Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health)

Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health) Court (s) Database Federal Court of Appeal Decisions Date 2003-07-07 Neutral citation 2003 FCA 299 File numbers A-617-02 Notes Digest Decision Content Date: 20030707 Docket: A-617-02 Citation: 2003 FCA 299 CORAM: LINDEN J.A. SEXTON J.A. MALONE J.A. BETWEEN: NOVARTIS PHARMACEUTICALS CANADA INC. Appellant and THE MINISTER OF HEALTH and THE ATTORNEY GENERAL OF CANADA Respondents Heard at Ottawa, Ontario, on June 10, 2003. Judgment delivered at Ottawa, Ontario, on July 7, 2003. REASONS FOR JUDGMENT OF THE COURT BY: MALONE J.A. CONCURRED IN BY: LINDEN J.A. SEXTON J.A. Date: 20030707 Docket: A-617-02 Citation: 2003 FCA 299 CORAM: LINDEN J.A. SEXTON J.A. MALONE J.A. BETWEEN: NOVARTIS PHARMACEUTICALS CANADA INC. Appellant and THE MINISTER OF HEALTH and THE ATTORNEY GENERAL OF CANADA Respondents REASONS FOR JUDGMENT MALONE J.A. INTRODUCTION [1] This is an appeal from an order of MacKay J. (the Applications Judge), dated October 7, 2002, dismissing the appellant's application for judicial review in relation to its Canadian Patent 1,300,021(the '021 patent), reported as (2002), 22 C.P.R. (4th) 361, 2002 FCT 1042. MacKay J. upheld the decision of the respondent Minister of Health (the Minister) to remove the '021 patent relating to Novartis' Estracomb patches from the Patent Register established under the Patented Medicines Notice of Compliance Regulations, SOR/93-133 (the NOC Regulations). ISSUE [2] The issue on appeal is whether a patent claim to a system of two patches which are applied to the skin of the patient constitutes a claim for the medicine itself or a claim for the use of the medicine within the meaning of paragraph 4(2)(b) of the NOC Regulations. LEGISLATIVE FRAMEWORK [3] Paragraph 4(2)(b) reads, in part: (2) A patent list submitted in respect of a drug must (2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants : [...] [...] (b) set out ... a claim for the medicine itself or a claim for the use of the medicine ... b) ... une revendication pour le médicament en soi ou une revendication pour l'utilisation du médicament ... [4] The definition of medicine is set out in section 2 of the NOC Regulations: 2. In these Regulations, 2. Les définitions qui suivent s'appliquent au présent règlement. [...] [...] "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. FACTS [5] The '021 patent contains six claims which are directed to two patches or a "therapeutic system for the ... administration of estrogens and gestagens" and a method for preparing these patches or therapeutic system. According to the claims, each patch is comprised of four discrete layers, most of which are made of plastic: a backing, a reservoir which contains the active ingredient which is administered to the patient, an adhesive layer and a peel-off layer. [6] The '021 patent was listed on the Patent Register in 1994 in respect of the drug Estracomb. Estracomb is a drug product used by women for the relief of menopausal and postmenopausal symptoms and the prevention of osteoporosis. It is sold in Canada by Novartis. [7] The active ingredients in Estracomb are estradiol, a natural estrogen hormone, and estradiol and norethindrone acetate, a progestin. The active ingredients are administered to the patients by two types of patches, which are applied to the skin over a 28-day treatment cycle. The Estraderm patch is used for the first 14 days and administers estradiol to the patient, while the Estragest patch is used for the last 14 days of the cycle and administers estradiol and norethindrone acetate. Transdermal administration of the active ingredients prevents the rapid metabolism of relatively large quantities of these ingredients, which would occur if they were administered orally. The patches enable the delivery of these active ingredients in a controlled, safe and efficacious manner. [8] The Minister, who is responsible for maintaining the Patent Register, commenced a general audit of the Register in 1998 to determine whether the patents already included were properly listed. It was in the context of the general audit that the Minister examined the '021 patent and determined that it did not contain a claim to the medicine or to the use of the medicine as required by paragraph 4(2)(b). Accordingly, he decided that the patent was ineligible for listing and removed it from the Patent Register. [9] The appellant commenced an application for judicial review of the Minister's decision. In dismissing that application, MacKay J. determined that the '021 patent was issued in relation to a system for the administration of medicine and does not contain a claim to the medicine itself or the use of the medicine as required by paragraph 4(2)(b). His decision was based on the authority of Glaxo Group Ltd. v. Novapharm Ltd. (1998), 79 C.P.R. (3d) 488 (F.C.T.D.) (Glaxo FCTD); which was upheld by this Court, (1999), 244 N.R. 199 (F.C.A.) (Glaxo FCA) ; leave to appeal to the Supreme Court of Canada dismissed, [1999] S.C.C.A. No. 391. [10] The Applications Judge also ruled that the fact the patches are regulated as drugs and not devices by the Minister under the Food and Drug Regulations, c. 870, is not determinative when construing the claims of the '021 patent. Further, the fact that the patches are regulated by the Patented Medicine Prices Review Board is also not determinative when deciding whether the patches are medicine for the purposes of the NOC Regulations. [11] A key component in determining this issue was MacKay J.'s analysis of the decisions in Glaxo and Hoffman-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.) (Hoffman); affirmed by this Court at (1995), 67 C.P.R. (3d) 25 (F.C.A.); leave to appeal to the Supreme Court of Canada dismissed, [1996] 3 S.C.R. xi. These two decisions stand for the proposition that a claim for a pharmaceutical preparation or composition is a "claim for the medicine itself", however, a patent for a medical device, which is used to administer, as opposed to being administered, is not a claim for a medicine. [12] Novartis now argues that Mackay J. did not correctly apply these two decisions, as he held that the present facts fell between the two cases, but was "more analogous" to the Glaxo decision, and therefore the patches are medical devices, and not medicine. Such an analysis, says the appellant, failed to address the correct question; namely, are patches pharmaceutical preparations and are they administered, or do the patches administer medicine. STANDARD OF REVIEW [13] As to the standard of review, McLachlin C.J. in Dr. Q v. College of Physicians and Surgeons of British Columbia, 2003 SCC 19, [2003] S.C.J. No. 18 (Dr. Q.) stated at paragraph 21 that the pragmatic and functional approach must be utilized in every judicial review of an administrative decision-maker, and that it is no longer sufficient to slot a particular issue, such as a question of law, into a pigeon hole of judicial review (see paragraphs 22 - 25). Rather, all four factors must be analysed. [14] Further, in Canadian Union of Public Employees v. Ontario (Minister of Labour), [2003] S.C.J. No. 28, 2003 SCC 29, at paragraph 150, the Supreme Court of Canada reconfirmed that the pragmatic and functional approach applies to decisions of Ministers: The Court has also affirmed that the "pragmatic and functional approach" applies to the judicial review not only of administrative tribunals but of decisions of Ministers: Baker, supra; Mount Sinai, supra, at para. 54; Dr. Q., at para. 21; Ryan, at para. 21. [15] Here, the Applications Judge made no reference to the pragmatic and functional approach or the four factors. Instead, he based his determination on his assessment that the matter concerned a question of law and the agreement of the parties that the standard should be correctness. The nature of the question, whether the question being reviewed concerns a question of law for example, is only one of the four factors in the pragmatic and functional approach, and on its own cannot determine the standard of review in judicial review. [16] However, the use of this judicial short cut is really of no consequence in this instance. If MacKay J. was satisfied on a correctness standard that the Minister properly removed the '021 patent from the Patent Register, then that decision is neither assailable on a reasonableness simplicitier nor patently unreasonable standard of review, since these standards are less intrusive. ANALYSIS [17] I am of the view that the Applications Judge was correct in holding that the Minister rightly construed the '021 patent not as claims for the medicine itself or for the use of the medicine within the meaning of paragraph 4(2)(b). In the Glaxo FCA decision, this Court recognized that a patent claiming a device used to administer a substance does not constitute a claim for the medicine itself or for the use of the medicine. Specifically, in Glaxo FCA this Court decided that a patent claiming an inhaler used to administer a medicament to patients did not contain claims for the medicine itself or the use of that medicine. On behalf of the unanimous panel, Décary J.A. stated: 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 medicaments 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. [Emphasis added] [18] Accordingly, the proper test to determine if the patches are medicine under the NOC Regulations is whether they are administered to the patient or whether they administer substances to the patient. It is acknowledged that the Applications Judge did not succinctly articulate this test, but instead stated that this case fell between Glaxo and Hoffmann, but was more analogous to the Glaxo case. However, MacKay J., in my view, did reach the correct result, and it is material that the facts of the Glaxo decision are far more proximate to this case then the facts in Hoffman. [19] The determination made by MacKay J. that the patches are not medicine does not conflict with the Glaxo decision, as asserted by the appellant. The Applications Judge did not hold that only active ingredients can comprise a medicine. The underlying theory of the Applications Judge's determination was that the patches are not administered, but instead administer medicine, and this is a direct application of the Glaxo decision. [20] In my analysis, MacKay J. correctly concluded that the ratio in Glaxo is applicable to this case. The evidence clearly establishes that the claims of the '021 patent are similar to those of the patent at issue in Glaxo. There, the inhaler was used to administer a medicament. Similarly, the patches claimed in the '021 patent are used to administer estradiol or estradiol and norethindrone acetate to patients. The fact that each of the patches is used over 14 days, where the inhaler is used and removed immediately, is of no significance. The claims of the '021 patent are in relation to a system for the administration of substances, not in relation to the substances themselves. Accordingly, the patent for the patches, the '021 patent, is not eligible for inclusion on the Patent Register. [21] MacKay J. also correctly distinguished this case from the Hoffman decision. Novartis relies on this case to argue that the patches are formulations of active and inactive ingredients and therefore constituted medicine within the meaning of the NOC Regulations. The patches, however, are different from the formulation at issue in Hoffman. There, the patent contained claims to a nasal spray composed of active and inactive ingredients which were physically mixed together in a formulation, and administered to the patient. This Court held that the formulation constituted a medicine within the meaning of the NOC Regulations. In this case, however, the patches claimed in the '021 patent are not formulations. The layers of the patches are not mixed with the estradiol or the estradiol and norethindrone acetate. Rather, they are all discrete and separate components, and only the estradiol or the estradiol and norethindrone acetate are administered to the patient. The other layers of the patches are never administered. Instead, each of the two patches is intentionally removed by the patient and discarded after 14 days. On these facts, it is clear that the patches are never administered, and therefore do not fall within the definition of medicine in the NOC Regulations. [22] Finally, the Applications Judge was correct in concluding that the manner in which the Estracomb patches are regulated under the Food and Drugs Regulations, as drugs and not devices, and by the Patented Medicine Prices Review Board are not determinative when construing the claims of the '021 patent. It is well established that courts will not look at matters extraneous matters to the patent in construing the claims of the patent (See Merck Frost Canada & Co. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 383, 2001 FCA 136). [23] In sum, MacKay J. was correct in upholding the Minister's decision to remove the '021 patent from the Patent Register. I would dismiss the appeal with costs. "B. Malone" J.A. "I agree A.M. Linden J.A." "I agree J. Edgar Sexton J.A." FEDERAL COURT OF APPEAL NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: A-617-02 STYLE OF CAUSE: Novartis Pharmaceuticals Canada Inc. -vs- The Minister of Health and the Attorney General of Canada PLACE OF HEARING: Ottawa, Ontario DATE OF HEARING: June 10, 2003 REASONS FOR JUDGMENT: MALONE J.A. CONCURRED IN BY: LINDEN J.A. SEXTON J.A. DATED: July 7, 2003 APPEARANCES: Mr. Anthony Creber FOR THE APPELLANT Ms. Jennifer Wilki Mr. Frederick Woyiwada FOR THE RESPONDENTS SOLICITORS OF RECORD: Gowling Lafleur Henderson LLP FOR THE APPELLANT Ottawa, Ontario Mr. Morris Rosenberg FOR THE RESPONDENTS Deputy Attorney General of Canada Ottawa, Ontario