Date: 19980320
Docket: T-366-97
BETWEEN:
SCHERING CANADA INC. and
SCHERING CORPORATION
Applicants
AND:
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
GIBSON J.:
[1] By Notice of Motion filed the 6th of March, 1998, the respondent, Apotex Inc. ("Apotex") seeks the following relief:
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1. An Order requiring Michael Barry Mitchell to reattend for further cross-examination and to provide answers to those questions refused to during the cross-examination of said affiant as more particularly described in Schedule "A" hereto; |
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2. An Order striking out the entire re-examination of Michael Barry Mitchell conducted on February 11, 1998; |
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3. Such further and other relief as to this Honourable Court may seem just. |
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[2] At the hearing of the motion before me at Ottawa on the 17th of March, the relief requested was substantially narrower. The first relief requested was reduced to an order marking U.S. Patent 4,282,233 as Exhibit 3 to the cross-examination on the 11th of February, 1998 of Dr. Michael Barry Mitchell on his affidavit filed in these proceedings, thus making U.S. Patent available as evidence in this proceeding. During the course of the cross-examination, the U.S. Patent was marked as Exhibit "A" for identification only. The second relief requested was reduced to an order striking out questions 196 and 197 and the related answer to question 197 on re-examination of Dr. Michael Barry Mitchell following immediately upon his cross-examination.
[3] Reference to the cross-examination of Dr. Mitchell discloses that U.S. Patent No. 4,282,233 establishes the priority date for Canadian Patent 1,160,230 and is referred to in Canadian Patent 1,272,480. The 230 Patent is at the base of this proceeding. While the 480 Patent is not in suit, counsel for Apotex argues that it is relevant to the questions at issue in suit.
[4] Counsel for the respondent sought to have the U.S. Patent marked as an Exhibit to the cross-examination on Dr. Mitchell, thus making it available as evidence in this proceeding. Counsel for Schering objected. I quote at some length the exchange that took place during the cross-examination of Dr. Mitchell:
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Q. Could you turn up the 230 patent for me. It is found, among other places, in McClelland's first affidavit at tab 2. |
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MR. CREBER: The 230, right? |
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MR. RADOMSKI: Yes. It is McClelland, tab 2. It is his first affidavit. |
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Q. You have read the 230 before? |
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Q. I am just looking at line 30 which says "Priority date: USA 160,795 80/06/19". Do you see that? |
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MR. CREBER: We will take your word for it. Out copy can't be read, but we will confirm it. The date if 80/06/19, June 19, 1980. |
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MR. RADOMSKI: Right, and the number is 160,795. |
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Q. Just keep your place there. |
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If you go to tab 2(a), if you have McClelland's, you have the 480 patent. If you go into the 480 patent to page 10, just before the start of the full first paragraph where it begins "alternatively", the last sentence before that reads: |
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"Examples of the latter two processes are disclosed in U.S. patent No. 4,282,233." |
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Do you know what that is a reference to? I am going to suggest to you that that patent number is a reference to the application which is found -- that patent emanated from the application that is referred to on the cover page of the 230 patent. |
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MR. CREBER: Do you have a copy? |
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MR. CREBER: That would be safer than asking to take a leap of faith. |
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MR. CREBER: What you have provided to me is a copy of U.S. Patent 4,282,233, and it has an application No. 160,795 and it refers to the inventor as Frank J. Villani. |
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Q. That number, the application number that Mr. Creber read, appears to accord with the number that is shown on line 30 of the 230 patent to which I took you. |
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A. Yes those numbers are correct. |
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MR. RADOMSKI: I would like to mark this as Exhibit 3 to the cross-examination. |
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MR. CREBER: Is this the only patent that issued on that U.S. application? |
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MR. RADOMSKI: I can't answer that question. |
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MR. CREBER: That is the one that is referred to in the 480 patent. |
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MR. RADOMSKI: Yes, and the same application that lead to that patent, obviously, is referred to in 230. |
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MR. CREBER: Yes, but the reason I am saying this is that U.S. practice is a little different than Canadian practice. So I was getting a little worried about continuations, continuations without having that whole history. I don't know the history. |
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I am not sure where you are going with this, but for the time being I just have a mild concern of: Is this everything? I am not sure what you are pulling out, but let's see where we go. |
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MR. RADOMSKI: I wasn't going any further with it. I merely wanted to mark it. |
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The purpose is to identify a document, a patent that is referred to in the 480 patent and to identify that which is referenced for priority date purposes in the 230 patent. |
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MR. CREBER: For priority date purposes, it would be the application as filed, not the patent as issued that would be germane. |
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MR. RADOMSKI: I appreciate that, but -- |
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MR. CREBER: Also, I don't know whether it occurred or not here and, quite often -- and I am not sure if it did or did not occur here -- a new matter can be added before the Canadian final date. So there may be something in that original application that is a little different than the Canadian application. I don't know; I haven't compared it; I haven't even considered it. I am just saying that I am not sure what the relevance is per se. |
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So if you could help me out on that, I would appreciate it. |
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MR. RADOMSKI: The relevance is, first, that you know our position on the 480 patent. |
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MR. CREBER: It is not in suit. |
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MR. RADOMSKI: I understand it is not in suit, but an argument is put forward in respect of the 480 patent which suggests that if a patent was issued for the 480 patent, that at least the patent office and the patentee, the applicant, must have thought that that which was being applied for was new, useful and unobvious or you couldn't have gotten a patent. |
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MR. CREBER: And it could be an improvement. |
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MR. RADOMSKI: It could be, but this is a matter of debate. That is a matter of interpretation of what occurred. |
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So the point of putting this in is that since the priority date is claimed by reference to the 160,795 application and since the 480 patent makes a reference in its disclosure to the patent which issued from -- or at least one of the patents; I don't know if it was the only one -- the 160,795 patent, it is relevant in assessing the argument as to what the 480 patent signifies and the extent to which it does deal with obviousness or not obviousness. It is relevant to know that when it makes reference to an example and it claims to have created an invention, it is really making reference to an example which forms the foundation for the 230 patent. So it is really to tie it back to the 230 patent. |
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MR. CREBER: The only point, though, Mr. Radomski, is if you want to go down that route, I suggest that you inquire of this witness some questions to support that. The document per se doesn't establish anything. |
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MR. RADOMSKI: That is going to be an argument that you have. That may be a deficiency in my position eventually. I may not have established everything I need to establish to make my argument, but I have been very frank with you. That is why I have put the document forward. |
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MR. CREBER: I am not sure what the relevance of this document to this witness is. He has not put the 480 patent in his affidavit. He has not commented on the 480 patent. You haven't asked him a question on the 480 patent and you are putting forward a document that is marginally relevant to the 480 patent, which isn't even in suit. So I am just not sure why this witness is being -- you haven't asked him anything about this. |
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MR. RADOMSKI: No, I don't have to ask him anything about any of the things you have said. Dr. Mitchell has given an affidavit that speaks to whether the Apotex process is an obvious chemical equivalent. In assessing whether that is an obvious chemical equivalent, this patent is relevant to that question. So I am entitled to cross-examine -- |
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MR. CREBER: You are entitled to cross-examine him as to this opinion on that issue. You are not entitled just to throw documents in front of him and not ask him a question. |
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MR. RADOMSKI: Of course I am. If it is relevant to the question of obvious chemical equivalents -- |
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MR. CREBER: Then ask him a question. |
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MR. RADOMSKI: I have. I am asking him whether this is the document, the patent that is referred to in the 480, and it obviously is. It also bears the application number that is referred to in the 230 patent. That is all I need to do. I don't need to try to make my argument through the witness. |
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MR. CREBER: No, but you should ask a relevant question because he -- |
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MR. RADOMSKI: I did. I asked him if that is the patent. |
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MR. CREBER: It is not being identified for any relevant purpose. |
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MR. RADOMSKI: It is. It goes to obvious chemical equivalents. It is a legal argument that I am going to make. |
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All I need to do is ask him whether this is the patent. |
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MR. CREBER: No. I have some trouble. If you have some questions that arise out of these documents, that is fair game. But you haven't asked him anything. |
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MR. RADOMSKI: I don't need to, Mr. Creber. |
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MR. CREBER: That is like putting a thesaurus in front of your witness and then not asking for any explanation. |
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MR. RADOMSKI: If the witness was misusing a word from the point of, say, a dictionary definition, I don't need to have him read the dictionary definition. I can simply put the dictionary in. |
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MR. CREBER: I disagree with you. The way an expert works is that the expert's testimony is the evidence, and the purpose of putting textbooks or thesauruses or dictionaries to an expert is hopefully to either get him to agree with the definition there or to dispute or to contradict him, but it goes to the issue of credibility. |
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As regards this document, you haven't asked any questions on how it goes to the credibility of this witness. How does it go to any issue? It is not this witness' testimony per se. |
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Right now, you haven't laid the foundation. I am not saying that you couldn't be able to, but I haven't seen it yet, so I do have some concerns. |
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MR. RADOMSKI: Tell you what, I am going to ask him a question. |
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Q. This U.S. patent that I have you to look at -- the number on that patent is the same patent number that is referred to on page 10 of the 480 patent. Is that correct? |
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MR. CREBER: The documents speak for themselves. Don't answer that. |
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Q. The application number which we see in this U.S. patent -- that is the same application number that we find on the cover of the 230 Canadian patent on line 30. Is that correct? |
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MR. CREBER: He has already answered that. |
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MR. RADOMSKI: Those are my questions in that regard. I would like to mark this as Exhibit 3. |
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MR. CREBER: I still have some objections because you haven't asked any relevant questions relating to it. |
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MR. RADOMSKI: Let's mark it as Exhibit A for identification if that is okay with you. |
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MR. RADOMSKI: This would be U.S. patent No. 4,282,233 |
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EXHIBIT NO. A (for identification): U.S. Patent No. 4,282,233. |
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[5] Counsel for Schering urged before me that counsel for Apotex had simply failed to establish a base for making the U.S. Patent available for use as evidence. In support of his position, he referred me to R. v. Marquard1 where Madame Justice McLauglin, writing for the majority, wrote:
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The proper procedure to be followed in examining an expert witness on other expert opinions found in papers or books is to ask the witness if she knows the work. If the answer is "no", or if the witness denies the work's authority, that is the end of the matter. Counsel cannot read from the work, since that would be to introduce it as evidence. If the answer is "yes", and the witness acknowledges the work's authority, then the witness has confirmed it by the witnesses' own testimony. Parts of it may be read to the witness, and to the extent they are confirmed, they become evidence in the case. |
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Here, this "proper procedure" was not followed. On the other hand, Schering's expert would hardly have denied knowing of the work and would hardly have failed to acknowledge its authority since the U.S. Patent in question is a Schering patent. Certainly no portion of the U.S. Patent was read to the witness and no portion of it was confirmed by the witness.
[6] Counsel for Apotex referred me to Abbott Laboratories Ltd. v. Nu-Pharm Inc.2 There, an equivalent to a question at issue in this matter, obvious chemical equivalents, was at issue. Mr. Justice Lutfy required that certain questions regarding authoritative literature be answered by an expert witness on cross-examination on his affidavit. That, of course, is not the issue on this motion. Rather, what is sought, is that the whole of the U.S. Patent, on which only a very basic question was posed during cross-examination of Dr. Mitchell, should be available to be brought into evidence.
[7] I conclude that a proper foundation to make it possible to bring the U.S. Patent into evidence was simply not established. In the result, the first relief sought on Apotex' motion will be denied.
[8] I turn then, to the second relief sought, that is, to strike out questions 196 and 197 and the related answer to question 197 on the re-examination of Dr. Mitchell. During the cross-examination of Dr. Mitchell, the following exchange took place:
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Q. In the Apotex scheme, the carboethoxy group, once it is added, nevertheless, remains subjected to at least one further reaction as you have depicted it; that is, the movement from intermediate 3 to Loratadine. Is that correct? |
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MR. CREBER: Could you define "subjective" [sic]? |
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Q. It is exposed to whatever is going on in the reaction from 3 to 4. |
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A. I would say that it was not subjected to anything because it is an inert component of that reaction, but it is clearly present in the molecule. |
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Q. And is exposed to whatever is going on. There may not be any impact on the carboethoxy group and, indeed, it doesn't appear that there is, but you would agree with me that the carboethoxy group in the Apotex scheme participates as part of intermediate 3 -- inertly perhaps, but is a participant in a reaction which occurs on intermediate 3? |
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A. Yes. This is an inert participant. |
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[9] On re-examination of Dr. Mitchell, the following exchange took place:
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Q. You may recollect that Mr. Radomski and you had a discussion relating to Exhibit E and this was discussing the carboethoxy and it being an inert participant in a number of the reactions on the Apotex scheme. |
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Can you just explain what is meant by the term "inert participant" and how that is relevant or germane to those reactions? |
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MR. RADOMSKI: Just before he does, I object. It is not a proper re-examination question. |
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MR. CREBER: You raised the first time the concept of an inert participant, and I think I have the right to let the witness complete those thoughts on that issue. |
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A. An "inert participant" I would describe as a portion of the molecule which did not take place or in which no reaction took place at that substituent, so that it was inert to the reaction conditions. No bonds surrounding that group were made, broken, formed and so on, so that it plays no part in a reaction. It is an inert bystander. |
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[10] In Janssen Pharmaceutica Inc. et al v. Apotex Inc. et al,3 Madame Justice Tremblay-Lamer wrote:
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The purpose of re-examination is to enable the witness to clarify any ambiguity or obscurity raised in cross-examination. It is proper to clear up confusion but improper to introduce fresh evidence or a new matter not covered in cross-examination. If the meaning of expressions used by the witness or cross-examiner is doubtful, it can be clarified. [citations omitted, emphasis added] |
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[11] In the last preceding quote from the transcript of cross-examination of Dr. Mitchell, the concepts "inert component", "participates... inertly" and "inert participant" appear for the first time in this proceeding. The questions at issue on re-examination went directly to the issue of what the witness meant when he used the term "inert participant". I find that the questions at issue fall directly within the principles enunciated by Madame Justice Tremblay-Lamer, for which substantial authority is cited. On the basis of the decision in Janssen Pharmaceutica, this application to strike will also be dismissed.
[12] In summary then, the totality of the Apotex motion at issue will be dismissed. Costs of the motion, if any, will be in the cause.
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Judge
Ottawa, Ontario
March 20, 1997
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1 [1993] 4 S.C.R. 223 at 251
2 (1996), 70 C.P.R. (3d) 11 (F.C.T.D.)
3 [1998] F.C.J. No. 106 (Q.L.) at paragraph 2.