Date: 20040427
Docket: A-171-03
Citation: 2004 FCA 168
Present: ROTHSTEIN J.A.
BETWEEN:
JANSSEN-ORTHO INC.
Appellant
(Applicant)
and
THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
(Respondents)
Heard at Toronto, Ontario, on April 22, 2004.
Order delivered at Ottawa, Ontario, on April 27, 2004.
REASONS FOR ORDER BY: ROTHSTEIN J.A.
Date: 20040427
Docket: A-171-03
Citation: 2004 FCA 168
Present: ROTHSTEIN J.A.
BETWEEN:
JANSSEN-ORTHO INC.
Appellant
(Applicant)
and
THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
(Respondents)
REASONS FOR ORDER
[1] This is an application for stay pending appeal of a February 9, 2004, judgment of this Court to the Supreme Court of Canada.
[2] In 1993, the Minister of Health included Janssen-Ortho Inc.'s (Janssen) 1,245,983 Patent (the '983 Patent) on the Patent Register he maintains under section 3 of the Patent Medicines (Notice of Compliance) Regulations, SOR/93-133. By letter of March 3, 2000, Janssen was advised that the Minister intended to remove the '983 Patent from the Patent Register. By letter of November 2, 2000, the Minister rejected Janssen's representations that he not remove the '983 Patent from the Patent Register.
[3] Janssen sought judicial review of that decision in the Trial Division (as it then was). The judicial review was dismissed. The appeal of that decision to this Court was dismissed on February 9, 2004. Janssen has now sought leave to appeal this Court's February 9, 2004, decision to the Supreme Court of Canada and seeks a stay to preclude the Minister of Health from removing the '983 Patent from the Patent Register until the Supreme Court has dealt with Janssen's leave application and appeal, if leave is granted.
[4] Until now, the Minister has consented to orders staying the removal of the '983 Patent from the Patent Register. The evidence indicates that the Minister only consented after reviewing motion materials. There is nothing in the Record which indicates why the Minister has changed his approach at this time. Whatever the reason, the Minister's prior consent is not determinative and the Court must satisfy itself that Janssen has met the tests required for a stay.
[5] It is unnecessary for me to comment on the questions of serious issue and balance of convenience. I have not been persuaded that Janssen has satisfied the irreparable harm test.
[6] In my opinion, this Court's decision in Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General), [2001] F.C.J. No. 16 (C.A.), is dispositive of the matter. In that case, it was decided that when an action for patent infringement is available, the inability of a patent holder to access the automatic stay provisions in the Patent Medicines (Notice of Compliance) Regulations did not constitute irreparable harm. That is precisely the situation here.
[7] If its '983 Patent is removed from the Patent Register, Janssen will not have the benefit of the automatic stay. But in the event of infringement by a competitor, it could bring an action for patent infringement. There is, therefore, no irreparable harm if the stay is dismissed and Janssen is ultimately successful in its appeal to the Supreme Court.
[8] Janssen, however, now seems to make an additional argument that it says was not before the Court in Bristol-Myers Squibb. According to Janssen, prior to the 1993 amendments to the Patent Act under which the Patent Medicines (Notice of Compliance) Regulations were promulgated, activities undertaken by a generic manufacturer to work-up a submission for a Notice of Compliance during the life of a patent constituted patent infringement. Generally, subsection 55.2(1) enacted in 1993 provides that activity which is reasonably related to the development and submission of information required to obtain a regulatory approval (including a Notice of Compliance) is not patent infringement. The practical effect of this subsection, in the context of Notice of Compliance submissions, is to enable generic manufacturers to position themselves to enter the market more quickly after expiry of a patent, rather than having to delay the commencement of their work-up for a Notice of Compliance until after the patent has expired.
[9] Janssen says that the automatic stay provision in section 7 of the Regulations was a quid pro quo for the loss patent holders suffered now that generic manufacturers are able to work-up their NOC submissions before a patent expires. It says if it is unable to invoke the automatic stay provisions of the Regulations that it will suffer an irreparable harm that cannot be quantified in damages.
[10] I accept that the automatic stay provision of the Regulations gives patent holders a procedural advantage over a traditional patent infringement suit against infringing competitors. However, I am unable to see how not being able to use this advantageous procedure constitutes a qualitative harm not capable of being compensated for in damages.
[11] Janssen submits that if the '983 Patent is removed from the Register, a generic competitor could obtain an NOC before the patent expires and Janssen will not have notice if the competitor markets its product before the patent expires. However, Janssen concedes that the Minister provides public notice of the issuance of all NOCs and in the course of discovery in any patent infringement suit, Janssen will be able to obtain all relevant information from the alleged infringing competitor as to its production and sales of the infringing product.
[12] It is true that Janssen will not have the benefit of the automatic stay under the Regulations. But the loss of that benefit simply means that should a generic competitor infringe its patent, Janssen will bring a patent infringement suit and recover damages for any proven infringement. Loss of a procedural advantage in these circumstances does not constitute irreparable harm.
[13] This case is not distinguishable from Bristol-Myers Squibb which is the controlling authority. As in Bristol-Myers Squibb, there is no evidence before me that an award of damages in a patent infringement suit would not be an adequate remedy.
[14] Irreparable harm not having been demonstrated, I would dismiss this application for stay with costs. Should the parties be unable to agree, they may contact the Registrar and a brief conference call will be scheduled for the Court to hear submissions and fix costs.
"Marshall Rothstein"
J.A.
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-171-03
STYLE OF CAUSE: Janssen-Ortho Inc. v. The Minister of Health and
The Attorney General of Canada
PLACE OF HEARING: Toronto
DATE OF HEARING: April 22, 2004
REASONS FOR ORDER: ROTHSTEIN J.A.
DATED: April 27, 2004
APPEARANCES:
|
Mr. Andrew M. Shaughnessy |
FOR THE APPELLANT(APPLICANT)
|
|
Department of Justice |
FOR THE RESPONDENTS (RESPONDENTS) |
SOLICITORS OF RECORD:
|
Toronto, Ontario |
FOR THE APPELLANT (APPLICANT) |
|
Deputy Attorney General of Canada |
FOR THE RESPONDENTS (RESPONDENTS) |