Date: 20010808
Docket: T-2280-00
Neutral Citation: 2001 FCT 862
BETWEEN:
MERCK FROSST CANADA & CO.
and
MERCK & CO., INC.
Applicants
AND
THE MINISTER OF HEALTH
and
APOTEX INC.
Respondents
[1] This is a motion for:
Re ANDS and Drug Master File
A. An order directing the Minister, within fourteen (14) days of this order to issue on this motion, to examine the documents appended as exhibit "CB-1" to the affidavit of Carol Barrette, and to:
(i) Verify that the portion of the Abbreviated New Drug Submission ("ANDS") and Drug Master File produced by Apotex (exhibit "CB-1") corresponds fully and accurately to the documentation presently in the Minister's file, and
(ii) In particular, verify that the Apotex ANDS and the Drug Master File to which it refers do not provide a detailed description of steps 1 or 2 of the four-step proposed method of manufacture;
(iii) Confirm to the parties that such verification has been effected and that the portion of the ANDS and Drug Master File produced by Apotex (exhibit "CB-1") corresponds fully and accurately to the information on file with the Minister or, where applicable, advise of any discrepancies or inaccuracies;
B. An order directing that any changes made during the pendency of the within proceedings to the detailed description of the method of manufacture portion of the Apotex ANDS and corresponding Drug Master File for simvastatin be produced forthwith by Apotex to the applicants at the time that the change is made;
C. An order directing the Minister to verify that any portion of the ANDS and corresponding Drug Master File produced by Apotex pursuant to paragraph B corresponds fully and accurately to the information on file with the Minister or to advise of any discrepancies or inaccuracies;
D. An order permitting the applicants to serve and file, within ten (10) days of the date of this order, a reply affidavit of Dr. James D. Wuest in respect of the portions of the Apotex ANDS and Drug Master file produced (exhibit "CB-1");
E. An order permitting the parties to include any documents provided pursuant to paragraphs A-D above in their application records and to rely on same at the hearing of the merits;
To strike or for reply and cross-examination
F. An order striking out questions 228 and following of the cross-examination of Dr. Robert A. McClelland held May 7, 2001;
G. An order directing that the parties shall not rely at the hearing on the merits on questions 228 and following of the transcript of the cross-examination of Dr. McClelland, nor the exhibit marked "A" for identification to the cross-examination of Dr. McClelland;
In the alternative to the relief sought in paragraphs F and G above:
H. An order permitting the applicants to file a reply affidavit of Dr. James D. Wuest in respect of matters raised in questions 228 and following of the McClelland cross-examination and in respect of the exhibit marked "A" for identification to said cross-examination, within ten (10) days of the date of this order;
I. An order compelling Dr. McClelland to re-attend for cross-examination in Montreal upon the matters raised in the exhibit marked "A" for identification to the McClelland cross-examination, at Apotex's expense;
Timetable
J. An order extending the timetable set by order of Pinard J. dated March 28, 2001, as follows:
(i) The applicants to serve and file a reply affidavit of Dr. James D. Wuest within ten (10) days of the date of this order;
(ii) Further cross-examinations as directed above to be held within thirty (30) days of this order;
(iii) The applicants' application record to be served and filed within thirty (30) days of the close of cross-examinations;
(iv) The respondents' application record to be served and filed within thirty (30) days of service of the applicants' application record;
Declaration of failure to co-operate
K. An order declaring that Apotex has failed to reasonably co-operate in expediting the application by a period to be set by the Court, and reserving the applicants' rights to seek a further order extending the delay, if necessary;
L. Such further and other relief as to this Honourable Court may seem just.
[2] The parties have informed the Court that they agree on paragraphs A, B, C and E of the notice of motion.
[3] The applicants have asked the Court that conclusion in paragraphs K and L should be adjourned sine die.
[4] I have carefully reviewed the materials and the transcript of the cross-examination of Dr. McClelland.
[5] Apotex has been aware since 1998, in the context of Court proceedings in T-418-98, that Dr. Steven A. Weissman ran the Detailed Process Description twice and did not obtain solid crude simvastatin at step 3 as described.
[6] Dr. Weissman provided evidence to the same effect in his affidavit in chief dated January 22, 2001.
[7] On February 21, 2001, Apotex filed the expert affidavits of Drs. Hendrickson, McClelland and Olah in response to the Weissman affidavit. None had carried out the procedure in answer to Dr. Weissman. Instead, they brought, in writing, explanations to why, in their view, Dr. Weissman did not obtain solid crude simvastatin as described.
[8] Dr. Olah was cross-examined in Los Angeles on May 4, 2001. He confirmed that he had not run the Detailed Process Description prior to his affidavit. Drs. Hendrickson and McClelland were cross-examined in Toronto on May 7, 2001. Both confirmed that prior to their affidavits, they had not carried out the Detailed Process Description.
[9] During the cross-examination of Dr. McClelland on May 7, 2001, Dr. McClelland stated that he had run the Detailed Process Description in his laboratory after his February 19, 2001 affidavit. (my emphasis)
[10] He then testified that he had run steps 3 and 4 of the Detailed Process Description five times in his laboratory in the period from April 18 to May 2, 2001 and that: "it works".
[11] The applicant also learned from that cross-examination that Dr. McClelland maintained a laboratory notebook giving details of his experimentation. During the cross-examination of Dr. McClelland, counsel for the applicants requested that the cross-examination be suspended in view of this new information in order to provide counsel with sufficient time to review the laboratory notebook and to confer with experts. Counsel for Apotex refused an agreement for a week or so, and agreed only on an adjournment for hours.
[12] In my view, it was not fair and I agree with counsel for the applicants that Dr. McClelland should re-attend for cross-examination.
[13] The applicants also request permission to file a reply affidavit of Dr. James D. Wuest commenting on the important and relevant differences between the method of manufacture disclosed in the detailed description of the Drug Master File as compared to the Detailed Process Description relied upon by Apotex in its notice of application, as well as to the revised patent application procedure introduced by Apotex on February 21, 2001.
[14] In my view the applicants did not have access to the detailed description in the Drug Master File before its disclosure by Apotex in response to the applicants' motion.
[15] I have no hesitation to conclude that the proposed reply of Dr. Wuest will assist the judge hearing the merits to appreciate the differences between the four process documents that are now before the Court and that relate to the justification of Apotex's allegation.
[16] For all these reasons THIS COURT ORDERS THAT:
- The Minister shall within thirty (30) days of this order examine the documents appended as exhibit "CB-1" to the affidavit of Carol Barrette, and
- The Minister shall verify that the portion of the Abbreviated New Drug Submission ("ANDS") and Drug Master File produced by Apotex (exhibit "CB-1") corresponds fully and accurately to the documentation presently in the Minister's file, and
- The Minister shall in particular, verify that the Apotex ANDS and the Drug Master File to which it refers do not provide a detailed description of steps 1 or 2 of the four-step proposed method of manufacture, and
- The Minister shall confirm to the parties that such verification has been effected and that the portion of the ANDS and Drug Master File produced by Apotex (exhibit "CB-1") corresponds fully and accurately to the information on file with the Minister or, where applicable, advise of any discrepancies or inaccuracies;
- Apotex shall produce forthwith to the applicants any changes made during the pendency of the within proceedings to the detailed description of the method of manufacture portion of the Apotex ANDS and corresponding Drug Master File for simvastatin at the time that the change is made;
- The Minister shall verify that any portion of the ANDS and corresponding Drug Master File produced by Apotex pursuant to paragraph B corresponds fully and accurately to the information on file with the Minister or to advise of any discrepancies or inaccuracies;
- The applicants are allowed to serve and file, within ten (10) days of the date of this order, a reply affidavit of Dr. James D. Wuest in respect of the portions of the Apotex ANDS and Drug Master File produced (exhibit "CB-1");
- The parties shall include any documents provided pursuant to paragraphs A-D above in their application records and to rely on same at the hearing of the merits;
- Dr. McClelland shall re-attend for cross-examination, in Toronto, upon the matters raised in the exhibit marked "A" for identification to the McClelland cross-examination, at Apotex's expense;
- The request for a declaration that Apotex has failed to reasonably cooperate in expediting the application is dismissed.
THIS COURT ALSO ORDERS THAT:
- The parties will be heard by teleconference at the date fixed by the Registrar to modify the timetable set by order of Justice Pinard dated Match 28, 2001, and also to hear the motion by Apotex for leave to rely upon the affidavits of Edward Lee-Ruff sworn July 13, 2001 and Dr. Robert McClelland sworn July 19, 2001 on the merits of this proceeding;
- Costs in the cause.
Pierre Blais
Judge
OTTAWA, ONTARIO
August 8, 2001
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD
COURT FILE NO.: T-2280-00
STYLE OF CAUSE: MERCK FROSST CANADA & CO. ET AL. v. THE MINISTER OF HEALTH ET AL.
PLACE OF HEARING: MONTRÉAL, QUÉBEC
DATE OF HEARING: JULY 30, 2001
REASONS FOR ORDER AND ORDER OF THE HONOURABLE MR. JUSTICE BLAIS
DATED: AUGUST 8, 2001
APPEARANCES:
Me. JUDITH ROBINSONFOR APPLICANT
Me. J. NELSON LANDRY FOR APPLICANT
Me. ANDREW R. BRODKINFOR RESPONDENT
Me. FRANCISCO COUTO FOR RESPONDENT
SOLICITORS OF RECORD:
OGILVY, RENAULTFOR APPLICANT
MONTRÉAL, QUÉBEC
OGILVY, RENAULT FOR APPLICANT
MONTRÉAL, QUÉBEC
GOODMANS FOR RESPONDENT
TORONTO, ONTARIO
MR. MORRIS ROSENBERGFOR RESPONDENT
DEPUTY ATTORNEY GENERAL OF CANADA