Date: 20021022
Docket: T-711-02
Neutral citation: 2002 FCT 1103
Toronto, Ontario, Tuesday, the 22nd day of October,2002
PRESENT: The Honourable Mr. Justice Campbell
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
- and -
THE MINISTER OF HEALTH and GENPHARM INC.
Respondents
REASONS FOR ORDER AND ORDER
[1] The application by the Applicants ("Abbott") upon which the present motion is brought is pursuant to s. 6 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"). Abbott's present motion concerns its Canadian Letters Patent No. 2, 261, 732 (the "'732 Patent"). The invention disclosed in the '732 Patent relates to a compound (6-O methylerythromycin A, crystal Form II ("Clarithromycin")) about which the water content of the solvent used in its manufacture is a certain infringement issue.
[2] Specifically, the evidence sought by Abbott from Genpharm under s. 6(7) of the Regulations concerns the composition of the solvent and the process for crystallizing Clarithromycin during what is known as the 1st and 2nd crystallization.
[3] I find that the following evidence with regard to this demand is relevant, required and important (Novartis AG v. Abbott Laboratories Ltd (2000), 7 C.P. R. (4th) 264 (F.C.A.):
a) The complete batch records and equipment information spelling out the complete and entire process for the production of Genpharm's Clarithromycin;
b) A proper description of equipment used in the treatment step including the mixing apparatus, the size and shape of the vessel in which the crystallization takes place, temperature control, cooling rate, and extent of stirring;
c) Information pertaining to the "in process contents" contained in Fermic S.A.'s "Description of Manufacture" contained in the DMF;
d) Any other relevant information with respect to solvent composition.
[4] On the record in the present motion, I find that the relevant evidence is contained in the Drug Master File ("DMF") and/or the Abbreviated New Drug Submission ("ANDS") filed with the Minister by Genpharm (Affidavit of Dr. D. Dodds, at paragraph 56, and Affidavit of Mr. A. Reddon, at paragraphs 23-29). With respect to compelling Genpharm to produce evidence from the DMF, Genpharm makes the argument that it cannot be required to produce it under s. 6(7)(a) of the Regulations since it is not contained in the ANDS filed by it.
[5] I do not accept this argument. I find that the new drug submission includes both the DMF and the ANDS and thus both fall within the definition of "submission for notice of compliance filed by the 2nd person" as the term is used in s. 6(7) of the Regulations. Accordingly, in the present motion I find that Genpharm is required to produce evidence from both the DMF and the ANDS.
ORDER
I HEREBY ORDER, pursuant to s. 6(7)(a) of the Regulations, that Genpharm produce the evidence cited in paragraph 3 above.
I FURTHER ORDER, pursuant to s. 6(7)(b) of the Regulations, that the Minister verify that the evidence produced corresponds to the information in the submission.
I ALSO ORDER that once the evidence is disclosed and verified as ordered, Abbott shall file its affidavits and documentary evidence within 75 days.
I award costs of this motion to Abbott in any event of the cause.
"Douglas R. Campbell"
J.F.C.C.
FEDERAL COURT OF CANADA
TRIAL DIVISION
Names of counsel and solicitors of record
DOCKET: T-711-02
STYLE OF CAUSE: ABBOTT LABORATORIES AND ABBOTT LABORATORIES LIMITED
Applicants
- and -
THE MINISTER OF HEALTH AND GENPHARM INC.
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: MONDAY, OCTOBER 21, 2002
REASONS FOR ORDER
AND ORDER BY: CAMPBELL J.
DATED: TUESDAY, OCTOBER 22, 2002
APPEARANCES BY: Mr. Steven Mason
For the Applicants
Ms. Barbara J. Murchie
For the Respondent, (Genpharm Inc.)
SOLICITORS OF RECORD: Mr. Steven Mason
McCarthy Tétrault LLP
Suite 4700
Toronto Dominion Bank Tower
Toronto Dominion Centre
Toronto, Ontario
M5K 1E6
For the Applicants
Sim, Hughes, Ashton & McKay LLP
6th Floor, 330 University Avenue
Toronto, Ontario
M5G 1R7
For the Respondent, (Genpharm Inc.)
FEDERAL COURT OF CANADA
Date:20021022
Docket: T-711-02
BETWEEN:
ABBOTT LABORATORIES AND ABBOTT LABORATORIES LIMITED
Applicants
- and -
THE MINISTER OF HEALTH ET AND
GENPHARM INC.
Respondents
REASONS FOR ORDER AND
ORDER