Docket: T-876-02
Reference: 2003 FC 920
BETWEEN:
GLAXOSMITHKLINE INC. and
SMITHKLINE BEECHAM P.L.C.
Applicants
AND:
APOTEX INC. and
THE MINISTER OF NATIONAL HEALTH
Respondents
[1] This is an application by the respondents for an order striking out the two affidavits filed by the applicants of Dr. Ravinder Kumar sworn April 1, 2003 and Dianne Azzarello sworn April 2, 2003.
[2] The applicants, GlaxoSmithKline Inc. and SmithKline Beecham P.L.C. ("GSK"), are the owners of the rights to Canadian Letters Patent 2,168,829, 2,210,023 and 2,211,522. On or about April 22, 2002, the respondent Apotex filed a Notice of Allegation alleging that the '522 patent was invalid by reason of obviousness. In response, the applicant GSK commenced the within proceeding by Notice of Application dated June 6, 2002, asserting that the allegation of invalidity of the patent was not justified, and in particular, that the invention described and claimed in the patent is inventive and not obvious in light of any of the references cited by Apotex.
[3] GSK filed a number of affidavits to support its position, including the two affidavits at issue in this application, those of Dr. Kumar and Dianne Azzarello. The respondent seeks to have these affidavits struck on the grounds that they are not relevant to the issue underlying the main action in this case, which is the question of obviousness. In turn GSK argues that the affidavits demonstrate that the prior art cited by Apotex in the Notice of Allegation is insufficient to establish the safety and efficacy of the drug to the satisfaction of Health Canada, and therefore by analogy, cannot be used to render the patent obvious.
[4] It is an established principle that motions to strike affidavits should be granted only in exceptional circumstances. One of the exceptions to this general rule is where the affidavit in question is clearly irrelevant, which is precisely the issue before the Court in the present application.
[5] After having carefully reviewed the affidavits in question as well as the oral and written submissions of the parties, I am satisfied that the affidavits are totally irrelevant to the question of obviousness and should therefore be struck in their entirety. The essence of the affidavits is that it is difficult to obtain an NOC from the Minister of Health and one will not be granted unless the safety and efficacy of that drug has been proven to Health Canada's satisfaction. In Ms. Azzarello's opinion, as stated in paragraph 25 of her affidavit, none of the documents filed by Apotex would meet the requirement of the Food and Drugs Act and Food and Drug Regulations to demonstrate the safety and efficacy of any product for the purposes of obtaining an NOC to support commercialization of such a product in Canada. Likewise, Dr. Kumar states in his affidavit that Health Canada requires that significant testing be carried out and that until such testing is carried out Health Canada should not grant an NOC to Apotex or to any party.
[6] Whether the Minister approves a product with relative ease or with considerable difficulty has no bearing whatsoever on whether product is inventive and not obvious. The affidavits in question speak to the high standards applied by the Minister of Health in determining whether an NOC should be granted. They do not address the question of obviousness which involves a consideration of the prior art and whether, by relying on that prior art, one would be led directly and without difficulty to the invention. The impugned affidavits contain absolutely nothing which is relevant to this debate. Instead, they simply conjecture that Apotex will have difficulty obtaining approval from Health Canada and more testing will have to be done.
[7] Furthermore, I do not agree with the applicants argument that Apotex will not be prejudiced by the inclusion of these two affidavits. Their position is that these are only two among many affidavits and most likely the shortest two at that. That does not change the fact that both time and money will have to be spent dealing with these clearly irrelevant affidavits and that this will result in delays that would indeed cause prejudice to the applicants.
O R D E R
[8] The application is allowed and the two affidavits are struck in their entirety. Costs are awarded to Apotex in the amount of $2000.00 payable forthwith, in any event of the cause.
JUDGE
OTTAWA, Ontario
July 25, 2003
FEDERAL COURT OF CANADA
SOLICITORS OF RECORD
DOCKET : T-876-02
STYLE OF CAUSE : GLAXOSMITHKLINE INC. ET AL v. APOTEX INC. ET AL
PLACE OF HEARING: Ottawa
DATE OF HEARING: July 17, 2003
REASONS : The Honourable Mr. Justice Rouleau
DATE OF REASONS: July 25, 2003
APPEARANCES: Mr. Jay Zakaib; Ms Chantal Sasunders;
Ms. Corine DeLellegrin
FOR THE APPLICANTS
Mr. A. Brodkin; Mr. N. Butterfield
FOR THE RESPONDENT
SOLICITORS OF RECORD:
Gowling Lafleur Henderson FOR THE APPLICANTS
Barristers & Solicitors
Mr. Harry Radomski
Goodmans
Barristers & solicitors FOR THE RESPONDENT APOTEX
Mr. Frederick Woyiwada
Department of Justice Canada FOR THE RESPONDENT MINISTER OF HEALTH