[1] This is an appeal of a judgment of the Federal Court dated April 29, 2004, dismissing an application made by Astrazeneca Canada Inc. under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. in respect of Apo-Omeprazole tablets for oral administration in strengths of 10 and 20 mg until after the expiration of Canadian patent No. 1,338,377. The reasons for judgment are reported as AstraZeneca Canada Inc. v. Apotex Inc. (2004), 34 C.P.R. (4th) 450.

[2] It was common ground in the Federal Court that the only relevant claim in the patent in issue is claim 1, and that for the purposes of this proceeding, it was to be assumed that at least one of the stabilizing agents specified in the patent, namely a potassium, sodium or aluminum salt, is an essential ingredient of claim 1. Thus, claim 1 does not cover a composition that does not comprise a potassium, sodium or aluminum salt.

[3] The relevant portion of the notice of allegation in issue in this case reads as follows:

The claims of this patent cover compositions comprising a medicine, a basic inorganic salt stabilizing agent selected from potassium, sodium and aluminum salts, and an enteric coating. Our tablets will not fall within the scope of any claim of this patent. More specifically, our tablets will not contain any such stabilizing agent. Even more specifically, our tables will contain no potassium sodium or aluminum salt whatsoever.

[4] Astrazeneca argues that the Judge erred in law in not concluding that the notice of allegation was deficient for failing to state whether the active ingredient in Apo-Omeprazole is omeprazole or omeprazole magnesium. The Judge had concluded that there is nothing in the Regulations that specifically requires that the active ingredient be identified. We agree with that conclusion, and the reasons given by the Judge for reaching that conclusion.

[5] We would add that there may be situations in which the identity of the active ingredient in a proposed drug must be stated because it is relevant to a particular allegation of non-infringement. It may be that in such a case, the active ingredient must be identified in order to give adequate notice to the first person. In this case, however, there is no reason to conclude that the allegation of non-infringement quoted above did not give Astrazeneca sufficient information to make a reasoned decision as to whether it should file a prohibition application: AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4^th) 272 (F.C.A.).

[6] Astrazeneca also argues that the Judge should have concluded that the allegation of non-infringement was not justified because Dr. Bernard Sherman, a witness for Apotex, admitted in cross-examination that Apo-Omeprazole would contain a sodium salt, contrary to an assertion in the notice of allegation. In fact, the Judge concluded, after a thorough review of the transcripts, that Dr. Sherman did not make any such admission. That was a conclusion that was open to her, and we would not disturb it. Nor did the Judge err in refusing to draw an adverse inference from the refusal of Dr. Sherman to answer certain questions about sodium salt in a continuation of the cross-examination that was convened to deal with certain new documents.

[7] The fact that Dr. Sherman did not make an admission left the Judge with no evidence at all that Apo-Omeprazole would contain a sodium salt. The onus was on Astrazeneca to establish that the non-infringement allegation was unjustified. The allegation of non-infringement was based on the factual assertion that Apo-Omeprazole would not contain a sodium salt. That factual assertion is assumed to be true, unless disproved. If, at the end of the hearing, there was no evidence that was capable of disproving that factual assertion, the only possible conclusion was that Astrazeneca did not meet the onus of establishing that the non-infringement allegation was unjustified. That is the conclusion the Judge reached.

[8] We are all of the view that the Judge was correct to dismiss Astrazeneca's application. This appeal will be dismissed with costs, fixed in the amount of $15,000, including disbursements and tax.

(s) "K. Sharlow"

J.A.

FEDERAL COURT OF APPEAL

NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET: A-293-04

APPEAL FROM A JUDGMENT OR AN ORDER OF THE FEDERAL COURT DATED APRIL 29, 2004, FEDERAL COURT FILE NO. T-660-02

STYLE OF CAUSE: ASTRAZENECA CANADA INC. v

APOTEX INC. ET AL.

PLACE OF HEARING: Ottawa, Ontario

DATE OF HEARING: June 7, 2005

REASONS FOR JUDGMENT OF THE COURT (Linden, Rothstein, Sharlow JJ.A.)

RENDERED FROM THE BENCH BY: Sharlow, J.A.

APPEARANCES:

Ms. Gunars A. Gaikis for the Appellant

Mr. Scott Beeser

Ms. Harry B. Radomski for the Respondent, Apotex Inc.

Mr. Andrew R. Brodkin

SOLICITORS OF RECORD:

Smart & Biggar for the Appellant

Toronto, Ontario

Goodmans LLP for the Respondent, Apotex Inc.

Toronto, Ontario

John H. Sims, Q.C. for the Respondent, Minister of Health

Deputy Attorney General of Canada

Gowling Lafleur Henderson LLP for the Respondent Takeda Chemical

Ottawa, Ontario Industries, Ltd.

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AstraZeneca Canada Inc. v. Apotex Inc., 2005 FCA 216

Citations2005 FCA 216

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2005 FCA 216