Date: 20070709
Docket: T-59-06
Citation: 2007 FC 729
Vancouver, British Columbia, July
9, 2007
PRESENT: The Honourable Mr. Justice O'Reilly
BETWEEN:
JANSSEN-ORTHO
INC.
Applicant
and
ATTORNEY GENERAL OF CANADA
and THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1]
Janssen-Ortho
Inc. asks me to overturn a decision of the Minister of Health refusing to list
its drug patent (Canadian Patent No. 2,265,668) on the register. The Minister
concluded that the ‘668 patent was not eligible to be listed because it did not
include a “claim for the medicine itself or a claim for the use of the
medicine” as required by the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133, ss. 3(1), 4(2)(b) (relevant enactments are
set out in an Annex).
[2]
Janssen-Ortho
argues that the Minister decision was incorrect. However, I can find no error and
must, therefore, dismiss this application for judicial review.
I. Issue
[3]
Did
the Minister err in refusing to list the ’668 patent?
II. Analysis
(a) Scope of
the Regulations
[4]
A
person who wishes to have a drug patent protected under the Regulations must
show that the patent contains a claim for “the medicine itself or a claim for
the use of the medicine” (s. 4(2)(b)). This requirement is met by
patents that claim formulations of active and inactive ingredients: Eli
Lilly Inc. v. Canada (Minister of Health), 2003 FCA
24, [2003] F.C.J. No. 75 (C.A.) (QL); Hoffman-La Roche Ltd. v. Canada (Minister of
National Health and Welfare), [1995] F.C.J. 985 (T.D.) (QL). However,
it is not met by patents for devices whose purpose is to administer an active
ingredient to a patient (such as inhalers or patches): Glaxo Group Ltd.
v. Novopharm Ltd., [1998] F.C.J. No. 155 (T.D.) (QL); Novartis
Pharmaceuticals Canada Inc. v. Canada (Minister of Health), 2003 FCA
299, [2003] F.C.J. No. 1065 (C.A.) (QL). Nor is it met by patents for
combinations of active and inactive ingredients which protect a “delivery
system” for a medicine rather than the “payload” itself: GlaxoSmithKline
Inc. v. Canada (Attorney General), 2005 FCA
197, [2005] F.C.J. No. 915 (C.A.) (QL) at para. 43-4; Biovail v. Canada (Minister of
Health),
2005 FC 1135, [2005] F.C.J. No. 1402 (T.D.) (QL), aff’d 2006 FCA 10, [2006]
F.C.J. No. 475 (C.A.) (QL).
(b) The
Minister’s decision
[5]
By
way of a letter dated December 13, 2005, the Director of the Office of Patented
Medicines and Liaison, on behalf of the Minister, informed Janssen-Ortho that
the ‘668 patent was ineligible for listing on the register. After summarizing
the decisions of this Court and of the Federal Court of Appeal, the Director
concluded that the ‘668 patent protects “tablets and dosage forms which could
be used in the administration of methylphenidate hydrochloride” but does not
include a claim for that medicine itself or for the use of that medicine.
[6]
The
question, then, is whether the ‘668 patent protects a delivery system or a
payload. If it claims the former, the Minister’s decision was correct. If it
claims the latter, the Minister was wrong.
(c) The ‘668 patent’s claims
[7]
Claims
1 to 7 of the patent relate to tablets containing methylphenidate or a
pharmaceutically acceptable salt of methylphenidate. Claims 8 to 25 cover
particular dosage forms for the various layers of the tablet. Claims 26 and 27
claim the use of the tablets and the dosage forms for the treatment of
attention deficit disorder (ADD).
[8]
Janssen-Ortho
argues that the patent includes claims for the medicine methylphenidate itself
and for the use of that medicine in the treatment of ADD. In my view, however,
the patent claims the design for a particular tablet containing
methylphenidate and the use of that tablet for the treatment of ADD.
[9]
Claim
1 of the ‘688 patent refers to a tablet containing methylphenidate with the
following characteristics:
• the
tablet’s length exceeds its width;
• there
is a drug composition containing methylphenidate in the tablet’s first layer;
• there
is a second layer containing a polymer;
• a
semipermeable layer surrounds the first and second layers;
• the
semipermeable layer contains a passageway at one end of the tablet which allows
for release of the methylphenidate contained in the first layer;
• the
methylphenidate is released over the course of two to 8 hours; and
• the
tablet is coated with a composition of methylphenidate.
[10]
As
I read them, the remaining claims (2 to 25) cover variations in the amounts of
the various constituent elements of the tablets and in the kinds of
non-medicinal ingredients. As mentioned, claims 26 and 27 relate to the use of
these various forms of the tablet in the treatment of ADD.
[11]
In
my view, these claims are not for the medicine methylphenidate or for its use.
They relate to a particular form of tablet that permits a desired release
profile for the tablet’s active ingredient, methylphenidate. This is borne out
not just by the drafting of the claims, but by the narrative portions of the
‘668 patent and by Janssen-Ortho’s own expert evidence.
[12]
The
‘668 summarizes the invention it contains as follows:
This invention relates to a dosage form
for delivering an increasing dose of drug. The invention concerns further a
dosage form for delivering an increasing dose of drug per unit time over an
extended time for continuous effective therapy.
[13]
The
patent states that the invention it discloses is intended to address problems
of drug tolerance. It notes that there is “a critical and pressing need” for
novel dosage forms that deliver drugs at a “sustained-ascending rate”. Therefore,
the object of the invention is to provide “a novel and unique dosage form that
overcomes the shortcomings known to the prior art and thereby makes an
advancement in the drug dispensing art”. The bulk of the patent’s disclosure
describes the benefits and mechanics of a tablet possessing the characteristics
set out in the claims, and described above. There is very little said about
methylphenidate. It is clear that the design is a generic one, which would
permit administration of many different medicines. For example, the patent
states that the overcoat of the tablet could contain “opioids, barbiturates,
hypnotics, psychostimulants, psychodepressants, central nervous system acting
drugs, analgesics and catecholamines”.
[14]
The
patent does mention that one of its aspects is a tablet containing
methylphenidate. It also includes detailed descriptions of tablets containing
methylphenidate among the various examples set out in the patent. However, all
of the examples emphasize the structure and mechanics of the tablet. The
particular active ingredient in each of them appears incidental to the workings
of the tablet.
[15]
Dr.
James W. McGinity, Professor of Pharmacy at the University of Texas, Austin, provided an
expert opinion to Janssen-Ortho. In it, he states that prior to the invention
in the ‘668 patent there was a need to find a way to deliver methylphenidate in
a sustained-ascending rate in order to deal with issues of tolerance and dosage
frequency. The solution to this problem lay in the creation of novel dosage
forms for methylphenidate. He states: “[I]t is clear that the disclosure in the ‘668 Patent
relates
to a pharmaceutical formulation in which an active ingredient such as
methylphenidate may be released in ascending profile and that this is achieved
by combining dimensions of the dosage form with certain non-medicinal elements”.
[16]
In
my view, Dr. McGinity’s opinion confirms that the main thrust of the ‘668
patent is a tablet that possesses the means of delivering an active ingredient
according to a particular release profile, and the use of such a tablet for the
treatment of ADD. It does not claim the medicine itself or the use of the
medicine.
[17]
Janssen-Ortho
raised a further argument at the hearing. It suggested that the existence of an
outer coating of methylphenidate was really the most important part of the
invention described in the ‘668 patent and, therefore, because the outer
coating was made up of methylphenidate itself, the patent contained a claim for
that medicine, and for the use of that medicine in the treatment of ADD. It submitted
that the outer coating is critical for dealing with young people who exhibit
symptoms of ADD in the schoolyard. Because the outer coating contains the
active ingredient, it will address symptoms immediately, while the rest of the
active ingredient is released gradually over the ensuing hours. Further, the
outer coating enhances the effectiveness of the remainder of the active
ingredient because there will still be some of the active ingredient in the
blood stream when the rest of it “kicks in”.
[18]
I
see no support for this submission. The patent mentions the outer coating, but
there is no indication in it that the outer coating is as important as
Janssen-Ortho suggests. In fact, the opposite is true. There is far more
discussion of the internal operation of the tablet and the need for release of
the medicine over a longer period of time. The same is true in Dr. McGinity’s
opinion. Further, the release profile for the tablet shows that the
methylphenidate in the outer coating dissipates in the first hour after
ingestion. It does not appear to contribute to an elevation in the amount of
active ingredient available over the ensuing hours, as Janssen-Ortho suggested.
[19]
Based
on the foregoing, I have concluded that the Minister did not err in finding
that the ‘668 was ineligible to be listed on the register. I must, therefore,
dismiss this application for judicial review with costs.
JUDGMENT
THIS COURT’S JUDGMENT IS
THAT:
1. The application for judicial
review is dismissed with costs.
"James
W. O'Reilly"
Annex
|
Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133
Register
3. (1) The Minister shall maintain a register of any
information submitted under section 4. To maintain it, the Minister may
refuse to add or may delete any information that does not meet the
requirements of that section.
Patent List
4.(2) A patent list submitted in respect of a
drug must
…
(b) set out any Canadian patent that is owned by
the person, or in respect of which the person has an exclusive licence or has
obtained the consent of the owner of the patent for the inclusion of the
patent on the patent list, that contains a claim for the medicine itself or a
claim for the use of the medicine and that the person wishes to have included
on the register;
|
Règlement
sur les médicaments brevetés (avis de conformité), DORS/93-133
Registre
3. (1) Le ministre tient un registre des renseignements fournis
aux termes de l'article 4. À cette fin, il peut refuser d'y ajouter ou en
supprimer tout renseignement qui n'est pas conforme aux exigences de cet
article.
Liste
de brevet
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 médicament en soi ou une revendication pour l'utilisation du
médicament, et qu'elle souhaite voir inscrit au registre;
|
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