Allergan v Apotex / Risedronate Dosage Form — Overview

Allergan Inc v Apotex Inc 2022 FC 260 Kane J

2,602,188 / risedronate / ACTONEL DR

This very long decision—262 pages and 946 paragraphs—turns largely on its facts. The length of the decision is a consequence of Kane J’s very thorough recitation of the arguments and evidence. The main point of interest arises from the somewhat unusual claim.

Allergan’s 188 patent relates to a dosage form of a bisphosphonate for use in treating osteoporosis. Bisphosphonates were well known for use in treating osteoporosis. Bisphosphonates were known to have poor bioavailability. One specific known problem was significantly lower absorption when taken with food—the “food effect”. The food effect was thought to be due to bisphosphonates forming complexes with ions, such as calcium and magnesium, from the food in the stomach. (Bisphosphonates were known to be absorbed in the small intestine.) The standard way of addressing the food effect in the prior art was to prescribe the bisphosphonate to be taken while fasting. This gave rise to compliance problems [273].

Allergan came up with a solution to the food effect, namely a dosage form comprising a combination of bisphosphonate with EDTA in an enteric coating. The enteric coating allows everything to pass into the small intestine, where the EDTA—a known chelating agent—binds to the cations and prevents them from binding to the bisphosphonate. This means that the dosage would be equally effective whether given with food or after fasting. Accordingly, Claim 1 of the 188 patent was to “An oral dosage form of a bisphosphonate for use with or without food or beverage intake, comprising...” All the claims incorporated the “for use with or without food” limitation. The “with or without” food structure of the claim is a bit odd, as “or” is normally used to signal alternatives, so that it might have been separated into two claims, one claiming use with food and one without. But given that the purpose of the invention was to overcome the food effect, the experts agreed, and Kane J held, that the claim should be construed to mean that the oral dosage can used “either with food or without food or beverage at the preference of the patient” [228]. That seems right to me.

But there’s a catch. Giving EDTA without food can cause irritation of the esophageal lining. Even though this was apparently an uncommon and fairly minor problem, and did not affect efficacy in treating osteoporosis, the product monograph for Allergan’s product, ACTONEL DR, consequently specified that it should be taken with food. The Apotex PM was essentially identical [905]. Consequently, Kane J held that Apotex’s product did not infringe, either directly or by inducement, because it was not for use with or without food, but only with food [921].

Kane J’s construction seems right, given the phrase “for use with or without food” in the claim. But I am puzzled as to why the patentee included those words in the first place. Kane J said this:

[225] For the ‘188 Patent, the ability to use the oral dosage form either with food or without food is set out in the claim because its purpose is to overcome the food effect (which is the problem of the extremely low absorption of the bisphosphonate when taken with food as opposed to when taken fasted). The oral dosage can be taken either with food or without food at the choice of the patient and the treatment effect will be similar (i.e., pharmaceutically effective absorption). The invention of the ‘188 Patent signalled a significant change in the administration of oral bisphosphonates, hence the emphasis on this feature.

It’s true that the advance was to allow a formulation that can be taken without food as well as with it, and it may be that is what motivated the applicant to include this phrase. But that does not mean that this feature has to be included in the claim itself. (I should note that this explanation was not central to Kane J’s reasoning, as it was not disputed that “with or without food” was an essential element.) So long as the compound itself is new, the purpose need not be specified: if an inventor comes up with a new drug that is useful for curing cancer, they are entitled to claim the compound per se, without restricting it to the use in curing cancer. In this case, the claimed composition* was new: it was essentially a selection over the closest prior art, a prior Brazilian patent application referred to as BR 601: see eg [366], [372]. So I’m at a bit of a loss to explain why it was included.** If the phrase was indeed unnecessary, that suggests the possibility that “for use without or without food” is not an essential element, but this argument was not run by Allergan [188]. So I presume there was some reason for including the phrase that is not apparent from the decision. I wonder if the phrase might have been added to placate an obstinate examiner? I note that even if it was added in response to an objection, it is not clear that this precludes a finding of non-essentiality: see Actavis [2017] UKSC 48 UKSC.

Allegan also argued that “for use with or without food” should be construed as meaning only ‘suitable for’, not intended for. Kane J rejected this argument, which I’ll discuss at more length in my next post.

In light of this construction, infringement turned on the factual issue as to whether the PM instructed use with food, or whether taking with food was optional. Allergan’s argument was to the effect that a skilled person would recognize that it would be effective if taken without food, since the side effects were minor. Nonetheless, as Kane J found [905]–[922], the PM clearly and repeated instructed that the product should be taken with food: eg ““Do not take ACTONEL DR before food or on an empty stomach. . .” That this instruction was to avoid abdominal pain rather than to enable effective absorption does not change the fact that the product was for use with food. Apotex’s PM was the same, and so Apotex did not infringe directly or by inducement.

There are a couple of other points to note. One of the expert witnesses had been ‘blinded’, but Kane J was not impressed: “I note that the jurisprudence is mixed on the treatment of blinded evidence. I favour the approach noted in Janssen Inc v Apotex Inc, 2019 FC 1355 at paras 58-59 . . . that blinded opinions are not necessarily given greater weight just because they are blinded.”

Another point is that the most relevant prior art, a prior Brazilian patent application referred to as BR 601, was obscure prior art; that is, it was available to the public, but it would not have been found by a skilled person in a reasonably diligent search [634]. This raised on the facts the holding in Hospira 2020 FCA 30 that the state of the art for the purposes of an obviousness attack includes all prior art. In my post on Hospira, I suggested that this holding leaves open the question of whether obscure prior art can be mosaiced in an obviousness attack.

Kane J noted that

[635] In accordance with Hospira at para 86, it would be an error for the Court to exclude BR 601 from the mosaic of prior art because it would not be found by the skilled person in a reasonably diligent search.

[636] As guided by Hospira, the likelihood that BR 601 would not turn up (and, based on the evidence, it would not turn up) is relevant to the obvious to try test; i.e., would the skilled person have thought to combine BR 601 with the other prior art to bridge the differences between the state of the art and the invention?

She then noted that

[637] This is a tricky distinction when applied to the facts. If BR 601 is part of the prior art, then the differences between the state of the art and the invention would need to account for whatever can be distilled from BR 601 as part of the “state of the art”. However, if the skilled person would not have found BR 601, how can the skilled person consider it in the context of combining it with other prior art at the obvious to try stage of the analysis of obviousness? This is only possible in circumstances where the unknown prior art is handed to the skilled person. To avoid this dilemma and running afoul of Hospira, I have considered BR 601 as if it were prior art, but as noted, the “teaching” of BR 601 requires careful scrutiny.

Ultimately, Kane J did not have to wrestle too directly with this “tricky distinction”, because, as I read it, BR 601 simply would not make the 188 patent obvious, no matter how it was used. BR 601 was at best a broad genus than encompassed the claimed invention, but did not point to it with any specificity, and did not give any hint of the special advantages of the 188 dosage form.

*The original version of the post said the "compound" was new: that is not correct. It is the claimed composition that was new. 

**Since the composition was new, it seems to me that it could have been claimed as such, without that phrase, in the same way a new compound can be claimed without specifying the use. 

No Mosaicing of Obscure Prior Art

dTechs EPM Ltd v British Columbia Hydro and Power Authority 2021 FC 190 Fothergill J

2,549,087 / Electrical Theft Detection System

I had intended to return from my blogging break with a post on the “inventive concept” aspects of Apotex v Shire 2021 FCA 52. That is turning into a bigger project than anticipated. I’ll have a few posts on that issue in another week or two. In the meantime I’ll catch up on the decisions that came out while I was on break, starting with dTechs.

In this decision Fothergill J held dTechs’ 087 patent to be not infringed, and also invalid for anticipation and obviousness. The decision turned almost entirely on claim construction and the facts. There were two legal points of interest, though the decision did not turn on either of them. First, Fothergill J held one of the claim elements to be non-essential. This is not unheard of, but unusual enough to be noteworthy. Of more general interest going forward, while Hospira 2020 FCA 30 held that obscure prior art is now part of the state of the art for the purposes of an obviousness attack, Fothergill J understood it as holding, or at least suggesting, that mosaicing of obscure prior art is not permitted.

The 087 patent relates to a system for detecting the theft of electrical power, such as by illegal marijuana grow-ops. The system works by monitoring the current power consumption at a primary line, that serves a number of downstream transformers, and comparing it to “known consumption patterns” to detect atypical power consumption patterns that might indicate power theft. The inventor and founder of dTechs was a former police officer who had become interested in the identification of marijuana grow operations by tracing the electricity theft during his investigations into organized crime and illegal drugs. He eventually quit the force to set up dTechs and commercialize his invention. The defendants were Awesense, which provided a similar system to BC Hydro, and BC Hydro itself. As usual, the defendants argued non-infringement and invalidity.

Infringement turned entirely on claim construction. Fothergill J adopted a construction of the term “known consumption patterns” that favoured the defendants [153], and non-infringement followed directly [174]. The main point of interest on claim construction was that Fothergill J held a different term, “notifying the utility” to be non-essential, applying the Free World 2000 SCC 66 test for essentiality [154–61]. This is noteworthy because it is quite unusual for a claim term to be held to be non-essential. However, this holding did not make any difference to the result, which turned entirely on the construction of “known consumption patterns.”

In a second point of interest, Fothergill J noted at [248] that in Hospira 2020 FCA 30 [86] the FCA held that all prior art should be considered part of the state of the art for the purpose of an obviousness attack, and not just prior art that would have been discoverable on a reasonably diligent search: see here. It’s convenient to refer to prior art that would have been discoverable on a reasonably diligent search as ‘obscure prior art.’ However, in Hospira “the Federal Court of Appeal acknowledged that the discoverability of a prior art reference may be relevant to the fourth step of the obviousness analysis” [249], in the following passage:

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

In my post on Hospira I noted that “This indicates that there can be no mosaicing of prior art that is not available in a reasonably diligent search.” The point was made somewhat tentatively in Hospira, with the FCA saying that the fact that the prior art is obscure “may” be relevant and that the skilled person “might” not have thought to combine the obscure prior art references. It was not entirely clear whether the FCA was stating a rule of law that mosaicing of obscure prior art is not permitted, or merely suggesting that that would be an issue to be considered on the facts. The “may” and “might” language suggests it is a factual issue, but if so, it is a very hypothetical matter of fact, given that in fact, the skilled person would not have found the obscure prior art as well. It’s a bit convoluted to say that there is a factual issue as to whether the skilled person would have thought to combine two pieces of prior art which she would not in fact have been aware of.

In any event, Fothergill J remarked that “[250] Even if the PSA lacks the ingenuity to combine more than one prior art reference to achieve the claimed invention” the claimed invention would nonetheless be obvious. So, he did apparently understand Hospira to be saying that mosaicing of obscure prior art is not permitted, though his holding that the 087 patent was obvious did not turn on the point.

Fothergill J also held that certain of the asserted claims were anticipated by BC Hydro’s prior practices. While those practices did not reflect the preferred embodiment of the invention, Fothergill J held on the facts that the prior practice would have necessarily infringed and so satisfied the test for anticipation [183], [192], [204]. Most of the asserted claimed were also anticipated by a report prepared by the inventor himself during his time on the police force, which proposed a system that eventually matured into the invention. One key issue on this point was whether the disclosure of the report to the police force was subject to an expectation of confidence. Fothergill J held on the facts that it was not: [209–12], [218]. Most claims were also anticipated by a prior publication, again following on the claim construction holdings and the rule that that which infringes if after anticipates if earlier [219]–[235].

Reconciling the Two Essentiality Tests in Free World

Allergan Inc v Sandoz Canada Inc 2020 FC 1189 Crampton CJ

2,507,002 / silodosin / RAPAFLO / NOC

In this NOC decision Crampton CJ held that Allergan’s 002 patent was not invalid for obviousness, but it was not infringed by Sandoz’s silodosin formulation. These holdings turned largely on the facts, though Crampton CJ’s discussion raised several interesting legal issues, the most important relating to the interpretation of s 53.1, which permits the use of prosecution history in claim construction in certain circumstances. I’ll discuss this in a subsequent post. This post will provide the background and discuss claim construction, which was determinative of infringement. In particular, I’ll consider the question of how to reconcile the two apparently different tests for essentiality set out by the SCC in paragraph 55 of Free World 2000 SCC 66. Really this is a discussion of a point that was raised more directly by Locke J in Shire v Apotex 2016 FC 382, though I didn’t discuss it when I blogged about that case.

The 002 patent relates to a solid dosage form of silodosin. Silodosin was known to be useful in treating dysuria associated with a kind of benign prostate tumour. However, it was difficult to formulate in a solid dosage form, in part because of its potent adhesive properties. The 002 patent reflects the inventors’ solution to this problem. There were two independent claims at issue. Claim 1 was to a capsule comprising a granule “prepared by wet granulation” of silodosin and various excipients, with a specified dissolution profile [63]. Claim 6 was a method claim comprising granulating silodosin, and other excipients by a “wet granualtion process” [63]. The meaning of the terms was not disputed [64], nor was it disputed that the Sandoz product included all the specified ingredients [21]. The only dispute was as to whether the wet granulation elements were essential [64].

Crampton CJ’s starting point is that all elements are presumed to be essential: [46]. He then adopted at [67] the two-pronged approach to essentiality set out by the SCC in Free World 2000 SCC 66 at the beginning of para 55:

For an element to be considered non-essential and thus substitutable, it must be shown either

(i) that on a purposive construction of the words of the claim it was clearly not intended to be essential, or

(ii) that at the date of publication of the patent, the skilled addressees would have appreciated that a particular element could be substituted without affecting the working of the invention

The difficulty is that in the same paragraph, only two sentences later, the SCC quoted with approval the three part-test set out by Hoffmann J in Improver [1989] RPC 69, which was intended to summarize Catnic:

(i) Does the variant have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no: –

(ii) Would this (i.e.: that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes: –

(iii) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.

As Locke J pointed out in Shire v Apotex 2016 FC 382 [135], these two tests are not entirely consistent. The first prong of the two-part test corresponds roughly to the third Improver question, and the second prong corresponds roughly to the first and second Improver questions, but the two-part test is disjunctive while the Improver questions are conjunctive [135]. The problem, then, is to try to understand what the SCC intended. Locke J suggested that the SCC probably intended the two-part test to be conjunctive, so that it would be necessary to establish both elements in order to establish that the element at issue is not essential [137].

A Product-by-Process Claim Is Not a Product Claim

Bayer Inc v Cobalt Pharmaceuticals Co / drospirenone (NOC) 2013 FC 573 O'Reilly J
            YASMIN® / drospirenone / 2,261,137

In this application Bayer sought an order of prohibition preventing Cobalt from launching a generic version of YASMIN® until the expiry of the ‘137 patent. O’Reilly J refused to grant the order on the basis on non-infringement, and he did not reach Cobalt’s invalidity arguments. The infringement issue turned entirely on claim construction. Bayer’s claim construction argument were far-fetched, and were dismissed by O’Reilly J without difficulty.

Drospirenone is a old compound. The first 12 claims of the ‘137 patent are claims to a process for the production of drospirenone. The description (p 6) states that “a key reaction” in the process is ruthenium-catalyzed oxidation of certain compounds, and all the process claims incorporate that step. Claim 13, the only claim in issue, was to “A product according to the process of claim 12,” wherein the product comprises drospirenone of specified purity. Cobalt alleged that its product would not infringe because its process for the production of drospirenone would not use a ruthenium salt as an oxidizing agent.

Bayer argued that the use of a ruthenium salt as an oxidizing agent was not an essential element of the claims [30]. O’Reilly J rejected this argument [31]-[36]. While identification of the essential elements can sometimes be difficult, in this case O’Reilly J’s analysis is very straightforward and compelling. All the claims included ruthenium and the description identified its use as “key.” There were no alternatives mentioned apart from chromium, which was mentioned only to be avoided; part of the stated purpose of the invention (p 9) was to avoid the use of chromium, for environmental reasons.

Bayer also argued that the SCC decision in Hoffmann-La Roche [1955] SCR 414 stands for the proposition that product-by-process claims should be read as claims to the product alone [13], so that it does not matter how Cobalt’s product was produced, so long as it was of the required purity. As OReilly J pointed out, what Hoffmann-La Roche really says is that you cannot obtain a new patent for an old compound, even though a new process for making it has been invented [20].

Finally, Bayer argued that a skilled person would read Claim 13 as a claim for the purer form of drospirenone, regardless of how it was made [24]. It is not surprising that O’Reilly J rejected this submission, given that the first words of Claim 13 are “A product according to the process of claim 12.”

Is the Essentiality of a Claim Element a Question of Fact?

Hollick Solar Systems Ltd v Matrix Energy Inc 2012 FCA 174 Létourneau JA: Blais CJ, Pelletier JA aff’g 2011 FC 1213 Scott J (blogged here)

Hollick brought an action alleging that Matrix infringed its patent in a solar air heating system. Matrix defended on the basis that its system did not infringe, as the patent specified that the heated air is removed into the building through a plenum at “the top” of the panels, while the defendant’s device placed the air intake at the bottom of the panel. Since a patent may be infringed despite a substitution of a non-essential element of the invention (Free World Trust 2000 SCC 66 [55]), the question was whether the location of the air intake at the top of the panel was an essential element. Scott J’s opinion is one of the very few decisions to actually apply the three-step Improver test for essentiality that was approved in Free World Trust at [55]-[56]. The first step in that test is to ask whether the “variant” – the defendant’s device – has “a material effect on the way the invention works.” But what is meant by “the invention”? The inventive concept, or the invention as claimed? This question was raised directly on the facts (though it was not addressed specifically in the decision), as it appears that the defendant’s system was less efficient, and the placement of the intake at the bottom was intended to avoid the claims. Scott J at trial held that it was essential, and therefore the defendant’s system did not infringe, as the placement had a material effect on the way the invention worked: “The criteria is not whether the variant improves the performance of the invention but rather does it have a significant effect on how the device functions, be it positive or negative” [59]. Because Scott J considered only the claims, and not the inventive concept in coming to this conclusion, it is implicit that he took “the invention” in the Improver test to mean the invention as claimed.

The only question dealt with on appeal was whether Scott J erred in holding that the placement of the intake was an essential element. The FCA affirmed, noting that the determination of whether there was a material effect depended on the testimony of expert witnesses, and “[w]e are in effect asked to second-guess the judge on his appreciation of expert evidence on factual issues and issues of credibility, and then substitute our own appreciation” [17]. The FCA stated that it was not persuaded that Scott J had made an error of law or an overriding and palpable error on a question of fact or mixed law and fact.

This holding has two interesting implications. First, it indirectly affirms that “the invention” in the Improver test means the invention as claimed, not the inventive concept. However, it is not particularly strong authority on this point, as the question of the correct interpretation of the Improver questions point was not raised specifically either at trial or on appeal. As I noted in my post on Scott J’s decision, my own view is that the better interpretation of the Improver questions is that “the invention” means the inventive concept. With that said, the answer is certainly not easy to extract from the “mangle” of the Improver decision.

Second, the standard of review applied by the FCA implies that the question of whether an element is material is a question of fact, or at least mixed fact and law, and is therefore entitled to deference. Does this also mean that the question of whether an element is essential is a question of fact? Are the three different questions in the Improver test to be assessed on different standards? This question is not easy to answer, given that the Improver test is not consistently used. The FCA’s point that evaluation of technical evidence was required is certainly compelling on the facts in Hollick, but its approach may be contrasted with that taken by the FCA in Easton Sports Canada Inc. v Bauer Hockey Corp 2011 FCA 83, (blogged here). In Bauer the FCA affirmed the trial decision that the element was essential only after a detailed consideration of the evidence, and rather than affirming on the basis of lack of error, the FCA held affirmatively that the element in question “is an essential feature of the claim” [54]. With that said, it is not clear whether this reflects any difference in principle, or simply reflects differences in the way the cases were argued.

Eurocopter v Bell Overview

Eurocopter v Bell Helicopter Textron Canada Limitée 2012 FC 113 Martineau J

Eurocopter v Bell is a familiar case name from numerous visits to the Federal Court on discovery matters, but now the infringement decision itself is available. It has not yet now been posted to the Federal Court website, but Alan Macek has made it available through his IPPractice site. Eurocopter’s patent in question, 2207787, relates to sled-type helicopter landing gear which was known as “Moustache” gear. Matineau J held that one claim was valid and infringed by Bell’s prototype “Legacy” landing gear, but no valid claims were infringed by Bell’s current “Production” gear. The most interesting legal aspect of the decision is that Martineau J held that Eurocopter as the successful patentee was entitled to punitive damages, which is extremely unusual in Canadian patent law. I will deal with that issue in a separate post. This post will provide a synopsis of the remainder of the decision.

The Improver Questions Resurrected

Hollick Solar Systems Ltd v Matrix Energy Inc 2011 FC 1213, Scott J

In his first patent decision, Scott J has walked right into the morass of the essential elements doctrine. Moreover, he applied the three question test approved in Free World Trust 2000 SCC 66 at [55]-[56]. These questions are normally known as the Improver questions, after the case in which Hoffmann J first set out these questions, but they might now be known as the Improver “mangle,” the term used by Lord Hoffmann when, in Kirin-Amgen Inc. v Hoechst Marion Roussel Ltd [2004] UKHL 46 at [52], he repudiated his own test. The Improver questions were applied in a few cases soon after Free World Trust, but have been almost entirely ignored by the Federal Courts in recent years. (The last case I know to apply them was Halford Seed Hawk 2004 FC 88 at [140]ff, aff’d 2006 FCA 275, though with some criticism at [14]-[15].)

The invention at issue in Hollick v Matrix was a system for solar preheating of building ventilation air. It is the last in the series of three patents granted to the same inventor. As I read the patents, in the first, 1,196,825, the inventive concept was to pre-heat incoming ventilation air by passing that air through a solar panel on the sunny wall of the building, thereby capturing both solar heat and waste heat escaping through the wall of the building. The second, US Patent 4,774,932, is for an improved collector panel with vertical corrugations. This patent at issue in this case, 1,326,619, is for a further improvement to the invention disclosed in the US patent. It divides the vertical corrugations into a series of offset panels in order to improve efficiency by preserving laminar air flow. All of these patents specify that the heated air is removed into the building through a plenum at “the top” of the panels. The defendant’s device in this case placed this air intake at the bottom of the panel. The question therefore was whether the location of the air intake at the top of the panel was an essential element.

The Faint Hope of the Essential Elements Doctrine

Bauer Hockey Corp. v. Easton Sports Canada Inc., 2011 FCA 83 Noël JA: Létourneau, Trudel JJA aff’g 2010 FC 361, 83 CPR(4th) 315 Gauthier J

The decision of the FCA in Bauer v Easton illustrates the deficiencies of the essential elements doctrine in claims construction.1 In principle the doctrine can sometimes rescue a patentee from a poorly drafted patent, but in this case it did not, and in general it is extremely difficult to predict how it will be applied. I suggest that it needs to abandoned entirely, or reinvigorated with a clarified version of the Improver questions, as discussed in my article, “The Essential Elements Doctrine in Patent Infringement" 22 IPJ 223, (draft version here.) As it stands, the doctrine adds complexity and reduces certainty, without offering more than a faint hope to a patentee with imperfect claims.

The doctrine is important when a claim includes an element that is not necessary to the patentability of the disclosed invention. If the element in question is “essential” a competitor can copy the inventive concept without infringing; conversely, if the problematic element is not “essential,” a defendant who copies all of the remaining essential elements will infringe the claim, even though its embodiment does not include the element in question. The dilemma in such cases is that if the court finds the element to be non-essential, it is in effect re-writing the claim by ignoring that element in determining infringement, but if it finds the element to be essential, it is allowing the competitor to freely take an invention that was invented and disclosed by the patentee. There is no easy way out of this dilemma. The Improver questions purported to offer a test, but that approach has not been applied in Canadian cases, despite its endorsement by the Supreme Court in Free World 2000 SCC 66 [55]-[56], and in the UK they have been repudiated by Lord Hoffmann himself as a “mangle” in Kirin-Amgen [2004] UKHL 46 [52].