Date: 20000121
Docket: T-1321-97
BETWEEN:
ELI LILLY AND COMPANY AND
ELI LILLY CANADA INC.
Plaintiffs
- and -
APOTEX INC.
Defendant
REASONS FOR ORDER
(Delivered orally from the Bench at Ottawa
on Friday, January 21, 2000)
Hugessen J.
[1] The motion before me this morning raises two issues. The action itself is one for infringement of a number of Canadian process patents for processes leading to the manufacture of the drug Cefaclor. The patents in issue do not cover the product but only the processes. It is common ground that the defendant imports bulk Cefaclor from offshore sources (two have been identified) and processes, manufactures and packages the bulk product into dosage forms and sells it here in Canada. There has been an order for the bifurcation of the trial pursuant to Rule 107 so that at the first stage only the issues of infringement and validity are to be tried; questions relating to remedies and the extent of the infringement will follow at a second stage, if necessary.
[2] The first issue raised in this motion has to do with the obligation of Apotex to produce documents relating to the process by which its offshore suppliers manufacture the bulk product which it, Apotex, acquires or acquired from them.
[3] Apotex says that it does not have the documents, other than those which it has already agreed to produce, dealing with the detail of that process. However, Apotex has filed with the Minister of Health a New Drug Submission or submissions with respect to its product so as to obtain a Notice of Compliance and a part of that submission would normally incorporate by reference material emanating from the supplier or suppliers indicating the process by which the bulk product has been manufactured.
[4] In my view, that material, that documentation, is documentation which can properly be said to be within the power or control of Apotex within the meaning of Rule 223. I refer to and rely upon two Ontario cases which were cited to me by counsel1.
[5] It seems to me that where one may reasonably expect, because of a relationship existing between a party and some third party, that a request for information will be honoured. It is proper to require that party to make such a request. Here it is my view that the relationship between the purchaser of a bulk drug intended for human consumption and the supplier of that drug is such that a request for the process information which was filed with the Minister of Health would be honoured. It also seems to me that the relationship between any citizen and any department of government with which that citizen files an application for any kind of governmental action is such that a request by that citizen to that department for a copy of the filing would normally be honoured.
[6] It therefore appears to me that Apotex has the obligation to make reasonable efforts to obtain the documents sought and I intend accordingly to order that within a period of time which counsel may address, Apotex shall be obliged to request both of its offshore suppliers and of the Minister of Health copies of the process information contained in the New Drug Submission or in the drug master file relating to those New Drugs Submissions for Cefaclor made by Apotex.
[7] The second issue has to do with information relating to sales by Apotex of the finished product here in Canada. I agree with the submissions of counsel for Apotex that that information is not relevant at this stage of the proceedings. The infringement, if infringement there is, is committed when the drug is imported into Canada. Evidence relating to sales is simply evidence as to the extent of infringement or as to further infringement and must be predicated as counsel submits on the fact of the patent process having been used in the manufacture offshore and the product thus manufactured having been imported into Canada.
[8] I do note, however, that in the cross-examination of Dr. Sherman on this motion, it appears that some sales records or summaries have been destroyed. I note that what has been destroyed appears simply to be the hard copies of materials that are preserved in electronic form in Apotex"s computers; but Apotex is on notice that any documents relating to sales although not as I have just held relevant at this stage of the trial may become relevant and there destruction from and after the commencement of this litigation would in my view constitute a very serious misdemeanour and could give rise to some extremely unfavourable inferences being drawn at trial.
[9] I will ask counsel for plaintiff to draft an order in accordance with Rule 394(1) and I would invite submissions from counsel on first of all the question of the time within which Apotex is to provide an affidavit as to its enquiries of its suppliers and of the Minister and the results thereof, secondly as to costs and third, if there are any, any consequential matters.
(LATER)
[10] Having heard counsel on the question of costs, I am satisfied that the plaintiff does enjoy substantial success on the present motion and I will make an order for costs in the amount of $1,000, plus disbursements, to be payable forthwith in any event of the cause.
"James K. Hugessen"
Judge
Ottawa, Ontario
January 21, 2000
__________________1Fedorczenko et al v. Jamieson et al, (1986) 56 O.R. (2d) 252 (C.A.); Triumbari et al v. Bloch (1987) 20 C.P.C.(2d) 277 (H.J.C).