Abbott laboratories v. Health (Minister of), 2002 FCT 1103

                                                                                                                                             Date: 20021022

                                                                                                                                          Docket: T-711-02

                                                                                                                  Neutral citation: 2002 FCT 1103

Toronto, Ontario, Tuesday, the 22^nd 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 1^st and 2^nd 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. (4^th) 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 2^nd 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

6^th 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