BETWEEN:
(Applicant)
and
THE ATTORNEY GENERAL OF CANADA
(Respondents)
Heard at Ottawa, Ontario, on September 19, 2006.
Judgment delivered at Ottawa, Ontario, on September 28, 2006.
REASONS FOR JUDGMENT BY: SHARLOW J.A.
CONCURRED IN BY: DÉCARY J.A.
PELLETIER J.A.
Docket: A-100-06
Citation: 2006 FCA 310
CORAM: DÉCARY J.A.
SHARLOW J.A.
PELLETIER J.A.
BETWEEN:
PFIZER CANADA INC.
Appellant
(Applicant)
and
MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
(Respondents)
REASONS FOR JUDGMENT
[1] This is an appeal by Pfizer Canada Inc. (Pfizer) of a judgment of the Federal Court (2006 FC 210) dismissing Pfizer’s application for judicial review of the decision of the Minister of Health not to list Canadian Patent No. 2,296,726 (the 726 patent) on the patent register maintained under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the NOC Regulations).
[2] The 726 patent makes a number of claims for pharmaceutical compositions consisting of the following: (1) amlodipine in one of a number of different forms (including amlodipine besylate), (2) a statin, which must be fluvastatin, rivastatin, or simvastatin, and (3) a carrier or diluent. The 726 patent also claims a number of uses for the claimed compositions. The 726 patent contains no claim for any form of amlodipine alone, or for the use of any form of amlodipine alone.
[3] Pfizer seeks to have the 726 patent listed against the drug Norvasc. Norvasc is a drug for which Pfizer has been issued a notice of compliance. Its only medicinal ingredient is amlodipine, in the form of amlodipine besylate.
[4] It is undisputed that amlodipine besylate is a “medicine” for the purposes of the NOC Regulations and the Food and Drug Regulations, C.R.C. 870, and that each of the statins named in the claims of the 726 patent is also a “medicine”.
[5] Paragraph 4(2)(a) of the NOC Regulations says that a patent may be listed in respect of a drug that contains a medicine only if the patent contains a claim for the medicine itself or a claim for the use of the medicine.
[6] In the Federal Court and in this Court, the Minister argued that the 726 patent cannot be listed against Norvasc because the 726 patent does not contain a claim for amlodipine besylate or for the use of amlodipine besylate. The Judge accepted the Minister’s argument as correct. I agree.
[7] I also agree with the Minister that this interpretation is consistent with the object of the NOC Regulations, which is to prevent the infringement of patents while permitting drug manufacturers to take advantage of the early working exception in section 55.2 of the Patent Act. Including the 726 patent on a patent list in respect of Norvasc will never disclose a possible infringement of the 726 patent.
[8] There are two reasons for that. First, no drug product could possibly infringe the 726 patent unless it contains both amlodipine and one of the statins named in the claims of the 726 patent. That conclusion is compelled by the claims of the 726 patent.
[9] Second, if a drug manufacturer wished to obtain a notice of compliance for a new drug product containing both amlodipine and a statin (thus raising the risk of an infringement of the 726 patent), the Food and Drug Regulations would not permit that drug manufacturer to file an abbreviated new drug submission using Norvasc as its Canadian reference product. That is because, by definition, a proposed new drug containing two medicinal ingredients cannot be the “pharmaceutical equivalent” of a drug that contains only one of those ingredients.
[10] In that regard, I refer to section C.08.002.1 of the Food and Drug Regulations (which sets out the statutory requirements for an abbreviated new drug submission), and the definition of “pharmaceutical equivalent” in section C.08.001.1 of the Food and Drug Regulations. Those provisions read in relevant part as follows:
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C.08.001.1. For the purposes of this Division, […] “pharmaceutical equivalent” means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; |
C.08.001.1. Less définitions qui suivent s'appliquent au présent titre. […] « équivalent pharmaceutique » S'entend d'une drogue nouvelle qui, par comparaison à une autre drogue, contient les mêmes quantités d'ingrédients médicinaux identiques, sous des formes posologiques comparables, mais pas nécessairement les mêmes ingrédients non médicinaux. |
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C.08.002.1. (1) A manufacturer of a new drug may file an abbreviated new drug submission for the new drug where, in comparison with a Canadian reference product, |
C.08.002.1 (1) Le fabricant d'une drogue nouvelle peut déposer à l'égard de celle-ci une présentation abrégée de drogue nouvelle si, par comparaison à un produit de référence canadien : |
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(a) the new drug is the pharmaceutical equivalent of the Canadian reference product; […]. |
a) la drogue nouvelle est un équivalent pharmaceutique du produit de référence canadien; […] |
[11] It is argued for Pfizer that there is no statutory bar to a generic drug manufacturer filing an abbreviated new drug submission that has two Canadian reference products, and in any case the Minister’s conclusion is contradicted by the decision of this Court in Eli Lilly Canada Inc. v. Canada (Minister of Health) (C.A.), [2003] 3 F.C. 140. (Eli Lilly).
[12] I am unable to find, in the Food and Drug Regulations or the jurisprudence cited by Pfizer, any support for the proposition that an abbreviated new drug submission may have two Canadian reference products. Nor can I conclude that Eli Lilly supports the position of Pfizer in this case.
[13] The issue in Eli Lilly was whether a patent that contained a claim for combination of ceftazidime (a medicinal ingredient) and lactose (a non-medicinal ingredient), could be listed in respect of Tazidime, which contained ceftazidime but not lactose. The question was whether the claim was for “the medicine itself”. The answer was yes, because the medicine in Tazidime and the medicine claimed by the patent was, for the purpose of the NOC Regulations, the same. It is implicit in the result in Eli Lilly that the phrase “a claim for the medicine itself” means a claim in a patent in which the only medicine claimed is the medicine contained in the drug for which the notice of compliance was issued. That was the case in Eli Lilly. It is not the case here.
[14] I would dismiss this appeal with costs.
“K. Sharlow”
J.A.
“I agree
Robert Décary J.A.”
“I agree
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-100-06
APPEAL FROM AN ORDER OF THE FEDERAL COURT DATED FEBRUARY 16, 2006, NO. T-283-05
STYLE OF CAUSE: Pfizer Canada Inc. v. Minister of Health and The Attorney General of Canada
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: September 19, 2006
REASONS FOR JUDGMENT BY: SHARLOW J.A.
PELLETIER J.A.
APPEARANCES:
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Alisse Houweling
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FOR THE APPELLANT |
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FOR THE RESPONDENTS |
SOLICITORS OF RECORD:
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Toronto, Ontario |
FOR THE APPELLANT
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Deputy Attorney General of Canada Ottawa, Ontario |
FOR THE RESPONDENTS |