Date: 20030724
Docket: T-1970-99
Citation: 2003 FC 911
OTTAWA, ONTARIO, THURSDAY, THE 24th DAY OF JULY, 2003
PRESENT: THE HONOURABLE MADAM JUSTICE SNIDER
BETWEEN:
PROCTER & GAMBLE PHARMACEUTICALS CANADA INC.
and THE PROCTER & GAMBLE COMPANY
Applicants
- and -
THE MINISTER OF HEALTH and GENPHARM INC.
Respondents
REASONS FOR ORDER AND ORDER
· Proctor & Gamble Pharmaceuticals Canada Inc. and the Proctor & Gamble Company (collectively, "P & G") have applied for:
· an order, pursuant to rule 399 of the Federal Court Rules, 1998, to vary the amended order of McKeown J.;
· an order pursuant to rule 53, quashing the Notice of Compliance ("NOC") issued by the Respondent Minister of Health (the "Minister") to Genpharm Inc. ("Genpharm") on June 3, 2003 for 200mg Gen-Etidronate oral dosage tablets containing etidronate disodium (the "June 3 NOC"); and
· an order granting to the moving parties their costs of this motion on a solicitor and client basis.
BACKGROUND
P & G owns Canadian patent number 1,338,376 (the "376 Patent") for the invention of a pharmaceutical regimen used in the treatment of osteoporosis, consisting of a kit containing 400mg etidronate or etidronate disodium tablets and tablets of 1250mg calcium carbonate ("Didrocal"). The 376 Patent relates to a new way of using an existing drug. This patent expires on April 9, 2008.
In addition to Didrocal, P & G makes and sells Didronel, which contains 200mg of etidronate disodium and is used for the treatment of Paget's Disease and hypercalcemia of malignancy. There is no Canadian patent for Didronel at this time. Although both Didrocal and Didronel appear similar, they are different drugs. The medicine in Didrocal is etidronate disodium in combination with calcium carbonate, whereas the medicine in Didronel is etidronate disodium alone. In addition, Didrocal is marketed only in a strength of 400mg etidronate disodium, while Didronel is marketed in a strength of 200mg.
On September 1, 1999, Genpharm filed a Notice of Allegation ("NOA") with the Minister for proposed 400mg tablets of etidronate (the "400mg tablets"). Genpharm named Didrocal as the Canadian reference product for the purpose of exhibiting bioequivalence and alleged that the 400mg tablets would not infringe the 376 Patent.
On September 27, 1999, Genpharm filed a NOA with the Minister for proposed 200mg oral dosage tablets of etidronate disodium (the "200mg tablets"), again naming Didrocal as the Canadian reference product and alleging that the 200mg tablets would not infringe the 376 Patent.
In response to these NOAs, P & G initiated proceedings against the Minister and Genpharm, seeking an Order prohibiting the Minister from issuing a NOC to Genpharm in connection with the 400mg tablets (Court File T-1825-99) and the 200mg tablets (Court File T-1970-99). These proceedings were heard together by McKeown J., who found that the NOAs were defective because the Detailed Statement did not raise sufficient facts to support an allegation that all claims would not be infringed. McKeown J. issued an Order prohibiting the Minister from issuing a NOC to Genpharm in connection with both the 200mg tablets and the 400mg tablets until the expiration of the 376 Patent (the "Order").
The Order was unanimously upheld by the Federal Court of Appeal on July 8, 2002. Rothstein J.A., writing for the Court, considered the merits of P & G's complaint that Genpharm's 200mg tablets and 400mg tablets would infringe the 376 Patent and concluded that the allegations of non-infringement were not justified. Genpharm's application for leave to appeal to the Supreme Court of Canada was dismissed on March 27, 2003.
In August 2002, Genpharm filed a second abbreviated new drug submission ("ANDS") for 200mg etidronate disodium tablets for Paget's disease and hypercalcemia of malignancy (the "August 2002 ANDS"). Didronel 200mg was listed as the reference product. Since P & G had no patent listed for 200mg Didronel, both Genpharm and the Minister determined that Genpharm was not required to notify P & G or provide a NOA (Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(1) [hereinafter the Regulations]). On June 3, 2003, the Minister issued a NOC to Genpharm for 200mg oral dosage tablets of etidronate disodium, to be marketed as Gen-Etidronate.
P & G asserts that Gen-Etidronate is the same drug caught by the Order of McKeown J. and that the Minister mistakenly issued the NOC to Genpharm. Rather than commencing an action for patent infringement once Genpharm begins sale of Gen-Etidronate or bringing a separate motion for contempt against the Minister, P & G has brought this motion under Rule 399, hoping for a speedy halt to the sale of Genpharm's product. P & G has also filed a separate application seeking an Order quashing the NOC.
ISSUES
This motion raises two issues:
1. Should the Order be varied to make clear to the Minister and Genpharm that the prohibition against issuance of an NOC for 200mg Gen-Etidronate tablets containing etridronate disodium includes the NOC for 200mg Gen-Etidronate tablets containing etridronate disodium approved on June 3, 2003?
2. Should the NOC, if issued contrary to the Order, be quashed by this Court in order to secure the most just, expeditious and least expensive determination of P & G's rights under the Order?
ANALYSIS
Issue #1: Should the Order be Varied?
The Order (as amended) issued by McKeown J. on October 15, 2001 states as follows:
The application is allowed and an order of prohibition shall be issued preventing the Respondent Minister of Health from issuing a Notice of Compliance to the Respondent Genpharm Inc. in connection with its tablets containing 200mg and 400mg of the drug etidronate disodium until after the expiration of reissued Canadian Letters Patent number 1,338,376 ("the 376 Patent").
P & G has brought a motion to vary this Order by adding the words "including nunc pro tunc, prohibiting the Notice of Compliance dated June 3, 2003 to Genpharm Inc. for 200mg Gen-Etidronate oral dosage format tablets." In P & G's submission, where the Crown has failed to comply with an order of the court, as here, it is appropriate for the party not in breach to apply to the court in the same proceedings to have the existing order renewed (Tetzlaff v. Canada (Minister of the Environment), [1992] 2 F.C. 215 (C.A.)).
In my view, Tetzlaff, supra is not of assistance in this case. In that case, the Minister complied with an order of Muldoon J. by appointing an Environmental Assessment Panel to conduct a public review of a project. However, the panel later resigned, effectively nullifying the Minister's compliance with the Order. The Federal Court of Appeal held that it was appropriate for the Tetzlaffs to request what was in effect a renewal of the order of Muldoon J. In the present case, the Minister did not fail to do something that he was ordered to do; rather, he allegedly did something that he was ordered not to do - he issued a NOC for the 200mg tablets. In addition, the Order remains in effect until the expiration of the 376 Patent. As a result, in my view, it is
not necessary or appropriate for the Applicants to request the renewal of the Order as was done in Tetzlaff, supra.
Rule 399(2) of the Federal Court Rules, 1998, if applicable to the facts of this case, provides P & G with an exceptional remedy. The relevant portion of Rule 399(2) provides that this Court may set aside or vary an order "by reason of a matter that arose or was discovered subsequent to the making of the order". This Rule does not give the Court a new original jurisdiction or a continuing jurisdiction to undertake a review of a judgment as if at first instance and cannot be used as a vehicle for revisiting judgements every time a change in the facts occurs (Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare), [2000] F.C.J. No. 2134 (C.A.) (QL) [hereinafter Zeneca Pharma]).
Due to its extraordinary nature, in order to successfully persuade me of the Rule's use in these circumstances, P & G must meet a stringent threefold test (Annacis Auto Terminals (1997) Ltd. v. Cali (The), [1999] F.C.J. No. 1579 (T.D.) [hereinafter Annacis Auto Terminals]; Saywack v. Canada (Minister of Employment and Immigration), [1986] 3 F.C. 189 (C.A.)):
1. there must be a new matter arising or discovered subsequent to the Order;
2. P & G must establish that they could not with reasonable diligence have discovered the new matter sooner; and
3. P & G must establish that if the new matter had initially been brought forward it would probably have resulted in a different original order.
(I) New Matter
In satisfying the first part of the test, P & G must convince me that this is a new matter. The term "matter" is a word of broad import and may encompass something broader than fresh evidence (Saywack, supra; Annacis Auto Terminals, supra). "Matter" refers to an element of the relief sought as opposed to an argument raised before the court (Haque v. Canada (Minister of Citizenship and Immigration), [2000] F.C.J. No. 1141 (T.D.) (QL)). The new matter must be relevant to the facts giving rise to the original Order (Sim v. Canada, [1996] F.C.J. No. 773 (T.D.) (QL); Zeneca Pharma, supra).
In this case, P & G submits that the new matter is the June 3 NOC issued by the Minister. Genpharm argues that the August 2002 ANDS is not a new matter because it is a separate submission for drug approval and is not relevant to the facts giving rise to the original Order.
In my view, there is some similarity between the facts of this case and those of the case that was argued before McKeown J. and the Court of Appeal. Just because the new ANDS was separately submitted and considered by the Minister does not automatically mean that we are dealing with a different matter that would preclude the application of Rule 399. Thus, the June 3 NOC may well be relevant to the facts that gave rise to the original Order and the first branch of the test for Rule 399 may be satisfied. However, of the three parts of the test, this one appears to be the least important in the context of the motion before me and I need not conclusively decide it.
(ii) Could Not Have Discovered the New Matter Sooner
As noted, P & G must demonstrate that they could not with reasonable diligence have discovered the new matter sooner. P & G submits that they could not have discovered the June 3 NOC sooner than it did. Information flowing from a drug manufacturer in the context of the Regulations, such as Genpharm, to the Minister is confidential (Apotex Inc. v. Canada (A.G.), [1993] F.C.J. No. 427 (T.D.) (QL); AB Hassle v. Canada (Minister of National Health and Welfare), [2000] 3 F.C. 360 (C.A.)). As a result, other parties, such as P & G will not be permitted to access that information (Apotex, supra). The NOC was issued on June 3. P & G submits that they became aware of this on June 13 and filed their Notice of Motion five days later.
However, the correspondence contained in Exhibits D through F to the Affidavit of Louise McLean indicates that P & G was made aware of Genpharm's intention to submit a 200mg etidronate product for approval in April 2002. P & G takes issue with this evidence, alleging that it is hearsay. In my view, these letters are not being relied upon for the truth of their contents and consequently do not constitute inadmissible hearsay. The portions of the correspondence related to Genpharm's ability to re-file an application for the 200mg tablets are relevant, irrespective of whether Genpharm actually had that ability, because they served to put P & G on notice that (a) Genpharm believed it could re-file without giving notice to P & G and (b) Genpharm was prepared to do so. As a result, these letters indicate that P & G was first made aware of Genpharm's intention to re-file an application for the 200mg tablets on April 9, 2002.
Therefore, although P & G was not actually aware of the June 3 NOC until June 13, five days before they filed their motion record, the evidence indicates that P & G was aware that a new NOC could be sought by Genpharm as early as April 2002. Although they could have done so, P & G did not take any steps in light of this information until June 18, 2003. I cannot conclude that P & G could not, with reasonable diligence, have discovered the matter sooner.
Since P & G is required to meet all three portions of the Rule 399 test, this conclusion would be enough to dispose of this issue. However, once again, I do not view this part of the test as the most important.
(iii) Original Order Would Probably Have Been Different
In the specific circumstances of this motion, the third part of the test is the most important. Regardless of whether this is a new matter (which it may be) and regardless of whether P & G could have discovered the new matter sooner (which is likely), the issue of whether the original Order would have been different if the Court had been aware of this third ANDS is of critical importance.
P & G submits that a careful reading of the judgment of Rothstein J.A. demonstrates that the Court of Appeal considered exactly the same drug (200mg tablets of etidronate disodium) that had been initially put forward by Genpharm for exactly the same purpose as in this case (the treatment of Paget's disease and hypocalcemia of malignancy). In his reasoning, Rothstein J.A. correctly saw through Genpharm's "ruse" and concluded that, in spite of whatever the company alleged as the use of the drug, Genpharm was attempting to tap into the lucrative osteoporosis market. Thus, P & G submits, by using exactly the same reasoning as the Court of Appeal, a prohibition to prevent the Minister from issuing the June 3 NOC would undoubtedly have been included in or contemplated by the original Order.
At the same time that P & G argues that the Order is "crystal clear", they are requesting that it be varied or clarified by adding a specific reference to a prohibition of Gen-Etidronate for the benefit of the Minister who has misapprehended it, as was done in the case of Whyte v. Sandpiper VI (The), 2002 FCT 572, [2002] F.C.J. No. 760 (QL). However, in my view, this case can be distinguished from Whyte, supra, where it was unclear whether the removal of the arrest warrant from the Defendant ship was a ground upon which the Defendants could be found in contempt of an Order of the Prothonotary. Heneghan J. issued an order ex proprio motu specifically including this as a ground of contempt, based on the Reasons for Order of the Prothonotary, that had made clear reference to the ground of contempt added by Heneghan J. to the Order. In contrast, in this case, the reasons of the Courts do not clearly refer to the tablets that are the subject of this motion.
In effect, I am being asked to step into the minds of McKeown J. and the honourable judges of the Court of Appeal who heard this matter and determine what they would have done if the August 2002 ANDS were before them. That makes this motion a very weighty request and one that I would grant only in the clearest of cases.
It is evident from the reasons that neither Court addressed specifically the issue of whether Genpharm's manufacture and sale of a Didronel-type product would lead to a patent infringement. The reasons of both Courts focus on the use of Genpharm's tablets in the management of osteoporosis and not in the treatment of hypercalcemia or Paget's disease.
McKeown J. dealt with the application before him on procedural grounds. Specifically, he did not consider the merits of the application. Accordingly, without any guidance from his decision, I have no way of knowing if he would have included the drug that is the subject of the June 3 NOC in the same Order. Subsequently, however, the Court of Appeal upheld the Order of McKeown J. and did consider, in some detail, the merits of the application.
It is apparent from the reasons of the Federal Court of Appeal that P & G was concerned that Genpharm planned to market its 200mg tablets for use in the management of osteoporosis; the lack of a warning in the product monograph that it should not be used for this purpose was cited as evidence of this plan. However, the product monograph for the 200mg tablets which are the subject of the June 3 NOC and this motion explicitly states that the drugs should not be used in the management of osteoporosis. As a result, I do not see it as a certain result that, faced with these facts, the Court of Appeal would have prohibited the Minister from issuing a NOC for this drug.
Further, I note that the original Order explicitly prohibits the Minister from issuing a NOC for the 200mg tablets until after the expiration of the 376 Patent. The August 2002 ANDS does not refer to a patented drug. In my view, had McKeown J. been aware of Genpharm's intention to file a new ANDS for the 200mg tablets related to Paget's disease and hypercalcemia, making reference to the non-patented Didronel, I am not convinced that his Order would have been different.
Finally, given the differences between the August 2002 ANDS and that considered by the Courts in the context of the original Order, it would be highly speculative to attempt to predict the outcome. Would both McKeown J. and the Court of Appeal have reached a different conclusion with respect to the Order and included within its scope all future submissions made by Genpharm seeking approval to sell etidronate disodium tablets, especially those that reference Didronel, for which no patent has been listed? In addition, would the Order have included reference to the August 2002 ANDS had the Courts been aware of Genpharm's intention to submit that ANDS? The record before me is not sufficient to resolve these uncertainties.
Given the number of issues that are raised, I cannot conclude that the Order would probably have been different. On the basis of the limited facts before me, I simply do not know. Thus, the third part of the test has not been satisfied and the requirements for the use of Rule 399 have not been met. Whether the issuance of a NOC for this product should be prohibited is something that can and should only be determined after a full hearing based on a complete record and not on the basis of Rule 399.
(iv) Conclusion
For these reasons, I would dismiss the motion for an order varying the Order of McKeown J. As noted earlier, P & G has filed a Notice of Application to quash the June 3 NOC. If the application proceeds, all parties will have a more comprehensive opportunity to examine the facts and issues related to the issuance of the June 3 NOC.
Issue #2: Should the NOC be Quashed?
Given my conclusions on the first issue, it is not necessary for me to address the second issue. Once again, I note P & G's separate application which, in a more direct manner, will address the issue.
COSTS
All parties sought costs of this motion on a solicitor-client basis. The parties have not persuaded me that, having regard to the nature of this motion, costs on a solicitor-client basis are warranted. Costs will be awarded to Genpharm and the Minister, assessed in accordance with column III of the table of Tariff B.
ORDER
This Court orders that the motion is dismissed with costs to the Respondents in accordance with column III of the table to Tariff B.
"Judith A. Snider"
F.C.C.J
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1970-99
STYLE OF CAUSE: PROCTER & GAMBLE PHARMACEUTICALS
CANADA INC. ET AL. v. THE MINISTER OF
HEALTH ET AL.
PLACE OF HEARING: OTTAWA
DATE OF HEARING: JULY 11, 2003
REASONS FOR ORDER AND ORDER OF THE HONOURABLE MADAM JUSTICE SNIDER
DATED: JULY 24, 2003
APPEARANCES:
ANDREW SHAUGHNESSY FOR THE APPLICANTS
SHEILA BLOCK
ROGER HUGHES FOR THE RESPONDENT
KAMLEH NICOLA GENPHARM INC.
ERIC PETERSON FOR THE RESPONDENT
THE MINISTER OF HEALTH
SOLICITORS OF RECORD:
TORYS LLP FOR THE APPLICANTS
TORONTO
SIM, HUGHES, ASHTON & McKAY LLP FOR THE RESPONDENT
TORONTO GENPHARM INC.
MORRIS ROSENBERG FOR THE RESPONDENT
DEPUTY ATTORNEY GENERAL THE MINISTER OF HEALTH
OF CANADA