Date: 20030307
Docket: T-189-02
Neutral citation: 2002 FCT 287
Vancouver, British Columbia, this 7th day of March, 2003
PRESENT: THE HONOURABLE MR. JUSTICE JOHN A. O'KEEFE
BETWEEN:
MERCK FROSST CANADA & CO.,
and MERCK & CO., INC.,
Applicants
- and -
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
[1] This is a motion on behalf of the applicants, Merck Frosst Canada & Co. ("Merck Frosst") and Merck & Co., Inc. ("Merck") for:
A. An order directing Apotex Inc. ("Apotex") to produce copies of the following parts of any Abbreviated New Drug Submission ("ANDS") it has filed for "x" controlled release 200/50 mg or 100/25 mg tablets.
(i) Copy of the dated submission certification which accompanied the filing with the Minister of Health (the "Minister") of Apotex's currently pending drug submission for "x" controlled release 200/50 mg or 100/25 mg tablets, if any such submission was filed.
(ii) Copy of the completed and duly signed and dated Drug Submission Application Form in respect of Apotex's currently pending drug submission for "x"controlled release 200/50 mg or 100/25 mg tablets, if any such submission was filed.
(iii) Copy of the acknowledgement of receipt from and generated by the Minister, that indicates the date of receipt of the Apotex alleged submission, and its file number and control number, if any.
(iv) Copy of the letter or other document from and generated by the Minister, that indicates the date of completion of the screening of the Apotex alleged submission, and its file number and control number.
(v) Copy of the portion of Apotex's alleged submission pertaining to "Formulation and Method of Manufacture" and designated as follows by Health Canada in the Drug Master File:
Part II - CHEMISTRY & MANUFACTURING
2.2 Dosage Forms
2.2.4 Formulation & Method of Manufacture
B. An order directing that any changes made to the Apotex formulations during these proceedings 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 paragraphs A and B corresponds fully and accurately to the information on file with the Minister and to advise of any discrepancies or inaccuracies.
D. An order permitting the applicants to include any documents provided pursuant to paragraphs A - C above in their application records and to rely on them at the hearing of the merits.
E. An order permitting the applicants to file the affidavits of Dr. Louis Cartilier and Dr. Brian Amsden in reply to the affidavits of Dr. Eli Shefter, Dr. Robert Langer and Dr. Gilbert Banker filed on behalf of Apotex Inc.
F. An order setting the following timetable for the completion of pre-hearing steps in this proceeding:
(i) Apotex will provide the documents identified in paragraph A above within ten (10) days of the date of this order.
(ii) The Minister of Health will provide the confirmation required by paragraph C above within thirty (30) days of the production of any documents pursuant to paragraphs A or B.
(iii) The applicants will serve and file the reply affidavits of Dr. Cartilier and Dr. Amsden within five (5) days of the date of this order.
(iv) All cross-examinations to be completed within ninety (90) days of the date of this order.
(v) The applicants' application record to be served and filed within thirty (30) days of receipt of the transcripts of all cross-examinations.
(vi) The respondents' application record to be served and filed within thirty (30) days of service of the applicants' application record.
G. Such further and other relief as to this Court may seem just.
H. An order granting costs to the applicants.
Background
[2] On December 19, 2001, Apotex served a Notice of Allegation ("NOA") upon Merck Frosst with respect to Canadian Letters Patent 1,318,602 (the "'602 Patent"). Apotex submitted to the Minister, a New Drug Submission for "x" controlled release 200/50 mg and 100/25 mg tablets for oral administration.
[3] In the NOA, Apotex alleged that no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by it of the aforementioned tablets.
[4] The applicants seek leave of the Court to file reply evidence to that of Apotex as the applicants allege that Apotex's witnesses raised issues for the first time in their affidavits that were not identified in the NOA. The applicants claim these issues could not have been anticipated.
[5] Apotex alleged in its NOA that certain claims in the '602 Patent are invalid on the basis that they are anticipated and obvious. In relation to anticipation, Apotex states that the specific claims of the '602 Patent are anticipated by the Sheth, U.S. Patent 4,424,235 (the "Sheth Patent"). In relation to obviousness, it alleged that the claims of the '602 Patent disclose nothing that is inventive from the view of a person skilled in the art at the relevant time
[6] The within proceeding was commenced as an application for prohibition pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133, as amended, (the "Regulations").
[7] Merck filed the affidavits of Dr. Louis Cartilier, Dr. Jean-Christophe Leroux and Dr. Brian G. Amsden in support of the motion.
[8] Apotex filed the affidavits of Dr. Gilbert Banker, Dr. Eli Shefter and Dr. Robert Langer, in response to the Merck affidavits.
[9] In the present motion, Merck has asked to file expert reply evidence to respond to issues it claims arose for the first time in Apotex's affidavits and to correct incorrect statements put in evidence by Apotex. Merck also seeks an order requiring Apotex to produce certain parts of its ANDS.
[10] Issues
1. Are the applicants entitled to file reply evidence?
2. Should the Court exercise its discretion to order Apotex to produce sufficient information from its ANDS to confirm whether and when it filed a New Drug Submission for 200/50 mg and 100/25 mg "x" controlled release tablets?
3. Is Apotex required to produce information from its ANDS pertaining to the formulation and method of manufacture of its tablets?
[11] Issue 1
Are the applicants entitled to file reply evidence?
An applicant may, with the leave of the Court, file affidavits in addition to those filed in chief pursuant to Rule 306 of the Federal Court Rules, 1998, S.O.R./98-106. This is provided for in Rule 312.
[12] In general, the Court agrees with the applicants' summary of factors that must be present in order for the filing of reply affidavits to be allowed. The applicants stated in paragraph 9 of their written representations:
This Court will permit reply affidavits to be filed by an applicant when:
(a) the respondent's evidence could not have been anticipated by the applicant;
(b) it may assist the Court in making its final determination;
(c) to refuse to do so would cause substantial prejudice to the applicant;
(d) it will serve the interests of justice;
(e) it will not cause unreasonable delay.
Order and Reasons for Order of Pinard J. rendered March 28, 2001 (T-2280-00)
Abbott Laboratories Ltd. v. Apotex Inc. (1998), 82 C.P.R. (3d) 216 (F.C.T.D.), per Rouleau J.
SmithKline Beecham Pharma Inc. v. Apotex Inc., unreported decision of Blais J. rendered September 3, 1999 in T-677-99.
Reply Affidavit Evidence
[13] In regard to the requirements that must be present in order to file reply evidence, I have reviewed the applicants' affidavits and am unable to find anywhere in the affidavits where it is established that the tendering of the additional affidavits would not delay the proceeding, that the evidence would assist the Court in the determination of the issues or that the filing of the affidavits would not cause unreasonable delay. Accordingly, I find there are sufficient grounds to dismiss the part of the motion dealing with the filing of additional affidavit evidence.
[14] However, if this finding is in error, I will now deal with the issue of whether the respondents' evidence could have been anticipated by the applicants.
Reply Evidence re: Capsules
[15] I have reviewed the affidavits of Dr. Cartilier and Dr. Amsden filed in this matter. When dealing with the anticipation of the '602 Patent, I note that references are made in those affidavits that the teachings of the Sheth Patent are not restricted to tablets, but also include capsules (see paragraphs 42, 47, 49 and 56 of the Cartilier Affidavit and paragraph 55 of the Amsden affidavit). I find that the Merck experts could have anticipated that Apotex might allege that the '602 Patent is anticipated on the basis that both affidavits refer to capsules. Accordingly, I would not allow reply affidavit evidence to be filed in this respect.
Floating Tablets
[16] The applicants wish to file reply affidavit evidence relating to whether the '602 Patent covers buoyant formulations. Upon review of the applicants' affidavits, I am satisfied that this issue was raised first by the applicants' in various expert affidavits. This issue was addressed by Dr. Amsden in paragraphs 50 to 53 of his affidavit and by Dr. Cartilier in paragraphs 42, 49, 50, 52, 56 and 57 of his affidavit. Not only could this issue have been anticipated, but it was raised for the first time by the applicants' own experts. Therefore, I will not permit the filing of additional affidavit evidence on this issue. I also note that when Apotex's expert, Dr. Eli Shefter, was commenting on buoyancy, he referred to Merck's affiant's statement in paragraph 61 of his affidavit sworn July 16, 2002.
Alleged Advantage of Buoyancy
[17] Apotex's expert, Dr. Banker, stated at paragraph 62 of his affidavit that "I believe the Sheth approach may offer real advantages for . . ." The applicants now wish to present reply evidence to show that scientific papers show that buoyant systems do not provide any significant advantages over non-buoyant systems. The applicants have already addressed the issue of buoyancy in paragraph 47 of Dr. Amsden's affidavit in chief.
[18] The new evidence to be offered by Dr. Amsden is to the effect that the buoyant systems (such as described in the Sheth Patent) do not provide any significant advantage over non-buoyant systems. This would appear to be a different conclusion than stated by him in paragraph 47 of his original affidavit. This issue was addressed by the applicants in the affidavit in chief of of Dr. Amsden. Accordingly, the proposed reply evidence is not permitted. This is not a situation where the applicants could not have anticipated the evidence of the respondents.
Mistakes in the Langer Affidavit
[19] The applicants wish to file reply evidence with respect to incorrect statements made by Apotex's expert, Dr. Langer, appearing in a section of his affidavit where he deals with and disagrees with statements made by Merck's expert witness. This is not a proper subject matter for reply evidence. This is simply a case of Apotex's expert disagreeing with Merck's experts. This can be addressed by cross-examination.
[20] In conclusion, with respect to reply evidence, I will not permit the filing of any of the reply evidence requested by Merck.
Request to Produce Portions of ANDS
[21] Subsection 6(7) of the Regulations, supra reads:
| (7) On the motion of a first person, the court may, at any time during a proceeding, (a) order a second person to produce any portion of the submission for a notice of compliance filed by the second person relevant to the disposition of the issues in the proceeding and may order that any change made to the portion during the proceeding be produced by the second person as it is made; and (b) order the Minister to verify that any portion produced corresponds fully to the information in the submission. |
(7) Sur requête de la première personne, le tribunal peut, au cours de l'instance: a) ordonner à la seconde personne de produire les extraits pertinents de la demande d'avis de conformité qu'elle a déposée et lui enjoindre de produire sans délai tout changement apporté à ces extraits au cours de l'instance; b) enjoindre au ministre de vérifier que les extraits produits correspondent fidèlement aux renseignements figurant dans la demande d'avis de conformité. |
[22] A decision pursuant to subsection 6(7) of the Regulations, supra is discretionary. An applicant must show on the balance of probabilities that disclosure should be ordered. The Federal Court of Appeal in Novartis Pharmaceuticals Canada Inc. v. Abbott Laboratories Ltd. [2000] F.C.J. No. 941 (QL) at paragraph 17 stated:
I think whether disclosure is required and is important are appropriate considerations for the exercise of discretion under subsection 6(7).
The applicants wish to have disclosure as they do not accept that Apotex filed an ANDS for the 100/25 mg dosage of the tablets as of December 19, 2001 and because the tablets for which Apotex seeks a Notice of Compliance are not manufactured in accordance with the Sheth Patent and therefore infringe the '602 Patent.
No ANDS for the 100/25 mg Dosage
[23] The applicants base their argument on the fact that in another application:
1. Dr. Sherman refused to answer whether Apotex had filed a submission for a notice of compliance in respect of a 100/25 mg dosage.
2. Paragraph 35 of the affidavit of Anni Bowes to the effect that Apotex had filed an ANDS for the 200/50 mg format.
3. Notation on a letter, dated December 14, 2001, from Bernard Sherman to David Lee, Patent-Officer-Legal re '602 Patent on which is a hand-written note states "Apotex submission is for 200/50 CR tablet NDS re dosage form".
[24] The allegations in an NOA are presumed to be true unless the contrary is indicated. The applicants urge that the evidence referred to in the preceding paragraph is sufficient to show that the NOA should not be presumed to be true. I do not agree. The evidence referred to above does not cause Apotex's allegation that it had filed an ANDS for both strengths of the tablets to not be presumed true. That being the case, the applicants have not satisfied me on the balance of probabilities that disclosure is required and is important, on this basis, so as to allow me to order disclosure pursuant to subsection 6(7) of the Regulations.
Disclosure Necessary in Relation to Infringement
[25] The applicants request information be disclosed showing the composition of the Apotex tablets and how they are manufactured. The evidence before me shows that in response to the order of Prothonotary Lafrenière, dated March 28, 2002, Apotex provided the composition of its tablets. The applicants, however, state that when their expert, Dr. Leroux, made tablets using Apotex's formulations, the tablets did not have the essential characteristics of the Sheth Patent.
[26] Apotex objected to this matter being raised as Dr. Leroux's affidavit was not included in the applicants' motion record. I heard argument on this issue and stated that I would rule on it in my decision. I am prepared to allow this point to be raised as the Leroux affidavit is part of the Court record in this matter. It is filed as document number 28 in the Court record (see Mountainbele Co. Ltd. et. al. v. W.T.C. Air Freight (H.K.) ltd. et. al. (1990) 128 N.F. 75 (F.C.A.)). As well, the submission was contained in the applicants' written representations.
[27] The evidence in Dr. Leroux's affidavit is to the effect that Apotex's proposed formulation will not produce a tablet that is in accordance with the Sheth Patent. Dr. Leroux explained the processes used by him in making the tablets according to Apotex's formulations.
[28] There is no question that a decision made under subsection 6(7) of the Regulations is discretionary. In SmithKline Beecham Pharma Inc. v. Apotex Inc. (1999) 3 C.P.R. (4th) 22 (F.C.T.D.) McGillis J. stated at page 27:
Although I have not summarized all of the evidence adduced by the parties on the motion, I have nevertheless carefully considered all of it in arriving at my decision. In my opinion, SmithKline has established on a balance of probabilities that disclosure of the full process for the manufacture of Apotex' paroxetine hydrochloride is required to provide a proper evidentiary foundation for assessing the allegation of non-infringement in relation, at least, to the product by process claim in claim 5 of the '023 patent. I also note that the evidence of Dr. Fallis that it would be "important", in determining the question of infringement, to assess the further processing done by Apotex after the recrystallization step revealed in the disclosed materials was not undermined in cross-examination. Apotex shall therefore produce to SmithKline pages 6 to 19 of the drug master file of its wholly owned subsidiary Brantford Chemicals. Those pages of the drug master file constitute a portion of the submission for a notice of compliance for the drug paroxetine hydrochloride filed by Apotex with the Minister and are relevant to the disposition of the issues raised in the proceeding.
To order disclosure pursuant to subsection 6(7) of the Regulations, I must be satisfied on a balance of probabilities that the disclosure of section 2.2.4 "Formulation & Method of Manufacture" is required to provide a proper evidentiary basis for assessing the allegation of non-infringement made by Apotex and that it would be important in determining the question of infringement to have this information. I have reviewed the affidavits referred to by the applicants in this motion and I am not satisfied on a balance of probabilities on the basis of the evidence contained in these affidavits that the disclosure of the section 2.2.4 of the ANDS is required or important in assessing Apotex's allegation of non-infringement. The applicants' expert, Dr. Leroux does not say that the disclosure of section 2.2.4 of the ANDS is required or important to the issue of non-infringement, nor does the other evidence filed on the motion establish these requirements on a balance of probabilities. Accordingly, I will not order the disclosure of section 2.2.4 "Formulation & Method of Manufacture" portion of the ANDS.
[29] The applicants' motion is dismissed.
ORDER
[30] IT IS ORDERED that:
1. The applicants' motion is dismissed.
2. I retain jurisdiction to deal with the timetable issue if such is still necessary
3. Costs shall be costs in the cause.
(Sgd.) "John A. O'Keefe"
J.F.C.C.
Vancouver, B.C.
March 7, 2003
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-189-02
STYLE OF CAUSE: MERCK FROSST CANADA & CO.,
and MERCK & CO., INC.
- and -
THE MINISTER OF HEALTH and APOTEX INC.
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: Monday, September 30, 2002
REASONS FOR ORDER AND ORDER: O'KEEFE J.
APPEARANCES:
Mr. Brian Daley
Ms. Judith Robinson FOR APPLICANTS
Mr. Andrew Brodkin
Ms. Natalie Butterfield FOR RESPONDENTS
SOLICITORS OF RECORD:
Ogilvy Renault S.E.N.C. FOR APPLICANTS
Goodmans LLP FOR RESPONDENT, APOTEX INC.
The Deputy Attorney General of Canada FOR RESPONDENT, MINISTER
OF HEALTH