Tension in the Sanofi Disclosure Analysis

Takeda Canada Inc v Apotex Inc 2024 FC 106 Furlanetto J

2,570,916 / dexlansoprazole / DEXILANT / NOC

Proton pump inhibitors (PPIs) are a class of compounds that decrease gastric acid level in the stomach [5]. PPIs are now a well-established treatment for GI disorders related to increased gastric acid [7]. It is desirable to have a once daily dosing regimen, but the formulations known at the time of the patent could result in nocturnal breakthrough events if used on a once-daily basis, resulting increased gastric acid production [12]. Takeda’s 916 patent aimed to address this problem with a “pulsatile” release formulation, comprising a PPI with “a first and a second dose,” which are released from the dosage form as “discrete pulses,” resulting in specified blood plasma concentrations [90], [92]. Takeda’s DEXILANT product is a pulsatile release formulation of the claimed type, which includes two types of delayed-release beads containing dexlansoprazole [6]. Apotex sought to sell a dexlansoprazole oral dose capsule product and Takeda brought this NOC action in response [2].

Furlanetto J addressed three claim construction issues, which all turned on the evidence. One question in particular turned on the meaning of “a first and a second dose” in the claims. Apotex argued that this means distinct amounts of PPI in the dosage form itself [97], as with the two types of delayed-release beads in DEXILANT. Takeda argued that the reference to two doses was not the amount of PPI in the formulation, but the amount of PPI released from the formulation [97]. In other words Takeda argued that even if there was only one form of PPI in the product, if it was released in two waves resulting in two distinct blood plasma peaks, that would fall within the claims. Furlanetto J accepted Apotex’s construction, for reasons that strike me as being straightforward and compelling [98]–[104]. (Her conclusions on the other two claim construction issues also strike me as being sound.)

In light of that construction, Apotex prevailed on infringement because it does not contain two different types of dexlansoprazole: “Characteristic of a single continuous, delayed release dosage form, each of the mini-tablets in the Apotex Product are identical” [119]. There was also an extended discussion of various labs tests which was a bit difficult to follow because of redactions. My impression is that Takeda was arguing that if you squint really hard, you can see two peaks in the plasma concentration curves. In any event, in the end Furlanetto J held that Apotex’s product would not infringe as Takeda failed to established that Apotex’s product comprised a first and a second dose of dexlansoprazole from the dosage form as two discrete pulses: “Rather, the evidence indicates that there is only one dose of dexlansoprazole in each 30 mg or 60 mg capsule of the Apotex Product that is released from the Apotex Product in a single, continuous delayed release fashion” [147].

To this point, the decision turned on the facts with no novel points of law. The conclusion on claim construction and infringement would have been sufficient to dismiss the action [148]. Furlanetto J nonetheless went on to address Apotex’s validity arguments, “which formed a significant portion of the parties’ arguments at trial” [148].

Anticipation

The anticipation argument raised a tricky point which turns ultimately on a tension in Sanofi 2008 SCC 61.

The focus was solely on the disclosure branch of the two part test for anticipation [151]. The key piece of prior art was Application 2,499,574, and in particular Example 57 which “provides a formulation that is close to DEXILANT® except that it includes the excipient PEG as part of the formulation” [168]. Apotex introduced evidence that the PEG would not affect the pharmacokinetics and that the blood plasma reached would exceed the threshold specified in the claims [169]–[170]. Furlanetto J held that Example 57 did not anticipate because “the heart of the invention of the 916 Patent is the recognition of the threshold plasma concentration and how to achieve and maintain it,” and “There was no suggestion in the 574 Application of any recognition of these properties, nor of their significance” [176]. Moreover, Example 57 did not disclose the blood plasma concentrations that would result, and for that to be determined, the capsules of example 57 would have had to be administered to humans and the PK properties would have to be identified and studied” [176]. It is not entirely clear to me if Example 57 comprised two different types of granules (see [202], suggesting it did), but it is clear that Example 11 did have two types [161], and Furlanetto J held that Example 11 did not anticipate because, inter alia, “there was no disclosure of any plasma concentration being a threshold which must be surpassed for pharmacological effect” [166].

So, Furlanetto J is saying that these examples did not anticipate because they did not disclose the properties of the compound described in the examples. This is contrary to the basic rule that “what infringes if later, anticipates if earlier”: Consolboard [1981] 1 SCR 504, 534. There is no requirement that anyone at the time would know of all the properties. As Lord Hoffmann said in Synthon [2005] UKHL 59 [22], in a passage quoted with approval in Sanofi 2008 SCC 61 [25], “whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied.” So, if a pharmaceutical company were to market a pill that in fact had two types of PPI and resulted in plasma concentrations that were in fact above the specified thresholds, that pill would infringe if sold after the patent issued, regardless of whether anyone had measured the plasma concentrations prior to litigation. By the same token, such a pill would anticipate if sold prior to the date of the patent, also regardless of whether anyone had ever measured the plasma levels. As Lord Hoffmann explained in Merrell Dow [1995] UKHL 14 [47], “whether or not a person is working a product invention is an objective fact independent of what he knows or thinks about what he is doing”; similarly in Synthon [2005] UKHL 59 [22], quoting Merrell Dow, Lord Hoffmann noted that “[t]he flag has been planted, even though the author or maker of the prior art was not aware that he was doing so.”

All of this is settled law, with Sanofi as the leading case, and indeed, it was expressly recognized as such by Furlanetto J [153]. Why then did she hold that the plasma concentrations had to be disclosed in order to anticipate? The problem lies in Sanofi itself. The quotes from Sanofi that I have given above are all from the discussion of general principles relating to anticipation. When the SCC in Sanofi discussed the disclosure requirement in particular, and in applying those principles to the facts, the SCC did indeed imply that the properties have to be disclosed in order to anticipate.

Recall that the question in Sanofi was whether the prior art disclosure of the racemate anticipated the claim to the enantiomer. The answer was no. But why? Under the general principles set out in Sanofi, the answer would have been that making the racemate would not infringe a claim to the enantiomer, and so the test that “the matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent” (Sanofi [25], quoting Synthon [2005] UKHL 59 [22]) would not be satisfied. More broadly, the question in Sanofi was framed as being whether disclosure of the genus can anticipate the species. The answer is no, because someone practising the genus would not inevitably infringe, as the genus might be practised without infringing, by selecting another species from the pool: see Sanofi [21].

But while that answer would have been straightforward on the general principles set out in Sanofi, the SCC changed its approach when it came to the discussion of the disclosure requirement specifically. The SCC said:

[31] Section 27(1) of the Act requires as a condition for obtaining a patent that the invention was not “known or used” and was not “described” in any patent or any publication more than two years before the patent application was filed. In the context of genus and selection patents, in E. I. Du Pont de Nemours & Co. (Witsiepe’s) Application, [1982] F.S.R. 303 (H.L.), Lord Wilberforce stated, at p. 311:

It is the absence of the discovery of the special advantages, as well as the fact of non-making, that makes it possible for such persons to make an invention related to a member of the class.

The compound made for the selection patent was only soundly predicted at the time of the genus patent. It was not made and its special advantages were not known. It is for those reasons that a patent should not be denied to the inventor who made and discovered the special advantages of the selection compound for the first time.

This is all true, but it runs together anticipation and obviousness.

The general point of Witsiepe’s Application is that a species may be patented over the genus. It is now understood that two separate hurdles must be overcome. The prior art disclosing the genus must not have specifically disclosed the species, or it will be anticipated. This is true even if it turns out that the species had special properties that were not appreciated in the prior art. Suppose that the genus patent specifically disclosed five especially preferred compounds by structure, and disclosed in vitro tests showing they were all effective in treating a disease. One of those, the lead compound, was commercialized and sold. It would not be possible to get a subsequent species patent on that compound, even if it was subsequently discovered, surprisingly and unexpectedly, that it had no side effects at all, while every other known member of the genus had significant side effects. That would be true even if no one had known that this was the only compound with no side effects (perhaps because the lead compound was the only one which was commercialized and the others had never been tested in humans). The same is true if the especially preferred compound had not been commercialized, but merely specifically disclosed, as there is no difference in principle between prior sale and prior publication. (If it were surprisingly and unexpectedly discovered that the compound was useful in treating an entirely different disease, it would be possible to get a patent on the use to treat that disease. That is not because the prior art must disclose the properties to anticipate; it is because making and using the compound for uses known in the prior art would not infringe the new use patent.) On the other hand, even if the species was not specifically disclosed, it must also have special properties. There is no “invention” in picking one member of the genus at random and finding that it has exactly the same properties as all the other known members. If it does not have special properties, it will be obvious, even if it is not specifically disclosed.

The quoted passage from Witsiepe’s Application’s runs these together: “It is the absence of the discovery of the special advantages [non-obviousness], as well as the fact of non-making [anticipation], that makes it possible for such persons to make an invention [new, useful and non-obvious subject matter] related to a member of the class.” And the following sentence from the SCC is to the same effect: “It was not made [not anticipated] and its special advantages were not known [not obvious].” It is true that both of these requirements must be satisfied for a selection patent to be valid. The problem is that in the heading to that section — “i. Disclosure” — and in the following paragraph, the SCC in Sanofi identified both of these separate requirements with the disclosure branch of anticipation:

[32] Where there is no such disclosure [of the special advantages], there is no discovery of the special advantages of the selection patent as compared to the genus patent, and the disclosure requirement to prove anticipation fails.

The SCC also ran obviousness and anticipation together in dealing with the disclosure requirement when applying the law to the facts. The special properties of the enantiomer were better activity and lower toxicity. The SCC said there was no anticipation because “[t]here was no evidence that the person skilled in the art would know from reading the [prior art genus patent] that the more active dextro-rotatory isomer would be less toxic than the racemate or levo-rotatory isomer or any of the other compounds made and tested” [40] and “[s]ince the ‘875 patent did not disclose the special advantages of the dextro-rotatory isomer and of its bisulfate salt, as compared to the levo-rotatory isomer or the racemate and their salts, or the other compounds made and tested or otherwise referred to in the ‘875 patent, the invention of the ‘777 patent cannot be said to have been disclosed” [41]. The approach set out on the facts in Sanofi was picked up in comments in Novo Nordisk 2010 FC 746 [170]–[174] and in Allergan 2022 FC 260, which were relied on by Takeda and quoted by Furlanetto J at [174], [175].

So, the reason that Furlanetto J’s analysis of disclosure in this case was inconsistent with the general test set out in Sanofi, is that the SCC’s analysis of disclosure in Sanofi was also inconsistent with the general test that it had just set out. The reason for this internal inconsistency in Sanofi is that it was a selection patent case. When the SCC addressed the broad principles of anticipation, it relied on the leading cases on anticipation generally. But when it got to the specifics, it turned to cases on selection patents specifically, which run anticipation and obviousness together.

I can’t fault Furlanetto J for following the SCC’s lead. But this case illustrates the problem with the view that the special properties must be disclosed in order to anticipate. The focus on disclosure of the properties didn’t make any difference in Sanofi itself because the enantiomers were not specifically described in the prior art in any event. But in this case, the focus on the properties may have made the difference. Because Furlanetto J held that the claims were not anticipated because the plasma concentrations were not disclosed, it is not entirely clear to me whether she would have held them to be anticipated on the “what infringes if later, anticipates if earlier” test. So suppose that the prior art did indeed disclose a formulation that would indeed infringe, so that the claims would be anticipated on that test. In particular, suppose that even though the plasma levels were not disclosed, the formulation disclosed in the prior art would in fact result in clinically effective plasma levels, exceeding the threshold set out in the claims. And since there is no difference between a prior publication and prior practice, suppose that the prior patentee had marketed its product to thousands of patients, who had taken it to successfully treat their GI disorders, all without measuring the plasma levels. Would the 916 patent be valid, so that the prior manufacturer would have to withdraw its product and turn the market over to Takeda? That can’t be.

When can a range anticipate a point?

AbbVie Corporation v JAMP Pharma Corporation 2023 FC 1520 McVeigh J

2,504,868 / 2,801,917 / 2,904,458 / adalimumab / HUMIRA / SIMLANDI

The most important aspect of this case was McVeigh J’s refusal to grant a permanent injunction to the successful patentee. I will discuss that in a separate post. McVeigh J also had a brief discussion of double patenting, which I discussed in a previous post that focused on NCS v Kobold 2023 FC 1486. This post provides an overview and addresses some miscellaneous issues, including McVeigh J’s brief but helpful discussion of as to when prior art that discloses a range can anticipate a point within a range.

This case involved three patents related to adalimumab, which is well known under the brand name HUMIRA for treatment of rheumatoid arthritis, inflammatory bowel disease (IBD) and psoriasis. The 868 patent relates to a dosing regimen for a known use (the treatment of IBD). McVeigh held the 868 patent to be invalid as being obvious to try [303], though an attack based on patentable subject matter failed [339]. The 917 patent relates to a second medical use — the treatment of hidradenitis suppurativa (HS) — and a dosing regimen. It seems that the use of adalimumab to treat HS was known [400], so the key issue, as with the 868 patent, was whether the dosing regimen was obvious. McVeigh J held on the facts that it was [402]. An attack based on patentable subject matter failed [413]–[415]. There was also an unusual attack based on “Claim term not described” which I will come back to. The 458 patent related to an adalimumab formulation, which McVeigh J found on the facts to be not anticipated [559] and not obvious [591]. Attacks based on overbreadth [592]–[603] and double patenting [604]–[620], also failed.

Identical Witness Statements

As discussed here, in dTechs 2023 FCA 115 [32], [34], the FCA addressed the role of counsel in the preparation of expert reports. Gauthier JA noted that while it is not unusual for expert reports to be prepared “in close collaboration with counsel,” this is not normally a significant problem, so long as the Court is ultimately “presented with the substantive and objective opinion of the expert.” Gauther JA also noted that “While counsel may make mistakes and overstep the bounds of what is permissible involvement, this will normally be revealed on cross-examination at trial, and will be considered by trial courts in assessing the evidence” [34]. Something along those lines happened here, albeit with a fact witness:

[210] Dr. Noertersheuser suffered significant credibility issues. It became apparent during his cross-examination that much of his statement was nearly identical, or word-for-word the same, as a witness statement made by Dr. George Richard Granneman on December 18, 2017 in US litigation. While this is not, in and of itself, hugely problematic, his responses on cross-examination reduced his credibility. He attempted to explain that perhaps he and Dr. Granneman had written identical statements because of how closely they had worked together in the past. He said they worked side by side and discussed things back then, and that must have been the reason they wrote identical statements. He was asked several times and confirmed that he independently came up with the exact same words but that he never copied. This is clearly inaccurate, and he would have better served the Court by admitting the statements were copied, instead of trying to claim that it was sheer coincidence.

[212] Unlike in Rovi, Dr. Noertersheuser was not an expert witness. Nonetheless, the word-for-word copying of Dr. Granneman’s report raised significant concerns about Dr. Noertersheuser’s impartiality. His inability to accept or acknowledge the paragraphs were word-for-word the same greatly impugned his credibility and reliability.

[215] The similarity between Dr. Noertersheuser (fact witness) and Dr. Granneman’s expert report went well beyond the appropriate limits. I will assess Dr. Noertersheuser’s evidence with some caution when it is in disagreement with other witnesses.

Treating his evidence with “some caution” is a very measured response.

Blinding the Witness

Over the past decade there have been various attempts to enhance the credibility of an expert on issues such as claim construction or obviousness by not informing the expert of the party’s position when they write their report. While some earlier decisions supported this practice, the trend more recently has been to be skeptical, generally on the view that the substance of the report is more important than whether the witness was blinded. Another concern is that it may impossible to truly blind a person who is an expert keeping abreast of developments in a particular field: see eg Hospira 2018 FC 259 [203]. That problem arose in a particularly acute form in this case, when one of the experts who had been ‘blinded’, forgot that she had previously provided expert evidence in another matter involving the 868 patent [247]–[249], [252]. McVeigh J expressed skepticism of the worth of the blinding process, saying “I rely on Dr. Baughman’s evidence, not for the fact that it was blinded but for the reasoning it provides” [250]. McVeigh J did not fault Dr. Baughman, whom McVeigh J found to have sincerely failed to recall her prior involvement”; nonetheless, while she did accept the evidence as credible and reliable, she only assigned a moderate weight to it [252].

When can a range anticipate a point?

The parties disagreed “as to whether prior art that discloses a range can anticipate a point within a range or embodiment. For example, has disclosure occurred if the range is 0.2-400 mg in the prior art, and the subsequent patent claims about 10 mg or a narrower range such as 0.10-100 mg” [157]. JAMP relied on several recent cases in which “the Federal Court held a range or a broad disclosure can anticipate a point within a range or an embodiment” [158]. After reviewing those cases, and discussing several blog posts in which I have argued that these decisions were clearly wrong, McVeigh J concluded as follows:

[173] I find that the law has developed that, where the evidence presented at trial shows that the range is narrow enough, such that a flag can be planted based on the context and examples given, then it is anticipated. If the evidence shows a very broad range that the Judge, with the experts’ assistance (if needed), does not see it as a precise enough to plant the flag before proceeding to the enablement stage, then it fails at the disclosure stage.

This statement of the law strikes me as sound and helpful (though I’m not sure it actually explains the prior cases or whether McVeigh J intended it as doing so). It is consistent with the EPC Examination Guidelines G.VI.8, which also strike me as sound:

A sub-range selected from a broader numerical range of the prior art is considered novel if both of the following two criteria are satisfied (see T 261/15):

(a) the selected sub-range is narrow compared to the known range;

(b) the selected sub-range is sufficiently far removed from any specific examples disclosed in the prior art.

The meaning of "narrow" and "sufficiently far removed" has to be decided on a case by case basis.

McVeigh J also applied her analysis to the facts in two instances, both holding that there was no anticipation.

JAMP argued that the asserted claims of the 917 Patent were anticipated by the 868 application [383]. Recall that the 917 patent relates to the use of adalimumab, a TNFα inhibitor, to treat HS according to a specified dosing regimen. The 868 application disclosed the use of TNFα inhibitors as a means of treating 16 broad categories of disorders, including HS, and presenting a large class of dosing elements with numerous choices for the specific TNFα inhibitor, the number of loading doses, the amount for each loading dose, the interval between loading doses, the interval between loading and maintenance dose (one hour, one day, one week, two weeks) and the amount of maintenance dose [387]. So, “a skilled person reading the 868 Application would have a range of dose amounts, dosing intervals, and durations of treatment to choose from when creating a multiple variable dosing regimen to treat an inflammatory-related disorder” [388]. In contrast, the 917 Patent claimed a much more specific dosing regime [389]. McVeigh J invoked her para 173 analysis [385] and concluded:

[390] Given the number of dosing elements disclosed in the 868 Application, it is not clear that a POSITA would know to select adalimumab and to administer it using the specific dosing regimen claimed in the 917 Patent. If the POSITA reading the prior art reference must adopt a specific way forward in order to infringe, yet there are numerous other ways to perform the prior art without necessarily infringing, then there is no disclosure: Shire [2021 FCA 52] at para 50.

This strikes me as straightforwardly correct, and consistent both binding jurisprudence, such as Shire and with McVeigh J’s summary statement at [173].

JAMP also argued that the asserted claims of the 458 Patent, claiming a formulation of adalimumab, were anticipated by the 181 Application, titled “Self-Buffering Protein Formulations” [539]. The 181 Application listed adalimumab among the proteins:

[545] The most preferred protein concentration range in the 181 Application is 20-150 mg/mL. This is a very large range. For the four proteins tested whose test results appeared in the 181 Application, there were concentrations of 90 mg/mL and 110 mg/mL which proved to be self-buffering within pH ranges which included 5.2. But there were other ranges tested too, and none of these proteins were adalimumab. Moreover, in the claims section of the 181 Application, these proteins are not introduced in the same claim as adalimumab and there is no indication of dependency between the claims that introduce these proteins and the claim which refers to adalimumab.

[546] As mentioned above, a range does not always anticipate a point, but it could if dependant on the facts of the particular patent. This is even truer where the range is very large or broad. Accordingly, I do not see how a range of protein concentration from 20-150 mg/mL can plant a flag at the specific concentration of 100 mg/mL, especially where specific examples of formulations given do not include the relevant protein.

Accordingly, she held the 181 application did not anticipate. Again, this strikes me as straightforwardly correct, and consistent both the binding jurisprudence and with McViegh J’s summary statement at [173].

Methods of medical treatment

It is still black letter law that methods of medical treatment are not patentable subject matter, though the jurisprudential basis for that proposition is shaky: see Hospira 2020 FCA 30 [48]–[49] (discussed here). However, no one really knows what a “method of medical treatment” is. That’s because there is no clear principle underpinning the rule. The rule was originally set out by the SCC in Tennessee Eastman [1974] SCR 111, primarily on the very logical basis that allowing patentability of methods of medical treatment would allow an end-run around what was then s 41, which restricted patents for medicine to product-by-process claims. Section 41 has since been repealed, but Tennessee Eastman had a tantalizing dictum — “I do not think so” — suggesting there might be more to it than that. Subsequent decisions of the SCC suggested that the bar might turn on the “essentially non-economic” nature of the methods of medical treatment: see Hospira 2020 FCA 30 [49], discussing Shell Oil [1982] 2 SCR 536, 554 and Wellcome / AZT 2002 SCC 77 [49]. But no one really knows what it means to say that professional skills are essentially non-economic. (Try telling that to a lawyer.)

In any event, the best current theory is that a claim that encompasses the skill of a medical professional is unpatentable. To say it’s the best theory is not to say it’s a correct theory, or even a good theory — see Hospira [51]–[52] — but that’s more or less where we are now. The problem is that no one really knows what it means for a claim to encompass the skill of a medical professional. As a result, we are all flailing in trying to give some kind of content to the putative rule that methods of medical treatment are unpatentable.

In this case, JAMP argued that the claims of the 868 and 917 patents, both directed to dosage regimens, were invalid as being directed to a method of medical treatment that requires the exercise of professional skill or judgment [332] saying that:

[333] where there is evidence that the dose would be changed over time in response to a patient’s needs, then that regimen is vulnerable to an attack on the basis that is an unpatentable method of medical treatment. In JAMP’s view, the dosing regimen must be appropriate for all.

McVeigh J rejected this argument, quoting the decision of Manson J in Janssen 2022 FC 1218 [171] (discussed here) to the effect that if a physician departs from the claimed dosage regimen “they would no longer be practicing the claimed invention” [338]. She followed this reasoning, concluding that “to the extent a minority of physicians wish to deviate from the claimed regimens at some point, this does not render the claims unpatentable; rather, it takes their conduct outside the scope of the patents like in Janssen” [339]. See similarly [413]–[415] respecting the 917 patent.

More broadly, this suggests that the incoherent state of the law has made the Federal Court wary of striking down patents on the basis that they claim unpatentable methods of medical treatment. This wariness strikes me as being entirely appropriate. This bar on patentability has no basis in the Act. While the courts can and do read text into a statute, this is normally done only after a careful purposive interpretation shows that adhering to the text would lead to an absurd or otherwise unacceptable result. The courts are right to be reluctant to use a judge-made doctrine to strike down a patent for an invention which is otherwise new, useful and non-obvious, without some clear principled basis for doing so.

Doses not subject to discretionary adjustment

The 917 patent claimed a dosage regimen “wherein said multiple doses are not subject to any discretionary adjustment by a physician or medical practitioner” [380]. This phrase was added by AbbVie during prosecution to overcome an examiner objection that the claim was to a method of medical treatment because it limits the professional skill or judgment of a physician [441]. The issue came up as part of an added matter attack, which I will return to below. For now, I’ll just point out McVeigh J’s remark that “AbbVie’s addition did not change claim 1, nor does it broaden the claim. Claim 1 would have had the same effect, with or without the additional statement” [443]. This is a relief. I don’t want to get too far into the weeds of how this phrase might be construed. (Surely any dosage regimen is subject to discretionary adjustment in some cases, eg if the patient has an unexpected life-threatening reaction to the first dose—would that mean all claims with that phrase would be invalid?) The larger point is that McVeigh J’s statement suggests that the issue of patentability of methods of medical treatment will be decided on substantive grounds, not by trying to make the issue disappear with drafting slight of hand. When the law is settled, but unworkably, it may be necessary to allow the use of drafting methods to get around the black letter law, as was done with Swiss form claims. But that is a second best solution. It is better to get the substantive law right in the first place, and the law on patentability of methods of medical treatment is currently sufficiently unsettled to allow us to try to do that.

Added matter

JAMP attacked the 917 patent for failure to comply with s 38.2(2): see [192]–[197], reviewing the law, and [416]–[444], further reviewing the law and applying it to the facts. This attack was referred to as a “Claim Term Not Described,” but I’ll call it an “added matter” attack, as is this the conventional term for the parallel issue in UK law. The issue arises regularly in UK law, because claim amendments are permitted in litigation, and the question is whether the amended claim impermissibly adds new matter. There is limited Canadian caselaw on this provision, with the main authority being Western Oilfield 2021 FCA 24 (discussed here).

38.2(2) provides as follows:

The specification and drawings contained in an application, other than a divisional application, may not be amended to add matter that cannot reasonably be inferred from the specification or drawings contained in the application on its filing date.

One issue that was raised was whether this provision can be the basis for an invalidity attack, or whether it is purely procedural.

After reviewing the authorities, including Western Oilfield, McVeigh J concluded that “the law currently stands, it is unclear whether a patent is invalid when a party adds a claim term that cannot be reasonably inferred from the specification or drawings” [197]. Western Oilfield is perhaps a bit ambiguous. The main issue was the nature of the test for whether the new matter could be inferred, and specifically whether the Canadian courts should follow the “strict” UK test. One reason for wariness given by the FCA was that “the U.K. provision provides explicitly for patent revocation. Section 38.2 does not” [143]. McVeigh J took this as a hint that perhaps invalidity is not a remedy for failure to comply with s 38.2(2), as I did I in my post on that aspect of Western Oilfield, where I said that Locke JA’s statement “raises the question of whether added matter contrary to s 38.2 is a basis for invalidating a claim in a granted patent, or whether it is only ground for refusing an amendment during prosecution.”

On re-reading, I don’t think that is what Locke JA was suggesting. As noted, the discussion was in the context of whether the strict UK test for inferability should be followed. The full paragraph was:

[143] The third reason to be wary of the strict U.K. test is that the U.K. provision provides explicitly for patent revocation. Section 38.2 does not. On the contrary, subsection 38.2(1) provides that, subject to certain limitations, a patent application may be amended. The provision of particular interest in the present appeal, subsection 38.2(2), provides for one of the contemplated limitations.

I think Locke JA’s point is that because an amendment is explicitly permitted, we should be wary of being too restrictive in permitting such amendments. That does not imply that invalidity is not the remedy when the amendment is not permitted, even under a more relaxed test. The FCA in Western Oilfield went on to hold that the amendment was reasonably inferable [147], so the Court did not explicitly address the remedy for failure to comply with this provision.

I’d also note that s 72 of the UK Act exhaustively states the grounds for invalidity of a patent, including that the invention is not patentable (72(1)(a)), which includes anticipation or obviousness, as well as added matter (72(1)(d)). The Canadian Act has no equivalent. Section 60 simply provides that patent may be declared invalid or void, but without listing the specific grounds, and s 59 is the same. And s 28.2, for example, dealing with novelty, only says that subject matter “must not” have been disclosed, but does not say explicitly that a claim may be invalidated on that basis. So, given that there is no provision in the Canadian Act expressly stating that a patent may be held invalid for anticipation, obviousness, inutility or insufficiency, the fact that there is no provision expressly providing that a patent may be held invalid on the basis of 38.2 does mean much. This is another reason for thinking that this comment by Locke JA was not intended to question whether invalidity was the appropriate remedy for failure to comply with 38.2(2).

In any event, while McVeigh J did not consider the matter settled by Western Oilfield, she went on to hold that when an amendment is made in violation of 38.2(2), a claim is indeed invalid [434]. This seems to me to be clearly correct. Suppose I invent the wheel and file an application fully disclosing and claiming the wheel. Then, after I filed, but before my patent is granted, someone else publicly discloses how to make and use mRNA vaccines. I then amend my application to disclose and claim how to make and use mRNA vaccines. My claim can’t possibly be valid, even if it somehow slips through the patent office. There isn’t any other provision that would clearly prohibit this kind of amendment, since the mRNA vaccine is new and non-obvious as of my filing date. Section 38.2(2) provides a straightforward basis for invalidating such a patent.

The issue arose on the facts because of the addition of the phrase “wherein said multiple doses are not subject to any discretionary adjustment by a physician or medical practitioner” to the 917 patent during prosecution, as discussed above. McVeigh J held that amendment did not result in invalidity:

[443] In my view, AbbVie’s addition did not change claim 1, nor does it broaden the claim. Claim 1 would have had the same effect, with or without the additional statement.

[444] However, that is not the issue. The issue is whether the added claim term was reasonably inferable from the 917 Patent disclosure. I find that though it does conflict with the disclosure, AbbVie has not gained anything more than it originally had.

It’s not clear to me what McVeigh J meant when she said the added term “does conflict with the disclosure” but the main point seems to be that since the amendment did not change the claim scope, nothing at all was added, so it follows that nothing that was not reasonably inferable was added.

Claim construction

The only real dispute between the parties was the definition of “treating” in Claim 1

[296] I agree and adopt JAMP’s experts’ construction, as, even given its ordinary meaning, treating does not always achieve a meaningful result. Treating means attaining some therapeutic results but does not demand a particular duration or result.

[297] Treating does not mean achieving a meaningful clinical response and I do not accept Dr. Marshall’s definition that there must be a “certain therapeutic effect” (Dr. Marshall Report at para 91). “Treating” means a physician administering or prescribing adalimumab to an IBD patient according to the dosing regimen of the patent.

This seems right to me, not just on the text.

The question goes to utility. Generally, clinical efficacy does not have to be established at the time of filing. If the research has proceeded to the point where there is sufficient information to support a valid patent, the patent agent will want to draft a valid claim. The drafter will never specify “clinical efficacy” in the claim unless it is crucial to validity, because doing so needlessly raises the bar for utility. It seems to be consistent with a purposive interpretation to construe the claims on the presumption that the drafter did not intend to draft the claim in a way that would undermine its validity.

The Whole Disclosure Must be Reviewed

Biogen Canada Inc v Pharmascience Inc 2022 FCA 143 Gauthier JA: Gleason, Rivoalen JJA affg Biogen Canada Inc v Taro Pharmaceuticals Inc 2020 FC 621 Manson J

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

            FC Mosaic FC Anticipation FC Medical Treatment

There has been an on-going debate in the case law as to whether recourse to the disclosure is always permissible in claim construction, or is permissible only if the claim terms are ambiguous. In this decision, Gauthier JA has given us a clear and definitive answer (my emphasis):

[73] [T]he point of the [claim construction] analysis is to interpret and respect the inventors’ objective intention as manifested in the words he used. This is why the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims. Indeed, one of the reasons for reviewing the disclosure is to determine whether the inventor actually defines particular words that could appear plain and simple even to a POSITA when reading only the claims.

Gauthier JA again emphasized the point

[71] Although the principles described by the Federal Court are not in dispute in this case, it is still important to reiterate that a patent’s description (also referred to as the disclosure) must be considered when construing claims.

And see [72] stating that “[p]urposive claim construction involves looking at words of the claims in context,” and the relevant context includes the description.

Moreover, Gauthier JA directly applied this principle in her analysis. The specific question was whether terms such as “for improving walking” incorporated a subjective assessment by the patient, or only a quantitatively measured improvement, as Manson J held [75]. While the FCA ultimately upheld Manson J’s claim construction on a deferential standard of review [142], this is not a case where the FCA affirmed the FC claim construction on a holistic appreciation and a deferential standard, perhaps glossing over some details. One of the appellant’s main arguments was that Manson J erred in construing certain contentious terms against what they considered to be conclusive evidence of agreement between the experts [77]. Gauthier JA consequently chose to go into considerable detail on claim construction to illustrate why it can be appropriate for a trial judge to reject expert evidence of how a skilled person would read a claim when that evidence is not supported by a proper application of the principles of purposive claim construction [86], [91]. (This case is also an excellent illustration of the principle that claim construction is a matter for the court.) Consequently, much of Gauthier JA’s discussion reflects the FCA’s own view as to the correct claim construction, not simply the application of a deferential standard of review.

Gauthier JA pointed out that the 277 patent expressly stated that all technical and scientific terms used have the same meanings as commonly understood by one of ordinary skill in the art, “[u]nless defined otherwise,” and indeed, certain specific expressions were given specific definitions [96]. Thus, Gauthier JA’s observation that one must review the disclosure “to determine whether the inventor actually defines particular words that could appear plain and simple” when reading only the claims was directly illustrated in this case. Similarly, she also noted the key contentious terms, namely “use for improving”, “use for increasing” or “use for reducing,” were common words that “[o]n their face . . . appear plain and simple” [82]. She nonetheless went on to consider the description at length [87]–[116], before reviewing the expert evidence and finally arriving at a conclusion on claim construction [142].

It is somewhat unfortunate that Gauthier JA did not refer to the debate over this point, but she cannot have been unaware of it. And this is not a situation where there was some clear and unambiguous statement from the FCA to the effect that recourse to the disclosure is impermissible unless the claim terms are ambiguous; rather, the debate has arisen because of a variety of ambiguous statements by the FCA: McHaffie J provided a thorough review of the cases in Guest Tek 2021 FC 276, discussed here. The point was also raised in Google v Sonos 2022 FC 1116 [40], released just a week after this decision. In that case, Zinn J reviewed the recent FC caselaw and agreed with McHaffie J that “[t]he exercise of construction must consider both the disclosure and the claims” [42]–[44]. Thus, there was already a consensus emerging at the FC level, which is consistent with the position stated by Gauthier JA. The key point is that recourse to the disclosure is always permissible, but “[t]he disclosure should not be used to enlarge or contract the scope of the claims, particularly through the addition of words or limitations not found in the claims” [42], quoting and agreeing with Guest Tek [47]. In the circumstances, I take it that Gauthier JA did not review the caselaw because she was of the view that the point was not sufficiently controversial to warrant it. In any event, given the very clear statement of principle, combined with its application to the facts, we can now take it as settled law that in carrying out claim construction, “the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims.”

Obviousness

After affirmed Manson J’s holding on claim construction, the FCA went on to affirm on his finding that the asserted claims were invalid for obviousness [170]. In my post on Manson J’s decision on this issue, I suggested that his analysis was notable for making a mosaic of obscure prior art. This issue was not raised at the FCA. I’ll discuss it further in my upcoming post on Google v Sonos 2022 FC 1116, which raises the same issue.

Anticipation

Manson J also held the 277 patent invalid for anticipation, noting that the key anticipatory prior art “is similar to the allegedly anticipatory art in Hospira [2020 FCA 30]” [133]. As discussed here, I had several concerns regarding the implications of Hospira, as reflected in Manson J’s analysis. It is therefore noteworthy that Gauthier JA declined to address anticipation:

[172] As mentioned, there is no need to discuss the Federal Court’s findings in respect of anticipation, nor is this the proper case to address in obiter the question of how Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2020 FCA 30 (Hospira) and the Federal Court’s conclusion on anticipation might have an impact on inventions requiring investments in large clinical trials, as briefly argued.

[173] That said, it is important to recall that nothing in these reasons or my conclusion that the appeal should be dismissed, should be understood as endorsing the conclusion of the Federal Court on anticipation. Also, neither this Court in Hospira nor the Federal Court intended to modify the well-established test enunciated in Sanofi (FC Decision at paras. 114-115).

Nor did Gauthier JA discuss Manson J’s holding that none of the asserted claims were invalid as covering unpatentable methods of medical treatment [FC 214], discussed here, as the issue was not raised before the FCA [33].

The Gillette Defence Is Typically Unhelpful

Western Oilfield Equipment Rentals Ltd v M-I LLC 2021 FCA 24 Locke JA: Gleason, Mactavish JJA affg 2019 FC 1606 O'Reilly J

            2,664,173 / Shaker and Degasser Combination

Friday’s post provided some background on this case and addressed the issue of reasonable compensation. Today’s post reviews Locke JA’s very helpful discussion of the Gillette defence. (The discussion did not turn on the way the issue arose on the facts and the issue did not affect the result.)

Locke JA began by reiterating the classic understanding of the Gillette defence, which permits a defence based on establishing that its allegedly infringing product is the same as, or not patentably distinct from, the prior art; if that can be established on the facts, the asserted claims must necessarily be invalid or not infringed: [75]–[76] citing Gillette (1913) 30 RPC 465 (HL) and JK Smit [1940] SCR 279. While this is not new law, it is important nonetheless, as Locke JA emphasized that “contrary to some of the jurisprudence of the Federal Court, the success of a Gillette defence does not depend on a conclusion that the claim in question is invalid for anticipation or obviousness. Quite the contrary, the principal benefit of a Gillette defence is to avoid the need to construe the claims and reach a conclusion on validity and infringement issues.” [79]. Locke JA noted that the FCA itself in Eurocopter had skirted with a similar misunderstanding [80]

The theory of the Gillette defence is that it permits “a shortcut around the often difficult and time-consuming process of construing the claims of a patent, and then determining whether those claims are valid and whether they have been infringed” [77]. Unfortunately, in practice the Gillette defence has often complicated rather than simplified the proceedings. The defendant will rarely risk everything on the Gillette defence, but will typically assert it as an alternative to the analysis of claim construction and validity [78]–[79]. This means that even when the Gillette defence is raised, the court will normally have to construe the claims and assess validity and infringement, in order to address the other anticipation and infringement arguments. In that case, the Gillette defence is superfluous; rather than simplifying proceedings, by obviating the need to consider infringement and validity, it complicates matters by introducing an extra and unnecessary argument, which may lead to confusion [79].

The general message is that when claim construction, validity and infringement are fully argued, it is probably preferable to avoid the Gillette defence entirely.

Prior Art Teaching Away from the Invention: Anticipated but Not Obvious

Swist v MEG Energy Corp 2021 FC 10 Fothergill J

2,800,746 / Pressure Assisted Oil Recovery

In this decision Fothergill J held Swist’s 746 patent was not infringed by MEG. He also held it to be invalid for anticipation and lack of utility, though the obviousness attack failed. The decision turns largely on the facts and on claim construction, except for the holding regarding utility. One curious aspect of the decision is that the 746 patent was anticipated by one piece of prior art, but not obvious over the same prior art. That is quite unusual, but the holding strikes me as sound on the particular facts. I am not so sure about the utility holding though.

The 746 patent relates to a method of extracting oil from oil sands. The oil contained in the oil sands, often referred to as bitumen, is too thick to be pumped out of the ground directly [2]. One standard technique is steam assisted gravity drainage [SAGD]. In SAGD, a pair of parallel horizontal wells are vertically separated by a distance of roughly four to eight metres. Steam is injected in the top “injector” well, forming a “steam chamber” that heats the oil and reduces its viscosity. The now mobile oil drains down by gravity into the bottom “production” well of the pair, and can then be pumped to the surface [15]–[16]. Several well pairs are often used in parallel for recovery from the entire reservoir. The steam chamber from adjacent well pairs will eventually merge as the reservoir is depleted.

 

There are a number of modifications of the basic SAGD method. The claimed invention is one such variant, which uses a third injector well placed between the adjacent SAGD well pairs [5].

 

The claimed invention also specified the timing of when the steam is injected into the third well [34]. In particular, the 746 patent claim a method where steam is injected into the third well prior to the merger of the steam chambers from the adjacent well pairs. 

There were several terms that required construction, but this turned on the expert evidence and I didn’t see anything noteworthy in this part of the decision. Infringement turned partly on the facts and partly on claim construction, and again I didn’t see anything of particular interest. (Which, by the way, I view as a good thing: new legal points are fun, but it's a sign that the legal system is working smoothly when a decision involves nothing more than the application of settled law to the facts at hand.)

Anticipation also turned largely on the facts, but one interesting point did arise. One piece of prior art, the “Arthur Patent” disclosed adjacent SAGD well pairs with an injection well between them [145].

Swist sought to distinguish the Arthur Patent on the basis of the timing of injection of steam into the third well [148]. In particular, while the 746 patent claimed a method with injection prior to the merger of the adjacent steam chambers, the Arthur Patent recommended injection into the third well after that merger, noting that premature injection might compromise production [153], [156]. Thus the Arthur Patent taught away from the 746 patent. However, while the Arthur Patent recommended late injection, it acknowledged that activation of the third well may occur at a “distinctly earlier stage” [154].

Fothergill J held that the Arthur Patent was anticipatory, as it disclosed all the essential elements of the relevant claims [159]. This is notwithstanding that it taught away from the 746 patent:

[151] The fact that prior art “teaches away” from an impugned patent, while potentially relevant to an obviousness allegation, is irrelevant to the anticipation analysis. The fact that a piece of prior art discloses formulations that would not infringe a patent, as well as formulations that do infringe, is irrelevant to assessing anticipation.

The point is not completely novel, but it seems the caselaw is limited. Fothergill J cited Valence v Phostech 2011 FC 174 [228], which directly supports the proposition, but with very little discussion. He also cited Aux Sable 2019 FC 581 [97]–[98] and Schering-Plough 2009 FC 1128 [86]–[90], which both support a slightly weaker proposition, that “the fact that a piece of prior art teaches formulations that would not infringe a patent, as well as formulation that do infringe, is irrelevant to assessing anticipation.” So, Fothergill J’s holding does have support, but it perhaps not well-established in the Canadian jurisprudence. (Though it does appear to be well-established in the US caselaw, as Fothergill J noted [152].)

Aside from the caselaw, it strikes me that Fothergill J’s holding is sound as a matter of principle. It is now well-established that a genus claim to a large group of chemical compounds does not in itself anticipate the species within that claim, except for those species that are specifically described. The specific identification of a species constitutes the disclosure part of the novelty requirement—planting the flag on the precise destination—and, so long as it is also enabled, it doesn’t generally matter whether the skilled person would actually choose to practice that particular species. A genus patent will often specify several especially preferred compounds, and it is clear that they will all be anticipated even if, as a practical matter, a skilled person would only actually want to make one or two of those, perhaps for manufacturability or regulatory reasons. I don’t see why it should make any difference why the skilled person would choose not to make a particular embodiment.

The fact that the Arthur Patent specifically described the method claimed in the 746 patent, yet taught away from it, led to the counter-intuitive conclusion that even though the 746 patent was anticipated by the Arthur Patent, it was not obvious over the Arthur Patent [214]. This is quite ususal, but nonetheless seems right on the unusual facts.

Fothergill J also held that the 746 patent lacked utility, essentially on the basis that the 746 patent was not in fact an improvement over the prior art SAGD method: “the claims lack utility because the subject mater of the invention is enhancement of traditional SAGD, and Swist’s invention does not provide this” [226]. This is even though the claims themselves do not specify that the claimed method is an improvement. This holding seems wrong to me. Every inventor hopes that their invention will be an improvement over the state of the art, but whether that is true in fact has long been held to be irrelevant to utility:

As Lord Herschell explained over a century ago, in BASF v Levinstein (1887) 4 RPC 449 (HL) at 466 (HL) a case dealing with a patent for a red dye:

The demand for a particular colour depends upon changing fashion and passing moods of fancy. The one which to-day may be in large demand may to-morrow be a drug in the market. Again, a process which at one time could not be worked at a profit on account of the expense of the materials employed may shortly afterwards be so worked by reason of a diminution in the cost of these materials. Is the person who patents such a process to be deprived of all benefit of his invention when it becomes a commercial success, because at the time the patent was granted it could not be worked at a profit?

And as the Supreme Court noted in Consolboard [1981] 1 SCR 504, it is enough that the invention “affords the public a useful choice.” See also Lowell v Lewis 15 F Cas 1018, 1019 (CCD Mass 1817), per Story J (rejecting the proposition that to satisfy the utility requirement the invention must supersede those in common use); Purdue Pharma v Pharmascience Inc 2009 FC 726 [8] (noting that “The inventor of a new pain killer will not be denied a patent simply because it is only half as effective as aspirin and twice as expensive”); Astrazeneca Canada Inc v Mylan Pharmaceuticals ULC / anastrozole (NOC) 2012 FCA 109 [37] (noting that a compound that is no better than existing alternatives nonetheless has patentable utility); Pfizer Canada Inc v Mylan Pharmaceuticals ULC (NOC) 2014 FC 38 [66] (“ It would not matter if other pain relievers were far more effective.”)

The Limits of Anticipation by Speculation

Teva Canada Innovation v Pharmascience Inc 2020 FC 1158 Kane J

2,702,437 / 2,760,802 / glatiramer acetate / Copaxone / Glatect / NOC

The patents at issue in this case relate to the use of glatiramer acetate for the treatment of multiple sclerosis [MS]. Glatiramer acetate was known to be effective in treating MS, with a standard dose of 20mg daily, administered by subcutaneous injection. The 437 patent claims the early use of glatiramer acetate for the purpose of delaying the development of MS, while the 802 patent claims a dosing regime of 40mg three times a week. The decision turned largely on the facts (to the tune of 936 paragraphs!), but a few points of interest were raised, particularly in the discussion of the 437 patent, which Kane J held to be novel, but invalid for obviousness. Kane J's holding that the 802 patent was not invalid for obviousness or lack of utility, and that it would be infringed by Pharmascience's 40mg product, turned on the facts.

MS is a disease of the central nervous system in which the patient’s own immune system attacks the myelin of the CNS. The early course of the disease is characterized by intermittent attacks, which include episodes of numbness, muscle weakness and spasticity, etc [73]. The disease also gives rise to lesions on the CNS resulting from destruction of the myelin sheath [71]. Patients who present with a single clinical attack having features typical of MS were considered to have a “clinically isolated syndrome” (CIS) [77]. CIS patients are at elevated risk for MS itself (also referred to as “clinically definite MS” or CDMS), but not all CIS is caused by MS, so CIS patients are not considered to actually have MS.

The inventive concept of the 437 patent is that glatiramer acetate could be used to delay the onset of clinically definite MS in CIS patents at risk of developing MS [569]. Accordingly, Claim 1 was to glatiramer acetate “for use in delaying the onset of clinically definite multiple sclerosis,” in a patient who presents with at least one lesion “suggestive of multiple sclerosis” and who is “at risk of developing” clinically definite MS, and “prior to development of clinically definite multiple sclerosis” [251].

The claim construction debate turned on the fact that around the time of filing, in 2007, the criteria for diagnosing MS were changing. The older Poser criteria relied on clinical signs, ie two clinical attacks. The new McDonald criteria were developed to take advantage of the use of MRI for diagnosis using direct detection of lesions characteristic of MS with less reliance on clinical signs. The result is that some patients who would not have been diagnosed as actually having MS using the Poser criteria, would be diagnosed as having it using the McDonald criteria. The 437 patent was apparently developed with the Poser criteria in mind and there was a long and involved argument as to whether the patients with MS according to the McDonald criteria would be included in the claim; if so, the claim would not be novel, as the use of glatiramer acetate for treating MS was known [305].

I must admit that I was having trouble following the argument and its significance, and I was relieved when Kane J stated that “In my view, far too much time and effort was devoted to debating the meaning of the terms, the evolving diagnostic criteria and the scope of the patients covered by the claims” [306] . All the experts construed the claims in accordance with their plain language, which did not specifically refer to either set of criteria by name, and “the claims mean what they say” [307]. Kane J held that on a plain reading of the claims they were directed to a patient who did not already have a confirmed diagnosis of MS, and so did not include patients who already met the McDonald criteria [329]. This reading seems eminently sensible to me. The result of this claim construction holding was to negate both anticipation based on the Pinchasi 2007 prior art [454] as well as the Gillette defence [396], [403].

In light of this conclusion on claim construction, the more interesting anticipation argument was based on the Karussis 2006 prior art. This was a report of an International Working Group for Treatment Optimization in MS [458]. The report suggested the use of therapies approved for treatment of MS itself, which prominently includes glatiramer acetate, as a possible treatment for patients at risk of developing MS (ie, those with CIS), but acknowledged that this was an inference and was not based on evidence [464], [465]. So, the Working Group concluded that “as [other therapies] and glatiramer acetate have been shown to be effective in [the most common form of diagnosed MS], and a patient with a CIS is highly likely to progress to MS, it is reasonable to propose early treatment with [therapies approved for treatment of MS] at the doses approved for MS, even though there is not yet evidence to support this approach” [465]. The question is whether this and similar statements anticipated the claims of the 437 patent.

This raises the issue of what I have called “anticipation by speculation,” as raised in Hospira 2020 FCA 30 and Biogen v Taro 2020 FC 621, which held that similarly speculative statements were anticipatory. As discussed here and here, my view is that Hospira and Biogen v Taro stretched anticipation to the very limit, and perhaps beyond. In this case, Kane J held that Karussis 2006 was not anticipatory. This is not to say that Kane J’s holding is necessarily inconsistent with Hospira and Biogen v Taro, which Kane J considered and distinguished on the facts: [479]–[482]. I won’t go through all the particular grounds, though I will say that the distinctions she draw struck me as generally reasonable; as always in borderline cases, some of the distinctions to be drawn will necessarily be fine and turn on the particular facts. The broader point is that Kane J’s holding illustrates that anticipation by speculation can only be pushed so far and the line is somewhere in this general vicinity.

One general observation made by Kane J is worth pointing out (my emphasis):

[484] In my view, if Karussis 2006 is anticipatory art, what would prevent a group of experts in any field from having discussions and speculating on the positive outcome of a clinical trial in progress, developed and implemented by others, in order to later argue that their speculation that the trial in progress would be successful anticipated the claims of a patent that are based on such clinical trials. This approach seems to be inconsistent with the objectives of the experimental use exemption established in the common law.

[485] As noted by Teva, the law recognizes that there is no disclosure for the purposes of anticipation where a prior use is experimental. If a patent cannot be anticipated by its own clinical study, in my view, it cannot be anticipated by the speculative recommendations of a group of experts who discuss the state of MS treatment, note the lack of evidence, and note that trials are underway.

Kane J then went on to hold that Karussis 2006 did not in any event satisfy the enablement branch of anticipation: [486]–[493].

All that was for nought, so far as Allergan is concerned, as Kane J then went on to find the 437 patent invalid for obviousness on an obvious-to-try analysis. This is likely to be common in cases where a clear suggestion to try the invention can be found in the prior art, especially since the holding in Hospira 2020 FCA 30 that the state of the art for purposes of an obviousness attack includes all prior art. Exactly where we draw the line on anticipation is now less important, because if an obscure piece of prior art does not quite reach the level of anticipation, it can still be used as the basis for an obviousness attack. With that said, it does not appear that the Hospira rule made any difference in this case; while Karussis 2006 was not common general knowledge, it reflected several studies that were [573].

I’ll finish with two quick points on obviousness.

First, Kane J clearly stated that the mere fact that it is not self-evident that the invention will work, before any experiments are undertaken, does not mean that it is not obvious.

[593] Dr. Selchen’s opinion that the invention was not self-evident appears to conflate the obvious to try test with the factor or consideration that informs the test, i.e., whether it was self-evident that it would work, in the sense of being effective for CIS patients to delay the onset of MS and achieve the other claimed benefits.

I entirely agree with Kane J on this, but it is a point that continues to pop up and cause confusion, as it did for Dr Selchen in this case.

Second, Kane J recognized and applied the “golden bonus” rule, usually traced back to Hallen v Brabantia [1991] RPC 195, 216 (CA), which says that if an invention is obvious for one reason, it does not become non-obvious merely because it has some non-obvious benefits (the "golden bonus"):

[594] Teva’s submission – that the therapeutic benefits or outcomes of the ‘437 Patent were not obvious or expected – does not diminish that the invention was obvious to try. In Janssen [2015 FC 184] at para 100 [see here], the Court explained, that “if a patentee obtains a workable formulation, the later discovery of one of its inherent characteristics does not add anything inventive to what had already been discovered: see Alcon Canada Inc. v Apotex Inc., 2012 FC 410 at para 45, [2012] FCJ No 1707 (QL).” In the present circumstances, once the POSITA pursued the use of glatiramer acetate for CIS patients, the claimed benefits would follow.

As Kane J notes, this is not an entirely new development in Canadian law, but it is nonetheless welcome to see the point expressly recognized and affirmed. I believe that this is the first time that the phrase “golden bonus” has actually been used in a Canadian case [510].

Camso v Soucy Affirmed from the Bench

Camso Inc c Soucy International Inc 2020 CAF 183 Nadon JA: Boivin, Leblanc JJA aff’g 2019 FC 255 Locke J

            2,372,949 / 2,388,294 / 2,822,562 / 2,825,509 / ATV Track Assemblies

At first instance, Locke J held all the claims at issue to be all the claims in issue to be invalid for anticipation and/or obviousness. As discussed here, his decision turned on claim construction and the facts. The FCA has now affirmed in a brief decision from the bench.

Does a Range Anticipate a Point Within the Range?

 Eli Lilly Canada Inc v Mylan Pharmaceuticals ULC 2020 FC 816 St-Louis J

            2,371,684 / tadalafil / CIALIS ADCIRCA

Lilly markets 2.5mg, 5mg, 10mg and 20mg strengths of tadalafil for the treatment of erectile dysfunction [11]. The defendants in this action are various generics that want to sell tadalfil in those dosage forms [13] The asserted claims of the 684 patent were to dosage forms of tadalafil for treating ED, namely doses from 1 to about 20 mg, as well as specific doses within that range, including 2.5, 5, 10 and 20 mg doses [197-213].

The question in this case was whether the 684 patent is valid over the prior art 2,226,784 application, which claims tadalafil for the treatment of ED, and discloses unit doses of tadalafil from 0.2 to 400 mg. St-Louis J held on the facts, that starting from the knowledge that doses from .02 to 400 mg were useful, it would be routine for the skilled team to carry out the trials necessary to narrow that down to the range providing the best balance between efficacy, and safety and tolerability, and they would be motivated to do so [325-28]. The claimed invention was therefore obvious to try [323, 330].

So far, so good, and I wish I could stop the post here. However, St-Louis J also held that the 784 application anticipated the 684 patent, which, with due respect, is clearly wrong. I’ll address that issue in this post. There is also some problematic discussion of selection patents, which I will discuss in the next post. And there are some difficulties with the discussion of the role of the inventive concept in the obviousness analysis, which I won’t address, as it did not seem to impact the obvious-to-try conclusion. St-Louis J, and the parties, appear to have been guided by the decision of de Montigny J in NOC proceedings involving the same patent, Lilly v Mylan 2015 FC 125, which has similar problems, though again the basic obvious-to-try analysis was not affected.

Display to the Public Not Enabling

Bombardier Recreational Products Inc v Arctic Cat, Inc 2020 FC 691 Roy J

            2,350,264

This litigation originally concerned four patents, three rider position patents and one frame construction patent. In his initial trial decision, 2017 FC 207 Roy J held the rider position patents to be invalid for insufficiency (see here), and this was upheld by the FCA: 2018 FCA 172 (here). Roy J had held that the frame construction patent was not infringed, but the FCA reversed on a point of claim construction, held that the frame construction patent was infringed, and remanded to Roy J for determination of validity and remedies [3]. No new law was applied, but there are a few points of interest: Roy J was strongly disinclined to apply issue estoppel based on foreign litigation to a question of validity; he was inclined to view claim construction points that had not been appealed as res judicata; the prior art was not enabling because public display after races without opportunity for inspection was not disclosure to the public; and lost profits were refused because of the difficulty of establishing a causal link between the single infringed patent and the lost sales.

Foreign issue estoppel
An initial question arose because Arctic Cat sought to argue that the frame construction patent was anticipated as a matter of issue estoppel, which applies to preclude re-litigation of an issue which has been conclusively and finally decided in previous litigation between the same parties or their privies [23]. In particular, Arctic Cat argued that issue estoppel applied because of a jury verdict in US District Court in Minnesota, finding that the asserted claims were anticipated and obvious [23], [30]. After carefully reviewing the relevant cases on foreign issue estoppel, Roy J held that this argument had no reasonable prospect of success [71]. He noted that while some cases had suggested that issue estoppel based on a foreign decision might be potentially be applicable regarding purely factual findings [52], [64], no cases had actually gone so far as to apply foreign issue estoppel even on a factual issue. Further, the great weight of authorities is to the effect that determinations of validity of a patent in a foreign court are not helpful and cannot be the basis for an estoppel argument [51], [66]. In short, Arctic Cat “has not been able to refer to one patent case where the proposition it advances has had even a measure of success” [64]. Nonetheless, Roy J did not (quite) hold that foreign issue estoppel could never apply to a determination of validity, but rather that:

It would take, it seems to me, a very strong demonstration in order to accept that the issue has been conclusively decided by a jury in a foreign jurisdiction with its own law applied by its own courts, such that the verdict would bar litigation before a Canadian court, preventing it from considering the validity of a Canadian patent, using its own substantive and procedural laws, and hearing Canadian admissible evidence.

On the facts, there was not nearly enough evidence, in particular related to whether the US law of anticipation is the same as that in Canada, for the argument to have any prospect of success [68].

Reconsideration of claim construction on remand?
An interesting procedural issue was raised. The construction of several terms was at issue in the first trial [77], but only the term “engine cradle” was considered on appeal [FCA 13], and it was on the construction of that term that the FCA reversed. The question therefore arose as to whether the construction of other contentious terms should be reconsidered in light of the FCA’s construction of “engine cradle.” The issue was important because one element of prior art, the “T/S sled,” did not anticipate on the original construction of the key issues, but might if the construction of certain terms was reconsidered. Roy J was inclined to the view that the construction of the other terms was res judicata [79], but he did not need to decide as he concluded, after reconsideration of the other terms, that the outcome was the same [80], [103]. The argument that the T/S sled anticipated therefore failed in light of the claim construction [108].

Disclosure to the public
One interesting point arose in respect of anticipation. Roy J held that even if the T/S sled embodied the claimed invention (which it did not), it would not anticipate because the enablement branch of anticipation was not satisfied. This is because the evidence was that the T/S sled was only on display after races and the essential elements of the invention would not have been apparent to a skilled person on mere visual inspection [112]. This strikes me as correct; anticipation requires that the invention be made available “to the public,” and while it is enough that the public had opportunity to access the invention, in this case even that opportunity was not established. This case is quite similar to Bauer v Easton 2010 FC 361 aff’d 2011 FCA 83 in which hockey skates embodying the invention were worn in a public arena by skaters subject to an obligation of confidence; this was held not to anticipate as visual inspection at a distance was not sufficient to provide an enabling disclosure of the invention, and members of the public were not free in law and equity to carry out a close examination of the skates that would have disclosed the essential elements of the invention.

The obviousness attack failed on the facts [124]. Roy J therefore held the frame patent to be valid and infringed [125]. 

Remedies
Turning to remedies, BRP sought lost profits for sales that it would have made but for the infringement and a reasonable royalty in respect of the remaining sale. 

The claim for lost profits failed, because BRP’s case on damages “was largely built on the four patents-in-suit having been infringed.” In light of the holding that only one patent was infringed, it was too difficult to make out the necessary causal link between the infringement of that single patent and the lost sales, as the rider position patents that had been held to be invalid, were a major driver of the lost sales [128], [136], [138], [144], [151].

The parties agreed that the hypothetical negotiation methodology was appropriate for establishing a reasonable royalty with a 50% split of the incremental profits attributable to the infringed patent [166], [174]. The key issue was therefore the assessment of the incremental profit. On this point Roy J preferred the evidence of BRP’s expert.

BRP sought the usual permanent injunction. Unsually, Arctic Cat resisted, not merely on the basis that there was no prospect of future infringement; on the contrary, it appears that it was Arctic Cat’s position that it should be permitted to continue to infringe: [183]. Arctic Cat advanced a variety of reasons why a permanent injunction should not be granted [183], all of which were rejected by Roy J [184]-[191], noting that “(a)n injunction normally will follow once the Court has found that a patent is valid and has been infringed” [185], quoting Abbvie 2014 FC 489 [35]. Roy J’s analysis was brief and I agree entirely, so I won’t recap it. I will plug the recent book I co-edited with Brad Biddle, Jorge Contreras, an d Brian Love, “Patent Remedies and Complex Products: Toward a Global Consensus” (open access) and especially Chapter 4 on Injunctive Relief, where we recommend that a permanent injunction be refused “if the negative effects of the injunction on enjoined parties would be disproportionate to the nature of the infringement and any noncompensable harm that the patentee will experience as a result of the absence of an injunction.”