
[34]
In my view a correct claim construction of the ‘792 Patent is:
(a) the “solid
preparation” claimed includes capsules;
(b) the “solid
preparation” is intended to disintegrate in the oral cavity and not
swallowed
for disintegration in the stomach;
(c) the “solid preparation” is rapidly disintegrable within the
meaning of the Patent.
[35]
The Minister’s interpretation of the Claims is consistent with the above
construction of the Claims of the ‘792 Patent. The Minister’s interpretation is
therefore correct.
VI. Did
the Minister err in deciding that the ‘792 Patent is not relevant to the PREVACID
delayed-release capsules?
[36]
In the context of this application, paragraph 4(7)(d) of the
Regulations requires a determination as to whether the ‘792 Patent is relevant
to the PREVACID 15 and 30 mg delayed-release capsules, a dosage form claimed in
the NOC.
[37]
The Minister’s finding is set out in David Lee’s letter of October 17,
2006. The following passage from the letter summarizes the finding:
The PREVACID products at issue in
the present matter are delayed-release capsules and granules for
delayed-release oral suspension. Each of these products are delayed-release
dosage forms comprised of enteric-coated granules (see page 35 of the PREVCID
Product Monograph dated November 5, 2004). As indicated in our February 2, 2006
and February 14, 2006 letters informing your client that the ‘792 Patent was
ineligible for listing on the Patent Register, the ‘792 Patent contains claims
to an orally rapidly disintegrating solid preparation. Thus, in order to
be eligible for listing on the Patent Register, the above-mentioned PREVACID
products must, in the OPML’s view, not only be solid preparations, but must
also be rapidly disintegrable in the oral cavity. [Emphasis in original.]
[38]
As discussed earlier in these reasons, I have determined the Minister’s
interpretation of the applicable claims of the ‘792 Patent is correct and his interpretation
of the NOC is reasonable. In order to determine the issue of relevancy of the
Patent to the dosage form, the Patent must be compared to the NOC. I find no
error in the Minister’s comparison of the claims of the ‘792 Patent and the
NOC.
[39]
In respect to the requirements of paragraph 4(7)(b) of the
Regulations, the only disagreement is whether PREVACID capsules are “orally …
disintegrable”. The Applicants submit and contend that the uncontested expert
evidence proves the PREVACID capsules are orally rapidly disintegrable for the
following reasons:
(i) Because,
when placed in the mouth (whole), they are capable of rapid disintegration and
therefore constitute “orally rapidly disintegrable solid preparations”; and
(ii) Because they can
also be administered by opening the capsule contents and sprinkling the
granules on food (applesauce). When administered in this way, it is a solid
preparation that is also capable of rapid disintegration and therefore
constitutes an “orally rapidly disintegrable solid preparations”.
[40]
As stated earlier in these reasons, I have found the Applicants’ stated
position to be inconsistent with the correct construction of the applicable
claims of the ‘792 Patent. I have also determined that the Minister did not err
in his interpretation of the NOC and the claims of the ‘792 Patent. The
impugned capsules are intended to be swallowed and are not, as a consequence,
orally disintegrable even though they are capable of rapid oral disintegration.
I am left to conclude that the Minister’s decision that the ‘792 Patent is not
relevant to the dosage form of the PREVACID delayed-released capsules to be
reasonable such that adding the Patent to the register, pursuant to paragraph
4(7)(b), cannot be allowed.
VII. Conclusion
[40]
For the above reasons, I will dismiss the application with costs
to the Respondents, to be assessed in accordance with the middle
of Column IV of Tariff B of the Federal Courts Rules, SOR/2004-283, s.
2.
JUDGMENT
THIS COURT ORDERS AND ADJUDGES that
1. The
application is dismissed;
2.
The Respondents are awarded costs to be assessed
in accordance with the middle of Column IV of Tariff B of the Federal
Courts Rules, SOR/2004-283, s. 2.
“Edmond P. Blanchard”
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