Patented Medicines (Notice of Compliance) Regulations (Re), docket T-2152-97

Date: 19980722

Docket: T-2152-97

IN THE MATTER OF A REFERENCE PURSUANT TO SUBSECTION 18.3(1) OF THE FEDERAL COURT ACT, R.S.C. 1985, C. F-7, REGARDING A QUESTION AS TO THE APPLICATION OF SECTION 7 OF THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS, SOR/93-133.

     REASONS FOR ORDER

WETSTON J.

[1]      By notice of a reference, the Director General of the Therapeutic Products Directorate, acting on behalf of the Minister of Health, has referred the following question of law concerning the application of s. 7 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133:

[2]      It is understood by the parties that the term "he", in the reference question, refers to the Minister, that "NOC" means "notice of compliance", that "Apotex" refers to Apotex Inc., that "the new claims" means new claims submitted by Apotex to the Minister by way of a supplemental abbreviated new drug submission ("SANDS") concerning additional indications for the drug Apo-lovastatin, that "NOA" means "notice of allegation" and "Merck" refers to Merck Frosst Canada Inc.

[3]      Paragraph 7(1)(b) of the Patented Medicines (Notice of Compliance) Regulations (hereinafter the "NOC Regulations") provides, in part:

[4]      Section 5 of the NOC Regulations provides, in part:

[5]      By order dated 22 May 1998, I answered the reference as follows: the Minister is not precluded by s. 7(1)(b) of the NOC Regulations from issuing a notice of compliance to Apotex for the new claims referred to in the reference question, namely, the slowing of the progression of coronary atherosclerosis in patients with coronary heart disease, and the significant reduction in major cardiovascular events and all-cause mortality. The following are my reasons for this decision.

[6]      What are the requirements imposed on Apotex by s. 5 of the NOC Regulations concerning its application for NOC's to be granted for new indications for the drug, Apo-lovastatin? As I indicated during the hearing, the question of law to be answered by this reference is limited to the record in this case, including, however, the record that was before me in court file T-1273-97: Reference RE: Patented Medicines (Notice of Compliance) Regulations (T-2152, 29 October 1997, F.C.T.D., Hugessen J.).

[7]      On 31 January 1984, Merck & Co. Inc. received a patent for the process by which it manufactures Lovastatin, which it consequently licensed to Merck, for the marketing and sale of lovastatin in Canada, under the trademark Mevacor. A second patent, dealing with the conversion of lovastatin into a lactone, was also granted on 13 September 1991. These patents were listed by Merck on the patent register maintained by the Minister shortly after the coming into force of the NOC Regulations.

[8]      On 30 June 1988, Merck received a NOC for the marketing and sale of Mevacor for the treatment of hypercholesterolemia. Merck sought additional NOC"s for Mevacor, for the treatment of slowing of the progression of coronary atherosclerosis in patients with coronary heart disease, and for the significant reduction in major cardiovascular events and all-cause mortality which were granted on 15 March 1995 and 24 June 1996 respectively.

[9]      On 25 March 1993, Apotex filed a NDS for Apo-lovastatin tablets in which Apo-lovastatin was compared to Mevacor. The indication contained in the NDS was for the treatment of hypercholesterolemia, which was the only approved indication for the use of Lovastatin at that time.

[10]      On 19 April 1993, Apotex served a NOA on Merck alleging that no claim for Lovastatin and no claim for the use of lovastatin, as contained within Merck's registered patents, would be infringed by the making, constructing, using or selling of Apo-lovastatin tablets by Apotex. On 23 April 1993, Apotex filed a copy of the NOA with the Minister, along with proof of service on Merck. The NOA contained a detailed statement of the legal and factual basis for the allegation which was later accompanied by a further detailed statement in early 1994, pursuant to an order of Cullen J, dated 20 December 1993.

[11]      Merck filed an application for prohibition in respect of the 1993 NOA on 1 June 1993, in which it contested Apotex's allegation concerning the manufacture of Apo-lovastatin. There is no indication on the record, however, that Merck ever contested Apotex"s allegation on the grounds that Merck"s registered patents contained claims for the use of Mevacor which would be violated by Apotex through the use of Apo-lovastatin.

[12]      On 26 March 1997, Mr. Justice Rothstein dismissed Merck"s application on the basis that the 30-month statutory stay which was applicable under the NOC Regulations at the time, had expired and, as such, the Court was without jurisdiction to issue a prohibition order under s. 6(2) of the NOC Regulations. The merits of Merck's challenge to Apotex's allegation were not addressed in this decision.

[13]      Accordingly, a NOC for Apo-lovastatin tablets was issued to Apotex on 26 March 1997, for use in the treatment of hypercholesterolemia. By way of supplemental abbreviated NDS ("SANDS") dated 9 July 1997, Apotex then requested a NOC for Apo-lovastatin tablets for the additional indications mentioned above.

[14]      In its SANDS, Apotex compared Apo-lovastatin with Mevacor, as it had in its original NDS. Further, the manufacturing process proposed by Apotex in its SANDS was the same as that which had been approved in its NOC for Apo-lovastatin, and had been the subject of Merck"s application for prohibition, dismissed approximately three months earlier by Rothstein J.

[15]      Apotex did not serve a new NOA or detailed statement on Merck in respect of its SANDS proposal for additional indications for Apo-lovastatin tablets, nor did it file proof of such service with the Minister. Rather, in support of its SANDS, Apotex filed the 1993 NOA along with proof of service made on Merck in April 1993.

[16]      The Minister has evaluated Apotex"s SANDS for the additional indications for Apo-lovastatin and has determined that it complies with all of the requirements of the Food and Drug Regulations .

[17]      The Minister and Apotex submitted that my decision in T-1273-97 fully answers the question in this reference. It was contended that Merck was provided with an opportunity to challenge Apotex"s allegation as to the use of Apo-lovastatin, made in 1993, and did not do so. Accordingly, it was submitted that s. 5 of the NOC Regulations was complied with, and that a NOC may therefore have been issued to Apotex for the additional indications, as Apotex"s SANDS has been determined to otherwise be in compliance with the Food and Drug Regulations .

[18]      Merck has argued that this case is unlike the matter before me in T-1273-97, where Apotex had sought a NOC for Apo-lovastatin using a re-filed NDS supported by the NOA linked to its previously filed NDS. It is submitted that, in this case, there is a distinct submission for a completely separate NOC, i.e. a NOC for additional indications for Apo-lovastatin tablets.

[19]      Merck submitted that the wording of s. 5 of the NOC Regulations is clear. A NDS has been filed for a new NOC for Apo-lovastatin by Apotex. Merck argued that while the Minister and Apotex contend that there are no new patent issues to be determined regarding Apo-lovastatin, the Minister does not possess any discretion to determine whether there are patent issues which might require application of the NOC Regulations, i.e. he has no authority to waive compliance. Rather, it was contended that the NOC Regulations have been specifically designed to afford patent-holders, such as Merck, with the opportunity to determine whether there are any patent issues which require an application for prohibition to be made under s. 6 each time a new NOC is sought.

[20]      Merck submitted that Apotex cannot rely on its 1993 NOA in support of its SANDS because the new indications referred to in the SANDS did not even exist at the time the 1993 NOA was served and filed. Merck further argued that the question of whether its patents contain claims for the use of Lovastatin is a matter for the Court to determine, should Merck conclude, after having been served with a new NOA in respect of the additional indications sought in Apotex"s SANDS, that it should seek an order of prohibition under s. 6 of the NOC Regulations . It was also argued that since there is no evidence concerning whether the additional indications sought in Apotex"s SANDS would infringe claims contained within Merck"s patents, no conclusions could be drawn as to infringement.

[21]      In my opinion, my decision in T-1273-97 does squarely address the issue raised in this reference. The Court of Appeal has held that the purpose of the NOC Regulations is to ensure that a NOC is not issued without a patent-holder having had the opportunity to defend its patent: Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 153 D.L.R. (4th) 68 at 78-79. In this case, it is clear that Merck received notice of Apotex's allegation that no claims concerning use contained within Merck's patents would be infringed by, among other things, the use of Apo-lovastatin.

[22]      The allegation and detailed statement provided by Apotex in the 1993 NOA, which was served with proof filed in accordance with the NOC Regulations, was made independently of the approval process required under the Food and Drug Regulations. As such, this allegation and detailed statement could be used to support any number of NDS's or SANDS for Apo-lovastatin, so long as the NOC sought is encompassed by the subject matter of the allegation.

[23]      As I stated in my decision in T-1273-97, the NDS review process is separate and distinct from the prohibition proceedings provided for under s. 6 of the NOC Regulations. It is the NOA, not a NDS or SANDS, that underpins prohibition proceedings under the NOC Regulations. While an allegation must be attached to a NDS or SANDS, the validity of an allegation with respect to a claim for the medicine itself or a claim for the use of a medicine only needs to be linked to the proposed method of manufacture or, as the case may be, use of the medicine specified in the NDS, prior to the issuance of a NOC: Smithkline Beecham Pharma Inc. v. The Minister of Health and Welfare et al. (T-2528-96, 24 November 1997, F.C.T.D.).

[24]      Recently, the Supreme Court of Canada, in.Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] S.C.J. No. 58 (Q.L.) approved of the approach to the NOC Regulations adopted in Smithkline Beecham, supra. While the issues before the Supreme Court were different than the issue in this reference, nevertheless Mr. Justice Iacobucci, writing for the Court, noted that Smithkline Beecham, supra, represents a correct statement of the law with respect to the timing of a NOA.

[25]      The opportunity for Merck to challenge Apotex's allegation concerning use was provided to Merck through the service of Apotex's 1993 NOA. In this regard, my finding in T-1273-97, concerning Merck's opportunity to challenge the Apotex allegation concerning the manufacture of Apo-lovastatin, is equally applicable in this case:

[26]      In this case, Merck received notice of Apotex's allegation as to possible claims to use in its patents approximately four years in advance of Apotex's filing a SANDS with the Minister in order to obtain an NOC for the additional indications for Apo-lovastatin. Merck's response, at the time, was to initiate prohibition proceedings only with regard to the proposed process of manufacture for Apo-lovastatin. In my opinion, it does not matter that, at the time the allegation was made, there was only one approved indication for the use of Lovastatin. If the patents could have supported any claim as to use, the issue could have been raised by Merck within the context of an existing prohibition proceeding.

[27]      The interpretation of the NOC Regulations urged by Merck, requiring a new NOA to be served by Apotex in respect of the proposed additional uses for Apo-lovastatin would needlessly extend the time before which Apotex could market Apo-lovastatin in respect of the additional indications, even though there is no evidence that there are any new patent claims at issue, or more importantly that Merck was already given the opportunity to contest claims as to use with service of the 1993 NOA. I cannot agree with Merck's approach as it is fundamentally incompatible with the objectives of the Act and NOC Regulations: Eli Lilly, supra.

[28]      Moreover, it is not accurate to depict the Minister as improperly exercising discretion to waive compliance with the NOC Regulations when he determines, in any particular case, that there are no new patent issues which could prevent the issuance of an NOC. Rather, under the NOC Regulations, the Minister is responsible for making a determination that the issuance of a NOC would not be in contravention of s. 7. In so doing, the Minister ascertains whether a NOA has been served, with proof of such service filed, and determines whether a prohibition application was made in respect of the allegation and detailed statement contained within the NOA, and if so, ascertains the current status of the prohibition proceeding.

[29]      In this case, the Minister concluded that a NOA was served, and that proof of such service was filed, in 1993. The Minister determined that there had been a prohibition proceeding in respect of claims concerning the manufacture of Apo-lovastatin, but that the proceeding had been dismissed because the applicants had run out of time. The process of manufacture contained within the Apotex SANDS was unchanged from that which was the subject of the dismissed prohibition proceeding, and there was no evidence that Merck had been deprived of the opportunity it was given in 1993 to contest Apotex's allegation concerning claims for use. Accordingly, the Minister determined that there were no other patent issues remaining, and that the new NOC should be issued.

[30]      In conclusion, the answer to the reference question is: NO. The Minister is not precluded by s. 7(1)(b) of the NOC Regulations from issuing a notice of compliance to Apotex for the new claims referred to in the reference question, because Apotex complied with the obligations imposed under s. 5 of the NOC Regulations by serving its NOA, and filing proof of such service, in 1993. As such , Merck was provided with the opportunity to challenge Apotex's allegation in respect of claims as to use, which for whatever reason, it chose not to utilise.

     Judge

Ottawa, Ontario

22 July 1998