T-442-96
| 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:
PFIZER CANADA INC. and
UCB PHARMA, INC.,
Applicants,
and
APOTEX, INC. and
THE MINISTER OF NATIONAL HEALTH AND WELFARE,
Respondents.
REASONS FOR ORDER
NOËL J.:
I have come to the conclusion that the three affiants need not answer any of the questions put to them subject to the two undertakings arising out of the examination of Dr. Tam which the Respondent Apotex has agreed to comply with.
With respect to questions intended to establish that the New Drug Submission ("NDS") had yet to be submitted when the Notice of Compliance ("NOC") was sought, they do not flow from any of the allegations contained in the Amended Originating Notice of Motion as it is presently framed. Indeed, the amended motion appears to be framed on the basis that the NDS had been submitted at the relevant time, and that is the basis upon which the amendment of the Originating Notice of Motion was sought and obtained before Denault J.1
The other broad category of questions pertains to what counsel described as the "workability" and the "reliability" of the process underlying the Notice of Allegation. The background for these questions from the Applicants' perspective is the belief that the process initially advanced to support the NOC was a "paper" process, and is not the process being advanced in conjunction with the NDS.
I note in this respect that Apotex has provided to the Applicants the details of the process which underlies the NDS. It follows that the Applicants are in a position to demonstrate that the processes in question are not the same if that be the case. The Applicants nevertheless insist on their right to demonstrate that the process underlying the Notice of Allegation is not commercially workable or reliable from a safety standpoint. That, they say, will allow them to demonstrate that Apotex does not intend to go to the market with a product produced by the process which it has disclosed in its Notice of Allegation.
I note to begin with that commercial workability and safety concerns are not matters relevant to the justification of an allegation of non-infringement made pursuant to the Patented Medicines (Notice of Compliance) Regulations. A non-infringing process, if established, will justify an allegation of non-infringement in a section 6 proceeding irrespective of whether or not the end product proves to be commercially viable or whether it is reliable from a safety point of view. Matters of safety, if they should arise, will be addressed by the Minister in conformity with the prescriptions of the Food and Drug Regulations and matters of commercial workability are of concern to Apotex only.
The Applicants nevertheless say that if they can prove that the process underlying Apotex's allegation of non-infringement is not commercially workable or reliable from a safety standpoint, it will show that Apotex does not intend to go to the market with a product produced by the process disclosed in its Notice of Allegation, but with a product produced by some other undisclosed process.
I agree with counsel for Apotex that this is tantamount to an allegation of fraud. The notion that Apotex would obtain an NOC by reference to a specified process and circumvent the Regulations by thereafter going to the market with a product produced by another process is preposterous. This type of allegation must be proven and cannot rest on mere insinuations. There is simply no foundation for the suggestion advanced by counsel for the Applicants in support of the questions for which he seeks answers.
Beyond this, the documents sought to be produced by Dr. McClelland and Dr. Tam are outside the scope of cross-examination.
The application is accordingly dismissed.
Marc Noël
Judge
Ottawa, Ontario
April 14, 1997
__________________1 The Order reads in part: "This Court being satisfied that the proposed amendments, mainly about the content of Apotex's New Drug Submission at the date of the Notice of Allegation, are necessary for the purpose of determining the real question in controversy between the parties, ... etc". (my emphasis)