Federal Court Decisions

     T-997-96

BETWEEN:

     HOFFMAN-LA ROCHE LIMITED and

     SYNTEX (U.S.A.) INC. and ELF SANOFI

     Applicants

     - and -

     THE MINISTER OF NATIONAL HEALTH AND WELFARE

     and APOTEX INC.

     Respondents

     REASONS FOR ORDER

JEROME, A.C.J.:

     This proceeding, commenced under the Patented Medicines (Notice of Compliance) Regulations ("Regulations"), came on for hearing before me at Toronto, Ontario, on May 28, 1997. At the close of oral argument, I took the matter under reserve and indicated that written reasons would follow, pending the disposition of a related motion by the Federal Court of Appeal.

     On March 22, 1996, the respondent Apotex Inc. ("Apotex") issued a notice of allegation pursuant to paragraph 5(3)(b) of the Regulations concerning its ticlopidine hydrocholoride tablets 250 mg. Apotex contended that patents 1,071,630, 1,113,469 and 1,176,170 would not be infringed by its making, constructing, using or selling of the medicine. The applicant responded by filing an Originating Notice of Motion in this Court which sought to prohibit the Minister of National Health and Welfare from issuing a Notice of Compliance on the grounds that the above patents would be infringed by Apotex. During the course of these proceedings, the applicant chose to restrict its comments to the '170 patent, the relevant portion of which reads:

Claim 1 ... and at least one pharmaceutically acceptable, non-volatile organic acid which is ascorbic acid, benzoic acid, cinnamic acid, citric acid, fumaric acid, glycolic acid, manelic acid, malic acid, malonic acid, or tartaric acid.

     Apotex' medicine will not contain any of the acids named in the patent.

     An identical motion, involving the same applicant, the same medicine, the same patents, and the same arguments, came before Madame Justice Reed in Hoffman-LaRoche Ltd. v. Canada (Minister of National Health and Welfare), (1996) 67 C.P.R. (3d) 484. Madame Justice Reed dismissed the motion on the grounds that the notice of allegation stated that none of the ten acids named in the '170 would be used by the respondent, Nu-Pharm, in the manufacture of its ticlopidine hydrochloride tablets. Thus, on a literal interpretation of the patent, no infringement would occur. The applicant in that case suggested that the Court should go beyond a mere literal interpretation and examine whether infringement in substance would occur. The applicant alleged that Nu-Pharm intended to use an acid similar in effect to those named and that it was thereby infringing the substance of the '170 patent. Madame Justice Reed did not adopt that reasoning and wrote at page 503 of her decision:

These proceedings are not infringement actions, nor are they actions for declarations of non-infringement. In keeping with the summary nature of the proceedings, in a situation such as the present, if the facts asserted by a respondent justify an allegation of non-infringement, insofar as the text of the relevant claim is concerned, then, the allegation is justified The proceeding is a summary one not designed to replace an action between the parties. With respect to patent 1,176,170 (file T-1964-93), then, the respondent's statement that it does not use one of the organic acids listed in the relevant claim of the patent justifies the allegation of non-infringement

                                     [emphasis added]

     That decision was appealed ((1996) 70 C.P.R. (3d) 206)) but Mr. Justice Stone, writing for a unanimous panel, dismissed the appeal stating at page 216:

In the present case, I cannot see that the Respondent was required to go further than it did in disclosing facts supporting its allegation of non-infringement or that the Motions Judge was required to make a determination beyond the one which she actually made. I respectfully subscribe to the views she expressed.

                                     [emphasis added]

Counsel for the applicant would distinguish these two cases on the basis that there was no evidence of substantive infringement before Madame Justice Reed, as there is in the case at bar, and that the underlined passages limit the judgements to that particular context.

     I do not adopt that line of reasoning. It is clear from a complete reading of the two cases referred to that Madame Justice Reed and the Court of Appeal were contemplating a situation where there was a notice of allegation containing an appropriate disclosure of the legal and factual basis for the declaration of non-infringement rather than a situation where there was a lack of relevant evidence. I agree with the reasoning in the above cases in that a proceeding pursuant to the Regulations should not be a full-blown examination into patent infringement but was designed to allow the Minister to issue a Notice of Compliance once it had been established that, based on a literal interpretation of the patent, no infringement would occur. Given that the notice of allegation at issue in the case at bar is identical to that which was considered in the above two cases, this motion must also be dismissed.

     Costs in the cause.

O T T A W A

September 10, 1997                      "James A. Jerome"

                             A.C.J.