Date: 20040520
Docket: T-1954-02
Citation: 2004 FC 736
Ottawa, Ontario, this 20th day of May 2004
Present: The Honourable Madam Justice Heneghan
BETWEEN:
ASTRAZENECA CANADA INC.
Applicant
and
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER AND ORDER
INTRODUCTION
[1] This application raises the narrow issue of whether an administrative SNDS, submitted pursuant to the policy concerning the change of a manufacturer's name, triggers the opportunity to list a patent pursuant to section 4 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the "NOC Regulations").
[2] Astrazeneca Canada Inc. (the "Applicant") seeks judicial review of the decision of Ms. Anne Bowes, delegate of the Minister of Health (the "Minister") dated October 22, 2002. In that decision, the Minister refused to add Canadian Patent No. 2,186,037 (the " '037 patent") to the Patent Register relative to the LOSEC (omeprazole) delayed release capsule in the 40 mg dosage. The Applicant seeks an order quashing the decision and a further order in the nature of mandamus requiring the Minister to list the '037 patent.
BACKGROUND
[3] The Applicant is a pharmaceutical manufacturer. On May 14, 2002, Ms. Karen Grandoni-Rocco, Manager, Regulatory Affairs, with the Applicant, wrote to Mrs. Marilyn Schwartz, Submissions and Information Policy Division, Therapeutic Products Directorate of Health Canada, and requested that the '037 patent be listed on the Patent Register for several pharmaceutical products, including LOSEC capsules in the 40 mg dosage.
[4] The Applicant submitted the required Patent Form IV, pursuant to the NOC Regulations, section 4 and referenced, for the LOSEC 40 mg capsules, the previously filed Submission 067991. According to the Applicant, this Submission was filed on July 12, 2000 as a Supplemental New Drug Submission ("SNDS") for a company name change as the result of a merger between Astra Pharma Inc. and Zeneca Pharma Inc. that took effect on January 1, 2000. The Patent Form IV stated that the '037 patent was filed on January 9, 1996 and was granted on April 16, 2002, with an expiry date of February 9, 1996.
[5] By letter dated June 12, 2002, Ms. Anne Bowes, Senior Patent Officer-Science, Office of Patented Medicines and Liaison with Health Canada, advised the Applicant that, following review of the submitted patent list, it was found to be ineligible for listing on the Patent Register. The letter addressed the ineligibility for listing relative to the 10 mg and 20 mg capsules as well; the issues with respect to those products have been resolved and the only remaining issue relates to the 40 mg capsules.
[6] Ms. Bowes advised that the submission referenced in the Patent Form IV for the 40 mg capsules was for a change in the manufacturer's name pursuant to the Changes in Manufacturer's Name and/or Patent Name published in April 1998, and said that such Submission is not sufficient to permit the listing of a patent. She put this position in the following terms:
...The Changes in Manufacturer's Name policy requires that all aspects of the drug product, including the conditions of manufacture and sale, must be identical to those previously authorized, except for the change in either manufacturer or brand name. The addition of a patent on the basis of a NOC for a name change is contrary to the scheme of section 4, which provides for the addition of a patent to be made within the strict time-requirements reflected in subsections 4(3), 4(4) and 4(6) of the Patented Medicines (Notice of Compliance) Regulations; see Bristol-Myers Squibb Canada Inc. v. A.G. (Canada) et al (January 19, 2001), Court File No. T-1768-00 (F.C.T.D.) affirmed (January 23, 2002), Court File No. A-44-01 (F.C.A.).
It is our position that the addition of a patent on the basis of a notice of compliance for a name change is contrary to the scheme provided for in section 4. Subsections 4(3), 4(4) and 4(6) provide for the addition of a patent to be made within strict time-requirements.
Pursuant to the authority vested in the Minister of Health by subsection 3(1) of the Regulations, the '037 patent will not be added to the Patent Register, subject to any written representations, as the '037 patent is not relevant to the drug outlined in the submission for NOC.
[7] The Applicant availed of the opportunity to make further submissions and did so in a letter, dated July 8, 2002, from its lawyers. Counsel for the Applicant argued that Ms. Bowes, as the Minister's delegate, had misinterpreted both the NOC Regulations and prevailing jurisprudence in denying the request to list the '037 patent.
[8] By letter dated October 22, 2002, Ms. Bowes confirmed the Minister's decision and said as follows:
Further, with respect only to submission # 067991, the TPD maintains that, being a submission filed for a change in manufacturer name, the submission does not afford Astra a valid opportunity to file a patent list. The decision in Eli Lilly has no bearing on this matter and our position on this point should be considered final.
[9] On November 21, 2002, the Applicant commenced this proceeding seeking judicial review of the decision. It filed the affidavit of Jacinta M. De Abreu in support of its application. That affidavit identifies and attaches, as exhibits, the following documents:
A. A certified copy of the '037 patent;
B. Copy of the letter dated May 14, 2002 from the Applicant to the Therapeutic Products Directorate, with enclosures;
C. Copy of the letter dated June 12, 2002 from Ms. Bowes, on behalf of Health Canada, to the Applicant;
D. Copy of confidential letter dated July 8, 2002 from Smart & Biggar, Solicitors for the Applicant, to Ms. Bowes;
E. Copy of letter dated October 22, 2002 from Ms. Bowes;
F. Copy of the Notice of Application for Judicial Review issued on November 21, 2002.
[10] In response, the Minister filed the affidavit of Ms. Bowes. The following documents are attached as exhibits to that affidavit:
A. Copy of the '037 patent;
B. Copy of the Therapeutic Products Directorate Policy Changes in Manufacturer's Name and/or Patent Name;
C. Copy of letter dated October 21, 1999 from Astrazeneca Canada Inc. to Submission and Information Policy Division, Bureau of Policy & Coordination;
D. Copy of Notice of Compliance dated October 24, 2000 issued to Astrazeneca for LOSEC capsules, including the 40 mg capsule, Drug Identification Number ("DIN"), 02016788;
E. Copies of Form IV: Patent Lists for several products, including LOSEC delayed release capsule 40 mg, dated May 14, 2002;
F. Copy of letter dated June 12, 2002 from Health Canada to the Applicant;
G. Copy of confidential letter dated July 8, 2002, from Smart & Biggar, Solicitors for the Applicant, to Health Canada;
H. Copy of letter dated October 22, 2002 from Health Canada to the solicitors for the Applicant.
[11] A Direction was issued on May 7, 2004, subsequent to the hearing of this application advising that it appeared that the documents submitted as Exhibit C to the affidavit of Ms. Bowes had been attached in error. By letter dated May 10,2004, counsel submitted the following documents which shall be treated as a supplement to Exhibit C, as follows:
i) copy of letter dated July 12, 2000 from AstraZeneca to Mrs. Marilyn Schwartz, Acting Manager, Submission and Information Policy Division, Bureau of Policy and Coordination;
ii) copy of the Certification Form filed by AstraZeneca entitled "Therapeutic Products Programme, Changes in Manufacturer's Name and/or Product Name, Administration Changes Certification Form".
SUBMISSIONS
i) The Applicant
[12] The Applicant argues that it has met the timing requirements, pursuant to the NOC Regulations to allow it to have the '037 patent listed on the Patent Register. The '037 patent issued on April 16, 2002. At that time, the Applicant had filed a SNDS for which a Notice of Compliance ("NOC") had been issued on October 24, 2000. The Applicant submitted its patent list on May 14, 2002, that is within thirty days of the issuance of the '037 patent for which application had been made on February 9, 1996. The application date for the patent pre-dated the Applicant's SNDS in July 2000.
[13] Relying on the recent decision of the Federal Court of Appeal in Abbott Laboratories v. Canada (Minister of Health) [2004] F.C.J. No. 708, 2004 FCA 154, the Applicant submits that having met the timing requirements set out in section 4 of the NOC Regulations and in the absence of any evidence that it is trying to circumvent the Regulations, the Court should not look at the substance of its SNDS but direct the Minister to list the '037 patent.
[14] The Applicant argues that the factual situation in this case is distinguishable from the facts at play in Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 C.P.R. (4th) 318 (F.C.T.D.), aff'd. (2002), 16 C.P.R. (4th) 425 (F.C.A.), Ferring Inc. v. Canada (Attorney General) (2003), 26 C.P.R. (4th) 155 (F.C.A.) and Toba Pharma Inc. v. Canada (Attorney General) (2002), 21 C.P.R. (4th) 232 (F.C.T.D.).
ii) The Minister
[15] The Respondent takes the position that, having regard to the regulatory framework set out in the NOC Regulations, an administrative SNDS cannot give rise to an opportunity to list a patent on the Patent Register. According to the Minister, the earlier decisions in Bristol-Myers Squibb, supra, Feering, supra and Toba Pharma, supra, apply to the present case. The recent decision of the Federal Court of Appeal in Abbott, supra, does not change the basic principle that a person seeking to add a patent to the Patent Register must comply with the strict time-lines set out in the NOC Regulations.
ANALYSIS AND DISPOSITION
[16] This requires consideration of the applicable regulatory regime which includes reference to the Food and Drug Regulations, C.R.C. 870, as amended (the "Food and Drug Regulations"). In Abbott, supra, the Federal Court of Appeal described that regime as follows;
5. If an NDS has already been filed and the manufacturer subsequently makes changes to its drug such that the information contained in the NDS is now significantly different in respect of certain specified matters, a manufacturer must make a Supplemental New Drug Submission (SNDS) in respect of its product. The Minister's approval of an SNDS is also indicated by an NOC.
6. Submitting either an NDS or an SNDS, and obtaining an NOC, grants an administrative remedy to protect a manufacturer's pre-existing patent rights. Specifically, if the timing requirements in section 4 of the PM(NOC) Regulations are met, the manufacturer can file patent lists with the Minister. Listing an eligible patent gives the patent holder an opportunity to invoke the PM(NOC) Regulations that will shield the manufacturer's product against generic competition for a statutorily-specified period of time, as the PM(NOC) Regulations stipulate that a generic drug manufacturer cannot obtain an NOC for its product without proving that its product does not infringe a listed pharmaceutical patent.
7. As the preceding summary sets out, both of these regulatory regimes touch Canadian patented pharmaceutical products. The Food and Drug Regulations are concerned with the safety and effectiveness of pharmaceutical products. The PM(NOC) Regulations balance the rights of holders of pharmaceutical patents and generic drug manufacturers. This second regulatory regime is driven by concerns relating to intellectual property and the appropriate scope of protection that it should be afforded. However, the Food and Drug Regulations and the PM(NOC) Regulations are connected. Compliance with the former is required to obtain concomitant patent benefits under the latter regime.
[17] The relevant provisions of the Food and Drug Regulations, are sections C.08.002 (1)(a)(b) and (2)(a) to (n); C.08.002.1 (1), (2) (a) to (e); C.08.003 (1)(a)(i) to (ii), (b), (2)(a) to (i), (3) and C.08.004 (1)(a), as follows:
| C.08.002. (1) No person shall sell or advertise a new drug unless
(a) the manufacturer of the new drug has filed with the Minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the Minister;
(b) the Minister has issued, pursuant to section C.08.004, a notice of compliance to the manufacturer of the new drug in respect of the new drug submission or abbreviated new drug submission;
...
(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:
(a) a description of the new drug and a statement of its proper name or its common name if there is no proper name;
(b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug;
(c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;(d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;
(e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug;
(f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug;
(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;
(h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;
(i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;
(j) a draft of every label to be used in conjunction with the new drug;
(k) a statement of all the representations to be made for the promotion of the new drug respecting
(i) the recommended route of administration of the new drug,
(ii) the proposed dosage of the new drug,
(iii) the claims to be made for the new drug, and
(iv) the contra-indications and side effects of the new drug;
(l) a description of the dosage form in which it is proposed that the new drug be sold;
(m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and
(n) for a drug intended for administration to food-producing animals, the withdrawal period of the new drug.
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C.08.002. (1) Il est interdit de vendre ou d'annoncer une drogue nouvelle, à moins que les conditions suivantes ne soient réunies :
a) le fabricant de la drogue nouvelle a, relativement à celle-ci, déposé auprès du ministre une présentation de drogue nouvelle ou une présentation abrégée de drogue nouvelle que celui-ci juge acceptable;
b) le ministre a, aux termes de l'article C.08.004, délivré au fabricant de la drogue nouvelle un avis de conformité relativement à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle;
...
(2) La présentation de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle, notamment :
a) une description de la drogue nouvelle et une mention de son nom propre ou, à défaut, de son nom usuel;
b) une mention de la marque nominative de la drogue nouvelle ou du nom ou code d'identification projeté pour celle-ci;
c) la liste quantitative des ingrédients de la drogue nouvelle et les spécifications relatives à chaque ingrédient;
d) la description des installations et de l'équipement à utiliser pour la fabrication, la préparation et l'emballage de la drogue nouvelle;
e) des précisions sur la méthode de fabrication et les mécanismes de contrôle à appliquer pour la fabrication, la préparation et l'emballage de la drogue nouvelle;
f) le détail des épreuves qui doivent être effectuées pour contrôler l'activité, la pureté, la stabilité et l'innocuité de la drogue nouvelle;
g) les rapports détaillés des épreuves effectuées en vue d'établir l'innocuité de la drogue nouvelle, aux fins et selon le mode d'emploi recommandés;
h) des preuves substantielles de l'efficacité clinique de la drogue nouvelle aux fins et selon le mode d'emploi recommandés;
i) la déclaration des noms et titres professionnels de tous les chercheurs à qui la drogue nouvelle a été vendue;
j) une esquisse de chacune des étiquettes qui doivent être employées relativement à la drogue nouvelle;
k) la déclaration de toutes les recommandations qui doivent être faites dans la réclame pour la drogue nouvelle, au sujet
(i) de la voie d'administration recommandée pour la drogue nouvelle,
(ii) de la posologie proposée pour la drogue nouvelle,
(iii) des propriétés attribuées à la drogue nouvelle,
(iv) des contre-indications et les effets secondaires de la drogue nouvelle;
l) la description de la forme posologique proposée pour la vente de la drogue nouvelle;
m) les éléments de preuve établissant que les lots d'essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d'une manière représentative de la production destinée au commerce;
n) dans le cas d'une drogue nouvelle destinée à être administrée à des animaux producteurs de denrées alimentaires, le délai d'attente applicable.
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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,
(a) the new drug is the pharmaceutical equivalent of the Canadian reference product;
(b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics;
(c) the route of administration of the new drug is the same as that of the Canadian reference product; and
(d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product.
C.08.002.1(2)
(2) An abbreviated new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:
(a) the information and material described in paragraphs C.08.002(2)(a) to (f) and (j) to (l);
(b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission;
(c) evidence from the comparative studies conducted in connection with the submission that the new drug is
(i) the pharmaceutical equivalent of the Canadian reference product, and
(ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies;
(d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and
(e) for a drug intended for administration to food-producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.
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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 :
a) la drogue nouvelle est un équivalent pharmaceutique du produit de référence canadien;
b) elle est bioéquivalente au produit de référence canadien d'après les caractéristiques pharmaceutiques et, si le ministre l'estime nécessaire, d'après les caractéristiques en matière de biodisponibilité;
c) la voie d'administration de la drogue nouvelle est identique à celle du produit de référence canadien;
d) les conditions thérapeutiques relatives à la drogue nouvelle figurent parmi celles qui s'appliquent au produit de référence canadien.
C.08.002.1(2)
(2) La présentation abrégée de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle, notamment :
a) les renseignements et le matériel visés aux alinéas C.08.002(2)a) à f) et j) à l);
b) les renseignements permettant d'identifier le produit de référence canadien utilisé pour les études comparatives menées dans le cadre de la présentation;
c) les éléments de preuve, provenant des études comparatives menées dans le cadre de la présentation, établissant que la drogue nouvelle :
(i) d'une part, est un équivalent pharmaceutique du produit de référence canadien,
(ii) d'autre part, si le ministre l'estime nécessaire d'après les caractéristiques pharmaceutiques et, le cas échéant, d'après les caractéristiques en matière de biodisponibilité de celle-ci, est bioéquivalente au produit de référence canadien selon les résultats des études en matière de biodisponibilité, des études pharmacodynamiques ou des études cliniques;
d) les éléments de preuve établissant que les lots d'essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d'une manière représentative de la production destinée au commerce;
e) dans le cas d'une drogue destinée à être administrée à des animaux producteurs de denrées alimentaires, les renseignements permettant de confirmer que le délai d'attente est identique à celui du produit de référence canadien.
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| C.08.003. (1) Notwithstanding section C.08.002, no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug and has not been suspended pursuant to section C.08.006, if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission or abbreviated new drug submission, unless
(a) the manufacturer of the new drug has filed with the Minister
(i) a supplement to that new drug submission, or(ii) a supplement to that abbreviated new drug submission;
(b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement;
...
(2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following:
(a) the description of the new drug;
(b) the brand name of the new drug or the identifying name or code proposed for the new drug;
(c) the specifications of the ingredients of the new drug;
(d) the plant and equipment used in manufacturing, preparation and packaging the new drug;
(e) the method of manufacture and the controls used in manufacturing, preparation and packaging the new drug;
(f) the tests applied to control the potency, purity, stability and safety of the new drug;
(g) the labels used in connection with the new drug;
(h) the representations made with regard to the new drug respecting
(i) the recommended route of administration of the new drug,
(ii) the dosage of the new drug,
(iii) the claims made for the new drug,
(iv) the contra-indications and side effects of the new drug, and
(v) the withdrawal period of the new drug; and
(i) the dosage form in which it is proposed that the new drug be sold.
C.08.003(3)
(3) A supplement to a new drug submission or to an abbreviated new drug submission, with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters.
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C.08.003. (1) Malgré l'article C.08.002, il est interdit de vendre une drogue nouvelle à l'égard de laquelle un avis de conformité a été délivré à son fabricant et n'a pas été suspendu aux termes de l'article C.08.006, lorsqu'un des éléments visés au paragraphe (2) diffère sensiblement des renseignements ou du matériel contenus dans la présentation de drogue nouvelle ou la présentation abrégée de drogue nouvelle, à moins que les conditions suivantes ne soient réunies :
a) le fabricant de la drogue nouvelle a déposé auprès du ministre :
(i) soit un supplément à la présentation de drogue nouvelle,
(ii) soit un supplément à la présentation abrégée de drogue nouvelle;
b) le ministre a délivré au fabricant un avis de conformité relativement au supplément;
...
(2) Pour l'application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants :
a) sa description;
b) sa marque nominative ou le nom ou code sous lequel il est proposé de l'identifier;
c) les spécifications de ses ingrédients;
d) les installations et l'équipement à utiliser pour sa fabrication, sa préparation et son emballage;
e) la méthode de fabrication et les mécanismes de contrôle à appliquer pour sa fabrication, sa préparation et son emballage;
f) les analyses effectuées pour contrôler son activité, sa pureté, sa stabilité et son innocuité;
g) les étiquettes à utiliser pour la drogue nouvelle;
h) les observations faites relativement :
(i) à la voie d'administration recommandée pour la drogue nouvelle,
(ii) à sa posologie,
(iii) aux propriétés qui lui sont attribuées,
(iv) à ses contre-indications et à ses effets secondaires,
(v) au délai d'attente applicable à celle-ci;
i) sa forme posologique proposée pour la vente.
C.08.003(3)
(3) Le supplément à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle doit contenir, à l'égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, les renseignements et le matériel nécessaires pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle relativement à ces éléments.
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| C.08.004. (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of a new drug submission or abbreviated new drug submission or a supplement to either submission,
(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or
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C.08.004. (1) Sous réserve de l'article C.08.004.1, après avoir terminé l'examen d'une présentation de drogue nouvelle, d'une présentation abrégée de drogue nouvelle ou d'un supplément à l'une de ces présentations, le ministre :
a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l'article C.08.005.1, délivre un avis de conformité;
...
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[18] The relevant provisions of the NOC Regulations are the definitions of "notice of compliance" and "patent list" in section 2, and section 4, as follows:
| 2. "notice of compliance" means a notice issued under section C.08.004 of the Food and Drug Regulations;
"patent list" means a list of all patents that is submitted pursuant to section 4;
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2. « avis de conformité » Avis délivré au titre de l'article C.08.004 du Règlement sur les aliments et drogues.
« liste de brevets » Liste de brevets soumise aux termes de l'article 4.
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| 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
(a) indicate the dosage form, strength and route of administration of the drug;
(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;
(c) contain a statement that, in respect of each patent, the person applying for a notice of compliance is the owner, 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;
(d) set out the date on which the term limited for the duration of each patent will expire pursuant to section 44 or 45 of the Patent Act; and
(e) set out the address in Canada for service on the person of any notice of an allegation referred to in paragraph 5(3)(b) or (c), or the name and address in Canada of another person on whom service may be made, with the same effect as if service had been made on the person.
(3) Subject to subsection (4), a person who submits a patent list must do so at the time the person files a submission for a notice of compliance.
(4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2).(5) When a first person submits a patent list or an amendment to an existing patent list in accordance with subsection (4), the first person must identify the submission to which the patent list or the amendment relates, including the date on which the submission was filed.
(6) A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in accordance with subsection (4).
(7) A person who submits a patent list or an amendment to an existing patent list under subsection (1) or (4) must certify that
(a) the information submitted is accurate; and
(b) the patents set out on the patent list or in the amendment are eligible for inclusion on the register and are relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for a notice of compliance has been filed.
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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 :
a) la forme posologique, la concentration et la voie d'administration de la drogue;
b) tout brevet canadien don't 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;
c) une déclaration portant, à l'égard de chaque brevet, que la personne qui demande l'avis de conformité en est le propriétaire, en détient la licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste;
d) la date d'expiration de la durée de chaque brevet aux termes des articles 44 ou 45 de la Loi sur les brevets;
e) l'adresse de la personne au Canada aux fins de signification de tout avis d'allégation visé aux alinéas 5(3)b) ou c), ou les nom et adresse au Canada d'une autre personne qui peut en recevoir signification avec le même effet que s'il s'agissait de la personne elle-même.
(3) Sous réserve du paragraphe (4), la personne qui soumet une liste de brevets doit le faire au moment du dépôt de la demande d'avis de conformité.
(4) La première personne peut, après la date de dépôt de la demande d'avis de conformité et dans les 30 jours suivant la délivrance d'un brevet qui est fondée sur une demande de brevet don't la date de dépôt est antérieure à celle de la demande d'avis de conformité, soumettre une liste de brevets, ou toute modification apportée à une liste de brevets, qui contient les renseignements visés au paragraphe (2).
(5) Lorsque la première personne soumet, conformément au paragraphe (4), une liste de brevets ou une modification apportée à une liste de brevets, elle doit indiquer la demande d'avis de conformité à laquelle se rapporte la liste ou la modification, en précisant notamment la date de dépôt de la demande.
(6) La personne qui soumet une liste de brevets doit la tenir à jour mais ne peut ajouter de brevets à une liste que si elle le fait en conformité avec le paragraphe (4).
(7) La personne qui soumet une liste de brevets ou une modification apportée à une liste de brevets aux termes des paragraphes (1) ou (4) doit remettre une attestation portant que :
a) les renseignements fournis sont exacts;
b) les brevets mentionnés dans la liste ou dans la modification sont admissibles à l'inscription au registre et sont pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue visée par la demande d'avis de conformité.
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[19] As appears from the foregoing extract from the Food and Drug Regulations, a NOC is to be obtained after a submission is made to the Minister. There are various types of submissions, that is a "new drug submission" pursuant to section C.08.002 (1)(a), an "abbreviated new drug submission" pursuant to section C.08.002.1 (1), and a "Supplement" to either a new drug submission or abbreviated drug submission pursuant to section C.08.003 (1)(a). The matters to be addressed in respect of these types of submissions include reference to the brand name and proper or common name of the new drug; see sections C.08.002.2 (6), C.008.002.1 (2)(a) and C.08.003 (2)(b). The Food and Drug Regulations do not require that any particular information is to be provided about the manufacturer's name or a change in the manufacturer's name.
[20] The Food and Drug Regulations require a manufacturer to submit a new submission when there has been a significant change in respect of any of the matters identified in section C.08.03 (2), including the description of the new drug, its brand name or identifying name or code, and the specifications of its ingredients.
[21] The definition of "notice of compliance" in the NOC Regulations incorporates the definition in the Food and Drug Regulations. It has been established that, for the purposes of the NOC Regulations, a "Submission for a notice of compliance" is a new drug submission, an abbreviated new drug submission, and a supplement to either of them. In this regard, I refer to Apotex Inc. v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.) at p. 287 where Justice McGillis said as follows:
In considering the expression "a submission for a notice of compliance" in sections 4 and 5 of the Patented Medicines (Notice of Compliance) Regulations, the mechanisms which trigger the issuance of a notice of compliance are, by virtue of the definition of "notice of compliance" in section 2, those specified in section C.08.004 of the Food and Drug Regulations, namely a new drug submission, an abbreviated new drug submission and a supplement to a new drug submission or to an abbreviated new drug submission. In the circumstances, the expression "submission for a notice of compliance", as used in sections 4 and 5 of the Patented Medicines (Notice of Compliance) Regulations means a new drug submission, an abbreviated new drug submission and a supplement to a new drug submission or to an abbreviated new drug submission.
[22] However, the question here is whether a NOC issued in response to something other than a NDS, ANDS or SNDS allows the holder of that NOC to submit a patent list pursuant to section 4(4) of the NOC Regulations. This question requires consideration of the purpose of the NOC Regulations and the consequences of listing a patent on the Patent Register.
[23] The NOC Regulations are subordinate legislation and stand to be interpreted on their own terms. However, the Regulatory Impact Analysis Statement ("RIAS") that accompanied the 1998 amendments to the Regulations may serve as a guide to Parliamentary intention as to the purpose and effect of those Regulations, although it is not part of the Regulations; see Bayer Inc. v. Canada (Attorney General) (1999), 87 C.P.R. (3d) 293 (F.C.A.) at 296.
[24] In Bristol-Myers Squibb, supra, at pages 324- 325 the trial judge referred to the RIAS for the 1998 amendments of the NOC Regulations. In part, the RIAS says as follows:
The link between the patent status of a drug and approval for a generic version of the drug is being maintained, to provide effective enforcement of patent rights, while at the same time ensuring that generic drugs can enter the market as soon as possible; either as soon as it is determined that they are not covered by a patent, or, where they are covered by a patent, immediately after the expiry of the patent. Overall, since the amendments are designed to make the Regulations fairer and more effective, and reduce unnecessary litigation, compliance costs to private sector parties should be reduced. The amendments will not significantly alter the costs of administering, or adjudicating cases under the Regulations.
The amendments reinforce the balance between providing a mechanism for the effective enforcement of patent rights and ensuring that generic drug products enter the market as soon as possible.
[25] The effect of adding a patent to the Patent Register is to provide the person submitting that patent access to the prohibition proceedings, to prevent the issuance of a NOC to another manufacturer with the result that a competitor will be delayed entry into the market. In this regard, I refer again to Abbott, supra, paragraph 6, quoted earlier in these reasons.
[26] The effect of the commencement of prohibition proceedings pursuant to the NOC Regulations, is to grant a statutory stay of up to twenty-four months, a situation that has been described as "draconian" by the Supreme Court of Canada in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193.
[27] According to the evidence submitted, the Applicant here filed a submission to the Minister relative only to the change of its name, in accordance with a policy concerning change of manufacturer's name. That is characterized by the Minister as an administrative submission. The submission does not relate to any change in the composition of the drug or of any of its constituent components. The certification form submitted by the Applicant on July 12, 2003, referred to above, contains the following information:
We certify that all aspects of the submission pertaining to:
Losec® Capsules 10 mg, 20 mg & 40 mg
submitted by:
AstraZeneca Canada Inc.
are identical to the
Losec® Capsules, Astra Pharma Inc. 10 mg: DIN 02119579
20 mg: DIN 00846503
40 mg: DIN 02016788
submission except for a change in the manufacturer/sponsor's name and/or product name and that the product will be manufactured in the same location with identical specifications and procedures.
[28] There was no debate about the relationship of the '037 patent to the Applicant's pharmaceutical products. The lack of an opportunity for comparison to the drug to which it relates was remarked upon in Toba Pharma Inc., supra where the Court concluded that the patent list there in issue could not be registered.
[29] The SNDS here in issue does not address a different indication for the Applicant's pharmaceutical product. I refer again to the recent decision in Abbott, supra, where the Federal Court of Appeal said the following at paragraph 25:
Although not defined in the Food and Drug Regulations, an indication is essentially the purpose for which a pharmaceutical product is used (see e.g. Apotex Inc. v. Minister of Health et al, (1999) 87 C.P.R. (3d) 271 at 273). For the purposes of filing an SNDS, an indication does not have to be new or novel, in the sense that this term is used in patent law. However, if a manufacturer proposes to use its pharmaceutical product for a purpose for which it has no prior approval, an SNDS is required. This is what occurred in the present matter. Thus, the Motions Judge was correct in stating that the SNDS related to the eradication of H. pylori and that Abbott had no prior authorization to sell or market the specific combination of Biaxin (clarithromycin), amoxicillin and lansoprazole to combat H. pylori infection. The fact that TAP had previously obtained approval for this combination is immaterial, as TAP is a different manufacturer.
[30] The Court here found that there was a new indication and distinguished the earlier decisions in Bristol-Myers Squibb, supra and Ferring, supra at paragraphs 27 and 28, and characterized those cases as being "examples of manifest attempts to list patents after the time limitations set out in section 4 of the PM(NOC) Regulations had expired".
[31] As appears from the text of section 4, quoted above, a patent list can be submitted either at the time that a person files a submission for a notice of compliance (s. 4(3)) or within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that predates the date of filing the submission (s. 4(4)). The Applicant claims to meet the requirements of section 4(4) and says that it is entitled to have its patent list included on the patent register.
[32] In effect, the Applicant says that as long as there is a submission for a NOC on the record when a patent is issued, for which an application was made prior to the filing date of that submission, that the patent is eligible for inclusion on the patent register without assessment of the underlying submission. In my opinion, this argument is flawed because it overlooks the Minister's discretion to accept a patent list and second, it depends upon a literal, mechanical view of the NOC Regulations.
[33] It is well established that the Minister has complete discretion to accept or reject a patent list, see Apotex Inc. v. Canada (Minister of National Health and Welfare (1999), 3 C.P.R. (4th) 1 (F.C.A.). Time-lines for submitting the patent list is a critical factor in making that decision, as illustrated by the decisions in Bristol-Myers Squibb, supra, Toba Pharma, supra and Ferring, supra.
[34] As well, the purpose of the NOC Regulations, according to the RIAS, is to balance the "effective enforcement of patent rights" and the earliest possible entry of generic drugs into the market, after the issuance of a NOC. This is consistent with the purpose of section 42 of the Patent Act, R.S.C. 1985, c. P-5, as amended, that is to protect the exclusive rights of a patentee. Section 55.2(4) authorizes the Governor-in-Council to enact such regulations as are "necessary for preventing the infringement of a patent ... in accordance with subsection (1)". Section 55.2(1) of the Patent Act, supra provides as follows:
| 55.2 (1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.
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55.2 (1) Il n'y a pas contrefaçon de brevet lorsque l'utilisation, la fabrication, la construction ou la vente d'une invention brevetée se justifie dans la seule mesure nécessaire à la préparation et à la production du dossier d'information qu'oblige à fournir une loi fédérale, provinciale ou étrangère réglementant la fabrication, la construction, l'utilisation ou la vente d'un produit.
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[35] Section 55.2(1) grants protection to a person who uses a patented invention for the limited purposes spelled out in that provision. By extension, the inclusion of a patent list on the patent register grants further protection to a person like the Applicant, that is access to the prohibition proceedings contemplated by section 6. The definition of "first person" in section 2 of the NOC Regulations refers to the holder of a patent list pursuant to section 4(1), as follows:
| "first person" means the person referred to in subsection 4(1);
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« première personne » La personne visée au paragraphe 4(1).
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| 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.
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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).
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[36] Again, I refer to Merck Frosst Canada, supra, where Justice Iacobucci described the effect of commencing a prohibition proceeding, at p. 214, as follows:
... The Regulations provide for what is, in effect, a statutory prohibition on, or injunction against, the granting of a NOC, commencing immediately upon the filing by a "first person" of an application for a court-imposed prohibition order and concluding only upon the earlier of the judicial determination of the application or the passage of 30 months. This prohibition takes effect automatically, without any consideration of the merits of the application; not even the ordinary requirements for an interlocutory injunction must be complied with. Under these conditions, and absent some prior indication to the contrary, I think it would be permissible for a generic producer to predict that either the patentee, the holder of a prior NOC, or both, is likely to attempt to protect or prolong their as-yet exclusive rights for as long as possible by taking advantage of the procedure set out in the Regulations.
[37] The operation of the NOC Regulations is connected with the assessment of the safety and efficacy of pharmaceutical products, pursuant to the Food and Drug Regulations. It is reasonable to conclude that the underlying submission for a patent list be related to the purpose of that regulatory scheme. In the present case, that relationship is not apparent. The underlying submission is only for an administrative change in the record of the manufacturer's name.
[38] In Toba Pharma, supra, the Court dealt with a similar situation where the applicant sought to ground an application for a patent list upon a SNDS that related to a change of the manufacturer's name and product name. The patentee had failed to submit the patent list within thirty days after its issuance. At pages 237-238, the Court said as follows:
In addition, an SNDS cannot be considered an appropriate opportunity to file a patent list. The purpose here was solely to indicate a change in the manufacturer's name and product name. The filing of a patent list on the basis of a NOC for a change in the manufacturer's name and product name in accordance with the policy on Changes in Manufacturer's Name and/or Product Name (referred to in the letter dated December 18, 2001) is contrary to the scheme of s. 4, which provides only for the addition of a patent to be made within the time requirements reflected in s-ss. 4(3), 4(4) and 4(6) of the Regulations.
[39] The Applicant has not shown why the decision in Toba Pharma, supra should not apply in the present case. The letter dated July 12, 2000 from the Applicant to Mrs. Schwartz, referred to above, clearly describes the submission as "an administrative New Drug Submission for the purpose of changing the company ownership of DINs and updating the product labelling with the new company name" [Emphasis added]. The Minister found this submission to be insufficient for the purpose of accepting the patent list submitted by the Applicant.
[40] The Minister's decision, involving an issue of interpretation of the NOC Regulations, is reviewable on the standard of correctness; see Merck & Co. et al. v. Canada (Attorney General) et al. (1999), 176 F.T.R. 21 (T.D.); aff'd (2000), 254 N.R. 68 sub nom Merck & Co. v. Nu-Pharm Inc.
(F.C.A.). In my opinion, the Minister correctly interpreted the Regulations in refusing to list the '037 patent and the application is dismissed, with costs to the Minister.
ORDER
The application is dismissed, with costs to the Minister.
"E. Heneghan"
J.F.C.
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
DOCKET: T-1954-02
STYLE OF CAUSE: ASTRAZENECA CANADA INC.
Applicant
- and -
THE MINISTER OF HEALTH
Respondent
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: APRIL 27, 2004
REASONS FOR ORDER
AND ORDER BY: HENEGHAN, J.
DATED: MAY 20, 2004
APPEARANCES BY: Ms Yoon Kang
For the Applicant
Ms Marie Crowley
For the Respondent
SOLICITORS OF RECORD: Yoon Kang
SMART & BIGGAR
Barristers and Solicitors
Suite 1500 - 438 University Avenue
Toronto, Ontario
M5G 2K8
For the Applicant
Morris Rosenberg
Deputy Attorney General of Canada
For the Respondent
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