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Date: 19991029


Docket: T-366-98


Between:


AB HASSLE, ASTRA AB and ASTRA PHARMA INC.


Applicants


AND


MINISTER OF NATIONAL HEALTH AND WELFARE

RHOXALPHARMA INC. and

TAKEDA CHEMICAL INDUSTRIES, LTD.


Respondents




REASONS FOR ORDER



RICHARD MORNEAU, PROTHONOTARY:

[1]      This is a motion brought by Rhoxalpharma Inc. under Rule 97 of the Federal Court Rules, 1998 (the Rules) for an order disposing of a series of objections in its favour; the objections had been raised by Astra during the cross-examination of one of its deponents, Dr. Jörgen Lindquist, and are divided into four categories.

[2]      The issue in the main proceeding between the parties is whether the gastric acid reduction medicine that Rhoxalpharma wishes to market contains an inert subcoating in addition to a core region and an enteric coating. The patents at issue cover a medicine with these three features. Rhoxalpharma maintains that its medicine does not have an inert subcoating or, if it does, the inert subcoating is of a type that does not fall within the scope of the patents at issue.

[3]      The main proceeding between the parties is not an ordinary action for patent infringement, but an application filed by Astra in March 1998 under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended. Accordingly, the scope of any cross-examination on an affidavit is limited to matters raised in the affidavit. In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302, at page 320, the Federal Court of Appeal dealt with this issue as follows:

         [T]he applicant cannot expect to be able to make his case out of the mouth of the respondent. Even when there is an opportunity to cross-examine, such cross-examination is far more limited in scope than examination for discovery and, apart from questions going to the witness' credibility, is limited to relevant matters arising from the affidavit itself.

[4]      It must be understood that Dr. Lindquist's affidavit is only one of many filed by the parties to date in support of their respective positions on the merits. As a result of an order of this Court, Dr. Lindquist's affidavit has, in fact, a very specific purpose: to reply to an affidavit filed by Rhoxalpharma dated October 27, 1998, and deposed to by Dr. Louis Cartilier. In that affidavit, Dr. Cartilier describes the results of his analysis of samples of Rhoxalpharma`s medicine and concludes that it does not contain an inert subcoating.

[5]      This is where Dr. Lindquist's affidavit comes into play. In his affidavit, Dr. Lindquist describes himself as a scientist specializing in analytical chemistry. On the strength of his expertise, Astra asked him to conduct tests on samples of Rhoxalpharma's medicine to determine whether the presence of an inert subcoating, as contemplated by the patents at issue, could be detected in it. When he performed the tests, Dr. Lindquist did not have specific information regarding the content or composition of the samples. It was only after the tests had been completed that Dr. Lindquist became aware of a Rhoxalpharma document listing the ingredients and general steps in the production process of Rhoxalpharma's medicine (Rhoxalpharma's list of ingredients).

[6]      Dr. Lindquist's affidavit was, therefore, submitted to report the results of the tests that were conducted to establish whether or not there was an inert subcoating. It is with respect to detecting that subcoating that Dr. Lindquist`s expertise and affidavit play a role.

[7]      It is apparent, however, that Dr. Lindquist is not an expert on the purpose of an inert subcoating or on the proper ingredients to put together (formulation) to create such a subcoating. This was not part of his mandate. Such knowledge seems to lie more within the expertise of Dr. McGinity, who submitted three affidavits on behalf of Astra in this case. However, it appears that no questions have been put to him about the issues in dispute.

Issues

     Category I

[8]      With respect to questions 219, 220 and 221 in this category, it is apparent that Dr. Lindquist has already answered these questions. He does not need to answer them again. Moreover, these questions, as well as question 216, deal with matters relating to the medicine`s formulation and are, therefore, beyond the deponent's field of expertise as well as outside the scope of matters raised in the affidavit.

[9]      With respect to question 222, when put in its full context, this question is incomplete and ambiguous. It need not be answered.

     Category II

[10]      I agree with counsel for Astra that the purpose of all questions in this category

is to obtain Dr. Lindquist's opinion as to what Rhoxalpharma is seeking to accomplish with its list of ingredients.

[11]      This category of questions need not be answered, as Rhoxalpharma is in a much better position to answer them. In addition, these questions again amount to questioning Dr. Lindquist about the medicine`s formulation.

    

     Category III

[12]      These questions also concern the formulation and need not be answered.

     Category IV

[13]      The two questions in this category seem to me to be improper and in the nature of a fishing expedition.

[14]      Accordingly, Rhoxalpharma's motion will be dismissed with costs.

                             Richard Morneau

                             prothonotary



MONTRÉAL, QUEBEC

October 29, 1999

Certified true translation


Mary Jo Egan, LL.B.



Date: 19991029


Docket: T-366-98


MONTREAL, QUÉBEC, THE 29th DAY OF OCTOBER 1999

Present:      RICHARD MORNEAU, PROTHONOTARY


Between:


AB HASSLE, ASTRA AB and ASTRA PHARMA INC.


Applicants


AND


MINISTER OF NATIONAL HEALTH AND WELFARE

RHOXALPHARMA INC. and

TAKEDA CHEMICAL INDUSTRIES, LTD.


Respondents






ORDER




The motion by the applicant, Rhoxalpharma Inc., is dismissed with costs.


                                

                                 Richard Morneau

                                 Prothonotary         

Certified true translation


Mary Jo Egan, LLB

Federal Court of Canada

Trial Division



Date: 19991029


Docket: T-366-98



Between:


AB HASSLE, ASTRA AB and ASTRA PHARMA INC.


Applicants

AND

MINISTER OF NATIONAL HEALTH AND WELFARE

RHOXALPHARMA INC. and

TAKEDA CHEMICAL INDUSTRIES, LTD.


Respondents










REASONS FOR ORDER








FEDERAL COURT OF CANADA

NAMES OF COUNSEL AND SOLICITORS OF RECORD

COURT FILE NO.:              T-366-98

STYLE OF CAUSE:          AB HASSLE, ASTRA AB and ASTRA PHARMA INC.

Applicants

                     AND

                     MINISTER OF NATIONAL HEALTH AND WELFARE

                     RHOXALPHARMA INC.

                     and

                     TAKEDA CHEMICAL INDUSTRIES, LTD.

Respondents

PLACE OF HEARING:              Montréal, Quebec

DATE OF HEARING:              October 25, 1999

REASONS FOR ORDER OF RICHARD MORNEAU, PROTHONOTARY

DATE OF REASONS FOR ORDER:      October 29, 1999

APPEARANCES:

J. Sheldon Hamilton                  for the applicants

Marie Lafleur                      for the respondent, Rhoxalpharma Inc.

SOLICITORS OF RECORD:

Smart & Biggar                  for the applicants

J. Sheldon Hamilton

Toronto, Ontario

Martineau Walker                  for the respondent Rhoxalpharma Inc.

Marie Lafleur

Montréal, Quebec

Morris Rosenberg                  for the respondent Minister of National Health and

Deputy Attorney General of Canada          Welfare

Gowling, Strathy & Henderson          for the respondent Takeda Chemical

Gary O'Neil                      Industries, Ltd.

Toronto, Ontario

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