Janssen Inc v Canada (Attorney General) Mactavish JA: Stratas, Rennie JJA 2021 FCA 137 affg
2020 FC 904 Zinn J
esketamine hydrochloride / SPRAVATO
The FCA decision in Janssen is a straightforward application of the doctrine of stare decisis,
with a loose end that raises some interesting questions for the application of stare decisis in the
context of statutory interpretation.
Data protection is available for an “innovative drug” pursuant to section C.08.004.1 of the Food
and Drug Regulations. “Innovative drug” is defined to mean:
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.
In a split decision in Takeda 2013 FCA 13, the FCA held that this definition should be
interpreted to mean that the enumerated variations—a salt, ester, enantiomer, solvate or
polymorph—were per se ineligible for data protection, regardless of the effort necessary to
develop the data: see here. Stratas JA, dissenting, would have held that data protection is
available for an enantiomer or other enumerated variation if regulatory approval for the drug
required the submission of confidential data generated by considerable effort and the medicinal
ingredient is materially different in terms of safety and efficacy: [22], Takeda [92]–[93]. I
described the interpretive issue as a “hard case” where the purposive considerations relied on by
Stratas JA pointed in one direction, while the textual and contextual considerations relied on by
the majority pulled the other way.
In this case, Janssen applied for data protection for SPRAVATO, in which the medicinal
ingredient is esketamine hydrochloride, an enantiomer of ketamine hydrochloride. Ketamine
hydrochloride is the medicinal ingredient in the previously approved drug KETALAR. The
Minister refused Janssen’s application. In the decision under appeal, Zinn J dismissed Janssen’s
application for judicial review of that decision: see here. Zinn J accepted that there were factual
differences between the cases. In particular, in Takeda both drugs were developed by the same
company and used in the same manner for the same indication [FC 25], while in this case the
enantiomer is indicated for an entirely different use: KETALAR is a narcotic, while SPRAVATO
is an antidepressant. Thus, as a matter of policy, there is a stronger case for granting data
protection in this case than in Takeda. (Note that in Takeda Stratas JA did not hold that data
protection should be available for the enantiomer at issue on the facts, but only that the matter
should be remitted for redetermination: Takeda [104]–[107].) However, as Zinn J pointed out,
these facts were not material to the majority reasoning in Takeda, which held that the listed
variations were per se ineligible, regardless of the amount of effort involved in developing the
data: [41], [FC 26], Takeda [141].
In this appeal, Janssen acknowledged that the decisions below were consistent with Takeda. Its
primary argument was that Takeda was wrongly decided and that Stratas JA’s interpretation of
the provisions was correct [42], [71]. The FCA rejected this argument on the grounds of stare
decisis, which permits departure from prior decisions only in “exceptional circumstances”:
[72]–[79]. The FCA provided a useful brief summary of the relevant principles, with the most
basic being that “one panel of this Court ought not to come to a different conclusion from a
different panel, merely because it is of the view that the first decision was wrongly decided” [73],
citing Miller 2002 FCA 370. The fact that Stratas JA was a member of both panels makes no
difference: [80]–[83].
I agree with this result on the facts of this case, but I’m not comfortable with the Miller test. The
law of stare decisis involves a trade-off between legal predictability and accuracy. In the easy
cases, there is no conflict; if the first decision to address a point of law is clearly correct, then we
get both predictability and accuracy by following it. But what if the first decision is wrong?
When should we sacrifice accuracy, by following a wrong decision, for the sake of predictability?
The Miller criteria set a very high bar for departing from a prior decision, giving very little
weight to accuracy. The prior decision may be overruled only when it is “is manifestly wrong, in
the sense that the Court overlooked a relevant statutory provision, or a case that ought to have
been followed”: [75] quoting Miller [10]. “Manifestly wrong” has a “narrow” meaning, which is
tantamount to saying the decision was made per incuriam: Olanzapine 2013 FCA 282 [8]. (It is a
bit odd that the test for whether the FCA must follow its own precedent is much the same as the
test for whether a lower court must follow a higher court.) Miller does implicitly acknowledge
the trade-off between predictability and accuracy, but it adopts a threshold test for accuracy;
where accuracy is unimportant outside the narrow threshold of manifestly wrong. This means
that with Miller there is significant room for a lock-in effect from the first decision, where the
initial decision may be generally considered to be wrongly decided, but will be reinforced by
subsequent cases because it does not rise to the point of being manifestly wrong.
An alternative might be some kind of balancing test, which would more explicitly consider how
likely it is that the prior decision was wrongly decided, how important the consequences are, and
how much actual loss of predictability there might be. It might be said that the very use of a
balancing approach to precedent would undermine predictability, because it would always be
uncertain how a later panel would assess that balance. But I’m not sure that’s so different from
where we are now, where problematic decisions are ignored, or gradually distinguished into
oblivion. (Though that is easier when the point is factually suffused, rather than a narrow point of
law.) How much worse would it be to explicitly recognize that some precedent is better than
others, rather than doing it sotto voce? Another possibility would be greater use of expanded
panels or en banc review, or some other approach entirely. I don’t have any answers here, but I
do see a problem.
The problem of wrong precedent being locked in is particularly important in the context of
statutory interpretation. As Professor Nina Varsava puts it “Does the judiciary have legitimate
authority to knowingly misinterpret and misapply statutory law?”: How to Realize the Value of
Stare Decisis 30 Yale J L & Human 62 (2018) 118. If the first decision interpreting a statutory
provision is “manifestly wrong,” it can be revisited, but I am not sure it is sound to stick with an
interpretation that is generally considered to be wrong, even if it is not “manifestly” wrong.
I should emphasize that I don’t think the main source of potential inaccuracy is poor legal
reasoning on the part of the first panel to decide the issue. On that score, I do think the Miller
criteria, amounting to whether the decision was made per incuriam, is appropriate. That is what
makes this case an easy one. As the Court noted, the point was fully argued in Takeda and
“[b]oth the majority and the minority decisions are thorough and carefully reasoned” [76].
Moreover, the case was a close call—my own view is that the majority decision was
correct—with good arguments on both sides. There is much to be lost in terms of predictability if
different panels flip-flop simply because they weigh close arguments slightly differently, and
little to be gained in terms of accuracy of interpretation, given that either decision is about
equally likely to represent the notional true intent of the legislature.
There are two other potential sources of inaccuracy that are much more important. One is that the
full implications of a decision may become apparent only over time, as they are applied to
different factual scenarios. A decision may be entirely well-reasoned and “right” given the
information available at the time it was decided, and yet turned out to be wrong with the benefit
of hindsight. That is largely what happened when, in Hospira 2016 FCA 215, the FCA departed from
Aqua-Gem 1993 CanLII 2939 (FCA) on the standard of review for discretionary decisions of
prothonotaries. The first reason the FCA gave for departing from Aqua-Gem was that experience
had shown that the Aqua-Gem standard was difficult to apply and had generated confusion that
detracted from the effective review of discretionary orders made by prothonotaries (Hospira
[46]–[50]). A second reason was the persuasiveness of the reasoning on the same question in the
Ontario courts (Hospira [51]–[55]). As I argued in my comment on Hospira, the FCA did not
follow Miller in deciding to overrule Aqua-Gem: neither of these factors is relevant under the
Miller test. Aqua-Gem was not poorly reasoned at the time it was decided (Hospira [49]) and it
certainly was not manifestly wrong. This illustrates that the Miller criteria are poorly suited to a
situation where the hindsight that comes with time and experience shows a prior decision to have
been “wrongly” decided, even though it was entirely reasonable on the information available to
the court at the time. None of these concerns are relevant to this case, as Takeda was recently
decided and, so far as I can tell, nothing in our subsequent experience would cause us to weigh
any of the arguments any differently.
Another source of error is when the case is poorly argued. This is perhaps particularly a problem
for trial decisions, because the sheer number of factual and legal issues to be addressed can mean
that a point that turns out to be important is not fully argued. My sense is that comity is not as
powerful in the Federal Court for that reason. If a novel issue of law has been decided in a single
prior FC decision, a subsequent FC judge will generally make their own assessment of the
arguments before them, with the prior decision considered as one factor with considerable
persuasive effect. (I’m afraid I can’t put my hands on particular examples right now.) This strikes
me as a good approach. There is not much loss of certainty in the law, because a holding of law
by the Federal Court is always liable to be overruled by the FCA in any event, and once a novel
point of law has been addressed once, it is likely to be more thoroughly argued the next time. The
same kind of problem can arise at the FCA level as well, particularly in cases (unlike Takeda),
where there are multiple legal and factual issues being appealed.
The problem of a poorly argued case is particularly troublesome in the context of statutory
interpretation. It’s disquieting to think that the law might depart from the intent of the legislature
simply because a private litigant had argued its case poorly in the first decision on the issue.
This brings me to the loose end in this case. Janssen argued that the FCA should admit new
evidence on appeal with respect to the effect of the repeal of NAFTA and the coming into force
of CUSMA, and the impact that CUSMA should have on the interpretation of the data protection
provisions [44]–[45]. In particular, “Janssen points out that under CUSMA, Canada agreed to
provide protection to “new pharmaceutical products”, which are specifically defined as products
that do not contain a chemical entity that has previously been approved” [46]: see CUSMA Art
20.48–20.49. Further, “Janssen notes that OSIP explicitly found that the medicinal ingredient in
SPRAVATO had not been previously approved in a drug in Canada, and that this would qualify
SPRAVATO for data protection under CUSMA” [46]. The FCA refused to admit the evidence
on procedural grounds. First, Janssen could and should have made the argument in the Federal
Court: [49]–[52]. The FCA noted that CUSMA was finalized in December 2019 and came into
force on July 1, 2020, just before Janssen served and filed its application record in the Federal
Court on July 17, 2020, and before its application was heard on August 31, 2020. Janssen
therefore had the opportunity to make substantive submissions that CUSMA had changed the
data protection regime, but failed to do so. Second, the question facing the Federal Court “was
not to decide whether esketamine hydrochloride should be entitled to data protection. Its task was
to determine whether OSIP’s decision to refuse data protection for SPRAVATO was reasonable,
based on the record before it. OSIP [the Office of Submissions and Intellectual Property]
rendered its decision on April 25, 2019, more than a year before the coming into force of
CUSMA and the exchange of correspondence between the parties. Consequently, the agreement
and the documents could have had no bearing on OSIP’s decision with respect to SPRAVATO,
and they were not relevant to the task that the Federal Court had to perform” [54]–[55]. Both of
these points strike me as compelling so far as procedural fairness to Janssen is concerned.
But what happens next time the same issue arises? Substantively, Janssen’s argument strikes me
as quite reasonable. It would certainly have been taken into account if the interpretative question
has been argued for the first time after CUSMA had come into force and it is at least possible
that it would have tipped the balance. But the interpretive question is no longer a matter of first
impression. As a matter of stare decisis, is the coming into force of CUSMA an “exceptional
circumstance” that would warrant departing from Takeda, even though the legislation itself has
not changed? This question raises an interesting point of principle. Suppose that the CUSMA
argument was a knock-down argument that made it clear that Stratas JA’s position was correct. (I
should say that this is purely for the sake of argument; I really have no opinion how the CUSMA
argument would play out if it were added to the interpretive mix.) If the enactment of CUSMA
was not an “exceptional circumstance” as a matter of the law of stare decisis, the result would be
that a clearly wrong interpretation of the legislation would prevail simply because a private party
had failed to make the argument at its first opportunity. I find this to be a troubling possibility;
though perhaps it is simply a reflection of the fact that the interpretation of legislation through
private litigation inevitably means that the interpretation will be shaped in part by the litigation
strategy of the parties. Professor Varsava goes to far as to suggest that we should abandon stare
decisis in the context of legislative interpretation, in part for that reason: see Varsava, How to
Realize the Value of Stare Decisis 30 Yale J L & Human 62 (2018) 117–18. I would not go that
far, but the point is an interesting one.
Because the FCA decided on procedural grounds, it was not necessary to address this question,
and the Court—wisely, in my view—did not discuss the substantive point even tangentially. The
door therefore remains open for this argument to be made. I expect we will find out the answer in
due course, after the CUSMA argument is properly made to OSIP and it winds its way back up to
the FCA on a more complete record.
