Date:
20061027
Docket: A-572-05
Citation: 2006 FCA 347
CORAM: DÉCARY
J.A.
LINDEN J.A.
PELLETIER
J.A.
BETWEEN:
GLAXOSMITHKLINE INC.
Applicant
and
ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT
PELLETIER J.A.
INTRODUCTION
[1]
This
is an appeal from the decision of Layden-Stevenson J., reported at 2005 FC 1444
(Reasons for Order), in which the learned judge dismissed an application for
judicial review of the Minister of Health's refusal to add Canadian Patent No.
2,391,111 (the '111 patent) to the patent register with respect to the drugs
ADVAIR, ADVAIR DISKUS, FLOVENT HFA, and VENTOLIN HFA. The '111 patent is unique
in that it incorporates into a formulation claim, not only the substances whose
ingestion is designed to achieve therapeutic results but also the device by
which those substances are administered to the patient. There have been other
attempts to gain protection for medical devices but, until now, none of those
attempts incorporated the device into the formulation of the medicine itself.
[2]
The
issue in this appeal, as it was in the Federal Court, is whether this novel
formulation contains "a claim for the medicine itself, or a claim for the
use of a medicine" as
those terms are used in subsection 4(2)(b) of the Patented Medicines
(Notice of Compliance) Regulations, S.O.R./93-133, as amended (the
Regulations).
THE FACTS
[3]
The
appellant GlaxoSmithKline Inc. (GSK) holds Notices of Compliances allowing it
to sell in Canada the
following drugs which contain the following medicines: ADVAIR (salemeterol
xinafoate/fluticasone propionate), ADVAIR DISKUS (salemeterol xinafoate/fluticasone
propionate), FLOVENT HFA (fluticasone propionate) and VENTOLIN HFA (salbumatol
sulphate). Within the 30 days following the issue of the '111 patent, GSK
sought to add it to the patent register in respect of each of these drugs. It
did so on the basis of claims 1 and 15 of the patent, reproduced below:
Claim 1:
A pharmaceutical
formulation comprising an aerosol suspension of a medicine selected from the
group consisting of salbutamol, salmeterol, fluticasone propionate,
beclomethasone dipropionate, terbutaline and any salts, esters and solvates
thereof and any mixtures thereof, in a propellant, said formulation further
comprising an aerosol container comprising a valve for administering the
aerosol suspension, said valve comprising a valve body having at least one
orifice to allow a quantity of the suspension to pass from the container into
the valve, characterised in that the valve further comprises a ring disposed
around the valve body, the ring providing a trough around the valve body, wherein
said trough is below the at least one orifice to reduce the volume of
suspension that can be accommodated within the container below the at least one
orifice when the container is orientated with the valve at the bottom.
Claim 15:
Use of a pharmaceutical
formulation comprising an aerosol suspension comprising a medicine selected
from the group consisting of salbutamol, salmeterol, fluticasone propionate,
beclomethasone dipropionate, terbutaline and any salts, esters and solvates
thereof and any mixtures thereof, in a propellant, for the treatment of
respiratory disorders, said formulation further comprising an aerosol container
comprising a valve, and the aerosol suspension being dispersed in the
container, said valve comprising a valve body having at least one orifice to
allow a quantity of the suspension to pass from the container into the valve,
characterised in that the valve further comprises a ring disposed around the
valve body, the ring providing a trough around the valve body, wherein said trough
is below the at least one orifice to reduce the volume of suspension that can
be accommodated within the container below the at least one orifice when the
container is orientated with the valve at the bottom.
[4]
The
Minister refused to list the '111 patent on the basis that it did not contain a
claim for the medicines or the use of the medicines in question. The Minister's
position is that:
[W]hile there are claims
within the '111 patent to a delivery system or device which could be used in
the administration of a variety of medicines, there is no claim within the '111
patent for any of the medicines listed in the above noted products [ADVAIR,
ADVAIR DISKUS, FLOVENT HFA, VENTOLINHFA] or their use as required under
subsection 4(2)(b) of the PM (NOC) Regulations.
[Reasons for Order, para.
12.]
[5]
GSK
brought an application for judicial review. In support of its application, it
filed the affidavit of Dr. Christopher Rhodes. The following portions of his
affidavit are of particular relevance to this appeal:
13. Formulations are
typically a mixture of active and inactive components. Generally, the role of
the inactive components is to ensure that the active component or components
are delivered to the patient in the appropriate manner and in the appropriate dose.
This is true in respect of all types of formulations including tablets,
capsules and aerosol formulations, by way of example.
14. Specifically
pharmaceutical formulations that are inhaled, such as aerosol formulations, by
necessity consist of an inhaled active compound and pharmaceutically inactive
materials that provide assistance in the effective therapeutic use of the drug.
15. Typically, these
pharmaceutically inactive materials include a propellant. The function of the
propellant is to act as a carrier so that the drug reaches the intended site of
therapeutic action. Other inactive compounds could include antioxidants and
antimicrobial preservatives.
16. An inhaled
formulation may also include mechanical components such as a valve that ensures
that the aerosol droplets are an appropriate size and that the drug is provided
in an appropriate amount. For example, if the droplets are too large, they will
become stuck in the patient's mouth. If the droplets are too small, they will
reach the intended therapeutic site, but will not remain there to effect the
intended therapeutic effect.
[A.B., p. 66-67.]
THE DECISION UNDER APPEAL
[6]
The
application judge dismissed the application for judicial review. From the very
beginning of her analysis, she focused on the difference between a medicine and
a device used to administer that medicine (Reasons for Order, para. 25).
[7]
After
reviewing the jurisprudence, the application judge turned her attention to the
'111 patent and concluded that it dealt with a system for the administration of
a medicine and did not contain a claim for the medicine itself. The material
portion of her reasons provides as follows:
30. …The system consists
of a medicine, a discrete propellant and a separate container using a special
valve. It is not a composition (or formulation) of explicit active and inactive
ingredients physically mixed together as in Hoffmann-La Roche. On
its face, the claim is directed primarily to a valve associated with an
aerosol container having certain characteristics designed to promote the more
efficient administration of an aerosol formulation. The fact that the claim is
described as a "formulation" is not determinative in this respect.
Dr. Rhodes does not address this issue in his affidavit and his evidence, therefore,
provides no assistance.
[8]
As a
result, the application judge dismissed the application for judicial review.
THE SUBMISSIONS IN ISSUE
[9]
The
appellant attacks the application judge's decision on two principal grounds. The
first is that the patent was not construed in the manner in which the Supreme
Court has held that patents should be construed, namely from the point of view
of a person skilled in the art, independently of any consideration of the
purpose for which the patent must be construed. (Whirlpool Corp. v. Camco Inc., 2000 SCC
67, [2000] 2 S.C.R. 1067 (S.C.C.) (Whirlpool)). The appellant submits that the only
evidence of the point of view of the person skilled in the art is the affidavit
of Dr. Rhodes. Since his evidence was uncontradicted, it
ought to have been given effect.
[10]
The
appellant's second line of attack is that the application judge, and the
Minister, misconstrued the patent in failing to recognize that it included a
claim for a medicine in formulation. The appellant's position is that the valve
to which the patent makes reference is simply another inactive ingredient, much
like an excipient. In Eli Lilly Canada Inc. v. Canada (Minister of Health), 2003 FCA 24, [2003] 3 F.C.
140, it was held that a claim for a medicine plus an inactive ingredient was a
claim for the medicine itself. In this case, a claim is made for a formulation
of each of the medicines contained in the drugs for which an NOC has been
issued, the formulation including as an inactive ingredient the appellant's
special valve.
ANALYSIS
[11]
These
facts raise the familiar problem of patents which refer to both a drug and a
means of administering that drug. In GlaxoSmithKline Inc. v. Canada
(Attorney General), 2005 FCA 197 (GlaxoSmithKline Inc.), I reviewed
the jurisprudence on this issue and concluded that, in the context of deciding
whether a patent contained a claim for the medicine itself, the fundamental
question was whether the patent in issue protects the medicine (the payload) or
the means by which the medicine is to be administered (the delivery system).
44. If the patent
protects the delivery system, then it does not contain a claim for the medicine
itself, or the use of the medicine, even if it contains a reference to the
medicine as payload. For example, in Janssen-Ortho Inc. v. Canada (Minister
of Health), (2003) 229 F.T.R. 268, 2003 FCT 286, confirmed by [2004] F.C.J.
No. 242 (F.C.A.), leave to appeal to the SCC denied, August 26, 2004, [2004]
S.C.C.A. No. 152, the patent protecting a patch type device specifically refers
to the medicine fentanyl but in the context of "a 'transdermal system' or
'device' designed for the transdermal administration of fentanyl...".
Heneghan J. found that it was not eligible for listing, in spite of the
specific reference to a medicine. She found that the patent described a patch
and that the patent contained no claim for the medicine itself. I take the
latter ground to be a recognition that a claim for a medicine as payload is not
a claim for the medicine itself.
[12]
As the
application judge noted, a perusal of the specification of the patent discloses
a detailed description of the workings of the valve by which the medicines
mentioned in the patent are to be dispensed to the patient. The specification,
it will be recalled, must "correctly and fully describe the invention and
its operation or use as contemplated by the inventor". (See subsection
27(3) of the Patent Act.)
[13]
The
opening words of the Specification are instructive:
This invention relates
to a valve for an aerosol container with the aid of which a quantity of the
contents thereof can be dispensed. The invention has particular application to
the dispensing of metered doses of medicines, though it is applicable to the
dispensing of aerosols generally.
[14]
To the
extent that the payload/delivery system dichotomy set out in GlaxoSmithKline
Inc. is good law, this patent would fall unequivocally on the delivery
system side of the dichotomy, even though specific drugs are named in the
patent as the payload.
[15]
GSK
opposes the categorization of its patent as one which protects the delivery
system on the basis that the patent claims a formulation of a medicine, which
formulation includes, as an inactive element, the valve assembly described in
the specification. As a result, the patent is, on its face, one which claims
certain medicines in a formulation, thus falling squarely within the decision
of this Court in Hoffmann-La Roche Ltd. v. Canada (Minister of Health and
Welfare) (1992), 62 C.P.R. (3d) 58 at 72 (F.C.T.D.); aff'd (1995) 67 C.P.R.
(3d) 25 (F.C.A.) (claims certain medicines in a formulation, thus falling
squarely within the decision of this Court in (Hoffmann-La Roche) leave
to appeal dismissed. It is inherent in the appellant's argument that the
formulation claimed must be treated as a whole, without parsing the individual
elements of the formulation, to determine which are more representative of the
nature of the patent.
[16]
In this
context, it is worth repeating a key paragraph from Hoffmann-La Roche
which underlies GSK's argument:
Against this background,
it seems clear that the words "drug" and "medicine" as they
appear in s. 4(1) of the Regulations are not used in contradistinction and are
not intended to draw a line between an active ingredient and a preparation or composition
which includes an active ingredient. Both types of substances when
capable or intended to be used for the treatment or prevention of a disease are
a "medicine" within the meaning of the Regulations and a claim for
the medicine itself, whether in the form of a single active ingredient or in
the form of a composition comes within the ambit of the Regulations.
[Hoffmann-La Roche, p. 74.]
[Emphasis added.]
[17]
The
reference to "substances" is a reference to the definition of
medicine in the Regulations:
"medicine"
means a substance intended or capable of being used for the diagnosis,
treatment, mitigation, or prevention of a disease, disorder or abnormal
physical state, or the symptoms thereof;
« médicament » Substance
destinée à servir ou pouvant servir au diagnostic, au traitement, à
l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état
physique anormal, ou de leurs symptômes. (medicine)
[Emphasis added.]
[18]
If one
were to substitute the definition of medicine for the word itself where it
appears in paragraph 4(2)(b) of the Regulations, the result would be as
follows:
|
4.(2)
A patent list submitted in respect of a drug must
…
(b)
set out any Canadian patent …that contains a claim for [a substance intended
or capable of being used for the diagnosis, treatment, mitigation or
prevention of a disease, disorder or abnormal physical state, or the symptoms
thereof] itself, or a claim for the use of the [substance intended or capable
etc] and that the person wishes to have included on the register.
|
4.
(2) La liste de brevets au sujet de la drogue doit contenir les renseignements
suivants :
…
b) tout brevet canadien dont la personne est
propriétaire ou à l'égard duquel elle détient une licence exclusive ou a
obtenu le consentement du propriétaire pour l'inclure dans la liste, qui
comporte une revendication pour le [substance destinée à servir ou
pouvant servir au diagnostic, au traitement, à l'atténuation ou à la
prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs
symptômes] en soi ou une revendication pour l'utilisation du [substance
destinée à servir ou pouvant agir etc], et qu'elle souhaite voir inscrit au
registre.
|
[19]
The terms "claim
for the medicine itself" and "claim for the use of the medicine"
are also defined terms but the result is the same if the definition of the word
"medicine" is substituted for that term in those definitions. In
either case, a medicine is a substance.
[20]
The
question of what is included within the term "substance" was dealt
with in Glaxo Group Ltd. v. Novopharm Ltd., [1998] F.C.J. No. 155, where
Tremblay-Lamer J. found that :
13. Therefore, in my view, the
Regulations do not extend the meaning of the word "substance" to
include mechanical devices made of metal and plastic which cannot be ingested
into the body. Consequently, I find that the Respondent's allegation is
justified.
[21]
This Court
confirmed this reasoning at [1999] F.C.J. No. 799 where it said:
6. With respect to the
substantive issue raised by Glaxo in its cross-appeal, we share the view of the
trial judge that the patents at issue, being patents for devices by which medicines
can be administered to or by patients rather than patents for the substance
being administered, are not a "medicine" within the meaning of the
Regulations.
[22]
As
a result, while the patent in issue may well claim a formulation, it does not,
taken as a whole, claim a substance or a combination of substances (such as a
medicine and an excipient) since "substance" is not broad enough to
include a mechanical device. If the patent does not claim a substance, it
cannot, by definition, claim a medicine. This leaves me with my earlier
conclusion that, for purposes of the Regulations, the patent protects the
delivery system rather than the payload.
[23]
While
the appellant is correct that Whirlpool is the authority on claims
construction, it is also true that the Regulations require the Minister, and
the Federal Courts on review, to make an additional legal determination with
respect to the patent, that is, whether it contains a claim for a medicine or
the use of a medicine as those terms are defined in the Regulations. The
jurisprudence draws a distinction between patents that claim the medicine (the
payload), and patents that protect a method of administering the medicine (the
delivery system). Nothing in Whirlpool precludes the Courts from making
such distinctions when determining whether a patent claims a medicine or its
use for the purposes of the Regulations.
[24]
So
far in these reasons, I have addressed only the issue of "a claim for the
medicine itself". The '111 patent also contains a claim for the use of the
formulation described in the claim for the treatment of respiratory disorders. If
the claim for the formulation does not contain a claim for a medicine, then, obviously,
a claim for the use of that formulation is not a claim for the use of a
medicine.
[25]
The
appeal should therefore be dismissed with costs.
"J.D.
Denis Pelletier"
"I agree
Robert Décary J.A."
"I agree
A.M. Linden J.A."
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