Promise of the Patent, Obviousness, and Overbreadth

Alcon Canada Inc v Cobalt Pharmaceuticals Co / olopatadine (NOC) 2014 FC 149 Gleason J
             2,447,924 / olopatadine / PATANOL

In Alcon v Cobalt / olopatadine (NOC), Gleason J held the 924 patent invalid for failure to satisfy the promised utility. It would be tempting to read this case as illustrating how the application of the promise doctrine has, or has not, changed since Plavix 2013 FCA 186 (blogged here). But I don’t really see this as a promise case at all. To my mind, on the facts as found by Gleason J, the claim is clearly invalid, and the more interesting question is on what ground it is invalid. I suggest that the better, or at least alternative, grounds for invalidity are that the claims at issue were obvious and overbroad.

The technical contribution underpinning the patent was the discovery that a common excipient, PVP, improves the physical stability of higher concentration olopatadine solutions [51]. On the facts, Gleason J found this insight not to be obvious [120]. As construed, the claims in issue, 2 and 7, were to olopatadine solution of a specified concentration, around the 0.2% found in PATANOL,

and PVP having an average molecular weight of 5000 [5K] to 1600K and in an amount sufficient to improve the physical stability of the solution” [47].

(The inventive concept also encompassed the fact that five other excipients, which were excluded from the claims, do not enhance stability, but this aspect of the patent was not ultimately significant to the finding of invalidity.)

The difficulty for Alcon is that while there was evidence 58K grade PVP would indeed stabilize 0.2% olopatadine solution [191], the evidence was not sufficient to either demonstrate or soundly predict that 1300K grade PVP would stabilize 0.2% olopatadine solution [197]. Consequently, Gleason J held that “the promise of utility” was not established across the entire range specified in Claim 2 [209].

The phrase “in an amount sufficient to improve the physical stability of the solution” did not help, because there was no evidence that any amount of PVP of that grade would improve physical stability. Claim 7 fell for essentially the same reason [215]. While Gleason J noted that the factual basis for a sound prediction had to be disclosed in the patent itself [125], this issue was not determinative, as there was no evidence extrinsic to the patent to show utility.

In some sense, the claimed invention had utility, in that the specified solution could be used to treat allergic and inflammatory eye reactions, even using 1300K PVP. So it seems natural to say that it lacks utility for the promised purpose, namely to stabilize the olopatadine solution. But Gleason J expressly held that the promise of the patent and its inventive concept are “one and the same” [60], [63]. Therefore we might equally say that the claimed invention lacks utility for the purpose of supporting the inventive step.

This is exactly the European position. This case is essentially the same as the famous decision of the EPO Appeal Board in T 0939/92 AgrEvo, which concerned a product claim for a class of chemical compounds useful as herbicides. While the patent sufficiently described how to make the claimed compounds, Board there was nothing inventive in doing so, and consequently, if there was any inventive step it must lie in the discovery that the compounds had herbicidal properties. Under the problem-and-solution approach to obviousness used by the EPO, the technical problem facing the inventor was to find new herbicidal compounds, and the question was whether it was obvious that the claimed compounds were the solution to this problem. But, the Board reasoned, the claimed compounds could only be an inventive solution to the problem if they were actually a solution to the problem: [2.6]. It is not obvious, in a literal sense, to say that a potion of cat hair and chocolate is a cure for cancer, but that claim is fanciful, rather than inventive, unless it is true (my example, not theirs). Consequently, the Board held that it had to be “credible” (“plausible” is now the usual term: see T 1329/04) that the compounds were herbicides, and moreover, this had to be true of “substantially all” the compounds falling within the claim [2.5.4, 2.6] Because this could not be established, the claims were held to be invalid as lacking the inventive step required by EPC Art 56.

The same line of reasoning is accepted in UK law, as was explained colorfully by Jacob LJ in Actavis v Novartis [2010] EWCA Civ 82, discussing the “5¼ inch plate paradox.”

[36] This runs like this. Suppose the patent claim is for a plate of diameter 5¼ inches. And suppose no-one can find a plate of that particular diameter in the prior art. Then (a) it is novel and (b) it is non-obvious for there is no particular reason to choose that diameter. The conclusion, that the plate is patentable, is so absurd that it cannot be so.

[37] What then is the answer to the paradox? It is this: the 5¼ inch limitation is purely arbitrary and non-technical. It solves no problem and advances the art not at all. It is not inventive. And although "inventive step" is defined as being one which is not obvious, one must always remember the purpose of that definition - to define what is inventive. That which is not inventive by any criteria is not made so by the definition. Trivial limitations, such as specifying the plate diameter, or painting a known machine blue for no technical reason are treated as obvious because they are not inventive.

So it is quite clear that in Europe, the 924 patent would have been found invalid for lack of inventive step (at least on the facts as found by Gleason J). But Gleason J held that the claimed invention was not obvious; she held that the inventive concept was that “PVP at sufficient concentrations improves the physical stability of higher concentration (0.2% to 0.6%) olopatadine solutions” [82], and that this concept was not obvious. The difference is that, implicitly at least, Gleason J did not require the claimed invention to be inventive across the full breadth of the claim. The inventive concept which she identified is that of the patent as a whole, not the inventive concept of the particular claims in issue. The inventive concept of Claim 2 in particular must be that PVP in the range of 5K to 1600K stabilizes olopatadine solutions. Suppose the claim in issue had been to 1300K PVP specifically. The European analysis would say that there is nothing inventive to a claim to 1300K PVP solution, because it does not in fact stabilize olopatadine solution. It is merely an “arbitrary” selection: T 0939/92 2.5.3. Consequently, a claim to the range including 1300K PVP is invalid on the principle that the claim must be valid across its breadth. It is clear in Canadian law that it is the inventive concept “of the claim in question,” which is at issue: Sanofi 2008 SCC 61, [67(2)], so the same analysis would imply that Claim 2 was invalid for obviousness in Canadian law as well.

The problem may also be characterized as one of overbreadth. While one way in which a claim may be overbroad is if the claim omits essential elements of the invention, the general principle is simply that “the monopoly claimed must not go beyond the consideration” Mullard Radio (1936) 53 RPC 323, 348 (HL). Straightforwardly, in this case a claim to 1300K PVP olopatadine solutions goes beyond the consideration, which is the discovery that 58K PVP olopatadine solutions has improved physical stability over what was previously known.

Gleason J did hold that the claim was overbroad, but she held that “overbreadth is simply another way of articulating the utility argument.” I am inclined to think that it is the other way around; the recent Canadian focus on utility, and the promise of the patent in particular, has led the parties and the courts characterize everything as an aspect of the promise doctrine. In the classic promise cases, the invention as claimed had sufficient utility to support a patent, and was otherwise valid, but some statement in the disclosure promised even greater utility, and that promise of greater utility was not met. In this case, the problem lies in the claim itself, which is where Gleason J found the promise at issue [55]. The real problem here is not that the specification promised more than the invention as claimed delivered; it is that the invention claimed more than the specification disclosed.

In UK law, the same problem might also be addressed as a matter of insufficiency, as discussed in Regeneron [2013] EWCA Civ 93 [100-01]:

It must therefore be possible to make a reasonable prediction the invention will work with substantially everything falling within the scope of the claim or, put another way, the assertion that the invention will work across the scope of the claim must be plausible or credible. . . .

On the other hand, if it is not possible to make such a prediction or if it is shown the prediction is wrong and the invention does not work with substantially all the products or methods falling within the scope of the claim then the scope of the monopoly will exceed the technical contribution the patentee has made to the art and the claim will be insufficient. It may also be invalid for obviousness, there being no invention in simply providing a class of products or methods which have no technically useful properties or purpose.

In context, the reference to insufficiency meant so-called “Biogen insufficiency.” I am not particularly a fan of Biogen insufficiency (and note that the EWCA says that the basis for invalidity may be either Biogen insufficiency or obviousness), as it is really another way of framing the overbreadth objection. Under the UK Patents Act 1949 the statutory basis for the overbreadth objection was the requirement in s 32(1)(i) that the be “fairly based” on the disclosure. The fair basis provision of the UK Act had been repealed by the time Biogen was decided, and As the High Court of Australia perceptively noted in Lockwood (No 1) [2004] HCA 58 [67], the House of Lords' reasoning in Biogen boils down “to the following Voltairean aphorism: ‘Since the fair basis doctrine no longer exists, it is necessary to invent it.’”

My inclination is to think that the obviousness and overbreadth approaches are most appropriate; the invention as claimed was not inventive, but arbitrary, and consequently the claim went beyond the consideration. For reasons just given, I do not see it as truly a promise case (whether or not the promise doctrine is sound), nor as a case of insufficiency, at least in the classical sense. But my point here is not to resolve this interesting conceptual debate, but simply to point out that while the promise doctrine is undoubtedly very powerful, not every defect in a patent is necessarily attributable to a false promise.

Cinar, Monsanto and Convoyed Goods

Cinar Corp v Robinson 2013 SCC 73, var’g 2011 QCCA 1361 var’g 2009 QCCS 3793

I have finally gotten around to reading through Cinar v Robinson, 2013 SCC 73, which is of interest in the patent context primarily because of its brief discussion of Monsanto v Schmeiser, 2004 SCC 34. Monsanto set out the differential profits approach to the accounting of profits remedy in patent law, and on a quick reading Cinar could be seen as suggesting that Monsanto does not state a general principled approach to an accounting, but rather a rule which applies in specific circumstances, namely when “an infringement allows the infringer to commercialize a good in a more profitable manner than he could have without the infringement” [80]. Despite this stray phrase, taken as a whole, it is clear that Cinar simply turned on the evidence, and no limitation on the differential profit approach was intended. On the contrary, Cinar reaffirms that lost profits from so-called “convoyed” goods are prima facie recoverable.

Use of Prosecution History in Claim Construction: The First Crack in the Free World Wall?

Distrimedic Inc v Dispill Inc 2013 FC 1043 de Montigny J
            2,207,045

I had somehow missed this decision last fall and was only alerted to it by the case note in the most recent IPIC bulletin. I am very glad it did not slip by me entirely, because it the case that we needed to generate a rational approach to the use of prosecution history in claim construction.

Residents of nursing homes often need a variety of different medicines to be dispensed on a weekly schedule at different times of the day. The ‘045 patent concerns a system for preparing a pill dispenser which facilitates keeping track of which pills are to be dispensed to which patient at what time of day. It consists of a plastic tray (“container-defining sheet”) with depressions to make a series of containers for holding pills to be taken four times per day (breakfast, lunch, dinner, and bedtime) over seven days [22]. After the pills are placed in the container, it is then covered by a sealing sheet on which is printed information about the prescription such as the names of the patient and the pharmacist, the date, and the medications in each container. All this was known in the prior art. It is important that the sealing sheet be properly aligned with the container, and because nursing home staff prepare many of these dispensers on a weekly basis, it is desirable to have a mechanism for aligning the container and the sealing sheet quickly and reliably. This was the problem facing the inventor [24]. The preferred solution, as described in the specification (p 3 line 13-15) was a positioning means comprising “one and preferably two upwardly projecting protuberances on the top surface of the recessed support,” and a corresponding number of “holes” in the container-sealing sheet (and see similarly p 8-9, describing the preferred embodiments).

Of course, an inventor is not confined to the most advantageous embodiment set out in the specification, and all the independent claims originally claimed a broader positioning means [206]:

Positioning means provided on at least the top surface of the container-defining sheet and on the container-sealing sheet to ensure that, in use, after the container-defining sheet is fitted onto the recessed support, the paper covering is peeled off from the bands of the container-sealing sheet and said container-sealing sheet is positioned on top of the top surface of the container-defining sheet, the bands covered with a self-adhesive material and their tearing lines be in exact superposition on top of the flanges and the dotted lines of the container-defining sheet.

These claims were originally allowed by the Patent Office, but the Notice of Allowance was withdrawn, and the claims were rejected when prior art, the Braverman Patent, was brought to the attention of the Patent Office [207].

In correspondence with the Patent Office, counsel for the applicant acknowledged that the Braverman Patent anticipated the invention as claimed, but pointed out that [208]:

BRAVERMAN does not disclose or suggest the following structural feature, which is the key feature of the present invention, namely:

d) positioning means provided on at least the top surface of the container defining sheet and on the container sealing sheet.

Such positioning means were defined in former claims 3 and 4 as being preferably protuberances and holes identified by reference numerals 5, 7 and 15 in the drawings of the present application.

Consequently, in order to overcome the objection based on the Braverman Patent, all the independent claims were amended to add a “wherein” clause specifying that the positioning means comprises

at least one upwardly projecting protuberance provided on the top surface of the recessed support, at least one hole provided into the container-defining sheet and at least one other hole provided in the container-sealing sheet, said at least one hole and one other hole being sized and positioned to correspond to and be engaged by said protuberance.

The defendant’s allegedly infringing container device had a raised outer edge of the container, and the sealing sheet was cut to fit, so that the sealing sheet was positioned by slipping it into the container. Prima facie, the defendant’s device did not use “holes” in the sealing sheet, so a key claim construction question was whether the positioning means defined by the wherein clause was an essential element of the claim.

Counsel for the defendants submitted that “it is difficult to imagine a clearer indication of the essentiality of a claim element than its addition to a claim in order to overcome an objection from the Patent Office” [208]. In my view this argument is entirely compelling. How can we allow a patentee to reclaim in litigation ground that was expressly given up in prosecution? This is the fundamental argument for the doctrine of file-wrapper estoppel, and the facts of Distrimedic powerfully illustrate the force of this argument.

Counsel for the patentee responded that prosecution history simply cannot be used in claim construction, relying on this paragraph from Free World 2000 SCC 66:

[66] In my view, those references to the inventor's intention refer to an objective manifestation of that intent in the patent claims, as interpreted by the person skilled in the art, and do not contemplate extrinsic evidence such as statements or admissions made in the course of patent prosecution. To allow such extrinsic evidence for the purpose of defining the monopoly would undermine the public notice function of the claims, and increase uncertainty as well as fuelling the already overheated engines of patent litigation. The current emphasis on purposive construction, which keeps the focus on the language of the claims, seems also to be inconsistent with opening the pandora's box of file wrapper estoppel. If significant representations are made to the Patent Office touching the scope of the claims, the Patent Office should insist where necessary on an amendment to the claims to reflect the representation.

de Montigny J responded by distinguishing Free World:

[210] While statements or admissions made in the course of patent prosecution shall not be used for the purpose of interpreting a claim, this is not what the Court is called upon to do in the case at bar. A change in the wording of a claim as a result of an objection from the Patent Office is an objective fact from which an inference may be drawn, and is not the same as representations made to the Patent Office.

There is a valid distinction between a statement or admission and a change in the wording of the claim, but, in my view, it is not enough to distinguish Free World, as statements and admissions were given only as examples of extrinsic evidence, and not an exhaustive definition. The general thrust of Free World is that extrinsic evidence and prosecution history generally are to be excluded.

However, the SCC’s holding in Free World is unpersuasive and unprincipled. The specific arguments made in [66] are unpersuasive:

[66] To allow such extrinsic evidence for the purpose of defining the monopoly would undermine the public notice function of the claims,

It would not undermine the notice function, because it operates purely as an estoppel. The worry seems to be that the public might be read the specification and claims, and believe they are safe, only to discover, after the prosecution history is consulted, that they are actually infringing. That would indeed be undesirable, because the public could not tread confidently based on the claims alone, but would have to consult the prosecution history before making any decisions. But this cannot happen. On the usual view, the prosecution history could only be used as an estoppel, preventing the patentee from reclaiming subject matter that it had given up in prosecution. The use of prosecution history can only narrow the claims, not expand them.

and increase uncertainty as well as fuelling the already overheated engines of patent litigation.

It will not increase uncertainty, because the prosecution history estoppel is not a free-standing tool. It will normally operate to clarify the meaning of claims that are uncertain on their face. In principle, the claim might be clear on its face, and then equally clear, but to the opposite effect, when the prosecution history is consulted, but this must be exceedingly rare in practice because it would mean that the examiner accepted a revision to the wording which, on its face, said the opposite of what the examiner had demanded. But in any event, even in that worst case, there would be no increase in uncertainty.

The current emphasis on purposive construction, which keeps the focus on the language of the claims, seems also to be inconsistent with opening the pandora's box of file wrapper estoppel.

It curious that Binnie J considers purposive interpretation to focus on the language of the claims, when Lord Diplock in Catnic [1982] RPC 183, 243 (HL) rejected a “purely literal” approach. The thrust of purposive construction, as compared to what went before, it to place more emphasis on the way a skilled person would read the claims. This necessarily requires going beyond the language of the claims, because a skilled person’s understanding is affected by the context of their experience in the field, their knowledge of the problems faced, and so on. Purposive construction clearly requires more extrinsic evidence, not less, than the lawyerly textual approach which it rejected. I do not see how it is inconsistent with using prosecution history. de Montigny J was quite right to say that “[a] purposive construction should obviously focus on the wording of a claim, obviously, but this is a far cry from saying that nothing else should be considered” [210]

If significant representations are made to the Patent Office touching the scope of the claims, the Patent Office should insist where necessary on an amendment to the claims to reflect the representation.

The Patent Office did insist on an amendment to reflect the representation, and the very reason we want to consult the prosecution history is to clarify the meaning of that amendment. We might always say that the Patent Office should have insisted on a clearer amendment, but the fact that textual expression is never perfect is the reason why claims construction is a crucial exercise in the first place.

The SCC’s position on the use of prosecution history estoppel is also unprincipled. As the SCC noted in Whirlpool 2000 SCC 67 [49e], a patent “is an enactment within the definition of ‘regulation’ in s. 2(1) of the Interpretation Act.” Purposive interpretation is really nothing more than the modern approach to statutory interpretation applied to the specific context of patents: see my article on “The Essential Elements Doctrine” (2011) 22 IPJ 223, 226-40. Prosecution history is the equivalent of legislative history. At one time there was an exclusionary rule against using any extrinsic aids to statutory interpretation, subject to a few narrow exceptions. That rule corresponds almost exactly to the exclusionary rule set out in Free World [66] – but that rule has long been abandoned in respect of legislation generally. (See generally Sullivan on the Construction of Statutes, 5^th ed, Ch 22.) The SCC now routinely consults legislative history in interpreting statutes. The practice is so common that citations are otiose; a quick database search will reveal multiple recent instances from the SCC alone. It is unprincipled to say that legislative history can be used to interpret legislation, and to acknowledge that patents are legislation as a matter of the Interpretation Act, and yet to refuse to use prosecution history, which is the equivalent of legislative history. Indeed, if anything, the argument in favour of considering prosecution history is even stronger than the argument for considering legislative history, as some of the traditional reasons for excluding legislative history, such as the difficulty of deciding who speaks for the legislature (see Sullivan at 595-98), have much less force in the patent context.

We should return briefly to de Montigny J’s distinction between representations and “[a] change in the wording of a claim as a result of an objection from the Patent Office [which] is an objective fact from which an inference may be drawn.” This is a sound distinction. The closest parallel in general statutory interpretation is legislative evolution, which is to say changes made in the succession of enacted texts. The use of legislative history is well established and is relatively uncontroversial, precisely because, as de Montigny J says, it is an objective fact (see Sullivan 577-78). If there is any kind of prosecution history which should be considered, this is it.

Finally, I note that the prosecution history was only one factor considered by de Montigny J in holding that the positioning means specified by the wherein clause was an essential element, and it was almost certainly not a determinative factor (see eg [211-12]). Consequently, de Montigny J’s holding regarding the use of the prosecution history could easily be distinguished by subsequent courts. It will be very interesting to see whether de Montigny J’s holding is indeed ignored, or if it is confined to changes in claim wording, or if it represents the first crack in the Free World wall, which might eventually lead to a more rational and principled approach to the use of prosecution history.

Relitigation of Same Patent Against Different Generic Survives Motion to Strike

Valeant Canada LP v Cobalt Pharma Co / diltiazem (NOC) 2013 FC 1254 Zinn J
             2,242,224 / diltiazem

In Sanofi-Aventis v Novopharm 2007 FCA 163 aff’g 2006 FC 1135 the FCA held that when an a patentee has failed in an NOC proceeding against one generic, it is an abuse of process to relitigate the same allegation of invalidity when made by second generic. In this case, Zinn J distinguished Sanofi-Aventis v Novopharm, and held that Valeant’s attempt to relitigate its ‘224 patent after having previously lost the same argument in Biovail Corp v Rhoxalpharma Inc 2005 FC 1424 (appeal dismissed for mootness 2006 FCA 92), at least survives a motion to strike.

The ‘224 patent is a formulation patent for diltiazem with a surfactant. Claim 35 and 36, which were at issue in both this litigation and Biovail, specify that the diltiazem “is released . . . with the help of a surfactant.” The question in both cases is whether, on the proper construction of these claims, the surfactant must be in the active layers, or whether it could also be in the sustained release lawyer: [10], [Biovail 28]. In Biovail Noël J held that these claims require that the surfactant be located in the active layer. In this litigation, Cobalt sought to have struck those parts of Valeant’s application which raised this same question.

Zinn J dismissed this motion, and allowed Valeant’s argument to stand. He distinguished Sanofi on the basis that “Unlike Sanofi, the present application turns on an issue of law not of fact” [22]. While this is true, this does not strike me as a particularly persuasive distinction. In Sanofi, the patentees argued that their application was not an abuse precisely because it was “a question of fact and that unlike questions of law, one court’s finding of fact is not binding on another judge considering a similar issue” [23]. Now, a prior FC decision is not strictly binding on a subsequent court at the same level, but is followed only as a matter of comity, but nonetheless, there is no evident reason why it is less abusive to relitigate a question of law than a question of fact. Certainly in Sanofi the FCA drew no such distinction: it referred generically about relitigating “the same issues” [26], and whether the allegations were “similar in all material respects” [8].

In Sanofi the FCA held that “[p]ermitting the same innovator to relitigate the same issues repeatedly poses a severe threat to the integrity of the adjudicative process,” because of the “risk of different courts reaching inconsistent results in respect of the same issues” [26], [26]. This does not strike me as entirely compelling; given that NOC proceedings are not in rem, we must accept the possibility of inconsistent results in NOC and infringement proceedings. I do not see this as a particular embarrassment, but simply a reflection of the facts that different evidence may lead to different results, and I don’t see why different factual conclusions in different NOC proceedings are any more embarrassing. With respect to questions of law, the need for legal certainty does make divergent interpretations more problematic, but I do not see the embarrassment. Questions of law may be difficult, and it may be desirable to have different interpretations tested in different proceedings before the law is finally settled. I do not think the FCA is, or should be embarrassed when it is overruled by the SCC. The law turns on the need for finality, not on the need to avoid judicial embarrassment. At the same level of court, the relevant principles are those of comity, which do not require slavish adherence to the first decision on a point of law. But whether it is persuasive or not, that was the basis for the FCA’s holding, and it applies equally in this context. Moreover, the FCA in Sanofi also pointed to the need for efficient use of judicial resources; one NOC proceeding and a subsequent infringement action is already enough litigation over a patent, without allowing multiple NOC proceedings.

Zinn J emphasized that “the blind application of the principle of consistency should not and cannot override fairness” [25]. What appears to be driving his decision is the concern that Noël J’s construction was wrong (and see also [38]), and, as just noted, comity alone is not sufficient reason to allow a wrong decision to stand. But that does not address the FCA’s point about efficiency in litigation, which implies that the patentee gets one shot at the NOC proceeding, and if it is not successful, whether rightly or wrongly, it must proceed by way of an infringement action. Zinn J rejected argument, saying “[32] Must a patentee be required to institute an infringement action or be forever foreclosed from advancing another interpretation of the claims of the patent in a future NOC proceeding? I fail to see any principled reason for adopting such a draconian position.” Whether or not there is a principled reason for such a position, it does appear to be the implication of the FCA Sanofi decision.

In any event, as Zinn J emphasized, this was only a motion to strike. Apart from the point that an argument should be clearly futile, or something close to it, in order to be struck [17-18], Zinn J held that even if this were an abuse of process, he would not exercise his discretion to strike Valeant’s argument on this issue. In part this was because on the particular facts of this case, there would be no judicial economy [38], as the ‘224 patent was one of two patents being litigated, and in Zinn J’s view the additional resources need to argue this point would be modest and could be compensated in costs. This point does go directly to the FCA’s point regarding the need for judicial economy. Zinn J’s other main point was that “I am satisfied, even considering judicial comity, that the position Valeant advances as to the interpretation of the ‘224 Patent has more than a mere possibility of success. To deny it an opportunity to present its case would be unfair” [38]. This brings us back to the points discussed above; there is a tension between justice and certainty; a strict rule that relitigation of the same issues is always an abuse comes down strongly on the side of certainty, but in Zinn J’s view, on these particular facts, the countervailing interest in justice outweighed the need for certainty and economy of judicial resources.

Construal of the Promise of the Patent, Post-Plavix, Post-Eurocopter

Pfizer Canada Inc v Mylan Pharmaceuticals ULC (NOC) 2014 FC 38 Harrington J
            2,177,576 / celecoxib / CELEBREX

The only question in this NOC proceeding was how to construe the promise of the patent. This is only the second decision since the FCA’s important Plavix, decision, 2013 FCA 186 (leave to appeal to SCC granted 30 Jan 2014) which emphasized that the promise must be explicit (blogged here), and it is the first since the FCA’s subsequent more aggressive application of the promise doctrine in Eurocopter 2013 FCA 219 (blogged here). The case is an interesting test of whether the Plavix decision marks a new attitude to the promise doctrine, as the promise language in this case was somewhat ambiguous, and the issue might have done either way. In the end, Harrington J construed the promise of the ‘576 modestly, with the result that the allegation of invalidity was not justified.

The claims of the ‘576 patent at issue claimed celecoxib itself (Claim 4), which is a COX-2 selective NSAID, and celecoxib for treating inflammation or inflammation-associated disorders (Claims 8-13) [34]. It was conceded that celecoxib was useful in the treatment of inflammation and the key question was whether the patent also promised reduced side-effects in humans [4].

The argument that the patent promised reduced side-effects turned on two main points. One is that the background to the invention, as set out in the description, is that the previously known NSAIDs, which were not COX-2 selective, caused a variety of side-effects, and so the problem faced by inventors was to reduce those side-effects [53]: “Otherwise, the patent would merely be offering another in a large class of compounds in a crowded field” [54]. The difficulty with that argument is that even if reduced side-effects is a commercial goal of the inventors, achieving the goal is not required as a matter of the law of utility: “it does not matter how crowded a field may be. If Celebrex® was new, which it was, and useful in treating inflammation, which it is, then the invention is entitled to letters patent” [66]. As the SCC put it in Consolboard [1981] 1 SCR 504, 525, “it is sufficient utility to support a patent that the invention . . . affords the public a useful choice.” Consequently, while the inventors no doubt sought a product with reduced side-effects in order develop a commercially successful product, it does not follow that they would promise to achieve that goal. While Harrington J’s reasoning on this point strikes me as entirely sound, it is in tension with Pfizer v Apotex / latanoprost (NOC) 2011 FCA 236, in which the FCA held that the patent implicitly reduced side-effects in chronic treatment of glaucoma, simply because glaucoma was a chronic disease. It seems increasingly clear that latanoprost marked a high-water mark in the aggressive interpretation of the promise.

The other main argument turned, naturally, on the wording of the patent itself. The key statements were that the discovery [28]-[32]:

(1) provides a viable target of inhibition which more effectively reduces inflammation and produces fewer and less drastic side effects

(2) Compounds of Formula I would be useful for […] the treatment of inflammation in a subject

(3) The compounds are useful as antiinflammatory agents, such as for the treatment of arthritis, with the additional benefit of having significantly less harmful side effects.

(4) Such preferred selectivity may indicate an ability to reduce the incidents of common NSAID-induced side effects.

(1) is ambiguous, as “target” may imply a goal, rather than a result [56]. (2) clearly does not imply a promise of reduced side effects. (3) was the main phrase relied on by Mylan, but this could be construed as a possible benefit, and not a promised use [57]. This is consistent even with the old leading cases on the promise doctrine: so, in Alsop’s Patent (1907), 24 RPC 733, 753 (Ch), Parker J noted that a patent would not be invalid merely because “the patentee has gone on to detail the useful purposes to which such result can be applied.” With respect to (4), Harrington J noted that “The word ‘may’ connotes a possibility; maybe yes, maybe no. While it was hoped the selectivity would reduce side effects, no such claim was made” [65]. He therefore concluded that the specification as a whole did not promise reduced side effects, and he declined to address the question of whether that putative promise was met [60].

In coming to this conclusion, Harrington J also noted that a promise should not be inferred, citing the FCA Plavix decision [68]. He also relied on the presumption set out by Zinn J in his Fournier / fenofibrate (NOC) 2012 FC 741 [126] - [127] decision (blogged here) that:

Where that promise - that claimed utility - is clearly and unequivocally expressed by the inventor in the claims of the patent, then that expression ought to be viewed as the promise of the patent. Any statement found elsewhere should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility.

If, as here, the claims are certain and unambiguous in stating the promise, then the disclosure should not be examined microscopically to find additional promises that are outside the scope of the inventor’s claimed monopoly.

On its face, Zinn J’s presumption applies only when there is a utility stated in the claims. In this case the utility was expressly stated in Claims 8 - 13, but there was no utility stated in Claim 1. Harrington J cited Zinn J as saying that “a utility not expressed in the claim portion of the specification ‘[…] should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility’” [70]. This seems to imply a broader presumption that any statement in the disclosure should be presumed to be a mere statement of advantage – not only when there is a utility expressed in the claims. This seems to expand on Zinn J’s statement in fenofibrate, but it is broadly consistent with the FCA’s Plavix requirement that any promise must be explicit.

Finally, Harrington J dealt with the FCA Eurocopter decision by saying that “as noted by Mr. Justice Mainville, speaking for the Court of Appeal, at para 26, the advantage ‘was principally embodied in claim 1 of the […] Patent.’ Thus, I do not see two competing schools of thought in the Court of Appeal.” [71]. If I understand correctly, Harrington J seems to be saying that Eurocopter was a case in which the promise was found in the claim itself. With respect, I do not read the claim that way. Claim 1 described the invention and embodied the key elements which produced the promised advantage (reduced ground resonance), and so in that sense it embodied the advantage, but there was no explicit reference to reduced ground resonance in the claim itself. I doubt whether Eurocopter and Plavix are really reconcilable, and given that Harrington J has followed Plavix, it is not surprising that his interpretation of Eurocopter is strained. I should say that I think that he was right to follow Plavix, because that decision had a full discussion of the correct approach to construing the promise of the patent, while the approach was only implicit in Eurocopter.

In summary, even in the pre-Plavix era, this decision might very well have turned out the same way, as the promise language at issue was relatively weak. But it might also have gone the other way, and on the whole it suggests that the Plavix decision will indeed have a moderating effect on the construal of the promise. Of course this is all subject to whatever the SCC might say in the Plavix appeal.

What Is a “Method of Medical Treatment”?

Novartis v Cobalt / zoledronate (NOC) 2014 FCA 17 Sharlow JA: Webb, Near JJA aff’g 2013 FC 985 Hughes J
            2,410,201 – ACLASTA – zolendronate

In a four paragraph decision in Cobalt / zolendronate, the FCA has affirmed Hughes J’s decision that Novartis’s ‘201 patent is invalid for claiming methods of medical treatment. The patentability of methods of medical treatment is a difficult area of Canadian law. There are two questions: Are methods of medical treatment patentable? What is a method of medical treatment? The answer to the first question is a clear "no," at least at the FCA level, but the answer to the second question remains obscure, with the result that we know that methods of medical treatment are unpatentable, but we don’t know how to tell whether or not a claimed invention is a method of medical treatment.

On the first question, the FCA has consistently held that methods of medical treatment are not patentable, relying, as in this case [3], on the SCC decision in Tennessee Eastman [1974] SCR 111. When Tennessee Eastman was decided, s 41 of the Act (now repealed) provided that substances intended for medicine could not be patented as such, but only in a product-by-process claim. As the SCC explained, this directly implies that a method of medical treatment consisting of using a compound to treat a disease cannot be claimed, or s 41 could be circumvented by claiming that method using the compound “however prepared” (177). But the SCC decision did not turn solely on the need to prevent an end-run around s 41. The decision also suggests that methods of medical treatment are unpatentable as not being within the definition of “invention.” However, the SCC’s reasoning on this point was extremely cursory. After noting that medicinal compounds and processes for making them were clearly “invention[s]”, the Court said:

But what of the method of medical or surgical treatment using the new substance? Can it too be claimed as an invention? In order to establish the utility of the substance this has to be defined to a certain extent. In the case of a drug, the desirable effects must be ascertained as well as the undesirable side effects. The proper doses have to be found as well as methods of administration and any counter-indications. May these therapeutic data be claimed in themselves as a separate invention consisting in a method of treatment embodying the use of the new drug? I do not think so, and it appears to me that s.41 definitely indicates that it is not so.

Text, context and purpose must all be considered in interpreting a statute. As I read Tennessee Eastman, the SCC is saying that s 41 is an important part of the context for interpreting “invention” which led it to conclude that methods of medical treatment did not fall within that definition. 

The problem is that s 41 was subsequently repealed: what does this mean for the interpretation of “invention”? Should we say that methods of medical treatment are excluded on the basis of “I do not think so,”; or should we say that just as s 41 implied that “invention” does not include methods of medical treatment, so the repeal of s 41 implies a corresponding amendment to the definition of “invention”? This question has no easy answer. The SCC subsequently addressed Tennessee Eastman in Wellcome / AZT 2002 SCC 77, [49] saying

Tennessee Eastman was concerned with the patentability of a surgical method for joining incisions or wounds by applying certain compounds. The decision was based on the former s. 41 of the Patent Act, now repealed. The Court concluded that the method (apart from the compounds) was not patentable. The policy rationale, as explained by Wilson J. in Shell Oil, supra, at p. 554, was that the unpatentable claim was

essentially non-economic and unrelated to trade, industry, or commerce. It was related rather to the area of professional skills.

The statement that “The decision was based on the former s. 41 of the Patent Act, now repealed,” implies that Tennessee Eastman really turned on s 41, which would imply that the definition of "invention" may have changed. But the statement regarding the policy rationale is much broader, and does not turn on s 41 at all, which would imply that the definition has not changed. And the notion that methods of medical treatment are “essentially non-economic” is a meaningless fiction, as the HCA authoritatively explained in its recent decision in Apotex v Sanofi-Aventis / leflunomide [2013] HCA 50, so that gives us no guidance one way or the other.

In the end, the FCA’s view that Tennessee Eastman is authority for the proposition that methods of medical treatment are not patentable is certainly a reasonable interpretation of that decision, but at the same time I am confident that the SCC would not feel itself bound by Tennessee Eastman to hold that methods of medical treatment are not patentable, if that question came before it today.

With all that said, given that the FCA has consistently maintained its view of Tennessee Eastman since ICI (1986) 9 CPR(3d) 289, it is clearly settled at the FCA level that methods of medical treatment are not patentable, and unless and until the SCC grants leave, the more pressing question is "What is a method of medical treatment"?

In my view, to answer this question it is essential to have a clear understanding of the rationale for the exclusion of methods of medical treatment. As noted, text, context and purpose are all important to statutory interpretation, and when the text at issue, namely “art” or “process,” is ambiguous, purpose plays a correspondingly more important role. Unfortunately, we do not have any clear rationale for the exclusion.

The rationale that methods of medical treatment are “essentially non-economic” has support in the jurisprudence, but it a fiction which provides absolutely no guidance as to where to draw the line between claims which are patentable and those which are not.

The rationale with probably the most support in the jurisprudence worldwide, is that medical practitioners should not be restrained from treating patients according to their best medical judgment out of fear of a patent infringement action. This rationale does provide guidance as to what kinds of claims should be unpatentable. It implies that claims which cannot be infringed by doctors should be patentable. This rationale also has some support in Wellcome / AZT 2002 SCC 77. Regardless of what it said about methods of medical treatment generally, the SCC was very clear that the claim at issue which was “A pharmaceutical formulation for use in the treatment or prophylaxis of AIDS comprising an effective amount of [AZT],” was not a method of medical treatment:

50 The AZT patent does not seek to "fence in" an area of medical treatment. It seeks the exclusive right to provide AZT as a commercial offering. How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession.

However, on this rationale the Swiss form claims at issue in Cobalt / zolendronate should have been patentable, as explained in my post on Hughes J’s decision.

A third rationale, adopted by Hughes J in the Cobalt / zolendronate is that claims which "include that which lies within the skill of the medical practitioner” are unpatentable [93] However, as I also discussed in my post on Hughes J’s decision, Hughes J interpreted this as meaning that any claim which requires medical skill to implement the invention is therefore unpatentable. So, the ‘201 patent at issue in this case directed that precise dosage “may be selected by the attending physician” [94], and therefore medical skill was required to practice the invention. Hughes J concluded that this meant the claims lay within the skill of the medical practitioner and were therefore unpatentable. However, this is very difficult to reconcile with the claim at issue in Wellcome / AZT which in the claim itself specified an “effective” amount of AZT. Determining the amount that is “effective” clearly requires the exercise of medical skill.

In summary, while we know that methods of medical treatment are not patentable, there is no clear rationale for this rule, and without a rationale, the scope of its application remains arbitrary and uncertain.

Thirty Years and Counting

University of California v. Commissioner of Patents 2014 FC 80 is an application for judicial review of an evidentiary decision by the Commissioner of Patents in a conflict proceeding involving patent applications which were filed more than 30 years ago. I don’t think I need to say any more about it.

Must the Factual Basis for Utility Be Disclosed in the Patent?

Pfizer Ireland Pharmaceuticals v Apotex Inc 2014 FCA 13 Sharlow J: Dawson, Mainville JJ aff’g 2012 FC 1339 Zinn J
            2,163,446 / VIAGRA / sildenafil

I hesitate to post this comment, because if I have understood the Apotex / Viagra decision correctly, the FCA, in a couple of short paragraphs which cite no authority, has wrought a major change in the law which is arguably inconsistent with SCC precedent, by requiring disclosure of the factual basis for demonstrated utility in the patent itself. This change is so radical and thinly reasoned that I can hardly believe that I have interpreted it correctly, hence my hesitation in posting. [UPDATE: On reconsideration, I've realized that my initial reading was indeed wrong: please see the update at the end of this post.] The decision is very short, and deserves to be read in full by every patent practitioner, so I hope that readers with a different interpretation of the holding will correct me.*

Tests Conducted by a Third Party Without Notice Held to Be Admissible Evidence

AbbVie Corp v Janssen Inc, 2014 FC 55 Hughes J

2,365,281 / anti-IL-12 antibodies / STELARA

One evidentiary point in AbbVie is worth noting. Janssen’s STELARA product was alleged to infringe AbbVie’s ‘281 patent, but only AbbVie, and not Janssen, conducted tests on the Janssen product [62]. For at least some of this testing, no prior notice was given to Janssen, and no one from Janssen attended [67]. Janssen moved to exclude the evidence as to this testing conducted by third parties at the request of AbbVie [63]. Hughes J refused to exclude the evidence. He noted:

[64] Unlike the practice in the United Kingdom as described in the “White Book”, Civil Procedure, Volume 2, 2013, Sweet & Maxwell, London at page 730, there is, as of yet, no Federal Courts of Canada Rule specifically directed to testing conducted for the purposes of trial. In Omark Industries (1960) Ltd v Gouger Saw Chain Co, (1965) 1 Ex C R 457 at page 516, Justice Noel discussed a “salutary” rule to the effect that an opposite party should be given notice of and an opportunity to attend at such experiments. He did, however, also say that an ex parte test may be admissible, subject to weight, particularly where, in his case the opposite party could readily have conducted the same test. Most recently Justice O’Reilly of this Court in Apotex Inc. v. Pfizer Canada Inc., 2013 FC 493 at paragraph 40,held that where a party had ample notice as to the testing and ample knowledge as to what would be done, a party cannot be held to say that the testing results are inadmissible because the party did not attend.

Hughes J reviewed the evidence briefly and held

[70] Given the evidence that I have, and having reviewed the criticisms made by Janssen and, given that Janssen did have a opportunity to cross-examine Dr Hughes, and that Janssen has provided no test results whatsoever, I conclude that the evidence of both tests is admissible. . .

New Biologics, Old Principles

AbbVie Corp v Janssen Inc, 2014 FC 55 Hughes J

2,365,281 / anti-IL-12 antibodies / STELARA

This decision comes via Alan Macek’s IPPractice, who reports that it is “the first biologic patent infringement trial decision of the Federal Court.” [But see update below] Despite the new subject matter, the decision is a fairly straightforward application of old principles.

The invention relates to human antibodies that bind human interleukin 12 (“IL-12"). Interleukins generally, and IL-12 in particular, were known to be implicated in immune system function [14]. Consequently, methods for inhibiting the activity of IL-12 were known to be likely candidates for treating diseases related to immune system disorders. Antibodies are components of the immune system which are capable of binding with great specificity to particular targets, such as IL-12, so one known strategy to inhibit the effect of IL-12 was to develop antibodies which would bind to IL-12, thereby blocking its function.

No Costs Awarded Due to Poor Case Management

AbbVie Corp v Janssen Inc, 2014 FC 55 Hughes J

2,365,281 / anti-IL-12 antibodies / STELARA

I’ve just finished reading the AbbVie decision, and I will post on the substantive issues shortly. But for this first post, I will start with the very last issue – costs. Unusually, Hughes J held that each party will bear their own costs. Here are the relevant paragraphs in full:

[186] I come to the issue of costs. As I expressed to Counsel during the trial, I am extremely disappointed that they did not take advantage of the Case Management and Trial Management process so as to narrow the issues, make appropriate agreements as to facts, and otherwise get this matter ready for trial; focusing on the important issues. The case has been instituted some four years ago, yet even up to and during the trial, Counsel was going back and forth as to issues and factual concessions. Expert reports were served that never were made part of the record. Letters rogatory were issued, yet never used. Other witnesses, whose names were mentioned from time to time, were never called. Discovery of the parties and named inventors were prolonged and numerous tedious motions were brought to compel yet further discovery. Scant portions of the discovery transcripts were deemed read in at trial; most of which could have been dealt with by an agreement as to facts. In all, the parties have not made full or proper use of the pre-trial process and management procedures, notwithstanding abundant applications to the Court about this or that point. We expect better.

[187] Therefore, each party will bear its own costs, except where there has been a particular Order of this Court awarding costs. Where costs have been left to the Trial Judge or in the cause, there will be no costs. 

Patent for Form I Efavirenz Not Infringed on the Facts

Bristol-Myers Squibb & Gilead Sciences v Teva / efavirenz (NOC) 2014 FC 30 Barnes J
             2,279,198 / efavirenz / ATRIPLA

In this NOC proceeding Barnes J dismissed Merck’s application for an order of prohibition in respect of Teva’s generic version of ATRIPLA on the basis that Merck had failed to establish infringement. The decision turns entirely on the facts, and raises no new issue of law.

ATRIPLA is an anti-viral used in treating HIV/AIDS which contains efavirenz as one of its three active ingredients. The ‘198 patent claims a particular crystalline form of efavirenz, Form I, and a process for producing it. It was common ground that Teva’s starting medicinal compound, “Form Teva,” does not contain Form I efavirenz [7]. It was also undisputed that
Form I is the most stable crystal form of efavirenz and, “with the input of sufficient energy, all metastable crystal forms of efavirenz, including Form Teva, will convert to Form I” [9]. The question on infringement is “whether Form Teva will convert in some measure to Form I during Teva’s tablet manufacturing process” [7]. In particular Barnes J held that “Claims 1 and 2 would be infringed if any detectable amount of Form I is found in Teva’s efavirenz product. It does not matter that the amount may be so small that it provides no medicinal advantage” [16].

The resolution of this question turned on the facts. Merck manufactured a sample of the Form Teva efavirenz and asked a Dr Taylor to subject it to processing intended to mimic the commercial manufacturing process. Dr Taylor’s process resulted in a very small amount of Form I being produced [35] and “The central issue in dispute between the parties is whether the mortar and pestle grinding carried out in Dr. Taylor's laboratory is a reliable proxy for the [omitted] that Teva employs in its manufacturing process” [38]. Barnes J concluded that the process used by Dr Taylor was sufficiently different from Teva’s tabletting process that it could not be inferred that any amount of Form I would be present in Teva’s tabletted product [45]. The process used by Dr Taylor would result in significantly more energy being put into the product than commercial tabletting, with the result that Form I was less likely to be created during Teva’s process. Consequently, Merck failed to meet its burden of proving that Teva's tablets would infringe [46].

A couple of notes. The applicants were Bristol-Myers Squibb & Gilead Sciences, the licensees, and Merck, the patentee. Barnes J used “Merck” as including all the applicants, which is why the decision refers to Merck while the abbreviated style of cause does not.

The ‘198 patent had previously been before Barnes J in Bristol-Myers Squibb Co. v. Mylan / efavirenz (NOC) 2012 FC 1142, which concerned SUSTIVA, which contains only efavirenz, in contrast to the ATRIPLA combination product. The same question of infringement was at issue in the SUSTIVA decision, and Merck lost there as well, but the evidence before Barnes J was substantially different and the reasoning was not the same. SUSTIVA is blogged here in respect of the ‘198 patent and here in respect of the other patent at issue.

Teva’s NOA also alleged the ‘198 patent was invalid, as did Mylan in SUSTIVA. Barnes J did not find it necessary to address these allegations in light of his conclusions regarding infringement, but he did say that "Teva presented a stronger case for invalidity on the ground of obviousness than was before me in the Mylan proceeding” [6].

When Is Identity of Medical Ingredients Determined for an ANDS?

Apotex Inc v. Canada (Health) 2013 FC 1217 Kane J
            Apo-telmisartan / MICARDIS

The abbreviated new drug submission process allows a generic manufacturer to obtain an NOC for its generic version of a new drug without submitting safety and effectiveness data, if it can establish that its generic version is the “pharmaceutical equivalent” of a Canadian reference product: Food and Drug Regulations C.08.002.1(1)(a). "Pharmaceutical equivalent" means a drug that contains identical amounts of the “identical medicinal ingredients,” but that does not necessarily contain the same non-medicinal ingredients: C.08.001.1. But what does “identical medicinal ingredients” mean, and at what point in the drug production and delivery cycle is identity established?

So, suppose the pure API for the branded product for which an NOC has been granted is a weak base, but it is formulated as a salt form. Can the branded product be used as a reference product if the generic drug is formulated as a pure base? That is, are the salt and the base considered to be the “identical medical ingredient”? Alternatively, once the tablets are swallowed, the salt of the branded product dissolves into the acid and base, and the active moiety in the blood stream is again the base. Can the branded product be used as a reference product on the basis that the medical ingredient is identical in the bloodstream, even if it is not identical in the tablet?

Springboard Injunction Against Non-Infringing Goods Permitted in the UK

The EWHC decision in Smith & Nephew Plc v Convatec Technologies Inc [2013] EWHC 3955 (Pat), summarized by the IPKat here, is interesting for holding that an injunction might properly be awarded against non-infringing goods, though on the facts Birss J declined to do so. Infringement turned on claim construction, and Birss J ultimately held that Smith & Nephew’s commercial product did not infringe Convatec’s patent [80], but four development experiments did infringe [110]. The data from the infringing experiments was a necessary part of the application for regulatory approval for the commercial product [111]. Even though the regulatory experiments were infringing, and the commercial product was not, the approval based on the infringing product was wide enough to authorize sale of the commercial product [112].

Convatex requested a “springboard” injunction restraining Smith & Nephew from selling its non-infringing commercial product until the date it would have obtained authorization if it had not infringed the patent. After reviewing the law, Birss J held that this type of injunction was permitted in a proper case [130]. He relied primarily on the decision of Judge Fysh in Dyson v Hoover (No. 2) [2001] RPC 27 and the CJEU in Generics v Smith Kline & French C-0316/95 (1997). In Dyson Judge Fysh QC reviewed the law relating to post-expiry injunctions. He noted that the issue before him was novel in that injunctions had been previously been granted against post-expiry sale of infringing goods which were in existence, and so infringed the patent, while he was being asked to grant an injunction against goods which would only come into existence after expiry [21], but he concluded that the court did indeed have the jurisdiction to grant such orders [36]. In Generics the CJEU, on reference from a Dutch court, held that an injunction could be granted to restrain post-expiry sales based on data derived from infringing products. Both Generics and Dyson might be narrowly distinguished on the basis that in both cases the commercial product sold post-expiry was within the scope of the claim, whereas in this case the commercial product was non-infringing [162], but Birss J concluded that “the essential point [is] that the court can intervene to deprive an infringer of an unwarranted advantage gained from their act of infringement” [129]. However, Birss J acknowledged that this injunction "would prevent Smith & Nephew from doing something which does not and never would have infringed a valid patent,” and while “[t]his is not a reason to refuse springboard relief altogether but it is a factor to take into account in deciding if the unwarranted advantage obtained would support it” [162].

He also noted that springboard damages are clearly permitted on the authority of Gerber v Lectra [1995] RPC 383 (Pat) aff’d [1997] RPC 443 (CA), and “If damages are in principle recoverable then I do not see why an injunction should not be able to be granted to prevent the harm occurring in the first place” [130]. Birss J also noted that the fact that springboard damages are available does not mean that an injunction should not be granted because damages are difficult to quantify [161], and so would not be an adequate remedy.

Ultimately Birss J concluded on the facts that Smith & Nephew would have been able to obtain marketing authorization by the time of his decision even if they had never infringed, as sufficient time had passed to allow them to obtain that authorization on the basis of the non-infringing process. He therefore refused to grant the springboard injunction [168].

Update: See Professor Tom Cotter's discussion of the case here, indicating that such injunctions are not available in US law, though this turns on the wording of the relevant provision of the Patent Act, rather than on general principles of equity.

Tension in the Obvious to Try Test

Gilead Science Inc v Teva Canada Ltd / tenofovir (NOC) 2013 FC 1270 Barnes J

2,261,619 / 2,298,059 / tenofovir disoproxil / TRUVADA VIREAD ATRIPLA

Tenofovir is a drug used in the treatment of HIV/AIDS. The ‘619 patent claims tenofovir disoproxil, a prodrug of tenofovir, while the ‘059 patent claims the fumarate salt of tenofovir disoproxil [3]. The main issue in respect of both patents was invalidity for obviousness, and in particular whether the invention was “obvious to try.” Barnes J held the ‘619 patent to be valid, and the ‘059 patent to be invalid. In my view, his application of the obvious to try analysis was correct, but the case reveals a tension in the obvious to try test which has emerged particularly since the FCA decision in Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 (blogged here).

In Sanofi 2008 SCC 61 the SCC held that an “obvious to try” test may be warranted as part of the obviousness analysis, and one factor to be considered is “Is it more or less self-evident that what is being tried ought to work?” [69]. This phrase contains an important ambiguity. Does “what is being tried” refer to the particular claimed invention? That is, to establish obviousness it is necessary that a posita could have predicted in advance of experimentation that the claimed invention would solve the problem at hand? Or does “what is being tried” refer simply to a solution to the problem? That is, it is more or less self-evident that a posita would be able to solve the problem at hand, even though it may not have been obvious prior to experimentation that the particular claimed invention would be the solution? For example, if the problem is to resolve a racemate into enantiomers, must it be predictable in advance that the claimed method would work, or it is sufficient if the claimed invention is one of three standard methods, and it is plain that one of them would work, even if not predictable which method in particular would be successful? The first, narrower, approach is more favourable to the patentee, while the broader approach is more likely to result in the invention being found obvious. (I should repeat that this question, whichever is correct, does not exhaust the obvious to try analysis; it is only one factor to be considered.)

Discovery of a New Mechanism of Action is Not an Invention

Alcon Canada Inc v Apotex Inc / olopatadine (NOC) 2012 FC 410 Barnes J
             2,195,094 / olopatadine / PATANOL / T-564-10

“Merely knowing something new about something old is not enough” to support a patent: Genentech Inc.'s Patent [1989] RPC 147, 208 (CA); see also Chamberlain & Hookham v Mayor of Bradford (1903), 20 RPC 673, 687 (HL). In particular, discovering the mechanism of action of a known drug will not support a patent if the use itself is not new: Lundbeck v Ratiopharm 2009 FC 1102 at [ 20], [149], [189-92]; Astrazeneca v Apotex / omeprazole (NOC), 2007 FC 688, [103]. The reason is that the claims define the scope of the invention, so it is the invention as claimed which must be novel. Discovery of a new mechanism of action does not lend novelty to an invention if a patent would prevent the public from doing that which was already known.

Alcon / olopatadine presents a slight variation on this theme. The inventors had discovered that a known compound had a previously unknown mechanism of action. However, no new therapuetic uses were explicitly disclosed, and the claims, on their face, claimed known uses. In this NOC proceeding, Alcon tried to remedy the problem by arguing that the claims should be construed to be limited to treatment of diseases which were dependent on the mechanism of action in question. This strategy failed. Barnes J recognized “purposive construction is capable of expanding or limiting a literal text” [28] but on the facts the interpretation proposed by Alcon could not be supported. A straightforward reading of the claims was clear, as Alcon acknowledged [33], and Barnes J might have decided the case on the principle that the text plays a dominant role, even in purposive interpretation: Canada Trustco 2005 SCC 54, [2005] 2 SCR 601 [10]. However, Barnes J did not decide on so narrow a ground. He recognized that “[e]ven a term that appears to be plain and unambiguous may, when read in the context, reasonably support a different meaning” [27] and he relied primarily on a purposive interpretation of the disclosure. Ultimately, the specification itself did not define a novel use, so the difficult question of whether the claims, properly construed, should be limited by the use disclosed but not explicitly claimed, did not really arise.

Olopatadine was a known compound which was known to be an antihistamine useful in treating allergic eye diseases in humans [20]. Allergic eye diseases arise when allergens bind to mast cells which then degranulate, releasing a variety of chemical mediators including histamines. The mediators cause the allergy symptoms [9]. An antihistamine suppresses the allergic response by blocking histamine receptors. A drawback of antihistamines is that they only block one type of mediator. There was therefore a recognized need for mast cell stabilizers, that would work by preventing degranulation. It was thought that compounds that were effective antihistamines were unlikely to be useful as mast cell stabilizers because they were observed in vitro to rupture mast cells – that is, antihistamines were generally thought to be mast cell destabilizers [14]. Alcon’s technical contribution was the discovery that olopatadine, even though it was known to be an antihistamine, was also a mast cell stabilizer at therapeutic doses [16].

The claims at issue in Alcon / olopatadine, Claim 8 and 20 of the ‘094 patent [20], were to the use of, and a composition of, 0.1% w/v of olopatadine “for treating allergic eye diseases.” The difficulty, as Alcon acknowledged, is that on a plain reading the claims were too broad [33]: “allergic eye diseases” encompasses any eye disease, whether mediated by antihistamines or other mediators, and “treating” encompasses relieving the symptoms by either blocking histamines, or by preventing mast cell degranulation. If so interpreted, the claims would be invalid as encompassing the known use of olopatadine as an antihistamine. Alcon argued that these words should be interpreted in light of the disclosure as meaning that the claimed composition must be a mast cell stabilizer for treatment of “an allergic eye disease wherein mast cell degranulation contributes to the development of the disease state” [23] (and see [33]).

The difficulty is that while the specification of the ‘094 patent discussed at length the novel discovery that olopatadine was a mast cell inhibitor, and it also stated clearly that it could therefore be used for treating allergic eye diseases, even the disclosure did not specify any new use: “While these activity profile features are described in the disclosure and quantified with respect to olopatadine’s mast cell stabilizing property, those references are similarly not tied to any new form of clinical use” [38]. If a new use had been clearly specified in the disclosure, but omitted from the claims, there would still be a difficult question of whether that use should be read as a limitation, on a purposive construction of the claims. But absent any clear limitation on the use somewhere, whether in the disclosure or the claims, there was no new invention disclosed at all, but only a new mechanism of action. As Barnes J put it:

[39] The disclosure passages Alcon relies upon also fail to clearly identify the nature or the scope of the invention. There is nothing in these passages which distinctly and explicitly identifies the subject matter of the invention whether as a new use or otherwise. While there are references to prophylactic use, dosing frequencies and demonstrated stabilization activity at specific concentrations, none of those features are clearly identified as an element of the inventive concept and none of that language is used in a way that would serve to clearly define the words in dispute in Claims 1 and 13.

This seems to me to be a fair reading of the specification. The disclosure does state that “[t]he present invention relates to topical ophthalmic formulations used for treating allergic eye such as allergic conjunctivitis, vernal conjunctivitis, vernal keratoconjunctivitis, and giant papillary conjunctivitis” (p1), and at the claim construction date it was apparently believed that all these were thought to have mast cell degranulation as all or part of the disease state, but the “such as” language is not limiting. In other circumstances one can imagine that Alcon might have objected strenuously to using a “such as” list to implicitly define a limitation on the uses to which the invention might be put.

The expert evidence foundered for the same reason (my emphasis):

[45] Except for a reference to a possible use as a prophylaxis, Dr. Church and the other Alcon witnesses identify no new clinical use for olopatadine that arises out of the discovery of its mast cell stabilizing properties beyond the sophism that if olopatadine was never used before as a mast cell stabilizer it therefore must be a new use. It seems to me that this approach seriously strains the meaning of the word “treating” and the concept of a new use discovery. The information discovered by Alcon may be useful but it does not, by that fact alone, constitute a new use for olopatadine. A clinician treats a patient for an allergic reaction in the eye by suppressing the troubling or damaging signs and symptoms of the disorder. In the absence of a new clinical use for an old drug, new knowledge about how it works is not patentable. Similarly, the discovery that olopatadine was more effective in the treatment of allergic eye diseases than initially understood (see Affidavit of Martin K. Church, Ph.D., D. Sc. (24 January 2011) at paras 42-43, 46-48 [ Affidavit of Dr. Church]) is unpatenable because the improved efficacy of the drug was inherent in its known utility as an antihistamine.