Indefinite Hiatus

I started this blog in January of 2011. As a professor, it would have been easy to work only on projects that piqued my curiosity, but I didn’t want to write on topics of purely academic interest. By committing myself to commenting on every patent case, I wanted to force myself to learn every area of patent law that was of practical relevance. While I haven’t completely succeeded, I have certainly learned a great deal over the past thirteen years. I hope I have also provided a resource that has been useful to the profession.

While blogging has been rewarding in many ways, it has also taken up a great deal of my time. Consequently, I have decided to take an indefinite hiatus in order to pursue other projects (including trying to finish a patent law treatise that I have been working on for almost as long as I have been blogging). I won’t be blogging for at least a few months. If I do return to blogging, it will be with reduced frequency, perhaps focusing solely on FCA decisions, or on select issues of particular interest.

Thank you to all the readers who have made this blog a success over the past decade.

Trademarks Act 7(a) Unjustified Threats Claim Fails on Second Branch

Valley Blades Ltd v Usinage Pro-24 Inc (Nordik Blades) 2023 FC 1749 St-Louis J

2,856,940 2,965,426 2,992,233 / Segmented Snow Plow Blades

Valley Blades and Nordik Blades are direct competitors in the market for snowplow blades [206]. Valley Blades brought a declaratory action seeking to have Nordik’s 940 patent declared invalid, and Nordik responded with an action claiming that Valley Blades infringed Nordik’s 426 and 233 patents. The patents are all related — the 426 is a divisional of the 940 and the 233 is a divisional of the 426 [46] — and the actions were consolidated Patent [46]. The action was bifurcated and infringement was conceded [7].

St-Louis J found that all the asserted claims were obvious in a very straightforward decision which turned entirely on the facts [88]–[174]. A previous post discussed the two other validity attacks, based on overbreadth and wilful misleading. This post deals with Valley Blades claim under 7(a) of the Trademarks Act for damages for business lost as a result of demand letters sent by Nordik to Valley Blades’ clients. Unusually, in this case the claim was dismissed in part because the demand letter was found not to discredit Valley Blades wares, even though the allegations of infringement were in fact false.

Subsection 7(a) of the Trademarks Act provides that “No person shall make a false or misleading statement tending to discredit the business, goods or services of a competitor.” The essential elements of such an action are (a) a false or misleading statement; (b) tending to discredit the business, wares or services of a competitor; and (c) resulting damage: S&S Industries [1966] SCR 419, 424. As McHaffie J noted in Fluid Energy 2020 FC 81 [49], quoted at [233], “It has long been recognized that a false allegation that a competitor infringes a patent may fall within subsection 7(a). This is so even if the falsity of the allegation may not be established until later, such as after a finding that the patent is invalid.” S&S Industries was itself such a case.

There are five key cases, all dealing with communications to customers of a competitor alleging that the competitor’s product infringed the patentee’s patent. In S&S Industries [1966] SCR 419 the SCC held the patentee liable pursuant to 7(a) for losses after a trial holding the patent invalid. The central holding is that there is no requirement of malice, so that an action under 7(a) may be sustained even though the falsity of the allegation — that is, a finding that the patent is invalid — is not established until later. Then, in M&I Door Systems (1989), 25 CPR (3d) 477 (FCTD) 523–24 Cullen J found the patent at issue to be invalid, but dismissed a counterclaim based on 7(a) on the basis that the cease and desist letters were “more informative than threatening” and apparently also because the allegation of infringement was “sincerely believed.” Cullen J cited no authority for this distinction—indeed, he cited no authority at all, not even S&S Industries. He decision seems to to be at odds with S&S Industries, as discussed here. There is no certainly no basis for the distinction between threatening and informative letters in S&S Industries, and the reference to the patentee’s sincere belief is clearly inconsistent with the SCC decision.

The distinction between threatening and informative letters was then picked up by Hughes J in Supertek 2016 FC 986 [10]–[11] and Manson J in Excalibre Oil Tools 2016 FC 1279 [282] (discussed here), though in both cases the letters at issue were held to be threatening, so that the second branch of the test was satisfied: see here. (In Excalibre, Manson J held the patentee liable under 7(a), while in Supertek, Hughes J that the third branch of the test, causation, had not been satisfied: see here.) Most recently, in Fluid Energy 2020 FC 81, the defendant in an infringement action sought an interlocutory injunction prohibiting the patentee from sending cease and desist letters to its suppliers, on the basis that the letters were actionable under 7(a). As discussed here, McHaffie J undertook a through review of the relevant law, again picking up the distinction between informative and threatening letters by way of Manson J’s Supertek decision. On the facts, he found the letters to be threatening and granted the injunction.

At this point, the distinction between threatening and informative letters seems to be established, though it is difficult to reconcile with S&S Industries, and the only case to actually dismiss a 7(a) action on this basis is M&I Door Systems. As I’ve said in posts on Excalibre and Supertek, here and here, I am not a proponent of this distinction.

The problem is to balance two competing concerns. If the patent is invalid, it is wrong to allow the patentee to use a cease and desist letter to divert business away from a competitor. If the patentee does so, it is not obtaining any legitimate reward for innovation — if the patent is not valid, it has not delivered the quid pro quo of a new and useful invention. If the litigation system were perfect, the competitor could bring a declaratory action for invalidity as soon as the allegation was made, and have the patent instantaneously declared invalid. If the patent is invalid, the business gained by the patentee from its cease and desist letter is simply exploiting the delays inherent in a real world litigation system, while at the same time chilling the legitimate competition which is the lifeblood of a healthy economy.

On the other hand, if the patent is valid, the patentee is entitled to those sales, and the customers should made aware that they exposing themselves to liability by purchasing potentially infringing goods. The problem is to try to balance the risk of illegitimate chilling of competition against the interest of both the patentee and the customers in the customer being made aware of the risk of infringement.

One approach is to hold the patentee liable for threatening letters but not for informative letters. This is appealing because delivering information about the potential for infringement is the socially beneficial aspect of the cease and desist letter.

However, this is not a satisfactory solution. If the patent is not valid and the letter diverts trade away from a legitimate non-infringing competitor, then the social harm arises, no matter how politely the letter is phrased. And any letter that conveys the necessary information — that the competitor’s product potentially infringes — will have a chilling effect, no matter how politely it is phrased. Any customer who consults a lawyer will be reacting to the prospect of a lawsuit, not to the tone of the letter.

As I have noted in previous posts, here and here, the problem of balancing these legitimate interests in the face of uncertainty over the merits is very similar to the problem faced by courts in granting an interlocutory injunction. In the context of an interlocutory injunction, if the injunction is granted and it ultimately turns out that the plaintiff’s rights are not vindicated, the plaintiff will be strictly liable on the undertaking for any loss to the defendant from having been enjoined for exercising what turn out to have been its legitimate rights.

In my view, the same solution should be adopted in this context. If the patent is ultimately determined to be invalid, a patentee should be strictly liable to its competitor for any lost sales caused by an allegation of infringement made known to a customer or other third party, which causes its competitor to lose sales, whether or not the allegation is made in good faith. Liability should not turn on whether the letter is phrased politely or aggressively, or whether the threat is direct or implicit. If the patentee is confident in the validity of its patent, it can go ahead and send the cease and desist letters to its competitor’s customers, secure in the knowledge that it will ultimately prevail. If it is less confident in the validity of its patent, it can refrain from sending such letters, and instead sue the competitor itself for infringement. If the patentee prevails in that lawsuit, it can get damages for the sales that it would have made. No doubt damages are not a perfect substitute for the sales themselves, but they are a reasonable substitute, and a patentee with a weak patent should not expect perfection. Confining a patentee with a weak patent to damages is surely worth it when the alternative is to allow the patentee to exploit the delays in the litigation system to extract unjustifiably high prices on the basis of an invalid patent.

With all that said, back to the case at hand.

Two statements were at issue. The second communication was a “Notice of patent infringement” sent to a number of Valley Blades’s customers after the patent was issued, threatening to sue “all entities who are purchasing or selling” infringing copies, ie the end-users themselves. In this context, St-Louis J discussed the distinction between informative and threatening letters [235]–[239]. She noted that it was unclear whether this distinction went to the first element (falsity) or second element (tending to discredit), but she in any event held that the Notice was threatening as it directly alleged infringement and theatened legal action [240]. She consequently held that both the first [240] and second elements of the test were satisfied [244]: the Notice was false, given that the patent was invalid, and discredited Valley Blades product by threatening infringement. This much is in line with the cases such as Excalibre and Supertek.

The first communication was a demand letter sent by Nordik to Valley Blades prior to the issuance of the patent, alleging that some of Valley Blades’ products were “exact copies” of Nordik’s product and would infringe the patent once granted [209]. This letter was also sent to one of Valley Blades major customers [209], with the intent of influencing that customer to buy Nordik’s product instead [218]. Ultimately the customer ordered from Nordik, even though Valley Blades offered a steep discount [219].

St-Louis J held this was not enough to establish Valley Blades’ claim under s 7(a). The first element was satisfied, as the statement was indeed false, given that an invalid patent cannot be infringed. But St-Louis J held that the second element was not satisfied. She held that there was “no evidence that Valley Blades’ clients have retained a bad impression of Valley Blades following Nordik Blades’ actions,” and “Valley Blades has not convinced me that the Demand Letter tended to discredit its product or business” [221].

St-Louis J’s analysis on this point was very brief — a single paragraph, after reviewing the facts [221] — and difficult to follow. She referenced the distinction between threatening and informative letters, but it is not clear what role, if any, it played in her reasoning. She found that the second branch was not satisfied because it was not established that the recipients had formed a “bad impression” of the product. This could be taken to imply that she has interpreted “disparagement” in 7(a) as requiring that the communication results in the recipient thinking less of the quality of the wares. If so, that is contrary to S&S Industries, which makes it clear that an allegation that the wares infringe a patent can “disparage” the wares, even without calling the technical merits of the goods into question. Moreover, I don’t see any substantial difference between the letters at issue in this case and those that were found to be threatening in Excalibre and Fluid Energy. Perhaps some distinction might be drawn, but none is immediately apparent, and St-Louis J did not attempt to draw any distinction. (Note that in Supertek the communications were oral.)

Damages

St-Louis also held that the third element, resulting damages, had not been established in respect of either the first or second communication.

In respect of the first communication, it was established that the letter was intended to induce the customer to buy Nordik’s product instead of Valley Blades’ product [218], and the customer did indeed purchase Nordik’s product, even though Valley Blades offered a steep discount [219] for a product which Nordik itself stated was a “copy” of Nordik’s product. This did not satisfy St-Louis J that there was a causal link between the letter and the decision to purchase Nordik’s product. This strikes me as an extraordinarily high evidentiary bar.

On the second communication, after receiving the Notice, one of Valley Blades customers returned a product that it had already received — the EconoFlex-M blades — in order to avoid any litigation risk [245]–[246]. However, Nordik argued that Valley Blades had not lost business because Township had accepted a substitute Valley Blades product. In light of this, St-Louis J held that she was not persuaded that Valley Blades had established damages. As discussed here, I am inclined to think that substantial damages should not be an element in the tort itself. In this case, it is clear that Valley Blades had to stop selling one product, and that should be enough. The quantum of the harm should be left to damages inquiry, rather than being used as a substantive threshold. That is particularly important when the harm is prospective, because if substantial damages are an element of the tort, an injunction cannot be granted. That is why the better view is that only potential damage is required, as Manson J noted in Excalibre [286].

Obviousness Attack Succeeds: Overbreadth and Wilful Misleading Fail

Valley Blades Ltd v Usinage Pro-24 Inc (Nordik Blades) 2023 FC 1749 St-Louis J

2,856,940 2,965,426 2,992,233 / Segmented Snow Plow Blades

Valley Blades and Nordik Blades are direct competitors in the market for snowplow blades [206]. Valley Blades brought a declaratory action seeking to have Nordik’s 940 patent declared invalid, and Nordik responded with an action claiming that Valley Blades infringed Nordik’s 426 and 233 patents. The patents are all related — the 426 is a divisional of the 940 and the 233 is a divisional of the 426 [46] — and the actions were consolidated Patent [46]. The action was bifurcated and infringement was conceded [7].

St-Louis J found that all the asserted claims were obvious in a very straightforward decision which turned entirely on the facts [88]–[174]. Indeed, that part of the decision was so straightforward that I won’t bother to summarize it. This post will deal with the two other validity attacks, while a subsequent post will address the defendant’s claim under the Trademarks Act s 7(a) for damages for business lost as a result of demand letters sent by Nordik to Valley Blades’ clients.

Overbreath

The first of the other validity attacks was based on overbreadth. In a two part article I have argued that the overbreadth requirement is almost always redundant: Overbreadth in Canadian Patent Law, 33 IPJ 21 and 33 IPJ 147. But the FCA in Seedlings 2021 FCA 154 [50], held that overbreadth is indeed an independent ground of invalidity, and since then parties attacking the patent have been trying to find a way to use overbreadth to launch novel attacks on the patent, so far without success.

In this case, St-Louis J summarized the law of overbreadth as follows:

[175] The law of overbreadth is rooted in the patent bargain; an inventor shall not reap the benefits of an expanded monopoly without a corresponding sufficient disclosure to the public (Seedlings Life Science Ventures, LLC v Pfizer Canada ULC, 2020 FC 1 at para 167).

[178] To identify whether an element goes to the “core of the invention,” the Court ought to consider whether implementing the invention without those elements would require inventive ingenuity (Seedlings FCA at para 63).

This is a fair summary of those decisions, but it is also a fair summary of the sufficiency requirement.

On the facts, Valley Blades argued that the claims at issue were “broader than the invention actually made by [the inventor]. It argues this is because the tapered shape of the Nordik Blades’ blades is not claimed in any of the Disputed Claims” [180]. Valley Blades relied on the inventor’s evidence: “during his examination for discovery in July 2020, [the inventor] was clear that he considered the shape of the Nordik Blades’ blades to be a part of his purported invention” [181]. This passage suggests that Valley Blades was arguing that “the invention” is what the inventor subjectively believed the invention to be. This is an outlandish argument. In the first place, the inventor very often does not know their true invention, because the inventor is not always aware of the complete prior art and so is not necessarily aware of their true contribution. Second, even if the inventor did have a more advanced invention in their head, how can that invalidate the patent they actually were granted? If Sargon invented the wheel, but the idea of a spoked wheel passed through his mind, a patent on the wheel would still be valid. That would be true whether he thought of the spoked wheel either before or after he filed his application for the wheel. It would also be true if he had said to a friend, “My invention is the spoked wheel” after filing his patent; and the same would be true if he had said that before filing the patent.

In response Nordik argued that “nothing demonstrates that the tapered shape is an essential element for the invention to work as claimed in the Nordik Patents” [186]. This seems to be saying that the patent was not overbroad because the claimed invention had utility even without the tapered shape. On this view, overbreadth seems to be a lack of utility argument in a different guise, which, as I explain in my article, is often the case. St-Louis J accepted Nordik’s position, saying “when I factor in all the evidence, I am not convinced on balance that the blades’ tapered shape was an omitted essential element of the invention and that the claims are invalid for claiming more than the invention that was made” [188].

Section 53 Wilful misleading

Valley Blades argued that the patents were invalid for wilful misleading under s 53(1) because some statements in the specifications exaggerated the benefits of the invention [192]. St-Louis J had no difficulty dismissing this attack. She noted that the threshold for establishing wilful misleading is high, and “even assuming that Nordik Blades somehow exaggerated the blade movement, the system’s efficiency, and the blade’s wear-and-tear, I find nothing amounts to the required threshold for statements violating section 53" [197].

In making this argument, Valley Blades relied on Ratiopharm v Pfizer 2009 FC 711, which St-Louis J distinguished on the basis that “the misstatements referred to in Ratiopharm appear considerably more serious—particularly as they relate to pharmaceutical products—than what has been raised against Nordik Blades” [197]. I’d also point out that the FC decision in Ratiopharm is not good authority in any event. While the decision was affirmed on appeal, the s 53 analysis was not. In Ratiopharm 2010 FCA 204 noted that:

[34] Pfizer expressed concern that the trial judge’s determination pursuant to subsection 53(1) of the Act was based on an overly broad interpretation of that subsection. I am of the view that the determination is confined to the unique and particular circumstances of this matter. It has limited, if any, value as a precedent.

Is a Patent Insufficient If it Requires a Minor Research Project to Practice?

Takeda Canada Inc v Apotex Inc 2024 FC 106 Furlanetto J

2,570,916 / dexlansoprazole / DEXILANT / NOC

As discussed in my last post, the patent at issue in this case related to a “pulsatile” dosage form of proton pump inhibitors (PPIs) 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]. As discussed in my last post, Furlanetto J held that Takeda had not established infringement. That aspect of her decision was entirely straightforward, and 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]. The last post discussed the novelty argument. This post deals with the remaining validity issues. It raises the thorny issue of whether the factual basis for a sound prediction must be disclosed in the patent; I review the debate, though in the end this decision adds nothing new, as the point was not contested. The other interesting issue is the treatment of sufficiency, which strikes me as problematic in apparently requiring a patentee to disclose in the patent the amount of active ingredient necessary for clinical efficacy.

Obviousness

There is nothing notable in the obviousness analysis, but a brief description is useful in understanding the utility argument. While pulsatile dosage forms were known in the prior art for dealing with the breakthrough effect, there were some differences between the prior art and the asserted claims: in particular, the asserted claims specified the plasma concentrations needed to prevent breakthrough [209] and also required the second dose to be larger, to compensate for reduced absorption in the lower digestive tract [213]–[215]. Furlanetto J held that these differences would not have been obvious, in an analysis that turned on the facts [217]–[227].

Utility

Furlanetto J stated that “where the utility is founded on a sound prediction, the factual basis for the prediction must be set out in the patent disclosure” to the extent it is not based on the CGK [231]. Whether the factual basis for a sound prediction needs to be disclosed in the patent is a long running debate seeming from an enigmatic statement in Wellcome / AZT 2002 SCC 77 [70]:

Thirdly, there must be proper disclosure. Normally, it is sufficient if the specification provides a full, clear and exact description of the nature of the invention and the manner in which it can be practised. . . . In this sort of case, however, the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly. Precise disclosure requirements in this regard do not arise for decision in this case because both the underlying facts (the test data) and the line of reasoning (the chain terminator effect) were in fact disclosed, and disclosure in this respect did not become an issue between the parties. I therefore say no more about it.

The Federal Courts initially understood this as requiring only the standard disclosure of how to make and use the invention: see eg Aventis Pharma v Apotex 2006 FCA 64 [28]–[35] affg 2005 FC 1283 [178]–[254]. Then, in Raloxifene 2008 FC 142 [164] affd 2009 FCA 97 [15], Hughes J interpreted this paragraph of Wellcome / AZT as requiring disclosure of the factual basis for the sound prediction in the patent itself. (There’s also a separate issue as to what is meant by “this sort of case”: see AstraZeneca FC 2014 FC 638 [141], discussed here.)

There are two main problems with this. First, the factual basis for sound prediction was not disclosed in the patent in the leading cases: see my post “The underlying facts were NOT in fact disclosed,” showing that the factual basis for the sound prediction was not disclosed in Wellcome / AZT itself; and see my comments to that post showing that the factual basis was not disclosed in Olin Mathieson [1970] RPC 157 (Ch) either, which Wellcome / AZT [60] identified as the case which gave “serious shape and substance” to the doctrine. Second, it seems clear that there is no duty to disclose the factual basis for demonstrated utility in the patent. (Initially it was entirely clear that there was no such duty, but after the enhanced disclosure requirement was advanced for sound prediction, there have been some hints that there is an enhanced disclosure requirements for demonstrated utility as well.) There is only one utility requirement in the Act, and it is often a very fine line between demonstrated utility and sound prediction — the difference will turn on exactly how much data has been collected. So, if the facts A, B, C and D are enough to demonstrate utility, but the facts A, B & C are only enough to establish a sound prediction, if the applicant is in possession of the facts A, B, C and D, it will not need to disclose any of them, but if the applicant is only in possession of the facts the facts A, B & C, they will need to be disclosed. It is difficult to see any rationale for this distinction. The only rationale that has been provided for the heightened disclosure requirement for sound prediction is the statement in Wellcome / AZT [70] that “the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly.” This statement is completely opaque, which is entirely understandable, given that it was expressly obiter. As a result, it is not clear what the rationale is for a heightened disclosure requirement for sound prediction; and it is double unclear as to what the rationale might be for distinguishing the disclosure requirement in a case of sound prediction from that when utility is demonstrated.

In this case, the parties evidently accepted that the factual basis must be disclosed in the patent, as Furlanetto J did not indicate that her statement at [231] was disputed. I’m not convinced that the the point is settled. Furlanetto J relied on Eurocopter 2013 FCA 219 [153], Apotex v Allergan 2015 FCA 137 [9] and Pharmascience v Teva 2022 FCA 2 [5]. Eurocoper says only that disclousre of the factual basis “may” be required and Apotex v Allergan merely paraphrased this in a brief decision affirming the decision below on the facts. Pharmascience v Teva 2022 FCA 2 is more directly on point, but even there Locke JA’s remarks are ambiguous, as discussed here. Since the parties did not dispute the point, this decision doesn’t add any authority to the debate. The issue will eventually have to be clarified by the FCA.

Given that position, the question was whether two examples provided a sufficient factual basis for a sound prediction of utility. The parties agreed that the requisite utility was simply “to give a pharmacological effect (i.e., as agreed by the parties in this context, an effect on gastric acid pH)” [233]. Furlanetto J found that a scintilla of utility had not been established on the facts [248], apparently because “the effect of a pulsatile release dosage form on gastric pH could not have been predicted” [244].

I have to admit, I find this very suprising. It is very well known that PPIs are effective in treating GI issues, at least when given in a large enough dose to meet threshold blood plasma levels. Claim 11, which was one of the assserted claims [2], specifies blood plasma levels of at least 450 ng/ml, which I take it is well over the threshold. Presumably if this concentration were achieved with a single dose, it would be effective. I find it very difficult to understand how it makes any difference if the same plasma level is achieved with pulsatile dose. But I have to admit that I couldn’t really follow the technical evidence reviewed by Furlanetto J, and anyway, it is a finding on the evidence.

Sufficiency

Furlanetto J held the disclosure was insufficient for two reasons.

[258] First, Example 1 does not provide sufficient information for the PSA to understand how the inventors arrived at the oral dosage data and steady state plasma concentrations in the patent. As highlighted earlier and explained by Dr. Davies, the experimentation said to underlie Example 1 yielded modelled results that would be known to the PSA to be significantly lower than actual steady state plasma concentration values. Further, the data was from an IV study alone at one time point and did not include the subsequent oral dosage modelling data that was necessary for the inventors to translate the results of the modelling to threshold concentrations for a pulsatile release oral dosage form to be used over a 24 hour time period.

I find this passage a bit difficult to understand. The second sentence suggests that the problem is that the data is misleading. If that is the issue, Takeda was right in saying that this was a disguised s 53 attack [260]. Alternatively, Furlanetto J might be saying that the defect was simply the failure to disclosure how the inventors “arrived at the oral dosage data and steady state plasma concentrations.” This seems to be saying that the inventors must disclose in the patent the experiments and reasoning process that led them to arrive at their invention. If that is what was meant, it is not correct. As it happens, this point was addressed by Manson J in his very recent decision in Proslide v WhiteWater 2024 FC 175, in which WhiteWater argued that “the key principle” of the law of sufficiency is that “information known by the patentee may be considered in assessing whether the disclosure is sufficient,” and that “[f]acts known by the inventor, and intentionally omitted or not communicated in the description of a patent can result in disclosure being insufficient”. Manson J rejected this argument, encapsulating the established law of sufficiency as follows:

[19] WhiteWater’s position broadens the scope of sufficient disclosure beyond what the law actually supports. Section 27(3) of the Patent Act, RSC, 1985, c P-4, requires the patent to make a full disclosure, but that requirement pertains to “the invention and its operation or use as contemplated by the inventor” in the patent. Therefore, the extent of the obligation to make sufficient disclosure is limited in two ways. First, the information need only pertain to the invention as disclosed and claimed by the patent. Second, that information must enable the skilled person to make or use that invention (Teva at paras 50-52, 70). Further disclosure is not necessary to meet the requirements of sufficiency as contemplated by section 27(3).

On the whole, I suspect that what Furlanetto J was really getting at in this paragraph was similar to her second point, which is easier to understand, so I’ll turn to that.

The second point turned on the fact that the patent claims a dosage form containing an amount of PPI that results in a specified plasma concentration, but it does not disclose the amount of the PPI that is required to achieve that concentration. The amount of PPI required to achieve the specified plasma levels would depend on a variety of factors, such as the exact dosage form, as the excipients can affect absorption [263]–[264]. Consequently, determining the exact amount of PPI to achieve the specified levels would require a non-trivial amount of routine research, albeit not rising to the level of invention.

Furlanetto J cited Idenix v Gilead 2017 FCA 161 [19] for the proposition that “[a] disclosure is insufficient if it necessitates the working out of a problem,” and Seedlings 2021 FCA 154 [68], Leo Pharma 2017 FCA 50 [59] and Teva 2012 SCC 60 [75] for the proposition that “a minor research project is too much,” though some non-inventive trial and error experimentation may be permitted [257]. Applying this threshold to the facts, she held on the facts that the effort requires was too much [268].

This is problematic. Novel drugs are often patented very early in the R&D process, often on the basis of in vitro tests only, at a point where identifying the actual dose and dosage form necessary for clinical efficacy is a very long way off. This is typically true when utility is based on a sound prediction, and is often true even when utility has been demonstrated. While the patent will typically state the quantity needed, this is normally little more than guesswork. For example, in ZYTIGA 2021 FCA 45, concerning the 2,661,422 patent, which related to a combination of abiraterone acetate & prednisone for treating prostate cancer (discussed here), the specification stated that the amount to be administered was “about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate” — a range of four orders of magnitude, and that for a compound that was already known. Similarly, in Rosiglitazone 2011 FC 239 (discussed here), the specification stated that the unit dose “normally contain an amount of the active ingredient in the range of from 0.1 to 1000 mg.” In HGS v Lilly [2011] UKSC 51, concerning EP(UK)0,939,804, relating to neutrokine alpha and related anitbodies, the specification stated that “[0125] As a general proposition, the total pharmaceutically effective amount of Neutrokine-α polypeptide administered parenterally per dose will be in the range of about 1 µg/kg/day to 10 mg/kg/day of patient body weight, although, as noted above, this will be subject to therapeutic discretion.”

It might be suggested that this case is different because the claims specified the requisite blood plasma concentration of the active ingredient and determining this concentration was part of the inventive concept. But sufficiency requires that the patentee disclose how to use the invention. Even when the plasma concentration is not specified, the skilled person still has to be able to practice the invention by determining an effective amount of the drug, so this doesn’t seem to be a difference in principle. A patent is sufficient if some trial and error is needed to find the clinically effective dose when a new compound is claimed, and the trial and error needed to find the dose needed to find the plasma concentration in this cases seems to be of the same nature, and if anything less extensive, given that the desired concentration is specified. But maybe there is more to this point that I am not seeing.

In coming to her conclusion, Furlanetto J relied primarily on the SCC Teva decision [267], which invalidated the patent for requiring what the decision repeatedly referred to as a “minor research project.” More specifically, and crucially, in Teva the skilled person would have to “undertake a minor research project to determine what the true invention was” [75] (my emphasis). This reference to determining the “true invention” was repeated consistently, in all the SCC’s references to a “minor research project”: see [17], [74], [75]. The issue in Teva was that the patent disclosed that one of the especially preferred compounds had been tested in humans and found to be effective, but the patent did not disclose which one. It was the failure to disclose which compound had been tested that constituted the failure to disclose “the true invention.” As the SCC noted in Teva, the trial judge felt that requiring the skilled person to undertake “a minor research project in order to determine which of the claims describes the true invention. . . plays games with the reader.” And as the FCA noted in Leo Pharma, the issue in Teva was that “the patentee had deliberately omitted essential information, thereby obscuring the fact that only one of the compounds claimed actually worked. Thus, the invention itself was not even properly disclosed” [58]. (See also Proslide [26], to the same effect.)

Thus the disclosure requirement at issue in Teva was not about disclosure of how to make the invention, it was disclosure of “the true invention.” And as the FCA pointed out in BRP v Arctic Cat 2018 FCA 172 [78], “[e]nablement (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 [Teva].” In this case there was no suggestion that Takeda had tried to conceal the true invention. The disclosure requirement at issue in this case was not disclosure of the true invention, but standard enablement, or how to practice the invention. And as the FCA further pointed out in Leo Pharma [58]–[59] and in BRP v Arctic Cat [78], the SCC in Teva did not change the traditional standard for sufficiency of disclosure of how to make the invention. In BRP v Arctic Cat [78], the FCA held that it was an error of law to apply the Teva standard for disclosure of the invention to the completely distinct context of enablement. With respect, it appears that Furlanetto J may have made that error in this case.

With all that said, I would return to the s 53 point. If Takeda actually knew the amount of active ingredient necessary to achieve the specified plasma concentrations and failed to disclose it, it is possible that there might be some kind of wilful misleading argument to be made. I don’t want to explore this further since it wasn’t at issue; the point is simply that a s 53 objection should be dealt with under s 53, and not by a strained interpretation of the sufficiency requirement.

Claims Broader

Apotex argued that the claims were overbroad “because the work of the inventors established that at least 1 hour was required between the pulsed doses; however, this 1 hour was not claimed” [270]. This seems to be redundant with utility, but in any event, it failed on the facts [274].

Ambiguity

A weak ambiguity attack also failed on the facts: [275]–[279].