IPIC Subject Matter Test Properly Subject to Appeal

Canada (Attorney General) v Benjamin Moore & Co 2022 FCA 194 Rennie JA

2,695,130 / 2,695,146 (applications)

This decision relates to a procedural wrinkle in the Benjamin Moore litigation, which is set to clarify the law relating to patentable subject matter. The Commissioner had refused two of Benjamin Moore’s applications on the basis that the claims were directed to non-statutory subject matter. Benjamin Moore appealed, and in Benjamin Moore 2022 FC 923, Gagné ACJ endorsed a particular test, proposed by the intervener, IPIC, for assessing patentable subject matter (see here). She then sent the applications back to CIPO for redetermination. The Attorney General had agreed that CIPO had used the wrong test, and that the files should be sent back for redetermination, but would have preferred that CIPO be instructed to decide the matter according to the principles set out in Choueifaty 2020 FC 837: [FC 39]. Significantly, Gagné ACJ instructed CIPO to use the IPIC test in paragraph 3 of the judgment itself.

The Attorney General then appealed. Benjamin Moore brought this motion to strike, arguing that the AG had no disagreement with the result—the files should be sent back for redetermination—and the appeal was brought to challenge the IPIC test. It is clear that the FCA, under the Federal Courts Act, s 27, only has jurisdiction to hear an appeal against the judgment, and Benjamin Moore argued that the appeal was in substance an appeal against the reasons.

The key question in this motion was therefore whether the appeal truly relates to the Federal Court’s judgment, or to its reasons for that judgment: [14]. Rennie JA noted that whether an appeal is taken from the reasons or the judgment is not always self-evident. The central policy consideration is “whether the appeal is a veiled attempt to keep the benefit of the judgment but realign the reasons for judgment. Sometimes a party will be successful in the result, but will not like the manner by which they succeeded. Courts must always be vigilant to guard against appeals brought on this basis” [25].

Rennie JA held that in this case, the appeal was an appeal against the judgment, not just the reasons, and so the motion was quashed. He discussed two prior FCA decisions, in Yansane 2017 FCA 48 and Fournier 2019 FCA 265 affg 2018 FC 464. In Yansane, the FCA had noted at [17] that “the Court often simply directs that reconsideration take place in accordance with its reasons,” and held that in such a case an appeal against the reasons was not permitted, as “only instructions explicitly stated in the judgment bind the subsequent decision-maker” [19]. In Fournier, the FC judgment stated that “The case is referred back to the Appeal Panel for reconsideration, taking into account these reasons.” The appellant asked the court to uphold the judgment, in the sense of referring the matter back to the Appeal Panel, but asked the FCA to declare that the FC had erred in its interpretation of a point of law. The FCA held that this was an impermissible attempt to appeal the reasons, and the reference to the “taking into account these reasons” did not change the essence of the appeal:

[31] I am therefore of the view that the addition of that statement in the formal judgment is not sufficient to incorporate therein the reasons in their entirety, much less to make of that statement a strict direction or even a directed verdict. If it were otherwise, reasons would always open up the possibility of an appeal.

He distinguished these decisions on the basis that they related to situations which there was a general reference to the reasons in the formal judgment [19],[20], whereas in this case “paragraph 3 of the judgment lays out a test for the Commissioner that can be uniquely enforced, separately from the accompanying reasons” [22], and

paragraph 3 of the Federal Court’s judgment is a specific direction in this respect, akin to a declaratory judgment. Consistent with [the prior cases], the specific direction in paragraph 3 forms part of the judgment and uniquely binds the Commissioner to a particular test in a way that the reasons alone do not [26].

This does distinguish the prior cases, though at first blush it might seem a bit formalistic. One response to that is simply to say that a line has to be drawn somewhere and any test that provides any degree of certainty has to be formalistic to some degree. Another response is that the distinction is by no means purely formal. Rennie JA noted that “This test responds to the only substantive consideration that was before the Federal Court, laying at the core of the Federal Court’s formal judgment in the matter” [26]. The formal point and the substantive point go hand in hand: when the particular legal test is found in the judgment itself, this is a very good indication that the court considered it to lie at the core of the decision. For both those reasons, I do find the distinction drawn by Rennie JA to be persuasive.

With all that said, it’s not entirely clear to me why the court has to be so vigilant to guard against a party seeking to “keep the benefit of the judgment but realign the reasons for judgment.” Victory on the facts in a case is always welcome, but for parties who are repeat players in the litigation system, as is true for many patent litigants, the shape of the law may be much more important in the long run. If the decision goes against a party, they have a full opportunity to reargue the law on appeal, and it’s not entirely clear to me why they should be denied that opportunity if the ruling goes in their favour, simply because the trial judge did not find the legal point important enough to put in the judgment itself. I’m sure there’s an answer to that question in the voluminous jurisprudence on the US “case or controversy” requirement, but I won’t pursue it, since the point is academic in this context, given that Rennie JA did allow the appeal to proceed.

 

Fixed Dosage Regimen is Patentable Subject Matter

Janssen Inc v Pharmascience Inc 2022 FC 1218 Manson J

2,655,335 / paliperidone regimens / INVEGA SUSTENNA / NOC

In this action, Manson J found that Janssen’s 335 patent was not invalid for obviousness or as claiming an unpatentable method of medical treatment. The obviousness decision turned on the facts; the discussion of methods of medical treatment is of more general interest, though it does not break new ground.

This decision followed from Manson J’s prior decision in Janssen v Pharmascience 2022 FC 62, a motion for summary trial, in which he found that Pharmascience’s proposed paliperidone product would induce infringement of the 335 patent [48]: see here. The 335 patent has been the subject of a variety of other litigation, of which the most relevant is Teva Paliperidone 2020 FC 593, in which, as mentioned here, Manson J found that the 335 patent was not obvious, in a decision that turned on the facts.

Paliperidone is a second-generation anti-psychotic, known to be useful in treating schizophrenia. “[S]chizophrenia is incurable and requires life long management with antipsychotic medications. Adherence to a treatment regimen is critical. . . . A leading cause of relapse is non-adherence, where patients do no [sic] take their antipsychotic medication as prescribed, or at all” [11]. One strategy to improve adherence is the use of long-acting formulations. The 335 Patent relates to a long-acting formulation, in particular a dosing regimen for injectable paliperidone palmitate “depot” formulations, which releases from the injection site slowly [12].

Manson J’s analysis on obviousness followed similar lines to his decision in Teva Paliperidone 2020 FC 593: he found the same inventive concept [127] and his findings on the differences between the state of the art and the inventive concept were also consistent with Teva Paliperidone [134]. The key question was whether these differences were obvious. While Pharmascience argued that there were some crucial differences in the evidence on this point between this case and Teva Paliperidone [135], Manson J again concluded that the 335 patent was not obvious or obvious-to-try, in an analysis that turned on the facts [136]–[147]. The key point is that while there was a general motivation to develop a depot formulation of paliperidone to address compliance problems [155], there was not a specific motivation to develop the claimed dosing regimens [153]–[155]. Consequently, the claimed dosing regimens were not obvious [159].

The question of whether the 335 patent claimed unpatentable methods of medical treatment was of more general interest. Manson J noted that the Federal Court and FCA have acknowledged that the jurisprudence as to what constitutes an unpatentable method of medical treatment is inconsistent [161]. He noted, helpfully, “there appears to be no question in the case law that claims to a vendible product are patentable as not being methods of medical treatment” [163]. Many of the claims at issue were “product” claims, in particular claims to prefilled syringes (claims 1 to 16) and Swiss-type claims (claims 33 to 48), and consequently clearly do not constitute unpatentable methods of medical treatment [163]. It is worth noting that Manson J expressly stated that the Swiss-type claims are “product” claims [109]; his holding in Hoffmann-La Roche v Sandoz 2021 FC 384, [95]–[109], that the Swiss-type claims should be construed as use claims now appears to be an outlier: see also my recent post on Janssen v Apotex 2022 FC 996.

The question therefore only arose in respect of the “use” claims: [163]. The justification for the bar on patenting methods of medical treatment is that claims to a method of medical treatment should not constrain a medical professional in the exercise of their skill and judgment: [166], quoting Hospira 2020 FCA 30 [52]. Manson J summarized the law as being that use claims to dosing regimens that are “restricted to particular dosages and specific administration schedules” have been found to be patentable subject matter, “whereas claims to dosages or schedules with ranges within which the physician must exercise skill and judgment have been found to not be a vendible product and thus not patentable” [164]. This is a point Manson J has made before, in Hoffmann-La Roche v Sandoz 2021 FC 384. As discussed here, I’m not sure that distinction entirely reconciles the cases; and Manson J immediately went on to note that claims involving dosage ranges have been held unpatentable “at least in some cases” [165]. Moreover, Manson J evidently does not consider the distinction to be sound in principle, saying the distinction “seems to have a questionable underpinning in resulting judgments based on this dichotomy” but “nevertheless that is where we are under the current state of decisions up to and including decisions in the Federal Court of Appeal” [165]. In other words, we can all recognize that the current state of the jurisprudence is unsatisfactory, but it is what it is, at least for now.

Despite the very confused state of the law, this turned out to be a relatively easy case. The use claims were to a very specific dosing regimen, with “no choices in respect of possible ranges for the dosage amounts, which are fixed at loading doses of 150 mg-eq. on Day 1, 100 mg-eq. on Day 8, and 75 mg-eq thereafter as the maintenance dose” [168]. These are the types of claims that have consistently been held to be patentable subject-matter. Manson J noted that while there was some flexibility in dosing windows, “those choices do not have clinical implications,” as they were incorporated into the regimen to allow for a missed dose, or for convenience in the injection site [170].

Manson J made two observations of general interest. First, as the FCA pointed out in Hospira [52], quoted at [166], “It would seem that a medical professional will be constrained in their exercise of skill” whether the patent claims a fixed dosage or a range of dosages. That is, if a medical professional decides, in their professional judgment, that a certain dosage is required, and that dosage is claimed in a claim to a fixed dosage, their skill will be constrained as much as if it fell within a claimed range. Manson J noted that, in this case, the use claims “do not prevent physicians from practicing in a manner they had previously ‘because they weren’t doing anything before’ the 335 Patent with paliperidone palmitate to treat schizophrenia” [167]. Note the shift from asking whether the medical professional is constrained in the exercise of their skill and judgment, to asking whether they are constrained from practising in the manner they had previously. It seems to me that the medical professional will never be prevented from practising in the manner that they had previously in any case in which the claim is not invalid for anticipation. A valid patent does not constrain a physician’s choices as compared with what they were doing previously; on the contrary, it expands their choices by disclosing new information about how to best treat patients, which would not have been available but for the lure of the patent.

Manson J also noted that “A physician can choose to implement a claimed specific dosing regimen or not; however, skill and judgment are not required to implement the claimed dosing regimens” [171], and for that reason, the claimed subject-matter was not an unpatentable method of medical treatment. This observation also illustrates that the exercise of skill and judgment is always required in medical treatment, even in the administration of a fixed dosage regime. If the exercise of skill and judgment in deciding whether a particular regime is appropriate is not objectionable, I have difficulty seeing why it is any more objectionable if some skill and judgment must be exercised in deciding the exact dose within a claimed range.

New Test for Patentable Subject Matter

Benjamin Moore & Co v Canada (Attorney General) 2022 FC 923 Gagné ACJ

2,695,130 / 2,695,146 (applications)

In a much anticipated decision, Gagné ACJ has endorsed a sound framework for assessing patentable subject matter pursuant to s 27(8). The appellant, Benjamin Moore, appealed decisions by the Commissioner refusing to grant the 130 and 146 Applications, on the basis that “the essential elements of each invention constituted a mere abstract theorem, falling under the statutory exception provided at section 27(8) of the Patent Act” [1]. The appeals were consolidated, and IPIC was granted leave to intervene.

Both applications were for computer-implemented inventions, relating to a method for selection of harmonious colour combinations [7]. The details of the invention and the claim don’t really matter, as the appeal turned on the ‘problem-solution’ approach used by the Commissioner to assess patentability, and not on its application to the 130 and 146 applications.

Indeed, the appeal didn’t even turn on the details of the ‘problem-solution’ approach to patentable subject matter, as everyone—including the Respondent Attorney General—agreed that it was wrong [23],[25]. As Gagné ACJ noted, in Choueifaty 2020 FC 837 (discussed here), Zinn J has held that the problem-solution approach was not correct, despite the “lip service” it paid to the jurisprudence [11],[31]. CIPO issued an updated Practice Notice after Choueifaty, which nonetheless continued to apply the problem-solution approach [12]. Thus all the parties agreed that the Commissioner erred in applying the problem-solution approach to the applications at issue in this case [17]–[21], [30].

The basic substantive problem with CIPO’s approach is that it effectively identified the inventive concept—under the guise of their interpretation of the “essential elements” or the “actual invention”—and then asked whether the inventive concept was abstract and hence prohibited under s 27(8). The problem with that approach is that the inventive concept is always abstract—it reflects the new information provided by the patent: for more discussion see here. That is why, as the SCC pointed out in Shell Oil [1982] 2 SCR 536, 554:

A disembodied idea is not per se patentable. But it will be patentable if it has a method of practical application.

Given that all parties agree that the Commissioner had applied the wrong approach, the only question was what to do about it. By the time of trial, the parties also agreed that the Court should not make its own determination, but should remit the matter to CIPO with instructions as to how to approach the issue [38]–[40]. So, the only real issue was what instructions the Court should provide to CIPO in remitting the applications back to it [41].

Gagné ACJ endorsed the framework proposed by IPIC [43]:

a) Purposively construe the claim;

b) Ask whether the construed claim as a whole consists of only a mere scientific principle or abstract theorem, or whether it comprises a practical application that employs a scientific principle or abstract theorem; and

c) If the construed claim comprises a practical application, assess the construed claim for the remaining patentability criteria: statutory categories and judicial exclusions, as well as novelty, obviousness, and utility.

I see this as a sensible framework. It won’t answer all the difficult questions, but it does provide a sound framework for doing so.*

An initial question is as to the scope of application of this framework. Gagné ACJ described the framework proposed by IPIC as being for “the assessment of the patentability of computer-implemented inventions” [43]. However, there is no obvious principled reason for restricting it to computer-implemented inventions, nor did Gagné ACJ suggest there is. She stated that the framework is consistent with Shell Oil [52], which, as she noted, “established that practical applications of scientific principles and abstract theorems, in that case a new use for existing chemical compounds, can constitute patentable inventions” [34]. Further, the appeal was taken because the Commissioner had rejected the applications on the basis that they were for “a mere abstract theorem, falling under the statutory exception provided at section 27(8) of the Patent Act” [1]. Consequently, I take this framework to be applicable to s 27(8) generally, and not just computer-implemented inventions; the reference to computer-implemented inventions is simply because that is the context where s 27(8) rejections have been most controversial recently.

Turning to the framework itself, step (a)—purposively construe the claims—is relatively anodyne; after all, a purposive construction of the claims is the first step in any validity analysis. But it does set the stage by emphasizing that the focus is on the claim, not the inventive concept.

Step (b) is the test for subject matter patentability which directly reflects both s 27(8) and Shell Oil. A “disembodied idea”— or a “scientific principle” or “abstract theorem”—is not patentable as such, but a claim to a practical application of an idea, principle, or theorem, is good subject matter. And s 27(8) provides that “No patent shall be granted for any mere scientific principle or abstract theorem.” The words “mere” and “abstract” are not superfluous. The word “mere” is not used as meaning a “trifle”—”Oh, that’s merely F=ma”—but rather in the sense of ‘pure’, or ‘nothing more than’ (apparently from Latin for “undiluted”). Similarly, there is no prohibition on patenting a theorem; the prohibition is against patenting an abstract theorem.

So, a claim to “F=ma” is not permitted; but if the claim is to a practical application, such as a new method of aiming a cannon, the fact that the inventive concept is a scientific principle is no objection. In Shell Oil, the inventive concept was the discovery that a known compound was useful as a herbicide; the claim was not to that discovery, but to the compound mixed with an adjuvant in a manner suitable for application to plants. That claim was valid, even though there was no ingenuity in adding the adjuvant once the scientific discovery had been made. The question is whether what was claimed is a practical application, not whether the inventive concept is abstract.

Step (b) reflects Shell Oil by emphasizing that the question is whether “the claim as a whole” is to a scientific principle or abstract theory; not whether the inventive concept is a scientific principle or abstract theory. The Court’s endorsement of this approach means that the Commissioner is not permitted to reject a claim simply because the inventive concept is a theorem, or a principle, or an idea; the claim can only be refused on the basis of s 27(8) if the claim as a whole is to nothing more than a theorem, principle, or idea. For further discussion, see my articles on 27(8), The Rule Against Abstract Claims, part I on History and Principles, (2011) 26 CIPR 205, and Part II on A Critical Perspective on US Jurisprudence, (2011) 27 CIPR 3.

Step (c) is mostly straightforward; after assessing the claim for patentability under s 27(8), assess it for patentability under the remaining requirements. There is one point to note. S 27(8) is not the only subject-matter exclusion. Higher life forms are not patentable under s 2, according to Harvard Mouse 2002 SCC 76. The claim at issue in Harvard Mouse was to an oncogenic mouse that was new, useful, and non-obvious [9] and would clearly pass step (b), as being a practical application of scientific knowledge. The Supreme Court, in a divided decision, nonetheless held the claim to be unpatentable under s 2. The reference to “statutory categories” in step (c), as being one of the remaining patentability criteria is evidently a nod to Harvard Mouse and the possibility of s 2 exclusions. Another example of a subject-matter exclusion that does not turn on s 27(8) is the judge-made prohibition on patenting methods of medical treatment (which stems ultimately from the dictum “I do not think so” in Tennessee Eastman [1974] SCR 111). The phrase “judicial exclusions” in step (c) evidently refers to this type of exclusion.

In my article The Structure of the Law of Patentable Subject Matter, (2011) 23 IPJ 169, I called this kind of restriction on patentability, whether based on s 2 or a judicial exception, a “field-specific exclusion” because it applies only to certain types of subject matter. This is in contrast with the rule against abstract claims, which, like novelty, obviousness and utility, applies to any kind of subject matter. I argued that to the extent that there is a good reason for excluding some forms of computer-implemented inventions, business methods, or any other controversial kinds of subject matter, this should be done by way of a field-specific exemption, not by the misuse of s 27(8).

This is not to say that CIPO, or the courts, should seek further field-specific exemptions. On the contrary, any such field-specific exemption should be implemented by the legislature. Such exemptions, as I explain in my article, are based on policy considerations. Harvard Mouse, with due respect for the majority, was an exercise in judicial policy-making with only a tenuous connection to the text of the act. (The textual hook is the view that a mouse is not a “composition of matter”.) While Harvard Mouse was largely based on moral or ethical considerations, most patent policy is based on encouraging innovation. There is little doubt that patents are more effective in some areas than in others, and it is certainly possible that patents actually impede innovation in certain fields. The problem is that it is very difficult to decide whether a particular field falls into one category or the other. There is a general consensus that patents are good for innovation in the pharmaceutical and chemical industries, but not much consensus beyond that. As one of the leading economists on this topic said in a review article on the topic of whether permitting patentability of business methods would increase or decrease business innovation, “[t]he only conclusion that is certain is that allowing business method patents will cause an increase in the patenting of business methods: Hall, “Business and Financial Method Patents, Innovation, and Policy” (2009) 56 Scot J Pol Econ 443, 459–60.

Further, even if we decide that eg business methods, should not be patentable, drawing a line between what is patentable and what is not, can be very difficult. The judicial exclusion of methods of medical treatment is a prominent illustration of how difficult this kind of line drawing is: see here and here. As another example, the Harvard Mouse prohibition on patenting higher life-forms is largely ineffective because cells of higher life forms are patentable, reflecting the difficulty of line drawing between higher and lower life forms. The common law method would be to develop such an exception one case at a time. Given the difficulty of the problem, that would create years and even decades of uncertainty, especially if the jurisprudence develops from appeals from CIPO rejections, as applicants are much less likely to spend money litigating an application for an invention that may turn out to be worthless.

The US has a much more extensive jurisprudence on patentable subject-matter, and despite numerous SCOTUS decisions, the area is a complete train-wreck, mixing exemptions that are perhaps justifiable (business methods) with those that are completely unjustifiable (diagnostic methods), in an extraordinarily confusing doctrinal framework. That is not a road we should follow. 

*I am a member of the IPIC Patent Committee which provided input to IPIC on the proposed approach. My comments in this post reflect my own views. 

A New Twist on the Patentability of Method of Medical Treatment

Hoffmann-La Roche Limited v Sandoz Canada Inc 2021 FC 384 Manson J

2,667,654 / 2,709,997 / pirfenidone / ESBRIET / NOC

Roche’s 654 and 997 patents at issue in this NOC proceeding relate to the use of pirfenidone in the treatment of idiopathic pulmonary fibrosis [IPF], a rare, chronic and incurable lung disease [7], [12]. Manson J held that Sandoz would induce infringement of the asserted claims of the 654 patent by making and selling its generic product, but the asserted claims of both patents were invalid for obviousness and as methods of medical treatment. The asserted claim of the 997 patent was also invalid for obviousness-type double patenting. Various other invalidity attacks failed. The obviousness analysis was legally straightforward and turned on the facts. This post will provide background and focus on the patentability of methods of medical treatment, where Manson J has introduced a novel twist into a confusing area of law. Another interesting issue relates to the construction of Swiss form claims, which I’ll deal with in a subsequent post.

It was common general knowledge at the relevant date that pirfenidone was under investigation as a treatment for IPF, and preliminary results were promising though inconclusive [70]. Consequently, the use of pirfenidone for the treatment of IPF could not be claimed. Instead, the 654 patent claimed a dose escalation regimen, intended to minimize side effects [8], [158]. The 997 patent claimed full dose treatment of a patient who had exhibited liver abnormality after initial treatment [10], [182]. The prior art indicated that treatment should be stopped if a patient developed liver function abnormalities with the use of pirfenidone, and the 997 patent disclosed that such patients could still receive the full dose, with suitable monitoring of liver function.

The 654 patent was held to be invalid on a straightforward obvious-to-try analysis, given that it was common general knowledge that a dose escalation regime was one way of minimizing side effects and that there was no particular difficulty in arriving at the claimed regime [166]–[181]. The 997 patent was obvious because management of drug-induced liver toxicity was part of the cgk and continuing treatment while doing so would be an obvious alternative to discontinuing treatment entirely if the benefits outweighed the risks [66(ii)], [190]. The 997 patent was also found to be invalid for obviousness-type double patenting over the 654 patent [148]–[153]. I’m a bit puzzled as to why this argument was run on a double-patenting basis, as the publication date of the 654 patent was June 26, 2008 and the claim date of the 997 patent was November 10, 2008 [9], [11], [153], so the 654 patent was prior art over the 997 patent and so, on Hospira 2020 FCA 30, would have been part of the state of the art against the 997 patent. Perhaps Sandoz felt it was safer to use double patenting rather than to rely on the Hospira doctrine—presumably the 654 patent was not part of the common general knowledge and would not have been discoverable in a reasonably diligent search.

Both patents had three distinct claim types [95]–[96]:

            1) “German-style” — Use of pirfenidone for treatment of IPF

2) “Swiss-style” — Use of pirfenidone in the manufacture of a medicament for treatment of IPF

3) “Product for use style” — pirfenidone for use in the treatment of IPF

Manson J construed all the claims as “use claims” including the Swiss-type claims [107], and consequently did not distinguish between them in assessing whether they claimed unpatentable methods of medical treatment. In this post, I’ll focus on the German-style claims of the 654 patent, which are use claims on their face, so as to avoid any of the tricky claim construction issues that arise with the Swiss-type claims.

Manson J stated that “Patent claims to methods of medical treatment are prohibited in Canada and are not patentable under section 2 of the Patent Act” [195]. This is perhaps now in doubt—see Cobalt 2015 FCA 116 [55]; Hospira 2020 FCA 30 [53]—but it’s well established at the Federal Court level and I won’t pursue the point here. The main battle ground is over what constitutes an unpatentable method of medical treatment: for background see here and here.

Claim 1 of the 654 patent was of the following form (the full claim is reproduced below):

1. Use of X for treatment of disorder Y at a [dosage regimen with fixed dose and schedule]

Manson J held this to be an unpatentable method of medical treatment, essentially for the following reason:

[195] Patent claims are invalid where they prevent or restrict physicians from applying their skill and judgment. . . . . [T]he crucial question remains of whether the 654 and 997 Asserted Claims encroach on the skill and judgment of physicians.

The claimed regimen specified fixed doses and a fixed schedule, and, as Manson J noted, such a regimen will not normally be held to be a method of medical treatment [197]. However, picking up on an obiter comment in AbbVie 2014 FC 1251 [114], Manson J held that a fixed dosage regime is patentable “unless there is evidence to contradict the claimed dosage” [197]. He held that such evidence exists in this case:

[204] [T]he evidence has established that there is a continued need for a physician’s exercise of skill and judgement, as the default dose escalation regimen is not appropriate for all patients taking pirfenidone for the treatment of IPF. There are several anticipated adverse effects and individualized patient characteristics that require the attention of the prescribing physician.

In particular, the specified dose escalation regimen would not be tolerable for all patients [205]; pirfenidone is associated with adverse effects that require individualized assessment [206]; deviations from the regimen might be warranted due to “dietary habits, experienced nausea, a patient’s assessment of the adverse events and frailty” [207].

The main take-away is that whether the claim is to a method of medical treatment doesn’t turn just on the claim itself, but requires a fact-based analysis as to how the treatment is likely to be administered in practice. The question isn’t whether the claim specifies a fixed dosage, but whether a fixed dosage will actually be administered in all cases. This is a novel holding. I wouldn’t say it is a departure from prior law. Rather, the prior cases have implicitly assumed that patentability is determined by the nature of the claimed subject-matter. That is, a claim to “the use of X to treat disorder Y” was considered to be patentable subject-matter, even if the use might be discontinued in practice. That assumption has now been disrupted.

A few observations:

1) This means that you can’t tell by reading the patent whether it claims patentable subject-matter. The question, on Manson J’s analysis, is whether it interferes with the physician’s skill and judgment in fact, not in principle. I find this odd for an attack that turns ultimately on whether the claimed subject-matter falls within a category specified in s 2. In Harvard Mouse 2002 SCC 76 [172], the SCC held higher life forms to be unpatentable in part because of concerns that “innocent bystanders” might inadvertently infringe through adventitious entry (see Harvard Mouse 2002 SCC 76 [172]. Under a fact-oriented approach, we might say that higher life forms are unpatentable if and only if the particular claimed form is likely to escape from the owner adventitiously. Of course, other validity attacks, such as obviousness or anticipation, turn on the facts, so it’s not objectionable in principle that validity should turn on the facts of the case, but it nonetheless seems strange to me for that to be true for subject-matter, though I can’t put my finger on exactly why.

2) The factual inquiry as to whether individualized assessment is necessary either radically disrupts established law or relies on an arbitrary distinction. For example, it is well established that “X for treatment of disorder Y” is patentable subject-matter: Wellcome / AZT 2002 SCC 77 [50]. From the little I know, in fact even AZT requires individualized assessment, eg if tolerance develops. More generally, I suspect that there are very few if any drugs that are well tolerated by 100% of the population and do not require any individualized assessment. If Manson J’s fact-based analysis is generally applicable, as suggested by his statements at [195], claims of the form “X for treatment of disorder Y” are unpatentable if it can be established on the facts that individualized assessment is necessary, or that some patients cannot tolerate the drug at all. If accepted, that would be a revolution in the law, resulting in the invalidation of many valuable patents. I can't imagine it would be very difficult to establish the factual basis for this kind of attack on a use claim, so I expect we will see it in due course. It will be interesting to see what happens.

An alternative would be to say that the fact-based inquiry applies only to claims to a fixed dosage or fixed dosage schedule: Manson J’s remarks at [195] were general, but his statement at [197] was more specific to those types of claims. In that case, the “rule” would be that “X for treatment of disorder Y” is patentable subject-matter regardless of whether individual deviations might be required, but “X for treatment of disorder Y at a fixed dosage” is patentable only if individual deviations are never required. Such a distinction strikes me as entirely unprincipled—though admittedly not more unprincipled than most of the distinctions in this area.

3) Manson J’s basic point was that the claim is unpatentable if it “prevent[s] or restrict[s] physicians from applying their skill and judgment.” This is the usual rationale for the restrictions on methods of medical treatment in the Federal Court caselaw. The difficulty with this rationale is that it isn’t consistent with the patentability of claims of the type “X for treatment of disorder Y.” As I noted in a previous post, the claim at issue in Wellcome / AZT was to a formulation comprising “an effective amount” of AZT ('277 claim 22). In the context of a use claim without any specific dosage regime, that effective amount must be determined by the physician in the exercise of their skill and judgment. Indeed, the SCC expressly held that the claims at issue were not unpatentable methods of medical treatment on the basis that the physician was left free to exercise her skill and judgment: “How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession” [50]. If claims of the form “X for treatment of disorder Y” don’t restrict physicians from applying their skill and judgment, then I don’t see how claims of the form “X for the treatment of disorder Y according to fixed dosage regimen” are any different. Adding Manson J’s point that an individualized assessment may be required to decide whether the claimed use is appropriate doesn’t make it any easier to reconcile this holding with Wellcome / AZT. To paraphrase, “How and when, if at all, [the claimed fixed dosage regimen] is employed is left to the professional skill and judgment of the medical profession.” That is precisely the reason given by the SCC in Wellcome / AZT for holding the claimed use was not a method of medical treatment and I can’t see how the point is any different when a fixed regimen is claimed instead of a use.

In making these observations I mean no criticism of Manson J, who had the unenviable task of applying incoherent principles in an inconsistent area of law. As the Court of Appeal has recognized, and as Manson J recognizes in this decision [195], the law relating to what constitutes an unpatentable method of medical treatment is confused and inconsistent at best. Manson J’s basic point that a claim is unpatentable if it encroaches on the skill and judgment of physicians strikes me as unpersuasive, but it is certainly not new: see eg Janssen / galantamine 2010 FC 1123 [55]. Indeed, it is the main justification for the rule against patentability of methods of medical treatment. With that said, the fact-based analysis undertaken by Manson J adds a new twist to an already twisted area of the law. It will be interesting to see what happens if someone tries to run this kind argument in respect of a more standard claim to “X for the treatment of Y.” I doubt that argument would succeed, but given the state of the law, anything is possible.

More broadly, this decision illustrates how incoherent this area of the law is. It also shows that the issue isn’t going to go away on its own. We will be facing incoherent and inconsistent decisions on this issue until the Court of Appeal takes it up. In Hospira, the FCA articulated a willingness to do so in the appropriate case. I rather doubt that this will be the case, given the holding on obviousness, but this will be worth keeping an eye on if it goes to the FCA.

Patentable Subject-Matter and Combinations

Apotex Inc v Janssen Inc 2021 FCA 45 Locke JA: Webb, Boivin JJA affg Janssen Inc v Apotex Inc 2019 FC 1355 Phelan J

            2,661,422 / abiraterone acetate & prednisone / ZYTIGA / old NOC

In this decision Locke JA for the FCA has affirmed Phelan Js decision under the old NOC regulations that Janssen’s 422 patent, to a combination of abiraterone acetate and prednisone for the treatment of a prostate cancer, to be valid and infringed by Apotex’s APO-ABIRATERONE product: see here and here for discussion of Phelan J’s decision. Locke JA's decision on appeal is relatively brief, but there are important developments in respect of demonstrated utility, a significant clarification of the obvious-to-try analysis, as well as observations on patentable subject-matter as it relates to combinations.

In this post I’ll outline the facts and discuss patentable subject-matter: the key point is simply that there is an open question as to whether a synergistic effect is required for a combination to constitute patentable subject-matter.

The technology is complicated [6], and I’m not sure the facts outlined below are entirely accurate, but I believe it is good enough to understand the issues. 

Facts

The invention relates to a treatment for prostate cancer, in particular a combination of abiraterone acetate and prednisone. Testosterone, produced primarily in the testes, was known to promote the growth of cancer cells. The primary treatment for prostate cancer was therefore suppression of androgens, specifically testosterone, in the testes. [7] However, testosterone is also produced in the adrenal gland, and patients will often see a resumption in the progress of their cancer even after testicular androgen production is suppressed. This is known as castration resistant prostate cancer (CRPC) [7].

It was known that CRPC could be treated by suppressing residual androgen production in the adrenal gland using adrenal androgen inhibitors, such as ketoconazole (KC) and aminoglutethimide (AG) [8]. However, the adrenal gland also produces other hormones, such as glucocorticoids, and suppression of androgen production in the adrenal gland could cause serious side effects due to suppressed glucocorticoid production [8]. Consequently, glucocorticoid replacement therapy, by co-administration of a glucocorticoid, such as prednisone and dexamethasone, was known to be desirable to minimize the side effects [9].

Abiraterone acetate (AA) was a known adrenal androgen inhibitor, though it seems to have been relatively new at the relevant time. It was known to have a different mechanicism of action from KC and AG, and consequently was not expected to require glucocorticoid replacement therapy [10]. The 422 patent claimed the combination of AA and prednisone for the treatment of prostate cancer [FC 38]. Apotex is seeking to market AA, but the product monograph will instruct that it be used in combination with prednisone, so inducing infringement [55]–[58] if the claims are valid.

On validity, Apotex argued (inter alia) that administering prednisone with an adrenal androgen inhibitor was known to be desirable, AA was an adrenal androgen inhibitor, and so it would be obvious to administer prednisone in combination with AA. Phelan J rejected this on the basis that AA’s different mechanism of action meant that it was not obvious that AA would have side effects that would require glucocorticoid replacement therapy with prednisone [FC 197]. This is even though, as it turns out, AA does have side effects, and glucocorticoid replacement therapy is required, and that is in fact why prednisone is administered in combination with AA in clinical practice today [5].

Even so, just throwing in prednisone along with AA would not constitute invention. Janssen argued that the combination was inventive because the inventors had discovered that, surprisingly, prednisone was useful in combination with AA because of synergistic anti-cancer effects, and not merely to treat side effects. Phelan J found that even though prednisone is in fact co-administered primarily to treat the side effects, there is a scintilla of synergistic effect [221].

As I noted in my post on Phelan J’s decision, “The result is that Janssen is able to prevent Apotex from marketing abiraterone in combination with prednisone to control side effects, on the basis of a mostly wrong ‘discovery’ that prednisone acts synergistically with abiraterone.”

Patentable Subject Matter

As discussed here, at first instance Phelan J indicated that in the case of a combination invention there is a requirement for a synergistic effect as a matter of “patentable subject matter” [132]. In my post I had suggested that any requirement for synergy in a combination should be addressed as a matter of obviousness, and not by a distinct requirement of patentable subject matter. Janssen made a similar argument in the FCA [21]. Locke JA remarked that the argument “is an interesting one,” but “this is not the case to decide the issue,” as Phelan J had accepted that there was a synergistic effect, and the point would not affect the outcome [22]. This is very welcome, as it shows that there is a live issue as to whether there is a separate subject-matter requirement in respect of combination inventions. The point can therefore be addressed in a suitable case without assuming that the law is settled.

While that’s all that can be drawn from this decision, I can’t resist the urge to elaborate on the issue. As I understand it, when patentable subject matter arises as a separate requirement, it means that the claimed subject-matter is of a nature that it cannot be patented, even if it is new, useful, non-obvious and fully disclosed. That was the case, for example in Harvard Mouse 2002 SCC 76, where a claim to an a “transgenic mouse” was held to be unpatentable, even if it was new, useful, inventive and fully disclosed. Similarly, it is substantively controversial whether methods of medical treatment—such as a claim of the form “use of compound X in range from A to B to treat disorder Y”—are patentable subject-matter, but the debate itself turns on the same concept of patentable subject-matter as Harvard Mouse; whether claims to subject-matter of that nature are unpatentable, even if the claimed subject-matter is new, useful and non-obvious.

I have difficulty seeing that kind of issue here. I think it is clear that a combination of the type claimed in this case may be patented. For example, suppose the cause of castration resistant prostate cancer was entirely unknown, and in a scientific breakthrough the inventors had discovered that the source was adrenal androgen production; they realized that AA could inhibit that production, and they also did enough testing to discover the side-effects, and realized that adding prednisone would relieve those side effects. On those facts, the combination of AA and prednisone would be new, useful and inventive, and I think it is uncontroversial a claim of exactly the same form as was at issue in this case would be patentable subject-matter. If that is right, then the objection on the facts in this case is not based on the same type of subject-matter objection that was addressed in Harvard Mouse. Another type of subject-matter objection is the rule against abstract claims, set out in s 27(8); but the claims in this case are clearly not abstract. So if there is actually a subject-matter objection here somewhere, it is of an entirely new type. As suggested in my previous post, rather than making up a new kind of subject-matter objection, the better way to proceed is treat the matter as a question of obviousness.

Locke JA also remarked that “An aggregation is problematic because it does not provide more than was already available to the public,” and in this case “there is no dispute that the combination in issue provides improved results over what was previously known” [23]. This seems right to me on the facts of the case, but I would suggest that the question should be simply whether the combination was obvious; this implies that while improved results are relevant — a combination that gives exactly the same results as the individual components is unlikely to be inventive—but it is not necessarily determinative. It may be obvious that the combination will give improved results, as when an adjuvant is used in combination with a vaccine, but that does not mean that the combination of a well-known adjuvant with an existing vaccine is inventive. Alternatively, it may be obvious to use the combination for other reasons, and the improved results is a “golden bonus” that does not transform the obvious into the non-obvious. In either of these scenarios, the claimed invention might be obvious even though it gives improved results.

On appeal, Apotex argued that in the case of a combination invention, the comparison should not be with the results of either drug alone, but with “the sum of the two component drugs” [19]. I’m not sure I understand this argument, which was set out only briefly, and in any event Locke JA rejected it [22]–[23].

CIPO's Approach to Patentability of Computer-Implemented Inventions

 Choueifaty v Canada (Attorney General) 2020 FC 837 Zinn J rev’g and remanding CD 1478

            Application 2,635,393

The vexed issue of patentable subject matter has reared its head once again. Choueifaty applied for a patent for a computer-implemented method for selecting an investment portfolio with the lowest level of risk for a given return [CD 25]; in brief, a computer-implemented business method. CIPO, applying its problem-solution approach to claim construction set out in MOPOP 12.02.02e [13], determined that the “essential elements” of the invention “are directed to a scheme or rules involving mere calculations used to construct the anti-benchmark portfolio and thus not directed to patentable subject matter” [CD 52], [16]. In CIPO’s view, the computer itself was not an essential element; had it been, the claim would have been allowed [17]: PN 2013-03.

In a brief decision, Zinn J reversed on the basis that the problem-solution approach is not the correct way to determine the essential elements of the claim; rather, the approach set out by the SCC in Whirlpool 2000 SCC 67 and Free World 2000 SCC 66, must be used [40]. CIPO relied on Genencor 2008 FC 608 for the proposition that the Whirlpool test is not applicable to patent examiners [34]. In light of the subsequent FCA decision in Amazon 2011 FCA 328, [43] which expressly held that CIPO must use the Whirlpool approach, Zinn J held that Genencor “is no longer good law” [35]. Zinn J therefore remitted the application to the Commissioner for reassessment in accordance with his reasons.

In my view, Zinn J’s decision is entirely correct so far as it goes, but in this post I want to step back and take a brief look at the bigger picture.

Restrained Approach to Patentability of Methods of Medical Treatment

Biogen Canada Inc v Taro Pharmaceuticals Inc 2020 FC 621 Manson J

            2,562,277 / fampidrine sustained release / FAMPYRA / NOC action

The claims at issue in the 277 patent were to the use of sustained release fampidrine for improving walking in a person with multiple sclerosis (MS) for a time period of at least two weeks at a unit dose of 10 mg twice daily” (Claim 17 is exemplary: [22]). These were attacked as being to an unpatentable method of medical treatment. The topic of the patentability of methods of medical treatment is incoherent, with authorities taking a variety of inconsistent positions, as I discuss here. The area is in need of thorough review, as the FCA has noted in Hospira 2020 FCA 30 [51-53], and Cobalt v Bayer 2015 FCA 116 [101]. In this case Manson J declined to follow some authorities that aggressively applied a rule against patenting of methods of medical treatment. This strongly suggests that Manson J favours a more moderate position.

In this case, the defendants drew analogies to Mylan 2010 FC 1123 and Novartis 2013 FC 985 aff’d 2014 FCA 17 in which similar claims had been held invalid. Manson J rejected these analogies, but without exactly distinguishing the cases. Dealing with Mylan, he effectively accepted the analogy — “I agree with the Defendants that the 277 Patent claims the use of a known compound for an established purpose using a known treatment methodology” [206] — but he noted that the claims at issue in Mylan would have been obvious, and he indicated that that was the more appropriate basis for the decision: “these general facts formed the basis of the obviousness finding, above. I do not agree that they also ground a separate finding of invalidity on the basis of unpatentable subject matter” [206]. Since Mylan itself was expressly decided on the basis that the claims at issue were directly to unpatentable methods of medical treatment, this seems to be a polite way of saying that he would not follow the holding in Mylan (which is of course not binding).

Dealing with Novartis, Manson J noted that “The Federal Court of Appeal summarily dismissed the appeal [in a four paragraph decision], finding that in order to allow the appeal, it would be necessary to conclude in the face of Tennessee Eastman that a method of medical treatment is patentable subject matter, or conclude that the Federal Court had misconstrued the patent” [208]. That is an entirely accurate description of the holding in Novartis FCA, but it is not clear how it distinguishes the case. Perhaps the suggestion is that the FCA did not fully consider the issue?

Manson J concluded that “I . . . do not accept the Defendants’ argument that Mylan and Novartis stand for a general proposition that any patent claim to ‘how and when’ a drug is administered covers unpatentable subject matter” [211]. That’s fair enough, but he didn’t explain what they do stand for.

I’m not faulting Manson J in this respect. The jurisprudence in this area is incoherent, and there are other authorities to the opposite effect that Manson J might have cited if he been inclined to delve more deeply into the issue. Because of the conflicting case law, there are a range of positions that might be justified, depending on which line of authority a judge chooses to follow. Overall, Manson J’s treatment of these cases strongly suggests that he favours a moderate position and is not inclined to be aggressive in invalidating patents on this basis.

Patentability of Methods of Medical Treatment “Deserves Deep Analysis”

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research 2020 FCA 30 Locke JA: Rivoalen, Nadon JJA var’g 2018 FC 259 Phelan J
            2,261,630 / infliximab / INFLECTRA

Kennedy Trust’s 630 patent covers the adjunctive use of methotrexate [MTX] and infliximab for the treatment of rheumatoid arthritis [RA] in patients who do not respond fully to MTX alone. As discussed here, Phelan J at first instance held that Hospira’s infliximab product INFLECTRA, infringed several valid claims of the 630 patent. This appeal, reversing Phelan J on several points, raises a number of interesting (and mostly unrelated) issues, which I'll cover in a series of posts, starting, in this post, with the FCA's desire to reform the law related to patentability of methods of medical treatment.

As I argued in this blog post, the law related to patentability of methods of medical treatment is incoherent. In Cobalt v Bayer 2015 FCA 116 [101], the FCA agreed that the current law on the issue “calls for full consideration by this Court or the Supreme Court in a case where the issue is squarely raised on the facts.” However, the issue was moot in Cobalt because the patent was not infringed [100], and the FCA devoted only a single paragraph to the issue.

In this case, Hospira again raised arguments related to patentability of methods of medical treatment. Locke JA devoted several paragraphs to reviewing the state of the law. He summarized the Federal Court jurisprudence as holding that a claim to “a substance intended for the treatment of a medical condition, can be good subject matter for a patent claim, but not if the claim encompasses the skill of a medical professional such as a dosage range rather than a fixed dosage” [51]. He remarked that “it is not clear to me that the decisions of the Supreme Court of Canada that form the basis of the principle that methods of medical treatment are not patentable justify a distinction between a fixed dosage (or interval of administration) and a range of dosages (or intervals)” [52]. He then cited Cobalt (and also my blog post, I am pleased to say) and stated that “I agree that this issue deserves deep analysis” [53]. He concluded by saying that “[u]nfortunately, this does not appear to be the case for such an analysis,” because the claims at issue are of a type that are clearly patentable even in the current state of the law.

I read this as a clear signal that the FCA is willing, and even eager, to undertake a review of the law on this issue itself, rather than leaving the matter to the SCC. Locke JA considered it “unfortunate” that the case did not lend itself to treating the issue in depth, and he clearly stated that he does not consider the current law to be determined by the SCC jurisprudence, so leaving leeway for the FCA. Even the fact that Locke JA devoted almost four pages to the issue indicates the FCA wants to deal with the issue. Hospira raised so many issues on appeal that “it will not be practical to address each one specifically,” so Locke JA generally did not address those that were without merit [15]. He did, nonetheless, choose to address methods of medical treatment at some length, even though it was ultimately without merit. The panel in this case was differently constituted from that in Cobalt (Pelletier, Stratas and Webb JJA), so we now have six judges on two different panels indicating a willingness to review the law related to the patentability of methods of medical treatment.

US Solicitor General Calls for Reconsideration of Mayo v Prometheus

Hikma Pharmaceuticals v. Vanda Pharmaceuticals, 16-2707, 1887 F3d 1117 (Fed Cir 2018) petition for certiorari No 18-817
            US 8,586,610

The patentable subject-matter jurisprudence of the Supreme Court of the United States is a train wreck of historic proportions. In the brief of the United States recommending that the Supreme Court of the United States deny certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals, 16-2707, 1887 F3d 1117 (Fed Cir 2018). the US Solicitor General has joined the chorus of voices calling for reconsideration of SCOTUS’s framework for assessing patentable subject-matter, especially as set out in Mayo v Prometheus 566 US 66 (2012) (hat tip to Patent Docs).

The 610 patent relates to the use of iloperidone to treat schizophrenia. The drug was already known for that use, but the inventors had discovered that people with a specific genetic variant, the “CYP2D6 genotype,” did not tolerate it well. The representative claim 1, in effect claimed testing a patient for the CYP2D6 genotype and administering a reduced dose to those who did not tolerate the drug. As pointed out by Patently-O, the claim at issue in Hikma v Vanda is substantively very difficult to distinguish from the diagnostic method claim at issue in Mayo. However, in Hikma it was framed as a method of treatment claim—”A method for treating a patient” comprising testing and then administering iloperidone at a low or high dose according to the results—while in Mayo the claim was to “A method of optimizing therapeutic efficacy for treatment” of the disorder at issue, comprising a step of “determining the level” of the relevant analyte, such that the result “indicates a need” to increase or decrease the drug. In the Fed Cir, the majority in Hikma nonetheless held the claim to be patentable subject matter, distinguishing Mayo on the basis that in Hikma the claims include specific treatment steps rather than merely directing the physician to consider the test results. Prost CJ, in dissent, was of the view that Mayo was not distinguishable.

In its brief, the Solicitor General has now argued that cert should be denied, on the basis that the majority had gotten the right result on the facts (21). However, the Solicitor General (12-13, 15) acknowledged the force of Prost CJ’s logic. More importantly, the Solicitor General did not confine itself to the particular claim at hand. Throughout the brief, the Solicitor General emphasized that the logic of Mayo calling into question the patentability of many types of inventions that have long been considered to be unquestionably good subject matter:

Nevertheless, as evidenced by the dissenting opinion below, it is arguably unclear how the longstanding and entirely correct rule that method-of-treatment claims are patent-eligible can be reconciled with mechanical application of Mayo’s two-step framework. (10)

Indeed, it is arguably unclear whether even a method of treating disease with a newly created drug would be deemed patent-eligible under a mechanical application of Mayo’s two-part test. (14, original emphasis).

The brief as a whole is a sustained critique of Mayo. The question is not if Mayo should be reviewed, but when; the brief argues that this is not the right case to address the “confusion” caused by the recent SCOTUS jurisprudence: “instead should provide additional guidance in a case where the current confusion has a material effect on the outcome,” in particular a diagnostic method case such as several where the Fed Cir has indicated that it might have gone the other way but for Mayo.

I wonder if the Solicitor General has another motive in recommending that cert be denied in Hikma. While the Solicitor General is of the view that Mayo needs to be rolled back, it’s not evident that SCOTUS will agree. If they take a diagnostic methods case and affirm that diagnostic methods are unpatentable, this would be bad, but only in the same way that the status quo is bad. If they took Hikma and reversed it, holding Mayo really does apply, the situation would be even worse than it is already.

I won’t say more than that: Patent Docs provides a longer review, and the brief itself is well worth reading for those with a real interest. (I might quibble with the analysis a little bit; the brief suggests that the root of the problem is Bilski, which marked a sharp departure from prior SCOTUS jurisprudence when it added expressly non-statutory exceptions to patentability (4, 8). In my view, the roots of the problem go deeper, back to Funk Bros: see The Rule Against Abstract Claims: A Critical Perspective on US Jurisprudence, (2011) 27 CIPR 3. But this is a minor point: I do agree that Bilski was a turning point and turning the clock back that far would be an improvement.)

Unfortunately, this debate remains relevant in Canadian law. The modern SCOTUS approach is clearly inconsistent with Shell Oil [1982] 2 SCR 536, the leading SCC decision on patentable subject matter. Unfortunately, CIPO has gone its own way on the issue of patentable subject matter, and diagnostic methods in particular, apparently inspired by US case law. It seems inevitable that the issue will be litigated in Canada, and when it does, the Solicitor General’s brief should give Canadian courts fair warning that the SCOTUS jurisprudence should not be followed.

Expanded State of the Art Circumvents Inquiry re Inventiveness of Selection

Janssen Inc v Apotex Inc 2019 FC 1355 Phelan J
            2,661,422 / abiraterone acetate & prednisone / ZYTIGA / old NOC

My last post outlined the unusual facts in this case, and discussed the overarching problem that arose. This post looks at a few points of legal interest that were raised, though none impacted the final decision. Briefly, Phelan J’s claim construction analysis reflects the ongoing debate as to whether it is always appropriate to look to the disclosure in construing the claims, or only if the claims are ambiguous; the obviousness analysis illustrates a problematic consequence of the holding in Ciba v SNF 2017 FCA 225 [51]-[63], that the state of the art for the purpose of an obviousness attack comprises all the prior art; the “patentable subject matter” analysis is, in my view, properly part of the obviousness analysis; and the utility analysis raises the question of what the SCC meant when it said in AstraZeneca 2017 SCC 36 [55] that the utility must be “related to the nature of the subject-matter.”

(As an aside, Phelan J uses the abbreviation “POS” to refer to a person skilled in the relevant art. I’m not sure I can endorse that abbreviation, given its slang meaning.)

Claim construction
Phelan J’s claim construction analysis reflects the ongoing debate over whether it is always appropriate to look to the disclosure in construing the claims, or whether recourse to the disclosure is permissible only if the claims are ambiguous when read on their own: see eg here, here and here.

Claim 3 is representative of the asserted claims [38]:

3. Use of a therapeutically effective amount of abiraterone acetate or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of prednisone, for the treatment of a prostate cancer in a human

Janssen argued that the claim should be construed as requiring that the combination be effective for treating cancer [117], which would encompass a combination where prednisone was used only to address side effects. Phelan J rejected this argument, holding that on a plain reading of the claim, anti-cancer efficacy of the prednisone itself was required.

The point of interest arises because the construction ultimately adopted by Phelan J was express in the disclosure: “[T]he amount of the additional anti-cancer agent [prednisone]. . . is an amount that is sufficient to treat the cancer whether administered alone or in combination with [abiraterone]” [Disclosure ¶ 44]. Phelan J nonetheless came to his conclusion without recourse to the disclosure: “Even if there was some confusion or ambiguity, recourse to the Disclosure confirms as reference that the amount of inhibitors or of steroid is an amount sufficient to treat cancer, whether administered alone or in combination. However, there is no need to refer to the Disclosure” [125, my emphasis]. This implies that Phelan J is of the view that recourse to the disclosure is improper unless the claims are ambiguous when read on their own. This is even though Phelan J, at the same time, considered it “essential” to refer to the express definitions set out in the disclosure at [23]-[33]. My own view is that it is always appropriate, and I would suggest that referring to the statement in [44] of the disclosure is no more or less appropriate than referring to the definitions set out ten paragraphs earlier. The point would have been truly interesting if Phelan J had arrived at the contrary construction without relying on the disclosure; but since the express statement in the disclosure confirmed the construction he had arrived at for other reasons, the issue was moot.

Patentable subject matter
Under the heading “Patentable Subject Matter” [128] - [142], separate from obviousness and utility, Phelan J held that “[t]o be a patentable combination, the 422 Patent must claim a combination with effects different from the sum of the effects of the elements” [132, original emphasis], citing R v American Optical Co [1950] Ex CR 344, 13 CPR 87 at 98-99 and Eli Lilly Canada Inc v Apotex Inc 2018 FC 736 at paras 71-72.

I have two concerns. First, it appears that Phelan J may be saying that the synergistic effect must be specified in the claims: “[t]he issue regarding patentability of the subject matter is whether the 422 Patent reads from the perspective of the POS as claiming a combination with synergistic effect or effects beyond those of either component drug” [132]; “[f]or the claimed combination to be patentable, the Asserted Claims supported by the disclosure of the 422 Patent from the perspective of a POS must claim that the combination of AA [abiraterone] and PN [prednisone] has a greater effect than either component alone” [133]. If that is what he is saying, it is not supported by the cases cited, which merely say that is essential to validity that “the combination should lead to a unitary result, and that such result should be different from the sum of the results of the elements” Eli Lilly [72], citing American Optical which is to the same effect.

The second point is one I have already expressed in my post on Eli Lilly here, but I’ll be a bit more direct. There is no requirement of “patentable subject matter.” The requirement is a matter of obviousness: “The real and ultimate question is: Is the combination obvious or not?: Albert Wood & Amcolite Ltd v Gowshall Ltd (1937) 54 RPC 37 at 40 (CA), quoted with approval in Wandscheer [1948] SCR 1 at 12; Bridgeview 2010 FCA 188 [51]. In most cases the result will be the same either way. If I take ibuprofen for my sprained ankle and calcium carbonate for my heartburn, and all that happens is that the pain in my ankle subsides, exactly as it would have with ibuprofen and no calcium carbonate, and my heartburn goes away, exactly as it would have with calcium carbonate and no ibuprofen, then there is no inventive step in putting the two together; to claim the combination would be a matter of arbitrary selection. But the issue really should be treated as a matter of obviousness, because there is a large body of law addressed to obviousness, and re-creating that law under a different name to address combinations cannot help, and it has the potential to do harm if the so-called law of collocation diverges from the established law of obviousness.

State of the art for the purpose of an obviousness attack
Under the “old” Patent Act the body of prior art that may be set up against the patent in an obviousness attack — the “state of the art” — did not include all publicly available information that could be set up in a novelty attack, but only that which was generally known to a person skilled in the art or which would be discovered in a reasonably diligent search. As Hughes J noted in Merck v Pharmascience 2010 FC 510 at [37], there is a “quaere” as to whether codification of the obviousness requirement in s 28.3 of the new Act, which requires a person skilled in the art to have regard to information “available to the public” as of the claim date —the same language used in respect of novelty in s 28.2— has changed the law in this respect, so that all publicly available prior art may be used in an obviousness attack, regardless of whether it would have been discovered by a reasonably diligent search. In my article, ‘What is the State of the Art for the Purpose of an Obviousness Attack?’ (2012) 27 CIPR 385, I reviewed the debate. Subsequently, as discussed here, in Ciba v SNF 2017 FCA 225 [51]-[63], the FCA, per Pelletier JA and Rennie JA, with Woods JA expressing no opinion on this point, held that the new s 28.3 had indeed changed the law, so that the state of the art for the purpose of an obviousness attack does indeed encompass all prior art that is available in a novelty attack.

Janssen Inc v Apotex is one of the few cases so far to actually consider this point in the obviousness analysis, with Phelan J accepting that the FCA in Ciba “confirmed that Apotex can choose the prior art elements that make the 422 Patent obvious as long as they were publically available prior to [the filing date]” [164].

The application to the facts illustrates a significant shortcoming of the new rule. The general problem facing the inventors was that “the primary treatment for metastatic prostate cancer has been androgen deprivation therapy [ADT] through medical or surgical castration to suppress androgen production in the testes” [17]. Unfortunately, in some instances the cancer would become castration resistant and the cancer would continue to progress [18]. The invention, to combine abiraterone acetate, which is a CYP17 enzyme inhibitor, and prednisone, with a putative synergistic effect, was aimed at addressing this problem. It appears that Janssen wanted to argue that focusing on a CYP17 inhibitor was itself inventive, as the mechanism for castration resistance was not known at the time, and there were multiple theories where a large number of different experimental compounds, representing different approaches, were being tested at the time [73]-[74], [148]. As I read this decision, this line of argument was effectively foreclosed because Apotex was able to base its attack on the specific prior art documents that focused on CYP17 inhibitors and abiraterone, without ever having to establish that these were part of the common general knowledge [164].

This means that the obviousness question turned from something like ‘Was it obvious to focus on CYP17 inhibitors?’ to ‘Given a focus on CYP17 inhibitors, was it obvious to combine a CYP17 inhibitor, specifically abiraterone, with prednisone?’ These are very different questions and one might easily imagine that the answer to the former is “No” at the same time that the answer to the latter is “Yes.” In that case, a combination that would not in fact have been obvious to a person skilled in the art because it was not obvious to select one of the components, might nonetheless be found to be legally obvious, because the question of whether it was obvious to select that component never arises. That strikes me as wrong in principle.

With all that said, on these facts the difference in these questions didn’t matter, as Phelan J found that even starting with abiraterone, it would not have been obvious to combine it with prednisone [192]. (I would also note that on the facts, it is not clear that it would have been non-obvious to select abiraterone as a starting point; given his holding on the law, Phelan J did not have to make that determination.)

(As an aside, at [97] Phelan J says “[t]he relevant date for obviousness . . . is the common general knowledge as of the Filing Date, August 23, 2007," and at [164] he states that it is proper to consider all prior art available prior to August 23, 2007— again, the filing date—and then he does go on to consider prior art that does appear to post-date the claim date. This is even though s 28.3(b) provides that the relevant date is the claim date, the patent’s “priority filing date based on a US Patent was August 25, 2006" [7], and priority does appear to have been claimed. I’m clearly missing something.)

Utility
Finally, in assessing utility, Phelan J required that there be a scintilla of utility in the sense of a synergistic effect, such that the combination has a greater effect than either abiraterone or prednisone on its own: see eg [219]-[221]. The alternative would be to ask whether there was a scintilla of utility in the sense that if the combination is given to a person suffering from prostate cancer, it has a scintilla of utility in treating that cancer—without requiring any synergistic effect. The question is what the SCC in AstraZeneca 2017 SCC 36 meant when it said that the utility must be “related to the nature of the subject-matter” [55]. I won’t go on about this, given this is already a very long post, but I will say that I consider it very much an open question as to whether a synergistic effect is required in a case such as this one. I am inclined to think it is not, and the question of synergy or lack thereof is really a matter that should be confined to the non-obviousness inquiry. The SCC in AstraZeneca at [55] went on to explain that “a proposed invention cannot be saved by an entirely unrelated use. It is not sufficient for an inventor seeking a patent for a machine to assert it is useful as a paperweight.” Even without a synergistic effect, the use of the combination to treat prostate cancer is clearly related to a claim “for the treatment of a prostate cancer in a human”; it is far removed from claiming the use of the compound as a paperweight, or landfill. Requiring a scintilla of a synergistic effect links utility to the inventive concept; that may be problematic, given how tricky it can be to identify the inventive concept. It also strikes me as unnecessary, as the need to establish synergy can be adequately addressed in the context of non-obviousness. With that said, perhaps a different set of facts will shed a different light on the issue. In this case, the point didn’t make any difference, as Phelan J held that there was evidence of a scintilla of a synergistic effect [221].