Strict PM(NOC) Time Limits are Still Strict

Merck Canada Inc v Canada (Health) 2021 FCA 224 Gauthier JA: Locke, Leblanc JJA affg Merck Canada Inc v Canada (Health) 2021 FC 345 Fothergill J

             2,830,806 / pembrolizumab / KEYTRUDA

Subsection 4(6) of the PM(NOC) Regulations permits a person to submit a patent for listing on the patent register within 30 days after issuance. Merck submitted the 806 patent for listing a day or two late [14]. Merck argued that the Minister had the discretion to extend the time limit, and, as a secondary argument, that the Covid-19 Time Limits Act applied to extend the deadline. The Minister rejected both these arguments and refused to list the 806 patent. Merck sought judicial review, arguing that the Minister’s decision was based on an unreasonable interpretation of the relevant provisions. Fothergill J at first instance found that the Minister’s determination on both these points was reasonable, as noted here. On appeal, Gauthier JA for FCA affirmed that Minister’s decision was reasonable.

The main substantive point emerging from the FCA decision is that the time limits under the PM(NOC) Regulations have always been strict, and nothing in the 2017 amendments changed this: [35]–[38]. The time limits are still strict, and the Federal Court is not going to be sympathetic to attempts to get around those limits, either now or in the future: see eg [25], [35]. It seems clear that this Minister’s decision would have been upheld even on a correctness standard.

Merck also argued that the Court has a general power to grant equitable relief which should be exercised in this case. Gauthier JA rejected this argument on the basis that it had been raised for the first time on appeal, and it was not appropriate in the circumstances for the FCA to consider it [63]–[66]. While Gauthier JA therefore did not expressly consider the merits of the argument, my sense is that she was distinctly unsympathetic (see [60]–[61]), and I would not hold out much hope for this argument even if it is properly raised in a subsequent case.

On an administrative law point, Gauthier JA noted that it is not unreasonable for the Minister to fail to consider cases that were not cited to it by Merck: “the decision maker is not required to embark on an analysis that would cover any possible line of reasoning (Vavilov at paras. 120 and 127). Regard must be given to the submissions made to the Minister” [22] and similarly [42].

Reasonableness Review Not Possible Without Reasons

Catalyst Pharmaceuticals, Inc. v. Canada (Attorney General) 2021 FC 505 St-Louis J

amifampridine / RUZURGI / FIRDAPSE

In this case Catalyst sought judicial review of the Minister of Health’s decision to issue an NOC to Médunik’s with respect to Médunik’s NDS for RUZURGI, on the basis that the NDS relied on a comparison with Catalyst’s innovative drug FIRDAPSE, contrary to the Data Protection Regulations, C.08.004.1 of the Food and Drug Regulations. Médunik’s NDS for RUZURGI and Catalyst’s NDS for FIRDAPSE proceeded in parallel, so that both products were being considered at the same time. This gave rise to a timing problem; the underlying issue in this case is exactly when a data protection for a drug product is triggered under C.08.004.1. St-Louis J quashed the Minister’s decision, but not because the Minister’s interpretation of the data protection regulations was unreasonable; rather, the problem was that the Minister did not provide any reasons at all for its decision which could have enabled meaningful review [193]. In the circumstances, St-Louis J declined to give any prospective guidance as to the proper interpretation of the provisions [194]–[196].

Catalyst’s FIRDAPSE NDS was filed on 6 Nov 2019, seeking an NOC and also data protection [13]. On November 19, 2019, the Minister informed Catalyst that FIRDAPSE appeared to be an “innovative drug,” eligible for data protection [13]. The NOC was issued on 31 July 2020 [17].

Médunik’s RUZURGI NDS was submitted in December 2019 [15]. The Product Monograph originally submitted made reference to FIRDAPSE [16] (though the exact nature of the reference is not clear). The RUZURGI PM as approved on 5 Aug 2021, did not refer to FIRDAPSE. The NOC was issued on 10 Aug 2020.

So, the RUZURGI NDS made reference to FIRDAPSE at a time when FIRDAPSE application was in process, and FIRDAPSE was considered by the Minister to be an innovative drug, but by the time the RUZURGI NOC was issued, the application no longer referred to FIRDAPSE. The substantive question was whether the data protection regulations are triggered in those circumstances.

The NOC issued to Médunik in respect of RUZURGI contained no reasons. It merely confirmed that the NDS complied with the relevant provisions of the Regulations [21].

In the absence of reasons, the AG tried to justify the Minister’s decision by introducing evidence of the internal process used by Health Canada, including eg the kind of internal checks of the Register of Innovative Drugs, when those checks were carried out etc — in effect, the court was provided with a flowchart of the approval process [65]–[119]. The AG essentially argued that the process disclosed by the evidence was consistent with a reasonable interpretation of the Regulations. As I understand it, Health Canada argued that the Minister interpreted the regulations to mean that a product can only be subject to data protection once the product is listed on the Register of Innovative Drugs that is currently marketed in Canada, which does not happen until the NOC is granted: [85]–[86], [115]. Put another way, the AG argued that a comparison that is made prior to “the designation of an innovative drug” is not captured by the Regulation: [180t].

But the specifics of the AG’s view of the Regulation ultimately did not matter. In the absence of reasons, St-Louis J did not have any evidence of the Minister’s actual interpretation of the provisions at the time the decision was made [135], [195]. In effect, she was being asked to review the AG’s post hoc speculation as to the Minister’s interpretation, rather than the Minister’s interpretation itself. This is not a proper basis for judicial review; in the absence of evidence of the Minister’s rationale, the Court cannot perform its role on judicial review [178]. Moreover, St-Louis J was not persuaded that the process outlined in the evidence was in fact followed in approving the RUZURGI NOC [180].

St-Louis J remarked that she was not persuaded that the procedure outlined in evidence was consistent with the Regulations even on a reasonableness review [179], but neither did she hold that it was not. In the circumstances, she held that it would be inappropriate for her to provide prospective guidance as to the interpretation of the Regulations [194]–[196].

Routine Correction of Inventorship

Secure Energy (Drilling Services) Inc v Canadian Energy Services LP 2021 FC 1169 Zinn J

            2,508,339 / Drilling Fluid and Methods of Use Thereof

This was a routine correction of inventorship under s 52, with Zinn J ordering the records of the Patent Office varied to remove one of the two named inventors from Secure Energy’s 339 patent. The error arose because the patent agent who prepared the application had simply asked one of the named inventors, Levey, for the names and addresses of all the inventors, without informing him of the test for inventorship [24]. Levey and the other named inventor, Ewanek, discussed the matter between themselves and decided that both should be listed, without either having the benefit of advice as to who would legally be considered an inventor [25]. In light of Levey’s uncontested evidence of the course of invention, based on his lab notebooks, Zinn J had no difficulty in finding that Levey was the sole inventor [34]–[41].

There was a minor complication because Ewanek, the named inventor who was removed from the 339 patent, was also the sole named inventor in a different patent for a related invention (the 2,624,834 patent), that was being asserted against Secure Energy by Canadian Energy Services. Secure asserted that it was the true owner of the 834 patent [6]. Because of this relationship, CES was a party to this proceeding. While CES did not contest the change in inventorship of the 339 patent, it wished to ensure that no findings would be made on the evidence relevant to both patents that might prejudice its position with respect to ownership of the 834 patent. Fortunately, Zinn J was able to decide the issue of the ownership of the 339 patent without recourse to any of the contested material [17], [34].

Blogging break

Next week is our fall reading week, and I'll be taking a vacation and a blogging break, resuming blogging around the 22nd.