Date : 19990412
Docket : T-1635-98
BETWEEN:
APOTEX INC.
Applicant
- and -
THE MINISTER OF HEALTH
and SMITHKLINE BEECHAM PHARMA INC.
Respondents
REASONS FOR JUDGMENT
McGILLIS J.
INTRODUCTION
[1] The applicant Apotex Inc. ("Apotex") seeks judicial review of a decision of the Minister of Health ("Minister") to add Canadian Letters Patent No. 2,178,637 ("'637 patent") to the patent Register ("Register") maintained under section 3 of the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133. In particular, Apotex alleges that the Minister erred in including the information relating to the '637 patent on the Register on the basis that the amended patent list did not fall within the time period prescribed in subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations.
FACTS
[2] On May 4, 1993, the respondent SmithKline Beecham Pharma Inc. ("SmithKline") was granted a notice of compliance under the Patented Medicines (Notice of Compliance) Regulations for 10 mg, 20 mg, 30 mg and 50 mg PAXIL tablets for therapeutic use in the treatment of depression. Separate drug identification numbers were issued for each dosage form of PAXIL. The medicinal ingredient in PAXIL tablets was listed in the notice of compliance as "paroxetine as paroxetine hydrochloride".
[3] On February 28, 1995, SmithKline filed a supplement to a new drug submission for a "new indication", namely that paroxetine could be used in the treatment of obsessive compulsive
disorder.
[4] On or about June 1, 1995, SmithKline filed another supplement to a new drug submission for a "new indication", namely that paroxetine could be used in the treatment of panic disorder.
[5] On November 9, 1995, two notices of compliance were issued to SmithKline in relation to 20 mg and 30 mg PAXIL tablets, for therapeutic use as an antidepressant, antiobsessional and
antipanic agent, based on the supplementary new drug submissions filed in February and June 1995.
No new drug identification numbers were issued for those dosage forms of PAXIL.
[6] On October 15, 1996 and August 27, 1997, Apotex sent SmithKline notices of allegation in relation to patents for the medicine paroxetine listed on the Register. In response, SmithKline instituted applications for prohibition under the Patented Medicines (Notice of Compliance) Regulations. Those applications form the subject of separate proceedings before the Court.
[7] On December 23, 1997, the '637 patent was issued to SmithKline for paroxetine tablets and a process to prepare them. The application for the patent was filed on December 14, 1994, with a priority date of December 15, 1993. The '637 patent includes claims to paroxetine formulations prepared in the absence of water, in particular by the direct compression or dry granulation of paroxetine followed by direct compression into tablets. The '637 patent notes that the invention relates to "novel formulations". In particular, the patent states, in part, as follows:
| To date, all tablets which have been sold have been formulated using an aqueous granulation process. It has surprisingly been found that formulation of paroxetine into tablets can be carried out reliably and on a commercial scale using a formulation process in which water is absent such as by direct compression or by dry granulation. |
|
[8] On January 20, 1998, SmithKline filed an amended patent list to add the '637 patent to the patent list relating to the notices of compliance issued in 1995.
[9] By letter dated February 11, 1998, an official from the Department of National Health and Welfare ("Department") advised counsel for SmithKline that the '637 patent could be included on the Register only with respect to 20 mg and 30 mg tablets of PAXIL. In her letter, the departmental official stated, in part, as follows:
| On review of the file, the amended patent list for PAXIL is eligible for inclusion on the Register with respect to the 20 and 30 mg tablets only. Section 4(5) of the Patented Medicines (Notice of Compliance) Regulations outlines the provision under which a first person may submit a patent list. Specifically, a first person shall file a patent list in respect of a patent that issued within the previous 30 days on the basis of an application filed before the date of filing of the submission. |
|
The following outlines the submissions relating to PAXIL:
| File No. File Type Dosage/Strength Date Filed Status |
|
| 08356 NDS 10, 20, 30, 50 mg TAB 90.06.11 NOC 93.05.04 |
|
| 034903 SNDS 10, 20, 30, 50 mg TAB 95.02.28 NOC 95.11.09 |
|
| 037228 SNDS 10, 20, 30, 50 mg TAB 95.06.01 NOC 95.11.09 |
|
| 045860 SNDS 10, 20, 30, 40 mg TAB 96.10.22 cancelled 97.09.08 |
|
...
| As indicated in your letter of 20 January 1998, the application for patent 2178637 was filed on 14 December 1994. Therefore, as submission numbers 034903 and 037228 are in compliance with Section 4(5) of the Regulations, patent 2178637 will be included on the Register for the 20 and 30 mg tablets only. |
|
[10] In other words, the departmental official indicated that, by virtue of subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, the '637 patent could be listed on the Register for 20 mg and 30 mg tablets of PAXIL. In that regard, she noted that the application for the '637 patent was filed on December 14, 1994, prior to the February 28, 1995 and June 1, 1995 filing dates of the two supplementary new drug submissions which resulted in the issuance of the two notices of compliance dated November 9, 1995.
[11] As a result, in or about February 1998, the Minister added the '637 patent to the Register for the medicine paroxetine in 20 mg and 30 mg tablets.
[12] By letter dated March 9, 1998, Dr. Bernard Sherman of Apotex wrote to the Department
indicating that, in his opinion, the '637 patent was improperly listed on the Register. In
that regard, he stated, in part, as follows:
| Section 4(5) of the Patented Medicines Regulations permits a patent to be added only if it is based on a patent application filed before the date of filing of the first person's New Drug Submission. |
|
| The date of filing of the patent application was Dec. 14, 1994. Paxil tablets have been on the Canadian market since 1993, so it is clear that the date of filing of the patent application was long after the date of filing of the New Drug Submission for Paxil. It is thus clear that this patent was improperly listed. |
|
[13] By letter dated April 1, 1998, an official of the Department responded to Dr. Sherman, in part, as follows:
| According to the Patented Medicines (Notice of Compliance) Regulations that were in effect as of March 12, 1993, Section 4(5) permits a first person, at any time after the date of filing of a submission [emphasis added] for a Notice of Compliance, to submit or amend a patent list in respect of a patent that issued within the previous 30 days on the basis of an application filed before the date of filing of the submission. It should be noted that a submission for an NOC includes not only a New Drug Submission, but also a Supplemental New Drug Submission, an Abbreviated New Drug Submission and a Supplemental Abbreviated New Drug Submission. |
|
| The amendment to the patent list in question was submitted within 30 days of the issuance of patent 2178637. This amendment related to two Supplemental New Drug Submissions which were filed after the date of filing of the patent application on December 14, 1994. Having determined that the requirements of Section 4(5) of the Regulations had been satisfied, the Therapeutic Products Programme added to the Register patent 2178637 for paroxetine 20 mg and 30 mg tablets. |
|
[14] Following the initial exchange of correspondence, Dr. Sherman wrote four further letters to the official, including three requests to reconsider the decision not to remove the '637 patent from the Register. The departmental official maintained his position that the '637 patent was properly listed on the Register and refused to delete it.
ISSUE
[15] The principal question to be determined on this application for judicial review is whether a supplement to a new drug submission constitutes a "submission for a notice of compliance" within the meaning of section 4 of the Patented Medicines (Notice of Compliance) Regulations.
ANALYSIS
i) legislative scheme
[16] The procedure for obtaining approval to sell a new drug in Canada is embodied in the legislative scheme contained in the Food and Drug Regulations, C.R.C. c. 870 and the Patented
Medicines (Notice of Compliance) Regulations. The pertinent regulatory provisions must be examined in order to determine the legislative requirements and the interplay between the two sets of Regulations.
[17] Any analysis of the legislative scheme must begin with an examination of the obligations imposed on a drug manufacturer by Part C, Division 8 of the Food and Drug Regulations, entitled "New Drugs".
[18] The term "new drug" is defined in section C.08.001 of the Food and Drug Regulations, in part, as follows:
| C.08.001. For the purposes of the Act and this Division, "new drug" means
| (a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug; ... |
|
C.08.001. Pour l"application de la Loi et du présent titre, "drogue nouvelle" désigne :
a) une drogue qui est constituée d"une substance ou renferme une substance, sous forme d"ingrédient actif ou inerte, de véhicule, d"enrobage, d"excipient, de solvant ou de tout autre constituant, laquelle substance n"a pas été vendue comme drogue au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l"innocuité et l"efficacité de ladite substance employée comme drogue; ...
|
[19] Since "new drug" is defined as a drug having certain characteristics, reference must be made to section 2 of the Food and Drugs Act, R.S.C. 1985, c. F-27, as amended, in which the term "drug" is defined, in part, as follows:
2. In this Act,
| "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, |
| (b) restoring, correcting or modifying organic functions 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; |
|
| b) à la restauration, à la correction ou à la modification des fonctions organiques chez l"être humain ou les animaux; ... |
|
|
[20] A review of Division 8 of the Food and Drug Regulations indicates that its purpose is to enable the Minister to assess the safety and effectiveness of a new drug in order to ensure the protection of Canadians. In order to achieve that objective, the Food and Drug Regulations prescribe various means by which a manufacturer must provide the requisite information to the Minister to enable him to discharge his legislatively mandated duty. In particular, the Food and Drug Regulations contemplate the flow of information from the manufacturer to the Minister by various mechanisms, including a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission and a supplement to an abbreviated new drug submission.
[21] Subsection C.08.002(1) of the Food and Drug Regulations prohibits a person from selling or advertising a new drug unless, among other things, the manufacturer has filed a new drug submission or an abbreviated new drug submission that is satisfactory to the Minister, and a notice of compliance has issued in respect of it. Subsection C.08.002(2) specifies the information and material to be provided by a manufacturer in a new drug submission to enable the Minister to assess the safety and effectiveness of the new drug. Furthermore, subsection C.08.002(3) provides the Minister with the discretion to require a manufacturer to provide additional information and material where he considers it necessary to assess the safety and effectiveness of the new drug.
[22] Subsection C.08.002.1(1) permits a manufacturer to file an abbreviated new drug submission for a new drug, in certain prescribed circumstances. In particular, an abbreviated new drug submission may be filed by a manufacturer where the new drug is the pharmaceutical equivalent of and bioequivalent with the Canadian reference product, the route of administration is the same, and the conditions of use fall within the conditions of use for the Canadian reference product. Subsections C.08.002.1(2) and (3) follow the same general scheme as section C.08.002 dealing with a new drug submission, and respectively provide for the filing of mandatory information and material, as well as information and material required in the Minister's discretion, in order to permit the Minister to assess the safety and effectiveness of the new drug.
[23] Section C.08.003 addresses the situation where a notice of compliance has issued to a manufacturer, but where certain specified matters in relation to the new drug differ "significantly" from the information originally provided in the new drug submission or in the abbreviated new drug submission. In such circumstances, the sale of the new drug is prohibited, even though a notice of compliance has issued, unless the manufacturer has filed a supplement to the new drug submission or to the abbreviated new drug submission and the Minister has issued a notice of compliance to the manufacturer "in respect of the supplement". In other words, where there is a "significant difference" in the new drug in relation to the matters specified in subsection C.08.003(2), such as the ingredients or the method of manufacture, there must be a notice of compliance issued in response to the supplementary submission before the new drug can be sold. By virtue of subsection C.08.003(3), a supplement to a new drug submission or to an abbreviated new drug submission must contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to the matters which are significantly different. Section C.08.003 reads as follows:
| 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; |
| (c) the notice of compliance in respect of the supplement has not been suspended pursuant to section C.08.006; and |
| (d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any label, including any package insert, product brochure and file card, intended for use in connection with the new drug, where a change with respect to any of the matters specified in subsection (2) is made that would require a change to the label. |
(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 of 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, |
| (v) the withdrawal period of the new drug; and |
| (i) the dosage in which it is proposed that the new drug be sold. |
(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.
|
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; |
| c) l'avis de conformité relatif au supplément n'a pas été suspendu aux termes de l'article C.08.006; |
| d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons de toute étiquette -- y compris une notice jointe à l'emballage, un dépliant et une fiche sur le produit -- destinée à être utilisée pour la drogue nouvelle, dans le cas où la modification d'un des éléments visés au paragraphe (2) nécessite un changement dans l'étiquette. |
(2) Pour l'application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants:
|
| 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, |
| (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. |
(3) Le supplément à la présentation de drogue nouvelle ou à la présentation abrégé de drogue nouvelle doit contenir, à l'égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, les renseignements et le materiel
nécessaires pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle relativement à ces éléments.
|
|
[24] Subsection C.08.004(1) accords to the Minister the power to issue a notice of compliance where a new drug submission, an abbreviated new drug submission or a supplement to either submission meets the requirements of the corresponding section of the Food and Drug Regulations. That provision states as follows:
| 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 |
| (b) if that submission or supplement does not comply with section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply. |
|
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; |
| b) si la présentation ou le supplément n"est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l"article C.08.005.1, on informe le fabricant. |
|
[25] Having reviewed the legislative scheme in the Food and Drug Regulations giving rise to the issuance of a notice of compliance, the provisions of the Patented Medicines (Notice of Compliance) Regulations pertaining to the maintenance of the Register and filing of a patent list must be considered.
[26] At the outset, it is important to note that section 2 of the Patented Medicines (Notice of Compliance) Regulations defines "notice of compliance" as follows:
| "notice of compliance" means a notice issued under section C.08.004 of the Food and Drug Regulations ; (avis de conformité)
|
"avis de conformité" Avis délivré au titre de l'article C.08.004 du Règlement sur les aliments et drogues. (notice of compliance)
|
[27] The definition of "notice of compliance" in section 2 of the Patented Medicines (Notice of Compliance) Regulations incorporates by reference section C.08.004 of the Food and Drug Regulations, as reproduced and described above, which accords the Minister the power to issue a notice of compliance in response to a new drug submission, an abbreviated new drug submission or a supplement to either submission.
[28] By virtue of subsections 3(1) and (2) of the Patented Medicines (Notice of Compliance) Regulations, the Minister is required to maintain a public register of any information submitted on a patent list pursuant to section 4. However, under subsection 3(3), that information cannot be included on the Register until the issuance of the notice of compliance "in respect of which the information was submitted". Section 3 provides as follows:
| 3. (1) On the 30th day after the coming into force of these Regulations, the Minister shall open and thereafter maintain a register of any information submitted pursuant to section 4.
(2) The register shall be open to public inspection during business hours.
|
3. (1) Le 30e jour suivant la date d"entrée en vigueur du présent règlement, le ministre ouvre un registre de tout renseignement soumis aux termes de l"article 4 et le tient à jour.
(2) Le registre est ouvert à l"inspection publique durant les heures de bureau.
|
| (3) No information submitted pursuant to section 4 shall be included on the register until after the issuance of the notice of compliance in respect of which the information was submitted.
|
(3) Aucun renseignement soumis aux termes de l"article 4 n"est consigné au registre avant la délivrance de l"avis de conformité à l"égard duquel il a été soumis.
|
[29] Section 4 governs the procedure to be followed in relation to the filing of a patent list. By virtue of subsection 4(1), a person who has filed a "submission for or has been issued a notice of compliance" may submit a patent list to the Minister for a drug that contains a medicine. The term "drug" is not defined in the Patented Medicines (Notice of Compliance) Regulations, but "medicine" is defined as follows in section 2:
| "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)
|
"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 )
|
[30] Subsection 4(2) requires the person to certify the patent list as accurate, and outlines its requisite contents. Under subsection 4(3), a person is required to submit a patent list at the time of the filing of the submission for a notice of compliance, subject to the exceptions specified in subsections 4(4) and (5). Subsection 4(4) deals with a situation where a submission was filed or a notice of compliance was issued prior to the enactment of the Patented Medicines (Notice of Compliance) Regulations. Subsection 4(5) provides, among other things, that a person may amend an existing patent list at any time after the filing of the submission for the notice of compliance "...in respect of a patent that issued within the previous 30 days on the basis of an application filed before
the date of filing of the submission". Section 4 provides as follows:
| 4.(1) A person who files, or before the coming into force of these Regulations 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.
(2) A patent list submitted pursuant to subsection (1) must be certified by the person to be accurate, and must set out
| (a) 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 patent list; ... |
(3) Subject to subsections (4) and (5), a person submitting a patent list shall do so at the time the person files a submission for a notice of compliance.
(4) Subject to subsection (5), a person who had already filed a submission for, or has been issued, a notice of compliance before the coming into force of these Regulations and who wishes to submit a patent list shall do so within 30 days after the day on which these Regulations come into force.
(5) At any time after the date of filing of the submission for a notice of compliance, the first person may submit a patent list that includes, or amend an existing patent list to include, the information referred to in subsection (2) in respect of a patent that issued within the previous 30 days on the basis of an application filed before the date of filing of the submission.
|
4. (1) La personne qui dépose ou qui, avant la date d"entrée en vigueur du présent règlement, a déposé une demande d"avis de conformité à l"égard d"une drogue qui contient un médicament ou a obtenu un tel avis peut soumettre au ministre une liste de brevets.
(2) La liste de brevets visée au paragraphe (1) doit faire l"objet d"une attestation de la personne quand à son exactitude et doit contenir les éléments suivants:
| a) 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 en vue de l"inclure dans la liste et qui comporte une revendication pour le médicament en soi ou une revendication pour l"utilisation du médicament et qu"elle souhaite inclure dans la liste; ... |
(3) Sous réserve des paragraphes (4) et (5), la personne qui soumet une liste de brevets doit le faire au moment du dépôt de sa demande d"avis de conformité.
(4) Sous réserve du paragraphe (5), la personne qui a déposé une demande d"avis de conformité ou qui a obtenu un tel avis avant la date d"entrée en vigueur du présent règlement et qui souhaite soumettre une liste de brevets doit le faire dans les 30 jours suivant cette date.
(5) La première personne peut, après la date de dépôt de la demande d"avis de conformité, soumettre une liste de brevets qui comprend les éléments visés au paragraphe (2) à l"égard d"un brevet qui a été délivré au cours des 30 jours précédents et qui était fondé sur une demande au tribunal déposée avant la date de ce dépôt ou elle peut modifier la liste de brevets existante pour inclure ces éléments.
|
ii) meaning of "submission for a notice of compliance" in subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations
[31] Counsel for Apotex argued, among other things, that the Minister erred in including the '637 patent on the Register with respect to the notices of compliance issued on November 9, 1995 for 20 mg and 30 mg PAXIL tablets, containing the medicinal ingredient paroxetine as paroxetine hydrochloride. In particular, he argued that, in February and June 1995, SmithKline had not made a "submission" for a notice of compliance within the meaning of subsection 4(5) of the Patented Medicines (Notice of Compliance Regulations), but rather had filed a supplement to a new drug submission. As a result, the application for the '637 patent in December 1994 was not filed "before the date of the filing of the submission", within the meaning of subsection 4(5). Since the application for the '637 patent was also outside the time limit in relation to the original new drug submission, filed by SmithKline in June 1990, the patent list could not properly be amended to include the '637 patent. The Minister therefore erred in including the information relating to the '637 patent on the Register. Counsel for Apotex further argued that the time limits in subsection 4(5) would be rendered ineffective and meaningless by interpreting "submission" to include a supplement to a new drug submission.
[32] In his argument concerning the interpretation to be accorded to subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, counsel for Apotex focussed on the meaning of the word "submission". In particular, he argued that "submission" means only a new drug submission or an abbreviated new drug submission, and does not include a supplement to either of those submissions. In support of that argument, he referred to the wording of subsection C.08.004(1) of the Food and Drug Regulations that draws a distinction between a "submission or supplement". However, he did not refer to the word "submission" in the context in which it appears throughout sections 4 and 5 of the Patented Medicines (Notice of Compliance) Regulations , namely as a "submission for a notice of compliance".
[33] In interpreting the term "submission", reference must be made to its use and meaning in both the Patented Medicines (Notice of Compliance) Regulations and in the Food and Drug Regulations, in particular sections C.08.003 and C.08.004.
[34] A review of the Patented Medicines (Notice of Compliance) Regulations reveals that the expression used throughout sections 4 and 5 is not a "submission", but rather a "submission for a notice of compliance". The term "notice of compliance" is defined in section 2 as meaning a notice issued under section C.08.004 of the Food and Drug Regulations. As a result, that provision must be examined, as well as the related sections in the Food and Drug Regulations.
[35] As indicated previously, the word "submission" appears throughout the provisions of Division 8 in the Food and Drug Regulations in the phrases "a new drug submission", an "abbreviated new drug submission" and "a supplement to a new drug submission or to an abbreviated new drug submission". Under paragraph C.08.003(1)(a) of the Food and Drug Regulations, the manufacturer must file a supplement to "that new drug submission" or to "that abbreviated new drug submission", following the issuance of a notice of compliance, in circumstances where certain matters in relation to the new drug differ significantly from the information or material contained in the new or the abbreviated new drug submission. Paragraph C.08.003(1)(b) also provides for the issuance of a notice of compliance in respect of the supplement. Furthermore, under subsection C.08.003(3), the supplement to the new drug submission or to the abbreviated new drug submission becomes the vehicle by which a manufacturer provides the Minister with sufficient information and material "with respect to the matters that are significantly different from those contained in the submission" in order to enable him to assess the safety and effectiveness of the new drug "in relation to those matters". In other words, a supplement does not vitiate or supplant the new or the abbreviated new drug submission, but rather constitutes an independent submission by the manufacturer in relation to certain specified matters which differ in significant respects from the information or material in the new or the abbreviated new drug submission. The independent or "stand alone" characteristic of a supplement to a new or to an abbreviated new drug submission is reinforced by paragraphs C.08.003(1)(b) and C.08.004(1)(a) which provide for the issuance of a notice of compliance in response to a supplement. In particular, paragraph C.08.004(1)(a) further reinforces the notion that a supplement constitutes a submission, in that it specifies unequivocally that all three informational mechanisms, namely a new drug submission, an abbreviated new drug submission or a supplement to either submission will give rise to the issuance of a notice of compliance in certain defined circumstances. As a result, the legislative scheme indicates clearly that a supplement to a new or to an abbreviated new drug submission is one type of submission that may be made by a drug manufacturer to obtain a notice of compliance to market a drug in Canada.
[36] 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.
[37] A review of the French version of the legislative scheme also supports my interpretation of the meaning to be accorded to the phrase "submission for a notice of compliance". In paragraph C.08.004(1)a) of the Food and Drug Regulations, the Minister "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...si la présentation ou le supplément est conforme... délivre un avis de conformité". The French and English versions are therefore entirely consistent, and the word "présentation" is used for the word "submission". However, there is an important change between the terminology used in the legislative drafting of the French version of paragraph C.08.004(1)a) and subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations. The importance of the change may be best illustrated by first making reference to the English text of the two regulatory provisions. In the English text of subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, the legislative drafters used the expression "submission for a notice of compliance" without making any reference to a supplement, contrary to the express terminology used in paragraph C.08.004(1)(a) of the Food and Drug Regulations. However, in subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, the French legislative drafters chose not to use either "présentation" or "supplément" as those words appeared in paragraph C.08.004(1)a) of the Food and Drug Regulations, but rather used the broader expression "une demande d'avis de conformité". By virtue of section 2 of the Patented Medicines (Notice of Compliance) Regulations, "avis de conformité" is defined as "avis délivré au titre de l'article C.08.004..." of the Food and Drug Regulations. Since it is clear beyond any question that "une demande d'avis de conformité" can be made by a new drug submission, an abbreviated new drug submission and a supplement to either submission, the language used in the French text unequivocally incorporates a supplement within the term "demande d'avis de conformité", and thereby expressly includes it within the ambit of subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations .
[38] In support of his position on the interpretation to be accorded to subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, counsel for Apotex relied on the decision Novopharm Ltd. v. Canada (Minister of National Health and Welfare) (1998), 78 C.P.R. (3d) 54 (F.C.T.D.), in which Hugessen J. dealt with an application to purge from the Register information from an amended patent list. In that case, Hugessen J. was not required, on the facts before him, to consider the meaning of the expression "submission for a notice of compliance", as used in subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, or the applicable provisions of the Food and Drug Regulations. However, since counsel for Apotex placed considerable reliance on that case, I will indicate why, in my opinion, it does not support his position in the present case.
[39] In Novopharm Ltd. v. Canada (Minister of National Health and Welfare), supra, the patentee was granted a notice of compliance in 1985 for terazosin hydrochloride in dosages of 1, 2 and 5 mg tablets, and a second notice of compliance in 1992 for 10 mg tablets. The new drug submissions in relation to which the notices of compliance issued were filed, respectively, in 1983 and 1991. In April 1993, within thirty days of the coming into force of the Patented Medicines (Notice of Compliance) Regulations, the patentee filed patent lists relating to the drugs covered by the notices of compliance. In October 1995, the patentee filed a new drug submission and was granted a notice of compliance for a "starter pack" of 1, 2 and 5 mg tablets of terazosin hydrochloride, packaged in order to permit a patient to take gradually increasing doses of the drug over a four week period. The drug was identical to the drug referred to in the notices of compliance granted in 1985 and 1992. In June 1997, the patentee obtained three new patents containing claims to the medicine terazosin hydrochloride. The applications for the patents were filed between 1991 and October 1995. Within thirty days of the issuance of the patents, the patentee filed amendments to the patent lists filed in respect of the 1985 and 1992 notices of compliance. The patentee did not file a new patent list in relation to the notice of compliance issued in October 1995 for the starter pack. The Minister accepted the amended patent lists and added the information to the Register.
[40] In dealing with the interpretation to be accorded to subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations, Hugessen J. noted, at p. 60, that the English version was "...clear in requiring that any such new patent must have been applied for prior to the filing of the [new drug submission] and must not have been issued more than thirty days prior to the filing of the amended (or new) patent list." However, the patentee argued, on the basis of the wording in the French text, that an amendment to an existing patent list could be made at any time and without any conditions. Hugessen J. found that the wording of the French text was problematic and, at best, "ambiguous" in certain respects. In particular, he emphasized the "puzzling" reference to "un brevet...qui était fondé sur une demande au tribunal", and the final phrase commencing with the words "ou elle peut". However, he rejected, on the basis that it had no merit, the patentee's argument that an existing patent list could be amended at any time and without any conditions. In the light of
that particular factual context, Hugessen J. made the following observations at page 61:
| [13] Finally, it would appear to me that a contextual reading of subsection 4(5) in the light of the Regulations, as a whole makes the interpretation proposed by Abbott untenable. Counsel was unable to suggest any rational policy objective which would support the imposition of tight time restrictions on the filing of a new or original patent list and yet allow patents to be added to an existing list virtually at will. Absent such a rationale, the proposed interpretation simply makes no sense. |
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[41] The second question considered by Hugessen J. related to the correctness of the Minister's decision to accept the amended list and to add the patents to the Register. In that regard, Hugessen J. stated as follows, at page 62:
| [18] In the first place, and on the particular facts of this case, I can see no justification whatever for the Minister acting as he has. He was faced with what was clearly stated to be an amendment to an existing patent list and one which equally clearly referred, by citing to their appropriate DINs, to the drugs which had been the subject of the Notice of Compliance issued to Abbot in 1985 and 1992. The Minister had the choice of accepting that amendment as filed or of rejecting it as being non-compliant with the Regulations. In fact, he did neither. Rather, having correctly viewed the amendment as being non-compliant (it was long out of time on the proper reading of subsection 4(5)) he proceeded to treat it as though it was an original patent list rather than an amendment of an existing list. Even more critical, however, he then failed to apply it to the only NDS in respect of which it might arguably have been filed, namely the NDS filed for the starter pack in 1995, but instead applied it to the NOC of 1985 and 1992 in respect of which it could not have been filed. |
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[42] In other words, Hugessen J. concluded that the amended patent lists fell outside of the time limits prescribed in subsection 4(5), in that the applications for the patents were filed between 1991 and October 1995 and not before the dates of the filing of the submissions for the notices of compliance in 1983 and 1991. Finally, at page 64, Hugessen J. reiterated that the patentee's list "could only have been filed" in relation to the new drug submission in 1995 for the starter pack.
[43] Having carefully considered the decision of Hugessen J. in Novopharm v. Canada (Minister of Health and Welfare), supra, I am unable to conclude that it supports any position advanced by counsel for Apotex. Indeed, to the contrary, Hugessen J. appears to at least suggest that the patentee could have filed its patent list in relation to the notice of compliance issued for the starter pack. That suggestion closely parallels the facts in the present case in which SmithKline filed its amended patent list not in relation to its first notice of compliance, but rather in relation to two later ones. Furthermore, the question of the meaning to be accorded to the term "submission for a notice of compliance" in subsection 4(5) was not in issue before Hugessen J., and his comments concerning the drafting of the French text did not relate in any manner whatever to any of the words or phrases at issue in the present case. Similarly, given the issue before him, Hugessen J. was not required to consider the relationship between the relevant provisions of the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations. Finally, the statement made by Hugessen J. concerning the "rational policy objective" has to be read in the context of the unmeritorious argument advanced by the patentee that an amendment to a patent list could be made "at any time", without regard to the time limits prescribed in subsection 4(5).
[44] Accordingly, I am of the opinion that the decision of Hugessen J. in Novopharm v. Canada (Minister of National Health and Welfare), supra does not support the argument of counsel for Apotex that SmithKline's amended patent list was filed outside of the time period prescribed in subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations.
iii) relevance of the '637 patent
[45] In his memorandum of fact and law, counsel for Apotex's "points in issue" and his legal submissions related solely to the question of the interpretation of subsection 4(5) of the Patented Medicines (Notice of Compliance) Regulations . However, in the "facts" portion of his memorandum, counsel for Apotex alleged that the '637 patent was not properly included on the Register on the basis that it was not relevant to the drugs in relation to which the notices of compliance issued. In that regard, he noted that SmithKline had applied for but had not yet obtained a notice of compliance to market tablets containing paroxetine prepared in the dry formulation method patented in the '637 patent. Even though counsel for Apotex did not properly raise or plead that issue, I will comment briefly on the question of the "relevance" of the '637 patent.
[46] Under subsection 4(1) of the Patented Medicines (Notice of Compliance) Regulations, a person who files a submission for or who has been issued a notice of compliance "in respect of a drug that contains a medicine" may submit a patent list to the Minister. By virtue of paragraph 4(2)(a), a patent list must set out any Canadian patent "...that contains a claim for the medicine itself or a claim for the use of the medicine...". Finally, under subsection 4(5), an amended patent list may be filed in certain circumstances.
[47] In the present case, SmithKline was issued two notices of compliance on November 9, 1995 for 20 mg and 30 mg of the drug PAXIL in tablet form, containing the medicinal ingredient paroxetine as paroxetine hydrochloride. The '637 patent was issued for paroxetine tablets and a process to prepare them, and includes claims to novel paroxetine formulations prepared in the absence of water. The '637 patent therefore contains a claim for the medicine paroxetine or a claim for the use of the medicine paroxetine, within the meaning of subsection 4(2). By virtue of subsection 4(1), SmithKline was a person who had been issued a notice of compliance in relation to PAXIL tablets, a drug containing the medicine paroxetine, and was thereby entitled to submit a patent list in accordance with subsection 4(2). SmithKline was further entitled, by virtue of subsection 4(5), to file an amended patent list in relation to a patent issued within the previous thirty days where the application for the patent was filed before the date of the filing of the submission for a notice of compliance. I have already determined that SmithKline complied with the requirements outlined in subsection 4(5) for filing an amended patent list. In the circumstances, SmithKline was entitled to include the '637 patent on an amended patent list relating to the notices of compliance issued in November 1995 in respect of the drug PAXIL containing the medicine paroxetine. The argument of Apotex's counsel that the '637 patent is not relevant to the drugs in relation to which the notices of compliance issued therefore has no merit. Furthermore, the argument advanced by counsel for Apotex would lead to the incongruous result that the newest patented formulation of the medicine paroxetine would not receive the protection accorded by the procedures provided in the Patented Medicines (Notice of Compliance) Regulations. That result would be inconsistent with the recognized purpose of those Regulations, namely the prevention of patent infringement by strengthening the rights of patentees [See for example Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 at 314 (F.C.A.), application for leave to appeal dismissed (1995), 58 CPR (3d) vii. (S.C.C.); ICN Pharmaceuticals, Inc. v. Canada (Patented Medicines Prices Review Board), [1997] 1 F.C. 32 at 40, 44 - 45 (C.A.)].
iii) applicability of pre-1998 amendment Regulations
[48] In his memorandum of fact and law, counsel for Apotex relied on and referred exclusively to the Patented Medicines (Notice of Compliance) Regulations, as amended in 1998 in SOR/98-166. However, the Minister's decision and all relevant matters occurred prior to the amendment of those Regulations in 1998. In the circumstances, I am of the opinion that the amended Patented Medicines (Notice of Compliance) Regulations have no application in these proceedings, and I have interpreted and applied the Regulations as they existed prior to their amendment in 1998.
DECISION
[49] For these reasons, I have determined that the Minister did not err in including the "637 patent on the Register. Given my conclusion in this matter, it is unnecessary for me to consider the other
issues raised by counsel. The application for judicial review is dismissed with costs.
D. McGillis
OTTAWA
April 12, 1999
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