"Foreign Prosecution History Is Inadmissible"

Gemak v Jempak 2020 FC 644 Lafrenière J

            2,276,428 / 2,337,069

After a decade in which it was almost unheard of for the Federal Court to grant a contested motion for summary trial or summary judgment in a patent case, it seems they are now raining down upon us, with Lafrenière J’s summary judgment decision in Gemak v Jempak following Manson J’s decisions in Viiv v Gilead 2020 FC 486 (here) and Canmar 2019 FC 1233 (here). Lafrenière J’s decision in this case is a good example of summary judgment being used to dispose expeditiously of a far-fetched claim construction argument. It is also notable for holding expressly that foreign prosecution history is not admissible under s 53.1. This is in tension with Manson J’s holding in Canmar that foreign prosecution history should be admissible, albeit only in “extraordinary circumstances” [73], [74], [77].

Gemak’s 428 patent at issue was to a dishwasher detergent pod. These pods commonly use percarbonate as a bleaching agent which is activated on exposure to water. Percarbonate is susceptible to degradation by contact with other detergent ingredients or by moisture. For that reason, the percarbonate must be coated to protect it prior to actual use of the pod. Claim 1 is representative [13]:

A detergent composition comprising a granulated percarbonate and a blend which encapsulates the percarbonate, the blend comprising . . . carboxymethyl cellulose [CMC]

Jempak’s detergent pods included percarbonate encapsulated in a protective coating. It was not really disputed that the use of CMC was an essential element of the claim [119]. It was also established that the protective coating used by Jempak did not comprise CMC. Gemak’s main argument was that CMC was present in the other detergent ingredients in Jempak’s pods, and that once the pod was assembled, the CMC in the other ingredients could adhere to the percarbonate coating, and that the resulting coating with CMC adhering to it would constitute “a blend” comprising CMC which encapsulates the percarbonate [121]. Lafrenière J rejected this on the view that “encapsulation refers to a protective coating (a blend) that is applied to the percarbonate during its manufacture to maintain the stability of the percarbonate and to prevent it from decomposing prematurely before use” [123]. Gemak’s position was not helped by its “evasive and defiant” expert witness [104].

It strikes me that this is an excellent example of the kind of argument that should not be allowed to proceed to a full trial. The patent system is rife with the potential for abuse, in large part due to the cost and complexity of patent litigation. The cost-effective disposition of weak claims is essential to ensuring that the patent system encourages innovation, rather than impeding it.

The other notable point is that Jampak sought to adduce evidence of the US prosecution history. Lafrenière J refused to allow this evidence, in part because it was introduced too late [77] and in part because it would not assist the court [78]. But he also held expressly that “foreign prosecution history is inadmissible” under the new s 53.1 of the Act: [86], and generally [82]-[86]. This holding was primarily based on a straightforward textual argument:

[83] Subsection 53.1(1) provides that the prosecution history may be admitted into evidence in an action to rebut any representation made by the patentee regarding claim construction, but only when specific conditions are met. In particular, subparagraph 53.1(1)(b)(ii) provides that the communication must be between the applicant and “the Commissioner, an officer or employee of the Patent Office or a member of a re-examination board.”

[84] The definition of “Commissioner” is set out in section 2 of the Patent Act as meaning the Commissioner of Patents, who is appointed by the Governor in Council and exercises the powers and performs the duties conferred and imposed on that officer by or pursuant to the Patent Act. The Patent Office described in section 3 as an office attached to the Department of Industry, or to such other department of the Government of Canada as may be determined by the Governor in Council.

Further,

[86] There is a further presumption against the legislature impliedly changing established law, particularly the common law. If Parliament had intended that communications prepared in respect of the prosecution of the application for a foreign patent could be admitted, clearer language would be required to effect that result. In the circumstances, I conclude that section 53.1 did not change the existing rule, as enunciated in Free World Trust, that foreign prosecution history is inadmissible.

I made some similar points in my blog post on Manson J’s decision in Canmar 2019 FC 1233 [77], which held that in “extraordinary” circumstances foreign prosecution history should be admissible to aid in construction of the Canadian claims.

On the other hand, “[t]he language of section 53.1 is limited to communications between the patentee and the Canadian Patent Office” [70]. In particular, per s 53.1(b)(ii), the communication must be between the applicant and “the Commissioner, an officer or employee of the Patent Office or a member of a re-examination board.”

Further, prior to the enactment of s 53.1, it was clear law that “statements made during prosecution of Canadian patent applications or corresponding foreign patent applications were neither relevant nor admissible with respect to construing terms used in issued Canadian patents” [58]; and Free World 2000 SCC 66 [66]. As a matter of statutory interpretation, “[i]t is presumed that the legislature does not intend to make any change in the existing law beyond that which is expressly stated in, or follows by necessary implication from, the language of the statute in question”: R v T (V) [1992] 1 SCR 749, quoting with approval Maxwell on the Interpretation of Statutes; and see also Parry Sound v OPSEU [2003] 2 SCR 157 [39]. This implies that s 53.1, in providing for admissibility of communications to the Canadian examiner, did not change the existing rule that foreign prosecution history is inadmissible.

I’d say that someone owes me a beer.

In any event, there is evidently some tension with Manson J’s holding in Canmar that foreign prosecution history should be admissible, albeit only in “extraordinary circumstances” [73], [74], [77]. Lafrenière J did not directly discuss Manson J’s holding on this point.

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.

Making a Mosaic of Obscure Prior Art Is Permissible in Obviousness Attack under Hospira

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

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

As outlined in my last post, the 277 patent, owned by Acorda and licenced to Biogen, relates to the use of sustained release fampidrine for improving walking in a person with multiple sclerosis (MS). In this decision Manson J held the 277 patent, to be anticipated and obvious, ultimately because the inventors had themselves disclosed the invention in a financial filing prior to the claim date. My last post dealt with anticipation. This post deals with obviousness. This case is the first clear application of the FCA’s holding in Hospira that the state of the art for the purpose of an obviousness attack includes all prior art, not just that which would be reasonably discoverable. For convenience, I’ll refer to prior art that is not part of the cgk or reasonably discoverable, as “obscure prior art.” Importantly, Manson J appears to have been of the view that it is permissible to mosaic various pieces of obscure prior art.

The prior art included a financial filing referred to as Acorda S-1, that disclosed results from a small clinical trial undertaken by Acorda, the MS-F201 trial, as well as the protocol for a second trial that was planned (the MS-F202 trial) [36, 122]. This was held to anticipate. It was also invoked in support of obviousness, along with the Goodman References (also disclosing the same trials), and a publication reporting the pharmacokinetic properties of fampridine SR (“Hayes”). Given the very small gap between this prior art and claimed invention, the holding that the claims were obvious in light of these references followed fairly directly [181-200].

The key issue on obviousness was not bridging the gap between the prior art and the claimed invention, but whether the prior art references were properly part of the state of the art. In particular, it was not established that any of these references would have been part of the common general knowledge or discoverable in a reasonably diligent search. As Manson J noted, prior to codification of the non-obviousness requirement in s 28.3, “citable prior art for obviousness was limited to that which would have been found by the POSITA in a reasonably diligent search” [152]. However, in Hospira 2020 FCA 30 the FCA held that “it is an error to exclude prior art from the obviousness analysis simply because it would not have been located in a reasonably diligent search” [153]. Biogen objected to this as being contrary to the intent of s 28.3, but as Manson J pointed out, “The Federal Court of Appeal’s decision in Hospira is both clear and binding on this Court. Prior art will not be excluded from the obviousness analysis solely because the POSITA would not have found it after a reasonably diligent search” [154]. Consequently, Manson J considered the prior art at issue to be part of the state of the art for an obviousness attack, without consideration of whether it would have been reasonably discoverable [163-64, 166].

That much follows directly from Hospira. But there was an important point left open in Hospira, where the FCA stated (my emphasis):

[86] The likelihood that a prior art reference would not have been located by a PSA may be relevant to consideration of step 4 of the obviousness analysis (whether differences between the state of the art and the inventive concept constitute steps which would have been obvious to the PSA) in that the uninventive PSA might not have thought to combine that prior art reference with other prior art to make the claimed invention.

In my post on Hospira, I said the following:

This indicates that there can be no mosaicing of prior art that is not available in a reasonably diligent search. Thus, obviousness can be assessed over the common general knowledge alone, or over one item of broader prior art plus cgk, but not over two items of broader public art plus cgk. I believe that this is essentially the UK position.

In other words, I read Hospira as saying that while one element of obscure prior art could be combined with the traditional state of the art (cgk or material reasonably discoverable), it was not necessarily permissible to combine two elements of obscure prior art, on the view that a POSITA who did not know about a piece of obscure prior art would not think to combine it with another piece of obscure prior art which she also did not know about.

However, Manson J did not read this paragraph the same way. He stated

[193] Following the Federal Court of Appeal’s guidance in Hospira that it may be relevant to consider the likelihood that a prior art reference would not have been located by the POSITA at this stage of the obviousness analysis, I am satisfied that the POSITA would have combined the pharmacokinetic parameters taught in Hayes 2003 with the fixed doses of 10 mg bid taught in the Acorda S-1. Both references report information on the Elan fampridine SR composition, and the Acorda S-1 states that the pharmacokinetic characteristics of fampridine SR in subjects with MS had been established in earlier trials sponsored by Elan.

There was no suggestion that either Hayes 2003 of Acorda S-1 were part of the cgk or were reasonably discoverable: in light of Manson J’s holding that it was wrong to exclude prior art from the obviousness analysis for that reason, he simply never addressed the question.

Consequently, in Biogen v Taro, Manson J did mosaic two elements of obscure prior art. He was evidently of the view that the only inquiry mandated by Hospira [86] is whether the POSITA, with both elements of prior art in hand, would find it obvious to combine them.

Manson J’s interpretation of Hospira [86] is certainly reasonable, but I like to think my interpretation is reasonable as well, so it’s not clear, at least to me, what the FCA intended. Presumably the point will be clarified by the FCA soon enough. If Manson J’s reading is correct, then the state of the art available for an obviousness attack in Canadian law now goes beyond what is available in either the US or the UK (at least as I understand the law in those jurisdictions.)

Anticipation by Speculation Redux

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

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

In Biogen v Taro, Manson J held the 277 patent, owned by Acorda and licenced to Biogen, to be anticipated and obvious, ultimately because the inventors had themselves disclosed the invention in a publicly available financial filing prior to the claim date. The novelty analysis raised the issue of anticipation by speculation that was recently addressed by the FCA in Hospira 2020 FCA 30 (here), and the obviousness discussion is the first clear application of the FCA’s holding in Hospira that the state of the art for the purpose of an obviousness attack includes all prior art, not just that which would be reasonably discoverable. Manson J rejected the argument that the claims were directed to unpatentable methods of medical treatment. This post provides an overview and deals with anticipation.

MS is a chronic disease of the nervous system. Impaired walking is one of the most commonly reported MS symptoms [12], to the extent that a standard measure of the MS patient’s disability is scored in part on the patient’s ability to walk [13]. The 277 patent relates to the use of sustained release fampidrine for improving walking in a person with multiple sclerosis (MS) [109].

Acorda conceived the idea of developing fampidrine SR as a treatment for MS. It conducted a small (36 subjects) phase 2 clinical trial, referred to as MS-F201, using doses from 10-40 mg bid, with pre-established endpoints related to mobility, including a timed 25 foot walk. The study failed, in the sense that most of the pre-established endpoints did not show any statistically significant difference as compared to placebo [33]. After re-analysis (less politely, data mining), Acorda discovered that MS-F201 showed a nominally significant difference in walking speed (as opposed to the pre-established endpoint of walking time) [34]. Acorda therefore planned a further phase 2 study, MS-F202, to evaluate walking speed [34].

In an effort to garner public investment, Acorda filed a financial document, referred to as “Acorda S-1,” with the SEC [121]. Acorda S-1 was prior art against the 277 patent [121]. Acorda S-1 disclosed the results from the MS-F201 trial, as well as the protocol for the planned MS-F202 trial [36, 122], that had not yet been undertaken.

The key question is whether Acorda S-1 anticipated the 277 patent. This raised the same question of anticipation by speculation that was addressed by the FCA in Hospira 2020 FCA 30 (here):

[126] The main thrust of Biogen’s novelty argument is that use claims, such as those at issue in the 277 Patent, are inextricably linked with their utility such that they are inventive because they convey “new knowledge to effect a desired result”. In this case, the claimed invention is the knowledge that 10 mg bid of fampridine SR results in a statistically significant and clinically meaningful improvement in walking in MS patients with walking disability. Disclosure of the MS-F202 protocol alone, without disclosure of its results, does not satisfy the disclosure requirement of the anticipation analysis.

Manson J rejected this, holding that disclosure of MS-F202 study design was anticipatory even if it had not actually been performed as the relevant time (citations omitted):

[138] Despite the lack of results from the MS-F202 study, the disclosure requirement is satisfied if performing what is described in the prior art reference would necessarily result in infringement. Performing the MS-F202 study protocol would necessarily result in infringement of the 277 Patent, and hence the disclosure requirement is satisfied for claims 17, 18, 31, and 32.

In this respect, as Manson J noted, the reference to MS-F202 “is similar to the allegedly anticipatory art in Hospira [2020 FCA 30]” [133]. I agree with Manson J that the cases are similar on this point, and I think he was bound to follow Hospira. (My sense is that Manson J agreed with the Hospira holding, as he cited it as “similar” rather than binding.)

With that said, I had and continue to have considerable difficulty with the holding in Hospira, which I described as “anticipation by suggestion.” The general thrust of Biogen’s argument is that a patent can’t be granted for a new use for a known product unless the use is demonstrated or soundly predicted: “The public should not be expected to pay an elevated price in exchange for speculation” Wellcome / AZT 2002 SCC 77 [37], even if that speculation subsequently turns out to be correct. If the prior art was not enough to support a patent, then it should not be enough to anticipate. So, on “the ‘unquestionable authority’ of Lord Westbury in Hills v. Evans [(1862), 45 ER 1195]” (Sanofi 2008 SCC 61, [24]), applying the law to the facts,

[The prior art Heard specification] unquestionably, according to the rules which we have endeavoured to ascertain, is not such information as will vitiate a subsequent patent, for it is not such information as will be sufficient to support a patent.

If an experiment is necessary to support a patent, it is perfectly clear that the results are required; a proposal to carry out the experiment is not enough: Wellcome / AZT 2002 SCC 77 [72]. So, as the SCC noted in Wellcome / AZT at [64], in Beecham v Bristol Labs [1978] R.P.C. 521 (HL), “claims in respect of a semi-synthetic penicillin were invalidated as being little more than an announcement of a research project.” (p. 570).

The reason, as Lord Westbury explained at 1201, is that a proposal “adds nothing to the real stock of practical knowledge of mankind, and ought not to derogate from the validity and the benefit of a subsequent invention.” This all flows from the principle that an invention is information, and to anticipate, the information provided by the prior art must be equal to that provided by the patent. This is the point of the requirement of enabling disclosure. As Lord Hoffmann stated in Merrell Dow [1995] UKHL 14 [28]:

An invention is a piece of information. Making matter available to the public within the meaning of [the statutory novelty provision] therefore requires the communication of information.

Again, per Lord Westbury at 1200, “the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent,” and “the prior knowledge of an invention to avoid a patent must be knowledge equal to that required to be given by a specification.” Statements to that effect are too numerous to cite in this post.

To the same effect, is the statement of Viscount Dunedin in Pope Appliance [1929] AC 269, 276: the general rule “may be expressed thus: Would a man who was grappling with the problem solved by the patent attacked, and having no knowledge of that patent, if he had had the alleged anticipation in his hand, have said, ‘That gives me what I wish?’”; and at 282 “Does the man attacking the problem find what he wants as a solution in the prior so-called anticipations?” When the prior art is a suggestion to carry out an experiment, the answer to these questions must be “no,” because the experiment remains to be carried out before the problem is solved.

Returning to the case at hand, if the patentee could not have been granted on the basis of the information disclosed in Acorda S-1, then Acorda S-1 should not anticipate, because Acorda S-1 does not put the public in possession of the invention. The rule is that infringement if after constitutes anticipation if before; but I don’t see that that rule implies that Acorda S-1 anticipates: actually performing the MS-F202 protocol would infringe; but proposing the MS-F202 protocol would not.

With that said, I’ve consulted with some US colleagues and it looks like the US Fed Cir adopts much the same approach as Hospira: see Rasmusson v SmithKline Beecham Corp., 413 F.3d 1318 (Fed Cir 2005) and Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc. 246 F.3d 1368 (Fed Cir 2001). The US cases don’t make sense to me either, but there they are.

While Biogen v Taro illustrates and applies the Hospira principle of anticipation by speculation, it is not a particularly clear example because there are a number of problems with the prior art disclosure.
So, Acorda S-1 reported the results of MS-F201 as follows:

The clinical trial demonstrated that doses up to 25 mg twice a day were well tolerated, and were associated with statistically significant improvements in walking speed and leg muscle strength.

A key element from the claim was to the use of fampridine SR at a dose of 10mg bid in treating a patient with MS “for improving walking in a statistically significant way” [109], and Acorda S-1 on its face disclosed that element [128]. However, so far as I can tell, the MS-F201 trial didn’t really show a statistically significant improvement in walking speed — it just showed that if you parse a data set enough ways, you’ll eventually find some correlation with p<0.05. I expect that’s why Manson J referred to it as showing a “nominally” significant difference in walking speed [34]. In any event, Acorda S-1 expressly stated that the results were statistically significant, and it’s not clear to me whether the data mining behind that result was reported in Acorda S-1.

Further, the essential elements of the claim also included the use of fampridine SR for a time period of at least two weeks at a unit dose of 10 mg bid [109], and it seems that Biogen was trying “a detailed parsing” of the claim elements in an effort to show that the two-week dosing period and the 10 mg bid dosage were not disclosed [129]. But the 10 mg bid dosage was disclosed by the MS-F201 trial, which also included a 10mb bid regime, so it was only the two-week time period that was not disclosed [131]. It is apparently at this point that the MS-F202 trial became relevant. But the MS-F202 trial also failed in terms of predefined endpoints [40] and “showed no meaningful difference in walking speed between the 10 mg, 15 mg and 20 mg bid doses” [43], so I’m not sure what Biogen’s basis was for arguing that MS-F202 revealed anything more than MS-F201.

Thus, while Biogen v Taro illustrates and applies the Hospira principle of anticipation by suggestion, it doesn’t really advance the law on this point. The facts don’t provide a particularly clean illustration of the issues because both the MS-F201 and MS-F202 studies were a fiesta of data-mining. I’d almost be inclined to say that they weren’t anticipatory because a skilled person wouldn’t believe anything that was said in either of them; but that’s not an issue that was raised in argument. I’ll end this post with one more quotation from Lord Westbury in Hill v Evans at 1201:

Now it is an admitted fact that that proposition [in the prior art] is untrue; it is a clear result, therefore, that the proposition would only mislead the individual who relied upon it.

Expediency of One Action Is Exclusive Purpose of Joinder Rules under PM(NOC) Regulations

Teva Canada Limited v Bayer et al 2020 FCA 86 Nadon JA: Pelletier, de Montigny JJA rev’g 2019 FC 1039 Pentney J

2,547,113 / 2,624,310 / 2,823,159 / 2,396,561/ rivaroxaban /XARELTO

This appeal clarifies several important procedural points under the new the PM(NOC) Regulations. In the main part of the decision, the FCA greatly clarified the meaning and implications of s 6.02, which provides that no action may be “joined” to a s 6(1) action during the period of the statutory stay. Two other points arose tangentially. The FCA also noted that procedural precedent under the former Regulations is not necessarily applicable under the new Regulations, given the change in purpose; and Nadon JA remarked that that disposing of cases brought under the Regulations within 24 months “remains a goal—not an obligation on the Court” [132].

This appeal concerns a motion to add defendants in a trial of common issues under the PM(NOC) Regulations. The issue of joining actions is important both for the usual procedural concerns of fairness and efficiency of adjudication, and also because it raises the issue of whether the first generic to serve an NOA can get a practical first-mover advantage over later generics. Under the US Hatch-Waxman patent linkage system, the first applicant to challenge a drug patent is entitled to 180 days of exclusivity against subsequent generic applicants (21 U.S.C. § 355(j)(5)), with the idea that this provides an incentive for the first generic to bear the cost of litigation. There is no equivalent statutory exclusivity period in the NOC Regulations, but the first generic to get its NOC will nonetheless get a practical head start.

In the underlying motion, Teva and Apotex resisted a motion to add Taro and Sandoz as additional defendants in the PM(NOC) action brought by Bayer against all four. Teva and Apotex argued, in part, that adding Taro and Sandoz would deprive Teva and Apotex of the potential first-mover advantage. As discussed here, in the decision under appeal Pentney J rejected this argument, and then went on to order Taro and Sandoz to be added, in light of a balancing of the usual considerations of balancing judicial economy against potential prejudice to the parties. While Pentney J did not provide the specific basis for his order, the FCA held that Rule 105 does give the discretion to make an order of that type [41].

The FCA also affirmed that the potential loss of the first-mover advantage should not be considered. While the procedural requirements under the PM(NOC) Regulations may result in a practical first-mover advantage, there is nothing in the Reuglations or the RIAS to suggest that this is the purpose: [53-54]. Indeed, the contrast with the US example where a first-mover advantage is explicitly provided for suggests that no such purpose was contemplated in the Canadian patent linkage system: [55].

The FCA nonetheless reversed. While Rule 105 permits an such an order to be made, it does not grant an unfettered discretion. In particular, the exercise of the discretion must not fall afoul of s 6.02 of the Regulations, which provides that no action may be “joined” to an action commenced under s 6(1) during the period of the statutory stay [81].

The FCA held that “joined” is not merely synonymous with “consolidated” [110]. This conclusion turned in part on the textual meaning of the two terms [99]-[121], where Nadon JA concluded that the words do not suggest that the meaning of “joining actions” is confined to consolidation: “Rather, they suggest that actions are joined whenever they are brought together, connected or brought into close association” [114].

The FCA’s conclusion turned primarily on the purpose of the Regulations. Nadon JA drew a very strong contrast between the purpose of s 6.02 and Rule 105:

[122] Having analyzed the wording of section 6.02 of the Regulations, I now turn to consider more closely the purpose of the prohibition. The entire raison d’être of the section 6.02 prohibition is to promote the expediency of one action, and one action only, instituted pursuant to subsection 6(1), in the context of the 24-month time period within which that action is meant to be determined. My meaning in saying that the prohibition is concerned with the expediency of one action only becomes clear when the purpose of the prohibition is contrasted with the purpose of Rule 105(a). The various forms of relief available under Rule 105(a) seek to promote the most expedient and least expensive determination of multiple proceedings before the Court that share similar issues. In other words, in making an order under Rule 105, a judge or a prothonotary seeks to achieve the most efficient and inexpensive way of dealing with two or more proceedings, both in the interest of the parties and of the Court. Not so with section 6.02 of the Regulations. Section 6.02 is exclusively concerned with the progress of a single action to ensure it is determined within the 24-month deadline that applies to it. The concerns that animate an order under Rule 105(a)—efficiencies and cost savings across multiple parties in multiple proceedings, and as they apply to the court—have no bearing on section 6.02 of the Regulations, the singular focus of which remains exclusively on determining that single action before its peculiar deadline. Thus, to make an order under Rule 105 for the arrangement of multiple proceedings that would result in time and cost savings for multiple parties and the court would still be contrary to the purpose of the section 6.02 prohibition if that arrangement made it at all less likely that any single action brought pursuant to subsection 6(1) would be determined within its 24-month deadline.

Further, the concern under s 6.02 “is whether the Rule 105 order could possibly result in the appellants’ actions exceeding their 24-month deadlines” [124] (emphasis added).
Nadon JA did not undertake a deep inquiry into exactly what would or would not be considered “joining” as the Court was satisfied that the practical effect of the order at issue was tantamount to a consolidation: [129], [131]. In coming to this conclusion, the FCA observed that while the discoveries that had taken place prior to the appeal were nominally conducted by all parties upon consent, the appellants were not “truly free to arrange their proceedings as they saw fit”: “I doubt very much that the Federal Court would have appreciated being advised by the appellants that they refused to cooperate with Taro and Sandoz in regard to the examinations on discovery or in regard to any motion arising from the common issues” [128].

Two other points deserve mention. Nadon JA noted that procedural precedent under the former Regulations would not necessarily be applicable under the new Regulations:

 [77] [I]t is not a foregone conclusion that the principles set out in Sanofi-Aventis [relating to abuse of process], which dealt with the former Regulations, will find identical application under the current Regulations, as the purpose of proceedings commenced under subsection 6(1) of the current Regulations differs from the purpose of proceedings commenced under the former Regulations.

Finally, Nadon JA also noted the 24-month period contemplated for the resolution of actions brought under the Regulations is a goal, not an obligation on the Court:

do not require the Federal Court to render judgment within 24 months. . . . Consequently, it is my view that, in case-managing these cases, judges should bear in mind that they are not positively duty-bound to decide them within the 24-month period. I wish to be clear that I am not suggesting that the 24-month guideline be dealt with flippantly. However, it should be recognized that disposing of cases within 24 months remains a goal—not an obligation on the Court. It bears recalling that even if, in a given case, judgment is rendered by the Federal Court in the 24-month period, appeals taken from such a judgment do not extend the stay period.

No Specific Prerequisites Before Having Recourse to Prosecution History in Claim Construction

Bauer Hockey Ltd. v. Sport Maska Inc. (CCM Hockey) 2020 FC 624 Grammond J

2,214,748

In this decision, Grammond J held that no valid claims of Bauer’s 748 patent were infringed. The decision turned largely on claim construction and Grammond J noted that if the parties had brought a motion for summary judgment or summary trial “a considerable amount of judicial resources would have been saved, and each party’s legal costs would have been substantially reduced” [29]. This indicates that Manson J is not alone among FC judges in seeing the need for increased use of summary proceedings: see Viiv Healthcare 2020 FC 486 (here) and Canmar 2019 FC 1233 (here). One noteworthy point is Grammond J’s holding that there are no specific requirements that must be triggered before reference to the prosecution history is permissible under s 53.1 [65].

The invention at issue relates to hockey skates. The uppers were traditionally made with two “quarters” that were sewn together. The 748 patent essentially claimed a one-piece quarter. It may seem obvious that the two pieces should be joined together, and this is exactly what Grammond J held [154-58] [184]. Grammond J addressed the “Beloit question” – 'If it was so easy, why was it not done before?' (my paraphrase of Beloit (1986), 8 CPR (3d) 289 (FCA) at 295, quoted at [146]), by noting that it had not been done before because of cost considerations and not because it was not technically feasible [162-65]. Bauer tried to rebut the prima facie obviousness case with arguments based on commercial success, but Grammond J rejected these, explaining that an adequate causal nexus between the commercial success and the invention specified by the claims had not been established [171-79].

On claim construction there has been an on-going debate as to whether recourse to the disclosure is always permissible, or is permissible only if the claim terms are ambiguous. Grammond J came down very firmly in favour of the former position:

[49] Legal interpretation is not an obscure practice governed by arcane rules. It is, as Lord Hoffmann once famously said, not very different from “the common sense principles by which any serious utterance would be interpreted in ordinary life.”

[55] The modern method [of interpretation] aims at helping the interpreter find clues about the meaning of a legal writing. There is no hierarchy of these clues, nor any predetermined order in which they are considered. In particular, the modern method rejects what is known as the “plain meaning rule,” or the idea that if one category of clues – the text – provides a “clear” answer, the other categories of clues are to be disregarded.

He noted that “Most recent decisions of the Federal Court of Appeal are in line with this approach,” [57], quoting Tetra Tech 2019 FCA 203 [86] and Tearlab 2019 FCA 179 [33] saying that “[c]laim construction requires that the disclosure and the claims be looked at as a whole.” I am entirely in agreement with Grammond J’s observations in this regard.

Without detracting from this general approach, Grammond J noted that patents have “certain distinctive characteristics” that need to be taken into account [51]. One in particular is reference to the prosecution history under s 53.1 which provides that communications between the patentee and the Patent Office “may be admitted into evidence to rebut any representation made by the patentee in the action or proceeding as to the construction of a claim in the patent.” In the specific of the modern approach to interpretation, Grammond J held that there are no specific requirements that must be triggered before reference to the prosecution history is permissible (emphasis added):

[65] Although the use of prosecution history is described in terms of estoppel in the United States, section 53.1 squarely makes this a matter of claims construction. When an issue of claims construction arises, the patentee is always making representations to the Court as to the proper construction of the claims and the defendant is always attempting to rebut those representations. Therefore, in my view, as long as the issue is one of claims construction, section 53.1 applies and the prosecution history is admissible. In other words, there is no need to identify a particular representation and rebuttal every time a reference is made to the prosecution history. It is simply integrated in the interpretive process.

Grammond J did have recourse to the prosecution history, but it served only to confirm the interpretation that was plain from the patent itself. This is not very surprising; the examiner made an obviousness objection, the applicant amended the claims to overcome it, and in litigation the patentee sought to reclaim the lost ground [103-06]. This illustrates why recourse to the prosecution history is often likely to be redundant: when the examiner accepts an amendment intended to restrict the scope of the claims, it will not be very surprising that the new language does indeed restrict the scope of the claims.

Direct Infringement of Product "For Use" Claim; No Inducement of Corresponding Use Claim

Janssen Inc v Teva Canada Ltd 2020 FC 593 Manson J
             2,655,335 / paliperidone palmitate / INVEGA SUSTENNA

Last Friday’s post gave an overview of this decision. As noted, the 335 patent relates to dosing regimens for long acting injectable paliperidone palmitate formulations for treatment of schizophrenia. The 335 patent has three sets of claims: product claims (to prefilled syringes adapted for administration according to the claimed dosing regimen; use claims (“use of a dosage form” etc); and Swiss claims (“use. . . for the manufacture of a medicament”). Yesterday’s post discussed induced infringement of the use claims. This post considers the direct infringement of the product and Swiss claims.

In respect of the product claims — the prefilled syringes — Teva argued that it could not directly infringe because they all require administration in accordance with the claimed dosing regimens; and alternatively, Teva submitted even if administration to patients was not required, Teva did not direct use in accordance with the claimed dosing regimens [234].

Manson J rejected these arguments after reviewing all the essential elements of product claim and finding they were all incorporated in Teva’s proposed product [252]. Claim 1 is to “Prefilled syringes containing a depot formulation of paliperidone . . . for administration by intramuscular injection to a psychiatric patient in need of treatment for schizophrenia.” As I see it, the key issue was the meaning of “for”. Teva’s argument seems to turn on the view that this means that the syringe had to actually be used for the specified purpose for the claim to be infringed. Manson J noted that the product was “capable, approved and intended” for the specified purpose, and that was enough to bring it within the claim. That makes sense as a matter ordinary grammar: I am boiling water “for tea” if I intend to use the water for tea, even if I get distracted and never actually make myself a cup of tea. The intended use was discerned primarily from Teva’s PM. I note that this approach to a claim “for” a purpose is essentially the same as that adopted by Lord Briggs (Lord Hodge concurring) and Arnold J (as he then was) in Warner-Lambert [2018] UKSC 56 var’g [2016] EWCA Civ 1006 var’g [2015] EWHC 2548 (Pat) Arnold J: see here.

Here is a key point (my emphasis):

[253] The Teva PM teaches that the prefilled syringes to be sold by Teva can be administered in combination according to the claimed dosing regimen. While this information may not rise to the level of “instructions to infringe” sufficient to induce practitioners to prescribe and use the syringes according to the claimed dosing regimen, it is sufficient to establish direct infringement of the product claims.

That is, claims to a product for a use are different from the corresponding use claims because the PM may establish intent to influence physicians to use the product in the specified manner, even if the PM does not in fact cause the physicians to use the product in the specified manner; the former is all that is necessary to establish direct infringement of a claim to a product “for” a specified purpose, while the latter is necessary to establish induced infringement of a use claim.

Turning to the Swiss-form claims, it is well known that Swiss claims were first developed as an end-run around the prohibition in European law on patenting methods of medical treatment. In form, they are a claim to a product, though they are intended to protect a use. As a result, in Novartis 2013 FC 985 Hughes J held that the court “should disregard the artificial nature of a Swiss claim and look at what is the real subject matter of the claim” [101]. In effect, Hughes J held that a Swiss claim should be construed as a use claim, even though, on its face, it is a product claim. Consequently, Hughes J held the claims at issue to be unpatentable methods of medical treatment [101]. In this case, Manson J took a different approach. He held that Swiss claims should be construed on the same principle as any other claim, namely as it would be understood by a skilled person [161], and consequently “The Swiss-type claims are capable of infringement if the medicament is adapted for administration to a psychiatric patient in need of treatment, according to the claimed dosing regimen” [163]. Consequently, the Swiss claims of the patent were directly infringed for the same reason that the product claims were directly infringed [256]. Manson J’s approach strikes as preferable. To the extent that Swiss form claims are objectionable as being an end-run around the prohibition on patenting methods of medical treatment, this should be addressed in the substantive law of subject-matter eligibility, rather than through a distorted construction of the claim itself.

With that in mind, there are two other minor points worth noting.

First, Manson J reiterated the need for clarification of the prohibition on patenting methods of medical treatment, though he noted that nothing turned on it in this case [143].

Second, Manson J admitted evidence of the prosecution history to rebut Janssen’s proposed claim construction on a particular point [140-42]. However, this had no effect on the result, as the plain meaning of the claim language supported the same construction as the prosecution history [140]. In effect, the claim on its face said X, during prosecution Janssen asserted that it meant X, the patent examiner evidently accepted that it meant X, but at trial Janssen asserted that it meant Y. This illustrates why the use of prosecution history can add needless complexity to a case; in establishing that a claim does indeed mean what it says on its face, it is not particularly helpful to go back and show that during prosecution the patentee agreed that it meant what it says on its face.

Split in Inducement Case-law Recognized

Janssen Inc v Teva Canada Ltd 2020 FC 593 Manson J
             2,655,335 / paliperidone palmitate / INVEGA SUSTENNA

In this NOC action, Manson J held that Janssen’s 335 patent, relating to dosing regimens for long acting injectable paliperidone palmitate formulations for treatment of schizophrenia, was not invalid for obviousness. He also held certain product claims would be infringed by the sale of Teva’s paliperidone palmitate product, though Teva would neither infringe nor induce infringement of the parallel use claims. He accordingly enjoined the sale of Teva’s product until the expiry of the 335 patent. The obviousness analysis turned on the facts. The most interesting part of the decision is Manson J’s analysis of inducement. Manson J acknowledged the apparent split in the case law on the second step of the Corlac test, which I identified in my paper “Is 'But For' Causation Necessary to Establish Inducement?” (available on SSRN). I’m not entirely persuaded by Manson J’s explanation of the split, but recognizing its existence is certainly a step in the right direction. The practical take-away is that product claims are crucial to effective enforcement of a dosage regimen invention.

Schizophrenia is a debilitating and incurable disease [4]. Antipsychotic drugs are the cornerstone of treatment and management [8]. A leading cause of relapse is non-adherence, where patients do not take their antipsychotic medication as prescribed [11]. “One strategy to ensure treatment adherence is the use of long acting formulations of antipsychotics. One type of long acting formulation is intramuscular injections of antipsychotic drugs, known as ‘depot formulations’ or ‘long acting injectables’. Once injected, the drug releases from the injection site slowly, providing the patient with a prolonged dose of the drug” [12]. Paliperidone was known in the prior art to be a useful antipsychotic, and it was available as an extended release tablet for oral administration [121]. The invention at issue relates to a dosage regimen for a depot formulation of paliperidone palmitate [15]. Specifically, the regimen consists of a first loading dose of 150 mg-eq of paliperidone palmitate administered into the deltoid muscle on day 1; a second loading dose of 100 mg-eq of paliperidone palmitate administered into the deltoid on day 8 + 2 days; and subsequent maintenance doses of 75 mg-eq of paliperidone palmitate administered into the deltoid or gluteal muscle monthly + 7 days after the second injection [19].

As paliperidone palmitate was a known antipsychotic and the use of long-acting depot formulations was also known, the validity of all the claims turned on the inventiveness of the dosing regimen itself [174]. Obviousness turned on a fairly straightforward application of the obvious-to-try analysis [198]. Manson J noted in particular that in order to design the regimen, it would be necessary to first determine the pharmacokinetic profile of paliperidone depot formulation, which was not disclosed in the prior art [201], [203], [208], and that in order to arrive at the appropriate regimen the POSITA would have had to carry out prolonged and arduous experimentation in the form of clinical trials to evaluate the safety and efficacy of a large number of variables including fixed doses, variable doses, and injection sites [203], [218]. Consequently, he held that the dosage regimen was inventive and the asserted claims were therefore not obvious [224].

Turning to infringement, the 335 patent has three sets of claims. Claims 1 to 16 are to prefilled syringes adapted for administration according to the claimed dosing regimen (“product” claims); claims 17 to 32 mirror the first sixteen claims, except that they are directed towards “use of a dosage form of paliperidone as paliperidone palmitate” rather than prefilled syringes [148] (“use” claims); and the final set of claims are the “use of paliperidone as paliperidone palmitate for the preparation [or manufacture] of a medicament” (Swiss-type claims).

The parties agreed that Teva would not directly infringe the “use” claims [153], [235], and infringement of those claims therefore turned on inducement. In my paper on Is 'But For' Causation Necessary to Establish Inducement? (available on SSRN), I noted that while the test for inducement set out in Corlac 2011 FCA 228 [162] requires at its second stage that the influence of the indirect party be the “but for” cause of direct infringement, there are a number of other cases that endorse a less stringent test. For example, Abbott v Novopharm 2007 FCA 251 [26] inducement was found on the basis that the proposed product monograph would be “an encouragement to infringe.”

In his decision, Manson J expressly acknowledged the divergence between these lines of cases, [259-64]. I am pleased to see the Federal Court recognize explicitly that there is an apparent split in the cases, as confronting the issue directly will help clarify the law. However, I am not entirely persuaded by Manson J’s analysis of the divergence. In Manson J’s view, the split is between the “earlier cases” [264], and the “more recent cases” [262]. The earlier cases only required “some nexus” to the generic company (the cases reviewed by Manson J were all NOC cases) [261], while “in more recent cases,” the Court has “scrupulously” applied the Corlac test, “with particular focus on the second prong” [262]. Manson J stated expressly that “The ‘but for’ influence required in the second prong of the Corlac test requires a higher threshold for establishing inducement than was applied in the earlier cases” [264].

Thus, if I understand correctly, Manson J is of the view that the law has changed, presumably in light of Corlac; or alternatively, the law has not changed, but since Corlac the courts have become more careful in applying what was always existing law. So, he says that in the earlier cases “the second and third prongs of the inducement test, influence by the generic on the infringing party and knowledge that this influence will result in infringement, appear not to have been fully considered” [261]. I have great difficulty with the view that the law has changed; as I discuss in my paper, Corlac cited a line of prior cases articulating the requirement in the same way, through Dableh [1996] 3 FC 751 (FCA) and Warner-Lambert (1988), 19 FTR 198, all the way back to Slater Steel (1968), 55 CPR 61 (Ex Ct).

I also have difficulty accepting the suggestion that the Court of Appeal in Abbott, for example, was simply careless in its application of the test, with the implication that the result would have been different had the Court been more careful. Manson J recognized that there was a line of cases that “are fairly consistent” than inducement can be established simply by making reference to the “new” infringing use, in cases involving a new use for a known compound ([259]), including three decisions by, or affirmed by, the FCA. One case might be carelessness, but a series of cases to the same effect is precedent.

My view, as discussed in my paper, is that the cases are consistent in the result, as the stringent “but for” nature of the second branch was not determinative in any decision except Slater Steel, while there are cases which apply the more relaxed standard, which would have gone the other way had a but for test been used. In my view, there is no split, but rather a single outlier, namely Slater Steel.

While Manson J clearly endorsed the application of a strict “but for” causation requirement at the second branch of the Corlac test, it is not clear to me whether his holding on this point was determinative. Whatever legal test is used, the facts are obviously crucial to the outcome of any particular case. As Manson J pointed out “[a]n important factor in all of these cases is the wording of the claims themselves” [266], along with the instructions in the product monograph, which is “a key document in the inducement analysis” [276]. Unfortunately, Manson J’s analysis of Teva’s product monograph is so heavily redacted that I cannot tell whether his application of a strict “but for” test was crucial to the outcome, or whether the inducement test failed primarily because the statements in the PM were too indirect, even on a more relaxed standard. My suspicion is that the “but for” element was crucial, but I really am not sure.

There is a related point that I found puzzling, probably because of the redactions. In arriving at his conclusion on inducement, Manson J emphasized evidence that physicians’ prescribing practices would be individualized based upon clinical symptoms and that psychiatric medical professionals are very familiar with using paliperidone palmitate in their practice [285-89]. Consequently, medical professionals would not “eschew good clinical practice in favour of a general recommendation in a PM” [286], and would instead “consider individual patient characteristics when prescribing and dispensing depot formulations of paliperidone palmitate rather than blindly following a number in a PM” [289]. For this reason he concluded that while some infringement would occur, “this infringement is the result of prescribing physicians’ skill and judgment applied to specific patient characteristics, rather than influence exercised by Teva via its PM” [290]. My puzzle with all of this is that Manson J had concluded that the dosage regimen was non-obvious and indeed was the result of a great deal of experimentation and research. If that is the case, it’s not clear to me why medical practitioners are not influenced by the PM, which apparently instructs use of the claimed regimen (again, this is not entirely clear because of the redactions). Is it that the claimed regimen, though inventive, is really not that good, and a skilled medical practitioner would have no difficulty coming up with something better on a case by case basis? In any event, I won’t speculate further. No doubt the point would be clear from the unredacted decision, or to someone with more familiarity with the facts.

No Opportunity to Appeal Means No Abuse of Process in Relitigating Previously Decided Issues

Amgen Inc v Pfizer Canada ULC 2020 FC 522 Southcott J
            1,341,537 / filgrastim / NEUPOGEN / NIVESTYM

My first post on this decision gave an overview of the facts and discussed the main substantive holding, namely that the invention was obvious. The decision also raised an issue of abuse of process, though one that should largely disappear with the new NOC actions.

Amgen had previously asserted the 537 patent against Apotex in proceedings under the old PM(NOC) Regulations, and lost before Hughes J who held the 537 patent invalid for obviousness: Amgen v Apotex 2015 FC 1261 [the Hughes Decision] (here) aff’d as moot 2016 FCA 196. Pfizer had earlier brought a motion seeking dismissal of Amgen’s on the basis of abuse of process. The motion was dismissed, 2018 FC 1078, but in affirming the decision dismissing the motion the FCA, 2019 FCA 249, stated that Pfizer was not precluded from raising the abuse of process doctrine at trial in connection with individual factual and legal findings in the Hughes Decision: see here. In this action, Pfizer accordingly argued that it would be an abuse of process for Amgen to re-litigate certain factual and legal issues that had been decided by Hughes J.

Southcott J exercised his discretion not to apply the abuse of process doctrine, primarily because Amgen had not had the opportunity to appeal the Hughes Decision [160]. Southcott J noted:

[164] In my view, it is unfair to hold Amgen to the results of the Apotex Decision in the current proceedings, when it did not have the benefit of substantive appellate review of that decision. As Amgen emphasizes, the Federal Court of Appeal in Amgen Canada dismissed Amgen’s appeal for mootness in part because it could pursue a subsequent infringement action (at para 22). In conclusion on this issue, regardless of the scope of Amgen’s burden to identify evidence warranting reconsideration of the issues before Justice Hughes,

This observation strikes me as compelling. Presumably such issues will largely disappear with the new NOC actions.

Appropriate and Inappropriate Use of Cease and Desist Letters

Fluid Energy Group Ltd v Exaltexx Inc 2020 FC 81 McHaffie J

2,892,876 / 2,961,777 / 2,961,787 / 2,961,792 / 2,961,794 / 2,961,783

In the action underlying this motion, Fluid brought an infringement action against Exaltexx, and then sent cease and desist letters directed at third parties doing business with Exaltexx. In this decision, McHaffie J granted an interlocutory injunction based on s 7(a) of the Trademarks Act, enjoining Fluid from sending such letters. Yesterday’s post provides an overview of the facts and discusses McHaffie J’s analysis of the “serious question” branch of the RJR-MacDonald [1994] 1 SCR 311 test for interlocutory injunctions, including his treatment of the substantive elements of s 7(1). This post deals with the remaining aspects of the interlocutory injunction analysis. The overarching message I take from McHaffie J’s decision is that cease and desist letters serving the “laudable purposes” of “providing notice of a legal claim and a potential lawsuit, allowing the recipient to assess the claim and their conduct, and initiating discussions leading to resolution of the dispute before litigation is commenced,” are appropriate and will not be enjoined; but letters intended to put pressure on a defendant to settle regardless of the merits are an abuse of the legal process and will not be permitted.

Interlocutory Injunctions and Cease and Desist Letters: Everything You Ever Wanted to Know

Fluid Energy Group Ltd v Exaltexx Inc 2020 FC 81 McHaffie J

2,892,876 / 2,961,777 / 2,961,787 / 2,961,792 / 2,961,794 / 2,961,783

McHaffie J’s decision in Fluid Energy Group v Exaltexx is a tour de force on an important issue, namely the availability of an interlocutory injunction based on s 7(a) of the Trademarks Act to enjoin cease and desist letters directed at third parties doing business with the defendant in an infringement action. The decision covers many issues, both procedural and substantive, that will be relevant to any situation involving threatening cease and desist letters. McHaffie J’s decision complements that of Manson J in Excalibre 2016 FC 1279 (aff’d on cross-appeal 2019 FCA 121, appeal dismissed for delay 2019 FCA 22), awarding damages under s 7(a) for letters threatening to bring infringement actions against end-users of the defendant’s product that was ultimately held to be non-infringing: see here, here and here. Both decisions are fully reasoned, and we now have a good body of recent law on the application of s 7(a) to cease and desist letters. The entire decision will be required reading on the issue, and as I have little to add to McHaffie J’s analysis, for the most part I will simply summarize the issues and highlight a few choice passages. This post will focus on the application of s 7(a) to cease and desist letters, and the next post will consider the interlocutory injunction issues.

Fluid and Exaltexx are competitors in the sale of “safe acids” to the oil and gas industry. These are strong acids that have been modified by blending them with additives to be more environmentally and dermatologically safe [8]. In the underlying action, the patentee, Fluid, asserts that Exaltexx infringes its patents relating to safe acids. After commencing the action, Fluid sent cease and desist letters to various companies doing business with Exaltexx, including two chemical suppliers and a small trucking company that hauls product from Exaltexx to one of its customers [23]. These letters made broad-ranging assertions of infringement covering Exaltexx products, and alleged that the recipients of the letters were also infringing or inducing infringement by doing business with Exaltexx [3], [15]. The letters threatened patent litigation against the companies if they refused to comply with the demand to immediately cease and desist [3]. The letters were intended to induce those companies to stop doing business with Exaltexx, and at least one, and possibly two, of the companies did cease doing business with Exaltexx as a result of the letters [118].

Sequential Unmasking of Expert Witnesses

Amgen Inc v Pfizer Canada ULC 2020 FC 522 Southcott J
            1,341,537 / filgrastim / NEUPOGEN / NIVESTYM

Wednesday’s post gave an overview of the facts and discussed the main substantive holding in this decision, namely that the invention was obvious. The decision also raises sequential instruction of expert witnesses as a way of improving the usefulness of “blinding” the experts.

Southcott J summarized the current law by accepting that “blinding is not a guarantee of reliability. Whether it is a sufficient reason to prefer the evidence of one expert over another depends on the details of the evidence in a particular case. [T]he effect of blinding is a question of relevance, reliability, and weight. It is not a doctrinal matter” [309] (citing 2016 FC 857 [59]).

Southcott J noted that some structural problems may arise that impede effective blinding. For example, effective blinding requires that the expert not have read the patent so as to avoid hindsight bias; but obviousness must be assessed from the perspective of a person skilled in the art to which the patent pertains, and it is necessary to read the patent to determine who the skilled person is.

In this case, Pfizer got around this problem in a manner that met with Southcott J’s approval. Pfizer had one expert read the patent and provide an opinion on the skilled person, and then the second expert was provided with that definition of the skilled person:

[318] This approach demonstrates a potential means of avoiding the concern about blinding creating a structural impediment to experts employing the required tools to formulate their opinions. If one expert provides an opinion defining the Skilled Person after reviewing the relevant patent, that definition can be provided to another expert, who can then give a blinded opinion from the perspective of the Skilled Person without having read the patent or the other experts’ opinions.

Southcott J remarked that while this methodology was not in itself a sufficient reason to prefer Pfizer’s experts over those of Amgen, “blinding is a factor favourable to the reliability of Pfizer’s expert opinions on the work that would flow from [the state of the art]” [320].

This calls to mind the concept of ‘sequential unmasking’ referred to by Arnold LJ in Akebia v Fibrogen [2020] EWHC 866 (Pat):

[36] This submission illustrates why it can be advantageous to try to instruct expert witnesses in sequence, first asking them about the common general knowledge, then showing them the prior art and asking them questions such as what steps would be obvious in the light of it and only then showing them the patent in suit. This is a procedure known as “sequential unmasking” in the psychological literature (see generally on this subject C.T. Robertson and A.S. Kesselheim (eds), Blinding as a Solution to Bias, Academic Press, 2016). The point of it is to try to avoid, or at least reduce, hindsight. In my opinion, it is desirable to try to minimise hindsight on the part of expert witnesses where possible. There is no rule or principle that experts must be instructed sequentially, however.

Arnold LJ went on to note that

[T]here are often real practical problems in doing so. To take just one obvious example, any discussion about the common general knowledge must start by identifying the skilled person or team. How is this to be done if the expert cannot be shown the patent? One way is to ask the expert to make an assumption, which they can check later when they see the patent; but that is not necessarily a perfect solution.

Another, arguably preferable solution to this problem, is that used by Pfizer here, namely providing the second expert with the first’s opinion as to the characteristics of the skilled person.

In any event, it seems that some form of sequential unmasking may be a real advance in terms of allowing experts to provide an effective yet properly blinded opinion.

A Two-Step Approach to Enablement?

Amgen Inc v Pfizer Canada ULC 2020 FC 522 Southcott J
            1,341,537 / filgrastim / NEUPOGEN / NIVESTYM

Wednesday’s post gave an overview of the facts and discussed the main substantive holding in this decision, namely that the invention was obvious. The decision also raised an important point regarding the proper approach to sufficiency, and more particularly enablement (how to practice the invention). I suggest the parties have gone astray, as a consequence of neglecting the FCA’s statements in Leo Pharma 2017 FCA 50 [58] and Bombardier v Arctic Cat 2018 FCA 172 [78] that the SCC decision in Teva 2012 SCC 60 did not change the law of enablement. Ultimately, the doctrinal point made no difference to the outcome, but it is worth discussing nonetheless, as it could cause serious difficulties in future cases.
In Teva 2012 SCC 60 (relating to VIAGRA), the patentee had tried to hide the fact that sildenafil was the particular compound that had been tested and found to be effective in treating ED. LeBel J for the Court stated that:

[80] As a matter of policy and sound statutory interpretation, patentees cannot be allowed to ‘game’ the system in this way. This, in my view, is the key issue in this appeal. It must be resolved against [the patentee].

Whatever one might think of the Court’s policy analysis, its statutory interpretation was the very opposite of “sound”; it would be more accurately described as a horrific train-wreck that particularly mangles s 58, which provides that claims stand or fall independently: see Siebrasse, The Duty to Disclose “The Invention”: The Wrong Tool for the Job, (2013) 25 IPJ 269. The Federal Courts have largely avoided getting tripped up by the SCC’s blithe disregard of doctrinal details and statutory text, and have instead (properly, in my view) understood Teva as representing a broad injunction against attempts to game the system, which was, after all, the “key issue” that was resolved against the patentee.

Unfortunately, Teva’s doctrinal misstep has reared its head in this case, in the context of the approach to sufficiency. The parties both accepted that

[454] In Novopharm SCC, [aka Teva] the Supreme Court set out a two-step analysis for determining whether a patent’s disclosure is sufficient. The first step is to define the nature of the invention in the patent (see Novopharm SCC at para 53). The entire patent must be considered in making this determination, not just a particular claim, as a patent is issued for one invention (see Novopharm SCC at paras 55-60). The second step is to determine whether the disclosure is sufficient to enable the skilled person to practice the invention, i.e. to produce the invention using only the instructions contained in the disclosure (see Novopharm SCC at paras 70-71). None of these principles are controversial between the parties.

The parties disputed whether both of these requirements were to be assessed as of the filing date, or whether the issue date is appropriate for the first step [455].

In my view, the issue of timing is a red herring. I suggest that the parties should not have accepted that these statements from Teva set out the proper approach, as it is wrong in principle and not required by law.

This two-step approach means that sufficiency is assessed in terms of the patent as a whole, and not on a claim-by-claim basis. That is contrary to the principle that claims stand and fall independently. Consider a hypothetical case in which the patent discloses a genus of compounds, as well as two specific especially preferred compounds A and B, all of which are novel, non-obvious, and soundly predicted to have the same utility. Suppose further that the patent provides perfectly clear directions as to how to make compound A, but it is established on the facts that the patent failed to disclose a key step in making compound B, so that it could not have been made without undue burden. (To avoid raising issues of “gaming the system,” we may assume that the failure to disclose how to make B was innocent in that the patentee used as specific brand of equipment that was crucial to success, but did not name the brand because it had not realized its importance: see eg by Badische Anilin (1898) 15 RPC 359 (CA).) The patent claims compounds A and B in separate claims. The sensible result is that the claim to A is valid, and the claim to B is invalid for lack of sufficiency. If the sufficiency requirement is applied to each claim independently, that result is straightforward. But if there is a prior step of determining the nature of “the invention,” a sensible result is out of reach. If the “invention” is compound A, does this mean that the claim to compound B is valid? If the “invention” is compound B, does this mean that the claim to compound A is invalid? If the “invention” is the genus, does this mean the claim to compound A is invalid, on the view that the claim to genus is invalid?

None of these options is a sensible result. Nor does the law force us into an absurdity. The FCA has pointed out in Leo Pharma 2017 FCA 50 [58] and again in Bombardier v Arctic Cat 2018 FCA 172 [78], that Teva did not change the law of enablement: see here. Gauthier JA made the point explicitly in Bombardier [78] (my emphasis):

Enablement (how to practice the invention) is a concept completely distinct from the disclosure of the invention itself, the latter of which was at issue in Pfizer [aka Teva].

The point at issue in the case at hand was enablement, ie that “the disclosure in the patent is not sufficient to practice this invention” [451]. Gauthier J’s holding in Bombardier therefore clearly applies: enablement is “completely distinct” from disclosure of the invention, and Teva should not have been relied on for this point.

This issue ultimately did not matter to the result. The sufficiency issue only arose if the claim was interpreted to require the claim protein to have to be pluripotent in the sense of stimulating growth in multiple cell lineages, [462]. Southcott J rejected this construction, and the sufficiency attack failed for that reason [463]. Nothing turned on the two-stag approach or the timing issue that the parties had disputed.