Date: 20020903
Docket: T-93-02
Neutral Citation: 2002 FCT 927
Ottawa, Ontario, September 3, 2002
PRESENT: THE HONOURABLE MR. JUSTICE BLAIS
APPLICATION UNDER the Food and Drugs Act, R.S.C. 1985,
c. F-27, Patented Medicines (Notice of Compliance) Regulations.
SOR 93/133, as amended, sections 18 and 18.1 of the Federal
Court Act, R.S.C. 1985, c. F-7, as amended and Rules 300-319
of the Federal Court Rules, 1998.
BETWEEN:
TOBA PHARMA INC.
Applicant
and
ATTORNEY GENERAL OF CANADA and
MINISTER OF HEALTH
Respondents
[1] This is an application brought by the applicant for judicial review under the Federal Court Act of a decision of the Minister of Health [hereinafter referred to as the "Minister"] dated December 18, 2001 wherein the Minister refused to list Canadian Patent 2,278,133 [hereinafter referred to as the " '133 patent"] on the patent register pursuant to the Patented Medicines (Notice of Compliance) Regulations [hereinafter referred to as the "Regulations"].
FACTS
[2] This case concerns a patent relating to the drug Sevoflurane, known by the brand name SEVORANE, SEVORANE AF and EVOTANE.
[3] The Minister issued Notices of Compliance (NOCs) first on the basis of a new drug submission for SEVORANE and later, on the basis of a supplement to a new drug submission (for the change of name) for SEVORANE AF.
[4] On June 26, 2001, the '133 patent was granted after the issuance of these two (2) NOCs.
[5] However, the patent information was not filed with the Minister within 30 days of the grant and so, pursuant to subsection 4(4) of the Regulations, it expired.
[6] The applicant subsequently attempted to have the '133 patent included on the register by filing it with a further supplement to a new drug submission (SNDS).
[7] That supplement was submitted for the purposes of recording a change in the manufacturer's name and product name. Specifically, as a result of a licensing agreement with Abbott Laboratories, the applicant was to market the drug under the name EVOTANE.
[8] A patent list accompanied the SNDS identifying the '133 patent to be added to the patent register.
[9] The Minister decided that the Regulations do not permit the inclusion of a drug on the patent register by filing a further supplement to a new drug submission. Consequently, by letter dated December 18, 2001, the Minister refused to list the '133 patent on the register.
[10] On December 21, 2001, the NOC was issued to the applicant for EVOTANE. It specified as the reason for the submission "New Manufacturer and Product Name."
[11] Though invited to do so, the applicant made no representations in response.
[12] On January 17, 2002, the applicant sought leave for judicial review of the decision rendered on December 18, 2001.
IMPUGNED DECISION
[13] The letter dated December 18, 2001 was signed by Ms. Anne Bowes, Patent Officer - Science, Submission and Information Policy Division and reads as follows:
RE: Patent List - Sevoflurane
SEVORANE AF
99.97% / bottle
Submission # 074788
Patent # 2278133
The above submission does not constitute an opportunity to file a patent list. The submission is for a change in the manufacturer's name and was submitted in accordance with the policy on Changes in Manufacturer's Name and / or Product Name published April 24, 1998. 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-requirement reflected in subsections 4(1), 4(4) and 4(6) of the PM(NOC) Regulations; see Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 CPR (4th) 318 (F.C.T.D.).
Therefore, pursuant to the authority vested in the Minister of Health by subsection 3(1) of the Regulations, patent 2278133 will not be added to the Patent Register against the above-noted product.
(my emphasis)
APPLICABLE LEGISLATION
[14] Subsection 3(1) of the Regulations requires the Minister to maintain a register.
| 3. (1) The Minister shall maintain a register of any information submitted under section 4. To maintain it, the Minister may refuse to add or may delete any information that does not meet the requirements of that section. |
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3. (1) Le ministre tient un registre des renseignements fournis aux termes de l'article 4. À cette fin, il peut refuser d'y ajouter ou en supprimer tout renseignement qui n'est pas conforme aux exigences de cet article. |
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[15] Section 4 of the Regulations pertains to the patent list. Subsections 4(1), 4(3), (4) and 4(6) address the strict timing requirements for the patent list.
| 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.
(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).
(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). |
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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).
(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).
(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). |
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APPLICANTS' POSITION
[16] The applicant submits that the Minister has unlawfully refused to list the '133 patent on the register. In so doing, the applicant contends that the Minister committed a reviewable error.
[17] The applicant argues that the Minister incorrectly applied the case of Bristol-Myers Squibb Canada Inc. v. Attorney General of Canada et al. (2001), 10 C.P.R. (4th) 318 (F.C.T.D.), aff'd (2002), 16 C.P.R. (4th) 425 (F.C.A.), as the applicant simply wishes to create a new patent list and is not trying to rectify an error or try to add a patent to an existing patent list.
RESPONDENT'S POSITION
[18] The respondent submits that the Regulations do not permit the inclusion on the register by filing a further supplement to a new drug submission; particularly when the supplement was submitted solely for the purposes of recording a change in the manufacturer's name and product name.
[19] Accordingly, the respondent is of the opinion that the Minister did not commit a reviewable error by refusing to list the '133 patent on the register.
ISSUE
[20] The sole issue is whether the Minister was correct in law in deciding that the applicant did not satisfy the requirements of section 4 of the Regulations and that the '133 patent is therefore ineligible for inclusion on the patent register.
ANALYSIS
Standard of review
[21] Both parties are in agreement that the appropriate standard of review in the present matter is that of correctness (see Bristol-Myers Squibb Canada Inc. v. Attorney General of Canada et al. (2001), 10 C.P.R. (4th) 318 (F.C.T.D.), aff'd (2002), 16 C.P.R. (4th) 425 (F.C.A.) and Warner-Lambert Canada Inc. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 129 (F.C.T.D.)).
The regulatory framework
[22] The purpose of the Regulations is two-fold: it is to create a mechanism to ensure compliance with the Patent Act and to prevent patent infringement. No person shall sell a drug in Canada unless that person has first obtained the NOC from the Minister in accordance with the requirements of the Food and Drug Act and the Food and Drug Regulations. An NOC attests, inter alia, to the safety and efficacy of that drug and is obtained once the submission is in compliance with all applicable regulatory requirements and fulfills the rigorous testing and approval requirements of the Minister.
Section 4 of the Regulations
[23] The process for inclusion of information on the patent register begins with the submission of a patent list in accordance with subsection 4(1) of the Regulations. The patent list must set out certain prescribed information pursuant to subsection 4(2) of the Regulations.
Timing requirements imposed by the Regulations
[24] The most relevant requirement of section 4 to the present case is the strict time requirement as set out in subsections 4(3), 4(4) and 4(6) of the Regulations. Thus, it becomes apparent that for timing purposes, the Regulations are linked with the NOC requirements.
[25] The respondent outlines that a patent list is eligible for inclusion on the register only if submitted at one (1) of three (3) points in time:
a. where the submission is made after the patent is granted:
i. at the time of submission of the relevant new drug submission,
or
ii. within 30 days of the Regulations coming into force, or
b. where the submission is made before the patent is granted
ii. within 30 days of the granting of a new patent.
[26] The applicant did not submit the patent information at anyone of these three (3) points in time. Thus, the '133 patent was not included on the patent register.
The filing of a patent list with an SNDS for change in the manufacturer's name and product name
[27] A patent list was filed in respect of the drug Sevoflurane (SEVORANE or SEVORANE AF). The patent list for EVORANE would therefore have been eligible for inclusion on the register only if it had been filed within 30 days after the grant of the EVORANE patent. This, however, was not done and accordingly the timing requirements of section 4 of the Regulations were not met.
[28] 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 section 4, which provides only for the addition of a patent to be made within the time requirements reflected in subsections 4(3), 4(4) and 4(6) of the Regulations.
[29] Therefore it was well within the Minister's discretion, granted to it by subsection 3(1) of the Regulations, to refuse this means of presenting a patent list.
The applicable jurisprudence
[30] The applicant has attempted to fit the specific circumstances of this case into certain broad legal concepts and interpret such concepts so as to support its position. The Court does not find this helpful, particularly in comparison to the relevant and specific case law put forward by the respondent.
[31] I find the case of Bristol-Myers Squibb Canada Inc. v. Attorney General of Canada et al. (2001), 10 C.P.R. (4th) 318 (F.C.T.D.), aff'd (2002), 16 C.P.R. (4th) 425 (F.C.A.) to be very instructive. In that case, Campbell J. concluded that a patent list filed with the SNDS for a change in brand name did not meet the requirements of section 4 of the Regulations. The facts in Bristol-Myers,supra are described as follows:
The applicant applied for a notice of compliance for a series of tablets of differing strength containing the medicine nefazadone hydrochloride, to be sold under the brand name Serzone. [...] Through inadvertence, it omitted from that list a further patent, the '436 patent. After the time limit had run out, the applicant made three attempts to have the '436 patent added to the register, each unsuccessful.
The applicant then sought registration of the '436 patent through the use of s. C.08.003 of the Food and Drug Regulations, C.R.C. 1978, c. 870. The applicant filed a supplemental new drug submission relating to a change in the name of its product from Serzone to Serzone-5HT [2]. It certified that only the product name differed as between the two submissions. Along with the second submission, the patentee filed a patent list including the '436 patent. The Minister issued a further notice of compliance and added the '436 patent to the patent register on the basis of s. 4(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. On further consideration, the Minister advised the patentee that the '436 patent was improperly included in the patent register in view of the express wording of s. 4(6) of the Regulations, which had been added in the amendment of 1998. The Minister fixed a date when the '436 patent would be removed from the register.
[32] It is true that Bristol-Myers, supra involved the filing of a patent list with an SNDS for change in brand name whereas the present matter involves the filing of a patent list with an SNDS for change in the manufacturer's name and product name, however, I find that the material facts on which this Court's reasoning was based in Bristol-Myers, supra are essentially the same. Specifically, it is the issue of circumventing the time constraints imposed by section 4 of the Regulations which are identical. On this issue, Campbell J. held:
[para 19] It is evident from the record that the underlying concern held by the Minister in reversing the decision to register the '436 Patent is forward looking. That is, to allow the use of Food and Drug Regulation C.08.003 by BMS in the present case would allow innovative companies to circumvent the timing requirements of NOC Regulation 4 by changing brand names in order to put patents on the Patent Register that were not there before, for which the time lines had not been complied with originally.
[para 21] I agree with the Minister's argument that to allow innovative companies to potentially add patents to the Patent Register by filing a patent list using BMS's Food and Drug Regulation C.08.003 strategy, is contrary to the specific intention of Parliament as expressed in NOC Regulation 4(6). Thus, I find that Food and Drug Regulation C.08.003 cannot be used to achieve the result pursued by BMS.
[33] The applicant is of the opinion that the case of Bristol-Myers, supra can be distinguished forseveral reasons, namely due to the highly specific fact situation. I find that the essence of the decision is applicable in the case at bar. Both Bristol-Myers Squibb and the applicant were attempting to avail themselves of a circuitous route with the intention of avoiding the timing requirements of the Regulations. This is not permissible.
[34] Therefore, I subscribe fully to the line of reasoning outlined by the Court in Bristol-Myers, supra and find parallel application in the case at bar as the Regulations could not have intended that a patent list be eligible for inclusion on the register where no comparison can be made to the drug to which it relates. Thus the patent list cannot be added on the basis of the SNDS filed for EVOTANE. Similarly, it cannot be added on the basis of the new drug submission filed for the '133 patent because it is out of time.
[35] Therefore, this application for judicial review is dismissed as the Minister committed no reviewable errors in refusing to include the '133 patent on the register.
[36] With costs in favour of the respondent.
Pierre Blais
Judge
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
DOCKET: T-93-02
STYLE OF CAUSE: TOBA PHARMA INC.
Applicant
and
ATTORNEY GENERAL OF CANADA and
MINISTER OF HEALTH
Respondents
PLACE OF HEARING: MONTRÉAL, QUÉBEC
DATE OF HEARING: August 15, 2002
REASONS FOR ORDER
AND ORDER BY: BLAIS J.
DATED: September 3, 2002
APPEARANCES BY: Mr. Daniel A. Artola
For the Applicant
Mr. F.B. Woyiwada
For the Respondent
SOLICITORS OF RECORD: Mr. Daniel A. Artola
McCarthy Tétrault LLP
Barristers & Solicitors
1170 Peel Street
Montréal, Québec
H3B 4S8
For the Applicant
Mr. F.B. Rick Woyiwada
Senior Counsel, Civil Litigation
Deputy Attorney General of Canada
Department of Justice
2nd Floor, East Memorial Bldg
284 Wellington Street
Ottawa, Ontario
K1A 0H8
For the Respondent