Merck Frosst Canada Inc. v. Canada ( Minister of National Health and Welfare )
T-953-95
Tremblay-Lamer J.
13/12/96
14 pp.
Application under Federal Court Act, ss. 18 and 18.1 and Federal Court Rules, R. 1602 seeking order quashing and withdrawing notices of compliance issued to respondent Apotex with respect to medicine lisinopril-Applicant, non-exlusive licensee of patent, entered into agreement with Zeneca Pharma Inc. (Zeneca), to manufacture and sell in Canada lisinopril made according to patent-By virtue of Food and Drugs Act and Regulations, applicant, and Zeneca, required to file new drug submission with Minister and obtain notice of compliance in order to sell lisinopril in Canada-In October 1990, Minister issued concomitant notices of compliance for lisinopril to both applicant and Zeneca-In June 1993, Apotex served Zeneca with two notices of allegation pertaining to use of lisinopril-Zeneca filed two applications for orders prohibiting Minister from issuing notice of compliance to Apotex for lisinopril until after expiration of two letters patent-Apotex denied infringement as had obtained supply of lisinopril prior to issuance of patents and tablets would purportedly be manufactured from supply-Present application initiated in case Zeneca's dismissed (in fact, ultimately dismissed by F.C.A.), based largely on Regulations, s. 7(1)(b) providing Minister cannot issue notice of compliance before second person complies with Regulations, s. 5 requirements-Application dismissed-Issue whether, under Regulations, s. 5(3), Apotex obliged to serve applicant with notice of allegation as consequence of its new drug submission with respect to manufacture and use of lisinopril-Under Regulations, with respect to lisinopril, Merck Frosst and Zeneca both first persons-Under Regulations, s. 5, drug manufacturer not required to compare or make reference to all of approved drugs marketed in Canada pursuant to notice of compliance-Apotex had no obligation to compare or make reference to Merck Frosst's lisinopril formula-Having decided not to, Apotex legitimately did not feel compelled to serve applicant Merck Frosst with notice of allegation-Parliament did not require notice of allegation be served on all first persons and not for Court to legislate such requirement-Further, as Apotex only compared its lisinopril tablets with those of Zeneca, Apotex only second person with respect to Zeneca's Zestril, not with respect to Merck Frosst's Prinivil-Minister therefore had duty to issue notice of compliance-Respondent Apotex had no obligation to serve notice of allegation on applicant Merck Frosst-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2, 4, 5, 7-Federal Court Act, R.S.C., 1985, c. F-7, ss. 18 (as am. by S.C. 1990, c. 8, s. 4), 18.1 (as enacted idem, s. 5)-Federal Court Rules, C.R.C., c. 663, R. 1602 (as enacted by SOR/92-43, s. 19)-Food and Drugs Act, R.S.C., 1985, c. F-27-Food and Drugs Regulations, C.R.C., c. 870.