PATENTS |
Practice |
Merck & Co., Inc. v. Canada (Attorney General)
A-804-99
Sharlow J.A.
13/3/00
15 pp.
Appeal from Motions Judge's determination notice of compliance should not have been issued for Nu-Enalapril--Merck patentee for enalapril maleate, medicinal ingredient in Vasotec--Obtained notice of compliance for Vasotec in 1987--Enalapril maleate also medicinal ingredient in Apo-Enalapril, for which Apotex obtained notice of compliance in 1993, but as Apo-Enalapril infringing Merck's patent no longer marketed--In September 1997 Nu-Pharm filed abbreviated new drug submission (ANDS) for Nu-Enalapril containing enalpril maleate--In ANDS information as to safety, efficacy of new drug inferred from similarity to "Canadian reference product" defined, inter alia, as drug in respect of which notice of compliance issued--Vasotec, Apo-Enalapril possible Canadian reference products--Requirements of Patented Medicines (Notice of Compliance) Regulations must also be satisfied before notice of compliance issuing--Register of "patent lists" foundation of those Regulations--Person obtaining notice of compliance for drug embodying patented medicine, and who is owner or exclusive licensee of patent, may file patent list--Anyone who files ANDS referring to drug for which patent list filed must comply with Patented Medicines (Notice of Compliance) Regulations, s. 5(1) requiring certain allegations be made by person filing submission for notice of compliance for drug comparing drug with, or making reference to, another drug marketed in Canada pursuant to notice of compliance issued to first person and in respect of which patent list submitted--No patent list for Apo-Enalapril because Apotex not holding patent--Notice of compliance for Apo-Enalapril obtained by comparison to Vasotec--Nu-Pharm's ANDS specifying only Apo-Enalapril as Canadian reference product--In 1999 Minister of Health issuing notice of compliance--Whether Regulation 5(1) engaged by filing of ANDS if Canadian reference product named not subject of patent list, but notice of compliance for Canadian reference product obtained by comparison to drug that is subject of patent list--Nu-Pharm Inc. v. Canada (Attorney General) (1997), 73 C.P.R. (3d) 510 (F.C.T.D.); affd (1998), 80 C.P.R. (3d) 74 (F.C.A.), wherein F.C.A. held cannot circumvent Regulations by cross-referencing drug submission to generic, which filed abbreviated new drug submission, applied--There Nu-Pharm submitting new drug submissions cross-referenced to ANDS previously filed by another generic drug company--Cross-referenced information consisting of tests demonstrating drugs essentially same as those manufactured by innovators for which patent lists filed--F.C.A. holding, while Nu-Pharm claiming to compare its drug to generic's drug, in essence comparing it to that of original patentee because generic compared its drug to that of patentee--ANDS for Nu-Enalapril, by using Apo-Enalapril as Canadian reference product, inviting comparison to Vasotec just as if Vasotec named, because new drug submission for Apo-Enalapril used Vasotec as Canadian reference product--Nu-Pharm cannot deny wishes comparison to be made between Nu-Enalapril and Vasotec nor avoid obligations of Regulation 5(1)--Food and Drug Regulations, s. C.08.004.1, precluding Minister from issuing notice of compliance to second manufacturer for five years if all three conditions therein met--Bayer Inc. v. Canada (Attorney General) (1999), 87 C.P.R. (3d) 293 (F.C.A.) holding Minister not relying on data contained in information, material filed by innovator when issues notice of compliance to generic drug manufacturer using innovator's drug as Canadian reference product; C.08.004.1 not automatically applying in such circumstances because similarity between two drugs could be determined without actually referring to innovator's confidential information filed with Minister--Nu-Pharm arguing to require compliance with Regulation 5(1) herein requiring modification of phrase "wishes to compare that drug with, or make reference to, another drug" in Regulation 5(1) so that reads "wishes to compare that drug directly or indirectly with, or make reference directly or indirectly to, another drug"--But Nu-Pharm not seeking indirect comparison to Vasotec--Seeking direct comparison to Vasotec although disguising fact by form of ANDS--Interpretation of Regulation 5(1) adopted by Motions Judge consistent with both words, objective of legislation--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5 (as am. by SOR/98-166, s. 4)--Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1 (as enacted by SOR/95-411, s. 6).