Merck & Co., Inc. v. Canada ( Attorney General )
T-398-99
McGillis J.
23/11/99
35 pp.
Application to quash Minister's decision to issue notice of compliance to Nu-Pharm Inc. for Nu-Enalapril, containing enalapril maleate-Merck & Co. owner of 1990 patent for enalapril, enalapril maleate-Merck Frosst licensee in Canada for that patent-Selling enalapril maleate under trade-mark "Vasotec"-In 1991 Merck commencing patent infringement action against Apotex Inc. in relation to patent-In 1993 Apotex obtaining notices of compliance for enalapril maleate-Began to sell under Apo-Enalap, Apo-Enalapril-Apotex found to have infringed certain claims in patent, permanent injunction issued against Apotex to prevent further infringement of patent-At all times, Apotex having close working relationship with Nu-Pharm Inc., generic drug company-In 1996 Nu-Pharm sending notice of allegation to Merck alleging purchasing from Apotex inventory acquired prior to issuance of patent-Merck instituted application to prohibit issuance of notice of compliance to Nu-Pharm-In 1997 Nu-Pharm filing abbreviated new drug submission, comparing NuEnalapril to Apo-Enalapril as Canadian reference product, to obtain notice of compliance-Containing no reference to Vasotec-Minister refusing to process Nu-Pharm's abbreviated new drug submission on basis Vasotec proper Canadian reference product-Nu-Pharm instituting application for mandamus to compel Minister to process abbreviated new drug submission, and to issue notice of compliance for NuEnalapril-Merck unaware of abbreviated new drug submission, mandamus proceedings-Cullen J. concluding Apo-Enalapril Canadian reference product, remitted matter to Minister for redetermination in Nu-Pharm Inc. v. Canada (Attorney General), [1999] 1 F.C. 620 (T.D.)-Minister not appealing that decision-Immediately upon becoming aware of decision, Merck instituting prohibition proceedings to prevent Minister from issuing notice of compliance-In 1999 Minister issuing notice of compliance to Nu-Pharm for Nu-Enalapril tablets in response to abbreviated new drug submission using Apo-Enalapril as Canadian reference product, containing no reference to Vasotec-Application allowed-In light of Cullen J.'s decision, analysis beginning from premise Nu-Pharm entitled to use Apo-Enalapril as Canadian reference produce for Nu-Enalapril for purposes of Food and Drug Regulations, and Minister required by Court order to process abbreviated new drug submission on that basis-Under Food And Drug Regulations, drug manufacturer must satisfy Minister of safety effectiveness of new drug before selling it in Canada-Before issuing notice of compliance under Food And Drug Regulations, s. C.08.004(1), Minister must determine whether Patented Medicines (Notice of Compliance) Regulations preventing issuance-Definition of "notice of compliance" in Patented Medicines (Notice of Compliance) Regulations, s. 2 incorporating by reference s. C.08.004 of Food and Drug Regulations, which requires Minister to issue notice of compliance in response to new drug submission, abbreviated new drug submission, supplement to either submission-Patented Medicines (Notice of Compliance) Regulations containing requirements to trigger application of regulations-Where provisions of s. 5(1) apply, express statutory prohibition preventing Minister from issuing notice of compliance until second person (usually generic manufacturer) complied with requirements of s. 5(1)-Purposive approach to statutory interpretation adopted in Rizzo & Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27 applied, as well as further guidance provided by S.C.C. in applying principles enunciated therein-Purpose of statute, intention of Parliament to be determined on basis of intrinsic, admissible extrinsic sources regarding Act's legislative history, context of enactment; all evidence of legislative intent must be considered, providing relevant, reliable-Regulatory Impact Analysis Statement, accompanying but not forming part of regulations, revealing government's intention and containing information as to purpose, effect of proposed regulation-Patented Medicines (Notice of Compliance) Regulations enacted to protect rights of patentees by preventing generic manufacturers from marketing drugs until expiry of all relevant patents-In enacting Patented Medicines (Notice of Compliance) Regulations government chose to accord primacy to protection of patent rights, but nevertheless permitted generic manufacturers to access regulatory approval system to enable generic products to be sold immediately following expiry of relevant patents-Basic purpose of regulations to prevent patent infringement-Although processes in Patented Medicines (Notice of Compliance) Regulations, Food and Drug Regulations separate, parallel, expressly linked by definition of "notice of compliance" in s. 2 of former-Therefore scheme, terminology in Food and Drug Regulations also considered to have complete contextual framework for interpretation of Patented Medicines (Notice of Compliance) Regulations, s. 5(1)-"Submission for notice of compliance" in s. 5(1) meaning abbreviated new drug submission in present case-Assistance in construing phrase "wishes to compare that drug with, or make a reference to, another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted" obtained by examining context in which notion of comparison of new drug with another drug used in Food and Drug Regulations-Scheme in Food and Drug Regulations concerning abbreviated new drug submission clearly establishing new drug must be compared with innovator's drug either directly or indirectly through another drug acceptable to Minister-Where abbreviated new drug submission naming another drug, not innovator's drug, as Canadian reference product, person filing submission cannot avoid application of patent protection scheme in Patented Medicines (Notice of Compliance) Regulations by simply stating does not wish to compare new drug to innovator's drug-Innovator's drug standard of comparison for assessment of bioequivalence, even where another drug accepted by Minister as Canadian reference product-Given context of overall legislative scheme, "wishes" in s. 5(1) must be subjected to objective standard-Even where no direct reference in abbreviated new drug submission to innovator's drug, in that another drug accepted by Minister for use as Canadian reference product, innovator's drug nevertheless, at least indirectly, standard underlying comparison for purposes of determining safety, effectiveness of new drug-Question of whether prohibition in Patented Medicines (Notice of Compliance) Regulations, s. 7 applied either pure question of law or question of mixed fact, law in relation to which Minister entitled to little, if any deference-Standard of review correctness-Minister prohibited by Patented Medicines (Notice of Compliance) Regulations, s. 7 from issuing notice of compliance to Nu-Pharm until such time as Nu-Pharm complying with s. 5-Minister erred in law by issuing notice of compliance to Nu-Pharm for NuEnalapril-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 "notice of compliance", 5 (as am. by SOR/98-166, s. 4), 7 (as am. idem, s. 6)-Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.