Schering Canada Inc. et al. v. Nu-Pharm Inc. et al., (1996) 114 F.T.R. 310 (TD)

• Judge: Muldoon, J.
• Court: Federal Court (Canada)
• Case Date: January 11, 1996
• Jurisdiction: Canada (Federal)
• Citations: (1996), 114 F.T.R. 310 (TD)

Schering Can. Inc. v. Nu-Pharm Inc. (1996), 114 F.T.R. 310 (TD)

MLB headnote and full text

In The Matter Of an application for an Order pursuant to section 55.2(4) of the Patent Act and section 6 of the Patented Medicines (Notice of Compliance) Regulations

Schering Canada Inc. and Schering Corporation (applicants) v. Nu-Pharm Inc. and The Minister of National Health and Welfare (respondents)

(T-1708-95)

Indexed As: Schering Canada Inc. et al. v. Nu-Pharm Inc. et al.

Federal Court of Canada

Trial Division

Muldoon, J.

June 24, 1996.

Summary:

Nu-Pharm filed a notice of allegations. Schering Canada et al. applied for an order prohibiting the Minister from issuing a notice of compliance until after its relevant patents expired. Nu-Pharm did not file its evidence in time under the Federal Court Rules. Nu-Pharm applied for an extension of time.

The Federal Court of Canada, Trial Division, in a decision not reported in this series of reports, denied an extension. Nu-Pharm appealed. Nu-Pharm then filed a second notice of allegations which was almost identical to the first. Schering applied for an order prohibiting the Minister from issuing a notice of compliance until after its relevant patents expired.

The Federal Court of Canada, Trial Division, in a decision reported 85 F.T.R. 271, held that the second notice of allegations was invalid. Nu-Pharm appealed. Nu-Pharm then filed a third notice of allegations which was almost identical to first. Schering sought a declaration that the third notice of allegations was void, of no effect and was not provided in compliance with the Patented Medicines (Notice of Compliance) Regulations.

The Federal Court of Canada, Trial Division, allowed the application and stayed the present proceedings until after the final determination of the proceedings respecting the first notice of compliance.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - In response to Nu-Pharm's notice of allegations, Schering sought an order prohibiting the Minister from issuing a notice of compliance until after Schering's patents expired - The Trial Division denied Nu-Pharm an extension of time to file evidence - Nu-Pharm filed a second notice of allegations almost identical to the first - The Trial Division declared the second invalid - Nu-Pharm appealed the two decisions and filed a third notice almost identical to the first - Schering sought a declaration that the third notice was invalid - The issue of the court's jurisdiction arose where the notice was filed with the Minister, not the court - The Federal Court of Canada, Trial Division, stated that although the notice was not a strikable court document, it had legal effect in contemplation of the law of Canada - The court granted the declaration "ex debito justiciae" and for the better administration of the laws of Canada.

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compliance - Practice - The Federal Court of Canada, Trial Division, suggested reform measures intended to render the regime of patented medicines regulations regarding notice of compliance less abusive and more just in application - See paragraph 24.

Cases Noticed:

Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R.(3d) 10 (F.C.T.D.), refd to. [para. 10].

Eli Lilly & Co. et al. v. Novopharm Ltd. et al. (1994), 81 F.T.R. 313 (T.D.), refd to. [para. 10].

Pharmacia Inc. et al. v. Bull (David) Laboratories (Canada) Inc. (1994), 175 N.R. 334; 58 C.P.R.(3d) 207 (F.C.A.), consd. [para. 10].

Bayer AG and Miles Canada Inc. v. Canada (Minister of National Health and Welfare) and Apotex Inc. (1993), 163 N.R. 183; 51 C.P.R.(3d) 329 (F.C.A.), refd to. [para. 24].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 5(1)(b)(iv) [para. 24].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Counsel:

Tony Creber, for the applicant;

Harry Radomski, for the respondent, Nu-Pharm.

Solicitors of Record:

Gowlings, Strathy & Henderson, Ottawa, Ontario, for the applicant;

Goodman Phillips & Vineberg, Toronto, Ontario, for the respondent, Nu-Pharm.

This application was heard at Ottawa, Ontario, on January 11, 1996, before Muldoon, J., of the Federal Court of Canada, Trial Division, who delivered the following reasons for order on June 24, 1996.