Catalyst Pharmaceuticals, Inc. v. Canada (Attorney General)

Catalyst Pharmaceuticals, Inc. v. Canada (Attorney General)
Court (s) Database
Federal Court Decisions
Date
2022-03-10
Neutral citation
2022 FC 292
File numbers
T-1047-21
Decision Content
Date: 20220310
Docket: T-1047-21
Reference: 2022 FC 292
Ottawa, Ontario, March 10, 2022
PRESENT: The Honourable Madam Justice St-Louis
BETWEEN:
CATALYST PHARMACEUTICALS, INC. AND KYE PHARMACEUTICALS INC.
Applicants
and
ATTORNEY GENERAL OF CANADA AND MÉDUNIK CANADA
Respondents
JUDGMENT AND REASONS
I. Introduction
[1] The Applicants, Catalyst Pharmaceuticals, Inc. [Catalyst] and KYE Pharmaceuticals Inc. [KYE] seek judicial review of the Minister of Health [the Minister]’s June 24, 2021 decision to issue Médunik Canada [Médunik] a Notice of Compliance [NOC] in respect of its New Drug Submission [NDS] for its RUZURGI 10 mg tablet [the Minister’s Decision].
[2] The Applicants challenge the Minister’s Decision as contrary to the data protection provisions of the Food and Drug Regulations, CRC, c 870 [the Food and Drug Regulations], and in particular, to its paragraph C.08.004.1(3)(b). They generally submit that the Minister’s Decision is unreasonable because the Minister (1) misinterpreted the timing requirement; and (2) wrongly decided that, as a matter of fact, Médunik and the Minister did not rely on Catalyst’s amifampridine phosphate product, i.e., FIRDAPSE’s data, and therefore there was no comparison.
[3] The Attorney General of Canada [the AGC] and Médunik oppose the application and respond, essentially, that the Minister’s interpretation of the data protection provisions, as well as his application to the matter at hand, are reasonable. They submit that the Minister reasonably interpreted and applied subsection C.08.004.1(3) of the Food and Drug Regulations, acted reasonably in accepting the explanations of the basis of its safety and efficacy approval of RUZURGI and that there is no basis for the Applicants’ new complaint about the “published articles”.
[4] The AGC and Médunik particularly caution the Court against assessing the Minister’s interpretation of the data protection provisions against the Court’s own favorable interpretation. They stress that the standard of reasonableness commands the Court to assess whether the Minister’s interpretation is a reasonable one.
[5] I am mindful that, under the standard of reasonableness, my role is not to decide the issue myself according to my own yardstick or determine what the correct decision would have been. As the Federal Court of Appeal reminded us again recently in Burlacu v Canada (Attorney general), 2022 FCA 10 at paragraph 18, the role of the Court is to approach the reasons provided by the Minister with “respectful attention”, with a view to understanding the chain of analysis and ensuring that the decision falls within a range of possible, acceptable outcomes that are defensible in respect of the facts and the law that constrain the Minister.
[6] However, and for the reasons exposed below, I conclude that the Minister’s Decision does not fall within a range of possible, acceptable outcomes that are defensible in respect of the facts and the law that constrain the Minister.
[7] First, I find the Minister’s interpretation of the data protection provisions in regards to the timing issue unreasonable. I find that the Minister’s interpretation is contrary to the text of subsection C.08.004.1(3) of the Food and Drug Regulations, and that it ignores the purpose and context of the data protection regime. Read in context and in its grammatical and ordinary sense, the data protection provisions of the Food and Drug Regulations cannot reasonably be interpreted as the Minister suggests.
[8] Second, I find the Minister’s application of the reliance issue unreasonable as he (1) does not actually apply the test he puts forth; and (2) unreasonably relies on only one set of explanations of Health Canada’s basis for the approval of RUZURGI, ignoring contradictory evidence.
[9] I will thus grant the Applicants’ application for judicial review.
[10] In their Memorandum of Fact and Law, the Applicants request an order (1) quashing Médunik’s NOC for RUZURGI dated June 24, 2021; (2) ordering the Minister not to issue a NOC to RUZURGI before (i) the end of a period of eight years after the day on which FIRDAPSE received its NOC (i.e., August 1, 2028); or (ii) in the alternative until Médunik files its own carcinogenicity and reproductive and developmental toxicity data; and (3) granting them costs, on a solicitor-client basis or on an elevated scale.
[11] The Respondents oppose these remedies, and suggest that, if the Court is to grant the application, it should, as usual, set the decision aside and send it back for a new determination.
[12] I have not been convinced that the situation warrants departure from the usual remedy. I will consequently set aside the decision and send it to the Minister for a new determination in light of these reasons.
II. Context
[13] Amifampridine treats an ultra-rare and debilitating autoimmune disorder called Lambert-Eaton myasthenic syndrome [LEMS]. Currently, some 200 Canadians suffer from LEMS. Until the approval of FIRDAPSE in July 2020, amifampridine was not commercially available in Canada. It was only available through Health Canada’s Special Access Program [SAP], which provides access to certain drugs that cannot otherwise be sold or distributed in Canada. Drugs accessed via the SAP are supplied directly by manufacturers to practitioners prescribing the drug, usually physicians. Amifampridine was supplied through the SAP by Jacobus Pharmaceuticals Co, the New Jersey based pharmaceutical company that ultimately licensed RUZURGI to Médunik.
[14] Catalyst is a Florida-based biopharmaceutical company and KYE is a Canadian company founded and incorporated in July of 2019. KYE’s first commercially launched product is FIRDAPSE, as a result of an agreement with Catalyst. Médunik is a manufacturer and supplier of pharmaceutical products based in Blainville, Québec.
[15] In 2019, both Catalyst and Médunik submitted a NDS in regards to an amifampridine drug. Catalyst’s drug, a phosphate salt, is marketed under the name FIRDAPSE by KYE in Canada, while Médunik’s drug, a free base, is marketed under the name RUZURGI. Health Canada granted both Catalyst and Médunik’s NDS priority review status and found both eligible for the innovative drug status. The first approved drug would thus be recognized as an innovative drug and benefit from the data protection provision of subsection C.08.004.1(3) of the Food and Drug Regulations.
[16] Subsection C.08.004.1(3) states that:
(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,
(3) Lorsque le fabricant demande la délivrance d’un avis de conformité pour une drogue nouvelle sur la base d’une comparaison directe ou indirecte entre celle-ci et la drogue innovante :
(a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and
a) le fabricant ne peut déposer pour cette drogue nouvelle de présentation de drogue nouvelle, de présentation abrégée de drogue nouvelle ou de supplément à l’une de ces présentations avant l’expiration d’un délai de six ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante;
(b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.
b) le ministre ne peut approuver une telle présentation ou un tel supplément et ne peut délivrer d’avis de conformité pour cette nouvelle drogue avant l’expiration d’un délai de huit ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante.
[17] Drugs determined to be “innovative drugs” are listed on the Register of Innovative Drugs [the Register], which the Minister is required to maintain pursuant to subsection C.08.004.1(9) of the Food and Drug Regulations. The Register confirms that data protection is granted from the date the drug’s NOC is issued.
[18] Within Health Canada, the Office of Submissions and Intellectual Property [the OSIP] is responsible for applying the data protection provisions. The Office of Patented Medicines and Liaison [the OPML] is part of the OSIP and is tasked with conducting the final review.
[19] On the other hand, within Health Canada, the Therapeutic Product Directorate [the TPD] is responsible for assessing the NDS’s safety and efficacy profile. It is divided into sections, among which two played a role in the RUZURGI NDS: the Bureau of Cardiology, Allergy and Neurological Sciences [the BCANS] and the Central Nervous System Division of the BCANS [the CNSD].
[20] Notably, in its RUZURGI NDS, Médunik included an Original Annotated Product Monograph [Product Monograph] for RUZURGI. In the part of the document dedicated to scientific information, under the heading related to non-clinical toxicology, Médunik addresses, inter alia, carcinogenicity and reproductive and developmental toxicity (Certified Tribunal Record [CTR]; Applicants Record [AR] at 302).
[21] Under the carcinogenicity heading, Médunik indicates that carcinogenicity studies of amifampridine have not been conducted. However, it adds information about (1) a 104-week carcinogenicity study conducted with the phosphate salt form of amifampridine, including a parenthetical reference to FIRDAPSE USPI 2018; and (2) a 2-year study rat dietary carcinogenicity study. Both descriptions are actually referring to the same study (Miller affidavit at para 39; AR at 1005-1006).
[22] Under the reproductive and development toxicity heading, Médunik again confirms that animal studies to assess the potential adverse effects of amifampridine on fertility and embryofetal development have not been conducted. However, again it adds information about animal studies conducted with the phosphate salt form of amifampridine on rats, again including a parenthetical reference to FIRDAPSE USPI 2018. The animal studies with amifampridine phosphate described in these excerpts are descriptions of Catalyst’s Development and Reproductive Toxicology study data (Miller affidavit at para 43; AR at 1007).
[23] Dr. Miller, the Chief Operating Officer and Chief Scientific Officer of Catalyst, affirms that these studies were part of the non-clinical development program required for FIRDAPSE to gain regulatory approval, and that they were submitted confidentially as part of the New Drug Application of FIRDAPSE in the United States and as part of its Canadian NDS (Miller affidavit at paras 17 and 22; AR at 1001-1002). The source of the information, i.e., FIRDAPSE USPI 2018, is the United States prescribing information approved by the US Food and Drug Administration in respect of the US market authorization for FIRDAPSE.
[24] I will refer to the two non-clinical FIRDAPSE studies Médunik included in its Product Monograph as the “Impugned Information”.
[25] Before this Court, Catalyst indicates having found, in July 2021, that Médunik also included information about some FIRDAPSE clinical efficacy studies in its NDS. These are the LMS-002, LMS-003, Haroldsen and DAPSEL studies referred to in the Miller and Zimmerman affidavits (AR at 4245ff). The Applicants accessed this information in July 2021 when Health Canada responded to their request for Access to Information, and informed them that the information was available on Heath Canada’s website. I tend to agree with the arguments outlined at paragraphs 81 and 82 of the Minister’s Memorandum of Fact and Law. However, in any event, given my conclusion on the Minister’s interpretation, I need not examine this argument.
[26] In 2019, as there were then no amifampridine innovative drug on the Register when Catalyst’s NDS and Médunik’s NDS were submitted, both were filed and accepted for review by Health Canada. As there were no amifampridine innovative drug on the Register at the time of filing, the OSIP did not examine if a manufacturer was seeking a NOC based on a direct or indirect comparison.
[27] On July 31, 2020, the Minister issued the FIRDAPSE NOC, recognized it as an innovative drug, placed FIRDAPSE on the Register and granted it the data protection found at subsection C.08.004.1(3) of the Food and Drug Regulations. The Register indicates the data protection to be effective as of July 31, 2020 (AR at 186), hence on the day of the FIRDAPSE NOC issuance. There is no indication that the protection was pending or dependant of FIRDAPSE having to be marketed in Canada, or as to what marketing means in this context, or again that anybody at Health Canada verified if FIRDAPSE was marketed prior to placing it on the Register.
[28] As we will see below, prior to the approval of the FIRDAPSE NOC, Médunik, the TPD and the OSIP communicated amongst themselves. They discussed the removal and subsequent reinstatement of the Impugned Information in the RUZURGI Product Monograph, as well as the impact of said reinstatement on the data protection.
[29] On July 31, 2020, the Director of the BCANS sent the Pharmaceutical Submission Executive Summary of RUZURGI [the Executive Summary] to the Director General of the TPD. I note that there are in fact two signed RUZURGI Executive Summaries, one dated July 31, 2020 and one dated August 5, 2020. I understand that the one dated July 31, 2020 was included in the NOC package and that the two bear no difference, save for their date. I will refer to the one dated July 31, 2020. On August 5, 2020, the RUZURGI Product Monograph containing the reinstated Impugned Information was approved. On August 10, 2020, a NOC was issued to Médunik for its RUZURGI amifampridine product, in oral, tablet, 10 mg form (AR at 3271).
[30] On August 17, 2020, the OPML issued its Data Protection Eligibility Assessment for RUZURGI. It identified the assessment as “preliminary” and recommended RUZURGI as being not eligible for data protection. On September 10, 2020, the OPML informed Médunik that RUZURGI was not an innovative drug.
[31] The Applicants challenged the Minister’s decision to issue the RUZURGI NOC by way of an application for judicial review before this Court. On May, 31, 2021, this Court granted the application, set aside the Minister’s decision to issue Médunik a NOC for its RUZURGI drug, and sent back the file to the Minister for a new determination (Catalyst Pharmaceuticals Inc v Canada (Attorney General), 2021 FC 505 [Catalyst 2021] in the T-984-20).
[32] On June 3, 2021, the OSIP wrote to Médunik and KYE. The OSIP indicated that, on behalf of the Minister, the OSIP will make a new determination as to whether, in consideration of the Minister’s determination in August 2020 that NDS No. 234655 for RUZURGI meets the regulatory requirement for safety and efficacy, it would contravene paragraph C.08.004.1(3)(b) to issue a NOC. The OSIP provided KYE and Médunik the opportunity to make submissions while indicating that it would also be considering the detailed submissions that were filed by the parties in the Applicants’ first challenge that led to the Catalyst 2021 decision.
[33] On June 9, 2021, Médunik filed its submissions with the OSIP. While arguing that it did not seek approval of its RUZURGI NDS on the basis of a comparison to FIRDAPSE, Médunik indicated, at page 8 of its submissions, that “[i]nformation pertaining to non-clinical studies using amifampridine phosphate (i.e., the impugned information) was added to the RUZURGI product monograph during the labelling review process at Health Canada’s request to ensure that it contains ‘publicly available’ and ‘known information’” (AR at 402).
[34] On June 10, 2021, KYE filed its submissions with the OSIP, arguing essentially that (1) the amendment check is flawed and should not be followed on this redetermination, referring to paragraphs 81 to 87 of the Memorandum of Fact and Law it filed in the Court file T-984-20; (2) Médunik is seeking a NOC on the basis of a direct or indirect comparison with FIRDAPSE; (3) the marketing exception does not apply; and (4) the public nature of data is irrelevant.
[35] On June 21, 2021, prompted by Médunik’s aforementioned statement that the Impugned Information was added at the request of Health Canada, the OSIP asked the Director of the BCANS for clarification.
[36] On June 23, 2021, the Director of the BCANS responded to the OSIP. He referred to the Impugned Information as the “publicly available safety information”, and indicated that (1) the publicly available safety information related to amifampridine phosphate (i.e. FIRDAPSE) was included in the original RUZURGI Product Monograph; (2) on June 16, 2020, the CNSD sent a clarification request to Médunik and requested that this information, originally proposed by Médunik, be removed; (3) on July 16, 2020, the CNSD sent a further clarification request to Médunik, requesting that the information be reinstated; and (4) on July 27, 2020, the information was reinstated to the originally proposed wording in the Product Monograph. The Director of the BCANS added that the rationale [the Rationale] for the request was previously set out in the Summary Basis for Decision [SBD] and Regulatory Decision Summary [RDS], both published after the August 10, 2020 RUZURGI NOC approval, and that it will be set out in his upcoming Addendum to the Executive Summary for the RUZURGI NDS dated June 23, 2021 [the Addendum].
[37] This Rationale, revealed initially in October 2020 in the SBD and in the RDS, reads like this:
While not essential for market authorization, publicly available safety information for the phosphate salt of amifampridine is included on the Product Monograph to ensure that it contains known information relevant to the optimal, safe, and effective use of Ruzurgi.
[38] According to the Director of the BCANS, this explains why, in July 2020, the BCANS requested Médunik to reinstate the FIRDAPSE carcinogenicity and reproductive toxicity studies in its RUZURGI Product Monograph.
[39] On June 23, 2021, the Director of the BCANS sent the Addendum to the Director General of the TPD and the Director of the OSIP. The Addendum indicates that it was prepared for litigation purposes. The Director of the BCANS indicates that said Addendum is prepared to clarify certain elements of the Executive Summary for the RUZURGI NDS in light of the Court’s decision of May 31, 2021, i.e., Catalyst 2021.
[40] In the Addendum, the Director of the BCANS outlines, inter alia, that the RUZURGI NDS was a stand-alone submission, including all the data required for review, with the exception of carcinogenicity, reproductive and developmental toxicity data. He cites an extract of the RUZURGI Executive Summary, and based on said statement, he concludes that it is clear that the approval of FIRDAPSE had no bearing on the recommendation for approval of RUZURGI. He adds that “[h]owever, some information related to carcinogenicity and reproductive and developmental toxicity was considered important safety information worth adding to the Product Monograph of RUZURGI. This safety information was publicly available from the US Prescribing Information for the US marketed FIRDAPSE product. It is often the case that known safety information, whether it be for individual active pharmaceutical ingredients or for classes of products, is included for awareness for the prescribers”.
[41] Notably, the Addendum makes no mention (1) of the information the BCANS had outlined in its June 23, 2021 email to the OSIP, hence that (i) on June 16, 2020, the CNSD had asked Médunik to remove the Impugned Information it had included in its original Product Monograph; (ii) on July 16, 2020, the CNSD requested Médunik reinstated the Impugned Information; and (iii) on July 27, 2020, it was reinstated; and (2) the fact that the Executive Summary submitted to the Director General of the TPD in July 2020 made no mention of this Rationale and that only the SBD and the RDS, published after the RUZURGI NOC was approved, added the Rationale.
[42] On June 24, 2021, the OSIP issued its reasons [the OSIP Reasons] and the Minister issued the RUZURGI NOC. Relevant to the understanding of this context, paragraph 73 of the OSIP Reasons includes a footnote pertaining to the statement that Médunik included in its June 2021 written submissions to the OSIP. Again, as a reminder, this statement outlined that the “Impugned Information” had been reinstated at the request of Health Canada.
[43] On July 5, 2021, the Applicants filed their Notice of Application challenging the Minister’s Decision before the Court.
[44] On July 28, 2021, the Applicants received a response to the Access to Information request they had filed for “all documents related to Médunik’s new drug submission No. 234655 created or amended on or after August 10, 2020”. The Applicants were informed that a portion of the record responsive to their request (Module 5 (Clinical)) had been proactively released and was available online. They accessed these documents and realized that the RUZURGI NDS also included clinical information pertaining to FIRDAPSE. I have addressed this information already.
[45] On July 21, 2021, the Director of the OSIP certified the CTR, and objected to producing some of the documents requested by the Applicants as part of the CTR.
[46] On August 11, 2021, the AGC provided 25 additional documents to the Applicants in response to a document request set out in their Notice of Application. These documents had not been previously released. They were tendered into evidence in this application, introduced by Ms. Diane Zimmerman (exhibits O1 to O25). These documents outline communications between Médunik, the BCANS and the OSIP in regards to the Impugned Information, and its impact on the data protection provisions.
[47] On August 27, 2021, the Applicants filed their Amended Notice of Application. Each parties successively filed their record and, from December 13 to 15, 2021, they presented their arguments to the Court.
III. The Minister’s Decision
[48] At the heart of this application, and of the Minister’s Decision, are the OSIP Reasons and OSIP’s determination that paragraph C.08.004.1(3)(b) of the Food and Drug Regulations does not prohibit the issuance of a NOC for RUZURGI because Médunik was not seeking a NOC on the basis of a direct or indirect comparison to FIRDAPSE as approved and marketed in Canada.
[49] RUZURGI’s safety and efficacy is not at play.
[50] The OSIP Reasons are contained in a 35-page document divided in the following five sections: (I) Regulatory Framework; (II) Points of interpretation of the data protection provisions particularly relevant for this new determination; (III) The RUZURGI NDS and the FIRDAPSE NDS; (IV) The RUZURGI NDS does not engage paragraph C.08.004.1(3)(b); and (V) Other comments.
[51] The OSIP divides the first section, Regulatory Framework, in four subsections. The OSIP examines (1) Drug submissions for New Drugs; (2) Product Monographs; (3) Data Protection for Innovative Drugs; and (4) the data protection provisions implement certain treaty obligations.
[52] Notably, the OSIP outlines the situation of subsequent entry drugs and subsequent entry manufacturers, and discusses the seemingly unrelated abbreviated new drug submission [ANDS], generics, bioequivalent or biosimilar drugs. It stresses that reference to subsequent entry drugs may be any drug whose approval is being sought through an NDS based on a comparison to a drug as approved in Canada.
[53] The OSIP explains inter alia that “[a]s part of the drug review process for either an NDS or ANDS, Health Canada reviews a product monograph” (OSIP Reasons at para 14; AR at 20). The OSIP asserts that it is normal for monographs to include safety information on the drug class or other similar drugs and that “[t]he inclusion of this safety information in the product monograph is not intended to be comparative information providing the basis of approval, but rather is part of the regulatory responsibility of a manufacturer and Health Canada to inform patients and health professionals about potentially relevant information” (OSIP Reasons at para 15; AR at 20).
[54] The OSIP adds that, after determining that the submission requirements are met, the Minister must issue a NOC pursuant to paragraphs C.08.004(1)(a) or C.08.004(3)(a). In short, “[…] where the Minister of Health determines that the data protection provisions are not engaged, the Minister does not have discretion to withhold an NOC if the other submission requirements are met” (OSIP Reasons at para 16). The OSIP cites the data protection provisions for innovative drug, namely paragraphs C.08.004.1(3)(a) and C.08.004.1(3)(b), and identified two points of regulatory interpretation, which are the meaning of “on the basis of” in the chapeau of the subsection and the connection and interaction between the two paragraphs. The chapeau of subsection C.08.004.1(3) refers to its first part, i.e., “If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug”.
[55] The OSIP cites subsection C.08.004.1(2) of the Food and Drug Regulations setting out that the purpose of the data protection provisions is to implement certain treaty obligations undertaken by Canada, namely article 20.48 of the Canada-United States-Mexico Agreement (CUSMA), paragraph 39(3) of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) and article 20.29 of the Comprehensive Economic and Trade Agreement (CETA). The OSIP cites the Regulatory Impact Analysis Statement [2006 RIAS] that accompanied the 2006 amendments to the data protection provisions.
[56] In regards to the second section of the OSIP Reasons, i.e., Points of interpretation of the data protection provisions particularly relevant for this new determination, the OSIP identifies two particularly relevant points, the first relates to the timing of the drug submission and the second, to the reliance on a comparison to an innovative drug.
[57] The first of the OSIP’s points of interpretation relates to timing – the information is assessed as of the time it is provided to Health Canada to determine whether the manufacturer is seeking approval on the basis of a comparison with an innovative drug, whether in an initial filing of a drug submission or in an amendment to a submission. OSIP’s position is that the data protection provisions must be interpreted, having regard to its wording, context and purpose of the provisions, to operate in a forward-looking manner in the sense that the manufacturer’s conduct needs to be evaluated when it occurs.
[58] The OSIP divides its timing interpretation analysis in five subsections.
[59] First, the OSIP states that only comparisons made when an innovative drug is approved and marketed in Canada can trigger the data protection provisions. This refers to the conditions contained in the chapeau of subsection C.08.004.1(3), as well as to the marketing requirement stated in subsection C.08.004.1(5).
[60] Per the OSIP’s timing interpretation, when the conditions of the chapeau are met, and subject to the marketing requirement, the provision becomes engaged and paragraph C.08.004.1(3)(a) provides the filing prohibition. If there is no innovative drug on the Register, paragraph C.08.004.1(3)(a) cannot be engaged and the manufacturer is allowed to file its NDS.
[61] The OSIP goes on to address the specific provision actually at issue in this new determination, which is paragraph C.08.004.1(3)(b) of the Food and Drug Regulations, and refers to it as the “prohibition to NOC issuance”. The OSIP outlines that paragraph (b) is likewise subject to the conditions in the chapeau and to the marketing requirement, but adds that it is subject to an additional condition, which is that paragraph (b) can be engaged only when and if the filing prohibition found at paragraph (a) was first engaged.
[62] Per the OSIP interpretation, paragraphs (a) and (b) are linked and work together so that paragraph (b) is engaged only if a manufacturer, initially prohibited from filing its NDS, becomes allowed to file a NDS after the 6-year no-filing period has elapsed. In such a case, the paragraph (b) “NOC issuance” prohibition becomes engaged until the total 8-year period (since the NOC issued) has elapsed.
[63] At the hearing, the AGC confirmed this aforementioned interpretation of paragraphs 41 and 42 of the OSIP Reasons to be the proper one.
[64] The OSIP justifies the link and dependence between paragraphs (a) and (b) by the legislator’s use of the term “that” before the expression “submission or supplement” in paragraph (b), which the OSIP asserts, can only refer to the submission or supplement found in paragraph (a). The OSIP adds that support for this explanation are contained in the 2006 RIAS.
[65] Notably, and as I will discuss later, the OSIP makes no mention of the fact that paragraph (b) clearly creates two prohibitions, not one. The first prohibition is that the Minister shall not approve that submission or supplement (i.e., the “approval prohibition”), while the second prohibition is that the Minister shall not issue a notice of compliance in respect of the new drug, (i.e., the “NOC issuance prohibition”).
[66] Once it establishes that paragraphs (a) and (b) are linked, the OSIP goes on to indicate that this interpretation suffers an exception whereby paragraphs (a) and (b) actually become independent and no longer work together. The OSIP argues that this exception occurs only if the manufacturer, initially allowed to file its NDS, subsequently amends it, and becomes considered as seeking a NOC on the basis of a direct or indirect comparison to an innovative drug. In that precise case, and only in that precise case, the OSIP considers that the same paragraphs (a) and (b) no longer work together. In fact, the OSIP considers first, that the prohibition to file of paragraph (a) no longer applies, despite the conditions in the chapeau being met, and second, that despite the fact that the amendment has been accepted for filing from the onset (not after 6 years), the NOC issuance prohibition applies.
[67] Second, the OSIP asserts that previous Federal Court jurisprudence is consistent with the OSIP’s interpretation of the data protection provisions. The OSIP acknowledges that the wording of subsection C.08.004.1(3) does not specifically address the situation of amendments made to a submission after it is first accepted for filing. It cites the Federal Court’s decision in Hospira Healthcare Corporation v Canada Health, 2015 FC 1205 [Hospira] to support its interpretation that amendments to submissions can trigger subsection C.08.004.1(3) as the additional information filed is also subject to the data protection provisions.
[68] Third, the OSIP asserts that its interpretation is consistent with the treaty obligations. It stresses that it is inherent in the idea of preventing subsequent entry manufacturer from engaging in “unfair commercial use” of protected data that the fairness of conduct needs to be assessed at the time the conduct occurs and not at a subsequent date after an innovative drug is approved in Canada. The OSIP thus asserts that, independent from the actual wording of the provision, the treaties are intended to be forward looking and not to prohibit the use of information submitted before the marketing approval of the new pharmaceutical product whose data is being protected, and its actual marketing.
[69] Fourth, the OSIP asserts that its interpretation is consistent with Health Canada’s Data Protection Guidance Document.
[70] Fifth and finally, the OSIP asserts that its interpretation also reflects the reality of preparing a typical subsequent entry submission for filing in Canada.
[71] The second of OSIP’s points of interpretation relates to the reliance on a comparison to an innovative drug.
[72] The OSIP outlines that the obligations to protect data only exist where a subsequent entry manufacturer relies on the data of the pharmaceutical product eligible for protection, as the objective of the treaty is not to provide a monopoly. The OSIP stresses that protection is not against competing drugs from other innovators. Another innovative company may thus decide at any time to conduct trials, file a submission and thereby provide access to a drug to Canadians. In summary, the OSIP asserts that only submissions for subsequent entry products relying on the safety and efficacy data filed to obtain approval of the innovative reference product will meet these criteria.
[73] The OSIP refers again to the chapeau of subsection C.08.004.1(3) which, the OSIP indicates, clearly sets out that the protection is only available where a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug. Notably, in this section, it is clear that the OSIP does not require the Minister to be relying on the protected information for approval. The sole mention of the Minister’s reliance on an innovator’s data is contained in the 2006 RIAS citation, which relates to the regime applicable to a generic.
[74] The OSIP indicates that the types of “comparison” intended to be captured by the provisions are those akin to where a generic manufacturer seeks to copy an innovative drug. It adds that only submissions for subsequent entry products are intended to be captured by the prohibitions as those are the products that are relying on comparisons to reference products and can therefore be copies of the innovative drug.
[75] In regards to the third section, i.e., The RUZURGI NDS and the FIRDAPSE NDS, the OSIP examines both NDS.
[76] In regards to the RUZURGI NDS, the OSIP confirms having conducted an initial intellectual property check at the time it received the NDS in order to determine whether the six-year no-filing period under paragraph C.08.004.1(3)(a) applied and whether the submission could thus be filed. As there was no approved innovative drug on the Register, there could be no comparison of any kind with an innovative drug and the data protection provisions could not be triggered. The RUZURGI NDS was forwarded into screening.
[77] The OSIP specifies that it had noted, presumably when the RUZURGI NDS was filed, that Médunik had included safety information regarding the phosphate salt version of the medicinal ingredient (which is the medicinal ingredient in the drug FIRDAPSE). It adds that “[…] Health Canada expects drug manufacturers applying for approval of a drug to provide available safety information about similar drugs” (OSIP Reasons at para 72).
[78] The OSIP goes on to describe the safety information on the phosphate salt of amifampridine contained in Médunik’s NDS as essentially, “[s]ummaries of publicly available safety data on the phosphate salt of amifampridine under the headings Carcinogenicity and Reproductive and Developmental Toxicity in the original draft annotated and final versions of the product monograph for RUZURGI. The information in these summaries was drawn from information in the published United States Prescribing Information and other published documents from the United States Food and Drug Administration for FIRDAPSE, as approved in the United States” (OSIP Reasons at para 73).
[79] The OSIP inserts a footnote in this description and refers to the statement made by Médunik, in its June 2021 submissions to the OSIP (see paragraph 73 of the OSIP Reasons). The OSIP clarifies that the information on the phosphate salt was initially submitted by Médunik in its Product Monograph, that it was removed at the request of Health Canada on June 16, 2020, but subsequently reinstated after the CNSD requested it on July 16, 2020. The OSIP notes that the rationale for including the information in the Product Monograph was explained in the SBD and the RDS and is now also explained in the Addendum of June 23, 2021.
[80] The OSIP indicates that the review of the RUZURGI was completed shortly after the FIRDAPSE NOC was issued and FIRDAPSE approved as an innovative drug. The OSIP confirms it was aware, when approving RUZURGI, that FIRDAPSE had been approved and recognised as an innovative drug. The OSIP determined then that the RUZURGI NDS did not engage paragraph C.08.004.1(3)(b) of the Food and Drug Regulations because its approval was not based on a direct or indirect comparison to FIRDAPSE as approved in Canada. The OSIP specifies having identified whether Médunik had made any amendments to its NDS since the time the FIDAPSE NOC was issued, confirmed it had not made any such amendments and thus concluded that the RUZURGI NDS did not engage paragraph C.08.004.1(3)(b), and that the provisions did not prohibit the issuance of a NOC.
[81] The OSIP outlines that the SBD and the RDS both contain the Rationale put forth to publicly explain why the FIRDAPSE studies are in the RUZURGI Product Monograph.
[82] In the fourth section of the OSIP Reasons, i.e., The RUZURGI NDS does not engage paragraph C.08.004.1(3)(b), the OSIP, as previously stated, asserts that the RUZURGI NDS does not engage paragraph C.08.004.1(3)(b) because of two reasons, which are based on the two specific points of interpretation described above: the timing and the reliance. The OSIP specifies that the “[…] two reasons are independent, and either reason is sufficient for the OSIP to conclude that paragraph C.08.004.1(3)(b) does not prohibit the issuance of a NOC for the RUZURGI NDS”.
[83] The OSIP asserts that the timing of when the information on the phosphate salt was included in the RUZURGI NDS means that it does not engage paragraph C.08.004.1(3)(b) of the Food and Drug Regulations. The OSIP raises that (a) only comparisons made when an innovative drug is approved and marketed in Canada can trigger the protections of subsection C.08.004.1(3); (b) the OSIP's final intellectual property check is not flawed (citing Hospira); (c) Catalyst's and KYE's interpretation is unreasonable because it would require data protection to apply retroactively to information submitted before there was an innovative drug and transform an entirely proper NDS into one that engaged the data protection provisions; (d) the availability of data protection as an incentive to drug development does not equate to market exclusivity in all circumstances; (e) the OSIP's interpretation avoids unjustifiably undermining the public interest in encouraging drug manufacturers from seeking approval of safe and effective drugs so that they can be made available to Canadians; and (f) the OSIP does not treat the Register as frozen, but does apply the provisions in a forward-looking manner.
[84] The OSIP repeats its position that if a submission is filed when there is no innovative drug listed on the Register, paragraph C.08.004.1(3)(b) does not prohibit the issuance of a NOC, i.e., the NOC issuance prohibition, unless the submission is amended after filing and during the course or the review to seek approval on the basis of a comparison to an innovative drug as approved and marketed in Canada; the RUZURGI NDS was not amended.
[85] The OSIP states its position that paragraph C.08.004.1(3)(b) of the Food and Drug Regulations does not prohibit the issuance of a NOC for the RUZURGI NDS because “[…] the safety