Is a Dosage Range Unpatentable as Being a Method of Medical Treatment?

Bayer Inc v Cobalt Pharmaceuticals Company / drospirenone (NOC) 2013 FC 1061 Hughes J
            YAZ / drospirenone / 2,179,728

As noted in my overview post, the Drospirenone decision is notable primarily as a development in the law relating to the patentability of methods of medical treatment, as Hughes J held four of the five claims at issue to be invalid on this basis.

Claims 1, 2, 6,7 and 8 were at issue [124]. All but Claim 8 were held to be invalid [162]. Claim 1, which is representative of the invalid claims, was as follows:

1. Use of an oral dosage form comprising an estrogen selected from

2.0 to 6.0 mg of 17-estradiol and

0.015 to 0.020 mg of ethinylestradiol;

and a gestagen selected from

0.05 to 0.075 mg of gestodene,

0.075 to 0.125 mg of levonorgestrel,

0.06 to 0.15 mg of desogestrel,

0.06 to 0.15 mg of 3-ketodesogestrel,

0.2 to 0.3 mg of norgestimate,

>0.35 to 0.75 mg of norethisterone,

0.1 mg of drospirenone to a drospirenone dose equivalent to 0.075 mg of gestodene, and

0.1 mg of cyproterone acetate to a cyproterone acetate dose equivalent to 0.075 mg of gestodene;

for contraception for a female of reproductive age who has not yet reached premenopause, by administration of the form of dosage for 23 or 24 days, beginning on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

Claim 2 restricted the estragen to ethinylestradiol, Claim 6 restricted the gestagen to one of the two listed in Claim 1, and Claim 7 was similar to Claim 1, but with somewhat more restricted dose ranges [158].

Claim 8, held to be valid, was as follows:

8. Use according to claim 1, whereby the estrogen is present in a dose of 20 µg of ethinylestradiol or an equivalent dose of 17-estradiol and the gestagen is present in a dose of 75 µg of gestodene or an equivalent dose of levonorgestrel, cyproterone acetate or drospirenone.

As noted by Hughes J, in contrast with the first four claims, “Claim 8 is restricted to a single dosage (not a range) of one of two estrogens; and a single dosage, not a range, of one of three gestagens” [159].

After referring to his Cobalt / zoledronate (NOC) 2013 FC 985 decision (blogged here) as summarizing the law, Hughes J held Claim 1, 2, 6 and 7 invalid for the following reasons (my emphasis):

[160 In the present case, all claims are clearly expressed in terms of use for a contraceptive. All claims except claim 8 provide for a range of dosages for one or both of the estrogen and gestagen components.

[162] The point, however, is not whether a commercial product is provided with fixed dosages and regimens. The point is, what do the claims say? All claims at issue are use claims, not product claims. All but claim 8 claim the use as a contraceptive of a two-component drug with each component to be selected from a choice of components, and with each component to be furnished at a dosage within a range of dosages. Claims 1, 2, 6 and 7 are not proper subject matter for a Canadian patent, as they do not claim a vendible product; they provide for a choice to be made by those prescribing or providing contraceptive drugs to choose between a variety of components and a variety of dosage ranges. Only claim 8 survives, as it is directed to a single dosage of each of two compounds.

Hughes J evidently wrote Cobalt / zoledronate with Drospirenone in mind, so the contrast between Claim 8 and the other four claims is directly reflected in the second pair of contrasting claims he identified at [91]-[92] of that decision:

• the substance X in the form of a 5 mg tablet for the treatment of Y [patenable]

• the use of substance X in a dosage range between A and B for the treatment of X [unpatentable].

From this, it follows directly that Claim 8 is patentable while the others are unpatentable. Drospirenone is helpful in explaining why Hughes J is of the view that claims to a dosage range are unpatentable, namely that “they provide for a choice to be made by those prescribing or providing contraceptive drugs to choose between a variety of components and a variety of dosage ranges” [162]. The implication is that by providing for a choice to be made, this implicates the professional skill of the prescribing doctor: (and see [161]).

I see two problems with this analysis. First, there is a distinction between a patent which requires the use of professional skill to practice the invention, and one in which professional skill may be exercised, but is not required, while practicing the invention. In Drospirenone, Hughes J held the claims to be useful, which implies that any combination with the specified range would work as an effective contraceptive. Professional skill might be exercised in practising the invention, to reduce side effects, for example, but in principle professional skill is not necessary to practice the invention effectively. Consider an analogy to a selection patent, in which the genus patent specifies that a broad range of compounds is effective for a particular purpose. It might well require professional skill, whether that of a doctor or engineer, depending on the patent, to get the most out of the invention; and if sufficient skill is required in choosing the best species, this might even be the basis for a valid selection patent. But the fact that professional skill is normally exercised in the practice of the genus patent, does not make the genus patent invalid. In this case, the patent does not “provide” for a choice to be made, in the sense of requiring a choice to practice the invention effectively, but rather it allows for a choice to be made. Put another way, elsewhere in this decision, Hughes J accepted that the word “about” is not vague and implies a range of about 10% around the specified value [103-06]. It would be possible to cover the entire range specified by Claim 1, by claims framed similarly to Claim 8, except to dosages “about” a single dosage. While this would require a very large number of claims, the difference between this multiplicity of specific dosage claims, and a single claim to a range of dosages, is purely formal. In summary, many patentable inventions allow for the exercise of professional skill in their implementation, and this alone does not make the claims invalid. While Claim 1 certainly allows for the exercise of professional skill, it does not seem to me to require it.

Moreover, even the suggestion that a claim is invalid if it requires the exercise of medical skill, is very difficult to reconcile with Wellcome / AZT 2002 SCC 77 which upheld a Claim 22 to the use of “an effective amount” of AZT. Surely choosing an effective amount of AZT implicates the professional skill of a doctor or pharmacist just as much as choosing from a specified range. Indeed, more skill is required by the AZT claim, because, as just noted, in this case any selection within the range specified by the ‘728 patent would work, whereas in the AZT claim, professional skill must be exercised to select an effective amount. (See also my post on Cobalt / zoledronate, making a similar point.)

More broadly, what is wrong with a claim which requires the exercise of professional skill? Many claims are of this nature, and the question is normally treated as one of sufficiency. It is well established that a claim requiring the exercise of professional skill is not invalid for that reason, so long as undue experimentation is not required. As discussed in my previous post, there may be a sense that the exercise of professional skill is inherently nebulous, but if that is the real objection, it should be dealt with directly, by invalidating for insufficiency or ambiguity, claims where the professional skill required by the claim is of a nature that is not described or cannot be reliably replicated.

If the objection relates to the exercise of medical skill in particular, we must ask what distinguishes medical skill from other professional skills. One answer is that there is a policy argument to be made that a physician should not be prevented from treating her patient to the best of her ability by fear of a patent action. But if that is the real objection, the better response is to address it directly, by providing a defence for physicians, as in the US under 35 USC § 287(c)(1). That is surely a policy decision for the legislature; and in any event, this policy goal is not aided by Hughes J’s distinction between dosage ranges and a single dosage; to the extent that the compositions encompassed by any of the Claims are “used” by the prescribing physician, allowing claims to specific dosages exposes physicians to liability; Claim 8 would be infringed by a physician who determines that the dosage specified by that claim is appropriate for her patient.

Ultimately, it seems to me that the distinction between a dosage range and a specific dosage is a formalism which lacks a a clear policy rationale, and is inconsistent with Wellcome / AZT.

It is also very disappointing to see the apparent resurrection, both in this decision [162] and in Cobalt / zolendronate and the case-law discussed therein, of the long-discredited “vendible product” test for patentable subject matter. This test was created by Morton J in Re GEC's Application, (1942) 60 RPC 1 at 4, where he stated that “a method or process is a manner of manufacture if it (a) results in the production of some vendible product or (b) improves or restores to its former condition a vendible product or (c) has the effect of preserving from deterioration some vendible product to which it is applied.” The list is curiously specific, if it is an attempt to reconcile difficult cases on narrow factual grounds – though Morton J did not cite specific authority for this proposition, referring merely to “cases cited to me”. But it is more bluntly described as legal gerrymandering, aimed at reaching a particular result on the facts. There is no unifying principle, either stated or apparent. While the phrase “vendible product” is repeated, it is not truly a unifying concept, as not every invention that affects a vendible product is patentable; only certain effects are within the scope of the rule. In particular, on the facts of the case, Morton J held that using a known compound for extinguishing a fire did not fall within the rule as stated, apparently because preserving a vendible product from fire does not amount to “preserving from deterioration.” This invisibly fine distinction was evidently developed for the purpose of allowing Morton J to hold the invention unpatentable. The application at issue was for a patent on a method of extinguishing incendiary bombs by means of a concentrated aqueous solution of a known substance (zinc chloride). Legal realism provides the most obvious explanation for the rule: the case was decided in the middle of World War II, just after the Blitz, and Morton J did not want the inventor to be able to hold London to ransom. While this is no doubt a reasonable concern, it does not warrant re-writing the law of patentable subject matter. In Canada today, this concern could be addressed by s 19 of the Act.

Regardless of the explanation for Morton J’s decision in Re GEC's Application, it is no longer good law. Morton J held that the claims in question on the basis that they were “nothing more than claims for a new use of an old substance, such use not being, in my view, a manner of manufacture.” This holding, which was made immediately after his statement of the vendible production rule, and which is apparently his application of that rule on the facts, is directly inconsistent with Shell Oil, [1982] 2 SCR 536, the leading SCC decision on patentable subject matter, which upheld the patentability of a new use for an old compound. Even prior to that, the vendible product rule itself has been effectively expunged from the law by the penetrating analysis of the High Court of Australia in NRDC (1961) 102 CLR 252 (HCA). For more discussion of the vendible product rule, see my article, The Rule Against Abstract Claims: History and Principles, 26 CIPR 205 at 224-25 (draft version here).

YAZ Overview

Bayer Inc v Cobalt Pharmaceuticals Company / drospirenone (NOC) 2013 FC 1061 Hughes J
            YAZ / drospirenone / 2,179,728 – 2,382,426

Cobalt sought an order of compliance allowing it to market a drospirenone + ethinylestradiol combination birth control product. Two patents were listed on the register. Hughes J granted the order of prohibition based on the ‘426 patent (which doesn’t expire until 2020), but dismissed it in respect of the earlier expiring ‘728 patent on the basis that the claims which were arguably infringed were unpatentable methods of medical treatment, as well as non-infringement. This decision is significant primarily as a development in the law relating to patentability of methods of medical treatment. Another point worth noting is that the promise of the patent respecting utility was modestly construed for both patents. The decision also raised an evidentiary point of interest. Other issues turned on the facts. This post discusses the evidentiary point and the promise of the patent.

Evidentiary point
Claim 31 of Bayer’s ‘426 patent was to a composition of drospirenone with a specified dissolution profile and the question of fact was whether Cobalt’s product fell within the specified parameters. The problem for Bayer was that Cobalt refused to provide samples to Bayer for testing: “Bayer complains that, despite a motion that it brought to compel Cobalt to produce samples, Cobalt refused to do so; and the Court would not compel it to do so” [33] (and see [66]). Despite this lack of direct evidence, Hughes J held in Bayer’s favour on the infringement issue:

[68] Given that Cobalt is obliged in its Notice of Allegation to provide sufficient information so that Bayer can come to grips with the allegations made; and, given that Cobalt has supplied no sample tablets nor any evidence as to the dissolution parameters of its tablets, I must conclude that Cobalt’s allegations as to non-infringement of claim 31, and dependent claims, of the '426 patent are not justified.

In the absence of evidence, the answer must turn on the burden of proof. Hughes J summarized the rule as being that “with respect to the second person’s [generic’s] allegations of non-infringement, the first person [innovator] bears the burden of proving that such allegations are not justified” [32], which would seem to imply that Cobalt should prevail. But more precisely, the generic must present “sufficient evidence to give the allegations in its NOA an air of reality”: see eg 2013 FC 573 [37]. Similarly, in 2011 FCA 215 [15], quoted by Hughes J, the FCA affirmed that “The determination must turn on whether there are allegations by the second person sufficiently substantiated to support a conclusion for administrative purposes (the issuance of a NOC) that an applicant's patent would not be infringed if the second person's product is put on the market” (FCA emphasis). So, Hughes J’s holding on this point illustrates that a mere statement that its product will not infringe does not amount to sufficient substantiation of the allegation of non-infringement to give the allegation an air of reality. However, it appears that if the generic does supply the product for testing, this is sufficient to substantiate the allegation of non-infringement, even if the innovator does not actually test it: see 2005 FC 1205 rev'd on related but distinct grounds 2007 FCA 209.

Promise of the Patent
While the obviousness issue in this case turned on the facts, a brief review is necessary to understand the utility issue. Drospirenone is acid-labile and would degrade (isomerize) in the presence of stomach acid, and micronization could be expected to exacerbate this problem. Consistently with this, degradation of micronized drospirenone was a serious problem in in vitro tests, and consequently Bayer initially worked on an enteric coated tablet. It turned out that micronized drospirenone nonetheless had good bioavailability in vivo. Hughes J held on the facts that the good bioavailability was non-obvious [87].

The ‘426 patent contained the following statement:

Without wishing to be limited to any particular theory, it appears that the in vitro dissolution rate of drospirenone is connected to the dissolution rate in vivo resulting in rapid absorption of drospirenone in vivo on oral administration of the compound. This is an advantage because isomerization of the compound in the gastric environment and/or hydrolysis in the intestine is substantially reduced, leading to a high bioavailability of the compound.

That is, the patent speculated that the reason for the good bioavailability was that fine particles of drospirenone were absorbed more quickly than they degraded. Hughes J indicated that Cobalt argued that this passage should be construed as a promise, so that the patent would lack utility unless this theory could be shown to be the correct explanation for the observed bioavailability [97]. (I must say that the passage from Cobalt’s NOA set out at [89] seems to me to be making the more modest argument that the studies relied on were not sufficient to show that a composition with the claim dissolution profile would be an effective contraceptive, but of course I do not have the advantage of the full record.)

Hughes J declined to read this statement as a promise. He quoted at length from the FCA’s recent Clopidogrel decision 2013 FCA 186 (blogged here), emphasizing that the promise must be explicit [94] and that “Courts should not strive to defeat otherwise valid patents” [93]. He concluded that the quoted passage from the patent was not a promise, but rather an effort to explain the mechanism of action [98].

Hughes J’s emphasis on the need to avoid being overly aggressive in construing the promise is, in my view, welcome, but his holding with respect to the ‘426 patent is not especially significant, as it seems to me that the passage in question would probably not have been construed as a promise even prior to Clopidogrel.

The promise analysis of the ‘728 patent is more interesting. The ‘728 patent claimed a low-dose contraceptive composition, with a 23-day dosage cycle. In effect, a lower dose is achieved by using a longer period of administration. The specification contained the statement that “The advantages of a combination preparation for oral contraception [with the claimed characteristics] can be characterized as follows” with four specific advantages listed [120]. The passage concludes by noting that “In summary, an intake [of the claimed composition] can produce the above-mentioned advantages. . .” [120]. This is very much the kind of statement that might be taken as a promise of utility. Hughes J did not construe this as a promise, finding that it was included in the patent to support non-obviousness, rather than as a promise of utility [120]:

[152] That list should not be elevated to a “promise”; it is simply an observation as to advantages expected to be achieved. As expressed by Pelletier JA in Sanofi-Aventis v Apotex Inc, [Clopidogrel] 2013 FCA 186 at paragraph 67, in alluding to a possibility, an inventor is not promising a result to be achieved; a goal is not necessarily a promise.

Because the statement in the ‘728 patent might easily have been construed as a promise, Hughes J’s holding on this point is significant in indicating that Clopidogrel may mark a real shift in approach. Of course, it shouldn’t be surprising that an FCA decision would influence the Federal Court, but there is still a great deal of subjectivity involved in assessing the promise of the patent, so the enthusiasm with which the FC embraces Clopidogrel will strongly influence its real impact. With that said, one decision does not make a trend. Moreover, the significance of the decision on this point is diminished because it was not determinative. While Hughes J rejected the utility attack, he held the key claims invalid for lack of patentable subject matter. A more stringent test of the impact of Clopidogrel will come when validity turns on the construction of the promise.

How (Not) to Cure an Inadvertent False Promise in a Granted Patent

F. Hoffmann-La Roche AG v. Commissioner of Patents 2013 FC 1001 Roy J

            Capecitabine / XELODA / 2,103,324

As reaffirmed in the recent FCA decision in Sanofi-Aventis v Apotex / clopidogrel 2013 FCA 186, the promise of the patent doctrine is now firmly established in Canadian law. If a patent promises a particular utility, utility will be measured against that promise: ibid [47]. However, there is no requirement that a patent contain a promise, and if it does not, the invention need have a “mere scintilla” of utility: ibid [49]. In the future, applicants may be able to draft patents that will avoid making promises, but what can be done about patents that have already been granted, but not yet litigated? This was the question faced by Hoffmann-La Roche, the applicant in this motion. While Roy J refused the application, the decision suggests the possibility that s 53(2) of the Act might be available to rectify a false promise in litigation.

Non-Obviousness Affirmed on the Facts in Teva / Zoledronate

Teva Canada Ltd v Novartis Pharmaceuticals Canada Inc / zoledronate (NOC) 2013 FCA 244 Gauthier JA: Evans, Near JJA aff’g 2013 FC 283 Hughes J
            ZOMETA ACLASTA / zoledronate / 1,338,937

In a brief decision from the bench, the FCA has affirmed Hughes J’s decision granting an order of prohibition in favour of Teva on the basis of deference in respect of his appreciation of the evidence.

This NOC proceeding initially concerned two patents, one to zoledronate (‘937) and a separate patent to a broad class of compounds including zoledronate (‘895). At first instance Hughes J held the ‘895 patent invalid for lack of utility, but the ‘937 patent was held to be valid and an order of prohibition was granted accordingly: see my post here. Teva appealed only the holding respecting the ‘937 patent, on the basis that Hughes J had erred in his obviousness analysis, arguing that Hughes J had misapplied the Windsurfing / Pozzoli test accepted by the SCC in Sanofi 2008 SCC 61 [3]. Teva argued that Hughes J set the bar for non-obviousness too high, based on his statement that “one cannot raise the bar too high in respect of obviousness. Research ought to be rewarded, not discouraged” [FC 161]. The FCA pointed out at [6] that this statement reflected a similar statement made by Rothstein J in Sanofi at [64]. The FCA then went on to emphasize the deferential standard of review for factual findings in respect of obviousness [11], and noted that “The Judge is presumed to have considered all the evidence before him” [12]. In the circumstances, the FCA concluded that there was no basis for interfering with Hughes J's conclusion.

Are Swiss Form Claims a Matter of Substance?

Novartis v Cobalt / zoledronate (NOC) 2013 FC 985

            2,410,201 – ACLASTA

It is now well-established in the Federal Courts that methods of medical treatment are not patentable, but how to define such unpatentable methods is very much an open question. In Cobalt / Zoledronate Hughes J, has reviewed and summarized the Supreme Court and Federal Court jurisprudence on this point, before concluding that all the claims at issue were unpatentable. In my view, to the extent his conclusions of law are supported by  the jurisprudence, they do not justify his conclusion on the facts that the Swiss form claims are to unpatentable subject matter.

Opening the Door to Punitive Damages in Patent Law?

Eurocopter v. Bell Helicopter Textron Canada Limitée 2013 FCA 219 Mainville JA: Noël, Trudel JJA aff’g 2012 FC 113 Martineau J
            2,207,787

Punitive damages are very rarely awarded in Canadian patent cases, yet in his trial decision in Eurocopter, Martineau J held that Eurocopter was entitled to punitive damages, essentially on the basis that Bell had intentionally copied helicopter landing gear which it knew to be patented [FC 431-33]. My post on this aspect of Martineau J’s decision argued that this holding is very problematic, as it is likely to having a chilling effect on desirable challenges to invalid patents. The FCA has now affirmed Eurocopter’s entitlement to punitive damages.

Line of Reasoning Supporting Sound Prediction Must Be Disclosed in the Patent

Eurocopter v. Bell Helicopter Textron Canada Limitée 2013 FCA 219 Mainville JA: Noël, Trudel JJA aff’g 2012 FC 113 Martineau J
            2,207,787

The doctrine of sound prediction of utility is routinely applied in the context of pharmaceutical and chemical inventions, but rarely – perhaps never, before Eurocopter – applied to a mechanical invention. Nonetheless, the FCA Eurocopter decision is a significant development in the law of sound prediction, which affirms and emphasizes what I consider to be the most problematic aspects of the doctrine.

Given the novelty of applying sound prediction in the mechanical context, Eurocopter argued that the doctrine doesn’t apply to mechanical inventions at all [144]. The FCA rejected this, on the ground that there is no reason in principle why the doctrine should not apply [146]. It may generally be easier to establish demonstrate utility in the context of mechanical inventions, but I cannot think of any reason why a mechanical patentee should be precluded from establishing utility on the basis of sound prediction if it cannot establish demonstrated utility. As Snider J noted in Imatinib 2013 FC 141 [164], sound prediction “is a way of showing that an invention is useful when the invention has not been directly demonstrated to work. Its introduction into Canadian law was not, as I understand it, to give a crushing hammer to those who challenge patents.” (See more here.)

Why then was Eurocopter arguing that the doctrine does not apply? The answer is that sound prediction has become a potent weapon for attacking patents, even though Snider J was right to say that it was not originally intended as such. The reason for this is the requirement that the factual basis for sound prediction must be disclosed in the patent if, and only if, utility is based on sound prediction. This point has previously been affirmed by the FCA in the Raloxifene 2009 FCA 97 [15] and Atomoxetine 2011 FCA 220 [46-47] decisions. The consequence is to draw a sharp distinction between demonstrated utility and sound prediction, with more stringent requirements for the latter. I have argued that this distinction is inconsistent with the Act, as there is no statutory basis for this distinction; there is only one utility requirement in the Act, not two requirements with two different criteria.. Again, as Snider J stated in Imatinib “Sound prediction is not a free-standing statutory requirement” [164].

No Sign of Changed Approach to the Promise Doctrine in First Post-Clopidogrel FCA Decision

Eurocopter v. Bell Helicopter Textron Canada Limitée 2013 FCA 219 Mainville JA: Noël, Trudel JJA aff’g 2012 FC 113 Martineau J
            2,207,787

While the promise of the patent doctrine and the requirement that the factual basis for sound prediction be disclosed in the patent are most closely associated with pharmaceutical patents, the FCA Eurocopter decision is significant on both issues, particularly when contrasted with the recent FCA Clopidogrel decision 2012 FCA 186. This post deals with the promise doctrine, while the next will deal with the factual basis issue. An overview of the facts in Eurocopter is provided in my last post.

In Clopidogrel decision, as discussed here, the FCA re-affirmed the promise doctrine, but it also adopted a relatively restrictive approach to construing the promise, emphasizing repeatedly that the promise must be “explicit,” and also noting that it should not be assumed that every patent has a promise. The question remains as to whether this change in tone will generate a real change in practice. Eurocopter is the first FCA decision since Clopidogrel to consider the issue. In Eurocopter the FCA affirmed, with little discussion, a fairly aggressive pre-Clopidogrel style of interpretation of the promise. Since Eurocopter was argued before Clopidogrel was released, this may simply reflect the fact that counsel would not have argued the Clopidogrel requirement for an express promise, and the FCA did not feel inclined to review the trial judge’s construction of the promise on its own initiative. But it is disquieting that the FCA simply accepted Martineau J’s construction, without even reference to the Clopidogrel approach.

FCA Affirms Eurocopter: Overview and Claim Construction

Eurocopter v. Bell Helicopter Textron Canada Limitée 2013 FCA 219 Mainville JA: Noël, Trudel JJA aff’g 2012 FC 113 Martineau J
            2,207,787 - new Act

The FCA decision in Eurocopter is most important for its discussion of punitive damages, and it is also significant for its discussion of two doctrines more closely associated with pharmaceutical patents, namely the promise of the patent doctrine and the requirement that the factual basis for sound prediction be disclosed in the patent. I will discuss both of these issues in subsequent posts. For now I will just say that any hopes raised by the FCA’s recent Clopidogrel decision that we might see some retrenchment in respect of the pharmaceutical doctrines (see here and here), must be significantly tempered by the FCA’s Eurocopter analysis. 

This post provides background and discusses the claim construction issues. Anticipation and obviousness were also raised on appeal, but they were dismissed essentially on the basis that the points raised turned on matters of fact on which the trial judge had made no overriding error.

What Is an “Oversight” in a Order?

Sanofi-Aventis v Apotex Inc 2013 FCA 209 amending Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 Pelletier JA: Noël, Gauthier JJA rev’g 2011 FC 1486 Boivin J
            1,336,777 – PLAVIX

This decision of the FCA amends its clopidogrel decision with respect to the parties affected by the judgment. The full style of cause in the case included Apotex Inc, Apotex Pharmachem Inc and Signa SA de CV as defendants / respondents. (Apotex contracted for Pharmachem to develop the Apotex product and process of manufacture, and Pharmachem transferred the technology to Signa, which manufactured the product according to Pharmachemm’s specification, and sold it in bulk to Apotex [2013 FCA 186 [86]].) The action against Signa was discontinued (FC [10] fn 3), but the style of cause was not changed [7]. Boivin J at trial held that the patent was invalid. This holding was reversed on appeal, which required the FCA to deal with infringement. As originally written, the FCA reasons stated that “As the Trial Judge made no findings of infringement against Apotex Pharmachem Inc. and Signa SA de CV, I would dismiss Sanofi's claims against them” [2013 FCA 186, [121]]. The original FCA judgment declared that Apotex Inc infringed the patent, and that the claim against Apotex Pharmachem and Signa was dismissed [1]. Sanofi brought this motion under Rule 397 asking the FCA to amend the judgment by (1) removing the reference to Signa, which stated that the claim against it was dismissed; and (2) adding a reference stating that Apotex Pharmachem was also liable for infringement.

Ambiguity(?) in Scope of Settlement

Procter & Gamble Co v Brushpoint Innovations Inc 2013 ONSC 5747 Charbonneau J

The parties entered into a settlement agreement in which Brushpoint undertook to “not make, construct, use, or sell, or induce others to make, construct, use or sell the Products, in Canada, while any of the Patents are in force.” P&G submitted that Brushpoint or its agents, by acts in Canada, had induced parties in the US to make and sell the product in the US [13]. If, properly interpreted, the covenant restricted Brushpoint from carrying out acts in Canada which induced others to make or sell the Products anywhere, then there was a breach; on the other hand, if it only restricted Brushpoint from inducing (by acts anywhere?) others to make or sell the products in Canada, there was no breach.

Charbonneau J held that on the proper interpretation, there was no breach; the covenant restricted Brushpoint only from inducing others from infringing in Canada. He arrived at this conclusion primarily on the text of the covenant itself, which he found to be “clear and unambiguous” [11]. If he had found the clause ambiguous, he would have arrived at the same conclusion based on the context, as the settlement was presumably intended to prevent Brushpoint from infringing the Canadian patents [12].

John Golden has a very interesting article on the related issue of the scope of injunctions: Injunctions as More (or Less) than “Off Switches”: Patent Infringement Injunctions’ Scope , 90 Tex L Rev 1399 (SSRN here). Here is the abstract:

Injunctions have often been viewed as mere "off switches" that prevent future violations of rights protected by so-called property rules. But injunctions in fact come in a variety of forms having different objects, scopes, and degrees of effectiveness. In practical situations, an injunction might amount to little more than a threat of higher-than-normal monetary sanctions delivered at substantially higher-than-normal speed.

This article builds on these insights by investigating the potential and actual scopes of injunctions against patent infringement. An economic model for infringer incentives shows how concerns of injunction scope are substantially analogous to widely examined concerns of patent scope. A new taxonomy provides named classifications for different forms of injunctions. A systematic study of patent-infringement injunctions issued by U.S. district courts in 2010 indicates how often these different forms appear in practice. Startlingly, this study suggests that the majority of such patent-infringement injunctions take an "obey the law" form that violates the Federal Rules of Civil Procedure, at least as the U.S. Court of Appeals for the Federal Circuit has traditionally understood those rules. In another indication of patent law's technology specificity, only 12% of the injunctions directed to biomedical-substance technology feature such apparent error. Meanwhile, courts frequently issue specially tailored injunctions that protect patent rights more or less than a conventional "do-not-infringe" order would. Prophylactic injunctions and other specially tailored injunctions should be recognized as legitimate forms of relief that can enable better balancing of concerns of notice, rights protection, rights limitation, and administrability.

ONCA Affirms that Disgorgement of Profits in NOC S 8 Claim Not Available in Ontario

Apotex Inc v Abbott Laboratories Ltd 2013 ONCA 555 Goudge JA: Watt, Pepall JJA aff’g 2013 ONSC 356, 107 CPR(4th) 332 Quigley J

The FCA has held definitively that disgorgement of the patentee’s profits is not available as a remedy in a claim under s 8 of the NOC Regulations: 2011 FCA 358 blogged here. Hoping to circumvent this holding, Apotex turned to the Ontario courts, seeking a disgorgement of the profits made by Abbott while Apotex had been kept out of the market by operation of the NOC Regulations. In brief reasons, the ONCA has now affirmed Quigley J’s lengthy summary judgment decision (blogged here) that this claim must fail, primarily on the basis that the operation of the NOC Regulations constitutes a valid juristic reason for Abbott’s profits [6].

Purposive Construction When the Inventor Is Mistaken as to the Inventive Contribution

ABB Technology AG v Hyundai Heavy Industries Co Ltd 2013 FC 947 Barnes J
            2,570,772 – 2,567,781

ABB Technology, in which both patents at issue were held to be invalid and not infringed, is a fairly straightforward case which turned largely on its facts. It does, however, illustrate an interesting point regarding purposive interpretation of the claims.

The Supreme Court has said that “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction” Western Electric Co [1934] SCR 570 at 574, quoted by the SCC inter alia in quoted by the SCC in Consolboard, supra note 58 at 521, in Whirlpool 2000 SCC 67 [49(g)[, and Free World, 2000 SCC 66 at [43]; and see Schmeiser, 2004 SCC 34, at [35] referring to this as “the guiding principle” of claim construction. In my article on “The Essential Elements Doctrine” (2011) 22 IPJ 223 (draft available here), I explained this as following from purposive construction. The disclosure is the quit pro quo for which the patent is granted, and the inventor will normally want to claim the full scope of the invention disclosed, in order to maximize the value of the patent, but not more, in order to avoid invalidity. So, as I argued in my article, a purposive analysis of the Patent Act implies that the presumed intention of the patentee should be to claim the full patentable extent of the invention disclosed. In my article I discussed problems which arise when the textual and purposive analyses conflict. ABB Technologies raises a common problem which I did not address: what happens when the inventor has misunderstood the nature of their contribution?

No New Cases for the Week of 1 September

No new patent / NOC / data protection cases were posted on the Federal Courts' websites for the week of 1 September 2013. 

One costs decision was released: Fournier Pharma Inc. v. Canada (Health) 2013 FC 862

The Duty to Disclose “The Invention”: The Wrong Tool for the Job

Teva Canada Ltd v Pfizer Canada Inc 2012 SCC 60

2,163,446 – Sildendafil – VIAGRA

My initial response to the SCC’s Sildenafil decision was quite positive about the general reasoning, though I was somewhat more critical of the doctrinal details of the decision. I have since completed a thorough analysis of the decision, which has caused me to substantially revise my opinion. In law, the doctrinal details matter, and in my article I argue that by using the wrong tool for the job, the SCC in Sildenafil did a poor job on the facts and damaged the tool of disclosure. My article, entitled “The Duty to Disclose ‘The Invention’: The Wrong Tool for the Job,” is forthcoming in the IPJ and is available in draft from SSRN. Here is the abstract:

In its Sildenafil decision, the Supreme Court of Canada held Pfizer’s Viagra patent to be invalid for failure to disclose “the invention,” though it provided no explicit definition of that term. I argue that on the best reading of the decision, “the invention” means the new, useful, non-obvious contribution to knowledge which is disclosed in the patent. While this is initially attractive, I argue that on this definition, a duty to disclose the invention is unsound as a matter of law and policy, because it implies that if any important claim in a patent is invalid, all the claims will be invalid. This eviscerates section 58 of the Patent Act, which provides that claims stand or fall independently. I argue that the Court’s reasoning was motivated by a mistaken belief that at the time of the application Pfizer had tested the other claimed compounds and knew them to be ineffective in treating ED, and that it claimed those compounds primarily to conceal the true invention. I argue that even if the Court’s understanding of the facts was correct, a duty to disclose the invention is not the appropriate tool to address the issue. The case properly raises questions relating to the duty of good faith disclosure, not a duty to disclose the invention.

My full analysis of the Sildenafil decision also confirms my initial view that Zinn J was wrong to grant summary judgment to Apotex in the subsequent impeachment action, Apotex v Pfizer / sildenafil 2012 FC 1339, in which he held the ‘446 patent to be of no force or effect, in part on the basis that “the determination by the Supreme Court in its Reasons that the '446 Patent fails to meet the requirement of sufficient disclosure pursuant to subsection 27(3) of the Patent Act is a legal determination binding on this Court and is dispositive of Apotex's claim in this action” [30]. While it is remarkably difficult to pin down precisely the core of the SCC’s legal reasoning in Sildenafil, the decision was clearly motivated by the belief that Pfizer had tried to “game” the system [Sildenafil 80; and see Imatinib 2013 FC 141, blogged here, in which Snider J at [387] emphasized this aspect of Sildenafil]. The SCC held this view because it apparently believed that Pfizer had tested the other compounds and knew them to lack utility. This is a factual question, and the SCC’s view appears to be wrong, in large part because the nature of the NOC proceedings did not allow the question to be fully explored. This illustrates the wisdom of the current rule that the results of NOC proceedings are not binding in a subsequent infringement or impeachment action. As the SCC said in Eli Lilly & Co v Novopharm Ltd [1998] 2 SCR 129, in affirming the rule developed in the Federal Courts (SCC’s emphasis):

[95] [T]he summary judicial review that is to be conducted on an application for a prohibition order under the Regulations is highly fact-specific and is generally considered to be binding only on the parties in the specific litigation. This is only appropriate, given the limited nature of the proceedings, the question that is to be answered, and the record generated for this limited purpose. [my emphasis]

[96] This point was reinforced more recently by Strayer J.A. in David Bull Laboratories, supra, at p. 600:

This Court is not prepared to accept that patentees and generic companies alike have been forced to make their sole assertion of their private rights through the summary procedure of a judicial review application. [SCC emphasis]

Note that in Eli Lilly v Novopharm the question on which the SCC refused to provide a binding declaration was whether the supply agreement constituted a sublicence. As a question of contractual interpretation, this would be a question of law, and despite having answered the question, the SCC refused to make a binding declaration, saying “For this Court to make a binding declaration concerning the private rights and obligations of the parties to the agreement would go well beyond the limited scope of the proceeding. Accordingly, I would deny the declarator relief requested by Novopharm” [97]. The same reasoning must surely hold with respect to the question of invalidity in Sildenafil, and for the same reason; my article on Sildenafil illustrates the perils of making a binding declaration based on the basis of the summary NOC proceeding.

A Principled Approach to Awarding an Accounting of Profits

Varco Canada Ltd v Pason Systems Corp 2013 FC 750 Phelan J
            2,094,313

The remedy of an accounting of profits has undergone a resurgence in Canada since the 1980s, and it is now regularly sought by a successful patentee. There are two major questions that have emerged: (1) what is the basis for the calculation of the quantum; (2) what is the basis for an entitlement to elect an accounting? The first question has been greatly clarified by the landmark SCC decision in Monsanto v Schmeiser, 2004 SCC 34 and the subsequent FCA decision in Monsanto v Rivett FCA 2010 FCA 207 which largely affirmed the approach taken by Zinn J at first instance, 2009 FC 317. Phelan J’s decision in Varco suggests that the Federal Court may be approaching a principled and theoretically sound consensus on the second question.

Canadian Duty of Candor in Response to a Requisition is Not the Same as the US Duty to Disclose Material Prior Art

Varco Canada Ltd v Pason Systems Corp 2013 FC 750 Phelan J
            2,094,313

The main invalidity argument made by the defendants in Varco v Pason was that the patent had been abandoned pursuant to s 73(1)(a) of the Act by reason failure to reply in good faith to the Examiner’s requisition [341]. The requisition asked for “an identification of any prior art cited in respect of the corresponding United States and European patent applications.” This reply to requisition duly provided the references cited to the USPTO [342]. The defendant argued that the disclosure to the USPTO did not comply with the US disclosure requirements, because it failed to disclose material prior art, and this failure to comply with the US disclosure requirements implied lack of good faith in responding to the Canadian requisition, even though even though the response did respond strictly to the requisition, in that all references cited to the USPTO had been identified [345].

The first difficulty with this argument is that in Corlac v Weatherford 2011 FCA 228 [150] the FCA held that s 73 cannot be used to attack the validity of a granted patent. Curiously, Phelan J did not rely on this holding, even though he had made the same point at trial in Weatherford 2010 FC 602, [344].

Instead, Phelan J emphasized that the US disclosure requirements are different from the Canadian disclosure requirements [348-49]:

Section 73 of the Canadian Patent Act requires a good faith response to a requisition from one examiner, rather than the free standing duty as described in US law.

It is not accurate to say or suggest that Canada does not have a duty of candor – it is just not of the same nature as the US principle. The question is “good faith in respect of what?” In Canada the good faith and duty of candor is in response to a question or inquiry. The response has to be fair and responsive, but it need not respond beyond that which is requested.

Whether or not the US disclosure requirement had been complied with, the relevant question was whether the Canadian requirement had been complied with [352]. In this case, it had been: “the term 'prior art cited', as used in the examiner’s requisition, meant the prior art reviewed by an examiner and applied against a foreign application. It does not mean any prior art listed in a search report; nor does it mean all the prior art of which an applicant is aware,” [357] and “There is no requirement to go beyond answering that which is asked or requested” [360].

Phelan J made it clear that he did not regret the narrower scope of the Canadian requirement:

[364] Despite the not so veiled invitation of the Defendants to have this Court go down the US route of “inequitable conduct”, I will not do so. The Canadian legislation is clear, the obligation is to respond directly and honestly. The US principle is highly unsatisfactory, not supported by Canadian principles or practice, and has been described by US witnesses as a “mess”.

This embraces the message of the FCA in Weatherford: the US experience with the inequitable conduct doctrine shows that an expansive duty of good faith disclosure is a cure worse than the disease, and it will not be judicially read into the Canadian Act.

Anticipation and Obviousness in Varco v Pason

Varco Canada Ltd v Pason Systems Corp 2013 FC 750 Phelan J
            2,094,313

Yesterday’s post looked at claim construction and infringement. The anticipation, obviousness and utility issues in Varco v Pason were also fairly straightforward, though the facts provide an interesting illustration of the problems of avoiding novelty-destroying disclosure of the invention during pre-filing field testing. The most interesting legal point is Phelan J’s comments regarding the relationship between the US and Canadian duties in disclosure to the patent office, made in relation to the abandonment argument, which I will discuss in a separate post.

Anticipation
The defendant’s anticipation attack based on the prior art wholly failed, as the closest prior art cited by the defendant did not come close to anticipating the essential elements of the invention [273-288]. The argument based on the inventor’s field testing [289]-[308] was more interesting, particularly when compared with Wenzel Downhole Tools 2012 FCA 333. New designs in downhole rig equipment have to be tested on operating wells, often wells operated by a third party, and the question is what steps have to be taken in order to avoid disclosing the invention during the testing process.

In Wenzel the question was whether a third party’s downhole bearing assembly had been disclosed during its testing. The assembly embodied all the essential elements of the invention and so would be anticipatory if it was made available to the public. Since the drilling company that had tested the assembly was not bound by any obligation of confidence, the question was only whether the assembly had been “made available.” The bearing assembly was enclosed in a metal casing giving no hint of what was inside. Had the user opened the casing and inspected the assembly, it would have been able to discern the essential elements of the invention, but it would not have been usual or easy for the user to open the casing and on the facts in Wenzel the user made no effort to do so. As discussed here, the FCA, in a split decision, held that this was anticipatory: “being available does not require that access to the information be easy, simply that it be possible using known methods and instruments” [69], and the test is “whether, in this case, there was an opportunity to access the relevant information during the rental” [74, original emphasis].

In considering whether the inventor’s field testing in Varco was anticipatory, Phelan J distinguished Wenzel on the facts. As in Wenzel, inspection of the exterior would not reveal the working of the invention, but in contrast to Wenzel, the inventor in this case took steps to ensure that the device could not be inspected, by locking the device when he was absent [297], [301]. And while there was no express confidentiality agreement with the driller, that was not fatal: “Although there was no evidence as to either industry practice or corporate understanding, Bowden’s actions to keep the invention from being observed or disclosed is consistent with his intent to keep it confidential. There is no suggestion that Union Pacific thought that the testing was not confidential nor is there evidence of enabling disclosure during the test period” [304].

While the facts do legitimately distinguish Wenzel, this case illustrates the potentially difficult nature of the “opportunity to access” test. Here, the driller had opportunity to access the invention in the sense of having physical access to the device in the inventor’s absence. It would no doubt have taken lock picking tools to access the device, which the driller presumably would not have had on hand, but in Wenzel it would also have taken special tools, available only off-site, to inspect the interior of the device. It seems to me that the real distinction between the cases is with respect to intent. In Wenzel it did not appear that the third party developer of the prior art device was attempting to keep the device secret, whereas the inventor in Varco clearly was, in anticipation of obtaining a patent. As I argued in my post on Wenzel, this is consistent with a purposive analysis of the novelty requirement. If the third party in Wenzel did not care whether the device was made public, it evidently did not think the lure of a patent was necessary to provide an incentive to develop the device. In this case, that the inventor took steps to the keep the device secret, shows that he was relying on the patent incentive. The difficulty with this analysis is that anticipation should be an objective test. I suggest that these cases show that while it is an objective test, in borderline cases subjective considerations may become relevant to tipping the balance one way or the other.

Obviousness
Phelan J relied heavily on long-felt need and commercial success in holding that the invention was not obvious: see [316], [319], [320], and especially [321]. He started his analysis with the question: “if it was so obvious, why was it not done before?” (See also Nichia v Argos [2007] EWCA Civ 741 [21], Beloit v Valmet 8 CPR (3d) 289, 295.) While these considerations are sometimes disparaged as being “secondary factors” which must be kept firmly in its place,” in my article "Secondary” Evidence of Obviousness is Not Secondary, (2012) 28 CIPR 279, I have argued in that when this question is not rebutted, as in this case, it speaks far more powerfully to non-obviousness than the evidence of expert witnesses, which is inevitably tainted by hindsight, as Phelan J pointed out [316].

Correction of Error in the Claim
The only utility argument of significance turned entirely on a drafting error: the words “increased” and “decreased” had been switched in Claim 9. Interpreted literally, the invention as claimed would not work. It was uncontroversial that a skilled reader would have readily recognized that “increased” should be read to mean “decreased”, and vice versa [336], and Phelan J accordingly interpreted the claim that way, with the result that the utility challenge failed. This is consistent with a long line of authority that the entire specification must be read with “a mind willing to understand,” and consequently readily discernable errors, even in the claims, will be read as corrected: see eg Procter & Gamble Co. v. Bristol-Myers Canada Ltd. (1979), 42 CPR (2d) 33, 36-37 (FCA); 2009 FC 991, [159]; 2010 FC 1265, [99].

(Thanks to Alan Macek's IPPractice blog for posting this decision before it has appeared on the FC website. )

Background and Infringement in Varco v Pason

Varco Canada Ltd v Pason Systems Corp 2013 FC 750 Phelan J
            2,094,313

The ‘313 patent at issue in this litigation is for an automatic drilling system for use in the petroleum industry. The most interesting part of the decision concerns remedies, and particularly the question of entitlement to an accounting. This post provides an overview of the facts and infringement. Subsequent posts will deal with validity and remedies.

Objective ("Secondary") Obviousness Factors in the Federal Circuit

In my article “Secondary” Evidence of Obviousness is Not Secondary, (2012) 28 CIPR 279 (draft version here), I argued that the dictum that the “primary” evidence of obviousness is that expert witnesses, and that “secondary” evidence “must be kept firmly in its place,” is unsound in law and policy. Both types of evidence have strengths and weaknesses and both must be assessed with due regard to their relative advantages. Expert witness evidence is susceptible to the hindsight bias, while it may be difficult to establish a causal link between objective (“secondary”) evidence and obviousness. In its recent decision in Plantronics, Inc v Aiph Inc (Fed Cir 2013), the US Federal Circuit has reaffirmed that failure to consider objective evidence is an error of law (slip op 18-19):

As a safeguard against ‘slipping into use of hindsight and to resist the temptation to read into the prior art the teachings of the invention in issue,’ we have required courts to consider evidence of the objective indicia of nonobviousness prior to making the ultimate determination of whether an invention is obvious. to . . . [A]ll evidence pertaining to the objective indicia of nonobviousness must be considered before reaching an obviousness conclusion. The significance of this fourth Graham factor cannot be overlooked or be relegated to ‘secondary status.’

Update: See also Leo Pharmaceutical Products, Ltd v Rae, 2012-1520 (Fed Cir 2013) in which the Fed Cir emphasized that “Objective indicia of nonobviousness play a critical role in the obviousness analysis. . . . This case illustrates a good reason for considering objective indicia as a critical piece of the obviousness analysis: Objective indicia “can be the most probative evidence of nonobviousness in the record, and enables the court to avert the trap of hindsight.” Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1310 (Fed. Cir. 2010)”

No New Cases for the Week of 4 August

No new patent / NOC / data protection cases were posted on the Federal Courts' websites for the week of 4 August 2013.

Gauthier J on Disclosure of Factual Basis for Sound Prediction

Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 Pelletier JA, concurred in by Noël, Gauthier JJA; separate concurring reasons by Gauthier JA, rev’g 2011 FC 1486 Boivin J
            1,336,777 – PLAVIX

In Lilly v Apotex / raloxifene 2009 FCA 97, [15] aff'g 2008 FC 142 [164], and subsequently in Novopharm v Lilly / atomoxetine 2011 FCA 220, [46-47] aff’g 2010 FC 915, [116-117], the FCA held that when utility is based on sound prediction, the factual basis for the prediction must be disclosed in the patent itself. The ultimate authority for this was a passage in the SCC decision in Wellcome / AZT 2002 SCC 77, [70]. In my article, “Must the Factual Basis for Sound Prediction be Disclosed in the Patent?” (2012) 28 CIPR 39 (draft version here), I argued that Wellcome / AZT did not mandate such a rule. I also argued that the requirement is unsound, in part because it creates a sharp distinction between demonstrated utility and sound prediction. Such a distinction cannot be supported on the Act, which contains only a single utility requirement.

The requirement to disclose the factual basis for sound prediction is conceptually distinct from the promise of the patent doctrine, but the two are linked in practice; the promise doctrine raises the bar for demonstrated utility, making it more likely that sound prediction will be invoked, and the factual basis doctrine makes it more difficult to establish sound prediction. This is illustrated by Boivin J’s decision at first instance in Clopidogrel. As explained here, because he held that the patent promised a relatively high level of utility, he found that the promise was not met. Boivin J held that there was, however, a good factual basis and sound line of reasoning supporting a sound prediction of utility, but the test for sound prediction was not satisfied because the factual basis was not disclosed in the patent itself. But for the promise doctrine, sound prediction would not have been raised, and but for the factual basis doctrine, the test for sound prediction would have been satisfied.

The Promise of Selection Patents

Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 Pelletier JA, concurred in by Noël, Gauthier JJA; separate concurring reasons by Gauthier JA, rev’g 2011 FC 1486 Boivin J
            1,336,777 – PLAVIX

The ‘777 patent at issue in Clopidogrel is a selection patent over Canadian patent 1,194,875. This decision illustrates how the promise of the patent doctrine has distorted the analysis of selection patents in Canadian law, but it also illustrates that ultimately nothing turns on this. This reinforces the view that it may be time to abandon the doctrine entirely.

In Clopidogrel the FCA re-affirmed the point made by the SCC in Sanofi 2008 SCC 61 [9] and subsequently by the FCA in Olanzapine (No 1) 2010 FCA 197 [33] that “a selection patent is like any other patent” [44], in that it must satisfy the requirements that the invention be new, useful and non-obvious. It is also clear that in order to be valid, a selection patent must possess some unexpected property as compared with the genus, be it the presence of an advantage or the avoidance of a disadvantage. The question then, is whether the unexpected property is required as a matter of utility, or as a matter of non-obviousness?

The Promise of the Patent Must Be Explicit

Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 Pelletier JA, concurred in by Noël, Gauthier JJA; separate concurring reasons by Gauthier JA, rev’g 2011 FC 1486 Boivin J
            1,336,777 – PLAVIX

In Canadian law, utility is measured by the promise of the patent:

Where the specification does not promise a specific result, no particular level of utility is required; a "mere scintilla" of utility will suffice. However, where the specification sets out an explicit "promise", utility will be measured against that promise. The question is whether the invention does what the patent promises it will do.

[47, original emphasis] quoting Olanzapine (No 1), 2010 FCA 197 [76]

This doctrine has resulted in a number of pharmaceutical patents being invalidated, and in my article “The False Doctrine of False Promise,” (2013) 29 CIPR 3 (draft version available here), I argued that the promise doctrine is both unsound in principle and contrary to the Canadian Patent Act. The FCA is evidently of the contrary opinion, as the Court expressly and emphatically reaffirmed that “The promise of the patent is the standard against which the utility of the invention described in the patent is measured,” [47]: and see [48], quoted above. The FCA also expressly affirmed what I have argued is the most objectionable aspect of the promise doctrine: “An inventor whose invention is described in a patent which would otherwise be valid can nonetheless promise more for his invention than required by the Act so as to render his patent invalid” [54].

However, the FCA did significantly modify the doctrine, by emphasizing that the promise must be explicit, and that not every patent necessarily contains a promise (my emphasis):

[49] If the inventor does not make an explicit promise of a specific result, the test for utility is a “mere scintilla” of utility. If, on the other hand, the inventor makes an explicit promise of a specific result, then utility will be assessed by reference to the terms of the explicit promise.

[50] When this Court said at paragraph 80 of Olanzapine, cited above, that the promise of the patent must be ascertained, it should not be taken to have assumed that every patent contains an explicit promise of a specific result since, subject to what is said below with respect to selection patents, there is no obligation on the part of the inventor to disclose the utility of his invention in the patent. In Olanzapine, the Court was simply indicating that the firs step in assessing utility was to determine the standard against which utility will be measured. This requires the Court to construe the patent to determine if a person skilled in the art would understand it to contain an explicit promise that the invention will achieve a specific result. If so, the inventor will be held to that promise. If there is no explicit promise of a specific result, then a mere scintilla of utility will do.

Moreover, on the facts, the FCA reversed Boivin J on the basis that “He erred in law in reading into the ‘777 patent a promise for use in humans on the basis of inferences, in the absence of language at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of the genus patent” [66]. The FCA held that the patent made no promise [71], and therefore the fact that the invention had sufficient utility to support a selection patent was enough.

While the FCA Clopidogrel decision is formally consistent with the prior case law, the decision departs from the current practice both in the Court’s insistence that the promise must be explicit for it to serve as the touchstone for utility, and in emphasizing that not every patent has such a promise. The focus in previous cases has been to determine what the promise of the patent was, and not whether the patent contains a promise at all. So, in Olanzapine (No 1) the FCA said “The promise of the patent must be ascertained, [80] and “the promise of the patent is to be ascertained at the outset of an analysis with respect to utility” [93]. Clopidogrel implies that this is no longer entirely accurate, as it must first be ascertained whether the patent has a promise at all. Because the of need to ascertain the promise, if the language of the specification was not express, it would be finely parsed to extract a promise. Clopidogrel holds that this fine parsing is also misguided.

If Clopidogrel represents the law going forward, we should expect to see utility measured by the promise less often, and consequently, fewer utility attacks will be successful. The crucial question will be how explicit a promise must be in order to establish the standard for utility. Given that the doctrine was specifically affirmed, and given that the specification never has a statement beginning “This patent promises...”, I expect that direct statements of use such as “The compounds of this invention . . . are useful in the treatment of high blood pressure [and are] useful in the treatment of cardiovascular disorders and particularly mammalian hypertension” will be treated as an explicit promise: see Sanofi v Apotex / Ramipril 2009 FC 676 [122]. But where exactly the line of “explicitness” will be drawn is difficult to predict for any given patent. As I noted in my False Promise article at 41, “The root of the difficulty is that, under the promise of the patent doctrine, the utility of the invention is defined in the disclosure. The traditional purpose of the disclosure is to describe how to make and use the invention.” This disconnect remains, even if the promise must be explicit.

I said “if Clopidogrel represents the law going forward,” because it is not clear whether the views of this panel represent the views of the Court as a whole, particularly in light of Pfizer v Apotex / latanoprost (NOC) 2011 FCA 236 in which Trudel JA (Sharlow, Stratas JJA concurring), very aggressively implied a promise which was certainly not explicit in the patent. Latanoprost and Clopidogrel simply cannot be reconciled, and Clopidogrel made no attempt to do so; the Latanoprost decision was never mentioned. The question is whether we have a split in the FCA – the two decisions did not share any judges – or whether Clopidogrel represents a new consensus. If the former, then the outcome of promise cases on appeal will depend on the particular panel of the FCA. I note that the two other FCA decisions since Latanoprost endorsed a modest interpretation of the patent: Anastrozole (NOC) 2012 FCA 109 Evans JA: Sharlow, Dawson JJA (blogged here) and Donepezil (NOC) 2012 FCA 103 Mainville JA: Sharlow, Gauthier JJA (blogged here), in which the FCA remarked that “the jurisprudence does not permit an unescorted and unchaperoned romp through the disclosure” [57]. This suggests that Clopidogrel represents the culmination of a trend, but I am hesitant to draw firm conclusions; with a such a small sample size, it may be that this is not a trend at all, but a reflection of the composition of the particular panels.

On the whole, the FCA Clopidogrel decision is a very welcome development which should restrain some of the worst excesses of the false promise doctrine. However, restraining those excesses is as far as the FCA was willing to go. This is the most extensive consideration of the promise of the patent doctrine that the FCA has undertaken. That the Court reaffirmed the doctrine at the same time that it significantly restricted it, means that there is no question but that the promise of the patent doctrine will remain part of Canadian law, at least until the SCC might choose to deal with it. That is unfortunate, as I remain of the view, expressed in my False Promise article, that the doctrine is unjustifiable in any version; but as the saying goes, half a loaf is better than none.