Bayer Inc. v. Apotex Inc.
T-420-98
Joyal J.
16/12/98
20 pp.
Motion by main respondent Apotex to dismiss prohibition proceedings-Motion in response to applicant Bayer's motion to prohibit Minister of Health from issuing to Apotex notice of compliance (NOC) in respect of drug "Nifedipine" on ground sale of drug by Apotex would constitute infringement of Bayer's Canadian patent no. 1,222,950 (950 patent) (Adalat XL)-Bayer alleging: (1) Apotex's notice of allegation (NOA) covering same drug issued in earlier proceedings, which were discontinued; (2) Apotex's tablet not bio-equivalent to Adalat XL osmotic tablet and, if it is, then would infringe 950 patent; (3) NOA invalid and void-Apotex responded by saying: (1) no evidence of infringement of 950 patent; (2) grounds raised by Bayer irrelevant or not of justiciable nature; (3) filing of new NOA by Apotex not abuse of process and doctrine of res judicata not applicable-Motion dismissed-Burden of Apotex of convincing Court motion should be dismissed quite high-Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 67 C.P.R. (3d) 484 (F.C.T.D.) suggesting conflicts between public safety-driven statute such as Food and Drugs Act and proprietary-driven statute such as Patent Act not easily reconciled, however following established: (1) burden of proof on applicant responding to NOA to prove, on balance of probabilities, one or more allegations in NOA not justified; (2) Court had no authority, during effective currency of proceedings, to compel production of evidence and there was no oral or documentary evidence; (3) Court cannot require that samples of drug proposed to be marketed be provided by applicant; (4) Court without jurisdiction to order filing and service of detailed statement or further and better detailed statement; and (5) case law has established that facts asserted in NOA to be taken as true until disproved-Proceedings neither infringement actions, nor actions for declarations of non-infringement-Proceeding summary one not designed to replace action between parties-Procedure herein meant to enable Minister to deal with application for NOC only when can be reasonably satisfied it will not issue in face of evidently infringed product-Absent such order, Minister free to deal with NOC in accordance with procedures set out in Food and Drugs Act-Rights of patentee in no way affected by ministerial proceedings-Conclusions: (1) allegation found in Apotex's NOA not bare assertion of non-infringement but specific allegation of fact at foundation of assertion of non-infringement; (2) transitional provisions found in new Regulations, s. 9 not grounds to raise procedural defects, but still remain matter for debate; (3) Bayer's argument Apotex cannot develop tablet bio-equivalent to 950 patent without infringing it not completely bereft of merit; (4) any doubt as to sufficiency of allegations must be resolved in favour of Bayer-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 9 (as am. by SOR/98-166, s. 9)-Food and Drugs Act, R.S.C., 1985, c. F-27-Patent Act, R.S.C., 1985, c. P-4-Food and Drug Regulations, C.R.C., c. 870.