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

Catalyst Pharmaceuticals, Inc. v. Canada (Attorney General)
Court (s) Database
Federal Court Decisions
Date
2021-05-31
Neutral citation
2021 FC 505
File numbers
T-984-20
Decision Content
Date: 20210531
Docket: T-984-20
Citation: 2021 FC 505
Ottawa, Ontario, May 31, 2021
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 August 10, 2020 decision of the Minister of Health [the Minister] to issue Médunik Canada [Médunik] a Notice of Compliance [NOC] with respect to Médunik’s New Drug Submission [NDS] for its amifampridine product, RUZURGI [the Decision].
[2] The Applicants challenge the Minister’s Decision as contrary to the data protection provisions of subsection C.08.004.1(3)(b) of the Food and Drug Regulations, CRC, c 870 [the Food and Drug Regulations].
[3] The Applicants seek a number of reliefs, including (1) quashing the Minister’s Decision and the NOC issued to Médunik; (2) prohibiting the Minister from issuing a NOC to Médunik in respect of its RUZURGI product until after August 1, 2028 (eight years after the date of issuance of Catalyst’s NOC for its amifampridine phosphate product, FIRDAPSE); and (3) in the alternative, referring the matter back to the Minister for redetermination in accordance with subsection C.08.004.1(3)(b) of the Food and Drug Regulations.
[4] In brief, and as a preliminary matter, I conclude that the Applicants have standing to bring their Application for judicial review [the Application], as they are directly affected by the Minister’s Decision, per section 18.1 of the Federal Courts Act (RSC 1985, c F-7 [the Federal Courts Act]). In particular, and as detailed below, I am satisfied that the Applicants’ challenge is not directed to the Minister’s Decision with respect to RUZURGI’s safety and efficacy, but to the application of the aforementioned data protection provisions of the Food and Drug Regulations.
[5] As to the merits, and for reasons set out below, I will grant the Application, quash the Minister’s Decision, and return it to the Minister for redetermination.
[6] As per the instructions of the Supreme Court of Canada in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 [Vavilov]. The Attorney General of Canada [AGC] and Médunik have each presented to the Court legal and factual constraints that must guide it in reviewing the Decision. They have first asserted that the legal constraints they present are reasonable and have been condoned by the Court in Hospira Healthcare Corporation v Canada (Health), 2015 FC 1205 [Hospira 2015] and, second, that these legal constraints were those actually applied by the Minister before issuing Médunik its NOC.
[7] The Court is not convinced that the Respondents’ interpretation of the Food and Drug Regulations data protection provisions, as presented by the AGC through his affiant, Dr. Kendra Cann, Patent Officer at “Legal, Health Canada,” and by both Respondents through their submissions, is proper or that it was condoned by the Court in Hospira 2015. However, even assuming that it is, and was, the evidence does not show that the Minister in fact applied the proposed scheme before issuing Médunik its NOC. In the absence of reasons in the Decision itself, of information in the CTR and the evidence, and of an affiant with more direct knowledge of how the decision was made, assuming the affiant’s knowledge could compensate the absence of reasons and lack of information; the Court could not decipher if the interpretation put forth by the Respondents is in fact the one adopted by the Minister at the time he made the Decision, or whether the protection granted to FIRDAPSE was fact even considered before the NOC was issued to Médunik.
[8] For these reasons, I will therefore quash the Decision and send the matter back to the Minister for redetermination.
II. Context
[9] Catalyst is a Florida-based biopharmaceutical company that defines itself as focused on investing in leading-edge science to develop and commercialise innovative therapies for those who suffer from rare and ultra-rare diseases. 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.
[10] Médunik is a manufacturer and supplier of pharmaceutical products based in Blainville, Québec.
[11] Amifampridine treats an ultra-rare and debilitating autoimmune disorder called Lambert-Eaton myasthenic syndrome (LEMS). Currently, some 200 Canadians who suffer from LEMS. Until the approval of FIRDAPSE, 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.
[12] On August 15, 2019, Catalyst requested “Priority Review” status for its New Drug Submission [NDS] pertaining to its amifampridine product, FIRDAPSE. On October 18, 2019, Health Canada granted Catalyst’s request, thus shortening the Minister’s review period from the typical 300 days to 180 days.
[13] On November 6, 2019, Catalyst submitted its NDS for FIRDAPSE. In its filing, it sought data protection, asking the Minister to classify FIRDAPSE as an “innovative drug” under section C.08.004.1 of the Food and Drug Regulations. On November 19, 2019, the Minister informed Catalyst that FIRDAPSE appeared to be an “innovative drug,” eligible for data protection.
[14] On February 7, 2020, following a response to a screening deficiency notice, the FIRDAPSE NDS was accepted into review (paragraph 33 of Dr. Cann’s affidavit; Applicants’ Record [AR] at page 1951).
[15] Médunik was also granted the “Priority Review” status it sought for its NDS regarding its amifampridine product, RUZURGI, and in December 2019, Médunik filed its NDS.
[16] The copy of the Original Annotated Product Monograph for RUZURGI, submitted by Médunik with its NDS and contained in the Certified Tribunal Record [CTR] (AR at pages 16 to 46), shows that Médunik included parenthetical references to FIRDAPSE USPI 2018. Dr. Cann believes that these references indicate that the source of the information is the United States Prescribing Information approved by the U.S. Food and Drug Administration in respect of the U.S. market authorisation for FIRDAPSE (paragraph 37 of Dr. Cann’s affidavit; AR at page 1951-52). It refers to two FIRDAPSE studies, one on carcinogenicity and the other on reproductive and development toxicity (AR at page 40).
[17] On July 31, 2020, the Minister granted Catalyst a NOC for its amifampridine product (supplied as amifampridine phosphate), FIRDAPSE, in oral, tablet, 10mg form (AR at page 89). The NOC is signed by Dr. J. Patrick Stewart, MD, CCFP(EM), Director General of the Therapeutics Products Directorate of Health Canada, and the Product Monograph and Certified Product Information Document are enclosed.
[18] The NOC issued to Catalyst includes no reasons. It merely confirms that the NDS complies with the requirements of sections C.08.002 and C.08.005.1 of the Food and Drug Regulations, and that it is issued pursuant to section C.08.004 of the Food and Drug Regulations.
[19] It is not disputed that, as the first approved amifampridine product in Canada, FIRDAPSE was recognised as an “innovative drug.” It was thus entitled to data protection under subsection C.08.004.1(3) of the Food and Drug Regulations.
[20] On August 10, 2020, a NOC was issued to Médunik for its RUZURGI amifampridine product, in oral, tablet, 10mg form (CTR at page 76). The NOC is also signed by Dr. J. Patrick Stewart, and the Product Monograph and Certified Product Information Document are again enclosed.
[21] Like the NOC issued to Catalyst, the NOC issued to Médunik contains no reasons. It merely confirms that the NDS complies with the relevant provisions that it is issued pursuant to section C.08.004 of the Food and Drug Regulations.
[22] We must turn to the CTR, prepared and certified by Dr. Cann, and to her affidavit and cross-examination for a glimpse into what happened to the RUZURGI NDS, particularly from July 31, 2020, when the NOC was issued to Catalyst for its FIRDAPSE product, which was recognised as an innovative drug, until August 10, 2020, when the NOC was issued to Médunik for its RUZURGI product.
[23] In regards to the RUZURGI NDS, the CTR (at pages 77 and following) reveals that on July 31, 2020, the “Manager, CNSD” addressed a “Manager Memo – Clinical” to the “Director BCANS.” At pages 2 and 3 of that Memo, the Manager states that “there is currently no cure or approved treatment for LEMS in Canada” and that “[c]urrently, there are no approved products in Canada for the treatment of LEMS,” while acknowledging that FIRDAPSE, produced by a different manufacturer than RUZURGI, was approved in Europe in 2009.
[24] On August 4, 2020, Ms. Jacqueline Farah sent Catalyst its July 31 NOC, along with the cover pages for the approved Product Monograph and Certified Product Information Document.
[25] On August 5, 2020, the “Director, BCANS” addressed a “Pharmaceutical Submission Executive Summary” [the Executive Summary] to the “Director General, Therapeutic Products Directorate,” [TPD] as part of the NOC package (AR at pages 52 and following). On the second page of the Executive Summary, the Director again states: “There is currently no cure or approved treatment for LEMS in Canada.” This statement is repeated at page 3, while the Director again acknowledges that FIRDAPSE was approved in Europe in 2009.
[26] As of August 5, 2020, the documentary evidence relating to the RUZURGI NDS, as contained in the CTR, makes no reference to the fact that another manufacturer’s NDS is under review, let alone to the fact that Catalyst was issued a NOC for FIRDAPSE, on July 31, 2020, as an “innovative drug” with the resulting data protection. To the contrary, on July 31 and August 5, 2020, the documents in the RUZURGI NDS repeatedly confirm that no such drug has yet been approved in Canada.
[27] On August 5, 2020, the Product Monograph for RUZURGI is approved. The name FIRDAPSE no longer appears in relation to the carcinogenicity and reproductive studies.
[28] The RUZURGI NOC signatures snapshot found at page 88 of the AR indicates that ANGZHANG (Ms. Angel Zhang, whose involvement is discussed below) “Performed IP Check,” without any details as to what this check entails or how it was conducted. The date of the IP Check is unclear, as two dates appear on the snapshot: August 5 and August 11, 2020.
[29] The “Notes to DG” section of the snapshot of the RUZURGI NOC package (page 50 and 51 of the AR; and Exhibit W of Dr. Cann’s affidavit) contains a box dedicated to the “OPML,” i.e. the Office of Patented Medicines and Liaison, part of the Office of Submissions and Intellectual Property [OSIP]. The information in this box relates to (1) the “IP CHECK,” where it is indicated that RUZURGI is “Off IP Hold;” (2) “Data Protection,” where the item “No DATA Protection to Add” is highlighted; and (3) the “PM(NOC) Regulations Requirements,” where the item “No Patents to Add” is highlighted. On August 10, 2020, at 3;51, Ms. Zhang added a note, in the other (right) column of the OPML box, indicating “NOTE to OPML: No longer eligible for DP.”
[30] In regards to the Intellectual Property (IP) Hold, at para 63 or her affidavit (page 1957 of the AR), Dr. Cann indicates that “[w]here the OSIP concludes that a NOC cannot be issued because the data protection provisions are triggered, it places the submission on Intellectual Property Hold and gives written notice to that effect to the manufacturer that submitted the NDS.” There is no information as to whether RUZURGI was ever on IP Hold, and then Off IP Hold, or if it was always Off IP Hold.
[31] There is no indication that the Executive Summary addressed on August 5, 2020 to the Director General of the TPD, who seems to be the person who signed the RUZURGI NOC, was amended to indicate that another (“innovative”) drug had been approved.
[32] It is not disputed, in these proceedings, that Médunik did not amend or supplement its NDS after July 31, 2020. However, I have found no indication, in the record, that any verification was done by the relevant authorities to verify if an amendment had been made between July 31 and August 10, 2020.
[33] On August 10, 2020, hence ten days after the NOC had been issued to Catalyst for FIRDAPSE, and the same day the RUZURGI NOC was issued, the Patent Officer – Science Office of the OPML addressed their final data protection eligibility assessment [DPEA] to the Director of the OSIP, and determined that FIRDAPSE was eligible for data protection.
[34] On August 13, 2020, a printout of the Register of Innovative Drugs (CTR at pages 117 and following) confirms FIRDAPSE’s status as an “innovative drug,” with a NOC date of July 31, 2020, a 6 year “no file” date of July 31, 2026, and data protection ending on July 31, 2028. The data protection is thus apparently granted from the date the NOC was issued, while there is no mention of FIRDAPSE’s marketing status (see discussion below).
[35] On August 14, 2020, Catalyst and KYE signed a License Agreement. KYE filed for an administrative NDS, and on September 24, 2020, the Minister issued a NOC to KYE.
[36] On August 26, 2020, the Applicants filed their Notice of Application, initially naming the Minister as one of the Respondents. The Minister was subsequently removed by Order on consent on September 15, 2020. In their Notice of Application, the Applicants included a request under Rule 317 of the Federal Courts Rules (SOR/98-106) [the Rules], for the Minister to send the Applicants and the Registry, while taking appropriate steps to maintain confidentiality, a certified copy of all material considered and created by the Minister, including all internal documentation and communications pertaining, or relevant, to the Minister’s Decision.
[37] On September 15, 2020, Dr. Cann certified that the documents attached, as listed, are true copies of the material requested by the Applicants, produced in accordance with Rules 317 and 318 of the Rules. Dr. Cann attached 13 documents to her Certificate under Rule 318, including an extract of the Register of Innovative Drugs as of August 13, 2010, hence after the Minister’s Decision was issued. On cross-examination, Dr. Cann explained that she selected the documents in consultation with three other persons at OPML and OSIP, i.e. Ms. Michelle Ciesielski, manager of OPML, Ms. Anne Bowes, director of OSIP, and Ms. Angel Zhang (AR at page 2454).
[38] On September 16, 2020, Madam Prothonotary Aylen issued a Protective Order, which was amended on October 20, 2020.
[39] On October 26, 2020, KYE informed Health Canada that it had begun selling FIRDAPSE in Canada (Reply Affidavit of Mr. Douglas Reynolds at para 3; AR at page 950).
[40] On October 16, 2020, Médunik addressed a letter to Health Canada to provide sponsor responses to the Summary Basis of Decision [SBD] Health Canada had provided (pages 2644 and following of the AR). The SBD sets out the basis for the recommendation for RUZURGI’s approval. Dr. Cann described this SBD as a key document. Again, months after FIRDAPSE’s approval, Health Canada’s SBD contains the statement that “[c]urrently, there is no cure or approved treatment for LEMS in Canada,” which Médunik crossed out, adding a comment to the effect that FIRDAPSE was approved in July 2020 (AR at page 2648).
[41] On November 5, 2020, Médunik filed its Motion to Strike the Notice of Application (for lack of standing) / Motion to Exclude the Applicants’ Evidence [the Motion]. The exclusion issues specifically concerned four fact affidavits and one expert affidavit, which were not before the Minister when the Minister’s Decision was rendered. The Applicants also filed a proposed reply affidavit by Mr. Reynold, which Médunik submits is equally inadmissible.
[42] I have ruled on this Motion separately. However, the parties agreed that the admissibility of the reply affidavit would be decided herein. I will admit the reply affidavit, which essentially provides information regarding the marketing of FIRDAPSE (this information is of no impact on my decision). I will nonetheless strike from the record paragraph 4 of the affidavit, where Mr. Reynolds appears to provide unsubstantiated opinion evidence or inadmissible expert evidence on the NOC process and the marketing of approved drugs.
III. The Applicants’ Standing to Bring the Application for Judicial Review
[43] I have not exercised my discretion to decide on the standing issue upon rendering my Order on Médunik’s Motion, having solely concluded that Médunik had not satisfied the stringent test required to strike the Application. I must therefore first decide whether or not the Applicants have standing to bring this Application, as per the parties’ submissions regarding the Motion.
[44] I am satisfied that the Applicants do have standing to bring their application for judicial review, as I am satisfied that they are not challenging the Minister’s Decision to grant a NOC on safety and efficacy grounds. They are rather challenging the Decision on the issue of whether the issuance of the NOC contravened the data protection provisions of the Food and Drug Regulations.
[45] Section 18.1 of the Federal Courts Act enables the AGC or anyone directly affected by the matter in respect of which relief is sought to file an application for judicial review. As per the words of Madam Prothonotary Tabib in Hospira Healthcare Corporation v Canada (Health), 2014 FC 179 at para 9 [Hospira 2014]:
[…] the appropriate test for determining whether a party has a direct interest is the same whether the party is a proposed applicant or a proposed respondent, and that it was most recently articulated by the Federal Court of Appeal in Forest Ethics Advocacy Assn. v Canada (National Energy Board), 2013 FCA 236 as follows:
“20. A party has a “direct interest” under subsection 18.1 (1) of the Federal Courts Act when its legal rights are affected, legal obligations are imposed on it, or it is prejudicially affected in some direct way : League for Human Rights of B'Nai Brith Canada v. Odynsky, 2010 FCA 307 at paragraphs 57-58; Rothmans of Pall Mall Canada Ltd. v. Canada (M.N.R.), [1976] 2 F.C. 500 (C.A.); Irving Shipbuilding Inc. v. Canada (A.G.), 2009 FCA 116.”
[46] In regards to the NOC challenge, the parties agree that a constant line of cases from this Court and the Federal Court of Appeal, outlined by Médunik in its Motion Record, confirms that a drug manufacturer does not have standing to challenge the Minister’s decision to grant a NOC on safety and efficacy grounds.
[47] However, as even the AGC outlines, that line of cases does not necessarily preclude a drug company from challenging another drug manufacturer’s NOC on the distinct and narrow issue of whether the issuance of the NOC contravened the data protection provisions of the Food and Drug Regulations.
[48] Two of the decisions cited by the parties involve the data protection provisions, and are thus most relevant to these proceedings: they are (1) Lundbeck Canada Inc v Canada (Health), 2008 FC 1379 [Lundbeck], in which the innovator company’s drug was not, and could not be, listed on the Register of Innovative Drugs, and which does not discuss the principles of standing as they might apply to the data protection provision; and (2) Hospira 2014, where it was decided that the innovator whose product is listed on the Register of Innovative Drugs is a person directly affected by the order sought and that it is to be added by as a respondent to the Application (the Federal Court of Appeal confirmed that this conclusion is not clearly wrong and that Lundbeck is properly distinguishable in Hospira Healthcare Corporation v Canada (Health), 2014 FCA 194). I am satisfied that the Applicants are in a position akin to that of Sanofi in Hospira 2014, although the Minister’s decision placed Sanofi, the innovator, as a respondent, as the NOC had been denied to Hospira; while Catalyst and KYE, also innovators, are Applicants, as the NOC has been granted to Médunik.
[49] I note that paragraph 4 of Hospira 2014 and paragraphs 1-15 and 17 of Hospira 2015 confirm that Hospira had indeed filed a NDS.
[50] As the Applicants submit, I agree that this line of decisions support the proposition that an innovator whose drug is listed on the Register of Innovative Drugs has standing to challenge a NOC issued to another company if it alleges that the NOC was issued in violation of the data protection afforded to its own product.
[51] Now, the difficulty here may reside in determining whether the Applicants in fact do allege solely that the Médunik NOC was issued in violation of Catalyst’s data protection, or, as the AGC argues, whether the Application tenably raises any genuine issue regarding the interpretation or application of the data protection provisions rather than challenging the Decision on safety and efficacy.
[52] I am satisfied that the nature of the Applicants’ challenge is directed at the interpretation and application of the data protection provisions of the Food and Drug Regulations, that their legal rights are affected, and that they have a direct interest under section 18.1 of the Federal Courts Act.
[53] Hence, given the aforementioned decisions, confirming that the Applicants have standing to challenge the Minister’s Decision to issue a NOC to Médunik if relying upon the data protection provisions, and given that I am satisfied the Applicants’ challenge is directed at the application of the data protection provisions, I conclude the Applicants have standing to bring their Application.
IV. The Regulatory Framework
[54] Per section C.08.002(1) of the Food and Drug Regulations, all drug manufacturers who wish to advertise and sell a new drug in Canada must first obtain a NOC by filing a new drug submission with the Minister.
[55] These proceedings concern new drug submissions [NDS], not abbreviated new drug submissions [ANDS]. In the case of a NDS, if the NDS complies with subsection C.08.002(2) and the Minister is satisfied that the drug is safe and effective, subsection C.08.004(1) provides that the Minister “shall” issue a NOC pursuant to the data protection regime.
[56] As per the AGC’s representations, section C.08.004.1.of the Food and Drug Regulations creates a data protection regime. It was established to implement certain international treaties. Pursuant to such treaties, Canada agreed to protect drug manufacturers from the unfair commercial use of undisclosed test or other data that they are required to file with Health Canada to obtain marketing approval (through an NOC) for a drug that uses a new chemical entity.
[57] The data protection provisions apply only where a NOC has been issued to an “innovative drug,” This term means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph (subsection C.08.004.1(1) of the Food and Drug Regulations).
[58] Drugs determined to be “innovative drugs” are listed on the Register of Innovative Drugs, which the Minister is required to maintain pursuant to subsection C.08.004.1(9) of the Food and Drug Regulations.
[59] Where a NOC has been issued to an “innovative drug,” subsection C.08.004.1(3) protects for prescribed periods the undisclosed data that was filed to obtain the NOC by preventing the filing and approval of a submission that seeks approval “on the basis of a direct or indirect comparison” to the innovative drug.
[60] Section C.08.004.1 indeed states:
(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,
(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
(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.
[61] Subsection C.08.004.1(5) provides that subsection C.08.004.1(3) does not apply if the innovative drug is not being marketed in Canada.
[62] The determination as to whether a manufacturer of a new drug is seeking a NOC on the basis of a direct or indirect comparison between the new drug and an innovative drug so as to contravene the data protection provisions is distinct from the Minister’s determination that a submission meets regulatory requirements for safety and efficacy.
[63] The regulatory framework does not directly address situations, such as the one at play in these proceedings, where: two NDSs are submitted almost concurrently, one potentially comparing its drug to the other; the NDSs for the two drugs are then processed almost concurrently; and the first one is approved and recognised as an innovative drug, thus benefiting from data protection before the second one is approved.
[64] The AGC has outlined its interpretation of the regulatory framework and the IP verification process which he submits is applied by Health Canada. The Respondents submit the process accords with the regulation and that it was in fact applied in approving RUZURGI’s NOC. It thus appears useful to outline this IP verification process and examine what information in the record in fact indicate if it was indeed applied.
V. IP Verifications in Health Canada’s NDS Approval Process
[65] The AGC, in its submissions, and Dr. Cann, in her affidavit, outline the IP verifications that are conducted by the OSIP, first when a NDS is filed, and second at the time it is examined for approval.
[66] This process is important to the Minister and Médunik’s case, as they essentially allege that (1) it represents in fact the Minister’s interpretation and application of the data protection provisions; (2) it accords with the data protection provisions and has been sanctioned by the Court in Hospira 2015; and (3) it was in fact applied in the process leading to the issuance of the NOC to Médunik for RUZURGI.
[67] The process described by the AGC and Dr. Cann consist of two main verifications, each containing two steps. As per the description, the first verification occurs at the time the NDS is presented (i.e. at the time of filing) to the Minister, and the second verification occurs before the NOC is issued. However, this first presentation of the process already warrants a caveat given that, as outlined below, Dr. Cann confirmed that the second verification does not, in fact, entirely occur “before” the NOC is issued.
A. First verification, at the time of filing: OSIP’s preliminary review of NDSs
(1) OSIP’s preliminary review of NDSs as described by Dr. Cann
[68] As per Dr. Cann’s affidavit, and I will purposively stick to the language used by Dr. Cann, the preliminary review of NDSs at the time of filing includes two steps: (1) the preliminary DPEA; and (2) the preliminary Intellectual Property Check [IP Check].
[69] In regards to the preliminary DPEA, Dr. Cann outlines that the OSIP makes two determinations. First, it determines whether or not the medicinal ingredient under consideration is a new chemical entity; and second, it determines whether or not the generation of the data that supports the approval of the medicinal ingredient under consideration required considerable effort.
[70] If a drug contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient, and if approval is sought on the basis of data, the origination of which involved considerable effort, the drug will be considered eligible for data protection. Only the first drug issued a NOC could qualify for data protection.
[71] In regards to the preliminary IP Check, it includes a determination of whether the submission seeks approval based on a comparison with an innovative drug listed on the Register of Innovative Drugs that is currently marketed in Canada.
[72] The OSIP’s practice in this regard, again per Dr. Cann’s testimony, is to review each submission to determine, in a variable order, whether (1) the Register of Innovative Drugs lists a relevant innovative drug; (2) the submission seeks approval based on a comparison with the innovative drug; and (3) the innovative drug is marketed in Canada. The OSIP forwards the submission for screening and review only if no innovative drug meets these three criteria.
[73] However, conversely, if there is no drug approved in Canada that could serve as a reference product, i.e. is listed on the Register of Innovative Drugs, the manufacturer cannot be seeking a NOC on the basis of a “direct or indirect comparison between the new drug and an innovative drug” (that is currently marketed in Canada) (AR at pages 2491-92). In those circumstances, the OSIP considers that the data protection provisions are not engaged, and the NDS can therefore be accepted into screening.
(2) OSIP’s preliminary review of the FIRDAPSE and RUZURGI NDSs
[74] It is not disputed that both the Catalyst and Médunik’s NDSs were pending before the Minister at the same time. The Minister granted “priority review” status to both NDSs, such that each review was conducted on a shortened timeline.
[75] In regards to the preliminary DPEA, as per Dr. Cann’s affidavit, the OSIP conducted it on each of FIRDAPSE and RUZURGI.
[76] In regards to FIRDAPSE, on November 15, 2019, a Patent Officer from the OPML sent FIRDAPSE’s preliminary DPEA. At page 10 of this preliminary DPEA, the Patent Officer indicates that (1) amifampridine phosphate has not been previously approved in a drug by the Minister, and it is not a variation of a previously approved medicinal ingredient; and (2) the FIRDAPSE drug submission seeks a notice of compliance on the basis of new and significant clinical trial data and is not a literature-based submission. The Patent Officer found FIRDAPSE to be eligible for data protection.
[77] On November 19, 2019, Dr. Cann, for Ms. Michelle Ciesielski, Manager OPML, wrote to Catalyst and indicated: “At this time, FIRDAPSE appears to be an ‘innovative drug’ and is therefore eligible for data protection” (AR at page 2100).
[78] Similarly, on January 10, 2020, a Patent Officer from the OPML sent RUZURGI’s preliminary DPEA. At page 12 of this preliminary DPEA, the Patent Officer indicates that (1) amifampridine has not been previously approved in a drug by the Minister and it is not an enumerated variation of a previously approved medicinal ingredient; and (2) the RUZURGI drug submission appear to seek a NOC on the basis of new and significant trial data and is not a literature-based submission (as seen from Section 4 of this document). The Patent Officer found RUZURGI to be eligible for data protection.
[79] Notably, under the section 2 “Previous Approvals” header of the assessment, the Patent Officer noted that amifampridine is “found in the DSTS” with respect to FIRDAPSE’s NDS, “with a CR date of 2019.11.06 and a classification of Priority-NAS” and is currently “INACTIVE 45” (AR at page 2120). The Officer also notes that the target date of 2020.01.11 “has passed and no response was received” (AR at page 2120).
[80] Under the aforementioned section 4, titled “Clinical Trial Information,” the Patent Officer notes that “reference is made to FIRDAPSE (Amifampridine phosphate) studies for Carcinogenicity and Reproductive and Development Toxicity in the Annotated Product Monograph” (AR at page 2121 [emphasis in original]). Finally, on page 12 of the assessment, immediately after confirming that RUZURGI is eligible for data protection, the Patent Officer again notes that the FIRDAPSE NDS has a status of “INACTIVE 45” (AR at page 2129).
[81] As we will see below, Dr. Cann confirmed that the OSIP relied on the preliminary DPEA for RUZURGI’s final IP verification. It is not known how, or if, the indications that FIRDAPSE is “inactive” were considered.
[82] On January 13, 2020, Ms. Michelle Ciesielski wrote to Médunik and indicated: “At this time, RUZURGI appears to be an ‘innovative drug’ and is therefore eligible for data protection” (AR at pages 2114-15).
[83] Exhibit J to Dr. Cann’s affidavit, which she confirmed was part of the RUZURGI preliminary DPEA, contains a note that reads “check approved PM at final DPEA stage” (AR at page 2165). Dr. Cann refrained from speculating as to the meaning of this note, and the Court is equally in the dark as to its meaning.
[84] However, again, Dr. Cann confirmed that the Minister relied on the preliminary DPEA at the final IP verification.
[85] In regards to the preliminary IP Check, Dr. Cann confirms that the OSIP’s preliminary IP Check resulted in the FIRDAPSE NDS being accepted into screening. She adds that, at the time of filing, there was no drug approved in Canada that could serve as a reference product for FIRDAPSE, and no relevant drug was listed on the Register of Innovative Drugs.
[86] Dr. Cann also confirms that the OSIP’s preliminary IP Check similarly resulted in the RUZURGI NDS being accepted into screening (AR at page 1951). As there was no relevant innovative drug listed on the Register of Innovative Drugs when Médunik filed the RUZURGI NDS, there was therefore no reason for the OSIP to reject the NDS.
[87] Dr. Cann confirms, in her affidavit, that OSIP’s preliminary IP Check includes a determination of whether the submission seeks approval based on a comparison with an innovative drug listed on the Register that is currently marketed in Canada. However, in regards to RUZURGI, she confirmed on cross-examination that, at the time of filing, OSIP would not have reviewed RUZURGI’s NDS to see whether it includes a comparison to an innovative drug as no such drug was listed on the Register of Innovative Drugs. Dr. Cann confirmed that in the absence of an innovative drug on the Register of Innovative Drugs, no one reviewed the submission to check whether there was a comparison.
[88] It is unknown why the RUZURGI January 10 preliminary DPEA, mentioned previously, contains a note that the RUZURGI NDS makes a “reference” to FIRDAPSE, or what that means.
[89] Dr. Cann confirmed that, despite what she indicated was included in OSIP’s preliminary IP Check, in RUZURGI’s case (1) no verifications were made as to whether or not RUZURGI’s NDS sought a NOC for a new drug on the basis of a direct or indirect comparison with an innovative drug, as there was no relevant innovative drug on the Register of Innovative Drugs; and (2) no verification was made as to whether or not the drug was marketed in Canada;
B. Second verification, before the NOC is issued: OSIP’s final checks for recommended NOCs
(1) OSIP’s final check for recommended NOCs as described by Dr. Cann
[90] As per the AGC’s submissions and Dr. Cann’s affidavit, once an NDS is accepted into screening, the relevant Health Canada Directorate assesses its compliance with the Food and Drug Regulations, including the requirements related to safety and efficacy. In the case of FIRDAPSE and RUZURGI, the BCANS, a bureau within the Therapeutic Products Directorate, carried out the clinical and non-clinical reviews. I need not address this in these proceedings.
[91] Dr. Cann outlines that, when Health Canada reviewers recommend that a drug receive a NOC, they prepare a “NOC package” of documents to support their recommendation. The NOC package undergoes various approvals until, ultimately, the Director General, here of TPD, determines whether to issue a NOC.
[92] The NOC package includes an executive summary setting out the basis for the recommendation for approval, including summaries and key findings and issues for the various types of reviews.
[93] The final check includes two steps, i.e. the final IP Check and the final DPEA.
[94] In regards to the final IP check, Dr. Cann explains that, en route to the final decision-maker, the NOC package, which includes the aforementioned executive summary, is routed to the OSIP for final IP Check.
[95] In her affidavit and on cross-examination, Dr. Cann indicated that the final IP Check includes (1) a determination of whether the submission seeks approval based on a comparison with an innovative drug listed on the Register of Innovative Drugs that is currently marketed in Canada; and (2) identifying submissions that require a final DPEA.
[96] In regards to the first of the two steps, as per Dr. Cann’s affidavit (at paragraph 45; AR at pages 1953-54), OSIP’s final IP Check process first evaluates whether an innovative drug has been listed on the Register of Innovative Drugs in the period between the filing and the approval.
[97] If no innovative drug is found in the search, the OSIP does not conduct the rest of the final IP Check.
[98] If the search detects an innovative drug, the OSIP then checks whether, after the innovative drug’s approval and marketing (Dr. Cann’s affidavit; AR page 1954), the NDS was amended such that the approval of the drug was being sought and recommended on the basis of a newly-introduced comparison with the now-approved and marketed innovative drug. This is the “amendment check.”
[99] Hence, if a relevant innovative drug has been approved and listed since the NDS was filed, the OSIP determines whether (1) the NDS has been amended since the approval of the relevant innovative drug; and (2) as a result of the amendment, an NDS has been evaluated, and has been recommended for approval, as an “NDS that seeks approval on the basis of a direct or indirect comparison with the now-approved and marketed innovative drug” (AR at page 1954 [my emphasis]).
[100] Where such an amendment (an amendment that post-dates the innovative drug’s NOC) results in such a comparison (a comparison that is the basis of the new drug’s approval), the data protection provision is triggered, and the OSIP places the NDS on intellectual property hold until the expiry of the innovative drug’s data protection term.
[101] As confirmed in her cross-examination, Dr. Cann did not attach to her affidavit any guidance documents, standard operating procedures, or other internal OSIP documents that would describe and substantiate the process outlined at paragraph 45 of her affidavit (pages 1953-54).
[102] Dr. Cann stressed that the drug’s marketing in Canada is a factor in the application of the data protection provisions.
[103] In regards to the final DPEA, it is worth noting again that it is conducted after the NOC is issued, because per Dr. Cann’s testimony, “there’s just not time to do it before the NOC issues” (AR at page 2465). Dr. Cann confirmed that the decision to issue the NOC is thus based on the preliminary DPEA, i.e. the one conducted at the time the NDS is submitted.
[104] One of the reasons the OSIP proceeds with a final DPEA is that another drug could have been approved since the preliminary DPEA was