Date: 20060330
Docket: T-114-05
Citation: 2006 FC 411
OTTAWA, ONTARIO, MARCH 30, 2006
PRESENT: DEPUTY JUDGE STRAYER
BETWEEN:
PROCTOR & GAMBLE
PHARMACEUTICALS CANADA INC.
Applicant
and
THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
REASONS FOR
JUDGMENT AND JUDGMENT
Introduction
[1]
This
is an application for judicial review seeking the quashing of a decision of the
Minister of Health not to list patents number 2,122,479 (‘479) and 2,293,815 (‘815).
The applicant is a licensee of both these patents. The decision identified in
the notice of application is that of the Minister dated December 23, 2004 in
which he refused to list these patents under section 4 of the Patented Medicines
(Notice of Compliance) Regulations (SOR/93-133). The applicant sought the
listing of these patents in relation to its drug Actonel, a drug marketed by it
in Canada consisting
of a tablet containing the active ingredient risedronate sodium. It is
indicated for the prevention and treatment of osteoporis and treatment of
Paget’s disease of the bone. Notices of Compliance for different dosages of
Actonel were issued in the years 1999-2002.
[2]
In
patent ‘815, issued on June 29, 2004, the first paragraph of the “Summary of
the Invention” states as follows:
The present invention is directed to
a pharmaceutical formulation in an oral generally oval shaped, including but
not limited to oval, modified oval and caplet shaped form. The dosage form is
film coated and comprised of a safe and effective amount of an active
ingredient and pharmaceutically-acceptable excipients. Said dosage forms
facilitate rapid esophageal transit time thereby avoiding the release of active
ingredient in the buccal cavity, pharynx, and esophagus and protecting the
epithelial and mucosal tissues thereof from erosion, ulceration or other like
irritation.
In the detailed description of the
invention there appears the following paragraph:
A. The Active Ingredient
The active ingredient herein may
be any ingredient that yields a therapeutic benefit and is required to be
delivered to the stomach of said human or other mammal. The benefits of the
present invention are particularly realized when the active ingredient if
released prior to entering the stomach may cause patient complaints such as
heartburn, esophageal burning, pain and/or difficulty upon swallowing and/or
pain existing behind and/or mid-sternum. Such active ingredients are those
which when dissolved have a pH below 2-3, drugs with cytotoxic activity
(caustic) and/or the local development of a hyperosmolar solution which causes
mucosal desiccation. Preferred actives are selected from the group consisting
of emperonium bormide, doxycycline, and other tetracyclines/antibiotics, iron
preparations, potassium chloride, quinidine, nonsteroidal anti-inflammatory
drugs, alprenolol, ascorbic acid, captopril, thophylline, zidovoudine (AZT) and
bisphosphonates. More preferred actives are risedronate, alendronate and
pamidronate, most preferred is risedronate. (emphasis added)
Claim
1 of patent ‘815 is as follows:
1.
An oral
dosage form comprising a safe and effective amount of a bisphosphonate wherein
said oral dosage form is oval shaped, about 0.23 to about 0.85 inches in
length, about 0.11 to about 0.4 inches in width, and about 0.075 to about 0.3
inches in thickness and said oral dosage form is film coated to facilitate
rapid esophageal transit and avoid irritation in the mouth, buccal cavity,
pharynx, and esophagus wherein said film coating allows for delivery of said
bisphosphonate to the stomach.
Among the claims it is only in claim 5 that
risedronate is identified as one possible active ingredient. Claim 6
specifically claims such a dosage form where the active ingredient is
risedronate.
[3]
Thus
it will be noted that the essence of the ‘815 invention is a film coated tablet
dosage which avoids irritation to the oesophagus and other upper passages,
delivering the active ingredient to the stomach where it is dissipated.
Risedronate is identified as one of the possible active ingredients to be
carried to the stomach in this fashion.
[4]
With
respect to patent ‘479, in its disclosures the invention is summarized in part
as follows:
SUMMARY OF THE INVENTION
The present invention is
directed to a novel enteric-coated oral dosage form of a risedronate active
ingredient comprised of a safe and effective amount of pharmaceutical
composition which is comprised of a risedronate active ingredient and
pharmaceutically-acceptable excipients. Said dosage forms prohibit the release
of the risedronate active ingredient in the buccal cavity, pharynx, esophagus,
and stomach thereby [sic] protects the epithelial and mucosal tissues thereof
from erosion, ulceration or other like irritation.
Accordingly, the novel
dosage forms described herein effect the delivery to the lower intestinal tract
of said human or other mammal of a safe and effective amount of the risedronate
active ingredient, and substantially alleviate esophagitis or esophageal
irritation which sometimes accompanies the oral administration of risedronate
active ingredients.
DETAILED DESCRIPTION OF THE
PRESENT INVENTION
The present invention is directed to
a novel enteric-coated oral dosage form of a risedronate active ingredient
comprised of a safe and effective amount of a pharmaceutical composition which
is comprised of a risedronate active ingredient and pharmaceutically-acceptable
excipients. Said dosage forms prohibit the release of the risedronate active
ingredient in the mouth, pharynx, and esophagus and thereby protects the epithelial
and mucosal tissues thereof from erosion, ulceration or other like irritation.
In addition, said dosage forms inhibit the release of the risedronate active
ingredient to the stomach and anterior duodenum.
Accordingly, the said dosage forms
effect the delivery to the lower intestinal tract of said human or other
mammal of a safe and effective amount of the risedronate active ingredient, and
substantially alleviate esophagitis or esophageal irritation which sometimes
accompanies the oral administration of risedronate active ingredients.
(emphasis added)
Claim
1 of the patent is as follows:
1.
An
enteric-coated oral dosage form of a risedronate active ingredient comprised of
a safe and effective amount of a pharmaceutical composition comprising a risedronate
active ingredient and pharmaceutically-acceptable excipients, wherein the
risedronate active ingredient or the dosage form is enteric-coated or both the
risedronate active ingredient and the dosage form are enteric-coated.
(emphasis added)
[5]
Thus
it may be seen that while patent ‘479 mentions an unspecified risedronate active
ingredient, it essentially involves an enteric-coated tablet. The film-coated
tablet of patent ‘815 was designed to carry the active ingredient as far as the
stomach; the enteric-coated tablet of ‘479 was designed to carry the active
ingredient farther into the lower intestinal tract. If Claim 1 of ‘479 is
ambiguous as to whether the delivery system or the payload is the invention,
the Specifications in the Summary and Description of the Invention makes clear that
its purpose is to secure the delayed-release of the active ingredients.
[6]
The
Minister’s representative in the letter of decision of December 23, 2004 which
is the decision to which the applicant specifically refers in its notice of
application for judicial review, concluded that neither the ‘815 patent nor the
‘479 patent was eligible for listing under section 4 of the Regulations because
“neither patent contains a claim to the medicine risedronate sodium, or its use
. . . .”. Counsel for the applicant alternatively argued that this decision does
not apply to patent ‘479 or, if it does, the Minister had not given the
applicant any warning in previous correspondence that he was contemplating
refusing to list patent ‘479 on this basis. In its notice of application,
however, and in written and oral submissions the applicant did not specifically
attack the decision on patent ‘479 on the grounds of procedure or denial of
fairness, and I must therefore address the validity of the decision as it is
written: it is apparently based on paragraph 4(2)(b) of the Patented
Medicines (Notice of Compliance) Regulations that neither patent could be
listed because neither contains a claim to the medicine risedronate sodium or
its use. The alternative to doing that would be simply to assume the validity
of this decision in respect of patent ‘479 as the applicant has declined to
attack it on its merits, taking the position that the decision does not mean
what it clearly says.
[7]
The
decision of December 23, 2004 also refused to list the ‘479 patent on the basis
of paragraph 4(7)(b) of the Regulations which requires that for a patent to be
eligible for inclusion in the patent list it must be relevant inter alia
to the dosage form of the drug (in this case Actonel) in association with which
the patent is to be listed. The Minister concluded that the ‘479 patent
contemplated as its dosage from an enteric-coated risedronate composition
whereas Actonel is a film-coated tablet.
[8]
I
must take it from the applicant’s notice of application that it challenges all
these elements in the decision.
Issues
(1) What is
the standard of review?
(2) Was the
Minister correct in refusing inclusion in the list because neither patent
claims a medicine or the use of a medicine?
(3) Was
the Minister correct in concluding that the dosage form claimed in patent
‘479 is not relevant to the dosage form of Actonel?
Analysis
Standard of
Review
[9]
The
parties are in agreement that the standard of review in this case is
correctness. I am satisfied that this conclusion would be justified by the
usual pragmatic functional analysis. While I recognize that the mere agreement
of the parties does not absolve a judge from making the necessary pragmatic and
functional analysis (See Novartis Pharmaceuticals Canada Inc. v. Minister of
Health (2003), 28 C.P.R. (4th) 1 (F.C.A.). However in this agreement
as to the standard of review the parties are in accord with several judicial determinations
that in such matters correctness is the proper standard. (See e.g. Eli Lilly
Canada Inc. v. Minister of Health, [2003] 3 F.C. 140 at para. 5 (F.C.A.))
The decisions involved here concern the interpretation of the patents and the
interpretation of the Regulations, matters which a judge is in as good a
position as the Minister to decide. It may also be noted that such decisions
can have precedential value. There is, of course, no privative clause
applicable.
Do Patents
‘815 and ‘479 Claim a “Medicine”?
[10]
Jurisprudence
in this field is roughly divided between the line of reasoning adopted by this
Court in Hoffmann-LaRoche Ltd. v. Minister of National Health and Welfare
(1995), 62 C.P.R. (3rd) 58 and approved by the Federal Court of
Appeal (1995), 67 C.P.R. (3rd)25; as compared to the line of “device
cases” recently reviewed by the Federal Court of Appeal in GlaxoSmithKline
Inc. v. Canada, 2005 FCA 197. In Hoffmann LaRoche Justice Marc Noël
was faced with the argument that where paragraph 4(1)(b) of the Regulations
requires that a patent, to be listed, contain “a claim for the medicine itself
or a claim for the use of the medicine” a formulation consisting of a medicine
as the active ingredient and other substances could not itself be a “medicine”.
He concluded instead as follows:
Pharmaceutical compositions with
therapeutic value are a medicine in common parlance. Indeed most active
ingredients must be combined with stabilized agents or absorption vehicles in
one form or another to allow a patient to effectively ingest the medicine and
achieve the intended therapeutic effect. As such, a medicine, like a drug, is
generally understood to be a preparation or composition including active and
non-active ingredients. (62 C.P.R. (3rd) at 72.)
[11]
On
the other hand, the “devices” cases have involved for the most part mechanical
or physical arrangements for administering medicines, and the patents that
claimed them have been found not to involve a claim for the medicine itself.
Examples of these are inhalers, transdermal patches, implants or even tablets
which are ingested but which involve physical devices such as osmotic pumps to
distribute active ingredients after the tablet is inside the human or animal.
[12]
A
means for rationalizing the distinction between a “formulation” approach and
the “device” cases was suggested recently by Justice Denis Pelletier in
separate concurring reasons in GlaxoSmithKline Inc. v. Canada (above). That
case involved patents related to tablets with a controlled rate release of
active substances or a system for a similar purpose. The entire panel was in
agreement that the patents in question did not specifically claim a particular
medicine because it made reference to the use of the tablets or the system for
the release of “active substances”. Justice Pelletier however preferred to
decide the matter on the basis that in reality the patents in question claimed
in respect of the “delivery system” and not in respect of the “payload”. He
analyzed the claims in the patents in question and rationalized the
jurisprudence as follows:
42. It is clear that these patents
are designed to protect the system by which a great number of compounds, be
they pesticide, herbicide, medicament, or room deodorizer, can be released into
an aqueous fluid in a controlled manner. The “active substances” referred to in
the patents are nothing more than the payload carried by the delivery system
protected by the patents.
43. If one reviews the “medical
devices” cases referred to above, one notes that the theme which runs through
them all is the dichotomy between the delivery system and its payload. The
attempts to define “claim for the use of the medicine itself” on the basis of
whether the ingredients are mixed, or the presence of physical devices, all
point to a more fundamental distinction between a delivery system and that
which is delivered by that system. The distinction articulated in Glaxo Group
Ltd. (C.A.) between devices for the administration of medicaments and the
medicaments which are themselves administered is another way of expressing the
difference between delivery system and payload. But, as this case shows, the
distinction is more difficult to make when a tablet is both the thing
administered and that which administers the drug. The distinction between
delivery system and payload bridges both types of tests by focussing on the
substance of the patent. Does the patent protect the delivery system or does it
protect the payload?
[13]
That
case has subsequently been followed by this Court in Biovail Corp. v. Canada,
[2005] F.C.J. No. 1402. In that case the patent described a kind of
control-release tablet made up of an active ingredient and two “intelligent
polymers”. Only one of the 32 claims in the patent mentioned the drug in issue.
Justice James O’Reilly. concluded that the patent was for a formulation for a
delivery system that can be used for many different medicines:
Biovail’s tablet involves mixing an
active ingredient with other substances, not inserting an active ingredient
into a mechanical capsule or shielding it within inactive layers and walls.
Still, the patent’s paramount purpose clearly is to protect the delivery
system, not the payload. (at para. 20).
[14]
Similarly
I have concluded that patent ‘815 does not contain a claim for a medicine or
“payload” but for a “delivery system”. Claim 1 is only in respect of a delivery
system. Claim 5 identifies risedronate as one possible active ingredient and
Claim 6 specifically claimed a dosage form where the active ingredient is
risedronate.
[15]
It
is perhaps appropriate at this point to consider when recourse may be had to
the disclosures to clarify the meaning of a claim. (That this Court should even
be trying to interpret patent claims in a summary proceeding for judicial
review, rather than in a trial for infringement, bespeaks the weakness of the
system created by these Regulations.) It is now well settled that in
interpreting claims the Court should take a purposive approach to the patent.
If the claim is clear and unambiguous then this Court should give it its
literal sense. If it is not then this Court may have recourse to the
disclosures which are supposed to set out the purpose of the invention in
relation to the problem to be solved by it. See e.g. Whirlpool Corp. v.
Camco Inc., [2000] 2 S.C.R. 1067 paras. 42-45, 49.
[16]
In
the case of patent ‘815 I think the claims are adequately clear to indicate
that it claims only a delivery system. However, if there is any uncertainty
that the invention which is claimed is with respect to the dosage form, I think
resort may be had to the disclosures to see that the paragraph quoted above (para.
2) from the “Summary of the Invention” describes only the form of the dose and
its purpose which is to avoid the release of the (unspecified) active
ingredient in the esophagus, etc. The opening words of the Detailed Description
states that “The active ingredient herein may be any ingredient that
yields a therapeutic benefit and is required to be delivered to the stomach of
said human or other mammal. . . .” (emphasis added)
[17]
I
have similarly concluded that patent ‘479 in reality claims a delivery system
and not a payload. It is true that in Claim 1 reference is made to “An
enteric-coated oral dosage form of a risedronate active ingredient . . .”.
First it may be noted that the claim is specific as to the form of the dosage
attached to its coating, and is unspecific as to what risedronate active
ingredient would be involved. If there is any ambiguity as to whether the claim
is for the form and coating of the dosage or as to the active ingredient, one
may again have resort to the disclosures, excerpts from which are quoted above.
The Summary of the Invention and its Detailed Description both make clear that
the purpose and function of the invention is to avoid the irritations that
would flow from the release of risedronate in the upper cavities including the
esophagus, the function of the enteric coating be to “effect the delivery to
the lower intestinal tract . . . of a safe and effective amount of risedronate
active ingredient, and substantially alleviate esophagitis or esophageal
irritation which some times accompanies the oral administration of risedronate
active ingredients”. I cannot interpret that to mean that the purpose of the
patent is to protect a monopoly on risedronate as a payload but rather to
protect a system of delivery of that payload to the “lower intestinal tract”.
[18]
Adopting,
with respect, the reasoning of Justice Pelletier in GlaxoSmithKline Inc.
(above) at paras. 42, 43, I do not believe that the scope of the claims should
depend on whether the payload is formulated with the delivery system or whether
the delivery system is a mechanical or physical device separate from the active
ingredient.
[19]
I
therefore will dismiss the application to have the Minister’s decision set
aside to the effect that neither patent ‘815 nor ‘479 contains a claim to a
medicine.
[20]
After
the hearing of this matter was concluded on February 14, 2006 counsel for the
Minister brought to my attention a decision of Justice Douglas Campbell, issued
on February 16, 2006 in Pfizer Canada Inc. v. Canada (Minister of Health),
2006 FC 210. I gave counsel for the applicant the opportunity to comment in
writing on this decision. I have concluded that this decision does not bear on
the present case. It appears to concern matters of evidence as to how generic
company applications for notices of compliance are or would be dealt with by
the Minister, to enable this Court to determine how paragraph 4(2)(b) of the
Regulations should be interpreted. While there was some conflicting evidence on
this subject referred to by the parties in the present case, I am satisfied
that determination of the meaning of paragraph 4(2)(b) is quite possible here without
resort to evidence as to how the Regulations may or may not be administered.
Is Patent ‘479
Relevant to Actonel?
[21]
Paragraph
4(7)(b) of the Regulations requires that a person seeking to have his patent
included in a patent list in association with a drug approved for sale by a
Notice of Compliance
must certify that . . .
(b) the patents set out on the patent
list . . . 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.
[22]
The
Minister has determined that patent ‘479 is not relevant to Actonel for the
following reason:
The ‘479 patent contains claims directed
to an enteric-coated risedronate composition. The dosage form of
ACTONEL, on the other hand, is that of a film-coated tablet. For this
reason . . . the dosage form described in the ‘479 patent [is] not relevant to
that of ACTONEL and . . .the ‘479 patent [is] thus ineligible for listing on
the Patent Register as a result.
[23]
The
Minister in support of this position argues that patent ‘479 is not relevant to
the “dosage form” of Actonel because Actonel is a rapid release drug whereas
the patent is for an enteric coated or modified-release dosage form for the
delivery of risedronate sodium.
[24]
The
applicant, on the other hand, argues that the relevant dosage form is that of a
tablet containing the drug and both Actonel and patent ‘479 involve the
administration of a drug by an oral tablet.
[25]
The
applicant relies principally on the decision of the Federal Court of Appeal in Eli
Lilly Canada Inc. v. Minister of Health, [2003] 3 F.C. 140. There a
majority of two concluded, as best I can understand it, that paragraph 4(7)(b)
does not require that the invention disclosed in the patent be included or
embodied in the drug named in the Notice of Compliance for it to be relevant to
that drug. Instead, as I infer from the facts, it is sufficient that both
contain the same active ingredient. Justice Sharlow, writing for herself and
Justice Malone, in reference to the words of paragraph 4(7)(b) quoted in
paragraph 18 (above) stated that these words do not describe any relationship
between the drug named in the notice of compliance and the patents that may be
included on the patent list. “Rather ‘the drug in respect of which the
submission for a notice of compliance has been filed’ is, simply, Tazidime”
(para. 34). In the context I take this to mean that because the patent was for
a formulation including the active ingredient ceftazidime, it could be listed
in association with any NOC drug containing ceftazidime as an active
ingredient.
[26]
Happily
I need not consider further the implications of this. Whatever its
significance, Justice Sharlow expressly said that the Minister in that case had
not taken a position based on paragraph 4(7)(b), that the patent in issue there
was not “relevant to the dosage form, strength and route of administration” of
the drug named in the NOC. (See Eli Lilly above at para. 28). But in the
present case the Minister has taken that position precisely: namely that patent
‘479 is not relevant to the dosage forms of Actonel. (see para. 22 above). This
is an issue expressly not raised in Eli Lilly and the decision has no
application.
[27]
As
discussed above I am satisfied that the invention of patent ‘479 is the
delivery system, the enteric coating on the tablet. Actonel embodies no such
delivery-system: it is in an immediate-release form.
[28]
The
applicant argues that the coating on a tablet does not pertain to “dosage
form”. It cited a remark made in passing by Justice Iacobucci in Eli Lilly
& Co. v. Novopharm Ltd., [1998] 2 S.C.R. 129 at para. 102, to the
effect that in that case the “final-dosage form” was distinguished from the
bulk form of the same drug by being coloured and pressed into tablet shape.
From this the applicant deduces that “dosage form” as referred to in the Patented
Medicines (Notice of Compliance) Regulations simply refers to the shape of
the tablet. Thus the fact that patent ‘479 contemplates an enteric-coated
tablet (where the coating for delayed-release purposes is the very invention
taught by the patent) is, in the applicant’s view, irrelevant to dosage form.
It should first be observed that Justice Iacobucci’s remark in the Eli Lilly
case (1998) (above) did not involve paragraph 4(7)(b) of the Regulations but
rather concerned a question of infringement and the rights of a licensee under
a license to change the “final-dosage form”. It is clear that he was not purporting
to give an exhaustive definition of “final-dosage form”. Secondly, patent ‘479
itself in its detailed description of the invention and in claim 1,
consistently refers to “an enteric-coated oral dosage form” clearly associating
the coating with the form. I am therefore satisfied that a tablet with an
enteric coating for delayed-release is a different dosage form from a tablet
with no such coating.
[29]
I
therefore conclude that patent ‘479 should not be listed because it is not
relevant to the dosage form of Actonel.
Disposition
[30]
The
application for judicial review will therefore be dismissed with costs.
JUDGMENT
IT IS HEREBY ORDERED AND
ADJUDGED THAT:
(1) the
application for judicial review be dismissed; and
(2) the
respondent be awarded costs of the application.
“Barry L. Strayer”
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