Date: 20000810
Docket: T-1321-97
BETWEEN:
ELI LILLY AND COMPANY and
ELI LILLY CANADA INC.
Plaintiffs
- and -
APOTEX INC.
Defendant
REASONS FOR ORDER
(Delivered from the Bench at Ottawa, Ontario
on Wednesday, August 9, 2000)
HUGESSEN J.
[1] I am not prepared to order the plaintiffs to produce documents relating to the state of knowledge of prior art on the part of the inventors or of the patentees at the time of the issue of the patents in suit. Such knowledge can only be relevant to the pleaded issue of obviousness. The test for obviousness is, in my view, and there is ample authority to this effect, an objective test. The touchstone is the person skilled in the art, whether or not the invention would have been obvious to that person. The actual knowledge of the inventor or inventors is irrelevant.
[2] With respect to paragraphs 2, 3 and 4, I am not satisfied that the great bulk of the documents requested are relevant. I accept as has been urged on me that relevance for the purposes of discovery is a broader concept than relevance for the purposes of trial. It remains, however, that both for discovery and for trial, relevance must be determined by reference to the pleadings in the case. It is the pleaded issues which determine relevance.
[3] I accept that the plaintiffs must and have offered to produce and will produce materials respecting any tests or examinations undertaken by them with respect to the inoperability of the patents which is alleged in paragraphs 13(g), 13(h) and 13(i) of the plea. I, on the other hand, equally accept the plaintiffs" position that the plea that the claims of some or all of the patents are overbroad is a plea which is to be tested by an examination of the claims and of the disclosures. It is an objective test which the Court must carry out with the aid of expert evidence and nothing that the inventors said or did is going to be of any assistance to the Court in that respect.
[4] I equally accept the plaintiffs" position with respect to the plea that there was no sound basis for prediction of utility of the claims or some of them as pleaded in the defence. Inutility as pleaded here is a form of overclaiming and, equally in my view, must be tested against an objective standard, namely do the claims go beyond what could have been predicted, thereby claiming more than what was invented; I accept what was said by Mr. Justice MacGuigan in Merck v. Apotex1:
| ... section 34 is not concerned with the sufficiency of the inventor"s knowledge. Rather, the issue is whether the information provided in the specification is sufficient to explain the functioning of the invention to a person skilled in the art. In other words, the analysis centres on what the inventor expressed in the specification, not on what the inventor knew. |
[5] That brings me to paragraph 5 which requests the production of foreign, not Canadian, file wrapper material. The only suggestion as to what might be relevant in such material with respect to the pleaded issues is prior art. I have already dealt with the issue of prior art. I am aware that there are some cases in this Court in which foreign file wrappers have been ordered produced. With respect, those cases may have turned on particular facts, or there may have been particular allegations which supported those orders for production. I am not aware that in this case, there are any allegations which would support the production sought and as I said at the beginning, I am of the view that the knowledge of the patentee or of the inventor of prior art is simply not relevant to the issue of obviousness.
[6] Finally, there are two categories of documents which need to be dealt with. The first has to do with the process used by the plaintiffs. The plaintiffs have offered to make productions with respect to the process actually employed by them based upon their drug master file at the Ministry of Health. It may be that further productions will become necessary as a result of that, but I am prepared to make an order that that will be produced and that there will also be a production by the plaintiffs to demonstrate or to give a picture of the effectiveness of the processes in suit.
[7] The last point taken was with respect to plaintiffs" production costs which are said to be relevant to the issue of commercial success. Commercial success is an issue, costs of production, however, are of only very marginal relevance to that issue. They are likely to involve a vast quantity of documentation. I have previously, in this same case, refused to give plaintiffs an order for production with respect to defendant"s costs based upon precisely the same reasoning. Counsel have now exchanged hats, so to speak, and Mr. Creber quite properly asks me to make the same type of order today as I made some six months ago. I think that is a proper request. There is a discretion remaining in the Court to restrict the scope of discovery and as I say, it seems to me that costing documents with respect to the issue of commercial success are of such marginal relevance that they are extremely unlikely to be of any help to anyone, bearing in mind particularly that we are dealing here with process patents and that they are intermediate processes.
[8] Costs to the plaintiffs in the cause.
"James K. Hugessen"
Judge
Ottawa, Ontario
August 10, 2000
__________________