Date: 20030619
Docket: A-105-03
Citation: 2003 FCA 274
CORAM: ROTHSTEIN J.A.
NOËL J.A.
SEXTON J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
and
FERRING INC.
Respondent
(Applicant)
and
THE ATTORNEY GENERAL OF CANADA
and THE MINISTER OF HEALTH
Respondents
(Respondents)
Docket: A-142-03
AND BETWEEN:
THE ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Appellants
(Respondents)
and
FERRING INC.
Respondent
(Applicant)
and
APOTEX INC.
Respondent
(Respondent)
Heard at Toronto, Ontario, on June 16, 2003.
Judgment delivered at Toronto, Ontario, on June 19, 2003.
REASONS FOR JUDGMENT BY: ROTHSTEIN J.A.
NOËL J.A.
SEXTON J.A.
Date: 20030619
Docket: A-105-03
Citation: 2003 FCA 274
CORAM: ROTHSTEIN J.A.
NOËL J.A.
SEXTON J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
and
FERRING INC.
Respondent
(Applicant)
and
THE ATTORNEY GENERAL OF CANADA
and THE MINISTER OF HEALTH
Respondents
(Respondents)
Docket: A-142-03
AND BETWEEN:
THE ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Appellants
(Respondents)
and
FERRING INC.
Respondent
(Applicant)
and
APOTEX INC.
Respondent
(Respondent)
REASONS FOR JUDGMENT
THE COURT
[1] These are two appeals brought by the Attorney General of Canada, the Minister of Health and Apotex Inc. (the appellants) from an order of an applications judge in which she granted two applications for judicial review by the respondent Ferring Inc. (Ferring). By her order, the applications judge directed that the Minister reinstate Ferring's Canadian Patent 2,166,296 (the 296 patent) on the Patent Register and that the Minister revoke the Notice of Compliance (NOC) which had been issued to Apotex for its generic drug Apo-Desmopressin.
[2] The appeals were consolidated by order of this Court. These reasons dispose of both appeals. The original will be filed in A-105-03 and a copy will be filed in A-142-03.
[3] In support of their appeal, the appellants contend that the decision of our Court in Bristol Myers Squibb Canada Inc. v. Attorney General of Canada and the Minister of Health and Apotex Inc. (2002), 16 C.P.R. (4th) 425 (BMS) is dispositive of the issue to be decided and that the applications judge erred in holding that this decision could be distinguished on its particular facts.
[4] In BMS, this Court confirmed a decision of the Trial Division (Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 C.P.R. (4th) 318) in which it was held that the strategic use of the trade name element of C.08.003 of the Food and Drug Regulations, C.R.C. 1978, c. 870 (F & D Regulations) to overcome the timing requirements prescribed by section 4 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended (the Patent Regulations) was contrary to the intent of the Patent Regulations and could not therefore be used to put a patent on the Patent Register.
[5] The strategy used in BMS is described in detail in the decision of the Trial Division. This strategy was devised by Bristol-Myers Squibb as a result of its inadvertent failure in 1993 to list an important patent (with respect to a drug marketed under the name Serzone) on the Patent Register within the 30 day period contemplated by subsection 4(4) of the Patent Regulations (SOR/93-133).
[6] After various unsuccessful attempts to rectify the error, Bristol-Myers Squibb resorted to a simple solution: changing the trade name from Serzone to Serzone-5HT2. To effect such a change, a first person is required to file a Supplementary New Drug Submission (SNDS) pursuant to C.08.003(2) of the F & D Regulations. As a SNDS constitutes a Submission for a Notice of Compliance within the meaning of section 4 of the Patent Regulations (Apotex Inc. v. Canada (Minister of Health)(1999), 87 C.P.R. (3d) 271 (F.C.T.D.) aff'd, (2001),11 C.P.R. (4th) 538 (F.C.A.)), Bristol-Myers Squibb argued that this gave it the right to list the patent which it had initially omitted to list.
[7] The Trial Division held that no such right accrued in the particular circumstances of this case, the critical circumstance being that the purpose of the trade name change was to overcome the time requirement embodied in subsection 4(4) of the Patent Regulations. The reasons state at paragraph 19:
... 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 compiled with originally.
[8] This decision was affirmed by this Court with brief reasons delivered from the Bench.
[9] The applications judge reached a different conclusion. She found that the literal meaning of the words had to be applied in construing section 4 of the Patent Regulations. Applying this literal meaning, she concluded that the NOC obtained by Ferring with respect to the trade name MINIRIN came within the ambit of section 4 and provided Ferring with the opportunity to place its 296 patent on the Patent Register. In reaching this conclusion, she placed particular reliance on the wide ambit of the words "in respect of a drug" in section 4 which she contrasted with words "for a drug" (reasons paragraphs 19 and 20), but she appears to have overlooked the French text which uses the words "pour une drogue".
[10] The applications judge distinguished BMS on the basis that, in her view, the SNDS in that case involved an attempt to amend an existing patent list while the SNDS in the present case did not. However, a review of the decision in BMS reveals that it did not involve an attempt to amend an existing patent list. While there had at one time been a patent list in respect of "Serzone", it had ceased to exist prior to the relevant time, as the only patent on the list had been deleted (see Bristol-Myers Squibb Canada Inc., supra, paragraphs 8 and 9). There was, therefore, no basis for the distinction made by the applications judge, and it is significant that she pointed to no other ground or basis for disregarding the decision in BMS.
[11] In the present case, Ferring placed itself outside the time line contemplated by subsection 4(4) of the Patent Regulations for listing the 296 patent by filing the SNDS for its formulation of Desmopressin Acetate (January 7, 1994) before having made its patent application covering this drug (June 22, 1994).
[12] After the 296 patent was issued on June 23, 1998 and upon receiving a request from Ferring to have it filed on the Patent Register, the Minister informed Ferring on July 22, 1998 that this could not be done because Ferring had not complied with the time requirements contemplated by subsection 4(4) of the Patent Regulations.
[13] The very next day, Ferring submitted a SNDS seeking a NOC for Desmopressin Acetate under the trade name MINIRIN. The evidence presented by Ferring itself indicates that its request to file the 296 patent in conjunction with this change of name was intended to secure rights under the Patent Regulations (affidavit of W. Richard Jeysman, Appeal Book, volume I, tab 6, paragraph 7). No other rationale was provided for the name change.
[14] Counsel for the respondent stressed that in contrast with BMS, MINIRIN was an existing trade name under which its Desmopressin Acetate was being marketed in other countries. That is so, but the established trade name in Canada was DDAVP, and the record reveals that Ferring continued to use that name in Canada for some two years after the NOC was obtained; it did not sell its Desmopressin Acetate under the name MINIRIN until after being questioned by the Minister about the use of the name in Canada.
[15] Against this background, it is apparent that the only conclusion that can be drawn is that, as in BMS, the change in trade name was part of a strategy designed to overcome the time limitation within which a first person must file its patent list under section 4 of the Patent Regulations. As was pointed out in BMS, this strategy, if sanctioned by the Court, would render the time requirements embodied in section 4 meaningless.
[16] We find support for this reasoning in Rizzo and Rizzo Shoes Ltd. (Re) [1998] 1 S.C.R. 27 where the Supreme Court of Canada indicated that where the literal application of the words of a statute defeats the purpose of a provision, the Court must place the greatest reliance on the purpose of the provision and on the context in which the words were enacted:
"....the legislature does not intend to produce absurd consequences. According to Côté, supra, an interpretation can be considered absurd if it leads to ridiculous or frivolous consequences, if it is extremely unreasonable or inequitable, if it is illogical or incoherent, or if it is incompatible with other provisions or with the object of the legislative enactment (at pp. 378-80). Sullivan echoes these comments noting that a label of absurdity can be attached to interpretations which defeat the purpose of a statute or render some aspect of it pointless or futile. (per Iacobucci J. writing for a unanimous Court at para. 27)
[17] In the present case, the literal interpretation given to section 4 by the applications judge would render the time requirements embodied in that section meaningless.
[18] We can see no basis for distinguishing the situation in the present case from the one which was before this court in BMS. It follows that the applications judge was bound to follow that precedent and that she erred in failing to do so.
[19] We would add that, in the absence of exceptional circumstances, this Court should abide by its own precedents (seeMiller v. Attorney General of Canada, 2002 FCA 370 at paragraphs 8 to 10). No such circumstance has been brought to our attention.
[20] The appeals will accordingly be allowed, the judgment of the applications judge set aside and the decisions of the Minister to remove Ferring's Canadian Patent 2.166.296 from the patent list and to issue a Notice of Compliance to Apotex for Apo-Desmopressin will be reinstated, with costs in favour of the appellants here and below.
"Marshall Rothstein"
J.A.
"Marc Noël"
J.A.
"J. E. Sexton"
J.A.
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-105-03
STYLE OF CAUSE: APOTEX INC.
Appellant
(Respondent)
and
FERRING INC.
Respondent
(Applicant)
and
THE ATTORNEY GENERAL OF CANADA
and THE MINISTER OF HEALTH
Respondents
(Respondents)
AND BETWEEN:
DOCKET: A-142-03
STYLE OF CAUSE:THE ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Appellants
(Respondents)
and
FERRING INC.
Respondent
(Applicant)
and
APOTEX INC.
Respondent
(Respondent)
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: JUNE 16, 2003
REASONS FOR
JUDGMENT BY: ROTHSTEIN J.A.
NOËL J.A.
SEXTON J.A.
DATED: JUNE 19, 2003
APPEARANCES: H.B. Radomski
N. DeLuca
For the Appellant,
Apotex Inc.
Rick Woyiwada
For the Appellant,
A.G.C. and the Minister of Health
Patrick Kierans
Darren Noseworthy
For the Respondent,
Ferring Inc.
SOLICITORS OF RECORD:
Goodmans LLP
Barristers & Solicitors
Toronto, Ontario
For the Appellant,
Apotex Inc.
Morris Rosenberg
Deputy Attorney General of Canada
For the Appellant,
A.G.C. and The Minister of Health
OGILVY RENAULT
Barristers & Solicitors
Montréal, Quebec
For the Respondent,
Ferring Inc.
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