Merck & Co., Inc. v. Canada ( Minister of Health )
T-1273-97
Wetston J.
31/3/98
35 pp.
Application for judicial review of Minister of Health's decision to issue notice of compliance (NOC) to Apotex Inc. for drug Apo-lovastatin-Four different microbes for manufacture of lovastatin identified in various documents: terreus microbe to which Merck's patent applied, and in respect of which its NOC's had been issued; flavipes microbe named in NDS filed by Apotex for manufacture of Apo-lovastatin in 1993, and in its re-filed NDS, accepted for review in 1995; obscurus microbe named in 1995 NDS; fuckelii microbe named in detailed statement of fact and law pursuant to Cullen J.'s order of December 1993 in prohibition proceeding to prevent Minister from issuing NOC to Apotex in respect of its NDS for Apolovastatin-Issues (1) whether Apotex failed to comply with Patented Medicines (Notice of Compliance) Regulations, s. 5; (2) whether Apotex made material misrepresentations to Minister in submissions in request for NOC for Apo-lovastatin; (3) whether Minister exceeded or fettered jurisdiction, or exercised powers for improper purpose, in granting NOC-Application dismissed-(1) Eli Lilly and Co. v. Nu-Pharm Inc. (1996), 69 C.P.R. (3d) 1 (F.C.A.) standing for proposition so long as its requirements (allegation must be attached to new drug submission (NDS), must be completed by detailed statement, and must be served on first person; in addition, proof of service must be provided to Minister) met, s. 5 not mandating particular sequence of compliance-Any sequence that can be inferred from wording of s. 5 to be interpreted as directory, rather than mandatory-At relevant time, Minister had NDS for Apo-lovastatin on file that satisfied all requirements under Food and Drugs Regulations-Does not matter whether NDS "new" or "re-filed", or same filed with Minister in 1993-NDS review process separate and distinct from prohibition proceedings provided for under NOC Regulations, s. 6-NOA, not NDS, underpinning prohibition proceedings-NDS not forming part of record in prohibition proceedings under s. 6, and not playing substantive role in determining outcome of such proceedings-Similarly, content of NDS, at any given point in time, however amended, not material to substantive effect of allegation, and any ongoing prohibition proceedings-NDS approval process and prohibition proceedings in relation to allegation separate and distinct-While allegation must be attached to NDS, validity of allegation with respect to claim for medicine itself or claim for use of medicine only needs to be linked to proposed method of manufacture of medicine specified in NDS prior to issuance of NOC-Opportunity to challenge allegation not diminished by fact notice of allegation given first, as containing sufficient information for first person to determine whether to seek prohibition order and for court to proceed to determine whether one should be granted-Conversely, interpretation requiring NOA to be served contemporaneously with, or later than, NDS would artificially extend 30-month legislative stay, whenever NDS delayed, or must be re-filed-Interpretation affording first person opportunity to needlessly extend time before which competitor can enter market, rather than simple opportunity to seek summary determination on merits of particular allegation, should be rejected as fundamentally incompatible with objectives of Act and NOC Regulations-Irrelevant, with respect to issue herein, that detailed statement prepared by Apotex in 1993 found to be insufficient by Cullen J. in December 1993, and that his decision not appealed-Notice of allegation and detailed statement had been provided to applicants, albeit more than three years earlier than date on which NDS updated, and proof of service filed with Minister-Apotex complied with order for better detailed statement in early 1994-Requirement of providing proof of service of NOA to Minister designed to ensure Minister will only grant NOC once first person had opportunity to challenge allegation under s. 6-Whether Minister receives such proof of service in advance of, contemporaneous with, or after any given NDS filed or amended can in no way affect his ability to confirm whether NOC should issue, based upon restrictions imposed under s. 7-Therefore clear Apotex has complied with s. 5-All requirements of s. 5 met, albeit in different sequence than submitted by Merck Frosst-(2) No serious misrepresentations made to Minister-Evidence concerning pre-clinical studies in 1991 and 1992 indicating conducted in context of Apotex obtaining compulsory licence where identity of microbe or process by which lovastatin manufactured not significant-Regardless of whether Apotex actually knew microbe infringing at time of filing of 1993 NDS, in light of findings concerning interpretation of NOC Regulations, s. 5 above, there can be no misrepresentation before Minister regarding identity of microbe as Minister, at this stage, not concerned with allegation of non-infringement-Pursuant to s. 7, point in time at which Minister must be satisfied that requirements of s. 5 met: prior to granting NOC-Also, Apotex's NDS made in respect of Apo-lovastatin tablets, not process by which lovastatin made-Only when Minister ready to issue NOC for Apo-lovastatin, manufactured using specific microbe, that link had to exist between allegation in respect of specific microbe, and proposed manufacturing process referred to in NDS-(3) Minister did not act improperly in granting NOC-Minister not under any duty to inform Merck of deemed withdrawal of 1993 NDS or to otherwise become involved in prohibition proceeding-Duty restricted to ensuring requirements of regulations met prior to issuance of NOC-Minister not under any obligation to ensure that second person's NDS linked, at all times, to NOA and detailed statement, or to inform first person of any differences that may exist between them-Neither Minister nor representatives under any duty to inform Court of withdrawal of NDS-Minister's role with respect to information provided by Apotex to protect public interest with respect to safety and effectiveness of drugs, not to preserve proprietary rights of either Apotex or Merck Frosst-Insufficient evidence that Minister's past consulting practice and procedures give rise to legitimate expectation that would require consultation prior to Minister making change to 1994 Notifiable Change Policy-Merck Frosst had no legitimate expectation as has not demonstrated it had been directly affected by policy change-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5, 6, 7.