Date: 20000615
Docket: T-106-00
Ottawa, Ontario, this 15th day of June, 2000
| PRESENT: THE HONOURABLE MR. JUSTICE JOHN A. O"KEEFE |
IN THE MATTER OF an application for an Order
pursuant to Section 55.2(4) of the Patent Act and
Section 6 of the Patented Medicines (Notice of
Compliance) Regulations
BETWEEN:
MERCK & CO., INC. and
MERCK FROSST CANADA & CO.
Applicants
- and -
NU-PHARM INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
O"KEEFE J.
[1] This is a motion by Merck & Co., Inc. and Merck Frosst Canada & Co. ("applicants") for the following:
1. An Order requiring the Respondent Nu-Pharm Inc. ("Nu-Pharm") to identify, by way of affidavit evidence to be filed by Nu-Pharm prior to the Applicants" affidavit evidence, the composition of Nu-Enalapril tablets, including the medicinal/active ingredient contained in the Nu-Enalapril tablets or used in the formulation of said tablets, all in accordance with paragraph 3(1).
2. An Order identifying the drug of the Applicant Merck Frosst Canada & Co. ("Merck Frosst") referenced by the Respondent in the Abbreviated New Drug Submission identified in its letter of December 16, 1999 purporting to be a Notice of Allegation.
3. An Order setting a schedule in this proceeding for the exchange of materials as follows:
a. the affidavits and documentary exhibits of the Respondent Nu-Pharm shall be served and filed within 75 days of the service of the Notice of Application to this proceeding; disposition of the Federal Court of Appeal appeal in number A-804-99;
b. the responding affidavits and documentary exhibits of the Applicants" [sic] Merck & Co., Inc. ("Merck") and Merck Frosst shall be served and filed within 75 days from the Judgment of the Federal Court of Appeal in Court No. A-804-99 or the receipt of the affidavits and documentary exhibits of the Respondent Nu-Pharm under 3(a), whichever is the later; receipt of Nu-Pharm"s evidence;
c. the reply affidavits and documentary exhibits, if any, of the Respondent Nu-Pharm shall be served and filed within 30 days of the service of the responding affidavits and documentary exhibits of the Applicants herein;
d. cross-examination on all affidavits shall be completed within 120 days of the service of the reply affidavit(s), if any, of the Respondent Nu-Pharm or 120 days from the date when such reply affidavit(s) would have been served (if no reply evidence of Nu-Pharm is filed and served);
e. Applicants" Records shall be filed and served within 60 days of completion of all cross-examinations;
f. the Respondent Nu-Pharm"s Record shall be filed and served within 30 days of service of the Applicants" Record;
g. the supplementary Records of Applicants, if any, shall be filed and served within 20 days of the service of the Respondents" Record.
4. In the absence of an Order under paragraph 3 hereof, an Order to extend the time for filing the Applicants" affidavits and documentary exhibits in support of the Applicants" Notice of Application to thirty days from the date of a final Order disposing of this motion.
5. Costs of this motion.
6. Such further and other relief as to this Honourable Court may seem just.
[2] The applicants commenced this proceeding on February 1, 2000 in response to a
letter from Nu-Pharm Inc. ( the "respondent Nu-Pharm") dated December 16, 1999, purporting to be a notice of allegation which was received by registered mail on or about December 21, 1999 (the "1999 Notice of Allegation"). The 1999 Notice of Allegation was delivered by the respondent Nu-Pharm in connection with its Nu-Enalapril tablets.
[3] The introductory paragraph of the 1999 Notice of Allegation states:
This Notice of Allegation is given as a result of the decision of Madam Justice McGillis dated November 23, 1999 in Federal Court File No. T-398-99. If the decision of Madam Justice McGillis is overturned on appeal from which no appeal is or can be taken, the Nu-Pharm Inc. intends to withdraw this Notice of Allegation. [sic]
[4] The 1999 Notice of Allegation states:
With respect to Canadian Letters Patent No. 1,275,349 (""349 Patent"), we allege that:
A. Claims 1, 8, and 11 are invalid, void and of no effect; and
B. With respect to each claim other than claims 1, 8 and 11, 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 us of Nu-Enalapril tablets in strengths of 2.5 mg, 5 mg, 10 mg and 20 mg for oral administration.
[5] The applicants claim that the 1999 Notice of Allegation is deficient in that it:
1. Fails to identify the medicine/active substance contained in the Nu-Enalapril tablets, as required by section 5 of the Patented Medicines (Notice of Compliance) Regulations.
2. Fails to identify the particular drug marketed in Canada pursuant to a Notice of Compliance ("NOC") with which Nu-Enalapril is compared with or referenced to, as required by section 5 of the Patented Medicines (Notice of Compliance) Regulations , and
3. Contains an incomplete "detailed statement of the legal and factual basis for the allegation" such that the basis of Nu-Pharm"s allegations of invalidity of claims 1, 8 and 11 of the "349 Patent are confusing, ambiguous, incomplete and unclear.
[6] The applicants complain that the 1999 Notice of Allegation:
- . Does not identify the medicine/active substance intended to be used to produce the drug nor the identity of the drug.
| 2. The allegations of invalidity cannot be fully understood nor can the applicants sufficiently respond to respondent Nu-Pharm"s allegations of invalidity. |
| 3. The allegations of invalidity are broad, generalized and lacking in sufficient, specific information so as to permit an adequate and proper response to be framed. |
| 4. It does not identify the particular drug presently marketed in Canada that the Abbreviated New Drug Submission of respondent Nu-Pharm will make a comparison with or a reference to for the purpose of demonstrating its bioequivalence. |
| [7] A Notice of Compliance ("NOC") was issued to the respondent Nu-Pharm on |
February 25, 1999 for Nu-Enalapril tablets identifying the Canadian Reference Product as "identical to Apo-Enalapril, Apotex, Inc." and the NOC identified the medicinal ingredient in the Nu-Enalapril tablets as "enalapril maleate". This NOC was declared to be invalid by a judgment of Justice McGillis of this Court on November 23, 1999, which decision was upheld by the Federal Court of Appeal.
| [8] The applicants rely on Rules 3, 8, 306 to 310 of the Federal Court Rules, 1998 |
and subsection 43(2) of the Patent Act.
| [9] The respondent Nu-Pharm opposes the motion and submits that the motion should |
be dismissed with costs.
Issues
| [10] 1. Is the respondent Nu-Pharm required to provide the further information |
requested by the applicants in paragraphs 1 and 2 of their motion?
| 2. In what order should the evidence be presented and when should it be |
| 3. Can a supplementary record be filed by the applicants, after the service of |
| the respondent Nu-Pharm"s record? |
Analysis and Decision
| Is the respondent Nu-Pharm required to provide the further information requested by the applicants in paragraphs 1 and 2 of their motion? |
The applicants have requested that respondent Nu-Pharm provide further information about the composition of Nu-Enalapril tablets, including the medicinal/active ingredient contained therein or used in the formulation of the tablets. The applicants have also asked for an Order identifying the drug of "Merck Frosst" referenced "in the Abbreviated New Drug Submission identified in its letter of December 16, 1999 purporting to be a notice of allegation".
| [12] The Federal Court of Appeal in Bayer AG v. Canada (Minister of National Health |
and Welfare) (1995) 60 C.P.R. (3d) 129 (F.C.A.) made the following statement in relation to notices of allegation at pages 133-34:
| In particular, this court in Pharmacia Inc. v. Canada (Minister of National Health and Welfare), Court File No. A-410-94, October 18, 1994, unreported, at p. 3 [since reported 58 C.P.R. (3d) 207, 51 A.C.W.S. (3d) 138] stated the following [at p. 209]: |
| It seems to us that while a notice of allegation does play an important role in the ultimate outcome of litigation of this nature, it is not a document by which the judicial review application may be launched under s.6 of the regulations. That document was put in as a piece of evidence by the appellants; it originated with the application filed before the Minister. Because it is not a document that was filed with the court but with the Minister, in our view the notice of allegation is beyond the reach of the court"s jurisdiction in a judicial review proceeding. That being so, the court, in our opinion, lacks jurisdiction to strike out the notice of allegation. |
| This clearly means that the court has no jurisdiction to make orders concerning the filing of notices of allegation or requiring them to be perfected in some way. The principle is that, by the scheme of the Regulations, the notice of allegation precedes the institution of prohibition proceedings in this court. It forms part of the background to that proceeding, perhaps what one might loosely refer to as part of the "cause of action". A court cannot order that a cause of action be created, or that it be created at a certain time, or in a certain way. It can only deal with it after it is created or allegedly created. Those who fail to file notices of allegation, or adequate notices of allegation, must assume their own risks when it comes to attacks on the adequacy of such allegations once prohibition proceedings are commenced before the court. |
| [13] The applicants" motion appears to be made in part to obtain more information |
about the allegations contained in the notice of allegation. By way of example, ground 11 deals with the deficiency of the notice of allegation. I am of the view that this Court does not have any jurisdiction in a judicial review proceeding to order the respondent Nu-Pharm to provide further particulars concerning the statements in the notice of allegation. As stated by the Court of Appeal in Bayer, ibid, those who file inadequate notices of allegation "must assume their own risks". I am not dealing in this motion with an application pursuant to subsection 6(7) of the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133 as amended. The applicants have made such a motion in paragraph E of their application in this matter. The Orders requested in paragraphs 1 and 2 of the motion are hereby denied.
[14] Issue 2
In what order should the evidence be presented and when should it be presented?
The applicants have asked me to issue an Order scheduling the proceedings in a certain manner, one component of such Order being a requirement that the respondent Nu-Pharm file its evidence prior to the applicants filing their evidence. The proposed Order would also schedule time frames by which the filings would be required to be completed.
| [15] In Merck Frosst Canada Inc. v. Canada (Minister of Health) (1998) 82 C.P.R. |
(2d) 417 (F.C.A.) the Court of Appeal discussed the order of filings and the presumption of subsection 6(6) of the Regulations and stated at page 419:
| Second, Merck should not be forced to file its own affidavit evidence with respect to Apotex"s process before Apotex files its own affidavit evidence. According to counsel, the presumption introduced in favour of the drug manufacturers when subsection 6(6) of the Regulations was added in 1998 changed the rules of the game and gave the manufacturers the right to have the last word in the filing of evidence. |
And at page 423:
| Fourth, the introduction of the presumption (whatever its real impact on the proceedings, an issue I need not address here) in the Regulations is irrelevant to the sequence of events prescribed by the Rules of the Court: it is at the end of the day, when all the evidence has been gathered under the Rules, that a judge will decide whether or not the presumption has been rebutted. |
| [16] Since this application is treated as an application for judicial review, Part 5 of the |
Federal Court Rules, 1998 ("Rules") apply. Rule 306 requires the applicants to file their supporting affidavits and documentary exhibits within 30 days after issuance of the notice of application. The respondent Nu-Pharm, by Rule 307, must serve and file any supporting affidavits and documentary exhibits within 30 days after service of the applicants" affidavits. Rule 308 requires that cross-examination on affidavits shall be completed within 20 days after the filing of the respondent Nu-Pharm"s affidavits or the expiration of the time for doing so, whichever is earlier. Rule 309 requires the applicants" record to be served and filed within 20 days after completion of cross-examination or the expiration of the time for doing so, whichever is earlier. Finally, Rule 310 requires the respondent Nu-Pharm to file its record within 20 days after service of the applicants" record.
| [17] As stated earlier, the applicants proposed that respondent Nu-Pharm be required to |
file its affidavits and supporting documents first and that these be filed within 75 days of the disposition of the appeal by the Federal Court of Appeal in Court File A-804-99.
| [18] The applicants argued, using Rule 3 as a basis, that I should adopt their proposal |
as this matter will only proceed if respondent Nu-Pharm fails in their appeal in Court File A-804-99. If the respondent Nu-Pharm succeeds, it will then withdraw the notice of allegation at issue in this matter. As well, the applicants submit that postponing the matter until the issue is resolved in Court File A-804-99 would be the most expeditious way to proceed in this case.
| [19] I do not agree with the position of the applicants. First, there is no legal basis for |
the respondent Nu-Pharm to present its affidavit and evidence prior to the applicants. The Rules simply do not provide for this. As well, there is no reason to postpone the proceedings in this application as applications under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations are to be dealt with in an expeditious manner (see Bayer A.G. v. Canada (Minister of National Health and Welfare) (1993) 51 C.P.R. (3d) 329 (F.C.A.)).
| [20] In my opinion the following schedule should apply in this proceeding: |
| 1. The applicants" supporting affidavits and documentary exhibits shall be due within 60 days of the date of this decision. |
| 2. The respondent Nu-Pharm"s evidence will be due within the period provided for in the Rules. |
| 3. Cross-examination on all affidavits shall be completed within 100 days after the filing of the respondent Nu-Pharm"s affidavits, if any, or within 100 days of the expiration of the time for doing so, whichever is earlier. |
| 4. The applicants" record shall be filed and served within 60 days of the completion of all cross-examinations. |
| 5. The respondent Nu-Pharm"s record shall be filed and served within 30 days of service of the applicants" record. |
| Can a supplementary record be filed by the applicants, after the service of the respondent Nu-Pharm"s record? |
| The applicants propose that they be allowed to file and serve a supplementary |
record, if any, within 20 days of the respondent Nu-Pharm"s record. The Rules make specific provision for the filing of a supplementary record. I believe that the request for an order to file a supplementary record is premature. If, on cross-examination of the affiants of any respondent Nu-Pharm affidavits reveals new relevant information, it would be highly unlikely that a judge would deny a motion pursuant to Rule 312 by Merck to file an additional record (see Merck Frost Canada Inc. v. Canada (Minister of Health) (1998) 82 C.P.R. (3d) 417 (F.C.A.) at pages 422-23). Accordingly, I would not grant an order to allow for the filing of a supplementary record at this time.
| [22] As neither party was fully successful, there shall be no order as to costs. |
| [23] In conclusion, it is my finding that: |
| 1. The respondent Nu-Pharm is not required to provide the further information in the manner requested by the applicants in paragraphs 1 and 2 of their motion. |
| 2. The evidence should be presented in the manner outlined in paragraph 20 of this decision. |
| 3. An Order allowing the filing of a supplementary record by the applicants will not issue at this time. |
ORDER
| [24] IT IS ORDERED that the respondent Nu-Pharm is not required to provide the |
further information in the manner requested by the applicants in paragraphs 1 and 2 of their motion.
| [25] IT IS FURTHER ORDERED that the evidence should be presented in the |
manner outlined in paragraph 20 of this decision.
| [26] IT IS FURTHER ORDERED that an Order allowing the filing of a |
supplementary record by the applicants will not issue at this time.
| [27] IT IS FURTHER ORDERED that there shall be no order as to costs. |
"John A. O"Keefe"
J.F.C.C.
Ottawa, Ontario
June 15, 2000
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