Date: 19980812

Docket: A-272-97

CORAM:      THE CHIEF JUSTICE

         LINDEN J.A.

         McDONALD J.A.

BETWEEN:

     APOTEX INC.

     Appellant

     - and -

     HOFFMAN-LA ROCHE LIMITED

     and SYNTEX (U.S.A.) INC.

     Respondents

     - and -

     THE MINISTER OF NATIONAL HEALTH AND WELFARE

     Respondent

Heard at Toronto, Ontario on Wednesday, February 18, 1998.

Judgment delivered at Ottawa, Ontario on Wednesday, August 12, 1998.

REASONS FOR JUDGMENT BY:      THE CHIEF JUSTICE

CONCURRED IN BY:      LINDEN J.A.

     McDONALD J.A.

Date: 19980812

Docket: A-272-97

CORAM:      THE CHIEF JUSTICE

         LINDEN J.A.

         McDONALD J.A.

BETWEEN:

     APOTEX INC.

     Appellant

     - and -

     HOFFMAN-LA ROCHE LIMITED

     and SYNTEX (U.S.A.) INC.

     Respondents

     - and -

     THE MINISTER OF NATIONAL HEALTH AND WELFARE

     Respondent

     REASONS FOR JUDGMENT

THE CHIEF JUSTICE

[1]      This is an appeal from the order of the Trial Division, dated 27 March 1997, prohibiting the Minister of National Health and Welfare ("the Minister") from issuing a notice of compliance to Apotex ("the appellant") in respect of the medicine ketorolac tromethamine until after the expiration of Canadian patent No. 1,102,809 ("the 809 patent")¹ in accordance with the Patented Medicines (Notice of Compliance) Regulations ("the regulations").

Facts

[2]      Syntex (U.S.A.) Inc. is the owner of the 809 patent, which expired on 19 June 1998. On or about 7 April 1993, Syntex (U.S.A.) Inc. and Hoffman-La Roche Limited, its corporate predecessor ("the respondents"), submitted a patent list in respect of ketorolac tromethamine and in particular, ketorolac tromethamine tablets 10 mg in which they listed, inter alia, the 809 patent².

[3]      On or about 5 May 1995, the appellant forwarded to the respondents, in accordance with paragraph 5(3)(b) of the regulations, a notice of allegation and detailed statement of the legal and factual basis for the allegation ("the notice of allegation")³.

[4]      In the notice of allegation, the appellant alleged both non-infringement and invalidity. More specifically, it alleged that no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling of ketorolac tromethamine tablets. Relevant to this appeal are the following passages of the notice of allegation⁴:

This patent has no claim for the use of the medicine. This patent does have claims for the medicine when made by a claimed process. However, until the patent 1102809 expires we will use ketorolac tromethamine only as made by a process not within the scope of claim 1 of the patent 1102809, and we hereby so undertake. Since all other claims are dependent directly or indirectly on claim 1, it also follows that no other claim will be infringed.

[...]

In addition, with regard to patent 1,102,809, we allege that all claims of the patent are invalid. The claims cover: a process for producing a compound of formula (a) or isomers thereof and esters or salts thereof which comprises any one or more of several steps, one of which is the single step of esterifying the carboxylic acid function in the compounds of formula (A) or converting them to salts. Hence, the claims include within their scope processes for producing a compound of formula (A) or converting them to salts.

The claims are invalid on the following grounds:

(i)      A process of esterifying compounds of formula (A) or converting them to salts is a process for producing esters or salts of a compound of formula (A), but it is not a process for producing a compound of formula (A). Hence, it is not a process for producing a compound of formula (A) and esters or salts thereof. Hence, the claim covers inoperable processes.

(ii)      A process for producing esters or salts of a compound of formula (A) by the step of esterifying the carboxylic acid function in compounds of formula (A) or converting into salts is obvious and non-inventive.

(iii)      The step of esterifying the carboxylic acid function in compounds of formula (A) or converting them into salts is not limited to methods or processes of manufacturing particularly described and claimed or by their obvious chemical equivalents, contrary to subsection 41(1) of the Patent Act as in force at the time of issue of the patent. More specifically, a claim for the making of salts of a compound of formula (A) which is claimed only as "converting each of them into pharmaceutically acceptable non-toxic salts" is a claim for the making of salts of the compound not limited to methods or processes particularly described and claimed.

(iv)      The claims do not set out distinctly and in explicit terms the method of performing the esterification of the carboxylic acid function in compounds of formula (A) or converting them into salts that is regarded as new or in which as exclusive property or privilege is claimed, contrary to subsection 34(2), formerly subsection 36(2) of the Patent Act.

[5]      In response to the notice of allegation, the respondents commenced an application, pursuant to subsection 6(1) of the regulations, for an order prohibiting the respondent Minister from issuing to the appellant a notice of compliance in respect of ketorolac tromethamine tablets until after the expiration of the 809 patent⁵. The application was brought on the following grounds: (i) Apotex had failed to comply with the regulations by not providing a detailed statement of the legal and factual basis for its allegation; (ii) Apotex" allegation that no claim of the 809 patent would be infringed is not justified and (iii) Apotex" allegation that all claims of the 809 patent would be invalid is not justified.

[6]      The application was heard by a Motions Judge in the Trial Division who issued the order claimed.

Reasons of the Motions Judge

[7]      The Motions Judge dealt first with the respondent's complaint concerning deficiencies in the appellant's detailed statement of the legal and factual basis for its allegations of non-infringement and invalidity. He concluded, based on the decision of this Court in Bayer et al. v. Canada⁶, that the alleged deficiencies were not fatal to the appellant's position, since, in his view, the appellant could not be expected to disclose confidential information in the absence of a protective order.

[8]      He then concluded, based on the decision of Noël J., in Syntex v. Novopharm⁷, that the appellant's allegation of non-infringement, made pursuant to subparagraph 5(1)(b)(iv) of the regulations was not justified, since the appellant did not establish that its process does not contain any of the steps set out in claim 1 of the respondent's 809 patent.

[9]      He found the evidence necessary to support the allegation of invalidity to be insufficient. Accordingly, he concluded that this allegation was also unjustified.

[10]      Finally, on jurisdictional grounds, he refused to give consideration to two grounds of invalidity advanced by the appellant because, so the Motions Judge said, they were not contained in the appellant's notice of allegation or detailed statement of legal and factual issues.

Issues

[11]      The appellant now appeals from that order alleging that the Motions Judge erred in concluding that none of the appellant's allegations were justified and in otherwise rejecting the other grounds of invalidity which the appellant raised.

---

Analysis

[12]      The appellant made lengthy written and oral submissions in support of the appeal, as did the respondent. At the conclusion of argument the Court reserved its decision, principally because it was represented to us by counsel during oral argument, that there was pending in the Court, an appeal from the judgment of Noël J. in Syntex, supra, on which the Motions Judge had relied to support his conclusion that the appellant's allegation of non-infringement was not justified.

[13]      Subsequent inquiries at the Registry of the Court indicate that a notice of appeal from the order of Noël J. was filed on 13 February 1996 and a notice of cross-appeal on 18 February 1996. They also indicate that the appellant in that appeal had discontinued the appeal on 1 May 1998 and the respondents their cross-appeal on 7 May 1998. In the result, the decision of Noël J. in Syntex, supra, remains unreversed.

[14]      In Syntex, supra, Noël J. was required to determine whether Novopharm's allegation of non-infringement in respect of the 809 patent, the same patent in issue in this appeal, was justified. The arguments there made were similar to those advanced by the appellant in this appeal. After a thorough review of the authorities bearing upon the construction of the 809 patent, Noël J. concluded that the allegation was not justified in that case. It is my respectful view that the reasons which he gave and which were adopted by the Motions Judge in this case are unexceptionable and apply with equal force to the allegation of non-infringement made in this appeal.

[15]      With respect to the remaining grounds of appeal, I am not persuaded that the appellant has demonstrated that the Motions Judge made any error of fact or law in his conclusions respecting the allegation of invalidity or his refusal to consider new grounds not contained in the notice of allegation, that would justify interference by this Court.

Conclusion

[16]      For these reasons, I would dismiss the appeal with costs.

     "Julius A. Isaac"

     C.J.

"I agree

A.M. Linden J.A."

"I agree

F.J. McDonald J.A."

     FEDERAL COURT OF APPEAL

Date: 19980812

Docket: A-272-97

BETWEEN:

     APOTEX INC.

     Appellant

     - and -

     HOFFMAN-LA ROCHE LIMITED

     and SYNTEX (U.S.A.) INC.

     Respondents

     - and -

     THE MINISTER OF NATIONAL HEALTH

     AND WELFARE

     Respondent

    

     REASONS FOR JUDGMENT

    

---

__________________

     ¹      Affividavit of Lorenzo Biondi, sworn 21 June 1993, Appeal Book, Vol. I, Tab 3, p. 84.

     ²      Affidavit of Lorenzo Biondi, Exhibit D, Appeal Book, Vol. I, Tab 3, p. 169.

     ³      Affidavit of Lorenzo Biondi, Exhibit E, Appeal Book, Vol. I, Tab 3, p. 171.

     ⁴      Reasons for Order of the Trial Division dated 27 March 1997, Appeal Book, Vol. I, Tab 1, pp. 4-5.

     ⁵      Originating Notice of Motion, Appeal Book, Vol. I, Tab 2, p. 10.

     ⁶      (1995), 60 C.P.R. (3d.) 129 (F.C.A.).

     ⁷      (1995), 65 C.P.R. (3d.) 499 (F.C.T.D.).