Date: 20040311
Docket: T-441-03
Citation: 2004 FC 370
Ottawa, Ontario, this 11th day of March, 2004
Present: The Honourable Mr. Justice Mosley
BETWEEN:
PFIZER CANADA INC.
Applicant
and
ATTORNEY-GENERAL OF CANADA
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1] Pfizer Canada Inc. ("Pfizer" or "applicant") seeks judicial review of a decision of the Minister of Health (the "Minister"), dated February 17, 2003. In that decision, a delegate of the Minister refused to add Canadian Patent No. 2, 088, 376 (the "'376 patent") to the Patent Register on the grounds that it does not contain a claim to the medicine verapamil hydrochloride, or its use, as required by subsection 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended (the "NOC Regulations"). Pfizer seeks an order setting aside this decision as well as an order directing the Minister to list the '376 patent on the Patent Register. The applicant also seeks costs in this application.
BACKGROUND
[2] On July 7, 1997, Pfizer[1] received a Notice of Compliance ("NOC") concerning its CHRONOVERA brand of verapamil hydrochloride in 180 and 240 mg strengths, in sustained release tablet form. CHRONOVERA verapamil hydrochloride tablets are used to treat hypertension and angina.
[3] The '376 patent was granted on May 1, 2001 and within 30 days, Pfizer applied to have the '376 patent added to the Patent Register for the drug CHRONOVERA, by submitting a "Form IV: Patent List" pursuant to subsection 4(4) of the NOC Regulations.
[4] The '376 patent is entitled "Dosage Form for Time-Varying Patterns of Drug Delivery" and contains seven claims. This patent describes the construction of a tablet that would allow for controlled release of the drug formulation to the patient after a certain time interval had passed following ingestion.
[5] As described in the '376 patent, after being swallowed, gastrointestinal fluids begin to permeate the outer wall of the tablet. They first dissolve the drug-free layer between the wall and the compartment holding the active drug component. The fluids then react with a drug-free composition inside the drug-free layer, causing gradual expansion. This gradual expansion of the drug-free composition causes the drug to be forced out slowly through an opening or "exit means" in the wall. The medicine is therefore made available to the patient after a measured delay and at a measured rate for the most beneficial therapeutic effect.
[6] Pfizer's CHRONOVERA tablets have a delay of 4-5 hours after ingestion, before there is any release of the medicine into the gastrointestinal tract, and thereafter the verapamil hydrochloride is released at a constant rate over 12 hours. This timing is beneficial as it allows for patients to take the tablets before going to bed, so that the drug substance will be released in the pre-dawn hours, when heart patients are at the greatest risk of suffering heart attacks, and there is no need to take subsequent tablets throughout the day due to the sustained and continued release of the drug substance.
[7] Claim 1 of the '376 patent describes the characteristics of the tablet, with reference to cross-section drawings, that provide for this delayed release of the administration of the drug substance. Claim 1 begins by stating:
A dosage form for use in a method of administering a drug to the gastrointestinal tract of a warm-blooded animal, which form is characterised by:-...
[8] Claim 1 then describes that the tablet is composed of six parts: a compartment, a wall that surrounds and forms the compartment made of a composition permeable to the passage of fluid, a first drug-free layer between the wall and the compartment, a particular dose amount of a drug for producing therapeutic effect, another drug-free composition made of a substance that expands on contact with fluid, and an opening or "exit means" in the wall.
[9] Claim 2 sets out sixteen specific drug substances that could be delivered via the dosage form described in claim 1. One of these drug substances is listed as "verapamil". Similarly, claim 3 lists eleven other drug groups. Claims 4 through 7 present modifications to the arrangement of the components set out in claim 1.
The Minister's Decision
[10] A delegate of the Minister determined that the '376 patent does not contain a claim for the medicine verapamil hydrochloride or a claim for the use of that medicine, contrary to the requirement of subsection 4(2)(b) of the NOC Regulations.
[11] By letter dated June 11, 2001, a delegate of the Minister informed Pfizer of its position, that subject to consideration of any written representations made from Pfizer, the '376 patent would not be added to the Patent Register. Pfizer submitted written representations, dated July 11, 2001.
[12] By letter dated February 17, 2003, the Minister's delegate confirmed its refusal to add the '376 patent to the Patent Register on the grounds that the "dosage form" referred to in the patent was not a claim for "medicine" within the meaning of subsection 4(2)(b) of the NOC Regulations. The Minister's delegate relied on Federal Court jurisprudence in coming to this conclusion. The decision stated, in part, as follows:
Whether a "dosage form" so described, with its ability to contain and release a medicine, is a "medicine" within the meaning of section 4 of the PM(NOC) Regulations, was answered in the decision of the Federal Court of Appeal in Glaxo Group Ltd. v. Novopharm Ltd. (1999), 87 C.P.R. (3d) 525 (F.C.A.) at page 527:
With respect to the substance 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 medicament can be administered to or by patients rather than for the substance being administered, are not a "medicine"within the meaning of the regulations.
This view was reinforced in both Novartis Pharmaceuticals Inc. v. Canada (Minister of Health) [2002] F.C.J. No. 1387 and Eli Lilly Canada Inc. v. Canada (Minister of Health) [2002] F.C.J. No. 1704, where the Federal Court again made it clear that patents which contained claims to systems or methods for the delivery of a medicine did not amount to a claim to the medicine under section 4 of the PM(NOC) Regulations. As a result, while there are claims within the '376 patent to a dosage form which could be used in the administration of a variety of medicines, it is the view of the TPD that there is no claim within the '376 patent to the medicine verapamil hydrochloride, as contemplated by subsection 4(2)(b) of the PM(NOC) Regulations.
APPLICANT'S SUBMISSIONS
[13] Pfizer submits that the '376 patent contains a "claim for the medicine itself" as defined in the NOC Regulations. Relying on Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.), aff'd (1995), 67 C.P.R. (3d) 25 (F.C.A.), leave to appeal to S.C.C. dismissed, [1996] S.C.C.A. No. 65 (QL) ("Hoffmann"), the applicant argues that the '376 patent claims formulations of active and inactive ingredients administered to patients in a particular dosage form. In Hoffmann, supra, the Federal Court of Appeal held that a "medicine" can mean more than just the active ingredient and may refer to a preparation or composition of active and non-active ingredients.
[14] Pfizer also refers to the definition of "drug" found in the Food and Drugs Act, R.S.C. 1985, c. F-7, section 2 and the definition of "medicine" found in section 2 of the NOC Regulations, to support its position.
[15] The applicant submits that other jurisprudence supports its position, namely Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140 (C.A.) ( "Eli Lilly FCA "), and argues that the claims at issue in Glaxo Group Ltd. v. Novopharm Ltd. (1998), 79 C.P.R. (3d) 488 (F.C.T.D.), aff'd on the substantive issue (1999), 87 C.P.R. (3d) 525 (F.C.A.) ("Glaxo") and Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health) (2002), 22 C.P.R. (4th) 361 (F.C.T.D.), aff'd [2003] F.C.J. No. 1065 (C.A.)(QL) ("Novartis"), are distinguished from the present situation.
[16] Pfizer relies on the affidavit evidence of Dr. James W.McGinity, Professor of Pharmacy at the College of Pharmacy, the University of Texas at Austin and Dianne Azzarello, a pharmacist licensed to practise in Ontario. Dr. McGinity's field of research is primarily focused on solid oral dosage forms and tablet technology. Pfizer submits that its evidence from witnesses, qualified as persons skilled in the art, has not been challenged through cross-examination or other expert opinion.
[17] Pfizer contends that the claims in the '376 patent are for a compressed tablet dosage form, or in other words, claims to pharmaceutical preparations. Such pharmaceutical preparation is, according to Pfizer, a "medicine" within the NOC Regulations.
[18] Pfizer submits that the '376 patent includes a claim to "medicine" that is administered to patients and has therapeutic effect. The dosage form of CHRONOVERA is a tablet, and the entire tablet is swallowed by patients. Ingestion of the active ingredient alone, without the controlled release afforded by the tablet, would be harmful and possibly fatal to the patient. The tablets are regulated as a drug and are manufactured, represented and sold as "medicine" for use in the treatment of hypertension and angina.
[19] The applicant submits that the Minister's interpretation that the claims in the '376 patent are only for a method of administering the active ingredient of the drug to patients, is incorrect. Pfizer submits that the claims are to a certain "dosage form" that contains the active ingredient, where the entire tablet is administered to the patient in order to achieve the desired therapeutic effect. Pursuant to the Hoffmann, supra, Glaxo, supra, and Novartis, supra, decisions, this is the determinative issue.
[20] The applicant argues that the Minister has employed an incorrect and overly narrow definition of "medicine", namely that "medicine" is limited to the active ingredient of a drug formulation. This definition is contrary to the established jurisprudence, particularly Hoffmann, supra, where the Court of Appeal explicitly rejected such interpretation.
[21] The applicant refers to many other patents currently listed on the Patent Register which claim dosage forms for slow or sustained release tablets, pellets, capsules or other formulations. Such patents were found to include claims for "medicine" and the applicant submits that they are no different from the verapamil hydrochloride tablets claimed in the '376 patent.
[22] Pfizer argues that the Minister's witness, Anne Bowes, Manager of Patents -Liaison for Health Canada, did not maintain a consistent definition of "medicine" on cross-examination. Pfizer argues that the Minister's witness took the position on cross-examination that "medicine" in the NOC Regulations could be limited to the active ingredient alone, a position that is clearly at odds with the Hoffmann decision. Therefore, it is questionable if the Minister correctly applied the definition "claim to a medicine itself" for the purposes of subsection 4(2)(b) of the NOC Regulations.
[23] Further, the court was urged to find that in ordinary common parlance, "medicine" was understood by the public to be the tablet that the patient swallows and not just the drug within it that has the therapeutic effect. Hence a claim to the medicine itself must apply to the tablet as a whole rather than to just what it contained.
RESPONDENT'S SUBMISSIONS
[24] The respondent submits that the '376 patent does not contain a claim for a "medicine", but rather contains claims for a system or method for the administration of a number of medicines. The patent, therefore, was properly refused for listing on the Patent Register, pursuant to subsection 4(2)(b) of the NOC Regulations.
[25] The respondent argues that the Act and the NOC Regulations provide for the Minister to make two separate decisions, first, whether a patent satisfies the prescribed requirements and second, if it does not, whether it should be excluded from the Patent Register, this second question involving some discretion on the part of the Minister. The respondent says that the standard of review is one of correctness, as this Court is just as experienced as the Minister to make a determination based on the legislation, the patent itself and the applicable jurisprudence. The respondent submits that if this Court determines that the '376 patent meets the requirements set out in the NOC Regulations for inclusion on the Register, then the Minister will add the patent to the Patent Register.
[26] The respondent argues that the '376 patent makes no claim for any medicine, particularly the medicine verapamil hydrochloride, the medicine contained in Pfizer's NOC. The respondent argues that the claims of the '376 patent relate to an arrangement for the administration of various substances, not to any of the substances themselves, and in particular, not to verapamil hydrochloride.
[27] The respondent submits that the jurisprudence of this court has recognized that a patent claiming a device used to administer a substance does not constitute a "claim for the medicine itself" or a "claim for the use of the medicine". In support, the respondent relies on Glaxo, supra, Janssen-Ortho Inc. v. Canada (Minister of Health) (2003), 24 C.P.R. (4th) 438 (F.C.T.D.), aff'd 2004 FCA 62 and Novartis, supra. The respondent argues that these decisions emphasize that the correct test to be applied is whether the invention is the medicine or administers the medicine.
[28] The respondent argues that although the invention, that is the tablet, is placed inside the body of the patient, once ingested, the invention of the '376 patent administers the medicine to the patient. The respondent refers to the decision of Eli Lilly Canada Inc. v. Canada (Attorney General) (2003), 26 C.P.R. (4th) 360 (F.C.T.D.) ("Eli Lilly FCTD") where the court upheld the Minister's decision to refuse to list a patent on the Patent Register, where the patent claimed a sustained release capsule for the administration of medicine to a cow, such capsule being ingested by the animal. The respondent says that the present case is analogous to the situation in Eli Lilly FCTD, supra.
[29] Further, the respondent submits that the '376 patent is not analogous to the formulation of active and inactive ingredients that was at issue in Hoffmann, supra. In that case, the patent contained claims to a nasal spray composed of active and inactive ingredients which were physically mixed together in a formulation and such formulation constituted a "medicine" within the meaning of the NOC Regulations. However, the respondent argues that in the present case, the active ingredient in the applicant's product, verapamil, is not mixed with various inactive ingredients, and pursuant to the design of the invention, the active ingredient and the excipients form discrete and separate components of the tablet.
ISSUE
[30] 1. Does the '376 patent contain a "claim for the medicine itself" and therefore meet the requirements of subsection 4(2)(b) of the NOC Regulations?
ANALYSIS
[31] At first impression, the applicant's argument that the patent in question is "for the medicine itself" had a certain attractiveness. On closer analysis, however, I am not satisfied that it withstands scrutiny.
[32] Subsections 3(1), 4(1) and 4(2)(b) of the NOC Regulations are relevant to this decision and provide as follows:
| 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.
4 (1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug..
(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; ... (emphasis added) |
|
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.
4 (1) La personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à l'égard de la drogue, accompagnée de l'attestation visée au paragraphe (7).
(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; ... (soulignée ajoutée)
|
[33] In addition, certain definitions provided in subsection 2(1) of the NOC Regulations are fundamental to this judicial review:
| "claim for the medicine itself" includes a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents; (revendication pour le médicament en soi)
... "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) ...
|
|
« revendication pour le médicament en soi » S'entend notamment d'une revendication, dans le brevet, pour le médicament en soi préparé ou produit selon les modes du procédé de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes. (claim for the medicine itself)
... « 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) ... |
[34] The standard of review to be applied by the Court to the Minister's decision not to list a patent on the Patent Register pursuant to the NOC Regulations is correctness: see Eli Lilly FCA, supra.
[35] The definition of "medicine" in the NOC Regulations, as meaning a "substance intended or capable of being used" for treating, diagnosing or preventing ailments, has been considered by this Court on many occasions. In Hoffmann, supra, at page 74, the court held that the terms "drug" and "medicine" were not intended to be interpreted in "contradistinction". The definition of "drug" reads:
| "drug" includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, ... |
|
« drogue » Sont compris parmi les drogues les substances ou mélanges de substances fabriqués, vendus ou présentés comme pouvant servir_: a) 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, chez l'être humain ou les animaux; ... |
The applicant's reliance on this definition of "drug" and the definition of "substance" found not in the NOC Regulations, but in a medical dictionary as meaning "that of which any material thing is composed; matter" does not further the argument that the '376 patent includes a "claim for the medicine itself", being Pfizer's CHRONOVERA tablets in the 180 mg and 240 mg strengths.
[36] Claim construction is a matter of law: Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067. In undertaking such construction, the Supreme Court of Canada in Whirlpool, supra, and Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, has held that patent claims are to be construed in a "purposive" way and the Court may look at the entire specification of the patent in order to understand the words as stated in any disputed claim, provided that such reference to the specification does not enlarge or contract the scope of the claim. In construing the claim in issue, the Court must identify the essential elements of that claim. In Whirlpool, supra, Justice Binnie stated at paragraph 45:
The key to purposive construction is therefore the identification by the court, with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the "essential" elements of his invention...
[37] In the present case, the objective of the '376 patent is to provide a novel dosage form which allows for a particular method of delivery of a variety of different drugs. The introduction of the specification reads as follows at page 1 of the patent:
DESCRIPTION OF TECHNICAL FIELD
This invention pertains to a novel dosage form for time-varying patterns of drug delivery. More particularly, the invention concerns a dosage form provided as an osmotic device comprising means for the rate-programmed delivery of a drug in time-varying patterns to a drug recipient.
DESCRIPTION OF BACKGROUND ART
Presently, pharmacy and medicine provide delivery systems for the constant-rate delivery of a drug to a drug-recipient user. The prior art provides infusion pumps as disclosed by..., oral matrix systems..., osmotic systems..., osmopolymer-powered systems..., and implants... for constant-rate delivery of a drug of the longest duration consistent with reproducible therapeutic results.
While these prior art delivery systems provide good therapy and achieve their intended results there are however, some therapeutic programs that require the dose of drug be administered in time-varying patterns of delivery. The time-varying patterns of drug delivery include (1) a drug-free interval followed by drug pulses of various duration for extended periods of time, (2) an immediate drug does followed by a drug-free interval followed by a drug-delivery period, and (3) a single dose followed by a delayed dose for optimum therapy, and like patterns of drug delivery.
...
[38] The specification of the '376 patent then describes some of the objects of the invention as follows at pages 2-3 of the patent:
DISCLOSURE OF OBJECTS OF THE INVENTION
... it is an immediate object of this invention to provide a novel dosage form that overcomes the shortcomings of the prior art and fully satisfies the critical and unfilled need for the dosage form.
Another primary object of this invention is to provide a dosage form for time-varying patterns of drug delivery for achieving optimum therapy.
Another primary object of this invention is to provide a programmable drug-delivery system that substantially fulfills the pressing need of the prior art and also represents an unexpected improvement in the dispensing art.
Another object of the present invention is to provide a programmable drug-delivery system adapted as a dosage form for a rate-programmed drug delivery at time-varying patterns.
Another object of the present invention is to provide a dosage form comprising structural means for providing drug-free intervals followed by drug-delivery periods of various time durations.
Another object of the present invention is to provide a dosage that can deliver an instant-pulse dose of a therapeutic drug, followed by a delayed delivery of drug, and then deliver a dose of drug.
...
Another object of the present invention is to provide a novel dosage form manufactured in the form of a drug delivery device comprising means for delivering a pulsed dose of drug to a human, means for providing a drug-free interval, and then providing a recurring pulse does of drug to the human.
[39] The problem which the '376 patent addresses is that the prior art had not revealed a delivery system for the administration of a drug in tablet form that would allow "time-varying patterns of delivery". There is no mention of verapamil or verapamil hydrochloride in these introductory portions of the specification. In fact, "verapamil" is only mentioned twice in the patent: in claim 2 of the patent, as one of several drugs that could be used in the dosage form described in claim 1, and also in examples 1 and 2 of the specification, where the process for making the dosage form using verapamil as the drug component is described. The introduction to the example section in the patent disclosure states at page 28 of the patent:
The following examples are merely illustrative of the present invention and they should not be considered as limiting the scope of the invention in any way as these examples and other equivalents thereof will become apparent to those versed in the art in the light of the present disclosure, the drawings and accompanying claims.
[40] Claim 1 of the '376 patent describes the characteristics of the invention, with reference to cross-section drawings of the tablet, that provides for differently timed patterns of release of the drug for administration to the patient. Claim 1 begins by stating:
A dosage form for use in a method of administering a drug to the gastrointestinal tract of a warm-blooded animal, which form is characterised by:-...
[41] Claim 1 then describes that the tablet is composed of six parts: a compartment, a wall that surrounds and forms the compartment made of a composition permeable to the passage of fluid, a first drug-free layer between the wall and the compartment, a particular dose amount of a drug for producing therapeutic effect, another drug-free composition made of a substance that expands on contact with fluid, and an opening or "exit means" in the wall.
[42] Claim 2 sets out sixteen specific drug substances that could be delivered via the dosage form described in claim 1. One of these drug substances is listed as "verapamil". Claim 2 reads, in part, as follows:
A dosage form as claimed in claim 1, wherein the drug is a member from the group consisting of verapamil, nimodipine, nitredipine, nisoldipine, nicardipine, felodpine, diltiazem,....
[43] Similarly, claim 3 lists eleven other drug groups. Claims 4 through 7 present modifications to the arrangement of the components set out in claim 1.
[44] In my opinion, the '376 patent does not claim protection for the "medicine" found in Pfizer's CHRONOVERA tablet. Rather, I construe the patent as being for a delivery system for the administration of any one of the 27 listed drugs, including verapamil hydrochloride. The "essential elements" of this invention are the features of the dosage form that allow for the time-varied delivery of various drugs. The delivery system is protected, not the listed drugs.
[45] In Glaxo, supra, the patent at issue disclosed a mechanical device, an"inhaler", for the administration of medicine, comprised of several metal components. The applicants in that case argued that the fact that the inhaler was not ingested into the body was immaterial, and that as long as its function was to deliver the active ingredient to the patient, it fell within the ratio of Hoffmann, supra, as being a medicine. Justice Tremblay-Lamer did not accept this argument and held that such interpretation of Hoffmann, supra, was incorrect because Hoffmann explicitly dealt with compositions of active and inactive ingredients which were physically mixed together and ingested into the body as a single composition and was not intended to apply to a mechanical device as an inactive ingredient. The Federal Court of Appeal affirmed this issue, while reversing on other grounds, and stated at page 527:
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.
[46] In Novartis, supra, the Federal Court of Appeal affirmed the test out in Glaxo, supra, and stated as follows at paragraphs 17-18:
... 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....
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....
[47] In Novartis, supra, the patent at issue related to estradiol patches, applied to the skin of the patient. The Federal Court of Appeal concluded that the trial judge was correct in determining that Glaxo, supra, applied to that case, as the patches claimed in the patent were used to administer the drug substance to the patient, and as such, related to a system for the administration of substances, rather than the substances themselves. In that case, Malone J.A. pointed out at paragraph 20 that the fact that the patches were used over 14 days, whereas the inhaler in Glaxo, supra, was used and removed from the patient immediately, was of "no significance".
[48] Similarly in the present case, the fact that the tablets claimed in the '376 patent are ingested does not alter their function in the therapeutic process as the device for administration of the medicine, rather than the medicine itself.
[49] The applicant urges a narrow analysis, where the fact that the delivery system used to administer the medicine is taken into the body rather than applied to the surface of the skin or otherwise used externally, is the paramount consideration. Whereas the respondent has focussed on the purpose of the patent, and the function of the invention at issue, being for a system of delivery of the medicine, over varying time intervals, which makes the therapeutic effect of certain drugs more beneficial. I believe that is the correct construction of the patent.
[50] Pfizer argues that the '376 patent claims the actual drug component, verapamil hydrochloride, as mixed with other inactive ingredients and that this formulation or substance is properly interpreted as "medicine" pursuant to the NOC Regulations. In his affidavit, Dr. McGinity asserts that the '376 patent deals with a claim for the medicine itself, that is verapamil hydrochloride tablets, as it addresses the active ingredient, being mixed with excipients and compressed into the final dosage form pursuant to the instructions set out in the patent. Relying on Hoffmann, supra, Pfizer contends that such a formulation, or "dosage form", combining active and non-active ingredients is a "claim for the medicine itself" within the meaning of the NOC Regulations.
[51] The difficulty with that argument is that the active ingredient in this case, the verapamil hydrochloride, is not mixed together with various inactive ingredients or excipients but rather the design of the tablet structure, as set out in claim 1 of the patent, allows for "discrete and separate components" of drug-free layers and the dose of the drug itself.
[52] In Novartis, supra, at paragraph 21, the Federal Court of Appeal distinguished the Hoffmann decision, on the grounds that the formulation of active and inactive ingredients were in that case mixed together, whereas in Novartis, the layers of the delivery system, that is the patches, were not mixed with the medicine, but rather the patches and the medicine formed "discrete and separate components", with the layers of the patches never being "administered" to the patient.
[53] In my opinion, the '376 patent provides for discrete and separate components of "drug-free" layers, surrounding the actual drug dose, and that these parts of the tablet should not be viewed as inactive ingredients of the drug substance itself.
[54] While the present situation takes the reasoning of Glaxo, supra, and Novartis, supra, to a further degree, in that those cases involved patented methods for the delivery of medicines that were not ingested along with the medicine, I am not persuaded that the application of those cases to the interpretation of the '376 patent inappropriately stretches the established law. Indeed, Justice Dawson in Eli Lilly FCTD, supra, has already held that a patent for a design of a sustained release capsule that was to be entirely ingested by cattle which included claims for several antibiotic drugs that could be administered via the new capsule invention, was not a "claim for the medicine itself" and therefore not eligible for inclusion on the Patent Register. Pfizer argues that this decision should be distinguished in that the patent in question applied to a mechanical capsule, complete with a piston to force the medicine into the cow's rumen. While there are certainly differences in construction between that "delivery system" and the one before me, the principles to be applied are, in my view, analogous.
[55] The purpose of the '376 patent, as I have outlined, is to provide for a new and improved delivery system for the administration of medicine. The sustained release and time-varied nature of this invention is described in the patent, as are ways of building the invention, that is the tablet, using different medicines. But the claims in the patent are not for "the medicine itself", as found in Pfizer's product for which a NOC was granted.
[56] During the hearing, counsel drew my attention to the recent decision of the Federal Court of Appeal in AB Hassle et al. v. Apotex Inc., [2003] F.C.J. No. 1601 (C.A.)(QL). This decision dealt with an appeal from an order of prohibition relating to an application for a NOC allegedly infringing a patent covering a pharmaceutical preparation known by the trademark "Losec". The prohibition was upheld. This decision is distinguishable, in my view, as the patent specifically applied to the pharmaceutical preparation in question.
[57] Having considered all the evidence before me, including the patent at issue, the affidavit evidence and jurisprudence, I am not persuaded by Pfizer's argument and find that the Minister's decision, dated February 17, 2003, was correct and that the '376 patent is not eligible for listing on the Patent Register with respect to the applicant's CHRONOVERA tablets.
ORDER
THIS COURT ORDERS that this application is dismissed, costs to the respondent.
"Richard G. Mosley"
F.C.J.
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-441-03
STYLE OF CAUSE: PFIZER CANADA INC.
AND
ATTORNEY-GENERAL OF CANADA
THE MINISTER OF HEALTH
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: Febraury 9, 2004
REASONS FOR ORDER
AND ORDER BY: The Honourable Mr. Justice Mosley
APPEARANCES:
Mr. Anthony Creber
Ms. Jennifer Wilkie FOR THE APPLICANT
Mr. Frederick Woyiwada FOR THE RESPONDENT
SOLICITORS OF RECORD:
ANTHONY CREBER
JENNIFER WILKIE
Gowling, Lafleur, Henderson, LLP
Barristers and Solicitors
Ottawa, Ontario FOR THE APPLICANT
MORRIS ROSENBERG FOR THE RESPONDENT
Deputy Attorney General of Canada
Ottawa, Ontario
[1] The Notice of Compliance in 1997 was issued to Searle Canada Inc. Following a merger with Pharmacia Canada Inc., a revised Notice of Compliance was issued in 2001. On December 2, 2003 an order from this Court was issued, amending the name of the applicant in the style of cause from Pharmacia Canada Inc. , to Pfizer Canada Inc.