Date: 20010501
Docket: A-511-00
Neutral citation: 2001 FCA 136
CORAM: STRAYER J.A.
ROTHSTEIN J.A.
EVANS J.A.
BETWEEN:
MERCK FROSST CANADA & CO.,
-and-
MERCK & CO., INC.,
Appellants
(Applicants)
- and -
THE MINISTER OF HEALTH,
-and-
THE ATTORNEY GENERAL FOR CANADA,
Respondents
(Respondents)
Heard at Ottawa, Ontario, on Tuesday, May 1, 2001.
Judgment delivered from the Bench on May 1, 2001.
REASONS FOR JUDGMENT OF THE COURT BY: EVANS J.A.
Date: 20010501
Docket: A-511-00
Neutral citation: 2001 FCA 136
CORAM: STRAYER J.A.
ROTHSTEIN J.A.
EVANS J.A.
BETWEEN:
MERCK FROSST CANADA & CO.,
-and-
MERCK & CO., INC.,
Appellants
(Applicants)
- and -
THE MINISTER OF HEALTH,
-and-
THE ATTORNEY GENERAL FOR CANADA,
Respondents
(Respondents)
(Delivered from the Bench at Ottawa, Ontario
on Tuesday, May 1, 2001)
[1] In 1990, Merck Frosst Canada & Co. obtained a Notice of Compliance ("NOC") authorising it to market a tablet, ZOCOR, containing simvastatin in its lactone form as its medicinal ingredient. In 1993, Merck Frosst Canada & Co. and Merck and Co. Inc. ("the appellants") listed on the patent register two patents that they held respecting simvastatin produced by a particular process.
[2] The question to be decided in this appeal is whether the Minister of Health erred in law when he refused to add to the register the patent that the appellants had obtained in 1999 (the '331 patent) for two metabolites of simvastatin, namely hydroxymethyl simvastatin and carboxy simvastatin, that are produced following the ingestion of simvastatin and its metabolism by the liver.
[3] The answer to this question depends on whether the '331 patent "contains a claim for the medicine itself" for the purpose of paragraph 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. The appellants contend that it does, because the metabolites have therapeutic effects, and are thus medicines, and were mentioned in the new drug submission on the basis of which it obtained a NOC for ZOCOR. The Minister maintains that, since the '331 patent does not contain a claim for simvastatin, the medicine for which the NOC was obtained, the '331 patent is not "a claim for the medicine itself".
[4] The relevant statutory provision immediately relevant to the disposition of this appeal is as follows:
| 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; |
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; |
|
[5] The appellants appeal from a decision of the Trial Division dismissing their application for judicial review challenging the refusal by the Minister of Health to add the '331 patent to the patent list with respect to ZOCOR. The Judge's reasons were as follows: even if the metabolites were medicines, they were not the medicine simvastatin, presumably because they have a different chemical structure from that of simvastatin in lactone form; the NOC issued for ZOCOR tablets states that the medicine that they contain is simvastatin, not the metabolites, which occur only after ingestion; and the '331 patent makes no claim for simvastatin. Accordingly, he concluded that the '331 patent did not contain "a claim for the medicine itself" and the Minister had correctly refused to add the '331 patent to the register.
[6] We have not been persuaded that, in reaching this result, the Judge made any error; indeed, we would endorse the reasons that he gave for his decision. We do not think that the Judge can be said to have interpreted either the Regulations or the NOC unduly narrowly or without proper regard to the statutory purpose of protecting patent holders from the potential infringement of their rights by those to whom NOCs are issued.
[7] The appellants argue that, unless the '331 patent is added to the register, a competitor who is able to manufacture a drug containing simvastatin produced by a non-patented process will be entitled to a NOC on proof that the drug is equivalent to ZOCOR. Since the competitor's drug, when ingested, will be metabolised into the patented metabolites, the '331 patent will be infringed. And, because the text of legislation must be interpreted in a manner consistent with its purpose, and the purpose of the NOC Regulations is to prevent the direct or indirect infringement of the rights of pharmaceutical patent holders, the "medicine itself" should be interpreted to include both simvastatin in lactone form, and its metabolites, the active therapeutic agents.
[8] Despite counsel's able submissions, we are not persuaded by this argument for two reasons. First, if successful, the appellants would be able to do indirectly what they could not do directly, that is, prevent a competitor from obtaining a NOC for a drug containing simvastatin produced by a non-infringing process. The appellants sought and obtained "product by process" patents for simvastatin, since the law at that time did not permit the issuance of a product patent for a medicine. When the Patent Act, R.S.C. 1985 c. P-4, was amended in 1993 (Patent Amendment Act, 1992, S.C. 1993, c. 2, section 3) to permit this, the appellants could not obtain a product patent for simvastatin because, as a result of their product by process patents, simvastatin was no longer novel.
[9] Second, we are unable to construe the '331 patent as claiming simvastatin. In construing the claims of a patent, a court is not entitled to consider such extraneous matters as the content of a new drug submission filed pursuant to the Food and Drug Regulations, C.R.C. 1978, c. 870. Accordingly, the fact that simvastatin in lactone form only has therapeutic effect after it has been metabolised in the body into the patented metabolites does not justify construing the claims of the '331 patent to include simvastatin in lactone form. Further, to disregard the terms of the NOC by treating ZOCOR tablets as containing the medicine simvastatin and its metabolites could compromise the ability of the Minister to discharge the important statutory responsibilities for ensuring the effectiveness and safety of new drugs.
[10] For these reasons, the appeal will be dismissed with costs.
J.A.