Date: 19981007
Dockets: T-2230-97
T-2660-96
| IN THE MATTER OF an application for an Order pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations and section 55.2(4) of the Patent Act. |
BETWEEN:
SMITHKLINE BEECHAM INC. and
BEECHAM GROUP p.I.c.
Applicants
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
LUTFY J.:
[1] This is an appeal from the order of the Associate Senior Prothonotary which dismissed the applicants" objections to certain questions asked during the cross-examination of two of their affiants.
[2] The applicants argue that their first affiant (Dr. Philip Elder) was not proffered as an expert witness and, accordingly, the questions in issue are improper because they invite the expression of an opinion. In their view, the questions also extend beyond the scope of the affidavit. This affiant is an employee of the applicants with "... considerable experience ... in the tableting of paroxetine hydrochloride".1 His affidavit establishes that he fabricated certain batches of tablets and powder blend for analytical investigations. The questions deal with tableting and conversion. The use of the phrase "tableting process aside" in the fifth question does not sufficiently distinguish this question from the others in view of the technical experience of the witness. While the issue may not be crystal clear, it was open to the Associate Senior Prothonotary to conclude that the questions are "... relevant matters arising from the affidavit".2 In addition, in my view, these questions are permissible even if they "... seek to elicit an expression of a technical opinion from a witness who is not an expert ..." but who has considerable tableting experience with the drug in issue.3 This is especially applicable where, as acknowledged by the applicants" counsel, the opinions of the expert witnesses are based on this affiant"s information. If the witness has the knowledge and the information to respond, his answers and their probative value will be assessed by the hearing judge.
[3] The applicants object to certain questions asked of their patent attorney (Mr. B.J. Russell) because, even if they came within the ambit of his affidavit, they relate to prior art when the validity of the patent is not in issue. This affiant asserted in his reply affidavit that "... the patent in suit contains the first ever disclosure of the preparation of any crystalline form of paroxetine hydrochloride".4 Again, it was open to the Associate Senior Prothonotary to conclude that the questions were relevant to the affiant"s evidence. In her order of December 18, 1997 in this proceeding, McGillis J. ruled that " ... the relevance of the impugned evidence and the applicability of the legal position to be advanced by Apotex ..." should be determined by the hearing judge. Part of the impugned evidence was linked to the issue of prior art. In my view, the same reasoning as that of McGillis J. applies to the disposition of the applicants" objections.
[4] The applicants have failed to establish that the order of the Associate Senior Prothonotary is "clearly wrong",5 if at all. Their motion will be dismissed.
[5] In closing, two recent decisions of the Court of Appeal strongly suggest that the objections could have been reserved for the hearing judge. In Apotex Inc. v. Bayer A.G. and Bayer Inc.,6 the Chief Justice reiterated the view of an earlier panel:
| We are also of the view that the observations made by this Court, differently constituted, in its reasons in Janssen Pharmaceutica et. al. v. Apotex Inc. et. al. (Court Files A-61-98 and A-62-98) on 8 September 1998 are apposite and bear repeating here: |
| The Court wishes to observe that considerable time, effort and resources have been devoted to the hearing of these interlocutory matters in both divisions of the Court. The motions were taken in the course of proceedings initiated under the NOC Regulations. Such proceedings are meant to be summary in nature and they generally raise complex and technical questions of fact. ... Where counsel seek an immediate resolution, they should be mindful that the motions judge has the discretion to defer their motion to the hearing whenever he or she is of the view that the motion could be more efficiently dealt with at that stage. |
[6] These observations of the Court of Appeal can be applied to cross-examinations in proceedings under the NOC Regulations. It seems to me that counsel are being urged to state the grounds for objections to questions, allow the witness to answer under reserve of the objections and, if necessary, have the permissibility of the questions resolved by the hearing judge. This general approach is consistent with Rule 95. There will be situations, however, where the question relates to an issue of privilege or is so patently irrelevant that the immediate attention of the Court would be warranted. No such exception arises in this case.
[7] The applicants will pay forthwith to Apotex costs of this motion in the amount of $1,500. Costs will be payable in only one of the two proceedings.
Judge
Ottawa, Ontario
October 7, 1998
__________________1 Applicants" Motion Record, p. 12.
2 Merck Frosst Canada Inc. v. Canada ((Minister of Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) at 320.
3 Risi Stone Ltd. v. Groupe Permacon Inc. (1994), 56 C.P.R. (3d) 381 (F.C.T.D.) at 388.
4 Applicants" Motion Record, p. 249.
5 Canada v.Aqua-Gem Investments Ltd., [1993] 2 F.C. 425 (C.A.) at 454 and 463.