Throwing Mud at the Wall

NCS Multistage Inc v Kobold Corporation 2023 FC 1486 McVeigh J

2,693,676 / 2,820,652 / 2,738,907 / 2,766,026 / 2,820,704 (NCS) / 3,027,571 (Kobold)

This case concerns six patents relating to downhole tools used in fracking. NCS sued Kobold for infringement of five NCS patents. In response, Kobold sued NCS for infringement of Kobold’s 571 patent. It did not go well for NCS — all the claims in issue for all five patents were declared invalid, while Kobold was successful in its infringement counterclaim.

In broad brush terms, this strikes me as a case where a major new technology created new problems with obvious solutions. Horizontal fracking is relatively recent. It presents some new problems, such as clearing debris away from the tool. In a vertical well, this is accomplished largely by gravity — debris falls to the bottom of the well — but in horizontal wells, some other methods are necessary. The methods claimed by NCS were generally obvious or had already been tried: for example, if debris is getting stuck in a moving part, machine out a bit more clearance to allow free movement of the debris [1191]. Several ancillary arguments were raised along the way, of which the most important is the discussion of double patenting. I’ll deal with double patenting and overbreadth in subsequent posts. This post will provide an overview and briefly address a few of the other legal issues.

This is a very long decision. That is a direct result of an “everything but the kitchen sink” approach: “[a]fter closing submissions, the parties had narrowed the scope of claims at issue down from approximately 145 claims across seven patents to approximately 123 claims at issue across six patents, still with 128 separate issues.” McVeigh J was not impressed. She quoted Locke JA’s comments in Western Oilfield 2021 FCA 24 [9] as to “the lack of wisdom of raising so many issues on appeal,” with the result that “the appellants’ approach suggests that they themselves cannot identify any issues that are particularly strong” [5]. She reiterated that “putting all these issues before the Court was an unwise litigation strategy” and warned that

[9] Lest this become a trend for this Court, or for the parties before it, I feel compelled to state that, in my view, putting these countless issues before the Court for simultaneous determination was detrimental to the aims of the parties in presenting the most clear and effective arguments. It is also contrary to the general principle of this Court to secure the just, most expeditious and least expensive outcome of every proceeding.

While McVeigh J directed her general comments at both parties, the fault lay primarily with NCS. Kobold successfully asserted one patent and four claims, which depended on three further claims [1623]. NCS asserted five patents and put over 120 claims in issue. NCS was comprehensively unsuccessful. All claims at issue — 128 in total — were declared invalid. Costs consequences followed: “There is a clear window here for an elevated lump sum costs award to incentivize efficiencies while sanctioning conduct with so many issues making it more complex.” Accordingly, McVeigh J awarded Kobold a lump sum of 45% of actual fees, up from the baseline of 37.5%, in significant part because “the multitude of claims and issues in this case unnecessarily enhanced the complexity of this case” [1671], [1674]. I must say that the 7.5% bump in the costs award strikes me as a modest sanction given the waste of judicial resources occasioned by NCS’s strategy. But maybe I am just inclined to be unsympathetic after having waded through 200 pages of claim construction.

While NCS’s strategy was certainly annoying, that doesn’t make it unwise. And while it failed in this case, that doesn’t necessarily mean it was a bad strategy; if you make a bet with good odds, it was a still a good bet to make, even if you lose. This is one of the most extreme versions of the kitchen sink strategy aka the “throw mud at the wall” strategy that I’ve seen, but that strategy is common enough in a more restrained form. This raises an interesting question about the ‘kitchen sink’ strategy: it makes the judges mad and risks an adverse costs award, but maybe that is worth it if it increases your chance of winning. I think it is pretty clear that the kitchen sink strategy sends a message to the court that you have a weak case. But given that you do have a weak case, is the kitchen sink strategy a good bet?

Of course, we can’t do a controlled study to see whether a more focused strategy is better, but I have to admit my eyes glazed over while reading hundreds of pages of claim construction, with each claim getting only a few paragraphs of analysis. And while I can’t see inside McVeigh J’s head, I have to suspect that it would have been easy for a few meritorious points to have been swamped by the routine of dismissing the unmeritorious arguments. This is particularly so because McVeigh J often found the evidence of NCS’s expert, Mr Lehr, to be wanting. He “took several positions which appeared at odds with expertise and historical facts” [92], and his arguments were regularly inconsistent with the documentary evidence: see eg [1286]. In some instances Mr. Lehr would read in new elements that were not in the claim at issue at all [1424]. I suspect NCS’s kitchen sink strategy had the effect of undermining the credibility of their own expert by inducing him to take unsupportable positions on weak claims that should never have been raised, rather than allowing him to take a stronger position on a smaller number of claims.

On the other hand, there were one or two places where the sheer volume of issues may have worked to NCS’s advantage. For example, Kobold did not carry its burden of showing that the 704 patent was obvious, because Kobold’s experts provided only conclusory statements and did not address inventiveness at the claim-by-claim level [1450]–[1452]. It is possible that these weaknesses in Kobold’s submissions were due to the sheer volume of arguments it had to deal with. (The claims were nonetheless invalid on other grounds.)

Some of the discussion was a bit difficult to follow because McVeigh J’s analysis sometimes plunged right into the weeds without making it clear why the issue mattered. Most of the hundreds of pages of claim construction were like that. While claim construction is antecedent to validity, without knowing “where the shoe pinches” it can be difficult to stay awake while reading about whether a “wedge” has to be wedge-shaped.

Priority and the use of file history

One argument that was particularly difficult to follow related to priority dates and the use of file history [1302]–[1337]. The Ravensberger patent (2,730,695), filed 11 Feb 2011 claimed an almost identical invention to the NCS 907 patent [1302], and claimed priority from US applications 12/842,099 (23 June 2010) and 12/971,932 (17 Dec 2010). The 907 patent was filed on 4 May 2011 and claimed priority to an 18 Oct 2010 US application (61/394,077). During prosecution of the 907 patent a protest was filed arguing that if the 907 patent could not claim priority from the US 077 application, then it was anticipated by the Ravensberger patent. (McVeigh J referred to the protest as being filed on 6 March 2012 [1305], but it appears she is referring to the protest filed on 26 March 2012.) The 907 patent nonetheless was granted, from which it might be inferred that the examiner had decided that it properly claimed priority from the 077 application. (Though I should say here that it is not clear to me why any of this mattered.) There was also a protest against the Ravensberger patent based on the 907 patent, apparently also raising a priority issue. NCS wanted to introduce the file history of the Ravensberger patent [1309]. (Again, I don’t understand what argument was being pursued and so I don’t know how the file history was supposed to be relevant.) McVeigh J reviewed this file history, and while she was of the view that the file history might in principle be used for purposes other than claim construction pursuant to s 53.1(1), she decided that she would not use the file history “essentially to re-argue the same protest in relation to the Ravensbergen when the Patent Office issued the patent with those priority dates” [1325]. That seems like a very reasonable conclusion, with the caveat that I don’t understand where the argument was going.

McVeigh J then stated that “[a]lthough Canadian jurisprudence does not appear to have directly addressed this question, priority can be asserted on a claim-by-claim basis” [1331]. I’m not aware of any caselaw on that point either, but nonetheless the point seems perfectly clear on the face of s 28.1(1): “The date of a claim . . . is. . . .” I expect that is why there is no jurisprudence on the point.

Then McVeigh J stated (my emphasis):

[1335] As such, it is possible for different claims to be subject to different priority dates relating to different, previously filed applications. However, I interpret this as taking place during the application process and not at the stage in an action where validity is being determined. This would amount to an ex post facto prosecution of the patent, and contrary to the role of this Court.

This is puzzling. On its face, the underlined sentence seems to to say that the Court cannot assess whether a claim can properly claim priority from a foreign filing. However, in the next paragraph McViegh J stated that “on this record with very limited argument and no expert assistance, I am not prepared to do a claim-by-claim review of priority dates” [1336]. That indicates that she would be prepared to assess priority, just not in the context of this particular patent and in particular given the (puzzling) reliance on the Ravensberger claim history. Further, in discussing Kobold’s 571 patent, McVeigh J did determine different claim dates for different claims [1586], saying “As stated earlier, I agree that it is possible to evaluate the claim date in the way NCS requests” [1580]. I take it the “earlier” is a reference to her discussion at [1302]–[1337] relating to the 907 patent. So, on the whole, it seems clear enough that McVeigh J is not suggesting that the claim date of different claims cannot be determined by the court. I would speculate that the underlined sentence was addressed to the specific argument being made by NCS — maybe to the effect that she was not prepared to review the priority date determinations made by the examiner in light of the prosecution history. That is a very reasonable position, which does not exclude the court reviewing the priority dates directly. I’ll just conclude by saying that it is perfectly clear from 28.2(1)(b) and 28.2(1), which governs anticipation generally, not just in the context of prosecution, that the claim date may be assessed by the court.

Grace Period

An invention must not have been obvious in light of the state of the art. Section 28.3(a) gives a one-year grace period which excludes information derived from the applicant from the state of the art. Kobold wanted to rely on a presentation referred to as “What up?” in attacking NCS’s patent. NCS objected that the presentation contained information derived from NCS and so could not be used [1258]. McVeigh J held that even if the presentation contained some information derived from NCS, 28.3(a) could not be used to exclude all information in the “What up?” presentation [1281]. That seems to be to be clearly correct. Both on the face of the Act and on a purposive analysis, it is only the information derived from the patentee that is excluded, not all information that is somehow associated with the information derived from the patentee.

Mosaicing art from different experts

NCS argued that in attacking the patent for obviousness, Kobold could only rely on references that were discussed by both of its experts, apparently on the view that where a piece of prior art is obvious, it should be obvious to both experts [1417]. McVeigh J rejected this: “I reject the proposition that references must be discussed by both (or all) experts where there is more than one expert giving their opinion for a single party. Once a piece of prior art forms part of the record, the Court is able to consider it under the obviousness analysis” [1418].

Inventive Concept

There has been a lot of controversy over the use of the inventive concept in claim construction: see here and here. My own view is that the EPO objective problem and solution approach is probably the best way: see here for my argument to that effect, and here, here and here describing the EPO approach. In this case, it seems that NCS’s expert generally wanted to characterize the inventive concept at a very abstract level, as being “active debris relief” [1097] (and see eg [1441]), but any real trouble was avoided by McVeigh J’s (clearly correct) insistence that obviousness must be addressed on a claim by claim basis: see eg [1435]–[1436]. In other instances, NCS’s expert described the inventive concept by simply paraphrasing the claims: see eg [1343]. That is a common approach, which is not necessarily a problem, but one has to ask what is gained by focusing on an ‘inventive concept’ that is just a paraphrase of the claims, as opposed to focusing on the claims themselves.

Ambiguity

It is difficult to establish ambiguity and consequently a successful attack based on ambiguity is rare, but in this case McVeigh J held two claims to be invalid as being “incapable of being meaningfully interpreted” [1530]; and see [1527]–[1532]. There is no new law here, but successful ambiguity attacks are rare enough that this one is noteworthy. (I did not review the claims myself so I do not have any independent opinion as to whether they were incapable of being meaningfully interpreted.)

Utility related to the nature of the invention

In AstraZeneca 2017 SCC 36 [53], the SCC stated that the utility of an invention must be “related to the nature of the subject-matter,” saying “a proposed invention cannot be saved by an entirely unrelated use. It is not sufficient for an inventor seeking a patent for a machine to assert it is useful as a paperweight.” We don’t see this argument used very often, but in this case NCS sought to save the 704 patent, which McVeigh J found to lack utility because it could not function without seals, by arguing that it would nonetheless be useful for cleaning the casing, presumably by pushing it through to shove debris, in the same way that a completely inoperative tool could be used. McVeigh J rejected this argument on the basis that cleaning did not relate to the nature of the invention [1512]. There is no new law, but as with ambiguity it’s noteworthy just because we don’t see this point raised very often. (NCS’s argument was a bit less absurd than the foregoing summary suggests, because an operable tool would clean the casing as part of its perforating and fracturing capabilities — but it was a desperate argument nonetheless.)

Remedy

McVeigh J allowed the successful patentee, Kobold to elect between an accounting and damages, saying “With respect to an accounting of profits, no evidence has been advanced to suggest the parties may not be entitled to this relief. With the bifurcated phase with respect to damages ahead, there is no reason to deny such relief given the Defendants came to the Court with clean hands” [1659]. The direct implication is that the successful patentee is presumptively entitled to an accounting, barring some reason for denying it, such as unclean hands. As I noted in a post on an earlier case, in a two part article forthcoming in the IPJ and summarized in a series of blog posts, I have argued that Nova v Dow 2022 SCC 43 wrought such a major change in the principles on which the quantum of an accounting is assessed that the courts should revisit the principles on which an accounting is granted.

The Role of the Inventive Concept in an Obvious to Try Analysis

Eli Lilly Canada Inc v Apotex Inc 2023 FCA 125 Rivoalen JA: de Montigny, Gleason JJA affg 2020 FC 816 St-Louis J

2,371,684 / tadalafil / CIALIS ADCIRCA / FC Selection / FC Anticipation

This case is ultimately a straightforward example of the asserted claims being invalid on an obvious-to-try analysis, but because of the way it was argued it also sheds some light on the role of the inventive concept in the obviousness analysis.

The asserted claims of the 684 patent are to dosage forms of tadalafil for treating ED, namely doses from 1 to about 20 mg, as well as specific doses within that range, including 2.5, 5, 10 and 20 mg doses [FC 197-213]. The question in this case was whether the 684 patent is valid over the prior art 2,226,784 patent, which claims tadalafil for the treatment of ED, and disclosed a dose range from 0.2 to 400 mg [12]. At trial, St-Louis J held on the facts that starting from the knowledge that doses from .02 to 400 mg were useful, it would be routine for the skilled team to carry out the trials necessary to narrow that down to the range providing the best balance between efficacy, and safety and tolerability, and they would be motivated to do so [FC 325–28]. The claimed invention was therefore obvious to try [FC 323, 330]. The FCA has now affirmed on that basis [65]–[80].

Lilly’s challenge on appeal was to find a question of law to attack in St-Louis J’s essentially factual finding. Lilly argued that St-Louis J had erred in her construction of the inventive concept, a question of law [48] arising at step 3 of the Windsurfing test for obviousness, which was adopted in Sanofi 2008 SCC 61 [67]. Lilly waffled in its argument as to what constituted the specific inventive concept, before settling on the position that the inventive concept is that the claimed dose remains effective in treating ED, with a reduced flushing side-effect as compared to larger doses of tadalafil [20]–[27], [61]. (As an aside, getting an extra four years of exclusivity on a popular drug on the basis of reduced flushing would be grist for the mill for critics of evergreening practices. From a PR perspective, it is probably a good thing for Lilly that this patent was invalidated.)

There has been a debate as to the role of inventive concept in assessing obviousness, which came to the fore in Shire 2021 FCA 52. One central issue is whether the inventive concept is the “end point” of the obviousness inquiry (Shire [65]), or is rather a “distraction” that can be avoided if it is unhelpful Ciba 2017 FCA 225 [76]–[77]: see here. Rivoalen JA held that in this case, it did not matter whether Lilly was right as to the nature of the inventive concept; the claims were invalid for obviousness in any event [49].

As noted, St-Louis J used an obvious-to-try analysis, which was endorsed by Rivoalen JA [65]. (So far as I can tell, Lilly did not dispute that the obvious-to-try test was appropriate.) St-Louis J found that carrying out a drug dosing study is typically done in Phase II clinical trials, and it is normally routine work [FC 325]. Such studies aim to identify the dosage that provides the best balance of efficacy, safety and tolerability [69]. In reviewing the factors relevant to an obvious-to-try analysis, Rivoalen JA pointed out that the reduced flushing that was eventually identified as an advantage of the optimal dose does not change the aim of identifying the dose range that offers the best balance [72]. Further, on the facts that the dosing study in this case was routine; again, this conclusion is not affected by the fact that reduced flushing turned out to be one of the advantages of the optimal dose [73]–[77]. After carrying out this routine dosing study, the skilled person would be motivated to identify and commercialize the optimal dose [79]. Consequently, the claimed dosage range was obvious [80].

To summarize, there was nothing inventive about carrying out the dosing study and identifying the optimal dose—and that conclusion does not depend on the precise properties of the final dose. While minimizing the flushing side effect was one goal of the dosing study, it is possible that the optimal dose would not have reduced flushing significantly; while flushing was a side effect of interest, it is a relatively minor side-effect, certainly compared to other side-effects such as passing out from low blood pressure. So, before carrying out the trials, the skilled person might not have predicted that the optimal dose would have reduced flushing. Nonetheless, there was nothing inventive about the dosing studies, even though not all the specific properties of the optimal dose could not have been predicted ex ante. This is really the whole point of the obvious-to-try analysis: when something is obvious to try (finding the optimal dose) and the trials themselves are routine, the resulting product is obvious, even if not all of its properties could have been predicted in advance.

In other words, apart from the distraction of the inventive concept debate, this was a perfectly ordinary application of the obvious-to-try test, and the patent was invalidated on that basis both at trial and on appeal.

What does this tell us about the role of the inventive concept? Rivoalen JA was very explicit that she was accepting Lilly’s construction of the inventive concept only for the sake of argument, and her conclusion did not turn on whether that was the true inventive concept [49], [61]. On its face, this implies that it is not always necessary to identify the inventive concept in order to assess obviousness.

But there is also a debate as to how to define the inventive concept. In this case, Lilly seemed to be using it to mean new information that was disclosed in the patent and embodied in the claimed subject-matter. But the inventive concept has also been equated to “the solution taught by the patent” (Bristol-Myers 2017 FCA 76 [65]). In a previous post, I argued that the focus on the obviousness inquiry should be on whether the subject-matter defined by the claim is the solution to the objective problem that would have faced the skilled person. This is consistent with Rivoalen JA’s analysis in this case. In a dosage study, the problem is to find the dose that best balances efficacy against side-effects. In this case, the solution to that problem was a dose from 1 to about 20 mg. On the facts, that solution was obvious on an obvious-to-try analysis.

So perhaps the underlying issue is how to define the inventive concept. If we define it as the solution to the objective problem, then perhaps it is the proper focus of the obviousness inquiry; that view is at least consistent with the result and analysis in this case. On that view, the real lesson of this case is that if we are going to use the inventive concept as part of the obviousness analysis, we cannot allow the patentee free rein in defining it.

Finally, St-Louis J had also held that that the 684 patent was anticipated by the prior art 784, and she had an extended discussion of whether the 684 patent was a selection patent, evidently on the view that this had important consequences for validity. I had criticized her analysis of both these points: see here and here. In light of her holding that the patent was invalid for obviousness, Rivoalen JA found it unnecessary to address these issues; she added that “[t]hese reasons, however, should not be viewed as endorsing the Judge’s findings or reasons in respect of these issues” [82].

Inventive Concept R.I.P.

Ciba Specialty Chemicals Water Treatments Ltd v SNF Inc 2017 FCA 225 Pelletier JA: Rennie, Woods JJA aff’g 2015 FC 997 Phelan J
            2,515,581

As discussed in yesterday’s post, in Ciba v SNF Pelletier JA and Rennie JA held that all matter available to the public may be used in an obviousness attack, not just that which was generally known or reasonably discoverable, though Woods JA expressed no opinion on this point. This was not the only clarification made to the obviousness analysis. The FCA, unanimously on this point,^* also stated that the focus of the obviousness inquiry should be on the claims, not the inventive concept:

[77] There may be cases in which the inventive concept can be grasped without difficulty but it appears to me that because “inventive concept” remains undefined, the search for it has brought considerable confusion into the law of obviousness. That uncertainty can be reduced by simply avoiding the inventive concept altogether and pursuing the alternate course of construing the claim. Until such time as the Supreme Court is able to develop a workable definition of the inventive concept, that appears to me to be a more useful use of the parties’ and the Federal Court’s time than arguing about a distraction or engaging in an unnecessary satellite debate.

In particular, the FCA noted that “[p]art of the difficulty in the search for the inventive concept is the use made, or to be made, of the disclosure portion of the specification of the patent,” and stated, quoting Conor v Angiotech [2008] UKHL 49, [19], “[t]he patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description” [74]. This is consistent with s 28.3 which refers to “the subject-matter defined by a claim” [75].

This is a more emphatic restatement of a similar point made in BMS v Teva / atazanavir 2017 FCA 76, in which, as discussed here, the FCA downplayed the importance of the inventive concept. (Pelletier JA also wrote the reasons in Atazanavir, with Rennie and Near JJA concurring.) I agree entirely with the Court on this point. The pursuit of the inventive concept had in many cases turned into a major satellite debate which brought confusion rather than clarity. Indeed, it may be that it is time to reconsider the entire Windsurfing/Pozzoli framework. While that approach was endorsed by the SCC in Sanofi / Plavix 2008 SCC 61, the FCA pointed out in Wenzel Downhole Tools 2012 FCA 333, [105], “the Supreme Court of Canada in Sanofi clearly indicated that there is no single or mandatory approach in the obviousness inquiry,” and as the FCA pointed out in Atazanavir “[i]t is true that the Windsurfing/Pozzoli framework does provide structure but it is not obvious that it has been useful.” [64]. In any event, that is a question for another day.

The FCA held that Phelan J had erred in his formulation of the Windsuring/Pozzoli framework [63], but I would suggest the errors are ultimately a reflection of problems with the Windsuring/Pozzoli framework itself. The second and third steps of that framework are [45]:

2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;

3) Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim or the claim as construed;

The FCA noted that in effect, Phelan J had “first defined the invention, then referred to the fact that the invention is an advance over the common general knowledge, and concluded that the difference between the two is the inventive concept” [65]

[66] This methodology appears to conflate steps 2 and 3 of the Windsurfing/Pozzoli framework as it was paraphrased by the Federal Court but instead of comparing the inventive step to the common general knowledge, it compares the invention to the common general knowledge to arrive at the inventive step.

While this observation is true enough, Phelan’s J’s approach has considerable appeal: after all, in the absence of any other guidance from the SCC, it seems quite reasonable to define the “inventive concept” as the difference between the state of the art and the invention. But, as the FCA pointed out, if that is the definition of the inventive concept, then the second and third steps of the Windsuring/Pozzoli framework are circular. On the other hand, if that is not the inventive concept, what is? No wonder the FCA held the whole inquiry is an unnecessary distraction.

Because the FCA held that Phelan J had applied the wrong legal test, the Court undertook the obviousness analysis de novo [69]. In so doing, Pelletier JA identified two distinct differences between the claim as construed and the prior art relied upon by SNF, namely the notions of an “effective rigidifying amount” and of “an aqueous solution of a water soluble polymer” [91]. Pelletier JA then considered separately whether either of these aspects of the claimed invention was inventive, at [94]-[95] and [93], respectively. Having concluded that both differences were obvious, it followed that the claimed invention was obvious [97].

This approach, of looking at different aspects of the invention separately to see whether any aspect might be inventive, calls to mind the approach used by the EPO, albeit in the context of the problem-solution approach to obviousness. For example, in T 0920/10, the BoA stated (citations omitted):

[14] Article 56 EPC stipulates that "an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to the skilled person". Therefore, in the board's understanding, the decision on whether or not the requirements of Article 56 EPC are fulfilled requires a mandatory examination as to whether or not the claimed subject-matter is obvious. Therefore, it has been established by case law that, if an initially formulated problem is found not to have been solved, the problem is reformulated to one which is considered as having been solved and the obviousness of the claimed subject-matter is then assessed on that new basis.

^*Woods JA reserved opinion “on the issue discussed at paragraphs 51 to 63" [99]. The discussion of the role of the inventive concept is later in Pelletier JA’s reasons, at [74]ff.

Important Course Correction on Inventive Concept

Bristol-Myers Squibb Canada Co v Teva Canada Ltd 2017 FCA 76 Pelletier JA: Near, Rennie JJA aff’g 2016 FC 580 Mactavish J
            2,317,736 /atazanavir / REYATAZ / NOC

The FCA’s Atazanavir decision is a welcome course correction dealing with the role of the inventive concept in the obviousness analysis. Since Sanofi / Plavix 2008 SCC 61, [67], endorsed the four-step Windsurfing/ Pozzoli framework, identifying the “inventive concept” in the second step has become an increasingly lengthy and contested aspect of an obviousness attack. The FCA’s Atazanavir decision has now pressed the reset button on this approach, emphasizing that Sanofi did not effect any radical change in the law on this point. This important – and short – decision is essential reading on the issue of obviousness.

Discovery of Something Unexpected about Something Obvious

Bristol-Myers Squibb v Teva (NOC) 2016 FC 580 Mactavish J
            2,250,840 / 2,317,736 / atazanavir / REYATAZ

In this NOC proceeding Mactavish J held Novartis’ 840 patent, which claims the compound atazanavir [53], to be valid in the face of obviousness and anticipation attacks, while she held BMS’s 736 patent, which claims the bisulfate salt of atazanavir [273], to be obvious. A central dispute between the parties in respect of both patents was whether the inventive concept of the claimed inventions comprised just the compound itself, as Teva argued, or the compound and all its properties, as the patentees argued. The idea is that the more properties that are part of the inventive concept, the less likely it is that they will all be predictable, and so the less likely it is that the patent will be held obvious. In this post, I will argue that this idea is wrong; the number of properties in the inventive concept does not affect how likely it is that the claimed invention will be held to be obvious. In another post I will suggest that multiplying the inventive concepts might actually make invalidity more likely. The 736 patent also raised a very tricky claim construction problem, which I will discuss in a subsequent post.

Atazanavir is used in the treatment of HIV/AIDS. The first class of anti-HIV drugs were known as nucleotide reverse transcriptase inhibitors (or NRTIs) [13]. While these had potent activity against HIV, they were susceptible to the evolution of drug resistance and had unpleasant side-effects [14], [15]. A new class of anti-HIV drugs was developed, known as protease inhibitors [16]. These has a number of advantages over NRTIs, but the first generation protease inhibitors had poor bioavailability, which resulted in poor compliance and a consequent potential for the development of drug resistance [22]. There was therefore a strong motivation to develop second-generation protease inhibitors [23]. One of these was atazanavir, which came on the market in 2003 and which remains one of the best second generation protease inhibitors [24-25]. The 840 patent, which claimed atazanavir and its salts, disclosed only the free base form. While the free base had good inherent bioavailability, it was not sufficiently orally bioavailable in solid form to be a viable product [266-67]. The problem facing the inventors of the 736 patent was to develop a form of atazanavir having properties suitable for an oral pharmaceutical dosage form, including improved oral bioavailability [268]. They performed a salt screen, and solved the problem with the bisulfate salt which was claimed in the 736 patent. (Ciba-Geigy, which became Novartis, developed atazanavir, and BMS acquired the rights to atazanavir from Novartis and then developed atazanavir bisulfate.)

Inventive Concept and the Promise of Utility Are Not Necessarily Coextensive

AstraZeneca Canada Inc v Apotex Inc / esomeprazole 2015 FCA 158 Dawson JA; Ryer, Webb JJA aff’g 2014 FC 638 Rennie J
            2,139,653 / esomeprazole / NEXIUM

The FCA’s brief Esomeprazole decision affirms a couple of important points that were raised in yesterday’s post (which I wrote before having read the FCA decision).

An initial, basic point is that the FCA affirmed Rennie J’s holding that the patent was invalid for failing to satisfy the promise of the patent, which was higher than the mere scintilla necessary to support a patent. As I remarked in my post on Rennie J’s decision, this shows that “the promise doctrine is alive and well post-Plavix FCA 2013 FCA 186.” This is not entirely surprising, as Plavix formally reaffirmed the promise doctrine, holding only that the promise must be explicit, but with the FCA’s affirmance in this case any thought that Plavix was the first step towards abandoning the doctrine entirely must now be laid to rest.

The FCA also stated that “[i]t is also now settled law that some promises can be construed to impose utility requirements across each of a patent’s claims, while other promises may touch only a subset of the claims,” citing Celecoxib 2014 FCA 250 (blogged here). While Rennie J in this case did not construe the promise on a claim-by-claim basis, the FCA held this was not an error in light of the evidence and submissions before him [6]. As noted in yesterday’s post, the distinction between overarching and claim-specific promises was applied by O'Reilly J in his Deferasirox decision.

AstraZeneca also argued that “the Federal Court erred by construing the utility of the claims in issue in a manner inconsistent with their inventive concept. AstraZeneca argues that because it is a fundamental rule of claim construction that a claim receives one interpretation for all purposes, there must be a unitary, harmonious understanding of the essential elements of the claim, inventive concept and utility” [10]. The FCA rejected this proposition as being unsupported by any jurisprudence. In my view, this holding is entirely correct. To elaborate on an example given in yesterday’s post, suppose a racemic compound is known to treat cancer though with side effects, and it is obvious to a skilled person that one of the enantiomers is therapeutically effective while the other is responsible for the side effects, but it is unusually difficult to resolve the enantiomers. If a patentee succeeds in resolving the enantiomers through inventive ingenuity and claims the therapeutically effective enantiomer, the claimed invention is surely patentable. But if the inventive concept and the promise of utility are coextensive, it would be held invalid; the enantiomer is useful, because it treats cancer (without side effects), but that was obvious to anyone. The reason the claim is valid is that the inventive concept, namely the method of separating the enantiomers, is distinct from the utility.

Application of Distinction Between Overarching Promise and Claim-Specific Promise

Novartis Pharmaceuticals Canada Inc v Teva Canada Ltd (NOC) 2015 FC 770 O'Reilly J
            2,255,951 / deferasirox / EXJADE

As discussed in Monday’s post, the ‘951 patent relates to iron chelators, which are used to treat disorders caused by excess iron in the body [7]. As usual, the utility attack turned on the promise of the patent. O'Reilly J’s Deferasirox decision illustrates once again that under the promise doctrine the validity of the patent will turn on a meticulous reading of the disclosure. It is also interesting as applying the recently developed distinction between an “overarching” promise, which will affect all claims, and a promise that is directed at one claim only. One point I would quibble with is that there seems to have been an implicit assumption that the stated utility is the same as the inventive concept. Consequently, while O’Reilly J explicitly stated that (for the compound claims) he applied the low standard for utility that applies in the absence of an explicit promise, the standard he actually applied was higher than a mere scintilla.

What is "the" Inventive Concept?

Alcon Canada Inc v Apotex Inc 2014 FC 791 Kane J

            2,606,370 / travoprost formulation / TRAVATAN Z / NOC

The ‘370 patent relates to formulations of travoprost, an anti-glaucoma drug, with a non-conventional preservative system, based on zinc ions. The motivation for the invention was to avoid the potentially harmful effects on the cornea of conventional preservatives such as benzalkonium chloride (BAK). In this NOC proceding Apotex successfully attacked the ‘370 patent as being obvious, though a inutility attack failed.

The conclusion that the claims at issue were obvious ultimately turned on the facts. One of Alcon’s own prior art products, the tear replacement product Systane Free, also used a non-conventional preservative system which very similar, even in the specific components, to the claimed formulation [236], [342]. The evidence accepted by Kane J was to the effect that it would have been obvious to extend the same preservative system to travoprost, given the acknowledged motivation to avoid the use of BAK [348].

Inventive Concept

There is, however, one aspect of Kane J’s opinion which I find disquieting. A substantial part of the obviousness analysis concerned the identification of the inventive concept [163]-[197], including extensive testimony from the experts, and a thorough parsing of the specification. (Kane J noted that because the claims were to a bare chemical formula, the inventive concept cannot be identified without looking at the specification [180], which, in my view, is clearly correct.) Kane J’s ultimate identification of the inventive concept drew heavily from elements identified in the specification itself. 

None of this analysis is objectionable in principle; certainly, expert evidence and the specification should be considered in assessing the putative inventive contribution. But the overall tenor of the analysis suggests a focus on identifying “the” inventive concept from the specification, which then becomes the focus of the obviousness analysis. This would be problematic in two respects. First, by focusing on the specification, this analysis could turn the obviousness inquiry into a subjective analysis, in which the question is whether the inventive contribution identified by the applicant is obvious. This is contrary to the principle that the obviousness analysis is objective. It would be evidently be wrong to hold an invention to be non-obvious because the applicant asserts in the specification that it is a work of genius, but it is also wrong to hold a patent obvious because the contribution identified by the applicant turns out to be obvious. For example, the inventor may believe that she has discovered a whole new class of compounds with unexpected properties, and she has claimed both the genus and some particular species. It may turn out that the inventor had overlooked some relevant prior art, and in fact it was obvious or anticipated that some members of the class had the properties in question, but it was nonetheless surprising that the particular claimed species had those properties. The question is not whether what the inventor thought she had contributed is truly inventive; it is whether what she actually contributed is inventive: see Nichia Corporation v Argos Ltd, [2007] EWCA Civ 741 at [14]-[19].

Second, as a corollary, it would be wrong to focus on identifying “the” inventive concept, which is thereafter the sole focus of the obviousness analysis. If a putative inventive concept is examined and found to be wanting, the objective nature of the obviousness analysis makes it necessary to ask whether some other aspect of the invention might be inventive. So, if an invention claims a solution to a problem, it may be non-obvious either because the solution was non-obvious, or because the problem itself was non-obvious; it is necessary to ask both questions, not just one. As the EPO Guidelines explain, the question is the formulation of the objective technical problem:

The objective technical problem derived in this way may not be what the applicant presented as "the problem" in his application. The latter may require reformulation, since the objective technical problem is based on objectively established facts, in particular appearing in the prior art revealed in the course of the proceedings, which may be different from the prior art of which the applicant was actually aware at the time the application was filed. In particular, the prior art cited in the search report may put the invention in an entirely different perspective from that apparent from reading the application only. Reformulation might lead to the objective technical problem being less ambitious than originally envisaged by the application.

It is true, of course, that the Windsurfing/ Pozzoli approach as approved by the SCC in Sanofi 2008 SCC 61 [67] refers to identification of the inventive concept as one of the steps, but the inventive concept is by no means the focus of the analysis. Indeed, the test is very casual about the inventive concept: “Identify the inventive concept of the claim in question or if that cannot readily be done, construe it.” That is, don’t worry too much about the inventive concept – the crucial question [67(4)] is whether the differences between the state of the art and the invention as claimed were obvious.

This is a long-winded discussion for a point that probably had no real effect on the result, but there was a similar problem with Kane J’s analysis in the earlier Travoprost case, 2014 FC 699 discussed here. I am concerned that this may signal a new trend that has the effect of improperly turning the obviousness analysis into a subjective inquiry, in the same way that the promise doctrine has made utility a subjective inquiry.

Utility

Turning then to utility, the issue turned entirely on the construction of the promise. Apotex argued that the patent promised minimization or reduction of side effects [352], while Alcon argued that the utility is simply to be useful and to meet the USP preservative efficacy testing standards [351]. Like O’Keefe J in the recent decision Dow v NOVA decision, 2014 FC 844 (blogged here), Kane J relied both on the leading FCA decision, Plavix 2013 FCA 186, for the proposition that the promised utility must be explicit [408], and that “not every statement of advantage in the specification rises to the level of promised utility” [356], and also on Zinn J’s statement in Fournier / Fenofibrate 2012 FC 741 (discussed here), for the proposition that the focus should be on the claims [360]. In light of this jurisprudence, and noting in particular the absence of any promise of reduced side effects in the claims [416], Kane J held in favour of Alcon’s interpretation of the promise [417]. This construction of the promise effectively decided the issue of utility in favour of Alcon, because Apotex’s argument was focused entirely on the promised utility as Apotex had construed it [427], and did not address the issue of demonstrated or soundly predicted utility from the perspective of “simple utility” [440]. The unchallenged evidence led by Alcon was therefore sufficient to establish utility on the basis of sound prediction [446].

Note: see also 2014 FC 699 in which the claims of a different patent, 2,129,287, were to the use of travoprost for the treatment of glaucoma, as opposed to the travoprost formulation. Kane J held the claims of the '287 patent were obvious and anticipated, though the utility attack also failed: see here.

"Scintilla" Standard for Utility Applied

The Dow Chemical Co v NOVA Chemicals Corp 2014 FC 844 O'Keefe J
            2,160,705 / film-grade polymers / ELITE SURPASS

In this action, O’Keefe J found Dow’s ‘705 patent related to film-grade polymers to be valid and infringed by Nova. The result turned largely on the evidence, and no novel points of law were raised. The decision does exemplify a modest approach to the construction of the promise of the patent – indeed, O’Keefe J held that there was no promise at all, and the “scintilla” standard for utility should be applied – and the treatment of the inventive concept of the patent in the context of obviousness is also of some interest.

Claim Construction and Infringement
Dow’s ‘705 patent relates to film-grade polymers, used to make products such as plastic bags. Toughness is a desirable property of such films, and the patent taught that a blend of two different types of polymers would produce compositions with good properties. The claims were to a polymer composition, comprising a blend of homogeneously branched polymers (with specified properties) and heterogeneously branched polymers (also with specified properties).

A large part of the case is taken up with claim construction. Dow prevailed on all points. No new points of law were raised. O’Keefe J applied the established principle of claim consistency, that is, the same words are given the same meaning throughout the claims [45]. He also adopted the standard interpretation of the term “comprising,” as meaning "including but not limited to" [54]. This is particularly welcome in light of the FCA’s disappointing holding in Purdue Pharma 2011 FCA 132 that “comprising” does not have a standard meaning (see here).

O’Keefe J then held that Nova’s product infringed. A variety of issues were raised in the infringement context, but these were all resolved either on the basis of the claim construction, or on the facts.

Utility
Turning to validity, the key question with respect to utility, not surprisingly, was the construction of the promise of the patent. While O’Keefe J’s opinion does not make new law, it is noteworthy in not only construing the promise modestly, but in expressly holding that there is no promise at all, so that the “scintilla” standard is applicable.

The key phrase in the specification was [185]:

Surprisingly, we have now discovered compositions useful in films and molded parts having synergistically enhanced physical properties, which compositions comprise . . .

The question was whether this constituted a promise of “synergistically enhanced physical properties.” O’Keefe held it did not. He quoted the leading FCA decision, Plavix 2013 FCA 186, but he relied particularly on Zinn J’s statement in Fournier / Fenofibrate 2012 FC 741, discussed here. As O’Keefe J accurately summarized it:

[183] The Fournier case and other cases tell us that we should look for the elevated promise or claimed utility in the claims of the patent. Further, any statement found elsewhere should be taken as a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility of the invention.

O’Keefe J concluded that the statement in question was not a promise; nor was there an promise anywhere else in the patent [192]. This is significant, because the phrase in question is the kind of statement which might well have been construed as being a promise under a more aggressive approach. In my view, the the introductory word “surprisingly” makes it clear that this statement is intended to identify why the invention is non-obvious, and not to make a promise of utility. However, it should be emphasized that O’Keefe J’s conclusion that the patent did not make any promise was not a matter of law. As is standard in construing the promise, extensive evidence was heard from experts, and this evidence was reviewed at length by O’Keefe J.

O’Keefe J then held that:

[195] Since I have found that the inventors did not make an explicit promise of a specific result, the test for utility will be a “mere scintilla” of utility.

This is significant, because in prior cases, even post-Plavix, which take a modest approach to the construction of the promise, the general practice has been to assess utility against a modestly construed promise, rather than expressly holding that the scintilla standard applies.

This conclusion with respect to the promise of the patent was determinative of utility, as all of NOVA’s arguments that the invention lacked utility turned on its claim of an enhanced promise [197].

Overbreadth and Anticipation
Attacks based on overbreadth and anticipation were rejected largely on the facts.

One point of some interest relates to the prior art Garza patent. As noted, the 705 patent claimed a blend of homogeneously and heterogeneously branched polymers. As O’Keefe J explained

[214] The Garza patent provides the reader with a broad description of compositions and asks the reader to pick polymers from a number of broad categories to make the blend.

[215] Indeed, by making a choice of certain polymers, a person would obtain a composition that was outside the claims of the ‘705 Patent.

O’Keefe J held that this did not make the Garza patent anticipatory, because “the jurisprudence explicitly states that the prior patent must disclose subject matter that if performed would 'necessarily result in infringement of that patent.' In this case, you could perform the Garza patent and not arrive at the invention of the ‘705 Patent” [217]. This conclusion is entirely in accordance with the established jurisprudence cited by O’Keefe J, and it would not be in the least noteworthy, but for Kane J’s recent holdings to the contrary (see here and here).

Obviousness
O’Keefe J’s conclusion that the claimed invention was not obvious turned largely on the facts, and on his identification of the inventive concept:

[244] In my view, the inventive concept of the ‘705 Patent is that you can use the SHC [of strain hardening coefficient] characteristic of the polymer used as component A in the claims of the ‘705 Patent, to predict that the composition would have the desired characteristics.

This statement of the inventive concept is interesting, as it is very far from the mere paraphrase of the claims which we often see. My own view, stated in previous posts, is that it is normally necessary to look to the disclosure, and indeed to the common general knowledge, to properly identify the inventive concept. It seems that this is what O’Keefe J has done. Unfortunately, it is not clear, at least to me, how he arrived at this inventive concept. My sense is that it turned on the expert evidence (see eg [261], [269]). I would consider this to be sound, but it would have been useful if O’Keefe J had elaborated on how he had arrived at this statement of the inventive concept.

There are a couple of other points of interest. One is that while O’Keefe J adverted to the controversial (in my view) proposition that so-called secondary factors such as commercial success should be given less weight in assessing obviousness [252], he nonetheless said that “one cannot ignore”the fact that NOVA had designed the infringing product in response to Dow’s patented product [252]. In my view, he was right to do so: see Secondary” Evidence of Obviousness is Not Secondary, (2012) 28 CIPR 279.

On another point, O’Keefe J held that an expert witness for NOVA, Dr Speed, has applied the wrong standard in his analysis because in response to the question as to whether the notional skilled work “has an imagination,” Dr Speed replied “I expect so.” [240]. O’Keefe J held this was inconsistent with the Beloit description of the “notional person” as a “technician skilled in the art but having no scintilla of inventiveness or imagination” [241]. While O'Keefe J was right as a matter of law, I have considerably sympathy for Dr Speed, who was tripped up by a conceptual problem with the standard obviousness analysis. On the one hand, it purports to be an essentially factual inquiry as to whether a person with certain characteristics – in this case at least an undergraduate degree in chemical engineering or a related field, and two years experience – would in fact have arrived at the invention without difficulty. This is nominally a factual inquiry, which turns on expert evidence. And yet, it is clear enough that no actual skilled person with an engineering degree and two years experience would be without any scintilla of imagination. Engineering, and science generally, are not fields in which automata can keep a job for two years, except perhaps as bottle washers. Dr Speed’s assessment that a skilled person, as defined in this case, would have some imagination, was no doubt correct as a matter of fact, but it was not right as a matter of law – which highlights the artificiality of the inquiry. 
 
Remedies
Dow was successful in establishing that its patent was valid and infringed. O’Keefe J allowed Dow to elect between an accounting and damages [283.2], without making any comment. An accounting is discretionary, and while it was for a long time allowed routinely, some recent cases have suggested that it should not be granted as a matter of course. O’Keefe J’s willingness to grant an accounting so readily may be significant, though it may simply be that the request was not opposed.

Construction of the Inventive Concept is Determinative of Obviousness

Alcon Canada Inc v Apotex Inc 2014 FC 699 Kane J
            2,129,287 / travoprost / TRAVATAN Z / NOC

Patent law is a technical area of law, and no doubt always will be, but at times it seems that the conceptual apparatus we deploy make the field even more complex than necessary. In this case, the concepts of selection patents and the inventive concept have generated some problematic analysis.

Travoprost is the isopropyl ester of (+)-fluprostenol [8]. It is a synthetic analogue of PGF_2α, which is a naturally occurring prostaglandin. The claims of the ‘287 Patent at issue (12, 27, 35 and 46) relate to the use of a therapeutically effective amount of travoprost for the treatment of glaucoma and ocular hypertension [123]. (The claims are all to a relatively small class of compounds encompassing travoprost – none relates solely to travoprost – but nothing turns on this.) The claims were held invalid as being anticipated and obvious, but an attack based on lack of utility failed.

There was considerable dispute as to whether the ‘287 patent was a selection patent over European Patent application EP 0 364 417. Kane J held that it was not a selection patent [152], but that even if it was the result would have been the same for all three grounds of attack [153]. I have suggested previously that the concept of selection patents generates more heat than light, and should probably be abandoned. Kane J’s Travoprost decision seems to me to reinforce this view, but given that the selection patent issue did not make any difference, I will refrain from further comment on this aspect of the decision. It is in any event clear that the ‘417 application, which discloses the use of a large class of prostaglandin derivatives, encompassing travoprost, for the treatment of glaucoma and ocular hypertension, was highly relevant prior art.

Anticipation
Kane J held the ‘287 patent to be anticipated in light of the ‘417 application, despite the fact that the travoprost was nowhere specifically disclosed in the ‘417 patent, on the basis that the compounds disclosed by the ‘417 patent encompassed travoprost [371].  In my view, Kane J’s holding with respect to anticipation is clearly wrong. It is the same error as was evident in her Valganciclovir decision, 2013 FC 718, as discussed here. I expect that in due course Kane J will be corrected by the FCA on this point, though not soon, as both Valganciclovir and Travoprost are NOC applications so cannot be appealed by the patentee. Kane J did state that “[a] person carrying out the prior disclosure in the ‘417 would, on a balance of probabilities, infringe the claims at issue of the ‘287" [371]. However, I can see no support in her reasons for this proposition. The ‘417 patent encompassed billions of compounds [269], and, as just noted, travoprost was not specifically described or made. Nothing in Kane J's decision explains why a person carrying out the disclosure of the ‘417 patent would make travoprost rather than one of the other billions of compounds encompassed by the disclosure.

Utility
With respect to utility, Apotex argued that the patent promised both greater inter-ocular pressure reduction and reduced side effects as compared with the compounds of the ‘417 application [202], [205]. Alcon argued that the patent promised only that travoprost would be useful or therapeutically effective for the treatment in humans, without any promise that it would be better than the compounds of the ‘417 patent [188]. Kane J held in Alcon’s favour [241]. She emphasized in particular Zinn J’s statement in Fournier / fenofibrate (NOC) 2012 FC 741 [126] 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" [181-82], [244]. The claims in question were to the use of travoprost in the treatment of glaucoma and ocular hypertension, without any mention of reduced side effects [185], and this was construed as the promise. Given this modest promise, utility was held to be soundly predicted.

Obviousness
Perhaps the most interesting part of the decision relates to obviousness. The ‘287 patent asserted [70] that

It has now been unexpectedly found that [the claimed compounds] show significantly greater IOP reduction than the compounds of [the ‘417 application] while having a similar or lower side effect profile.

Kane J held that the patent was obvious whether or not it was in fact true that the properties of the claimed compounds were unexpected. This is because she found that the inventive concept was simply that travoprost will be therapeutically effective in the treatment of glaucoma and ocular hypertension [461, 167], and it is the inventive concept, and not the disclosed properties of the invention, which are the focus of the obviousness analysis [463]. (See similarly [468-69].) Because the ‘417 application disclosed that all the disclosed compounds were effective in the treatment of glaucoma and ocular hypertension, and the compounds of the ‘287 patent were encompassed by the ‘417 application, it follows straightforwardly that it was obvious that the compounds of the ‘287 patent would be effective in the treatment of glaucoma and ocular hypertension.

This conclusion is striking. On Kane J’s holding, even if the claimed compounds were in fact substantially more effective than the prior art, and had fewer side effects, and no skilled person could have predicted this, the claims would still be obvious. In my view, this conclusion is wrong because Kane J’s identification of the inventive concept is wrong. In assessing the inventive concept Kane J focused on the fact that the claims did not refer to the purported advantages such as increased efficacy and fewer side effects [167], but, as the SCC has pointed out “The inventive concept of the claims is not readily discernable from the claims themselves. A bare chemical formula in a patent claim may not be sufficient to determine its inventiveness” Sanofi 2008 SCC 61 [77]. As the Court’s example indicates, it is the properties of a new chemical compound that will determine whether it is obvious, but these properties will not be set out in the claims, because if the compound is new, the patentee is entitled to claim the compound itself. For that reason it is necessary to look to the disclosure to identify the inventive concept. (See also COMBIGAN 2012 FCA 308 , blogged here.) It is true that in this case, the claims are to the use of travoprost, not to the compound itself, but the principle is the same: "[p]atents are essentially about information as to what to make or do" Aerotel [2006] EWCA Civ 1371, Jacob LJ [32]), and as Lord Hoffmann said in Biogen [1996] UKHL 18, [14], "[w]henever anything inventive is done for the first time it is the result of the addition of a new idea to the existing stock of knowledge." The quid pro quo for a patent is not the thing claimed, but the information disclosed in the specification: Consolboard [1981] 1 SCR 504, 517. Consequently, it is the information in the patent that makes the invention obvious or not, and information is found in the disclosure. The claims merely define the scope of the patent exclusivity.

I cannot criticize Kane J too much for this, as the concept of the “inventive concept” has been cloudy from the outset: the SCC in Sanofi could not even decide whether it is necessary to identify the inventive concept in order to assess obviousness. As I have suggested before, I am increasingly inclined to think that the European problem-solution approach would provide a more structured way of identifying the inventive concept for the purposes of the obviousness analysis. The problem in this case was clearly to find a prostaglandin analogue with improved properties, and the question should be whether travoprost solved that problem, ie whether it in fact had improved properties.

With that said, Kane J’s decision suggests that travoprost might well have been held to be obvious even if the inventive concept had included its properties. In particular, the ‘417 application disclosed utility for treating glaucoma, the “Woodward” prior art suggested improved properties [418], [435], [472], and the combination might have made the improved properties of the ‘287 patent obvious. That is of course just speculation without an express finding to that effect; I only want to be clear that I am not saying that the ‘287 patent was necessarily non-obvious, but only that the analysis was not properly focused.

The Inventive Concept as the Focus of the Obviousness Analysis

Hoffman-La Roche Ltd v Apotex Inc / valganciclovir (NOC) 2013 FC 718, Kane J
            2,154,721 VALCYTE

Yesterday’s post discussed anticipation. This post discusses obviousness, which was the other main validity issue. Ultimately, obviousness turned largely on the facts, but the analysis raised an important question as to whether the focus of the obviousness inquiry should be the invention as claimed, the inventive concept of the specification, or the inventive concept of the individual claims.

Valganciclovir is the mono-L-valine ester of ganciclovir [32]. Ganciclovir is an antiviral nucleoside which effective in the treatment of certain herpes viruses [4]. Acyclovir is another antiviral nucleoside which effective in the treatment of certain herpes viruses. Both acyclovir and ganciclovir suffered from poor bioavailability when taken orally. In the prior art the L-valyl ester of acyclovir, valaciclovir, was the acyclovir prodrug with the best oral bioavailability. (As I understand it, an “L-valyl” ester and an “L-valine” ester are the same.) The question was whether the good bioavailability of the L-valyl ester of acyclovir made it obvious to develop the same ester of ganciclovir in order to improve bioavailability. Kane J held it did. This conclusion turned largely on the facts.

The Inventive Concept Must Be Construed with Reference to the Disclosure

Apotex Inc v Allergan Inc / COMBIGAN (NOC) 2012 FCA 308 Noël JA: Stratas, Webb JJA aff’g for different reasons 2012 FC 767 Hughes J

            2,440,764 – COMBIGAN – brimonidine / timolol

The decision of the FCA in Apotex / COMBIGAN provides an important clarification of the second step of the Windsurfing/ Pozzoli approach to obviousness by establishing that it is necessary to have reference to the entire specification in order to construe the inventive concept. Implicitly, the statement by Jacob LJ that if any difficulty arises in determining the inventive concept, it can simply be ignored in favour of a focus on the claim as construed, is not the law in Canada.

The second step of the Windsurfing/ Pozzoli approach to obviousness, as approved by the Supreme Court in Sanofi 2008 SCC 61, [67] is to “[i]dentify the inventive concept of the claim in question or if that cannot readily be done, construe it.” This raises two questions. How is the inventive concept to be determined? As Hughes J put it in the decision under appeal, “The question is whether the “inventive concept” is something different from the claim at issue, even when that claim has been construed by the Court. Is the Court to embark on two separate missions; one to construe the claim, the other to define the inventive concept?” [135] Secondly, why bother construing the inventive concept at all? Jacob LJ remarked in Pozzoli [2007] EWCA Civ 588 [19] that identification of the inventive concept “can develop into an unnecessary satellite debate” and in such cases “the sensible way to proceed is to forget it and simply to work on the features of the claim,” as “[i]n the end what matters is/are the difference(s) between what is claimed and the prior art.” In Actavis UK Ltd v Novartis AG [2010] EWCA Civ 82 [20] he remarked similarly that “[t]he "inventive concept" can be a distraction or helpful. It is a distraction almost as soon as there is an argument as to what it is. It is helpful when the parties are agreed as to what it is.”