OTTAWA, ONTARIO, December 29, 2006
PRESENT: The Honourable Mr. Justice von Finckenstein
BETWEEN:
Applicants
and
THE ATTORNEY GENERAL OF CANADA
and APOTEX INC.
Respondents
REASONS FOR ORDER AND ORDER
[1] This is a motion for stay in conjunction with an application for Judicial Review by Sanofi-Adventis Canada Inc. (“Sanofi”) regarding the Minister of Health’s (“Minister”) decision of December 13, 2006 to grant a Notice of Compliance (“NOC”) to Apotex Inc. ( “Apotex”).
[2] Sanofi makes and sells Ramipril, an ACE inhibitor, i.e. a medicine used in drugs to treat cardiovascular problems such as preventing and treating hypertensions. This use of ramipril for this purpose will hereinafter be referred to as the “old use”. Sanofi sells Ramipril under the brand name ALTACE and it has been sold in Canada for the old use since January of 1994. Sanofi claims that ALTACE is its largest and most successful product in Canada and represents a very substantial proportion of its annual sales in Canada. The chronology of events is as follows.
Old use
[3] Sanofi filed its application for an NOC for ramipril for the old use on August 7, 1992 and received its NOC on October 2, 1993.
HOPE use
[4] On April 3, 2000 Sanofi filed a Supplemental New Drug Submission (SNDS) No. 066094 in respect of ALTACE for a new indication, called the “HOPE indication.” HOPE stands for Heart Outcomes Prevention Evaluation.
[5] On February 13, 2001, Sanofi received an NOC in respect of the HOPE submission.
Updated Pharmacology use
[6] On December 20, 2002, Sanofi filed submission number 082094 in respect of ALTACE. The submission was to “Update the action and clinical pharmacology section of the product monograph with regards to managements of patients with increased risk of cardiovascular events” (the “Updated Pharmacology Submission”).
[7] On November 6, 2003, Sanofi received an NOC in respect of the Updated Pharmacology Submission (the “Updated Pharmacology NOC”).
Patents
[8] On August 25, 2000, Sanofi filed a foreign priority patent application for what ultimately became Canadian Letters Patent No. 2,382,387 (the “387 Patent”), entitled “PHARMACEUTICAL FORMULATIONS AND USE THEREOF IN THE PREVENTION OF STROKE, DIABETES AND/OR CONGESTIVE HEART FAILURE”. The 387 Patent was filed in Canada on February 26, 2002.
[9] On August 30, 2000, Sanofi filed a foreign priority patent application for what ultimately became Canadian Letters Patent No. 2,382,549 (the “549 Patent”), entitled “USE OF INHIBITORS OF THE RENIN-ANGIOTENSIN SYSTEM IN THE PREVENTION OF CARDIOVASCULAR EVENTS”. The 549 Patent was filed in Canada on February 27, 2002.
[10] On March 15, 2005, the 549 Patent issued. It was added to the Patent Register two days later. The 549 Patent was added to the Patent Register by way of Sanofi’s submission of a “Form IV”, which submission relates to the 549 Patent to the Updated Pharmacology Submission.
[11] On June 21, 2005, the 387 Patent issued. It was added to the Patent Register seven days later. The 387 Patent was added to the Patent Register by way of Sanofi’s submission of a “Form IV”, which submission relates to the 387 Patent to the Updated Pharmacology Submission.
Apotex’s allegations
[12] On July 25, 2003, Apotex filed ANDS number 085886 in respect of Apo-Ramipril (“Apotex ANDS”). The Apotex submission involved a bioequivalence comparison between drug product Apotex had manufactured in November 2001 and a supply of the then-approved old use of ALTACE.
[13] Apotex in a Notice of Allegation (“NOA”) dated November 29, 2005 addressed the 387 Patent and the 549 Patent alleging, inter alia, irrelevancy, improper listing, invalidity, non-infringement in respect of both patents, and also double patenting in respect of the 549 Patent.
Litigation history
[14] In response to these allegations, Sanofi commenced an application on January 17, 2006 (File No. T-87-06) to prohibit the Minister from issuing an NOC to Apotex. By virtue of s. 7(1)(e) of the NOC Regulations, no NOC may be issued until the earlier of a court disposition of the application or the expiration of 24 months after receipt of proof of the making of an application under subsection 6(1) of the NOC Regulations.
[15] These proceedings were in mid stream. Cross examinations on the affidavit evidence filed in the proceedings were taking place and no date for the hearing had been set when on November 3, 2006, the Supreme Court of Canada rendered its decision in AstraZeneca Canada Inc. v. Canada (Minister of Health), [2006] SCC 49.
[16] In that case, Binnie J. made the following statement:
H. The Broader Statutory Purpose
38 I repeat that Parliament's stated purpose in authorizing the NOC Regulations was to permit the early working of the patented invention (s. 55.2(4)). As Apotex did not make use of the patented inventions taught by the 037 and 470 patents, Apotex is not on this occasion within the mischief aimed at by the NOC Regulations.
39 By imposing the 24-month delay called for by the NOC Regulations, the decision of the Federal Court of Appeal undermines achievement of the balance struck by Parliament between the objectives of the FDA and regulations thereunder (making safe and effective drugs available to the public) and the Patent Act and its regulations (preventing abuse of the early working exception to patent infringement). Given the evident (and entirely understandable) commercial strategy of the innovative drug companies to evergreen their products by adding bells and whistles to a pioneering product even after the original patent for that pioneering product has expired, the decision of the Federal Court of Appeal would reward evergreening even if the generic manufacturer (and thus the public) does not thereby derive any benefit from the subsequently listed patents. In my view, s. 5(1) of the NOC Regulations requires a patent-specific analysis, i.e. the generic manufacturer is only required to address the cluster of patents listed against submissions relevant to the NOC that gave rise to the comparator drug, in this case the 1989 version of Losec 20.
40 If AstraZeneca had brought to market a Losec 20 product pursuant to the later NOCs and if Apotex had made reference to that modified product for the purpose of demonstrating bioequivalence, Apotex would have been required to file a notice of allegation with respect to the 037 and 470 patents.
41 However, it is clear that AstraZeneca did not market any product pursuant to the subsequent NOCs and that the preconditions to any obligations of Apotex under s. 5(1) were therefore not triggered.
(Underlining added.)
[17] Apotex, on the basis of rationale in the AstraZeneca decision, asked the Minister to grant it the requested NOC. The Minister’s representative summarized Apotex’s argument as follows:
In your correspondence, you state that patents 2,382,387 (“the ‘387 patent”) and 2,382,549 (“the ‘549 patent”) were added to the Patent Register in respect of your comparator drug, ALTACE, in connection with a supplement to a new drug submission (“S/NDS”) filed by sanofi-aventis Canada Inc. (“sanofi-aventis”) for which an NOC was issued on November 6, 2003. In light of our interpretation of the recent AstraZeneca decision, you take the position that since your ANDS was submitted before November 6, 2003, Apotex is not required to address the ‘387 patent or the ‘549 patent under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”).
(Gordon Affidavit, Exhibit 1: Exhibit “3”, Applicant’s Motion Record, Vol. 2 at 383.)
[18] The Minster’s representative, Mr. Lee, Director of the Office of Patented Medicines and Liaison by letter of December 8, 2006, which was copied to Sanofi, refused to do so. Mr. Lee essentially agreed with Apotex but concluded that an NOC could not be granted as matters were presently before the court. The key paragraphs of his letter read as follows:
These patents were added in respect of sanofi-aventis’ S/NDS number 082094 for a change to the Product Monograph for ALTACE. A comparison of the sanofi-aventis’ product monograph and Apotex’s monograph shows that Apotex has not incorporated the change. Therefore, Apotex does not have to address the ‘549 and the ‘387 patents.
Note, however, that at this time, the TPD [Therapeutic Products Directorate of Health Canada] is unable to issue an NOC to Apotex for these products as, in our view, we are bound by the 24 month stay imposed by the PM(NOC) Regulations in respect of the prohibition proceeding in T-87-06. You will, therefore, be required to dispose of that proceeding prior to the issuance of an NOC.
(Gordon Affidavit, Exhibit 1: Exhibit “3”, Applicant’s Motion Record, Vol. 2 at 407-08.)
[19] Sanofi did not agree with Mr. Lee’s interpretation of the AstraZeneca case. Discussions between Sanofi’ counsel and Mr. Lee took place on December 12, 2006 which ultimately proved unproductive. As Mr. Lee was unwilling to confirm that no NOC would be issue, Sanofi commenced an application for judicial review on December 12 (File number T 2989-06) to quash Mr. Lee’s decision as set out in the letter of December 8, 2006. That application was served on the representatives of the Minister that same day.
[20] However, the next day, on December 13, 2006, an NOC was issued to Apotex. The Minister’s representative, Mr. Omer Boudreau, Director General of the Therapeutics Products directorate, Health Products and Food Branch explained his reasoning for issuing an NOC to Apotex in a letter to Sanofi’s counsel:
In light of our interpretation of the AstraZeneca decision, Apotex is no longer required to address the ‘387 and the ‘549 patents. As such, Apotex is no longer considered to be a “second person” in respect of the ‘387 and the ‘549 patents pursuant to the PM(NOC) Regulations. It follows, therefore, that section 7 of the PM(NOC) Regulations is not applicable to prohibit the issuance of the NOC.
Therefore, an NOC has been issued in respect of Apotex’s ANDS number 085886, as all the relevant requirements of both the PM(NOC) Regulations and the Food and Drug Regulations [C.R.C., c. 870] have been met.
(Gordon Affidavit, Exhibit 1: Exhibit “6”, Applicant’s Motion Record, Vol. 2 at 413.)
[21] Sanofi then brought a second judicial review application (file No T 2196-06) to have the decision dated December 13, 2006 set aside. In support of that judicial review application, Sanofi now brings this motion for an interim stay.
[22] Ratiopharm, another generic drug company, on December 13, 2006, also received an NOC from the Minister to market ramipril for its old use. However, that NOC was authorized by Sanofi.
Relief sought
[23] In the present motion, Sanofi asks for the following relief:
1. An Order pursuant to Section 18.2 of the Federal Courts Act staying the operation and effect of the decisions dated December 8 and 13, 2006, on behalf of the Minister of health, which decisions are the subject of the judicial review proceedings herein, pending disposition of the judicial review, or until a date to be fixed by this Court.
2. An Order pursuant to Section 18.2 of the Federal Courts Act staying the operation of a Notice of Compliance (“NOC”) issued on December 13, 2006 to Apotex Inc. (“Apotex”) in respect of Apotex’s Abbreviated New Drug Submission (“ANDS”), Submission number 085886, for its APO-RAMIPRIL 1.25 mg, 2.5 mg, 5 mg, and 10 mg capsules, pending the earlier of either the disposition of the judicial review proceedings herein, or the termination of the 24 month statutory stay in place in respect of the application commenced pursuant to the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) in Federal Court File T-87-06 (the “co-pending NOC proceeding”).
3. Interim Orders, if necessary, in respect of paragraphs 1 and 2 above pending the hearing and determination of the present motion.
4. An Order scheduling the hearing of the judicial review applications herein on an expedited basis.
5. An Order, if necessary, abridging the time for service and filing of the Motion Records herein.
6. A Protective Order, in a form to be agreed by counsel, or as ordered by this Honourable Court.
Issue
[24] Clearly the issue is whether a stay can and should be granted under these circumstances.
Analysis
The parties made extensive arguments before me concerning the application of the tri-partite test laid down in Manitoba (Attorney General) v. Metropolitan Stores (MTS) Ltd., [1987] 1 S.C.R. 110, 38 D.L.R. (4th) 321. While this is the traditional way of assessing interim and interlocutory applications this application in my view raises a more fundamental issue, namely, respect for the courts and ongoing court proceedings.
Respect for the Court
[25] The prohibition proceedings under file No T-87-06 are not yet complete, and no hearing date has been set. The Minister is a party to these proceedings as these prohibition proceedings are directed against him. Admittedly, traditionally he plays a somewhat passive role and the dispute is principally litigated between the generic company and the innovator drug company, yet he is undeniably a party and, as stated before, any resulting prohibition order will be directed against him. Action T-87-06 is an ongoing litigation regarding the interpretation, application and relevancy of both the 387 and the 549 Patents. Initially, Mr. Lee from the Office of Patent Medicines and Liaison took the right stance when he stated to Apotex that the T-87-06 proceedings would have to be disposed off by the court before the Minister could grant an NOC.
[26] As a party to the litigation the Minister could not unilaterally take steps rendering the litigation superfluous. He should have pointed to s. 6(5) of the NOC Regulations and ask that Apotex bring a motion to have the prohibition application declared redundant in light of AstraZeneca. It would then be up to the court to decide whether it agrees with the interpretation of AstraZeneca as advanced by Apotex and the Minister or not.
[27] This is precisely the course followed in somewhat analogous proceedings, also concerning Ramipril and the AstraZeneca decision, with respect to Canadian Patents 2023089 and 2055948. In Sanofi-Aventis Canada Inc. v. Novopharm Limited, 2006 FC 1547, my colleague Justice Hughes did not allow just such an application to dismiss the proceedings under s. 6(5)(b) of the NOC Regulations as being redundant, scandalous, frivolous or otherwise an abuse in respect of one or both parties. The issue obviously is not as clear cut as Mr. Boudreau sees it.
[28] No such application was brought by Apotex. Instead of proceeding that way, and in face of the judicial review application by Sanofi contesting Mr. Lee’s decision of December 8, 2006 (proceedings T-2989-06), the Minster chose to interpret the AstraZeneca case himself and act on his own interpretation. By issuing the NOC to Apotex he rendered the whole T-87-06 proceedings redundant. He also totally ignored the fact that there was a dispute with regard to how AstraZeneca should be interpreted and applied. Clearly, Sonafi held a different view than Apotex and the Minister was fully aware of that fact as Sanofi actually commenced judicial review proceedings to have Mr. Lee’s decision quashed.
[29] Apotex argues that the issue of the NOC prohibition proceedings are moot and thus, the Court has no power to remedy the situation. In its factum Apotex explains its position as follows:
55. The Federal Court and Federal Court of Appeal have repeatedly and consistently held that once an NOC has issued to a second person, the Regulations have no operation in respect of that extant NOC. The courts cannot “stay” the operation of a decision to grant an NOC that has already resulted in the issuance of that NOC: the issue is moot. The possibility of a reviewable legal error is an irrelevancy.
There was no bar to the issuance of the Notice of Compliance
on that date. Accordingly, the motion to stay the issuance of a Notice of
Compliance cannot succeed since the Notice of Compliance was already issued
under subsection 7(1) of the Patented Medicines (Notice of Compliance)
Regulations. [emphasis added by Apotex]
Janssen-Ortho Inc. v. Novopharm
Ltd., 2005 FCA 2 at para. 9
[The first person] contend[s] that this Court (the Court of
Appeal) has the power under s. 52 of the Federal Court Act to do what
the Trial Judge should have done, namely issue the prohibition.
…
The issue of these NOCs foreclosed any attempts to continue prohibition
proceedings under the Regulations, as the summary procedure therein was spent.
…
The Regulations make no mention of certiorari to quash an NOC lawfully
issued by the Minister or any other remedy in the form of a declaratory
judgment.
..
The only remedy available to the appellants is an order for prohibition. But,
for reasons already given, no such order can be made by this Court, because, in
each appeal, the Minister has issued an NOC as he was entitled by law to do.
This lawful administrative action taken by the Minister under the Regulations
has rendered the appeals moot.
Pfizer Canada
Inc. v. Nu-Pharm Inc.,
Pfizer Canada Inc. v. Apotex Inc. (2001), 11 C.P.R. (4th) 245 (F.C.A) at
paras. 20, 21, 26, 27
…
57. The Federal Courts have similarly held that relief under sections 18 and 18.1 of the Federal Courts Act to ensure that the Minister complies with his duties under the Regulations is superfluous and cannot be sought. For instance, in a companion case to the AstraZeneca case, Kelen J. held that any possible failure of the Minister to correctly assess whether a generic drug submission changed so as to raise patent concerns was not addressable by way of judicial review. Similarly, prohibition orders cannot be restored once an NOC issues on the basis of a change in facts.
(Footnotes deleted.)
[30] I cannot accede to this proposition. All the cases relied on by Apotex are situations where the NOC proceedings have spent their course. In such an event, indeed the issue is moot and all the first person can do is to commence infringement proceedings and seek an interlocutory injunction.
[31] However, in this instance the NOC proceedings are not spent. They are in full force and were hotly contested when the Minister took his unilateral action in the face of a legislative stay. Once prohibition proceedings have been commenced it is up to the court, not the Minister, to decide if the proceedings have become redundant by reason of any intervening judicial decisions. In this case however, the Minister in effect usurped the functions of the court and took it upon himself to decide that the prohibitions proceedings were redundant.
[32] In my view the issuance of the NOC in light of the subsisting prohibition application and in light of the co-pending judicial review application show an utter disrespect by the Minister for the court and the proceedings in front of it (to which the Minister is a party).
[33] In the absence of legislative provisions to the contrary, a court has inherent powers to control its own process and administer justice. I see nothing in section 18.2 of the Federal Courts Act, R.S.C. 1985, c. F-7 or the NOC Regulations that restricts those inherent powers in the present circumstances.
[34] In my view this serious lack of respect for the court and the non-observance of the legislative stay provided for in the NOC Regulations should not be rewarded by letting the persons displaying a lack of respect to the court, i.e. the Minister of Health and Apotex, from enjoying the fruits of the unauthorized act. Accordingly, a stay order will issue ordering the Minister and Apotex to comport themselves as if the NOC of December 13, 2006 had not been issued until such time as the judicial review application has been heard.
Metropolitan Stores Analysis
[35] The Court also undertook an analysis of the stay request on the basis of the tri-partite test set out in Metropolitan Stores, supra, in case the foregoing conclusion is not upheld on appeal.
[36] The test provides that applicants are entitled to relief only if they can satisfy all of the following elements:
(i) There must be a serious question to be tried;
(ii) The moving party would suffer irreparable harm if the application was granted; and
(iii) The balance of convenience favours the grant of the stay.
[37] In my view the Applicant does not meet that test as it failed to establish the irreparable harm element for the following reasons.
[38] The nature of the “irreparable harm” to be met has been neatly summarized by Justice Russell in Aventis Pharma S.A. v. Novopharm Ltd., 2005 FC 815, 40 C.P.R. (4th) 210 at paras. 59-61 (F.C.), aff’d 2005 FCA 390, 44 C.P.R. (4th) 326:
As Mr. Justice Kelen pointed out in Pfizer Ireland Pharmaceuticals, at para. 25, it is well established in the jurisprudence that an interlocutory or interim injunction should only be granted in cases where there is clear evidence of irreparable harm. The Plaintiffs must adduce "clear and not speculative" evidence that irreparable harm will follow the entry of Novopharm's Novo-enoxaparin into the market.
It is also well understood that irreparable harm refers to the nature of the harm suffered rather than its magnitude. As the Supreme Court of Canada pointed out in RJR-MacDonald, it is "harm which either cannot be quantified in monetary terms or which cannot be cured, usually because one party cannot collect damages from the other." (p. 341)
Furthermore, difficulty in precisely calculating damages does not constitute irreparable harm, provided there is some reasonably accurate way of measuring those damages. See Merck & Co. v. Nu-Pharm Inc. (2000), 4 C.P.R. (4th) 464 at 476 para. 32 (F.C.T.D.).
[39] This part of the test requires Sanofi to demonstrate that it will suffer irreparable harm if a stay is not granted. In the present motion, Sanofi makes the following arguments with respect to irreparable harm: 1) harm to the general public; 2) reduction in revenue; 3) immediate reduction in total workforce; 4) likely manufacturing facility closure; 5) harm to new products; 6) permanent loss of ALTACE market share; 7) reductions in workforce; 8) significant number of talented employees would leave for opportunities with other companies; and 9) new products would suffer since marketing budgets and new product launches are financed in large part by revenues from successful products such as ALTACE.
[40] In approaching the second element, Sanofi attempts to argue that a stay of the Minister’s decision is necessary and in the interests of justice. However, Sanofi failed to appreciate that with respect to harm to the general public, the Supreme Court in RJR-MacDonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311, 111 D.L.R. (4th) 385 at paragraph 57 indicated that harms to the public interest should be more appropriately dealt with in the third part of the analysis dealing with the balance of convenience.
[41] With respect to the rest of Sanofi’s assertions of irreparable harm, only the affidavit evidence of Benoit Gravel was provided. Mr. Gravel is the Vice-President, ALTACE Franchise, Business Support, Resource Allocation and Execution Excellence and a member of the Executive Committee at Sanofi-Aventis Canada Inc. He is responsible for all of the marketing and sales activities in Canada related to Sanofi’s ALTACE brand.
[42] The affidavit of Gravel asserts that the impact of Apotex entering the market with its generic ramipril product will be “devastating” and will result in “millions of dollars of lost ALTACE sales within the first few weeks” and will also reduce ALTACE sales by 90% within the first two or three years. In addition, Mr. Gravel asserts that the introduction of a generic ramipril product would force Sanofi to reduce its workforce and because of the lack of ALTACE, it may call for a partial or complete closure of Sanofi’s manufacturing facility. Mr. Gravel also postulates that the loss of revenue would have a significant impact on the marketing of new products. Finally, Mr. Gravel contends that a generic ramipril product would result in a permanent loss of market share since Sanofi would be unable to regain its previous market position due to the competitive state of the pharmaceutical marketplace.
[43] The evidence of Mr. Gravel with respect to irreparable harm is countered by Apotex’s witnesses, Stephen R. Cole and Aidan M. Hollis.
[44] Mr. Cole is the principal of Cole Valuation Partners Limited, a Toronto firm practicing in the fields of business valuation, damage quantification and investigative and forensic accounting. Mr. Hollis is an Associate Professor of Economics at the University of Calgary. He is also a Research Fellow of the Institute of Advanced Policy Research and has been a Research Fellow of the Institute of Health Economics. Since 1998, his research has been focused mainly on pharmaceutical markets.
[45] The key shortcomings and criticisms of Mr. Gravel’s assertions are that he does not provide an estimate as to how large the reduction in revenue would be for Sanofi; any course of conduct adopted by Sanofi which destroys Sanofi’s ability to maximize its profits is not credible and inconsistent with profit maximizing behaviour if Sanofi believes that it has a successful application; and that Mr. Gravel fails to provide adequate information to support his assertions.
[46] After a thorough review of Mr. Gravel’s evidence, the Court is of the view that there is no clear evidence of irreparable harm to Sanofi. What is revealed by the evidence are mere assertions and speculations as to the harms to be suffered by Sanofi and no supporting data was provided by Mr. Gravel. Sanofi has the duty to demonstrate that it will suffer market share losses and other harms that are irreparable because they cannot be compensated by monetary damages with any degree of precision. It has not done so.
[47] Mr. Gravel main assertion was that the “introduction of a generic product ramipril product will reduce ALTACE sales by about 80% by the twelfth month” and that the “reduced revenue stream caused by generic competition would necessitate immediate and drastic reductions in expenses and human resources at Sanofi-Aventis.” However, what he fails to include or distinguish in his analysis is the impact of Ratiopharm (as authorized by Sanofi) entering the market to produce a generic version of ramipril.
[48] Mr. Gravel made a number of other assertions, which are not well supported by the evidence, was imprecise and was also speculative. These include assertions that there will be an immediate reduction in total workforce, likely manufacturing facility closure, and harms to new products, and permanent loss of ALTACE market share. These drastic projections do not seem likely as what Sanofi seeks is only an interim stay of perhaps a few months until the judicial review has been decided and the evidence reveals that Sanofi is in a very comfortable financial position such that it will be able to absorb any temporary loss of revenue, in the event that its application is later proved to be successful. The evidence shows that for the first nine months of 2006, its unaudited consolidated income statement shows that its net income after taxes was $3.431 billion euros (Exhibit AH-9 of the Affidavit of Aidan M. Hollis, Motion Record of Apotex, Inc. Vol III at 626).
[49] What Mr. Gravel failed to reveal is how he came upon these unproven conclusions and he also failed to state any specifics as to monetary damages or losses. Sanofi did not demonstrate how the losses they asserted differed from the general course of a generic product entering the market as the nature of NOC proceedings and the substitution/interchangeability regimes are that the innovator drug company will ultimately lose some market share. How that generates into Sanofi suffering irreparable harm in the interim is unclear and speculative. The evidence also does not reveal why the usual loss quantification methodology applied in these cases will be unable to quantify the financial loss that Sanofi argues it will suffer if a stay is not granted. On the other hand, Mr. Cole asserts that any potential losses will be quantifiable and after applying the Preservation Mode, he estimates that the damages would be in the range of $10 million to $20 million, depending on the pre-tax operating margins.
[50] The result of the evidence is that the Court is left to speculate as to what Sanofi’s actual damage will be and there is no indication that the harms to Sanofi will be so irreparable that it cannot be calculated by monetary means. Thus, Sanofi’s assertions remain speculative and unsubstantiated.
Conclusion
[51] As stated before, the stay requested will issue. The parties have asked for an expedited review of the co-pending judicial review and I see no reason for not granting the order. The parties are asked to contact the Judicial Administrator to arrange for a hearing in late March 2007. Sanofi has agreed to provide an appropriate undertaking to compensate Apotex for any relevant damages caused by the grant of the stay order sought that this court may subsequently find Sanofi should pay.
ORDER
THIS COURT ORDERS that:
- This application for a stay is granted.
- The operation of Notice of Compliance issued on December 13, 2006 to Apotex Inc. in respect of Apotex’s Abbreviated new Drug Submission number 085886 for its Apo-Ramipril 1.23mg,2.5 mg, 5 mg and 10 mg capsules is stayed until the earlier of
- The disposition of the judicial review proceedings herein, or
- The termination of the 24 month statutory stay in place in respect of the application commenced under the NOC Regulations in Federal Court File T-87-06.
- Both Apotex and the Minister of Health shall comport themselves in the interim as if the NOC referred to in point 2) was not issued.
- The Parties’ request for an expedited hearing of the underlying application for judicial review is granted. The parties shall communicate with the Judicial Administrator for a hearing date in late March 2007 and shall then present the court with a schedule setting out the necessary steps and time periods to meet that hearing date.
- Sanofi shall file an undertaking in accordance with paragraph 24(c) of its notice of motion which reads as follows:
c) Sanofi-Aventis will provide an appropriate undertaking to compensate Apotex for any relevant damages caused by the grant of this stay orders sought, that this Court may subsequently find Sanofi-Aventis should pay.
- Costs for this motion to follow the cause.
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-2196-06
STYLE OF CAUSE: SANOFI-AVENTIS CANADA INC. v.
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL OF CANADA
and APOTEX INC.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: December 21, 2006
AND ORDER: VON FINCKENSTEIN J.
APPEARANCES:
Gunars A. Gaikis
A. David Morrow
J. Sheldon Hamilton FOR THE APPLICANTS
Harry B Radomski
Andrew Brodkin
Miles Hastie
Benjamin Hackett
F.B Rick Woyiwada FOR THE RESPONDENTS
SOLICITORS OF RECORD:
Smart & Biggar FOR THE APPLICANTS
Toronto, Ontario
Goodmans LLP
Toronto, Ontario
John H. Sims, Q.C. FOR THE RESPONDENTS
Deputy Attorney General of Canada