Date: 20021122
Docket No.: T-1898-01
Neutral Citation: 2002 FCT 1205
Ottawa, Ontario, this 22nd day of November, 2002
PRESENT: THE HONOURABLE MR. JUSTICE BLANCHARD
BETWEEN:
BRISTOL-MYERS SQUIBB COMPANY and
BRISTOL-MYERS SQUIBB CANADA INC.
Applicants
- and -
THE ATTORNEY GENERAL OF CANADA and
BIOLYSE PHARMA CORPORATION
Respondents
REASONS FOR ORDER AND ORDER
INTRODUCTION
[1] This is an application for judicial review of a decision by the Minister of Health to issue a notice of compliance under the Patented Medecine (NOC) Regulations (SOR/99-133), as amended. The applicants claim that the Minister failed to comply with the requirements of the said Regulations when he issued a notice of compliance ("NOC") to Biolyse in relation to its new drug submission for "PACLITAXEL for injection". The applicants argue that they should have received a notice of allegation ("NOA") before the issuance of the NOC, as envisioned by paragraph 7(1)(b) and s. 5 of the Regulations. As such, the applicants claim that the Minister committed a reviewable error. At the heart of the dispute is whether either subsection 5(1) or subsection 5(1.1) of the Patented Medicine (NOC) Regulations is engaged by the facts of this case.
[2] The applicants seek an order quashing the notice of compliance; a declaration that the Minister of Health failed to require Biolyse to comply with section 5 of the Patented Medicines (Notice of Compliance) Regulations; an order prohibiting the Minister from granting a NOC to Biolyse in respect of "PACLITAXEL for injection" before the latest of the number of events listed in Patented Medicines (NOC) Regulations subsection 7(1) occurs; and costs.
FACTS
[3] The applicant Bristol-Myers Squibb Company is the owner of two Canadian patents in relation to 6 mg/ml injectable paclitaxel solutions. The patents are numbered 2,086,874 ("'874") and 2,132,936 ("'936"), and expire in 2013 and 2014 respectively. The drug is marketed under the name "Taxol". Bristol-Myers Squibb Company's Canadian subsidiary, Bristol-Myers Squibb Canada ("BMS"), holds notices of compliance and has submitted patent lists in respect of the drug Taxol.
[4] Taxol contains paclitaxel which is derived from the bark of a yew tree, taxus brevifolia. The drug formulation consists of paclitaxel combined with Cremophor EL (polyethoxylated castor oil) and dehydrated alcohol. It is approved for treatment of breast, ovarian, and non-small-cell lung cancer.
[5] On March 22, 2001, Biolyse submitted a new drug submission ("NDS") in relation to its drug, a 6 mg/ml injection of paclitaxel solution, which is derived from the twigs and needles of the Canadian yew bush, taxus canadensis.
[6] In 1999, Biolyse sought and received input from the Therapeutic Products Directorate of Health Canada ("TPD/HC") concerning whether its drug submission should take the form of an NDS or an abbreviated new drug submission ("ANDS"). The TPD/HC recommended an NDS, largely on the basis that Biolyse's proposed drug emanated from a novel botanical source. Biolyse conducted clinical trials and submitted this data, along with data from the public domain regarding the safety and efficacy of the product.
[7] A NOC was issued to Biolyse on September 20, 2001 in the following terms:
9427-B1591/1-21
Submission Number/Numéro de présentation: 066127
Product name/Nom du produit: PACLITAXEL for injection, 6 mg/ml
Medicinal Ingredient(s)/Ingrédient(s) médicinal(aux): paclitaxel
Therapeutic Classification/Classification Thérapeutique: Antineoplastic Agent
Drug Identification Numbers/
Identification Numérique de(s) drogues(s): 02244372
The drug was approved for treatment of advanced breast cancer and non-small cell lung cancer. The Minister determined that s. 5 of the Patented Medicines (Notice of Compliance) Regulations was not engaged and as a result issued the NOC without requiring that Biolyse send a notice of allegation to BMS.
STATUTORY AND REGULATORY SCHEME
[8] The Food and Drug Regulations, C.R.C. 1985, c. 870, as amended, together with the Patented Medicines (Notice of Compliance) Regulations, provide a framework whereby a drug manufacturer may obtain a notice of compliance and thereby market its drugs in Canada. This scheme imposes two processes, an administrative one that is designed to ensure safety and efficacy, and a judicial one that is designed to protect the interests of patent holders. As noted by Marceau J.A. in Merck & Co. v. Canada (Minister of Health), (1999), 249 N.R. 110 at p. 114 [Merck 1]: "...[t]hese are parallel processes. Matching them is achieved only through their results: the Minister cannot issue a NOC without regard to the findings established by the two processes." The term "notice of compliance" appears in both sets of regulations, providing an "express link" between the two, as noted by McGillis J. in Merck & Co. v. Canada (Attorney General), (1999), 176 F.T.R. 21 at 38 [Merck 2].
[9] The Food and Drug Regulations envision two forms of new drug submissions. C.08.002.(1) provides in part as follows:
| C.08.002.(1) No person shall sell or advertise a new drug unless
(a) the manufacturer of the new drug has filed with the Minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the Minister; (Emphasis added)
(b) the Minister has issued, pursuant to section C.08.004, a notice of compliance to the manufacturer of the new drug in respect of the new drug submission or abbreviated new drug submission; |
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C.08.002.(1) Il est interdit de vendre ou d'annoncer une drogue nouvelle, à moins que les conditions suivantes ne soient réunies :
a) le fabricant de la drogue nouvelle a, relativement à celle-ci, déposé auprès du ministre une présentation de drogue nouvelle ou une présentation abrégée de drogue nouvelle que celui-ci juge acceptable; (Je souligne)
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| b) le ministre a, aux termes de l'article C.08.004, délivré au fabricant de la drogue nouvelle un avis de conformité relativement à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle; |
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[10] A new drug submission must include a description of the drug, the use for which the NOC is sought, and detailed reports of clinical effectiveness. The submission must contain "sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug" [C.08.002(2)].
[11] An abbreviated new drug submission, by contrast, is an appropriate submission for drugs that are copies of existing drugs for which safety and efficacy have already been proved. The ANDS relies on the clinical studies of a previously approved "Canadian reference product". The new drug must be the "pharmaceutical equivalent" of the reference drug [C.08.002.1.(1)(a)].
[12] The Patent Act, R.S.C. 1985, c. P-4, as amended, provides in subsection 55.2(4) that the "Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention...".
[13] Subsection 7(1) of the Patented Medicines (NOC) Regulations provides that the Minister shall not issue a NOC to a second person before the latest of a series of events, one of which is "(b) the day on which the second person complies with section 5".
[14] Subsection 5(1) of the Patented Medicines (NOC) Regulations provides:
| Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug 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, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. |
5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue :
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité. |
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[15] Subsections 5(1.1) and 5(1.2), added in 1999, provide:
| Subject to subsection (1.2), where subsection (1) does not apply and where a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine found in 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, the person shall, in the submission, with respect to each patent included on the register in respect of the other drug containing the medicine, where the drug has the same route of administration and a comparable strength and dosage form, (a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.
5(1.2) Where a person referred to in subsection (1.1) has served, in accordance with paragraph (3)(b) or (c), a notice of allegation on a first person in respect of a patent included on the register, the person is not required to serve a notice of allegation in respect of the same submission, the same allegation and the same patent on another first person. |
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5(1.1) Sous réserve du paragraphe (1.2), lorsque le paragraphe (1) ne s'applique pas, la personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament que l'on trouve dans une autre drogue qui a été commercialisée au Canada par suite de la délivrance d'un avis de conformité à la première personne et à l'égard de laquelle une liste de brevets a été soumise doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre visant cette autre drogue contenant ce médicament, lorsque celle-ci présente la même voie d'administration et une forme posologique et une concentration comparables : a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne soit pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité.
5(1.2) Si une personne visée au paragraphe (1.1) a signifié, conformément aux alinéas (3)b) ou c), un avis d'allégation à une première personne à l'égard d'un brevet inscrit au registre, elle n'est tenue de signifier un avis d'allégation à l'égard de la même demande, de la même allégation et du même brevet à aucune autre première personne.
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[16] Where a person makes an allegation under paragraph 5(1)(b) or paragraph 5(1.1)(b), he must "provide a detailed statement of the legal and factual basis for the allegation" and serve a notice of allegation on the first person [subsection 5(3)].
[17] Section 6 provides that after a notice of allegation is sent, the first person may apply, within 45 days, to a court for an order prohibiting the Minister from issuing a NOC until after the expiration of the patent so long as the allegation is unjustified.
[18] Once a first person has applied for a prohibition order under s. 6, paragraph 7(1)(e) of the Patented Medicines (NOC) Regulations is triggered, and provides that the Minister shall not issue a NOC until the expiration of 24 months after the s. 6 application.
ISSUES
[19] The following issues will be considered in this judicial review application:
A. Is this judicial review application properly brought under s. 18.1 of the Federal Court Act?
B. Is subsection 5(1) of the Patented Medicines (NOC) Regulations engaged on the facts of this application?
C. Is subsection 5(1.1) of the Patented Medicines (NOC) Regulations engaged on the facts of this application?
D. Did the Minister commit a reviewable error when he determined that subsection 5(1.1) did not apply to the facts of this application?
STANDARD OF REVIEW
[20] The applicable standard of review, on the issue of whether s. 5 of the Patented Medicines (NOC) Regulations is engaged on the facts of this case, is disputed. The Attorney General of Canada argued that the issue before the Court is a jurisdictional one: Did the Minister err in deciding he had the jurisdiction to issue the NOC? The essence of the Attorney General's argument is that such a question does not automatically call for the application of the correctness standard, but rather, calls for the jurisdictional question to be but one factor to be considered in applying the pragmatic and functional approach to be determination of the appropriate standard of review. [See Society of Composers, Authors and Music Publishers of Canada v. Canadian Association of Internet Providers, 2002 FCA 106, [2002] F.C.J. No. 691 (QL) at paras 46 and 47].
[21] The Attorney General contends that another factor to be considered is the Minister's scientific and technical expertise. On the facts of this case, he argues that the issue of whether the NOC was issued on the basis of a comparison or reference to the Bristol-Myers product is "plainly a complex and technical one" requiring the application of the specialized expertise of the Minister. Accordingly, the Minister is entitled to deference and his decision ought to be reviewable on a standard of reasonableness.
[22] I am of the view that, while the expertise of the Minister may well come into play in making determinations about the safety and efficacy on the evaluation of scientific evidence, such expertise is not engaged for the proper construction of s. 5 of the Patented Medicines (NOC) Regulations. In my view, the Minister would arguably have no greater expertise on this issue than the Court, and consequently a low level of deference is warranted.
[23] I accept the Attorney General's contention that to invoke jurisdiction does not dispense with the need to conduct a pragmatic or functional analysis to determine the applicable standard of review. In conducting such an analysis, the factors set out in Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982, require consideration. I do not intend to canvass all of the factors in these reasons. However, the purpose of the statute and its regulations are important factors worthy of specific mention in these reasons, given the circumstances of this case.
[24] In Pushpanathan, supra, Bastarache J. stated at page 1008 that "[w]here the purposes of the statute and of the decision-maker are conceived not primarily in terms of establishing rights as between parties, or as entitlements, but rather as a delicate balancing between different constituencies, then the appropriateness of court supervision diminishes." The purpose of the notice of compliance provisions of the Food and Drug Regulations is to protect public health by assuring a certain level of safety and efficacy for drugs. As such, the decision that a new drug submission has satisfied the Food and Drug Regulations is a polycentric one, given that it involves the implementation of "social and economic policy in a broad sense." [Pfizer Canada Inc. v. Minister of National Health and Welfare et. al., 12 C.P.R. (3d) 438 at 440.] In the instant case, we are dealing specifically with the applicability of the Patented Medicines (NOC) Regulations which provide for a parallel but separate administrative process from that of the Food and Drugs Regulations. The purpose of the Patent Act and the Patented Medicines (NOC) Regulations is to protect patent rights. The decision to grant a NOC under the Patented Medicines (NOC) Regulations process is made on a judicial basis involving the interests of the new drug applicant and potentially the interests of an existing patent holder and, as such, deals primarily in terms of establishing rights between parties as opposed to a polycentric decision. [Merck 1, supra, at 114.]
[25] Guided by the analysis set out in Pushpanathan, supra, I am therefore of the view that the decision to grant a NOC made under the Patented Medicines (NOC) Regulations warrants a low level of deference on judicial review.
[26] In Merck 2, supra, the legal question was whether subsection 5(1) (and therefore s. 7) of the Patented Medicines (NOC) Regulations were engaged by the facts of the case. In the circumstances of that case, McGillis J. applied the correctness standard of review. She stated at page 43, paragraph 68:
...The question of whether the prohibitions in section 7 of the Patented Medicines (Notice of Compliance) Regulations applied in the present case was either a pure question of law or a question of mixed fact and law in relation to which the Minister should be entitled to little, if any, deference. In the circumstances, correctness is the proper standard of review.
This decision was affirmed by the Federal Court of Appeal.
[27] I am in substantial agreement with the reasons of McGillis J. in Merck 2, supra, particularly with regards to those paragraphs of her reasons dealing with statutory interpretation and standard of review.
[28] I conclude that the appropriate standard of review applicable to the issue of whether s. 5 of the Regulations is engaged on the facts of this application is correctness. The issue before the Court presents a question of mixed law and fact with precedential value. This finding is based on a "pragmatic or functional analysis" and a consideration of the factors set out in Pushpanathan, supra.
[29] Further, I am not satisfied that the standard already established by McGillis J. in Merck 2, supra, is inappropriate or that the nature of the statutory provision in dispute in the instant case is so manifestly different from that considered by McGillis J. that a pragmatic or functional analysis requires the application of a different standard of review. [See Society of Composers, supra, per Evans J.A., at paragraphs 37 and 38.]
ANALYSIS OF THE ISSUES
A. Is this judicial review application properly brought under s. 18.1 of the Federal Court Act?
[30] The respondent Biolyse argues that the applicants lack standing for an application under s. 18.1 of the Federal Court Act, R.S.C. 1985, c. F-7, because they have failed to show that they are "directly affected". Biolyse claims that the potential financial impact on the applicants that could result from the Minister's decision to issue the NOC is insufficient to "directly affect" the applicant for the purposes of s. 18.1 of the Federal Court Act.
[31] This line of argument was not pursued during oral submissions. However, counsel for Biolyse argued that the Patented Medicines (NOC) Regulations do not provide for the quashing of a NOC and that the Regulations were not meant to replace private law remedies. As such, it was open to BMS to pursue a patent infringement action if warranted.
[32] The applicants are proceeding not under the Patented Medicines (NOC) Regulations, but under s. 18.1 of the Federal Court Act. In my view, this is an appropriate proceeding for the remedies the applicant seeks.
[33] In Merck 2, supra, McGillis J. quashed a notice of compliance for failure to comply with s. 5 of the Patented Medicines (NOC) Regulations. This judgment was upheld by the Federal Court of Appeal. Clearly standing had been established. While a patent infringement action is open to the applicant, the Regulations set out a scheme that is designed to give notice to those whose patent rights may be infringed. A party's right to instigate a patent infringement action should have no bearing on its right to seek to quash a NOC improperly issued, and judicial review of a ministerial decision not to require service of a NOA where a party is of the view that the Minister erred in rendering such decision.
[34] In my view, on the evidence, the applicants' interest insofar as its patents are concerned is clearly "directly affected" by the NDS. This finding is based on the Minister's determination during the NOC process that the submitted drug contains the same medicine found in the applicants' drug Taxol namely, paclitaxel.
B. Is subsection 5(1) of the Patented Medicines (NOC) Regulations engaged on the facts of this application?
[35] The applicants argue that Biolyse's NDS contained a sufficient number of references to Bristol-Myers product Taxol to engage subsection 5(1), namely, that Biolyse "compared the drug" or "made reference to" Taxol for the purpose of demonstrating bioequivalence on the basis of pharmaceutical characteristics.
[36] The applicants submit that there were extensive indirect and direct references to BMS' Taxol in Biolyse's drug submission. They claim that the heavy reliance on studies using Taxol submitted as data from the public domain constitutes an indirect reference. The applicants also argue that there are direct comparisons to Taxol's impurity profile and reliance on Taxol's product monograph. The applicant's expert states that a typical NDS contains 300-500 volumes of material, whereas the Biolyse NDS filled only 17 volumes, and suggests that the NDS did not contain enough data to be a "stand alone" submission.
[37] The respondent, Biolyse, argues that there was no Canadian reference product designated on its NDS and that Biolyse did not request and did not receive a declaration of bioequivalence. Biolyse was asked to "provide data from the public domain and link this information to the broader safety and efficacy of the product". According to Biolyse, the numerous references to other drugs in its application served to demonstrate its drug's safety and efficacy and not to demonstrate bioequivalence.
[38] The determinative issue on the applicability of subsection 5(1) in this application is whether Biolyse compared or referenced Taxol on the basis of pharmaceutical characteristics. The comparative analysis under subsection 5(1) is twofold; firstly, to establish bioequivalence with another drug with the objective to demonstrate the safety and efficacy of the drug; and secondly, to verify for patent infringement "...with respect to each patent on the registry in respect of the other drug."
[39] Biolyse did not compare its drug or make reference to another drug for the purpose of demonstrating bioequivalence. Biolyse did not apply for a declaration of equivalence nor was one granted.
[40] On the evidence, the Biolyse submission contains clinical studies on sick patients; specifically those with advanced breast cancer unresponsive to usual treatments and those with locally advanced non-small-cell lung cancer. The safety and efficacy of the Biolyse product assessment was based on those studies and on what was known to scientists in the public realm about paclitaxel. This is consistent with the usual procedure for a NDS. In my view, the language in subsection 5(1) is clear. Without a second drug used for comparative purposes to assess the safety and efficacy of the new product, subsection 5(1) has no application. Further, a second person would be unable to comply with the requirements under the subsection to provide the specified information, "...with respect to each patent on the register in respect of the other drug", since no "other drug" is identified in this instance.
[41] I therefore find that the Biolyse submission is not one to which subsection 5(1) of the Patented Medicines (NOC) Regulations applies. However, this determination is not dispositive of this application in light of my subsequent finding in these reasons that subsection 5(1.1) is indeed engaged on the facts of this application.
C. Is subsection 5(1.1) of the Patented Medicines (NOC) Regulations engaged on the facts of this application?
[42] The applicants submit that subsection 5(1.1) of the Patented Medicines (NOC) Regulations applies to this case, and that the Minister should not have issued the NOC before ensuring that BMS was sent a notice of allegation as a first person whose drug "has been marketed in Canada pursuant to a notice of compliance ... and in respect of which a patent list has been submitted".
[43] The applicants urge that the terms of subsection 5(1.1) apply, and that (i) Biolyse's drug "contains a medicine found in another drug... marketed in Canada and in respect of which a patent list has been submitted"; (ii) the drug has the "same route of administration"; and (iii) "comparable strength and dosage form".
[44] In support of this claim, the applicants, in their written submissions, state that "like BMS' Taxol, the paclitaxel intended to be sold by Biolyse is a 6 mg/ml solution of paclitaxel containing polyoxyethylated castor oil (Creomphor EL) and dehydrated alcohol. As such, not only does Biolyse's paclitaxel have the same strength, dosage form and route of administration as Taxol; it even has the same formulation as Taxol."
[45] On cross-examination, the President of Biolyse admitted that the structural formula and molecular weight of the compound paclitaxel used in Biolyse's drug is the same as that of the paclitaxel used in Taxol by BMS. She also stated that the Biolyse product has the same dosage form as Taxol and the same route of administration.
[46] On cross-examination, the witness for the TPD/HC stated that both "PACLITAXEL for injection" and Taxol contain the same compound, paclitaxel. She further stated that the molecular weight of the two sources of paclitaxel is identical, the stereo-chemistry is the same, and they are the same medicinal ingredient. She agreed with the statement of counsel that "while it may confirm a different plant source, the product that is isolated is identical".
[47] The respondent Attorney General admits that, given the literal wording of subsection 5(1.1) and "without regard for regulatory context and intended purpose", the case at hand "may appear to apply to the Biolyse drug". However, he argues that the section was intended to apply only to the Merck 2, supra, situation, and "was not intended to reflect any change in policy" nor expand the scope of the regulations.
[48] The Attorney General of Canada argued, and it was not disputed, that subsection 5(1.1) was enacted in response to a particular situation, that in Merck 2, supra. In that case, company A had submitted patent lists and held a NOC in respect of a drug. Company B obtained a NOC based on a reference to Company A's drug, in compliance with the Patented Medicines (NOC) Regulations. Company C then submitted a NOC and named Company B's generic drug as the Canadian reference product. The result of this chain of events was that Company C was able to avoid the operation of the Regulations, since Company B had not submitted a patent list in respect of its generic drug. Therefore Company C did not send a NOA to the innovator, Company A, even though its drug was identical.
[49] The Attorney General of Canada notes that the Regulatory Impact Analysis Statement ("RIAS") concerning subsection 5(1.1) states that "present amendments do not reflect any change in policy" and "are designed to clarify the law and reaffirm the application" of the existing Regulations.
[50] In view of the mischief intended to be addressed by subsection 5(1.1) and the RIAS statements that the provision did not reflect a change in policy, the Attorney General of Canada argues that subsection 5(1.1) should apply only where a new drug submission relies on comparisons with another drug as the basis for approval. In the present case, because no Canadian reference product was named and no comparative studies were presented, subsection 5(1.1) was not applied. Counsel states that "the mere fact that a drug includes a previously-approved medicine is not sufficient to attract the application of subsection 5(1.1)".
[51] I disagree with this interpretation of subsection 5(1.1). To embrace the interpretation proposed by counsel for the Attorney General of Canada would require that I disregard the plain wording of subsection 5(1.1). That section is triggered when a drug for which a NOC is sought contains "a medicine found in 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". When the Minister issued the NOC to Biolyse on September 20, 2001, he confirmed that Biolyse's drug contains the medicine paclitaxel, a medicine which is also found in another drug that has been marketed in Canada namely, Taxol by BMS. BMS has been granted notices of compliance in respect of Taxol, and has submitted patent lists in respect of Taxol. Subsection 5(1.1) further requires that the new drug have "the same route of administration" and a "comparable strength and dosage form". The evidence establishes that Biolyse's "PACLITAXEL for injection" has the same route of administration as Taxol (intravenous injection) and is of identical strength and dosage form as Taxol (6 mg/ml).
[52] A plain reading of subsection 5(1.1) is consistent with a purposive approach to the interpretation of the Patented Medicines (NOC) Regulations. The Regulations are intended to prevent the infringement of patent rights while, as noted by the Attorney General of Canada, allowing generic producers to work up submissions prior to the expiry of relevant patents and thereby facilitate the entry of generic drugs onto the market.
[53] This interpretation is reinforced by the RIAS, which states that "subsection 5(1.1) will be triggered when the second or subsequent entry manufacturer's drug contains the same medicine, employs the same route of administration and has a comparable strength and dosage form as the drug listed on the patent register."
[54] I therefore conclude that the drug for which Biolyse sought a NOC contains a medicine, paclitaxel, which is found in another drug, Taxol, that has been marketed in Canada pursuant to a NOC issued to a first person, BMS, and in respect of which a patent list has been submitted. Consequently, subsection 5(1.1) is engaged on the facts of this application and the Minister erred by failing to require that a notice of allegation be served on the applicants in compliance therewith.
D. Did the Minister commit a reviewable error in not requiring that Biolyse comply with s. 5 prior to granting the NOC?
[55] The uncontradicted evidence is that the paclitaxel found in Biolyse's drug is identical to the paclitaxel found in BMS' Taxol. There is no requirement in subsection 5(1.1) that the new drug submission must rely on comparisons with approved drugs, nor that the type of submission must be an ANDS. The Minister misinterpreted subsection 5(1.1) in deciding that only submissions based on comparative studies trigger subsection 5(1.1).
[56] I am of the view that the Minister committed a reviewable error in determining that subsection 5(1.1) of the Patented Medicines (NOC) Regulations does not apply to the Biolyse NDS. The decision to issue a NOC to Biolyse without requiring service of a NOA on the applicants is therefore reviewable.
[57] On the facts of this case, the Minister erred in issuing a NOC to the respondent Biolyse until the first person, BMS, was served with a notice of allegation as required by s. 7 of the Patented Medicines (NOC) Regulations.
[58] For the above reasons, the application for judicial review will be allowed with costs to the applicants.
[59] The applicants will have the declaratory relief sought and the notice of compliance will be quashed. In the circumstances, and in light of these reasons, I am of the view that it is not necessary to issue the prohibition order sought since the relief sought is identical to the obligation imposed on the Minister by the Regulations.
ORDER
1. IT IS ORDERED that the judicial review is allowed and the relief requested by the applicants is granted as follows, and is otherwise denied.
2. THIS COURT DECLARES that the Minister failed to require Biolyse to comply with s. 5 of the Patented Medicines (NOC) Regulations including sending a NOA to BMS Canada in respect of "PACLITAXEL for injection, 6mg/ml", before granting a NOC to Biolyse in respect of "PACLITAXES for injection, 6mg/ml".
3. IT IS ORDERED that the NOC granted by the Minister to Biolyse in connection with Biolyse's New Drug Submission 066127 for "PACLITAXEL for injection, 6mg/ml" is quashed.
4. Costs of this application to the applicants.
"Edmond P. Blanchard"
Judge
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1898-01
STYLE OF CAUSE: Bristol-Myers Squibb Company et al. v. The Attorney General of Canada et al.
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: October 22, 2002
REASONS FOR ORDER AND ORDER: BLANCHARD J.
DATED: November 22, 2002
APPEARANCES:
Patrick Smith/Anthony G. Creber FOR APPLICANT
Douglas N. Deeth/Gordon S. Jepson FOR RESPONDENT BIOLYSE
Frederick Woyiwada FOR RESPONDENT Attorney Gen.
SOLICITORS OF RECORD:
Gowling Lafleur Henderson LLP FOR APPLICANT
2600 - 160 Elgin Street
P.O. Box 466, Station D
Ottawa, Ontario, K1P 1C3
DEETH WILLIAMS WALL LLP FOR RESPONDENT BIOLYSE
150 York Street, suite 400
Toronto, Ontario, M5H 3S5
Morris Rosenberg FOR RESPONDENT Attorney Gen.
Deputy Attorney General of Canada
Department of Justice
Ottawa, Ontario, K1A 0H8