Nu-Pharm Inc. v. Abbott Laboratories Ltd, docket T-1520-97

     T-1520-97

BETWEEN:

     NU-PHARM INC.,

     APOTEX INC.,

     and BRANTFORD CHEMICALS INC.

     - and -

     ABBOTT LABORATORIES, LIMITED

     and ABBOTT LABORATORIES

     Respondents

     REASONS FOR ORDER

     The applicants apply for an interlocutory injunction restraining the respondents under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 from seeking to prohibit the Minister of Health and Welfare from issuing Notices of Compliance to the applicants for terazosin hydrochloride dihydrate¹ (THD). The facts giving rise to the application are these: by order dated June 9, 1997 Lutfy J. issued an order of prohibition, prohibiting the Minister of National Health and Welfare from issuing a Notice of Compliance to Nu-Pharm for THD until after expiry of Abbott's patent 1081229. Abbott's patent 1081229 expired July 8, 1997. Nu-Pharm and Apotex say that as of July 8, 1997, the Minister was free to issue to them Notices of Compliance for THD.

     However, on June 3rd, 1997, Abbott was granted three new patents pertaining to terazosin hydrochloride. On June 9, 1997 these patents were submitted by Abbott to the Minister pursuant to subsection 4(5) of the Regulations as amendments to its existing patent list. On July 4 and July 7, 1997 respectively, Apotex and Nu-Pharm each issued a Notice of Allegation pursuant to subparagraph 5(1)(b)(iv) of the Regulations alleging that no claim for the medicine itself and no claim for the use of the medicine would be infringed by their making, constructing, using or selling THD. On July 31, 1997, Abbott responded to the Notices of Allegation by filing Originating Notices of Motion in this Court for orders to prohibit the Minister from issuing Notices of Compliance to Apotex and Nu-Pharm based on the three new patents added to their patent list and to which Apotex and Nu-Pharm were comparing their proposed THD.

     The applicants say that the three patents added to Abbott's patent list either concern medicines that are not relevant to THD or, if relevant, that the patents cover processes or intermediates that have no therapeutic value and cannot be characterized as "a claim for the medicine itself" as required by the Regulations (see Deprenyl Research Ltd. v. Apotex Inc. (1994), 55 C.P.R. (3d) 171 at 175 and 176, affirmed (1995), 60 C.P.R. (3d) 501 (F.C.A.) and Eli Lilly and Co. v. Apotex Inc. (1995), 63 C.P.R. (3d) 245 at 250, affirmed (1996), 68 C.P.R. (3d) 126 (F.C.A.)).

     Further, the applicants say that the question of whether a Notice of Compliance may now issue to them is res judicata in that Lutfy J.'s order of June 9, 1997 provided that the Minister was prohibited from issuing a Notice of Compliance until expiry of Abbott's patent 1081229, which indeed did expire on July 8, 1997. They say that upon a proper reading of that order, the Minister is no longer prohibited from issuing them a Notice of Compliance in respect of THD and the issue is now res judicata.

     In addition, the applicants say that Abbott cannot, in a claim under a new patent seek to protect an old product namely THD which is now off patent.

     The applicants say that Abbott's prohibition applications constitute an abuse of the process. They say the Court has inherent jurisdiction to control its process and to prevent abuse and that an injunction in this case will prevent the abuse.

     While prima face, the applicants make an arguable case that they should not be required to go through prohibition proceedings under the Regulations and potentially be kept off the market for another 30 months, they have not satisfied me this is a case of abuse of the process nor that this application is properly before the Court.

     The process they complain of is Abbott's prohibition applications in court files T-1652-97 and T-1653-97. The way in which they characterize the relief they seek is to restrain Abbott "from further applying to this Court...pursuant to the provisions of the...Regulations for an order prohibiting the Minister...from issuing a Notice of Compliance to..." Nu-Pharm and Apotex. However, the prohibition applications have already been filed. An order restraining Abbott from further applying under the Regulations would therefore not assist the applicants. The only relief that might assist them would be a mandatory injunction requiring Abbott to withdraw the prohibition applications that have been filed and indeed they did seek that relief. However, apart from the fact that a mandatory injunction is an extremely rare form of relief (see Sharpe, Injunctions and Specific Reforms 1983, para. 190), I am not satisfied that Abbott's prohibition application constitutes an abuse of the process. The applicants issued Notices of Allegation and the prohibition applications are the response to those Notices. The prohibition applications are contemplated by the Regulations. Indeed, there is a time limit within which to file prohibition applications. It may be that the prohibition applications are without merit. However, there is nothing about the prohibition applications per se that appears to be abusive.

     It may be that the real substance of the applicants' complaint is Abbott's adding three new patents to its patent list. However, this is a process before the Minister and not before the Court. I have not been satisfied that the applicants have demonstrated that this is a case of abuse of the Court's process.

     There are additional difficulties with the applicants' motion. These proceedings have been brought by way of originating notice of motion. However, under Rule 400, all actions are commenced by filing a statement of claim or a declaration, unless a statute or regulation specifically provide otherwise. Under Rule 2(1), an originating notice of motion is not an action. Rule 321.1 upon which the applicants rely, is not a statutory basis for commencing a proceeding by way of originating notice of motion. The originating motion must be authorized by an Act of Parliament, which is not the case here.

     Even if there were not these procedural difficulties, I am not satisfied there is evidence of irreparable harm that is clear and not speculative. The applicants say that every day they are prevented from marketing THD they are denied large amount of revenue and presumably profit. I assume that applicants' position is that there is no way for them to be compensated if they are ultimately successful in demonstrating that Abbott's prohibition applications are without merit. However, the evidence is not clear that the Minister has not issued Notices of Compliance to the applicants solely because of the current prohibition applications. While the Minister may be unsure what action to take in light of the addition of the three new patents to Abbott's list and the Notices of Allegation of the applicants referable thereto and the resulting prohibition applications, it would be speculative for the Court to assume that this is the sole reason for the Minister not issuing the Notices of Compliance to the applicants. Therefore, I am not satisfied the applicants have demonstrated irreparable harm attributable to any action of Abbott.

     As a result, the application for interlocutory injunction is dismissed. As there is no statutory basis for the originating notice of motion the entire proceeding is also dismissed. With the consent of Abbott, the dismissal of the interlocutory injunction and the originating notice of motion is without prejudice to other steps the applicants may take to deal with Abbott's prohibition proceedings. In accordance with the request of the applicants, cost are reserved.

     In view of the unusual circumstances that pertain in this case, the prohibition proceedings brought by Abbott should be expedited, and the Court will entertain an application by the applicants in those proceedings to commence the hearing on the merits to deal with a preliminary motion that they may wish to bring on the grounds that the prohibition applications are not well-founded by reason of the arguments made in this failed interlocutory injunction application.

     Marshall Rothstein

     J U D G E

OTTAWA, ONTARIO

SEPTEMBER 5, 1997

     ¹      Abbott sells terazosin hydrochloride dihydrate under the trade-mark "hytrin". Hytrin is a drug used in the treatment of hypertension and in certain doses benign prostatic hypertrophy.